Belluscura Regulatory News (BELL)

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF ENGLISH LAW BY VIRTUE OF THE EUROPEAN (WITHDRAWAL) ACT 2018, AS AMENDED. ON PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

Belluscura plc

("Belluscura" or the "Company" or "Group")

 Final Results for the year ended 31 December 2022

Transformational year and positive outlook as global demand for portable oxygen concentrators is forecast to grow from $2.3bn in 2021 to $5.7bn by 2030 representing a CAGR of 10.6%1

LONDON, U.K. AND PLANO, TX, U.S. (29 June 2023). Belluscura plc (AIM:BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces its audited Final Results for the year ended 31 December 2022.

Financial Highlights:

· Group revenue of $1.54 million (2021: $0.42 million)

· Adjusted loss from operations of $6.2 million (2021: $4.2 million)

· Basic loss per share of $0.07 (2021: $0.06)

· Net Cash as at 31 December 2022 of $2.04 million

· Inventory and inventory deposits at 31 December 2022 of $10.8 million (2021: $1.8m)

Operational highlights:

Distribution

· Built significant US distribution and commenced international roll-out

Manufacturing

· Established high quality manufacturing facilities in both the US and China

· Both the in-house and China facilities provide outstanding quality, lower costs and increased capacity to support scaling the business

X-PLOR®

· Launched the next generation X-PLOR which provides more oxygen by weight than any portable oxygen concentrator in its class

· Good momentum, with initial new standing purchase orders exceeding 1,000 units for the latest generation X-PLOR, as we lay foundations for international expansion

Post Year End:

DISCOV-R™

· Released DISCOV-R for Pre-Market Evaluation in June 2023

· DISCOV-R is the first ambulatory pulse-dose and two-litre continuous flow POC in the world. Weighing c.40% less than any comparable dual flow oxygen concentrator on the market, the DISCOV-R produces nearly three times the oxygen by weight than concentrators in its class

· Significant pre-launch demand for DISCOV-R™, with over 125 distributors having requested access

· Expect DISCOV-R to be covered by two CMS codes making the device significantly more profitable for the Durable Medical Equipment providers

Further progress

· Currently evaluating proposals with third parties interested in white labelling the X-PLOR product for the US market

· Further strengthened the Board with the appointment of Robert Fary as VP of Sales

· Post year end raised net proceeds of £7.2m or $8.8m

Robert Rauker, Chief Executive Officer, Belluscura plc, commented on the results and outlook:

"The Group has made considerable progress in the year to 31 December 2022, during which it launched the next generation X-PLOR, built up significant distribution across the US and commenced an international roll out, established high quality manufacturing facilities and developed the DISCOV-R for a well-received launch in 2023. 

"Trading in the first half of 2023 has continued in line with our expectations for the full year, with a significant second half weighting expected, as previously stated. Demand for X-PLOR, which is predominantly a Direct to Consumer unit, is growing, and we expect our affiliation with GoodRX, a leading digital healthcare platform that makes healthcare affordable and convenient for all Americans, will help it to continue to gain momentum over the coming months.

"The commercial launch of DISCOV-R will be transformational for the Group. Having received a positive reception at Medtrade, we are very encouraged by the fact that over 125 distributors have requested access to DISCOV-R, with the distributors indicating potentially significant demand for units.

"Following the recent fundraising, and as we are now utilising the Company's previously high inventory levels, the Company is well positioned to deliver substantial growth in the coming years. We look forward to the future with confidence."

 1 Source: https://www.precedenceresearch.com/portable-oxygen-concentrators-market

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About Belluscura plc (www.belluscura.com)

Belluscura is a UK medical device company focused on developing oxygen enrichment technology spanning broad industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health and economic outcomes for the patients, healthcare providers and insurance organisations.

The Annual Report and Accounts have today been posted to shareholders, and is available from the Company's website www.belluscura.com.

CHAIRMAN'S STATEMENT

I am pleased to report on the performance of Belluscura in my second year as Chairman following the Company's listing on AIM in May 2021.

Belluscura is a business founded on the principle of making healthcare both more affordable and more available while making strong returns for our shareholders.

The Group's first product, X-PLOR, received 510(k) clearance from the Food and Drug Administration ("FDA") on 2 March 2021, and was commercially launched in September 2021. The next-generation X-PLOR was launched in September 2022, with the latest generation launched in April 2023 gaining good momentum.

Our ground-breaking DISCOV-R device, which delivers more oxygen by weight than any device currently available, is expected to be fully commercially launched in Q3 2023. A significant number of Distributors have already requested access to the DISCOV-R and we expect it to have a major impact on the success of the Group.

Our products are now manufactured both in the US and China, with high quality facilities in place enabling the quality standard accreditations required to apply for access to international markets.

We believe that the DISCOV-R and X-PLOR products will provide significant growth for the Group. The global demand for medical oxygen continues to grow with an estimated 300m1 people suffering from Chronic Obstructive Pulmonary Disease ("COPD") and the disease is expected to become the leading cause of death worldwide in 15 years.

With a strong management team in place and the recently raised funds to execute on bringing Belluscura's category-leading technology to market, the Board looks forward with confidence in the Group's ability to capture its market opportunities. 

Adam Reynolds

Non-Executive Chairman

29 June 2023

1 Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5921960/

CHIEF EXECUTIVE'S REVIEW

The Group is pleased to report on the considerable progress made in the year to 31 December 2022, during which it launched the next generation X-PLOR, built up significant distribution across the US and commenced an international roll out, while it also established high quality manufacturing facilities and developed the DISCOV-R™ for a well-received launch in 2023. 

Considerable progress in 2022

Built significant US distribution and commenced international roll-out

Since the launch of the first-generation X-PLOR in September 2021, the Group is now distributing throughout the US through multiple sales channels including through Distributors and Durable Medical Equipment Providers both Online and Bricks and Mortar, Medical Supply Warehouses, Medical Device Intermediaries, Hospitals and Direct to Consumer. In December 2022, we also signed our first international distribution agreement, with MedHealth Supplies of South Africa, which sells to one of the world's leading respiratory device suppliers.

Established high quality manufacturing facilities

The Group's continued progress has been enabled by expanding the manufacturing of the X-PLOR in the US and China, which has provided increased capacity, much improved quality controls and, importantly, lower costs.

In March 2022, we signed a manufacturing Master Supply Agreement ("MSA") with InnoMax Medical Technology, Ltd ("InnoMax") to manufacture the X-PLOR portable oxygen concentrator ("POC") in China, more than doubling our manufacturing capacity in 2023 and enabling us to accelerate our international expansion by opening up markets in Asia and beyond. Innomax are anticipated to directly source most of their own components from the second half of 2023, which will also result in a significant margin improvement and a reduction in the Company's inventory levels.

In April 2022, the Group took the decision to transfer its US manufacturing in-house, to increase production output at high quality standards, and achieve a significant reduction in production costs. This was successfully completed at the end of July 2022, enabling the achievement of ISO:13485 accreditation. The manufacturing facility is already demonstrating the required product quality to build a significant customer base and repeat orders, underpinning the building of a strong brand reputation for our best-in-class technology.

Following this transition and having achieved ISO13485 accreditation, we are confident in having both the quality of manufacturing facilities and the inventory levels to increase production significantly, as we expand our sales channels and are able to apply to distribute products internationally. In December 2022 we produced 536 units in our in-house facility and with Innomax having started production in Q2 2023 this will more than double production of X-PLOR. Even with the rapid increase in volumes, the production quality of our in-house facility has been outstanding, with no units returned due to defects.

Launched the next generation X-PLOR

The next generation X-PLOR, launched in September 2022, has been well received by the market based upon its performance and reliability. It provides more oxygen by weight than any portable oxygen concentrator in its class and is the first POC with a mobile app that connects to phones, tablets, pulse oximeters and wearables (the NOMAD Biometric App). By 31 December 2022, the Company had shipped or received orders for 2,850 X-PLOR units, with 1,226 units being shipped in 2022, up three-fold compared with the previous year (2021: 377).

Building on strong foundations in 2023

Good momentum with X-PLOR, as we lay foundations for international expansion

The Company is pleased with the sales momentum of the latest generation X-PLOR portable oxygen concentrator released in April 2023, for which initial new standing purchase orders exceeding 1,000 units were secured.

Having begun its global expansion in December 2022 with sales of the X-PLOR in South Africa, Shenzhen Belluscura Technology Company Limited was registered in April 2023 in preparation for commercial launch of the X-PLOR in China later in 2023, once China National Medical Products Administration registration is received. The Company expects further global expansion from late 2023 and early 2024 once CE and UKCA marks are approved and anticipated regulatory clearances in Hong Kong, Europe, UK, Canada, Singapore and Australia are received.

The Company continues to evaluate several proposals with third parties interested in white labelling the X-PLOR product for the US market. Such agreements will require the Company to evaluate the set up and potential additional production costs with the anticipated increased sales volume.

Significant pre-launch demand for DISCOV-R™

In March 2023, the Company unveiled its new DISCOV-R portable oxygen concentrator at Medtrade in Dallas, Texas, and was awarded the Silver Award in the Best New Product category. This is a considerable achievement when taking account of the fact that most of the leading respiratory device companies were exhibiting at the show which is the largest home medical equipment ("HME") trade show and conference in the US.

The Company started it premarket evaluation of the DISCOV-R POC Q2 2023, with full commercialisation anticipated in H2 2023. DISCOV-R is the first ambulatory pulse-dose and two-litre continuous flow POC in the world. Weighing c.40% less than any comparable dual flow oxygen concentrator on the market, the DISCOV-R produces nearly three times the oxygen by weight than concentrators in its class. The DISCOV-R will also include the transformational NOMAD Biometric App.

The DISCOV-R has been met with significant pre-launch demand with over 125 durable medical equipment providers and internet retailers already requesting access to this innovative device. The Board believe that amounts to only 2%. of the durable equipment companies in the US. With two litres of continuous flow and eight levels of pulse dose delivery, the Company anticipates the product being covered by both Centres for Medicare & Medicaid Services ("CMS") codes E1390 and E1392, stationary and portable concentrator, respectively. The DISCOV-R being covered by both CMS codes would make the device significantly more profitable for Durable Medical Equipment providers.

We believe the significant technical advantages of the DISCOV-R over its competitors, combined with the anticipated dual CMS reimbursement codes, will result in the DISCOV-R accounting for 70 per cent of the Group's production volume and 80 to 85 per cent. of revenue by 2025. 

Preliminary estimated unit volume demand for production is now estimated to exceed 2,000 units per month and the profitability of a DISCOV-R device is anticipated to be approximately 250% higher than an X-PLOR.

To meet this demand, the Company has been focusing significant resources to bring the DISCOV-R™ to market as soon as possible and to increase production and manufacturing capacity in the US and China where the product will be manufactured.

Funds raised to enable the commercial launch of DISCOV-R

Since the beginning of 2023, the Company has raised net proceeds of £7.2m ($8.8m), through the issue of 10% Unsecured Convertible Loan Notes, via a Placing and Broker Option in January and February, to raise £4.3m ($5.1m) net of expenses, and an equity issue, via a Placing, a Subscription by certain Directors, and a Retail Offer in May, which raised £2.9m ($3.7m) net of expenses.

The net proceeds will be used for finalising the development of, complete the pre-market evaluation of and commercially launching the DISCOV-R; as well as for extending sales channels of the latest generation X-PLOR and general working capital requirements for the Group, thereby providing the Group with the funds to capitalise on its significant market opportunities.

Further strengthened the Board

As announced in May 2023, the Board has decided to reinforce the executive team with the addition of relevant skills and expertise in global sales, by the appointment, subject to satisfactory completion of the requisite due diligence and nominated adviser checks, of Robert Fary as Executive Director, who joined the Company as Senior Vice President of Global Sales in January.

Robert's deep knowledge of the portable oxygen concentrator sector and its channels to market will be invaluable in driving sales of both the DISCOV-R and X-PLOR globally. He has thirty-years of experience in the respiratory industry where he has held leadership roles at major oxygen concentrator manufacturers and durable medical equipment companies. During the past two decades, Robert's industry leading team was directly responsible for or contributed to the sale of over 1 million portable oxygen concentrators, generating revenues in excess of $1 billion. He has already had a successful impact on sales of the X-PLOR, having secured standing purchase orders exceeding 1,000 units for the next generation X-PLOR following its launch in April 2023. Robert also participated in the Subscription as part of the previously mentioned Placing.

Outlook

We continue to build the foundations for significant growth in the coming years.

Trading in the first half of 2023 is in line with our expectations for the full year, with a significant second half weighting expected, as previously stated. Demand for X-PLOR, which is predominantly a Direct to Consumer unit, is growing, and we expect that our affiliation with GoodRX, a leading digital healthcare platform that makes healthcare affordable and convenient for all Americans, and new internet retailers will help X-PLOR to continue to gain momentum over the coming months.

The full commercial launch of DISCOV-R will be transformational for the Group. Having received a positive reception at Medtrade, we are very encouraged by the fact that 125 distributors have requested access to DISCOV-R, with the distributors indicating potentially significant demand for units.

Following the recent fundraising, and as we are now utilising the Company's previously high inventory levels, the Company is well positioned to deliver substantial growth in the coming years. We look forward to the future with confidence.

Robert Rauker

Chief Executive Officer

29 June 2023

FINANCIAL REVIEW

Income statement

Revenue for the year to 31 December 2022 was $1.54m before discounts of $0.14m (2021: $0.42m). Revenue of $0.56m was generated in the first 3 months of the year before the Board took the decision to bring our US manufacturing in-house from our contract manufacturer. This decision was taken to improve the longer-term prospects for the Group through increased manufacturing capacity, reduced manufacturing costs and giving greater scalability and agility in manufacturing and product improvements. The transfer was successfully completed in just under three months. Revenue in the second half of the year was $0.98m following the launch of the 2nd generation X-PLOR device in October 2022. All revenue was generated in the US.

There was a small Product Gross Profit in the year of $68,105 (2021: Loss $52,171). With the Group trying to establish its products in the market, pricing was deliberately competitive to establish early B2B sales combined with cost of goods sold reflecting the initial volume higher input costs. Other operating income was $8,703 (2021: $209,690).

Administrative expenses were $8.07m, up 51% (2021: $5.34m). (See note 6.3 to the accounts) The increase of $2.73m was primarily due to:

· Amortisation & Inventory: Due to the rapid development of the next generation X-PLOR, launched in June this year, the Group felt it prudent to accelerate the amortisation of development costs associated with the first generation product, with a charge in the period of $2.91m (2021: $0.16m), along with a stock provision of $0.61m (2021: $nil) for obsolete raw material inventory and inventory adjustments.

· Staff, Marketing & Other Overheads: The Group continued to strengthen the team particularly in Engineering and Quality to manage in-house manufacturing and reduce external consultancy costs. $6.00m (2021: $4.22m).

· Royalties: Since the launch of X-PLOR in 2021, the Group's minimum royalty payments due are charged to the profit & loss account rather than capitalised in Product Development. $0.76m (2021: $0.15m).

· Realised and Unrealised foreign exchange movements: The US$ strengthened against £Sterling by 12% during the year (1 January 2022 - $1.35:£1.00; 31 December 2022 - $1.21:£1.00). Due to the size of the Intercompany Loan from the PLC to the US subsidiary which is fixed in £Sterling, this creates an accounting presentational impact between Administration Expenses: Gain $2.88m (2021: Gain $0.73m) and Other Comprehensive Income: Loss $3.77m (2021: Loss $1.15m), which to a large extent can be netted off against one another.

Operating Loss for the year was $8.13m (2021: $5.19m), Total Comprehensive Loss was $11.98m (2021: $6.37m).

Adjusted EBITDA Loss of $6.20m (2021: $4.18m) (See note 26 to the accounts). The Board considers that Adjusted EBITDA to be an important key performance indicator. It is a more accurate measure of underlying business performance as it removes the impact of non-cash accounting adjustments.

Loss per share

The basic and diluted loss per share was $0.068 (2021: $0.055).

Financial position

The Group net assets as at 31 December 2022 were $20.35m (2021: $24.67m). This comprised total assets of $23.60m (2021: $26.00m) and total liabilities of $3.25m (2021: $1.33m). The total assets included intangible assets (capitalised research and development costs), property, plant and equipment and right-of-use assets of $9.07m (2021: $7.05m). Net cash at 23 June 2023 following receipt of the placing proceeds was $4.2m.

Cashflow

At 31 December 2022 the Group had net cash of $2.04m (2021: $15.89m). During the year, net cash inflow from funds raised in the year was $7.47m (2021: $25.47m), net cash outflow from operating activities was $14.91m (2021: $7.33m).

Both the decision to bring our US manufacturing in-house from our contract manufacturer along with the initial support of the set-up of Innomax manufacturing in China, resulted in significant investment in Raw Material Inventory and Deposits which, at 31 December 2022, stood at $10.77m (2021: $ 1.78m).

2021 Restatement

In 2021 the Group's established an Employee Benefit Trust (EBT). The Company loaned the EBT funds for the purpose of buying shares with any shares held by the EBT to be distributed to employees exercising share options once vesting conditions are satisfied. The EBT has been consolidated at 31 December 2022 and 31 December 2021. The effect of the 2021 restatement consists of an increase in cash of $302,000 and a corresponding reduction in debtors.

Dividends

No dividend is recommended (2021: £nil) due to the early stage of the development of the Group.

Events after the reporting period

Events after the reporting period are detailed in Note 28 to the Accounts.

These events include fundraising of both convertible equity loan notes and equity.

Analysis of Financial and non-Financial Key Performance Indicators

The Board continues to monitor performance regularly throughout the year by reviewing a range of key performance indicators. These include revenue growth, progress towards operational break even, expenditure (both current and investment) control against budget and cash used and remaining.

The Directors expect further improvement in performance in future periods as it achieves success in the Group's strategy to launch its products and grow through continual investment.

Change of auditors

As announced on 30 March 2023, Gerald Edelman LLP, were appointed as auditor to the Company with immediate effect, replacing Gravita Audit Limited.

Gravita Audit Limited, which was recently formed by the combination of Jeffreys Henry LLP, Arram Berlyn Gardner LLP and Propel, notified the Company that, following a recent review in conjunction with the Institute of Chartered Accountants in England and Wales (the "ICAEW"), it did not have sufficient capacity to satisfy its regulatory requirements in respect of its engagement with the Company and was, therefore, required to resign as auditor with effect from 29 March 2023.

Gravita Audit Limited confirmed that there were no circumstances connected with their resignation which they consider should be brought to the attention of the Company's members or creditors in accordance with Section 519 of the Companies Act 2006.

Principal Risks and Uncertainties

The Group actively considers and manages its risks. The Directors consider the following areas of business and operational risk and details how this risk is managed or mitigated:

· Generating revenue. The Group's primary source of revenue is from sales of its X-PLOR product. Management performs regular reviews of the sector to ensure it is targeting large markets.

· Successful product development. The Group received FDA 510(k) clearance for X-PLOR on 2 March 2021. The Group's follow-on products are in advanced development and are based upon shared technology with X-PLOR. The Board regularly monitors the carrying value of capitalised product development in the light of plans for future revenue and margin.

· Credit risk. The Group's principal financial assets are cash, and trade and other receivables. The Group monitors receivables and should any be the subject of an identified loss event, allowance is made for impairment if required. At the end of the period the Group had four customers. The credit risk on liquid funds is limited because the counterparties are banks with high credit-ratings assigned by international credit-rating agencies. Further, apart from intercompany consolidated transactions the Group has no current debt outstanding (excluding leases capitalised under IFRS16).

· Liquidity risk. To support expansion plans for future development, the Group regularly reviews its financing arrangements and cash flows to ensure there is sufficient funding in place.

· Foreign exchange risk. As the Group holds Sterling cash deposits and reports its financial performance in US Dollars, this exposes the Group to a potential unrealised currency risk on its Sterling bank balances. This relates to the raising of capital in the United Kingdom. The Directors review this exposure on a regular basis.

Contingent Liabilities

On 24 February 2017, the Company entered into a co-exclusive licence and development agreement with Separation Design Group, LLC and SDG (together the "SDG Parties") ("SDG Licence") which was subsequently amended by an amendment agreement dated 19 March 2022. Pursuant to the SDG Licence: if by 3 September 2025, cumulative sales of the X-PLOR and DISCOV-R have not exceeded $20 million dollars, Belluscura must make a one-time payment of $3 million to the SDG Parties to maintain the exclusive SDG licence. By 31 December 2022 cumulative sales of X-PLOR were $1.8 million. No provision has been made in these Financial Statements. 

Companies Act S.172

The Directors acknowledge their duty under s.172 of the Companies Act 2006 and consider that they have, both individually and together, acted in the way that, in good faith, would be most likely to promote the success of the Company for the benefit of its members as a whole. In doing so, they have had regard (amongst other matters) to:

· the likely consequences of any decision in the long term. The Group's long-term strategic objectives, including progress made during the year and principal risks to these objectives, are shown in the Chairman Statement, Chief Executive's Review and Financial Review.

· the interests of the Company's employees. Our employees are fundamental to us achieving our long-term strategic objectives. We aim to be a responsible employer in our approach to the pay and benefits our employees receive. Further details can be found in the Remuneration Report.

· the impact of the Company's operations on the community and the environment. The Group operates honestly and transparently. We consider the impact on the environment, the people who work for us and the wider community and how we can minimise this.

· the desirability of the Company maintaining a reputation for high standards of business conduct. Our intention is to behave in a responsible manner, operating a high standard of business conduct and good corporate governance.

· the need to act fairly as between members of the Company. Our intention is to behave responsibly towards our shareholders and treat them fairly and equally so that they may benefit from the successful delivery of our strategic objectives.

COVID-19 and Russia/Ukraine

The Board have reviewed and assessed the impact of the COVID-19 pandemic on the Group. Whilst we face similar challenges to other businesses caused by COVID-19 disruption, we believe that we are in a strong position to progress, and the pandemic actually created a larger market for our products.

The Board have reviewed and assessed the impact of the current Russia/Ukraine conflict on the Group. The Group believe that based upon our current structure and plans that there will be minimal impact on the Group.

Tony DyerChief Financial Officer

29 June 2023

CONSOLIDATED STATEMENT OF PROFIT & LOSS AND OTHER COMPREHENSIVE INCOME

For the year ended 31 December 2022

Items in the statement above are disclosed net of tax.

The notes on pages 16 to 38 are an integral part of these consolidated financial statements.

Adjusted EBITDA1

1 Reconciliation to Adjusted EBITDA measure

Adjusted EBITDA is the Group's key adjusted profit measure. Total comprehensive loss for the year is adjusted to exclude; Foreign exchange translation differences along with unrealised and unrealised foreign exchange movements, depreciation and amortisation of product development, costs relating to fundraising activities, surrendered share options and share option taxes, minimum royalties in excess of sales royalties, share based payments, obsolete 1st generation X-PLOR inventory adjustments and contract manufacturer capacity costs.

2 Net foreign exchange movements

The US$ strengthened against £Sterling by 12% during the year (1 January 2022 - $1.35:£1.00; 31 December 2022 - $1.21:£1.00). Due to the size of the Intercompany Loan from the PLC to the US subsidiary which is fixed in £Sterling, this creates an accounting presentational impact between Administration Expenses and Other Comprehensive Income, which to a large extent can be netted off against one another.

· Realised FX movements in administrative expenses arise from the revaluation of £Sterling cash balances into US$

· Unrealised FX movements in administrative expenses arise from the revaluation of the Intercompany Loan fixed in £Sterling into US$

· Foreign currency translation differences in Other Comprehensive Income arise from the revaluation of the PLC balance sheet into US$

CONSOLIDATED BALANCE SHEET

As at 31 December 2022

1 Results are restated to reflect the consolidation of the Employee Benefit Trust into the Group Accounts

The notes on pages 16 to 38 are an integral part of these financial statements.

The financial statements on pages 10 to 38 were authorised for issue by the Board of Directors on 29 June 2023 and were signed on its behalf.

Robert Rauker Tony Dyer

Chief Executive Officer Chief Financial Officer

Belluscura plc

registered number 09910883

COMPANY BALANCE SHEET

At 31 December 2022

The Parent Company's loss before tax for the period 31 December 2022 was $3,820,378 (2021: $3,668,779).

The Group has used the exemption under S408 CA 2006 not to disclose the company income statement.

The notes on pages 16 to 38 are an integral part of these financial statements.

The financial statements on pages 10 to 38 were authorised for issue by the Board of Directors on 29 June 2023.

Robert Rauker Tony Dyer

Chief Executive Officer Chief Financial Officer

Belluscura plc

registered number 09910883

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

For the year ended 31 December 2022

The notes on pages 16 to 38 are an integral part of these financial statements.

COMPANY STATEMENT OF CHANGES IN EQUITY

For the year ended 31 December 2022

The notes on pages 16 to 38 are an integral part of these financial statements.

CONSOLIDATED STATEMENT OF CASH FLOWS

For the year ended 31 December 2022

1 Results are restated to reflect the consolidation of the Employee Benefit Trust into the Group Accounts

The notes on pages 16 to 38 are an integral part of these financial statements.

NOTES TO THE ACCOUNTS

For the year ended 31 December 2022

1. General Information

Belluscura plc is a public company limited by shares incorporated in England and Wales and domiciled in the UK. Company Registration No. 09910883. On 28 November 2017 the Company changed its name from Belluscura Limited to Belluscura plc.

The principal accounting policies applied in the preparation of these consolidated financial statements are set out below. These policies have been consistently applied, unless otherwise stated.

2. Accounting Policies

2.1 Statement of compliance

The Group financial statements consolidate those of the Company and its subsidiaries (together referred to as the "Group"). The parent company financial statements present information about the Company as a separate entity and not about its Group.

These consolidated financial statements are prepared in accordance with United Kingdom adopted International Financial Reporting Standards (IFRS) and issued by the International Accounting Standards Board (IASB). The consolidated financial statements are presented in US Dollars, the Group's functional currency.

The financial statements for the Company have been prepared in accordance with Financial Reporting Standard 101 by applying the recognition and measurement requirements of United Kingdom adopted International Financial Reporting Standards ("IFRS"), amended where necessary in order to comply with Companies Act 2006. The Company has notified shareholders of this disclosure.

Critical accounting estimates and judgements made by the directors, in the application of these accounting policies that have significant effect on the financial statements are disclosed in note 4 (a)-(c) applicable for the whole Group and 4 (d) applicable for the Company only.

In these financial statements, the Company has applied the exemptions available under FRS 101 in respect of the following disclosures:

· a Cash Flow Statement and related notes;

· Disclosures in respect of transactions with wholly owned subsidiaries;

· Disclosures in respect of capital management; 

· The effects of new but not yet effective IFRSs;

· Disclosures in respect of the compensation of Key Management Personnel; and

· Related party transactions with wholly owned members of the Group

As the consolidated financial statements include the equivalent disclosures, the Company has also taken the exemptions under FRS 101 available in respect of the following disclosures

· Certain disclosures required by IFRS 13 Fair Value Measurement and the disclosures required by IFRS 7 Financial Instrument Disclosures.

· IFRS 2 Share Based Payments in respect of group settled share based payments

The accounting policies set out below have, unless otherwise stated, been applied consistently to all periods presented in these financial statements

2.1.1 Going concern

Commercial Background

US FDA 510(k) clearance of the Group's X-PLOR was received on 2 March 2021. The Group launched X-PLOR in the US in September 2021, the next generation X-PLOR in October 2022 and released the DISCOV-R for Pre-Market Evaluation in June 2023.

In March 2022, we signed a manufacturing Master Supply Agreement ("MSA") with InnoMax Medical Technology, Ltd ("InnoMax") to manufacture the X-PLOR portable POC in China alongside US manufacturing. Innomax is anticipated to directly source most of their own components from the second half of 2023, which will also result in a significant margin improvement and reduction in the Company's inventory levels.

In April 2022, the Group took the decision to transfer its US manufacturing in-house, to increase production output at high quality standards, and achieve a significant reduction in production costs. This was successfully completed at the end of July 2022.

The decision to bring our US manufacturing in-house from our contract manufacturer along with the initial support of the set-up of Innomax manufacturing in China, resulted in significant investment in Raw Material Inventory and Deposits which, at 31 December 2022, stood at $10.77m (2021: $1.78m). Cash was $2.04m.

Fundraising

The Group raised $22.5m after expenses in its IPO on the AIM market of the London Stock Exchange on 28 May 2021 and $7.1m after expenses from investors in May 2022 to support the inventory requirements of the new manufacturing agreement. Since 31 December 2022, $5.1m after expenses was raised through the placing of Loan Notes in February 2023, and $3.7m after expenses through an equity placing in June 2023.

At 20 June 2023, the Group held approximately $9.6 in Raw Material Inventory, Inventory deposits and Finished Goods. Cash was $4.2, including the $3.7m raised in June 2023, as referred to below.

Prospects and Forecasts

The launch in Summer 2023 of the award winning DISCOV-R product will be transformational for the Group. We already have over 125 Distributors requesting access to the DISCOV-R, and we expect demand to be significant. The majority of the development and capital costs for DISCOV-R have already been incurred. 

The Group's forecasts, including the expected significant demand for the DISCOV-R, alongside the release of working capital through the sale of goods from its existing inventory, indicate that the Group has sufficient cash reserves to operate within the level of its current facilities for a period of 12 months from the date of approval of the financial statements.

The Group's forecasts, taking account of reasonably possible downsides in trading performance and development costs/timelines, and the risks to these projections (set out in the Principal Risks and Uncertainties section of the Group Strategic Report on Page 8) have been considered by the Board in its assessment of these forecasts.

Based on the above, the directors believe it remains appropriate to prepare the financial statements on a going concern basis.

2.1.2 Measurement convention

The financial statements are prepared on the historical cost basis except that assets and liabilities are stated at their fair value.

2.1.3 Changes in accounting policy

In these financial statements, where the Group has adopted new or updated standards, there is not a material impact on the financial information and on the Company's future financial statements.

2.2 Basis of Consolidation

Belluscura plc was incorporated on 10 December 2015. On 16 May 2016, a US incorporated company, Belluscura LLC, was formed as a 100% owned subsidiary. Subsidiaries are entities controlled by the Group.

The Group controls an entity when it is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. In assessing control, the Group takes into consideration potential voting rights. The acquisition date is the date on which control is transferred to the acquirer. The financial statements of subsidiaries are included in the consolidated financial statements from the date that control commences until the date that control ceases. Losses applicable to the non-controlling interests in a subsidiary are allocated to the non-controlling interests even if doing so causes the non-controlling interests to have a deficit balance.

Intra-group balances and transactions, and any unrealised income and expenses arising from intra-group transactions, are eliminated. Unrealised losses are eliminated in the same way as unrealised gains, but only to the extent that there is no evidence of impairment.

IFRS 13 did not affect any fair value measurements of the Group's assets or liabilities and therefore had no effect on the Group's financial position or performance.

2.3 Foreign currencies

(a) Functional and presentation currency

These consolidated financial statements are presented in US Dollars which is the presentation currency of the Group, because the majority of the Group's transactions are undertaken in US Dollars. Each entity within the Group has its own functional currency which is dependent on the primary economic environment in which that subsidiary operates.

(b) Transactions and balances

Foreign currency transactions are translated into functional currency using the exchange rates prevailing at the dates of the transactions or valuation where items are re-measured. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at the year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in the income statement. Foreign exchange gains and losses that relate to borrowings and cash and cash equivalents are presented in the income statement within 'finance income or costs'.

(c) Group companies

The results and financial position of all Group entities (none of which has the currency of a hyper-inflationary economy) that have a functional currency different from the presentation currency are translated into the presentation currency as follows:

(i) assets and liabilities for each balance sheet presented are translated at the closing exchange rates at the date of that balance sheet

(ii) income and expense for each income statement are translated at the average rates of exchange during the year (unless this average is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the rate on the dates of the transactions)

(iii) all resulting exchange differences are recognised in other comprehensive income.

2.4 Business combinations

All business combinations are accounted for by applying the acquisition method. Business combinations are accounted for using the acquisition method as at the acquisition date, which is the date on which control is transferred to the Group.

For acquisitions on or after 1 January 2010, the Group measures goodwill at the acquisition date as:

· the fair value of the consideration transferred; plus

· the recognised amount of any non-controlling interests in the acquiree; plus

· the fair value of the existing equity interest in the acquiree; less

· the net recognised amount (generally fair value) of the identifiable assets acquired and liabilities assumed.

When the excess is negative, a bargain purchase gain is recognised immediately in profit or loss. Costs related to the acquisition, other than those associated with the issue of debt or equity securities, are expensed as incurred.

Any contingent consideration payable is recognised at fair value at the acquisition date. If the contingent consideration is classified as equity, it is not remeasured and settlement is accounted for within equity. Otherwise, subsequent changes to the fair value of the contingent consideration are recognised in profit or loss.

On a transaction-by-transaction basis, the Group elects to measure non-controlling interests, which have both present ownership interests and are entitled to a proportionate share of net assets of the acquiree in the event of liquidation, either at its fair value or at its proportionate interest in the recognised amount of the identifiable net assets of the acquiree at the acquisition date. All other non-controlling interests are measured at their fair value at the acquisition date.

2.5 Employee benefits

Short-term employee benefit obligations are measured on an undiscounted basis and are expensed as the related service is provided. A liability is recognised for the amount expected to be paid under short-term cash bonus or profit-sharing plans if the Group has a present legal or constructive obligation to pay this amount as a result of past service provided by the employee and the obligation can be estimated reliably.

Share-based payment transactions

Share-based payment arrangements in which the Group receives goods or services as consideration for its own equity instruments are accounted for as equity-settled share-based payment transactions.

The grant date fair value of share-based payment awards granted to employees is recognised as an employee expense, with a corresponding increase in equity, over the period that the employees become unconditionally entitled to the awards. The fair value of the options granted is measured using an option valuation model, taking into account the terms and conditions upon which the options were granted. 

The amount recognised as an expense is adjusted to reflect the actual number of awards for which the related service and non-market vesting conditions are expected to be met, such that the amount ultimately recognised as an expense is based on the number of awards that do meet the related service and non-market performance conditions at the vesting date.

For share-based payment awards with non-vesting conditions, the grant date fair value of the share-based payment is measured to reflect such conditions and there is no true-up for differences between expected and actual outcomes.

2.6 Interest income and expenses

Interest income and interest payable is recognised in profit or loss as it accrues, using the effective interest method.

2.7 Property, plant and equipment

Property, plant and equipment are stated at historical cost less depreciation and accumulated impairment losses. Historical cost includes expenditure that is directly attributable to the acquisition of the items.

Subsequent costs are included in the asset's carrying amount or recognised as a separate asset, as appropriate, only when it is probable that future economic benefits associated with the item will flow to the Group and the cost of the item can be measured reliably. All other repairs and maintenance are charged to the income statement during the financial period in which they are incurred.

Depreciation of assets is calculated is provided to write off the cost less the estimated residual value of tangible fixed assets by equal instalments over the estimated useful economic lives as follows: Furniture - 5 years; Computer equipment - 3 years; Leasehold improvements - 5 years.

The assets' residual values and useful lives are reviewed, and adjusted if appropriate, at the end of each reporting period. An asset's carrying amount is written down immediately to its recoverable amount if the assets carrying value is greater than its estimated recoverable amount.

Gains and losses on disposals are determined by comparing proceeds with the carrying amount and are recognised within administrative expenses in the income statement. When re-valued assets are sold, the amounts are included in other reserves are transferred to retained earnings.

2.8 Intangible assets

Licences and development costs

Costs associated with the acquisition of Licences for technologies and distribution rights are recognised as an intangible asset when they meet the criteria for capitalisation. That is, they are separately identifiable, measurable and it is probable that economic benefit will flow to the entity.

Further development costs attributable to the licenced technology and recognised as an intangible asset when the following criteria are met:

(i) it is technically feasible to complete the technology for commercialisation so it will be available for use;

(ii) management intends to complete the technology and use or sell it;

(iii) there is an ability to use or sell the technology;

(iv) it can be demonstrated how the technology will generate probable future economic benefits;

(v) adequate technical, financial and other resources to complete the development and to use or sell the technology are available; and

(vi) the expenditure attributable to the technology during its development can be reliable measured.

Licences and their associated development costs are amortised over the life of the licence or the underlying patents, whichever is shorter. The estimated useful life of the licences and development costs is 10-15 years.

Development costs are amortised from the date products are launched, taking into account the Directors opinion as to the expected further development of the technology and is regularly reassessed.

2.9 Impairment of non-financial assets

The carrying amounts of the non-financial assets, other than inventories and deferred tax assets, are reviewed at each reporting date to determine whether there is any indication of impairment. If any such indication exists, then the asset's recoverable amount is estimated. For goodwill, and intangible assets that have indefinite useful lives or that are not yet available for use, the recoverable amount is estimated each year at the same time.

The recoverable amount of an asset or cash-generating unit is the greater of its value in use and its fair value less costs to sell. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset. For the purpose of impairment testing, assets that cannot be tested individually are grouped together into the smallest group of assets that generates cash inflows from continuing use that are largely independent of the cash inflows of other assets or groups of assets (the "cash-generating unit").

An impairment loss is recognised if the carrying amount of an asset or its CGU exceeds its estimated recoverable amount. Impairment losses are recognised in profit or loss. Impairment losses recognised in respect of CGUs are allocated first to reduce the carrying amount of any goodwill allocated to the units, and then to reduce the carrying amounts of the other assets in the unit (group of units) on a pro rata basis.

An impairment loss in respect of goodwill is not reversed. In respect of other assets, impairment losses recognised in prior periods are assessed at each reporting date for any indications that the loss has decreased or no longer exists. An impairment loss is reversed if there has been a change in the estimates used to determine the recoverable amount. An impairment loss is reversed only to the extent that the asset's carrying amount does not exceed the carrying amount that would have been determined, net of depreciation or amortisation, if no impairment loss had been recognised.

2.10 Financial assets

2.10.1 Classification

The Group classifies its financial assets depending on the purpose for which the asset was acquired. Management determines the classification of its financial assets at initial recognition. During the financial period the Group held loans and receivables that are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are included in current assets, except for maturities that are greater than 12 months after the end of the reporting year. These are classified as noncurrent assets. The Group's loans and receivables comprise 'trade and other receivables' in the balance sheet. The Group also has cash and cash equivalents.

2.10.2 Recognition and measurement

Loans and receivables are recognised on the trade date in which the transaction took place, and are recognised at their fair value with transaction costs expensed in the income statement. Financial assets are derecognised when the rights to receive cash flows from the loans or receivables have been collected, expired or transferred and the Group has subsequently transferred substantially all risks and rewards of ownership.

2.11 Offsetting financial instruments

Financial assets and liabilities are offset and the net amount reported in the balance sheet when there is a legally enforceable right to offset the recognised amounts and there is the intention to settle on a net basis or realise the asset and settle the liability simultaneously.

2.12 Impairment of financial assets

Assets carried at amortised cost

A financial asset not carried at fair value through profit or loss is assessed at each reporting date to determine whether there is objective evidence that it is impaired. A financial asset is impaired if objective evidence indicates that a loss event has occurred after the initial recognition of the asset, and that the loss event had a negative effect on the estimated future cash flows of that asset that can be estimated reliably.

An impairment loss in respect of a financial asset measured at amortised cost is calculated as the difference between its carrying amount and the present value of the estimated future cash flows discounted at the asset's original effective interest rate. Interest on the impaired asset continues to be recognised through the unwinding of the discount. When a subsequent event causes the amount of impairment loss to decrease, the decrease in impairment loss is reversed through profit or loss.

Evidence of impairment may include indications of that the debtors or a group of debtors is experiencing significant financial difficulty, default or delinquency in interest or principal payments, the probability that they will enter bankruptcy or other financial reorganisation, and where observable data indicate that there is a measurable decrease in the estimated future cash flows, such as changes in arrears or economic conditions that correlate with defaults.

For loans and receivables category, the amount of the loss is measured as the difference between the assets carrying amount and the present value of estimated future cash flows (excluding future credit losses that have not been incurred) discounted at the financial asset's original effective interest rate. The carrying amount of the asset is reduced and the amount of the loss is recognised in the consolidated income statement. If a loan or held-to maturity investment has a variable interest rate, the discount rate for measuring any impairment loss is the current effective interest rate determined under the contract. As a practical expedient, the Group may measure impairment on the basis of an instrument's fair value using an observable market price.

If, in a subsequent year, the amount of the impairment loss decreases and the decrease can be related objectively to an event occurring after the impairment was recognised (such as the improvement in the debtor's credit rating), the reversal of the previously recognised impairment loss is recognised in the consolidated income statement.

2.13 Leases

At the inception of a contract, the Group assesses whether a contract is, or contains, a lease. A contract is, or contains, a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration.

As a lessee

The Group recognises a right-of-use asset and a lease liability at the lease commencement date. The right-of-use asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for any lease payments made at or before the commencement date, plus any initial direct costs incurred, less any lease incentives received.

The right-of-use asset is subsequently depreciated using the straight-line method from the commencement date to the end of the lease term, unless the lease transfers ownership of the underlying asset to the Group by the end of the lease term or the cost of the right-of-use asset reflects that the Group will exercise a purchase option. In that case the right-of-use asset will be depreciated over the useful life of the underlying asset, which is determined on the same basis as those of property and equipment. In addition, the right-of-use asset is periodically reduced by impairment losses, if any, and adjusted for certain remeasurements of the lease liability.

The lease liability is initially measured at the present value of the lease payments that are not paid at the commencement date, discounted using the interest rate implicit in the lease or, if that rate cannot be readily determined, the Group's incremental borrowing rate.

Lease payments included in the measurement of the lease liability comprise the following:

- fixed payments, including in-substance fixed payments;

- variable lease payments that depend on an index or a rate, initially measured using the index or rate as at the commencement date

- amounts expected to be payable under a residual value guarantee; and

- the exercise price under a purchase option that the Group is reasonably certain to exercise,

- lease payments in an optional renewal period if the Group is reasonably certain to exercise an extension option, and

- penalties for early termination of a lease unless the Group is reasonably certain not to terminate early.

The lease liability is measured at amortised cost using the effective interest method. It is remeasured when there is a change in future lease payments arising from a change in an index or rate, there is a change in the Group's estimate of the amount expected to be payable under a residual value guarantee, if the Group changes its assessment of whether it will exercise a purchase, extension or termination option or if there is a revised in-substance fixed lease payment.

When the lease liability is remeasured in this way, a corresponding adjustment is made to the carrying amount of the right-of-use asset, to the extent that the right-of-use asset is reduced to nil, with any further adjustment required from the remeasurement being recorded in profit or loss.

The Group presents right-of-use assets that do not meet the definition of investment property in 'property, plant and equipment' and lease liabilities in 'loans and borrowings' in the statement of financial position.

Short-term leases and leases of low-value assets

The Group has elected not to recognise right-of-use assets and lease liabilities for lease of low-value assets (liabilities under $5,000 per annum) and short-term leases (less than 12 months). The Group recognises the lease payments associated with these leases as an expense on a straight-line basis over the lease term.

2.14 Inventory

Inventory comprises goods held for resale and are stated at the lower of cost or net realisable value. Cost is based on First In, First Out (FIFO) principle and includes all direct expenditure and other appropriate attributable costs incurred in bringing the inventory to its present location and condition.

2.15 Trade receivables

Trade receivables are amounts due from customers for the sale of goods in the ordinary course of business. Collection is normally expected within three months or less (in the normal operating cycle of the business) and is classified as current assets. In the rare circumstances that they exceed a period of greater than one year they are presented as non-current assets.

Trade receivables are recognised initially at fair value and subsequently measured at amortised cost using the effective interest method, less any provision for impairment.

2.16 Cash and cash equivalents

In the consolidated statement of cash flows, cash and cash equivalents includes cash in hand, deposits held at call with other banks, other short term highly liquid investments with maturities of three months or less and bank overdrafts.

2.17 Equity

Share capital and share premium

The share capital account has been established to represent the nominal value for all share issues. The share premium account has been established to represent the excess of proceeds over the nominal value for all share issues, including the excess of the exercise share price over the nominal value of the shares on the exercise of share options as and when they occur. Incremental costs directly attributable to the issue of new ordinary shares and new shares options are shown in equity as a deduction, net of tax, from the proceeds.

Capital contribution

Capital contributions are contributions made by the ultimate parent for which no consideration is given. 

Retained earnings

Retained earnings are the consolidated retained earnings and share based payments reserve for the Group or Company.

Translation reserve

The translation reserve is the accumulated reserves created by Foreign Exchange Differences on the consolidation of Group balances into the reporting currency of US$.

2.18 Trade payables

Trade payables are obligations to pay for goods and services that have been acquired in the ordinary course of business from suppliers. Accounts payable are classified as current liabilities if payment is due within one year or less (or in the normal operating cycle of business if longer). If not, they are presented as non-current liabilities.

Trade payables are recognised initially at fair value and subsequently measured at amortised cost using the effective interest rate method.

2.19 Current and deferred tax

The tax expense for the period comprises current and deferred tax. Tax is recognised in the consolidated income statement, except to the extent that it relates to items recognised in other comprehensive income or directly in equity. In this case, the tax is also recognised in other comprehensive income or directly in equity, respectively.

The current income tax charge is calculated on the basis of tax laws enacted or substantively enacted at the balance sheet date in the countries where the Company and its subsidiaries operate and generate taxable income. Management periodically evaluates positions taken in tax returns with respect to situations in which applicable tax regulation is subject to interpretation and establishes provisions where appropriate on amounts expected to be paid to the tax authorities.

Deferred income tax is recognised on temporary timing differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. However, deferred tax liabilities are not recognised if they arise from the initial recognition of goodwill; deferred income tax is not accounted for if it arises from initial recognition of an asset or liability in a transaction other than a business combination that at the time of the transaction affects neither accounting nor taxable profit or loss.

Deferred income tax is determined using tax rates (and laws) that have been enacted or substantively enacted by the balance sheet date and are expected to apply when the related deferred income tax asset is realised or the deferred income tax liability is settled. Deferred income tax assets are recognised only to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilised.

Deferred income tax liabilities are provided on taxable temporary differences arising from investments in subsidiaries except for deferred income tax liability where the timing of the reversal of the temporary difference is controlled by the Group and probably will not reverse in the foreseeable future.

Deferred income tax assets are recognised on deductible temporary differences arising from investments in subsidiaries only to the extent that it is probable the temporary difference will reverse in full in the future and there is sufficient taxable profit available against which the temporary difference can be utilised.

Deferred income tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets against current tax liabilities and when the deferred income tax assets and liabilities relate to income taxes levied by the same taxation authority on either the same taxable entity or different taxable entities where there is an intention to settle balances on a net basis. 

2.20 Provisions

Provisions and any other anticipated foreseen liabilities are recognised: when the Group has a present legal or constructive obligation as a result of past events; it is probable that an outflow of resources will be required to settle the obligation; and the amount has been reliably estimated. Restructuring provisions comprise lease termination penalties, and employee termination payments. Provisions are not recognised for future operating losses.

Where there are a number of similar obligations, the likelihood that an outflow will be required in settlement is determined by considering a class of obligations as a whole. A provision is recognised even if the likelihood of an outflow with respect to any one item included in the same class of obligations may be small.

Provisions are measured at the present value of the expenditures expected to be required to settle the obligation using a pre-tax rate that reflects current market assessments of the time value of money and the risks specific to the obligation. The increase in the provision due to the passage of time is recognised as an interest expense.

2.21 Revenue recognition

Revenue is measured at the fair value of the consideration received or receivable, and represents amounts receivable for the goods supplied, stated net of discounts, and value added taxes. The Group recognises revenue when the amount of revenue can reliably be measured; when it is probable that future economic benefits will flow to the Group; and when specific criteria have been met for each of the Group's activities, described below. The Group bases its estimate of return on historical results taking into consideration type of customer, type of transaction and specifics of each arrangement.

Income is recognised on the sale of goods when the goods have been shipped to the customer.

Interest income is accrued on a time basis, by reference to the principal outstanding and at the effective interest rate applicable.

2.22 Government grants

Government grants are recognised at the fair value of the asset received or receivable when there is reasonable assurance that the grant conditions will be met and the grants will be received. A grant that specifies performance conditions is recognised in income when the performance conditions are met. Where a grant does not specify performance conditions it is recognised in income when the proceeds are received or receivable. A grant received before the recognition criteria are satisfied is recognised as a liability

3. Financial Risk Management

The Company's Directors review the financial risk of the Group. Due to the early stage of its operations the Group has not entered into any form of hedging instruments to assist in the management of risk during the period under review.

3.1 Financial risk factors

Liquidity Risk

Cash flow forecasting is performed on a Group basis. Directors monitor rolling forecasts of the Group's liquidity requirements to ensure it has sufficient cash to meet operational needs.

At the reporting date the Group held bank balances of US $1,790,836. The contractual maturities of financial liabilities are shown in note 17.

Market risk

Market risk is the risk that changes in market prices, such as foreign exchange rates, interest rates and equity prices will affect the Group's income or the value of its holdings of financial instruments.

Foreign exchange risk arises when individual Group entities enter into transactions denominated in a currency other than their functional currency. The Group's policy is, where possible, to allow Group entities to settle liabilities denominated in their functional currency, with the cash generated from their own operations in that currency. Where Group entities have liabilities denominated in a currency other than their functional currency (and have insufficient reserves of that currency to settle them), cash already denominated in that currency will, where possible, be transferred from elsewhere within the Group.

Due to low value and number of financial transactions that involve foreign currency and the fact that the Group has no borrowings to manage, the Directors have not entered into any arrangements, adopted or approved the use of derivative financial instruments to assist in the management of the exposure of these risks. The Group's exposure to foreign currency risk is based on the carrying amount for monetary financial instruments.

The gross foreign currency exposure below is with respect of pound Sterling to US Dollars.

The trade receivables shown above relates to the UK entity's intercompany balance with the US entity, which will be repaid in Sterling.

A 10% percent strengthening of the pound sterling against the US Dollar at 31 December 2022 would have increased (decreased) equity and profit or loss by the amounts shown below. This calculation assumes that the change occurred at the balance sheet date and had been applied to risk exposures existing at that date.

This analysis assumes that all other variables, in particular other exchange rates and interest rates, remain constant. The analysis is performed on the same basis for 31 December 2021.

A 10% percent weakening of the above currencies against the pound sterling at 31 December 2022 would have had the equal but opposite effect on the above currencies to the amounts shown above, on the basis that all other variables remain constant.

Translation exposures

The Group's results, as presented in US Dollars, are subject to fluctuations as a result of exchange rate movements. The Group does not hedge this translation exposure to its earnings.

Gains or losses arise on the retranslation of the net assets of foreign operations at different reporting dates and are recognised within the consolidated statement of comprehensive income. They will predominantly relate to the retranslation of opening net assets at closing foreign exchange rates, together with the retranslation of retained foreign profits for the year (that have been accounted for in the consolidated income statement at average rates) at closing rates. Exchange rates for major currencies are set out below

The following exchange rates have been used in the translation of the results of foreign operations:

3.2 Capital management

The Group's objectives when managing capital are to safeguard the Group's ability to continue as a going concern in order to provide returns for shareholders, benefits for other stakeholders and to maintain an optimal capital structure to reduce the cost of capital.

In order to adjust or maintain the capital structure, the Group may adjust the level of dividends paid to its shareholders, return capital to shareholders, issue new shares or sell assets to reduce borrowings. This policy is periodically reviewed by the Directors, and the Group's strategy remains unchanged for the foreseeable future.

The capital structure of the Group consists of cash and bank balances and equity consisting of issued share capital, reserves and retained earnings of the Group.

3.3 Fair value

Financial instruments are measured at fair value including cash and cash equivalents trade and other payables, and borrowings.

Due to their short-term nature, the carrying value of cash and cash equivalents, trade and other receivables, and trade and other payables approximate their fair value.

4. Critical accounting estimates and judgements

Estimates and judgements are continually evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances.

Key judgement

The following judgement (apart from those involving estimates) have had the most significant effect on amounts recognised in the financial statements. 

(a)  Intangible fixed assets (see note 13)

Intangible fixed assets, are depreciated over their useful lives taking into account residual values, where appropriate. The actual lives of the assets and residual values are assessed annually and may vary depending on the number of factors. In re-assessing asset lives, factors such as technological innovation, product life cycles and maintenance programmes are taken into account. Residual value assessments consider issues such as future market conditions, the remaining life of the asset and projected disposal values. Development costs attributable to the licenced technology and recognised as an intangible asset when the criteria in note 2.8 are met.

(b)  Impairment reviews

The Group undertakes an impairment review annually, or more frequently if events or changes in circumstances indicate that the carrying value may not be recoverable. In respect of impairment reviews, the key assumptions are as follows:

· Growth rates. The value in use of the intangible assets is calculated from cash flow projections for the relevant business activities based on the latest financial projections covering the anticipated useful economic life of the intangible assets.

· Discount rates. The pre-tax discount rate used to calculate value is determined in relation to the relevant business activities and their geographic location, using external benchmarks where possible to arrive at a relevant weighted average cost of capital.

(c)  Deferred taxes

Deferred tax liabilities are always provided for in full. Deferred tax assets are recognised to the extent that it is probable that the underlying deductible temporary differences will be able to be offset against future taxable income. Deferred tax assets and liabilities are calculated, without discounting, at tax rates that are expected to apply to their respective period of realisation, provided they are enacted or substantively enacted at the balance sheet date. Deferred tax is recognised as a component of the tax expense in the income statement, except where it relates to items charged or credited to other comprehensive income or directly to equity.

(d)  Recoverability of intercompany debt by the Company from its subsidiaries.

The directors assess the recoverability of amounts owed by the subsidiary to the parent company, which requires judgement to be made. This involves forecasting sales revenues to be earned by the subsidiary which will enable it to repay the parent company.

5. Segmental reporting

The chief operating decision makers consider that in the year to 31 December 2022 there is only one operating segment, being the sale of oxygen concentrators in the United States. The Group generated gross revenue of $1,542,948 less discounts of $144,866 in the year (2021: $420,316; nil). All sales were in the United States.

6. Other operating income and administrative expenses

6.1 Other operating income

6.2 Other direct costs

6.3 Expenses by nature 

As disclosed in the Admission Document, published ahead of admission to trading on AIM in May 2022, Robert Rauker agreed to surrender part of the options over 439,373 ordinary shares granted on 29 October 2019 and over 815,496 ordinary shares granted on 7 May 2021 in exchange for a cash payment. The consideration paid by the Company to Mr Rauker in relation to the surrender of the respective parts of Mr Rauker's options was calculated based on the difference between the Placing Price of 45p per share and the exercise price per Share payable by the Option Holder for the respective option multiplied by the number of Shares that are being surrendered. This amount is included within Employee Benefit Expense.

6.4 Auditor remuneration

During the period, the Group (including its subsidiaries) obtained the following services provided by the auditor and its associates:

7. Employees

7.1 Directors' emoluments

No Directors received share options during the year. On 10 August 2022 CEO, Robert Rauker exercised options over 690,395 ordinary shares at an average exercise price of 11.7 pence. The net 455,064 shares, after deduction of appropriate taxes, were subsequently transferred to Mr Rauker's ex-wife pursuant to a divorce settlement. On 7 December 2022 Robert Rauker exercised 179,537 Warrant Shares at an average price of 13.45 pence per share and Tony Dyer exercised 141,404 Warrant Shares at a price of 13.00 pence per share.

7.2 Employee benefit expense

7.3 Average number of people employed

8. Finance income and costs