Bioretec Ltd Company
announcement 16 May 2024 at 8:30
a.m.
TAMPERE,
Finland, May 16, 2024 /PRNewswire/ -- This
announcement summarizes Bioretec Ltd's business review for
January-March 2024. The complete
business review is attached to this release as a PDF file and
available on the company's website at
https://bioretec.com/investors/investors-in-english/releases.
January-March 2024 in
brief
- Net sales amounted to EUR 682
thousand (1-3/2023: EUR 1,071
thousand).
- The sales margin was EUR 478
(718) thousand, or 70.1% (67.0%) of net sales. The sales margin of
2024 includes other income of EUR 60
thousand accrued relating to the Business Finland grant.
When excluding the grant effect, the sales margin for the current
reporting period is EUR 418 thousand,
or 61.3%. The main reason for the lower sales margin percentage has
been the planned production shutdown due to the ramp-up of new
production capacity.
- EBITDA was EUR -1,112 (-491)
thousand. EBITDA was EUR -1,112 (-
491) thousand. It was burdened by increased personnel costs due to
headcount growth and additional fixed costs relating to U.S.
commercialization and R&D projects.
- The result for the reporting period amounted to EUR -1,097 (-557) thousand.
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
figures
|
|
EUR 1,000 unless
otherwise noted
|
1-3/2024
|
1-3/2023
|
Change
|
1-12/2023
|
Net sales
|
682
|
1,071
|
-36.4 %
|
3,906
|
Sales margin
|
478
|
718
|
-33.4 %
|
2,810
|
Sales margin, % of net
sales
|
70.1 %
|
67.0 %
|
|
71.9 %
|
EBITDA
|
-1,112
|
-491
|
126.6 %
|
-2,833
|
EBIT
|
-1,139
|
-543
|
109.6 %
|
-3,034
|
Profit/-loss for the
period (+/-)
|
-1,097
|
-557
|
97.0 %
|
-3,789
|
R&D spend on total
costs, %
|
25.9 %
|
24.8 %
|
|
25.6 %
|
Equity ratio,
%
|
74.3 %
|
44.3 %
|
|
77.3 %
|
Cash and cash
equivalents at end of period
|
5,981
|
587
|
919.3 %
|
6,910
|
Number of personnel at
end of period
|
39
|
28
|
39.3 %
|
37
|
Key events during the reporting period
- European market authorization application for the
RemeOsTM trauma screw proceeded to expert panel
evaluation. The approval is estimated to be granted during the
second quarter of 2024.
- Bioretec was granted an FDA Breakthrough Device Designation
status for its RemeOs™ Spinal Interbody Cage.
- Bioretec's RemeOs™ biodegradable magnesium alloy composition
was granted a patent by the U.S. Patent Office.
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:
- half-year report for January-June
2024 on Thursday 15 August
2024
- business review for January-September
2024 on Thursday 14 November
2024
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
Further inquiries:
|
|
Timo
Lehtonen
|
|
Johanna
Salko
|
CEO
|
|
CFO
|
+358 50 433
8493
|
|
+358 40 754
8172
|
timo.lehtonen@bioretec.com
|
|
johanna.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 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)
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/bioretec/r/bioretec-ltd-s-business-review-january-march-2024--controlled-launch-in-the-u-s--progresses,c3982524
The following files are available for download:
https://mb.cision.com/Main/20509/3982524/2800943.pdf
|
Bioretec Business
Review January-March 2024
|
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SOURCE Bioretec