Kuros Biosciences increases the annual guidance for 2025, The company reports 77% year-over-year increase for the first nine months of 2025

Ad hoc announcement pursuant to Article 53 of the SIX listing rules

Kuros Biosciences increases the annual guidance for 2025
The company reports 77% year-over-year increase for the first nine months of 2025

Financial & Operational Highlights

• Total Medical Device sales rose by 77% to USD 101.1 million for the first nine months of 2025 (9M 2024: USD 57.2 million)
• Direct MagnetOs™ sales increased by 76% to USD 99.7 million for the first nine months of 2025 (9M 2024: USD 56.7 million)
• EBITDA for the Group reached USD 7.4 million (9M 2024: USD 1.6 million)
• Adjusted EBITDA^* arrived at USD 12.2 million, after adjusting import tariffs of around USD 0.7 million, resulting in a margin of 12.1% (9M 2024: 6.5 million at 11.3%)
• As of September 30, 2025, the Group’s cash position increased to USD 20.0 million (June 30, 2025: USD 18.4 million) despite continued investments in net-working capital, transformation and strategic growth initiatives
  
  

Regulatory, Commercial & Clinical Highlights

• Kuros Biosciences initiated the full commercial launch of MagnetOs™ MIS Delivery System in the U.S. following FDA clearance and successful initial cases, establishing a new standard in minimally invasive advanced graft delivery with a mechanism of action supported by Level I clinical evidence¹
• Kuros received Saudi Food and Drug Authority (SFDA) approval for MagnetOs Putty and MagnetOs Granules in Saudi Arabia, a key milestone in Kuros’s Middle East and North Africa (MENA) expansion and approval by one of the region’s most rigorous regulatory authorities

Outlook

• As in the previous year, the Group expects sales in the second half of the year in line with usual seasonal trends. Accordingly, the Group is raising its sales guidance and now expects growth of at least 70% for 2025
  
  

Schlieren (Zürich), Switzerland, October 16, 2025 – Kuros Biosciences (“Kuros” or the “Company”) a leader in innovative biologic technologies, today announced its financial performance for the first nine months of 2025. Total group revenue reached USD 101.1 million, up by 77% compared with the same period in 2024. Revenue from Direct MagnetOs product sales rose 76% year-on-year to USD 99.7 million (9M 2024: USD 56.7 million).

The Group achieved an EBITDA of USD 7.4 million for the first nine months of 2025, up from USD 1.6 million in the prior-year period. Excluding tariff, Adjusted EBITDA^* amounted to USD 12.2 million (9M 2024: USD 6.5 million), representing a margin of 12.1%. The Group expects the tariff effect to be temporary as it implements mitigation measures such as adapting its supply chain and establishing a new production footprint in the U.S.

Cash and cash equivalent stood at USD 20.0 million, up from USD 18.4 million as of June 30, 2025, despite continued investments in net-working capital, transformation and strategic growth initiatives.

Following U.S. FDA clearance and the successful completion of initial U.S. cases earlier this year, Kuros has now commenced the full commercial launch of the MagnetOs MIS Delivery System. Purpose-built for minimally invasive spine procedures, MagnetOs MIS is the only prefilled, sterile, human tissue–free bone graft delivery system with a mechanism of action that is backed by Level I clinical evidence.^1,2 The system delivers MagnetOs efficiently and precisely into hard-to-reach spaces – three times faster than traditional funnel-based delivery methods – offering surgeons a new standard in handling and reliability for minimally invasive surgery.^3,4 The system debuted at the Society for Minimally Invasive Spine Surgery (SMISS) 2025 Annual Meeting, where Dr. Matthew Maserati presented early clinical experience highlighting its ease of use and performance in his MIS fusion procedures.

MagnetOs Putty and MagnetOs Granules were recently approved by the SFDA, marking a major milestone in Kuros’s strategic expansion across the MENA region. As one of the most rigorous regulatory bodies within the Gulf Cooperation Council (GCC), SFDA approval represents a key demonstration of trust in the safety and quality of MagnetOs. Saudi Arabia represents a significant growth opportunity for Kuros.

This approval paves the way for broader access to MagnetOs in one of the region’s most influential markets and underscores Kuros’s commitment to delivering proven, next-generation bone graft solutions worldwide.

Chris Fair, Chief Executive Officer of Kuros Biosciences, stated: "Kuros has recorded a 77% increase in revenue over the first nine months of 2025, marking a significant milestone in our continued expansion. Strong EBITDA underpins our dedication to strategic investment and qualitative growth, with an emphasis on organic development initiatives. Our key growth drivers – including ongoing execution in the spinal market, the launch of innovative technologies like MIS, and expansion into new regions such as extremities and Saudi Arabia – position us to achieve sustained, high-quality growth and deliver lasting value to patients, healthcare professionals, and shareholders around the world."

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About MagnetOs
Growing bone with MagnetOs^TM gives surgeons confidence where it matters most – delivering predictable fusion outcomes.² In a Level I human clinical study published in Spine, MagnetOs achieved nearly twice the fusion rate of autograft (79% vs. 47%) in posterolateral fusions (PLFs).² Among active smokers – who made up 1 in 5 patients – the fusion difference between MagnetOs and autograft was even more dramatic.^†‡2,5 MagnetOs grows bone on its own thanks to NeedleGrip^TM – a proprietary submicron surface technology that harnesses the immune system to stimulate bone growth, without added cells or growth factors.^§¶6-8 Ready-to-use, easy to mold, and reliably staying put, MagnetOs carries no intrinsic risk of human tissue-related disease transmission and is FDA cleared for use throughout the spine, including interbody procedures.^#1,3,9-12

Indications Statement
Please refer to the instructions for use for your local region for a full list of indications, contraindications, warnings, and precautions.

About Kuros Biosciences
Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies. With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company’s first commercial product, MagnetOs^TM, is a unique advanced bone graft that has already been used across five continents. For more information on the company, its products and pipeline, visit kurosbio.com.

Forward Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors. Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

^* Adjusted EBITDA excludes recurring and one-time share-based compensation, the relevant social security charges and additionally excludes the temporary tariff-related cost. Management believes this supplemental measure provides useful information to investors by illustrating underlying operating performance before the impact of newly introduced import duties.
^†19 of initial 100 patients were active smokers.
^‡ Radiographic fusion data of the smoker subgroup were not statistically analyzed as a subgroup and were not included in the peer-reviewed publication of the study.^2
§ Results from in vitro or in vivo laboratory testing may not be predictive of clinical experience in humans. For important safety and intended use information please visit kurosbio.com. 
^¶ MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft. 
^# MagnetOs must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Flex Matrix must be hydrated with BMA & mixed with autograft in posterolateral spine & intervertebral disc space. MagnetOs Granules must be hydrated with blood in the intervertebral disc space.

1. Instructions for Use (IFU) MagnetOs MIS (US).
2. Stempels, et al. Spine. 2024;49(19):1323-1331.
3. Data on file. MagnetOs MIS.
4. Data on file. MagnetOs Putty and MagnetOs Easypack Putty.
5. Van Dijk, LA. 24th SGS Annual Meeting (Swiss Society of Spinal Surgery). Basel, Switzerland. Aug 2024.
6. Van Dijk, et al. eCM. 2021;41:756-73.
7. Van Dijk, et al. J Immunol Regen Med. 2023;19:100070.
8. Duan, et al. eCM. 2019; 37:60-73.
9. Instructions for Use (IFU) MagnetOs Granules (US).
10. Instructions for Use (IFU) MagnetOs Putty (US).
11. Instructions for Use (IFU) MagnetOs Easypack Putty (US).
12. Instructions for Use (IFU) MagnetOs Flex Matrix (US).

Attachment

• Kuros Press Release Q3 2025 Results 2025 10-16-2025

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