- Continuation of the strategy focused on access to the US and
Chinese markets for SONOVEIN®, and its improvement through
R&D;
- Rapid start-up of the pivotal study in the United States:
two-thirds of treatments have already been completed to date;
- A capital increase of €8.4 M subscribed by the main reference
shareholders in May 2023;
- Opening up to the Chinese market through our joint venture with
the Furui Group, a long-standing shareholder in Theraclion;
- Continued R&D efforts by Theraclion to further improve
SONOVEIN® notably through AI and robotics, with major concrete
milestones expected in the next two years;
- More than 2,000 veins treated, and sales efforts for SONOVEIN®
not yet really underway.
Regulatory News:
THERACLION (ISIN : FR0010120402 ; Mnemo : ALTHE), an
innovative company developing a robotic platform for non-invasive
high-intensity focused ultrasound (HIFU) therapy, presents its
2023 financial results and reviews the execution of its
strategy.
U.S. pivotal study underway
An initial feasibility study in 2022 showed 100% feasibility and
95% absence of venous reflux. A larger pivotal study began in
October 2023. A larger pivotal study, designed to accelerate entry
into the world's leading varicose vein treatment market, began in
October 2023. Treatment has begun at the four study centers in
Europe and the United States, and over two-thirds of patients have
been treated to date. Study results will be available after a
12-month follow-up period, in accordance with the protocol approved
by the Food & Drug Administration (FDA). U.S. marketing
authorization is expected following review by early 2026.
The foundations of value creation: R&D and AI
Significant progress has been made in developing new
technological building blocks, notably in artificial intelligence,
robotics and acoustics. By combining the system’s real-time imaging
capabilities with robotics, AI algorithms will be implemented in
order to automate certain tasks, speed up procedures and
considerably simplify interactions between physicians and
SONOVEIN®. At the same time, partnerships with a dozen reference
centers in Europe are continuing (some of them already account for
100 to 150 treatments a year), improving treatment protocols and
contributing to the rapid advancement of the technology. Concrete
milestones in transformative improvements to SONOVEIN® are expected
over the next two years.
A successful capital increase
A capital increase of €8.4 M was carried out at the end of May,
mainly thanks to the historical shareholders, including notably
Furui, a Theraclion SA shareholder since 2016. In addition to an
initial investment of €6 M, Furui has committed to further funding
of €1 M, subject to Theraclion meeting specific operational
targets. An initial payment was made following the launch of the
pivotal study in the United States.
A new partner to accelerate access to the Chinese
market
Close collaboration has been established between Furui and
Theraclion in order to conquer the Chinese market. Theraclion has
licensed its technologies and brands to Theraclion China, the
pre-existing joint venture between the two companies, in return for
€3 M fee. Theraclion China was consolidated and restructured in
2023 in order to actively launch its execution plan in early 2024.
These advances enabled €2 M in license royalties to be invoiced to
Theraclion China for Echopulse® and SONOVEIN® at the end of
2023.
Results 2023
In K€
31/12/2022
31/12/2023
Var. %
Turnover
1 235
1 822
48%
Grants
7
2
-71%
Other products
125
2 093
1576%
Total Revenues
1 360
3 917
188%
COGS (purchase and stocks variation)
466
331
-29%
External charges
3 820
2 573
-33%
Personnel charges
3 102
3 153
2%
Other operational Charges
287
1 014
253%
Total operating expenses
7 675
7 070
-8%
Operating result
-6 314
-3 153
-50%
Financial result
-8
-1 955
23179%
Non recurring result
350
384
10%
R&D tax credit
-1 002
-1 049
5%
Net result
-4 971
-3 675
-26%
Accounts approved by the Board of Directors on March 26,
2023.
On the business front, Theraclion focuses on supporting and
assisting centers currently using its products in the treatment of
their patients and does not devote resources to prospecting for new
customers. In this context, the company is not currently focusing
on generating significant sales but is instead directing its
resources primarily towards product and treatment protocol
improvements, as well as clinical trials.
Theraclion SA reported sales of €1,822 K in 2023, up
48%
Instrument sales are up 58% and include the sale of a limited
number of systems. Sales of consumables, recurrent in most cases,
amounted to €506 K, up 41%, driven by a significant increase in the
varicose vein indication, up 61%. In line with its strategy,
Theraclion is making SONOVEIN® available to reference centers
involved in the development of treatment protocols, while also
integrating it into their business practices. Hence, Theraclion's
performance on this revenue item in 2023 reflects these treatment
centers’ favorable adoption of Theraclion's solutions.
Operating revenues amounted to €3,917 K, including €2,000 K in
royalties from licenses granted to the Theraclion China joint
venture.
Operating expenses came to €7,070 K, down by €605 K. External
expenses came to €2,573 K, compared with €3,820 K in 2022. This
decrease is due to a reduction in spending, particularly in the
first half of 2023, and to lower R&D spending in 2023.
Personnel costs remain at a level comparable with 2022 (+€50
K).
Total expenditures on R&D and development of new products
amounted to €3.9 M (compared with €4.3 M in 2022). This amount
includes people-related expenses and costs incurred for the
development and prototyping, the establishment of treatment
protocols, and clinical trial in the United States. They are €402 K
lower than in 2022, the year in which the FDA feasibility study was
carried out and finalized. In addition, the pivotal U.S. study
began in the fourth quarter of 2023, with a limited impact on 2023
expenses (€175 K). R&D investments are expected to intensify in
2025 and 2026 until FDA approval is obtained.
Theraclion's Hong Kong subsidiary was set up in 2015 in order to
address the Asian market with Echopulse®, targeting treatment of
fibroadenoma of the breast and thyroid. Given the refocusing on the
vein treatment market and on improving the product's design and
functionalities, it was decided to restrict the subsidiary's
expenditure and short-term commercial ambitions, while continuing
to support existing customers and maintain the installed base. The
subsidiary's shares and related receivable have been written down
by 1,879K€. Taking into account exchange losses, financial interest
and charges on marketable securities, net financial income came to
a loss of 1,955K€.
The research tax credit amounted to €1,049 K at the end of
December 2023, compared with €1,001 K in 2022. The company received
€998 K in respect of the 2022 research tax credit in December
2023.
Net loss came to €3,675 K, down €1.3 M on 2022.
Net cash position
In K€
31/12/2022
31/12/2023
Var
Treasury
2 489
7 815
5 326
Medium-term cash position
31
-31
Total cash and cash equivalents
2 520
7 815
5 295
Bank loans
-2 506
-1 947
559
Net cash position
14
5 868
5 854
Theraclion's net cash position is €5.9 M on December 31, 2023.
Expected short-term cash inflows include license royalty payments
of €2 M.
About Theraclion
Theraclion is a French MedTech company committed to developing a
non-invasive alternative to surgery through the innovative use of
focused ultrasound.
The HIFU (high-intensity focused ultrasound) treatment method
concentrates therapeutic ultrasound on an internal focal point from
outside the body. It requires no incisions or operating room,
leaves no scars and allows patients to return immediately to their
daily activities.
Theraclion is developing SONOVEIN®, a CE-marked robotic platform
for HIFU treatment of varicose veins, with the potential to replace
millions of surgical procedures every year.
Based in Malakoff (Paris), the Theraclion team is made up of
about thirty people, mainly in technological and clinical
development.
For more information, please visit
www.theraclion.com and follow the account on
LinkedIn.
Theraclion is listed on Euronext Growth Paris Eligible for the
PEA-PME scheme Mnemonic: ALTHE - ISIN code: FR0010120402 LEI:
9695007X7HA7A1GCYD29
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240327270963/en/
Theraclion contact
Martin Deterre Chief Executive Officer
contact@theraclion.com
Theraclion (EU:ALTHE)
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