Safe reports first-half 2021 financial results and announces ISO13485 certification of its Safe Medical integrated manufacturing facility
30 September 2021 - 8:38PM
Safe reports first-half 2021 financial results and announces
ISO13485 certification of its Safe Medical integrated manufacturing
facility
- Sales up 22% in the first half of 2021 despite
conservative plans in hospitals
- ISO13485 certification by AFAQ/AFNOR of the group's new
industrial activities and start of integrated production by Safe
Medical
- Operating profit of -€4M, at the level of the first
half of 2019
-
End of €8.4 million bond financing
line
Éragny-sur-Oise, France, September 30th,
2021 at 5:35 p.m. CET – Safe (FR0013467123 –
ALSAF), a company specialising in the design,
manufacture and marketing of ready-to-use technologies for back
surgery, with a particular focus on the safety of emergency
vertebral fractures, publishes its half-yearly financial results as
of June 30, 2021 and announces Safe Medical's ISO13485 integrated
manufacturing certification.
Safe’s half-year financial report will be
available by September 30th in the Investors > Documentation
section of the Company’s website (www.SafeOrthopaedics.com).
Revenues as of June 30,
2021
In thousands of euros –IFRS |
30/06/2021 |
30/06/2020 |
Revenues – Direct sales |
773 |
882 |
Revenues – Indirect sales |
556 |
843 |
Revenues - Production
subcontracting |
776 |
|
Adjusted total
revenues |
2 105 |
1 725 |
Other income |
4 |
3 |
Purchases used and changes in
inventories |
(1
425) |
(1
211) |
External costs |
(973) |
(939) |
Personnel costs |
(3
341) |
(2
413) |
Other operating expenses |
(377) |
(357) |
Operating income / (loss)
before non-recurring items |
(4 006) |
(3 191) |
Other operating income (expenses) |
(6) |
0 |
Operating income /
(loss) |
(4 012) |
(3 191) |
Financial income / (loss) |
(204) |
(352) |
Net income / (loss) |
(4 216) |
(3 543) |
In the first half of 2021, sales rose by 22% (after application of
IFRS 15) compared with the first half of 2020, despite the
deployment of white plans in hospitals leading to the postponement
of surgeries classified as "non-urgent". This change is mainly due
to the integration of Safe Medical sales following its entry into
the scope of consolidation at the end of July 2020. On a
like-for-like basis, Safe Orthopaedics sales were down 23% despite
strong growth of 190% in Germany (€197k in H1 2021 vs. €68k in H1
2020) and in the United States, where the group has recruited a
sales manager and initiated direct marketing.
The increase in personnel expenses, resulting
from the integration of Safe Medical and its Tunisian subsidiary in
July 2020 carried out to ensure a return to growth following the
health crisis, combined with the control of external expenses and
the correlation between the level of sales and purchases consumed,
allow the group to post an OIR identical to that of the first half
of 2019.
Since the acquisition of LCI Medical, renamed
Safe Medical, the group has made significant investments in its
French industrial site, subsidized to the tune of eight hundred
thousand euros as part of the government's stimulus plan, and has
announced the start of integrated production following the Safe
Medical AFAQ certification audit and the annual audit by GMED, Safe
Orthopaedics' notified body.
"Safe Group closes the first half of 2021 with
an overall half-year sales growth of 25% {excluding IFRS15 impact}
compared to the first half of 2020 driven by a 67% sales growth in
the second quarter. In addition, our Group has completed its
strategic transformation in record time: one year after the
acquisition of LCI Medical, the certification of our integrated
production site provides us with the means to accelerate our
innovation, reduce our manufacturing lead times and secure the
implementation of the new regulatory requirements imposed by the
MDR," commented Pierre Dumouchel, Chairman and CEO of Safe Group.
"The launch of Sicamore, Hickory and the finalization of SORA by
Safe Orthopaedics, combined with Safe Medical's new industrial
services, reinforces our strategy of being the leader in
orthopaedic ready-to-use products, while providing our sales teams
with the prospect of sustained growth in the coming quarters».
As a reminder, the revenue for the first half of
2019 was €2,041k and allows us to note that, despite the impact of
the health crisis still being very significant in the first half of
2021, the group's revenue has exceeded its first half 2019
level.
Safe Medical's new ISO 13485-certified cleanroom
infrastructure marks the beginning of the cleanroom packaging
activity. This new activity is designed to support Safe Medical's
return to growth, which has already been observed in the first half
of the year, and will enable the company to offer its customers the
entire subcontracting chain, from production to packaging in an ISO
7 environment offering them reduced production times, cost savings
and unique innovation support.
Cash position
At June 30, 2021, the Group's audited cash
position amounted to €3.9 million, compared with €3.2 million at
the end of June 2020. As a reminder, the balance of the stimulus
package grant still to be received is €400k. In addition, as
indicated in the conversion monitoring document for the second
financing program, available on the company's website in the
section Investors > Documentation, all of the OCEANE bonds in
the program were converted by September 22, 2021.
Next financial publication
Third quarter 2021 sales, October 7, 2021 (after
market close)
About Safe GroupThe Safe Group
is a French medical technology group that brings together Safe
Orthopaedics, a pioneer in ready-to-use technologies for spinal
pathologies, and Safe Medical (formerly LCI Medical), a
subcontractor of medical devices for orthopaedic surgery. The group
employs approximately 150 people.
Safe Orthopaedics develops and manufactures kits
combining sterile implants and single-use instruments, available at
all times to the surgeon. These technologies are part of a
minimally invasive approach aimed at reducing the risk of
contamination and infection, to the benefit of the patient and with
a positive impact on hospitalisation times and costs. Protected by
18 patent families, SteriSpineTM kits are CE marked and FDA
approved. Safe Orthopaedics is headquartered in the Paris region
(95610 Eragny sur Oise - France) and has subsidiaries in the UK,
Germany, the USA and the Lyon region where the manufacturing
company is located.For more information:
www.SafeOrthopaedics.com
Safe Medical (formerly LCI Medical) produces
implantable medical devices and ready-to-use instruments. It has an
innovation centre and two production sites in France and Tunisia,
offering numerous industrial services: design, industrialisation,
machining, finishing and sterile packaging. Supported by the French
recovery plan in 2020, the company is investing in additive
printing and will be operational in 2022 with this new technology.
For more information: www.safemedical.fr
Contacts
Safe
Orthopaedics
François-Henri Reynaud
Chief Financial and Administrative Officer
Tel: +33 (0)1 34 21 50
00
investors@safeorthopaedics.com
Press RelationsUlysse
CommunicationPierre-Louis Germain / +33 (0)6 64 79
97 61 / plgermain@ulysse-communication.com Bruno
Arabian / +33 (0)6 87 88 47 26 /
barabian@ulysse-communication.com
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