Preparations for commercial phase initiated (unaudited)

BBS-Bioactive Bone Substitutes Plc, Financial Statements Bulletin 2023, 26 February 2024 at 5.45 p.m. (EET)

This is a summary of BBS-Bioactive Bone Substitutes Plc’s Financial Statements Bulletin for January–December 2023. 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/.

Preparations for commercial phase initiated

JULY-DECEMBER HIGHLIGHTS

• In the second half of 2023, BBS made significant progress in the CE marking process of its first product, ARTEBONE® Paste, and continued ramping up production capabilities. In November, the company received confirmation from the Notified Body that the company’s quality system had received final approval, and in the same month the consultation with the Medicines Agency began.

• In October, the company appointed Juliusz Rakowski as the new CEO, and at the turn of the year other management team appointments were announced as part of the ongoing transition from research and development to the commercial phase. In the second half of the year, the company started initial commercialization measures and discussions with potential distributors.

• In November-December, the company carried out a rights issue, raising a total of approx. 1.75 million euros in net proceeds.

• The company generated no revenue during the review period.

• The financial result in the review period was EUR -1.84 (-1.42) million

• Cash flow from operations was EUR -1.49 (-1.32) million.

• Cash and cash equivalents on 31 December 2023 were EUR 1.97 (1.52) million.

YEAR 2023

• In addition to the share issue mentioned above in Nov-Dec, the company arranged a rights issue in May-June, raising a total of approx. EUR 3.1 million in net proceeds.

• The company generated no revenue during the review period.

• The financial result in the review period was EUR –3.48 (-3.09) million.

• Cash flow from operations was EUR –2.92 (-2.82) million

• Cash and cash equivalents on 31 December 2023 were EUR 1.97 (1.52) million.

Story continues

OUTLOOK

Guidance for 2024
BBS expects the authorities’ decision on approving the CE marking application during the second quarter of 2024. The company expects commercial operations to begin at the end of the second half of 2024.

Assumptions

Based on the currently available information, the company’s view is that there are no longer product risks associated with the remaining technical phases of the regulatory approval process, as the company has met the requirements related to the product. According to the management, the main actual challenge is predicting the time required for the final phases of the official approval process, which the company cannot entirely control. The achievement of the guidance requires that the approval process proceeds without significant delays on the part of the authorities, including the final audit by the Notified Body. The company has not yet received the exact date for the audit, but estimates it to take place in spring of 2024.

The company has initiated the preliminary commercialization measures for ARTEBONE® Paste and sales are expected to begin at the end of 2024. Sales are estimated to be moderate during the current year and to increase gradually during the following year.

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.

KEY FIGURES

1) Equity ratio = Equity / (Balance sheet total – Advances received)
2) EPS = Net Profit (Loss) / Average number of outstanding shares in the period
3) Shareholders’ Equity / Total number of outstanding shares at the end of the period

CEO JULIUSZ RAKOWSKI

During the second half of the year, BBS progressed as planned with the CE marking process. The most significant news at the end of the year was the notification from the Notified Body that the company’s quality system had been approved. At the same time, we received information that the Medicines Agency’s consultancy conducted by Fimea, which is essential for the final product approval, began in November 2023. Thus, I am pleased to be able to state that all the final steps of the CE marking process have been initiated. According to the company’s management, approval is attainable in the second quarter of 2024.

According to our assessment, there is no longer actual product risk associated with the remaining product approval process. The company cannot control authorities’ schedules, but as the approval process continues to make expected progress, we have initiated preparations for the commercial phase already in 2023.

At the turn of the year, several new members were appointed to the company’s management team, adding valuable experience for both sales and production functions in the commercial phase. During the second half of the year, we continued fine-tuning production lines and processes, as well as carrying out validation batches in production.

In February 2024, after the reporting period, we took part in the prestigious American Academy of Orthopedic Surgeons exhibition in United States. Several European industrial operators, pharmaceutical companies, and distributors were also present at the event. Meetings with potential customers reinforced my confidence in the market’s expectations for the product.

ARTEBONE® Paste combines bone minerals with growth factors, making it unique and as effective as using the patient’s own bone graft. At the same time, the outcome for healing is better than by using minerals alone. For this reason, we believe we have the potential to displace the over 600 synthetic bone graft materials currently on the market. Once we have obtained the approval, we will finally be able to start selling the product, through which the the company will move into a new phase.

As we have stated before, the approval processes for medical devices are typically lengthy, and the frustratingly slow progress of regulatory process has required patience from everyone involved. This patience will still be required in the spring. During the beginning of the year, we will continue to support the authorities in every way possible to ensure that we may receive the approvals according to the schedule. At the same time, we continue preparations for the commercial phase. The Notified Body has already submitted additional questions and requests for further information. I am pleased to say no significant non-conformities have surfaced in these inquiries.

EVENTS AFTER PERIOD-END

On January 2, 2024, the company announced that Kimmo Tyni has been appointed as the Production Director of BBS-Bioactive Bone Substitutes Oyj, starting from January 15, 2024.

On January 31, 2024, the company’s board decided on a free share issue of 1,000,000 shares to the company itself. The issuance is intended to prepare for potential conversion of loan capital and other possible measures within the framework of the authorizations granted by the extraordinary general meeting on October 23, 2023. After the directed share issue, BBS holds a total of 1,000,000 of its own shares, representing 4.9 percent of the company’s shares thereafter.

On February 21, 2024, the company announced that it has agreed to draw down an instalment of EUR 500,000 with RiverFort Global Opportunities PCC Ltd (“RiverFort”) in accordance with the terms of the financing agreement announced on September 30, 2021. BBS will pay a transaction fee of EUR 45,000 by transferring 74,915 of its own shares to RiverFort at a price of EUR 0.6007 per share. The reference price is, according to the original financing agreement, tied to the average share price over the five (5) trading days preceding the payment of each instalment (VWAP). After the drawdown, BBS will issue 416,195 warrants to RiverFort (with an exercise price of EUR 0.8410 per share, 140% of the reference price) with a validity period of 48 months. After the transfers, BBS will have in total of 925 085 treasury shares.

FINANCIAL CALENDAR FOR 2024

• Financial Statements Release for the year 2023 will be published on 26 February 2024

• The Annual Report for the year 2023 will be published during the week 13/2024 at the latest.

• The Annual General Meeting is planned to be held on 30 April 2024

• Half-year financial report January-June 2024 will be published on 30 August 2024

The Company’s previously published reports can be found on the BBS investor website at: https://www.bbs-artebone.fi/investors/financial-reports/.

26 February 2024
BBS-Bioactive Bone Substitutes Plc
Board of Directors

Distribution
Nasdaq Helsinki

https://www.bbs-artebone.fi/

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 since February 2018. The company’s head office is located in Oulu, and it employs more than 22 people.

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