Bioretec Ltd’s Half Year Report 2023 (unaudited): Historic achievement supported by the strong sales

Bioretec Ltd    Company announcement     11 August 2023 at 9.00 a.m. EET

This is a summary of Bioretec Ltd’s half year report 2023. The complete half year report with tables is attached to this release and available at company web pages at  https://bioretec.com/investors/investors-in-english/releases

 

January-June 2023 in brief

 

• Net sales increased by 33% and amounted to EUR 1,891 thousand (1–6/2022: EUR 1,422 thousand).
• Sales margin was EUR 1,327 (1,018) thousand or 70.2% (71.6 %) of net sales, with year-on-year growth of 30,4%.
• Net profit (loss) for the reporting period amounted to EUR -2,075 (-1,367) thousand, including the total cost of the financing arrangement, which was EUR 795 thousand.
• Earnings per share (undiluted) were EUR -0.11 (-0.10).

 

Key events in January-June 2023

 

• In March 2023, Bioretec received market authorization for its biodegradable RemeOs™ magnesium screw in the U.S.
• In April 2023, Bioretec announced that it will update and refocus its product portfolio to accelerate the commercialization of its products and to provide an offering responding better to the market demand and that it will refine its U.S. go-to-market strategy.
• In April 2023, Bioretec successfully completed a private placement and raised EUR 10 million. The proceeds from the placement will be used to accelerate the U.S. commercialization and distribution of Bioretec’s RemeOs™ products, to facilitate the expansion of manufacturing capacity for RemeOs™ products, and to enhance the product development of other RemeOs™ products.
• In May 2023, Bioretec appointed Dr. Jeremy Dublon as a Regulatory Advisor to support the company’s U.S. go-to-market strategy.
• In June 2023, Bioretec invested in a CNC machining center to increase RemeOs™ production capacity.

 

This half-year report is unaudited. Full year 2022 figures are audited.

 

Key Figures

 

EUR 1,000	H1 2022	H1 2022	Change, %	Vuosi 2022
Net sales	1,891	1,422	33.0%	2,942
Sales margin	1,327	1,018	30.4%	2,139
Sales margin, %	70.2%	71.6%		72.7%
EBITDA	-1,130	-1,196	-5.5%	-2,112
EBIT	-1,233	-1,285	-4.1%	-2,292
Net profit (loss)	-2,075	-1,367	51.8%	-2,416
R&D spend on total costs, %	29.2%	30.7%		28.1%
Equity ratio, %	85.6%	52.5%		55.2%
Cash and cash equivalents	9,196	3,847	139.1%	1,223
Earnings per share (undiluted)	-0.11	-0.10		-0,17
Earnings per share (diluted)	-0.09	-0.07		-0,12
Number of shares at the end of the period (undiluted)	19,136,858	14,111,858		14,111,858
Number of shares at the end of the period (diluted)	23,908,133	19,679,006		19,608,126
Personnel (at the end of the period)	30	27	11.1%	28

 

Timo Lehtonen, CEO of Bioretec Ltd:

 

” I am thrilled to share the excellent success of Bioretec in the first half of 2023. Our relentless pursuit of excellence and dedication to innovation has propelled us to new heights.

 

In March, we achieved a historic milestone by obtaining the US FDA market authorization for our groundbreaking RemeOsTM magnesium screw. This exceptional accomplishment not only highlights the strength of our product innovation and regulatory capabilities but also sets a solid foundation for accelerating growth in the lucrative US market and beyond. Staying steadfast in our commitment, we are now focused on the product launch, making it available to patients and healthcare providers across the U.S., starting with a controlled roll-out in renowned top-tier clinics and academic centers. This achievement marks a pivotal moment in our journey toward transforming patient care.

 

Building on this success and the company’s long-term commitment to commercializing innovative products, we completed a funding round, securing EUR 10 million in gross proceeds through a private placement with institutional and qualified investors. These funds will be instrumental in accelerating the commercialization and distribution of our RemeOs™ products in the United States, as well as expanding production capacity and furthering the development of our diverse RemeOs™ product range.

 

With a strategic focus on meeting market demands and driving competitive advantages, we updated and refocused our product portfolio by announcing the addition of RemeOs™ staples and RemeOs™ plates into our product range. Anticipated to hit the market in 2026 and 2027, respectively, these additions will enable us to offer even more comprehensive solutions to our customers. Concurrently, we recalibrated our financial targets to reflect our ambitious vision. By the end of 2027, we are now aiming for net sales of EUR 62 million, and we are confident in achieving positive cash flow from operating activities by the end of 2026.

 

During the first half of the year 2023, our net sales experienced strong growth of 33 percent year on year, with a significant boost coming from the Asian market, particularly China. Notably, we have also witnessed significant growth in the United States with our FDA-registered Activa product range. We are strongly dedicated to further strengthen our U.S. presence, especially with the upcoming roll-out of RemeOs™ products, and we are relentlessly working for the RemeOs™ screws indication expansion to fortify the growth in the US.

 

To accommodate future demand, we have made anticipated investments in our production capabilities. With the acquisition of a new CNC machining center, we are now well-prepared to increase the production capacity of RemeOs™ screws and enhance the production of Activa implants, ensuring timely and reliable delivery to our customers.

 

The heart of our success lies in our dedicated team. Our personnel have displayed exceptional dedication and performance throughout the first half of the year. Their efforts have allowed us to expand our customer base, strengthen distribution agreements, drive product development, and secure U.S. market authorization. To each member of our team, I extend my heartfelt gratitude for their unwavering commitment to Bioretec's mission. We have also been fortunate to gain valuable expertise through our strengthened Scientific Advisory Board as well as from our U.S. Regulatory Advisor, providing invaluable insights for our product development, upcoming launches, and expansion plan, particularly in the U.S. market. Furthermore, we welcome our new Director of Operations, who brings invaluable expertise to our team.

 

Looking ahead, we are optimistic about receiving EU market authorization for our RemeOs™ screws in 2023. As well, we are continuing the breakthrough device designation program for the indication expansion of RemeOs™ screws in the U.S. to capitalize on the potential for robust growth. These strategic initiatives are an integral part of our strategy to offer advanced and cutting-edge solutions that cater to the evolving needs of healthcare professionals and patients alike.

 

As we progress through the rest of 2023, Bioretec remains steadfast in our dedication to innovation, patient care, and commercial excellence. Together, we will continue to make a profound impact on the world of medical devices, advancing healthcare and improving lives.”

 

Tampere, 11 August 2023

 

Board of Directors

Bioretec Ltd

 

For additional information about the report:

 

Timo Lehtonen   Johanna Salko

toimitusjohtaja    talousjohtaja

+358 50 433 8493   +358 40 754 8172

[email protected]  [email protected]

 

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 bioresorbable materials for enhanced surgical outcomes. The RemeOs™ implants are resorbed 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, CE-mark is expected to be received during 2023. Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical bone fracture treatment.

Better Healing – Better Life. www.bioretec.com

 

Appendix

Bioretec Ltd half year report January – June 2023 (PDF)