Bioretec Ltd Company release 13 November 2025 at 8.30 a.m. EET
TAMPERE, Finland, Nov. 13, 2025/PRNewswire/ -- This announcement summarizes Bioretec Ltd's business review for January--September 2025. The complete business review is attached to this release as a PDF file and available on the company's website at https://investors.bioretec.com/en/reports_and_presentations.
July--September 2025 in brief
-- Net sales amounted to EUR 715 thousand (7--9/2024: EUR 685 thousand).
-- The sales margin (excl. other income) was EUR 441 (499) thousand, or
61.6% (72.9%) of net sales.
-- EBITDA was EUR -1,768 (-1,353) thousand.
-- The result for the reporting period amounted to EUR -1,854 (-1,367)
thousand.
January--September 2025 in brief
-- Net sales amounted to EUR 2,789 thousand (1--9/2024: EUR 2,746 thousand).
-- The sales margin (excl. other income) was EUR 1,749 (1,951) thousand, or
62.7% (71.0%) of net sales.
-- EBITDA was EUR -6,325 (-3,217) thousand.
-- The result for the reporting period amounted to EUR -7,482 (-3,251)
thousand.
Key figures
Change, Change,
EUR 1,000 7--9/2025 7--9/2024 % 1--9/2025 1--9/2024 % 1--12/2024
--------------- --------- --------- ------- --------- --------- ------- ----------
Net sales 715 685 4.5 % 2,789 2,746 1.6 % 4,544
--------------- --------- --------- ------- --------- --------- ------- ----------
Sales margin 533 562 -5.0 % 2,043 2,084 -2.0 % 3,391
--------------- --------- --------- ------- --------- --------- ------- ----------
Sales margin
(excl. other
income) 441 499 -11.7 % 1,749 1,951 -10.3 % 3,221
--------------- --------- --------- ------- --------- --------- ------- ----------
Sales, margin,
% of net sales 74.5 % 82.0 % 73.3 % 75.9 % 74.6 %
--------------- --------- --------- ------- --------- --------- ------- ----------
Sales margin, %
(excl. other
income) 61.6 % 72.9 % 62.7 % 71.0 % 70.9 %
--------------- --------- --------- ------- --------- --------- ------- ----------
EBITDA -1,768 -1,353 -6,325 -3,217 -4,053
--------------- --------- --------- ------- --------- --------- ------- ----------
EBIT -1,823 -1,395 -6,483 -3,316 -4,202
--------------- --------- --------- ------- --------- --------- ------- ----------
Profit / loss
for the period -1,854 -1,367 -7,482 -3,251 -4,614
--------------- --------- --------- ------- --------- --------- ------- ----------
R&D
expenditure, %
of net sales 111.2 % 66.1 % 79.9 % 47.6 % 48.0 %
--------------- --------- --------- ------- --------- --------- ------- ----------
Equity ratio, % 83.7 % 73.1 % 83.7 % 73.1 % 84.9 %
--------------- --------- --------- ------- --------- --------- ------- ----------
Cash and cash
equivalents
(end of
period) 7,263 2,377 205.5 % 7,263 2,377 205.5 % 6,289
--------------- --------- --------- ------- --------- --------- ------- ----------
Number of
personnel (end
of period) 64 44 45.5 % 64 44 45.5 % 47
--------------- --------- --------- ------- --------- --------- ------- ----------
Key events during July--September 2025
-- Bioretec appointed Sarah van Hellenberg Hubar-Fisher as Chief Executive
Officer on 27 August 2025. Van Hellenberg Hubar-Fisher served previously
as Bioretec's interim CEO since May 2025 and as a member of the company's
Board of Directors since 2021.
-- Bioretec appointed René Eve as Director of Operations and as a
member of the Management Team on 11 July 2025.
-- Bioretec appointed Jordy Winters as Vice President of Sales Outside U.S.
and as a member of the Management Team on 2 September 2025. In parallel,
Rami Ojala, previously Vice President of OUS Sales, transitioned into the
newly created role of Head of Global Medical Education.
-- Bioretec updated the commercialization status of RemeOs$(TM)$ DrillPin on
12 September 2025. Bioretec is assessing its overall commercialization
strategy and pipeline, including the commercialization of the DrillPin in
the U.S., and will provide an update by the end of 2025.
-- Bioretec appointed Anne-Mari Matikainen as Interim Chief Financial
Officer and as a member of the Management Team on 15 September 2025. The
recruitment process for a new permanent CFO has been initiated.
CEO Sarah van Hellenberg Hubar-Fisher's comments: Strengthening commercial foundations and strategy design
"Almost six months have passed since I assumed my position as Bioretec's CEO. While I remain very enthusiastic about Bioretec's next phase of growth and the opportunity to lead us there, it has become increasingly evident that corrective actions and strategy adjustment are required to set us up for a clear path to success. As announced in late October, we concluded that our previous financial targets are unattainable given lengthened FDA approval timelines, our financing needs, and the planned strategic readjustment initiatives. In addition, we restated our previously reported H1/2025 figures due to incorrect accounting treatment related to past stocking distributor agreements. While these announcements were certainly unpleasant, they were necessary to clean the slate and ensure that the focus of our business is on the strength of our breakthrough technology.
The year 2025 has been, and will continue to be, a period of transition for Bioretec. With a change of both CEO and CFO, as well as the strengthening of our commercial leadership, we will continue to build market presence and to prepare for future acceleration of sales that can be only driven by clear investment in people and strategy today."
Strengthening our commercialization expertise
"The biggest lesson we have learned is that our U.S. model and related growth expectations rely on the move from a stocking distribution model to direct distribution, excluding our partnership in pediatrics. It also requires an investment in local presence driven by experienced talent to ensure commercial competitiveness and success. Outside of the U.S., knowing where to focus our time and resources for optimal value is key to our performance. A full review of 'where to play' and how to execute geography is essential for our commercial success. These adjustments in our commercialization strategy have already been initiated.
In the third quarter, we strengthened our commercialization expertise in the U.S. with the appointment of Blake Helm as VP of Sales, Area West. Blake brings more than twenty years of sales and distribution management expertise in orthopedics to Bioretec's growing U.S. presence. In addition, we increased the number of direct distribution partners in the U.S. by 7 to a total of 15 partners during the third quarter.
Outside the U.S. (OUS), we appointed Jordy Winters as Vice President of Sales (OUS). He will spearhead Bioretec's commercialization strategy outside the U.S. and advance our expansion into new markets. With nearly two decades of experience in global orthopedic commercial leadership, Jordy's expertise and international perspective will be instrumental to defining where and how we play in international markets as we continue to expand Bioretec's impact outside of the United States. Rami Ojala, previously VP of Sales (OUS), has transitioned into the newly created role, Head of Global Medical Education, developing surgeon training programs and educational initiatives to support clinical adoption of Bioretec's technologies worldwide."
Determined progress in the third quarter
"While we are finalizing our new strategy, we have continued to focus on our ongoing operations. Our net sales in the third quarter prove that our Activa products are continuing to perform, whereas the breakthrough commercial impact of RemeOs(TM) is still underway. Our growth model for RemeOs(TM) is dependent on a broader portfolio of the product family (especially in the U.S.), and reliant on clear investment in training and education as well as brand and product awareness.
The third quarter represents our largest direct sales revenue in the U.S. to date. This is already an important signal of growth in the right places. Progress was further demonstrated by our October 1 announcement after the reporting period, acknowledging that the U.S. Centers for Medicare & Medicaid Services $(CMS)$ granted our RemeOs(TM) Trauma Screw Transitional Pass-Through Payment (TPT) status. In addition, we closed a 3-year commercial distribution deal with OrthoPediatrics, specifically for the U.S. pediatric market in the last month of the quarter, further enhancing our distribution presence."
New strategy published by the end of the year
"The end of the year marks an important stage in shaping Bioretec's future. Together with our strengthened international leadership, we will carefully consider the needed strategic readjustments in order to best position Bioretec for the journey ahead and to ensure the successful commercialization of our groundbreaking products. We will provide an update regarding our commercialization strategy and pipeline, along with revised financial targets, by the end of 2025.
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