Dato for ledelsens godkendelse af årsrapporten:2023-09-27
Beskrivelse af usædvanlige forhold, der kan have påvirket indregningen eller målingen:Correction of material misstatements
Capitalization of R&D expenses (and related grant income and loan interests)
During the financial year, management concluded that the Company incorrectly capitalized expenses related to research and development in the balance sheet as of 31 March 2022 and prior periods since the incurred research and development expenses did not qualify for capitalisation. Intangible assets arising from internal development projects can only be recognised in the statement of financial position, if it can be documented with sufficient certainty that the future income from the development project exceeds costs. Due to the general uncertainty related to the development of the drug candidates, Management concludes that internal development costs were incorrectly capitalised, and can only be capitalised if the product has been fully developed and all necessary approvals from the authorities have been obtained.
Further, the Company incorrectly included capitalised grant income and loan interest expenses as part of the research and development intangible asset capitalised in the balance sheet which also did not qualify for capitalisation. Due to the significance of the matter the Company has treated the matter in accordance with the provisions in section 52(2) of the Danish Financial Statements Act regarding correction of material misstatements. Consequently, the comparatives and the equity as of 31 March 2022 has been restated in these financial statements, including income tax impact. Reference is made to note 1 for further description.
Investments in group enterprises
During the financial year, management concluded that the Company incorrectly carried the value of investments in group enterprises at cost without recognizing impairment of the investment as of 31 March 2022 and prior periods. The subsidiary is without activity and hence the cost associated with the investment was impaired to zero. Due to the significance of the matter the Company has treated the matter in accordance with the provisions in section 52(2) of the Danish Financial Statements Act regarding correction of material misstatements.
Consequently, the comparatives and the equity as of 31 March 2022 has been restated in these financial statements, including income tax impact. Reference is made to note 1 for further description.
The restatements impact the comparatives for financial year 2021/22 ending 31 March 2022, and the opening equity 1 April 2022 and 1 April 2021 as follows:
- In the comparative financial period ending 31 March 2021, grant income increased by DKK 139 thousand (from DKK 0 thousand to DKK 139 thousand), research and development costs increased by DKK 6,641 thousand (from DKK 0 thousand to DKK 6,641 thousand, salary costs increased by DKK 950 thousand (from DKK 64 thousand to DKK 1,014 thousand), income or loss from equity investments in group enterprises decreased by 1,399 thousand (from -141 thousand to DKK -1,540), interest expenses increased DKK 1,163 thousand (from DKK 68 thousand to DKK 1,232 thousand), and loss before tax decreased DKK 10,015 thousand (from DKK -780 thousand to DKK -10,795 thousand). Loss after tax decreased by DKK 10,015 thousand (from DKK -780 thousand to DKK -10,795 thousand).
- The balance sheet total as of 31 March 2022 decreased by DKK 15,618 thousand (from DKK 18,746 thousand to DKK 3,128 thousand).
- The equity as of 1 April 2022 decreased by DKK 15,618 thousand (from DKK -752 thousand to DKK -16,370 thousand).
- The equity as of 1 April 2021 decreased by DKK 5,603 thousand (from DKK 28 thousand to DKK -5,575 thousand).
For the year ended 31 March 2023, R&D expenses are expensed as incurred consistent with prior years, and grant income and loan interests are recognised in the income statement when incurred consistent with prior years. Further, impairment of investments in group enterprises are recognised in the income statement consistent with prior years.
Going concern
After the balance sheet date, the Company has received new funding, EUR 9. 3 million, which enables the Company to continue the planned research and development activities for the 12 months period ending 31 March 2024. On this basis, Management has prepared the financial statements applying the going concern assumption.
Statement by Management on the annual report
Identifikation af den godkendte årsrapport:Today, the Board of Directors and the Executive Board have discussed and approved the annual report of Breye Therapeutics ApS for the financial year 1 April 2022 - 31 March 2023.
Management's review
Beskrivelse af virksomhedens væsentligste aktiviteter:The Company, Breye Therapeutics ApS, is an early stage biopharmaceutical company developing first in class and orally administered therapies suited for early treatment intervention in patients with diabetic retinopathy (DR) and age-related macular degeneration (AMD) being at risk of further disease progression and vision loss.
The company's lead therapy, danegaptide, is a clinical asset with a documented safety profile in human trial subjects and has been in licensed from Zealand Pharma A/S. It is a small molecule suitable for oral therapy which can uniquely address a large and growing unmet medical need for more effective and less burdensome therapies for patients with DR. A second therapeutic program was aquired from Golgi Neurosciences S. r.l.
The Company, Breye Therapeutics ApS, has an experienced management team within drug development and is working with world leading scientists and retinal specialists to advance its early portfolio of products.
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