- Net profit of €1.1m in the parent Company financial
statements (loss of €0.8m in consolidated statements*), reflecting
effective cost control in a context of growth and investment in
surgical planning technologies using artificial
intelligence
- Significant improvement in margin on implant sales to 67% in
the parent Company financial statements (in 71% consolidated
statements*), vs. 63% in 2022
- Solid cash position of €6.8m (€6.9m in consolidated
statements*) at December 31, 2023
Regulatory News:
SMAIO (Software, Machines and
Adaptative Implants in Orthopaedics – Euronext
Growth Paris, ISIN: FR0014005I80 / Ticker: ALSMA), a French player
specialized in complex spine surgery with a global offer comprising
software, adaptative implants and related services, today published
its 2023 annual results1 approved by the Board of Directors on
April 15, 2024.
Philippe ROUSSOULY, Chairman and CEO of SMAIO, said: “The
year 2023 marked a major turning point in SMAIO's history with the
achievement of our 3 main objectives. First of all, the FDA's
510(k) certification of the customized version of our surgical
planning software enabled us to receive a $3 million payment from
our American partner, NuVasive. This demonstrates our expertise and
paves the way for the upcoming release of a brand-new surgical
planning platform incorporating artificial intelligence to model
the spine and provide practitioners with an optimized simulation of
the surgical outcomes to be achieved. In the second part of the
year, we activated several major user centers of SMAIO solutions in
the US, demonstrating the increasing adoption of our technology by
surgeons and validating the relevance of the various training
programs we have conducted in the US over the past months. Finally,
we have strengthened our financial structure through non-dilutive
funding of €2.5 million, providing us with the necessary resources
to continue deploying our growth strategy focused on the North
American market."
Full-year 2023 results
SMAIO SA
Simplified income statement
(SMAIO SA – parent Company - in €m)
2023
2022
Sales
7.6
2.4
Capitalized production
1.1
0.7
Operating income
8.9
3.2
Operating expenses
(8.2)
(7.2)
Operating profit/(loss)
0.7
(4.0)
Exceptional income/(expenses)
-
6.6
Net profit/(loss)
1.1
2.8
Taking into account intra-group sales of implants, which are
strongly linked to the growth of SMAIO's U.S. subsidiary, SMAIO
SA’s sales 2023 amounted to €7.6 million, up +212%
compared to 2022. After neutralizing intra-group sales of implants
between SMAIO SA and its U.S. subsidiary SMAIO USA and considering
only the hospital implant sales conducted by the latter, SMAIO
Group’s sales came to €5.4 million*, representing a
+120% growth compared to 2022. Sales of the Kheiron system,
consisting of customized implants and rods, were particularly
strong in the last quarter of the year (+40% vs. Q4 2022) due to
surgeries performed in the U.S., initiated during the second half
of 2023.
Capitalized production reached €1.1 million compared with
€0.7 million in 2022, reflecting SMAIO's R&D efforts and
enabling to position the Company as a key differentiator in the
spinal surgery sector.
The margin on the purchase cost of implant sales has
continued its upward trend, up from 63% in 2022 to 67% in 2023 (71%
on a consolidated basis*). This trend is the direct result of the
optimization of the Company's purchasing prices, coupled with the
growth in international sales in high value-added markets. This
margin should continue to increase significantly for SMAIO from
2024 with the ramp-up of the U.S. subsidiary, a market where
margins have historically been higher.
The increase in other operating expenses is the result of
the efforts made by SMAIO in R&D, since its IPO in April 2022,
with the strengthening of its software development teams
integrating artificial intelligence (AI) and the promotion of its
solutions through the "Sagittal Alignment Academy" training courses
held in Europe and the United States.
In view of the above, operating profit for 2023 stands at
€0.7 million, compared with a loss of -€4.0 million in 2022.
After considering a research tax credit of €0.4 million, net
profit for 2023 stood at €1.1 million, compared with a profit
of €2.8 million for the same period in 2022, which was the result
of exceptional income following the cancellation of SMAIO's debts
to its main shareholder, Sylorus Scientific, prior to the company's
IPO.
SMAIO Group (for information
only)
SMAIO does not exceed any of the 3 thresholds set by art.
R233-17 of the French Commercial Code and did not produce
consolidated financial statements for the year ended December 31,
2023. However, to provide accurate and comparable financial
information, the Company is informing the public of the SMAIO
Group's consolidated results after elimination of internal
transactions and non-tax consolidation restatements.
Simplified income statement
(Consolidated statements - in €m)
2023
2022
Sales
5.4
2.4
of which France
1.1
1.1
of which US
0.3
-
of which Rest of the World
1.2
1.3
of which milestone payment
2.8
-
Operating profit/(loss)
(1.1)
(4.0)
Exceptional income/(expenses)
-
6.6
Net profit/(loss)
(0.8)
2.8
* Unaudited figures
The SMAIO Group's operating result amounted to -€1.1 million,
after restatement of sales of implants, instruments and services
between the parent company SMAIO SA and its U.S. subsidiary SMAIO
USA in order to give it the necessary resources to implement its
strategy of entering the U.S. market, and after incorporating the
margin on the purchase cost of implant sales to U.S. hospitals, at
91%.
Solid financial structure
The cash position of SMAIO SA was €6.8 million at December 31,
2023 (€6.9 million in consolidated statements* and €6.5 million
after deduction of the portion of bank loans still to be repaid in
2024), compared with €5.7 million at December 31, 2022. This
increase is due to a good control over cash burn levels, the
milestone payment from NuVasive, and the receipt of a non-dilutive
financing of €2.5 million in the form of a R&D loan from
Bpifrance Innovation (€1 million, that includes a 3-year grace
period) and two loans from a banking pool, including BNP Paribas
and Société Générale (€1.5 million, 4-year maturity).
The equity of SMAIO SA stood at €10.8 million (€8.9 million in
consolidated statements*) at Decembre 31, 2023, compared with €9.8
million at December 31, 2022.
2023 highlights
- FDA 510(k) clearance for customized version of surgical
planning software co-developed with NuVasive
In June 2023, SMAIO announced that it had obtained FDA 510(k)
clearance for the customized version of its "Balance Analyzer 3D"
surgical planning software, co-developed with NuVasive. The
achievement of this first milestone, in line with the roadmap
presented by SMAIO at the time of its IPO in April 2022, triggered
the payment of $3 million by NuVasive to SMAIO. Following the
acquisition of NuVasive by Globus Medical, a U.S. company
specializing in spinal instruments and implants, SMAIO is
continuing discussions with the latter on the next steps in the
partnership, which includes an additional payment linked to the
development of a future version of the Balance Analyzer 3D, the
core technologies of which can be used by both companies. SMAIO
will keep the market informed of the outcome of discussions with
Globus Medical.
- Success of a new "Sagittal Alignment Think Thank"
educational program in the United States
As a follow-up to the first four Sagittal Alignment Academy
training programs for its European (Copenhagen, Madrid and Brussels
in October 2022 and April 2023) and North American (Dallas in
November 2022) customers, SMAIO has accelerated the dissemination
of its holistic approach to spine surgery in the United States with
the first Sagittal Alignment Think Tank in November 2023.
SMAIO's goal is to develop a consensus with North American
surgeons on a patient-specific method of spinal realignment, based
on the extensive data in SMAIO's KEOPS database, from which it is
developing several technologies using artificial intelligence2.
These training courses provide an opportunity to understand how the
i-kontrol platform can be used to accurately plan and perform
spinal realignment surgery in daily practice.
Strategy and outlook
SMAIO is continuing to implement its strategic plan presented at
the time of the IPO, and will continue to build its growth by
investing its resources in 2 main areas:
- The development of highly innovative solutions based on the
Kheiron system and the KEOPS Balance Analyzer 3D planning software,
for its own use or through customized versions incorporating
artificial intelligence.
- The development of its commercial activity in the United States
via its complete i-kontrol package or its customized planning
solutions using SMAIO's new AI platform, which is currently being
rolled out, with the aim of reaching around ten i-kontrol surgeons
and around forty users of the AI planning platform on a recurring
basis by the end of 2025.
Upcoming financial events:
- Annual General Meeting: June 18, 2024
- Sales for the first half of 2024: July 16, 2024 (after
market close)
- Half-year 2024 results: October 15, 2024 (after market
close)
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 40 highly specialized staff.
For further information, please visit our website:
www.smaio.com
Listing market: Euronext Growth Paris ISIN:
FR0014005I80 Ticker: 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 audit procedures on the annual accounts have been
completed. The management report, the corporate governance report,
the annual financial statements and the auditor's report relating
to these annual financial statements will be available within the
legal deadlines on the Company's website (www.smaio-finance.com)
and on the Euronext website (www.euronext.com).
2 The artificial intelligence embedded in SMAIO's software can,
for example, automatically identify key anatomical landmarks on
X-rays, enabling the patient's spine to be modelled in 3D while
measuring the corresponding shape and position angles, or simulate
the most appropriate spinal shape to be restored for each patient
by surgery, as well as the effects of surgery on the spinal
alignment of non-operated levels, and the subsequent positioning of
the pelvis.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240416628332/en/
SMAIO Philippe Roussouly Chief Executive Officer Renaut
Fritsch Chief Financial Officer investors@smaio.com
NewCap Dusan Oresansky/Aurélie Manavarere 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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