A year of rebuilding and renewed focus

Bioretec Ltd Company announcement 13 February 2025 at 9:30 a.m.

TAMPERE, Finland, Feb. 13, 2026 /PRNewswire/ -- This company announcement is a summary of Bioretec Ltd's financial statements bulletin for January–December 2025. 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://investors.bioretec.com/en/reports_and_presentations The financial statements bulletin is unaudited.

July–December 2025 in brief

• Net sales amounted to EUR 1,448 thousand (6–12/2024: EUR 2,482 thousand)
• Sales margin was EUR 1,006 (1,770) thousand, or 69.5% (71.3%) of net sales
• EBITDA was EUR -3,919 (-2,189) thousand
• The result for the reporting period amounted to EUR -3,855 (-2,730) thousand
• On December 16, Bioretec updated its strategy for 2026–2028 and provided new financial targets for the strategy period

January–December 2025 in brief

• Net sales amounted to EUR 3,522 thousand (1–12/2024: EUR 4,544 thousand)
• Sales margin was EUR 2,314 (3,221) thousand, or 65.7% (70.9%) of net sales
• EBITDA was EUR -8,476 (-4,053) thousand
• The result for the reporting period amounted to EUR -9,483 (-4,614) thousand
• The Board of Directors proposes that no dividend be distributed for the financial period January 1 – December 31, 2025

Key figures

Significant events in 2025

• On January 31, Bioretec announced that it has received CE mark approval of its RemeOsTM Trauma Screw portfolio, allowing for market launch in Europe.
• On March 7, Bioretec announced the appointment of Mirva Ekman as Quality Director and member of the Management Team as of April 22, 2025. As part of the transition, Mari Ruotsalainen, previously RA/QA Director, will continue as a member of the Management Team as Regulatory Affairs Director.
• On March 21, Bioretec announced that its Board of Directors has decided on a new option program for the CEO.
• On May 8, Bioretec announced that CEO Alan Donze will resign from his position and will remain available for the company until July 7, 2025.
• On May 15, Bioretec announced that it has appointed Sarah van Hellenberg Hubar-Fisher as the company's interim CEO.
• On May 28, Bioretec's Board of Directors resolved on a rights issue of approximately EUR 9.2 million.
• On June 24, Bioretec announced the final results of the successful rights issue. Bioretec received gross proceeds of approximately EUR 9.2 million from the offering.
• On July 11, Bioretec announced the appointment of René Eve as Director of Operations and member of the Management Team as of August 18, 2025. Esa Hallinen, former Director of Operations, will pursue a career outside Bioretec.
• On August 27, Bioretec announced that it has appointed Sarah van Hellenberg Hubar-Fisher as CEO.
• On September 2, Bioretec announced the appointment of Jordy Winters as Vice President of OUS Sales and member of the Management Team. In parallel, Rami Ojala, previously Vice President of OUS Sales, will transition into the newly created role of Head of Global Medical Education.
• On September 4, Bioretec announced the appointment of Dr. Christopher W. DiGiovanni to the Scientific Advisory Board.
• On September 12, Bioretec updated the commercialization status of RemeOsTM DrillPin. The planned commercialization of the DrillPin in the U.S. will progress on a revised timeline to reflect recent FDA guidance on data requirements specific to novel materials.
• On September 15, Bioretec announced the appointment of Anne-Mari Matikainen as interim CFO. Former CFO Johanna Salko will support the company during the transition phase until November 30, 2025.
• On September 16, Bioretec announced the composition of the Shareholders' Nomination Board, consisting of Tor-Oskar Karlberg from Stephen Industries Inc Oy, Rami Vehmas from Keskinäinen Eläkevakuutusyhtiö Ilmarinen, and Heinz Moitzi from W&M GmbH.
• On October 1, Bioretec announced on that the RemeOsTM Trauma Screw has been granted Transitional Pass-Through Payment (TPT) status by the U.S. Centers for Medicare & Medicaid Services (CMS).
• On October 27, Bioretec announced that the company is in the process of assessing and updating its overall commercialization strategy and pipeline and will be providing an update by the end of 2025. In the course of its assessment, the Board of Directors of Bioretec concluded that the financial targets published on October 4, 2024 were unattainable and will likely not be met. Accordingly, Bioretec withdrew its previously disclosed financial targets.
• On October 27, Bioretec announced that it adjusts and restates previously reported H1/2025 figures and does not expect accelerated sales in 2025. Bioretec published the corrected H1/2025 half year report on October 31, 2025.
• On November 12, Bioretec announced that it initiates change negotiations to enhance operational efficiency and competitiveness. The negotiations will focus on Bioretec's production and marketing functions in Finland. The change negotiations were completed on December 4.
• On December 14, Bioretec announced that it has been granted FDA Breakthrough Device Designation status for its RemeOsTM DrillPin, becoming the third Breakthrough Device Designation granted to Bioretec by the FDA (Trauma Screw 2021, Spinal Cage 2024).
• On December 16, Bioretec updated its strategy for 2026–2028 and provided new financial targets for the strategy period. The new financial targets are to reach net sales exceeding EUR 10 million by the end of the year 2028 and to maintain an average sales margin exceeding 70% during the strategy period.

CEO Sarah van Hellenberg Hubar-Fisher's comments

A year of rebuilding and renewed focus

"2025 was a year of transition and rebuilding. After stepping into the CEO role in May, it quickly became clear to me and the leadership team that to unlock Bioretec's full potential, we first needed to strengthen the foundation. We therefore spent the year reviewing every aspect of our operations, commercial structure, and performance to ensure a stable base, capable of supporting Bioretec's future growth. As a result of these necessary adjustments, we exit the year with a more agile commercial organization, a strengthened strategic focus, and greater readiness to execute our next phase.

Our financial results reflect a year of taking one step back to reposition for lasting progress. Absorbing significant changes in leadership roles, commercial capabilities, distribution models, and ordering cycles were investments in resilience and scalability. The deliberate transition from stocking distributors to a direct distribution model in the United States in 2025, marks a strategic move that provides stronger transparency, predictability and long-term quality of net sales. While the financial results reflected the impact of strategic resets, they also reinforced the value of decisive action. At the same time, continued R&D momentum advanced our world class portfolio, further paving the way for sustainable topline growth.

Looking ahead, our commitment is to clarity of execution, anchored by measurable goals, data-driven accountability, and clear communication around our strategy and its developments. Despite ongoing macroeconomic headwinds, the healthcare sector remains strongly receptive to Bioretec's leading absorbable technologies focused on healing. With disciplined execution and clear objectives, Bioretec enters 2026 better aligned, more resilient, and ready to capture market opportunity.

Commercial momentum

Commercial momentum is accelerating as we actively expand awareness of Bioretec's technology across key markets. In H2 2025, we re-established our commercial presence in high impact geographic regions where Bioretec's technology had been underrepresented. Demand for next-generation biomaterial solutions is clear—and our sharpened "where to play" strategy ensures we are targeting the right markets with precision. We now have greater insight into adoption timelines, regulatory pathways, and procurement dynamics within both the U.S. and international markets and are prepared to execute with clear intent.

Across all key geographies, we've deepened our understanding of key drivers of adoption—from pricing strategies and clinical advocacy to surgeon education and partnership engagement- and converted those insights into actions. These foundations are already showing results: direct sales revenue in the U.S. grew for three consecutive quarters in 2025, representing commercial growth in both our Activa and RemeOsTM product families, a strong signal that our rebuilt commercial strategy and structure is poised to deliver. Outside of the U.S., the activation of key markets with new distribution partners, contractual improvements, and a full review of margin improvement opportunities, strengthens our market position and aligns with more profitable performance in the year ahead. 

In addition to our world class Scientific Advisory Board, 2025 marked the establishment of our Key Opinion Leader (KOL) network in the United States, bringing fresh guidance and support for Bioretec's commercial strategy from respected thought leaders in their field. With an energized pipeline, new product launches ahead, and a renewed go-to-market strategy in place, Bioretec enters 2026 positioned to accelerate.

Milestones for the RemeOsTM product family

Our RemeOs™ product family achieved important milestones in 2025. The CE mark approval for the Trauma Screw in January marked a major step into commercialization for countries that recognize the CE mark. Since then, the RemeOs™ line has advanced from development to early commercial uptake, bolstered by new surgeon experiences and country-level approvals.

Regulatory and reimbursement progress in the U.S. further strengthened our position with key milestones in the fourth quarter. In October, the RemeOs™ Trauma Screw received Transitional Pass-Through Payment status from CMS, underscoring the economic potential of absorbable metal technology. Shortly after, the FDA granted Breakthrough Device Designation for the DrillPin—our third such designation, and a first for any absorbable implant company worldwide. These achievements affirm the clinical and economic relevance and differentiation of Bioretec's portfolio and highlight our capacity to lead this emerging segment.

Focus on performance and growth

December marked the announcement of our updated near-term strategy for the period 2026–2028. The strategy prioritizes disciplined execution, capital efficiency, and continued innovation through the expansion of the RemeOs™ platform. Our financial trajectory balances our ambition with the recognition of the resources needed to advance in our key markets and the opportunity for acceleration through key partnerships. The strategy is designed to translate opportunity into results, concentrated resources where we see the strongest clinical demand and commercial return.

Our financial trajectory is both deliberate and balanced. We are advancing priority markets while preserving the flexibility to accelerate through select partnerships that enhance scale, access, or capability. This approach aligns ambition with operating discipline and reflects our commitment to sustainable value creation.

Throughout 2025, Bioretec strengthened its operating foundation. We sharpened accountability, reinforced the organization, and demonstrated the resilience required to execute through change. The team, fully aligned with the Board and shareholders, has demonstrated the resilience needed to navigate change and has emerged stronger and in position to deliver.

We now enter 2026 with renewed confidence, clear priorities, and a unified organization ready to execute on our priorities. The rebuilding phase was essential; the momentum now begins."

Board of Director's dividend proposal

On December 31, 2025, the parent company's distributable funds totaled EUR 8,031,881.58. The Board of Directors proposes that the parent company loss of EUR 7,848,906.59 for the financial period from January 1 to December 31, 2025 be credited in the equity as Profit (loss) for previous accounting periods and that no dividend be distributed.

Financial reporting and Annual General Meeting in 2026

In 2026, Bioretec will publish the following financial reports:

• Annual report, Board of Directors' report and financial statements for 2025 on Friday, March 13, 2026
• Business review for January–March 2026 on Thursday, May 14, 2026
• Half-year report for January–June 2026 on Thursday, August 13, 2026
• Business review for January–September 2026 on Thursday, November 12, 2026

The releases will be published as company releases and will be available online on Bioretec's website at https://investors.bioretec.com/en/reports_and_presentations

Bioretec Ltd's Annual General Meeting is planned to be held on Friday, May 8, 2026. The company's Board of Directors will convene the Annual General Meeting separately later.

Webcast

A webcast for investors and media will be arranged on February 13, 2026 at 1:00 p.m. EET.

The webcast can be streamed live at https://events.inderes.com/bioretec/2025-results A recording of the webcast can be viewed at the same address later the same day.

During the event, Bioretec's CEO Sarah van Hellenberg Hubar-Fisher and CFO Tuukka Paavola will review the 2025 results and the main events of the review period. The event is held in English.

Tampere, 13 February 2026
Board of Directors
Bioretec Ltd.

For additional information:
Sarah van Hellenberg Hubar-Fisher, CEO
+31 6 1544 8736
sarah.hubar-fisher@bioretec.com

Tuukka Paavola, CFO
+358 50 386 0013
tuukka.paavola@bioretec.com

Certified Adviser
Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. 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. 

The company's latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable 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 first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025.

Bioretec's Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients.

Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit www.bioretec.com

Appendix

Bioretec Ltd's financial statements bulletin January–December 2025 (pdf)

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