- Global Offering composed of a reserved offering for qualified
investors and a public offering for retail investors via the
PrimaryBid platform
- Issue price for new shares set at 0.77 euro per share
- Closing of the PrimaryBid Offer on January 30, 2025 at 11:00 pm
CET and of the Reserved Offering on January 31, 2025 before market
opening, subject to early closure
- Cash runway extended to mid-May 2025 post-global offering
- Estimated residual financing need over the next 12 months,
post-global offering, of between €30 to 35 million
Regulatory News:
NOT FOR DISTRIBUTION DIRECTLY OR INDIRECTLY IN
THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA, SOUTH AFRICA OR
JAPAN
CARMAT (FR0010907956, ALCAR), designer and developer of the
world’s most advanced total artificial heart, aiming to provide a
therapeutic alternative for people suffering from advanced
biventricular heart failure (the “Company” or
“CARMAT”), today announces the launch of a global offering
of approximately €10 million, through the issuance of new shares at
a fixed price of 0.77 euro per share, targeting both qualified
investors (as defined below) and retail investors via the
PrimaryBid platform (the “Global Offering”).
Stéphane Piat, Chief Executive Officer of CARMAT, states:
"As Aeson® artificial heart is gaining traction across Europe, in
offering a real solution for patients suffering from advanced heart
failure, and as our commercial outlook for 2025 and beyond is
highly promising, we are launching today a share capital increase,
with the strong and renewed support of our two largest
shareholders, Lohas (Pierre Bastid) and Sante Holdings.
With 42 Aeson® implants performed in 2024 across five European
countries, including France, and sales of €7 million - 2.5 times
higher than in 2023- we are demonstrating that Aeson® addresses a
real and growing need among physicians and provides a tangible
alternative for patients with advanced heart failure.
Today, 60 hospitals across 17 countries have been trained in
Aeson®, and nearly half of them have already performed their first
implant. The strong attendance at our inaugural "Aeson® European
User Meeting" in late 2024, which gathered over 100 leading experts
in cardiology, reflects the growing adoption of our therapy. We are
already seeing the impact of this momentum in early 2025, and we
anticipate that it will translate into a significant increase in
our sales. This is why we approach 2025 with strong confidence in
our ability to at least double our sales vs 2024, especially as
several publications in leading scientific journals - expected in
the first quarter – should provide clinical evidence of Aeson®’s
performance.
These commercial and operational achievements have also sparked
interest from new investors. In this context, we are also pursuing
discussions with several financial players who could commit to
supporting CARMAT significantly and in the long-run. Should these
discussions conclude in a positive way, CARMAT could benefit from
substantial financial backing, enhancing our financing runway and
strengthening our financial position. This would position us
ideally to execute our strategic roadmap and carry-on progressing
towards profitability.
In the short-term, the global offering launched today will
enable us to strengthen our cash position and pursue our growth
trajectory, while continuing our efforts to secure other
longer-term financing. At this crucial moment in our journey, we
are delighted to be able to open this global offering to both
professional and individual investors, whose support has never
wavered.”
A €10 million Global Offering and
continued active exploration of significant additional
financing
Prior to the Global Offering, the Company’s existing financial
resources allow it to fund its operations until February 2025.
Based on its current business plan, CARMAT estimates its 12-month
financing needs at approximately €40-45 million.
The main purpose of the Global Offering is to strengthen the
Company’s equity position and finance its short-term working
capital requirements. If fully subscribed, the net proceeds will
extend CARMAT’s cash runway to mid-May 2025, enabling the Company
to continue the expansion of its commercial footprint in Europe,
the advancement of the EFICAS clinical study in France, and the
scaling up of its production capabilities.
Following the Global Offering, the Company will still need to
secure an additional c. €30 to 35 million to fund its activities
over the next 12 months.
In this context, the Company continues to actively explore all
options for additional financing and is discussing, in particular,
with various financial players likely to support CARMAT over the
long term.
However, there is currently no guarantee that these will
ultimately lead to financial support for the Company, whatever the
amount, or even that they will materialize before the end of the
Company's financial horizon.
Recent developments and
outlook
Key
achievements1
In 2024, CARMAT achieved significant progress, demonstrating the
growing adoption of its therapy and increasing confidence from the
medical community in the Aeson® artificial heart. The Company
performed 42 Aeson® implants, bringing the total number of treated
patients to over 90 since the beginning of implants. This strong
commercial momentum translated into €7 million in revenue, a
2.5-fold increase compared to 2023. In parallel, CARMAT reduced its
cash burn2 by over 20%, bringing it to below €3.8 million per month
in 2024, reflecting a highly disciplined financial management
approach that the Company intends to maintain.
On the operational front, 60 hospitals3 have been trained in
using the Aeson® heart. Among these centers, 43% have already
performed at least one implant, and 6 hospitals have firmly
integrated Aeson® into their therapeutic practice, having performed
4 or more implants. These figures confirm the growing adoption of
the therapy, which was also evident during the 1st "Aeson® European
User Meeting" in November 2024. At this event, 100% of the 41
attending centers expressed their intention to perform at least one
implant in 2025, with 70% planning to carry out multiple
implants.
Furthermore, 70% of the planned enrollments in the EFICAS study
in France (i.e. 36 implants out of 52 targeted) had been completed
by the end of 2024. Ten French hospitals are participating in this
study, which is critical both for accelerating the therapy’s
deployment in Europe and for securing reimbursement. Among these 10
centers, 2 have already performed 7 Aeson® implants each. Based on
the current recruitment pace, CARMAT anticipates completing
enrollments in the first half of 2025 and publishing preliminary
results4 by the end of 2025.
All these advances testify to the medical community's growing
interest in Aeson®, supported by substantial clinical results,
representing a cumulative patient support time5 of nearly 40
years.
High-value milestones expected in
2025
As announced in its January 8, 20256, press release, CARMAT
anticipates several significant value-creating milestones in 2025,
including:
- In Q1 2025: Two major scientific publications in leading
medical journals, one covering patients placed on “ECLS7” prior to
Aeson® implant and the other focusing on patients with pulmonary
hypertension who have received Aeson®.
- In H1 2025: Completion of enrollments in the EFICAS study (52
patients).
- In H2 2025:
- Initiation of a dedicated clinical study for patients
ineligible for heart transplant, with the long-term goal of
obtaining the destination therapy8 indication;
- Completion of the second patient cohort of the EFS study in the
United States;
- By the end of 2025: Publication of the EFICAS study9 results,
and
- For full-year 2025: At least a doubling of sales compared to
2024, along with further “cash burn” reduction10.
Based on the momentum observed in January 2025, the Company
confirms that it is currently on track to achieve all its key
operational and commercial objectives, including its target of
doubling sales.
Terms of the Global
Offering
The Global Offering will be carried out through two distinct but
concomitant transactions:
- A reserved offering of newly issued shares, without
shareholders’ preferential subscription rights, targeting
individuals, companies, or investment funds - whether French or
foreign - that regularly invest, or have invested at least €1
million over the past 36 months, in the life sciences or technology
sectors. This offering is carried out pursuant to the 6th
resolution of the Company's combined general meeting dated December
30, 2024 (the "EGM") and under the provisions of Article L.
225-138 of the French Commercial Code (the "Reserved
Offering"); and
- A public offering in France of newly issued shares intended for
retail investors via the PrimaryBid platform. This offering will be
allocated proportionally based on demand, within the limit of the
amount allocated to the public offering, with potential reductions
in case of oversubscription. It is carried out under the provisions
of Article L. 225-136 of the French Commercial Code (in accordance
with the 2nd resolution of the General Meeting) (the "PrimaryBid
Offering").
The total amount raised in the Global Offering will be
determined solely by the subscription orders received in each
tranche, with no possibility of reallocating amounts from one
tranche to the other. It is specified that the PrimaryBid Offering
to retail investors is ancillary to the Reserved Offering and will
be capped at the lower of (i) 6,174,718 euros (including issue
premium), taking into account the PrimaryBid Offering made in May
2024, and (ii) 20% of the amount of the Fundraising. In any event,
the PrimaryBid Offering will not be completed if the capital
increase under the Reserved Offer is not completed.
The price per share of the Reserved Offering will be equal to
€0.77 (representing a discount of 29.1% to CARMAT's closing share
price on January 29, 2025, i.e. €1.086, and a discount of 29.7% to
CARMAT's average volume-weighted average share price over the last
5 trading days prior to the determination of the issue price (i.e.
the trading days of January 23, 24, 27, 28 and 29, 2025), i.e.
€1.09456). The subscription price of the new shares under the
PrimaryBid Offering will be equal to the price of the new shares
offered under the Reserved Offering.
The final number of shares to be issued will be determined by
the Company’s Chief Executive Officer, pursuant to and within the
limits of the delegations of authority granted by the Board of
Directors as of the date of this press release. The maximum number
of new shares that may be issued under the Global Offering is 250
million, in accordance with the resolutions of the General Meeting.
The final number of shares to be issued will be announced in a
subsequent press release.
The accelerated book-building process for the Reserved Offering
will begin immediately and is expected to close before market
opening tomorrow, subject to early closing. The PrimaryBid Offering
also begins immediately and is expected to close at 11:00 pm (Paris
time) today, subject to early closing. The Company will announce
the results of the Global Offering as soon as possible following
the closing of the book-building process via a press release.
The Reserved Offering will be made available to institutional
investors in France and outside of France, except in the United
States, South Africa, Canada, Australia, and Japan. These investors
must fall within the category of qualified investors defined in the
aforementioned 6th resolution.
Existing shareholders Lohas SARL/Les Bastidons (the family
offices of Mr. Pierre Bastid) and Santé Holdings SRL (the family
office of Dr. Antonino Ligresti), who respectively held 13.9% and
13.8% of the Company’s capital before the Global Offering, have
committed to subscribing €3.5 million each under the Reserved
Offering. The total subscription commitments received by the
Company, as described above, amount to €7 million.
Settlement-delivery of the new shares and their admission to
trading on the Euronext Growth® Paris multilateral trading facility
are expected to take place on February 4, 2025. The new shares will
be of the same category and fully fungible with the existing
shares, carrying all attached rights, and will be admitted to
trading on Euronext Growth® Paris under the same ISIN code
FR0010907956.
Bank Degroof Petercam SA/NV and Invest Securities are acting as
Global Coordinators, Joint Lead Managers, and Joint Bookrunners for
the Reserved Offering (together, the "Placement Agents").
The Reserved Offering is subject to a placement agreement signed
today between the Company and the Placement Agents.
For the PrimaryBid Offering, investors may only subscribe
through PrimaryBid’s partners listed on the PrimaryBid website
(www.PrimaryBid.fr). The PrimaryBid Offering is governed by an
engagement letter entered into between the Company and PrimaryBid
and is not subject to a placement agreement. For more details,
please visit www.PrimaryBid.fr.
The Global Offering is not subject to a prospectus requiring an
approval from the French Financial Market Authority (Autorité des
Marchés Financiers) (the "AMF").
The public’s attention is drawn to the risk factors related to
the Company and its activities, as presented in Chapter 2 of the
2023 Universal Registration Document, filed with the AMF on April
30, 2024, under number D.24-0374, as updated by an amendment to the
2023 Universal Registration Document filed with the AMF on
September 17, 2024, under number D.24-0374-A01 (together, the "2023
Universal Registration Document"). Copies of these documents are
available free of charge from CARMAT (36, avenue de l’Europe –
Immeuble l’Étendard – Energy III – 78140 Vélizy-Villacoublay), as
well as on the websites of CARMAT (www.carmatsa.com/en/) and the
AMF (www.amf-france.org).
Additionally, investors are invited to consider the specific
risks associated with the Global Offering, including: (i) the
market price of the Company’s shares could fluctuate and fall below
the subscription price of the newly issued shares issued in
connection with the Global Offering, (ii) the volatility and
liquidity of the Company’s shares could experience significant
fluctuations, (iii) sales of the Company’s shares on the market
could negatively impact the share price, (iv) Company’s
shareholders could suffer potentially significant dilution due to
future capital increases necessary for the Company’s financing
needs, as well as the conversion of the European Investment Bank
(EIB) loan11 and the funding agreement with Vester Finance12, and
(v) since the securities are not intended to be listed on a
regulated market, investors will not benefit from the guarantees
associated with such markets.
As part of the Global Offering, the Company has agreed to a
lock-up commitment period starting from the signing date of the
placement agreement entered into between the Company and the
Placement Agents today and expiring 30 days after the
settlement-delivery of the Reserved Offering, subject to customary
exceptions and the issuance of shares as part of the conversion
("equitization") of the EIB loan and the financing line agreed with
Vester Finance, allowing the Company to potentially utilize this
facility during the aforementioned lock-up period.
It is specified that no lock-up commitment has been requested
from the Company’s existing shareholders or from investors who have
committed to subscribe to the Reserved Offering.
This press release does not constitute a prospectus within the
meaning of Regulation (EU) 2017/1129 of the European Parliament and
of the Council of June 14, 2017, as amended, nor an offer to the
public.
***
About CARMAT
CARMAT is a French MedTech that designs, manufactures and
markets the Aeson® artificial heart. The Company’s ambition is to
make Aeson® the first alternative to a heart transplant, and thus
provide a therapeutic solution to people suffering from end-stage
biventricular heart failure, who are facing a well-known shortfall
in available human grafts. The world’s first physiological
artificial heart that is highly hemocompatible, pulsatile and
self-regulated, Aeson® could save, every year, the lives of
thousands of patients waiting for a heart transplant. The device
offers patients quality of life and mobility thanks to its
ergonomic and portable external power supply system that is
continuously connected to the implanted prosthesis. Aeson® is
commercially available as a bridge to transplant in the European
Union and other countries that recognize CE marking. Aeson® is also
currently being assessed within the framework of an Early
Feasibility Study (EFS) in the United States. Founded in 2008,
CARMAT is based in the Paris region, with its head offices located
in Vélizy-Villacoublay and its production site in Bois-d’Arcy. The
Company can rely on the talent and expertise of a multidisciplinary
team of circa 200 highly specialized people. CARMAT is listed on
the Euronext Growth market in Paris (Ticker: ALCAR / ISIN code:
FR0010907956).
For more information, please go to www.carmatsa.com and follow
us on LinkedIn.
Name: CARMAT ISIN code:
FR0010907956 Ticker: ALCAR
Disclaimer
This press release does not constitute an offer to sell nor a
solicitation of an offer to buy, nor shall there be any sale of
shares in any state or jurisdiction in which such an offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or
jurisdiction.
The distribution of this document may, in certain jurisdictions,
be restricted by local legislations. Persons into whose possession
this document comes are required to inform themselves about and to
observe any such potential local restrictions.
This press release is an advertisement and not a prospectus
within the meaning of Regulation (EU) 2017/1129 of the European
Parliament and of the Council of 14 June 2017 (as amended, the
“Prospectus Regulation”). Any decision to purchase shares must be
made solely on the basis of publicly available information on the
Company.
In France, the offer of CARMAT shares described below will be
made in the context of (i) two capital increases reserved to one or
more specified categories of beneficiaries, pursuant to article L.
225-138 of the French commercial code and applicable regulatory
provisions and (ii) a public offering in France primarily intended
to retail investors through the PrimaryBid platform. Pursuant to
article 211-3 of the General regulations of the French financial
markets authority (Autorité des marchés financiers) (the “AMF”) and
articles 1(4) and 3 of the Prospectus Regulation, the offer of
CARMAT shares will not require the publication of a prospectus
approved by the AMF.
With respect to Member States of the European Economic Area, no
action has been taken or will be taken to permit a public offering
of the securities referred to in this press release requiring the
publication of a prospectus in any Member State. Therefore, such
securities may not be and shall not be offered in any Member State
other than in accordance with the exemptions of Article 1(4) of
Prospectus Regulation or, otherwise, in cases not requiring the
publication of a prospectus under Article 3 of the Prospectus
Regulation and/or the applicable regulations in such Member
State.
This press release and the information it contains are being
distributed to and are only intended for persons who are (x)
outside the United Kingdom or (y) in the United Kingdom and are (i)
investment professionals falling within Article 19(5) of the
Financial Services and Markets Act 2000 (Financial Promotion) Order
2005, as amended (the “Order”), (ii) high net worth entities and
other such persons falling within Article 49(2)(a) to (d) of the
Order (“high net worth companies”, “unincorporated associations”,
etc.) or (iii) other persons to whom an invitation or inducement to
participate in investment activity (within the meaning of Section
21 of the Financial Services and Market Act 2000) may otherwise
lawfully be communicated or caused to be communicated (all such
persons in (y)(i), (y)(ii) and (y)(iii) together being referred to
as “Relevant Persons”). Any invitation, offer or agreement to
subscribe, purchase or otherwise acquire securities to which this
press release relates will only be engaged with Relevant Persons.
Any person who is not a Relevant Person should not act or rely on
this press release or any of its contents.
This press release may not be distributed, directly or
indirectly, in or into the United States. This press release and
the information contained therein does not, and will not,
constitute an offer of securities for sale, nor the solicitation of
an offer to purchase, securities in the United States or any other
jurisdiction where restrictions may apply. Securities may not be
offered or sold in the United States absent registration or an
exemption from registration under the U.S. Securities Act of 1933,
as amended (the “Securities Act”). The securities of CARMAT have
not been and will not be registered under the Securities Act, and
CARMAT does not intend to conduct a public offering in the United
States.
MIFID II Product Governance/Target Market: solely for the
purposes of the requirements of article 9.8 of the EU Delegated
Directive 2017/593 relating to the product approval process, the
target market assessment in respect of the shares of CARMAT has led
to the conclusion in relation to the type of clients criteria only
that: (i) the type of clients to whom the shares are targeted is
eligible counterparties and professional clients and retail
clients, each as defined in Directive 2014/65/EU, as amended
(“MiFID II”); and (ii) all channels for distribution of the shares
of CARMAT to eligible counterparties and professional clients and
retail clients are appropriate. Any person subsequently offering,
selling or recommending the shares of CARMAT (a “distributor”)
should take into consideration the type of clients assessment;
however, a distributor subject to MiFID II is responsible for
undertaking its own target market assessment in respect of the
shares of CARMAT and determining appropriate distribution
channels.
The distribution of this press release may be subject to legal
or regulatory restrictions in certain jurisdictions. Any person who
comes into possession of this press release must inform him or
herself of and comply with any such restrictions.
Any decision to subscribe for or purchase the shares or other
securities of CARMAT must be made solely based on information
publicly available about CARMAT. Such information is not the
responsibility of Bank Degroof Petercam SA/NV and Invest Securities
and has not been independently verified by Bank Degroof Petercam
SA/NV and Invest Securities.
_________________________________ 1 Data as of December 31,
2024. 2 Cash burn related to operations and investments. 3
Including 10 hospitals participating in the EFICAS study in France:
AP-HP GHU Pitié Salpêtrière, Hôpital Européen Georges Pompidou, CHU
de Rennes, CHU de Strasbourg, Hospices Civils de Lyon, CHRU de
Lille, Hôpital Marie-Lannelongue, CHU de Montpellier, CHU de Nantes
and CHU de Dijon. 4 Results on 52 patients. The primary endpoint of
the study was support with Aeson® at 6 months or transplantation
within 6 months, without disabling stroke. 5 Total amount of time
patients have been on Aeson® support since the first-in-man implant
back in 2013. 6 The January 8, 2025 press release and the recording
of the January 8, 2025 webinar are available on the CARMAT website.
7 ECLS or ECMO: Blood oxygenation by extracorporeal circulation. 8
Destination Therapy (“DT”) indication: indication that would enable
the patient to remain permanently supported by the Aeson®
artificial heart, without subsequent heart transplant. 9 Subject to
recruitment being completed by the end of the first half of 2025.
10 Cash burn from operating and investing activities. 11 For
further details on this equitization, please refer to the press
release published by the Company on June 13, 2024 and to section
3.1.7 of CARMAT's 2023 universal registration document. 12 For
further details on this financing line, please refer to the press
release published by the Company on July 5, 2024.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250130701109/en/
CARMAT Stéphane Piat Chief Executive Officer
Pascale d’Arbonneau Deputy Chief Executive Officer &
Chief Financial Officer Tel.: +33 1 39 45 64 50
contact@carmatsas.com
Alize RP Press Relations
Caroline Carmagnol Tel.: +33 6 64 18 99 59
carmat@alizerp.com
NewCap Financial Communication & Investor
Relations
Dusan Oresansky Jérémy Digel Tel.: +33 1 44 71 94
92 carmat@newcap.eu
Carmat (EU:ALCAR)
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