Bioretec Ltd  Company release 31 October 2025 at 8.30 a.m. EET

TAMPERE, Finland, Oct. 31, 2025 /PRNewswire/ -- Bioretec announced on 27 October 2025 that it will adjust and restate its previously reported figures for H1/2025.

The adjustment and restatement is related to the sales and distribution agreement with Tri-State Biologics ("TSB"), originally announced on 22 November 2024 (the "TSB Distribution Agreement"). The TSB Distribution Agreement was, upon its signing, based on a stocking distribution model, whereby TSB first purchases products from Bioretec for further sale and distribution by TSB to hospitals in the target geography. Following the signing of the TSB Distribution Agreement, a product repurchase addendum was added on 5 May 2025 to the TSB Distribution Agreement, whereby Bioretec would repurchase from TSB such unpaid products for which TSB was unable to procure purchasers within the payment terms ("Repurchase Addendum"). Following such repurchase under the Repurchase Addendum, Bioretec could then distribute such unpaid products directly to end-users itself, similarly to direct distribution models to which Bioretec is aiming to shift towards in an effort to move away from stocking distribution models in the United States, excluding the Orthopediatrics agreement focused solely on the pediatrics market.

In the company release dated 27 October 2025, Bioretec estimated that the corrections made in the accounting treatment related to the Repurchase Addendum and the products to be repurchased would result in a decrease of previously reported H1/2025 net sales of EUR 0.52 million, as well as an increase in costs of EUR 0.65 million. However, after further review, it was also determined that a one-time credit invoice related to the conclusion of a previous U.S. pilot distributor agreement with Spartan Medical had been incorrectly booked against net sales in Q2/2025. While the Repurchase Addendum causes a restatement of H1/2025 net sales by EUR 0.52 Million as per the company release dated 27 October 2025, the corrected accounting treatment of the aforementioned credit invoice of Spartan Medical offsets this reduction in net sales. 

In this corrected half-year report, the aforementioned one-time credit invoice related to Spartan Medical's distribution agreement (of EUR 0.5 million), as well as the products to be repurchased worth approximately EUR 0.65 million under the TSB Distribution Agreement, are now reported in other expenses, increasing the previously reported other expenses by a total of approximately EUR 1.1 million. The previously reported total level of net sales remains mostly unchanged and represents the true volume of realized sales during the period of April-June 2025. Other minor changes detected during further review, related to changes in inventory and operating expenses, have also been adjusted

This company announcement is a summary of restated Bioretec Ltd's half-year report for January–June 2025. The complete half-year report 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 half-year report is unaudited.

April–June 2025 in brief

• Bioretec successfully closed a funding round of EUR 9 million, demonstrating investor confidence in the company.
• Activa sales developed as expected, with growth particularly in China and Asia, while momentum for RemeOsTM sales builds globally.
• First surgeries performed with RemeOs Trauma Screw in Europe mark another key event supporting the commercialization of RemeOs product line worldwide.
• Net sales decreased by 50.9% and amounted to EUR 678 thousand (4–6/2024: EUR 1,379 thousand). The comparison period included a high initial delivery to a new distributor outside the U.S.
• Sales margin (excl. other income) was EUR 486 (1,033) thousand, or 71.7% (74.9%) of net sales. Sales margin reflects preparation for commercial growth and was impacted by an increase in materials and services costs related to the shift in distribution partners, as well as the lower margin of sales to China. Sales margin during the market development and scale-up phases is planned to improve as sales increase and direct distribution channel partners are well established.
• Profit (loss) for the reporting period was EUR -4,330 (-787) thousand. The cost of the rights issue financing round arranged in June 2025 amounted to EUR 1,065 thousand.
• Earnings per share (undiluted) were EUR -0.14 (-0.04).

January–June 2025 in brief

• Net sales amounted to EUR 2,074 thousand (1–6/2024: EUR 2,061 thousand).
• Sales margin (excl. other income) was EUR 1,308 (1,451) thousand or 63.1% (70.4%) of net sales. The sales margin includes other income of EUR 202 (72) thousand accrued relating to received grants.
• Profit (loss) for the reporting period was EUR -5,628 (-1,884) thousand.
• Earnings per share (undiluted) were EUR -0.18 (-0.09).

Key figures

Key events in April–June 2025

• Bioretec's Board of Directors appointed MBA Sarah van Hellenberg Hubar-Fisher as the company's interim CEO as of 15 May 2025, following the resignation of CEO Alan Donze.
• Mirva Ekman, M.Sc. (Mechanical Engineering), was appointed Quality Director and member of the Management Team as of 22 April 2025.
• Bioretec arranged a rights issue in June 2025, where shareholders were offered up to 6,156,618 new shares for subscription primarily on the basis of shareholders' pre-emptive subscription right in the same proportion as they already hold shares in the company and secondarily by other shareholders or by other persons. The objective of the rights issue was to strengthen Bioretec's capital structure and to ensure its ability to implement its RemeOs™ commercialisation strategy. The rights issue was oversubscribed and Bioretec received gross proceeds of approximately EUR 9.2 million from the rights issue. As a result of the rights issue, the total number of shares in Bioretec increased by 6,156,618 from 24,626,474 to 30,783,092.

Sarah van Hellenberg Hubar-Fisher, Interim CEO of Bioretec Ltd:

The second quarter included the close of our successful funding round of EUR 9 million, highlighting investors' confidence in our innovative product offering, market potential, and strategic direction. This funding round supports the needed investment in leadership resourcing for marketing and sales, global capacity building in operations, and continued R&D investment to support our robust product pipeline. Commercial traction in H1 was highlighted by continued Activa sales development with demand particularly in China and Asia, and the first surgical cases with the RemeOs Trauma Screw being performed in Europe. 

Our robust product pipeline advanced on multiple fronts, including ongoing work to advance 510(k) submissions for the RemeOs cannulated screw in the U.S., progress in our Breakthrough designated and patented hybrid composite for the RemeOs Spinal Interbody Cage program, ethical approval for first in human DrillPin clinical trials, and the commencement of post-marketing clinical follow-up for the CE-marked RemeOs line. In support of our broadened distribution network in the U.S. and the growing demand for efficiency and infection control in that market, we completed the launch of sterile, single-use instruments for our Activa cannulated screw, with the first instruments delivered and now available for use.

Sales margin reflects our commitment to prepare for commercial and operational growth namely in the U.S. market. The margin was impacted by an increase in materials and services costs, such as instrumentation and logistics costs, related to our commercial strategy to shift from using solely stocking distributors to including also direct distribution partners in the U.S.. Furthermore, the first two quarters of the year resulted in high volume demand as a percentage of revenue coming from China, with slightly lower margins.  Sales margin during the market development and scale-up phases is planned to improve as our sales increase and direct distribution channel partners are well established.

The first half of the year also marked a period of transition in the organization from a leadership perspective. It has been an honor for me to step in as interim CEO of Bioretec in mid-May, and I am proud of the oversubscribed funding round we completed in June. I want to thank our shareholders for their strong participation and continued confidence in our journey ahead.  As we continue to focus on scale and strategy refinement, I remain confident that Bioretec is well-positioned to deliver value to shareholders and patients alike.

Financial reporting in 2025

In 2025, Bioretec will publish the following financial reports:

• Business review for January–September 2025 on Thursday 13 November 2025

The financial reports will be available online at Bioretec Ltd's website at

https://investors.bioretec.com/en/reports_and_presentations.

Tampere, 31 October 2025
Board of Directors
Bioretec Ltd

For additional information about the report:

Sarah van Hellenberg Hubar-Fisher   
CEO
+31 6 1544 8736

Anne-Mari Matikainen
Interim CFO
+358 50 322 1069 

Certified Adviser

Nordic Certified Adviser AB, 
+46 70 551 67 29

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.  

Bioretec's Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA polymer. These implants deliver secure fixation through patented innovations and naturally degrade in approximately two years, eliminating the need for costly and invasive removal surgeries while supporting optimal bone regeneration. Activa products are both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients.

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. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit https://bioretec.com.

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SOURCE Bioretec