Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings - Stephen Industries Inc Oy
Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings - Stephen Industries Inc Oy
Bioretec Ltd Company announcement 20 May 2024 at 7:00 p.m. EEST
Bioretec Ltd has on 20th May 2024 received a notification in accordance with the Securities Market Act, according to which the holdings of shares and votes of Stephen Industries Inc Oy in Bioretec Ltd have before 19 April 2024 crossed the threshold of 10%. The reason for the flagging notification is the amendment to the Securities Market Act, which expanded the flagging obligation to companies listed on the Nasdaq First North Growth Market Finland.
Total position of Stephen Industries Inc Oy according to the notification:
|
|
% of shares and voting rights |
% of shares and voting rights through financial instruments |
Total of both in % |
Total number of shares and voting rights of the issuer |
|
Resulting situation on the date on which threshold was crossed or reached |
10.85% |
0% |
10.85% |
20,336,858 |
|
Position of previous notification (if applicable) |
|
|
|
|
Notified details of the resulting situation on the date on which the threshold was crossed:
|
|
Number of shares and voting rights |
% of shares and voting rights |
||
|
Class/type of shares |
Direct (SMA 9:5) |
Indirect (SMA 9:6 and 9:7) |
Direct (SMA 9:5) |
Indirect (SMA 9:6 and 9:7) |
|
FI4000480454 |
2,206,370 |
0 |
10.85% |
0% |
|
SUBTOTAL |
2,206,370 |
10.85% |
||
After 19 April 2024, Stephen Industries Inc Oy holds 10.85% of the shares and votes.
Further enquiries
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
Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings (Stephen Industries Inc Oy)
Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings (Stephen Industries Inc Oy)
Bioretec Ltd Company announcement 20 May 2024 at 7:00 p.m. EEST
Bioretec Ltd has on 20th May 2024 received a notification in accordance with the Securities Market Act, according to which the holdings of shares and votes of Stephen Industries Inc Oy in Bioretec Ltd have before 19 April 2024 crossed the threshold of 10%. The reason for the flagging notification is the amendment to the Securities Market Act, which expanded the flagging obligation to companies listed on the Nasdaq First North Growth Market Finland.
Total position of Stephen Industries Inc Oy according to the notification:
|
|
% of shares and voting rights |
% of shares and voting rights through financial instruments |
Total of both in % |
Total number of shares and voting rights of the issuer |
|
Resulting situation on the date on which threshold was crossed or reached |
10.85% |
0% |
10.85% |
20,336,858 |
|
Position of previous notification (if applicable) |
|
|
|
|
Notified details of the resulting situation on the date on which the threshold was crossed:
|
|
Number of shares and voting rights |
% of shares and voting rights |
||
|
Class/type of shares |
Direct (SMA 9:5) |
Indirect (SMA 9:6 and 9:7) |
Direct (SMA 9:5) |
Indirect (SMA 9:6 and 9:7) |
|
FI4000480454 |
2,206,370 |
0 |
10.85% |
0% |
|
SUBTOTAL |
2,206,370 |
10.85% |
||
After 19 April 2024, Stephen Industries Inc Oy holds 10.85% of the shares and votes.
Further enquiries
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
Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings (Stephen Industries Inc Oy)
Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings (Stephen Industries Inc Oy)
Bioretec Ltd Company announcement 20 May 2024 at 7:00 p.m. EEST
Bioretec Ltd has on 20th May 2024 received a notification in accordance with the Securities Market Act, according to which the holdings of shares and votes of Stephen Industries Inc Oy in Bioretec Ltd have before 19 April 2024 crossed the threshold of 10%. The reason for the flagging notification is the amendment to the Securities Market Act, which expanded the flagging obligation to companies listed on the Nasdaq First North Growth Market Finland.
Total position of Stephen Industries Inc Oy according to the notification:
|
|
% of shares and voting rights |
% of shares and voting rights through financial instruments |
Total of both in % |
Total number of shares and voting rights of the issuer |
|
Resulting situation on the date on which threshold was crossed or reached |
10.85% |
0% |
10.85% |
20,336,858 |
|
Position of previous notification (if applicable) |
|
|
|
|
Notified details of the resulting situation on the date on which the threshold was crossed:
|
|
Number of shares and voting rights |
% of shares and voting rights |
||
|
Class/type of shares |
Direct (SMA 9:5) |
Indirect (SMA 9:6 and 9:7) |
Direct (SMA 9:5) |
Indirect (SMA 9:6 and 9:7) |
|
FI4000480454 |
2,206,370 |
0 |
10.85% |
0% |
|
SUBTOTAL |
2,206,370 |
10.85% |
||
After 19 April 2024, Stephen Industries Inc Oy holds 10.85% of the shares and votes.
Further enquiries
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: Alan Donze has been appointed as Bioretec's new CEO
Inside information: Alan Donze has been appointed as Bioretec's new CEO
Bioretec Ltd Inside information 20 May 2024 at 6:00 p.m. EEST
Bioretec Ltd is pleased to announce that Mr. Alan Donze has been appointed CEO of Bioretec as of today, 20 May 2024. He will start in this position immediately. With a distinguished career spanning the banking and medical device industries, Mr. Donze brings a wealth of experience and expertise to the Bioretec organization.
Mr. Donze began his career journey in the banking industry, serving as the Vice President of Commercial Lending and Leveraged Finance for a regional predecessor to Chase bank. He left banking to begin his medical device career as a Regional Sales Representative for Stryker Endoscopy in 1991. Over his 13 years at Stryker, Mr. Donze’s responsibilities increased to various senior management positions, including Vice President General Manager of Stryker Endoscopic Service and Vice President General Manager of Stryker Communications, a division he was given the tremendous opportunity to create and build from the ground up. Mr. Donze has also held senior leadership positions for a number of other medical device and technology companies including Smith+Nephew, Bioventus, and Lima Corporate and venture-led startups such as Isotis Orthobiologics, Aerobiotix and Rx.Health. Mr. Donze received his Bachelor of Science in Finance from Louisiana State University.
"We are excited to announce the appointment of Alan Donze as our new Chief Executive Officer. With his proven track record of leadership and vision, we are confident that Alan will lead our company to new heights of commercial success. Alan brings with him 30 years of sales and marketing leadership experience in medical devices, where he has demonstrated a deep understanding of market dynamics and a relentless drive for excellence. His strategic insights and passion for Bioretec's mission make him the ideal leader to guide us into the future," says Tomi Numminen, Bioretec's Chairman of the Board.
"I am honored to be given the opportunity to lead Bioretec to the next level and deeply appreciate the confidence placed in me by the Board of Directors. Bioretec’s groundbreaking work in developing alternatives to traditional metal implants represents a significant advancement in the medical field. Our products have the potential to reduce the need for invasive surgeries and improve patient outcomes, aligning with a critical need within the healthcare community. I am eager to contribute to Bioretec’s mission by expanding our efforts to introduce these transformative solutions to the benefit of many more patients. I look forward to the journey ahead and to our continued growth and success,” says Alan Donze.
Timo Lehtonen, Bioretec's CEO since 2019, will transfer to the position of Chief Technology Officer (CTO) and continue to lead the development of Bioretec’s future product pipeline.
"It has been a privilege to lead Bioretec since 2019 and support its remarkable growth through interesting, challenging times. I am excited to focus my efforts on advancing the RemeOs™product pipeline. Together with Alan, I am confident we will continue to strengthen our growth and transform bone fracture care. In my forthcoming role as CTO, I will leverage my extensive experience in innovation, product development, and regulatory expertise to support the management team and our skilled personnel. Our goal is to achieve the best possible outcomes in redefining bone fracture treatment and improving patients' quality of life," says Timo Lehtonen.
"I would like to thank Timo Lehtonen for his passionate and dedicated leadership as our CEO over the past five years. Under his guidance, Bioretec has grown strongly and strengthened its position as a leading innovator in biodegradable technologies. With its biodegradable metal implants, the company has significantly modernized the surgical treatment of bone fractures, which significantly increases the quality of the lives of the patients. Our mutual and succesful path with Timo continues while he assumes the role of CTO in which role he continues to provide important support for the future development of our product pipeline," says Chairman of the Board Tomi Numminen.
Further enquiries
Tomi Numminen, Chairman of the Board, tel. +358 40 581 2132
Certified advisor
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 has been received in the U.S. in March 2023, and in Europe, the CE-mark is expected to be received during the second quarter of 2024. Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
Bioretec Ltd’s business review January–March 2024: Controlled launch in the U.S. progresses
Bioretec Ltd’s business review January–March 2024: Controlled launch in the U.S. progresses
Bioretec Ltd Company announcement 16 May 2024 at 8:30 a.m.
This announcement summarizes Bioretec Ltd’s business review for January–March 2024. The complete business review is attached to this release as a PDF file and available on the company’s website at https://bioretec.com/investors/investors-in-english/releases.
January–March 2024 in brief
- Net sales amounted to EUR 682 thousand (1–3/2023: EUR 1,071 thousand).
- The sales margin was EUR 478 (718) thousand, or 70.1% (67.0%) of net sales. The sales margin of 2024 includes other income of EUR 60 thousand accrued relating to the Business Finland grant. When excluding the grant effect, the sales margin for the current reporting period is EUR 418 thousand, or 61.3%. The main reason for the lower sales margin percentage has been the planned production shutdown due to the ramp-up of new production capacity.
- EBITDA was EUR -1,112 (-491) thousand. EBITDA was EUR -1,112 (- 491) thousand. It was burdened by increased personnel costs due to headcount growth and additional fixed costs relating to U.S. commercialization and R&D projects.
- The result for the reporting period amounted to EUR -1,097 (-557) thousand.
This business review is unaudited. This is Bioretec’s first business review for the first quarter, and comparison period figures have not been published earlier.
Key figures
|
EUR 1,000 unless otherwise noted |
1–3/2024 |
1–3/2023 |
Change |
1–12/2023 |
|
Net sales |
682 |
1,071 |
-36.4% |
3,906 |
|
Sales margin |
478 |
718 |
-33.4% |
2,810 |
|
Sales margin, % of net sales |
70.1% |
67.0% |
|
71.9% |
|
EBITDA |
-1,112 |
-491 |
126.6% |
-2,833 |
|
EBIT |
-1,139 |
-543 |
109.6% |
-3,034 |
|
Profit/-loss for the period (+/-) |
-1,097 |
-557 |
97.0% |
-3,789 |
|
R&D spend on total costs, % |
25.9% |
24.8% |
|
25.6% |
|
Equity ratio, % |
74.3% |
44.3% |
|
77.3% |
|
Cash and cash equivalents at end of period |
5,981 |
587 |
919.3% |
6,910 |
|
Number of personnel at end of period |
39 |
28 |
39.3% |
37 |
Key events during the reporting period
- European market authorization application for the RemeOsTM trauma screw proceeded to expert panel evaluation. The approval is estimated to be granted during the second quarter of 2024.
- Bioretec was granted an FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage.
- Bioretec’s RemeOs™ biodegradable magnesium alloy composition was granted a patent by the U.S. Patent Office.
Timo Lehtonen, CEO of Bioretec Ltd:
” In the first quarter of 2024, our focus was on the production and distribution of our Activa product line as the U.S. market continued to utilize inventories of the RemeOs™ trauma screw from Q4 2023. Net sales this quarter were distinctly marked by contributions from different regions: Europe accounted for 27% of net sales (19% in the comparison period), the U.S. increased from 16% to 24%, while the rest of the world decreased from 65% to 49%.
The controlled launch of RemeOs™ trauma screw continued, with an evolving number of surgeries performed utilizing this innovative product. We are actively collecting and analyzing follow-up data from the surgeries to assess the efficacy of the fracture healing treated with our screws.
In preparation for continued US sales growth, the need to enhance our production capabilities resulted in a planned production shutdown In January, which is reflected in our profitability numbers for this period. This operational enhancement included the commissioning, qualification, and ramp-up of the new CNC machine dedicated to our trauma screw line and increasing our resource allocation to operational personnel and projects, setting the stage for increased output in subsequent quarters.
Looking ahead, we are waiting to receive market authorization for the RemeOs™ trauma screws in Europe during the second quarter of 2024. Our development efforts are ongoing for the next RemeOs™ pipeline products, supported by the new RemeOs™ magnesium alloy patent and the new FDA Breakthrough Device Designation received for the Spinal Interbody Cage. Additionally, we are advancing our plans for the next U.S. market authorization and initiating the RemeOs™ DrillPin clinical study in Austria, waiting for the ethical committee and other regulatory approvals to start the First-in-Human study.
As we have concentrated on enhancing our production capabilities in the first quarter, we project that our net sales will be more heavily concentrated in the second half of the year. This strategic growth platform building has been required to expand production capabilities to serve the future anticipated market demand and product portfolio expansions.
We are grateful to our investors, customers, and personnel for their continued confidence and support. Your trust encourages our commitment to innovation and excellence as we navigate these exciting opportunities and challenges.”
Financial reporting in 2024
In 2024, Bioretec will publish the following financial reports:
- 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.
Tampere, 16 May 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, the 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
Appendix
Bioretec Ltd’s business review January–March 2024 (pdf)
Resolutions of Bioretec Ltd´s Annual General Meeting and the constitutive meeting of the Board of Directors
Resolutions of Bioretec Ltd´s Annual General Meeting and the constitutive meeting of the Board of Directors
Bioretec Ltd Company announcement 26 April 2024 at 12:15 p.m. EEST
The Annual General Meeting of Bioretec Ltd was held on 26 April 2024 in Tampere, Finland.
The Annual General Meeting approved the financial statements for the financial year 1 January–31 December 2023 and resolved to discharge the members of the Board of Directors and the CEO from liability for the financial period 1 January–31 December 2023.
The Annual General Meeting resolved in accordance with the proposal of the Board of Directors that the loss of EUR 3,721,314.67 for the financial period 1 January–31 December 2023 will be booked in the balance sheet as equity under profit/loss for previous financial periods and that no dividend will be distributed.
Number of members of the Board of Directors, election of members of the Board and their remuneration
The Annual General Meeting resolved that the number of members of the Board of Directors will be five (5). Tomi Numminen, Michael Piccirillo, Sarah van Hellenberg Hubar-Fisher, Päivi Malinen and Kustaa Poutiainen were re-elected as members of the Board. The term of the Board of Directors will end at the closing of the Annual General Meeting 2025.
The Annual General Meeting resolved that the Chairman of the Board will be paid EUR 10,000 per month. The Chairman will participate in the operative management of the company in the upcoming term. Members of the Board will be paid EUR 1,500 per month. 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.
The Annual General Meeting resolved that the company may enter into a consultancy agreement with Valugen GmbH for the services of Michael Piccirillo in connection with establishing the company’s 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.
Election and remuneration of auditor
The Annual General Meeting elected audit firm PricewaterhouseCoopers Oy as the auditor of the company until the closing of the 2025 Annual General Meeting. Audit firm PricewaterhouseCoopers Oy has notified the company that it will appoint Kalle Laaksonen, Authorized Public Accountant, as the responsible auditor. The auditor will be compensated as reasonably invoiced.
Authorization of the Board of Directors to resolve on the issuance of shares and special rights entitling to shares
The Annual General Meeting authorized 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 the new shares to be issued based on the special rights) can be issued, which on the date
of the notice to the Annual General Meeting corresponded approximately to 15 per cent 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 was authorized to resolve on all terms for share issues and granting of special rights entitling to shares in the company. The Board of Directors was 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.
Establishment of a Shareholders’ Nomination Board and Approval of the Charter
The Annual General Meeting resolved to establish a Shareholders’ 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.
The Annual General Meeting resolved to approve the Charter of the Shareholders’ Nomination Board, which had been attached to the notice to the Annual General Meeting and is available on the company’s website at https://bioretec.com/agm2024.
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 will not have a voting right nor be counted in the quorum of the Nomination Board.
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.
Minutes of the Annual General Meeting
The minutes of the Annual General Meeting will be available no later than 10 May 2024 on the company's website at https://bioretec.com/investors/investors-in-english/governance/general-meetings/annual-general-meeting-2024.
Resolutions of the constitutive meeting of the Board of Directors
At its constitutive meeting held after the Annual General Meeting, the Board of Directors of Bioretec Ltd elected Tomi Numminen as the chairperson of the Board.
The Board resolved to establish an [Audit Committee and a Nomination /Remuneration Committee]. The members of the Committees were elected as follows:
- Audit Committee: Tomi Numminen (chairperson), Päivi Malinen and Sarah van Hellenberg Hubar-Fisher
- Nomination / Remuneration Committee: Päivi Malinen (chairperson), Michael Piccirillo and Kustaa Poutiainen
The Board assessed the independence of its members in accordance with the Finnish Corporate Governance Code for listed companies. The Board concluded that of its members Kustaa Poutiainen is not independent of the company’s significant shareholders and Tomi Numminen and Michael Piccirillo are not independent of the company. Valugen GmbH, a company owned by Michael Piccirillo, receives remuneration from the company for consulting assignments and Tomi Numminen has received compensation for consulting assignments during the past year. In addition, the Board concluded that based on an overall assessment, the other Board members are independent of both the company and its significant shareholders.
Further enquiries
Tomi Numminen, Chairman of the Board of Directors, tel. +358 40 581 2132
Timo Lehtonen, CEO, tel. +358 50 433 8493
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of bioresorbable 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 bioresorbable materials for enhanced surgical outcomes. The RemeOs™ implants are resorbed 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 receive second quarter of 2024. Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
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