- Sales of implants and instruments up +81% to €2.2
million
- Margin on implant sales up sharply to 79% from 71% at end
2023, driven by the ramp-up of surgeries in the United
States
- Good management of operating expenses (+16%), reflecting
targeted, controlled sales deployment in the US market
- Solid cash position of €5.1m at June 30, 2024
- Creation of a scientific advisory board with the appointment
of first two North American surgeons, experts in spinal
alignment
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 first-half 2024 results1 approved by the Board of Directors on
October 14, 2024 and announced the creation of a scientific
advisory board to support its development in the United States.
Philippe ROUSSOULY, Chairman and CEO of SMAIO, said: “The
first half of 2024 was marked by strong sales growth momentum in
the US market, which now accounts for more than a third of our
commercial activity. This performance reflects the successful
launch of SMAIO's targeted growth strategy, based on the rapid
adoption of our solutions by a dozen prescribing surgical centers
in the United States.
This is the result of the educational work carried out by the
company over the past two years on its vertebral realignment
concept, through training courses, practical sessions and “think
tanks” organized in key centers. This work will continue to develop
over the coming months, and we are confident of sustained sales
growth in the United States, where margins in the spinal surgery
segment are the highest in the world. In this respect, we are
delighted to initiate the creation of a North American scientific
advisory board, comprising leading surgeons, which will enable us
to accelerate the dissemination of our technology in this key
market.
The company is also continuing to manage its sales and marketing
costs very carefully, using a number of local distributors who are
paid according to sales, while benefiting from the support of our
customer support team, and my direct presence in the United States
to develop new accounts.
The sales growth that will be driven by the North American
market, combined with strict control of fixed costs incurred by the
company mainly for innovation, maintenance and development of new
industrial certifications for its products, as well as a targeted
promotional strategy, supported by recognized KOLs, should enable
SMAIO to position itself as an international leader in the spinal
realignment market and generate profitable growth over time."
First-half 2024 consolidated results
Simplified income statement
H1 2024
H1 2023 pro forma**
H1 2023
(SMAIO consolidated financial statements*,
€ millions)
Sales
2.2
1.2
4.0
of which France
0.6
0.6
0.6
of which the United States
0.8
-
-
of which rest of the world
0.8
0.6
0.6
of which milestone payment
-
-
2.8
Capitalized production
0.4
0.4
0.4
Operating income
2.6
1.6
4.4
Operating expenses
(4.3)
(3.7)
(3.7)
Operating profit/(loss)
(1.7)
(1.9)
0.9
Financial profit/(loss)
0.1
(0.1)
(0.1)
Net profit/(loss) - Group share
(1.2)
(1.7)
1.1
* Data not audited ** To provide comparable information, the
company is presenting a simplified income statement including pro
forma H1 2023 figures, excluding the milestone payment.
Sales for the first half of 2024 amounted to €2.2
million, compared with €4.0 million for the same period in 2023,
which included a €2.8 million milestone payment from NuVasive.
SMAIO's implant and instrument sales generated €2.1 million in
the first half of 2024, up 80% on the first half of 2023, driven by
the opening of its US subsidiary (€0.8 million in the first half of
2024) and increased business activity in Scandinavia.
The margin on implant sales, which account for 95% of
SMAIO's total business, stands at 79%, up 8 points on December 31,
2023 (71%) and 12 points on June 30, 2023 (67%) due to the start of
billing in the United States, where margins are the highest in the
sector.
Operating expenses rose by €0.6 million compared to the
first half of 2023, mainly as a result of a mechanical increase in
commissions on sales in the US market, which are keeping pace with
sales growth, a rise in payroll as the Group finalizes the
structuring of its operational teams, notably for customer support
in the United States, and, lastly, depreciation and amortization
charges directly correlated with R&D efforts, mainly to develop
the artificial intelligence modules deployed in the surgical
planning offering.
Taking these factors into account, consolidated operating
income showed a loss of €1.7 million for the first half of
2024, compared with a profit of €0.9 million for the same period in
2023, which included a non-recurring milestone payment of €2.8
million.
After recognition of financial income of €0.1 million,
mainly from returns on capital-guaranteed cash investments, total
tax income of €0.4 million including a €0.2 million research
tax credit, and deferred taxes, SMAIO's net income for the
first half of 2024 was a loss of €1.2 million.
Solid financial structure
The cash position of SMAIO at June 30, 2024 was €5.1 million,
compared with €6.9 million at December 31, 2023. This trend
demonstrates the ability of SMAIO to develop its business in new,
high-potential markets, and to invest in R&D and business
development - growth drivers for the Group - while keeping its
costs under control.
Shareholders' equity of SMAIO stood at €8 million at June 30,
2024, compared with €9.3 million at December 31, 2023.
Significant post-closing event
Creation of a leading scientific advisory
board to support development in the United States
After around 100 surgeries performed by SMAIO in the United
States since the beginning of 2024, the Company is initiating the
creation of a North American scientific advisory board. As such,
Dr. Brian J. Neuman (orthopedic surgeon) and Dr. Camilo
Molina (neurosurgeon), both practicing at the prestigious
Washington University School of Medicine in St. Louis, have agreed
to join this new scientific board, with the following main
missions:
- collaborate with SMAIO in the development of implant
technologies and software, adapting them to the specific needs of
North American patients and surgeons;
- contribute to the analysis and publication of scientific
results obtained through the use of SMAIO technologies, in
particular those using artificial intelligence;
- communicate with their peers about the benefits of using SMAIO
technologies for both patient and surgeon;
- train peers in the use of SMAIO technologies for the planning
and execution of spine realignment surgery.
This new scientific advisory board is a major strategic resource
for SMAIO and will provide the Company with expertise and support
for its development in the United States, as well as facilitating
the organization of "Sagittal Alignment Think Thanks" across North
America.
Philippe ROUSSOULY, Chairman and CEO of SMAIO, comments:
" We are pleased and honored to formalize this collaboration with
Brian J. Neuman and Camilo Molina, who share SMAIO's values and
philosophy, and are among the most renowned experts in complex
spine surgery in the United States. This agreement demonstrates
both the attention paid by the Company to the management of its
financial resources, and the long-term confidence that surgeons
have in the project undertaken. We are confident that we will soon
be able to announce similar agreements with other leading U.S.
surgeons. Their expertise will considerably strengthen our position
in the North American market, which is not highly demanding but
also lucrative, and will help to spread our innovative technology
to a growing number of surgeons in this geographic area of
strategic importance to our growth. We are convinced that our close
cooperation will ultimately enable us to establish a new paradigm
in the treatment of U.S. patients, based on the consideration of
individual morphological specificities, and thus improve surgical
outcomes".
Brian J. Neuman, Chief of the Spine Division at Washington
University in St. Louis, states: "We are delighted to be
joining SMAIO's scientific project, which aims to significantly
improve care of patients requiring surgical spine realignment. Our
aim is to play an active role in the development of SMAIO's
technologies before introducing their benefits to other surgeons
facing the same challenges as those who receive daily treatment at
Washington University”.
Camilo Molina, Head of Complex Neurosurgery Department at
Washington University in St. Louis, adds: "As an innovative
European company with expertise in spine realignment thanks to a
comprehensive database, SMAIO has tremendous development potential
and will have to constantly take into account the specific
requirements of the North American market to perform on a large
scale. Our aim is to bring our expertise to the exciting scientific
and technological research projects launched by the Company in the
spine realignment field supported by artificial intelligence, while
gearing future developments towards user experience as optimized as
possible given the constraints that we face in the United
States."
The profiles of the two founding members of the scientific
advisory board and their remuneration, mainly in the form of
warrants issued to their benefit, are detailed in the appendix to
this press release.
Strategy and outlook
Over the coming months, SMAIO will continue to implement its
strategic plan and build growth based on the following key
drivers:
- Pursue commercial deployment in the United States, a
high value-added market where the Group intends to accelerate its
development, notably through Think Tanks, discussions with KOLs and
training courses for surgeons at reference centers. Within this
framework, the two surgeons from the newly formed scientific
advisory board, Brian J. Neuman and Camilo Molina, will have
actively participated in the preparation of an upcoming Think Tank
to be held in New York in early December 2024.
- Continuously invest in the development of new
functionalities and progressively integrate artificial
intelligence into SMAIO's planning solutions. In this respect, the
presentation this summer at the Las Vegas congress, organized by
the international Spine Study Group, of the new preoperative
planning platform connected to the future KEOPS-4ME artificial
intelligence modules was very well received. Demonstrations were
given by Dr. Mike Kelly (Rady Children's Hospital-San Diego), one
of the US's leading specialists in the treatment of spinal
deformities, on scoliosis realignment simulators. Thanks to these
developments, SMAIO intends to make spinal alignment planning both
more realistic and faster.
On the strength of these ambitions, SMAIO should experience
sustained growth momentum over the coming six months.
Upcoming financial news:
- Full-year 2024 sales: Tuesday, January 21, 2025 (after
market close)
- Full-year 2024 results: Tuesday, April 15, 2025 (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.
APPENDIX
Profile of the founding members of the scientific advisory
board
Dr. Brian J. Neuman is an orthopedic surgeon at
Washington University in St. Louis, specializing in the surgical
treatment of complex spinal deformity conditions for adult and
pediatric patients. He is professor in the Orthopedics Department
at Washington University in St. Louis and is involved in many
international spine societies where he collaborates with
international experts to develop and validate new surgical
techniques, as well as methods to better assess the impact of
patient and surgical factors on overall outcomes following ASD
surgery. His studies, published in leading scientific journals,
focus on improving spine surgery outcomes by integrating robotics
and minimally invasive surgery techniques.
Dr. Camilo Molina is neurosurgeon and associated
professor of neurosurgery and orthopedic surgery at Washington
University in St. Louis. He is director of the Spine Deformities
and Oncology Department, and co-director of the Department of
Patient Safety and Quality Improvement. As Deputy Director of Spine
Innovation at the Center for Innovation in Neuroscience and
Technology, he is involved in several research projects and
specializes in the treatment of spine disorders, including tumors,
deformities and trauma. He also contributed to the first
FDA-approved augmented reality-assisted spine surgery procedure in
the United States.
As member of the American Association of Neurological Surgeons
(FAANS), North American Spine Society (NASS) and Congress of
Neurological Surgeons (CNS), he has received numerous awards for
his contributions to neurosurgery and spine research, including the
Johns Hopkins Dept. of Neurosurgery Harvey Cushing Research Award,
the Howard Hughes Medical Institute Medical Student Fellows Grant,
and the AO Spine Hansjorg Wyss Foundation Award.
Scientific advisory board remuneration
The commitment of the members of the scientific advisory board
will involve several dozen hours of scientific work each year for
the benefit of the Company, valued at hourly rates fully in line
with current market practices in the United States.
In this context, and to preserve its financial resources, SMAIO
has implemented an original method of remunerating the surgeons, to
the extent that they will be remunerated mainly by the allocation
of a total number of 150,000 share subscription warrants (the
"Warrants") to their benefit.
Summary of the terms and conditions of Warrants issue to the
first members of the scientific advisory board
This issue follows the delegation of authority granted to the
Board of Directors by the Combined General Meeting of June 18,
2024, under the terms of the 12th resolution, of an extraordinary
character (issue of ordinary shares and/or any other securities
giving immediate and/or deferred access by any means to the
Company's capital, with cancellation of shareholders' preferential
subscription rights in favor of a category of persons) and the
decisions of the Board of Directors on October 14, 2024.
The Warrants will be issued for cash, to be paid up in full by
cash payment or by offsetting against certain, liquid and payable
debts held by the beneficiary surgeons against SMAIO on the date of
their subscription, it being specified that the Board of Directors
meeting of October 14, 2024 set the unit subscription price of the
Warrants at an amount of two euros and twenty-seven cents (€2.27)
per Warrant.
In addition, the warrants will not be listed, will be issued in
registered form and will be registered in the name of their holder
in a pure registered account in the Company's share accounts.
Each warrant will entitle its holder to subscribe for one (1)
ordinary share in the Company, subject to compliance by the members
of the scientific advisory board with all the legal and regulatory
conditions and those set out in the plan regulations relating to
the warrants, issued at a total unit price, including issue
premium, of three euros and six hundred and eighty-three
ten-thousandths of a euro (€3.0683), i.e. a par value of nineteen
euro cents (€0.19) and two euros and eight thousand seven hundred
and eighty-three ten-thousandths of a euro (€2.8783) issue premium
per SMAIO share.
In accordance with the delegation of authority granted by the
Combined Shareholders' Meeting of June 18, 2024, the subscription
price of the shares allotted on exercise of the warrants shall be
at least equal to the volume-weighted average of the share prices
for the last three (3) trading days prior to the Board of
Directors' meeting of October 14, 2024, less a maximum discount of
twenty percent (20.00%) compared with the stated average.
The maximum number of shares that may be issued on exercise of
the Warrants is therefore 150,000 ordinary shares, representing
around 2.87% of the Company's current capital. These shares will be
registered and subject to all legal and statutory provisions and
will carry dividend rights as from the date of their creation, it
being specified that the new shares will be assimilated to the
existing ordinary shares. Details of the dilutive effects of this
operation are presented below.
By the end of 2024, several more US surgeons are expected to
join SMAIO's scientific advisory board and should benefit from a
remuneration scheme like that described above.
Impact of the issue on equity per share:
Equity per share (in
€)
Prior to the Warrants issue
€1.53
After exercise of the 150,000 Warrants
and issue of 150,000 corresponding new shares
€1.61
Impact of the issue on the situation of a
shareholder:
Shareholder interest (in
%)
Prior to the issue of the
warrants
1.00%
After exercise of the 150,000 Warrants
and issue of 150,000 corresponding new shares
0.97%
1 Data not audited. The half-yearly financial report on SMAIO's
consolidated financial statements is available, in French, on the
Company's website (www.smaio-finance.com) and on the Euronext
website ((www.euronext.com).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241015118808/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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