- Very strong growth in international sales driven by the $3
million (approx. €2.8 million) milestone payment from
NuVasive
- Solid cash position of €7.3 million at June 30, 2023,
excluding €1.5 million in non-dilutive financing obtained from
SMAIO’s longstanding banking partners
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 comprehensive offer including
software, adaptative implants and related services, today published
its sales for the first half of 2023 and issued an update on its
development.
Philippe ROUSSOULY, Chairman and CEO of SMAIO, said: “The
first half of 2023 was firstly marked by the achievement of a major
milestone for SMAIO with the granting of FDA 510(k) clearance for a
customized version of the KEOPS Balance Analyzer 3D surgery
planning software co-developed with NuVasive. In accordance with
the plan, this clearance triggered a $3 million payment from our
American partner. This partnership is the cornerstone of our US
market access strategy. Firstly, it demonstrates the capabilities
of the technological collaboration between the two companies, and,
secondly, it provides NuVasive clients, primarily in the United
States, with the possibility of using our high-performance
customized surgery planning services in the near future. These
activities should thus create additional recurring revenue flows
from the end of 2023 or early 2024, depending on registration
timeframes in selected North American centers. These flows should
help improve the Company’s profitability indicators and reduce its
cash requirements. Furthermore, during the semester, SMAIO has
focused its commercial efforts on training ambassador surgeons on
the American market for the dissemination of its comprehensive
i-kontrol offer. Following registration procedures in targeted
American hospitals, several complex surgeries could be performed
during the second half of the year. At the same time, the confirmed
participation of more than 30 surgeons specialized in complex
surgery in the “Sagittal Alignment Think Tank” organized by SMAIO
in November 2023 in San Diego is an extremely positive sign of the
rapid ramping up of the Company’s reputation in the United States.
Consequently, this targeted and controlled strategic investment
policy, combined with the use of non-dilutive financing levers
carried out in advantageous conditions with Bpifrance and the
Company’s longstanding banking partners (BNP Paribas, Société
Générale), enabled SMAIO to have a comfortable cash position at
June 30, 2023. Within this context, the Company will continue its
efforts to achieve the $2 million second milestone payment with
NuVasive, further strengthening its partnership while significantly
developing its sales and profitability”.
First-half 2023 sales
In € thousands
June 30, 2023
June 30, 2022
Change
Sales*
3,997
1,318
+203.3%
France
612
605
+1.2%
International
3,385
713
+374.8%
* Unaudited data
Sales totaled €4.0 million in the first half of 2023, up +203%
compared with the first half of 2022 (€1.3m).
International activity saw very strong growth compared with the
same period of 2022 (+375%). This substantial increase was
primarily due to the $3 million (approx. €2.8 million) milestone
payment received from NuVasive, a leading player in technological
innovations for spine surgery, following the granting of FDA 510(k)
clearance for a customized version of the surgery planning software
co-developed with this partner, in line with the roadmap published
at the time of the Company’s IPO. Moreover, sales of implants and
instruments have recorded good growth via distributors in Spain and
in Sweden, as well as a new distributor in Australia.
Excluding the NuVasive milestone payment, first-half 2023
revenue primarily consisted of sales of the Kheiron system
comprising customized implants and rods (€1.2 million). Kheiron
sales should be driven by the opening up of the US market in the
second half of 2023, with a number of American centers currently in
the final stages of the registration process for SMAIO’s
implantable devices.
Regarding the software segment, the latter should increase over
coming semesters thanks to the partnership and licensing agreement
signed with NuVasive. Within this framework, SMAIO could provide
its planning services to NuVasive’s clients and generate additional
recurring revenue by the end of 2023 or early 2024, depending on
the required registration timeframes in the targeted American
hospitals.
Solid financial structure
The Company had a cash position of €7.3 million at June 30, 2023
compared with €5.7 million at December 31, 2022. This increase was
due to good control over cash burn levels, the payment relating to
the milestone achieved with NuVasive and the receipt of the €1
million Bpifrance Innovation R&D loan that includes a 3-year
grace period.
Moreover, the Company’s cash position will benefit from the
drawdown, in September, of €1.5 million in the form of loans from
BNP Paribas and Société Générale. These loans have a maturity of 4
years.
This level of cash will allow SMAIO to finance its development
in accordance with the strategy presented at the time of the
Company’s IPO, in April 2022.
Upcoming financial publication
- H1 2023 results: Wednesday, October 18, 2023, after
market
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230718157070/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
SMAIO (EU:ALSMA)
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