- First-half 2022 sales up +28% to €1.3 million
- Improvement in the sales margin thanks to better implant
procurement conditions
- Exceptional income of +€7.4 million resulting from the
dropping of the current account held by the Otsuka Group in SMAIO’s
favor
- Success of April’s IPO: cash position of €7.3 million at
June 30, 2022
Regulatory News:
SMAIO (Software, Machines and
Adaptative Implants in Orthopaedics – Euronext
Growth Paris ISIN: FR0014005I80 / Ticker: ALSMA, eligible for
PEA-PME equity savings plans), a French player specialized in
complex spine surgery with a global offer comprising software,
adaptative implants and related services, today published its
results for the first half of 20221, approved by the Board of
Directors on September 26, 2022.
Philippe ROUSSOULY, Chairman and CEO of SMAIO, commented:
“This first half of 2022 was marked by the strengthening of our
financial capabilities and the strategic contract signed with our
American partner NuVasive within the framework of our Initial
Public Offering on the Euronext Growth market in Paris. At the same
time, we have continued our commercial development, notably abroad
where our revenue has recorded substantial growth, whilst improving
our sales margin thanks to better implant procurement conditions.
In the United States, our priority market, we have met key
milestones with the first surgical procedures performed and the
granting of two FDA 510(k) clearances for our surgery planning
software and our patient-specific rods. Building on our
strengthened financial situation and this positive momentum, in the
coming months we will focus on organizing training programs in
order to promote SMAIO’s technologies and services internationally,
with a particular emphasis on the United States. Furthermore, in
early 2023, our partnership agreement with NuVasive should allow us
to obtain a first milestone payment of $3 million followed by
recurrent revenue thanks to imaging analysis services undertaken by
SMAIO’s operators for NuVasive’s clients”.
First-half 2022 results
Simplified income statement (€
millions)
H1 2022
H1 2021
Sales
1.32
1.03
Operating income
1.70
1.53
Operating expenses
(3.45)
(3.29)
Operating profit/(loss)
(1.75)
(1.76)
Exceptional income/(expenses)
7.40
(0.3)
Net profit/(loss)
5.37
(1.60)
Sales totaled €1.3 million in the first half of 2022, an
increase of +28% compared with the first half of 2021 (€1.0
million). This improvement was the result of buoyant growth in
international activity (+119%), and notably of the ramping up of
our historical distributors in Spain and Scandinavia, new
distribution agreements signed in the Baltic states and Greece and
the first surgical procedures performed in the United States.
As in 2021, sales of implants and rods accounted for almost all
of the Company’s sales (96%). The software segment, with the Keops
platform, accounted for the balance (4%) and will see substantial
growth over the coming semesters, notably following the granting of
510(k) clearance by the FDA and thanks to the partnership and
licensing agreement signed with NuVasive, a global leader in spine
technology innovation.
SMAIO’s gross margin reached a new high of 60%, versus
52% at end-June 2021 and 55% at end-December 2021, thanks to an
increased presence on international markets, historically more
lucrative, and the more advantageous implant procurement conditions
obtained in 2021. The margin on implant sales alone also saw a
significant improvement, increasing from 50% in H1 2021 to 63% in
the same period of 2022.
Other operating expenses increased in the first half of
2022, primarily as a result of the amortization of the new sets of
instruments loaned out or given to hospitals on consignment, the
amortization of R&D costs reflecting the intensification of the
Company’s innovation efforts, as well as inventory depreciations.
Amortization, impairment and provision charges came to €0.6 million
in the first half of 2022, vs. €0.5 million a year earlier,
The operating loss was €1.75 million in the first half of
2022, stable compared with the first half of 2021.
Exceptional items totaled +€7.40 million and consisted
entirely of the dropping of the current account held by Japanese
group Otsuka – longstanding SMAIO shareholder – to the Company’s
benefit.
Once a tax expense of €0.27 million is taken into account, there
was a net profit of €5.4 million in the first half of 2022
compared with a net loss of €1.6 million in the same period of
2021.
Strengthened financial structure
SMAIO had cash and cash equivalents of €7.33 million at June 30,
2022, compared with €0.57 million at December 31, 2021. This figure
notably includes the €7.5 million net proceeds of the Company’s IPO
on the Euronext Growth market in Paris in April 2022. This cash
position will allow the Company to finance its development in
accordance with the strategy presented to the financial community
at that time.
Shareholders’ equity stood at €12.32 million at end-June 2022,
vs. -€0.62 million at end-December 2021.
On February 1, 2022, Otsuka announced that it was discontinuing
its activities in orthopedics and took the decision to transfer its
interests to SMAIO’s Vice-President of Operations, as well as its
current account to SMAIO’s only other shareholder, Sylorus
Scientific2. Furthermore, it also decided to entirely cancel
SMAIO’s current account debt, thus making the Company
debt-free.
H1 2022 highlights
- Value-creating partnership with NuVasive, a global leader in
spine technology innovation
Sharing a similar vision of the importance of spinal realignment
planning and implant placement to achieve favorable, repeatable and
long-lasting results, in the first quarter of 2022 NuVasive and
SMAIO signed a partnership and licensing agreement to further
develop SMAIO’s surgical planning solutions and to support the
innovation pipeline and commercialization efforts.
As part of this collaboration, NuVasive has pledged to invest a
total of $10 million (~€9 million3) in the Company, of which $5
million (~€4.5 million3) has already been invested within the
framework of SMAIO’s IPO, the balance consisting of milestone
payments that will be made when the Company receives FDA 510(k)
clearance for two software solutions interfacing with the U.S.
group’s technological platforms. NuVasive has exclusivity regarding
the planning tool development partnerships implemented by SMAIO for
a three-year period from the date on which the second software
solution is approved.
Moreover, within the framework of this partnership, SMAIO will
put in place an image analysis and planning assistance service for
NuVasive’s clients, which will be billed and will thus generate
recurring payments proportional to the number of analyses
performed. This partnership leaves SMAIO free to distribute its own
customized bending solutions and the remainder of its KHEIRON
implant range either directly or via its network of
distributors.
- Two 510(k) clearances to accelerate development in the
United States
In June, SMAIO announced that it had been granted two 510(k)
clearances by the FDA for the key components of its i-Kontrol
platform: the Balance Analyzer 3D surgery planning software and the
K-rod patient-specific union rod. Thanks to these approvals, SMAIO
can now offer its i-Kontrol solution to North American medical
centers. These clearances represent a major step in the American
market penetration strategy that will be based on the distribution
of the comprehensive i-Kontrol solution to key centers invited to
participate in training programs called the “sagittal alignment
academy”, as well as on imaging analysis services distributed via
NuVasive’s network as soon as the first version of the SMAIO
surgery planning software jointly developed with its California
partner is approved.
Strategy and outlook
Over the coming months, and in accordance with the strategy
announced at the time of its IPO, the Company will pursue three key
objectives:
1. The ramping up of the partnership with NuVasive, focusing on
the development of a customized version of the i-plan platform for
NuVasive and, at the same time, an image analysis service
offer.
2. The marketing of the i-Kontrol solution in Europe, the United
States and Australia. To achieve this, the Company will build on
its own sales force, its partner NuVasive in the United States and
a network of distributors and agents.
3. The development of innovative R&D projects aimed at
improving the accuracy, speed and reliability of spine surgery,
with morphologically adapted guides 3D-printed from scans of the
vertebrae to be operated upon enabling implants to be accurately
positioned in the pedicles, or morphologically adapted trackers
allowing vertebrae to be detected in space in order to steer them
or guide a robotic arm.
About SMAIO
A precursor in the use of clinical data and imaging of the
spine, SMAIO designs global solutions for spine surgery
specialists. The Company has recognized expertise thanks to KEOPS,
its Big Data management software that has become a global reference
with more than 100,000 patient cases documented.
SMAIO offers spine surgeons a comprehensive platform, I-Kontrol,
incorporating planning, implants and related services, enabling
them to treat spinal pathologies in a safe, effective and lasting
way.
SMAIO is positioned at the forefront of innovation with the
ambition of providing surgeons with the first active robotic
solution enabling a high level of performance and repeatability to
be achieved.
Based in Lyon, France, SMAIO benefits from the skill and
expertise of more than 30 highly specialized staff.
For further information, please visit our website:
www.smaio.com
Listing market: Euronext Growth Paris ISIN:
FR0014005I80 Mnemonic: ALSMA
Disclaimer
This press release contains non-factual elements, including, but
not limited to, certain statements regarding future results and
other future events. These statements are based on the current
vision and assumptions of the management of the Company. They
incorporate known and unknown risks and uncertainties that could
result in significant differences in results, profitability and
expected events. In addition, SMAIO, its shareholders and its
affiliates, directors, officers, counsels and employees have not
verified the accuracy of, and make no representations or warranties
about, statistical information or forecast information contained
within this news release and that originates or is derived from
third party sources or industry publications; these statistical
data and forecast information are only used in this press release
for information purposes. Finally, this press release may be
drafted in French and in English. In the event of differences
between the two texts, the French version will prevail.
1 The half-year financial report relating to these first-half
financial statements will be posted within the statutory time
limits on the Company’s website (www.smaio-finance.com) and the
Euronext website (www.euronext.com). 2 Sylorus Scientific SA is 80%
owned by Mr. Philippe Roussouly, Chairman and CEO of SMAIO, and 20%
owned by Mr. Pierre Roussouly (Philippe’s father). 3 based on an
exchange rate of 1.10 dollars per euro at the time the contract was
implemented in March 2022
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220927005911/en/
SMAIO Philippe Roussouly Chief Executive Officer Renaut
Fritsch Chief Financial Officer investors@smaio.com
NewCap Dusan Oresansky/Quentin Massé Investor Relations
smaio@newcap.eu Tel.: +33 (0)1 44 71 94 92
NewCap Arthur Rouillé Media Relations smaio@newcap.eu
Tel.: +33 (0)1 44 71 00 15
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