- Revenue of €4.3 million in the first half of 2023, +4% compared
with H1 2022
- Continued dynamic R&D investment coupled with strict
management of operating expenses, down 4% over the period
- Planned capital increase with preferential subscription rights,
guaranteed up to €5.0 million by Sanyou Medical and subject to a
General Meeting to be convened
Regulatory News:
IMPLANET (Euronext Growth: ALIMP, FR0013470168, eligible for
PEA-PME plans), a medical technology company specializing in
vertebral implants for orthopedic surgery and the distribution of
technological medical equipment, today announced its results for
the first half of the current financial year, ending June 30, 2023,
as approved by the Board of Directors on September 26, 2023.
Ludovic Lastennet, IMPLANET’s CEO, stated: “In line with
previous years, IMPLANET pursued its profound transformation in the
first few months of 2023. In addition to the various product
launches we achieved through our merger with OSD and our alliance
with Sanyou Medical, we succeeded in controlling our operating
expenses while maintaining a proactive investment policy. This last
point, essential to our strategy, will enable us in the short and
medium term to secure the renewal of our CE markings and marketing
authorizations across the world. At the same time, our strategic
partnership with Sanyou enjoyed its first technological and
commercial advances during this period. We are also looking forward
to announcing the first training courses for Chinese surgeons and
the pre-launch of our JAZZ® range in China, as part of the
preparation of the CFDA (Chinese Health Authorities) dossier, for
which submission is still scheduled for the end of this year. Our
alliance with our Chinese partner will thus see further progress in
the coming months, notably through a fund-raising operation
scheduled for January 2024, which will boost our financial
visibility and to which Sanyou intends to make a major
contribution.”
In € thousands - IFRS - Simplified income
statement
H1 2023
H1 2022
Change %
Revenue
4,268
4,112
4%
Cost of goods sold
-1,805
-1,502
20%
Gross margin
2,463
2,611
-6%
Gross margin %
57.7%
63.5%
-5.8 bp
Operating costs
-4,583
-4,798
-4%
Recurring operating profit/loss
-2,119
-2,188
3%
Other non-recurring operating income and
expenses
-89
0
n.a
Operating profit/loss
-2 209
-2 188
-3%
Financial profit/loss
-62
-103
-160%
Net result
-2,270
-2,084
-9%
*Unaudited figures
Revenue
In the first half of 2023, revenue came to €4.27 million, up +4%
on the first half of 2022.
Sales in the Spine business slowed slightly, by around 4%, from
€4.09 million to €3.94 million. Sales in the French and US markets,
where the Company operates directly, were stable over the period,
at €1.80 million and €0.80 million respectively. Export business,
particularly in Europe and Latin America, was down by around 10%
compared with the first half of 20221.
On the other hand, the Company confirmed the sales momentum of
its new SMTP Medical Equipment business over the period and
recorded the first positive results of the partnership with Sanyou
Medical. Indeed, as announced on June 21, 2023, the Company
initiated the launch of a minimally invasive pedicle screw
positioning system in Europe and has already booked its first
orders.
Gross margin and operating
income
The gross margin was €2.46 million in the first half of 2023
versus €2.61 million for the same period of 2022, a decrease of
approximately 6%. This decrease was mainly a result of the product
mix, the launch of the SMTP medical equipment ranges and the
minimally invasive pedicle screw positioning system leading to a
decrease in the gross margin from 63.5% to 57.7% between the first
half of 2022 and the first half of 2023.
At the same time, over the period the Company continued its
policy of investing in quality control and regulatory affairs in
order to secure the renewal of its marking and marketing approvals
for its implants under the new European Medical Device Regulation
(MDR), while successfully reducing its operating expenses by €0.22
million compared with the first half of 2022. This decrease has
been the result of tight control over operating spending and a
decrease in the commissions paid to sales agents in France and the
United States.
As a result, the recurring operating loss was reduced by 3%, to
-€2.12 million in the first half of 2023 compared with -€2.19
million in the first half of 2022.
Given these elements, non-recurring exceptional expenses of
€0.09m and a financial result of -€0.06m, the net result was -€2.27
million in the first half of 2023 compared with -€2.08 million in
the first half of 2022.
Cash position
As of June 30, 2023, Implanet had a cash position of €1.5
million. It stood at €0.3 million on August 31, 2023.
The cash position, which is lower than anticipated following a
cyclical slowdown in business in the United States in July and
August, and the postponement of the launch of the first SMTP
medical equipment in France, is not sufficient in view of the
Company's current operational development plan to finance business
over the next twelve months, and in particular the needs associated
with the continued development of the Sanyou Medical project.
In this context, IMPLANET needs to find new financing in the
short term. The Company is looking into the most appropriate means
of financing to enable it to implement its development plan.
Accordingly, the Company plans to launch a new fundraising
operation with preferential subscription rights (DPS) for an amount
of between €5.5 million and €6.4 million in January 2024.
To this end, the Company plans to convene its shareholders at a
General Meeting in November 2023, in order to obtain the necessary
financial authorization required for its eventual
implementation.
SHANGHAI SANYOU MEDICAL Co. LTD, a 41.03% shareholder in
IMPLANET, committed itself, in the event of the implementation of
such a transaction, to subscribe to the capital increase in cash,
on an irreducible and reducible basis, subject to (i) the approval
of Sanyou's Board of Directors, (ii) obtaining prior approval from
the Autorité des marchés financiers (AMF) for a waiver of the
obligation to file a public tender offer (in accordance with
provisions 234-8 and 234-9, 2° of the AMF General Regulations) in
the event of a post-transaction crossing of the 50% capital
threshold, and (iii) control by the relevant Chinese government
authorities.
Depending on the level of participation of IMPLANET's
shareholders, Sanyou Medical could be required to exceed the
threshold of 50% of IMPLANET's capital and voting rights, i.e. the
threshold constituting the implementation of a mandatory tender
offer.
As the implementation of such an operation would require several
months (time needed to convene a General Meeting, time needed to
obtain a waiver from the obligation to file a takeover bid, and
time needed to obtain the approval of the relevant Chinese
government authorities), the Company is actively seeking bridge
financing.
Several proposals are currently under consideration for the
implementation of a short-term financing of €1.0 million, which
could take the form of a loan either in the form of OCAs or dry
bonds, although the Company wishes to give preference to the
implementation of financing in the latter form.
Based on current business assumptions and anticipated commercial
developments with Sanyou Medical, the Company estimates that this
capital increase, for a minimum amount of €5.0 million, would give
it financial visibility of over 12 months once completed.
2023 1st half-year
highlights
- Commercial launch of the ultrasound surgical scalpel from SMTP,
a subsidiary of Sanyou Medical, in March 2023;
- FDA approval for the SqualeTM range of anterior cervical cages
in the United States;
- Commercial launch in Europe of the MIS range, a minimally
invasive pedicle screw positioning system.
Strategy and outlook for the coming 12
months
- Finalize the registration of existing products within the
framework of the European Medical Device Regulation (MDR).
- Reinvigorate the Company’s presence in the United States:
- strengthen the resources and commercial means made available to
the historical team;
- strengthen the Company’s direct approach by expanding our
scientific team of thought leaders;
- successfully register, with the FDA, the OriginTM product range
resulting from the OSD acquisition.
- Strengthen market momentum and the product offering:
- continue developing our existing strategic partnerships in the
United States (SeaSpine) and Germany (ulrich medical®);
- deploy the commercial and technological partnership with Sanyou
Medical to jointly develop an innovative new European range of
hybrid posterior fixation;
- initiate the distribution of the JAZZ® platform in China (the
world’s largest spine market by volume) with Sanyou Medical;
- distribute technological medical equipment in Europe such as
SMTP Technology Co.’s ultrasound surgical scalpel.
Upcoming financial press
release
- 2023 third-quarter revenue, October 17, 2023, after
market close
About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that
manufactures high-quality implants for orthopedic surgery and
distributing medical technology equipment. Its activity revolves
around a comprehensive innovative solution for improving the
treatment of spinal pathologies (JAZZ®) complemented by the product
range offered by Orthopaedic & Spine Development (OSD),
acquired in May 2021 (thoraco-lumbar screws, cages and cervical
plates). Implanet’s tried-and-tested orthopedic platform is based
on the traceability of its products. Protected by four families of
international patents, JAZZ® has obtained 510(k) regulatory
clearance from the Food and Drug Administration (FDA) in the United
States, the CE mark in Europe and ANVISA approval in Brazil. In
2022, IMPLANET entered into a commercial, technological and
financial partnership with SANYOU MEDICAL, China's second largest
medical device manufacturer. IMPLANET employs 43 staff and recorded
a consolidated revenue of €8.0 million in 2022. Based near Bordeaux
in France, IMPLANET opened a US subsidiary in Boston in 2013.
IMPLANET is listed on the Euronext Growth market in Paris.
For further information, please visit www.Implanet.com.
Disclaimer
This press release contains forward-looking statements about
Implanet and its business. Implanet believes that these
forward-looking statements are based on reasonable assumptions.
However, no assurance can be given that the forecasts expressed in
these forward-looking statements will materialize, as they are
subject to risks, including those described in Implanet's reference
document filed with the Autorité des marchés financiers (AMF) on
April 16, 2018 under number D.18-0337 and in the annual financial
report for December 31, 2022, which are available on the Company's
website (www.implanet-invest.com), and to changes in economic
conditions, financial markets and the markets in which Implanet
operates. The forward-looking statements contained in this press
release are also subject to risks that are unknown to Implanet or
that Implanet does not currently consider material. The occurrence
of some or all of these risks could cause Implanet's actual
results, financial condition, performance or achievements to differ
materially from those expressed in the forward-looking statements.
This press release is for information purposes only and does not
and shall not under any circumstances constitute an offer to sell
or subscribe, or the solicitation of an order to buy or subscribe,
Implanet securities in any country.
1 See press release published by the Company on July 11,
2023
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230927103167/en/
IMPLANET Ludovic Lastennet, CEO David Dieumegard, CFO
Tél. : +33 (0)5 57 99 55 55 investors@Implanet.com
NewCap Investor Relations Mathilde Bohin Nicolas Fossiez
Tél.: +33 (0)1 44 71 94 94 Implanet@newcap.eu
NewCap Media Relations Arthur Rouillé Tél.: +33 (0)1 44
71 94 94 Implanet@newcap.eu
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