Mithra Pharmaceuticals S A : Interim Financial Report as at 30 June 2021

Interim Financial Report

as at 30 June 2021

This report is prepared in accordance with article 13 of the Royal Decree of 14 November 2007.

Mithra Pharmaceuticals SA (hereinafter "Mithra" or the "Company") has prepared its interim financial report in French and in English. In case of discrepancies between both versions, the French version shall prevail.

Mithra Pharmaceuticals SA/NV,

A limited liability company (société anonyme / naamloze vennootschap) incorporated under Belgian law, with its registered office at rue Saint-Georges 5, 4000 Liège (enterprise number 0466.526.646)

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Table of contents
I.	Interim management report......................................................................................................................	5
1.	Corporate presentation ........................................................................................................................	5
2.	Operational Highlights including post-period end.................................................................................	5
3.	Financial highlights...............................................................................................................................	6
4.	Corporate Governance.........................................................................................................................	7
	4.1. Capital and shares ........................................................................................................................	7
	4.2. Shareholders & Shareholder structure ..........................................................................................	8
	4.3. Change and/or renewal in the composition of corporate bodies ...................................................	9
5.	Principal risks and uncertainties.........................................................................................................	10
6.	Related party transactions .................................................................................................................	15
II.	Interim condensed consolidated financial statements for the six months ended 30 June 2021 ............	17
1.	Interim consolidated statement of profit or loss..................................................................................	17
2.	Interim consolidated statement of comprehensive loss .....................................................................	18
3.	Interim consolidated statement of financial position...........................................................................	19
4.	Interim consolidated statement of changes in equity .........................................................................	20
5.	Interim consolidated statement of cash flow ......................................................................................	21
6. Notes to interim condensed consolidated financial statements .............................................................	22
	6.1. Significant changes in the current reporting period.........................................................................	22
	6.2. Summary of significant accounting policies ....................................................................................	22
	6.3. Segment and revenue information ..................................................................................................	23
	6.4. Profit and loss information ..............................................................................................................	25
	6.5. Intangible assets and goodwill ........................................................................................................	25
	6.6. Property, plant and equipment and right of use assets...................................................................	25
	6.7. Inventories ......................................................................................................................................	26
	6.8. Contract assets and liabilities .........................................................................................................	26
	6.9. Trade and other receivables ...........................................................................................................	27
	6.10. Equity ............................................................................................................................................	27
	6.11. Financial liabilities .........................................................................................................................	29
	6.12. Fair value measurement of financial instruments .........................................................................	30
	6.13. Trade and other payables .............................................................................................................	34
	6.14. Deferred tax assets and liabilities .................................................................................................	34
	6.15. Share-based payments .................................................................................................................	35
	6.16. Commitments ................................................................................................................................	35
	6.17. Events after reporting period.........................................................................................................	36
	6.18. Alternative performance measures ...............................................................................................	36
III. Statement of the responsible persons......................................................................................................	38
IV. Statutory auditor's report .........................................................................................................................	40

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I.

Interim management report

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1. Interim management report

1. Corporate presentation

Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women's Health by providing them, through innovation, new choices 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 lifespan. To do so, Mithra explores the potential of Estetrol, a unique native estrogen, in a wide range of applications including women's health and much more (Covid-19, neuroprotection…). At its technological platform - Mithra CDMO -, Mithra develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. A variety of resources that enable it to offer a complete spectrum of research, development and specialist manufacturing to partners.

Active in more than 100 countries around the world, Mithra has an approximate headcount of 300 staff members and is a limited liability company headquartered in Liège, Belgium. On 30 June 2015, The Group launched its Initial Public Offering on Euronext Brussels.

2. Operational Highlights including post-period end

Mithra has achieved a series of milestones in the first six months of 2021 both with regards to its E4 (Estetrol) unique native estrogen pipeline and its Complex Therapeutics business.

• Marketing authorization for Estelle® obtained in Canada (March), United States (April), Europe (May) and Russia (September). Estetrol is the first new estrogen introduced in over 50 years.
• Successful commercial launch of Estelle® in the United States by Mayne Pharma (June) and in Canada by Searchlight Pharma (September) under the trademark Nextstellis®. Marketing exclusivity granted for five years by the FDA as a new chemical entity (NCE).
• Launch of Estelle® phased European commercialization by Richter under the trademark Drovelis® in Germany, Hungary, Poland and Austria.
• Phase III Donesta®: recruitment completion of American study and additional recruitment in the European study. Primary efficacy data of both studies on track for end of 2021. Depending on the evolution of the Covid-19 situation, study results and regulatory approvals, marketing authorization expected for Donesta® in H1 2024 for the United States/Canada and in H2 2024 for Europe.
• Based on regulatory agencies' feedback, the Board of Directors decided that the initial PeriNesta® development project was no longer timely nor a priority for the Company. Alternative scenarios based on Estelle® and Donesta® could potentially target this perimenopausal market without incurring substantial development costs.
• Topline results of the Coronesta Phase II study, which aimed to assess the safety and efficacy of estetrol (E4) for the treatment of patients who were hospitalized with moderate Covid-19. E4 did not differ from placebo on the primary study endpoint, but the results further support the unique safety profile of estetrol.
• Acquisition of full licensing and distribution rights on Zoreline®, allowing Mithra to significantly increase its margin in some of the most attractive locations outside of Mithra's former geographical scope.
• Launch of an animal PK/PD comparative study for Zoreline® with first results expected by the end of 2021.
• Commercial launch of Myring® in Italy (Farmitalia), Switzerland (Labatec), Poland and France (Zentiva).
• Commercialization agreement for Tibelia® signed with Dampe for Venezuela and additional commercial launches in Chile, Switzerland, UAE and KSA.

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