Bioretec Ltd Inside information 27 October 2025 at 9.14 p.m. EEST
TAMPERE, Finland, Oct. 27, 2025 /PRNewswire/ -- On 22 November 2024, Bioretec Ltd ("Bioretec" or the "Company"), announced through a press release a new sales and distribution agreement with Tri-State Biologics ("TSB"), enabling the sale and distribution of implants and instrument sets to hospitals within Greater New York City, Philadelphia, New Jersey, Connecticut, and Massachusetts area (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, it became evident that the sales of Bioretec's products in 2025 were not progressing in line with expectations of the TSB Distribution Agreement, and 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 its unaudited half-year report covering the financial period from 1 January 2025 to 30 June 2025 published on 14 August 2025 (the "H1 Report"), Bioretec reported net sales of approximately EUR 2.06 million. The net sales in the H1 Report included the sales proceeds of the full stock of products initially sold by Bioretec to TSB in the amount of approximately EUR 0.52 million. The net sales in the H1 Report, however, did not take into account the addition of the Repurchase Addendum under the TSB Distribution Agreement and the resulting potential for Bioretec to repurchase products from TSB. As a result, the net sales reported by Bioretec in the H1 Report were reported overly optimistically without full provision for the Repurchase Addendum and without provision for the volume of products that are now being repurchased under the Repurchase Addendum, resulting in the need to make a corresponding adjustment to the net sales reported in the H1 Report. Taking into account the repurchase under the Repurchase Addendum, the adjusted and restated net sales for the period covered by the H1 Report is approximately EUR 1.54 million (instead of approximately EUR 2.06 million as previously reported). Other cost effects of products sold earlier under the TSB Distribution Agreement will equal to an additional adjustment of approximately EUR 0.65 million when compared to the H1 Report.
The adjustment and restatement of net sales reported in the H1 Report will result in the restatement of also other financial information included in the H1 Report, and Bioretec will release adjusted and restated financial information for the financial period from 1 January 2025 to 30 June 2025 as soon as practicably possible.
In connection with the publication of the H1 Report, Bioretec also stated on 14 August 2025 that it will continue to focus on building market presence and to prepare for the expected acceleration of sales through the remainder of the year. The repurchase under the Repurchase Addendum, as well as Bioretec's efforts to shift from using solely stocking distributors to also using direct distribution partners in the U.S., have removed Bioretec's expectations for the acceleration of sales through the remainder of 2025, and net sales for the full year 2025 are expected to be significantly less than what was expected in connection with the H1 Report announced on 14 August 2025.
As previously announced, the Company will also provide an updated commercialization strategy and pipeline along with its revised financial targets by the end of 2025 as it, e.g. aims to shift from stocking distributors to direct distribution partners in the U.S.
Further enquiries
Sarah van Hellenberg Hubar-Fisher, CEO, +31 6 1544 8736
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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