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#TEK Capital investee company #BELL Belluscura PLC – Orders for over 6,500 DISCOV-R™ received
LONDON, U.K. AND PLANO, TX, U.S. (16 August 2023). Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces that it has received purchase orders for over 6,500 of its next-generation DISCOV-R portable oxygen concentrator. This represents approximately $15 million of potential revenue to the Company, with initial production of the DISCOV-R expected to begin by the end of this quarter.
Following the pre-market launch of DISCOV-R and a patient usability study in June 2023, the Company plans a controlled roll out of the DISCOV-R this autumn and into 2024 to meet growing demand for the device amid substantial interest from medical device distributors, retailers, patients and durable medical equipment (DME) providers, among others.
The DISCOV-R is expected to be the world’s first ambulatory two litre continuous flow, eight level pulse dose portable oxygen concentrator when it is released. With the ability to produce two litres of continuous flow and maximum single pulse dose volumes exceeding 110ml, the Company believes that the DISCOV-R will be covered by both CMS E1390 (stationary) and E1392 (portable) reimbursement codes, making the DISCOV-R a better financial option for the thousands of homecare oxygen providers. It will also produce nearly three times as much oxygen by weight than its dual flow competitors.
The recent purchase orders follow the signing of several distribution agreements with medical device distributors and other home healthcare providers, including a distribution agreement with a division of McKesson, one of the largest distributors of pharmaceuticals and medical devices in North America, earlier this month and a marketing agreement with GoodRx®, a leading digital healthcare platform, in February 2023. The Company has received multiple additional requests from leading oxygen homecare providers in the US to distribute the DISCOV-R.
The Company will update the market later this year as it plans its controlled roll out of the DISCOV-R this autumn and into 2024.
Substantial progress on X-PLOR® and proprietary NOMAD biometric app
At the same time, the Company continues to progress its CE and UKCA registration mark application for its X-PLOR® portable oxygen concentrator. Since resources in the US were redirected to completing the development and launch of the DISCOV-R, production of X-PLOR by our Chinese partner, Innomax Medical Technology Ltd (Innomax), has now progressed, with 1,500 units recently being manufactured and shipped to the US for distribution.
The Company recently established a subsidiary and hired its first employees in Shenzhen, China as it prepares for the anticipated registration of the X-PLOR for sale and distribution in China and Hong Kong later this year. The Company and Innomax believe there is a significant market opportunity in China with approximately 100 million people suffering from COPD.
Additionally, the Company continues to drive innovation in telemedicine and artificial intelligence with its proprietary NOMAD biometric app. The NOMAD app will allow users of the DISCOV-R to track performance data on their concentrator and connected devices such as an Apple® or Samsung® Watch, FitBit® device or Nonin® and Masimo® pulse oximeters. The collective information can then be provided to a patient’s healthcare provider in person or remotely.
The Company is already working on the next-generation NOMAD app that will alert patients when their blood oxygen saturation level has varied beyond parameters set by their doctor, which is expected to help patients better monitor their conditions, but also improve the efficiency of the device by delivering supplemental oxygen as needed.
Bob Fary. Sr Vice President of Global Sales, Belluscura plc, commented:
“We are very excited about the overwhelming interest in the DISCOV-R by online retail sellers and other medical equipment providers. Following the pre-market launch of the product and the patient usability study in June, initial feedback suggests we will receive the same or greater level of interest from leading home healthcare providers once it is launched commercially.”
Bob Rauker, Chief Executive Officer, Belluscura plc, commented:
“We believe the DISCOV-R, combined with our proprietary NOMAD app, will be transformational to the portable oxygen industry and patient outcomes. This is reflected by early demand for the product prior to its full commercial launch, which is expected to take place later this year. The significant number of orders received demonstrates the substantial appetite for this product and we anticipate adding several more of these providers to our distribution network as we balance the high demand with production expectations over the next twelve months.
“This marks another exciting development for the Company, delivering on our strategy to design and manufacture highly differentiated, high quality and high margin products. Amid growing sales and continued progress with our X-PLOR device and NOMAD app, we continue to seek further opportunities to improve the quality of life for our end users”.
For further information please contact:
Belluscura plc |
Tel: +44 (0)20 3128 8100 |
Adam Reynolds, Chairman |
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SPARK Advisory Partners Limited Nominated Adviser |
Tel: +44 (0)20 3368 3550 |
Neil Baldwin / Jade Bayat |
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Dowgate Capital Limited Broker |
Tel: +44 (0)20 3903 7715 |
James Serjeant / Russell Cook |
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MHP Financial PR & Investor Relations |
Tel: +44 (0)20 3128 8100 email: Belluscura@mhpgroup.com |
Katie Hunt/Matthew Taylor |
#TEK TekCapital PLC investee Co. #BELL Belluscura PLC – Belluscura begins manufacturing in China
LONDON, U.K. AND PLANO, TX, U.S. (3 April 2023). Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen concentrator (“POC”) technology, provides an update on recent progress.
Manufacturing in China
Belluscura has commenced manufacturing in China of its X-PLORTM portable oxygen concentrator.
This follows the manufacturing agreement announced in March 2022 with InnoMax Medical Technology, Ltd to manufacture the X-PLOR portable POC in China, enabling the Company to accelerate its international expansion by opening up markets in Asia and beyond. Regulatory approval and distribution within China are expected over the summer.
Strong growth is expected in the Asia Pacific market, with the medical oxygen concentrator industry expected to reach $1 bn by 20271 and nearly 100 million people in China with chronic obstructive pulmonary disease (“COPD”)2.
Medtrade Award
Belluscura is proud to announce that having debuted the DISCOV-R™ portable oxygen concentrator at Medtrade between the 29-30 March this year, it was awarded the Silver Award in the Best New Product category.
Held since 1979, Medtrade is the largest home medical equipment (“HME”) trade show and conference in the US, with hundreds of HME manufacturers exhibiting and thousands of HME providers attending the conference each year for the largest annual sourcing opportunity for home medical equipment.
The DISCOV-R, which is scheduled to launch in the US this summer, was described by numerous attendees as ‘transformational’ to the supplemental oxygen industry, given its amazing weight of only c.6.5 lbs, ability to produce 2,000ml of pulse and continuous flow oxygen, and its Nomad BiometricTM App that can connect via Bluetooth® to smartphones, wearable fitness devices and other monitors.
The U.S. home medical equipment market generated $12.07 billion in 2021 and is estimated to reach $19.89 billion by 2031, witnessing a CAGR of 5.1% from 2022 to 2031, according to research from Allied Market Research published in February 20233.
Continued progress across the business
Orders of the X-PLOR portable concentrator continue to grow, as new distributors are brought on board, and are in line with company expectations.
We continue to move forward with the CE and UK CA mark registration processes, with a number of approvals anticipated later this year.
Robert Rauker, Chief Executive Officer, Belluscura plc, commented:
“We continue to make good progress, with manufacturing in China commencing, increased orders for X-PLOR and the tremendous reception of DISCOV-R by the industry at Medtrade.”
1 Source: Coherent Market Insights – https://www.coherentmarketinsights.com/market-insight/oxygen-concentrators-market-198
2 Source: ScienceDaily – https://www.sciencedaily.com/releases/2018/04/180409185331.htm
3 Source: Allied Market Research – https://www.alliedmarketresearch.com/us-home-medical-equipment-market-A11059
For further information, please contact:
Belluscura plc
www.belluscura.com
Robert Rauker, Chief Executive Officer
via MHP
Anthony Dyer, Chief Financial Officer
SPARK Advisory Partners Limited (NOMAD)
Tel: +44 (0)20 3368 3550
Neil Baldwin
Dowgate Capital Limited (Broker)
Tel: +44 (0)20 3903 7715
James Serjeant / Nicholas Chambers
MHP (Financial PR and Investor Relations)
Tel: +44 (0)20 3128 8100
Katie Hunt / Pete Lambie / Matthew Taylor
Email: belluscura@mhpgroup.com
#TEK Tek Capital PLC investee co #BELL Belluscura PLC – Placing of Unsecured Convertible Loan Notes
Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, today announces that it has raised approximately $5.0 million (£4.1 million) through the conditional issue of a 10% Unsecured Convertible Loan Notes 2026 (the “Placing Loan Notes”) (the “Placing”).
Dowgate Capital Limited (“Dowgate”) is acting as sole placing agent, bookrunner and broker in connection with the Placing a nd SPARK Advisory Partners Limited (“SPARK”) is acting as the Company’s nominated adviser.
Background to the Placing
The Company announced on 13 January 2023 that it has made considerable progress in the past year. In March 2022, the Company signed a manufacturing Master Supply Agreement (“MSA”) with InnoMax Medical Technology, Ltd (“InnoMax”) to manufacture the X-PLOR portable POC in China and 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, simultaneously achieving ISO:13485 accreditation, which allows the Company to apply for international registrations.
The Company launched the next generation X-PLOR in September 2022, which has been well received by the market based upon its performance and reliability and is now distributing throughout the US through multiple sales channels. In addition, the collaboration agreement with the VGM Group has resulted in 17 new distribution agreements in the last three months, and in December 2022 the Company signed its first international distribution agreement with MedHealth Supplies of South Africa, with the first shipment selling out within 48 hours.
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). The Company stated that at the year-end it had retained cash balances of $1.8 million, which together with inventory and inventory deposits, amounted to $11.9 million.
The Company is pleased with the sales momentum of X-PLOR, aided by the InnoMax agreement in China, and the successful change of strategy to in-house manufacture which has resulted in improved quality controls. The expanded global operation and in-house manufacturing capability has led to a growth in inventory levels and therefore requires additional cash resources to finance raw materials. These inventory levels will see a significant downward trend over the next 12 months as the InnoMax operation comes fully on stream.
Further, in order for the Company to deliver on a successful launch of the DISCOV-R product, which is expected to be launched for pre-market evaluation in Q1 2023, with full commercialisation anticipated in Q2, the Board is seeking to raise a minimum of $5.0 million through the Placing Loan Notes. The Company has also issued a Broker Option to enable Dowgate to arrange the placing of further loan notes to raise up to an additional approximately $5.0m (the “Broker Option Loan Notes”), together with the Placing Loan Notes (the “Loan Notes”).
Placing of Loan Notes
Dowgate has conditionally placed $5.0 million (£4.1 million) of the Placing Loan Notes with a select group of investors, including certain existing Belluscura shareholders (“Shareholders”).
Pursuant to a placing agreement between the Company, SPARK and Dowgate dated 27 January 2023 (the “Placing Agreement”), Dowgate has conditionally agreed to use its reasonable endeavours to place $5.0 million (£4.1 million) of the Placing Loan Notes. The Placing is conditional, inter alia, upon passing certain resolutions (the “Resolutions”) that will be proposed at a shareholders’ meeting to be held on or around 16 February 2023 (the “General Meeting”).
The Placing is not being underwritten (in whole or in part) by Dowgate, SPARK or any other person.
Broker Option
Given that the Placing has not been offered on a pre-emptive basis and in order to accommodate potential additional demand for Loan Notes, the Company has granted the Broker Option to Dowgate to enable Dowgate to fulfil any additional requests to participate in the Placing, for up to a further approximately $5.0 million (£4.0 million). The Broker Option is exercisable by Dowgate at its absolute discretion, at any point up to 5.00pm on 9 February 2023 and there is no obligation on Dowgate to exercise the Broker Option or to seek to procure subscribers for any Broker Option Loan Notes pursuant to the Broker Option. Any Broker Option Loan Notes issued pursuant to the exercise of the Broker Option will be issued on the same terms and conditions as the Placing Loan Notes.
The Placing and Broker Option (together the “Convertible Loan Note Financing”) when combined will, if the Broker Option is exercised in full, and assuming all interest on the Loan Notes is capitalised, result in the issue upon conversion of the Loan Notes up to 21,590,029 Belluscura new ordinary shares, representing approximately 14.9% of the enlarged issued share capital of the Company.
Terms of the Loan Notes
The key terms of the Loan Notes are:
Instrument 10% Convertible Unsecured Loan Notes 2026 constituted pursuant to a loan note instrument dated 27 January 2023 (the “Instrument”). The Loan notes will be transferable in accordance with the terms of the Instrument but will not be listed on a public market
Issue Price Loan Notes of £1.00 issued at par
Conversion Convertible into ordinary shares at a conversion price of 50 pence per share. Conversion at the holder’s election on the final business day of each quarter, commencing on 30 June 2023 and otherwise automatically at 3 years from the date of the Instrument (the “Maturity Date”)
Repayment On the Maturity Date, unless otherwise converted
Term Three years from date of issue. Loan Notes are not redeemable in cash, other than in exceptional circumstances, but are converted into ordinary shares in the capital of the Company on their Maturity Date in accordance with the terms of the Instrument.
Coupon 10% per annum, paid annually. The coupon to be paid in cash or capitalised at the Company’s discretion
Minimum size £1,000
Directors’ and connected party participation in the Placing
David Poutney and Adam Reynolds are Directors of the Company. Nigel Wray is a Substantial Shareholder (as defined by the AIM Rules). Each of David Poutney, Adam Reynolds and Nigel Wray have agreed that they will participate in the Placing as set out below.
Name |
Holding of Existing Ordinary Shares |
Current holding as percentage of Existing Ordinary Shares |
Placing Loan Notes Subscribed |
Number of Shares issued on Conversion of Loan Notes (in event of conversion)** |
David Poutney* |
12,455,731 |
10.1% |
£500,000 |
1,000,000 |
Adam Reynolds |
1,728,176 |
1.4% |
£25,000 |
50,000 |
Nigel Wray |
13,564,413 |
11.0% |
£500,000 |
1,000,000 |
* includes 2,658,314 Ordinary Shares held by Vivienne Poutney, Mr Poutney’s spouse.
** excluding any accrued interest on the Loan Notes that may be capitalised at the Company’s option
Related Party Transaction – participation in the Placing
As set out above Directors David Poutney and Adam Reynolds, and Substantial Shareholder Nigel Wray have agreed that they will participate in the Placing of the Loan Notes.
The participation in the Placing by each of David Poutney and Adam Reynolds constitute related party transactions under the AIM Rules for Companies. As such, David Poutney and Adam Reynolds are not considered independent for the purposes of AIM Rule 13 in relation to these related party transactions.
Robert Rauker, Anthony Dyer, Dr. Patrick Strollo and Richard Piper who are Directors of the Company, are considered independent in relation to the consideration of these related party transactions under AIM Rule 13.
Having consulted with SPARK, the Company’s nominated adviser, the Independent Directors consider that the terms of each of David Poutney’s and Adam Reynolds’ participation in the Placing of Loan Notes are fair and reasonable insofar as Shareholders are concerned.
All the Directors are considered independent in relation to the consideration of the participation in the Placing by Nigel Wray.
Having consulted with SPARK, the Company’s nominated adviser, the Directors consider that the terms of Nigel Wray’s participation in the Placing of Loan Notes are fair and reasonable insofar as Shareholders are concerned.
Related Party Transaction – Dowgate’s participation in the Placing Agreement
As set out above, certain Directors and a Substantial Shareholder have agreed to participate in the Placing. The proposed participation by these parties constitute related party transactions under Rule 13 of the AIM Rules.
David Poutney, a Non-Executive Director of the Company, is Chairman of, and a major shareholder in, Dowgate Group Limited (“Dowgate Group”) and Chief Executive of Dowgate, a wholly owned subsidiary of Dowgate Group. As set out above, Dowgate is party to the Placing Agreement, under which Dowgate will receive:
– a fee of £40,000;
– commission amounting to 5% of funds raised in the Placing*; and
– commission amounting to 5% of funds raised under the Broker Option*,
* excepting any subscriptions made by Directors
Entering into the Placing Agreement constitutes a related party transaction under the AIM Rules for Companies.
As David Poutney is not considered independent for the purposes of AIM Rule 13, Robert Rauker, Anthony Dyer, Dr. Patrick Strollo, Adam Reynolds and Richard Piper (the “Independent Directors”) have considered the terms of this related party transaction for the purposes of AIM Rule 13.
Having consulted with SPARK, the Company’s nominated adviser, the Independent Directors consider that the terms of the Placing Agreement are fair and reasonable insofar as shareholders are concerned.
Shareholders’ Meeting
The issue of the Loan Notes is conditional on the passing of certain resolutions (the “Resolutions”) that will be proposed at the General Meeting. The Resolutions will, inter alia, increase the current authority to disapplying the relevant statutory pre-emption rights in relation to the issue of new ordinary shares in the Company, sufficient to enable the conversion of the Loan Notes in full. The Resolutions will also seek an amendment to the Company’s Articles of Association to amend the restriction on the Company’s borrowing powers and align it with that of guidelines issued by The Investment Management Association. The amendments to the Articles of Association will allow the Company to incur borrowings up to an amount equal to two times its adjusted capital and reserves from time to time and, as a result, the Company will be permitted to issue the Loan Notes.
It is expected that, subject, inter alia, to approval by Shareholders of the Resolutions at the General Meeting the Loan Notes will be issued to placees on or around 17 February 2023.
A Circular and notice of the General Meeting are expected to be sent to Shareholders on or around 31 January 2023. Notice of the General Meeting will made available on the Company’s website: www.belluscura.com.
For the purposes of this announcement, a currency exchange rate of $1:£1.2375 has been used.
For further information please contact:
Belluscura plc |
Tel: +44 (0)20 3128 8100 |
Adam Reynolds, Chairman Robert Rauker, Chief Executive Officer Anthony Dyer, Chief Financial Officer |
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|
|
SPARK Advisory Partners Limited Nominated Adviser |
Tel: +44 (0)20 3368 3550 |
Neil Baldwin |
|
|
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Dowgate Capital Limited Broker and Bookrunner |
Tel: +44 (0)20 3903 7715 |
James Serjeant / Russell Cook |
|
|
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MHP Financial PR & Investor Relations |
Tel: +44 (0)20 3128 8100 |
Katie Hunt/Peter Lambie/ Matthew Taylor |
email: Belluscura@mhpgroup.com |