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COMPANY INFORMATION
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CONTENTS
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CHAIRMAN'S STATEMENT
FOR THE YEAR ENDED 31 DECEMBER 2023
The chairman presents his statement for the year ended 31 December 2023.
2023 was a challenging year for the Biotech industry, with cash conservation and the reprioritisation of clinical assets being a common theme contributing to the loss for the year. Despite this the group has continued to expand its customer base, has active programmes with the largest pharmaceutical companies and completed a number of material milestones.
I am pleased that the group completed two major infrastructure developments which began in 2021. Firstly, the research and manufacturing facility build and expansion at its headquarters in Hampton was concluded. The new facility enables maximum production capacity for DNA greater than the current estimated annual global demand for DNA, positioning Touchlight to support the increased demands that will arise from the next generation of modern therapeutics but with a footprint which is a fraction of the space required by conventional bioreactor-based plasmid DNA manufacture. Secondly the SAP S4/HANA Enterprise Resource Planning (ERP) system implementation and digital transformation was completed and forms the basis of a scalable manufacturing operation. The business has focused considerable resource and effort on these two critical tasks and completion of these projects underpins our growth strategy. The new facility, along with the ERP system and our industry leading expertise, positions the business to support our clients as they progress through their clinical programmes.
As well as the focus on building the infrastructure it has also been a year of commercial and technical achievements which continue to strengthen the foundation of the business. Early in the year the group reached a new industry milestone for enzymatic DNA following the FDA acceptance of the Drug Master File (DMF) for Good Manufacturing Practice (GMP) grade dbDNA. This achievement marks the first time a DMF has been accepted for an enzymatically produced DNA platform. Customers now have the option to gain access to the dbDNA proprietary manufacturing process information through the DMF for their IND submissions in the U.S. saving time and effort and is an important milestone in our strategy of regulatory engagement to enable broad utilisation of dbDNA across the genetic medicine industry. Shortly afterwards, one of our clients achieved the first FDA clearance of an Investigational New Drug (IND) application in the U.S. utilising dbDNA, representing a significant further step towards clinical adoption of dbDNA.
We were delighted to secure a grant from the Department for Science, Innovation and Technology, to support the acceleration of the group’s acquisition of scale up equipment, which in turn supported the group’s facility expansion. The grant will also help drive Touchlight’s ability to provide materials as part of client API (Active Pharmaceutical Ingredient) programmes. The grant funded collaboration with the Bill & Melinda Gates Foundation to advance our proprietary DNA vaccine platform, announced in late 2022, progressed well in 2023 and we are excited to see the potential of our platform compared to mRNA vaccines.
Post the December 2023 period end Touchlight, alongside continuing commercial progress, achieved several milestones. Three in particular are significant.
Firstly, we signed a licence with GSK for the use of dbDNA in the production of mRNA. The agreement includes an upfront payment, potential development and commercial milestone payments and royalties upon commercialisation. Secondly, we received GMP certification, and became the first synthetic DNA manufacturer globally to gain regulatory approval to produce Active Pharmaceutical Ingredients (API). Thirdly, we disposed of our Touchlight Aquaculture subsidiary to Ceva Animal Health, the 5th largest global animal health company. The acquiror has been granted rights to develop and manufacture future products using Touchlight’s dbDNA technology across the animal health field. These achievements position the company well to support our growing customer base.
We have built one of the largest DNA manufacturing facilities in the world and are pioneering the field of synthetic DNA that affords benefits of speed, purity and control. We continue to look forward with confidence to delivering into the global DNA market.
J Ohlson
Chairman
Date:20 March 2025
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BUSINESS HIGHLIGHTS
FOR THE YEAR ENDED 31 DECEMBER 2023
Significant progress and key milestones achieved as demonstrated by (i) completion of multi million pound facility to enable DNA production at scale (ii) FDA acceptance of Drug Master File for Touchlight’s dbDNA, recognising dbDNA as the first enzymatic DNA platform with a DMF; and (iii) ERP SAP platform becoming operational in 2023.
Post period end (i) facility in Hampton UK receives GMP certification, as a result Touchlight becomes the first synthetic DNA manufacturer globally to gain regulatory approval to produce Active Pharmaceutical Ingredient (API), (ii) disposal of Touchlight Aquaculture subsidiary to Ceva Animal Health. Acquiror granted rights to develop and manufacture future products using Touchlight’s dbDNA technology across the animal health field; and (iii) signs patent license with GSK.
Business developments
∙US Food and Drug Administration (FDA) acceptance of Drug Master File for Touchlight’s dbDNA.
∙FDA clearance granted for an Investigational New Drug application in the USA utilising dbDNA. dbDNA will be used as an in vitro transcription template for mRNA production in the manufacturing of a cell therapy product in a trial by one of Touchlight’s clients.
∙Grant awarded from the Department for Science, Innovation and Technology, delivered through the Life Sciences Innovative Manufacturing Fund.
∙Completion of the redevelopment and expansion of our manufacturing facility in London, UK, including an additional 11 GMP suites, to create one of the world’s largest DNA manufacturing sites to enable DNA production at scale.
∙Launch of a new customer offering of a Discovery grade dbDNA that enables customers to receive quick and easy access to 0.5 to 1mg RUO grade dbDNA, which can be ready to use in as little as 4 weeks.
∙Collaborate with Curia to expand their mRNA manufacturing offerings with an additional differentiated source of DNA raw material. Touchlight will directly manufacture dbDNA on behalf of Curia’s customers.
∙Continued investment into building a scalable, digitised infrastructure with the SAP S/4HANA ERP system becoming operational in 2023.
∙dbDNA used as a critical starting material to support Versameb’s first-in-human clinical study to treat chronic stress urinary incontinence (SUI). This marks the third product to enter clinical development using the dbDNA platform, further demonstrating its regulatory adoption in both the US and Europe.
Financial highlights
∙Revenue of £4.4 million (FY22 £15.6 million).
∙Cash at year end of £17.8 million (FY22: £38.5 million).
∙Reported loss £40.8 million (FY22: Restated loss £8.3 million).
Post-period events
∙Hampton UK facility receives GMP certification. Touchlight becomes the world’s first synthetic DNA manufacturer to receive regulatory approval to produce Active Pharmaceutical Ingredients (API). This milestone uniquely positions the company to support its expanding customer base in developing DNA vaccines and non-viral gene therapies.
∙Disposes of Touchlight Aquaculture subsidiary to Ceva Animal Health (Ceva), the 5th largest global animal health company. Acquiror granted rights to develop and manufacture future products using Touchlight’s dbDNA technology across the animal health field.
∙Signs patent license with GSK, granting non-exclusive rights to use Touchlight’s dbDNA technology for the development and production of mRNA-based products.
∙Agreement with University of Liverpool for the use of dbDNA in the development of a fully-personalised therapeutic neoantigen DNA vaccine for patients with non-small cell lung cancer.
∙Wins two grants from Innovate UK to support R&D, one for the use of dbDNA in AAV production and the other to further develop and characterise Touchlight’s new genome editing product, mbDNA.
∙Awarded further grant form the Office of Naval Research (ONR) and the Defence Science and Technology Laboratory (Dstl) following successful proof of concept studies, in order to develop DNA-enabled biobattery prototype with real-world applicability.
∙CPI, a leading technology innovation centre in the UK, has selected Touchlight to supply research and GMP-grade enzymatic DNA for the development and manufacture of RNA therapeutics and vaccines.
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GROUP STRATEGIC REPORT
FOR THE YEAR ENDED 31 DECEMBER 2023
The directors present their Strategic Report together with the audited financial statements for the year ended 31 December 2023.
The publication of the human genome in the early 2000s has driven an acceleration in medical advances, enabling a new era of therapies targeted at a range of diseases. As a result, transformative therapies (AAV, lentivirus, cell therapy) are being utilised in the management of previously untreatable conditions, including cancers and rare genetic diseases. More recently, the SARSCoV2 pandemic has accelerated the utilisation of nucleic acid therapies including messenger RNA (mRNA) and DNA.
Such advanced therapy relies upon DNA, making it the basis of genetic medicine. As a result, the market for DNA has shown rapid growth. It is estimated that the market for DNA globally supports ~3,000 preclinical, clinical and commercial products, and is presently approximately £600m p.a. The market is expected to continue to grow strongly to >£2.6bn in 2032. Whilst these trends are highly positive, supply chain challenges remain to fully globalise genetic medicine, including the manufacture of DNA.
The Touchlight Holdings Limited group ("Touchlight") utilises its proprietary intellectual property to make synthetic DNA for use in the development and manufacture of products to support large scale adoption and deployment of genetic medicine. The group has a threefold strategy: to innovate through DNA, to generate a social benefit, and provide a return to shareholders.
To achieve these objectives the group has:
∙A state of the art facility, incorporating clinical grade manufacturing suites focused on commercial dbDNA production; and
∙Invented, patented and scaled an advanced DNA amplification platform.
Touchlight is well placed to address global DNA supply.
Revenues of £4.4 million were generated in the year (FY2022: £15.6 million) including the receipt of £1.8 million of licensing and royalty income (FY2022: £12.5 million). The prior year includes a material upfront signing fee from a licensing transaction from which the business expects to benefit in the future.
The group closed the year with a healthy cash balance of £17.8 million (FY2022: £38.5 million). As well as losses incurred in the year, there was significant CAPEX incurred in the year of £6.5m which includes spend on completing the facility expansion to enable manufacturing at scale as well as on the ERP software alongside working capital requirements.
Net liabilities closed at £44.3 million (FY2022: net assets of £2.7 million). The group's result for the year rose from a £8 million restated loss in 2022 to a loss of £48.7 million in 2023. The net assets and loss for FY2022 have been restated following a prior period adjustment (see Note 27 to the Financial Statements).
Further information about the group's performance for the year is included in the Chairman's Statement on page 2.
This year saw the completion of the build to expand the manufacturing capabilities of the group. The extensive facility expansion enables DNA production at scale and includes a further 11 GMP suites, taking the total to 15. Alongside investing in our physical manufacturing capabilities, the group has invested in an Enterprise Resource Planning (ERP) system to manage group wide operations and support its growth strategy, which became operational in 2023.
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GROUP STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
This section lays out risks that are specific to the Touchlight business and those of a general nature, which either individually or collectively could affect the future operating and financial performance of Touchlight. Touchlight seeks to manage the risks to minimise the potential impact however several of these risks are outside the control of the business.
∙Product risk. To date the manufacturing business product offering is proving attractive to customers however continuing market acceptance of Touchlight's range of products will depend on potential customers finding the offerings more attractive than alternatives and Touchlight's continued ability to manufacture at scale. Touchlight seeks to mitigate this risk through constant contact with the customer base and continued research, development and innovation.
∙Partnership risk. Touchlight is engaged in partnerships and licensing arrangements. Such arrangements will invariably expose the business to counterparty risk. Touchlight seeks to mitigate this risk through ensuring adequate liquidity at the Group level.
∙Dependence on key personnel. Touchlight is dependent on its scientific and management team. The loss (whether temporary or permanent) of these people could materially impact research and development activities. Touchlight seeks to mitigate this risk through competitive remuneration and succession planning.
∙Competition. The sector is characterised by ongoing and continuous technological innovation which in time may impact on Touchlight. Touchlight seeks to mitigate his through constant monitoring of the competitive space.
∙Economic environment and market conditions. The operating costs of Touchlight may be affected by currency fluctuations, inflation, legislative and other future political decisions. Touchlight seeks to mitigate this through close monitoring of the cost base and the economic environment.
∙Group intellectual property. Touchlight is dependent on its intellectual property. Copying of this by competitors or challenges to it would materially impact the business. Touchlight seeks to mitigate this risk through extensive patent protection and legal defence as and when required.
The above list of risks is not exhaustive and other unforeseen risks may in the future impact on the performance of Touchlight's business.
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GROUP STRATEGIC REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
In preparing the financial statements the directors are required to assess the group and company's ability to continue to trade as a going concern for the foreseeable future.
The closing net liability position in December 2023 was £44.3 million (FY2022: £2.7 million). The closing cash balance was £17.8 million in December 2023 (FY2022: £38.5 million).
The business environment remains uncertain due to ongoing events in Ukraine and the impact of inflation and increasing interest rates on global financial markets.
The directors have performed an assessment of going concern. Assessments have been undertaken around customer and supply continuity as well as forecast cash flow.
Any future impact is most likely to come from customers and their purchasing requirements. Interruptions to customer operations could potentially impact their ability to meet payment timescales leading to a reduction in the group's cash receipts. The directors have sought to reduce this potential impact by maintaining communication channels with customers in order to anticipate any risks.
The duration and severity of the impact of the economic climate have been carefully monitored. If the period of impact of either was to extend further or the assessed impact on revenue and cash flows be more severe than anticipated, the group would look to adjust its operations as and when required. Through the modelling of potential scenarios via stress testing, the directors have considered how sensitive operations were in relation to a decline in cash flow. The results indicated that the group and company is well placed to continue to operate, with no requirement for additional funding or substantial headcount reductions for a period of at least 12 months from the date of approval of this report.
The directors have reviewed the cash flow forecasts, based on their best assessment of future performance and the stress testing completed, and believe that the group will have sufficient financing to remain a going concern for the foreseeable future. As such, the directors continue to adopt the going concern basis of accounting in preparing the annual financial statements.
The key performance indicator ("KPI") is the closing cash balance, which was £17.8 million at 31 December 2023 (FY2022: £38.5 million).
As the business grows, it is anticipated that more KPIs including growth in sales and earnings before interest and tax will be added.
This report was approved by the board and signed on its behalf.
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DIRECTORS' REPORT
FOR THE YEAR ENDED 31 DECEMBER 2023
The directors present their report and the financial statements for the year ended 31 December 2023.
The parent company, Touchlight Holdings Limited, is a holding company. The subsidiary companies are contract, development and manufacturing organisations, which produce synthetic DNA for advanced medicines and for therapeutic use and carry out associated activities, including research and development.
The directors who served during the year and up to the date of this report were:
I Eschweiler
The directors are responsible for preparing the Group 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 Group's financial statements and then apply them consistently;
∙make judgments 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 Group 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 the Group 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 the Group and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities.
The loss for the year, after taxation and minority interests, amounted to £48,678,953 (2022: Restated loss £7,919,614).
The directors do not recommend payment of a dividend.
The directors are satisfied with the progress and expect further positive developments in the future, please see the group strategic report for an indication of the future business development.
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DIRECTORS' REPORT (CONTINUED)
FOR THE YEAR ENDED 31 DECEMBER 2023
The company held third party indemnity insurance cover for the directors and officers of the group and parent company during the current and prior year.
The Company has chosen, in accordance with Section 414C(11) of the Companies Act 2006 (Strategic Report and Directors' Report) Regulations 2013, to set out within the Group's Strategic Report the Company's Strategic Report Information Required by Schedule 7 of the Large and Medium Sized Companies and Groups (Accounts and Reports) Regulation 2008. This includes information that would have been included in the business review and details of the principal
risks and uncertainties.
Details of significant events affecting the Group since the year end have been included in the Group Strategic Report on pages 2 to 5.
Lewis Golden LLP resigned as auditors, with Deloitte LLP filling a casual vacancy. Deloitte LLP, were appointed in accordance with section 485 of the Companies Act 2006.
This report was approved by the board and signed on its behalf.
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INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF TOUCHLIGHT HOLDINGS LIMITED
∙ give a true and fair view of the state of the group’s and of the parent company’s affairs as at 31 December 2023 and of the group’s loss for the year then ended;
∙have been properly prepared in accordance with United Kingdom Generally Accepted Accounting Practice, including Financial Reporting Standard 102 “The Financial Reporting Standard applicable in the UK and Republic of Ireland”; and
∙have been prepared in accordance with the requirements of the Companies Act 2006.
We have audited the financial statements which comprise:
∙the consolidated statement of comprehensive income;
∙the consolidated and parent company statements of financial position;
∙the consolidated and parent company statements of changes in equity;
∙the consolidated statement of cash flows;
∙the consolidated analysis of net debt; and
∙the related notes 1 to 34.
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 Group 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 Group's or the parent 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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INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF TOUCHLIGHT HOLDINGS LIMITED (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.
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 Group financial statements.
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.
Extent to which the audit was considered capable of detecting irregularities, including fraud
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.
We considered the nature of the group’s industry and its control environment, and reviewed the group’s documentation of their policies and procedures relating to fraud and compliance with laws and regulations. We also enquired of management and the directors about their own identification and assessment of the risks of irregularities, including those that are specific to the group’s business sector.
We obtained an understanding of the legal and regulatory framework that the group operates in, and identified the key laws and regulations that:
∙had a direct effect on the determination of material amounts and disclosures in the financial statements. This included the UK Companies Act, and tax legislation; and
∙do not have a direct effect on the financial statements but compliance with which may be fundamental to the group’s
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INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF TOUCHLIGHT HOLDINGS LIMITED (CONTINUED)
ability to operate or to avoid a material penalty. These included GMP regulations and data protection legislation.
We discussed among the audit engagement team including relevant internal specialists regarding the opportunities and incentives that may exist within the organisation for fraud and how and where fraud might occur in the financial statements.
As a result of performing the above, we identified the greatest potential for fraud in the following areas, and our procedures performed to address it are described below:
Valuation of Intangible asset
Owing to the loss-making nature of the group, we identified a significant risk around the carrying value of capitalised licences.
Procedures performed:
∙Reviewed management’s model supporting the carrying value of the asset.
∙Challenged the underlying assumptions therein, obtaining support for the key inputs.
∙Compared to other forecasts prepared by management.
Accounting for preference shares
A material error in historical accounting for preference shares issued by the company in previous years was identified (see note 27).
Procedures performed:
∙We reviewed management’s revaluation with the support of in-house financial instrument accounting and valuation specialists.
∙We challenged management and their advisers on the accounting treatment and the valuation of the amount treated as liability.
∙We reviewed the disclosures in the financial statements.
Management override
In common with all audits under ISAs (UK), we are also required to perform specific procedures to respond to the risk of management override. In addressing the risk of fraud through management override of controls, we tested the appropriateness of journal entries and other adjustments; assessed whether the judgements made in making accounting estimates are indicative of a potential bias; and evaluated the business rationale of any significant transactions that are unusual or outside the normal course of business.
In addition to the above, our procedures to respond to the risks identified included the following:
∙reviewing financial statement disclosures by testing to supporting documentation to assess compliance with provisions of relevant laws and regulations described as having a direct effect on the financial statements;
∙performing analytical procedures to identify any unusual or unexpected relationships that may indicate risks of material misstatement due to fraud;
∙enquiring of management and external legal counsel concerning actual and potential litigation and claims, and instances of non-compliance with laws and regulations; and
∙reading minutes of meetings of those charged with governance.
Report on other legal and regulatory requirements
Opinions on other matters prescribed by the Companies Act 2006
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 group and of the parent company and their environment obtained in the course of the audit, we have not identified any material misstatements in the strategic report or the directors’ report.
Matters on which we are required to report by exception
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INDEPENDENT AUDITORS' REPORT TO THE MEMBERS OF TOUCHLIGHT HOLDINGS LIMITED (CONTINUED)
Under the Companies Act 2006 we are required to report in respect of the following matters if, in our opinion:
∙adequate accounting records have not been kept by the parent company, or returns adequate for our audit have not been received from branches not visited by us; or
∙the parent company financial statements are not in agreement with the accounting records and returns; or
∙certain disclosures of directors’ remuneration specified by law are not made; or
∙we have not received all the information and explanations we require for our audit.
We have nothing to report in respect of these matters.
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
Cambridge
Statutory Auditor
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CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 31 DECEMBER 2023
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CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2023
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CONSOLIDATED STATEMENT OF FINANCIAL POSITION (CONTINUED)
AS AT 31 DECEMBER 2023
The financial statements were approved and authorised for issue by the board and were signed on its behalf by:
The notes on pages 23 to 54 form part of these financial statements.
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COMPANY STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2023
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COMPANY STATEMENT OF FINANCIAL POSITION (CONTINUED)
AS AT 31 DECEMBER 2023
The financial statements were approved and authorised for issue by the board and were signed on its behalf by:
The notes on pages 23 to 54 form part of these financial statements.
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CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2022
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