Notice of Annual General Meeting (AGM) of Bioretec Ltd
Notice of Annual General Meeting (AGM) of Bioretec Ltd
Bioretec Ltd Company announcement 5 April 2024 at 3:00 p.m. EET
The shareholders of Bioretec Ltd are hereby invited to the Annual General Meeting to be held on 26 April 2024 at 10:00 a.m. (Finnish time) at Bioretec premises in the auditorium of Tampark, at the address Yrittäjänkulma 5, FI-33710 Tampere, Finland.
A shareholder may participate in the Annual General Meeting and exercise their rights at the meeting by way of proxy representation. A proxy representative shall present a dated power of attorney or, in another reliable manner, demonstrate their right to represent the shareholder. A proxy template is enclosed in Appendix 1 to this Notice.
Shareholders wishing to participate in the meeting must register for the meeting no later than on 16 April 2024 at 4:00 p.m. (Finnish time). Instructions for registration are set out below in section C. INSTRUCTIONS FOR THE PARTICIPANTS
- Agenda of the Annual General Meeting
The items on the agenda for the General Meeting are the following:
- Opening of the meeting
- Calling the meeting to order
- Election of persons to scrutinize the minutes and to supervise the counting of votes
- Recording the legality of the meeting
- Recording the attendance at the meeting and adoption of the list of votes
- Presentation of the financial statements, consolidated financial statements, and the report of the Board of Directors for the financial period 1 January - 31 December 2023 and the CEO's review for the period.
- Presentation of the auditor's report
- Approval of the financial statements, including the consolidated financial statements
- Treatment of profit or loss
The Board of Directors of the company proposes that the Annual General Meeting resolves to credit the loss of EUR 3,721,314.67 for the financial period from 1 January to 31 December 2023 to the equity as profit/loss from preceding financial periods and that no dividend shall be distributed.
- Resolution on the discharge from liability of the members of the Board of Directors and the CEO for the financial period 1 January - 31 December 2023
- Resolution on the remuneration of the members of the Board of Directors and the auditor
Four shareholders of the company, representing in total more than 21 % of all shares and votes represented by the shares, jointly propose to the Annual General Meeting that the following remuneration will be paid to the members of the Board of Directors to be elected for the term beginning at the end of the Annual General Meeting and ending at the end of the 2025 Annual General Meeting:
- EUR 10,000 per month for the Chair of the Board of Directors. The Chair will participate in the operative management of the company in the upcoming term; and
- EUR 1,500 per month for the members of the Board of Directors.
In addition, the shareholders in question propose that the reasonable travel expenses of the members of the Board of Directors shall be reimbursed in accordance with the maximum amount of the respective travel allowance base approved by the Tax Administration.
Notwithstanding his possible election to the Board of Directors, the company may enter into a consultancy agreement with Valugen GmbH in respect of the services of Michael Piccirillo in connection with establishing a scientific advisory board, to create key opinion leader connections. The consulting fee payable pursuant to such agreement shall not exceed EUR 3,000 per month.
The Board of Directors of the company proposes to the Annual General Meeting that the auditor will be compensated as reasonably invoiced.
- Resolution on the number of members of the Board of Directors
According to the Articles of Association, the Board of Directors consists of a minimum of three (3) and a maximum of seven (7) members. The current number of board members is five.
Four shareholders of the company, representing in total more than 21% of all shares and votes represented by the shares, jointly propose to the Annual General Meeting that five (5) ordinary members be elected to the Board of Directors.
- Election of members of the Board of Directors
Four shareholders of the company, representing in total more than 21% of all shares and votes represented by the shares, jointly propose to the Annual General Meeting that Tomi Numminen, Michael Piccirillo, Sarah van Hellenberg Hubar-Fisher, Päivi Malinen and Kustaa Poutiainen are re-elected as members of the Board of Directors for a term starting at the end of the Annual General Meeting and expiring at the conclusion of the 2025 Annual General Meeting.
Pekka Simula has informed that he is not available for re-election to the Bioretec Board of Directors.
The afore-mentioned shareholders propose that the Annual General Meeting resolve on the proposal regarding election of members of the Board of Directors as a whole. All nominees have given their consent for election.
- Election of auditors
Four shareholders of the company, representing more than 21% of all shares and votes represented by the shares, propose to the Annual General Meeting that the auditing firm PricewaterhouseCoopers Oy would be elected as the auditor of the company until the conclusion of the 2025 Annual General Meeting. The auditing firm PricewaterhouseCoopers has notified the company that it will appoint Kalle Laaksonen, Authorized Public Accountant, as the responsible auditor.
- Authorization of the Board of Directors to resolve on the issuance of shares and special rights entitling to shares
The Board of Directors proposes that the Annual General Meeting authorizes the Board of Directors to resolve on the issuance of shares, as well as the issuance of option rights and other special rights entitling to shares pursuant to Chapter 10 of the Finnish Companies Act, as follows:
Pursuant to the authorization, up to 3,000,000 shares (including new shares to be issued based on the special rights) may be issued, which on the date of this notice corresponds approximately to 15% of all the shares in the company.
Shares or special rights entitling to shares may be issued in one or more tranches, either with or without payment. The shares issued pursuant to the authorization may be new shares or shares in the company's possession.
The authorization may be used for financing or execution of acquisitions or other business arrangements, to strengthen the balance sheet and financial position of the company, for implementing the company's share-based incentive plans, or for other purposes determined by the Board of Directors.
Pursuant to the authorization, the Board of Directors may resolve upon issuing new shares, without consideration, to the company itself.
The Board of Directors is authorized to resolve on all terms for share issues and granting of special rights entitling to shares in the company. The Board of Directors is authorized to resolve on a directed share issue and issuance of special rights entitling to shares according to the shareholders’ pre-emptive rights and/or in deviation from the shareholders' pre-emptive right, provided that there is a weighty financial reason for the company to do so.
The authorization is valid until the end of the next Annual General Meeting, however, no longer than until 30 June 2025. The authorization cancels the previous unused share issue authorizations, with the exception of the authorization given by the annual general meeting on 26 May 2023 to organize the option program 2023-1.
- Establishment of a Shareholders’ Nomination Board and Approval of the Charter
The Board of Directors proposes that the Annual General Meeting resolve to establish a shareholders’ nomination board (“Nomination Board”), responsible for annually preparing and presenting to the Annual General Meeting and, if necessary, to an Extraordinary General Meeting, proposals on the composition (number of the members of the Board of Directors and the nominees) and remuneration of the Board of Directors. In addition, the Nomination Board is responsible for identifying candidates to succeed members of the Board of Directors and preparing principles for diversity for the Board of Directors.
In addition, the Board of Directors proposes that the Annual General Meeting resolve to approve the Charter of the Shareholders’ Nomination Board in the form of appendix 2 of this notice. The Charter is also available at the company’s website at https://bioretec.com/agm2024 .
In accordance with the proposal, the Nomination Board consists of three (3) members. The Company's three (3) largest shareholders are each entitled to nominate one member. The Chair of the Board of Directors of the Company serves as an expert in the Nomination Board and shall not have a voting right nor be counted in the quorum of the Nomination Board.
The three (3) shareholders with the largest number of votes for all shares of the company on the last business day of August preceding the Annual General Meeting have the right to nominate the members representing the shareholders. The nomination right is determined in accordance with the shareholder register maintained by Euroclear Finland Oy.
If a shareholder who has diversified their holdings into several funds or group companies and who (if the Company's shares were traded on a regulated market) would have an obligation under the Securities Markets Act (746/2012, as amended) to take these holdings into account when notifying changes in their holding (flagging obligation), submits a motivated written request to the Chair of the Board of Directors no later than on the second last business day of August in the year preceding the Annual General Meeting, the holdings of such a shareholder shall be aggregated in calculating the decisive number of votes for the right of nomination.
If a holder of the nominee-registered shares wishes to exercise their right to nominate, the holder must submit a reliable report of the number of shares they own on the last business day of August in the year preceding the Annual General Meeting. The report must be submitted to the Chair of the Board of Directors no later than the fourth business day of September in the year preceding the Annual General Meeting.
If a shareholder does not wish to exercise their right to nominate, the right shall pass to the next largest shareholder who would not otherwise have the right to nominate a member to the Nomination Board.
The Chair of the Board of Directors shall convene the first meeting of the Nomination Board for each term. A representative of the largest shareholder shall be elected as the Chair of the Nomination Board, unless the Nomination Board expressly decides otherwise.
The members of the Nomination Board, the shareholders appointing them and any changes to the composition of the Nomination Board are published by a company release.
The Nomination Board is established for the time being until the General Meeting decides otherwise. The members of the Nomination Board are appointed annually and the term of office of the members ends when new members have been appointed to the Nomination Board.
- Closing of the meeting
- DOCUMENTS OF THE GENERAL MEETING
Documents referred to in Chapter 5, Section 21 of the Finnish Companies Act are available and printable at the company's website: https://bioretec.com/agm2024 .
The meeting minutes of the Annual General Meeting will be available on the company's website no later than 10 May 2024.
C. INSTRUCTIONS FOR THE PARTICIPANTS
Eligibility to attend and registration for the Annual General Meeting
- Shareholder registered in the shareholders’ register
Each shareholder who is registered on 16 April 2024 in the shareholders’ register of the company held by Euroclear Finland Ltd., has the right to participate in the General Meeting. A shareholder whose shares are registered on his/her/its personal Finnish book-entry account is registered in the shareholders’ register of the company.
A shareholder, who wants to participate in the General Meeting, shall register for the
meeting no later than on 16 April 2024 at 4:00 p.m. (Finnish time), by which time the registration must be received.
The registration may take place by:
a) email to the address IR@bioretec.com,
b) phone to the number +358 20 778 9500 or
c) mail to the address Bioretec Oy, Yrittäjänkulma 5, FI-33710 Tampere.
In connection with the registration, a shareholder shall notify his/her/its name, personal identification number, address, email address, and the name of a possible assistant or proxy representative and the personal identification number of a proxy representative. Shareholder, his/her/its representative or proxy representative shall, when necessary, be able to prove his/her/its identity and/or right of representation.
- Holders of nominee-registered shares
A holder of nominee-registered shares has the right to participate in the General Meeting by virtue of such shares, based on which the shareholder on the record date of the General Meeting, i.e. on 16 April 2024, would be entitled to be registered in the shareholders’ register of the company maintained by Euroclear Finland Ltd. The right to participate in the General Meeting requires, in addition, that the shareholder has on the basis of such shares been registered into the temporary shareholders’ register of the company held by Euroclear Finland Ltd. at the latest on 23 April 2024 by 10:00 a.m. (Finnish time). As regards nominee-registered shares this constitutes due registration for the General Meeting.
A holder of nominee-registered shares is advised to request without delay necessary instructions regarding the registration in the temporary shareholder’s register of the company, the issuance of proxy documents and voting instructions, and registration for the General Meeting from his/her/its custodian bank. The account management organization of the custodian bank shall register a holder of nominee-registered shares who wants to participate in the General Meeting into the temporary shareholders’ register of the company at the latest on the date and time mentioned above.
- Proxy representative and powers of attorney
A shareholder may participate in the General Meeting and exercise his/her/its rights at the meeting by way of proxy representation. A proxy representative shall produce a dated proxy document or otherwise provide reliable evidence of the right to represent the shareholder. The authorization applies to one meeting only unless otherwise stated. If a shareholder participates in the General Meeting by means of several proxy representatives representing the shareholder with shares at different securities accounts, the shares by which each proxy representative represents the shareholder shall be identified in connection with the registration for the General Meeting. The sample power of attorney is enclosed to this notice.
Proxies, if any, are requested to be delivered to the company's office at Bioretec Oy, Yrittäjänkulma 5, FI-33710 Tampere, Finland, or to the email address IR@bioretec.com before the end of the registration period.
Other instructions / information
A shareholder present at the General Meeting has the right ask questions pursuant to Chapter 5, Section 25 of the Companies Act with respect to the matters to be considered at the General Meeting.
The shareholders do not have the possibility to vote in advance.
Personal information collected by Bioretec Ltd shall be used only in connection with the General Meeting and the processing of related necessary registrations and for shareholder communication. The privacy statement in respect of the General Meeting is available at the company’s website https://bioretec.com/agm2024.
Bioretec Ltd has a total of 20.336.858 shares on the date of publication of the notice of the meeting 5 April 2024. The company does not have any Bioretec shares in its possession. Possible changes in shareholding occurring after the date of registration for the General Meeting shall not affect the shareholder’s right to participate in the meeting nor the voting rights of a shareholder.
Tampere, 5 April 2024
BIORETEC LTD
BOARD OF DIRECTORS
Contact Persons
Tomi Numminen, Chairman of the Board of Directors, tomi.numminen@bioretec.com
Timo Lehtonen, CEO, timo.lehtonen@bioretec.com
APPENDICES
- Proxy template
- Charter of the Shareholders’ Nomination Board
Inside information: Bioretec’s RemeOs™ biodegradable magnesium alloy composition has been allowed a patent by the U.S. Patent office
Inside information: Bioretec’s RemeOs™ biodegradable magnesium alloy composition has been allowed a patent by the U.S. Patent office
Bioretec Ltd Inside information 21 March 2024 at 7:00 p.m. EET
Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has been allowed a patent by the U.S. patent office for its RemeOs™ magnesium alloy composition. The U.S. patent office will grant and publish the patent after the Company´s confirmation.
Allowed patent concerns RemeOs™ magnesium-calcium-zinc alloy composition for orthopedic implants[1]. The patent also includes the usage of the RemeOs™ magnesium alloy in the manufacturing of orthopedic implants or a part of such implants for all patient populations. The patented magnesium alloy material is used in Bioretec's RemeOs™ trauma screws and forthcoming pipeline products.
Bioretec is now moving forward with the application process for this allowed patent to an international PCT application covering regions outside of the United States.
"The allowance of this patent for RemeOs™ biodegradable metal composition in the U.S., which is our main target market, is an integral part of our IPR strategy and protection of RemeOs™ technology", says Timo Lehtonen, CEO of Bioretec.
Further enquiries
Timo Lehtonen, CEO, +358 50 433 8493
Johanna Salko, CFO, +358 40 754 8172
Certified adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, CE mark is expected to be received during the second quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
[1] Magnesium alloy with Ca in the range of 0.550-0.700 weight-% and Zn in the range of 0.400 - 0.700 weight-%
Bioretec Ltd’s Annual Report and Financial Statements 2023 published
Bioretec Ltd’s Annual Report and Financial Statements 2023 published
Bioretec Ltd Company announcement 15 March 2024 at 5:30 p.m. EET
Bioretec Ltd has today published its 2023 Annual Report, Financial Statements and Report by the Board of Directors. The publications are attached to this release and also available in Finnish and English on the company’s website at www.bioretec.com/investors/investors-in-english/reports-and-presentations.
Further enquiries
Timo Lehtonen, CEO, +358 50 433 8493
Johanna Salko, CFO, +358 40 754 8172
Certified adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, CE mark is expected to be received during the second quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage
Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage
Bioretec Ltd Inside information 14 March 2024 at 3.45 p.m. EET
Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation for its RemeOs™ Spinal Interbody Cage implant from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in spinal surgery. RemeOs Spinal Interbody Cages are intended to be used to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine.
Obtaining the Breakthrough Device Designation status is an important milestone in getting the product launched into the U.S. markets, and therefore, Bioretec will evaluate the potential acceleration of RemeOs Spinal Cage product development as well as resource allocation requirements, which might impact the future capital needs of the Company.
Bioretec's biodegradable RemeOs™ Spinal Interbody Cage met the strict criteria set for entering the FDA’s Breakthrough Device Designation program. FDA requires a breakthrough technology to provide more effective treatment for life-threatening or irreversibly debilitating conditions or diseases. In addition, breakthrough technology must either represent a completely new form of treatment or offer significant advantages over existing approved or cleared alternatives, including the potential to reduce the need for hospitalization, improve patient’s quality of life, and create long-term clinical benefits, or alternatively represent a form of treatment that is in the best interest of patients. Under the Breakthrough Devices Program, the FDA will enable an ongoing and prioritized interactive discussion between Bioretec and the authorities regarding the commercial access of RemeOs™ Spinal Interbody Cage implant in the U.S. market.
“This designation gives us another validation of our expertise in creating innovative products for the unmet clinical needs in the orthopedic field. I am enthusiastic about the future prospects and the market opportunities of this product, which is based on the patented hybrid technology”, states Timo Lehtonen, the CEO of Bioretec.
Further enquiries
Timo Lehtonen, CEO, +358 50 433 8493
Johanna Salko, CFO, +358 40 754 8172
Certified adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, CE mark is expected to be received during the second quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
Inside information: Bioretec's European market authorization for RemeOs trauma screw has proceeded to expert panel evaluation, the approval is estimated during the Q2 2024
Inside information: Bioretec's European market authorization for RemeOs trauma screw has proceeded to expert panel evaluation, the approval is estimated during the Q2 2024
Bioretec Ltd Inside information 8 March 2024 at 9:15 p.m. EET
Bioretec Ltd., a pioneer in bioresorbable orthopedic implants, European market authorization application of the RemeOs™ trauma screw has, according to the information received from the Notified Body, progressed to the expert panel stage. The duration of the evaluation is a maximum of 60 days. After this step, the process returns to the Notified Body. Based on the information, the company estimates that the CE mark will be obtained during the second quarter of 2024 instead of the previous estimate of the first quarter of 2024.
Further enquiries
Timo Lehtonen, CEO, +358 50 433 8493
Johanna Salko, CFO, +358 40 754 8172
Certified adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, CE mark is expected to be received during the second quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
Bioretec Ltd’s financial statements bulletin 2023: Another successful year in the growth trajectory
Bioretec Ltd’s financial statements bulletin 2023: Another successful year in the growth trajectory
Bioretec Ltd Company announcement 16 February 2024 at 8:00 a.m.
This announcement is a summary of Bioretec Ltd’s financial statements bulletin for January–December 2023. The complete financial statements bulletin with tables is attached to this release as a pdf file and available at the company’s web pages at https://bioretec.com/investors/investors-in-english/releases.
July–December 2023 in brief
- Net sales increased by 33% and amounted to EUR 2,016 thousand (7-12/2022: EUR 1,520 thousand).
- Sales margin was EUR 1,483 (1,121) thousand or 73.6% (73.8%) of net sales, with year-on-year growth of 32%.
- Net loss for the period amounted to EUR -1,714 (-1,049) thousand.
- Earnings per share (undiluted) were EUR -0.09 (-0.07).
January–December 2023 in brief
- Net sales grew 33% and amounted to EUR 3,906 thousand (1-12/2022: EUR 2,942 thousand).
- Sales margin was EUR 2,810 (2,139) thousand or 71.9% (72.7%) of net sales, with year-on-year growth of 31%.
- Net loss for the period amounted to EUR -3,789 (-2,416) thousand.
- Earnings per share (undiluted) were EUR -0.19 (-0.17).
- The Board of Directors proposes that no dividend be distributed for the financial period 1 January–31 December 2023.
Key events in 2023
- In March 2023, Bioretec was granted a De Novo market authorization for its biodegradable RemeOs™ magnesium screw in the U.S.
- In April 2023, Bioretec announced that it will update and refocus its product portfolio and refine its U.S. go-to-market strategy, and consequently update its financial targets.
- In April 2023, Bioretec successfully completed a private placement and raised EUR 10 million.
- In May 2023, Bioretec appointed Dr. Jeremy Dublon as a Regulatory Advisor to support the company’s U.S. go-to-market strategy.
- In June 2023, Bioretec invested in a CNC machining center to increase the RemeOs™ production capacity.
- In August 2023, Bioretec announced its revised Scientific Advisory Board, whose members are the world's leading orthopedic experts in their own specialty.
- In September 2023, Bioretec entered into a distribution agreement with Spartan Medical for the RemeOs™ screws launch in the U.S.
- In October 2023, Bioretec changed its estimate for the granting of the European market authorization for its biodegradable RemeOs™ trauma screw and estimated that the approval will move to the first quarter of 2024.
- In November 2023, Bioretec´s Board of Directors initiated a recruitment process for a new CEO.
This financial statements bulletin is unaudited. The full-year 2022 figures are audited.
Key figures
|
EUR 1,000 |
H2 2023 |
H2 2022 |
Change, % |
FY 2023 |
FY 2022 |
Change, % |
|
Net sales |
2,016 |
1,520 |
32.6% |
3,906 |
2,942 |
32.8% |
|
Sales margin |
1,483 |
1,121 |
32.3% |
2,810 |
2,139 |
31.4% |
|
Sales margin, % |
73.6% |
73.8% |
|
71.9% |
72.7% |
|
|
EBITDA |
-1,703 |
-916 |
85.9% |
-2,833 |
-2,112 |
34.1% |
|
EBIT |
-1,801 |
-1,006 |
78.9% |
-3,034 |
-2,292 |
32.4% |
|
Net profit (loss) |
-1,714 |
-1,049 |
63.3% |
-3,789 |
-2,416 |
56.8% |
|
R&D spend on total costs, % |
22.7% |
25.3% |
|
25.6% |
28.1% |
|
|
Equity ratio, % |
77.3% |
55.2% |
|
77.3% |
55.2% |
|
|
Cash and cash equivalents |
6,910 |
1,223 |
465.1% |
6,910 |
1,223 |
465.1% |
|
Earnings per share (undiluted) |
-0.09 |
-0.07 |
18.0% |
-0.19 |
-0.17 |
13.3% |
|
Earnings per share (diluted) |
-0.07 |
-0.05 |
28.6% |
-0.15 |
-0.12 |
23.4% |
|
Number of shares at the end of the period (undiluted) |
19,536,858 |
14,111,858 |
|
19,536,858 |
14,111,858 |
|
|
Number of shares (diluted) |
24,908,133 |
19,608,126 |
|
24,908,133 |
19,608,126 |
|
|
Number of personnel at the end of the period |
37 |
28 |
32.1% |
37 |
28 |
32.1% |
Timo Lehtonen, CEO of Bioretec Ltd:
”In 2023, Bioretec achieved a historic milestone by becoming the first player to receive an FDA market authorization in the U.S. for a biodegradable metal product with our RemeOs™ magnesium alloy screw. This landmark achievement not only signifies our entry into the world's largest orthopedic market but also sets a strong foundation for the future commercialization of our innovative RemeOs™ product line. Our continuous efforts in developing advanced, bioabsorbable orthopedic solutions also resulted in the year ending with the highest net sales in Bioretec's history.
Following the FDA market authorization, we conducted a diligent evaluation process for various distribution channels, which resulted in a partnership with Spartan Medical. This collaboration is particularly strategic, given Spartan's network and experience in both civilian and Department of Defense and Veterans healthcare (DOD & VA) markets. After signing the distribution agreement, we initiated the hospital approvals processes and the roll-out of our RemeOs™ products in chosen top-tier U.S. academic centers and hospitals. As these processes are time-consuming, we are currently awaiting approvals from these selected academic centers and hospitals. The shipments of the RemeOs™ magnesium screws to Spartan started in the fourth quarter of 2023, and the first surgery using the RemeOs™ screws has been performed.
Last spring, we took in a significant stride in fortifying our financial position through a successful funding round. Despite the challenges presented by the financial market conditions, we managed to secure EUR 10 million in gross proceeds through a directed share issue targeting institutional and other experienced investors. This capital infusion is vital for our company, as it will catalyze the acceleration of commercialization and distribution efforts for our RemeOs™ product line. Additionally, the funds will be instrumental in furthering our product development initiatives and expanding our production capacity, positioning us well for future growth. Therefore, after the funding round, we marked an anticipated decision in Bioretec’s growth trajectory by investing in a new CNC machining center currently dedicated only to our RemeOs™ screws, and the commissioning was completed in January 2024. To further support our growing operations, we've embarked on expanding our production facility space. Additionally, we are investing in a new ERP system scheduled for implementation in 2024. This system is designed to streamline our operations and enhance efficiency, enabling us to surpass our 2023 achievement of delivering products for more than 35 thousand surgical operations. Parallel to these measures, we are also accelerating our product development by expanding our organization and continuing to innovate to meet the evolving demands of the market.
In 2023, we experienced robust growth, with net sales increasing by 33 percent from the previous year, reaching EUR 3.9 million. A significant contributor to this growth was the introduction of our new RemeOs™ screw in the U.S. market, amounting to EUR 374 thousand in its first half year. Meanwhile, China remained a key market for the Activa product group, representing over 50% of our Activa product sales totaling EUR 3.5 million. The sales of RemeOs™ and Activa products in the U.S. showed convincing growth, resulting in nearly 22% of total net sales. In Europe, we faced several market challenges. The discontinuation of deliveries to Russia significantly impacted our operations in Europe. Additionally, this region is still grappling with the aftereffects of the pandemic and acute shortage of hospital staffing, further straining our sales in this market.
As we progress into the first quarter of 2024, we anticipate that we will finally obtain the market authorization for our RemeOs™ trauma screw in Europe. The delay is due to prolonged Notified Body approval processes. Obtaining the CE mark will pave the way for the product's commercialization in the European market. Concurrently, we are set to continue the roll-out of the RemeOs™ screws in the U.S. market and are dedicating substantial resources towards the development of new products in the RemeOs™ series. As part of the expansion plans, we are preparing the next U.S. market authorization application for the RemeOs™ screws, and we have entered into an agreement to conduct a clinical trial of the RemeOs™ DrillPin at the Medical University Hospital in Graz, Austria. This trial is an essential step towards our objective of commercializing the DrillPin in 2025.
As the first half of the year 2024 will partly be burdened by production interruptions (e.g., validation and the ramp-up of our new CNC machining center), we expect our net sales to be generated to a greater extent during the second half of the year. Also, as our RemeOs™ product pipeline is mainly in the development and commercialization phase, we will continue to invest heavily both in S&M and R&D in the forthcoming year. The recruitment process for Bioretec's new CEO is currently underway, and I am transitioning into another leadership position within the organization. I am thrilled to focus my efforts on the future for supporting the RemeOs™ product pipeline's forthcoming endeavors. I am confident that together with the new CEO, we will strengthen our growth to transform bone fracture care and significantly enhance patients’ quality of life.”
Financial reporting and Annual General Meeting in 2024
In 2024, Bioretec will publish the following financial reports:
- annual report for 2023 during week 11/2024 at the latest (week commencing on 11 March 2024)
- business review for January–March 2024 on Thursday 16 May 2024
- half-year report for January–June 2024 on Thursday 15 August 2024
- business review for January–September 2024 on Thursday 14 November 2024
The releases will be available online at Bioretec Ltd’s website at
https://bioretec.com/investors/investors-in-english/reports-and-presentations.
Bioretec Ltd’s Annual General Meeting is planned to be held on Friday, 26 April 2024. The company's Board of Directors will convene the Annual General Meeting separately later.
Tampere, 16 February 2024
Board of Directors
Bioretec Ltd
Further inquiries:
Timo Lehtonen Johanna Salko
CEO CFO
+358 50 433 8493 +358 40 754 8172
timo.lehtonen@bioretec.com johanna.salko@bioretec.com
Certified advisor:
Nordic Certified Adviser AB, p. +46 70 551 67 29
Information about Bioretec
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, CE mark is expected to be received during the first quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
Appendix
Bioretec Ltd’s financial statements bulletin January–December 2023 (pdf)
Bioretec and Stephen Industries donate medical devices to Ukraine
Bioretec and Stephen Industries donate medical devices to Ukraine
Bioretec Ltd Press release 8 February 2024 at 5:00 p.m. EET
Bioretec Oy and its largest shareholder, Stephen Industries Inc Oy, are donating biodegradable implants and instruments used in orthopedic surgeries to Ukraine for use in approximately 900 surgeries. The aid is based on a request from the Orthopedic Trauma Hospital in Kyiv, and the delivery is coordinated by the Finnish and Ukrainian authorities.
"The war, which has been going on for almost two years, has caused a huge amount of human suffering in Ukraine. With the donation, we want to show our support for Ukrainians and the independence of Ukraine", says Kustaa Poutiainen, chairman of the board of Stephen Industries Inc Oy.
The Finnish company Bioretec Oy is a pioneer in the development of biodegradable implants. One advantage of the usage of the product is, that the implants do not have to be removed, which reduces the overall need for surgery.
"Ukraine is in need of many kinds of assistance and its healthcare is working at its limits. As a manufacturer of biodegradable orthopedic implants, we can support Ukraine by donating our products, which eliminate the need for implant removal surgeries, increasingly allocating the resources of the medical staff to acute treatment," says Timo Lehtonen, CEO of Bioretec Oy.
Further enquiries
Timo Lehtonen, CEO, +358 50 433 8493
Johanna Salko, CFO, +358 40 754 8172
Information about Bioretec
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, CE mark is expected to be received during the first quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
Bioretec Ltd´s manufacturer's declaration on the legal extension of the validity of Activa product certifications
Bioretec Ltd´s manufacturer's declaration on the legal extension of the validity of Activa product certifications
Bioretec Ltd Press release 26 January 2024 at 7.50 p.m. EET
In relation to Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, in particular with respect to
- the validity of certificates issued under Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) or Council Directive 93/42/EEC on Medical Devices (MOD) (Directive Certificates) andlor1
- the compliance of the devices and us as their manufacturer with the conditions for the continued placing on the market and putting into service
We, as the manufacturer, declare the validity of legal extension for the following Activa Products groups; ActivaPin™, ActivaScrew™, ActivaScrew™ Interference TCP, Activa IM-Nail, and Instruments Product Groups, and in separate attachment ActivaScrew™ Interference Product Groups
See the attachments:
- Mfr Declaration_Extension of MDR Transitional Period_AP, AS, ASI TCP, IM-Nail, Instruments_with logo.pdf
- Mfr Declaration_Extension of MDR Transitional Period_ASI_with logo.pdf
Further enquiries
Mari Ruotsalainen, Director, QA&RA, +358 40 766 5691
New shares in Bioretec Ltd subscribed with option rights have been registered into the Trade Register
New shares in Bioretec Ltd subscribed with option rights have been registered into the Trade Register
Bioretec Ltd Company announcement 18 January 2024 at 8:00 a.m. EEST
An aggregate number of 800,000 new shares of Bioretec Ltd have been subscribed for with option rights under the company’s option program 2019–1. The new shares have been registered into the Trade Register maintained by the Finnish Patent and Registration Office on 18 January 2024. The total subscription price of EUR 120,000.00 will be recorded in Bioretec's reserve of invested unrestricted equity, and the company's share capital will remain unchanged.
Following the registration of the new shares, the total number of shares in Bioretec is 20,336,858.
The new shares will be issued in the book-entry system on or about 19 January 2024. The new shares will confer shareholder rights in the company as of their registration on the investors' book-entry accounts. Trading in the new shares is expected to commence on the Nasdaq First North Growth Market Finland marketplace on or about 22 January 2024.
Further enquiries
Timo Lehtonen, CEO, +358 50 433 8493
Johanna Salko, CFO, +358 40 754 8172
Certified adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Information about Bioretec
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark is expected to be received during the first quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
Bioretec Ltd – Managers’ transactions
Bioretec Ltd – Managers’ transactions
Bioretec Ltd Managers’ transactions 9 January 2024 at 17.00 p.m. EET
Bioretec Oy - Managers' Transactions
____________________________________________
Person subject to the notification requirement
Name: Michael Piccirillo
Position: Member of the Board/Deputy member
Issuer: Bioretec Oy
LEI: 7437008736AG7HY51K13
Notification type: INITIAL NOTIFICATION
Reference number: 48928/4/4
____________________________________________
Transaction date: 2023-01-12
Venue: FIRST NORTH GROWTH MARKET FINLAND (FSME)
Instrument type: SHARE
ISIN: FI4000480454
Nature of transaction: ACQUISITION
Transaction details
(1): Volume: 2447 Unit price: 1.95 EUR
Aggregated transactions (1):
Volume: 2447 Volume weighted average price: 1.95 EUR
Further enquiries
Timo Lehtonen, CEO, tel. +358 50 433 8493
Johanna Salko, CFO, tel. +358 40 754 8172
Certified adviser: Nordic Certified Adviser AB, +46 70 551 67 29
Information about Bioretec
Bioretec is a globally operating Finnish medical device company that continues to pioneer the Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, CE mark is expected to be received during the first quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com