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Registered number:
FOR THE YEAR ENDED 31 DECEMBER 2024
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BIOCRUCIBLE LTD
COMPANY INFORMATION
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BIOCRUCIBLE LTD
CONTENTS
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BIOCRUCIBLE LTD
STRATEGIC REPORT
FOR THE YEAR ENDED 31 DECEMBER 2024
The directors present their report and the financial statements for the year ended 31 December 2024.
Principal Activities The principal activities of the company and group were focused on the development of its home pregnancy tests and novel molecular diagnostic technology for use in the Point of Care and Over-the-Counter channels within the women’s health, global respiratory and infectious disease markets.
The company continues to focus its investments on the research and development of healthcare diagnostic devices for the use in focus areas such as women’s health, respiratory and infectious disease detection. These efforts are being conducted in close collaboration with key global strategic partners and government agencies through the funding and development of these key projects to ensure alignment with evolving market needs within key geographies.
In 2024, the company made considerable progress in the development of our pregnancy tests and molecular multiplex platform technology. For our pregnancy tests, the company further progressed towards the completion of the design and V&V phases for both the digital and visual pregnancy products including achieving the ability to transfer data to both mobile and web-based applications. Given this progress in 2024, the company believes it will be able to launch clinical trials for both digital and visual pregnancy tests in 2025. For our molecular multiplex platform technology, the company was able to successfully develop a prototype with the creation of multiplex assays that include COVID-19, Flu A and Flu B. With this significant milestone in the development of our molecular technology, the company believes it is now able to progress the product to the final design and V&V stages in 2025.
The directors consider that the following are the principal risks and uncertainties which the company faces:
Credit risks The company policies are aimed at minimising financial losses related to obligations from other third parties and require that deferred terms are only granted to customers/third parties who demonstrate an appropriate payment history and satisfy credit worthiness procedures. Competitive risks The company operates in a competitive environment in which other companies in the healthcare medical device space may develop and market products more successfully. However, there has been continued investment in the company's research and development and manufacturing capabilities in order for the company to maintain its competitive technology platforms against competition. Employment risk The company's technology is diverse, and the company's success will depend on its ability to attract and retain staff with relevant experience in a discipline. The company actively monitors its compensation strategy and market data to ensure its position competitively with comparable companies in industry and geography. Foreign exchange risk The directors acknowledge that there exists a foreign exchange risk at a local entity level. Foreign exchange risk for the Sapphiros group is managed by Sapphiros parent entities.
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BIOCRUCIBLE LTD
STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
Supply chain and manufacturing risk
While the Company is exposed to risks arising from global supply chain disruptions, the Company attempts to mitigate these risks through supplier diversification. To reduce dependency and enhance supply security, efforts are ongoing to diversify the supplier base and to expand internal capabilities. Intellectual property protection and competition risk The Company continues to invest in building and protecting our intellectual property (IP) portfolio, which consists of patents, trademarks, trade secrets and copyright. This portfolio is a critical asset that underpins the Company's competitive advantage and long-term value. As part of its IP strategy, the Company is prepared to enforce its rights against infringement by competitors or new market entrants. However, IP enforcement and litigation can be costly and time-consuming, and there is no guarantee of a successful outcome. As such, the risk of IP disputes remains a material consideration for the Company. Liquidity risk The solvency and liquidity of the company are ensured by the cash availability from Sapphiros group's treasury.
The directors monitor a range of key performance indicators (KPls) on a regular basis to manage the underlying trading businesses and enable operational management to react to new growth opportunities. As the company’s current year’s turnover is primarily related to labour recharges from related parties within the KKR Sapphiros LP group, the company’s critical financial metrics monitored by the directors are research and development and administrative expenditures.
Research and development expenditure increased by 7% for the period ending in 2024 versus the same period ending for 2023. In 2024, the company continued to invest in research and development activities to further the development of our digital and visual pregnancy test and our molecular multiplex platform technology. The main drivers for this increase in R&D expenditure were due to the increase in employee related costs as headcount increased from 48 in 2023 to 57 in 2024 and increases in other costs such as lab consumables and clinical samples to support number of key projects during the year. Administrative expenditures increased by 50% for the period ending 2024 versus the same period ending for 2023. In 2024, the company invested in key administrative activities such filing new patents, expansion in office space and employee related costs to support the expansion of R&D projects. The main drivers for the increase in administrative costs year over year were due to the increase in employee related costs as headcount increased from 26 in 2023 to 30 in 2024, expansion of office space to support infrastructure growth and foreign exchange impact related to the revaluation of amounts owed to group undertakings which are held in USD. The directors regard continued investment in these areas as a prerequisite for continued success in the medium-to-long-term future. The directors are satisfied with the results for the period and are confident that future developments will generate satisfactory results and that future growth is expected in the business, due to innovative technologies and new product releases.
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BIOCRUCIBLE LTD
STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
This report was approved by the board on 23 December 2025 and signed on its behalf.
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BIOCRUCIBLE LTD
DIRECTORS' REPORT
FOR THE YEAR ENDED 31 DECEMBER 2024
The directors present their report and the financial statements for the year ended 31 December 2024.
The directors are responsible for preparing the strategic report, the directors' report and the financial statements in accordance with applicable law and regulations.
In preparing these financial statements, the directors are required to:
∙select suitable accounting policies for the Company's financial statements and then apply them consistently;
∙make judgements and accounting estimates that are reasonable and prudent;
∙prepare the financial statements on the going concern basis unless it is inappropriate to presume that the Company will continue in business.
The directors are responsible for keeping adequate accounting records that are sufficient to show and explain the Company's transactions and disclose with reasonable accuracy at any time the financial position of the Company and to enable them to ensure that the financial statements comply with the Companies Act 2006. They are also responsible for safeguarding the assets of the Company and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities.
The loss for the year, after taxation, amounted to £8,609,304 (2023 - loss £5,083,636).
The directors who served during the year were:
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BIOCRUCIBLE LTD
DIRECTORS' REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2024
The auditors, Lakin Rose Limited, will be proposed for reappointment in accordance with section 485 of the Companies Act 2006.
This report was approved by the board on
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BIOCRUCIBLE LTD
INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF BIOCRUCIBLE LTD
We have audited the financial statements of Biocrucible Ltd (the 'Company') for the year ended 31 December 2024, which comprise the statement of income and retained earnings, the analysis of net debt, the balance sheet, the statement of cash flows and the related notes, including a summary of significant accounting policies. The financial reporting framework that has been applied in their preparation is applicable law and United Kingdom Accounting Standards, including Financial Reporting Standard 102 ‘The Financial Reporting Standard applicable in the UK and Republic of Ireland' (United Kingdom Generally Accepted Accounting Practice).
We conducted our audit in accordance with International Standards on Auditing (UK) (ISAs (UK)) and applicable law. Our responsibilities under those standards are further described in the Auditors' responsibilities for the audit of the financial statements section of our report. We are independent of the Company in accordance with the ethical requirements that are relevant to our audit of the financial statements in the United Kingdom, including the Financial Reporting Council's Ethical Standard and we have fulfilled our other ethical responsibilities in accordance with these requirements. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
In auditing the financial statements, we have concluded that the directors' use of the going concern basis of accounting in the preparation of the financial statements is appropriate.
Based on the work we have performed, we have not identified any material uncertainties relating to events or conditions that, individually or collectively, may cast significant doubt on the company's ability to continue as a going concern for a period of at least twelve months from when the financial statements are authorised for issue.
Our responsibilities and the responsibilities of the directors with respect to going concern are described in the relevant sections of this report.
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BIOCRUCIBLE LTD
INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF BIOCRUCIBLE LTD (CONTINUED)
The other information comprises the information included in the Annual Report other than the financial statements and our auditors' report thereon. The directors are responsible for the other information contained within the Annual Report. Our opinion on the financial statements does not cover the other information and, except to the extent otherwise explicitly stated in our report, we do not express any form of assurance conclusion thereon. Our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the course of the audit, or otherwise appears to be materially misstated. If we identify such material inconsistencies or apparent material misstatements, we are required to determine whether this gives rise to a material misstatement in the financial statements themselves. If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact.
We have nothing to report in this regard.
In our opinion, based on the work undertaken in the course of the audit:
∙the information given in the strategic report and the directors' report for the financial year for which the financial statements are prepared is consistent with the financial statements; and
∙the strategic report and the directors' report have been prepared in accordance with applicable legal requirements.
In the light of the knowledge and understanding of the Company and its environment obtained in the course of the audit, we have not identified material misstatements in the strategic report or the directors' report.
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BIOCRUCIBLE LTD
INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF BIOCRUCIBLE LTD (CONTINUED)
Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditors' report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs (UK) will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements.
Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design procedures in line with our responsibilities, outlined above, to detect material misstatements in respect of irregularities, including fraud. The extent to which our procedures are capable of detecting irregularities, including fraud is detailed below:
Extent to which the audit was considered capable of detecting irregularities, including fraud We identify and assess the risks of material misstatement of the financial statements, whether due to fraud or error, and then design and perform audit procedures responsive to those risks, including obtaining audit evidence that is sufficient and appropriate to provide a basis for our opinion. Identifying and assessing potential risks related to irregularities In identifying and assessing risks of material misstatement in respect of irregularities, including fraud and non-compliance with laws and regulations, we considered the following: • the nature of the industry and sector, control environment and business performance including the design of the company’s remuneration policies, key drivers for management remuneration, bonus levels and performance targets; • results of our enquiries of management about their own identification and assessment of the risks of irregularities; • any matters we identified having obtained and reviewed the company’s documentation of their policies and procedures relating to: - identifying, evaluating and complying with laws and regulations and whether they were aware of any instances of noncompliance; - detecting and responding to the risks of fraud and whether they have knowledge of any actual, suspected or alleged fraud; - the internal controls established to mitigate risks of fraud or non-compliance with laws and regulations; • the matters discussed among the audit engagement team and involving relevant internal specialists regarding how and where fraud might occur in the financial statements and any potential indicators of fraud. As a result of these procedures, we considered the opportunities and incentives that may exist within the organisation for fraud and identified the greatest potential for fraud in relation to revenue recognition. In common with all audits under ISAs (UK), we are also required to perform specific procedures to respond to the risk of management override. We also obtained an understanding of the legal and regulatory frameworks that the company operates in, focusing on provisions of those laws and regulations that had a direct effect on the determination of material amounts and disclosures in the financial statements. The key laws and regulations we considered in this context included the UK Companies Act and UK tax legislation. In addition, we considered provisions of other laws and regulations that do not have a direct effect on the financial statements but compliance with which may be fundamental to the company’s ability to operate or to avoid a material penalty. We identified no such laws and regulations applicable to the company.
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BIOCRUCIBLE LTD
INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF BIOCRUCIBLE LTD (CONTINUED)
Audit response to risks identified
As a result of performing the above, we identified revenue recognition as a key audit risk related to the potential risk of fraud. Our procedures to respond to risks identified included the following: • reviewing the financial statement disclosures and testing to supporting documentation to assess compliance with provisions of relevant laws and regulations described as having a direct effect on the financial statements; • enquiring of management concerning actual and potential litigation and claims; • performing analytical procedures to identify any unusual or unexpected relationships that may indicate risks of material misstatement due to fraud; • reading minutes of meetings of those charged with governance; • obtained an understanding of provisions and held discussions with management to understand the basis of recognition or non-recognition of provisions; and • in addressing the risk of fraud through management override of controls, testing the appropriateness of journal entries and other adjustments; assessing whether the judgements made in making accounting estimates are indicative of a potential bias; and evaluating the business rationale of any significant transactions that are unusual or outside the normal course of business. We also communicated relevant identified laws and regulations and potential fraud risks to all engagement team members including internal specialists, and remained alert to any indications of fraud or non-compliance with laws and regulations throughout the audit.
A further description of our responsibilities for the audit of the financial statements is located on the Financial Reporting Council's website at: www.frc.org.uk/auditorsresponsibilities. This description forms part of our auditors' report.
This report is made solely to the Company's members, as a body, in accordance with Chapter 3 of Part 16 of the Companies Act 2006. Our audit work has been undertaken so that we might state to the Company's members those matters we are required to state to them in an auditors' report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the Company and the Company's members, as a body, for our audit work, for this report, or for the opinions we have formed.
for and on behalf of
Chartered Accountants
Statutory Auditors
Cambridge House
Camboro Business Park
Girton
CB3 0QH
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BIOCRUCIBLE LTD
STATEMENT OF INCOME AND RETAINED EARNINGS
FOR THE YEAR ENDED 31 DECEMBER 2024
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BIOCRUCIBLE LTD
REGISTERED NUMBER: 11614863
BALANCE SHEET
AS AT 31 DECEMBER 2024
The financial statements were approved and authorised for issue by the board and were signed on its behalf on
The notes on pages 14 to 26 form part of these financial statements.
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BIOCRUCIBLE LTD
STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED 31 DECEMBER 2024
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BIOCRUCIBLE LTD
ANALYSIS OF NET DEBT
FOR THE YEAR ENDED 31 DECEMBER 2024
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
The company is a private company limited by shares and is incorporated in England and Wales. The address of the registered office is The Emmanuel Building Suite 2, Chesterford Research Campus, Little Chesterford, Saffron Walden, Essex, CB10 1XL.
2.Accounting policies
The financial statements have been prepared under the historical cost convention unless otherwise specified within these accounting policies and in accordance with Financial Reporting Standard 102, the Financial Reporting Standard applicable in the UK and the Republic of Ireland and the requirements and the Companies Act 2006. The disclosure requirements of Section 1A of FRS 102 have been applied other than where additional disclosure is required to show a true and fair view.
The following principal accounting policies have been applied:
The financial statements have been prepared on the going concern basis which assumes that the company will continue as a going concern for the foreseeable future. The parent company of the group (“the parent company”) continues to financially support the company.
The company will continue to develop diagnostic products for commercial sale in the field of women’s health, respiratory and infectious disease detection for the near term which has been the primary use of the company’s funds to date. The company has sufficient resources to complete development and initial preparation for clinical activities for these products. The parent company is at advanced stages in securing additional funds from new distribution partners and government agencies and has already received significant funds in 2025. Remaining diligence discussions have progressed to an advanced stage and financing is expected to be finalised by quarter two of 2026. This will ensure that the company can continue to trade for at least the next twelve months. The parent company plans to seek additional funding through private equity offerings, collaboration agreements, strategic alliances and licensing agreements. However, the parent company may not be able to obtain financing on acceptable terms, or at all, and may not be able to enter into strategic alliances or other arrangements on favourable terms, or at all. The terms of any financing may adversely affect the holdings or the rights to existing members of the parent company . If the parent company is unable to obtain financing or funding, it could be required to delay, reduce, or eliminate research and development programmes, product portfolio expansion or future commercialisation efforts in the field of women’s health respiratory and infectious disease detection, which would significantly reduce the required cash needed to continue as a going concern in the ordinary course of business. The directors of the parent company do not believe there is a material uncertainty regarding the parent company’s ability to secure sufficient financing or funding, therefore the directors of the company consider it is appropriate that the financial statements should be prepared on a going concern basis.
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
2.Accounting policies (continued)
Functional and presentation currency
Transactions and balances
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
2.Accounting policies (continued)
Grants of a revenue nature are recognised in the statement of income and retained earnings in the same period as the related expenditure.
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
2.Accounting policies (continued)
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
2.Accounting policies (continued)
All intangible assets are considered to have a finite useful life. If a reliable estimate of the useful life cannot be made, the useful life shall not exceed ten years.
The estimated useful lives range as follows:
Depreciation is charged so as to allocate the cost of assets less their residual value over their estimated useful lives, using the straight-line method.
Depreciation is provided on the following basis:
The assets' residual values, useful lives and depreciation methods are reviewed, and adjusted prospectively if appropriate, or if there is an indication of a significant change since the last reporting date.
Gains and losses on disposals are determined by comparing the proceeds with the carrying amount and are recognised in profit or loss.
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
2.Accounting policies (continued)
The company only enters into basic financial instrument transactions that result in the recognition of final assets and liabilities like trade and other debtors and creditors, loans from banks and other third parties, loans to related parties and investments in ordinary shares.
Financial liabilities and equity are classified according to the substance of the financial instrument's contractual obligations, rather than the financial instrument's legal form.
Financial liabilities within the scope of Section 12 of FRS 102 are initially classified as financial liabilities at fair value through profit or loss, loans and borrowings, or as derivatives designated as hedging instruments in an effective hedge, as appropriate. The company determines the classification of its financial liabilities at initial recognition. All financial liabilities are recognised initially at fair value and in the case of loans and borrowings, plus directly attributable transaction costs.
Analysis of turnover by country of destination:
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
10.Taxation (continued)
There were no factors that may affect future tax charges.
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
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BIOCRUCIBLE LTD
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2024
The company operates a defined contributions pensions scheme. The assets of the scheme are held separately from those of the company in independently administered funds. Contributions to the scheme during the year were £239,734 (2023 - £193,571). The outstanding contributions due to the funds at the balance sheet date were £52,298 (2023 - £39,679).
The company's immediate parent company and smallest group for which consolidated financial statements are prepared is
The ultimate controlling party is
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