BBS-Bioactive Bone Substitutes Plc, Financial Statements Bulletin, 24 February 2023 at 3.00 p.m.
BBS advances towards the CE marking of its first product
This is a summary of BBS-Bioactive Bone Substitutes Plc’s Financial Statements Bulletin for January–December 2022. The entire report is attached to this Company Announcement as a pdf file. The report is also available on BBS-Bioactive Bone Substitutes Plc’s website at https://www.bbs-artebone.fi/.
JULY-DECEMBER (H2) HIGHLIGHTS
The figures in the review are rounded, so the sum of the individual figures may differ from the total presented. BBS's accounting period is a calendar year. Figures in parentheses refer to the corresponding period of the previous year, unless otherwise stated. The information in the review is unaudited.
Guidance for 2023
No revenue is expected during 2023.
Board of Directors’ outlook for 2023
The company has submitted the CE marking application for its first product (ARTEBONE® Paste) to the notified body on 9 March 2022. Based on a survey* conducted for the Notified Body, the average application processing times increased in 2022. Due to this, the company estimates that, based on currently available information, it is unlikely to receive the final CE marking approval by the end of March 2023. The company expects authorities’ decision on approving the application during 2023.
Preparations for commercial operations will begin towards the end of 2023.
Further measures are required to ensure the sufficiency of the company's financing in order to implement the company’s plans following the expected approval of the CE marking. The company continues discussions to secure additional funding to enable the continuation of the development work as well as initiating commercial activities.
*MedTech Europe Survey Report:. https://www.medtecheurope.org/wp-content/uploads/2022/07/medtech-europe-survey-report-analysing-the-availability-of-medical-devices-in-2022-in-connection-to-the-medical-device-regulation-mdr-implementation.pdf
|Other operating income||9||16||64||61|
|Depreciationa and amortization||112||119||225||231|
|Other operational expenses||756||481||1,446||1,144|
|Profit/Loss for the period||-1,416||-1,463||-3,093||-2,771|
|Cash flow for business operations||-1,320||-1,155||-2,816||-2,520|
|Change in cash resources||-1,872||-698||281||-2,202|
|Equity ratio1), %||40.0||34.6||40.0||34.6|
|Earnings per share2), EUR||-0.15||-0.22||-0.38||-0.42|
|Earnings per share, EUR, diluted||-0.14||-0.22||-0.35||-0.41|
|Number of shares at the end of period||9,668,351||6,737,889||9,668,351||6,737,889|
|Average number of shares in the period||9,450,846||6,615,855||8,211,650||6,593,872|
|Equity per share 3), EUR||0.44||0.54||0.44||0.54|
|Cash and cash equivalents||1,517||1,236||1,517||1,236|
|Balance sheet total||10,688||10,506||10,688||10,506|
1) Equity ratio = Equity / (Balance sheet total – Advances received)
2 )EPS = Profit(Loss) / Average number of outstanding shares in the period
3 )Equity / Total number of outstanding shares at the end of the period
CEO ILKKA KANGASNIEMI
During the second half of the year, BBS focused on advancing the CE marking process with the Notified Body, aimed at facilitating the sales and marketing of our first product (ARTEBONE® Paste) in the EU region. During the autumn months, we continued to refine production lines and processes, while finalizing production validation procedures, ensuring the ability to produce products consistently for the upcoming launch.
The CE marking procedure involves two key streams: quality system approval and product approval. With regards to the first, significant progress was made in the latter half of the year. In November, the Notified Body conducted a successful audit, and no critical non-conformities were reported regarding the quality system. The final audit for the quality system is scheduled for early March.
It is also noteworthy that the Notified Body has already submitted the initial questions and supplemental requests regarding product approval, and there were no critical non-conformities in these submissions.
Obtaining product approval requires close collaboration between the Notified Body and the Medicines Agency. So far, the process has progressed at a slower pace, and cooperation has yet to commence. Given the current backlog of application processing, as reported in public surveys, the company announced in December that it was unlikely to receive the final CE marking approval by the end of March 2023. Despite the delays in the regulatory process, the company still believes that receiving the approval is achievable in 2023.
The product approval process for medical devices can be time-consuming and requires patience. Although progress has been slow, the company's financial situation remains stable until July-August. The management team is able to adjust the allocation of funds based on its decisions. Currently, the company is exploring multiple options for additional funding to secure the continuation of development work and well as preparations for commercial operations during the congested approval process..
We are steadfastly advancing towards our objective: to bring a new generation of safe bone fillers to a thriving market, improving patients' lives and streamlining the overburdened healthcare system.
EVENTS AFTER PERIOD-END
The company has on 13 February 2023 applied for The Delisting of Secondary Listing on Nasdaq First North Growth Market Sweden. When making the decision, the board has taken into account the low trading volumes of BBS shares after the company's listing in 2018, as well as the small number of shareholders registered with Euroclear Sweden AB. The board has also assessed the additional costs incurred by the company and the administrative responsibilities arising from compliance with the listing requirements in connection with the parallel listing. The last day of trading in the shares of BBS on Nasdaq First North Growth Market Sweden shall be March 3, 2023.
FINANCIAL CALENDAR FOR 2023
The company's previously published reports can be found on the BBS investor website at: https://www.bbs-artebone.fi/investors/financial-reports/.
24 February 2023
BBS-Bioactive Bone Substitutes Plc
Board of Directors
BBS in brief
BBS-Bioactive Bone Substitutes Plc is a Finnish orthobiology company whose core competence is the development, commercialization and manufacture of easy-to-use bone implants that promote bone formation and healing. Bone substitutes, i.e. implants, are intended for the treatment of various bone damage, bone healing problems and bone diseases instead of autologous and bank bone grafts. BBS aims to become one of the leading players in the field of bioactive implants intended for bone healing problems.
BBS was founded in 2003, and the company has been listed on Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden since February 2018. The company's head office is located in Oulu, and it employs 20 people.