- Positive EBITDA in the second half of
2019
- Net loss reduced by 70%
- Net Income positive US operations
Regulatory News:
SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an
innovative company that deploys its DSG® (Dynamic Surgical
Guidance) sensing technology to secure and streamline the placement
of bone implants, reported today its full-year 2019 financial
results as approved by the Board of Directors on March 19,
2020.
€ thousands – IFRS audited
Dec 31, 2019
Dec 31, 2018
Revenue
6 829
7 575
Gross Margin
5 768
6 553
Gross margin (% of revenue)
84,5%
86,5%
Sales, distribution & marketing
3 500
4 840
Administrative costs
1 855
1 853
Research & Development
724
932
Operating profit / (loss)
- 311
-1 073
Non-recurring operating costs
-120
-37
Financial Result
-643
-1 205
Income Tax
-389
19
Net profit / (loss)
-686
-2 334
EBITDA
-50
-586
Pierre Jérôme, co-founder, Chairman and CEO of SpineGuard,
said: “The reorganization plan we initiated mid-2017 and the
efforts made since then allowed us to reach breakeven while
continuing to deploy our real time sensing technology in new
applications aimed at securing bone implant placement. Thanks to
our financial discipline and compelling technological advances, we
managed to obtain safeguard protection in France and Chapter 11
protection in the US. This favorable legal framework will enable
the amendment of our debt. In parallel, we are actively pursuing
our ambitious innovation strategy and the set-up of industrial
partnerships on a sound basis in a context which is obviously
significantly impacted by the propagation of the COVID-19 virus,
for the very short term at least.”
EBITDA improved by 91% and is positive in the second
half-year
EBITDA improved by 91% at € -50k compared to € -586k in
2018.
EBITDA was € 301k positive in the second half of FY2019.
The current operating loss was reduced by 71% to € - 311k (vs. €
-1,073k in 2018).
Gross margin decreased by 200 bps at 84.5% mainly in reason of
adjusted manufacturing costs.
Operating expenses decreased by 20% or € 1,546k reflecting both
the full impact of the company reorganization and a rigorous
control of operational expenses over the year.
Operating cash flow was positive at € 224k (vs. € -669k in
2018).
At Dec. 31, 2019, cash and cash equivalents were € 1.3M, plus
the secured € 0.7M of convertible bonds (OCAPI) for a total of €
2.0M. Working capital requirements were € 512k vs. € 782k in
2018.
Financial expenses mainly correspond to the interest charges of
the venture loans with, Norgine Venture and Harbert European Growth
Capital. There are € 148k of non-cash financial income related to
the compliance with IFRS accounting principles on financing
instruments.
2019: the strategic turn continues to deliver results
Robotics: in 2018, the company materialized two critical
milestones for the smooth integration of DSG technology into
surgical robots. In 2019, SpineGuard successfully completed a
feasibility study in collaboration with the laboratory ‘Institut
des Systèmes Intelligents et de Robotique’ of the Paris Sorbonne
University (ISIR). This experiment demonstrated how DSG technology
stops a surgical robot automatically when an impending bone breach
is detected. It also highlighted the efficacy and adequacy of DSG
as applied to robotic surgeries in order to automate breach
detection. The long-term goal is to automate skeletal implant
placements. These achievements also provided ground for IP and were
also showcased to potential industrial strategic partners in
collaboration with Healthios Capital Markets, the US bank assisting
the company in that purpose.
Visualization of the signal (DSG Connect): in 2019,
SpineGuard finalized its next generation of products ‘PediGuard DSG
Connect’. They will be enabled by a visualization software embedded
into a tablet coupled with ‘bluetooth like’ technology. The Company
filed its CE mark dossier at the end of September 2019 and
progressed in parallel with its 510k filing to be submitted to the
FDA in the first half of 2020. The company is aiming at
pre-commercial launch in Europe and the USA in the course of
2020.
Dental Implantology (worldwide licensing): the pertinence
of DSG technology beyond spine has been demonstrated by the CE mark
and the manufacturing of the first generation of products
(‘SafeGuard’) dedicated to the dental market. The partnership with
ConfiDent ABC (Adin Group) in the context of the worldwide
licensing agreement continues with great momentum.
2020 PERSPECTIVES
The collaboration with our industry partner Adin Dental/
ConfiDent on the dental application will intensify in 2020 with the
co-development of a next generation DSG embedded product, fruit of
the feedback on the first generation tested in 2019.
The search for strategic alliances with industry players notably
for the robotic application continues with the venture bank
Healthios Capital Markets.
Lastly, the DSG Connect platform should soon be CE Marked
cleared and the FDA filing is progressing. This strategic
high-value innovation is already used experimentally by the company
to guide surgical robots. It will be deployed to the full PediGuard
range and Smart Screw products. The company believes that it will
bring a renewed sales momentum in particular in Europe and the USA,
but also in other high potential geographies such as Brazil, Saudi
Arabia and Turkey. Of course, the pace will highly depend on the
containment of the COVID-19 outbreak and the resuming of a normal
activity in the hospitals. For now, in a growing number of
countries, most of the elective surgeries are being postponed to
prepare for and focus on COVID-19 patients.
Additional information on “safeguard” and Chapter 11
proceedings
SpineGuard is planning to release early next week updated
information regarding the ongoing progress of its voluntary filings
made mid-February, in France and the USA, under the ‘safeguard’ and
Chapter 11 procedures. On this occasion, SpineGuard may communicate
regarding the resuming of trading on Euronext.
Next financial press release: 2020 first quarter revenue
on April 23, 2020
About SpineGuard® Founded in 2009 in France and the USA
by Pierre Jérôme and Stéphane Bette, SpineGuard is an innovative
company deploying its proprietary radiation-free real time sensing
technology DSG® (Dynamic Surgical Guidance) to secure and
streamline the placement of implants in the skeleton. SpineGuard
designs, develops and markets medical devices that have been used
in over 75,000 surgical procedures worldwide. Fifteen studies
published in peer-reviewed scientific journals have demonstrated
the multiple benefits DSG® offers to patients, surgeons, surgical
staff and hospitals. Building on these solid fundamentals and
several strategic partnerships, SpineGuard has expanded its
technology platform in a disruptive innovation: the « smart »
pedicle screw launched late 2017 and is broadening the scope of
applications in dental implantology and surgical robotics. DSG® was
co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D.,
and Alain Vanquaethem, Biomedical Engineer.
For further information, visit www.spineguard.com
Disclaimer The SpineGuard securities may not be offered
or sold in the United States as they have not been and will not be
registered under the Securities Act or any United States state
securities laws, and SpineGuard does not intend to make a public
offer of its securities in the United States. This is an
announcement and not a prospectus, and the information contained
herein does and shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be any sale of the
securities referred to herein in the United States in which such
offer, solicitation or sale would be unlawful prior to registration
or exemption from registration.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200319005310/en/
SpineGuard Pierre Jérôme Chairman and CEO Tél. : +33 1 45
18 45 19 p.jerome@spineguard.com
Manuel Lanfossi Chief Financial Officer
m.lanfossi@spineguard.com
Europe / NewCap Investor Relations & Financial
Communication Mathilde Bohin / Pierre Laurent Tél. : +33 1 44 71 94
94 spineguard@newcap.eu
Spineguard (EU:ALSGD)
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