Bioretec Ltd Company announcement 15 August 2024
at 8:00 a.m.
TAMPERE,
Finland, Aug. 15, 2024 /PRNewswire/ -- This
announcement is a summary of Bioretec Ltd's half-year report
January-June 2024. The complete
half-year report with tables is attached to this release as a pdf
file and available at the company's web pages at
https://bioretec.com/investors/investors-in-english/releases.
April-June 2024 in
brief
- Net sales increased by 68% and amounted to EUR 1,379 thousand (4-6/2023: EUR 820 thousand).
- Sales margin (excl. other income) was EUR 1,033 (609) thousand, or 74.9% (74.3%) of net
sales.
- Profit (loss) for the reporting period was EUR -787 (-1,518) thousand. The comparison period
included the cost of financing arrangement amounting to
EUR 795 thousand.
January-June 2024 in
brief
- Net sales amounted to EUR 2,061
thousand (1-6/2023: EUR 1,891
thousand).
- Sales margin (excl. other income) was EUR 1,451 (1,327) thousand or 70.4% (70.2%) of
net sales. The sales margin in January-June
2024 includes other income of EUR
72 (0) thousand accrued relating to a Business Finland
grant.
- Profit (loss) for the reporting period was EUR -1,884 (-2,075) thousand.
- Earnings per share (undiluted) were EUR
-0.09 (-0.11).
Key figures
EUR
1,000
|
4-6/2024
|
4-6/2023
|
Change, %
|
1-6/2024
|
1-6/2023
|
Change, %
|
1-12/2023
|
Net sales
|
1,379
|
820
|
68.3 %
|
2,061
|
1,891
|
9.0 %
|
3,906
|
Sales margin
|
1,045
|
609
|
71.6 %
|
1,523
|
1,327
|
14.8 %
|
2,810
|
Sales margin (excl.
other income)
|
1,033
|
609
|
69.8 %
|
1,451
|
1,327
|
9.4 %
|
2,728
|
Sales margin, % of net
sales
|
75.7
|
74.3
|
|
73.9 %
|
70.2 %
|
|
71.9 %
|
Sales margin% (excl.
other income)
|
74.9
|
74.3
|
|
70.4 %
|
70.2 %
|
|
69.8 %
|
EBITDA
|
-752
|
-639
|
17.8 %
|
-1,864
|
-1,130
|
65.0 %
|
-2,833
|
EBIT
|
-782
|
-690
|
13.4 %
|
-1,921
|
-1,233
|
55.8 %
|
-3,034
|
Profit/-loss for the
period (+/-)
|
-787
|
-1,518
|
-48.2 %
|
-1,884
|
-2,075
|
-9.2 %
|
-3,789
|
R&D spend on total
costs, %
|
23.9 %
|
33.5 %
|
|
24.8 %
|
29.2 %
|
|
25.6 %
|
Equity ratio,
%
|
77.9 %
|
85.6 %
|
|
77.9 %
|
85.6 %
|
|
77.3 %
|
Cash and cash
equivalents at the end of the period
|
3,947
|
9,196
|
-57.1 %
|
3,947
|
9,196
|
-57.1 %
|
6,910
|
Earnings per share
(undiluted)
|
-0.04
|
-0.07
|
|
-0.09
|
-0.11
|
|
-0.19
|
Earnings per share
(diluted)
|
-0.04
|
-0.06
|
|
-0.08
|
-0.09
|
|
-0.15
|
Shares at end of period
(undiluted)
|
20,336, 858
|
19,136, 858
|
|
20,336, 858
|
19,136, 858
|
|
19,536, 858
|
Shares at end of period
(diluted)
|
24,908, 133
|
23,908, 133
|
|
24,908, 133
|
23,908, 133
|
|
24,908, 133
|
Personnel at end of
period
|
43
|
30
|
43.3 %
|
43
|
30
|
43.3 %
|
37
|
Key events in April-June
2024
- In May, Alan Donze was appointed
Bioretec's CEO.
- In June, Frank Sarcone was
appointed as Vice President of Sales for the US and a member of the
Management team.
- Also in June, Bioretec communicated positive clinical outcomes
from the controlled launch of RemeOs™ trauma screw.
- European market authorization application for the RemeOsTM
trauma screw returned from expert panel evaluation in June and the
market authorization is expected later compared to earlier estimate
(Q2/2024).
Alan Donze, CEO of Bioretec
Ltd:
"Bioretec's controlled launch plan was designed to
systematically gather surgeon feedback and clinical evidence from
selected hospitals. In the first half of the year, we received
invaluable positive feedback from surgeons regarding the user
experience. More importantly, all treated patients experienced the
expected healing outcomes, which will facilitate expansion outside
the controlled launch plan centers. Our research and development
efforts have been focused on expanding the RemeOs™ product
portfolio in the U.S. Notably, the FDA granted another Breakthrough
Device designation to Bioretec for the RemeOs™ Spinal Cage, an
osteopromotive and absorbable cervical spine interbody device made
from patented hybrid composite. After my first weeks as the CEO of
Bioretec, I am very excited about the opportunities presented by
the RemeOs™ product line, which we are actively expanding.
The controlled launch of the RemeOs™ trauma screw has proceeded
as expected. All surgical procedures using RemeOs™ technology in
the U.S. have been successful, with all cases achieving fracture
healing and no adverse events or complications during the follow-up
period. With these expected positive outcomes and feedback from
surgeons, we are preparing to enter the next phase of the launch in
the U.S. This phase will involve expanding the distribution of the
trauma screw from a selected group of hospitals to a broader
network. With the recent appointment of a new VP of Sales in the
U.S., we have bolstered our management team, positioning us to
enhance our commercialization efforts in this market.
The strong global performance of the Activa product line marked
Bioretec's second quarter of 2024. Net sales grew by 68% from the
first quarter due in part to a planned shutdown for new machinery
investments resulting in an expected backlog. Sales in the United States saw significant growth,
while in Europe, the increase was
primarily driven by robust demand from new distributors. However,
net sales in the rest of the world declined due to a slight
decrease in demand in China, where
governmental volume-based procurement initiatives and other changes
affected orders. Our sales margin remained consistent with the
previous year, ending at 70.4% (70.2%). As part of our strategic
implementation and increased recruitment efforts, operating
expenses rose. We hired a sales leader in Germany and Austria in the first half of the year and will
initiate direct sales in these markets during the second half of
the year.
European CE market authorization application for the RemeOs™
trauma screw is progressing, although the process has been extended
beyond the prior estimate. The Expert panel review was completed
during the second quarter and our application has now returned to
the Notified Body for the final steps of the market approval
process. The anticipated European market authorization will provide
substantial ability to gather real-world evidence of a variety of
indications, which will support indication expansions also in the
U.S. In other respects, we saw good development with our R&D
efforts. I am especially excited about the unprecedented RemeOs™
Spinal Interbody Cage implant, which recently received the FDA
Breakthrough Device Designation in the U.S. market. We will be
evaluating our resource needs required for bringing it to the
market, together with the other RemeOs™ products in the
pipeline.
As we focused on ramping up our production capacity in the first
half of the year, we anticipate that our net sales will be more
robust in the second half. Expanding production capacity and
investing in U.S. market development are crucial components of
building our growth platform. We continue with our efforts to
introduce more RemeOs™ products to the market incrementally through
the US FDA process."
Financial reporting in 2024
In 2024, Bioretec will publish the following financial
reports:
- 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, 15 August 2024
Board of Directors
Bioretec Ltd
Further inquiries:
Alan
Donze
Johanna
Salko
CEO
CFO
+358 40 663 5011
+358 40 754 8172
alan.donze@bioretec.com
johanna.salko@bioretec.com
Certified advisor:
Nordic Certified Adviser AB,
p. +46 70 551 6729
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 approval process is
currently on-going. 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 half year report January-June 2024 (pdf)
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/bioretec/r/bioretec-ltd-s-half-year-report-january-june-2024--remeos--trauma-screw-controlled-launch-in-the-u-s,c4024528
The following files are available for download:
https://mb.cision.com/Main/20509/4024528/2945476.pdf
|
Bioretec Half year
report 2024
|
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SOURCE Bioretec