Bioretec Ltd's business review January-March 2024: Controlled launch in the U.S. progresses

January-March 2024 in brief January- March 2024in brief This business review is unaudited. This is Bioretec's first business review for the first quarter, and comparison period figures have not been published earlier. Key events during the reporting period Timo Lehtonen, CEO of Bioretec Ltd: "In the first quarter of 2024, our focus was on the production and distribution of our Activa product line as the U.S. market continued to utilize inventories of the RemeOs™ trauma...

January-March 2024 in brief

This business review is unaudited. This is Bioretec's first business review for the first quarter, and comparison period figures have not been published earlier.

Key events during the reporting period

Timo Lehtonen, CEO of Bioretec Ltd:

"In the first quarter of 2024, our focus was on the production and distribution of our Activa product line as the U.S. market continued to utilize inventories of the RemeOs™ trauma screw from Q4 2023. Net sales this quarter were distinctly marked by contributions from different regions: Europe accounted for 27% of net sales (19% in the comparison period), the U.S. increased from 16% to 24%, while the rest of the world decreased from 65% to 49%.

The controlled launch of RemeOs™ trauma screw continued, with an evolving number of surgeries performed utilizing this innovative product. We are actively collecting and analyzing follow-up data from the surgeries to assess the efficacy of the fracture healing treated with our screws.

In preparation for continued US sales growth, the need to enhance our production capabilities resulted in a planned production shutdown In January, which is reflected in our profitability numbers for this period. This operational enhancement included the commissioning, qualification, and ramp-up of the new CNC machine dedicated to our trauma screw line and increasing our resource allocation to operational personnel and projects, setting the stage for increased output in subsequent quarters.

Looking ahead, we are waiting to receive market authorization for the RemeOs™ trauma screws in Europe during the second quarter of 2024. Our development efforts are ongoing for the next RemeOs™ pipeline products, supported by the new RemeOs™ magnesium alloy patent and the new FDA Breakthrough Device Designation received for the Spinal Interbody Cage. Additionally, we are advancing our plans for the next U.S. market authorization and initiating the RemeOs™ DrillPin clinical study in Austria, waiting for the ethical committee and other regulatory approvals to start the First-in-Human study.

As we have concentrated on enhancing our production capabilities in the first quarter, we project that our net sales will be more heavily concentrated in the second half of the year. This strategic growth platform building has been required to expand production capabilities to serve the future anticipated market demand and product portfolio expansions.

We are grateful to our investors, customers, and personnel for their continued confidence and support. Your trust encourages our commitment to innovation and excellence as we navigate these exciting opportunities and challenges."

Financial reporting in 2024

In 2024, Bioretec will publish the following financial reports:

The releases will be available online at Bioretec Ltd's website at

https://bioretec.com/investors/investors-in-english/reports-and-presentations

Tampere, 16 May 2024

Board of Directors
Bioretec Ltd 

Certified advisor: 
Nordic Certified Adviser AB, p. +46 70 551 67 29

Information about Bioretec

Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. 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 is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable 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 combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark is expected to be received during the second quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.

Better healing - Better life. www.bioretec.com

Appendix

Bioretec Ltd's business review January-March 2024 (pdf)

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