2022 Half Year Results

as at 30 June 2022

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

Interim management report .............................................................................................................................................

5

1.

Corporate presentation ................................................................................................................................................

5

2.

Operational Highlights including post-period end...................................................................................................

5

3.

Financial highlights.......................................................................................................................................................

6

4. Corporate Governance .................................................................................................................................................

7

Capital and shares .................................................................................................................................................

7

Shareholders & Shareholder structure ..............................................................................................................

9

Change and/or renewal in the composition of corporate bodies..............................................................

10

5.

Principal risks and uncertainties .............................................................................................................................

11

6.

Related party transactions .......................................................................................................................................

24

Interim condensed consolidated financial statements for the six months ended 30 June 2022..................

26

1.

Interim consolidated statement of profit or loss .................................................................................................

26

2.

Interim consolidated statement of comprehensive loss....................................................................................

27

3.

Interim consolidated statement of financial position .........................................................................................

28

4.

Interim consolidated statement of changes in equity ........................................................................................

29

5.

Interim consolidated statement of cash flow.......................................................................................................

30

6.

Notes to interim condensed consolidated financial statements......................................................................

31

6.1. Significant changes in the current reporting period ....................................................................................

31

6.2. Summary of significant accounting policies.................................................................................................

31

6.3. Segment and revenue information..................................................................................................................

33

6.4. Profit and loss information ...............................................................................................................................

34

6.5. Intangible assets and goodwill.........................................................................................................................

35

6.6. Property, plant and equipment and right of use assets ..............................................................................

35

6.7. Inventories............................................................................................................................................................

36

6.8. Contract assets ...................................................................................................................................................

36

6.9. Trade and other receivables..............................................................................................................................

37

6.10. Equity.................................................................................................................................................................

37

6.11. Financial liabilities...........................................................................................................................................

39

6.12. Fair value measurement of financial instruments ...................................................................................

40

6.13. Trade and other payables..............................................................................................................................

43

6.14. Deferred tax assets and liabilities................................................................................................................

43

6.15. Share-based payments ..................................................................................................................................

44

6.16. Commitments..................................................................................................................................................

45

6.17. Events after reporting period ........................................................................................................................

45

6.18. Alternative performance measures.............................................................................................................

46

III. Statement of the responsible persons......................................................................................................................

49

IV. Statutory auditor's report ............................................................................................................................................

51

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I.

Interim management report

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Interim management report

1. Corporate presentation

Mithra (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.

Active in more than 100 countries around the world, Mithra has an approximate headcount of about 300 collaborators and is headquartered in Liège, Belgium.

2. Operational Highlights including post-period end

Mithra has pursued its deliverables' achievements in the first six months of 2022 both with regards to its estetrol unique native estrogen pipeline and its Complex Therapeutics business.

  • Successful commercial launch of contraceptive pill ESTELLE® in Australia by Mayne Pharma (July) under the trademark NEXTSTELLIS®.
  • Launch of a direct-to-consumer (DTC) campaign in the United States by Mayne Pharma (July) to further increase awareness of NEXTSTELLIS® contraceptive in the U.S.
  • Positive top-line efficacy results from DONESTA® Phase 3 Program, which demonstrated a meaningful reduction in vasomotor symptoms (VSM) from baseline and compared to placebo.
  • Launch of the recruitment of 300 additional menopausal non hysterectomised women for the DONESTA® European Study (C301), following the decision of the independent Data and Safety Monitoring Board (DSMB).
  • Successful commercial launch of vaginal contraceptive ring MYRING® in Canada by Searchlight Pharma (February) and reception in August of FDA approval in the U.S. by Mayne Pharma, where MYRING® will be commercialized under the trademark HALOETTE®.
  • Collaboration with MedinCell for the development of two long-acting injectable innovative products to address major global healthcare challenges: 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
  • Changes within Mithra's Board of Directors: appointment of Mr. Christian Moretti as Chairman and of
    Mr. Erik Van Den Eynden as Vice-Chairman; resignation of Mr. Ajit Shetty and Mr. François Fornieri.

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Mithra Pharmaceuticals SA published this content on 23 September 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 23 September 2022 05:39:09 UTC.