Unaudited Preliminary Results for the year ended 31 December 2021

Transformational year and positive outlook as the global demand for medical oxygen is forecast to grow from $3.14bn in 2021 to $5.64bn by 2027 representing a CAGR of 10.17%

LONDON, U.K. AND PLANO, TX, U.S. (22 February 2022). Belluscura plc (AIM:BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces its unaudited Preliminary Results for the year ended 31 December 2021, maiden full year results since Admission to AIM in May 2021. 

Financial Highlights:

• Group revenue of $0.4 million (2020: $nil)
• Adjusted loss from operations of $4.2 million (2020: $1.3 million)
• Basic loss per share of $0.06 (2020: $0.04)
• Net Cash as at 31 December 2021 of $15.6 million

Operational highlights:

• X-PLO₂R® received 510(k) Clearance from the Food and Drug Administration (“FDA”) on 2 March 2021.
• Admission to AIM on 28 May 2021.
• Oversubscribed equity fundraising of £17.5 million ($24.5 million) from new and existing investors.
• Sales of 377 units in the period to 31 December 2021 following the launch of X-PLOR in September 2021, 25% above current consensus forecasts and 150% above initial forecasts for 2021.

Outlook:

• Trading in the first six weeks of 2022 has continued to accelerate and the Group has:
  • increased the number of distributors to more than 10
  • combined sales and orders for more X-PLOR units than were sold in the prior year
• Production to be increased commensurate with market demand and manufacturing capabilities which are expected to grow significantly.
• The Group continues to satisfactorily progress regulatory clearances in territories outside the United States.
• Development of the next generation follow-on products, the X-PLOR CX and X-PLOR DX, continues to progress well with the expected launch of these products in Q2 2022 and Q3 2022 respectively.

Robert Rauker, Chief Executive Officer, Belluscura plc, commented:

“We are delighted with the progress we made in 2021, having successfully launched our first X-PLOR product into the growing supplemental oxygen market. Alongside this, we have continued to develop our follow-on products which will be launched in 2022. The Company has a strong balance sheet and is well positioned to deliver substantial growth in 2022.  We look forward to the future with confidence.”

For further information please contact:

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.

CHAIRMAN’S STATEMENT

I am pleased to report on the performance of Belluscura as my first year as Chairman after listing on AIM in May 2021. Belluscura is a business founded on the principle of making healthcare both more affordable and more available while returning a strong profit to our shareholders. In February 2017, the Group entered into a co-exclusive licence and development agreement with Separation Design Group IP Holdings LLC (“SDG”) to complete the development of the X-PLOR, a portable oxygen concentrator, used to deliver concentrated oxygen to a patient requiring oxygen therapy. Belluscura and SDG delivered a working prototype within five months of acquiring the X-PLOR licence. X-PLOR received 510(k) clearance from the Food and Drug Administration (“FDA”) on 2 March 2021. Our products are currently manufactured in the US and the Group is delighted to have commercially launched the X-PLOR in September 2021. The Group has also developed follow-on products which will target the same oxygen markets and continues to work on other oxygen enrichment technologies in complementary markets We believe that the X-PLOR range of products will provide significant growth for the Group. The global demand for medical oxygen continues to grow with an estimated 300m people suffering from Chronic Obstructive Pulmonary Disease (“COPD”) and the disease expecting to become the leading cause of death worldwide in 15 years. Additionally, even though the COVID-19 pandemic appears to be easing, recent studies reveal that nearly one in five people that contracted COVID-19 showed lung abnormalities, potentially resulting in a future need for supplemental oxygen¹. The Company looks forward with optimism and will be updating shareholders on a regular basis.

Adam Reynolds Non-Executive Chairman

¹ The unmet global burden of COPD – UCL Respiratory, University College London, London, UK – https://discovery.ucl.ac.uk/id/eprint/10052604/

CHIEF EXECUTIVE’S REVIEW

2021 has been a transformational year for Belluscura. On 2 March 2021 we received 510(k) clearance from the US FDA for the X-PLOR Portable Oxygen Concentrator. This underpinned our successful £17.5 million ($24.5 million) fundraise and IPO listing on AIM on 28 May 2021. Whilst we had many distributor enquiries, both in the US and internationally, in order to manage the launch and ensure we would have continuity of supply to our customers, we limited the number of initial distributor agreements. We signed our first distribution agreement in June 2021 and now have more than ten in place. Following a successful Pre-Market Evaluation, where the units were tested with 17 volunteer oxygen users, we launched the X-PLOR in early September and in the four months to 31 December 2021 we sold 377 X-PLOR units, significantly exceeding our initial forecasts. Our device is priced competitively for the B2B market and during 2022 we will expand into the B2C marketplace which allows the Company to retain higher gross margins. Recognising the current global supply chain challenges, the Company has significantly increased inventory levels of key components and other raw materials to pre-empt any potential disruption on production levels allowing them to be maintained in the current financial year and beyond. Inevitably, whilst these shortages remain, costs are higher, but as we increase volume and the shortages ease, we will start to benefit from economies of scale along with the potential benefits of reducing costs in 2023. The Group’s manufacturing capability has been scaled up significantly to ensure that the Company can continue to meet the increased demand from US distributors, with the Company continuing to broaden its sales network with both online and brick & mortar distributors. The Company also continues to move forward toward launching the product outside the US, having received multiple enquiries from distributors globally. We continue to strengthen the Belluscura team, increasing headcount from 9 at the time of IPO to 16 at the end of the year. We will continue to invest in our engineering and manufacturing capability along with sales and marketing to build out our B2B sales, B2C sales and the brand. We will also invest in our quality and compliance infrastructure that any fast-growing business requires. Forecasts of the supplementary oxygen market now expect it to grow from $3.14bn in 2021 to $5.64bn by 2027, representing a CAGR of 10.17%². The longer-term impact on oxygen requirements for recovering COVID-19 patients is yet unknown; however, there has been increased demand for oxygen related devices globally. In addition, supply chain disruption has caused a shortage of devices across the industry, which opens up opportunities for Belluscura.

Outlook

Trading in the beginning of 2022 has continued to accelerate. In the first six weeks of 2022 we increased the number of distributors to more than 10 and had combined sales and orders for more X-PLOR units than the total number of X-PLOR units we sold in 2021. We will increase production commensurate with market demand and manufacturing capabilities which we expect to grow significantly. The Group also continues to satisfactorily progress regulatory clearances in territories outside the US. Development of the follow-on products, the X-PLOR CX and X-PLOR DX, continues to progress well with the expected launch of these next generation products to be in Q2 2022 and Q3 2022 respectively. The Company has a strong balance sheet and is well positioned to deliver substantial growth in 2022.  We look forward to the future with confidence.

Robert Rauker
Chief Executive Officer

^{2 Medical Oxygen Concentrators & Oxygen Cylinders Market Research Report by Product, by Technology, by End-user, by Region – Global Forecast to 2027 – Cumulative Impact of COVID-19 (yahoo.com)}

FINANCIAL REVIEW

Income statement

Revenue for the year to 31 December 2021 was $420,316 (2020: $nil). This revenue was generated in the final four months of the year following the launch of the X-PLOR. All
revenue was generated in the US. There was a small Product Gross Loss in the year of $52,171 (2020: $nil). With X-PLOR being the Group’s first product to be launched, pricing was deliberately competitive to establish early B2B sales, with cost of goods sold reflecting the initial small volumes. Other income of $209,690 (2020: $11,493) was from COVID-19 related grants and forgiven loans. Operating Loss for the year was $5.19m (2020: $1.95m) and Total Comprehensive Loss was $6.37m (2020: $1.59m). Adjusted Operating Loss of $4.21m (2020: $1.30m) is calculated before IFRS2 Share Based Payment Charge and Surrendered Share Options (Note 6.2), Depreciation, Amortisation, Interest, Exchange Differences and IPO Costs. Note 15 Alternative Performance Measure reconciles the Total Comprehensive Loss to the Adjusted Operating Loss.

 Loss per share

The basic and diluted loss per share was $0.055 (2020: $0.036).

 Financial position

The Group net assets at 31 December 2021 were $24.67m (2020: $4.67m). This comprised total assets of $26.00m (2020: $5.24m) and total liabilities of $1.34m (2020: $0.57m). The total assets included intangible assets (capitalised research and development costs), property, plant and equipment and right-of-use assets of $7.05m (2020: $4.52m).

 Cashflow

The Group had net cash of $15.59m (2020: $0.52m) as at 31 December 2021. The net cash inflow of funds raised in the year was $25.51m (2020: $2.25m). During the period the net cash outflow from operating activities was $7.33m (2020: $$1.47m). The Group raised £17.5 million ($24.5 million) from investors in May when its shares were admitted to trading on AIM, before expenses of £1.4 million ($1.9 million); of which £0.5 million ($0.6 million) were charged to the Income Statement and £0.9 million ($1.3 million) were charged to the Share Premium Account. These funds are being applied in pursuing the Group’s strategic objectives.

 Dividends

No dividend is recommended (2020: £nil) due to the early stage of the development of the Group.

 Events after the reporting period

At the date of these Preliminary Results, there were no events after the reporting period.

Change of auditors

Subsequent to the Annual General Meeting at which shareholders approved the re-appointment of KPMG LLP as the Group’s independent auditor, and as requested by the Board, the Audit Committee considered the appointment of a new independent auditor for the year ending 31 December 2021. The Board accepted the Committee’s recommendation that Jeffreys Henry LLP be appointed as the Group’s independent auditor. The Board wishes to thank KPMG for their work as the Group’s independent auditor since 2017.

 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 license 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 2021. Pursuant to the SDG Licence: if by 3 September 2025, cumulative sales of the X-PLOR 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.

COVID-19

The Board have reviewed and assessed the impact of the COVID-19 pandemic on the Group. This did result in the FDA clearance process being elongated, however clearance was received on 2 March 2021. We face similar challenges to many businesses due to the disruption caused by COVID-19, however, we believe that we are in a strong position to progress.

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.

Tony Dyer Chief Financial Officer

CONSOLIDATED STATEMENT OF PROFIT AND LOSS AND OTHER COMPREHENSIVE INCOME

CONSOLIDATED BALANCE SHEET

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

CONSOLIDATED STATEMENT OF CASH FLOWS