- Improved net result and US operations
profitable
- Strengthened investments for innovation
- Cash runway over 24 months
- Back to growth in 1Q22
Regulatory News:
SpineGuard (FR0011464452 – ALSGD) (Paris:ALSGD), an
innovative company that deploys its DSG (Dynamic Surgical Guidance)
sensing technology to secure and streamline the placement of bone
implants, announced today its full-year 2021 financial results, as
approved by the Board of Directors on April 28, 2022 and its first
quarter 2022 sales.
€ thousands – IFRS audited
2021
2020
Revenue
4 405
4 852
Gross Margin
3 606
4 036
Gross margin (% of revenue)
81,9 %
83,2%
Sales, distribution & marketing
2 660
2 578
Administrative costs
1 394
1 740
Research & Development
791
680
Operating profit / (loss)
-1 239
-961
Non-recurring operating costs
-110
-875
Financial Result
-299
-844
Income Tax
-76
-37
Net profit / (loss)
-1 725
-2 716
EBITDA
-1 063
-1 284
Pierre Jérôme, co-founder, Chairman and CEO of SpineGuard,
said: “In 2021, we considerably strengthened the company
financially while significantly advancing our innovation pipeline
and putting in place the necessary means to boost the commercial
dynamic in the United States. We are now back to growth in this
first quarter of 2022 despite the impact of the Omicron variant on
elective surgery’s activity in January and February. This first
quarter is already proving particularly fruitful for SpineGuard
with consecutively the signing of a very promising partnership with
WishBone Medical in pediatric orthopedics, the 19th clinical
publication on our DSG technology, our first patent in robotics and
the clearance by the FDA for the commercial release of the Threaded
PediGuard in anterior approach spine surgery. Three of these four
great achievements directly concern the US market, the largest and
most strategic for SpineGuard.”
Net operating result under control and increased investments
for innovation
The Company increased its investments for innovation and
strengthened its commercial activity in the United States while
maintaining strict discipline on expenses.
The Net Loss was reduced to € -1,725K vs. € -2,716K in 2020.
Gross margin decreased by 130 bps at 81.9% vs. 83.2% mainly due
to the lower percentage of sales made in the United States where
sales prices are higher than in the rest of the world. Sales prices
remained stable in the United States while they increased in the
rest of the world due to a significantly different country mix
compared to 2020.
Operating expenses decreased by 3.1% or € 153K reflecting a
rigorous control of operational expenses over the year in the still
impacting context of the Covid-19 pandemic. Non-recurring operating
costs are mainly related to the French “sauvegarde” and US Chapter
11 proceedings at € 110K vs. € 875K in 2020.
Working capital requirements were € -133K vs. € -176K in
2020.
Financial expenses were € -299K mainly corresponding to the
interest charges of the venture loan with Norgine Venture, Harbert
European Growth Capital and Bpifrance. There are € 44K of forex
rate gains and € 179K of non-cash financial expenses, which have no
impact on the cash and are related to the compliance with IFRS
accounting principles on financing instruments.
Cash runway extended over 24 months
At December 31, 2021, cash and cash equivalents were € 5.2M,
plus the secured € 5.0M of convertible warrants (BSAR) secured with
Nice & Green. As of March 31, 2022, cash and cash equivalents
were € 4.3M. With the balance of the equity line of € 5.0M,
SpineGuard’s cash runway stands at over 24 months.
In addition, should 100% of the Warrants be exercised, the free
allocation of Redeemable Warrants set up in June 2021 may generate
gross proceeds of € 5,370K and would extend by 24 month the cash
runway.
Significant R&D advances
Robotic application:
In 2021, the collaborative work with the ISIR of Sorbonne
University made solid progress with the implementation of a new
platform of experimental equipment including a medical grade
robotic arm, a programmable drilling set, as well as various
equipment. This enabled specific 3rd generation programming for the
automated detection of bone breaches and the performance of a
large-scale in-vitro study which produced outstanding results: 100%
success in 104 drillings with a submillimeter precision. In
parallel, the Company took steps for its IP protection.
The European collaboration project Faros (Functional Accurate
RObotic Surgery) continued, with tangible results expected in 2022,
which will reinforce the value proposition of the DSG technology
and bring differentiation to orthopedic robots.
Robotic DSG application to a smart drill:
The company started in 2021 the development of a universal
solution called "SUD" (Smart Universal Drill), aiming at enhancing
orthopedic power drills currently used in hospitals. This device
integrating the fruits of the robotic DSG program will allow for
the detection of an impending bone breach to automatically stop the
drilling thus preventing neurologic or vascular complications. It
will be universal in the field of orthopedic surgery, in spine and
beyond, because it will adapt to any drill in the market and to any
surgical technique used by the surgeon: manual, navigated, or
guided by a robotic arm.
Connectivity and signal visualization:
The new generation of PediGuard “DSG Connect” products includes
a Bluetooth-like transmitter as well as data visualization and
processing software on a dedicated tablet. This new platform aims
to facilitate the interpretation of the DSG signal by surgeons and
to allow them to record data for follow-up and research purposes
for the measurement of bone quality. Over a hundred surgeries were
performed as part of the pre-launch in Europe, the United States
and Brazil despite the constraints of the pandemic. The extremely
encouraging feedback from the first users should allow a full
commercial launch during the NASS (North American Spine Society)
and the Eurospine in October of this year.
Bone Quality Measurement (BQM):
In 2021, Sorbonne University finalized the collection of DSG
data from the surgeries performed at the Trousseau Hospital of
Paris to feed the algorithms of our robotics program and measure
bone quality.
Dental implantology – worldwide license and collaboration
with ConfiDent ABC, a subsidiary of Adin Group:
The partnership with ConfiDent ABC (Adin Group) within the
framework of the exclusive worldwide license agreement for DSG
technology for dental implantology continues with the objective to
launch a disruptive product in this field.
Strengthening of intellectual property:
In 2021, the Company consolidated and extended its international
patent portfolio with the following highlights:
- Obtention of the "Real Time" patent in Japan and the United
States after the 2020 granting in China. These patents extend the
protection of DSG technology until 2035 in geographies representing
major markets in the sector,
- Multiple applications were filed in the field of robotics and
dental,
- A total of 80 patents and applications, in 17 families as of
today.
End of the French ‘sauvegarde’ and US Chapter 11
proceedings
On March 24, 2021, the Commercial Court of Creteil ended the
voluntary French ‘sauvegarde’ proceeding engaged by the Company.
The U.S. court of Delaware did the same on August 24, 2021. The
company is now executing the agreed plans.
2022 First quarter revenue
Global revenue in the first quarter of 2022 was € 1,131K vs. €
1,049K in Q1 2021 a 7.9% increase as reported in a context
significantly impacted by the Omicron variant peaks of infection in
January and February which forced many hospitals to defer elective
surgeries particularly in the US and in Europe due to staff
shortages and in order to face the new influx of Covid-19
patients.
SpineGuard sold 1,361 DSG units in the first quarter of 2022 vs.
1,360 units in Q1 2021 of which 569 units in the USA vs. 558 in
2021.
US revenue increased by 6% as reported (-2% cc) at € 739K vs. €
700K. Outside the USA, the positive dynamics initiated in the
second half of 2020 continued, and revenue grew by 13% at € 392K
vs. € 348K in the first quarter of 2021. This is the sixth
consecutive quarter with double digit growth OUS.
2022 Perspectives
SpineGuard is focusing on the following priorities while
investing selectively to remain close to breakeven:
- Boost commercial activities with the launch of the DSG-Connect
visual interface and the partnership with WishBone Medical
- Deploy the DSG digital technology in the surgical robotic
field
- Develop a Smart Universal Drill (SUD) embedding the DSG AI
- Support ConfiDent with the design and scale-up of the DSG
dental applications
- Sign new strategic partnerships
Next events: General Meeting on June 8, 2022 2022
half-year revenue on July 12, 2022
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 85,000 surgical
procedures worldwide. Nineteen studies published in peer-reviewed
scientific journals have demonstrated the multiple benefits DSG®
offers to patients, surgeons, surgical staff and hospitals.
Building on these strong fundamentals and several strategic
partnerships, SpineGuard has expanded the scope of its DSG®
technology in innovative applications such as the « smart » pedicle
screw, the DSG Connect visualization and registration interface,
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. SpineGuard has engaged in
multiple ESG initiatives.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220428005705/en/
SpineGuard Pierre Jérôme CEO & Chairman Tel: +33 1 45
18 45 19 p.jerome@spineguard.com
SpineGuard Manuel Lanfossi CFO Tel: +33 1 45 18 45 19
m.lanfossi@spineguard.com
NewCap Investor Relations & Financial Communication
Mathilde Bohin / Pierre Laurent Tel.: +33 1 44 71 94 94
spineguard@newcap.eu
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