- SMAIO first-half 2023 sales at €4.0m, excluding intra-group1
transactions, up a sustained +203% thanks to NuVasive milestone
payment of $3m (~€2.8m)
- Further improvement in margin on “non-group” implant sales
to 67% vs. 63% in 2022 and 55% in 2021
- Solid cash position of €7.3m at June 30, 2023, excluding
€1.5m non-dilutive financing obtained from SMAIO's longstanding
banking partners
Regulatory News:
SMAIO (Software, Machines and
Adaptative Implants in Orthopaedics – Euronext
Growth Paris, ISIN Code: FR0014005I80 / Mnemonic: ALSMA), a French
player specialized in complex spine surgery with a comprehensive
offer including software, adaptative implants and related services,
today published its first-half 20232 results, approved by the Board
of Directors on October 17, 2023.
Philippe ROUSSOULY, Chairman and CEO of SMAIO, comments:
"In the first half of 2023, we have efficiently deployed our
strategic plan in the United States, leveraging our collaboration
with NuVasive and training local prescribing surgeons to enable the
spread of our i-kontrol offering. At the same time, we have
improved our profitability indicators, with margins on implant
sales reaching 67% thanks to the optimization of our purchasing
conditions. Finally, we have pursued a targeted R&D policy
which has enabled us to preserve our cash position in preparation
for our commercial expansion. Building on these achievements, we
look forward to the coming half-years with confidence, as we
continue to implement our strategic plan, which will focus
primarily on increasing our sales and boosting our
profitability."
First-half 2023 results – parent company financial
statements
Simplified income statement (parent
company financial statements, € millions)
H1 2023
H2 2022
SMAIO sales
4.9
1.3
- of which intra-Group sales to SMAIO
USA
0.9
-
Operating income
5.5
1.7
Operating expenses
(3.9)
(3.5)
Operating profit/(loss)
1.6
(1.7)
Exceptional income/(expenses)
-
7.4
Net profit/(loss)
1.6
5.4
SMAIO USA, a wholly owned subsidiary of SMAIO, was incorporated
at the end of 2022 to expand into the strategic US market. Not
exceeding any of the 3 thresholds set by art. R233-17 of the French
Commercial Code, and as the SMAIO USA subsidiary does not make a
material contribution to Group earnings, SMAIO has not produced
consolidated financial statements for the first half of 2023.
Considering intra-Group sales of implants, instruments and
services of €0.9m to the SMAIO USA subsidiary, SMAIO sales
totaled €4.9 million.
Strong sales growth was driven by international business, which
accounted for 88% of total sales to June 30, 2023, and mainly
includes a $3 million (around €2.8 million) payment from NuVasive3
following FDA 510(k) certification of a customized version of its
surgical planning software.
Restated for intra-group transactions with its US subsidiary,
SMAIO sales for the 1st half of 2023 came to €4.0 million,
up +203% on the first half of 2022, as published on July 18,
2023.
Half-year sales of the Kheiron system, comprising custom-made
implants and rods, remained stable compared to the same period in
2022, with good growth in Spain and Sweden. The ramp-up of the
Kheiron system should be supported by the opening of the US market
in the second half of 2023, with several US centers finalizing
registration procedures for SMAIO implantable devices.
The software segment is expected to grow in the coming halves
thanks to the partnership and licensing agreement signed with
NuVasive. Under this agreement, SMAIO, through its US subsidiary
SMAIO USA, will be able to offer its planning services to NuVasive
customers and generate additional recurring revenues from late 2023
/ early 2024, depending on the registration times required in the
targeted US hospitals.
The margin on implant sales, restated for intra-group
operations with its subsidiary SMAIO USA, improved significantly to
67% in the first half of 2023, compared with 63% in the first half
of 2022 and 55% in 2021. This margin should increase automatically
as the US subsidiary gains strength in a highly profitable
market.
Other operating expenses rose mainly because of the
Company's sustained efforts to promote its various solutions to
surgeons via training courses in Europe and the United States.
Depreciation, amortization and provisions remained stable at €0.6
million.
In view of the above, SMAIO's operating income for the
first half of 2023 is a profit of €1.6 million (€0.9 million
restated for intra-group transactions with its subsidiary SMAIO
USA), compared with a loss of €1.8 million for the first half of
2022.
After considering tax income of €0.1 million, SMAIO's net
profit for the first half of 2023 stood at €1.6 million,
compared with a profit of €5.4 million for the first half of 2022,
the latter having benefited from exceptional income of €7.4 million
linked to the abandonment of the current account held by the
Japanese group Otsuka - SMAIO's historical shareholder - to the
Company’s benefit.
Solid financial structure
Cash position at June 30, 2023 stood at €7.3 million, 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.
SMAIO continued to optimize its financial structure with two
loans from a banking pool comprising BNP Paribas and Société
Générale, for a total of €1.5 million and a 4-year maturity. The
two loans were drawn down on September 1st and October 1st, 2023
respectively.
Considering intra-group transactions with its subsidiary SMAIO
USA, the Company's shareholders' equity stood at €11.4 million at
June 30, 2023 (€10.7 million restated for intra-group
transactions), compared with €9.7 million at December 31, 2022.
Strategy and outlook: implementation of growth plan and
development in the United States
The Company is continuing to implement its strategic plan
presented at the time of the IPO in April 2022, and will focus
on:
- pursuing its efforts to develop custom planning software for
NuVasive;
- accelerating the marketing of the i-kontrol solution in Europe,
Australia and the United States through its American
subsidiary;
- maintaining the development of innovative R&D projects
aimed at improving the accuracy, speed and reliability of spine
surgery, such as morphologically adapted guides 3D-printed from
scans of the vertebrae to be operated on, 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 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 SMAIO sales came to €4.9m, including intra-group transactions
with its subsidiary SMAIO USA. 2 Data not audited. The half-yearly
financial report on SMAIO's parent company financial statements is
available, in French, on the Company's website
(www.smaio-finance.com) and on the Euronext website
(www.euronext.com). 3 On February 9, 2023, Globus Medical, a
U.S.-based company that manufactures and markets a full range of
spinal devices and implants, signed an agreement to acquire
NuVasive in an all-stock transaction valued at approximately $3.1
billion. As of the date of the publication of the half-year
financial report and the information available to SMAIO, NuVasive
owns 15.55% of the Company's share capital. To the best of the
Company's knowledge, this transaction does not impact the
commercial agreement between SMAIO and NuVasive.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231018085933/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 94 98
SMAIO (EU:ALSMA)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
SMAIO (EU:ALSMA)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024