Slides
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Webcast February 13, 2026 Financial Statements Bulletin January–December 2025
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Today’s speakers Sarah van Hellenberg Hubar-Fisher CEO Tuukka Paavola CFO
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2025: Rebuilding for Commercial Growth Key transitions in preparation for the next phase of growth • CEO & CFO transition • 5 Management Team member changes • New U.S. Distributor Operating Model • Go-to-Market strategy and operations adjustments • Organizational performance enhancements • Updated financial targets ' 26-’28
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2025 U.S. milestones Accelerating Growth through Regulatory Wins, Partnerships, and Execution Regulatory & Market Access FDA Breakthrough TPT Payment 17 VAC Approvals FDA Breakthrough Device Designation granted for RemeOs DrillPin- our 3rd- the first and only absorbable implant company globally to achieve this recognition CMS Transitional Pass-Through granted for RemeOs Screw LAG Solid 17 VAC approvals secured from leading clinics and institutions Pediatric channel developed with OrthoPediatrics; near-term quotas established Execution & Growth 60% Q/Q Growth KOLs Signed Q4 '25 60% Average Q/Q Growth achieved in US direct sales (2025) New KOLs signed in Q4 2025 driving early adoption & volume Sales quotas deployed and actively managed across distributor network Data-driven sales execution using targeted analytics across RemeOs and Activa Over 20 active distributor partners in • Alabama, Arizona, California, Florida, Illinois, Indiana, Louisiana, Maine, Massachusetts, Michigan, New Hampshire, New Jersey, Ohio, Pennsylvania, Tennessee, Texas & Utah Launched Training and Education and Surgeon led webinars Note: 1) Pass-through-payment is a US reimbursement pathway used to compensate hospitals and surgeons for the usage of innovative medical technologies not yet fully covered by standard M edicare rates; 2) Key Opinion Leader;3) Value Analysis Committee.
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2025 OUS milestones Strategic expansion and diversification in key OUS markets Current Footprint & New Partners Distributor changes completed YE 2025: Joint Operations Ltd appointed in UK & Ireland; Joint Operations GmbH in Germany & Austria. New distribution partners onboarded by February in Switzerland, China, and Turkey. 3-year ('26-'28) minimum quota volumes agreed across all new distributor agreements for the strategic period. Strategic Initiatives China Diversification: RemeOs introduction planned for Q1 EU Focus: Targeting hybrid payor, high value -recognition markets (e.g., Spain). ROW preparation: Canada, UAE and LATAM market targeting and planning underway Evidence Generation: RemeOs Real World Evidence data generation strategy strictly tied to sales execution. Bioretec curre nt fo otprint outside of the US Bioretec planned future foo tprint outside of the US January 2025: CE mark approval for the RemeOsTM Trauma Screw portfolio
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Financials 2025 Financial results reflect absorbing significant changes to leadership and operating model EUR 1,000 unless otherwise indicated 1–12/2025 1–12/2024 Change, % Net sales 3,522 4,544 -22.5% Sales margin 65.7% 70.9% EBITDA -8,476 -4,053 Profit / loss for the period -9,483 -4,614 Cash and cash equivalents 4,126 6,289 -34.4% Number of personnel 60 47 27.7%
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Strategic Priorities & Financial Targets for 2026–2028 Industry Leading Innovation World Class Clinical and Economic Evidence Generation Global Excellence in Commercialization Generation Demonstrate industry leading innovation, clinical evidence generation, and commercial scale by progressing a strong R&D pipeline and introducing at least one new product or indication every 12–18 months, reflected by sustained R&D investments. Build strong market presence and solidify our commercial position in the U.S. through direct distribution channels, targeted Key Opinion Leader engagement strategies, and high-impact training and education. Upgrade our OUS commercial strategy through updated distribution partner selections with rigorous and clear commercial targets and a focused effort on RemeOs launches in high value markets. Establish RemeOs as the leading metal alloy absorbable solution in the orthopedic implant market globally. • Reach net sales exceeding EUR 10 million by the end of the year 2028 • Maintain an average sales margin exceeding 70% during the strategy period Financial Targets The financial targe ts are de pendent on the necessary capital infusio ns re quired to grow in key marke ts like the U.S. and curr ently do not refle ctthe opportunity for acceleratio n thro ugh k ey partnerships.
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Recognized Leadership in Driving the Shift to Absorbables https://www.databridgemarketresearch.com/reports/global-bioabsorbable-orthopedic-implants-market Bioretec will lead the charge on bioabsorbable implant growth globally
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Near Term Product Launches: Path to Growth 3 Near Term Approvals position Bioretec for Market Leadership Activa Headless FDA 510(k) Pending Sizes: 3.5 - 4.5 mm Length: 20–90 mm TAM: ~$0.5B Target: Trauma RemeOs FT Screw FDA 510(k) Path TAM: ~$1.4B Target: Trauma RemeOs DrillPin Trials Enrolling Sizes: 3.5 – 4.0 mm Length: 24 – 50 mm Sizes: 1.9–3.2 mmSizes: TAM: ~$2.1BTAM: Market Disruption Self-drilling (No K-wire) 850K Hammertoe Surgeries Eliminates pin tract infections Source: Global Data report 2023, Orthoworld report 2024, Verified M arket Reports 2024, Company Information BREA KTHROUG H DEVIC E BREA KTHROUG H DEVIC E
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Product Pipeline — Estimated Launch Cadence Each major product launch adds €3–5M annual revenue potential at scale Short -Term Mid-Term Long -Term Re meOs FT Headless 2026 ~$0.7B TAM Fully threaded headless compression screw targeting small bon e fixation. Re meOs DrillPin 2026 ~$2.1B TAM BREA KTHROUG H DEVIC E Game-changer: Self -drilling pin targeting 850K+ hammertoe surgeries an nually. Activa Headless 2026 ~$0.7B TAM Polymer headless screw expanding pediatric and han d/wrist indications. Differentiated Trauma ~$3.0B TAM ESIN nails, specialty screws, staples, and an chors leveraging absorbable tech nology. Re meOs Upper Extremities ~$1.4B TAM Expansion of indication labels to include wrist, elbo w, and shoulder applications. Spine P ortfolio ~$3.0B TAM SI Joint Screw and Interbody Cages utilizing osteopromotive benefits. IM-Nails ~$2.6B TAM Large bone in tramedullary nails for tibia and femur fractures. ≈≈ Plates ~$4.0B TAM Comprehensive plating systems replacing permanent hardware. BREA KTHROUG H DEVIC E BREA KTHR OUG H DEVIC E In house development In-house development + partners In-house development + partners + licencing Mg alloy Hybrid
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Market Momentum: Leading Surgeons are Ready for the Absorbable Shift Prof. Dr. Christopher DiGiovanni FACFAS, double Board Certified Foot and Ankle surgeon, “Absorbable fixation is positioned to become an increasingly important part of foot and ankle surgery. My engagement with the Bioretec Scientific Advisor Board r eflects an interest in supporting the careful scientific research, development, and advancement of these technologies .” Dr. Robert Leland FACFAS, Board Certified Foot & Ankle Surgeon “Bioretec impla nts have d elivered predictable healing of fractures, fusions and osteotomities without the need for hardware removal . I’m excited for the future of bioabsorbable implants in general and Bioretec’s implants specifically as this technology becomes more integrated into patient care. ” Dr. Gary Stewart Board Certified Foot & Ankle Surgeon, FACFAS “I have found RemeOs to provide ex cellent initial fix ation as well as long - term reduction and fixation with the added benefit of not necessitating hardware removal ” Dr. James Cottom DPM, FACFAS "“This technology is amazing , and I feel it will be a major d isruptor in the orthopedic im plant m arket. I look forward to treating my patients with a metal free option going forward! ” Surgeon Scientific Advisory Board + expanding KOL network driving peer -to-peer adoption
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Questions & Answers Two Absorbable Technologies, One Goal — Healing Beyond Absorption
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Activa Proprietary manufacturing process extends protection beyond current patent life Clear repeat market demand and comparable valuation benchmarking with Ossio in the US US Upper Extremities remains untapped in current resourcing model, ready now RemeOs Trauma Near term trauma portfolio expected in <18 months Stronger than bone when it matters: Flexural strength 3–4× cortical bone, then gradual load transfer back to the healing bone as it resorbs RemeOs Spine Pre-comm ercial partnership strategy SI screw serving as strategic door opener expecte d to be game changing for spine procedures Cage already Breakthrough Designated Preclinical readouts expected within strategic period 3 distinct product families to drive value, 3 different IP families DrillPin gamechanger: Self-drilling sim plicity: No pre -drill, no extra hardware, fe we r steps than other absorbables , real versatility - indication base expands to where fiber -based nails are restricted. TAP program invite. Pathways to value creation
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$14B+ market potential with strong absorbables CAGR Total addressable market $3.0B $2.6B $3.0B Mid to long-term $0.5B $2.1B $1.4B Short-term $14.0B +$10.0B $4.0B$1.4B Addressable market for full product line-up >$14B… … with strong absorbables outlook (CAGR 10%+) Plates Spine portfolio IM-Nails Differentiated Trauma Addressable market, 2024 estimate $1.4 (56%) $.04B (6%) $0.7B (38%) 2033 $2.5B Absorbable Stainless steel + Titanium + Trauma Screw market alone to reach ~$2.5B by 2033 RemeOs is positioned to take share from full trauma/extremities/sports med in the near term + spine Sole commercialized productcurrently Headless cannulated screws DrillPin Trauma Screws Activa is positioned to capture share in Ped. Trauma/extremities, sports med Source: Global Data report 2023, Orthoworld report 2024, Verified Market Reports 2024
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Two Absorbable Technologies, One Goal — Healing Beyond Absorption