This is a summary of Bioretec Ltd's financial statements bulletin for January-December 2022. The complete financial statements bulletin with tables is attached to this release as a pdf file and available on the company's web pages at https://bioretec.com/investors/investors-in-english/releases.
July-December 2022 in brief
Net sales increased by 59% and amounted to EUR 1,520 thousand (7-12/2021: EUR 956 thousand).
Sales margin was EUR 1,121 (598) thousand or 73.8% (62.6%) of net sales, with year-on-year growth of 87%.
Net profit (loss) for the period amounted to EUR -1,049 (-3,226) thousand.
Earnings per share (undiluted) were EUR -0.07 (-0.23).
January-December 2022 in brief
Net sales increased by 47% and amounted to 2,942 thousand euros (1-12/2021: 2,003 thousand euros).
Sales margin was EUR 2,139 (1,376) thousand or 72.7% (68.7%) of net sales, with year-on-year growth of 55%.
Net profit (loss) for the period amounted to EUR -2,416 (-6,017) thousand. Net loss for the comparison period was affected by the costs related to the equity funding expenses and the impact on profit of accrued interest on capital loans totaling EUR 3.35 million.
Earnings per share (undiluted) were EUR -0.17 (-0.43).
The Board of Directors proposes that no dividend will be paid for 2022.
This financial statements bulletin is unaudited. The full-year 2021 figures are audited.
Key figures
+-------------+----------+----------+-------+----------+----------+-------+
|EUR 1,000    |H2 2022   |H2 2021   |Change,|FY 2022   |FY 2021   |Change,|
|             |          |          |%      |          |          |%      |
+-------------+----------+----------+-------+----------+----------+-------+
|Net sales    |1,520     |956       |58.9%  |2,942     |2,003     |46.9%  |
+-------------+----------+----------+-------+----------+----------+-------+
|Sales margin |1,121     |598       |87.4%  |2,139     |1,376     |55.4%  |
+-------------+----------+----------+-------+----------+----------+-------+
|Sales margin,|73.8%     |62.6%     |       |72.7%     |68.7%     |       |
|%            |          |          |       |          |          |       |
+-------------+----------+----------+-------+----------+----------+-------+
|EBITDA       |-916      |-1,340    |-31.6% |-2,112    |-2,497    |-15.4% |
+-------------+----------+----------+-------+----------+----------+-------+
|EBIT         |-1,006    |-1,438    |-30.0% |-2,292    |-2,666    |-14.0% |
+-------------+----------+----------+-------+----------+----------+-------+
|Net profit   |-1,049    |-3,226    |-67.5% |-2,416    |-6,017    |-59.8% |
|(loss)       |          |          |       |          |          |       |
+-------------+----------+----------+-------+----------+----------+-------+
|R&D spend on |25.3%     |23.1%     |       |28.1%     |34.7%     |       |
|total costs, |          |          |       |          |          |       |
|%            |          |          |       |          |          |       |
+-------------+----------+----------+-------+----------+----------+-------+
|Equity ratio,|55.2%     |50.6%     |       |55.2%     |50.6%     |       |
|%            |          |          |       |          |          |       |
+-------------+----------+----------+-------+----------+----------+-------+
|Cash and cash|1,223     |6,621     |-81.5% |1,223     |6,621     |-81.5% |
|equivalents  |          |          |       |          |          |       |
+-------------+----------+----------+-------+----------+----------+-------+
|Earnings per |-0.07     |-0.23     |-67.5% |-0.17     |-0.43     |-59.8% |
|share        |          |          |       |          |          |       |
|(undiluted)  |          |          |       |          |          |       |
+-------------+----------+----------+-------+----------+----------+-------+
|Earnings per |-0.05     |-0.16     |-67.4% |-0.12     |-0.31     |-59.7% |
|share        |          |          |       |          |          |       |
|(diluted)    |          |          |       |          |          |       |
+-------------+----------+----------+-------+----------+----------+-------+
|Number of    |14,111,858|14,111,858|       |14,111,858|14,111,858|       |
|shares at the|          |          |       |          |          |       |
|end of the   |          |          |       |          |          |       |
|period       |          |          |       |          |          |       |
|(undiluted)  |          |          |       |          |          |       |
+-------------+----------+----------+-------+----------+----------+-------+
|Number of    |19,608,126|19,679,006|       |19,608,126|19,679,006|       |
|shares       |          |          |       |          |          |       |
|(diluted)    |          |          |       |          |          |       |
+-------------+----------+----------+-------+----------+----------+-------+
|Personnel1   |28        |26        |7.7%   |28        |26        |7.7 %  |
+-------------+----------+----------+-------+----------+----------+-------+
1Number of personnel at the end of the period
Timo Lehtonen, CEO of Bioretec Ltd:
"Highlights of the year included the U.S. market approval application submission of the game-changing bioresorbable RemeOs™ trauma screw to enable entry into the world's largest orthopedic market, supported by excellent in vivo and clinical evidence of the unique properties of the RemeOs™ technology, and a nearly 50 percent increase in sales of the Activa product family, resulting in record high sales for 2022, close to EUR 3 million.
At the beginning of 2023, the RemeOs™ trauma screw continues on the path to being the first bioresorbable metallic orthopedic implant in the US market, the world's largest and most profitable market.
We began the year 2022 with a strong focus on our first-ever U.S. De Novo application request for the bioresorbable magnesium alloy RemeOs™ trauma screw initially based on the Breakthrough Device Designation- status, received in 2021.  After submitting the De Novo Request last May, we delivered clarification request responses to the FDA (U.S. Food and Drug Administration) within their required deadlines in the last quarter of the year.  Based on this progress and the FDA has, according to its internal guidelines, a maximum of 90 days to make a decision, we expect to have market authorization in the U.S. in April 2023.
We are excited about receiving the market approvals not only in the U.S. but also in Europe during the forthcoming year, as the submission of the EU market authorization (CE mark) application for RemeOs™ trauma screws took place right at the end of 2021. We expect the European CE mark approval to be received later in the year as the number of applications resulting from the change in regulations (MDR) has overwhelmed the notified bodies and the average approval time is currently around 18 months.
The first half of the year already showed strong sales with 36% growth year-on-year, and the trend even improved during the second half yielding a substantial 59% growth. Our full-year 2022 net sales grew approximately 47 percent from the previous year. I am very pleased with the net sales growth of our current Activa products, as well as the fact that profitability remained approximately at the same level as in 2021, despite it was affected by the increase in raw material, logistics, and energy costs caused by inflation and the global political situation.
One main growth driver has been our investment in long-term partnerships with our distributor network and key opinion leaders (KOLs). Our renewed education and product training programs for customers in both legacy and new markets e.g., Israel, have been a key element of our relationship development. Additionally, post-coronavirus pandemic resource shortages have been a driving force for increased demand for bioresorbable products that reduce both the number of surgeries and hospital stays. The competitive pricing of our products along with our good customer relationships have furthermore contributed to sales growth in several market areas.
A big appreciation belongs to our committed team for enabling and generating growth. Our team has worked tirelessly to further strengthen our existing customer relationships, acquire new customer relationships, and ensure deliveries correspond to the significantly increased demand.
As a result of the growing demand for our products, we have during the year 2022 focused on increasing the capacity and capability of the production. In addition, we are currently evaluating alternative financial means to support our continued growth, the expansion of our production capacity, and most importantly, the commercialization of our new technology.
We are entering 2023 with positive momentum after our first full year as a listed company. The year 2022 accelerated our transition to becoming one of the leading companies in the growing orthopedic bioresorbable trauma product market with our submission for both the CE mark (Europe) and FDA approval (US) of our innovative and novel RemeOs™ bioresorbable metal screw. When cleared, RemeOs™ will, based on the company information, be the first bioresorbable metallic trauma screw in the U.S. market. We are genuinely excited about preparing for the launch of our products and the start of sales in these markets this year.
In addition to our team, I would also like to warmly thank our customers, partners, and investors for their trust in Bioretec."
Financial reporting and Annual General Meeting in 2023
Bioretec will publish its Annual Report, including the Financial Statements, for the year 2022 during week 11/2023, at the latest.
Bioretec's Annual General Meeting is planned to be held on 14 April 2023.
Bioretec's Half-year Report for January-June 2023 will be published on 11 August 2023.
The reports will be available immediately after publication on the company's website at
https://bioretec.com/investors/investors-in-english/reports-and-presentations.
Tampere, 17 February 2023
Board of Directors
Bioretec Ltd
Further inquiries:
Timo LehtonenJohanna Salko
CEOCFO
+358 50 433 8493+358 40 754 8172
timo.lehtonen@bioretec.comjohanna.salko@bioretec.com
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 bioresorbable 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 authorizations are expected in the U.S. during April 2023 and in Europe during 2023. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical possibilities.
Better healing - Better life. www.bioretec.com
Appendix
Bioretec Ltd's financial statements bulletin January-December 2022 (pdf)