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Annual
report

2022

Transforming women's health through innovation

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The year 2022 was marked by many operational challenges and advances for our company, despite a particularly turbulent international context. We are very satisfied with the resilience shown by Mithra and our teams’ ability to deliver many scientific and commercial achievements.
We would like to thank all our shareholders for their ongoing support and loyalty. We remain confident in the extraordinary potential of our products and our future indications, and hope that our various operational and commercial achievements will result in a stock market valuation that reflects the intrinsic value of our products.

David Horn Solomon

Chief Executive Officer

Highlights 2022

Commercialization of Donesta®
Signature of a binding heads of terms with Gedeon Richter for the commercialization of Donesta® in about 90 territories through an exclusive license in Europe, Russia, Central Asia, Latin America and through a semi-exclusive license in Brazil, Australia and New Zealand
Estelle®’s success
Throughout the year, successive commercial launches of Estelle® by our partners Gedeon Richter and Mayne Pharma took place in various geographies worldwide such as UK, Switzerland, Russia and Australia.
Collaboration with MedinCell
Development of two long-acting injectable innovative products:

  • a 3-month long acting injectable designed as an additional tool to fight Malaria and;
  • a long-acting injectable of tacrolimus for transplant patients aiming at improving efficacity, tolerance and patient observance.
Positive top-line efficacy results from Donesta® Phase 3 Program
Those results demonstrate a meaningful reduction in vasomotor symptoms (VSM) from baseline and compared to placebo. All co-primary efficacy endpoints were statistically (all p<0.05) met in both studies and confirmed in April 2022.
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Outlook 2023

Increase of Estelle®’s commercial geographical footprint
2023 will pave the way to a global expansion with commercial launches expected in Brazil, Chile, Ecuador, Peru, Uzbekistan, Taiwan and Thailand.
Donesta®: last steps ahead of commercialization
License agreement for the commercialization of Donesta®, the first Estetrol-based hormone therapy in February 2023

Progressing negotiations around the license agreement for Donesta® in the US with anticipated announcement of partnership by the end of the first half 2023
The potential of Estetrol for wound healing
Preclinical data positively demonstrated that E4 improves wound closure and dampens local inflammation compared to other estrogens, supported by a unique gene signature. This supports the use of E4 in clinic for wound healing indication.
Beyond E4 with tyrosine kinases inhibitors
Preclinical studies confirm the broad potential of CSF-1R to treat different pathologies, including endometriosis, cancer and inflammatory disorders.

Tyrosine kinase inhibitors are the third fastest growing therapeutic class in 2021, with a 14% increase in revenues representing USD 45.8 billion.

First conclusive data reinforce Mithra’s intent to acquire BCI Pharma’s IP rights and finalize the acquisition option to develop new tyrosine kinase inhibitors.
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Research & development

Revealing Estetrol’s capabilities

Thanks to its unique profile, Estetrol could address unmet needs in various therapeutic areas such as contraception, menopause, neuroprotection in newborns and wound healing.

Estelle®

Contraception
First E4-based contraceptive pill composed of 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) Commercialized since 2021, including in the United States, Canada and Europe, Estelle® signs off a new era in Combined Oral Contraceptive

Donesta®

Menopause

Innovative E4-based hormone therapy targeting several major menopausal symptoms

Currently in its last stages of development (Phase III)

Neuroprotection

Treatment of neonatal hypoxic ischemic encephalopathy (HIE), a life-threatening form of brain injury

Currently under clinical program (Phase I study)

Wound healing

Treatment enabling faster and more effective healing

Positive preclinical data have demonstrated the efficacy of Estetrol for topical application to promote wound healing and support its use in clinic

Mithra CDMO

From concept to commercialization

End-to-end services

A fully integrated end-to-end contract development and manufacturing platform designed to service Mithra’s innovative pharmaceutical pipeline as well as to support external parties with their pharmaceutical development and manufacturing needs

Expertise

Specialized in sterile injectables and polymeric forms with dedicated accreditations

Partnerships

Collaborations with external companies for the development and manufacturing of highly complex formulations, such as two long-acting injectable products for MedinCell, an innovative long-acting vaginal ring for VaRi Biosciences as well as the production of nearly 1 million vaginal rings, Myring®

Key figures

Revenues

EUR

0

million

Mainly driven by an out-licensing upfront payment of EUR 44.7 million for Donesta®

Product sales of Estelle®

EUR

0

million

Product sales of generic portfolio

EUR

0

million

CDMO R&D contracting revenue

EUR

0

million

ESG strategy

Improvements take time and progress is not always as linear as we would like it to be. In 2022, we continued our development towards sustainability and implemented our sustainability strategy, because we aim at always rethinking the way we work and operate to successfully address climate, social and governance challenges.
Commercialization of Donesta®
Signature of a binding heads of terms with Gedeon Richter for the commercialization of Donesta® in about 90 territories through an exclusive license in Europe, Russia, Central Asia, Latin America and through a semi-exclusive license in Brazil, Australia and New Zealand.
Estelle®’s success
Throughout the year, successive commercial launches of Estelle® by our partners Gedeon Richter and Mayne Pharma took place in various geographies worldwide such as UK, Switzerland, Russia and Australia.
Collaboration with MedinCell
Development of two long-acting injectable innovative products:

  • a 3-month long acting injectable designed as an additional tool to fight Malaria and;
  • a long-acting injectable of tacrolimus for transplant patients aiming at improving efficacity, tolerance and patient observance.
Positive top-line efficacy results from Donesta® Phase 3 Program
Those results demonstrate a meaningful reduction in vasomotor symptoms (VSM) from baseline and compared to placebo. All co-primary efficacy endpoints were statistically (all p<0.05) met in both studies and confirmed in April 2022.
Previous slide
Next slide

ESG strategy

Improvements take time and progress is not always as linear as we would like it to be. In 2022, we continued our development towards sustainability and implemented our sustainability strategy, because we aim at always rethinking the way we work and operate to successfully address climate, social and governance challenges.
Planet​
  • Increasing our share of energy from renewable sources to reach around 30% of for our Mithra CDMO
  • Reduction of our greenhouse gas emissions (20%) and waste production (almost 30%)
Patients
  • To stay at the cutting edge in their field of expertise, our R&D teams attended 9 international scientific congresses and published 8 manuscripts.
  • In 2022, there were no product recall and 100% successful inspections and audits.
People
  • To give our employees the opportunity to develop their knowledge and skills, we have doubled our investment in collaborators training.
  • To attract and retain talents, we upgraded our employee benefits program by including hospitalization, ambulatory and dental insurance as well as seniority leave.
Ethics and integrity
  • Our ambition is to embed a responsible sourcing policy in our daily purchase practices. To achieve this objective, our target is to ensure that 50% of Mithra’s direct and indirect purchases are ethically sourced by 2025.
  • Compliance and ethical standards training has been systematized for all staff members as part of their onboarding process.
Women empowerment
  • At Mithra, 56% of our collaborators are women. Additionally, our Board of Directors is composed of 55% of women.
  • As women’s health is at the heart of our mission and because 1 in 8 women in Belgium is affected by breast cancer, it seemed more than obvious for Mithra to renew its participation to support the annual Think Pink campaign.
Previous slide
Next slide

ESG strategy

Improvements take time and progress is not always as linear as we would like it to be. In 2022, we continued our development towards sustainability and implemented our sustainability strategy, because we aim at always rethinking the way we work and operate to successfully address climate, social and governance challenges.

Planet

Increasing our share of energy from renewable sources to reach around 30% of for our Mithra CDMO

Reduction of our greenhouse gas emissions (20%) and waste production (almost 30%)

Patients

To stay at the cutting edge in their field of expertise, our R&D teams attended 9 international scientific congresses and published 8 manuscripts.

In 2022, there were no product recall and 100% successful inspections and audits.

People

To give our employees the opportunity to develop their knowledge and skills, we have doubled our investment in collaborators training.

To attract and retain talents, we upgraded our employee benefits program by including hospitalization, ambulatory and dental insurance as well as seniority leave.

Ethics and integrity

Our ambition is to embed a responsible sourcing policy in our daily purchase practices.

To achieve this objective, our target is to ensure that 50% of Mithra’s direct and indirect purchases are ethically sourced by 2025.

Compliance and ethical standards training has been systematized for all staff members as part of their onboarding process.

Women empowerment

At Mithra, 56% of our collaborators are women. Additionally, our Board of Directors is composed of 55% of women.

As women’s health is at the heart of our mission and because 1 in 8 women in Belgium is affected by breast cancer, it seemed more than obvious for Mithra to renew its participation to support the annual Think Pink campaign.

Investor Relations

investorrelations@mithra.com

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