Belluscura Regulatory News (BELL)

13 January 2023

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", the "Company" or the "Group")

Year-end trading update

LONDON, U.K. AND PLANO, TX, U.S. (13 January 2023). Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen concentrator ("POC") technology, provides a trading update for the year ended 31 December 2022.

The Group is pleased to announce that it has made considerable progress this year. Since the launch of the 1st generation X-PLOR in September 2021, the Group is now distributing throughout the US through multiple sales channels: Distributors and Durable Medical Equipment Providers both Online and Bricks and Mortar, Medical Supply Warehouses, Medical Device Intermediaries, Hospitals and Direct to Consumer.

In addition, the collaboration agreement with the VGM Group has already resulted in 17 new distribution agreements in the last 3 months, including the agreement with a leading durable medical equipment provider and distributor in the US, announced in September 2022, which serves nearly 2 million patients both online and through over 1,000 locations.

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. We have already received orders for over 1,000 units, with their first shipment sold out within 48 hours.

In December we produced a record 536 units in our in-house facility and with Innomax coming on-line in Q1 this will more than double production of X-PLOR. Of important note, even with the rapid increase in volume, the production quality of our in-house facility has been outstanding, with no units returned due to defects.

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 (2021: 377). As at the year end, the Adjusted EBITDA1 loss is anticipated to be in line with market expectations and retained cash balances of $1.8 million, which together with inventory and inventory deposits, amounted to $11.9 million. 

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).

The first DISCOV-RTM POCs expect to be launched for pre-market evaluation in Q1 2023, with full commercialisation anticipated in Q2. 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 3 times the oxygen by weight than its competition. Distributors are very excited about DISCOV-R and it is already receiving pre-orders. The DISCOV-R will also include the transformational NOMAD Biometric App.

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, 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 reduction in the Company's inventory levels.

Given the strong demand, 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 commensurate with market demand, as we expand our sales channels and are able to apply to distribute products internationally.

Robert Rauker, CEO of Belluscura plc, commented:

"During the year we have made considerable progress. We have enhanced our production, quality accreditation and supply chain, positioning us well to deliver on the demand we are seeing for our devices, as we expand our distribution partners and geographical reach. Market reception for the next generation X-PLOR and Nomad App has been extremely positive, with an encouraging level of forward orders.

"We are very excited about the upcoming launch of the DISCOV-R, which we believe will be a transformational product, and we look to the future with confidence."

1Adjusted EBITDA is earnings before interest, tax, depreciation, amortisation, share-based payment expense, foreign exchange movements and non-recurring items

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.