- 2023 sales of €2.8 million, i.e. 17 Aeson® implants, including
11 in the last quarter
- 2024 sales forecast of around €14 million
- Active exploration of financing options to extend, in the
short-term, the Company's financial horizon beyond May 2024.
- 12-month financing requirements estimated at around €45
million
Regulatory News:
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 reports its annual results for the year
ending December 31, 2023, and provides an update on its progress
and prospects for 2024.
The annual financial statements were approved by the Board of
Directors on April 22, 2024, on a going concern basis. On April 30,
2024, the Company will publish its 2023 Universal Registration
Document, including the annual financial report and the statutory
auditor’s report, whose audit procedures are being finalized.
Readers’ attention is drawn to the fact that the Company’s cash
runway extends to mid-May 2024. Should the financings anticipated
by the CARMAT not materialize by that date, the Company would then
have to make significant adjustments to his annual financial
statements.
Stéphane Piat, Chief Executive Officer of CARMAT,
commented: "In many respects, 2023 has been a structuring year
for CARMAT, crowned in December by the symbolic milestone of 50
CARMAT heart implants since the start of our clinical experience,
and by the opening of a second production building in
Bois-d'Arcy.
Backed by a first-class industrial tool, sized to support our
growth, we can now look forward with confidence to the commercial
deployment of our therapy. The momentum in Aeson® sales that began
in the last quarter of 2023, with 11 implantations, has continued
since the start of 2024, at an average rate of around 3 implants
per month.
To date, we are on track with our targets for the training of
additional hospitals, and implants as part of the EFICAS study. Our
geographical deployment is continuing, and 25 of the 39 hospitals
trained to commercial implants have already referred patients to
CARMAT, confirming the medical community's strong interest in our
therapy and its potential. All these advances enable us to
anticipate a substantial gradual growth in our sales over the
coming months, and revenue of around €14 million for 2024.
I would like to thank all our teams for their resilience,
particularly over the past two challenging years. I would also like
to express my gratitude to our shareholders, both historical and
more recent, whose trust enables us to make progress towards our
goal of making CARMAT a leading player in the treatment of advanced
heart failure."
Simplified income statement (€
millions)
2023
2022
Revenue
2.8
0.3
Net operating expense
-52.5
-51.9
Net financial expense
-3.1
-3.8
Net non-recurring income
-
-
Research and innovation tax credit
+1.7
+2.1
Net loss
-53.9
-53.7
Revenues of €2.8 million corresponded to the sale of 17 Aeson®
artificial hearts, including 7 in a commercial set-up in Germany
and Italy, and 10 in the EFICAS clinical trial in France.
As a result of a tight cost control, the operating loss for the
year was contained at €52.5 million, on par with that of 2022
(€51.9 million).
In 2023, CARMAT has dedicated most of its efforts and
resources to:
- sales development, supported by the
training of new hospitals (33 centers trained for commercial
implants by December 31, 2023), and by preparations for the
introduction of Aeson® in 8 additional countries;
- the extension of its Bois-d'Arcy
manufacturing site, enabling it to reach a capacity of 500 hearts
per year by early 2024;
- the acceleration of the EFICAS study in
France (10 implantations in 2023, including 7 in the last quarter);
and
- ongoing discussions with the FDA with a
view to bringing Aeson® to the US market in 2027.
Taking into account net financial expense (-€3.1 million),
non-recurring items and the research tax credit (+€1.7 million),
the net loss for 2023 is €53.9 million, virtually unchanged from
2022.
As of December 31, 2023, the Company's cash position stood at
€8.0 million (versus €51.4 million at the end of 2022), reflecting
the following cash flows:
(€ millions)
2023
2022
Cash flow from operating activities
-53.5
-54.4
Cash flow from investment activities
-4.9
-2.0
Cash flow from financing activities
+15.0
+68.6
Change in cash position
-43.4
+12.2
Cash flow from operating and investing activities in 2023 stood
at -€58.4 million, up €2 million on 2022, due to higher industrial
capital expenditure, associated with the extension of the Company's
manufacturing capacity.
In terms of financing, in 2023 the Company received:
- €7 million as part of a private placement
in October 2023 with 3 of the Company's core shareholders (Lohas,
Sante Holdings and Therabel Invest);
- €5.8 million under the €13.2 million1 mixed
financing granted to CARMAT in April 2023 as part of the "France
2030" plan;
- €2.2 million under the €2.5 million grant
awarded to CARMAT at the end of 2022 as a winner of the European
Union's2 "EIC Accelerator" program; and
- the second €0.7 million tranche of the
total €1.4 million grant (known as "CAP23")3 awarded to CARMAT
under the "Plan de Relance pour l'industrie - Secteurs
Stratégiques" call for projects.
In April 2023, CARMAT also made the first half-yearly repayment
of €0.7 million due under its PGE (government-backed loan)
contracted with BNP Paribas in 2020.
Net financial debt
As of December 31, 2023, taking into account the debt
rescheduling agreement signed4 in March 2024 with its financial
creditors, CARMAT's net financial debt5 was as follows:
(€ millions)
31.12.2023
+ Long-term financial liabilities
57.4
+ Short-term financial liabilities
0.2
- Cash and cash equivalents
-8.0
Net financial debt
49.6
This agreement, successfully negotiated by the Company with its
three bank creditors (the European Investment Bank - "EIB", BNP
Paribas - "BNPP", and Bpifrance - "BPI"), enables CARMAT to
alleviate its short-term cash constraints, in particular by
reducing the cash flows associated with repayment of the said loans
by more than €30 million, compared with the initial schedules, over
the period 2024-2025. As a result of this agreement, short-term
financial liabilities at December 31, 2023 are limited to €0.2
million. Through the equitization6 of the EIB loan, this agreement
should also significantly limit cash flows linked to repayments
over the 2026-2028 period.
Financing horizon
Given in particular the capital increase of €16.5 million (gross
amount) carried out in January 2024, CARMAT's financial resources
allow the Company, according to its current business plan, to
finance its activities until mid-May 2024. The Company estimates
its 12-month financing needs at around €45 million.
CARMAT is working very actively on initiatives aimed at
strengthening its equity capital and cash position in the short
term.
The Company thus anticipates a gradual extension of its
financing horizon to 12 months, in several stages: a forthcoming
capital increase, supported by historical shareholders, which
should enable it to strengthen its cash position and thus pursue
its activities beyond May 2024; then other additional initiatives
(including one or more further capital increases) enabling it to
further extend its financing horizon, bearing in mind that the
expected growth in the Company's sales should strengthen CARMAT's
attractiveness to investors, and thus facilitate the securing of
new financing in the future. It should also be noted that the
Company applies strict financial discipline, aimed at reducing its
cash burn on operations and capital expenditure by around 20%
between 2023 and 2024.
CARMAT is constantly pursuing an active investor relations
policy, and seeking new financing (equity, public support or other
types of financing) both in France and abroad. It believes it can
count, to a certain extent, on the support of some of its key
shareholders.
Based on these considerations, the going concern assumption was
adopted by the Board of Directors, which approved the financial
statements for 2023. However, there is no guarantee that the
anticipated financing will be available. This creates a significant
degree of uncertainty that could jeopardize the Company's ability
to continue as a going concern and could lead to the Company being
placed in receivership (“redressement judiciaire”) in the short to
medium term.
Milestone of 50 Aeson® implants since inception reached in
2023
Since the 1st implant in December 2013, CARMAT technology has
been widely disseminated through clinical trials and then
commercially: by December 31, 2023, 50 patients had benefited from
the Aeson® heart since the Company's inception, in 8 different
countries, bringing the cumulative experience to over 22
patient-years. By the end of 2023, 13 patients were living with the
Aeson® device.
With strong support from leading cardiologists in Europe and the
United States, Aeson® is gradually becoming a benchmark solution
for transplant-eligible patients awaiting the availability of a
human heart.
Early sales momentum
CARMAT's revenue of €2.8 million in 2023 corresponds to the sale
of 17 Aeson® prostheses, including 11 in the last quarter,
demonstrating a solid start to the sales momentum (with a rate of
around one implant per week achieved in the last quarter),
underpinned by CARMAT's ability to roll out its therapy on a large
scale industrially and commercially.
It should be noted that sales of Aeson® were limited during the
first half of 2023 by the low number of prostheses available over
the period, due to supplier supply problems which delayed the
ramp-up of production as initially planned by the Company.
Production rates gradually returned to normal from the summer
onwards.
By December 31, 2023, 33 hospitals in 11 different countries had
been trained and were therefore ready to carry out Aeson® implants
on a commercial basis.
Acceleration of the EFICAS study in France
The EFICAS study aims to gather additional data on the efficacy
and safety of the Aeson® heart, as well as medico-economic data to
support the device's value proposition and reimbursement. It is due
to include 52 patients eligible for transplantation in France and
should be completed in 2025.
10 patients were included in 2023 in this clinical study (in 6
different hospitals in Paris, Lille, Lyon, Le Plessis-Robinson and
Montpellier), including 7 during the fourth quarter of the year,
bringing the total number of inclusions in this study to 11
patients by December 31, 2023.
At the same date, 8 French hospitals7 had already been trained
for implantations within the framework of the study.
This is an essential study for the future marketing and
reimbursement of Aeson® in France, but also to support the
application for PMA (marketing authorization) in the United States,
which the Company anticipates, at this stage, during the latter
part of 2026.
As a reminder, CARMAT has received €13 million from the French
national innovation8 fund to partially finance this study.
Manufacturing capacity increased to 500 hearts per
year
In 2023, CARMAT continued to invest in its industrial
facilities, particularly with the opening of a second production
building at Bois-d'Arcy, enabling it to increase its manufacturing
capacity to 500 hearts per year from early 2024, corresponding to
potential annual sales of around €100 million.
The Company has also continued to implement its multi-year
roadmap aimed at strengthening its base of industrial suppliers and
subcontractors, with a view to reinforcing continuity of supply and
reducing Aeson®’s manufacturing cost.
Strengthening Aeson® reliability
In 2023, Aeson® continued to demonstrate a safety profile that
clearly sets it apart from all other mechanical circulatory
assistance systems: since its inception, Aeson® has not given rise
to any gastrointestinal bleedings or disabling strokes.
At the end of the year, CARMAT also implemented a software
enhancement for Aeson®, which significantly strengthens the safety
profile of its device: from now on, for many potential malfunctions
linked to the prosthesis's electronic components, the Aeson®
software will automatically "correct" said faults by appropriately
adapting the artificial heart's operation, so that the patient's
support is not impacted.
Secured non-dilutive financing of €13 million as part of the
"France 2030" plan
In April 2023, the Company was awarded a total of €13.2 million
in blended financing (including €7.9 million in grants and €5.3
million in repayable advances) as part of the "France 2030" plan.
The aim is to support the increase in annual production capacity of
Aeson® artificial hearts to 1,000 per year within 5 years, and to
reduce the production cost of the prosthesis. This financing is
structured in tranches available according to the progress of the
project over the period 2023-2026. A total of €5.8 million was
perceived in 2023 by CARMAT.
Adapting governance
The Combined General Meeting of May 11, 2023 approved the
appointment of Therabel Invest, represented by Mr. Laurent Kirsch,
as a director of the Company, for a 3-year term. Mr. Laurent Kirsch
brings to the Board his extensive experience of the healthcare
industry, including at international level, as well as his
financial expertise. At the date of publication of this press
release, the Board of Directors, chaired by Alexandre Conroy,
comprised 12 directors, 7 of whom were independent.
Since the beginning of 2024, CARMAT has implanted 11 Aeson®
hearts, at a rate of around 3 per month.
Strong momentum in EFICAS study implants
Sales momentum is particularly strong in the EFICAS study in
France, with 8 implants since January 1, 2024, in 7 different
hospitals, which is fully in line with the target of around 30
implantations by 2024.
To date, 19 implants have already been carried out since the
start of the study, in which 10 centers are now taking part (two
more than at the end of 2023: CHU Dijon-Bourgogne and CHU de
Nantes), confirming the expected completion of the study in H1
2025, in line with the objective10.
Ongoing commercial deployment
Since the beginning of the year, 6 new hospitals have been
trained, bringing to 39 the number of centers able to carry out
Aeson® commercial implants in 14 different countries. This confirms
the Company's target of around fifty trained centers by the end of
the year.
To date, of these 39 centers, 12 have already carried out at
least one commercial implant of Aeson® and 25 have already referred
patients for a potential implantation, confirming the strong
interest of the medical community in the therapy.
3 commercial implants have been completed since January 1, 2024,
including 2 in Germany and 1 for the first time in Poland, in
April.
In addition to the three countries already commercially active
(Germany, Italy and Poland), 5 others are now fully activated and
ready to carry out implants (Switzerland, Austria, Slovenia, Greece
and Israel). In 2024, the Company anticipates the activation of
several other European countries, either through direct sales or
through distributors with whom distribution contracts have already
been signed or are in the process of being signed.
Based on these encouraging indicators, the Company anticipates a
substantial gradual sales growth over the year, and revenue of
around €14 million for 2024.
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 and the information contained herein do not
constitute an offer to sell or subscribe, nor a solicitation of an
order to buy or subscribe to CARMAT shares in any country. This
press release may contain forward-looking statements by the company
regarding its objectives and prospects. These forward-looking
statements are based on the current estimates and anticipations of
the company's management and are subject to risk factors and
uncertainties such as the company's ability to implement its
strategy, the pace of development of CARMAT's production and sales,
the pace and results of ongoing or planned clinical trials,
technological evolution and competitive environment, regulatory
changes, industrial risks, and all risks associated with the
company's growth management. The company's objectives mentioned in
this press release may not be achieved due to these elements or
other risk factors and uncertainties.
Significant and specific risks of the company are those
described in its universal registration document filed with the
French Financial Markets Authority (Autorité des marchés financiers
- the “AMF”) under number D.23-0323 and in its amendment
filed with the AMF on January 17, 2024 under number D.23-0323-A1.
Readers' attention is particularly drawn to the fact that the
company's current cash runway is limited to mid-May 2024. Readers
and investors are also advised that other risks, unknown or not
considered significant and specific, may or could exist.
Aeson® is an active implantable medical device commercially
available in the European Union and other countries recognizing CE
marking. The Aeson® total artificial heart is intended to replace
the ventricles of the native heart and is indicated as a bridge to
transplant for patients suffering from end-stage biventricular
heart failure (INTERMACS classes 1-4) who cannot benefit from
maximal medical therapy or a left ventricular assist device (LVAD)
and who are likely to undergo a heart transplant within 180 days of
implantation. The decision to implant and the surgical procedure
must be carried out by healthcare professionals trained by the
manufacturer. The documentation (clinician manual, patient manual,
and alarm booklet) should be carefully read to understand the
features of Aeson® and the information necessary for patient
selection and proper use (contraindications, precautions, side
effects). In the United States, Aeson® is currently exclusively
available as part of an Early Feasibility Study approved by the
Food & Drug Administration (FDA).
1 Mixed financing of €13.2 million, including a €7.9 million
grant and a €5.3 million conditional advance, to be received in
several instalments over the period 2023-2026, depending on the
achievement of operational milestones. 2 The final balance of this
grant (€0.4 million) is expected in 2024. 3 The final balance of
this grant (€0.35 million) is expected in 2024. 4 The financial
debt rescheduling agreement entered into by the Company in March
2024, with the banks BNP Paribas and Bpifrance (for the PGEs) and
with the European Investment Bank, is detailed in the Company's
press release of March 22, 2024. 5 Financial liabilities include
the principal (€30 million) and interest due on the EIB (European
Investment Bank) loan, the outstanding principal (€9.5 million) and
interest due on the two state-guaranteed loans (PGE), as well as
interest on the €14.5 million repayable advance obtained from
Bpifrance, and on the €2.3 million repayable advance received in
2023 as part of the "France 2023 (Santé)" Plan. Long-term financial
liabilities correspond to those with maturities in excess of 12
months. The characteristics and conditions of the loans (before the
March 2024 rescheduling agreement) and the repayable advance from
Bpifrance are described in Section 3 of the Company's 2022
universal registration document. 6 For further details on
equitization, please refer to the press release mentioned in note
4. 7 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 and CHU de
Montpellier. 8 This funding is received as and when the sites are
set up as part of the study. 9 Data as of April 23, 2024. 10 As a
reminder, the EFICAS study involves a total of 52 implantations of
Aeson®.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240423648307/en/
CARMAT Stéphane Piat Chief Executive Officer
Pascale d’Arbonneau 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
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