Bioretec Ltd's Half-year report 2025: Strong support for future growth from a successful rights issue

TAMPERE, Finland, Aug. 14, 2025 /PRNewswire/ -- Bioretec Ltd  Company announcement 14 August 2025 at 8.00 am EEST

This company announcement is a summary of 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 RemeOs^TM 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 51.7% and amounted to EUR 665 thousand (4–6/2024: EUR 1,379 thousand). The net sales was impacted by a one-time credit invoice related to the conclusion of a U.S. pilot distribution agreement, and a shift from stocking to direct distribution partners in the U.S.. Furthermore, the comparison period included a high initial delivery to a new distributor outside the U.S. Sales to stocking distributors are lumpy and may cause quarterly variance in net sales.
• Sales margin (excl. other income) was EUR 194 (1,033) thousand, or 29.1% (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 -3,504 (-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 -0.12 (-0.04).

January–June 2025 in brief

• Net sales amounted to EUR 2,062 thousand (1–6/2024: EUR 2,061 thousand).
• Sales margin (excl. other income) was EUR 1,016 (1,451) thousand or 49.3% (70.4%) of net sales. The sales margin includes other income of EUR 202 (71) thousand accrued relating to received grants.
• Profit (loss) for the reporting period was EUR -4,801 (-1,884) thousand.
• Earnings per share (undiluted) were EUR -0.16 (-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 continued across our portfolio. Activa sales developed as expected, with growth particularly in China and Asia, while we built momentum for RemeOs globally. Notably, the first surgeries with the RemeOs Trauma Screw were now also performed in Europe, signaling early adoption and setting the stage for increased global utilization in the second half of the year.

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.

Net sales in the first half of the year were stable compared to the year prior as planned, reflecting market development efforts for our breakthrough technology. Net sales in the second quarter was impacted by both a one-time credit invoice related to the conclusion of a U.S. pilot distribution agreement with Spartan Medical as well as a shift in distribution partners and additional direct distribution needs. Furthermore, the comparison period included a high initial delivery to a new distributor and in general, our sales to stocking distributors are lumpy and may cause quarterly variance in net sales. We continue to focus on building market presence and to prepare for the expected acceleration of sales through the remainder of the year.

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 continued growth and long-term 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, 14 August 2025

Board of Directors

Bioretec Ltd

For additional information about the report:
Sarah van Hellenberg Hubar-Fisher  Johanna Salko
Interim CEO     CFO
+31 6 1544 8736    +358 40 754 8172   

Certified adviser
Nordic Certified Adviser
+46 70 551 67 29

Information about Bioretec

Bioretec is a globally operating Finnish medical device pioneer at the forefront of redefining the future of orthopedics with breakthrough absorbable implant technologies that provide sustainable and natural bone healing. Bioretec's Activa® and magnesium-based RemeOs™ platforms combine high strength with complete biodegradability, eliminating costly removal surgeries and enabling faster, safer recovery. The company's products are trusted by surgeons in approximately 40 countries worldwide. With the first RemeOs U.S. market authorization received in 2023, CE mark approval in 2025, and a robust innovation pipeline, Bioretec is positioned to disrupt the USD 10+ billion orthopedic trauma and spine market by delivering value-driven solutions that meet the needs of patients, surgeons, and healthcare systems globally.

Better healing – Better life. www.bioretec.com

Appendix

Bioretec Ltd's half year report 2025 (pdf)

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