Transforming womens health through innovation
ANNUAL REPORT
2021
3
Activity report
Letter to shareholders 6
2021 Highlights
8
2022 Outlook 12
Mithra, inspired by women 14
Our staff 15
ESG strategy 16
Research & Development 36
Estetrol platform
Estelle
®
40
Donesta
®
42
Beyond women’s health 46
Complex therapeutics
Myring
®
48
Tibelia
®
49
Zoreline
®
50
Mithra CDMO 52
Financial highlights 54
Mithra share 56
Shareholding structure 57
2022 Financial calendar 58
Governance 60
Contents
2
Corporate Governance and
Financial Statements
Board of directors’ report 69
Statement of responsibility 109
Statutory’s auditor report
110
Consolidated nancial statements
116
Notes to the consolidated nancial statements 122
1
Corporate governance
and nancial statements
Activity report
4 5
ACTIVITY REPORT
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
deciency 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
prole, 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 efcacy results for our
phase III Donesta
®
, reinforcing our condence 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 proles, 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 dened by the United Nations. Our
various achievements and aspirations are detailed in a new
section of this annual report.
Leon Van Rompay,
Chief Executive Ofcer
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 diversication 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.
9
2021 Highlights
8
May
Appointment of a new Board of
Directors for a two-year-mandate.
For the rst time, this board
achieves perfect parity with 5
women directors and 5 men
directors, as well as 5 independent
and 5 non-independent directors.
Approval of Estelle
®
in whole
Europe.
FDA marketing exclusivity for
Estelle
®
as a new chemical entity.
June
Launch of Estelle
®
under the
trademark Nextstellis
®
in the United
States. Estetrol is the rst new
estrogen introduced in the US in
over 50 years
Acquisition of full licensing and
distribution rights for the Zoreline
®
implant as well as a successful
renegotiation of the earnouts
for Zoreline
®
and Myring
®
- two
Complex Therapeutics in Mithra’s
portfolio.
July
Partnership with the Belgian biotech
ExeVir for the manufacturing of
innovative Covid-19 treatments
at Mithra CDMO’s new Injectable
Facility.
Mobilization of Mithra staff
members to support Walloon
victims of the devastating floods
through two main actions : a
nancial donation to the Belgian
Red Cross and the onsite gathering
of a volunteers’ crew to work side
by side to help those affected.
February
Appointment of Leon Van Rompay
as Chief Executive Ofcer.
Mr. VanRompay has more than
40 years of experience in the
international pharmaceutical
industry.
March
First marketing authorization for the
contraceptive pill Estelle
®
obtained in
Canada.
Launch of Myring
®
in Italy, the
fourth largest market in the world,
under the brand name Kirkos
®
by
Farmitalia
Positive opinion for Estelle
®
from the
Committee for Medicinal Products
for Human Use (CHMP) of EMA.
April
FDA approval for Estelle
®
for
commercialization in the US by
Mayne Pharma.
Presentation of Mithras new
production line dedicated to
injectable products to Walloon’s
Health Minister, Christie Morreale.
10 11
August
Commercial launch of Nextstellis
®
by Searchlight
Pharma on the Canadian market. E4 is the
rst new estrogen in a COC in the Canadian
market in more than half a century.
September
Approval delivered from the Russian Medicines Agency
(Roszdravnadzor) on the registration application of
Estelle
®
in Russia.
Completion of recruitment for Donesta
®
Phase III
clinical program in the United States and Canada.
Topline results of the Coronesta Phase II study in the
safety and efcacy assessment of estetrol for the
treatment of hospitalized patients with moderate
Covid-19.
November
Mithra’s R&D and manufacturing center welcomes
investors and analysts to give a strategic update of its
pipeline during its Investor Day.
Extension of the Donesta
®
Clinical Program with
three new studies carried out on estetrol’s effect on
symptoms signicantly impacting postmenopausal
women’s quality of life: vulvovaginal atrophy, skin
health and hair quality.
Diversication of the R&D pipeline through
rights’ acquisition option relating to a development
program led by the Belgian company BCI Pharma
on innovative kinase inhibitors notably indicated for
the treatment of female cancers and endometriosis.
Approval of Estelle
®
under the trademark
Nextstellis
®
in Australia.
Opening of the European Society of
Gynecology congress by Mithra and
Gedeon Richter Pharma.
December
Presentation of data about Estelle
®
s clinical trials at
the 30
th
World Congress on Controversies in Obstetrics,
Gynecology and Infertility.
October
Launch of Estelle
®
in Belgium under the brand
name Drovelis
®
by Gedeon Richter Pharma
and under the brand name Lydisilka
®
by Ceres Pharma.
2022 Outlook
Estelle
®
s commercial rollout
In 2021, the worldwide launch of rst estetrol-based product, the contraceptive
pill Estelle
®
took place in the United States, Canada and a dozen of European
countries. We are condent that our innovative pill will continue to further
increase its market penetration in these territories and expand to
additional regions, namely in Europe (Czech Republic, Portugal,
Switzerland, UK as well as Nordic countries) and Australia. New
marketing authorizations are also anticipated in 2022, as well
as additional regulatory submissions in Latin America.
12 13
Geopolitical situation in Eastern Region
Since the beginning of the conflict in Ukraine, we are monitoring closely the
geopolitical situation in order to anticipate potential impact on Mithra’s and
partners activities, in particular Estelle
®
launch in Russia foreseen in H2 2022, a
region which only represents 1% in terms of revenues for 2022.
On the R&D side, we are currently analyzing the situation regarding the potential
impact on the recruitment for the additional European Donesta
®
study (C301) that
should be completed by the end of H1 2022. About 10% of the recruitment sites
are located in Russia and we have activated a mitigation plan in order to replace
these sites with other sites in the United States and Europe and to avoid any delay
in the submission to the European Medicines Agency.
Final stretch for Donesta
®
Clinical Program
Early 2022, we received our rst top line clinical phase 3
results of Donesta
®
, which have conrmed the tremendous
potential as an innovative hormone therapy to treat many
symptoms of estrogen loss simultaneously or sequentially
throughout the entire menopausal period. These positive
efcacy results enable us to step up our contacts with
interested partners for the signature of a License & Supply
agreement. We look forward to advancing our clinical
development, including the initiation of three additional
studies (vulvovaginal atrophy, skin and hair quality) aimed
at reshaping Donesta
®
s prole as a hormone therapy
targeting a broad range of major menopausal symptoms.
The primary safety results are anticipated for end 2022 in
the United States/Canada and for end H1 2023 in Europe.
Launch of E4-clinical
program in neuroprotection
In addition to its two E4-based products for
contraception and menopause, Mithra is
developing E4’s potential in other therapeutic
areas, particularly in neuroprotection for the
treatment of hypoxic ischemic encephalopathy
(HIE), a life-threatening form of neonatal
asphyxia. This R&D program will enter clinical
trials in H1 2022 with a phase 1 study to collect
safety, tolerability and pharmacokinetic data
with Mithra’s E4-based formulation on adults.
Results are anticipated in H2 2022.
Further expansion of
contraceptive Myring
®
Following the successful launches of our vaginal
contraceptive ring Myring
®
in key regions such
as Italy and Canada in 2021, we plan to further
expand market coverage with additional launches
in the second half of the year. We are moving
closer to approval for Myring
®
in the United
States, the world’s largest market, hopefully later
in the calendar year 2022.
For over twenty years Mithra has dedicated its
researches so as to redene women’s health,
transform their daily lives in an innovative way
and unlock emerging opportunities in healthcare
with a focus on contraception and menopause.
Thanks to the commitment of nearly
350 collaborators, Mithra stands by its goals
to meet women’s needs at all stages in their
lives through the of new products offering better
ecacy, safety and convenience.
14 15
Our staff
Mithra,
inspired
by women
12
nationalities
Average age:
32 years
252
employees
87
engagements
44%
men
56%
women
> 350
collaborators
IPO in 2015
Founded in
1999
Specialists in
Womens
Health
Partnerships in
>100
countries
Break through
innovation with
the unique hormone
Estetrol (E4)
Mithra unveils
its sustainability strategy
ESG : Environnement, Social and Governance
In the past years, we implemented in our strategy of value creation several
initiatives in order to reduce the environmental footprint of our operations,
to improve the life balance of our employees and to strengthen our relations
with our stakeholders. As we faced numerous events resulting from climate
change, 2021 has again showed us that it is more crucial than ever to make
human activities more sustainable.
Considering this environment in which we are evolving, Environmental, Social and Governance (ESG) topics represent
opportunities and challenges our company has to deal with every single day as we aim to create value for our stakeholders
and shareholders in a sustainable way.
To ensure that sustainability is embedded in our corporate strategy and that our sustainability ambitions translate into
reality, we launched a strategic exercise in 2021 and set up a Sustainability Committee composed of our company
key representatives. With the role to develop a sustainability strategy based on the 17 Sustainable Development Goals
(SDGs) dened by the United Nations, the Committee met on a regular basis to dene the key material topics for Mithra
to work on in terms of sustainability. Within the company structure, this Committee reports directly to the Executive
Committee.
Board of
directors
Audit and Risk
Committee
Executive
Committee
Sustainability
Committee
Nomination &
Remuneration
Committee
16 17
> Decides on the Company’s
values, strategy, risk
preference and key policies
> Provides entrepreneurial
leadership to the Company
and enables risks to be
assessed and managed
> Ensures the necessary
leadership, nancial and
human resources are in
place for the Company to
meet its objectives
> Assists the Board in all matters
relating to:
The selection and
recommendation of qualied
candidates for membership
of the Board
The nomination of the CEO
and of the members of the
Executive Committee
The remuneration of the
independent Directors, of the
CEO and of the members of
the Executive Committee
> Assists the Board in
fullling its monitoring
responsibilities in respect
to control, including
responsibilities for
the nancial reporting
process, the system of
internal control and risk
management and the
external audit process
> Handles the day-to-day management
of the Company
> Proposes and implements the
corporate strategy, taking into
account the Company’s values,
strategy, key policies, plans and
budgets as set out by the Board
> Develops and proposes the corporate
sustainability strategy
> Oversees the implementation, in
collaboration with the operational
teams, of the corporate sustainability
strategy as set out by the Board
19
To build our sustainability strategy,
we rst carried out what is called
an SDG mapping and assessment
with the support of an experienced
external consultant. This exercise
enabled us to identify and assess
the links between Mithra’s
operations and products and the
17 United Nations Sustainable
Development Goals.
The objective of this analysis was
to build our sustainability strategy
on a referenced framework, in
order to allow our shareholders and
stakeholders to compare Mithra’s
impact to that of other companies,
based on international recognized
standards. Our aim was also to
ensure that our strategy focused
on the goals to which we can most
contribute.
Our contribution to the
Sustainable Development
Goals
20
15
10
5
0
-5
-10
-15
-20
ESG : Environnement, Social and Governance
Out of these nine SDGs, the most signicant SDGs Mithra relates to and can contribute to are:
Good health and well-being (SDG 3), Decent work and economic growth (SDG 8) and Responsible consumption and production (SDG 12).
We contribute to SDG 3, i.e. “Ensure
healthy lives and promote well-being
for all at all ages”, and among other
targets, to target 3.7, i.e. “By 2030,
ensure universal access to sexual
and reproductive health care services,
including for family planning,
information and education, and the
integration of reproductive health into
national strategies and programmes”.
We contribute to SDG 8, i.e. “Promote
sustained, inclusive and sustainable
economic growth, full and productive
employment and decent work for
all”, and for example to target 8.5, i.e.
“By 2030, achieve full and productive
employment and decent work for all
women and men, including for young
people and persons with disabilities,
and equal pay for work of equal value”.
We also contribute to SDG 12, i.e.
“Ensure sustainable consumption and
production patterns”, and for example
to target 12.2, i.e. “By 2030, achieve
the sustainable management and
efcient use of natural resources”.
Our contribution to these 9 SDGs
Our SDG assessment showed that we contribute positively to Good health and well-being (SDG 3), to Quality education (SDG 4),
to Gender equality (SDG 5) and to Industry, innovation and infrastructure (SDG 9).
We contribute positively to Good health and well-being (SDG 3) and to Gender equality (SDG 5) because, as a biotech company
specialized in women’s health, improving the health, quality of life and well-being of women is at the heart of our priorities. As we
strive to develop innovative solutions, we enhance scientic research and encourage innovation, thereby contributing to Industry,
innovation and infrastructure (SDG9). As for Quality education (SDG4), we contribute to achieving it as allowing our collaborators
to develop their knowledge and skills is of utmost importance for us.
Our assessment also revealed that our impact on Clean water and sanitation (SDG 6), on Affordable and clean energy (SDG 7),
on Decent work and economic growth (SDG 8) and on Responsible consumption and production (SDG 12) is less positive. This is
mainly due to the environmental footprint of our operations. As for our impact on Life below water (SDG 14), it is positive if we only
consider our products, and not our operations.
Genesis of our
sustainability strategy
The results of our SDG mapping
and assessment led us to develop
a sustainability strategy that
broadens our primary mission of
improving women’s life. We want
to improve people’s life, not only the
life of our patients but also the life
of our collaborators, while reducing
our environmental footprint. Our
goal is also to achieve clear and
transparent communication on our
sustainability objectives, initiatives
and key performance indicators.
1
Good
health and
well-being
2
Quality
education
3
Gender
equality
4
Clean water
and sanitation
5
Affordable and
clean energy
6
Decent work and
economic growth
7
Industry, innovation
and infrastructure
8
Responsible
consumption
and production
9
Life below
water
We can contribute to 9 SDGs
Our detailed SDG mapping showed that, out of the 17 SDGs,
there are 9 SDGs we have a link with.
18
Most signicant SDGs
20 21
Key material topics
ESG : Environnement, Social and Governance
1.
Patients
Innovate to develop safe
solutions that address
the unmet needs of
our patients in order to
improve their daily life
Responsible R&D
Product safety & quality
Access to healthcare
Reduce the
environmental
impact of our
solutions and
operations
Environmental
impact of
operations
Product ecotoxicity
Improve the health
and well-being of our
collaborators, ensuring
they have the chance
to develop their skills
and equal opportunities
irrelevant of gender
Talent management &
development
Attractiveness & turn-
over
Equal opportunities
irrelevant of gender
Health and well-being
at work
Create an environment
that ensures we
apply the highest
ethical standards, in
terms of governance,
communication and
sourcing
Governance &
business ethics
Responsible
communication
Responsible sourcing
Support impactful
and meaningful
projects that aim
to help women
gain well-being and
empowerment
Women
empowerment
& community
involvement
2.
Planet
3.
People
4.
Ethics and
integrity
5.
Women
empowerment
Our sustainability strategy is based on ve key material topics and thirteen subtopics.
These topics and subtopics were identied by conducting a materiality assessment, which is the process of
identifying and assessing the potential environmental, social and governance issues that could affect your business
to then dene the topics that matter most to your internal and external stakeholders. These topics then inform
company strategy, targets and reporting.
On the basis of our SDG mapping and assessment and guided by our external consultant, our Sustainability
Committee brainstormed to identify and assess the environmental, social and governance topics that were most
relevant for Mithra. Together we listed the potential topics and selected the most relevant ones, which each member
of the Committee then prioritized. This exercise led to a prioritization matrix and to a list of priority topics.
The members of our Executive Committee have been involved in our materiality assessment and it is our ambition
to collect the feedback from our external stakeholders at a later stage.
22 23
Patients
1.
ESG : Environnement, Social and Governance
As a company dedicated to women’s
health, our mission has always been
to offer women innovative solutions
that address their needs and offer
them better ecacy, safety and
quality of life.
Responsible Research & Development
At Mithra, we value innovation and expertise to pursue our
mission of a better health for women. Our ambition is to
develop innovative solutions that address their current and
future unmet needs and that offer an improved benet-risk
prole, for them as well as for the environment.
To this end, we invested 76.6 million euros into research and
development in 2021, submitted 21 abstracts and published
4 manuscripts in scientic journals. To ensure that our
Research & Development teams stay at the cutting edge
in science, we also attended no less than 9 international
scientic congresses.
Product safety and quality
The safety of our patients is of utmost importance to us.
Our goal is to ensure that our products are safe and efcient
for all patients, both during clinical trials and once they are
commercialized.
To prevent all risks associated with product safety and
quality, we already comply with all the guidelines issued by
the regulatory authorities. Besides these strict regulations,
we have decided to add three new ambitious targets:
1. Succeed all GxP
1
inspections and customer
audits (no critical observations)
2. Digitalize Mithra’s quality system by end 2022
3. Increase our suppliers and partners global
quality oversight to 30% by end 2022 and to
100% by end 2025
Safety and quality reporting
2021
(reference year)
Rate of successful audits
(no critical observations)
100%
Number of recalls issued 1 minor recall
SOP in place for suppliers and
partners monitoring
No
Compliance monitoring adverse
event reports – 15 days
100%
Compliance monitoring adverse
event reports – 90 days
100%
Compliance monitoring periodic
safety update reports
100%
Achievements and initiatives
To ensure that we keep offering efcient and safe drugs to
our patients, a series of initiatives were launched. A quality
plan for 2022 has been dened and is currently being
implemented. This plan includes the implementation of a
digital quality management system (eQMS) that will help
improve information trackability (e.g. by reducing document
loss and human errors), leading ultimately to the improved
quality of our products. This digitalization project will be fully
operational by the end of 2022. Our quality team will also be
reinforced and one of our collaborators will be fully dedicated
to the global quality oversight of our suppliers and partners
(i.e. drug products suppliers, nished products suppliers,
packaging suppliers and commercial partners) and will
be in charge, a.o. of suppliers and partners quality audits,
periodical quality reviews, potential deviation follow-ups,
changes management and quality KPI follow-ups.
We are also proud to say that all adverse events reports were
submitted on time. Compliance to these timelines is very
important as it provides assurance that marketing authorization
holders have adequate systems in place for the safety
monitoring of medicines on the market. All periodic safety
update reports (PSURs) were also submitted on time. These
reports are pharmacovigilance documents intended to provide
an evaluation of the benet-risk balance of a medicinal product
at dened time points during the post-authorization phase. Each
marketing authorization holder is responsible for submitting
PSURs for its own products and should submit PSURs to the
EMA according to dened timelines. An appropriate quality
system should be in place in order to avoid failure to comply
with these timelines.
Access to healthcare
Beyond the efcacy, safety and quality of products, biotech-
nological and pharmaceutical companies also have the social
responsibility to make their products available to the greatest
number of people. Even if access to healthcare is a core
responsibility of public authorities, this challenge is managed
in partnership with the biotech and pharma companies
who must pay attention to their pricing, distribution and
affordability policies.
At Mithra, we strive towards universal access to our
medicines in sexual and reproductive health.To achieve this
ambitious goal, we have set a series of targets:
1. Increase the geographical availability of our
products to 70 new countries by 2030, of which
30% of developing countries
2. Contribute to healthcare cost containment and
stay within the 15% price range of other similar
products of the same category, for reproductive
health products
Our access to medicines reporting

2021
(reference year)
Number of countries in which our
products are available
24
Number of developing countries in
which our products are available
3
Number of products available that
target WHO priority therapeutic
areas
2
Board level representation for
Access to Healthcare issues
No
CSR or other committee oversees
Access to Healthcare issues
Yes
Number of orphan drugs available
on the market
0
Number of orphan drugs in the
pipeline
1
Price difference as compared to
market for reproductive health
products
Maximum 15%

Our two main commercialized health solutions target
reproductive health, an area dened as a priority by the World
Health Organization (WHO). Our monthly contraceptive
vaginal ring, Myring
®
, is already available in 13 countries.
As for our innovative contraceptive pill Estelle
®
, which was
launched in 2021, it is already available in 11 countries.
Together with our partners, we are planning to launch
Estelle
®
in 19 additional countries in 2022.
1 Common term for all good practices used in the pharmaceutical sector
24 25
Planet
Heatwaves, droughts, oods,
earthquakes… The signs of
human-induced climate change
become more and more visible each
day. As our planet and nature face
disruption and as human well-being is
threatened, urgent actions are required
to reduce the risks associated with
climate change. As a company, we
must play our part and reduce the
environmental impacts that result
from our operations and products.
Environmental impact of operations
To reduce the environmental footprint of our operations and
protect the planet, we have set four ambitious targets:
1. Reduce our Greenhouse Gas Emissions by 55%
by 2030
2. Increase our share of renewable energy to 70%
by 2030
3. Reduce our water consumption by 20% by 2030
4. Reduce our waste production by 20% by 2030
Environmental reporting
2021
(reference year)
GHG emissions
(tons of CO
2
equivalents)
3.887
Energy consumption (MWh) 11.509
Share of energy from renewable
sources (%)
4
Water consumption (m
3
) 25.468
Waste production (tons) 79
Climate protection activities
To ensure we meet our ambitious targets of environmental
footprint reduction, we have launched a series of initiatives.
A few of them are listed below.
Our R&D and manufacturing platform, Mithra CDMO, was
already equipped with 1850 solar panels that covered 9%
of our electricity consumption. To increase our share of
energy from renewable sources, a brand-new eld of 2748
solar panels was installed. These panels will be operational
in May 2022 and will cover around 28% of our electricity
consumption, tripling our share of energy from renewable
sources.
2.
ESG : Environnement, Social and Governance
Mithra currently employs more than 300 collaborators, based
on two sites. Even though the implementation of structural
homeworking has already helped reduce the environmental
impact of our fleet, we are committed to further reducing it
but also to offer mobility solutions that answer to the new
ways of working and meet our collaborators’ needs. To this
end, our human resources team is currently developing a
mobility project which should be launched end 2022 (more
details on this project in the ‘People’ section of this report).
Product ecotoxicity
Either naturally or synthetically produced, estrogens are
commonly found in the aquatic environment. Every year, more
than 700 kg of the synthetic estrogen ethinylestradiol(EE2),
which is present in almost all combined contraceptive pills,
are discharged into wastewater. These endocrine disruptors
can influence the sexual differentiation of shes and disrupt
aquatic ecosystems.
Mithra is mindful of the environmental footprint of its
solutions. We are committed to monitor and reduce the
environmental impact of our solutions and will therefore
conduct an environmental risk assessment for all new
Mithra product candidates, so as to determine their PEC/
PNEC ratio
2
.
In the case of Estelle
®
, the studies conducted on a
representative sh species showed that estetrol, at
environmental predicted concentrations, presented none of
the adverse effects induced by the natural estrogens estrone
and estradiol and by the synthetic estrogen ethinylestradiol,
i.e. reduced egg production, decreased testicular growth,
delayed maturation, development of male and female
genital glands in males, and even feminization.
The results also indicated that estetrol did not
accumulate in living organisms and was likely
to disappear rapidly from both water and
sediment. The PEC/PNEC ratio of estetrol
is therefore below 1 and we are proud
to say that the positive environmental
prole of estetrol is highlighted in Estelle
®
s leaflet in Europe
and Canada: “Environmental risk assessment studies with
estetrol including the Japanese medaka sh extended one
generation reproduction test indicated that the predicted
environmental exposure to estetrol will not affect the aquatic
ecosystem”. As we wanted to characterize the environmental
prole of the E4/DRSP combination of our contraceptive pill
Estelle
®
and not only the environmental prole of estetrol
alone, a complementary ecotoxicity study is currently being
conducted at the University of Namur.
2 The PEC/PNEC ratio is the ratio between the Predicted Environmental Concentration and the Predicted No Effect Concentration. If the PEC/PNEC ratio
of a product is below 1, it means that the use of this product will have no effect on the environment.
26 27
People
Our collaborators work each day with
the ambition to bring patients ecient
and safe solutions that will improve
their quality of life.
As we embarked on our sustainability journey, human
resources management remained one of our top priorities.
Our ambition is to support our collaborators and ensure their
work-life balance. On top of this, it is critical that we offer
them both the chance to develop their talents and equal
opportunities no matter their gender.
To achieve this goal, we dened, during our materiality
assessment, four specic subtopics to work on:
1. Talent management and development
2. Attractiveness and turnover
3. Equal opportunities irrelevant of gender
4. Health and well-being at work
Talent management & continuous
development
To deliver on our ambition of bringing patients efcient
and safe solutions, we largely depend on the skills of our
collaborators to innovate. It is therefore key that our talents
have the opportunity to develop their knowledge and skills.
At Mithra, our goal is to ensure the continuous talent
development of all our collaborators. Our strategy regarding
talent management and development aims at increasing the
number of training hours per employee.
With our HR team, we are currently working on the development
of an internal mobility plan that will be fully implemented by the
end of 2022 and on the development of a talent development
plan for all employees that will be fully implemented by end
2023. Our talent development plan will for example include the
systematization of our mentorship program.
We have dened several Key Performance Indicators that we
will monitor as of this year, namely the total number of training
hours, the total amount of training expenditure, the percentage
of employees who had a performance appraisal, the number
of internal position changes and the number of internal
promotions. We have also dened three KPIs that are more
related to our R&D collaborators, i.e. the number of scientic
publications, presentations and abstracts, the number of
research projects involving the academic world and the
number of academic investigators involved in our clinical trials.
Attractiveness & turnover
To achieve our mission and ensure the excellence and
specicity of our expertise, we must be in a position to attract
the talents we need and to retain our employees.
As Mithra operates in a highly specialized sector and
therefore in a highly competitive industry in terms of talents,
it is vital that we offer a fullling and caring work environment
with a sense of purpose, a shared vision and common values.
We are determined to keep making Mithra a safe and caring
company that supports its collaborators and strive for their
well-being. Our target is to align our staff turnover on the
chemistry & life science sector staff turnover, by reducing it
to 20% by 2025 and to between 10% and 15% by 2030.
Our attractiveness and turnover performance
While we remain a biotech company, our staff is expanding.
It grew by 95% in the last three years and by 215% in the last
ve years. We hired 87 new collaborators in 2021 and 18 new
hires are planned in 2022.
3.
2021
(reference year)
Number of employees 252
Number of new hires 87
Staff turnover rate (%) 26,7
Staff voluntary turnover rate (%) 86
Staff involuntary turnover rate (%) 14
Average length of service (years) 2,7
To measure our attractiveness and turnover performance,
we also dened other KPIs besides the ones listed above,
e.g. the number of applications received. These KPIs are
monitored as of this year.
Our initiatives
To attract and retain talents, we upgraded our employee
benets program. Early 2021, our program included life
and hospitalization insurance as well as parental leave. A
series of new benets were recently added, such as dental
and ambulatory healthcare insurance for all employees as
well as a seniority leave.
Our HR team is now working on several initiatives that will
be launched in 2022 and 2023. These initiatives include a
benchmark project, a cafeteria plan and a mobility project.
The benchmark project was kicked off in July 2021. As our
organization grows quickly and as we evolve in a highly
competitive sector in terms of talents, we felt it was time to
deep dive into our remuneration and extra-legal packages,
both internally and externally. The main objective of this
project is to align our salaries on those of the market,
which will allow us to both attract the right candidates and
retain our employees.
Building further on the benchmark project, our human
resources team also plans to develop, at the end of 2022,
a cafeteria plan to optimize even more our salaries and
compensation packages. Our goal with this project is
to meet the various generational and personal needs
of our employees and to offer them more flexibility and
individuality when it comes to their wage. This project will
also help us attract, retain and motivate current and future
employees and will improve our employer branding.
Finally, our human resources and procurement teams
kicked off in the rst quarter of 2022 a mobility project
around the Belgian government’s mobility plan, with
the ambition to reshape our current company car fleet
with more sustainable and environmentally friendly
alternatives.
I was lucky enough to join Mithra ahead of the commercial launch of Myring
®
and to
experience the transition from an R&D project to a commercial product: it was really
an exciting challenge! At Mithra, I love the impact we can have and how much our input
is valued in decision-making. I feel very useful and I really appreciate being able to
contribute to shaping projects. In our company, there is always an opportunity for
development and evolution and it is rewarding.
Maud De Fays
Operational Excellence Manager
ESG : Environnement, Social and Governance
28 29
other Belgian companies Mensura conducted a survey for.
The survey also indicated that our employees are highly
motivated, and they are not planning to leave Mithra
anytime soon. A point of attention that our collaborators
raised through this survey is however their work-life
balance, a well-being indicator that is of paramount
importance and that we are currently trying to improve
(see below). This quantitative survey is now being followed
by qualitative interviews with specic groups. Once these
interviews are completed, an action plan will be dened
along with an implementation planning.
To improve the work-life balance of our collaborators and
their overall well-being, we also implemented a hybrid
working model. When Covid-19 forced us into lockdown
back in March 2020, we adapted and implemented
homeworking to ensure the continuity of our activities.
With the lifting of most health restrictions, we have
recently moved to a structural homeworking regime that
enables our employees whose function allows it to better
juggle between their work and life needs.
Born from a common desire of the communication and
human resources departments to develop a positive
approach to work, we also have a Happy Team that
is currently made of eight employees from different
departments with the following purpose: coordinating
internal activities and various initiatives in order to promote
cohesion and well-being at work. From the organization
of breakfasts to an outdoor staff day, the collection of
waste around the workplace to a series of fundraisers to
raise awareness of causes that are close to our hearts,
the Happy Team has the joy of Mithra collaborators as its
creed.
The initiatives that we launched and implemented so far are
evaluated by our Committee for Prevention and Protection
at Work. Created in January 2021 following Mithras
rst social elections in 2020 and with representatives
from the unions, the management and our Prevention
Advisor, this Committee is dedicated to contributing to our
collaborators’ safety, health and well-being.
Equal opportunities irrelevant of
gender
At Mithra, we work every day with the ambition to improve
women’s life. It is only normal that we guarantee gender
equality to our collaborators.
Our goal is to achieve gender parity at all levels of the
company and to offer equal salary for equal function.
To achieve this goal, we have dened two ambitious
targets:
1. Raise the number of women in management to
50% by 2030
2. Reduce the gender pay gap to 0% by 2030
Our performance in terms of gender equality
2021
(reference year)
Women in whole company (%) 56
Women in management
3
(%) 23,9
Women in Executive Committee
4
(%) 14
Gender pay gap (%) 5,92
In 2021, our Board of directors was renewed for a two-year
mandate, achieving for the very rst time a perfect gender
parity, with ve female directors and ve male directors.
We are now developing monitoring tools which will allow
us to develop an action plan ensuring that gender parity is
also achieved for all function levels within our company.
Safety, health and well-being at work
In 2021, the Covid-19 pandemic still very much ruled our
lives. As they too struggled through these challenging and
uncertain times, our collaborators showed great resilience
and kept giving the best of themselves.
To support our employees in their mission, we are
committed to offer them a safe and caring environment
that ensures their safety and both their physical and mental
well-being. At Mithra, the safety, health and well-being of
our collaborators are of paramount importance and are
considered as priority objectives.
As a responsible company, our ambition is to achieve
the highest level of safety and health, by limiting the risk
of occupational accidents and diseases, and to create a
pleasant working environment for our employees.
Our target is to reach for zero accident and to reduce
absenteeism.
To ensure we achieve our target, we already launched a
series of initiatives to strengthen the health and well-being
programme we already had in place. With our Prevention
Advisor, we were of course already committed to respect
the regional, national and European legislations related
to safety and health and to integrate them at all levels
of the company. As such, as part of their onboarding
program, all new employees were already required to take
a safety self-training. They also received a safety welcome
brochure that they could check at any time.
Besides this, in October 2021, we conducted, via an online
questionnaire and with the help of our partner Mensura
5
,
a survey on well-being at work. The objective was to get
feedback from our collaborators so as to determine how
Mithra scored in terms of well-being indicators, namely
with regards to motivation, stress, absenteeism and
work-life balance, to try and reduce the psychological risks
associated with work. The rst results of this quantitative
survey showed that Mithra is within the benchmark of the
3 ManagementisdenedasCEON-2
4 OurExecutiveManagementTeamiscomposedofourChiefExecutiveOfcer,ourChiefExecutiveOfcer/ChiefBusinessDevelopmentOfcerunderleaveofabsence,ourChairoftheScientic
AdvisoryBoard,ourChiefFinancialOfcer,ourChiefLegalOfcer,ourChiefScienticOfcer,ourChiefSupplyChainOfcer,ourChiefManufacturingOfcer,ourChiefBusinessDevelopmentOfcer,
ourChiefHumanResourcesOfcer,ourGroupInvestorRelationsManager,ourGroupCommunicationManager,ourGroupQualityManagerandourGroupITManager
5 BelgianexternalserviceforPreventionandProtectionatWork
3.
ESG : Environnement, Social and Governance
30 31
ESG : Environnement, Social and Governance
Responsible communication
As a stock listed company, our duty is to ensure a fair and
transparent communication towards all our shareholders
and stakeholders. To achieve this, we have set ve targets:
1. Improve our nancial disclosures
2. Improve our non-nancial disclosures
3. Increase access to Management for our
shareholders
4. Increase our number of roadshows
5. Increase our number of events with retail
shareholders
To measure our progress in terms of communication, we
have dened several KPIs:
2021
(reference year)
Number of roadshows attended 5
Number of institutional investors
conferences attended
8
Number of retail investors
conferences attended
2
Access to Executive Committee
members (CEO, CFO, CBO & CSO)
(number of days/year)
13
MSCI rating BBB
While Mithra does not fall under the scope of the Non-Financial
Reporting Directive (NFRD), we have decided to develop
and implement a corporate social responsibility strategy in
2021 so as to improve our non-nancial disclosures for all
our stakeholders and prepare our teams to the upcoming
requirements of the Corporate Sustainability Reporting Directive
(CSRD).
Responsible sourcing
In addition to the classic quality and price criteria, we are
committed to apply a due diligence with all partners and
suppliers to avoid violations of human rights and workers’
rights, negative environmental impacts and unfair practices.
Our ambition is to embed a responsible sourcing policy in our
daily purchase practices.
To achieve this objective, we have dened two ambitious
targets:
1. Ensure 50% of Mithra’s direct and indirect
purchases are ethically sourced by 2025
2. Ensure 75% of Mithra’s direct and indirect
purchases are ethically sourced by 2030
We have dened several KPIs and, as of 2022, we will report
on the percentage of direct purchases that are ethically
sourced, on the percentage of indirect purchases that are
ethically sourced and on the percentage of suppliers and
partners that were ethically screened.
Our supply chain team is currently working on developing
a questionnaire that will be integrated in our quality
questionnaire and that will be sent to our current and
future partners and suppliers so as to ensure they have
sustainability and compliance policies in place. We will rst
focus on our partners and suppliers involved in the E4 project
and we will tackle the partners and suppliers involved in our
other projects at a later stage.
Ethics and integrity
4.
Independency Gender parity
Board of directors 5/10 (50%)
5 Men : 50%
5 Woman : 50%
Executive committee -
8 Men : 89%
1 Women : 11%
Audit committee 2/3 (67%)
3 Men : 100%
0 Women : 0%
Nomination and
remuneration committee
2/3 (67%)
2 Men : 67%
1 Women : 33%
At Mithra, we strive to create an
environment that ensures we apply the
highest ethical standards, whether in
terms of governance, communication or
sourcing.
Governance & business ethics
We attach great value to good corporate governance and
to business ethics and we are aware that these topics are of
utmost importance for all our stakeholders. With our corporate
governance charter, our dealing code and our business code
of conduct as amended from time to time to reflect the most
recent legal updates, we are condent to be well equipped to
ensure the proper governance of our company.
Our objective at Mithra is to guarantee that we are compliant
with all governance and business regulations in place to
create an environment where everyone is committed to the
application of the highest ethical standards.
To achieve this objective, we have dened two targets:
1. Increase transparency on oversight of
management (ownership and control), on conicts
of interests, on equal treatment between major
and minor shareholders and on business ethics
compliance
2. Systematize training on compliance and
ethical standards as part of the overall training
programme
To achieve these targets, we already launched a series
of initiatives. Since 2021, for example, in addition to the
governance documents sent to our staff members when
they join our company and in addition to the training of
our Directors and Executive Committee members, our
compliance ofcer has systematised the compliance and
ethical standards training for everyone. As such, as part of
their onboarding process, new collaborators will receive
a compliance training that will include a test. We have
dened the percentage of collaborators who pass (score of
minimum 80%) the test on ethical standards as a KPI that we
will monitor as of 2022.
Our governance and business ethics performance
2021 (reference year)
Corporate Governance Charter
In place and available
on our website
Dealing Code
In place and available
on our website
GDPR policy
In place and available
on our website
+ GDPR Committee in
place
Business Code of Conduct
(Briberyandanti-corruptionpolicy)
In place and available
on our website
Independent Chairman of the
Board of Directors
Yes
Split of the roles of CEO and
Chairman of the Board
Yes
32 33
Women empowerment
In 2020 women represented 49 % of
the world population. Yet, women
are also too often victims of abuses,
violence or discrimination. So much so
that gender equality has been dened
as one of 17 Sustainable Development
Goals by the United Nations.
At Mithra, women are at the heart of everything we do. We
work each day with the ambition to develop solutions that
meet their needs for efcient and safe solutions. Beyond our
day to day activities, we want to extend our commitment to
women and support impactful and meaningful projects that
empower them.
Our objective is to improve access to information about
women’s health and to develop a sponsorship strategy that
is coherent with our core business.
Launched in 2016 by Mithra with the goal to provide reliable
information about women’s health, Gyn&Co is a reference
website focusing exclusively on female health. With articles,
videos and advice from gynecologists and women’s health
specialists, the website attracts nearly 4 million regular
readers each year. Thanks to its 360° approach to the
questions that women may ask themselves whatever their
age or the hormonal stage they are going through, Gyn&Co
is a real wealth of information that is keen to expose female
taboos.
At the occasion of the International Women’s Rights Day
2022, we decided to give more visibility on Gyn&Co to
projects launched by women for women, such as the Belgian
non-prot organization “Toi mon endo”. This association
works daily to raise awareness among women and their
entourage about endometriosis, a disease that affects nearly
one in ten menstruating women.
Because women’s health is at heart of our mission and
because 1 in 8 women in Belgium is affected by breast
cancer, it also seemed more than obvious for us to participate
in the Think Pink campaign in October 2021. After one month
of activities to raise as much money as possible to support
the association, we were proud to say we raised a signicant
amount to help ght breast cancer.
5.
ESG : Environnement, Social and Governance
For several years now, Mithra has been supporting
the Belgian basketball club “Les Castors de
Braine” whose female team plays in the rst
Belgian national division and has held the Belgian
championship title since 2014. As unequal pay
is still a fact in all professional elds, including in
sports, where top female athletes are generally
paid less than their male counterparts, it is our
ambition to help change the situation with this
partnership.
In 2022, we are also supporting the Belgian
Ladies Open golf tournament, which will take
place from May 27 to 29 at Naxhelet golf course.
More than just another international female golf
tournament, this round of the Ladies European
Tour wants to show that golf is accessible to all
(with free admission and free golf initiations) and
especially to women. It ts perfectly into the Golf
Power campaign, launched in 2021 by the Belgian
French-speaking Golf Association, which was
then the rst Belgian sports federation to commit
to more women in sports.
34 35
Research &
Development
37
Complex therapeutics
Mithra has a unique expertise in the development of complex and innovative products in the elds of
contraception, menopause and hormone-dependent cancers. It is one of the few companies in the world that
masters polymer technology, used for vaginal rings, implants or intra-uterine devices. This technology ensures
a controlled release of the drug over a period of time with a minimum of side effects
Today, Mithra counts two complementary platforms: its portfolio of
innovative products based on Estetrol (E4) and its portfolio of complex
therapeutics. The whole supported by the Mithra CDMO, a technological
platform offering a wide range of services going from pharmaceutical
development to commercial manufacturing.
Research & Development
Myring
®
> Contraception
Contraceptive vaginal ring
made of ethylene-vinyl
acetate (EVA) copolymers,
releasing a combination of
hormones.
Tibelia
®
> Menopause
Tablet composed of tibolone,
a synthetic steroid used
for hormone therapy in
menopause.
Zoreline
®
> Hormone-dependent cancers
Biodegradable subcutaneous
implant indicated for prostate and
breast cancer and gynecological
indications (endometriosis, uterine
broids, etc.).
36
Estetrol in
women’s health and
beyond
Estetrol (E4) is a native estrogen
produced by the human fetus,
passing in maternal blood at
relatively high levels during
pregnancy. Thanks to its unique
mode of action, tolerance and
safety prole, E4, synthesized
from plant sources, could
represent a major breakthrough
in several therapeutic areas of
women’s health and beyond, such
as neuroprotection in newborns
and wound healing.
Product Indication Phase 1 Phase 2 Phase 3 Market approval
ESTETROL
Estelle
®
Contraception
Donesta
®
Menopause
US : H1 2024
EU : H2 2024
Neuroprotection
Launch Phase 1 H1 2022
Wound healing
Pre-clinical development
Formulation / Clinical Filing Market approval
COMPLEX
THERAPEUTICS
Myring
®
Contraception
EU / RoW:
Commercialized
US: H2 2022
Tibelia
®
Menopause
Commercialized
Zoreline
®
Oncology
2025
Estelle
®
> Contraception
Combined Oral Contraceptive
launched in 2021.
Neuroprotection
Treatment of hypoxic ischemic encephalopathy
(HIE), a life-threatening form of neonatal asphyxia.
Wound healing
Treatment enabling faster and more
effective healing.
Donesta
®
> Menopause
Next generation of hormone therapy
addressing menopausal symptoms.
38
Recognized as a new active substance in both Europe and the
United States, Mithra’s core asset, estetrol (E4), has successfully
achieved its rst major milestone by obtaining the green light from
the EMA and FDA Authorities for its rst E4-based product, the
contraceptive Estelle
®
. Following positive top-line
results from Donesta
®
phase III studies in
menopausal women, Mithra is more than ever
condent of its agship asset potential
in women’s health and beyond.
R&D: Estetrol platform
The many potential applications of estetrol
(E4) have been at the core of Mithras research
for many years. Produced by the human
fetus during pregnancy, this estrogen
passes in the maternal blood at high
levels. Estetrol shows a favorable
safety prole and a specic mode of
action compared to other estrogens.
Thanks to its improved benet/risk
prole, estetrol could represent a major
breakthrough in various therapeutic
areas like contraception and
menopause, but could also address
unmet needs in other elds such
as neonatal encephalopathy.
39
Brain
Breast
Liver
Cardiovascular
system
Uterus
& vagina
Bone
Cardiovascular
system
Environmentally-friendly prole
Either naturally produced by the human body or synthetically, estrogens
are commonly found in the aquatic environment. Every year, more than
700kg of the synthetic estrogen EE2, which is present in almost all
combined contraceptive pills, are discharged into wastewater. These
endocrine disruptors can influence the sexual differentiation of sh and
disrupt aquatic ecosystems.
In 2020, the results of an environmental assessment study indicated the
interesting ecological prole of estetrol. In these trials conducted on a
representative sh species, estetrol showed none of the adverse effects
induced by natural (E1, E2) and synthetic (EE2) estrogens, even at very
low concentrations: reduced egg production, decreased testicular growth,
delayed maturation, development of male and female genital glands in
males, and even feminization. The results also indicate that estetrol does
not accumulate in living organisms and is likely to disappear rapidly from
both water and sediment. Further studies are underway at the Belgian
University of Namur, with top-line results expected in the rst half of 2022.
A new active substance
By the end of 2020, the European Medicines Agency qualied estetrol as
a New Active Substance. This is the rst time in more than 80 years that
a new active substance, in this case a new estrogen, has appeared in the
eld of contraceptive solutions. A few months later, the US Food and Drug
Administration followed Its European counterpart and granted marketing
exclusivity as a new chemical entity.
Mithra continues to
booster its IP portfolio
including with filing new
patent applications but also
by registering trademarks,
designs and protecting its
know-how.
* In presence of Estradiol (E2); ** Sex Hormone Binding Globulin
Visser et al. Climacteric 2008 | Mawet et al. Eur J Contracept Reprod Health Care 2015 | Gérardet al. J Endocrinol
2015 | Abot et al. EMBO Mol Med 2014 | Coelingh Bennink et al. Climacteric 2008 | Heegaard et al. Climacteric
2008 | Holinka et al. Biol Reprod. 1980 | Holinka et al. Climacteric 2008 | Pluchino et al. J Steroid Biochem Mol
Biol 2014 | Tskitishvili et al. Exp Neurol 2014 | Guivarc’h et al. J Am Heart Assoc 2018 | Kluft et al. Contraception
2017 | Douxls et al. Contraception 2020 | Klipping et al. Contraception 2021
Favorable safety prole
> Similar to other estrogens, E4 has
also a benecial and positive impact
on the cardiovascular system, brain,
bone and endometrium
> Unlike other estrogens, E4 has a limited
impact on the liver and breast
Breast: mixed activity on breast
cell proliferation, migration and
invasion*, limited impact on breast at
therapeutic dose
Liver:
minimal impact on SHBG** synthesis
minimal impact on synthesis of
coagulation factors (lower risk of VTE)
limited lipid impact (including
triglycerides)
Estetrol (E4)
A new chemical entity with multiple potential
History of estetrol
Egon Diczfalusy discovers the hormone estetrol (E4) in 1965 at the Karolinska
Institute in Stockholm, Sweden. In 2001, working at Pantarhei Biosciences,
the Dutch researcher Herjan Coelingh Bennink decides to further explore this
native hormone present in high-concentrations by pregnant women only.
Pantarhei launch pre-clinical and phase I and IIa studies in women’s health
and oncology. In 2009, Mithra and Pantarhei launched a joint venture to
accelerate the development of a combined oral contraceptive containing
E4 and a progestin. In 2013, Mithra takes over Pantarhei’s shares and,
two years later, acquires the worldwide rights of E4 in various uses as
of contraception and menopause while Pantarhei keeps the rights
for pursuing their work in oncology and veterinary use. Since 2015,
Mithra conducted various studies on contraception, menopause
and other applications beyond women’s health.
4140
In 2021, our commercial partners have been working hard on increasing Estelle
®
’s
awareness among Healthcare Professionals and achieved encouraging gures despite
the headwind caused by the Covid-19. From a nancial perspective, the approval of
Estelle, directly followed by its commercial launch in the United States, Canada and a
dozen of European countries (Austria, Germany, France, Luxemburg, Hungary, Italy,
Slovakia, Poland, Czech Republic and Belgium), has enabled Mithra to more than double
our revenues in 2021 compared to last year, with EUR 13.4 million. In 2022, Estelle
®
should be launched in additional European countries like Czech Republic, Portugal,
Switzerland, UK, Nordic countries and Australia.
2021 represents an historical turning point
for Mithra with the worldwide commercial
launch of its rst estetrol-based product
Estelle
®
, leading to a cash collection of two
major out-licensing milestones for an amount
of EUR 24 million and product sales of
EUR 13.4 million. In 2022, Estelle
®
is expected
to increase its market penetration, with
additional launches in a range of additional
regions, including Europe and Australia.
Estelle
®
Worldwide commercial launch
R&D: Estetrol platform
When speaking with patients about their contraceptive
options, one of the most common concerns is side effects.
Nextstellis
®
is a new innovative contraceptive that
has been shown in clinical trials to be not only safe
and effective but also well tolerated with a desirable
bleeding profile and a minimal impact on triglycerides,
cholesterol and glucose, as well as weight, and
endocrine markers.
Mitchell Creinin,
Professor and Director of Family Planning
at the University of California
First authorization
from the Canadian
Authorities
FDA approval
8
March
15
April
European
approval
20
May
FDA marketing
exclusivity
27
May
US commercial
launch under
the trademark
Nextstellis
®
21
June
Launch of Drovelis
®
phased European
commercialization
Canadian
launch under
the trademark
Nextstellis
®
1
July
19
AUGUST
Approval
in Russia
16
September
Approval
in Australia
29
November
Positive opinion of
the CHMP of the
European Medicines
Agency
26
March
The rst six months of 2021 have been historical for Mithra, with the achievement of a huge milestone by obtaining marketing
authorizations for its rst E4-based product Estelle
®
. The market authorizations received today address more than 80% of the
world contraceptive global market which is estimated around EUR 7.5 Bn.
In addition to the US, Canada, Europe, Russia, Australia has received its market authorization end of 2021 and our partner Mayne
Pharma is anticipating commercial launch in the second half of 2022. Additional Market Authorizations are expected in 2022, in
particular in Brazil, the largest South American market with a value close to EUR 450 million.
Still around
EUR 290 million cash
to be collected for Estelle
®
out-licensing and sales
related milestones.
2021
International
Women’s
Rights Day
4342
Convinced of the potential of E4 on other major estrogen deciency symptoms
affecting a majority of postmenopausal women, Mithra decided to extend its
Donesta
®
Clinical Program, while repositioning its second E4-based product
candidate as a global alternative for millions of menopausal women.
Early 2022, positive top-line results from Phase 3 Studies demonstrated a
meaningful reduction in vasomotor symptoms from baseline and compared
to placebo, conrming the promising potential of Donesta
®
.
Donesta
®
An innovative hormone therapy targeting
several major menopausal symptoms
Launched in late 2019, the Donesta
®
Phase III clinical program called
“E4Comfort” aims to recruit approximately 2,300 postmenopausal women
(40-65 years) and includes 2 pivotal studies: one in North America (United
States/Canada – C302); and a second spread over Europe, Latam, Russia
and North America (C301). Both studies are worldwide randomized,
multicenter, double-blind, placebo-controlled trials.
The studies’ primary objective is to measure the effect of treatment on
frequency and severity of moderate to severe VMS (i.e. hot flushes), with
different doses of estetrol (15 mg and 20 mg), in menopausal women at
4and 12 weeks of treatment. Many parameters such as the impact on breast
density, endometrial safety, health-related quality of life and lipids, glucose
metabolism and hemostasis parameters are also among the secondary
objectives of these studies.
R&D: Estetrol platform
Our first top line clinical phase III results of our
Donesta
®
have confirmed the tremendous potential as
an innovative hormone therapy to treat many symptoms
of estrogen loss simultaneously or sequentially
throughout the entire menopausal period. We look
forward to advancing our clinical development,
including the initiation of three additional studies aimed
at broadening the scope and the value of Donesta
®
in line
with our new business development strategy.
Leon Van Rompay, CEO
Positive top-line results
In January 2022, Mithra announced positive top-line results
from “E4 Comfort” studies. Both studies demonstrated a
meaningful reduction in VMS frequency and severity from
baseline and compared to placebo. At week 12, the results
showed a reduction up to 80% in the frequency of hot flushes
when compared to baseline. Regarding the severity, this
reduction was up to 56% compared to baseline. All co-primary
efcacy endpoints were statistically (all p<0.01) met in both
studies, except for a borderline non-signicant result for the
severity criteria at week 4 in the C302 study, which reached
and exceeded statistical signicance by week 5 (p<0.01).
Both studies also showed that the number and severity of
hot flushes continued to decrease week after week until
the end of the study, i. e. 3 months of treatment. Secondary
endpoints evaluated at 3 months in the C301 study suggest
a very positive impact of Donesta
®
on the quality of life (hot
flushes, mood swings, anxiety, sleep, joint pain, skin & hair
quality, libido,…) as measured by validated patient-reported
outcome questionnaire. For C302 study, results for secondary
endpoints at 3 and 12 months are expected end 2022.
About
25 million women
pass through
menopause each
year
Women spend
+/- 40% of
their life time
in menopause
44 45
Additional studies
Convinced of the potential of E4 on other major estrogen
deciency symptoms affecting a majority of postmenopausal
women, Mithra decided to broaden the scope of its Clinical
Program by launching three additional studies:
1. A Phase 3 study on the effect of E4 on vulvovaginal
atrophy (vaginal dryness, pain during intercourse,
urinary tract infections)
2. A Phase 2 study on the effect of E4 on skin texture,
quality and appearance;
3. A Phase 2 study on the effect of E4 on hair texture,
quality and appearance.
These three additional studies funded by Mithra for an amount
of approximately EUR 20 million will be launched in 2022,
depending on regulatory agencies’ feedback.
Following the publication of the WHI study in
2001, more than 65% of women decided to stop
their hormonal treatment for fear of developing
breast cancer or a cardiovascular disease.
While this correlation was categorically denied
by the scientific community as early as 2006,
only 1 in 10 postmenopausal women in the world
today choose to take hormonal treatment to
relieve the many side effects impacting both
their private and professional lives. We are
convinced that thanks to its safety profile,
Donesta
®
can offer a real complete alternative
to significantly improve these women’s quality
of life and therefore be a gamechanger.
Graham Dixon, CSO
Large unmet medical need
As presented during Mithras Investor Day held in
November 2021, a quantitative market research
program surveying over 1000 prescribers and
women conrmed a large unmet medical need
in the menopause market. One in two women
currently do not seek medical treatment because
of their safety concerns of current hormonal
treatment. The research conrmed that women
suffer from bothersome symptoms beyond
hot flushes and highlighted the signicant
opportunity for a novel, safe hormone therapy
to treat menopausal symptoms beyond VMS.
The global menopause market is currently worth
nearly USD 10 billion and is expected to reach
around USD 17 billion by 2027.
2022 milestones
The Donesta
®
Phase III Clinical Program is still ongoing with patients completing a treatment duration for 52 weeks. The
recruitment of 300 additional non-hysterectomised women for the European Donesta
®
study (C301) should be completed
by the end of H1 2022. Following the geopolitical situation in Eastern Europe, Mithra has activated a mitigation plan in order
to switch the planned Russian recruitment sites with other sites.
The primary safety data are anticipated at the end 2022 for the American study and for end H1 2023 for the European study.
Depending on the evolution of the Covid-19 situation, the potential impact of the geopolitical situation in Eastern Europe on
recruitment, the study results and regulatory authorizations, Mithra believes it could achieve marketing authorization for
Donesta
®
in H1 2024 for the United States and in H2 2024 for Europe.
Only 1 in 10
menopausal
women take
hormone therapy
Blockbuster
market with
around 47 million
new entrants each
year globally
By 2030, the
world population
of menopausal and
postmenopausal
women is projected to
increase by over
1.2 billion
46 47
R&D: Estetrol platform
In addition to its two E4-based product for contraception
and menopause, Mithra is developing E4’s potential in other
therapeutic areas, particularly in neuroprotection for the
treatment of hypoxic ischemic encephalopathy (HIE),
a life-threatening form of neonatal asphyxia.
Two clinical programs
beyond womens health
Estetrol has orphan drug status in Europe and US for
the treatment of hypoxic ischemic encephalopathy
(HIE). This severe form of neonatal asphyxia affects
approximately 30,000 newborns each year in Europe
and the United States. It is caused by a reduced blood
or oxygen supply to the baby’s brain before, during or
just after birth.
Nearly one in four affected infants will die before leaving
the neonatal intensive care unit. Among surviving infants,
there are severe neurological problems and long-term
disability are observed. Currently, infants are treated with
therapeutic hypothermia or ‘cooling’ to reduce brain damage, but
this treatment has limited efcacy and comes at high cost. Given
its signicant mortality and morbidity in newborns and the lack
of available therapeutic alternatives, the development of a new
Estetrol-based treatment could address a real unmet medical need.
In 2021, we have developed an intravenous formulation for this
neuroprotection indication. The results of a conrmatory large
animal study done in pigs will be available in the rst semester 2022.
We are also in the nal stages of preparation for a PK study using
Mithra’s E4-based formulation in adults healthy volunteers. This
Phase I study is expected to be initiated in H1 2022, with results
anticipated in H2 2022.
Estetrol for wound healing
In 2021, Mithra has also developed a topical formulation for the wound
healing indication. An interesting indication, as there are no EMA-approved
pharmaceutical products for treatment of wounds. We aim to start our
program by focusing on acute wounds or surgical wounds. We anticipate
being in the clinic with this project in 2023, with a proof-of-concept study in
these acute wounds.
Diversification of asset-based
pipeline in a fast-growing market
Considering its advanced asset-based pipeline, which has seen two major
commercial launches over the past two years (Estelle
®
and Myring
®
), Mithra
is strengthening its leadership position in women’s health by acquiring a new
innovative development axis in a fast-growing market: inhibitors of tyrosine
kinases, notably indicated in the treatment of cancer and endometriosis.
In November 2021, Mithra acquired the rights relating to two development programs led by the Belgian company BCI Pharma
on innovative inhibitors of CSF1R kinase.
These CSF1R inhibitors are part of a new innovative class of immune-modulatory drugs with established clinical tolerability
and proven efcacy. They act on the CSF1 receptor which is involved in many inflammatory processes and is over expressed
in many pathologies, in particular cancers, neurological disorders and autoimmune diseases.
Under the terms of the contract, Mithra has an option to acquire patents covering CSF1R inhibitor series with upfront
payment of EUR 2.25 million on execution of option, following the rst results conducted by BCI Pharma.
Mithra will fund the preclinical and clinical development with a focus on female cancers and endometriosis, while potentially
targeting other orphan indications, such as metastatic breast cancer (TNBC). Currently in the preclinical stage, BCI Pharma
should initiate clinical development in 2023, with marketing authorizations expected for 2031.
The innovative class of
tyrosine kinases inhibitors
represents the third fastest
growing therapeutic class in
2020, with a 17% increase in
revenues to USD 40.3 billion.
R&D: Kinase inhibitors
Given its
significant
mortality and
morbidity in newborns
and the lack of available
therapeutic alternatives,
the development of a new
Estetrol-based treatment
could address a real unmet
medical need.
49
Successfully launched in 2019, the
Myring
®
contraceptive vaginal ring
continues its commercial expansion
in several key regions. Additional
launches are expected in 2022, in
particular in the United States, the
largest global market.
In 2021, we succeeded to launch our vaginal
contraceptive ring in additional European countries,
like Poland, France and in particular in Italy, the fourth
largest worldwide contraceptive rings market with
2 million vaginal rings sold per year. In addition to Chile and
Switzerland, Myring
®
is also available in Canada as the rst
generic product.
The approval of the American regulatory authorities is
awaited for the second half of 2022, for commercialization in
the United States by Mayne Pharma. Additional commercial
launches are also planned in Venezuela, Israël, United Arab
Emirates, Saudi Arabia, Paraguay, Argentina and Dominican
Republic.
Buyout of all earnouts
In 2021, Mithra strengthened its development strategy with
the complete buyout of all remaining contingent payments
obligation (earnouts) linked to Myring
®
and Zoreline
®
. In
line with the strategy of renegotiating the Estelle
®
earnouts
in 2019, Mithra succeeded to further reduce the fair value
of its contingent payments obligation reported under “Other
nancial liabilities” on its balance sheet. Under the terms of
this agreement signed with SVR Invest BV, Mithra bought
back all contingent payments linked to
these two products for an amount
of EUR 8.5 million compared
to the EUR 8.8 million
booked as at fair value on
December2020.
R&D: Complex therapeutics
54 mm
Ø 4 mm
Future marketing
Marketed
48
Tibelia
®
is a complex oral
formulation composed of tibolone, a
synthetic steroid for use in hormone
therapy. Developed by Mithra as
a bioequivalent version of Livial
®
,
Tibelia
®
relieves menopausal
symptoms and prevents
osteoporosis in postmenopausal
women at high risk of future
fractures and intolerant to other
drugs.
In 2021, Mithra has further expanded its global coverage
with commercial launches in Chile, Switzerland,
Netherlands and United Arab Emirates. In a global market
estimated at EUR 97 million, Tibelia
®
is now marketed
in about 40 countries and will be available this year in
6 additional territories: South Africa, Moldavia, Bulgaria,
Italy, Taiwan and Kingdom of Saudi Arabia.
Myring
®
is a exible
contraceptive
vaginal ring, made of
ethylene vinyl acetate
copolymers, and is
bioequivalent to
NuvaRing
®
.
New commercial
agreements in 2021:
> Venezuela (Dampe)
> Malaysia
(Eurodrug)
Myring
®
The hormonal contraceptive
vaginal ring
Tibelia
®
Menopause & osteoporosis
50
R&D: Complex therapeutics
Implant
13-18 mm
Gosereline
After the Tibelia
®
tablet and the Myring
®
vaginal ring, already commercialized, the
Zoreline
®
implant is Mithra’s next priority
project based on the polymer technology.
This biodegradable subcutaneous implant
based on goserelin is used to treat prostate
cancer, breast cancer and gynaecological
indications such as endometriosis and
uterine broids.
Mithra obtained all wide spend to Zoreline
®
during the course of last
year. We have been spending the time developing a PK/PD model which
uses the animal data and the clinical data we have already generated in
order to optimize the nal formulations, which will be a one-month and
the three-month injectable depot. We expect the PK/PD study, which
will be the denitive study to gain approval to start in half one next year.
51
Global licensing rights
In June 2021, Mithra successfully acquired full licensing
and distribution rights for Zoreline
®
held by SVR invest
for an amount of EUR 8.5 million. Mithra holds 100% of
worldwide licensing territorial rights (vs 50% previously),
including important territories such as China, Canada
and Australia, that should represent more than 70% of
market opportunity by 2025. This acquisition allows
Mithra to signicantly increase its margin in some of the
most attractive geographies outside of Mithras former
territorial scope. As conrmed by a group of independent
experts, this agreement holds signicantly more value
for Mithra than remaining in the as-is scenario, balanced
by the earn-outs extinction and the positive return on
investment expected for Zoreline
®
on a global scale.
Signicant business opportunity
Zoreline
®
represents a signicant business opportunity in
a market dominated by the branded Zoladex
®
, with annual
worldwide revenues of nearly EUR 733 million (4.22 million
in volume). Zoladex
®
has been off patent for around
20 years and no generic version has been approved to
date, except in a few Eastern European countries, which
demonstrates the complexity of the development of such
a drug.
The development of long-acting hormonal products has been at the
heart of Mithra’s expertise since the beginning. We were the first and
the only one to succeed in developing a generic of the IUD Mirena
®
,
before developing successfully the Tibelia
®
tablet and the Myring
®
contraceptive ring. In the past two years, we have made significant
progress in the development of both formulations of Zoreline
®
and we
strongly believe in the capacity of our teams to bring Zoreline
®
to the
worldwide market as first generic.
Graham Dixon, CSO
We are very pleased with this
renegotiation which enables
Mithra to extinguish all
contingent payments and to own
the full commercial rights of
Zoreline
®
for key countries that
should represent the majority of
the global market opportunity by
2025, in particular China which
is worth more than 33% of the
market opportunity.
Jean-Manuel Fontaine,
CBO
Two formulations
> One-month implant
containing 3.6 mg of
goserelin, mainly for
combined therapies in
breast cancer
> Three-month implant
containing 10.8 mg of
goserelin, to be used
primarily in the eld of
prostate cancer
Zoreline
®
Hormone-dependent cancer
52 53
Mithra CDMO has continued
its expansion in 2021 with the
accreditation of a new manufacturing
facility fully dedicated to ll & nish
production of complex liquid injectables
and biologicals in vials, pre-lled
syringes or cartridges. Thanks to this
high value-added expertise, Mithra’s
R&D and manufacturing platform
strengthens its position in the European
CDMO ecosystem.
Mithra CDMO
Bridging expertise for successful pharmaceutical
development
Mithra CDMO offers a complete spectrum of solutions from
early drug development, clinical batches and commercial
manufacturing, with an unique expertise on complex
polymeric products (vaginal ring, implants,..). Since July
2021, Mithra CDMO is also operating a new manufacturing
facility fully dedicated to ll & nish production of complex
liquid injectables and biologicals in vials, pre-lled syringes
or cartridges.
An integrated R&D and
manufacturing platform
specialized in sterile
injectables and polymeric
forms
> 15,000 m² facilities in Liège
(Belgium)
> Expertise in polymeric forms
and sterile injectables
> Dedicated R&D and production
areas
> Full drug development services
> Pilot, clinical & commercial
batches
> GMP standards compliance
(EMA / FDA)
Sterile injectables
> State of the art and exible injectables facility providing end-to-end Fill and Finish services
> Complex liquid products (higher viscosity, oxygen sensitive, oily solutions, potent products…)
> Large molecule biological products (MAbs, proteins, …)
> Fill & Finish in different formats (vials, pre-lled syringes, cartridges)
> Small to medium batches (pre-clinical, clinical and commercial stage)
> Up to 8 million units/year
> Aseptic processing, sterile ltration, nal sterilization
We are very pleased to collaborate with Mithra CDMO which has
built a cutting-edge new fill and finish manufacturing facility.
Being able to collaborate with great partners in Europe such
as Mithra are not only key to our success, but also helps the
growth of the biotech ecosystem in Belgium and across Europe.
Torsten Mummenbrauer,
CEO of ExeVir Bio
Collaboration with ExeVir Bio
Following the accreditation of the injectable facility, Mithra
CDMO concluded a new collaboration to utilize its ll and
nish capabilities for ExeVir’s innovative therapies. The
Belgian biotech ExeVir develops novel llama-derived antibody
therapies for potential treatment and prevention of Covid-19.
The selection of Mithra CDMO for the lling operations
of ExeVir’s innovative Covid-19 therapeutic conrms its
condence in Mithra’s technological know-how and state-of-
the-art infrastructure.
28%
green energy
produced by
5000 solar
panels
54
55
Financial highlights
Year ended 31 December
2021 2020
Revenues 22,668 9,030
Cost of sales (15,724) (3,457)
Gross prot 6,945 5,573
Research and development expenses (76,577) (69,310)
General and administrative expenses (10,021) (8,126)
Selling expenses (1,541) (1,251)
Other operating income 4,809 6,574
REBITDA
1
(76,385) (66,540)
Share-based payments expenses (1,065) (7,267)
EBITDA
2
(77,450) (73,807)
Depreciation (10,426) (6,136)
Non-recurring items - (3,734)
Loss from operations
3
(87,875) (83,678)
Change in the fair value of contingent consideration payable (19,265) (18,114)
Net fair value gains/(losses) on nancial assets at fair value
through prot or loss
4
(6,351) (4,925)
Financial income 2,838 1,782
Financial expenses (13,116) (5,987)
Loss before taxes (123,769) (110,922)
Income taxes 6,895 18,835
Net loss for the period (116,875) (92,086)
1 EBITDA is an alternative performance measure calculated by excluding the depreciation and amortization from EBIT (loss from operations) from the consolidated statement of prot or
loss prepared in accordance with IFRS (please refer to note 9.34).
2 REBITDA is an alternative performance measure calculated by excluding the non-recurring items and the depreciation & amortization from EBIT (loss from operations) from the consolidated
statement of prot or loss prepared in accordance with IFRS (please refer to note 9.34)
3 Fair values are computed on the contingent considerations payables which are reported under Other nancial liabilities – Estelle® (please refer to note 9.17)
4 ThefairvaluelossonnancialassetsismainlymadeofthechargeofEUR8.0millionrelatedtocontingentreceivablewithCERES,partiallycompensatedbyafairvaluegainoncontractassets
(re-evaluationofMayne’ssharesuptotheirissuanceinMay2021)forEUR1.6million(pleaserefertonote9.17)
Figures presented below (in thousands of euro) are management gures
Product sales Estelle
®
13.4
million
Revenues
22.7
million
> Revenues at EUR 22.7 million compared to EUR 9.0 million in 2020, mainly driven by EUR 13.4 million rst product
sales of Estelle
®
in the US, Canada and Europe; and an out-licensing revenue of EUR 3.7 million following the
acquisition of full global licensing and distribution rights for Zoreline
®
allowing a deferred revenue to be recognized.
> Cash collection of two major Estelle
®
out-licensing milestones with Mayne (USD 11 million) and Gedeon Richter
(EUR15 million), without impact on revenue as already recognized in 2019 as per IFRS15. Still around EUR 290million
cash to be collected for Estelle
®
out-licensing and sales related milestones.
> R&D expenses (excluding depreciation, as presented in the alternative performance measure) stand at
EUR 76.6 million compared to EUR 69.3 million in 2020. These R&D expenses are the result of the ramp-up of
activities under the Phase III Donesta
®
.
> EBITDA stands at EUR -77.5 million compared to EUR -73.8 million at 2020. The variance is mainly explained by
operating expenses increase, notably R&D expenses, compensated by gross prot increase and other operating
income decrease.
> Below EBITDA, a net fair value loss on nancial assets of EUR -6.4 million has been recognized. This loss is mainly
explained by a charge of EUR 8 million related to a contingent receivable with Ceres Pharma, partly compensated by
a gain on contract assets (related to the Mayne US deal).
> Reception of 85.8 million ordinary shares (an Estelle
®
out-licensing milestones for the US territory) allowing the
Company to become the rst shareholder (with 9.57%) of Mayne Pharma Group Ltd, an Australia-listed company on
ASX.
> Complete buyout of all earnouts linked to Myring
®
and Zoreline
®
, cancelling related amounts reported in the balance
sheet in December 2020 (EUR 8.8 million) and thus facilitates Mithra’s equity story. This deal also allowed the
Company to increase the value of Zoreline
®
IP rights on our balance sheet by EUR 8.5 million.
> As contractually agreed, an instalment of EUR 25 million was paid to former owners of Uteron Pharma . This payment
contributed to further decrease the liability reported at fair value on the balance sheet (from EUR 115.7 million in
December 2020 to EUR 110.0 million in December 2021).
> EUR 32.9 million net cash position, on the top of which the following facilities are available :
EUR 100 million flexible equity nancing agreement contracted with Goldman Sachs International in February
2022 with a rst drawing request exercised on 4 February 2022 for an amount of EUR 10 million;
EUR 41 million as per December 31, 2021 in the framework of LDA capital commitment agreement (the Company
has agreed with Goldman Sachs during any drawing period to not issue any put option notice under the LDA capital
facility). Following the put option issued on 20 December 2021, a capital increase for an amount of EUR 8.1million
was completed on 14 February 2022 leading to an amount available under the LDA capital commitment of around
EUR 33 million.
> New credit line concluded for an amount of EUR 15 million. This additional nancing facility and the previously
contracted credit line (EUR 20 million) are fully drown as per year end.
> Equity stands at EUR 33.8 million, reduced compared to December 2020 (EUR 157.7 million) by the total
comprehensive loss for the period (EUR 134.2 million), partially compensated by two capital increases for a total
amount of EUR 9.2 million (LDA capital and exercise of subscription rights).
5756
1 François Fornieri holds warrants entitling him to
subscribe 952,790 additional shares of Mithra through
Yima SRL, a company fully owned by François Fornieri.
2 Marc Coucke holds his shareholding partially through
Alychlo NV, which he controls.
3 Bart Versluys holds his shareholding through Scorpiaux
BVBA, controlled by Bart Versluys.
4 François Fornieri, Alychlo NV and Noshaq SA jointly
hold 300,000 warrants (share lending warrants)
Mithra share
Mithra (Euxonext: MITRA) is listed on Euronext Brussels and is part of the BEL Mid index.
The group is also part of the BEL Health Care and Euronext 150 indices.
In 2021, the average share price was € 21.32 per share. The highest level was € 28
on 30 March 2021 and the lowest level € 17.8 on 24 September 2021. With a market
capitalization of € 880 million as of 31.12.2021 and an average daily volume published
by Euronext of 60,465 shares, Mithra has sufcient liquidity to be on the radar of major
institutional investors.
Total number of shares with voting rights:
44,051,259
Shareholding structure
This graph shows our shareholder structure as of December 31, 2021, based on the transparency
declarations made by shareholders.
Notication obligations are required by Belgian law or according to Mithras articles of association,
when the shareholding exceeds the thresholds of 3%, 5% or any multiple of 5%.
49.07%
Free Float
24.94%
François Fornieri
1,4
10.86%
Marc Coucke
2,4
11.27%
Noshaq SA
4
3.86%
Bart Versluys
3
30 March 2021
24 September 2021
58 59
April 15
2021
Annual Report
May 19
Annual General
Meeting of
Shareholders
March 8
2021
Annual results
September 23
2022
Half Year Results
2022 Financial Calendar
Analysts
As of December 31, 2021, Mithra was covered by seven sell-side analysts who publish regular reports on the
stock. Besides the regular individual exchanges, Mithra organizes two webinars at the time of the publication of its
half-year/annual results, and an Investor Day. The Management of the company participates in these conference
calls in order to present the nancial and strategic performances of the company. These conferences are accessible
to all the investors and available in replay on Mithra website.
Alexandru
Cogut
Daan
Vandenberk
Mohamed
Kaabouni
Beatrice
Allen
Laura
Roba
Maxime
Stranart
Thomas
Vranken
Our nancial
community
Institutional investors
Mithra interacts with the institutional investors during roadshows and
conferences to which the members of the Executive Management
take part with the person in charge of the investor relations. These
international roadshows and conferences allow to establish a
dialogue and to meet the community of institutional investors in order
to present Mithras strategy and its nancial performances.
Individual investors
Each investor has the possibility to subscribe
to a newsletter on the Company’s corporate
website in order to receive press releases.
The investor relations can be reached at
investorrelations@mithra.com and answers all
questions and requests for information.
Participation in
8 conferences and 5
roadshows, during which
the Executive Management
met investors located in
Europe, UK and US.
Mithra organized an
Investor Day on 29 November
2021. During this event, attended
by institutional shareholders and
sell-side analysts, Mithra unveiled
its new strategy for its product
candidate Donesta
®
and announced
a diversication of the R&D pipeline
through rights’ acquisition option
relating to a development programs
led by the Belgian company
BCI Pharma on innovative
kinase inhibitors.
In 2021
60 61
Board of Directors
Patricia van Dijck
Independent Director
Ms. Patricia van Dijck holds a degree in medicine and a specialization
in clinical biology and pharmaceutical medicine from the Catholic
University of Louvain (UCL).
She began her career in the pharmaceutical industry in 1996 as an
International Medical Advisor at UCB. She then became Medical
Director at Lundbeck, before being appointed Managing Director in
2007. In 2011, Mrs. van Dijck joined Novartis Belux as Head of Market
Access & Public Affairs, before joining the mother company in Basel
in 2014 as Head Patient Access Excellence. Since 2018, she has been
working for GSK Belux as Market Access & Public Affairs Director.
Erik Van den Eynden
Independent Director
Mr. Erik Van Den Eynden graduated in Economics at the University
of Antwerp and has more than 30 years of experience in the
banking sector.
He joined ING in 1990, where he held various commercial and
management positions, including District Manager, Head of
MidCorporates & Institutionals, CEO of ING Insurance Belgium
& Luxembourg. From 2017 to 2020, he held the position of CEO
of ING Belgium. In March 2021, Mr. Van den Eynden became
CEO of the Straco Investment Group active in real estate project
development, investments and private equity.
Liesbeth Weynants
Independent Director
Ms. Liesbeth Weynants holds a master’s
degree in law from the University of Leuven
and is specialized in pharmaceutical and
regulatory law with a focus on the life
sciences sector.
She has extensive expertise in intellectual
property and patent law for innovative
medicines (AbbVie, Allergan, Biogen,
Boehringer Ingelheim, Celgene, J&J,
Lundbeck, Merck, Novartis, Sano...) and
is currently Managing Partner at the law
rm Hoyng Rokh Monegier as well as
Professor of Intellectual Property Law at
the VUB.
An Cloet
Independent Director
Ms. An Cloet holds a Master’s degree in Pharmacy from the University
of Leuven and a Degree in Business and Administration from the
University of Louvain.
She has over 25 years of pharmaceutical experience in multiple
therapeutic domains, in particular women’s health (contraception,
osteoporosis, fertility). She built her career within MSD, where she
has held various positions in Business Development, Marketing and
Corporate Strategy. Since 2019, Ms Cloet is External Affairs Director
at MSD Belux.
Ajit Shetty,
Chairman,
Independent Director
Mr. Ajit Shetty holds an MSc and PhD in Metallurgy from Cambridge University and an
MBA from Carnegie-Mellon University.
He started his career in 1976 at Janssen Pharmaceutica, where he held various positions
in Finance and Business Development. He was instrumental in developing Janssen
into a worldwide multinational within Johnson & Johnson. He served as President of
Janssen USA from 1984 to 1990, before becoming Executive Vice President Finance
of Janssen Belgium. From 1999 to 2008, he served as Managing Director of Janssen
and as Chairman from 2004, while also serving on the Johnson & Johnson Operating
Committee.
Elected “Manager of the Year” in Flanders in 2004, he was made a baron by King Albert II
of Belgium in 2007. He is chairman of the Flemish Institute for Biotechnology (VIB) and
a member of the board of directors of various pharmaceutical companies in Belgium,
the United States and China. He is also a trustee of Carnegie-Mellon University.
With a proven expertise in all the elds covering pharmaceutical products
development, Mithras new Board of Directors can rely on 10 Directors with varied
and complementary proles. For the rst time, the Board achieves perfect gender
parity with 5 women directors and 5 men directors as well 5 independent and 5
non-independent directors.
62 63
Board of Directors
François Fornieri
Non-Executive Director
Mr. François Fornieri is a chemical
engineer (ISIL) with a Master’s degree
in Management (HEC). He has
over 30 years of experience in the
pharmaceutical industry.
He began his career at Sano, before
joining the Marketing department of
the Bayer-Schering group. In 1999,
he founded Mithra and ensures the
direction of the company during nearly
20 years. He is also the co-founder
of Uteron Pharma, which he sold to
the American group Watson-Actavis
(2010-2013). Elected “Manager of the
Year” in Wallonia in 2011, Mr. Fornieri
is also an Ofcer of the Walloon
Order of Merit and won the Essenscia
Innovation Award in 2019.
Valérie Gordenne
Non-Executive Director
Ms. Valérie Gordenne holds a Master’s
degree in Pharmacy from the University
of Liège.
She has over 20 years of experience
in pharmaceutical Research &
Development with extensive leadership
experience in full drug development
across a range of therapeutic areas,
in particular in women’s health (CSO
Mithra, CEO Novalon, General Manager
Odyssea). Through the management
of various functions and activities, she
has developed a deep operational and
strategic knowledge and expertise in
drug development. She is currently
Chief Scientic Ofcer at Auxin Surgery,
CEO of the start-up Odix and advisor in
regulatory affairs.
Gaëtan Servais
Non-Executive Director
Mr. Gaëtan Servais graduated in
economics from the University of
Liege, where he started his career as
a research assistant.
In 1995, he joined the Federal
Planning Bureau as an expert and
later the Economic and Social
Council of the Walloon Region. In
2001, he became Chief of Staff for
several ministers of the Walloon
government. Since 2007, he has
been CEO of the Liège-based
investment fund Noshaq, which
offers nancing solutions for the
creation and growth of companies.
Jean-Michel Foidart
Executive Director
Professor Jean-Michel Foidart graduated in Gynecology
from the University of Liège and also obtained a PhD in cell
biology and biochemistry, before directing its Department
of Gynecology-Obstetrics.
Co-founder of Mithra, he is the author of more than
1300 publications on women’s health and experimental
oncology. Professor Foidart holds the Francqui Chair,
Doctor Honoris Causa of the Pierre and Marie Curie
University of Paris and the Paul Sabatier University
of Toulouse. He is Ofcer of the Order of Leopold II,
Commander, Grand Ofcer of the Order of the Crown,
Professor Extraordinary, Honorary of the ULg and
Perpetual Secretary of the Royal Academy of Medicine of
Belgium. He was also General Secretary of the European
Society of Gynecology and member of multiple editorial
boards of international peer-reviewed journals.
Amel Tounsi
Non-Executive Director
Ms. Amel Tounsi holds a PhD in Biomedical
and Pharmaceutical Sciences from the
University of Louvain.
She has a broad experience in cell-therapy
development. During her career in the biotech
sector (Celyad, Texere, Analis, Masthercell),
she acquired a strong expertise in Business
Development and Company Development
strategy. Since January 2021, she works as
an Investment Manager at the Liège-based
investment fund Noshaq.
64
Management committee
Leon Van Rompay
Chief Executive Ocer
Jean-Michel Foidart
President of the Scientic Council
Jean-Manuel Fontaine
Chief Business Ocer
65
Cedric Darcis
Chief Legal Ocer
Renaat Baas
CDMO Site Director
Benjamin Brands
Chief Supply Chain Ocer
Maud Vanderthommen
Group Communication Manager
Benoît Mathieu
Group Investor Relations Manager
Frederic Constant
Group Quality Manager
Stijn Vlaminck
Group IT Manager
Christophe Maréchal
Chief Financial Ocer
Graham Dixon
Chief Scientic Ocer
Laurence Schyns
Chief Human Resources Ocer
66
CORPORATE GOVERNANCE AND FINANCIAL STATEMENTS
67
69
1. Report of the Board of directors ......................................................................................................................................... 71
Analysis of results/operations .................................................................................................................................... 71
Statement of financial position analysis ................................................................................................................... 72
Cash flow analysis ......................................................................................................................................................... 73
Corporate governance statement............................................................................................................................... 74
Transactions within the authorized capital .............................................................................................................. 94
Acquisition of own securities ...................................................................................................................................... 95
Use of financial instruments by the Group as per art. 3:6 CCA ............................................................................ 95
Circumstances that could considerably affect the development of the Group................................................. 95
Research and development ...................................................................................................................................... 101
Conflicting interests of directors (Art. 7:96 of the CCA) ...................................................................................... 103
Independence and expertise of at least one member of the Audit committee .............................................. 106
Going concern assessment ...................................................................................................................................... 106
Appropriation of results ............................................................................................................................................. 107
Important events after the reporting period .......................................................................................................... 107
1.15. Grant of discharge to the directors and the statutory auditor ........................................................................... 108
2. Responsibility statement ................................................................................................................................................... 109
3. Auditor report ........................................................................................................................................................................ 110
4. Consolidated statement of profit and loss ..................................................................................................................... 116
5. Consolidated statement of comprehensive loss ........................................................................................................... 117
6. Consolidated statement of financial position ................................................................................................................ 118
7. Consolidated statement of changes in equity ............................................................................................................... 120
8. Consolidated statement of cash flow .............................................................................................................................. 121
9. Notes to the consolidated financial statements ........................................................................................................... 122
General information .................................................................................................................................................... 122
Summary of Significant Accounting Policies ........................................................................................................ 122
Financial risk management....................................................................................................................................... 133
Critical accounting estimates and judgements .................................................................................................... 137
Segment information and revenue .......................................................................................................................... 139
Other intangible assets .............................................................................................................................................. 141
Property, plant and equipment ................................................................................................................................. 143
Lease Right-of-use assets ..................................................................................................................................... 144
Goodwill & IP R&D ....................................................................................................................................................... 144
Other non-current assets........................................................................................................................................... 146
Inventories .................................................................................................................................................................... 146
Trade and other receivables ..................................................................................................................................... 146
Cash and cash equivalents ....................................................................................................................................... 147
Equity ............................................................................................................................................................................. 147
Financial liabilities ....................................................................................................................................................... 149
Trade payables and other current liabilities........................................................................................................... 154
Financial instruments ................................................................................................................................................ 155
Contract assets and liabilities .................................................................................................................................. 159
70
Other operating income ............................................................................................................................................. 161
Expenses by nature .................................................................................................................................................... 161
Employee benefit expenses ...................................................................................................................................... 162
Retirement benefit schemes .................................................................................................................................... 162
Financial income and expense ................................................................................................................................. 163
Income tax .................................................................................................................................................................... 163
Result per share .......................................................................................................................................................... 165
Share-based payments .............................................................................................................................................. 165
Contingencies and arbitrations ................................................................................................................................ 168
Commitments .............................................................................................................................................................. 168
Related party transactions ........................................................................................................................................ 168
Events after the reporting period ............................................................................................................................. 171
Mithra Pharmaceuticals companies consolidation scope ................................................................................. 172
Disclosure audit fees .................................................................................................................................................. 173
Condensed statutory financial statements of Mithra SA.................................................................................... 173
Alternative performance measures ......................................................................................................................... 176
71
1. Report of the Board of directors
Analysis of results/operations
The net loss for the year 2021 was EUR 116,875k (loss of EUR 92,086k for 2020) on a consolidated basis.
The operating loss of EUR 87,875k in 2021 compared to the operating profit EUR 83,678k in 2020 is mainly explained
by the decrease of revenues and the increase of R&D activity.
The loss before taxes amounts at EUR 123,769k in 2021, the gap between operating loss and loss before taxes is
mainly the result of the increase in interest charges and fair value losses.
1.1.1. Total income
Group revenues increased to EUR 22,668k in 2021 (EUR 9,030k in 2020) and are mainly driven by product sales and
by our first deliveries of Estelle
®
(EUR 13.4 million) to our European, US and Canadian partners. Sales from generic
products in our portfolio, at EUR 3.8 million, remained steady compared to last year.
Out-licensing revenue, at EUR 4.6 million, are essentially Zoreline
®
milestones (EUR 3.7 million), previously invoiced
and paid, that could be recognized in line with the agreement signed with SVR Invest BV for the full global licensing
and distribution rights for the Zoreline
®
implant. EUR 0.5 million relates to performance obligation achieved in the
framework of Mayne Pharma agreement for Estelle
®
Australia. Otherwise, no new significant partnership was signed
during 2021 and no other triggering event on our portfolio of signed contracts, implying that no additional
performance obligations (and related revenues) could be recognized in our accounts
1.1.2. Research and development expenses
R&D expenses increased by 9% in 2021 to EUR 85,243k (2020: EUR 78,458k) due to the ramp up of the Donesta
®
Phase III “E4 Comfort” clinical program. R&D expenses for Donesta
®
should continue to increase in the first half of
2022.
1.1.3. General and administrative expenses and selling expenses
G&A and selling expenses decreased by 17%, essentially due to a much lower impact of share-based payments
accounting entries (charge of EUR 1.1 million compared to EUR 7.3 million in 2020), while the ramp-up of activities
was important over the period.
1.1.4. Other operating income
Other operating income decreased by 27% mainly because in 2020 additional grants from the Walloon Region (of
EUR 2,252k) have been recognized.
1.1.5. Change in fair value of contingent consideration payable, financial assets at
fair value through profit and loss
Estelle® approval and positive top-line results from Donesta
®
phase 3 studies led to a review of the different
scenarios and probabilities related to the financial liability against former owners of Uteron Pharma, hence the EUR
19.3 million change in fair value charge recorded in 2021 accounts.
The fair value loss on financial assets is mainly made of the charge of EUR 8.0 million related to contingent receivable
with CERES, partially compensated by a fair value gain on contract assets (reevaluation of Mayne’s shares up to their
issuance in May 2021) for EUR 1.6 million.
1.1.6. Financial income
Financial income increased by EUR 1,056k and are mainly explained by the impact of the remeasurement of
refundable government advances from the Walloon Region measured at amortized cost.
72
1.1.7. Financial expense
Financial expenses significant increase by EUR 7,129k is mostly driven by the interest charges of the EUR 125 million
convertible bond negotiated in December 2020.
1.1.8. Branches
The Company has no branches. Refer to detailed table about the group structure in note 9.31.
Statement of financial position analysis
Total assets decreased to EUR 421,918k as of 31 December 2021 (EUR 521,985k at the end of previous year).
1.2.1. Non-current assets
As of 31 December 2021, the Statement of financial position shows a total of EUR 322,528k in Non-current assets,
the largest of which are Other intangible assets (EUR 104,954k), Deferred tax assets (EUR 63,456k), Right-of-use
assets (EUR 69,322k) and Property, plant and equipment (EUR 38,354k).
Tangible fixed assets (Property, plant and equipment and the Right-of-use assets) increased by EUR 8,183k, mainly
relating to machinery and equipment in the production facility for the manufacturing of pharmaceuticals products
(Mithra CDMO) and their related development costs for machine settings and improvement.
Other intangible assets consist mainly of a portfolio of acquired product rights, market access rights and internally
generated intangible assets. The Net book value relates mainly to IP rights such as Estelle
®
for EUR 29,663k, Myring
®
for EUR 11,425k, Zoreline
®
for EUR 32,882k and Donesta
®
which qualified as an asset deal, for EUR 8,000k. Over
2021, the increase of EUR 15,949k is explained by the acquisition of full licensing and distribution rights of Zoreline
®
held by SVR Invest, including important territories such as China, Canada and Australia for an amount of EUR 8.5
million (in addition to the initial book value amount of EUR 24,400k) and of a capitalization of development costs
related to the project “E4 synthesis” (for EUR 5.5m) and the project Estelle
®
(for EUR 3.0m) arising from development.
Following the reception of Estelle
®
Marketing authorization, intellectual property rights and internally generated
research and development for this project are now considered as available for use and depreciated (for EUR 1m).
Deferred tax assets increased by EUR 12,551k mainly due to the recognition of additional assets arising from
available tax losses carried forward.
Since 2020, the Group uses derivative financial instruments to manage its exposure to foreign exchange rate risk
arising from operational activities (cash flow hedges). In 2021, EUR has weakened significantly against the USD, with
the foreign currency spot rate decreasing, which has caused the fair value of foreign exchange derivative hedges to
decrease from EUR +9 065k to EUR -4,683k at 31 December 2021 (major amount hence recorded at fair value in the
Derivatives financial liabilities).
The increase of Investment in equity securities mainly explained by the reception of 85.8 million ordinary shares (an
Estelle
®
out-licensing milestones for the US territory) allowing the Company to become the first shareholder (with
9.57%) of Mayne Pharma Group Ltd, an Australia-listed company on ASX.
In 2021, Other non-current assets decrease is mainly the result of the fair value loss on financial assets which is
made of the charge of EUR 8.0 million related to contingent receivable with CERES compensated by the increase of
the R&D tax credit.
1.2.2. Current assets
As of 31 December 2021, the Statement of financial position shows a total of EUR 99,389k in Current assets, mainly
Inventories for EUR 43,852k (EUR 8,470k higher than previous year) in the context of Estelle
®
commercial launch as
from June 2021.
Contract assets decreased by EUR 38,950k mainly because of cash collection of two major Estelle
®
out-licensing
milestones with Mayne (USD 11 million) and Gedeon Richter (EUR 15 million) and because of the reception of 85.8
million ordinary shares of Mayne Pharma Group Ltd, without impact on revenue as already recognized in 2019 as
per IFRS 15.
Cash decreased to EUR 32,872k from EUR 138,675k in 2020, mainly explained by operating expenses increase,
notably R&D expenses related to the activities under the Phase III Donesta®, by the payment of an instalment of EUR
73
25 million to former owners of Uteron Pharma and by the complete buyout of all earnouts linked to Myring
®
and
Zoreline® with a first payment of EUR 8.5 million.
1.2.3. Equity
Total Equity at year-end decreased to EUR 33,840k from EUR 157,737k in 2020, mainly due to the total
comprehensive loss for the period (EUR 134,175k), partially compensated by two capital increases for a total amount
of EUR 9.2 million (LDA capital and exercise of subscription rights).
1.2.4. Non-current liabilities
Current liabilities slightly decreased to EUR 292,285k at the end of 2021, compared to EUR 293,500k in 2020.
Contract liabilities decreased as a result of the recognition of the out-licensing revenue, at EUR 3.7 million related to
Zoreline® milestones, previously invoices and paid, in line with the agreement signed with SVR Invest BV for the full
global licensing and distribution rights for the Zoreline
®
implant.
This impact on Non- current liabilities is partially offset by the increase of the Derivative financial liabilities because
of the foreign currency spot rate (EUR/USD) decreasing which has caused the fair value of foreign exchange
derivative hedges to decrease from EUR +9 065k to EUR -4,683k at 31 December 2021.
1.2.5. Current liabilities
Current liabilities increased to EUR 95,793k at the end of year 2021, compared to EUR 70,747k in 2020, primarily due
the increase of the current portion of other loans which include new credit line concluded for an amount of EUR 15
million. This additional financing facility and the previously contracted credit line (EUR 20 million) for a total of EUR
35 million have been fully drown during 2021. This has been partially offset by the decrease in the current portion of
other financial liabilities, linked to the evolution of Estelle
®
contingent consideration payable. This liability decreased
following the payment of an instalment of EUR 25 million to former owners of Uteron Pharma, compensated by a
change in fair value (EUR 19.3m).
Cash flow analysis
Full year cash flow of the group amounts to EUR -105,824k :
Cash flow from operating activities of EUR -74,387k for 2021.
Cash flow from investing activities of EUR -54,682k : The acquisition of tangible assets relates predominately
to the capitalization of development costs in the framework of CDMO facility and equipment and its
production zones. The acquisition of intangible assets consists in the capitalization of development costs
related to the project “E4 synthesis” and the project Estelle
®
. The Other financial liabilities payments are
mainly composed of the complete buyout of all earnouts linked to Myring
®
and Zoreline
®
with a first payment
of EUR 8.5 million and of an instalment of EUR 25 million paid to former owners of Uteron Pharma.
Cash flow from financing activities amounts to EUR 23,245k : during the year, the Group has secured capital
increases for a total amount of EUR 9.2 million (LDA capital and exercise of subscription rights). A new credit
line was concluded for an amount of EUR 15 million. This additional financing facility and the previously
contracted credit line (EUR 20 million) are fully drown as per year end. At the opposite, the lease
reimbursement and interest payments amount to EUR 9,479k.
In consideration of the conservative assumptions mentioned in the note 1.12 Going concern, the Board of directors
has analyzed the financial statements and accounting policies and, made the assessment that the current cash
position of EUR 32.9 million at 31 December 2021 strengthened by post-year end flexible equity financing agreement
contracted with Goldman Sachs International for EUR 100 million and a capital increase for an amount of EUR 8.1
million completed on 14 February 2022 under the LDA capital agreement facility will allow the Group to keep up with
operating expenses and capital expenditure requirements at least until April 2023 (twelve months at least after the
issuance of this report).
74
Corporate governance statement
1.4.1. Introduction
This Corporate Governance Statement is included in the Company's report of the Board of directors on the statutory
accounts for the financial year ended on 31 December 2021 in accordance with Article 3:6, §2 of the Belgian
Companies and Associations Code.
On 17 May 2019, the Belgian royal decree of 12 May 2019 designating the corporate governance code to be complied
with by listed companies was published in the Belgian Official Gazette. On the basis of this royal decree, Belgian
listed companies are required to designate the new 2020 Belgian Corporate Governance Code (the "2020 Code") as
reference code within the meaning of Article 3:6, §2 of the Belgian Companies and Associations Code of 23 March
2019, as amended (the "Belgian Companies and Associations Code"). The 2020 Code applies compulsorily to
reporting years beginning on or after 1 January 2020 (compulsory application).
The 2020 Code is available on the website of the Belgian Corporate Governance Committee
(www.corporategovernancecommittee.be).
1.4.2. Reference code
The Corporate Governance of the Company is organized pursuant to the Belgian Companies and Associations Code,
the Company’s articles of association and the Company’s Corporate Governance Charter.
The Company’s Corporate Governance Charter was adopted by the Board of directors on 20 April 2020 and updated
on 22 April 2020. It was drafted in accordance with the recommendations set out in the 2020 Code.
For the financial year ended on 31 December 2021, the Company complied to a large extent with the provisions of
the 2020 Code, except for the following deviation which the Company believed was justified in view of the Company’s
specific situation. In line with the “comply-or-explain” principle of said 2020 Code, the Company did not fully comply
with the following provision:
Provisions 4.10 to 4.16 of the 2020 Code: The Company decided not to appoint a formal internal auditor because of
the size of the Company. However, the Risk and Audit committee regularly evaluates the need for this function and/or
commissions external parties to conduct specific internal audit missions and report back to Board of directors.
The Company’s Corporate Governance Charter, together with the articles of association of the Company, are
available on the Company’s website (www.mithra.com), mentioning the date of the most recent update, in a clearly
recognizable part of the Company’s website under the heading “Investors“, separate from the commercial
information.
1.4.3. Share capital & shares
On 31 December 2021, the share capital of the Company amounts to EUR 32,249,706.40 and is fully paid-up. It is
represented by 44,051,259 ordinary shares, each representing a fractional value of (rounded) EUR 0.7321 and
representing one 44,051,259
th
of the share capital
1
. The Company's shares do not have a nominal value. The
Company’s shares are admitted to listing and trading on the regulated market of Euronext Brussels, under the ticker
“MITRA”.
In addition to the outstanding shares, the Company has a number of subscription rights, that are exercisable into
ordinary shares, consisting of:
1,394,900 outstanding share options, issued by the Company on 5 November 2018 to the benefit of
members of the staff, as well as consultants of the Company, subject to the terms and conditions that are
determined by the Board of directors, entitling their holders thereof to subscribe for 1 share upon exercise
of 1 relevant share option (the "2018 Share Options");
1
Post period, on 14
th
February 2022, the share capital of the Company amounts is EUR 32,573,434.43 and is fully paid-up. It is
represented by 44,493,450 ordinary shares, each representing a fractional value of (rounded) EUR 0.7321 and representing one
44,493,450
th
of the share capital. On 21th March, the share capital of the Company amounts is EUR 32,849,581.09 and is fully paid-
up. It is represented by 44,870,648 ordinary shares, each representing a fractional value of (rounded) EUR 0.7321 and representing
one 44,870,648
th
of the share capital.
75
subscription rights exercisable for a maximum number of 690,000 new shares of the Company at an
exercise price of EUR 27.00 per ordinary share (subject to customary adjustments), issued by the Company
on 22 July 2020 to the benefit of LDA Capital Limited, subject to the terms and conditions, entitling LDA
Capital Limited to subscribe for 1 share upon exercise of 1 relevant subscription right (the “LDA Warrants”);
subscription rights exercisable for a maximum number of 300,000 new shares of the Company at an
exercise price of EUR 27.00 per ordinary share (subject to customary adjustments), issued by the Company
on 7 September 2020 to the benefit of certain shareholders of the Company, subject to the terms and
conditions, entitling their holders to subscribe for 1 share upon exercise of 1 relevant subscription right (the
“Share Lending Warrants”);
390,717 outstanding share options, issued by the Company on 20 November 2020 to the benefit of members
of the personnel of the Company, subject to the terms and conditions that are determined by the Board of
directors, entitling their holders thereof to subscribe for 1 share upon exercise of 1 relevant Share Option
(the "2020 Share Options"). On the date of the present report, a total of 316,000 warrants have already been
granted to members of the personnel, while 74,717 remaining;
On 10 December 2020, the Company issued senior unsecured convertible bonds due 17 December 2025 for
an amount of EUR 125 million. The convertible bonds are convertible into ordinary shares of the Company
at an initial conversion price of EUR 25.1917, representing a 25.00% premium above the reference price of
EUR 20.1533, being the volume weighted average price of a Company's share on Euronext Brussels from
market open to the close of trading on 10 December 2020. The convertible bonds were issued in
dematerialised form in the denomination of EUR 100,000 each. Unless previously converted, redeemed or
purchased and cancelled, the convertible bonds will be redeemed at par on the stated maturity date, which
is expected to be 17 December 2025. The number of ordinary shares potentially to be issued based on this
operation amount to 4,96 million.
The Master Confirmation Agreement dated 4s February 2022 between the Company and Goldman Sachs
International provides that should a change of control occur, an adjustment on the economics of the
contract shall occur. This Adjustment shall be determined by the Calculation Agent based on the 2006 ISDA
Definitions and the definitions and provisions of the 2002 ISDA Equity Derivatives Definitions rules in each
case as published by the International Swaps and Derivatives Association, Inc, using customary
mechanisms. Should the Adjustment be rejected by the Company following a change of control, it may in
some circumstances cause a termination of the Master Confirmation Agreement.
Form and transferability of the shares
The shares of the company can take the form of dematerialized shares. All the company's shares are fully paid-up
and are freely transferable. On 31 December 2021, all of the 44,051,259 existing shares have been admitted to trading
on the regulated market of Euronext Brussels.
Currency
The company's shares do not have a nominal value, but each reflects the same fraction of the Company's share
capital, which is denominated in euro.
Voting rights attached to the shares
Each shareholder of the company is entitled to one vote per share. Shareholders may vote by proxy, subject to the
rules described in the Company's articles of association.
Voting rights can be mainly suspended in relation to shares:
which are not fully paid up, notwithstanding the request thereto of the Board of directors of the Company;
to which more than one person is entitled or on which more than one person has rights in rem (droits réels)
on, except in the event a single representative is appointed for the exercise of the voting right vis-à-vis the
Company;
which entitle their holder to voting rights above the threshold of 3%, 5%, 10%, 15%, 20% and any further
multiple of 5% of the total number of voting rights attached to the outstanding financial instruments of the
Company on the date of the relevant general shareholders' meeting, in the event that the relevant shareholder
has not notified the Company and the FSMA at least 20 calendar days prior to the date of the general
shareholders' meeting in accordance with the applicable rules on disclosure of major shareholdings; and
76
of which the voting right was suspended by a competent court or the FSMA.
Pursuant to the Belgian Companies and Associations Code, the voting rights attached to shares owned by the
Company, or a person acting in its own name but on behalf of the Company, or acquired by a subsidiary of the
Company, as the case may be, are suspended.
Dividends and dividend policy
All of the shares of the Company entitle the holder thereof to an equal right to participate in dividends in respect of
the financial year ending on 31 December 2021 and future years. All of the shares participate equally in the
Company's profits (if any). Pursuant to the Belgian Companies and Associations Code, the shareholders can in
principle decide on the distribution of profits with a simple majority vote at the occasion of the annual general
shareholders' meeting, based on the most recent statutory audited financial statements, prepared in accordance
with Belgian GAAP and based on a (non-binding) proposal of the Company's Board of directors. The Belgian
Companies and Associations Code and the Company's articles of association also authorise the Board of directors
to declare interim dividends without shareholder approval. The right to pay such interim dividends is, however,
subject to certain legal restrictions.
Additional financial restrictions and other limitations may be contained in future credit agreements.
1.4.4. Shareholders & shareholder structure
Shareholders structure
The table below provides an overview of the shareholders that notified the Company of their shareholding in the
Company pursuant to applicable transparency disclosure rules, as of 31st of December 2021.
% of voting rights
1
24.94%
5
10.86%
11.27%
3.86%
2.68%
1. The percentage of voting rights is calculated as per the closing date and taking into account the total number of outstanding shares of the
Company as of such date.
2. François Fornieri holds in direct and through Yima SRL warrants entitling him to subscribe still 952,790 additional shares of Mithra.
3. Marc Coucke holds his shareholding partially through Alychlo NV, which he controls.
4. François Fornieri, Alychlo NV and Noshaq SA jointly hold 300,000 warrants (share lending warrants).
5. Post period, on 23 March 2022, the shareholding is adapted as follow: Mr François Fornieri, 24,97%; Mr Marc Coucke, 9,24 %; NOSHAQ SA,
11,31%; Scorpiaux 3,79 %; Ogesip SA invest, 2.63%.
No other shareholders, alone or in concert with other shareholders, notified the Company of a participation or an
agreement to act in concert in relation to 3% or more of the current total existing voting rights attached to the voting
securities of the Company.
The most recent transparency declarations, including the abovementioned declarations, are available on the
Company’s website www.mithra.com.
Shareholders’ arrangements
To the Board of directors’ best knowledge, no shareholders’ agreement exists among shareholders of the Company
with respect to the Company.
77
1.4.5. Board of directors
Composition of the board
The Company has opted for a "one tier" governance structure whereby the Board of directors is the ultimate decision-
making body, with the overall responsibility for the management and control of the Company and is authorized to
carry out all actions that are considered necessary or useful to achieve the Company's object. The Board of directors
has all powers except for those reserved to the general shareholders' meeting by law or by the Company's articles of
association. The Board of directors acts as a collegiate body.
Since the 20
th
May 2021 (the last Ordinary Shareholders' Meeting
3
), the Board of directors consisted of ten (10)
members (with a minimum of three (3) members set out in the articles of association), of which one (1) is Executive
Director and nine (9) are Non-Executive Directors, including five (5) Independent Directors in the meaning of the Article
7:87 of the Belgian Companies and Associations Code.
Since this Ordinary Shareholders' Meeting, the Company has continued to comply with the requirement of gender
diversity and Article 2.1 of the Company's Corporate Governance Charter. Indeed, the Board of directors currently
has five (5) female directors.
On 21
st
January 2021, in accordance with the Internal Governance Code, the Board of directors has decided to entrust
the position of CEO ad interim to Mr Christophe Maréchal until further decision by the Board. Moreover, according to
article 7:95 of the BCC and article 19 of the Company’s articles of association and taking into account the need for
the Company to ensure continuity of management, the directors of the Company have consented to set in motion
the temporary succession plan provided for in Schedule D, section C, “In case of temporary unavailability (no longer
than 6 months leave)” of the Company’s Corporate Governance Charter. Members of the Executive Committee have
been until further decision by the Board, able to function in different silos depending on their area of expertise. These
responsibilities have been carried out under the supervision of Christophe Maréchal who assumed ad interim the
CEO’s task and responsibilities as per the Charter of the Company.
On 3 February 2021, the Board of directors accepted that Yima SRL (represented by Mr. François Fornieri) takes a
step back as CEO, until further notice and for a maximum period of 12 months, following his indictment in the context
of an external file not related to Mithra. As a result hereof, the Board of directors has decided to appoint Van Rompay
Management BV (represented by Mr. Leon Van Rompay) as CEO ad interim until further notice.
On 15 October 2021, Yima SRL (represented by Mr. François Fornieri) decided, in consultation with the Board of
directors, to remain on the sidelines of his executive functions, as long as the legal case related to insider trading is
pending. As the founder and principal shareholder of the Company, he continues to fully fulfill his role as a member
of the Board of directors and to support the strategy of the Company from this seat. Following the decision of Mr.
Fornieri, Mithra’s Board of directors confirmed Van Rompay Management BV (represented by Mr. Leon Van Rompay)
as Chief Executive Officer.
The roles and responsibilities of the Board of directors, its composition, structure and organization are described in
detail in Companys articles of association and Company's Corporate Governance Charter (available on the
Company’s website, www.mithra.com). The Company's Corporate Governance Charter specifies the criteria that
Directors must satisfy in order to qualify as Independent Directors.
Since the General Shareholders' Meeting of 20 May 2021, directors are appointed for a maximum term of two years,
which is renewable.
78
The composition of Mithra’s Board of directors was as follows during the financial year 2021:
Name
Position
Term
1
Nature of
Mandate
Board of directors Committee
Membership
Attendance² to
2021 Board
meetings
Yima SRL
(permanent representative:
Mr. François Fornieri)
Director
2023
Non-Executive
-
12/12
Sunathim BV
(permanent representative:
Mr. Ajit Shetty)
Director
2023
3
Chair
6
Independent
Nomination and
Remuneration Committee
12/12
(6/6)
TicaConsult BV
(permanent representative:
Mr. Erik Van Den Eynden)
Director
2023
3
Independent
Risk and Audit committee
(Chair)
12/12
(8/8)
Noshaq SA
(permanent representative:
Mr. Gaëtan Servais)
Director
2023
Non-Executive
Risk and Audit committee
12/12
(8/8)
Eva Consulting SRL
(permanent representative:
Mr. Jean-Michel Foidart)
Director
2023
Executive
-
12/12
Mrs. Patricia van Dijck
Director
2023
Independent
Nomination and
Remuneration Committee
(Chair)
4
12/12
(4/4)
Mrs. Amel Tounsi
Director
2023
Non-Executive
Nomination and
Remuneration Committee
6/6
(4/4)
Alius Modi SRL
(permanent representative:
Mrs. Valérie Gordenne)
Director
2023
Non-Executive
Risk and Audit committee
6/6
(4/4)
Mrs. An Cloet
Director
2023
Independent
-
6/6
Mrs. Liesbeth Weynants
Director
2023
Independent
-
5/6
Selva Luxembourg SA
(permanent representative
Mr. Christian Moretti)
Director
2021
5
Non-executive
-
6/6
(2/2)
Ahok BVBA
(permanent representative
Mr. Koen Hoffman)
Director
2021
5
Independent
Audit committee (Chair)
5
6/6
(4/4)
1. The term of the mandate of the Director will expire immediately after the Annual General Shareholders' Meeting held in the year set forth next
to the Director’s name.
2. The number of meetings attended by each Director should take into account the nomination of new Directors during the financial year.
3. On 25 November 2020, seven (7) directors resigned. Between the 1st January and the 19th May 2021, the Board of directors included two co-
opted directors to fill in the vacancy seats pursuant to provision 7:88 §1 of the BCAC:
Sunathim BV (represented by Mr. Ajit Shetty) was co-opted by the Board of directors as Independent Director, until the General
Shareholders' Meeting of 2021;
Mr. Erik Van Den Eynden was co-opted by the Board of directors as Independent Director. On 22 December 2020, at the request of
Mr. Erik Van Den Eynden, the Board of directors agreed to replace him by TicaConsult BV (represented by Mr. Erik Van Den Eynden).
4. As of 25
th
November 2020 until 14
th
June 2021, Mrs. Van Dijck was Chair ad interim of the Board of directors. Sunathim BV (permanent
representative: Mr. Ajit Shetty) succeeded her as of 14
th
June 2021.
5. These two mandates were not renewed at the ordinary General Meeting of May 20, 2021. Selva Luxembourg SA (permanent representative Mr.
Christian Moretti) and Ahok BVBA (permanent representative Mr. Koen Hoffman) participate in all Board meetings (and committee meetings at the
request of the Chairs) as observers.
6. Since a resolution of the Board of directors of June 14, 2021.
More detailed information on the Board of directorsresponsibilities, duties, composition and operation can be found
on the Company’s website (www.mithra.com) in the Company's articles of association and Corporate Governance
Charter.
79
Activity report
In 2021, twelve Board meetings have been held (in case two distinct meetings take place successively, the two
meetings have not been taken into account hereinabove).
The Board meetings were mainly related to the financial results and financial reporting, including the half-year and
financial statements and budget, the Company’s financing strategy and related capital transaction, Supply strategy
and R&D progress, important agreements or (expected) acquisitions and divestments, and continuous evaluation of
the structure and the strategy of the Company.
In addition, the Board of directors met to resolve on various (conditional) capital increases or transaction, the grant
of additional share options and the reinforcement of the Executive Management Team.
Performance evaluation of the board
Under the lead of the Chair and assisted by the Nomination and Remuneration Committee (and possibly also by
external experts) the Company’s Board of Directors will conduct, every 3 years, a self-evaluation in respect of its size,
composition, performance and those of its Committees, as well as in respect of its interaction with the executive
management. The evaluation shall have the following objectives:
Assessing how the Board or the relevant Committee operates;
Checking that the important issues are suitably prepared and discussed;
Evaluating the actual contribution of each Director’s work, the Director’s presence at Board and Committee
meetings and his constructive involvement in discussions and decision-making; and
Checking the Board’s or Committee’s current composition against the Board’s or Committee’s desired
composition.
The Non-Executive Directors shall annually assess their interaction with the Executive Management Team. In this
respect, Non-Executive Directors shall meet at least once a year in absence of the CEO and the other executive
directors, if any. No formal Board decision can be taken at such meeting.
There is a periodic evaluation of the contribution of each director aiming at adapting the composition of the Board
of directors. At the time of their re-election, the directors’ commitments and contributions are evaluated within the
Board of directors, and the Board of directors ensures that any appointment or re-election allows an appropriate
balance of skills, knowledge and experience to be maintained. The same applies at the time of appointment or re-
election of the Chairs (of the Board of directors and of the Board committees).
The Board shall act on the results of the performance evaluation by recognising its strengths and addressing its
weaknesses. Where appropriate, this will involve proposing new members for appointment, proposing not to re-elect
existing members or taking any measure deemed appropriate for the effective operation of the Board.
This evaluation took place in fiscal year 2018 and will be renewed in fiscal year 2022-2023 (the evaluation has been
postponed to the year 2022-2023 to correspond with the renewal of the Board of directors). The Board always acts
on the results of the performance evaluation by recognizing its strengths and addressing its weaknesses. Where
appropriate, this could involve proposing new members for appointment, proposing not to re-elect existing members
or taking any measure deemed appropriate for the effective operation of the Board of Directors.
1.4.6. Risk and Audit committee
The Board of directors has set up a Risk and Audit committee, in line with the Belgian Companies and Associations
Code.
More detailed information on the Risk and Audit committee’s responsibilities can be found in the Company's
Corporate Governance Charter, which can be found on Mithra’s website (www.mithra.com).
The Chair of the Risk and Audit committee reports to the meeting of the Board of directors subsequent to each
meeting of the Risk and Audit committee on its activities, conclusions, recommendations and resolutions. On an
80
annual basis, the Chair of the Risk and Audit committee also reports to the Board of directors on the Risk and Audit
committee’s performance.
Composition
The Risk and Audit committee is composed of three (3) members, which are exclusively Non-Executive Directors. At
least one of its members should be an independent Director in the meaning of article 7:87 of the Belgian Companies
and Associations Code.
At least one of its members has the necessary expertise with regard to accounting and auditing. The Board of
Directors ensures that the Risk and Audit committeee has the necessary and sufficient expertise with regards to
accounting, audit and finance, in order to fulfil its role in an adequate manner. The Chair of the Risk and Audit
committee is not the Chair of the Board of directors. The CEO and CFO can attend the meetings in an advisory and
non-voting capacity. At least twice a year, the Risk and Audit committeee meets the Statutory Auditor in order to
discuss questions regarding its mandate, the audit procedure and, in particular, the potential weaknesses identified
in the control.
The following Directors are members of the Risk and Audit committeee: TicaConsult BV (permanent representative:
Mr. Erik Van Den Eynden), Noshaq SA (permanent representative: Mr. Gaëtan Servais), Alius Modi SRL (permanent
representative: Mrs. Valérie Gordenne). Before the General Meeting of May 20, 2021, the Committeee was composed
of Ahok BVBA (permanent representative Mr. Koen Hoffman), TicaConsult BV (permanent representative: Mr. Erik
Van Den Eynden), and Noshaq SA (permanent representative: Mr. Gaëtan Servais). TicaConsult BV (permanent
represenative: Mr. Erik Van Den Eynden) and Ahok BV (permanent representative: Mr. Koen Hoffman) were both
Independent Directors.
Activity report
The Risk and Audit committee met eight (8) times in 2021. The statutory auditor was present at 2 of these eight
meetings.
The main topics discussed were the interim half-year and annual financial information and figures, the budget, the
statutory auditor’s external audit, internal control, risk management and compliance including the implementation
of a Business Code of Conduct, the review of the equity transactions. The opinion of the Risk and Audit committee
has also been specifically requested on transactions where there were conflicts of interest.
Attendance was as follows: Ahok BV (permanent representative: Mr. Koen Hoffman): 4/4, Noshaq SA (permanent
representative: Mr. Gaëtan Servais): 8/8, TicaConsult BV (permanent representative: Mr. Erik Van Den Eynden): 8/8,
and Alius Modi (permanent representative: Mrs. Valérie Gordenne): 4/4 . The number of meetings attended by each
Director should take into account the expiration of the term of the mandate of certain Directors during the year as
well as the nomination of new Directors during the financial year.
1.4.7. Nomination and remuneration committee
The Board of directors has set up a remuneration committee, in line with the Belgian Companies and Associations
Code. As the remuneration committee also performs the task of a nomination committee, it is called the nomination
and remuneration committee.
More detailed information on the nomination and remuneration committee’s responsibilities can be found in the
Company's Corporate Governance Charter, which can be found on Mithra’s website (www.mithra.com). In principle,
the nomination and remuneration committee will meet at least two (2) times per year.
Composition
The nomination and remuneration committee is composed of three members, which are exclusively non-executive
directors. The majority of its members are independent directors in the meaning of article 7:87 of the Belgian
Companies and Associations Code.
The nomination and remuneration committee has the necessary expertise in terms of remuneration policy, which is
evidenced by the experience and the previous roles of its members.
The following Directors are members of the nomination and remuneration committee: Mrs. Patricia van Dijck, Mrs.
Amel Tounsi, Sunathim BV (permanent representative: Mr. Ajit Shetty). Mrs. Patricia van Dijck and Sunathim BV
(permanent representative: Mr. Ajit Shetty) are both Independent Directors. Before the General Meeting of
81
May 20, 2021, the Committee was composed of Mrs. Patricia van Dijck, Sunathim BV (permanent representative: Mr.
Ajit Shetty) and Selva Luxembourg SA (permanent representative Mr. Christian Moretti). Mrs. Patricia van Dijck and
Sunathim BV (permanent representative: Mr. Ajit Shetty) were both Independent Directors.
The CEO is invited to attend the meetings of the Nomination and Remuneration Committee in an advisory and non-
voting capacity. He does not attend discussions concerning his own remuneration.
The Chair of the Nomination & Remuneration Committee reports to the Board subsequent to each Committee
meeting on its activities, conclusions, recommendations and resolutions. The Chair of the Nomination &
Remuneration Committee shall, on an annual basis, report to the Board on the Nomination & Remuneration
Committee’s performance. Every three (3) years, the Nomination & Remuneration Committee reviews its terms of
reference and its own effectiveness and recommends any necessary changes to the Board.
Activity report
The Nomination & Remuneration Committee met six (6) times in 2021.
The main topics discussed were the preparation of the remuneration report, the performance of the CEO and other
members of the Executive Management Team, their appointment, resignation, and remuneration (including the grant
of subscription rights), the composition of the Executive Management Team, the assessment of the contractual
conditions giving right to bonuses to the CEO, the implementation of a new Corporate Governance Charter and the
renewal of the Board of directors.
Attendance was as follows: Mrs. Patricia van Dijck (6/6), Mrs. Amel Tounsi (4/4), Sunathim BV (permanent
representative: Mr. Ajit Shetty) (6/6) and Selva Luxembourg SA (permanent representative Mr. Christian Moretti)
(2/2).The number of meetings attended by each Director should take into account the expiration of the term of the
mandate of certain Directors during the year as well as the nomination of new Directors during the financial year.
Executive Management
By a decision of 15 June 2015, the Board of directors of the Company set up an Executive Management Team. The
Executive Management Team is an advisory committee of the Board of directors.
The Executive Management Team’s mission is to discuss and consult with the Board and advise the Board on the
day-to-day management of the Company in accordance with the Company’s values, strategy, general policy and
budget, as determined by the Board.
While exercising its advisory responsibilities, the Executive Management Team shall be guided by the interests of
the Company and its business.
More detailed information on the Executive Management Team’s responsibilities can be found in the Company's
Corporate Governance Charter, which can be found on Mithra’s website. (www.mithra.com).
Composition
The Executive Management Team is currently composed of fourteen (14) members: the Chief Executive Officer
(CEO)
1
the Chief Executive Officer (CEO) / under leave of absence
2
, The Chief Financial Officer (CFO), the Chief Legal
Officer (CLO), the Chief Scientific Officer (CSO), the Chief Supply Chain Officer (CSCO), the Chief Manufacturing
Officer (CMO)
3
, Chief Business Officer (CBO), the Chief Human Resources Officer (CHRO), the Group Quality Manager,
the Group Communication Manager, the Group Investor Relations Manager (IRO), the Group IT Manager (GITM) and
the Chair of the Scientific Advisory Board.
The Executive Management Team is chaired by the CEO of the Company. Furthermore, the Chair may invite additional
personnel to attend a meeting of the Executive Management Team.
The members of the Executive Committee as of the date of this report are listed in the table below:
82
Name
Function
Van Rompay Management BV (permanent representative:
Mr. Leon Van Rompay)
1
Chief Executive Officer (CEO)
Yima SRL (permanent representative: Mr. François Fornieri)
1
Chief Executive Officer under leave of absence, Chief
Business Development Officer under leave of absence
Eva Consulting SRL (permanent representative:
Mr. Jean-Michel Foidart)
Chair of the Scientific Advisory Board
CMM&C SRL (permanent representative: Mr. Christophe Maréchal)
1
Chief Financial Officer (CFO)
M. Cédric Darcis
Chief Legal Officer ( CL0)
GD Lifescience SRL (permanent representative: Mr Graham Dixon)
Chief Scientific Officer (CSO)
BGL Consulting SRL (permanent representative:
Mr. Benjamin Brands)
Chief Supply Chain Officer (CCO)
MAREBA BVBA (permanent representative: Mr Renaat Baes)
Chief Manufacturing Officer (CMO)
2
Novafontis SRL (permanent representative: Mr. Jean-Manuel
Fontaine)
Chief Business Officer (CBO)
Acta Group SA (permanent representative : Ms. Laurence Schyns)
5
Chief Human Resources Officer (CHRO),
Mr. Benoît Mathieu
Group Investor Relations Manager
Mrs. Maud Vanderthommen
Group Communication Manager
Mr. Frédéric Constant
Group Quality Manager
T Mundi BV (permanent representative : Stijn Vlaminck)
3
Group IT Manager
IARA SRL (permanent representative : Mrs. Jessica Salmon)
4
Corporate Controlling Officer and Executive Deputy
1. On 21st January 2021, in accordance with the Internal Governance Code, the Board of directors has decided to entrust the position of CEO
ad interim to Mr Christophe Maréchal until further decision by the Board. Moreover, according to article 7:95 of the BCC and article 19 of the
Company’s articles of association and taking into account the need for the Company to ensure continuity of management, the directors of
the Company have consented to set in motion the temporary succession plan provided for in Schedule D, section C, “In case of temporary
unavailability (no longer than 6 months leave)” of the Company’s Corporate Governance Charter. Members of the Executive Committee
have been until further decision by the Board, able to function in different silos depending on their area of expertise. These responsibilities
have been carried out under the supervision of Christophe Maréchal who assumed ad interim the CEO’s task and responsibilities as per the
Charter of the Company. On 3 February 2021, the Board of directors accepted that Yima SRL (represented by Mr. François Fornieri) takes
a step back as CEO, until further notice, for a maximum period of 12 months, following his indictment in the context of an external file not
related to Mithra. As a result, hereof, the Board of directors has decided to appoint Leon Van Rompay as CEO ad interim until further notice.
On 15 October 2021, Yima SRL (represented by Mr. François Fornieri) decided, in consultation with the Board of directors, to remain on the
sidelines of his executive functions, as long as the legal case related to insider trading is pending. As the founder and principal shareholder
of the company, he will continue to fully fulfill his role as a member of the Board of directors and to support the strategy of the Company
from this seat. Following the decision of Mr. Fornieri, Mithra’s Board of directors confirmed Leon Van Rompay as Chief Executive Officer.For
further information, please see the press releases published by the Company on 21 January 2021, 4 February 2021 and 15 October 2021
on its website (https://investors.mithra.com/en/press-releases/).
2. Post Period, on 3 March 2022, upon recommendation of the Nomination and Remuneration Committee, the Board of directors changed the
job title of the CMO in order to become the CDMO Site Director of the Company.
3. Post period, on 1
st
February 2022, under request of T Mundi BV (permanent representative: Stijn Vlaminck), the performance of its duties
have been transferred to the company Hof Vlaminck SCS (permanent representative: Stijn Vlaminck).
4. On 12
th
April 2021, the Board of directors ratified the termination of the consultancy contract between IARA SRL and the Company with
effect from 23th March 2021.
5. The Board of directors validated this appointment by a resolution of March 5, 2022 on the recommendation of the Nomination and
Remuneration Committee of the same day
83
Activity report
In 2021, The Executive Management Team met regularly and at least once every month. The CEO reported and
advised the Board on the day-to-day management at every meeting.
1.4.8. Diversity and inclusiveness
Article 7:86 of the Belgian Companies and Associations Code provides that at least one third of the members of the
Board of directors should be of the opposite gender. In order to calculate the required number of Directors of a
different gender, fractions must be rounded to the nearest whole number. These gender diversity requirements are
applicable to the composition of the Board of directors of companies, the securities of which are listed, for the first
time as from the first day of the sixth year following the date they became publicly listed. If, for any reason
whatsoever, the composition of the Board of directors does not or no longer meets the conditions laid down here
above, the first General Shareholders' Meeting that follows shall constitute a Board of directors that meets these
requirements.
Since the Annual General Shareholders' Meeting of 16 May 2019, the Company complied with the gender diversity
requirements set by article 7:86 of the Belgian Companies and Associations Code (and Article 2.1 of the CBGE). The
Board of directors still comply with the requirement of gender diversity as. The Board of directors currently has five
(5) female directors (representing a ratio of 50.00% female Directors against 50.00% male Directors). In the future,
the Company undertakes to take gender diversity into consideration when renewing the members of its Board of
directors and when filling new positions.
1.4.9. Principal characteristics of internal control and risk management
The Company operates a risk management and control framework in accordance with the Belgian Companies and
Associations Code and the 2020 Code. The Group is exposed to a wide variety of risks within the context of its
business operations that can result in its objectives being affected or not achieved. Controlling those risks is a core
task of the Board of directors (including the Risk and Audit committee), the Executive Management Team and all
other employees with managerial responsibilities.
The Executive Management Team leads the Company within the framework of prudent and effective control, which
enables it to assess and manage risks. The Executive Management Team develops, maintains and ongoingly
improves (including with the support of external advisers) adequate internal control and risk management
procedures so as to offer a reasonable assurance concerning the realization of goals, the reliability of the financial
information, the observance of applicable laws and regulations and to enable the execution of internal control and
risk management procedures.
The Executive Management Team is an advisory committee to the Board of directors and the CEO on the day-to-day
management of the Company. Each member of the Executive Management Team has individually been made
responsible for certain aspects of the day-to-day management of the Company and its business (in case of the CEO,
by way of a delegation from the Board of directors; in case of the other Executive Management Team members, by
way of a formal delegation of authority from the CEO). In the case that any decision to be taken by a member of the
Executive Management Team could be material to the Company (or falls outside the scope of the delegation of
authority), it shall be presented and discussed at a meeting of the Executive Management Team. The Executive
Management Team meets several times per month.
During those Executive Management Team meetings, there is a follow-up on the progress of various Group projects,
clinical studies, business development deals, and other material matters.
The process of gathering financial information is organized on a monthly (work in progress), quarterly, half-year and
annual basis, and reports of such information are made available to the CEO and the Risk and Audit committee. The
finance team (strengthened during 2021 due to the ram-up of our activities) produces the accounting figures and
reports under the supervision of the CFO. The accounts are kept by an ERP (formally Dynamics AX migrated to D365
upgraded version early 2021). The cash and working capital are monitored on a continuous basis.
The quality of the internal control and risk management is assessed during the course of the financial year and on
an ad hoc basis with internal audits (supply chain, IT, PO validation workflows, working capital management, etc.)
carried out on the basis of potential risks identified. The conclusions are shared and validated with the Risk and Audit
committee. During the financial year, the Risk and Audit committee undertakes reviews of the half-year closures and
specific accounting treatments. It reviews the disputes and puts all the questions it deems relevant to the Auditor,
to the CFO or to the Executive Management Team of the Company.
84
During the period under review, the Company has mandated Ernst & Young (“EY”) in order to audit the Company’s
current governance policies with the view of assisting the Company to set up optimized governance policies suited
for a fully-fledged commercial Company. Most of the conclusions of this audit are very positive for the Company,
minor areas of improvement are being implemented.
The Risk and Audit committee assists the Board of directors in the execution of its task to control the Executive
Management Team.
Control environment
The Executive Management Team has organized the internal control environment, which is monitored by the Risk
and Audit committee. The Risk and Audit committee decided not to create an internal audit role, since the scope of
the business does not justify a full-time role.
The role of the Risk and Audit committee is to assist the Board of directors in fulfilling its monitoring responsibilities,
as stipulated in the Company’s Corporate Governance Charter and the Business Code of Conduct. These
responsibilities include the financial reporting process, internal control and risk management systems (including the
Company’s process for monitoring compliance with laws and regulations) and the external audit process.
Dealing code
With a view to preventing market abuse (insider dealing and market manipulation), the Board of directors has
established a dealing code. The dealing code describes the declaration and conduct obligations of Directors,
executives and workers of the Group with respect to transactions in shares and other financial instruments of the
Company. The dealing code sets limits on carrying out transactions in shares and other financial instruments of the
Company and allows dealing by the above-mentioned persons only during certain windows.
1.4.10. Statutory auditor
BDO Réviseurs d’Entreprises SCRL, with registered office at Rue de Waucomont 51, , 4651 Herve, Belgium, member
of the Institut des Réviseurs d’Entreprises/Instituut der Bedrijfsrevisoren, represented by Cédric Antonelli, auditor,
has been renewed as Statutory Auditor of the Company on 20 May 2021 for a term of three (3) years ending
immediately after the Shareholders Meeting to be held in 2024 which will deliberate and resolve on the financial
statements for the financial year ended on 31 December 2023. BDO Réviseurs d’Entreprises SCRL is a member of
the Belgian Institute of Certified Auditors (“Institut des Réviseurs d’Entreprises”) (membership number B00023).
The Statutory Auditor as the auditor responsible for the audit of the consolidated financial statements, confirms
annually in writing to the Risk and Audit committee his or her independence from the Company, discloses annually
to the Risk and Audit committee any additional services provided to the Company, and discusses with the Risk and
Audit committee the threats to his or her independence and the safeguards applied to mitigate those threats as
documented by him or her.
During the past fiscal year, in addition to its usual activity, the Statutory Auditor performed additional activities on
behalf of the Company mainly for the issuance of special reports, for participation to meeting of the Risk and Audit
committee and for participation to special projects.
In 2021, the Company spent EUR 211,344 for fees related to the activities of the auditor, split as follows:
In Euro (€)
Auditor’s fees for statutory and consolidated financial statements
158,000
Fees for exceptional services or special missions (audit related)
31,522
Tax consultancy (audit related)
-
Fees for exceptional services or special missions (external to audit)
-
Tax consultancy (external to audit)
21,822
Total
211,344
1.4.11. Information that has an impact in case of public takeover bids
No takeover bid has been instigated by third parties in respect of the Company’s equity during the current financial
year.
85
The Company provides the following information in accordance with Article 34 of the Belgian Royal Decree dated
14 November 2007:
Share capital and shares
The share capital of the Company amounts to EUR 32,249,706.40 and is fully paid-up. It is represented by 44,051,259
ordinary shares, each representing a fractional value of (rounded) EUR 0.7321 and representing one 44,051,259th of
the share capital. The Company's shares do not have a nominal value
2
.
Restrictions, either legal or prescribed by the articles of association, on the transfer of shares
Other than the applicable Belgian legislation on the disclosure of significant shareholdings and the Company's
articles of association, there are no restrictions on the transfer of shares.
Special control rights
There are no holders of any shares with special control rights.
Possible control mechanism provided for in a shareholding system of the personnel, when
control rights are not exercised directly by the personnel
There are no share option plans for the personnel other than the share option plans disclosed elsewhere in this
report. These share option plans contain provisions on accelerated vesting in case of change of control.
Restrictions, either legal or prescribed by the articles of association, on voting rights
Each shareholder of the Company is entitled to one vote per share. Voting rights may be suspended as provided in
the Company's articles of association and the applicable laws and articles.
Agreements between shareholders that may result in restrictions the transfer of securities
and/or the exercise of voting rights
There are no agreements between shareholders which are known by the Company that may result in restrictions on
the transfer of securities and/or the exercise of voting rights.
Rules governing the appointment and replacement of Board members and the amendment of
the issuer’s articles of association
The rules governing appointment and replacement of Board members and amendment to articles of association are
set out in the current versions of the Company's articles of association and the Company's Corporate Governance
Charter.
Powers of the Board of directors
The powers of the Board of directors, more specifically with regard to the power to issue or redeem shares are set
out in the Company's articles of association. The Board of directors was not granted the authorization to purchase
its own shares "to avoid imminent and serious danger to the Company" (i.e., to defend against public takeover bids). The
Board of directors is however authorised to dispose of listed shares or certificates, in accordance with article 7:218
of the Belgian Companies and Associations Code (this authorisation extends to disposals made by its direct
subsidiaries, as defined in article 3:22 of the Belgian Companies and Associations Code).
2
This is the share capital of the Company as of December 31, 2021. Post period, on 14
th
February 2022, the share capital of the
Company amounts EUR 32,573,434.43 and is fully paid-up. It is represented by 44,493,450 ordinary shares, each representing a
fractional value of (rounded) EUR 0.7320 and representing one 44,493,450th of the share capital. On 21th March, the share capital
of the Company amounts is EUR 32,849,581.09 and is fully paid-up. It is represented by 44,870,648 ordinary shares, each
representing a fractional value of (rounded) EUR 0.7320 and representing one 44,870,648
th
of the share capital.
,
86
Change of control clauses
At the date of this report, the Company is a party to the following significant agreements which, upon a change of
control of the Company or following a takeover bid can enter into force or, subject to certain conditions, can be, as
the case may be, amended, terminated by the other parties thereto or give the other parties thereto (or beneficial
holders with respect to bonds) a right to an accelerated repayment of outstanding debt obligations of the Company
under such agreements:
The asset purchase agreement dated July 28th, 2018 by means of which the Company sold its generic
division to Ceres Pharma NV. The terms of this agreement provide a change of control clause under which,
in the event of Change of Control on the level of Mithra Pharma, all of the earn-outs which are not yet due by
CERES PHARMA at that moment shall be reduced with 50%.
The agreement of 30
th
September 2019 between the Company and the former shareholders of Uteron
Pharma concerning the Company’s remaining payment obligations in connection with the earn-outs
agreement. Under the terms of this agreement, any outstanding earn-out amount shall become immediately
and fully payable early in case of Change of Control within the meaning of the aforementioned provision
within the Company.
A put option agreement entered into on 23 April 2020 by the Company, LDA Capital Limited, LDA Capital,
LLC, and three existing shareholders of the Company (i.e., François Fornieri, Alychlo NV and Noshaq SA) (the
"Put Option Agreement") provides (amongst other things) that it may be terminated forthwith during the
commitment period (as defined in the Put Option Agreement) by LDA Capital Limited by giving written notice
of such termination to the Company if there has been a material change in ownership (which has been
defined as any sale or disposal of shares of the Company or other transaction or event which results in the
officers and Directors of the Company on the date of the Put Option Agreement owning, directly or indirectly,
less than five % the Company's shares in issue from time to time); and
On 17 December 2020, the Company issued 4.250 per cent. convertible bonds for a total principal amount
of EUR 125,000,000 million due on 17 December 2025. Conditions 5(b)(x) and 6(d) of the terms and
conditions of the convertible bonds provide that, if a change of control over the Company occurs, the
conversion price of the convertible bonds will be adjusted in proportion to the already elapsed time since the
closing date (i.e. 17 December 2020) and the bondholders may request the early redemption of their
convertible bonds at their principal amount, together with the accrued and unpaid interests.
Furthermore, as aforementioned, the share option plans of the 2015 Share Options, 2018 Share Options, the
LDA warrant plan, the Share Lending Warrants and 2020 Share options issued by the Company also contain
take-over protection provisions pursuant to which, in the event of a liquidity event resulting from a public bid
or otherwise, that modifies the (direct or indirect) control (as defined under Belgian law) exercised over the
Company, the share options holders shall have the right to exercise their share options, irrespective of
exercise periods/limitations provided by the plan.
The Master Confirmation Agreement dated 4th February 2022 between the Company and Goldman Sachs
International provides that should a change of control occur, an adjustment on the economics of the
contract shall occur. This Adjustment shall be determined by the Calculation Agent based on the 2006 ISDA
Definitions and the definitions and provisions of the 2002 ISDA Equity Derivatives Definitions rules in each
case as published by the International Swaps and Derivatives Association, Inc, using customary
mechanisms. Should the Adjustment be rejected by the Company following a change of control, it may in
some circumstances cause a termination of the Master Confirmation Agreement.
Agreements between the Company and the members of its Board or its personnel
At the date of this report, there is no agreement between the Company and the members of its Board or its personnel,
which provide for indemnities if the Board members resign or have to cease their functions without a valid reason or
if the employment of the members of the personnel is terminated due to a public takeover bid.
As mentioned and described in the remuneration report, post period, on 23th November 2021, the Board of directors
approved a bonus plan. Insofar as needed and applicable (considering its limited financial importance for the
company), this bonus plan provides, among other things, that, in case of a transaction leading inter alia to a change
of control over the Company and/or its affiliates, members of the management team and certain other managers
shall be entitled to a bonus of an aggregate amount of 0.75% of the aggregate purchase price of the shares sold in
the transaction.
87
1.4.12. Remuneration report
As prescribed by provision 3:6, §3 of the CCA, please find below the remuneration report pursuant to financial year
2021 prepared by the Nomination and Remuneration Committee. It will be submitted to the General Meeting of
Shareholders.
The Remuneration and Nomination Committee confirms that, for the duration of the financial year 2021, the
members of the Board of directors and the executive Committee, were subject to a remuneration policy compliant
with the Corporate Governance Charter which has been amended in April 2020 to reflect the new provisions of the
CCA as well as the Code of Corporate Governance 2020 (CBGE 2020). The Board of directors upon recommendation
of the Nomination and Remuneration Committee prepared a remuneration policy in accordance with provision 7:89
of the CCA which has been approved by the General Meeting of 22 May 2021’s.
The Directors as well as the members of the Executive Management Team are paid by Mithra Pharmaceuticals SA,
parent company of the Mithra Group even though, members can perform tasks for the subsidiaries of the Group.
Directors
Procedure applied in 2021 in order to comply with the remuneration policy and to determine the
individual remuneration
In 2021 still, the Nomination and Remuneration Committee recommended the level of remuneration for Directors,
including the Chairman of the Board, which is subject to approval by the Board of directors and, subsequently, by the
Annual Shareholders Meeting.
The Nomination and Remuneration Committee benchmarked the Directors’ compensation against peer companies.
The level of remuneration should be sufficient to attract, retain and motivate Directors who match the profile
determined by the Board.
Apart from their remuneration, all Directors will be entitled to a reimbursement of out-of-pocket expenses actually
incurred as a result of their participation in meetings of the Board of directors.
The level of remuneration of the Directors was determined at the occasion of the Companys Initial Public Offering
on 8 June 2015 and explained in the Prospectus issued by the Company in that context. The Company’s policy with
respect to the remuneration of its Directors has been further detailed in its 2020 Corporate Governance Charter.
Those principles have been used by the Board of directors, upon recommendation of the Nomination and
Remuneration Committee, to draft a remuneration policy proposal which has been submitted to the General Meeting
on 20th May 2021. The remuneration of the Directors has been disclosed to the Company’s shareholders in
accordance with the applicable laws and regulations.
The Directors’ mandate may be terminated ad nutum (at any time) without any form of compensation. There are no
employment or service agreements that provide for notice periods or indemnities between the Company and the
members of the Board of directors, who are not members of the Executive Management Team. This information has
been further detailed in the draft remuneration policy which has been submitted for approval to the last General
Meeting (which can be found on Mithra’s website (www.mithra.com).
Remuneration policy applied during 2021
The remuneration package for the Non-Executive Directors (whether or not independent) approved by the
Shareholders Meeting of 8 June 2015 is made up of a fixed annual fee of EUR 20,000. The fee is supplemented with
a fixed annual fee of EUR 5,000 for membership of each committee of the Board of directors, and an additional fixed
annual fee of EUR 20,000 for the Chairman of the Board. Changes to these fees will be submitted to the Shareholders
Meeting for approval.
There is no performance-related remuneration for Non-Executive Directors. Therefore, the percentage for those non-
executive Directors is 100% of fix remuneration.
Apart from the above remuneration for Non-Executive Directors (whether or not independent), all Directors will be
entitled to a reimbursement of out-of-pocket expenses incurred as a result of participation in meetings of the Board
of directors.
The total amount of the remuneration and the benefits paid in 2021 to the Non-Executive Directors (in such capacity)
was EUR 194,170 (gross, excluding VAT), split as follows:
88
Name
Nature
Remunerations
3
As member of a
committee
As chairman
of the board
YIMA SRL
Non-exec
-
-
-
NOSHAQ SA
Non-exec
20,000
5,000
-
Ahok BVBA
2
Independent
8,333
2,083
-
Alius Modi SRL
Non-exec
11,667
2,500
-
A. Tounsi
Non-exec
11,667
2,500
-
P. van Dijck
1
Independent
20,000
5,000
10,000
A. Cloet
Independent
11,667
-
-
L. Weynants
Independent
11,667
-
-
Selva Luxembourg SA
2
Non-exec
8,333
2,083
-
Sunathim BV
Independent
20,000
5,000
11,667
TicaConsult BV
Independent
20,000
5,000
-
1. Mrs. Patricia Van Dijck was appointed as ad interim chairman of the Board on the 25
th
November 2020 until June 2021. Sunathim BV
(permanent representative: Mr. Ajit Shetty) succeeded her as of 20
th
May 2021.
2. These two mandates were not renewed at the ordinary General Meeting of May 20, 2021. Selva Luxembourg SA (permanent representative
Mr. Christian Moretti) and Ahok BVBA (permanent representative Mr. Koen Hoffman) participate now in all Board meetings as observers.
3. The Remuneration attended by each Director should take into account the nomination of new Directors during the financial year.
The table below provides an overview of the shares and warrants held by the current members of the Board on the
31st of December 2021.
Share / Warrantholder
Shares
%
3
Warrants*
%
Shares and
Warrants
%
YIMA SRL (permanent
representative: Mr François
Fornieri) (CEO)
0.00
0
952,790
47,15%
952,790
2.06
Mr François Fornieri
(permanent representative of
YIMA SRL)
10,984,330
24.93
150,000
7,42
11,134,330
24,17
AHOK BVBA (permanent
representative : Mr Koen
Hoffman)
0.00
0.00
0
0.00
0
0.00
Koen Hoffman (permanent
representative of Ahok BVBA)
(together with Ahok BVBA)
0.00
0.00
0
0.00
0
0.00
NOSHAQ SA (permanent
representative: Gaëtan Servais)
4,965,848
11.27
75,000
3,71
5,040,848
10.94
Gaëtan Servais (permanent
representative of NOSHAQ SA)
0.00
0.00
0
0.00
0
0.00
Eva Consulting SRL
(permanent representative :
Jean-Michel Foidart)
0.00
0.00
52,695
2,6
52,695
0.11
Mr Jean-Michel Foidart
(permanent representative of
Eva Consulting SRL) (together
with Eva Consulting SRL)
20,370
0.04
0
0.00
20,370
0.00
Mrs Patricia Van Dijck
0.00
0.00
0
0.00
0
0.00
3
On the 31
st
of December 2021
89
Selva Luxembourg SA
(permanent representative M.
Christian Moretti)
689,655
0,01
0
0.00
689,655
1.49
Christian Moretti (permanent
representative of de Selva
Luxembourg SA)
0.00
0.00
0
0.00
0
0.00
Sunathim BV (permanent
representative Ajit Shetty)
0.00
0.00
0
0.00
0
0.00
Mr Ajit Shetty (permanent
representative of Sunathim BV)
780
0.00
0
0.00
0
0.00
TicaConsult BV (permanent
representative Mr Erik Van Den
Eynden)
0.00
0.00
0
0.00
0
0.00
Mr Erik Van Den Eynden
(permanent representative of
TicaConsult BV)
0.00
0.00
0
0.00
0
0.00
Alius Modi SRL (permanent
representative Valérie
Gordenne )
0.00
0.00
0
0.00
0
0.00
Valérie Gordenne (permanent
representative of Alius Modi
BV)
37,500
0.08
0
0.00
37,500
0.08
Mrs Amel Tounsi
0.00
0.00
0
0.00
0
0.00
Mrs An Cloet
0.00
0.00
0
0.00
0
0.00
Mrs Liesbeth Weynants
0.00
0.00
0
0.00
0
0.00
Subtotal
16,698,483
36.33
1,230,485
60.88
17,928,968
38.91**
* corresponds to the amount of shares following warrant conversion.
**the figures in this table are based on unilateral statements made by the Directors.
During the fiscal year 2021, the Executive-Director perceived its remuneration as a fix amount and there was no
remuneration by means of warrants. No variable remuneration were paid.
Executive Management team
Procedure applied in 2021 in order to comply with the remuneration policy and to determine the
individual remuneration
The remuneration of the members of the Executive Management Team is determined by the Board of directors upon
recommendation of the Nomination and Remuneration Committee and subsequent to the CEO’s recommendation
to this Committee (except for his own remuneration). The Company strives to be competitive in the European market.
Remuneration policy applied during 2021
The level and structure of the remuneration of the members of the Executive Management Team is such that
qualified and expert professionals can be recruited, retained and motivated taking into account the nature and scope
of their individual responsibilities.
The remuneration of the members of the Executive Management Team currently consists of the following elements:
Each member of the Executive Management Team is entitled to a basic fixed remuneration designed to fit
responsibilities, relevant experience and competences, in line with market rates for equivalent positions;
Each member of the Executive Management Team currently participates in, and/or in the future may be
offered the possibility to participate in a stock based incentive scheme or stock option in accordance with
the recommendations set by the Nomination and Remuneration Committee, upon the recommendation by
the CEO to such committee (except in respect of his own remuneration) and after (in respect of future stock
90
based incentive schemes) prior shareholder approval of the scheme itself by way of a resolution at the
Annual Shareholders Meeting;
Each member of the Executive Management Team is entitled to a number of fringe benefits (to the
exception, however, of those managers engaged on the basis of service agreements), which may include
participating in a defined contribution pension or retirement scheme, disability insurance and life insurance,
a company car, and/or a lump-sum expense allowance according to general Company policy.
The Company’s policy with respect to the remuneration of its Executive Management team has been further detailed
in its 2020 Corporate Governance Charter. Those principles have been used by the Board of directors, upon
recommendation of the Nomination and Remuneration Committee, to draft a remuneration policy that was approved
by the General Meeting of 20th May 2021.
In addition to the 2015 Warrant Plan, in order to include new members of the Executive Management team, a short-
and long-term performance-based remuneration and incentive scheme has been elaborated within the Nomination
and Remuneration Committee, validated by the Board of directors and formally approved by the Extraordinary
General Meeting of shareholders on 5 November 2018 (Warrant Plan 20218). Such scheme is based on objectives
which are, in accordance with Article 520bis of the BCC (article 7:90 of the CCA), pre-determined by an explicit
decision of the Board of directors and were chosen so as to link rewards to corporate and individual performance,
thereby aligning on an annual basis the interests of all members of the Executive Management Team with the
interests of the Company and its shareholders and benchmarked with the practices in the sector.
Following the implementation of the BCCA, the Board of directors decided to issue a new warrant plan (Warrant Plan
2020) within the framework of the authorized capital for members of its personnel. The purpose of the Warrant Plan
2020 is to create a share option plan for the members of the personnel in accordance with the provisions of the
BCCA. The number of share options issued under this plan, 390,717 warrants is the same as the number of share
options which have not yet been granted under the Warrant Plan 2018 which was created in November 2018 in
accordance with the provisions of the (old) Belgian Companies Code. Therefore, the Board of directors also decided
to no longer grant an equal number of outstanding share options under the Warrant Plan 2018 that have not yet been
granted to the selected participants of the Warrant Plan 2018. This Warrant Plan 2020 has a longevity period of 10
years and is not subject to vesting conditions.
The amount of remunerations and benefits paid in 2021 to the CEO and the other members of the Executive
Management Team, (gross, excluding VAT) is shown in the table below:
Thousands of Euro (€)
Total
Of which CEO
Basic remuneration
2,937
440
Variable Remuneration
260
-
Group Insurance (pension, invalidity, life)
16
-
Other benefits (car, cell phone, hospitalization)
46
-
Total
3,259
440
Only the members of the Executive Management Team which performed their services through an employment
contract had a Group Insurance scheme which covered pension benefits throughout the year 2021. The Group
insurance amounted to 4% of this yearly gross remuneration (3% in charge of the Company and 1% in his own charge)
and was cashable when the employee would reach 65 years old. In case the employee would leave the Company, he
would keep the collected amounts and the Group insurance would cease to his profit.
The table below provides an overview of the shares and warrants held by the members of the Executive Management
Team, including the Executive Director on 31 December 2021 (i.e. the CEO). The share-based payment costs related
to warrants held by the members of the Executive Management Team represent EUR 154k, out of the total share-
based payment costs of EUR 1,064k included in the net loss for the period.
91
Shares / Warrants holder
Shares
%
Warrants
%
Shares and
Warrants
%
Van Rompay Management BV
(permanent representative:
Mr. Leon Van Rompay)
1
(CEO)
0
0.00
0
0
0
0
YIMA SRL
2
(permanent representative:
Mr. François Fornieri
0.00
0.00
952,790
47.15
952,790
2.06
Mr. François Fornieri (permanent
representative of YIMA SRL)
2
10,984,330
24.93
150,000
7.42
11,134,330
24.17
Mr. Christophe Maréchal
(representative of and together with
CMM&C SRL BVBA)
0
0.00
235,502
11.65
235,502
0.51
Mr. Jean-Michel Foidart
(representative of and together with
Eva Consulting SRL)
20,370
0.05
0
0.00
20,370
0.04
Mr. Benjamin Brands
(representative of and together with
BGL Consulting SRL)
0
0.00
67,695
3.35
67,695
0.15
Mr. Jean-Manuel Fontaine
(representative of and together with
Novafontis SA)
28
0.00
52,695
0.02
52,723
0.11
Mr. Graham Dixon
(representative of and together with
GD Lifescience SRL)
0
0.00
25,000
1.24
25,000
0
Mr. Cédric Darcis
0
0.00
52,695
0.03
52,695
0.11
Mr. Renaat Baes (representative of
and together with
MAREBA SRL)
0
0.00
35,000
0.01
35,000
0.07
Mrs. Maud Vanderthommen
0
0.00
15,000
0.00
15,000
0.03
Subtotal
11,004,728
24,98
1,586,377
70,87%
12,591,105
27.33%
Total
44,051,259
100.00%
2,020,900
100.00%
46,072,159
100.00%
1. On 3 February 2021, the Board of directors decided to appoint Van Rompay Management BV (represented by Mr. Leon Van Rompay) as
CEO ad Interim until further notice. On 15 October, the Board of directors has confirmed the appointment of Mr. Leon Van Rompay as Chief
Executive Officer of the company. For further information, please see the press releases published by the Company on 4 February 2021
and 15 October on its website (https://investors.mithra.com/en/press-releases/).
2. On 3 February 2021, the Board of directors accepted that Yima SRL (represented by Mr. François Fornieri) take a step back as CEO, until
further notice, for a maximum of 12 months. Consequently, for the time being, François Fornieri (through Yima SRL or in any other way)
does not exercise any executive function within the Mithra Group. On 15 October, YIMA SRL (represented by Mr. François Fornieri have
decided, in consultation with the Board of directors to remain on the sidelines of his executive functions, as long as its legal case related to
insider trading is pending. For further information, please see the press release published by the Company on 4 February 2021 and 15
October on its website (https://investors.mithra.com/en/press-releases/).
The Company has put in place five warrants plans since its incorporation, three of which are performance-related for
the Executive Management Team amongst others.
First, the Extraordinary Shareholders Meeting of the Company of 2 March 2015 approved, upon proposal of the Board
of directors, the issuance of warrants giving right to subscribe for 1,796,850 shares, which, on a fully-diluted basis,
represented 5.56% additional Shares at the time.
These warrants (1089) have been granted free of charge. All warrants have been accepted by the relevant
beneficiaries. Each warrant entitled its holder to subscribe for 1,650 Shares of the Company at a subscription price
of EUR 5,646.00 per 1,650 Shares (a part corresponding to the par value of the existing Shares on the day the
warrants are exercised will be allocated to the share capital). The balance will be booked as an issue premium.
92
These warrants can be exercised as from 1 January 2019 and have a term of 8 years as from the date of grant. Upon
expiration of the term, they become null and void.
As part of that plan, on 30
th
of January 2019, an increase of capital took place following the exercise of 15 warrants
pursuant the 2015 Warrant Plan ("2015 Warrant Plan") corresponding to a contribution of EUR 84,690. In accordance
with the 2015 Warrant Plan, the exercise period started on January 1, 2019. An amount of EUR 18,119.48 was
therefore contributed in cash to the share capital of Mithra and the balance of EUR 66,570.52 was allocated to the
Company's "share premium" account. This exercise of 15 warrants led to the issue of 24,750 shares (1 warrant being
equivalent to 1,650 shares) which on February 15
th
, 2019 were admitted to trading on the regulated market. As a
result, Mithra's share capital on January 30, 2019 amounted to EUR 27,573,880.18 corresponding to 37,664,245
ordinary shares.
A second increase took place on 24 April 2019, following the exercise of 15 warrants pursuant the 2015 Warrant Plan
("2015 Warrant Plan") corresponding to a contribution of EUR 84,690. An amount of EUR 18,119.40 was therefore
contributed in cash to the share capital of Mithra and the balance of EUR 66,570.52 was allocated to the Company's
"share premium" account. This exercise of 15 warrants resulted in the issue of 24,750 shares (1 warrant being
equivalent to 1,650 shares) which, on May 9, 2019, were admitted to listing on the regulated market. As a result,
Mithra's share capital at 24 April 2019 amounted to EUR 27,591,999.58 corresponding to 37,688,995 fully paid-up
ordinary shares. The shares have no par value but represent the same fraction of the Company's share capital, which
is denominated in euros. Each share entitles its holder to one voting right. The number of voting rights held by the
shareholders was 37,688,995 at 30 June 2019.
Finally, on 21 May 2021, the third capital increase took place following the exercise of 620 warrants from the 2015
Warrant Plan corresponding to a contribution of EUR 3.500.520. An amount of EUR 748,836 was therefore
contributed in cash to the share capital of the Company and the balance of EUR 2.751.684 was allocated to the
Company’s share premium account. This exercise of 620 warrants resulted in the issue of 1,023,000 shares (1
warrant being equivalent to 1,650 shares) which, on 14 May 2021 were admitted to listing on the regulated market.
As a result, Mithra's share capital at May 21 amounted to EUR 32,019,708;40 corresponding to 43,737,097 fully paid-
up ordinary shares. The shares have no par value but represent the same fraction of the Company's share capital,
which is denominated in euros. Each share entitles its holder to one voting right.
On 5 November 2018, Mithra’s Extraordinary General Meeting approved the issuance of a maximum of 1,881,974
warrants under the Warrant Plan 2018, for the benefit of key employees, members of the management team and
certain Directors. The warrants are expiring five years (maximum holding period) after the date of issuance. They are
generally not transferable and in principle, cannot be exercised prior to the date of the grant’s second anniversary
(i.e. as from 6 November 2020 subject to exercise conditions). The warrants are subject to vesting conditions which
have all been met in 2019. Each warrant gives the right to subscribe to one new Mithra share. Should the warrants
be exercised, Mithra will apply for the listing of the resulting new shares on Euronext Brussels. The warrants as such
will not be listed on any stock exchange market.
Out of the maximum of 1,881,974 warrants which have been issued, a number of 1,394,000have been offered and
accepted by beneficiaries until the period under review.
Following the implementation of the new BCCA, the Board of directors decided to issue a new warrant plan (Warrant
Plan 2020) within the framework of the authorized capital for members of its personnel. The purpose of the Warrant
Plan 2020 is to create a share option plan for the members of the personnel in accordance with the provisions of the
BCCA. The number of share options issued under this plan, 390,717 warrants, is the same as the number of share
options which have not yet been granted under the Warrant Plan 2018 which was created in November 2018 in
accordance with the provisions of the (old) Belgian Companies Code of 7 May 1999. Therefore, the Board of directors
also decided to no longer grant an equal number of outstanding share options under the Warrant Plan 2018 that
have not yet been granted to the selected participants of the Warrant Plan 2018. The Warrant Plan 2020 has a
longevity period of 10 years and is not subject to vesting conditions.
Additionally, a number of 1,394,900 of new warrants (representing 1,394,900 new shares) shall in principle be
exercisable, as from 6 November 2020 subject to exercise conditions pursuant to the Warrant Plan 2018. The
amount of 390,717 warrants issued as per the Warrant Plan 2020, representing 390,717 new shares are immediately
exercisable upon grant. Up to date an amount of 316,000 warrants has been granted per this 2020 Warrant Plan.
In 2021, ten (10) members of the Executive Management Team (including CEO) perform their functions based on a
service agreement, whereas four (4) members of the Executive Management Team are engaged based on an
employment agreement. Both sorts of contracts can be terminated at any time, subject to certain pre-agreed notice
periods, which may, at the discretion of the Company, be replaced by a corresponding compensatory payment.
93
The service agreement with the CEO, Van Rompay Management BV, sets out a notice period (or notice indemnity in
lieu of notice period) of 1 month.
The members of the Executive Management Team perceive part of their remuneration as a fix amount and part of
their remuneration in the form of warrants.
The grant of warrants to members of the Executive Management Team has been duly justified in all the issued
warrant plan and is performance related driven in order to keep the Executive Management Team interested in the
long-term performance of the Company. The purpose is to attract high qualified profiles to help the Company achieve
its goals.
Remuneration evolution
In the last five years, the performance of the Company scaled up as the Company progressively signed license and
supply agreements as the clinical studies for its product portfolio were moving forward. Notably the Company has
performed significantly well in 2018 and 2019 signing several landmark deals and cashing in important milestones
payments.
In 2021, the Company did not sign any significant deals reducing its EBIT.
Upon recommendation of the Nomination and Remuneration Committee, on 23th November 2021, the Board of
directors approved a bonus plan, which aims at motivating and retaining management. Among other things, this
bonus plan provides that:
a) in case of a transaction leading inter alia to a change of control over the Company and/or its affiliates,
members of the executive management team and certain other managers shall be entitled to a bonus of an
aggregate amount of 0.75% of the aggregate purchase price of the shares sold in the transaction; or
b) should such transaction as mentioned in a) above have not yet occurred, in case the Company’s market
capitalization exceeds EUR 1,5 billion for a period of 30 consecutive trading days, members of the executive
management team shall be entitled to a bonus of 2% of the average amount by which the market capitalization
exceeds EUR 1,5 billion during the relevant period. The bonus mentioned in b) above shall only become payable once.
Remuneration of Executive Committee, Employees and Company Performance over 5 years.
The below table is a summary of the evolution of total remuneration of the CEO, Executive Committee, the average
employee cost compared to company performance over the last five years.
Thousands of Euro (€)
2017
2018
2019
2020
2021
Remuneration of CEO
795
1,225
1,009
919
440
Change year on year
54%
-18%
-9%
-52%
Remuneration of the Executive Management Team
2,529
2,353
2,537
2,538
3,259
Change year on year
-7%
8%
0%
28%
Company performance
R&D expenses
48,185
35,713
57,073
78,458
85,243
Change year on year
-26%
60%
37%
9%
Cash and cash equivalents at end of period
36,190
118,949
49,720
138,675
32,872
Change year on year
229%
-58%
179%
-76%
Average share price
9.80
25.70
26.40
20.40
21.32
Change year on year
162%
3%
-23%
5%
FTE during the year
93
118
160
206
238
Change year on year
27%
36%
29%
16%
Average cost of employees on FTE basis
Average cost per FTE
70.67
67.49
69.20
67.91
75.32
Change year on year
-4%
3%
-2%
11%
4
The number of management members has evolved over time. While the executive management team included 10 members in 2020, it includes
14 members in 2021.
For further explanations with respect to the personnel benefit on a consolidated basis, please refer to section 9.21.
94
Total Remuneration of CEO versus Lowest Remunerated Employee
The below table shows a comparison of the 2021 remuneration of our CEO (in €), to the 2021 remuneration of the
lowest paid fulltime Company employee (in €). The remuneration includes fixed and variable remuneration as well as
employee benefits, excluding employer social security charge.
2021
Ratio of total remuneration of CEO versus lowest remunerated
employee
1:16
During fiscal year 2021, the lowest remuneration of the Company’s employee amounted to a yearly gross amount of
EUR 27,396 whereas the highest remuneration granted at management level goes to the CEO, with a yearly gross
amount of EUR 439,717.
Claw-back provisions
There are no provisions allowing the Company to reclaim any variable remuneration paid to Executive Management
based on incorrect financial information. This point is currently under revision with the draft remuneration policy
proposal which is subject to the General Meeting’s approval.
Miscellaneous
In general, the company has no intention to compensate in a subjective or discretionary manner.
Transactions within the authorized capital
By virtue of the resolution of the ordinary and extraordinary general shareholders' meeting of the Company held on
20
May 2021, as published by excerpt in the Annexes to the Belgian Official Gazette of 27 May 2021 under number
0332497, the Board of directors of the Company has been granted certain powers to increase the Company's share
capital in the framework of the authorised capital. The powers under the authorised capital have been set out in
Article 7 of the Company's Articles of Association.
In the framework of this authorisation granted by the ordinary and extraordinary general shareholders' meeting, the
Board of directors has been authorised to increase, in one or more transactions, the share capital of the Company
within the limits provided by law, in particular by issuing convertible bonds and subscription rights, with a maximum
amount of EUR 32,019,708. 40 (excluding issue premium, as the case may be). The Board of directors is specifically
authorised to use this authorisation for the following transactions:
Share capital increases or issuances of convertible bonds or subscription rights with disapplication or
limitation of preferential subscription rights of the shareholders.
Share capital increases or issuances of convertible bonds or subscription rights with disapplication or
limitation of preferential subscription rights of shareholders to the benefit of one or more specific persons,
other than members of the personnel of the Company and its subsidiaries.
Share capital increases effected by incorporation of reserves.
The capital increases that can be effected according to the aforementioned authorisation may take any form
whatsoever, in particular contributions in cash or in kind, with or without issue premium, and also by incorporation
of reserves and/or issue premiums and/or profits carried forward, to the extent permitted by law.
The aforementioned authorisation is valid for a period of five (5) years as of the date of the publication of the relevant
resolution of the extraordinary general shareholders' meeting in the Annexes to the Belgian Official Gazette, i.e.,
starting on 27 May2021 and until27 May 2024.
So far, the Board of directors has used its powers under the (renewed) authorised capital only once post period, on
the 4 February 2022 in relation to the potential issuance of new shares to the benefit of Goldman Sachs International
for an aggregate amount of EUR 100,000,000 (including issue premium) pursuant to the Equity Financing Agreement
executed on the same date. The first drawing request, exercised on 4 February 2022, amounts to EUR 10 million.
The second drawing request, exercised on 21 March 2022, amounts to EUR 5 million.
During the period under review, the Company used the previous authorization with respect to the use of the
authorized capital granted to the Board of directors on the extraordinary general meeting dated 29 November 2019
95
as published in the Annexes to the Belgian Official Gazette on the 30 December 2019 under the number 19168869
for the following:
- On 2 July 2021, the Company launched a second Put Option Notice pursuant to the Put Option Agreement
entered into with LDA Capital Ltd which materialized in a capital increase resulting in the issuance on the
10 November 2021 of 314,162 new shares to the benefit of LDA Capital for an aggregate amount of EUR
229,998 (excluding issue premium);
On 20 December 2021, the Company launched a third Put Option Notice pursuant to the Put Option Agreement
entered into with LDA Capital which materialized in a capital increase resulting in the issuance on the 14 February
2022 (post period) of 442,191 new shares to the benefit of LDA Capital for an aggregate amount of EUR 323,728.03
(excluding issue premium).
Acquisition of own securities
Neither Mithra Pharmaceuticals SA nor any direct affiliate or any nominee acting in his own name but on behalf of
the Company or of any direct affiliate, have acquired any of the Company’s shares. Mithra Pharmaceuticals SA has
not issued profit-sharing certificates or any other certificates.
Use of financial instruments by the Group as per art. 3:6 CCA
The Group uses derivative financial instruments to manage its exposure to foreign exchange risk arising from
operating activities (cash flow hedge). Mithra's risk management objective is to hedge the US Dollars (USD) foreign
currency exposure arising from the Estelle
®
license and supply agreement in USD between Mithra and Mayne
Pharma LLC. Mithra has a transactional USD exposure of 217 million USD in 2021 arising from the regulatory and
sales related license milestones under the Mayne Pharma agreement. This exposure is hedged by forward exchange
contracts maturing in the period 2020-2025 and entered into by Mithra Pharmaceuticals SA and Estetra SRL.
The Group uses debt instruments. In December 2020, the Group negotiated a EUR 125 million senior unsecured
convertible bonds due 17 December 2025. The Bonds will be convertible into ordinary shares of the company. The
Bonds were issued at 100% of their principal amount and bear a coupon of 4.250% per annum, payable semi-annualy
in arrear in equal instalments on 17 December and 17 June of each year, beginning on 17 June 2021.
Circumstances that could considerably affect the development of
the Group
The Group has a business structure; built on:
(i) a development portfolio which includes the development of Estetrol-based product candidates
in the menopause indications as well as other potential indications such as wound healing, NHIE,
and of Complex Therapeutics;
(ii) the CDMO development and manufacturing facility, which will manufacture an important part of
its innovative products, but also provides services for customer in terms of development and
manufacturing of third parties’ products), and
(iii) a commercialized portfolio of our former Estetrol-based product candidate Estelle
®
in the field of
oral contraception in several regions (Canada, US, Europe, United-Kingdom, Iceland, Norway,
Australia and Russia), branded generics, OTC products in several regions.
(iv) a diversification of the R&D pipeline through rights’ acquisition option relating to a development
programs led by the Belgian company BCI Pharma on innovative kinase inhibitors notably
indicated for the treatment of female cancers and endometriosis.
Therefore, the risk factors related to each of these pillars are presented separately (as each has a different set of
risks associated with it). As Mithra has transitioned towards a commercial biopharma company in 2021, most focus
is on the development portfolio and products’ commercial launch.
The Group’s exposure to price risk, credit risk, liquidity risk and cash flow risk are detailed in note 9.3 (Financial Risk
Management).
96
(i) Except Estelle
®
, no Estetrol-based product candidates have been formally registered nor commercialised and the
lead product candidate Estelle
®
is currently approved in Canada, the US, in Europe, United-Kingdom, Iceland,
Norway, Australia and Russia. Some of these events took place following the analysed period. Therefore, the
successful development of the Group’s Estetrol-based other product candidates remains uncertain. Estetrol-
based product candidates must undergo pre-clinical and clinical testing supporting the clinical development
thereof, the results of which, are uncertain and could substantially delay, which in turn could substantially
increase costs, or prevent the Estetrol-based product candidates from reaching the market.
Except Estelle
®
in the abovementioned countries, the Group’s other Estetrol-based product candidates have not been
approved nor commercialised.
In parallel, the agencies could require a number of additional studies to be conducted other than the pivotal studies
which are not expected to have a significant impact on any (potential) marketing authorisation approval, although
these will play a role in determining the labelling and leaflet restrictions the product candidate would have upon
approval (if any). Donesta
®
is currently in Phase III of clinical trial for use in menopausal hormone therapy. The data
currently available would seem to suggest that Estetrol decreases hot flushes in a dose-dependent manner. However
larger populations will be necessary to optimally see a difference in the results between the different Estetrol doses
tested and the placebo group as well as to confirm the minimum effective dose of E4 and longer treatment periods
as recommended by regulatory guidance (12 months) will complete the safety assessment of the product in post-
menopausal population .
Despite the recent positive opinion/approval on Estelle
®
in the abovementioned regions, all Estetrol-based product
candidates will be subject to extensive (pre-)clinical trials supporting the clinical development thereof to demonstrate
safety and efficacy in humans (which will take several years) before they can apply for the necessary regulatory
approval to enter the market and potentially obtain marketing authorisation with the relevant regulatory authorities.
The Group does not know whether future clinical trials will begin on time, will need to be redesigned or will be
completed on schedule. For Estelle
®
the activities announced during the current reporting period were completed
with the filing activities and the obtention of the first market authorizations in significant countries. As for Donesta
®
and the ongoing Phase 3 clinical trials, providing precise timing estimates for the development and registration (if
any) of Donesta
®
beyond the Phases of clinical development is thus difficult to predict.
At any stage of development, the triggering of certain contingent payments and “royalty payments”, may be
discontinued based on review of available pre-clinical and clinical data, the estimated costs of continued
development, market considerations and other factors such as the development of Estetrol-based product
candidates.
Any further delays in completing clinical trials or negative results will delay the Group’s ability to generate revenues
from product sales of Estetrol-based product candidates, if any. This could have a material adverse effect on the
Group’s business, prospects, financial condition and results of operation.
(ii) The Group is, for its future development and pipeline, currently heavily focused on, and investing in, the
development of its Estetrol-based product candidates. Its ability to realise substantial product revenues and,
eventually, profitability in line with the investments envisaged will mostly depend on its ability to successfully
develop, register and commercialise Estetrol-based product candidates.
The Group’s E4 pipeline currently comprises Estelle
®
, an original innovative product already approved in significant parts
of the globe and one other product candidates which would, upon their marketing authorisation, be joining the list of
original innovative products. The Group is dedicating the majority of its available cash resources to the development
of this innovative Estetrol-based product candidates. If the Group would be unsuccessful in developing,
commercialising and/or partnering this innovative original product, this would materially impact the revenue and
profitability potential of the Group. In that case, the nature of the Group’s pipeline would comprise the commercialisation
of the Estelle
®
, capable of generating a future return investment, but also of the development (either directly or indirectly)
of Complex Therapeutics and Injectables, both of the later present market opportunities of a level which is
significantly lower than the opportunity offered by the development of innovative original products. Both activities
have a profile which is more limited in terms of funding needs and growth potential compared to the development of
innovative product candidates.
(iii) In order to successfully develop, register and commercialise its Estetrol-based product candidates, the Group will
need to successfully pursue the continuous and successful transition from an initial focus on development and
commercialisation of generic products to a dedicated to in the development and commercialisation of innovative
and original product candidates.
97
The Group has, to date, received series of market authorisations for Estelle
®
and the product is being commercialized
progressively around the worldin significant parts of the globe (see above) for Estelle
®
but is only starting its
commercialisation. It still needs to pursue the development of its other E4-based products such as its development
programs in Menopause, Wound Healing, Neonatal Encephalopathy Donesta
®
. Such development, registration and
commercialisation present significant new challenges.
In preparation, the Group has expanded and continues to expand its organisation and has attracted and continues
to attract a number of experienced collaborators in this new field of development. However, the Group may not be
able to successfully integrate their experience and know-how, and to continue to further successfully expand its
organisation and successfully conclude every development step. A failure to successfully do so could cause delays in
the clinical development and/or the regulatory approval process, which could ultimately delay or even prevent the
commercialisation of the Group’s innovative product candidates. This could have a material adverse effect on the
Group’s business, prospects, financial condition and operations.
(iv) Complex therapeutics Zoreline
®
currently under development by the Group has not yet received any regulatory
approval. Myring
®
received regulatory approval for Europe and Canada but is still waiting for it in the US. Complex
Therapeutics must undergo bioequivalence or pharmacodynamics or any other studies, which could be subject
to delays, which in turn could substantially increase costs, or prevent these generic products from reaching the
market on time.
All complex therapeutics will be subject to bioequivalence or pharmacodynamics or other studies (as deemed fit by
the relevant regulatory agencies), to demonstrate that the generic product is bioequivalent to the previously approved
drug, before they can receive the necessary regulatory approval to enter the market. In 2016, Myring
®
was the first
complex therapeutic solution produced by Mithra to demonstrate bioequivalence; for the other products (including
Zoreline
®
), this is not yet the case. Any delays in completing studies, will delay the Group’s ability to generate
revenues from product sales of complex therapeutical solutions products if any. In case the Group would come late
in the market, dependent on the market as of the point when three to five generics have been approved, it will suffer
from significantly reduced market share, revenues and cashflows for the relevant generic product.
(v) The strategy chosen by the Group to diversify its R&D portfolio by triggering an option to purchase relating to a
development program led by the Belgian company BCI Pharma on innovative kinase inhibitors notably indicated
for the treatment of female cancers and endometriosis could not deliver on the Group’s expectations.
This project diversifies the portfolio in terms of chemistry and indication. It also provides the opportunity to obtain
composition of matter IP on the compounds themselves. The project might not deliver in the cancer or
endometriosis indications. However other opportunities to valorize the program exist in therapeutic indications
outside of womens health eg pain, inflammatory disease, neurodegenerative disorders. In addition, two distinct
chemical series are being proposed to reduce the risk in only one series.
(vi) The Group’s products may not obtain regulatory approval when expected, if at all, and even after obtaining
approval, the drugs will be subject to ongoing regulation.
Upon completion of the relevant studies, the Group’s products must obtain marketing approval from the European
Medicines Agency (EMA), the US Food and Drug Administration (FDA) or competent regulatory authorities in other
jurisdictions before the products can be commercialised in a given market, and each such approval will need to be
periodically renewed. Each regulatory agency may impose its own requirements and may refuse to grant or may
require additional data before granting marketing approval even if marketing approval has been granted by other
agencies. Changes in regulatory approval policies or enactment of additional regulatory approval requirements may
delay or prevent the products from obtaining or renewing marketing approval. Also, post-approval manufacturing
and marketing of the Group‘s products may show different safety and efficacy profiles to those demonstrated in the
data on which approval to test or market said products was based. Such circumstances could lead to the withdrawal
or suspension of approval. All of this could have a material adverse effect on the Group’s business, prospects,
financial condition and results of operation.
(vii) The Group, being only commercially present in selected regions, will need to rely on additional commercial
partners for the distribution of its products in other regions.
The Group’s product candidates are being developed, like Estelle
®
in significant parts of the globe (see above), with
the intention to be commercialized throughout the world. The Company has no commercial organisation in place to
launch its product candidates in these markets on its own.
98
Until now the Group has never marketed a product outside of the Benelux and has therefore limited experience in the
fields of sales, marketing and distribution in other markets. The Group does currently not intend to deploy itself a
sales and distribution organisation elsewhere in the world and will rely for the distribution of its products on license
and supply deals with commercial partners.
The Company has not contracted with any new major partners with respect to its product portfolio. Some partners
have been identified and some are still to be, but there can be no assurance that the Group will ever find an agreement
with them and even identify such un-identified partners. Therefore, its products might not be commercialised in all
the markets the Group currently intends to commercialise its products. The Group’s dependence on partners for the
commercialisation of its products in certain regions results in a number of risks (including, but not limited to, less
control over the partner’s use of resources, timing, success, marketing of competing products by the partner, impact
of future business combinations, ability to address COVID turmoil).
The Company has entered into several partnerships involving its CDMO’s expertise namely in the injectables’
industry, the latest of which concerning a manufacturing collaboration for innovative COVID-19 treatment.
The Company has entered into partnerships regarding sourcing of raw materials including essential active
pharmaceutical ingredients such as E4.Therefore the possibility for the Company to meet its production’s
commitments towards their counterparts depends on its sourcing arrangements and its partners compliance with
their own obligations, commitments which may have been impacted by COVID or any other drawbacks that the
Company’s partners may have faced during these challenging economical times. Notably, the Company has been
informed by its E4 sourcing partner that they would have difficulties delivering the contractually defined quantities
for the year 2021/2022 to the Company. In order to mitigate these potential delivery delays from our E4 sourcing
partner, the Company has secured other alternatives in order to diversify its E4 supply sources and to meet the
increasing sales forecasts of its commercial partners.
(viii) The pharmaceutical industry is highly competitive and subject to rapid technological changes. If the Group’s
current or future competitors develop equally or more effective and/or more economical technologies and
products, the Group’s competitive position and operations would be negatively impacted
The market for pharmaceutical products is highly competitive. The Group’s competitors in the Women’s Health
market include many established pharmaceutical, biotechnology and chemical companies, such as Bayer, MSD,
Pfizer, Therapeutics MD, Exeltis and Allergan, many of which have substantially larger financial, research and
development, marketing and personnel resources than the Group and could, therefore, more quickly adapt to
changes in the marketplace and regulatory environment. Competitors may currently be developing or may in the
future develop technologies and products that are more effective, safe or economically viable than any current or
future technology or product of the Group. Competing products may gain faster or broader market acceptance than
the Group‘s products (if and when marketed) and medical advances or rapid technological development by
competitors may result in the Group‘s product candidates becoming non-competitive or obsolete before the Group
is able to recover its research and development and commercialisation expenses. This could have a material adverse
effect on the Group’s business, prospects, financial condition and results of operation.
(ix) The Group’s patents and other intellectual property rights may not adequately protect its technology and products,
which may impede the Group’s ability to compete effectively.
The success of the Group will depend in part on its ability to obtain, maintain and enforce its patents and other
intellectual property rights for technologies and products in all territories of interest to the Group. The Group directly
holds various families of patents for the E4/DRSP pill Estelle
®
E4/DRSP pill and the menopause product candidate
Donesta®, menopause product candidate. For the Estelle
®
contraceptive product,
Extensions of the indication patent end date have been requested (and some are already granted) for US, Canada
and some European countries based on the first Marketing authorization of E4/DRSP in those territories. The patent
families covering the use of Estetrol in menopause will expire in 2022 in Europe and Canada and in 2025 in the United
States. For the Donesta® product candidate, new several patent applications have been filed to strengthen the
protection of the product and product candidate, the outcome and scope of which are still undetermined. The Group
also holds five families protecting different synthesis pathways for E4, whose main patents expire in 2032. The Group
will also seek to protect market exclusivity once marketing authorization is granted (where applicable) through
market/data exclusivity systems (between three and ten years maximum depending on the territory).
The success of the Group will depend in part on its ability to obtain, maintain and enforce its patents and other
intellectual property rights for technologies and products in all territories of interest to the Group. The Group’s patents
and other intellectual property rights may not adequately protect its technology and products, which may impede
99
the Company’s ability to compete effectively. The Group relies on a combination of patent(s) (applications),
trademarks, designs and trade secrets, and uses of non-disclosure, confidentiality and other contractual agreements
to protect its technology. The Group generally seeks patent protection where possible to reinforce its protection
around its technology and products.
However, the Group may be unable to adequately protect the intellectual property rights and trade secrets relating
to its products. The Group cannot be certain that patents will be issued with respect to the Group’s pending or future
patent applications. In addition, the Group does not know whether any issued patents will be upheld as valid or proven
enforceable against alleged infringers or whether they will prevent the development of competitive patents or provide
meaningful protection against competitors.
ESTELLE
®
, DONESTA
®
, MYRING
®
and ZORELINE
®
are registered trademarks of Mithra Pharmaceuticals or an
affiliate thereof.
(x) The Group has a history of operating losses, is accumulating deficits and may never become profitable.
The Group has experienced operating losses since 2012 (EUR 116.9 million during the period of 2021). These losses
have resulted principally from costs incurred in research & development and from general and administrative costs
associated with the operations. In the future, the Group intends to continue the clinical trial program for its candidate
products, conduct pre-clinical trials in support of clinical development and regulatory compliance activities that,
together with anticipated general and administrative expenses will result in the Group incurring further significant and
increased expenses for the next several years as a result of these activities.
There can be no assurance that the Group will ever earn significant revenues or achieve profitability resulting from
its research and development activities.
The Group is also subject to the following risks, in addition to the risks mentioned above:
The commercial success of the Company’s products will depend on attaining significant market
acceptance among physicians, patients, healthcare payers and the medical community.
The Company's supply of innovative E4 products will depend on the production resources chosen by
the Company.
The Company may be exposed to product liability, no-fault liability or other claims and the risk exists
that the Company may not be able to obtain adequate insurance or that the related damages exceed its
current and future insurance cover.
The Company may require access to additional funding in the future and if the Company fails to obtain
such funding, the Company may need to delay, scale back or eliminate the development and
commercialisation of some of its products.
The Company may infringe on the patents or intellectual property rights of others and may face patent
litigation, which may be costly and time consuming.
The Company’s patents and other intellectual property rights may not adequately protect its technology
and products, which may impede the Company’s ability to compete effectively.
The Company’s success depends on its key people, and it must continue to attract and retain key
employees and consultants.
The Company must effectively manage the growth of its operations and the integration of acquisitions
recently made or to be made in the future may not occur successfully.
The Company has obtained significant grants and subsidies (mostly in the form of “avances
récupérables” refundable government advances). The terms of certain of these agreements may
hamper the Company in its flexibility to choose a convenient location for its activities.
100
The Company has to comply with high standards of manufacturing in accordance with GMPs and other
manufacturing regulations. In complying with these regulations, the Company must expend significant
time, money and effort in the areas of design and development, testing, production, record-keeping and
quality control to assure that the products meet applicable specifications and other regulatory
requirements. The failure to comply with these requirements could result in an enforcement action
against the Company, including the seizure of products and shutting down of production. The Company
may also be subject to audits by the Competent Authorities. If the Company fails to comply with GMPs
or other applicable manufacturing regulations, the Company’s ability to develop and commercialize the
products could suffer significant interruptions and delay.
(xi) The Company or third parties upon whom the Company depends may be adversely affected by natural disasters
and/or global health pandemics, and/or war conflicts in Eastern Europe, and its business, financial condition and
results of operations could be adversely affected.
COVID-19 Impact
The occurrence of unforeseen or catastrophic events, including extreme weather events and other natural disasters,
man-made disasters, or the emergence of epidemics or pandemics, depending on their scale, may cause different
degrees of damage to the national and local economies and could cause a disruption in the Company’s operations
and have a material adverse effect on its financial condition and results of operations. Man-made disasters,
pandemics, and other events connected with the regions in which the Company operates could have similar effects.
If a natural disaster, health pandemic, or other event beyond its control occurred that prevented the Company from
using all or a significant portion of its office and/or lab spaces, damaged critical infrastructure, such as its
manufacturing facilities or its manufacturing facilities of its third-party contract manufacturers, or that otherwise
disrupted operations, it may be difficult for the Company to continue its business for a substantial period of time.
On March 11, 2020 the World Health Organization declared the novel strain of coronavirus (COVID-19) a global
pandemic and recommended containment and mitigation measures worldwide. As of the date of this Annual Report,
Belgium, where the Company operates, has been impacted by temporary closures. The length or severity of this
pandemic is currently being mitigated by the Government but whether or not new outbursts linked to the
developments of new variants cannot be predicted. The Company has mitigated the potential impacts from COVID-
19 and its variants on the planned development activities of the Company but cannot exclude further COVID-19
impact materialization on development or commercial activities (delays in the recruitment of patients, patient
concerns linked to hospital environment, slower commercial launch ramp-up of Estelle® due to COVID-19
restrictions, or material absences in teams).
Indeed, with COVID-19 and its variants still active in the United States and Europe, the business operations of the
Company could be delayed or interrupted, particularly if a large portion of its employees become ill or customers
being less accessible. COVID-19 may also affect employees of third-party organizations located in affected
geographies that the Company relies upon to carry out its clinical trials. The spread of COVID-19, or another infectious
disease, could also negatively affect the operations at its third-party suppliers, which could result in delays or
disruptions in the supply of drug product used in its clinical trials. In addition, the Company is taking temporary
precautionary measures intended to help minimize the risk of the virus to its employees, increasing hygiene
measures in compliance with governmental requests.
Further, timely enrollment in clinical trials is reliant on clinical trial sites which may be adversely affected by global
health matters, including, among other things, pandemics such as COVID-19. For example, many of the Company’s
clinical trial sites are located in regions currently being afflicted by COVID-19. Some factors from the COVID-19
outbreak that the Company believes will adversely affect enrollment in its trials at least on a temporary basis include:
- the diversion of healthcare resources away from the conduct of clinical trial matters to focus on pandemic
concerns, including the attention of physicians serving as Company’s clinical trial investigators, hospitals
serving as its clinical trial sites and hospital staff supporting the conduct of its clinical trials;
- limitations on travel that interrupt key trial activities, such as clinical trial site initiations and monitoring;
- interruption in global shipping affecting the transport of clinical trial materials, such as investigational drug
product used in our trials; and
- employee absences that delay necessary interactions with local regulators, ethics committees and other
important agencies and contractors.
The impact of COVID-19 on its business linked to the outburst of new variants is uncertain at this time and will
depend on future developments, which are uncertain and cannot be predicted, including new information which may
emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact,
101
among other things, but prolonged closures or other business disruptions may negatively affect its operations and
the operations of its agents, contractors, consultants or collaborators, which could have a material adverse impact
its business, results of operations and financial condition.
Natural Flood Impact
The Company’s premises’ (Head Quarter and CDMO) have not been impacted by the natural flood which took place
in the Liege area on the 15 and 16 July 2021.
Conflicts in Eastern Europe
The Company continues to monitor the geopolitical situation in Eastern Europe and risk assessment on Mithra’s and
partners activities, in particular Estelle® launch in Russia foreseen in H2 2022. On the R&D side, the Company is
currently analyzing the situation regarding the potential impact on the recruitment for the additional European
Donesta® study (C301) that should be completed by the end of H1 2022 as the Company had several active sites in
Russia. However, at this date of this report the Company is confident that it shall be able to recruit the accurate
number of patients in the other geographic regions selected for the study. If needed, the Company will activate a
mitigation plan in order to switch the planned Russian recruitment sites with other sites.
From a business perspective the conflict between Ukraine and Russia should have a limited impact on budgeted
2022 revenue (about 1%). Russia and Ukraine represent a small percentage of EU overall business and the events
should not disrupt GR/Mithra commercially. Mithra continues to monitor the situation closely.
Research and development
We are committeed to fully exploiting the potential of E4 (Estetrol) as well as our technologic platform in Complex
Therapeutics to develop a diverse and broad portfolio of therapeutic treatments focused on Women’s Health.
Additionally, the Company has diversified its R&D portfolio by acquiring an option to purchase development
programs led by the Belgian company BCI Pharma on innovative kinase inhibitors notably indicated for the treatment
of female cancers and endometriosis.
With regard to E4, most focus is on Mithra’s late-stage product candidates, Estelle
®
for contraception with market
authorization approval obtained in all key geographic areas and Donesta
®
for menopause (Phase III) with top lines
efficacy results obtained post period in January 2022. Furthermore, Mithra is exploring additional indications in
Women’s Health , as well as indications beyond Women’s Health, such as, wound healing and neuroprotection.
In January 2020, an ecotoxicity study revealed that Estetrol had a more environmentally friendly profile compared to
other estrogens. Additional comparative studies are ongoing at the University of Namur to deepen this finding. In
November 2020, the Company received the qualification of Estetrol as a "New Active Substance" (NAS) by the
European Medicines Agency (EMA). This is the first NAS designation in contraception in over 80 years and the
achievements of many years of work for the Company. In 2021, the Company received market authorizations for
Estelle
®
in key geographic areas such as Canada, Europe, US, Russia and Australia. Moreover, the label was revised
with a new wording on the expected low impact of E4 on the environment.
Post period, the Company obtained efficacy top line results for the Phase III E4Comfort program of oral hormonal
therapy Donesta
®
(menopause) which demonstrated a meaningful reduction in vasomotor symptoms from baseline
and compared to placebo. The positive efficacy data strongly move forward the Clinical Program, recently extended
with 3 additional studies to further broaden the scope of Donesta® as a global alternative for millions of menopausal
women (i) a phase 3 study on the effect of E4 on Vulvovaginal atrophy, (ii) a Phase 2 study on the effect of E4 on skin
texture, quality, (iii) a Phase 2 study on the effect on hair texture, quality and appearance.
The safety profile of Donesta® has been confirmed by end-year independent Data Safety Monitoring Board (DSMB),
which recommended to continue the Phase III Clinical Program as planned. in March 202, the DSMB further
confirmed an expected pharmacological profile during the trial from initiation until the safety evaluation of 2213
subjects treated. The Primary safety results anticipated for end 2022 in the United States/Canada and for end H1
2023 in Europe. The Company is on track to target marketing authorization in 2024. Indeed, in September 2021, the
Company announced a slight delay in the Donesta® program conducted in Europe mostly due to a higher level of
drop out than excepted linked to patient’s reticence to visit hospitals because of COVID-19 and amongst others to
perform medical visits as recommended by the protocol. Therefore, the Company decided to recruit up to 300
additional non-hysterectomized patients to address the regulatory requirements to obtain approval for use in the
non-hysterectomized women which represents more than 70% of the market. .
102
The clinical program on Estetrol’s effect in Covid-19 treatment did not show any difference of E4 from placebo on
the primary study endpoint, but E4 was well-tolerated with no apparent safety signals in the patient population. This
Phase II "Coronesta" trial aimed to study the action of Estetrol on the immune, inflammatory and vascular response
of patients (male/female) infected with Covid-19. As the results did not differ from placebo, the Company decided
not to perform complimentary researches. .
Regarding PeriNesta
®
, the Company held several discussions and meetings with the scientific community and the
European and American regulatory agencies. As announced in March 2021, the Company also decided to work on
alternative development strategies in addition to the initial scenario.
Following a strategic meeting held on September 20 & 21, 2021, the Board of directors analyzed both regulatory
agencies’ feedback as for the initial development project of PeriNesta
®
, as well as the additional budget required to
achieve this development in accordance with the regulatory expectations compared to the initial EUR 20 million.
Accordingly, the Board decided that the initial PeriNesta
®
development project was no longer timely nor a priority for
the Company and that alternative scenarios based on Estelle
®
and Donesta
®
could potentially target this
perimenopausal market without incurring substantial development costs. Therefore, the targeted market
authorization initially planned for 2023 is no longer achievable in this opportunistic development project. With this
pipeline covering contraception and menopause, Mithra will explore in parallel the most judicious way to meet the
specific needs of women during the transitional phase of perimenopause.
Further strengthening Estetrol Intellectual Property portfolio thanks to a new patent extending the 35 patent-family
filed by Mithra. Exclusivity of Estelle
®
and Donesta
®
product candidates is extended until 2036 in Europe. A similar
application is currently being examined in the United States.
For the Complex Therapeutics, Mithra launched Myring
®
in Europe and has provided to the FDA the additional data
requested for the US launch after receipt of a complete response letter in October 2021.
At the same time, the Company continue to advance our research work on Zoreline
®
formulations, having obtained
supportive PK results in 2018. This unfortunately did not extend to the all key pharmacodynamic parameters of
suppression of sex hormone levels. However, based on this study, the company has learned that a subsequent
clinical study with a prototype 3-month formulation is now used in a PD modelling to optimize the release profiles of
both the 1 month and 3-month formulations. Formulation development is now almost complete and the final
formulations to be tested in humans will be performed based on data from a rabbit model. It is anticipated that a
clinical study for the 1-month study will be initiated in 1H 2023. Approval is still expected in 2025.
Furthermore, Mithra will pursue the budgeted investments to further advance the technological CDMO facility in
terms of performance, applicability and scale; in order to offer third-parties the opportunity to develop sterile
injectables; and to prepare the polymeric forms and hormonal tablets zones for the production of its proprietary
products.
Moreover, Mithra is strengthening its leadership position in women's health by acquiring a new innovative
development axis in a fast-growing market: inhibitors of tyrosine kinases, notably indicated in the treatment of cancer
and endometriosis. Mithra acquired the rights relating to two development programs led by the Belgian company
BCI Pharma on innovative inhibitors of CSF1R kinase. These CSF1R inhibitors are part of a new innovative class of
immune-modulatory drugs with established clinical tolerability4 and proven efficacy. They act on the CSF1 receptor
which is involved in many inflammatory processes and is over expressed in many pathologies, in particular cancers,
neurological disorders and autoimmune diseases. The innovative class of tyrosine kinases inhibitors represents the
third fastest growing therapeutic class in 2020, with a 17% increase in revenues to USD 40.3 billion.
Under the terms of the contract, Mithra has an option to acquire patents covering CSF1R inhibitor series with upfront
payment of EUR 2.25 million on execution of option, following the first results conducted by BCI Pharma. Mithra will
fund the preclinical and clinical development with a focus on female cancers and endometriosis, while potentially
targeting other orphan indications, such as metastatic breast cancer (TNBC). Currently in the preclinical stage, BCI
Pharma should initiate clinical development in 2023, with marketing authorizations expected for 2031.
In addition, Mithra intends to initiate new discovery programs which might lead to the development and
commercialization of drug candidates; and is committeed to seek, maintain and expand the know-how, technologies
and intellectual property position.
103
Conflicting interests of directors (Art. 7:96 of the CCA)
The Directors report that during the financial year under review two decisions have been taken that fall within the
provisions of Art. 7:96 of the CCA. As required by the law, those minutes parts of the relevant meetings of the Board
of directors relating to such conflicts of interest are reproduced hereunder.
Furthermore, during the same financial year, there has been no transaction or other contractual relationship between
the Group, and a Director or Executive Manager other than those that fall within the provisions of Art. 7:96 of the CCA
or that have been disclosed under “related party transactions” set out below pursuant to Art. 7:97 of the CCA.
Meeting of the Board of directors of 3 February 2021 (free translation of minutes from French)
The following directors are participating in person or by video conference at the February 3, 2021 meeting of the
Board of directors of Mithra Pharmaceuticals SA (the "Company") : (…)
STATEMENTS OF THE INTERIM PRESIDENT:
The meeting began at 8:30 p.m. with Ms. Patricia van Dijck, acting as Chair ad interim of the Board of directors. She
declared that the meeting was duly convened as an emergency. She stated that the urgency had been properly
justified in the notice of meeting in accordance with the requirements of the Company's Articles of Association and
Corporate Governance Charter, and that no justification for sending out notices of meeting was required, as all
directors were present at the meeting. This was confirmed by the Board of directors.
The ad interim of the Board of directors states that the agenda for the meeting is as follows:
1. Submission of, and discussion on, the Nomination and Remuneration Committee's (the "CNR") opinion on
Suspension (as defined below);
2. Discussion of the suspension of Yima SRL's appointment as managing director, and of the management
agreement entered on September 3, 2015 between Yima SRL (represented by Mr. François Fornieri) and the
Company, as amended on July 12, 2018 (collectively, the "Management Agreement"), with immediate effect until
further notice and decision of the Board of directors (the "Suspension");
3. Discussion of, and approval or ratification of, the Suspension and the agreement to be entered into between
Yima SRL, Mr. François Fornieri and the Company regarding the Suspension (the "Suspension Agreement")
PRIOR DECLARATIONS OF INDIVIDUAL DIRECTOR
Prior declarations of Yima SRL
Prior to the deliberations and decisions of the Board of directors, Yima SRL (whose permanent representative is Mr.
François Fornieri), director of the Company, made the following declarations in accordance with Article 7:96 of the
CCA.
Yima SRL has informed the Board of directors that the agenda includes, inter alia, the Suspension, as well as the
approval of the Suspension Agreement. The Suspension relates, among other things, to a reduction in the fees of
Yima SRL. Yima SRL has informed the Board of directors that, for the above-mentioned reasons, it may be in a
situation of conflict of interest within the meaning of Article 7:96 of the CCA. Yima SRL will also inform the Company's
auditor of the above, in accordance with Article 7:96 of the CCA. Accordingly, Yima SRL has informed the Board of
directors that it will not take part in the further deliberations and decisions of the Board of directors regarding agenda
items 1, 2 and 3.
Yima SRL did not participate in the deliberations and decisions of the Board of directors referred to in the first three
items on the agenda.
PRIOR DECLARATIONS OF THE OTHER DIRECTORS
None of the other directors declare that they have an interest in the decisions to be taken by the Board of directors
that would require the application of the procedure provided for in articles 7:96 and/or 7:97 of the CCA.
DELIBERATION AND DECISIONS
On the proposal of the Chairman ad interim, the Board of directors commenced deliberations on the items on the
agenda.
The Chairman ad interim clarifies that the Board of directors of the Company is convened following the indictment of
Mr. François Fornieri in connection with functions he previously performed in a company outside Mithra, the decision
of the Board of directors of January 21, 2021 (whereby the CFO was appointed as CEO ad interim), and various
104
previous contacts between directors. The decisions to be taken concern the management and governance of the
Company as well as the continuity of operations
Deliberation and decisions on agenda items 1 through 3
The Chair ad interim then submitted the Suspension Agreement to the members of the Board of directors who had
not declared a conflict of interest. The Suspension Agreement is attached to the minutes of the meeting as an
Appendix.
The Chairman of the CNR, Mr. Christian Moretti, then presented the recommandation of the CNR regarding the
Suspension.
All directors, with the exception of Yima SRL, read the details of the Chair, the Suspension Agreement and the
recommendation of the CNR on the Suspension, as well as the prior statements of Yima SRL pursuant to Article 7:96
of the Companies and Associations Code.
The CNR has conducted an assessment of the consequences for the Company of the indictment of Mr. François
Fornieri with respect to the interests of the Company, its shareholders and other stakeholders.
Following the indictment, third parties with financial, business or other relationships, as well as shareholders,
investors and other stakeholders, have questioned the Company or expressed their concerns. The indictment of Mr.
Fornieri and the ongoing investigations of him are of significant concern to the above-mentioned persons and
institutions and other stakeholders. The CNR therefore believes that the Suspension is in the best interests of the
Company, its shareholders and other stakeholders.
In light of the foregoing, the CNR has subsequently negotiated the agreement to be entered into between Yima SRL,
Mr. François Fornieri and the Company relating to the Suspension. The principal terms of this agreement can be
summarized as follows:
- The exercise by Yima SRL of its mandate of Managing Director of the Company (and of any comparable mandate
within the Company's subsidiaries) will be suspended, until further notice and decision of the Board of directors, for
a maximum of 12 months.
- During the Suspension, the Company intends to appoint an interim CEO, who will be temporarily responsible for the
day-to-day management of the Company and its subsidiaries.
- During the Suspension, the Company, at the intervention or prior request of the CEO ad interim, may solicit Yima
SRL for the provision of "senior advisor" consultancy services, excluding the exercise of any executive or
management function. These consultancy services will be remunerated by a fee for a basic monthly amount of EUR
20,000, excluding VAT, increased by EUR 2,000, excluding VAT, per day of actual consultancy (on the basis of 8
working hours per day). The Company will also reimburse the expenses incurred by Yima SRL for the provision of
such consultancy services.
The Suspension Agreement also contains certain other undertakings of Yima SRL that will continue to apply during
the Suspension Period, as well as certain practical terms of the collaboration.
The directors have noted the proposals and recommendations of the CNR and confirm that they are of the view that
the Suspension and the provisions of the Suspension Agreement are in the best interests of the Company, its
shareholders and other stakeholders.
After considering the recommandation of the CNR on the Suspension, and after deliberation, the members of the
Board of directors, with the exception of Yima SRL, have unanimously:
(a) VOTED to approve the Suspension, and accordingly to suspend the delegation of managing director of Yima SRL,
as well as the execution of the Management Agreement, effective immediately, until further notice, for a maximum
of 12 months, pursuant to the Suspension Agreement.
(b) DECIDED to approve the Suspension Agreement.
Meeting of the Board of directors of 23 November 2021 (free translation of minutes from French)
On November 23, 2021, at 6:35 p.m., the Board of directors (hereinafter the "Board") of MITHRA PHARMACEUTICALS
SA (hereinafter the "Company") met in person (rue de l'Expansion 57, 4400 Flémalle) as well as by means of a
conference call.
105
AGENDA
1. Approval of the minutes of the September 21, 2021 meeting;
2. Report of the Nomination and Remuneration Committee;
3. Report of the Risk and Audit committee;
4. Finance Item;
PRIOR DECLARATIONS OF INDIVIDUAL DIRECTOR
(…)
2. Report of the Nomination and Remuneration Committee;
2.1. Bonus Plan
The management, including the CEO, present at the meeting left the room.
Eva Consulting SRL represented by Professor Jean-Michel Foidart indicates that as a potential beneficiary of the
bonus plan, he could benefit directly from the resolution to be taken by the Board. He is therefore affected by a
conflict of interest situation within the meaning of article 7:96 of the CCA and consequently leaves the meeting in
order not to attend the deliberations and decision-making in this case. The Board recognized that article 7:96 of the
CCA was applicable to this decision.
DELIBERATION AND DECISIONS
Before leaving the room with all the management present at the meeting, the CLO, in collaboration with the Chair of
the Nomination and Remuneration Committee, took care to explain in summary the Bonus Plan that was elaborated
and communicated to the Board in accordance with the Remuneration Policy applicable to the Company and
approved by its AGM in 2021 (Appendix II).
(….)
In view of the discussions, the Chairman concluded that the plan meets the approval of the Board, subject to three
points:
(…)
Subject to the three points mentioned above, the Board agrees.
Decision: On the recommendation of the Nomination and Remuneration Committee, the Board approves the
proposed bonus plan (Annex II) with the exception of the following three points:
(…)
With respect to the three points mentioned above, the Board invites the Nomination and Remuneration Committee
to formulate a new proposal acceptable to the Board. Management is also invited to further explain to the Board the
reasons for not approving the plan at the Annual General Meeting. All three points will be decided at a future Board
meeting.
(….)
4
4. Finance item ;
4.2. Sale of NOSHAQ participations
PRIOR DECLARATIONS OF INDIVIDUAL DIRECTORS
Prior to any deliberation or discussion on this item, G. Servais and A. Tounsi indicate, as CEO of NOSHAQ and
employee of NOSHAQ, that they have an indirect financial interest in the realization of the decision to be taken on
this item. In accordance with Section 7:96 of the CCA, they withdrew from the Committee meeting so as not to take
part in the deliberation and vote on this decision. The Board recognized that section 7:96 of the CCA was applicable
to this operation.
The CLO explained that, in accordance with the request of the Board of directors formulated last April, the transfer
of the 11 participations held by Mithra in the NOSHAQ Company was conditional upon the insertion of a price revision
4
These three items were decided upon at the Board of Directors meeting of 3 December 2021.
106
clause of 60 months in the share transfer agreement. A proposal of clause was communicated in this direction to
NOSHAQ on which it marked its agreement in principle.
Decision: After analysis of the clause proposed by the management and on the recommendation of the Risk and
Audit committee, the Board accepts this transfer of NOSHAQ shares under the conditions set out in the letter
proposed by the Company's legal department (Annex 3) and in particular the insertion, in the transfer agreement, of
a price revision clause. The Board also gives a mandate to the CLO of the Company with power of delegation to
finalize the sale operations, including the drafting of the sale agreement and the signature thereof.
Independence and expertise of at least one member of the Audit
committee
As previously disclosed, the Risk and Audit Committte is composed of the following three members: (i) one of which
satisfy to the independence criterias as set forth by provision 7:87, §1st CCA and (ii) all of them meet the expertise
requirement of that very article:
TicaConsult BVBA (Erik Van Den Eynden) has more than 30 years’ experience in banking. After joining ING (formerly
BBL) in 1990, he held various commercial and management positions throughout the bank, including director of a
branch district, CEO of ING Insurance Belgium, Luxembourg & Variable Annuities Europe, head of MidCorporates and
Institutionals at ING in Belgium and most recently CEO of ING in Belgium from 2017 to 2020. He holds a degree in
economics from the University of Antwerp.
TicaConsult BVBA also satisfies the independence criteria as prescribed by provision 7:87, §1st CCA.
NOSHAQ SA (standing representative: Mr Gaëtan Servais) - Mr Servais is a graduate in economics from the University
of Liège, where he began his career as a research assistant. In 1995, Mr Servais joined the Federal Plan Budget as
an expert and, following this, the Economic and Social Council of the Walloon Region. From 2001, he was private
secretary to a number of Ministers in the Walloon Government. Since 2007, has been CEO of Meusinvest, a financial
company whose business is structured into a number of subsidiaries in order to best meet the financing needs for
small to medium enterprises (SME) located in the Province of Liège.
Alius Modi SRL (Valérie Gordenne) has more than twenty-three (23) years of experience in pharmaceutical Research
& Development with extensive leadership experience in full development across a range of therapeutic areas (women
health: oncology, contraception, menopause) and product application (implantable (biodegradable) devices, oral
form, sterile injectable). She has developed a deep operational and strategic knowledge and expertise in drug
development through the management of various functions and activities (Chemistry, manufacturing & controls
(CMC), clinical supply manufacturing, market supply manufacturing, Global drug supply (clinical & market supply
distribution), Quality management (FDA, EU, ANVISA …(pre-approval) inspection), Regulatory Affairs (IB, IMPD, IND,
Briefing package, interactions with FDA, EMA, Health Canada), e-CTD submission and post approval variations,
Clinical development (phase I to IV), Intellectual property and trademarks). Mrs. Gordenne held various scientific and
management positions throughout the pharmaceutical field, including Chief Scientific Officer of the Company
between January 2015 and March 2019.
Going concern assessment
End of 2021, Mithra has a total of EUR 336.6 million accumulated losses on its balance sheet and realized a
consolidated net loss of EUR 116.9 million for the year ended 31 December 2021. Based on going concern accounting
principles, the Board is to justify the going concern during twelve months following the issuance of the report. Based
on their assessment, the Management and Board of directors consider it appropriate to prepare the financial
statements on a going concern basis. Indeed, the assessment is based on following assumptions such as expected
R&D clinical results and further business deals (mainly Donesta deal foreseen in H2 2022) as well as on the
monitoring of our funding activities, noting that a total amount of EUR 100 million flexible equity financing agreement
contracted with Goldman Sachs International in February 2022 are currently available with a first drawing request
exercised on 4 February 2022 for an amount of EUR 10 million and a second one exercised on 21 March 2022 for an
amount of EUR 5 million.
In consideration of those above-mentioned conservative assumptions, the Board of directors has analyzed the
financial statements and accounting policies and, made the assessment that the current cash position of EUR (32.9
million) at 31 December 2021 strengthened by post-year end flexible equity financing agreement contracted with
Goldman Sachs International for EUR 100 million and a capital increase for an amount of EUR 8.1 million completed
on 14 February 2022 under the LDA capital agreement facility will allow the Group to keep up with operating expenses
107
and capital expenditure requirements at least until April 2023 (twelve months at least after the issuance of this
report).
Appropriation of results
Mithra Pharmaceuticals SA, the parent Company, ended the financial year 2021 with a net loss of EUR 883,844.
The Board of directors proposed to appropriate the loss of the year of EUR 883,844 to accumulated loss. This brings
the total amount of retained losses to EUR 121,559,662.
Important events after the reporting period
Post-period, in January 2022, the Company announced positive top-line results from Donesta
®
phase 3 studies for
the treatment of vasomotor symptoms in post-menopausal women. Donesta
®
demonstrated a meaningful reduction
in vasomotor symptoms from baseline and compared to placebo. All co-primary efficacy endpoints were statistically
(all p<0.01) met in C301 (Europe, Latam and Russia) and in C302 (North America) studies, except for a borderline
non-significant result for the severity criteria at week 4 in the C302 study, which reached and exceeded statistical
significance by week 5 (p<0.01). Both studies also showed that the number and severity of hot flushes continued to
decrease week after week until the end of the study, i. e. 3 months of treatment. Secondary endpoints evaluated at
3 months in the C301 study suggest a very positive impact of Donesta
®
on the quality of life.
In February 2022, Mithra announced the commercial launch of its vaginal contraceptive ring Myring
®
under the
brandname Haloette
®
in Canada, a market which is worth approximately CAD $11.5 million (EUR 8 million) a year
and represented exclusively by the originator Nuvaring
®
.
Also, in February 2022, the Company entered into a 2-year equity financing agreement with Goldman Sachs
International (“GSI”), pursuant to which the Company can at its sole discretion require GSI to provide funding to the
Company for an aggregate amount of up to EUR 100,000,000 in return for issuing GSI with call options over the
Company’s ordinary shares. The Company will access this funding through several drawings, which must be at least
22 trading days apart. On the same day, Mithra exercised its first drawing request which amounted to EUR 10 million.
Further to Mithra’s first drawing request, GSI has elected to exercise a call option for an amount of EUR 5 million.
This call option will result in the issuance of 377,198 shares of the Company. In March, Mithra decided to exercise a
second drawing request for an amount of EUR 5 million
Since the beginning of the conflict in Ukraine in February 2022, Mithra has been monitoring the geopolitical situation
in order to manage the potential impact on Mithra’s and partners activities, in particular Estelle
®
launch in Russia
foreseen in H2 2022. On the R&D side, the Company has activated a mitigation plan in order to switch the planned
Russian recruitment sites with other sites for the additional European Donesta
®
study (C301), which should be
completed by the end of H1 2022.
There were no other subsequent events that occur between 2021 year-end and the date when the financial
statements have been authorized by the Board for issue.
108
1.15. Grant of discharge to the directors and the statutory auditor
You are requested, for Mithra Pharmaceuticals SA, in accordance with the law and the Articles of Association, to
grant discharge to the Directors and the Statutory Auditor for the duties carried out by them during the financial year
ending 31 December 2021.
This report will be deposited according to the legal requirements and can be consulted at the Company’s address.
Liege, 15 April 2022
For the Board of directors,
Van Rompay Management BVBA
(with Mr. Leon Van Rompay as
Permanent Representative)
Managing Director
Sunathim BV
(with Mr. Ajit Shetty as Permanent
Representative)
Chairman of the Board of Director
109
2. Responsibility statement
We hereby certify that, to the best of our knowledge, the consolidated financial statements as of
31 December 2021, prepared in accordance with the International Financial Reporting Standards as adopted
by the European Union, and the legal requirements applicable in Belgium, give a true and fair view of the
assets, liabilities, financial position and loss of the Group and the undertakings included in the consolidation
taken as a whole, and that the management report includes a fair review of the development and the
performance of the business and the position of the Group and the undertakings included in the consolidation
taken as a whole, together with a description of the principal risks and uncertainties that they face.
On behalf of the Board of Directors
Sunathim BV, Président Van Rompay Management SRL,
(represented by M. Ajit Shetty) (represented by Leon Van Rompay)
Chairman of the Board of Directors Managing Director
CMM&C SRL, represented by
Christophe Maréchal, CFO
110
3. Auditor report
STATUTORY AUDITOR’S REPORT TO THE GENERAL MEETING OF MITHRA
PHARMACEUTICALS SA FOR THE YEAR ENDED 31 DECEMBER 2021
(CONSOLIDATED FINANCIAL STATEMENTS)
In the context of the statutory audit of the consolidated financial statements of
MITHRA PHARMACEUTICALS SA (‘the Company’) and its subsidiaries (together referred to as 'the
Group'), we hereby present our statutory auditor’s report. It includes our report of the
consolidated financial statements and the other legal and regulatory requirements. This report is
an integrated whole and is indivisible.
We have been appointed as statutory auditor by the general meeting of 20 May 2021, following
the proposal formulated by the board of directors and issued upon recommendation of the Audit
Committee and upon presentation by the works’ council. Our statutory auditor’s mandate expires
on the date of the General Meeting deliberating on the financial statements closed on 31 December
2023. We have performed the statutory audit of the consolidated financial statements of MITHRA
PHARMACEUTICALS SA for 7 consecutive years.
Unqualified opinion
We have performed the statutory audit of the
Group’s consolidated financial statements,
which comprise the consolidated statement of
financial position as at 31 December 2021,
and the consolidated statement of profit or
loss and other comprehensive income, the
consolidated statement of changes in equity
and the consolidated statement of cash flows
for the year then ended, and notes to the
consolidated financial statements, including a
summary of significant accounting policies
and other explanatory information, and which
is characterized by a consolidated statement
of financial position total of
421.918 (000) EUR and for which consolidated
income statement and other comprehensive
income shows a loss for the year of 116 875
(000) EUR.
In our opinion, the consolidated financial
statements give a true and fair view of the
Group’s net equity and financial position as at
31 December 2021, as well as of its
consolidated financial performance and its
consolidated cash flows for the year then
ended, in accordance with International
Financial Reporting Standards (IFRS) as
adopted by the European Union and with the
legal and regulatory requirements applicable
in Belgium.
Basis for unqualified opinion
We conducted our audit in accordance with
International Standards on Auditing (ISA) as
applicable in Belgium. Our responsibilities
under those standards are further described
in the 'Statutory auditor's responsibilities for
the audit of the consolidated financial
statements' section in this report. We have
complied with all the ethical requirements
that are relevant to the audit of consolidated
financial statements in Belgium, including
those concerning independence.
We have obtained from the administrative
body and company officials the explanations
and information necessary for performing our
audit.
REPORT ON THE CONSOLIDATED
FINANCIAL STATEMENTS
111
We believe that the audit evidence we have
obtained is sufficient and appropriate to
provide a basis for our opinion.
Key audit matters
Key audit matters are those matters that, in
our professional judgment, were of most
significance in our audit of the consolidated
financial statements of the current year.
These matters were addressed in the context
of our audit of the consolidated financial
statements as a whole, and in forming our
opinion thereon, and we do not provide a
separate opinion on these matters.
Contingent consideration valuation
Description of the matter
As a result of the acquisitions of Estetra SRL
in 2015, the consolidated financial statements
include a contingent consideration towards
the previous owners. Additionally, during the
second semester of 2019, an amendment to
the sellers of Estetra (Uteron) agreement was
signed with significant impacts. As disclosed
in the notes 9.15.3 to the consolidated
financial statements, this contingent liability
is reported at fair value in the statement of
financial position.
We consider this area a key audit matter
requiring high auditor’s attention because of
the fact that the valuation of the contingent
consideration is complex, contains key
judgmental areas and is strongly affected by
assumptions with regards to expected future
cash flows, cash position, discount rate and
market conditions.
Procedures performed
Our audit procedures included, among others,
the following:
We have analyzed and reviewed the
Company’s fair value calculation including
the significant underlying assumptions and
checked whether an adequate valuation
model was applied;
We have analyzed the consistency of the
underlying data used in the valuation
model and compared these with the latest
Board approved business plan;
We consulted a valuation expert in our
firm to assess the methodology, clerical
accuracy and discount rate as applied;
We have performed an assessment of the
reasonableness of key assumptions,
notably expected future cash flows and
cash position, probabilities applied to the
different scenario’s and discount rate;
We reviewed the sensitivity analysis
prepared by management to understand
the effect of a change in assumptions;
We reviewed the completeness and
adequacy of the disclosures to the
consolidated financial statements.
Deferred tax assets
Description of the matter
As described in the notes 9.24.2 to the
consolidated financial statements, the Group
accounts for deferred tax assets on its tax
losses carried forward and on the temporary
differences arising between the tax bases of
assets and liabilities and their carrying
amounts in the IFRS financial statements to
the extent that it is probable that future
taxable profits will be realized for which
unused tax losses and tax credits can be used.
We consider this area a key audit matter
requiring high auditor’s attention because of
its significance to the financial statements
and the critical judgment made to assess the
recoverability of the deferred tax assets.
Procedures performed
Our audit procedures included, among others,
the following:
We have reconciled the total amount of
tax losses carried forward available to the
Group to supporting evidence;
We have reviewed the taxable impact of
the relevant IFRS accounting entries;
We consulted a tax expert in our firm to
assess the methodology and clerical
accuracy in the prepared tax plan;
112
We have challenged the judgment made
by the management about taxable profits
in the foreseeable future, taking into
account the tax strategy of the Group;
We have reviewed the accounting entries;
We reviewed the completeness and
adequacy of the disclosures as included in
disclosures to the consolidated financial
statements.
Financial funding
Description of the matter
As described in the notes 9.4.1 to the
consolidated financial statements, the
Company has disclosed that based on its
current scope of activities, the Group
estimates that its treasury position as of 31
December 2021 is sufficient to cover its cash
requirements at least until April 2023, so that
there is no going concern issue as of today.
This area was important to our audit given
the important estimates linked to the high
expected cash burn ratio on short term, based
on the group’s assessment of R&D clinical
results, related business deals and funding
activities, including the conditions linked to
the new flexible equity financing agreement
contracted after year-end.
Procedures performed
Our audit procedures included, among others,
the following:
We obtained the business plan and the cash
forecast for the year 2022 and 2023 and
reviewed it for reasonableness;
We challenged the assumptions underlying
this budget and cash forecast, especially
with respect to the level of expected
revenues, the financing possibilities, the
operating expenses and other cash outs;
We compared the total of expected licence
revenues included in the budget and cash
forecast with those expected from existing
agreements;
We analyzed the financing instruments
signed after closing date. We discussed
with management any potential future
financing possibilities and assessed their
reasonableness;
We verified the adequacy and
completeness of the disclosures as
included in the notes 9.4.1 of the financial
statements.
Responsibilities of the administrative body
for the drafting of the consolidated
financial statements
The administrative body is responsible for the
preparation of consolidated financial
statements that give a true and fair view in
accordance with the International Financial
Reporting Standards (IFRS) as adopted by the
European Union and with the legal and
regulatory provisions applicable in Belgium,
and for such internal control as the
administrative body determines is necessary
to enable the preparation of consolidated
financial statements that are free from
material misstatements, whether due to fraud
or error.
In preparing the consolidated financial
statements, the administrative body is
responsible for assessing the Group’s ability
to continue as a going concern, disclosing, as
applicable, matters related to going concern
and using the going concern basis of
accounting unless the administrative body
either intends to liquidate the Group or to
cease operations, or has no realistic
alternative but to do so.
Statutory auditor’s responsibilities for the
audit of the consolidated financial
statements
Our objectives are to obtain reasonable
assurance about whether the consolidated
financial statements as a whole are free from
material misstatement, whether due to fraud
or error, and to issue a statutory auditor’s
report that includes our opinion. Reasonable
assurance is a high level of assurance, but it
is not a guarantee that an audit conducted in
accordance with ISAs will always detect a
material misstatement when it exists.
Misstatements can arise from fraud or error
and are considered material if, individually or
113
in the aggregate, they could reasonably be
expected to influence the economic decisions
of users taken on the basis of these
consolidated financial statements.
When executing our audit, we respect the
legal, regulatory and normative framework
applicable for the audit of the consolidated
financial statements in Belgium. However, a
statutory audit does not guarantee the future
viability of the Group, neither the efficiency
and effectiveness of the management of the
Group by the administrative body. Our
responsibilities regarding the continuity
assumption applied by the administrative
body are described below.
As part of an audit in accordance with ISAs,
we exercise professional judgment and
maintain professional skepticism throughout
the audit. We also:
Identify and assess the risks of material
misstatement of the consolidated financial
statements, whether due to fraud or error,
design and perform audit procedures
responsive to those risks, and obtain audit
evidence that is sufficient and appropriate
to provide a basis for our opinion. The risk
of not detecting a material misstatement
resulting from fraud is higher than for one
resulting from error, as fraud may involve
collusion, forgery, intentional omissions,
misrepresentations, or the override of
internal control;
Obtain an understanding of internal control
relevant to the audit in order to design
audit procedures that are appropriate in
the circumstances, but not for the purpose
of expressing an opinion on the
effectiveness of the Group’s internal
control;
Evaluate the appropriateness of accounting
policies used and the reasonableness of
accounting estimates and related
disclosures made by the administrative
body;
Conclude on the appropriateness of the
administrative body’s use of the going
concern basis of accounting and, based on
the audit evidence obtained, whether a
material uncertainty exists related to
events or conditions that may cast
significant doubt on the Group’s ability to
continue as a going concern. If we conclude
that a material uncertainty exists, we are
required to draw attention in our statutory
auditor’s report to the related disclosures
in the consolidated financial statements or,
if such disclosures are inadequate, to
modify our opinion. Our conclusions are
based on the audit evidence obtained up to
the date of our statutory auditor’s report.
However, future events or conditions may
cause the Group to cease to continue as a
going concern;
Evaluate the overall presentation,
structure and content of the consolidated
financial statements and whether the
consolidated financial statements
represent the underlying transactions and
events in a manner that achieves fair
presentation;
Obtain sufficient appropriate audit
evidence regarding the financial
information of the entities or business
activities within the Group to express an
opinion on the consolidated financial
statements. We are responsible for the
management, the supervision and the
performance of the Group audit. We
assume full responsibility for the auditor’s
opinion.
We communicate with the Audit Committee
regarding, among other matters, the planned
scope and timing of the audit and significant
audit findings, including any significant
deficiencies in internal control identified
during the audit.
We also provide the audit committee with a
statement that we respected the relevant
ethical requirements relating to
independence, and we communicate with
them about all relationships and other issues
which may influence our independence, and,
if applicable, about the related measures to
guarantee our independence.
114
From the matters communicated with the
Audit Committee, we determine those
matters that were of most significance in the
audit of the consolidated financial statements
of the current year, and are therefore the key
audit matters. We describe these matters in
our statutory auditor’s report, unless law or
regulation precludes public disclosure about
the matter.
OTHER LEGAL AND REGULATORY
REQUIREMENTS
Responsibilities of the administrative body
The administrative body is responsible for the
preparation and the contents of the director’s
report on the consolidated financial
statements and for the other information
included in the annual report on the
consolidated financial statements.
Responsibilities of the statutory auditor
In the context of our mission and in
accordance with the Belgian standard (version
revised 2020) which is complementary to the
International Standards on Auditing (ISA) as
applicable in Belgium, it is our responsibility
to verify, in all material aspects, the
management report on the consolidated
financial statements and the other
information included in the management
report on the consolidated financial
statements, as well as to report on these
elements.
Aspects relating to the director’s report on
the consolidated financial statements and
to the other information included in the
annual report on the consolidated financial
statements
In our opinion, after having performed
specific procedures in relation to the
director’s report, this report is consistent
with the consolidated financial statements for
the same financial year, and it is prepared in
accordance with article 3:32 of the Code of
companies and associations.
In the context of our audit of the
consolidated financial statements, we are
also responsible for considering, in particular
based on the knowledge we have obtained
during the audit, whether the director’s
report on the consolidated financial
statements (Chapter 1 Report of the Board of
Directors) contains any material
misstatements, i.e. any information which is
inadequately disclosed or otherwise
misleading. Based on the procedures we have
performed, there are no material
misstatements we have to report to you.
Statement concerning independence
Our audit firm and our network did not
provide services which are incompatible
with the statutory audit of the consolidated
financial statements and our audit firm
remained independent of the Group during
the terms of our mandate.
The fees related to additional services
which are compatible with the statutory
audit as referred to in article 3:65 of the
Code of companies and associations were
duly itemised and valued in the notes to
the consolidated financial statements.
European Single Electronic Format (ESEF)
In accordance with the standard on auditing
the conformity of financial statements with
the European Single Electronic Format
(hereinafter “ESEF”), we also audited the
conformity of the ESEF format with the
regulatory technical standards established by
Commission Delegated Regulation (EU)
2019/815 of 17 December 2018 (hereinafter:
“Delegated Regulation”).
The managing body is responsible for
preparing, in accordance with ESEF
requirements, the consolidated financial
statements in the form of an electronic file in
ESEF format (hereinafter “digital consolidated
115
financial statements”) included in the annual
financial report.
It is our responsibility to obtain sufficient and
appropriate supporting information to
conclude that the format and mark-up
language of the digital consolidated financial
statements comply in all material aspects
with the ESEF requirements under the
Delegated Regulation.
Based on our work, we believe that the
format and the marking of information in the
official French version of the digital
consolidated financial statements included in
the annual financial report of MITHRA
PHARMACEUTICALS SA as at 31 December
2021 comply in all material aspects with the
ESEF requirements under the Delegated
Regulation.
Other statements
This report is in compliance with the contents
of our additional report to the Audit
Committee as referred to in article 11 of
regulation (EU) No 537/2014.
Battice, April 14, 2022
BDO Réviseurs d’Entreprises SRL
Statutory auditor
Represented by Cédric ANTONELLI
116
4. Consolidated statement of profit and loss
Year ended 31 December
Thousands of Euro (€)
Notes
2021
2020
Revenue
9.5
22,668
9,030
Cost of sales
9.20, 9.21
(15,724)
(3,457)
Gross profit
6,945
5,573
Research and development expenses
9.20, 9.21
(85,243)
(78,458)
General and administrative expenses
9.20, 9.21
(12,515)
(15,933)
Selling expenses
9.20, 9.21
(1,871)
(1,434)
Other operating income
9.19
4,809
6,574
Loss from operations
(87,875)
(83,678)
Change in fair value of contingent consideration payable
9.15, 9.17
(19,265)
(18,114)
Net fair value gains/(losses) on financial assets at fair value
through profit or loss
9.17
(6,351)
(4,925)
Financial income
9.23
2,838
1,782
Financial expenses
9.23
(13,116)
(5,987)
Loss before taxes
(123,769)
(110,922)
Income taxes
9.24
6,895
18,835
NET LOSS FOR THE PERIOD
(116,875)
(92,086)
Result for the purpose of basic loss per share, being net
loss
(116,875)
(92,086)
Weighted average number of shares for the purpose of basic
loss per share
43,429,809
40,988,235
Basic loss per share (in Euro)
9.25
(2.69)
(2.25)
Diluted loss per share (in Euro)
9.25
(2.69)
(2.25)
The accompanying notes are an integral part of these financial statements.
117
5. Consolidated statement of comprehensive loss
Year ended 31 December
Thousands of Euro (€)
Notes
2021
2020
Net loss for the period
(116,875)
(92,086)
Other comprehensive income or (loss)
(17,300)
3,000
Items that may be reclassified to profit or loss:
Currency translation differences
-
(66)
Gains/(losses) on cash flow hedges
9.17
(14,390)
10,415
Income taxes relating to these items
3,597
(2,576)
Items that will not be reclassified to profit or loss:
Changes in the fair value of equity investments at fair
value through other comprehensive income or loss
9.17
(6,508)
(4,772)
Total comprehensive loss for the period
(134,175)
(89,086)
Attributable to
Owners of the parent
(134,175)
(89,086)
Non-controlling interests
-
-
TOTAL COMPREHENSIVE LOSS FOR THE PERIOD
(134,175)
(89,086)
The accompanying notes are an integral part of these financial statements.
118
6. Consolidated statement of financial position
As at 31 December
Thousands of Euro (€)
Notes
2021
2020
ASSETS
Property, plant and equipment
9.7
38,354
29,921
Right-of-use assets
9.8
69,322
69,572
Goodwill
9.9
5,233
5,233
Other intangible assets
9.6
104,954
89,005
Deferred income tax assets
9.24
63,456
50,905
Contract assets
9.18
49
200
Derivatives financial assets
9.17
-
6,184
Investment in equity securities
9.17
31,898
18,088
Other non-current assets
9.10
9,263
14,401
Non-current assets
322,528
283,509
Inventories
9.11
43,852
35,382
Contract assets
9.18
12,522
51,472
Derivatives financial assets
9.17
100
2,881
Trade and other receivables
9.12
10,044
10,052
Other short-term deposits
-
14
Cash and cash equivalents
9.13
32,872
138,675
Current assets
99,389
238,475
TOTAL ASSETS
421,918
521,985
119
As at 31 December
Thousands of Euro (€)
Notes
2021
2020
EQUITY AND LIABILITIES
Share capital
9.14
32,250
31,271
Additional paid-in-capital
9.14
340,769
332,535
Other reserves
9.14
(2,545)
13,690
Accumulated deficit
7
(336,633)
(219,759)
Equity attributable to equity holders
33,840
157,737
Subordinated loans
9.15
11,629
12,610
Other loans
9.15
113,608
111,898
Lease liabilities
9.15
42,353
44,282
Refundable government advances
9.15
12,769
15,195
Other financial liabilities
9.15, 9.17
102,675
101,180
Derivatives financial liabilities
9.17
2,897
-
Contract liabilities
9.18
-
3,706
Provisions
9.28
266
266
Deferred tax liabilities
9.24
6,089
4,363
Non-current liabilities
292,285
293,500
Current portion of subordinated loans
9.15
1,314
1,002
Current portion of other loans
9.15
45,253
10,475
Current portion of lease liabilities
9.15
6,561
7,315
Current portion of refundable government advances
9.15
1,617
1,259
Current portion of other financial liabilities
9.15, 9.17
15,829
23,424
Derivatives financial liabilities
9.17
1,886
-
Trade and other payables
9.16
23,331
27,272
Current liabilities
95,793
70,747
TOTAL EQUITY AND LIABILITIES
421,918
521,985
The accompanying notes are an integral part of these financial statements.
120
7. Consolidated statement of changes in equity
Thousands of Euro (€)
Share capital
Additional
paid-in-
capital
Other reserves
Accumulated
deficit
Total
equity
Notes
9.14.1
9.14.1
9.14.2
Balance as at 1 January 2020
28,649
258,898
3,423
(127,673)
163,298
Net loss for the period
(92,086)
(92,086)
Currency translation differences
(66)
(66)
Gains/(losses) on cash flow hedges
7,838
7,838
Changes in the fair value of equity investments at fair value
through other comprehensive income or loss
(4,772)
(4,772)
Total comprehensive loss for the period
-
-
3,000
(92,086)
(89,086)
Capital increase of 23 June 2020, net of transaction costs
2,505
60,813
63,318
LDA capital increase of 5 August 2020, net of transaction
costs
117
1,733
1,850
Value of conversion rights on convertible bonds, net of
transaction costs
11,091
11,091
Share-based payments expense
7,267
7,267
Balance as at 31 December 2020
31,271
332,535
13,690
(219,759)
157,737
Balance as at 1 January 2021
31,271
332,535
13,690
(219,759)
157,737
Net loss for the period
(116,875)
(116,875)
Gains/(losses) on cash flow hedges
(10,792)
(10,792)
Changes in the fair value of equity investments at fair value
through other comprehensive income or loss
(6,508)
(6,508)
Total comprehensive loss for the period
-
-
(17,300)
(116,875)
(134,175)
Capital increase exercise of subscription rights 6 May 2021
749
2,752
3,501
LDA capital increase of 10 November 2021, net of
transaction costs
230
5,483
5,713
Share-based payments expense
1,065
1,065
Balance as at 31 December 2021
32,250
340,769
(2,545)
(336,634)
33,840
The accompanying notes are an integral part of these financial statements.
121
8. Consolidated statement of cash flow
As at 31 December
Thousands of Euro (€)
Notes
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES
Result from operations
(87,875)
(83,678)
Adjustments for:
Depreciation, amortization and impairment charges
9.6, 9.7, 9.8
10,426
9,767
R&D tax credit
9.19
(2,185)
(1,864)
Share-based payments
9.26
1,065
7,267
Realized foreign exchange gains/(losses)
9.23, 5
(1,247)
2,769
Grant income
9.19
(356)
(2,833)
Gain on derecognition of contingent consideration payable
(366)
-
Subtotal
(80,538)
(68,572)
Increase/(decrease) in trade and other payables
9.16
(2,048)
521
(Increase)/decrease in trade and other receivables
9.12
(341)
2,186
(Increase)/decrease in inventories
9.11
(8,470)
(19,105)
(Increase)/decrease in contract assets and liabilities
9.18
17,010
4,945
Net cash (used in)/ provided by operating activities
(74,387)
(80,025)
CASH FLOWS FROM INVESTING ACTIVITIES
Payment for acquisition of tangible fixed assets
9.7
(11,483)
(10,645)
Proceeds from disposal of tangible fixed assets
9.7
-
23
Payment for acquisition of intangible fixed assets
9.6
(9,699)
(5,585)
Other financial liabilities payments
9.17
(33,500)
-
Net cash (used in)/ provided by investing activities
(54,682)
(16,207)
CASH FLOWS FROM FINANCING ACTIVITIES
Repayment of subordinated loans and other loans
9.15
(49,845)
(36,431)
Repayment of refundable government advances
9.15
(804)
(927)
Proceeds from subordinated loans and other loans
9.15
83,600
35,556
Proceeds from refundable government advances and
other grants
9.15
41
5,835
Lease payments
9.15
(7,193)
(3,475)
Interests paid
9.23
(11,765)
(3,503)
Proceeds from issuance of shares (net of issue costs)
9.14
9,213
65,731
Proceeds from issuance of convertible bonds (net of
transaction costs)
9.14, 9.17
-
122,401
Net cash (used in)/provided by financing activities
23,245
185,187
Net increase/(decrease) in cash and cash equivalents
(105,824)
88,954
Cash and cash equivalents at beginning of year
138,675
49,720
Effects of exchange rate changes on cash and cash
equivalents
21
-
Cash and cash equivalents at end of period
32,872
138,675
The accompanying notes are an integral part of these financial statements,
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9. Notes to the consolidated financial statements
General information
Mithra Pharmaceuticals SA (Euronext MITRA) is a Belgian biotech company dedicated to transforming Women’s
Health by offering new choices through innovation, with a particular focus on contraception and menopause.
Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs
throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of
applications in women health and beyond. After having successfully launched the first estetrol-based product in
2021, the contraceptive pill Estelle®, Mithra is now focusing on its second product Donesta®, the next-generation
hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception,
menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and
specialist manufacturing at its technological platform Mithra CDMO.
Mithra Pharmaceuticals SA is a limited liability company (Société Anonyme) governed by Belgian law with its
registered office at Rue Saint-Georges 5, 4000 Liège, Belgium.
Significant changes in the current reporting period
The financial position and performance of the Group was particularly affected by the following events and
transactions during the reporting period:
Estelle
®
obtained its Marketing authorization in Canada (March), the United States (April), Europe (May) and
Russia (September). Thanks to these authorizations, commercial launch of Estelle
®
has already successfully
occurred in the United States and Canada, under the trademark Nextstellis
®
, and in several European
countries under the trademark Drovelis
®
.
Note : For more details about the operations during this period, please refer to 9.15 Financial liabilities, to 9.6 Other
intangible assets and to 9.5 Segment information and revenue
In June, Mithra signed an agreement with SVR Invest BV for the buy-back of all contingent payments linked
to Myring
®
and Zoreline
®
as well as for the acquisition of the full global licensing and distribution rights for
the Zoreline
®
implant.
Note : For more details about the operations during this period, please refer to 9.15 Financial liabilities, to 9.6 Other
intangible assets and to 9.5 Segment information and revenue
To date, Mithra expects that its existing treasury position will be sufficient, based on the current scope of
activities, to fund operating expenses and capital expenditure requirements at least until twelve months
following the issuance of the report. The current cash position of EUR 32.9 million at 31 December 2021
strengthened by post-year end flexible equity financing agreement contracted with Goldman Sachs
International for EUR 100 million and a capital increase for an amount of EUR 8.1 million completed on 14
February 2022 under the LDA capital agreement facility will allow the Group to keep up with operating
expenses and capital expenditure requirements at least until April 2023.
Note : For more details about the operations during this period, please refer to 9.4.1 Going concern assessment and to 9.3.1
c Liquidity risk
Summary of Significant Accounting Policies
The consolidated financial statements are presented in thousands of euro (unless stated otherwise). The
consolidated financial statements for the financial year ended 31 December 2021 have been authorized for issue by
the Board of Directors of 12 April 2022. The financial statements have been prepared on historical cost basis. Any
exceptions to the historical cost price method are disclosed in the accounting policies described hereafter.
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9.2.1. Basis of presentation
The financial statements have been prepared on a going concern basis and in accordance with the main accounting
principles set out in this section. The Group is expecting losses in the coming years, which is inherent to the current
stage of the Group’s business life cycle as a biotech company. In this respect, the following underlying assumptions
have been used:
The continued positive evolution of the development of products and timely market approvals in countries
where the products will be filed;
The availability of additional financial resources to deal with the remaining development expenses and to
fund the cash requirements in the first years of commercialization of the different products.
The consolidated financial statements were prepared in accordance with IFRS as adopted by the European
Union (“EU”).
9.2.2. Significant accounting policies
The financial statements have been prepared in accordance with the same accounting policies adopted in the
Group’s last annual financial statements for the year ended 31 December 2020 and are consistent with them.
Following Estelle® Marketing authorization, intellectual property rights and internally generated research and
development for this project are now considered as available for use. Amortization is calculated using the straight-
line method to allocate the cost of these intangibles on the longest of the patent protection life and the useful life of
the product. The estimated useful life and amortization method are reviewed at the end of each reporting period.
The new standards and interpretations effective for the first time for periods beginning on (or after) 1 January 2021
do not impact the Group’s consolidated financial statements.
The accounting policies have been applied consistently across the Group for the purposes of preparation of these
financial statements.
9.2.3. Use of accounting judgments, estimates and assumptions
When preparing the financial statements, management undertakes a number of judgments, estimates and
assumptions about recognition and measurement of assets, liabilities, income and expenses. The actual results may
differ from the judgments, estimates and assumptions made by management, and will seldom equal the estimated
results.
The judgments, estimate and assumptions applied in the financial statements, including the key sources of
estimation uncertainty, are disclosed in note 9.4, Critical accounting estimates and judgments.
9.2.4. Changes in accounting policies and disclosures
During the current financial period, the Group has adopted all the new and revised Standards and Interpretations
issued by the International Accounting Standards Board (IASB) and the International Financial Reporting
Interpretations Committee (IFRIC) of the IASB as adopted by the European Union and effective for the accounting
year starting on January 1, 2021. The Group has not applied any new IFRS requirements that are not yet effective as
of December 31, 2021.
The following new Standards, Interpretations and Amendments issued by the IASB and the IFRIC as adopted by the
European Union are effective for the financial period.
IFRS 3 Business Combinations Amendments to clarify the definition of a business (October 2018)
Amendments to IFRS 9, IAS 39 and IFRS 7 Interest Rate Benchmark Reform - Phase 1 (September
2019)
IAS 1 Presentation of Financial Statements Amendments regarding the definition of material
(October 2018)
IAS 8 Accounting Policies, Changes in Accounting Estimates and Errors Amendments regarding the
definition of material (October 2018)
Amendments to References to the Conceptual Framework in IFRS Standards (March 2018)
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Summary of Standards and Interpretations issued but not yet effective in the current period
The Group elected not to early adopt the following new Standards, Interpretations and Amendments, which
have been issued by the IASB and the IFRIC but are not yet effective as per December 31, 2021 and/or not yet
adopted by the European Union as per December 31, 2021 and for which the impact might be relevant:
Amendment to IFRS 16, ‘Leases’ COVID-19 related rent concessions Extension of the practical
expedient*
A number of narrow - scope amendments to IFRS 3, IAS 16, IAS 37 and some annual improvements
on IFRS 1, IFRS 9, IAS 41 and IFRS 16*
Amendments to IAS 1, Presentation of financial statements’, on classification of liabilities*
Narrow scope amendments to IAS 1, Practice statement 2 and IAS 8*
Amendment to IAS 12 deferred tax related to assets and liabilities arising from a single transaction*
IFRS 17, ‘Insurance contracts’, as amended in December 2021*
* Not yet endorsed by the EU as of December 31, 2021
None of the other new standards, interpretations and amendments, which are effective for periods beginning
after January 1, 2021 which have been issued by the IASB and the IFRIC but are not yet effective as per
December 31, 2021 and/or not yet adopted by the European Union as per December 31, 2021, are expected to
have a material effect on the Group's future financial statements.
9.2.5. Basis of consolidation
a) Subsidiaries
The consolidated financial statements include all the subsidiaries over which the Group has control,
Control is achieved when the investor
has power over the investee;
is exposed or has rights to variable returns from its involvement with the investee; and
has the ability to use its power to affect its returns.
If facts and circumstances indicate that there are changes to one or more of the three elements of control listed above,
the investor shall reassess whether it controls the investee.
Subsidiaries are fully consolidated from the date on which control is transferred to the group, they are deconsolidated
from the date that control ceases.
The acquisition method of accounting is used to account for business combinations by the group (refer to note 9.2.6)
Intercompany transactions and balances, as well as unrealised gains on transactions between group companies are
eliminated, Unrealised losses are also eliminated unless the transaction provides evidence of an impairment of the
transferred asset, Accounting policies of subsidiaries have been changed where necessary to ensure consistency with
the policies adopted by the group.
Any non-controlling interests in the results and equity of subsidiaries are shown separately in the consolidated
statement of profit or loss, statement of comprehensive income, statement of changes in equity and statement of
financial position, respectively.
b) Associates
An associate is an entity over which the Group has significant influence, Significant influence is the power to participate
in the financial and operating policy decisions of the investee but is not control or joint control over those policies.
A joint venture is a joint arrangement whereby the parties that have joint control of the arrangement have rights to
the net asset of the joint arrangement, Joint control is the contractually agreed sharing of control of an arrangement,
which exists only when decisions about the relevant activities require unanimous consent of the parties sharing
control.
125
The results and assets and liabilities of associates or joint ventures are incorporated in these consolidated financial
statements using the equity method of accounting. Under the equity method, an investment in an associate or
joint venture is initially recognised at cost and adjusted for the Group’s share of the profit or loss and other
comprehensive income of the associate or joint venture. When the Group’s share of losses of an associate or joint
venture exceeds its interest in that associate or joint venture, the Group discontinues recognising its share of further
losses.
An investment in an associate or joint venture is accounted for using the equity method from the date on which the
investee becomes an associate or a joint venture. On acquisition of the investment, any excess of the cost of the
investment over the Group’s share of the net fair value of the identifiable assets and liabilities of the investee is
recognized as goodwill, which is included within the carrying amount of the investment. The requirements of IAS 39
are applied to determine whether it is necessary to recognise any impairment loss with respect to the Group’s
investment in an associate or a joint venture. When necessary, the entire carrying amount of the investment
(including goodwill) is tested for impairment in accordance with IAS 36 (Impairment of Assets), by comparing its
recoverable amount with its carrying amount. Any impairment loss recognised forms part of the carrying amount of
the investment. Any reversal of that impairment loss is recognised in accordance with IAS 36 to the extent that the
recoverable amount of the investment subsequently increases.
9.2.6. Business combinations
The Group applies the acquisition accounting method to account for business combinations. Identifiable assets
acquired, and liabilities and contingent liabilities assumed, are, with limited exceptions, measured initially at their fair
values at the acquisition date. The consideration transferred for the acquisition of a subsidiary is the fair value of the
assets transferred, the liabilities incurred to the former owners of the acquiree and the equity interest issued by the
Group. This includes the fair value of any contingent consideration. Where the consideration transferred, together
with the non-controlling interest, exceeds the fair value of the net assets, liabilities and contingent liabilities acquired,
the excess is recorded as goodwill. The costs of acquisition are charged to the income statement in the period in which
they are incurred.
Where not all of the equity of a subsidiary is acquired, the non-controlling interest is recognised either at fair value or
at the non-controlling interest’s share of the net assets of the subsidiary, on a case-by-case basis. Changes in the
Group’s ownership percentage of subsidiaries are accounted for within equity.
Where settlement of any part of cash consideration is deferred, the amounts payable in the future are discounted to
their present value as at the date of exchange. The discount rate used is the entity’s incremental borrowing rate, being
the rate at which a similar borrowing could be obtained from an independent financier under comparable terms and
conditions.
Contingent consideration is classified either as equity or a financial liability. Amounts classified as a financial liability
are subsequently remeasured to fair value with changes in fair value recognised in profit or loss.
If the business combination is achieved in stages, the acquisition date carrying value of the acquirer’s previously held
equity interest in the acquire is remeasured to fair value at the acquisition date. Any gains or losses arising from such
remeasurement are recognised in profit or loss.
9.2.7. Segment information
An operating segment is a component of an entity:
which exercises operating activities with which profits are being gained and with which costs can be made
(including profits and costs from transactions with other components of the entity);
of which the operational results are being judged regularly by the highest function of the entity who can take
important operational decisions in order to make decisions regarding the allocation of resources and to
evaluate the financial results of the segment and;
for which separate financial information is available. That is engaged either in providing specific products or
services (business segment), or in providing products or services within a particular economic environment
(geographical segment), which is subject to risks and rewards that are different from those of other
segments.
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9.2.8. Foreign currency translation
The Group’s consolidated financial statements are presented in Euros, which is also the parent company’s functional
currency.
Foreign currency transactions are translated into the functional currency of each entity using the exchange rates
prevailing at the dates of the transactions. At the end of each reporting period the entity shall (a) translate the foreign
currency monetary items at closing rate, (b) translate non-monetary items measured at historical cost in a foreign
currency, using the exchange rate of the transaction date, (c) translate non-monetary items measured at fair value
in a foreign currency using the exchange rates at the date the fair value was determined. Foreign exchange gains
and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates
of monetary assets and liabilities denominated in foreign currencies are recognized in the income statement within
‘financial income or cost’.
On consolidation, assets and liabilities including related goodwill of components of the Group, are translated into
Euros at the financial year’s closing rate. Exchange adjustments arising when translating the financial statements of
foreign subsidiaries, and those arising on loans to or from a foreign operation for which settlement is neither planned
nor likely to occur and which therefore form part of the net investment in the foreign operation, are recognized initially
in other comprehensive income and reclassified from equity to profit or loss on disposal or partial disposal of the net
investment.
9.2.9. Intangible assets
a) Research & development costs
Expenditure on research activities is recognised as an expense in the period in which it is incurred.
An internally generated intangible asset arising from development is recognised to the extent that all conditions
for capitalisation have been satisfied as specified in IAS 38:
the technical feasibility of completing the intangible asset so that it will be available for use or sale;
the intention to complete the intangible asset and use or sell it;
the ability to use or sell the intangible asset;
how the intangible asset will generate probable future economic benefits;
the availability of adequate technical, financial and other resources to complete the development and to use
or sell the intangible asset; and
the ability to measure reliably the expenditure attributable to the intangible asset during its development.
This recognition is conventional when a regulatory filing has been made in a major market and the approval from the
regulators is considered as highly probable. Some of its products which are capitalised as from current year do not
require any regulatory approval.
The amount initially recognised for internally-generated intangible assets is the sum of the expenditure incurred from
the date when the intangible asset first meets the recognition criteria listed above. Where no internally-generated
intangible asset can be recognised, development expenditure is recognised in profit or loss in the period in which it
is incurred.
Subsequent to initial recognition, internally-generated intangible assets are reported at cost less accumulated
amortisation and accumulated impairment losses, on the same basis as intangible assets that are acquired
separately.
b) Acquired intangible assets
Separately acquired intangible assets are shown at historical cost. Contingent payments based on future
performance are an attribute of a fair value measurement throughout the life of the asset. The contingent payments
will be disclosed as a contingent liability. When the contingent liability becomes a liability the re-measurement at the
end of each reporting period shall be accounted for as an adjustment to the cost of intangible assets to the extent
that it relates to future benefits and reporting periods. Intellectual property rights, patents, licenses, know-how and
software with a finite useful life are carried at cost less accumulated amortisation. Amortisation is calculated using
the straight-line method to allocate the cost of these intangibles over their estimated useful lives of 7 to 10 years
and starts at the moment the assets are available for use.
127
In the event an asset has an indefinite life, this fact is disclosed along with the reasons for being deemed to have an
indefinite life.
Intangible assets acquired in a business combination, including in-process research and development, are
initially measured as explained in paragraph 9.2.6
9.2.10. Property, plant and equipment
Property, plant and equipment is carried at historical cost, less subsequent depreciation. Historical costs are
capitalized and include expenditure that is directly attributable to the acquisition of the assets, expenditure for
bringing the asset to the location and condition necessary for it to be capable of operating in the intended manner,
including the in-house development costs.
Borrowing costs that are directly attributable to the acquisition, construction or production of a qualifying asset, here
the CDMO platform, form part of the cost of that asset. Other borrowing costs are recognised as an expense.
Borrowing costs are interest and other costs that Mithra CDMO incurs in connection with the borrowing of funds.
Subsequent costs are included in the asset’s carrying amount or recognised as a separate asset, as appropriate, only
when it is probable that future economic benefits associated with the item will flow to the Group and the cost of the
item can be measured reliably. The carrying amount of the replaced part is derecognised. All other repair and
maintenance expenses are charged to the profit and loss during the financial period in which they are incurred.
Land is not depreciated. Depreciation on other assets is calculated using the straight-line method to allocate their
cost to their residual values over their estimated useful lives, as follows:
Buildings and components: 15-30 years
Machinery: 5-15 years
Vehicles: 3-5 years
Furniture and equipment: 5-8 years
ICT and other equipment: 3-5 years
Specific machines are depreciated using unit of production depreciation method.
The acquisition value of the assets have been analysed by component and specific useful lives and residual values
were applied to each of them. The residual value of the building is estimated to correspond to the cost of the structure
of the building. An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s
carrying amount is greater than its estimated recoverable amount.
Gains and losses on disposals are determined by comparing the proceeds with the carrying amount and are
recognised within ‘Other operating income or expenses’ in the income statement.
9.2.11. Impairment of tangible, intangible assets and of goodwill
Assets with an indefinite useful life are tested for impairment annually and at each reporting date, and whenever there
is an indication that the asset might be impaired. Assets that are subject to amortisation are reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The
recoverable amount is the higher of fair value less costs to sell and value in use. To determine fair value less cost to
sell, the forecasted future cash flows are discounted to their present value using a pre-tax discount rate that reflects
current market assessments of the time value of money and the risks specific to the asset.
If the recoverable amount of an asset or cash-generating unit is estimated to be less than the carrying amount, the
carrying amount of the asset is reduced to its recoverable amount. A cash-generating unit is the smallest identifiable
Group of assets that generates cash inflows that are largely independent of the cash flows from other assets or
Group of assets. An impairment loss is immediately recognised as an expense. Intangible and tangible assets other
than goodwill that suffered an impairment are reviewed for possible reversal of the impairment at each reporting date.
Where an impairment loss subsequently reverses, the carrying amount of the asset is increased to the revised
estimate of its recoverable amount, but so that the increased carrying amount does not exceed the carrying amount
that would have been determined had no impairment loss been recognised for the asset in prior years. A reversal of
an impairment loss is recognised as income. An impairment loss recognised for goodwill shall not be reversed in a
subsequent period
128
9.2.12. Inventories
The inventories mainly consist of raw material, semi-finished goods and finshed goods.
Trade goods are valued at the lower of cost and net realisable value. Cost is determined using the first-in, first-out
(FIFO) method. Net realisable value represents the estimated selling price less all estimated costs of completion and
costs to be incurred in marketing, selling and distribution.
Write-offs are performed based on the shelf life of the products.
Regarding pre-launch inventory, we record them once the product has attained a stage in the development process
of having been subject to a market authorization application filing and has a well characterized manufacturing
process. In addition, we must have an internal sales forecast that includes an assessment that sales will exceed the
manufacturing costs plus the expected cost to distribute the product. Finally, product stability data must exist so
that we can assert that capitalized inventory is anticipated to be sold, based on the sales projections noted above,
prior to anticipated expiration of a product’s shelf life. If approval for these product candidates is not received, or
approval is not received timely compared to our estimates for product shelf life, we will write-off the related amounts
of pre-launch inventory in the period of that determination.
9.2.13. Trade receivables
Trade receivables are amounts due from customers for merchandise sold or services performed in the ordinary course
of business and are recognized initially at fair value and subsequently measured at amortised cost using the effective
interest method less allowance for expected credit losses.
9.2.14. Other Short-term investments
Term deposits with an initial term of more than three months are held to maturity and measured at amortized cost.
9.2.15. Cash and cash equivalents
Cash and cash equivalentsare carried in the balance sheet at nominal value. For the purposes of the cash flow
statement, cash and cash equivalents comprise cash on hand and deposits held on call with banks. In the balance
sheet, bank overdrafts, if any, are included in borrowings in current liabilities.
9.2.16. Share capital
Ordinary shares are classified as equity.
Incremental costs directly attributable to the issue of new ordinary shares or options are shown in equity as a
deduction, net of tax, from the proceeds.
Equity instruments issued by the Company are recorded in the amount of the proceeds received, net of direct
issue costs.
9.2.17. Convertible bond
The Group issued a Euro-denominated bond in December 2020, convertible into a fixed number of equity instruments
(conversion price of EUR 25.1917). It is deemed as a “compound instrument”, comprising both a liability and an equity
component:
- The issuer’s obligation to pay interest and, potentially, to redeem the bond in cash, is a financial liability; and
- The holder’s right to call for shares of the issuer is an equity instrument.
The economic effect of issuing such an instrument is substantially the same as simultaneously issuing a debt
instrument with an early settlement provision and warrants to purchase ordinary shares or issuing a debt instrument
with detachable share purchase warrants.
The liability and equity components are accounted for separately, and the liability and equity components shown
separately in the statement of financial position. This treatment is commonly referred to as “split accounting”. On
initial recognition of a compound instrument such as a convertible bond, IAS 32 requires the issuer to:
(a) Identify the various components of the instrument;
(b) Determine the fair value of the liability component (see below); and
129
(c) Determine the equity component as a residual amount, essentially the issue proceeds of the instrument less the
liability component determined in (b) above.
The liability component of the convertible bond is measured first, at the fair value of a similar liability that does not
have an associated equity conversion feature. The Group has also an option to redeem the bond under certains
conditions (soft call option). This call meets the definition of an embedded derivative but was not accounted for as
a separate derivative because the repayment price is equal to the amortized cost of the host debt instrument and
therefore under one of the exceptions in IFRS 9. Indeed, it is to be considered to be ‘closely related’ to the debt host
contract and consequently, no separate accounting is required for the call option.
In practical terms, the measurement at the fair value of a similar liability that does not have an associated equity
conversion feature is done by determining the net present value of all potential contractually determined future cash
flows under the instrument (principal and interest), discounted at the rate of interest applied by the market at the
time of issue to instruments of comparable credit status and providing substantially the same cash flows, on the
same terms, but without the conversion option. The fair value of any embedded non-equity derivative features is then
determined and included in the liability component. Thereafter, the liability component is accounted for in
accordance with the requirements of IFRS 9 for the measurement of financial liabilities.
The equity component is recorded as the difference between the fair value of the compound instrument (the total
issue proceeds of the bond) and the liability component as determined above. The methodology of “split accounting”
in IAS 32 has the effect that no gain or loss arises from the initial recognition of the separate components of the
instruments.
After initial recognition, the classification of the liability and equity components of the convertible bond is not revised,
for example as a result of a change in the likelihood that a conversion option will be exercised. The amount originally
credited to equity is subsequently neither remeasured or reclassified to profit or loss. The effective interest rate
(6.89%) shown in profit or loss for the convertible bond is equivalent to the rate that would have been paid for non-
convertible debt increased by the transaction costs, while coupon is fixed at 4.25%. In effect, the dilution of
shareholder value represented by the embedded conversion right is shown as an interest expense.
9.2.18. Trade payables
Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of
business from suppliers.Trade payables are recognised initially at fair value and subsequently measured at
amortised cost using the effective interest method.
9.2.19. Borrowings
Borrowings are recognised initially at fair value, net of transaction costs incurred. Borrowings are subsequently carried
at amortised cost; any difference between the proceeds (net of transaction costs) and the redemption value is
recognised in the profit or loss over the term of the borrowings using the effective interest method.
Fees paid on the establishment of loan facilities are recognised as transaction costs of the loan to the extent that is
probable that some or all of the facility will be drawn down. In this case, the fee is deferred until the draw-down
occurs. To the extent there is no evidence that it is probable that some or all of the facility will be drawn down, the
fee is capitalised as a pre-payment for liquidity services and amortised over the period of the facility to which it relates.
130
9.2.20. Current and deferred income tax
The tax expense or credit for the period comprises current and deferred tax. Tax is recognised in the income
statement, except to the extent that it relates to items recognised in other comprehensive income or directly in equity.
The current income tax charge is calculated on the basis of the tax laws enacted or substantively enacted at the
balance sheet date in the countries where the Company and its subsidiaries operate and generate taxable income.
Management periodically evaluates positions taken in tax returns with respect to situations in which applicable
tax regulation is subject to interpretation. It establishes provisions where appropriate on the basis of amounts
expected to be paid to the tax authorities.
Deferred income tax is recognised, using the liability method, on temporary differences arising between the tax bases
of assets and liabilities and their carrying amounts in the consolidated financial statements. However, deferred tax
liabilities are not recognised if they arise from the initial recognition of goodwill. Deferred income tax is not accounted
for if it arises from initial recognition of an asset or liability in a transaction other than a business combination that at
the time of the transaction affects neither accounting nor taxable profit or loss. Deferred income tax is determined
using tax rates (and laws) that have been enacted or substantially enacted by the balance sheet date and are
expected to apply when the related deferred income tax asset is realised or the deferred income tax liability is settled.
Deferred tax assets are recognised only to the extent that it is probable that future taxable profit will be available
against which the temporary differences can be utilised.
9.2.21. Leases liabilities
The Group leases various offices and cars.
The Group has applied IFRS 16 to all contracts in force at 1 January 2019 and previously identified as leases in
accordance with IAS 17 and IFRIC 4.
Assets and liabilities arising from a lease are initially measured on a present value basis. Lease liabilities include the
net present value of the following lease payments:
fixed payments (including in-substance fixed payments), less any lease incentives receivable;
variable lease payments that are based on an index or a rate;
amounts expected to be payable by the lessee under residual value guarantees;
the exercise price of a purchase option if the lessee is reasonably certain to exercise that option; and
payments of penalties for terminating the lease, if the lease term reflects the lessee exercising that option.
The lease term covers the non-cancellable period for which the Group has the right to use an underlying asset,
together with both:
(a) periods covered by an option to extend the lease if the Group is reasonably certain to exercise that option; and
(b) periods covered by an option to terminate the lease if the Group is reasonably certain not to exercise that option.
The lease payments are discounted using the interest rate implicit in the lease. If that rate cannot be determined, the
lessee’s incremental borrowing rate is used, being the rate that the lessee would have to pay to borrow the funds
necessary to obtain an asset of similar value in a similar economic environment with similar terms and conditions.
Right-of-use assets are measured at cost comprising the following:
the amount of the initial measurement of lease liability;
any lease payments made at or before the commencement date less any lease incentives received;
any initial direct costs; and
restoration costs.
The Group measures its right-of-use assets similarly to other non-financial assets (such as property, plant and
equipment) and lease liabilities similarly to other financial liabilities. Therefore, the nature of the expenses related to
those leases changes as we recognize a depreciation of the right-of-use assets and an interest expense on the lease
liabilities. The depreciation is done on a straight-line basis.
Payments associated with short-term leases and leases of low-value assets are recognized on a straight-line basis
as an expense in profit or loss. Short-term leases are leases with a lease term of 12 months or less.
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9.2.22. Revenue recognition
Net sales encompass revenue recognised resulting from transferring control over products sold to customers.
In addition, the Group has entered into a number of contracts through which it “out-licenses” to customers
the IP
5
it developed related to drugs that have not yet received regulatory approval. Generally, under the
terms of the license, the licensee can further develop the IP, and manufacture and/or sell the resulting
commercialized product. The Group typically receives an upfront fee, milestone payments for specific
clinical or other development-based outcomes, and sales-based milestones or royalties as consideration for
the license. Some arrangements also include ongoing involvement by the Group, who may provide R&D
6
and/or manufacturing services relating to the licensed IP.
Licenses coupled with other services, such as R&D, must be assessed to determine if the license is distinct
(that is, the customer must be able to benefit from the IP on its own or together with other resources that
are readily available to the customer, and the Group’s promise to transfer the IP must be separately
identifiable from other promises in the contract). If the license is not distinct, then the license is combined
with other goods or services into a single performance obligation. Revenue is then recognised as the Group
satisfies the combined performance obligation.
If the license is distinct, revenue is recognised at the point in time the license is granted to the extent that
the license provides the customer a “right to use” of a company’s IP as it then exists. Revenue from a distinct
license is recognized over time if and only if the license is qualified as “right to access”, which is the case
when the three following criteria are met:
a) The entity (is reasonably expected to) undertakes activities that will significantly affect the IP to which
the customer has rights;
b) The customer’s rights to the IP expose it to the positive/negative effects of the activities that the entity
undertakes in (a);
c) No goods or services are transferred to the customer as the entity undertakes the activities in (a).
Milestone payments represent a form of variable consideration as the payments are contingent on the
occurrence of future events. Milestone payments are estimated and included in the transaction price based
on either the expected value (probability-weighted estimate) or most likely amount approach. The most likely
amount is the most predictive for milestone payments with a binary outcome (i.e., the Group receives all or
none of the milestone payment). Variable consideration is only recognised as revenue when the related
performance obligation is satisfied, and the company determines that it is highly probable that there will not
be a significant reversal of cumulative revenue recognised in future periods. This then results in a catch up
of revenue at that moment for any performance obligations satisfied until that moment.
Sales-based royalties received in connection with the license of IP, also called variable supply prices
represent a form of variable consideration as the payments are contingent on the occurrence of future
events which is customer’s subsequent sales. Variable supply prices payments are estimated and included
in the transaction price based when the order is made available to the customer (Ex Works sales), the Group's
performance obligation is fully fulfilled. Variable income can therefore be recognized at the same time as
fixed income if it is considered highly probable (in the relatively short term (<1 year).
For R&D services agreement where no license is granted, revenue is recognised over time using the output
methods for determining the stage of completion of the services.
For manufacturing and supply agreements, revenue is recognised at a point in time when the transfer of
control over the related products is achieved.
The Group takes advantage of the practical expedients (i) not to account for significant financing
components where the time difference between receiving consideration and transferring control of goods
(or services) to its customers is one year or less and (ii) to expense the incremental costs of obtaining a
contract when the amortisation period of the asset otherwise recognised would have been one year or less.
5
Intellectual property
6
Research and development
132
Contract assets and liabilities
Contract assets arise when the Group recognises revenue in excess of the amount billed to the customer
and the right to payment is contingent on conditions other than simply the passage of time, such as the
completion of a related performance obligation.
Contract liabilities represent the obligation to transfer goods or services to a customer for which the Group
has received consideration (or an amount of consideration is due) from the customer. If a customer pays
consideration before the Group transfers goods or services to the customer, a contract liability is recognised
when the payment is made, or the payment is due (whichever is earlier). Contract liabilities are recognised
as revenue when the Group performs under the contract.
9.2.23. Government grants and advances
Government grants are recognised as revenue on a systematic basis over the periods in which the entity recognises
the related costs as expenses for which the grants are intended to compensate.
Refundable advances are accounted for as interest free loans for which the benefit of the below-market rate of interest
is treated as a government grant. The benefit of the below-market rate of interest is measured as the difference
between the initial fair value of the loan and the proceeds received. Accordingly, when estimating the liability, the
Company (i) determines its best-estimate of the period during which it will benefit from the advance and (ii)
determines the amount of the liability as the difference between the nominal amount of the loan and its discounted
and risk-adjusted value using a market rate for a liability with similar risk profile to the Company. The liability is
subsequently measured at amortised cost using the cumulative catch-up approach under which the carrying amount
of the liability is adjusted to the present value of the future estimated cash flows, discounted at the liability’s original
effective interest rate. The resulting adjustment is recognised within profit or loss. When there is reasonable
assurance that the Company will comply with the conditions attaching to the grant, and that the grant will be received,
the benefit is accounted for in deduction of the related research and development expenses that it is intended to
compensate.
Repayment of refundable advances may be forgiven in certain circumstances. The liability component of refundable
advances is treated as a government grant and taken to income only when there is reasonable assurance that the entity
will meet the terms for forgiveness of the advance.
9.2.24. Share-based payment arrangements
Equity-settled share-based payments to employees and others providing similar services are measured at the fair
value of the equity instruments at the grant date. Details regarding the determination of the fair value of equity-settled
share- based payment transactions are set out in note 9.26.
The fair value determined at the grant date of the equity-settled share-based payments is expensed on a straight-
line basis over the vesting period, based on the Group’s estimate of equity instruments that will eventually vest, with
a corresponding increase in equity. At the end of each reporting period, the Group revises its estimate of the number
of equity instruments expected to vest. The impact of the revision of the original estimates, if any, is recognised in
profit or loss such that the cumulative expense reflects the revised estimate, with a corresponding adjustment to the
equity- settled share-based payment reserve.
If the entity cancels or settles a grant of equity instruments during the vesting period (other than a grant cancelled
by forfeiture when the vesting conditions are not satisfied), the entity accounts for the cancellation or settlement as
an acceleration of vesting and shall recognise immediately the amount that otherwise would have been recognised
for services received over the remainder of the vesting period.
The Group currently does not have cash-settled share-based payment arrangements.
Regarding non-employee share-based payment awards, there are measured at the fair value of the consideration
received or the fair value of the equity instruments issued, whichever can be more reliably measured. The
measurement date for equity-classified non-employee share-based payment awards is the earlier of the date at
which:
A commitment for performance by the counterparty is reached, and
The date at which the counterparty’s performance is complete.
133
9.2.25. R&D tax credit
Companies that invest in research and development of new environmentally friendly products and advanced
technologies can benefit from increased investment incentives or a tax credit following Belgian tax law, according to
each company's choice. The tax credit may be calculated either as a one-off credit or spread over the depreciation
period. Excess tax credit is carried forward, and the remaining balance after five years is refunded, which may result
in a cash benefit. The tax credit applies to tangible and intangible fixed assets used for R&D of new products and
technologies that do not have a negative impact on the environment (green investments), including R&D expenses
capitalized under Belgian GAAP.
The tax credit should be claimed in the year in which the investment takes place.
Regarding the accounting treatment, the Group follows IAS 20 after assessing its situation carefully because the tax
credit can be directly settled in cash and some conditions not related to taxes for receiving the tax credit exist. Tax
credit is presented as other operating income in the Consolidated Statement of Income.
9.2.26. Investments in equity securities
The group has elected to recognise changes in the fair value of certain investments in equity securities in Other
comprehensive income (for those that are strategic investments, not held for trading). The changes are accumulated
through other comprehensive income to Other reserves within equity. The group transfers amounts from this reserve
to retained earnings when the relevant equity securities are derecognized.
9.2.27. Derivative financial instruments and hedging activities
The Group enters into derivative financial instruments to manage its exposure to foreign exchange rate risk arising
from operational activities (cash flow hedges). The Group’s policy is not to enter into speculative transactions,
Derivative financial instruments are initially recognized at fair value and are subsequently revalued to fair value at
each reporting date.
a) Derivatives qualifying for cash flow hedging
For qualifying hedge relationships, the Group documents at the inception of the transaction the relationship between
hedging instruments and hedged items, as well as its risk management objective and strategy for undertaking the
hedge.
The effective portion of changes in the fair value of derivative financial instruments qualifying as cash flow hedges
is recognized in the cash flow hedge reserve within equity. Gains or losses relating to the ineffective portion are
recognized in the income statement. Amounts deferred in equity are subsequently released to the income statement
in the periods in which the hedged item impacts the income statement. However, if a committed or forecast
transaction is no longer expected to occur, then the cumulative gain or loss that was reported in equity is immediately
transferred to the income statement.
b) Derivatives which do not qualify for hedging
Changes in fair value of derivative financial instruments that do not qualify for hedge accounting are immediately
recognized in the income statement.
Financial risk management
9.3.1. Financial risk factors
a) Market risk
The Group’s overall risk management program focuses on the unpredictability of financial markets and seeks to
minimize potential adverse effects on the Group’s financial performance.
Cash flow and fair value interest rate risk
The Group’s interest rate risk arises from long-term and short-term borrowings. Borrowings issued at variable rates
expose the Group to cash flow interest rate risk, but the current interest rate environment in Europe is stable, with
interest rates even being negative. Borrowings issued at fixed rates expose the Group to fair value interest rate risk.
134
Group policy is to maintain the majority of its long-term borrowings in fixed rate instruments. All borrowings are euro
denominated.
Based on the simulations performed, the impact on post tax profit and equity of a 1% shift would not be significant.
Foreign exchange risk
The Group is materially exposed to both the USD and the AUD. Any future exchange rate risks that might materially
expose the Group will be monitored closely. If appropriate, adequate mitigating actions will be taken.
The main part of the exposure to US dollar at year-end 2021 is related to a significant backlog of license milestones
to be collected in the coming years under the US License and Supply contract signed with Mayne Pharma
(216.960k USD of regulatory and sales related milestone payments). A milestone payment of 8.750k USD had already
been collected at inception of the contract and immediately converted into Euros. As a result of receiving FDA
approval for Estelle® in 2021, an additional milestone payment of 11 .000k USD has been collected and converted
into Euros with the partial settlement of derivative financial instruments. These two milestones were no longer
carrying a US dollar exposure at year end as they were collected and converted in Euros.
Since 2020, the Group uses derivative financial instruments to manage its exposure to foreign exchange rate risk
arising from operational activities (cash flow hedges). Mithra’s risk management objective is to hedge the USD
exposure arising from the Estelle
®
license and supply agreement contracted in USD between Mithra and Mayne
Pharma LLC. This exposure is hedged with FX forwards maturing in the period 2020-2025.The derivative financial
instruments are initially recorded at fair value on balance sheet and are subsequently revalued to fair value through
OCI at each reporting date. Positive fair values are reported as assets, negative fair values as liabilities, and as
current/non-current based on maturities of hedging contracts.
The maturity table for the outstanding foreign currency hedges (forward sale of USD against EUR) is the following:
Time to maturity
Hedged Amounts (kUSD)
Average Hedge Rate
- < 1 year
106,960
1.17
- 1-2 years
30,000
1.21
- 2-5 years
80,000
1.25
Total
216,960
1.20
If USD was to weaken against EURO implying a 10% increase of the forward rate, compared to year-end USD forward
rates used for the fair value measurement, these fair values of hedging contracts would be expected to increase
from EUR -4,683k to EUR 12,143k. In case of 10% strengthening of USD forward rates against EURO, fair values
would be expected to decrease to EUR -25,247k.
Example with a 10% weakening USD :
Forward rates
recalculated at
31/12/21
MTM's at
31/12/21 in EUR
Fwd rates -10%
MTM's 10% USD
weakening in EUR
Delta in EUR
1.1378
-361,224
1.2516
238,002
-599,227
1.1373
-515,689
1.2511
363,554
-879,243
1.1375
64,425
1.2513
2,062,384
-1,997,958
1.1380
35,882
1.2518
1,111,117
-1,075,235
1.1521
-1,009,389
1.2673
2,936,087
-3,945,476
1.1741
-713,011
1.2915
1,609,858
-2,322,869
1.1982
-1,032,655
1.3181
2,002,075
-3,034,730
1.2241
-1,150,981
1.3465
1,819,640
-2,970,621
-4,682,643
12,142,716
-16,825,359
135
Since end of 2020, EURO has weakened significantly towards USD, with the foreign currency spot rate decreasing
from 1,19 to 1,13. This has caused the market value of FX derivative hedges to decrease from EUR 3 574k at 31
December 2020 to EUR -4 683k at 31 December 2021. The average hedge rates are made of an FX spot element
which was quoted on the trading date to which our counterparties (banks) added CVA (Credit Valuation Adjustment)
and KVA (Capital Valuation Adjustment) elements. For the fair value calculations, the FX spot element and other
adjustments at the year-end closing were also considered.
The US License and Supply contract was also structured with consideration received in the form of Mayne Pharma’s
ordinary shares. Mayne Pharma issued 4.95% of their outstanding shares to Mithra when signing the contract (a
financial asset at fair value through other comprehensive income at year-end) and a further 4.65% has been issued
after reception of FDA approval in 2021 (reception of 85.8 million ordinary shares) allowing the Company to become
the first shareholder (with 9.57%) of Mayne Pharma Group Ltd, an Australia-listed company on ASX.
Contract asset related to the second part of Mayne shares receivable was reversed and the EUR 20.3 million (value
of shares at the emission date with 0,37 AUD/share on ASX) booked under equity securities.
These two equity tranches represent 168.872.626 ordinary shares of Mayne Pharma which at year-end at 0.3
AUD/share on the Australian Stock Exchange (ASX) would represent AUD 49.8 million compared to AUD 58,2 million
last year.
This Australian dollar exposure was still not hedged at year-end as the share price has continued to be very volatile.
It was then complex to determine an underlying Australian dollar amount to be hedged, and to apply in consequence
a net investment hedge accounting treatment (using FX forward contracts).This exposure will of course be closely
monitored and a net investment strategy (potentially on part of the underlying value) might be considered in the
future.
Price risks
The Group is exposed to price risks since 2019. The main part of the exposure to price risks at year-end 2021 was
related to a significant backlog of license milestones to be collected in the coming years under the US License and
Supply contract signed with Mayne Pharma (up to 216.960k USD of regulatory and sales related).
Mithra will receive down payment and milestone fees in equity & cash of at least around USD 290 million. In addition
to that, a transfer price comprising fixed and variable components based on a percentage of high double-digit net
sales over a 20-year period.
The reception of 85.8 million ordinary shares (an Estelle® out-licensing milestones for the US territory), allowing the
Company to become the first shareholder (with 9.57%) of Mayne Pharma Group Ltd, an Australia-listed company on
ASX, reduced the global price risks from last year because the share’s price is conditioned to the stock market price
conditions since Mayne Pharma is quoted on the Australian Stock Exchange (ASX).
b) Credit risk
Credit risk relates to the risk that a counterparty will fail to fulfil their contractual obligations with the result that the
Group would suffer a loss. The Group’s policy focuses on only working with creditworthy counterparties and, where
necessary, requiring adequate securities. Information about the creditworthiness of counterparties is provided by
independent rating agencies and, if this is not available, the Group uses information that is publicly available as well
as its own internal records. Credit risk is managed by the financial department of the parent company by means of
individual follow-up of credit per counterparty and credit insurance coverage.
An aging analysis of the debtor is also evaluated on a regular basis for potential doubtful debts. An analysis of trade
receivables at 31 December 2021 and 31 December 2020 is shown below.
Thousands of Euro (€)
Past due but not impaired
Year
Carrying amount
Neither impaired nor past
due
0-60
days
61-90
days
91-120 days
>120 days
2021
6,952
2,749
2,591
1,092
520
0
2020
6735
6,096
450
122
15
52
136
IFRS 9 requires the Group to recognise a loss allowance for expected credit losses on trade receivables and contract
assets. In particular, the Group applies the simplified approach to providing for expected credit losses prescribed by
IFRS 9, which permits the use of the lifetime expected loss allowance for all trade receivables. The Group allows an
average debtor’s payment period of 30 days after invoice date. To measure the expected credit losses, trade
receivables have been grouped based on shared credit risk characteristics and the days past due. In assessing the
credit risk characteristics, the group takes into account any indicators of impairment up until the reporting date, and
it apply a definition of default that is consistent with the definition used for internal credit risk management purposes
and consider qualitative factors where appropriate. Given the current nature of trade receivables, the loss allowance
provision as at year-end is zero.
It is management’s opinion that at the above reporting dates no further provision for doubtful debts was required.
The above table shows the analysis of trade receivables out of contract assets, which are neither impaired nor past
due.
The overall collectability risk for the remaining debt can be considered as immaterial as per management’s
computation following IFRS 9.
The credit risk on cash investments or cash available on banks accounts is limited given that the counterparties are
banks with high credit scores attributed by international rating agencies. The financial institutions have credit ratings
varying from A to AA- (upper-medium grade) and are thus considered as low credit risk.
c) Liquidity risk
Thanks to the successful IPO, subsequent capital increases, convertible bond, the capital commitment line with LDA
Capital Limited for up to EUR 50 million, committeed bank loans of EUR 35 million for which maturities have been
extended until March 2023 (fully drawn), and an additional financing agreement contracted in 2022 with Goldman
Sachs for EUR 100 million (of which EUR 60 million could be drawn in 2022), the Group maintains sufficient cash to
finance its business development strategy, and to carry on its R&D expenses. Management reviews cash flow
forecasts on a regular basis to determine whether the Group has sufficient cash reserves to meet future working
capital requirements and to take advantage of business opportunities.
The liquidity risk mainly relates to non-current borrowings. The non-current debts primarily relate to contingent and
deferred consideration payable in relation to historical acquisitions.
The maturity analysis of non-derivative financial liabilities is shown below.
137
Thousands
of Euro (€)
Less than
3 months
Between 3
months and 1
year
Between 1
and 2 years
Between 2
and 5 years
Over 5 years
Total
At 31 December 2021
26,796
22,996
105,761
301,637
53,141
510,330
Subordinated loans & other loans
903
1,931
38,225
8,970
12,347
62,376
Convertible bonds
-
5,313
5,313
135,625
146,250
Lease liabilities
2,562
5,217
6,331
16,577
21,893
52,579
Contingent consideration payable &
refundable government advances
-
10,536
55,892
140,465
18,901
225,794
Trade and other payables
23,331
-
-
-
-
23,331
At 31 December 2020
55,939
19,118
41,565
253,415
184,510
554,548
Subordinated loans & other loans
5,056
1,771
2,763
7,202
12,356
29,149
Convertible bonds
5,313
5,313
140,938
151,563
Lease liabilities
3,611
5,662
7,201
18,911
28,113
63,499
Contingent consideration payable &
refundable government advances
20,000
6,373
26,289
86,364
144,041
283,066
Trade and other payables
27,272
-
-
-
-
27,272
In December 2020, the Group has completed a placement of EUR 125 million senior unsecured convertible bonds
due 17 December 2025. The annual coupon of 4.250% is included in the table above.
Post year-end, the maturities of straight loans ING & BELFIUS, presented under subordinated loans & other loans for
an amount of EUR 35 million as per December 31, 2021, have been extended to March 31, 2023.
The contingent consideration for Estetra has been included for the remaining cash payments of 185 million knowing
that there is still uncertainty about the payment period given the evolution of the group's cash position. The difference
between the above table and the amounts detailed in sections 9.16. Financial liabilities and 9.18. Financial
instruments are due to the fact that the amounts above are undiscounted meaning that no discount rate neither
probabilities of success of research nor commercialisation have been applied to them.
Moreover, we computed the variable part of the refundable government advances and contingent consideration
payable based on the existing business plan at 31 December 2021. The fixed part of the refundable government
advances is of course independent of these assumptions.
For more details on borrowings and other financial liabilities, refer to notes 9.15. (Financial liabilities) and 9.17.
(Financial instruments). As the amounts included in the maturity tables are the contractual undiscounted cash flows,
including principal and interest payments, these amounts will not reconcile to the amounts disclosed in the balance
sheet.
d) Capital risk management
The Group’s objectives when managing capital are to safeguard the Group’s ability to continue as a going concern
in order to be in a position to provide returns for shareholders in the future and benefits for other stakeholders and
to obtain over time an optimal capital structure to reduce the cost of capital.
The Group makes the necessary adjustments in the light of changes in the economic circumstances, risks
associated to the different assets and the projected cash needs of the current and projected research activities. The
current cash situation and the anticipated cash burn / generation are the most important parameters in assessing
the capital structure. The Company objective is to maintain the capital structure at a level to be able to finance its
activities for at least twelve months. Cash income from new partnerships is taken into account and, if needed and
possible, the Company can issue new shares or enter into financing agreements.
Critical accounting estimates and judgements
The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting
estimates. It also requires management to exercise its judgment in the process of applying the Group’s accounting
policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates
are significant to the consolidated financial statements are disclosed below.
138
9.4.1. Going concern
The financial statements have been prepared on a going concern basis and in accordance with the main accounting
principles set out above.
End of 2021, Mithra has a total of EUR 336.6 million accumulated losses on its balance sheet and realized a
consolidated net loss of EUR 116.9 million for the year ended 31 December 2021. Based on going concern accounting
principles, the Board is to justify the going concern during twelve months following the issuance of the report. Based
on their assessment, the Management and Board of directors consider it appropriate to prepare the financial
statements on a going concern basis. Indeed, the assessment is based on following assumptions such as expected
R&D clinical results and further business deals (mainly Donesta deal foreseen in H2 2022) as well as on the
monitoring of our funding activities, noting that a total amount of EUR 100 million flexible equity financing agreement
contracted with Goldman Sachs International in February 2022 are currently available with a first drawing request
exercised on 4 February 2022 for an amount of EUR 10 million and a second one exercised on 21 March 2022 for an
amount of EUR 5 million.
In consideration of those above-mentioned conservative assumptions, the Board of directors has analyzed the
financial statements and accounting policies and, made the assessment that the current cash position of EUR 32.9
million at 31 December 2021 strengthened by post-year end flexible equity financing agreement contracted with
Goldman Sachs International for EUR 100 million and a capital increase for an amount of EUR 8.1 million completed
on 14 February 2022 under the LDA capital agreement facility will allow the Group to keep up with operating expenses
and capital expenditure requirements at least until April 2023 (twelve month at least after the issuance of this report).
9.4.2. Out-licensing contracts with customers
Revenue from license granting contracts should be accounted for based on the substance of the agreements
between the entity and its business partners. IFRS 15 requires management to exercise its judgment, notably in the
following key areas:
a) Determine if the license is distinct from any other performance obligations in the contract;
b) Determine the transaction price, including estimates of any agreed variable consideration, taking into
account the constraining limit of the “highly probable” criteria;
c) Determine if a performance obligation is satisfied at the reporting date.
Management makes its judgments taking into account all information available about the clinical status of the
underlying projects at the reporting date and the legal analysis of the contracts performed by its legal counsel. Please
refer to 9.18 Contract assets and liabilities.
9.4.3. R&D capitalisation
R&D capitalisation involves a great deal of judgment linked to evaluating whether all conditions to capitalized
development costs have been met. The judgment relates mainly to criteria such as the technical feasibility of a
project and the economic benefits that will result from the project. This analysis is done on a project basis and with
the involvement of internal project managers. Please refer to 9.6 Other intangible assets.
9.4.4. Estimated impairment
The Group tests annually whether goodwill and indefinite useful life intangible assets have suffered any impairment,
in accordance with the accounting policy stated in note 9.2.11. This involves the identification of potential
impairment indicators and the use of significant assumptions including future cash flows, discount rate and
probabilities of success. These estimates are performed taking into account all information available about the
clinical status of the underlying project, some external benchmarks and the relevant market economic conditions at
reporting date. Please refer to note 9.6. Other Intangible Assets and 9.9 Goodwill & IP R&D for the impairment testing
performed for those assets.
9.4.5. Income taxes
Significant judgment is required in determining the tax income or expense. The Group is subject to income taxes in
different jurisdictions and there are many transactions and calculations for which the ultimate tax determination is
uncertain during the ordinary course of business. Measurement of the deferred tax asset related to the tax loss carry-
139
forward involves significant judgement, notably related to the foreseeable future taxable profits. We refer to section
9.24 Income tax.
9.4.6. Measurement of provisions
Significant judgement is required in the estimation of present obligations that arise from past events including legal
claims and other items. These judgments are based on the Group’s prior experiences and are the best estimate of
the Group’s liability for these issues.
9.4.7. Useful life and residual value
An estimation of the residual values and useful life of tangible assets and intangible assets is required to be made
at least annually. Judgement is required in estimating the useful life of fixed asset categories. The residual value is
the best estimate of the amount that would be obtained from the disposal of the asset, after deducting the estimated
costs of disposal, if the asset was already of the age and in the condition expected at the end of its useful life. Both
residual value and useful life of tangible assets are determined based upon discussions with local engineers. Please
refer to note 9.6 Other Intangible Assets and 9.9 Goodwill & IP R&D.
9.4.8. Fair value measurement of contingent consideration payable and
consideration receivable
Monetary contingent consideration that the acquirer is due to pay or receive is within the scope of IFRS 9.
Valuation methods, usually discounted cash flow analysis, are used to determine the fair value of some of the
Company’s liabilities that are not traded in an active market. These valuation methods require judgement; the main
assumptions and variables used are future cash flows per projects, likelihood of approval (LOA), discount rate and
long-term growth rate. These assumptions are based on external benchmarks, management’s estimates based on
experience of the entity and on internal analysis.
Also, as from 2019, the fair value measurement of contingent consideration receivable is considered to be a
significant estimate. In this respect, the expected value method is applied, based on probability weighted amounts
within several possible scenarios. This valuation methodology requires judgments about the different possible
scenarios and their respective probability, as well as about the discount rate applied to the expected cash flows.
Please refer to note 9.17.3 Financial Assets and Liabilities accounted for at fair value. Measurement of refundable
cash advances
The remeasurement of refundable cash advances using the cumulative catch up method requires periodic re-
estimation of the contractual cash flows required to repay the liability towards the Walloon Region. Management
revise periodically the business plan of each products concerned and the probability of success of related clinical
trials. Please refer to note 9.15.2 Refundable government advances.
9.4.9. Derivative financial instruments qualifying for cash hedge accounting
Management judgment is required in the estimation about the fulfilment of the effectiveness requirements for an
arrangement to qualify for hedge accounting. For qualifying hedge relationships, the Group documents at the
inception of the transaction the relationship between the hedging instruments and the hedged transactions, as well
as its risk management objective and strategy for undertaking the hedge.
The effective portion of changes in the fair value of derivative financial instruments qualifying as cash flow hedges
are deferred to equity, while gains or losses relating to the ineffective portion are recognized in the income statement.
Please refer to note 9.17.3 Financial Assets and Liabilities accounted for at fair value.
Segment information and revenue
9.5.1. Description of segments
The Group has identified three reportable segments of its business: Product sales for the sales related to Mithra’s
complex therapeutic products (Myring
®
), E4 products and the remaining portfolio of generic products, Out-licensing
business for partnership deals and Other for the R&D services rendered to third parties. Hence, a distinction is being
made in the information provided regularly to the chief operating decision maker, being the Chief Executive Officer.
140
9.5.2. Revenue
Year ended 31 December
Thousands of Euro (€)
2021
2020
Product Sales
17,207
3,576
Out-licensing
4,642
5,446
Other
819
8
Total revenues
22,668
9,030
Group revenue, at EUR 22.7 million more than doubled compared to last year (EUR 9.0 million) thanks to our first
Estelle
®
product sales (EUR 13.4 million) in the US, Europe and Canada while sales of other product in our portfolio
remained steady.
Out-licensing is mainly driven by a EUR 3.7 million deferred revenue, previously invoiced and paid, that was
recognized following the acquisition of full global licensing and distribution rights for Zoreline
®
.
9.5.3. Disaggregation of revenue
The tables below show the segment information for the reportable segments for the year ended 31 December 2021
and 2020, as well as the basis on which revenue is recognized:
Year ended 31 December 2021
Thousands of Euro (€)
Product sales
Out-licensing
Others
Primary Geographic Markets
Belgium
875
-
137
Europe (excl. Belgium)
4,609
3,995
682
Outside Europe
11,723
647
-
Total
17,207
4,642
819
Product type
Generics
3,841
4,144
-
E4 contraception
13,366
498
-
E4 Menopause
-
-
Others
-
819
Total
17,207
4,642
819
Timing of transfer of goods and services
At a point in time
17,207
4,642
819
Over time
-
-
-
Total
17,207
4,642
819
141
Year ended 31 December 2020
Thousands of Euro (€)
Product sales
Out-licensing
Others
Primary Geographic Markets
Belgium
1,878
-
-
Europe (excl. Belgium)
704
924
8
Outside Europe
994
4,522
-
Total
3,576
5,446
8
Product type
Generics
3,576
(43)
-
E4 contraception
-
4,967
-
E4 Menopause
-
-
-
Others
-
522
8
Total
3,576
5,446
8
Timing of transfer of goods and services
At a point in time
3,576
5,446
8
Over time
-
-
-
Total
3,576
5,446
8
Other intangible assets
Thousands of Euro (€)
Operating
license
Intellectual
property rights
Software
licences
Development
costs
Total
Costs
At 31 December 2019
3,471
78,406
1,834
7,627
91,336
Additions
-
-
791
4,794
5,586
Disposals
-
-
-
-
-
At 31 December 2020
3,471
78,406
2,625
12,421
96,923
Additions
100
9,250
734
8,515
18,599
Disposals
-
-
-
-
-
At 31 December 2021
3,571
87,656
3,359
20,936
115,522
Accumulated amortisation
At 31 December 2019
3,165
-
497
186
3,848
Amortisation expense and impairment
96
3,450
325
199
4,070
At 31 December 2020
3,261
3,450
822
385
7,918
Amortisation expense and impairment
88
1,486
442
634
2,650
At 31 December 2021
3,349
4,936
1,264
1,019
10,568
Net book value
At 31 December 2019
305
78,406
1,337
7,441
87,490
Cost
3,471
78,406
2,625
12,421
96,923
Accumulated amortisation and
impairment
3,261
3,450
822
385
7,918
At 31 December 2020
209
74,956
1,804
12,036
89,005
Cost
3,571
87,656
3,359
20,936
115,522
Accumulated amortisation and
impairment
3,349
4,936
1,264
1,019
10,568
At 31 December 2021
222
82,720
2,095
19,917
104,954
Other intangible assets consist mainly of a portfolio of acquired product rights, market access fees and development
costs. This section primarily includes the intellectual property rights acquired for Estelle
®
, Zoreline
®
, Myring
®
and the
142
Donesta
®
asset deal, as well as development costs in the framework of E4 activity (the project “E4 synthesis” and
the project Estelle® with the development costs which occurred after the application for market authorization, and
now relating to phase IV).
The main additions of the financial year 2021 are:
Internally generated E4 assets arising from development for EUR 8.5 million;
Acquisition of full licensing and distribution rights of Zoreline
®
held by SVR Invest, including important
territories such as China, Canada and Australia for an amount of EUR 8.5 million;
Rights’ acquisition option (EUR 0.8 million financial commitment) relating to a development programs led
by the Belgian company BCI Pharma on innovative kinase inhibitors notably indicated for the treatment of
female cancers and endometriosis;
Softwares and IT capital expenditures.
Following Estelle
®
Marketing authorization, intellectual property rights and internally generated research and
development for this project are now considered as available for use. Amortization is calculated using the straight-
line method to allocate the cost of these intangibles on the longest of the patent protection life and the useful life of
the product. The estimated useful life and amortization method are reviewed at the end of each reporting period.
Most of intellectual property rights, except Estelle
®
, are not yet amortised because they are not yet available for use.
Myring
®
intellectual property rights is also considered as not fully available for use. Product sales occurred since
product launch in some countries in Europe in 2020 and in Canada and Chile in 2021. However, major market
targeted for this product is USA.
During the period of development, the assets are tested for impairment. No impairments indicators have been
identified on Other intangible assets.
Intellectual property rights
Thousands of Euro (€)
2021
2020
Clinical Status
Intangible Estelle®
29,663
30,686
Commercialized in US, Europe & Canada
Donesta® asset deal
8,000
8,000
Phase 3 ongoing
Intangible Zoreline®
32,882
24,382
New formulations are being assessed on animals
Intangible Myring®
11,425
11,425
UE: commercialized
US: application for market authorization filed
Others
750
463
N/A (Kinase innovative inhibitors rights’
acquisition option against BCI Pharma)
Total
82,720
74,956
143
Property, plant and equipment
Thousands of Euro (€)
Land and buildings
Fixtures and
equipment
Motor Vehicles
Total
Cost
At 31 December 2019
2,775
25,530
111
28,416
Additions
542
8,437
-
8,979
Disposals
-
(5)
(17)
(22)
At 31 December 2020
3,317
33,962
94
37,373
Additions
1,162
10,375
-
11,536
Disposals
-
-
(15)
(15)
At 31 December 2021
4,479
44,337
79
48,894
Accumulated depreciation
At 31 December 2019
829
4,000
85
4,914
Amortisation expense
222
2,322
(7)
2,537
At 31 December 2020
1,051
6,322
78
7,451
Amortisation expense
179
2,912
(3)
3,089
At 31 December 2021
1,230
9,234
75
10,540
Net book value
At 31 December 2019
1,946
21,530
26
23,502
Cost
3,317
33,962
94
37,373
Accumulated amortisation
1,051
6,322
78
7,451
At 31 December 2020
2,266
27,639
16
29,921
Cost
4,479
44,337
79
48,894
Accumulated amortisation
1,230
9,234
75
10,540
At 31 December 2021
3,248
35,102
4
38,354
Property, plant and equipment increased by EUR 8,433k, mainly relating to machinery and equipment in the
production facility for the manufacturing of pharmaceuticals products (Mithra CDMO) and their related development
costs for machine settings and improvement. During the financial year, the Company invested in the installation of
additional solar panels to reduce the environmental impact of its facility.
144
Lease Right-of-use assets
Thousands of Euro (€)
Land and Buildings
Fixtures and
equipment
Vehicles
Total
Cost
At 31 December 2019
47,364
27,882
919
76,165
Additions
379
3,416
469
4,264
Grants related to assets
-
(1,724)
-
(1,724)
Disposals
-
-
-
-
At 31 December 2020
47,743
29,573
1,388
78,704
Additions
123
2,616
1,736
4,475
Disposals
-
-
(262)
(262)
At 31 December 2021
47,866
32,189
2,862
82,918
Accumulated depreciation
At 31 December 2019
4,813
404
413
5,630
Amortisation expense
2,487
510
504
3,501
At 31 December 2020
7,300
915
917
9,132
Amortisation expense
2,304
1,717
443
4,464
At 31 December 2021
9,604
2,632
1,360
13,596
Net book value
At 31 December 2019
42,551
27,478
506
70,535
Cost
47,743
29,573
1,388
78,704
Accumulated amortisation
7,300
915
917
9,132
At 31 December 2020
40,443
28,658
471
69,572
Cost
47,866
32,189
2,862
82,918
Accumulated amortisation
9,604
2,632
1,360
13,596
At 31 December 2021
38,263
29,557
1,502
69,322
Thousands of Euro (€)
As at 31 December
2021
2020
Interest expense on lease liabilities
(2,174)
(2,241)
Expense relating to leases of low-value assets or short-term leases
(322)
(83)
Goodwill & IP R&D
Goodwill results entirely from the acquisition of Estetra (EUR 3,814k) and Novalon (EUR 1,420k) performed in 2015.
Goodwill are allocated to CGU’s that are tested for impairment
7
at least annually. In the year of acquisition of Estetra
and Novalon, management confirmed the validity of the expected cash flow approach used when acquiring the
businesses, breaking down the risks and using all expectations about possible cash flows and discounting the
expected value at a different rate depending on the CGU (CGU Myring 12,56%, CGU Zoreline, 14,78% and CGU Estelle
11,28%).
Regarding the recoverable value of Estelle
®
, no probability of success of R&D/commercial stage is needed anymore
since the commercial launch occurred in June 2021, thus no impairment loss was identified. The same conclusion
applies for Donesta
®
and the Novalon products.
More specifically, the assets related to Estetra and Novalon products are tested for impairment in groups of assets
described as three different cash-generating units (CGUs), being Estelle
®
, Myring
®
and Zoreline
®
.
145
Thousands of Euro (€)
2021
2020
CGU value Estelle®
33,476
34,500
CGU value Zorelin
33,876
25,376
CGU value Myring®
11,851
11,851
Total
79,203
71,727
For the reconciliation with the total amount of IP R&D please refer to note 9.6, “Other intangible assets”, the difference
with the CGU total is the amount of the Goodwill (Estelle EUR 3,814k and Myring and Zoreline for EUR 1,420k).
In 2021, the increase is explained by the acquisition of full licensing and distribution rights of Zoreline
®
held by SVR
Invest, including important territories such as China, Canada and Australia for an amount of EUR 8.5 million.
Also, since the reception of US Estelle® Marketing authorization in early 2021, the Company began to amortize the
related intellectual property rights and internally generated research and development, as this project is considered
as available for use as from this date.
The recoverable amounts are based on the fair value less cost to sell methodology which use some risk-adjusted
discounted cash flow models for a period of 10 years. If any terminal value is included, further cash flows are
extrapolated using a negative long-term growth rate. Probabilities of success are also different by CGU and are
updated based on latest information about clinical results; The discount rate applied was updated following the
specific product covered by the IP rights; Each model/product has its own WACC in 2021. Management’s
assessment is that the recoverable amounts exceeds their carrying value and that no impairment is required.
Assumptions 2021:
Intangible assets tested
Probability of sucess in 2021
Phase 2
Phase 3
WACC
Estelle®
100%
100%
11.28%
R&D
Commercial
WACC
Zoreline®
80%
55%
14.78%
Myring®
90%
75%
12.56%
Assumptions 2020:
Intangible assets tested
Probability of sucess in 2020
Phase 2
Phase 3
WACC
Estelle®
100%
90%
11,72%
R&D
Commercial
WACC
Zoreline®
80%
55%
14,80%
Myring®
90%
75%
13,09%
A sensitivity analysis has been performed on the impairment testing. Mithra performed the sensitivity test by
increasing the discount rate by 1 percentage point for Estelle, this did not result in any impairment losses.
For Myring
®
, Mithra tested the asset by applying a delay of six months for US approval reception from the FDA, this
did not result in any impairment losses while no FDA approval at all (under a worst-case scenario) would result in an
impairment loss of EUR 11,9 million on the intangible assets (and EUR 7.6 million on the contract assets).
For Zoreline
®
, we tested a reasonable change in the assumptions relating to the Pos of 80% (R&D) and 55%
(commercial). A drop in the cumulative probability (R&D / commercial) from 44% to 27% does not change the test
conclusions.
146
Other non-current assets
Thousands of Euro (€)
As at 31 December
2021
2020
R&D tax credit receivable
8,123
5,628
Advance payments
1,100
550
Other long-term receivables
40
224
Contingent consideration receivable
-
7,999
Total other non-current assets
9,263
14,401
In 2021, we can notice a decrease of Other non-current assets mainly explained by :
An increase of the R&D tax credit receivable which is tax incentive for R&D investments that have no impact
or reduce the impact on the environment (please refer to Note 9.19);
A decrease of contingent consideration receivable against Cerese Pharma : further to the acquisition of
Ceres Pharma by Naxicap Partners and latest financial info received from Ceres, it is currently deemed
unlikely that necessary financial performance of the assets sold will be met in order to receive the
contingent consideration receivables of two times EUR 5 million (discounted) by 2023. Obviously, expected
financial performance of the assets sold will be followed closely and regularly and part or whole of the
contingent consideration receivable may very well be reinstated if considered as likely.
Inventories
Thousands of Euro (€)
As at 31 December
2021
2020
Raw materials & consumables
38,887
32,442
Semi-finished goods
5,032
2,915
Finished goods
5
25
Total at cost
43,924
35,382
Cumulated amounts written off at the beginning of the period
-
(150)
Reversal of write-down of inventories credited to expense in the period
-
150
Cumulated amounts written off at the end of the period
(72)
-
Total net carrying amount
43,852
35,382
Inventories increased to EUR 43,852k from EUR 35,382k in 2020, mainly because of the commercial launch of
Estelle
®
which represents 84% of the total inventory in 2021.
Trade and other receivables
Thousands of Euro (€)
As at 31 December
2021
2020
Trade receivables
4,640
5,287
Recoverable VAT
1,681
2,389
Prepayments
2,312
1,568
Other
1,410
809
Total trade and other receivables
10,044
10,053
Trade and other receivables are steady compared to previous closing. Prepayments as of December 31, 2021 relate
to advance payments to ICON for Donesta Phase III. The section other includes a receivable following the disposal
of equity shares of NOSHAQ for a total amount of EUR 565k, leading to a financial capital gain of EUR 367k (please
refer to the note 9.29 Related party transactions).
147
Cash and cash equivalents
As at 31 December
Thousands of Euro (€)
2021
2020
Cash at bank and in hand
32,872
138,675
Total cash and cash equivalents
32,872
138,675
Equity
9.14.1. Share capital and additional paid-in capital
At 31 December 2021 and 31 December 2020, the Company’s share capital was represented by the following
number of shares (units), all fully paid up and without nominal value:
As at 31 December
2021
2020
Number of shares (issued and fully paid)
44,051,259
42,714,097
The shares have no nominal value, but they represent the same fraction of the Company's capital, which is
denominated in euros. Each share entitles its holder to one voting right.
In addition, the Company has still a number of subscription rights, that are exercisable into ordinary shares. We refer
to note 9.26 Share-based payments.
The change in the number of shares during the periods ending on 31 December 2021 and on 31 December 2020 is
as follows:
Thousands of Euro (€)
Number of
shares
Share capital
Additional paid-in
capital
Total
Balance at 31 December 2019
39,133,245
28,649
258,898
287,547
- Capital increase
3,580,852
2,622
62,546
65,168
- Value of conversion rights on convertibles
bonds
-
-
11,091
11,091
Balance at 31 December 2020
42,714,097
31,271
332,535
363,806
- Capital increases
1,337,162
979
8,235
9,214
Balance at 31 December 2021
44,051,259
32,250
340,769
373,020
During the period under review, two capital increases took place :
On 6 May 2021 with the issuance of 1,023,000 new shares for a total amount of EUR 3,500,520 as the result
of the exercise of 620 subscription rights (warrants) pursuant to the warrant plan initiated on March 2, 2015.
There are no more outstanding warrants arising from this 2015 Warrant Plan.
On 2 July 2021, the Company launched a second Put Option Notice pursuant to the Put Option Agreement
entered into with LDA Capital Ltd which materialized in a capital increase resulting in the issuance on the
10 November 2021 of 314,162 new shares to the benefit of LDA Capital for an aggregate amount of EUR
229,998 (excluding issue premium);
148
9.14.2. Other reserves
The table below presents the breakdown of other reserves within equity:
Thousands of Euro (€)
Share-based
payment
reserve
Financial
assets at
FVOCI and
foreign
currency
translation
reserves
Cash flow
hedge
reserve
Total other
reserves
Balance as at 1 January 2020
8,448
(5,024)
-
3,424
Currency translation differences
(66)
(66)
Gains/(losses) on cash flow hedges
7,838
7,838
Changes in the fair value of equity investments at fair value through
other comprehensive income or loss
(4,772)
(4,772)
Total comprehensive loss for the period
-
(4,838)
7,838
3,000
Share-based payments expense
7,267
7,267
Balance as at 31 December 2020
15,714
(9,862)
7,838
13,690
Balance as at 1 January 2021
15,714
(9,862)
7,838
13,690
Gains/(losses) on cash flow hedges
(10,792)
(10,792)
Changes in the fair value of equity investments at fair value through
other comprehensive income or loss
(6,508)
(6,508)
Total comprehensive loss for the period
-
(6,508)
(10,792)
(17,300)
Share-based payments expense
1,065
1,065
Balance as at 31 December 2021
16,779
(16,370)
(2,954)
(2,545)
Share-based payment reserve
Please refer to note 9.26.
Financial assets at fair value through other comprehensive income or loss
The group has elected to recognize changes in the fair value of certain investments in equity securities in Other
comprehensive income or loss, as explained in note 9.17 Financial Instruments. These changes are accumulated
through other comprehensive income or loss and other reserves within equity. The group transfers amounts from
this reserve to retained earnings when the relevant equity securities are derecognized.
As at December 31, 2021, the other reserves contain the cumulative changes in fair value of financial assets through
other comprehensive income or loss (Mayne shares) for EUR 16.4 million.
Cash flow hedge reserve
In the first quarter of 2020, the Group entered into derivative financial instruments to manage its exposure to
foreign exchange rate risk arising from operational activities (cash flow hedges). The effective portion of
changes in the fair value of derivative financial instruments qualifying as cash flow hedges is deferred to equity.
Amounts deferred in equity are subsequently released to the income statement in the periods in which the
hedged transaction impacts the income statement.
149
As at December 31, 2021, the cash flow hedge reserve contains the cumulative changes in fair value of hedge
instruments for EUR 3.0 million. Please refer to note 9.3 Financial Risk Management.
Financial liabilities
An overview of the financial liabilities is shown below.
As at 31 December
Thousands of Euro (€)
2021
2020
Total
Current
Non-Current
Total
Current
Non-Current
Subordinated loans
12,943
1,314
11,629
13,612
1,002
12,610
Other loans
158,861
45,253
113,608
122,373
10,475
111,898
Bank loans
45,150
40,187
4,963
10,713
5,162
5,551
Convertible bonds
113,711
5,066
108,645
111,310
5,313
105,997
Capital grants
-
-
-
350
-
350
Lease liabilities
48,914
6,561
42,353
51,597
7,315
44,282
Refundable government advances
14,386
1,617
12,769
16,454
1,259
15,195
Sub-total liabilities arising from financing
activities
235,105
54,746
180,359
204,036
20,051
183,985
Other financial liabilities
118,504
15,829
102,675
124,604
23,424
101,180
Derivatives financial liabilities
4,783
1,886
2,897
-
-
-
Total financial liabilities
358,392
72,461
285,931
328,640
43,475
285,165
Here is the roll forward of liabilities arising from financing activities over the year 2021:
Thousands of Euro (€)
2020
Cash flows
Non-cash
changes
2021
Inflow
Outflow
Additions
Reclassification
Classification
of part of the
proceeds in
grant income
Amortized
costs
adjustments
Subordinated loans
13,612
(669)
12,943
Other loans
122,373
83,600
(54,503)
-
(61)
(261)
7,714
158,861
Bank loans
10,713
83,600
(49,163)
45,150
Convertible bonds
111,310
(5,313)
7,714
113,711
Capital grants
350
-
(28)
-
(61)
(261)
-
-
Lease liabilities
51,597
(7,193)
4,510
48,914
Refundable government
advances
16,454
181
(804)
61
(140)
(1,365)
14,386
Total
204,036
83,781
(63,170)
4,510
-
(401)
6,349
235,105
During 2021, new credit line was concluded for an amount of EUR 15 million. This additional financing facility and
the previously contracted credit line (EUR 20 million, available since 2020) were fully drown end of 2021.
The debt component of convertible bond issued in December 2020 is the present value of all cash flows (coupons
and redemption) discounted. Cash outflow for this debt consists in an interest payment during the period.
Here is the roll forward of liabilities arising from financing activities over the year 2020:
150
Thousands of Euro (€)
2019
Cash flows
Non-cash
changes
2020
Inflow
Outflow
Additions
Classification
of part of the
proceeds in
equity
Classification
of part of the
proceeds in
grant income
Amortized
costs
adjustments
Subordinated loans
12,769
1,238
(395)
13,612
Other loans
12,812
156,776
(36,054)
(11,091)
(70)
122,373
Bank loans
12,392
34,375
(36,054)
10,713
Convertible bonds
-
122,401
(11,091)
111,310
Capital grants
420
(70)
350
Lease liabilities
52,474
-
(3,475)
2,598
51,597
Refundable government
advances
13,877
2,752
(927)
(581)
1,333
16,454
Total
91,933
160,766
(40,851)
2,598
(11,091)
(581)
1,263
204,036
9.15.1. Subordinated loans, other loans and lease liabilities
The detailed breakdown and the characteristics of the subordinated loans, the other loans and the lease liabilities as
follows:
Thousands of Euro (€)
Interest rate %
Fixed / Variable
Maturity
2021
2020
NON-CURRENT
Subordinated loans (non-current)
11,629
12,610
Unsecured subordinated loans
0
62
Development Brazilian/Dutch
subsidiary
4.95%
Fixed
2022
0
62
Secured subordinated loans
11,629
12,548
CDMO Phase 1
4.00%
Fixed
2035
7,628
8,214
CDMO Phase 2
4.00%
Fixed
2034
4,001
4,334
Other loans (non-current)
113,608
111,548
Investment loans
2.00%
Fixed
2023
712
222
Working capital funding
5.24%
Fixed
2023
56
137
Convetible bond
6.89%
Fixed
2025
108,645
105,997
Belfius
1.89%
Fixed
2027
2,588
3,163
CBC Covid
1.50%
Fixed
2024
90
162
Innodem
2.57%
Fixed
2026
1,517
1,867
Lease liabilities (non-current)
42,353
44,282
Leasing “Intégrale” (Immo Phase I)
5.40%
Fixed
2032
19,736
21,568
Leasing « Intégrale » (Immo Phase
II)
5.75%
Fixed
2034
7,492
8,033
Leasing ING Lease (solar panels)
3.00%
Fixed
2026
213
259
Leasing CBC Lease
2.00%
Fixed
2021
0
314
Dettes ING Lease
0.745%
Variable
2026
5,135
2,551
Leasing ING Lease (Phase 2)
3.00%
Fixed
2026
4,574
5,673
Leasing ING Lease (Phase I)
3.14%
Fixed
2026
4,118
5,483
Other lease liabilities
1.33%-1.44%
Fixed
Variable
1,086
402
Total non-current
167,590
168,440
Please note that the convertible bond interest rate, 6.89%, is the effective interest rate, so including the conversion
into interest expense of the embedded conversion right and the transaction costs, while the coupon of the bonds is
fixed at 4.25%.
151
Thousands of Euro (€)
Interest rate %
Fixed / Variable
Maturity
2021
2020
CURRENT
Subordinated loans (current)
1,314
1,002
Unsecured subordinated loans
62
83
Development Brazilian/Dutch subsidiary
4.95%
Fixed
2022
62
83
Secured subordinated loans
1,252
919
CDMO Phase 1
4.00%
Fixed
2035
586
586
CDMO Phase 2
4.00%
Fixed
2034
666
333
Other loans (current)
45,253
10,475
Straight Loans ING & CBC
Variable
2022
4,000
4,000
Straight Loans ING & BELFIUS
Variable
2023
35,000
Working capital funding
5.24%
Fixed
2023
81
108
Investment loans
2.00%
Fixed
2023
110
77
Convetible bond
6.89%
Fixed
2025
5,066
5,313
Belfius
1.89%
Fixed
2027
575
575
CBC Covid
1.50%
Fixed
2024
71
53
Innodem
2.57%
Fixed
2026
350
350
Lease liabilities (current)
6,561
7,315
Leasing “Intégrale” (Immo Phase I)
5.40%
Fixed
2032
2,284
1,810
Leasing « Intégrale » (Immo Phase II)
5.75%
Fixed
2034
675
535
Leasing ING Lease (solar panels)
3.00%
Fixed
2026
46
48
Leasing CBC Lease
2.00%
Fixed
2021
314
504
Leasing ING Lease (Phase 2)
3.00%
Fixed
2026
1,095
1,054
Leasing ING Lease (Phase I)
3.14%
Fixed
2026
1,360
1,310
Other lease liabilities
1.33%-1.44%
Fixed
Variable
787
2,054
Total current
53,128
18,793
Post year-end, the maturities of straight loans ING & BELFIUS, presented under current portion of other loans for a
total amount of EUR 35 million as per December 31, 2021, have been extended to March 31, 2023.
Straight loans are secured with pledges on receivables, receivable pledge mandates and mortgage mandates in
respect of the office building owned by the Company.
Convertible bond :
The 17 December 2020, Mithra issued EUR 125 million in senior unsecured convertible bonds due 17 December
2025. The bonds are convertible into ordinary shares of the company at an initial conversion price of EUR 25.1917,
representing a 25% premium above the reference price of EUR 20.1533, being the volume weighted average price of
a share on Euronext Brussels from market open to the close of trading on 10 December 2020. The Bonds are issued
at 100% of their principal amount and bear a coupon of 4.250% per annum, payable semi-annually in arrear in equal
instalments on 17 December and 17 June of each year, beginning on 17 June 2021.
The convertible bond was initially presented in the balance sheet as follows:
Other loans (debt component of convertible bond)
Balance at 1 January 2020
-
Issued amount (convertible bond)
125,000
Equity component
(Additional paid-in capital - Value of conversion rights on convertible bonds)
(11,334)
Debt transaction costs
(2,447)
Interests
92
Balance as at 31 December 2020
111,310
152
The initial fair value of the liability portion of the bond was determined using a market interest rate for an equivalent
non-convertible bond at the issue date. The liability is subsequently recognised on an amortised cost basis until
extinguished on conversion or maturity of the bonds. The remainder of the proceeds is allocated to the conversion
option and recognised in shareholders’ equity, and not subsequently remeasured.
At the date of issuance, the debt component for a total of EUR 111,310k is the present value of all cash flows
(coupons and redemption) discounted at the yield of an equivalent straight bond of 6.4%. Each period the carrying
amount increases by the difference between the interest expense (6.4%) and the cash coupon payment. During the
financial year ended 2021, the movement is as follows:
Other loans (debt component of convertible bond)
Balance as at 1 January 2021
111,310
Amortized costs adjustments
7,714
Interest payments
(5,313)
Balance at 31 December 2021
113,711
The equity component for EUR 11,334k is deemed to be the residual amount initially computed by substracting the
debt component from the issue amount (recorded in additional paid-in capital). The equity component is not
revalued. The effective interest rate shown in profit or loss for a simple convertible bond is equivalent to the rate that
would have been paid for non-convertible debt and including transaction costs, thus here 6.89%.
9.15.2. Refundable government advances
The Group has also been awarded refundable advances support from the Walloon Region. Payment of awarded
amounts that have not yet been received is subject to the achievement of certain milestones. Grants are subject to
certain obligations. In case such obligations are not complied with, the grants could be suspended, reviewed or
reclaimed. The Group has the obligation to continue the development of the project subject to the grant. In case such
project is abandoned, the Group should return rights to the results and the data generated in the project to the Société
Publique Wallonne (SPW), in which case the repayment obligation also lapses. The Company’s ongoing grant
programs are mainly refundable advances.
The refundable advances have a fixed repayment part and variable repayment scheme. The variable part is
dependent on the success of the project (i.e. based on a percentage of turnover). It should be noted that, while the
variable parts of these advances are only due upon commercialization, the fixed parts are due in any event. The fixed
and variable part can never exceed the double of the initial received amount. The final variable part to be repaid will
depend on the performance of the product candidate.
Thousands of Euro (€)
Year ended 31 December
2021
2020
Refundable government advances Estetra
8,525
9,992
Other refundable government advances
5,861
6,462
Total refundable government advances
14,386
16,454
The below table gives the details of refundable governments advances granted to the group and repayments done
in 2021:
153
Thousands of Euro (€)
Amount of
grant
Decision
year on
fixed
repayments
part
% of fixed
repay-ment
part
% applied on
turnover for
variable
repayment
part
Maximum
repayment
amount
Amount
reimbursed in
2021
AR 6875 and 6139 - Estelle
8,220
1/12/2012
30%
0,60%
200%
405
AR 6926 - Estelle
2,009
1/12/2012
30%
0,20%
200%
69
AR 7492 - Donesta
2,898
1/12/2015
30%
0,10%
200%
120
AR 1510597 - Septime
206
1/7/2016
30%
0,01%
200%
3
AR 8322 - Eco E4
178
9/30/2022
30%
0,01%
200%
AR 7551 - Bio Synthesis
747
1/12/2015
30%
0,26%
200%
AR 6137 - Zoreline
1,826
1/12/2009
30%
3,30%
200%
84
AR 7410 - Zoreline
5,265
1/12/2015
30%
2.65%
200%
AR 8792 - Zoreline
2,925
12/23/2019
30%
1,46%
200%
AR 7585 - Development EVA
1,188
1/11/2016
30%
0,21%
200%
5
AR 6138 - Drosperinone Novalon
626
1/12/2009
30%
0,50%
200%
23
AR 8359 - E4 & Covid-19
2,105
4/30/2021
30%
0,98%
200%
20
AR 8433 - E4 & Covid-19
723
4/30/2021
30%
0,34%
200%
54
AR 1710127 - Estepig
208
1/12/2017
30%
0,01%
200%
AR 7411 - Co-extrusion CDMO
441
1/12/2015
30%
0,40%
200%
22
AR 8522 - E4 Neuro
209
9/30/2022
30%
0.30%
200%
Total
29,774
804
The net positive amortized costs adjustment of EUR 1,365k has been recorded to the amounts of refundable
government advances since we updated our forecasts of sales from the related projects, the related income and
expenses have been reported in the Financial income and expenses line.
Mithra does not consider conducting further clinical developments in the field of COVID-19 (press release 24-09-
2021). The Phase II Study conducted in 2020 and 2021, partly funded by refundable government advances,
demonstrates further support to the unique safety profile of Estetrol with these first data in comorbid patients, both
male and female. However, no direct revenue from any COVID-19 product will occur, so the variable repayment debt
related to these advances is no longer relevant.
The determination of the amount to be paid to the Walloon Region under the signed agreement is subject to a high
degree of uncertainty as it depends on the amount of the future sales that Mithra will generate in the future.
Probability of success
Product/projects related to the refundable
advances
Phase 2
Phase 3
WACC
Discount rate
used for the fix
part
Estelle®
100%
100%
13.88%
/11.50%
2.27%
Donesta®
100%
38%
13.88%
2.27%
Covid-19
0%
0%
13.16%
2.27%
Product/projects related to the refundable
advances
R&D
Commercial
WACC
Discount rate
used for the fix
part
Zoreline®
80%
55%
13.88%
/13.16%/14.7%
2.27%
Others
90%
75%
13.88%
/12.48%/13.16%
2.27%
A sensitivity analysis of the carrying amount of refundable advances has been done in case of adverse changes in
assumptions. Mithra tested reasonable sensitivity to changes in the business plan and a simulated increase of up
154
to 3 percentage point in the discount rate used would not change the findings of the Group's analysis. A sensitivity
to changes in the business plan and a simulated increase of up to 30 percentage point in the probability of success
of would not change the findings of the Group’s analysis neither.
Sensitivity analysis for refundable advances in thousands of Euro (€):
Business plan
evolution
Probability of success
-30%
-15%
0%
15%
30%
-5%
13,030
13,578
14,126
14,674
15,222
-3%
13,126
13,678
13,828
13,978
14,530
0%
13,270
13,828
14,386
14,944
15,503
3%
13,414
13,978
14,944
15,911
16,475
5%
13,510
14,078
14,646
15,215
15,783
Since 2021, Estelle (AR 6139, 6926, 6875) probability of success achieved 100% and Covid (8359, 8433) probability
of success, as well as revenue, amount to zero. In the previous sensitivity analysis, those parameters were fixed.
9.15.3. Other financial liabilities
As at December 31, 2021, other financial liabilities at fair value relates only to Estelle
®
(EUR 110,004k).
In June 2021, the Group renegotiated the earnouts relating to Zoreline
®
and Myring
®
, with the complete buyout of all
remaining contingent payments obligation, cancelling related amounts reported in the balance sheet in December
2020 at fair value (EUR 8.8 million). In this context, Zoreline
®
financial liability following the acquisition of full licensing
and distribution rights is accounted at amortized cost (EUR 8.5 million liability spread over the next four years).
The decrease of the fair value of Estelle
®
contingent consideration is mainly explained by the payment of an
instalment of EUR 25 million to former owners of Uteron Pharma during the financial year 2021 partially offset by
the EUR 19.3 million change in fair value charge recorded in 2021 accounts after the review of the different scenarios
and probabilities related to the financial liability.
Year ended 31 December
2021
2020
Total
Current
Non-Current
Total
Current
Non-Current
Estelle ®
110,004
11,329
98,675
115,739
22,917
92,821
Myring ®
-
-
-
3,137
507
2,630
Zoreline ®
8,500
4,500
4,000
5,729
-
5,729
Total Other financial liabilities
118,504
15,829
102,675
124,604
23,424
101,180
A sensitivity analysis has been performed on the fair value of the contingent considerations, see note 9.17 Financial
instruments.
Trade payables and other current liabilities
Thousands of Euro (€)
As at 31 December
2021
2020
Trade accounts payable
16,915
23,325
Invoices to receive
4,253
1,927
VAT payable
-
36
Salaries and social security payable
1,219
1,309
Accrued charges
631
675
Other debts
312
-
Trade payables and other current liabilities
23,331
27,272
155
Financial instruments
9.17.1. Presentation of financial assets and liabilities
The following table presents the Company’s financial assets and financial liabilities measured and recognized or
unrecognized at fair value at 31 December 2021 :
Thousands of Euro (€)
Balance at
31
December
2021
Recognised fair
value
measurements
Fair value
measure-
ment
hierarchy
Unrecognised
fair value
measure-
ments
Financial assets
Financial assets at fair value through profit and loss
Other non-current assets contingent consideration receivable
-
-
Level 3
-
Contract assets Mayne shares receivable
-
-
Level 1
-
Derivatives financial assets
-
-
Level 2
-
Financial assets at fair value through other comprehensive income
Investments in equity securities
31,898
31,898
Level 1
-
Derivatives financial assets
100
100
Level 2
-
Financial assets at amortised cost
Other non-current assets - other than above
9,263
-
-
9,263
Contract assets other than above
12,571
-
-
12,571
Trade and other receivables
10,044
-
-
10,044
Cash and cash equivalents
32,872
-
-
32,872
Financial liabilities
Financial liabilities at fair value through profit or loss
Other financial liabilities - Estelle ®
110,004
110,004
Level 3
-
Financial liabilities at fair value through other comprehensive
income
Derivatives financial liabilities
4,783
4,783
Level 2
-
Financial liabilities at amortised cost
Subordinated loans
12,943
-
-
12,943
Other loans - Convertible bond
113,711
-
-
113,711
Other loans - others
45,150
Lease liabilities
48,914
-
-
48,914
Refundable government advances
14,386
-
-
14,386
Trade and other payables
23,331
-
-
23,331
Other financial liabilities - Zoreline ®
8,500
8,500
156
The following table presents the Companys financial assets and financial liabilities measured and recognized or
unrecognized at fair value at 31 December 2020 :
Thousands of Euro (€)
Balance as at
31 December
2020
Recognised
fair value
measurements
Fair value
measurement
hierarchy
Unrecognised
fair value
measurements
Financial assets
Financial assets at fair value through profit and loss
Other non-current assets contingent consideration receivable
7,999
7,999
Level 3
-
Contract assets Mayne shares receivable
18,670
18,670
Level 1
-
Derivatives financial assets
14
14
Level 2
-
Financial assets at fair value through other comprehensive
income
Investments in equity securities
18,088
18,088
Level 1
-
Derivatives financial assets
9,051
9,051
Level 2
-
Financial assets at amortised cost
Other non-current assets - other than above
6,402
-
-
6,402
Contract assets other than above
33,002
-
-
33,002
Trade and other receivables
10,052
-
-
10,052
Other short-term deposits
14
-
-
14
Cash and cash equivalents
138,675
-
-
138,675
Financial liabilities
Financial liabilities at fair value through profit or loss
Other financial liabilities
124,604
124,604
Level 3
-
Financial liabilities at amortised cost
Subordinated loans
13,612
-
-
13,612
Other loans - Convertible bond
111,310
-
-
111,310
Other loans - others
11,063
11,063
Lease liabilities
51,597
-
-
51,597
Refundable government advances
16,454
-
-
16,454
Trade and other payables
27,272
-
-
27,272
9.17.2. Financial assets and liabilities not accounted for at fair value
Financial assets:
The fair value of trade and other receivables, other short-term deposits and cash and cash equivalents does not
materially differ from their carrying amounts. Fair value would typically be measured as Level 2. The fact that their
carrying value approximates their fair value is due to the short maturity of these assets.
Financial liabilities:
For a significant part of the loans, the fair values are not materially different to their carrying amounts, since the
interest payable on those loans is close to current market rates because they are recent, or the loans have short
maturities. For Lease liabilities the incremental borrowing rate has been determined at transition to IFRS 16 on 1
January 2019.
9.17.3. Financial assets and liabilities accounted for at fair value
Fair value hierarchy :
Fair values are measured according to the following hierarchies:
Level 1: fair value measurements are those derived from quoted prices (unadjusted) in active markets
for identical assets or liabilities
157
Level 2: fair value measurements are those derived from inputs other than quoted prices included
within Level 1 that are observable for the asset or liability, either directly (i.e. as prices) or indirectly (i.e.
derived from prices)
Level 3: fair value measurements are those derived from valuation techniques that include inputs for
the asset or liability that are not based on observable market data (unobservable inputs)
Financial assets :
There are four categories of financial assets: Contingent consideration receivables, Contract assets, Derivative
financial assets and Investments in equity securities.
Thousands of Euro (€)
Fair value measurement hierarchy
Assets recognized or disclosed at
fair value
Other non-current assets contingent consideration
receivable
Level 3
-
Contract assets Mayne shares receivable
Level 1
-
Derivatives financial assets
Level 2
100
Investments in equity securities
Level 1
31,898
Balance at 31 December 2021
31,998
Other non-current assets contingent consideration receivable
Thousands of Euro (€)
Other non-current assets contingent consideration
receivable
Balance as at 1 January 2021
7,999
Fair value loss through profit of loss
(7,999)
Balance at 31 December 2021
-
Further to the acquisition of Ceres Pharma by Naxicap Partners and latest financial info received from Ceres, it is
currently deemed unlikely that necessary financial performance of the assets sold will be met in order to receive the
contingent consideration receivables of two times EUR 5 million (discounted) by 2023.
Obviously, expected financial performance of the assets sold will be followed closely and regularly, part or whole of
the contingent consideration receivable may very well be reinstated if considered as likely by 2023.
Contract assets Mayne shares receivable
Regarding the contract assets, the variability associated with the Mayne share price gives rise to an embedded
derivative so that in accordance with IFRS 9, the receivable should be classified as fair value through profit or loss.
As a result of receiving FDA approval for Estelle
®
, Mayne Pharma issued 85.8 million ordinary shares to the intention
of the Company. Contract assets related to Mayne shares receivable were reversed and the EUR 20.3 million (value
of shares at the emission date) booked under equity securities.
Until the issuance of shares in May 2021, the variability of Mayne share price led to a gain through profit or loss of
EUR 1.6 million.
The roll forward of contract assets related to Mayne shares is as follow:
Thousands of Euro (€)
Contract assets Mayne shares receivable
Balance as at 1 January 2021
18,670
Fair value gain through profit or loss
1,648
Share issuance - transfer to investments in equity securities
(20,318)
Balance at 31 December 2021
-
158
Derivatives financial assets
The Group entered into derivative financial instruments to manage its exposure to foreign exchange rate risk arising
from operational activities (cash flow hedges). The effective portion of changes in the fair value of derivative financial
instruments qualifying as cash flow hedges is deferred to equity. Amounts deferred in equity are subsequently
released to the income statement in the periods in which the hedged transaction impacts the income statement.
Thousands of Euro (€)
Derivatives financial assets
Balance as at 1 January 2021
9,065
Fair value loss through profit of loss
(14)
Fair value loss through other comprehensive income
(8,951)
Balance at 31 December 2021
100
Investments in equity securities
Financial assets at fair value through other comprehensive income (FVOCI) comprise equity securities which are not
held for trading, and which the group has irrevocably elected at initial recognition to recognize in this category. These
are strategic investments and the group considers this classification to be more relevant.
Changes in Investments in equity securities relating to Mayne shares are explained by the issuance of the second
tranche of shares and decreases in Mayne's share price as well as the AUD / EUR conversion rate as of December
31, 2021.
Thousands of Euro (€)
Investments in equity securities
Balance as at 1 January 2021
18,088
Share issuance - transfer from contract assets
20,318
Fair value loss through other comprehensive income
(6,508)
Balance at 31 December 2021
31,898
Financial liabilities :
There are two categories of financial liabilities: Other financial liabilities and Derivative financial liabilities. We
considered a level 2 or 3 under the fair value measurement hierarchy.
Thousands of Euro (€)
Fair value measurement hierarchy
Liabilities recognized or disclosed
at fair value
Other financial liabilities
Level 3
110,004
Derivatives financial liabilities
Level 2
4,783
Balance at 31 December 2021
114,787
Other financial liabilities
The roll forward of other financial liabilities measured at fair value is as follow:
Thousands of Euro (€)
Other financial liabilities
Balance as at 1 January 2021
124,604
Payments related to Estelle ®
(25,000)
Payment related to Zoreline ® and Myring ®
(8,500)
Gain on derecognition of contingent consideration payable
(366)
Fair value loss through profit of loss
19,266
Balance at 31 December 2021
110,004
159
As at December 31, 2021, other financial liabilities at fair value relates only to Estelle
®
. In June 2021, the Group
renegotiated the earnouts relating to Zoreline
®
and Myring
®
, with the complete buyout of all remaining contingent
payments obligation. In this context, Zoreline
®
financial liability following the acquisition of full licensing and
distribution rights is accounted at amortized cost (EUR 8.5 million liability spread over the next four years).
The fair value of the contingent payments has been determined using a probability weighting approach applied to
discounted cash flows. When relevant, a risk-adjusted discounted cash flow model was used where all future cash
flows are probabilized and then discounted.
2021 assumptions for Estelle:
Contingent considerations relating to
Estelle®
Total cash-out until
2028
Partial cash-out until 2028
Net Present Value
Alternative 1
50%
50%
98,542
Alternative 2
67%
33%
110,004
Alternative 3
75%
25%
116,888
Alternative 4
100%
0%
132,927
2020 assumptions for Estelle:
Contingent considerations relating to
Estelle®
Total cash-out until
2028
Partial cash-out until 2028
Net Present Value
Alternative 1
50%
50%
107,921
Alternative 2
60%
40%
115,739
Alternative 3
70%
30%
125,087
Alternatives 1, 3 and 4 are not used for the measurement of the liability but are to be used for disclosing sensitivity
of the value to the probability factors used (a level 3 input).
The increase of fair value for the contingent consideration for Estelle
®
(EUR 110,004k in December 2021 compared
to 115,739k in 2020) is explained by cash out flow of EUR 25,000k, compensated by change in fair value (loss through
profit or loss) of EUR 19,266k. Indeed, Estelle
®
approval and positive top-line results from Donesta
®
phase 3 studies
led to a review of the different scenarios and probabilities related to the financial liability against former owners of
Uteron Pharma. Additionally, the WACC updated in 2021 (11.34%) is slightly lower than the one used for previous
closings (11.87% in 2020).
Derivatives financial liabilities
The Group entered into derivative financial instruments to manage its exposure to foreign exchange rate risk arising
from operational activities (cash flow hedges). The effective portion of changes in the fair value of derivative financial
instruments qualifying as cash flow hedges is deferred to equity. Amounts deferred in equity are subsequently
released to the income statement in the periods in which the hedged transaction impacts the income statement.
Thousands of Euro (€)
Derivatives financial liabilities
Balance as at 1 January 2021
-
Fair value loss through other comprehensive income
4,783
Balance at 31 December 2021
4,783
Contract assets and liabilities
Amounts received or milestones to be received in the near future have been recognized as revenue to the extent that
it is highly probable that no reversal will be done in the future.
160
Most of the out-licensing contracts have a single performance obligation which is the grant of the license. Some
contracts also contain other performances such as manufacture and supply obligations, which are distinct from the
license grant.
An analysis has been conducted in order to determine whether the single performance obligation was satisfied as at
31 December 2021.
9.18.1. Contract assets
The tables below present the roll forward of the related contract assets:
Thousands of Euro (€)
Balance as at 1 January 2021
51,672
Fair value gain through profit or loss
1,648
Share issuance - transfer to investments in equity securities
(20,318)
Revenue billed during the period already recognized in previous years
(24,688)
Currency translation differences
285
Revenue recognized during the period
3,972
Balance at 31 December 2021
12,571
As a result of receiving FDA and EMA approval for Estelle
®
, previously unbilled revenue was invoiced, leading to a
cash collection about EUR 24.5 million. Additionally, Mayne Pharma issued 85.8 million ordinary shares to the benefit
of the Company. Contract asset related to Mayne shares receivable was reversed and the EUR 20.3 million (value of
shares at the emission date) booked under equity securities.
Revenue recognized during the period is mostly “variable supply price” on Estelle® products (EUR 3.5 million) that
were delivered in 2021 and on which royalties will be due by our partners in the next quarters according to their own
sales of Estelle
®
on their markets.
Besides the above, the balance of contract assets as at 31 December 2021 considers unbilled milestones revenue
for EUR 9.1 million, among which EUR 7.6 million relates to Mayne Pharma for Myring™, 1 million relates to Gedeon
Richter for Estelle
®
in Latin America and EUR 0.5 million relates to performance obligation achieved in the framework
of Mayne Pharma agreement for Estelle
®
.
9.18.2. Contract liabilities
The contract liabilities were the result of amounts already invoiced (and paid by customer) in the context of Zoreline
®
license agreement but not recognized in revenue as the related performance obligations were not yet satisfied as at
31 December 2020.
The table below presents the roll forward of the contract liabilities:
Thousands of Euro (€)
Balance as at 1 January 2021
3,706
Recognition as revenue
(3,706)
Balance at 31 December 2021
-
Zoreline
®
milestones, could be recognized in line with the agreement signed with SVR Invest BV in June 2021 for the
full global licensing and distribution rights for the Zoreline
®
implant, terminating the former agreement with GSP and
delivering Mithra from any performance obligation. Indeed, the renegotiation of earnouts relating to Complex
Therapeutics extinguished the previous performance obligation of the Company. Please refer to the note 9.5.2.
161
Other operating income
Year ended 31 December
Thousands of Euro (€)
2021
2020
R&D tax credit
2,566
1,864
Grant income
357
2,833
Other revenues
1,886
1,877
Other operating income
4,809
6,574
Other operating income is mostly composed of R&D tax credit and grant income. Please refer to note 9.15.2.
Refundable government advances for more info on grants income. Other revenues at EUR 1.9 million remained stable
while R&D tax credit increase is directly related to higher R&D expenses related to Donesta Phase III clinical study.
Expenses by nature
A breakdown of the expenses by nature of the costs of goods sold, research and development costs, general and
administrative and selling costs is summarized below.
Thousands of Euro (€)
Year ended 31 December
2021
2020
Costs by nature
Trade goods, raw materials and consumables
16,142
5,836
Employee benefit expenses
13,917
17,372
External service providers
66,299
58,368
Corporate branding expenses
378
695
Depreciation, amortization and impairment charges
10,426
9,873
Commissions
12
70
Operating lease payments
322
83
IT expenses
1,686
971
Maintenance and repair expenses
1,513
1,086
Other expenses
4,657
4,929
Total costs by nature
115,352
99,282
Costs by type
Cost of sales
15,724
3,457
Research and development expenses
85,243
78,458
General and administrative expenses
12,515
15,933
Selling expenses
1,871
1,434
Total costs by type
115,352
99,282
Total costs increased by EUR 16.1 million over the year ended December 31, 2021, which represents an increase of
16.2% compared to 2020. This variance primarily relates to :
An increase in trade goods, raw materials and consumables following commercial launch of Estelle
®
in
June 2021;
A decrease in employee benefit expenses: we refer to the note 9.21.
An increase in external service providers charges, mainly explained by the ramp up of the Donesta
®
Phase
III “E4 Comfort” clinical program;
An increase in IT and Maintenance and repair expenses to improve work efficiency and to support the
development of our activities.
Depreciation, amortization and impairment charges are steady although during 2021, we can notice an increase in
depreciation of property, plant and equipment and right-of-use assets following production zones accreditation in
Mithra CDMO facility and an increase in amortization of other intangible assets following reception of Estelle
®
162
Marketing authorization (intellectual property rights and internally generated research and development for this
project are now considered as available for use). Those variations are offset by the impairment charges of EUR 3.5
million booked in 2020.
Employee benefit expenses
The costs related to personnel (before deduction of own cost capitalized) can be summarised as follows:
Thousands of Euro (€)
Year ended 31 December
2021
2020
Wages, salaries, fees & bonuses
16,728
13,648
Pension costs: defined contribution
plan
385
342
Share-based payments
1,065
7,267
Total
18,178
21,257
In 2021, wages and salaries are increasing because of the hiring of new employees over the year while share-based
payments are significantly decreasing regarding 2020, for more detail please refer to the note 9.26 Share-based
payments.
A part of the employee benefit expenses (EUR 4.2 million) have been capitalized in Assets mainly relating to
employees from CDMO working on machinery/equipment settings and improvement in the production facility for the
manufacturing of pharmaceuticals products, for more detail please refer to the note 9.7 Property, plant and
equipment.
In 2021, the Group employed 248 full time employees at year-end (229 full time employees in 2020) which can be
allocated to the following departments:
Number of employees
As at 31 December
2021
2020
Research and development staff
52
51
Other G&A and Production staff
197
178
Total
248
229
Retirement benefit schemes
The Group offers several post-employment, death, disability and healthcare benefit schemes. All employees have
access to these schemes. The death, disability and healthcare benefits granted to employees of the Group are
covered by external insurance companies, where premiums are paid annually and charged to the income statement
as they become payable.
The post-employment pension plans granted to employees of the Group are defined contribution plans. A defined
contribution plan is a pension plan under which the Group pays a fixed contribution into a separate entity. The
contribution obligations to the defined contribution plans are expensed by the Group in the income statement as they
were incurred. Although defined contribution plans in Belgium are legally subject to a minimum guaranteed return of
1.75% on employer contributions and employee contributions, the post-employment pension plans are accounted
for as defined contribution plans, since the legally required return is guaranteed by the external insurance company.
Any liability that may currently result is immaterial.
163
Financial income and expense
Thousands of Euro (€)
Year ended 31 December
2021
2020
Interest income
-
-
Unrealized foreign exchange gains
201
Realized foreign exchange gains
149
1,612
Gain on share disposals
367
-
Remeasurement of refundable government advances
1,782
Other financial income
339
171
Total financial income
2,838
1,782
Financial income increased by EUR 1,056k. During the year ended December 2021, financial income mainly relates
to :
The positive impact of the remeasurement of refundable government advances measured at amortized
cost. Mithra does not envisage to conduct further clinical developments in the field of COVID-19 (press
release 24-09-2021). The Phase II Study conducted in 2020 and 2021, partly funded by refundable
government advances, demonstrates, further support the unique safety profile of Estetrol with these first
data in comorbid patients, both male and female. However, no direct revenue from any COVID-19 product
will occur, so the variable repayment debt related to these advances is no longer relevant (please refer to
note 9.14. Equity).
The gain on share disposals following the selling back of NOSHAQ SA shares, at a price agreed in the
historic shareholder agreement (please refer to note 9.29 Related party transactions).
Previous year, financial income was primarily driven by realized exchange gain on foreign USD hedging contract (EUR
862k recorded in profit or loss accounts) and other realized exchange gains.
Thousands of Euro (€)
Year ended 31 December
2021
2020
Interest payments
(11,765)
(3,503)
Remeasurement of refundable government advances
(310)
(1,355)
Unrealized foreign exchange losses
50
(828)
Realized foreign exchange losses
(741)
(242)
Other financial expenses
(350)
(59)
Total financial expense
(13,116)
(5,987)
Financial expenses primarily include interest payments. The increase is mostly driven by the interest charges of the
EUR 125 million convertible bond negotiated in December 2020 (please refer to note 9.14. Equity).
Income tax
The tax expenses consist of:
Thousands of Euro (€)
Year ended 31 December
2021
2020
Current tax income / (expense)
(315)
(35)
Deferred tax income/(expense) related to temporary
differences and tax losses
7,211
18,871
Withholding tax income / (expense)
(1)
(1)
Total
6,895
18,835
164
The income taxes in 2020 and 2021 are the result of temporary differences and tax losses carried forward and is
thus a non-cash item.
The Group reported a total deferred tax asset of EUR 6,895k as at 31 December 2021, this deferred tax is to be set
off against future taxable income.
The consolidated unused tax losses carried forward at 31 December 2021 amounted to 119 million euros.
9.24.1. Reconciliation effective versus theoretical taxes
The tax result for the year can be reconciled as follows:
Thousands of Euro (€)
Year ended 31 December
2021
2020
Income / Loss (-) before tax
(123,769)
(110,922)
Country's statutory tax rate
25%
25%
Tax expenses / income (-) (theoretical)
(30,942)
(27,730)
Tax expenses / income (-) in income statement (effective)
(6,895)
(18,835)
Difference in tax expenses / income (-) to explain
24,048
8,896
- Tax credit for R&D investments
2,076
2,727
- Temporary differences for which no deferred tax income was recognized
8,248
(3,193)
- Tax losses for which no deferred tax income was recognised
2,141
10,154
- Share-based payment expenses
266
1,817
- Withholding taxes
(1)
1
- Temporary differences with different tax rates
10,164
(2,179)
- Other
1,154
(431)
Total
24,048
8,896
9.24.2. Deferred tax assets
A detailed overview of the deferred tax asset is shown below:
Thousands of Euro (€)
Year ended 31 December
2021
2020
Deferred tax asset to be recovered
after more than 12 months
63,456
50,905
Deferred tax assets
63,456
50,905
The increase of EUR 12,551 k is mainly explained by the increase of tax losses in 2021 in the subsidiaries of the
Group, all located in Belgium and subject to Belgian Tax law.
Management is convinced that such companies will generate sufficient profits in the future in order to be able to
recover the fiscal losses carried forward and justify the recognition of the deferred tax asset particularly for Estetra
thanks to out-licensing contract negotiations related to Donesta
®
and to the sales related to Estelle
®
that will
generate much profits in the coming years.
Here are the critical judgments used for the recognition of the deferred tax assets:
i. Total amount of historical tax losses available was exceeding 300 million, knowing that about 60% of these
losses are valued within the DTAs (mainly Estetra and Novalon), we considered a balance of 40% as non-
recoverable in the future.
ii. Beginning of the commercial launch of Donesta expected to occur end of 2024 with a strong growth from
2025 to 2027. The commercial launch of Zoreline expected for 2025.
165
iii. Tax losses carried forward expected to be consumed within a 7-year horizon (end of 2028) for the
subsidiaries Estetra and Novalon, taking into account that we consider using the tax consolidation
mechanism available between Belgian companies on an annual basis.
Through the utilization of the tax losses carried forward and these PID/IID deductions, Mithra expects to significantly
reduce its effective tax rate to less than 5% for its E4 product pipeline, compared to 25% for the standard Belgian
commercial tax rate. This low rate is expected to apply to the majority of future income related to E4-based products.
The movement in the deferred tax asset is as follows*:
Temporary Differences
Thousands of Euro (€)
Contingent
consideration
Other
Tax
Losses
Total
At 1 January 2020
17,913
(1,754)
18,272
34,431
(Charged) / credited to income statement
9,053
(4,283)
11,703
16,474
At 31 December 2020
26,966
(6,037)
29,975
50,905
(Charged) / credited to income statement
(1,132)
(1,968)
15,652
12,551
At 31 December 2021
25,834
(8,005)
45,627
63,456
*Charges/credited to income statement amounts in 2021 including EUR 3,597 k coming from cash flow hedges
which is booked under other comprehensive income.
9.24.3. Deferred tax Liabilities
The deferred tax liabilities (EUR 6,089k in 2021 and EUR 4,363k in 2020) result from temporary differences arising
from the difference between the fair values of assets acquired at the acquisition date and their tax bases, DTA and DTL
are offset by legal entity.
Result per share
Basic loss per share is calculated by dividing the net result attributable to shareholders by the weighted average number
of shares.
The basic and diluted earnings per share are identical due to inclusion of potential ordinary share will result in an anti-
dilutive effect:
Year ended 31 December
Thousands of Euro (€)
2021
2020
Result for the purpose of basic loss per share
(116,875)
(92,086)
Weighted average number of shares for
the purpose of basic loss per share
43,429,809
40,988,235
Basic loss per share (in Euro)
(2.69)
(2.25)
Diluted loss per share (in Euro)
(2.69)
(2.25)
Please refer to the section 9.31 for a description of share transactions that occurred after the end of the reporting
period and that were not retrospectively adjusted in the calculation of result per share.
Share-based payments
By a decision of the extraordinary shareholders’ meeting of 2 March 2015 the Company issued 1,089 warrants primarily
to key management with an exercise price of EUR 5,646 per warrant. Warrants are conditional on the person
completing 4 years of service (vesting period). These warrants are exercisable as of 2019. The fair value of the
1.089 warrants at grant date is estimated at EUR 2,789k.
During 2019 two capital increases have taken place due to the exercise of warrants (15 warrants on January 30,
2019 and 15 warrants on April 24, 2019).
On January 30, 2019, a capital increase took place following the exercise of 15 warrants within the 2015 Warrant
Plan ("2015 Warrant Plan") corresponding to a contribution of EUR 84,690. In accordance with the 2015 Warrant
166
Plan, the exercise period started on January 1, 2019. An amount of EUR 18,119.48 was therefore contributed in cash
to the share capital of Mithra and the balance of EUR 66,570.52 was allocated to the Company's "share premium"
account. This exercise of 15 warrants resulted in the issue of 24,750 shares (1 warrant being equivalent to
1,650 shares) which on February 13, 2019 were admitted to listing on the regulated market. As a result, Mithra's
share capital on January 30, 2019 amounted to EUR 27,573,880.18 corresponding to 37,664,245 ordinary shares.
A second capital increase took place on April 24, 2019, following the exercise of 15 warrants from the 2015 Warrant
Plan ("2015 Warrant Plan") corresponding to a contribution of EUR 84,690. An amount of EUR 18,119.40 was
therefore contributed in cash to the share capital of Mithra and the balance of EUR 66,570.52 was allocated to the
Company's "share premium" account. This exercise of 15 warrants resulted in the issue of 24,750 shares (1 warrant
being equivalent to 1,650 shares) which, on May 9, 2019, were admitted to listing on the regulated market. As a result,
Mithra's share capital at April 24, 2019 amounted to EUR 27,591,999.58 corresponding to 37,688,995 fully paid-up
ordinary shares. The shares have no par value but represent the same fraction of the Company's share capital, which
is denominated in euros. Each share entitles its holder to one voting right.
Finally, on 21 May 2021, the third capital increase took place following the exercise of 620 warrants from the 2015
Warrant Plan corresponding to a contribution of EUR 3.500.520. An amount of EUR 748,836 was therefore
contributed in cash to the share capital of the Company and the balance of EUR 2.751.684 was allocated to the
Company’s share premium account. This exercise of 620 warrants resulted in the issue of 1,023,000 shares (1
warrant being equivalent to 1,650 shares) which, on 14 May 2021 were admitted to listing on the regulated market.
As a result, Mithra's share capital at May 21 amounted to EUR 32,019,708;40 corresponding to 43,737,097 fully paid-
up ordinary shares. The shares have no par value but represent the same fraction of the Company's share capital,
which is denominated in euros. Each share entitles its holder to one voting right.
On 5 November 2018, Mithra’s extraordinary general meeting approved the issuance of a maximum of
1,881,974 warrants under the Warrant Plan 2018”, for the benefit of key employees, members of the
management team and certain directors with an exercise price of EUR 24.05 or EUR 24.09 depending on the
status (employee or not) of the beneficiary. The warrants have a term of five years as from the date of issuance.
They are generally not transferable and, in principle, cannot be exercised prior to the date of the grant’s second
anniversary (i.e. at the earliest 6 November 2020 subject to exercise conditions). All of the offered warrants are
subject to a service condition of two years. Furthermore, a portion of 30% of these offered warrants were subject to
additional market and non-market vesting conditions. The market condition, upon which the vesting is dependent
from the share market price, was included in the grant date fair value calculation (see the discount applied in the
table below). This condition was met during financial year 2019. Out of the maximum of 1,881,974 warrants which
have been issued, a number of 1,394,900 warrants (corresponding to 1,394,900 new shares) were offered and
accepted by the beneficiaries. The remaining warrants are unused as the Board of directors undertook not to offer
them by issuing the Warrant Plan 2020 pursuant to the CCA.
Roll forward of the number of warrants :
Number of warrants
Year ended 31 December
Weighted average exercise
price (in Euro)
2021 Number of
warrants
Weighted average exercise
price (in Euro)
2020 Number of
warrants
Outstanding and granted as
of 1st January
18.8
2,701,520
15.68
1,307,825
Granted
19.0
10,000
24.80
1,393,695
Forfeited
-
-
Exercised
5,646.0
-620
-
Expired
-
-
As of 31 December
24.30
2,710,900
18.77
2,701,520
Regarding warrant Plan 2018, out of the maximum of 1,881,974 warants, a total of 1,394,900 warrants have been
offered and accepted, As the exercise price is different for management companies and for employees, we’ve
determined two different fair value amounts. The fair value of the warrants at grant date is estimated at EUR 13,994k.
The fair value of each option is estimated using the Black & Scholes model based on the following assumptions: (i)
first we valued separately the warrants granted to the management co’s and those granted to the employees, (ii)
167
secondly, we also valued separately the warrants that are subject to vesting conditions from those who were already
definitely acquired by the beneficiaries upon grant,
The fair value of the warrants at grant date was estimated at EUR 6,705k for the warrants definitely acquired and
EUR 2,918k for the remaining 30% subject to vesting conditions, at EUR 4,370k for warrants acquired at 100% and
at EUR 2,189k for warrants granted to LDA lenders and LDA (see below).
In July and September 2020, the Company summoned two Extraordinary General Meetings during which the
issuance of two warrant plans were approved: (i) a warrant plan for the benefit of LDA Capital Ltd, under which a
maximum of 690,000 warrants were to be issued pursuant to the transaction announced by the Company on April
23, 2020 and (ii) another warrants plan for the benefit of reference shareholders ("Share Lending Warrants") for a
maximum of 300,000 warrants.
The first plan is accounted for using IFRS 2 because 690,000 warrants exercisable at EUR 27 with an expiry date of
23 April 2023, were issued to LDA Capital as part of the EUR 50 million standby equity funding facility costs. Upon
signing the Put Option Agreement on 23 April 2020, it provided Mithra the flexibility to draw down capital as required
at their election and accordingly, a vesting period of 3 years was considered due to the capital commitment made
for this period, at the end of which the full warrants will become exercisable (knowing that the warrants become
exercisable within this period in proportion of the funding ratio). As such, EUR 220k from the total fair value
(EUR 1,581k) of the options granted at that date was expensed in the profit and loss statement for the year ended
31 December 2020, the remaining part will be taken into expenses until the end of the 3 years of vesting period.
Same treatment has been applied on the second plan ("Share Lending Warrants") in compensation for their service
of supporting the construction of this financing deal by lending their shares for each of the future equity transactions
to be executed. As such, EUR 68k from the total fair value (EUR 608k) of the options granted at that date was
expensed in the profit and loss statement for the year ended 31 December 2020, the remaining part will be taken
into expenses until the end of the 3 years of vesting period.
In 2021, 10,000 warrants have been offered and accepted to management companies. As such, EUR 89k (the total
fair value) of the options granted at that date was expensed in the profit and loss statement for the year ended 31
December 2021.
The fair value of each option is estimated using the Black & Scholes model based on the following assumptions:
Plan 2018
(Grant 1 - 70%)
Plan 2018
(Grant 1 - 30%)
Plan 2018
(Grant 2 - 100%)
Plan 2018
(Grant 3 -
100%)
Number of warrants granted
866,837.00
371,502.00
97,695.00
67,528.00
Exercise price per warrant
EUR 24.05-24.09
EUR 24.05-24.09
EUR 24.09-25.72
EUR 25.5-27.5
Expected dividend yield
-
-
-
-
Expected stock price volatility
38%
38%
38%
38%
Risk-free interest rate
0%
0%
0%
0%
Expected duration
5 years
5 years
5 years
5 years
Fair value at grant date
EUR 6,705k
EUR 2,918k
EUR 753k
EUR 586k
Discount related to market
condition
-
0.1437
-
Plan 2018
(Grant 4 - 100%)
Plan 2020
(LDA)
Plan 2020
(LDA)
Plan 2020
(Mgmt Grant 1)
Plan 2020
(Mgmt Grant 2)
Number of warrants granted
87,695.00
690,000.00
300,000.00
316,000.00
10,000
Exercise price per warrant
EUR 16.54
EUR 27
EUR 27
EUR 17.87
EUR 18.96
Expected dividend yield
-
-
-
-
-
Expected stock price volatility
37,50%
37,50%
37,50%
37,50%
37,50%
Risk-free interest rate
0,36%
0,36%
0,36%
0,36%
0,36%
Expected duration
5 years
3 years
3 years
10 years
10 years
Fair value at grant date
EUR 479k
EUR 1,581k
EUR 608k
EUR 2,552k
EUR 87k
The annualized standard deviation in the stock price has been determined based on historical estimate while the
risk-free interest rate has been determined based on a government bond with maturity closest to option expiration.
168
During the period 2021, a charge of EUR 1,065k has been recognized at the consolidated statement of income (in
General and administrative expenses).
Contingencies and arbitrations
Organon/Merck patent dispute
Since 2008, Mithra is involved in a legal proceeding against Organon NV (now Merck Sharp and Dohme BV). The
proceeding concerns the alleged patent infringement caused by the commercialisation by Mithra and its partner
DocPharma BVBA (now Mylan) of a generic drug named Heria. Currently, Organon is claiming for provisional
damages of EUR 2,770k including actual loss of profit as well as the reimbursement of cost for establishing the
infringement attorney’s fees and expert’s expenses. A first instance judgement was rendered on 11 December 2015
that concluded in a partial infringement of Organon’s patent. An expert was appointed by Commercial Court to advise
on the damages suffered by Organon and Merck because of the partial infringement. A final report of the judicial
expert dated November 22, 2019 assessed that damage at EUR 551k. That amount is, however, questionable in the
light of several objective factors. The case is pending at the appeal level and the hearing has not yet been fixed.
A provision of EUR 266k has been recorded in the accounts in accordance with management's assessment of the
liability that can result.
Conditional payments
For more details on contingent consideration payments, reference is made to section 9.17.4.
The contingent considerations relating to the asset deal Donesta
®
are not accounted for based on accounting policy
9.2.6.
As the acquisition of Donesta
®
qualified as an asset deal because the definition of a business as defined in IFRS 3
was not met the transaction was measured initially at cost. Subsequently the intangible assets will be measured
at their cost less any accumulated amortisation and any accumulated impairment losses. The transaction price
further contains several instalments which, since the date of acquisition, are considered as a contingent price based
on future performance, hence this measurement is more an attribute of fair value measurement throughout the life
of the asset than being representative of the cost model upon initial recognition of the asset. Hence, the contingent
payments are disclosed as a contingent liability for an amount of EUR 12,000k, with any liability being re-measured
at the end of each reporting period as an adjustment to the cost of intangible assets to the extent that it relates to
future reporting periods.
Commitments
Collaborative research and development arrangements
In September 2019, Mithra contracted with ICON Plc to manage the pivotal Phase III trial of Donesta
®
to demonstrate
the long-term efficacy and safety of Estetrol in the relief of vasomotor symptoms in postmenopausal and
hysterectomized women in the US. The expenses needed to conclude the study are currently forecasted at
approximately EUR 12 million.
On November 6, 2019, the Company also entered into a contract with ICON Plc for a similar study in Europe and the
rest of the world. The expenses needed to conclude the study are currently forecasted at approximately EUR 24
million.
Related party transactions
The Company has implemented processes to enable its compliance with provision 7:97 CCA. During this fiscal year
2021, on 24 June 2021, the Company carried on a transaction with related parties in accordance with section 7:97
of the companies and association code. For further information, please see the press release dated 24 June 2021.
Additionally, the Company has no reporting event linked to the application of article 7:97 §6 CCA.
For fiscal year 2021, the related parties with which other transactions have occurred, but who were at the time of the
decision or the conclusion of the operations were below the materiality threshold as foreseen by provision 7:97 CCA
are as follows:
169
YIMA SRL (an entity controlled by François Fornieri, a Director of the Company during part of the reporting
period);
NOSHAQ SA (an entity which is our shareholder, and a Director of the Company);
Le Bocholtz SA (an entity controlled by François Fornieri, a Director of the Company);
Eva Consulting SRL (an entity controlled by M. Jean-Michel Foidart), a Director and member of the key
management of the Company;
JAZZ A LIEGE ASBL, (an entity in which Mr Gaëtan Servais (permanent representative of NOSHAQ SA,
director of the Company) acted as Director);
Eklo ASBL (ex C.I.D.E. SOCRAN ASBL), an entity in which Mr Gaëtan Servais (permanent representative of
NOSHAQ SA, director of the Company) indirectly acts as Director);
François Fornieri (permanent representative of YIMA SRL, director of the Company); Jean-Michel Foidart
(permanent representative of Eva consulting SRL, Director of the Company and member of the key
management of the Company).
Protection Unit SA an entity in which Mr François Fornieri (managing director of the Company) is shareholder
and where NOSHAQ Partners SCRl (director of the Company) is director.
Transactions between the Company and its subsidiaries, which are related parties, are eliminated in the consolidated
accounts and no further information is provided here in this Section. However, the associate Targetome has been
included as a related party.
Assets acquired from related parties
In 2021, Mithra did acquired assets from SVR Invest SRL as related parties as indicated above, please refer to note
9.5 Segment Information, 9.6 Other intangible assets and 9.15 Financial liabilities.
Assets sold to related parties
In November 2021, Mithra sold its 11 participations held in the NOSHAQ Company to NOSHAQ SA for a total amount
of EUR 565,221.05. This sale was subject to the conclusion of a formal agreement wherein an anti-embarrassment
clause in favor of Mithra should certain designated transactions would occur on the NOSHAQ SA shares within a
given time périod, please refer to note 9.23. Financial income and expense.
Key management compensation
Refer to the table below for the compensations paid to key management:
Thousands of Euro (€)
Total
Of which CEO
Basic remuneration
2,937
440
Variable Remuneration
260
-
Group Insurance (pension, invalidity, life)
16
-
Other benefits (car, cell phone, hospitalization)
46
-
Total
3,259
440
170
Sales/Purchase of other services and goods
Thousands of Euro (€)
Type of services
2021
2020
Total services rendered to entities controlled by or with significant influence
from key management / directors
40
-
F. Fornieri
Recharge of misc. Expenses
40
-
Total services purchased from entities controlled by or with significant influence
from key management / directors
1,482
547
Alychlo NV
Share lending facility
51
17
Bocholtz
Membership
2
4
Eklo Asbl
Research studies
50
Corporate Unit
Services
1
-
Millésime Chocolat
1
-
JAZZ A LIEGE ASBL
Sponsoring
63
5
Noshaq SA
Share lending facility
101
34
Protection Unit
Guarding
304
302
SVR Invest SRL
Interest charge
267
-
YIMA SRL
Rental services builiding Foulons
141
168
YIMA SRL
Non-executive consulting services
450
-
YIMA SRL
Share lending facility
51
17
On top of the above, an amount of EUR 25.0 million was paid during the course of 2021 to ex Uteron shareholders
who include, amongst others, Mr F. Fornieri, Mr JM. Foidard and L. Van Rompay, please refer to note 9.17 Financial
instruments.
As per IAS 24 definition of “related parties transaction”, the Company purchased services in the form of share lending
facility from the below reference shareholders. In exchange for their services, the Company has granted warrants to
those shareholders in proportion to their sharelending.
François Fornieri ( permanent representative of YIMA SRL, director of the Company);
Alychlo NV (en entity controlled by Marc Coucke, a director of the Company);
Noshaq SA (en entity in which Gaetan Servais is permanent representative, a director of the Company)
For more details, please refer to note 9.26 Share-based payments.
Aggregated trade receivable / payable balance due from / to related parties
Thousands of Euro (€)
2021
2020
Receivables from entities controlled by or with significant influence from key
management / directors
-
39
Payables to entities controlled by or with significant influence from key management /
directors
80
160
Payables to other related parties
-
-
Loans to or from related parties and other debts from related parties
Thousands of Euro (€)
2021
2020
Loan from / to entities controlled by key management / directors
-
-
171
Transactions with non-executive Directors
The total amount of the remunerations and the benefits paid in 2021 to the non-executive directors (in such capacity)
was EUR 194.170 (gross, excluding VAT), split as follows:
Name
Nature
Remunerations
3
As member of a
committee
As chairman
of the board
YIMA SRL
Non-exec
-
-
-
NOSHAQ SA
Non-exec
20,000
5,000
-
Ahok BVBA
2
Independent
8,333
2,083
-
Alius Modi SRL
Non-exec
11,667
2,500
-
A. Tounsi
Non-exec
11,667
2,500
-
P. van Dijck
1
Independent
20,000
5,000
10,000
A. Cloet
Independent
11,667
-
-
L. Weynants
Independent
11,667
-
-
Selva Luxembourg SA
2
Non-exec
8,333
2,083
-
Sunathim BV
Independent
20,000
5,000
11,667
TicaConsult BV
Independent
20,000
5,000
-
Events after the reporting period
Post-period, in January 2022, the Company announced positive top-line results from Donesta® phase 3 studies for
the treatment of vasomotor symptoms in post-menopausal women. Donesta® demonstrated a meaningful
reduction in vasomotor symptoms from baseline and compared to placebo. All co-primary efficacy endpoints were
statistically (all p<0.01) met in C301 (Europe, Latam and Russia) and in C302 (North America) studies, except for a
borderline non-significant result for the severity criteria at week 4 in the C302 study, which reached and exceeded
statistical significance by week 5 (p<0.01). Both studies also showed that the number and severity of hot flushes
continued to decrease week after week until the end of the study, i. e. 3 months of treatment. Secondary endpoints
evaluated at 3 months in the C301 study suggest a very positive impact of Donesta® on the quality of life.
In February 2022, Mithra announced the commercial launch of its vaginal contraceptive ring Myring® under the
brandname Haloette® in Canada, a market which is worth approximately CAD $11.5 million (EUR 8 million) a year
and represented exclusively by the originator Nuvaring®.
Also, in February 2022, the Company entered into a 2-year equity financing agreement with Goldman Sachs
International (“GSI”), pursuant to which the Company can at its sole discretion require GSI to provide funding to the
Company for an aggregate amount of up to EUR 100,000,000 in return for issuing GSI with call options over the
Company’s ordinary shares. The Company will access this funding through several drawings, which must be at least
22 trading days apart. On the same day, Mithra exercised its first drawing request on 4 February 2022 which
amounted to EUR 10 million. Further to Mithra’s first drawing request, GSI has elected to exercise a call option for
an amount of EUR 5 million. This call option will result in the issuance of 377,198 shares of the Company. On 21
March 2022, Mithra decided to exercise a second drawing request for an amount of EUR 5 million according to the
terms of the equity funding agreement signed with Goldman Sachs International ("GSI").
Post year-end, the maturities of straight loans ING & BELFIUS, presented under current portion of other loans for a
total amount of EUR 35,000k as per December 31, 2021, have been extended to March 31, 2023.
Since the beginning of the conflict in Ukraine in February 2022, Mithra has been monitoring the geopolitical situation
in order to manage the potential impact on Mithra’s and partners activities, in particular Estelle® launch in Russia
foreseen in H2 2022. On the R&D side, the Company has activated a mitigation plan in order to switch the planned
Russian recruitment sites with other sites for the additional European Donesta® study (C301), which should be
completed by the end of H1 2022.
There were no other subsequent events that occur between 2021 year-end and the date when the financial
statements have been authorized by the Board for issue.
172
Mithra Pharmaceuticals companies consolidation scope
Mithra Pharmaceuticals SA is the parent company with its registered office at Rue Saint-Georges 5, 4000 Liège,
Belgium.
9.31.1. Subsidiaries
The Group’s financial statements consolidate those of the following undertakings
8
:
The Company has the following subsidiaries
2021 ownership %
2020 ownership %
Mithra Recherche
et Développement SA
100%
100%
Registered office
Rue Saint-Georges 5
4000 Liège
Incorporation Date
6/13/2013
Company registration n°
534.909.666
Neuralis SA
100%
100%
Registered office
Rue Saint-Georges 5
4000 Liège
Incorporation Date
1/7/2013
Company registration n°
0535.840.470
Mithra Lëtzebuerg SA
100%
100%
Registered office
Boulevard de la Petrusse
124,
L-2330 Luxembourg
Incorporation Date
12/27/2012
Company registration n°
LU25909011
Mithra Pharmaceuticals CDMO SA
100%
100%
Registered office
Rue Saint-Georges 5
4000 Liège
Incorporation Date
41438
Company registration n°
534.912.933
Mithra Pharmaceuticals GmbH
In the process of liquidation
In the process of liquidation
Registered office
Promenade 3-9 Raumm
22
DE - 52076 Aachen
Germany
Incorporation Date
12/27/2013
Company registration n°
DE 295257855
WeCare Pharmaceuticals BV
100%
100%
Registered office
Lagedijk 1-3, NL -1541
KA Koog aan de Zaan
Incorporation Date
9/23/2013
Company registration n°
NL08165405B01
Novalon SA
100%
100%
Registered office
Rue Saint-Georges 5
4000 Liège
Incorporation Date
11/17/2005
Company registration n°
877.126.557
Estetra SRL
100%
100%
Registered office
Rue Saint Georges, 5
4000 Liège
8
Please note that the shareholding percentage is considered at a consolidated level. Therefore, the 100% are held by the Company or one of
its subsidiaries.
173
Incorporation Date
1/9/2009
Company registration n°
818.257.356
Donesta Bioscience BV
100%
100%
Registered office
Boslaan 11
3701 CH Zeist
The Netherlands
Incorporation Date
12/23/2011
Company registration n°
54167116
9.31.2. Associates
The following associate is accounted for using the equity method in the Group’s financial statements:
The Company has the following associate
2021 ownership %
2020 ownership %
Targetome SA
The Company has decided to terminate the companies’ activities and to initiate the legal proceedings related to the
liquidation of the company so that its value was derecognized. Measures are being taken in this direction.
Disclosure audit fees
In Euro (€)
Auditor’s fees for statutory and consolidated financial statements
158,000
Fees for exceptional services or special missions (audit related)
31,522
Tax consultancy (audit related)
-
Fees for exceptional services or special missions (external to audit)
-
Tax consultancy (external to audit)
21,822
Total
211,344
Condensed statutory financial statements of Mithra SA
In accordance with Art. 3:17 of the CCA, the condensed statutory standalone financial statements of Mithra
Pharmaceuticals SA are presented. These condensed statements have been drawn up using the same accounting
principles for preparing the complete set of statutory financial statements of Mithra Pharmaceuticals SA at and for
the year ending 31 December 2021 in Belgian GAAP.
The statutory auditor, BDO Réviseurs d’entreprises, has issued a clean audit opinion on the statutory financial
statements as at 14 April 2022.
The management report, the statutory financial statements of Mithra Pharmaceuticals SA and the report of the
statutory auditor will be filed with the appropriate authorities and are available at the Company’s registered offices.
174
Thousands of Euro (€)
Asset
2021
2020
Fixed assets
149,959
139,552
Intangible fixed assets
1,254
1,224
Tangible fixed assets
1,718
1,943
Financial fixed assets
146,986
136,386
Current assets
310,112
306,504
Other long-term receivables
55
66
Inventories
-
12
Trade and other receivables
289,428
178,931
Cash at bank and in hand
17,043
123,111
Deferred charges and accrued income
3,587
4,384
Total assets
460,071
446,056
Thousands of Euro (€)
Liabilities
2021
2020
Equity
249,882
241,538
Capital
32,250
31,271
Share premium account
338,594
330,345
Reserves
598
598
Accumulated losses
(121,560)
(120,676)
Provisions
266
266
Amounts payable after more than one year
159,273
165,451
Current liabilities
50,384
38,489
Current portion of long-term debts
6,178
26,193
Amounts payable within one year
44,207
12,297
Deferred charges and accrued income
266
313
Total Liabilities
460,071
446,056
175
Thousands of Euro (€)
Summary income statement
2021
2020
Operating income
15,855
17,930
Turnover
15,677
16,682
Other operating income
178
1,248
Operating charges
(14,047)
(16,874)
Cost of goods sold
(142)
(463)
Services and other goods
(10,037)
(11,698)
Remuneration, social security costs and pensions
(3,223)
(2,947)
Depreciations of and amounts written off formation expenses,
intangible and tangible fixed assets
(601)
(298)
Other operating charges
(43)
(1,468)
Operating profit
1,808
1,056
Financial result
(2,680)
(22,353)
Financial income
4,819
2,152
Recurrent financial charges
(7,154)
(4,428)
Non recurrent financial charges
(345)
(20,077)
Profit/(loss) for the year before taxes
(872)
(21,297)
Taxes
(12)
(1)
Profit (loss) for the period available for appropriation
(884)
(21,298)
Thousands of Euro (€)
Capital statement
2021
2020
A. Capital
1. Issued capital
- At the end of the previous year
31,271
28,649
- Changes during the year
979
2,622
- At the end of this year
32,250
31,271
2. Capital representation
2.1 Shares without par value
- Bearer and dematerialised
44,051,259
42,714,097
B. Own shares
-
-
C. Commitmentes to issue shares
-
-
D. Autorised capital not issued
-
-
176
Alternative performance measures
Mithra decided to use some alternative performance measures (APMs) that are not defined in IFRS but that provide
helpful additional information to better assess how the business has performed over the period. Mithra decided to
use REBITDA and EBITDA in order to provide information on recurring items, but those measures should not be
viewed in isolation or as an alternative to the measures presented in accordance with IFRS.
REBITDA is an alternative performance measure calculated by excluding the non-recurring items and the
depreciation & amortization from EBIT (loss from operations) from the consolidated statement of profit or loss
prepared in accordance with IFRS. The Group considers share-based payments as non-recurring item above EBITDA
and one-off item, impairment charges on Other intangible assets in 2020, as non-recurring item below EBITDA.
EBITDA is an alternative performance measure calculated by excluding the depreciation and amortization from EBIT
(loss from operations) from the consolidated statement of profit or loss prepared in accordance with IFRS.
Financial Highlights (management figures) are presented as follows in the first part of this annual report :
Year ended 31 December
Thousands of Euro (€)
2021
2020
Revenue
22,668
9,030
Cost of sales
(15,724)
(3,457)
Gross profit
6,945
5,573
Research and development expenses
(76,577)
(69,310)
General and administrative expenses
(10,021)
(8,126)
Selling expenses
(1,541)
(1,251)
Other operating income
4,809
6,574
REBITDA
(76,385)
(66,540)
Share-based payments expenses
(1,065)
(7,267)
EBITDA
(77,450)
(73,807)
Depreciation
(10,426)
(6,136)
Non-recurring items
-
(3,734)
Loss from operations
(87,875)
(83,678)
Change in fair value of contingent consideration payable
(19,265)
(18,114)
Net fair value gains/(losses) on financial assets at fair value through profit or loss
(6,351)
(4,925)
Financial income
2,838
1,782
Financial expenses
(13,116)
(5,987)
Loss before taxes
(123,769)
(110,922)
Income taxes
6,895
18,835
NET LOSS FOR THE PERIOD
(116,875)
(92,086)
Please refer to the table below for the reconciliation to loss from operations as presented within consolidated
statement of profit or loss :
177
Year ended 31 December
Thousands of Euro (€)
2021
2020
Loss from operations
(87,875)
(83,678)
Depreciation
10,426
6,136
Non-recurring items impairment charges on Other intangible assets
-
3,734
Share-based payments
1,065
7,267
REBITDA
(76,385)
(66,540)
Share-based payments
(1,065)
(7,267)
EBITDA
(77,450)
(73,807)
178
Rue Saint-Georges 5
4000 Liège
Belgium
+32 4 349 28 22
info@mithra.com
www.mithra.com
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