BBS-Bioactive Bone Substitutes Plc, Company Announcement, 25 August 2022 at 10.00 (CEST)
BBS approaches the CE marking of its first product
This release is a summary of BBS-Bioactive Bone Substitutes Plc’s half-yearly report January–June 2022. The entire report is attached to this stock exchange release as a pdf file. The report is also available on BBS-Bioactive Bone Substitutes Plc’s website at https://www.bbs-artebone.fi/.
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 2022
No revenue is expected during 2022.
Board of Directors outlook for 2022-23
The company has submitted the CE marking application for its first product (ARTEBONE® Paste) to the notified body, and the CE marking process is expected to take 8-12 months from the submission date (March 9, 2022), according to the announcement by the authorities. Thus, the company expects authorities to announce the decision on the approval of the application in 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.
|Other operating income||55||45||60|
|Personnel expenses||728||479||1 199|
|Depreciationa and amortization||113||113||214|
|Other operational expenses||689||663||1 144|
|Profit/Loss for the period||-1 676||-1 308||-2 771|
|Cash flow for business operations||-1 496||-1365||-2 520|
|Change in cash resources||2 153||-1 504||-2 202|
|Equity ratio1), %||43,4||42,3||35,0|
|Earnings per share2), EUR||-0,24||-0,20||-0,42|
|Earnings per share, EUR, diluted||-0,24||-0,19||-0,41|
|Number of shares at the end of period||9 671 459||6 571 525||6 981 525|
|Average number of shares in the period||7 130 966||6 571 525||5 668 393|
|Equity per share||0,58||0,73||0,53|
|Cash and cash equivalents||3 390||1 934||1 236|
|Equity||5 475||4 780||3 634|
|Balance sheet total||12 618||11 303||10 516|
1)Equity ratio = Equity / (Balance sheet total – Advances received)
2)EPS = Profit(Loss) / Average number of share in the period
CEO ILKKA KANGASNIEMI
During the first half of 2022, BBS made positive progress towards its targets. In March, we submitted the CE marking application for our first product (ARTEBONE® Paste bone filler) to the notified body. The approval of the application will enable us to market and sell the product within the European Union.
The approval of the CE marking is the most important target for BBS, and our employees worked hard to enable submitting the application. Now this work continues as part of the application approval process, which according to the authorities' announcement will take 8-12 months from the date of submission (March 9, 2022). During the approval process, the authorities shall also certify the quality system of our production lines. Once these actions have been completed, we can enter the commercial phase.
We expect to receive the approval in 2023, after which the unique new generation bone substitute we have developed can be introduced to the market. During the approval process, we have continued to implement the actions required by the registration as well as ramped up production. To finance these activities, we arranged a rights issue in May –June, in which we raised a total of approximately EUR 3.1 million in net proceeds for the company. Almost 2,000 shareholders from Finland and Sweden took part in the offering. While the issue was not fully subscribed, considering the unfavorable capital market situation during the subscription period, I am satisfied with the end result. In December 2022 and May 2023, those who took part in the offering will have the opportunity to subscribe for additional shares with their warrants. The company plans to use these additional proceeds for marketing and launch preparations, to enable a faster transition to the commercial phase. I would like to thank all the subscribers for the trust they have shown in the company so far.
The company's financing is now secured for this year, and management can adjust the use of funds with its decisions. We are currently discussing additional funding to secure the continuation of development work and the starting of commercial operations, once the approval for the CE marking has been received.
I am proud of our team. They have solved all the challenges during our journey, despite several issues which have impacted our company’s operations and our operating environment. These have included the significant reform of the medical device regulation (MDR), the pandemic and the effects of the war in Ukraine. We have an important goal: the introduction of a new generation treatment to the market offering a safe, functional and cost-effective way to treat difficult bone fractures and ossification problems. The need for our product has only continued to increase. This goal guides and motivates all our actions during the second half-year.
EVENTS AFTER PERIOD-END
The company announced after the review period on August 8, 2022, that Hanna Tölli, the chief operating officer and member of the BBS management team, will be on personal leave from August 8, 2022 to October 23, 2023. Jussi Jukka, who previously worked as BBS's production manager, was appointed as the new production manager and member of the management team from August 8, 2022.
The financial statement bulletin for 2022 will be published on March 23, 2023.
The company's previously published reports can be found on the BBS investor website at: https://www.bbs-artebone.fi/investors/financial-reports/.
BBS-Bioactive Bone Substitutes Oyj
Board of Directors