- Half-year sales of €3.3 million, exceeding 2023 full-year
sales
- 20 implants of the Aeson® artificial heart performed in the
first half of 2024
- 17% cash-burn1 reduction compared to the first half of
2023
- 2024 anticipated annual sales of €8 to €12 million
- Other 2024 operational objectives on track
- Active exploration of financing options to extend in the
near-term the Company's cash runway beyond the end of September
2024
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 announces its results for the first half
ending June 30, 20242, and provides an update on its progress and
prospects.
Stéphane Piat, Chief Executive Officer of CARMAT,
comments: “The outcome of the first half of 2024 is very positive.
With sales of €3.3 million, we have in just 6 months, exceeded our
2023 full-year sales. Achieving 20 Aeson® implants in the first
half of the year is a very encouraging indicator for such an
innovative device, which is still in its launch phase. In the
second quarter of 2024, we performed twice as many implants as in
the first quarter.
But beyond these numbers, the feedback and numerous spontaneous
testimonials from European physicians who have carried out Aeson®
implants, speak for themselves and give us confidence in the
progressive development of our truly unique therapy, which meets a
real need and literally “gives life back to patients”.
For the rest of the year, we anticipate a traction in implants,
both in the EFICAS study and commercially, which should enable us
to achieve annual sales of €8 to €12 million in 2024. In 2024, we
therefore plan to multiply our revenue by 3 or 4 versus 2023.
In addition, we anticipate several key catalysts in 2025,
including the publication of significant clinical results, which
should confirm these expert testimonials, and thus objectify the
safety and efficacy of our therapy. These results should play a key
role in accelerating our growth. Finally, in 2025, we also
anticipate resuming our PIVOTAL study in Europe, with patients not
eligible for heart transplant, with a view to eventually obtaining
the destination therapy indication that has always been and remains
CARMAT's ultimate goal.
The development of a breakthrough therapy such as ours is
necessarily an obstacle race. So far, we have overcome all hurdles,
not without difficulty, but successfully. We therefore look forward
to the next steps with confidence, resilience and the same winning
spirit.”
Abbreviated Income statement (in
millions of euros)
6 months
ended June 30, 2024
6 months
ended June 30, 2023
Revenue
3,3
0.6
Net operating expense
(25.4)
(25.9)
Net financial expense
(1.7)
(1.7)
Net non-recurring income
0.1
-
Research and innovation tax credit
0.8
1.0
Net loss
(26.2)
(26.7)
CARMAT generated €3.3 million in revenue in the first half of
2024, corresponding to the sale of seven artificial hearts for
commercial implants (in Germany, Italy and Poland) and 13 as part
of the EFICAS clinical study in France.
In the first six months of the year, CARMAT’s efforts and
resources were predominantly focused on:
- deploying and developing its business in
Europe; - stepping up its EFICAS clinical study in France; -
continuing discussions with the FDA with a view to starting up the
second cohort of its EFS (early feasibility study) in the United
States; - strengthening its financial structure.
The Company continued to keep tight control over its operating
expenses, enabling it to slightly reduce its net operating expense
to €25.4 million in the first half of 2024 (versus 2023).
After taking into account net financial expense of €1.7 million,
net non-recurring income of €0.1 million and €0.8 million in income
from the research tax credit, CARMAT ended the first half of 2024
with a net loss of €26.2 million (compared with a €26.7 million net
loss in the first six months of 2023).
- Cash and financial structure
Cash position and cash runway
At June 30, 2024, the Company had €11.4 million in cash and cash
equivalents, versus €8.0 million at December 31, 2023.
The variation over the first half 2024 can be analyzed as
follows:
(in millions of euros)
6 months
ended June 30, 2024
6 months
ended June 30, 2023
Net cash used in operating activities
(25.7)
(30.7)
Net cash used in investing activities
(1.1)
(1.6)
Net cash from financing activities
30.3
4.7
Cash and cash equivalents at end of
period
3.4
(27.6)
The cash burn used in operating and investing activities in the
first half of 2024 decreased by 17% compared with that of the first
half of 2023, in line with a planned trajectory that the Company is
determined to continue during the rest of 2024 and in the coming
years.
In the first half of 2024, CARMAT obtained the following
funds:
- an aggregate €32.5 million in proceeds from
two capital increases (€16.5 million in January and €16.0 million
in May); and - €0.3 million corresponding to the final tranche of
the total €1.4 million "CAP23" grant awarded to CARMAT as a winner
of the French government's "Industrial Recovery Plan - Strategic
Sectors" call for projects.
In addition, on July 5, 2024, i.e., after the half-year close,
CARMAT set up a flexible equity financing line with Vester
Finance3, involving the issue of up to 3,500,000 shares
(corresponding to c. €8.2 million based on CARMAT’s share price of
€2.345 on June 30, 2024) over a 24-month period, with CARMAT
immediately receiving €2.2 million.
In view of all of these factors4, and based on its current
business plan, CARMAT’s confirmed financial resources should enable
it to fund its business until end-September 2024. The Company is
actively working on various financing options to secure in the very
short-term, the financial resources it requires to continue as a
going concern beyond that date5. The Company estimates its
financing requirements over the next 12 months to be c. €45
million.
Net debt
On March 22, 2024, the Company reached an agreement with all of
its lenders – the European Investment Bank (EIB), BNP Paribas
(BNPP) and Bpifrance (BPI) – on new repayment terms for its bank
loans6.
Taking into account this agreement, CARMAT’s net debt at June
30, 2024 was €47.1 million, breaking down as follows:
(in millions of euros)
June 30, 2024
+ Long-term financial liabilities (>12
months)
57.3
+ Short-term financial liabilities (<12
months)
1.2
- Cash and cash equivalents
(11.4)
(Net cash)/Net debt
47.1
Short-term financial liabilities comprise:
- €0.2 million in interest due on tranches 2
and 3 of the EIB loan; and - an aggregate €1.0 million in principal
and interest payments due on the government-guaranteed loans
("PGEs") taken out with BNPP and BPI.
- First-half 2024 highlights
Marked acceleration in Sales
Twenty Aeson® implants were performed in the first half of 2024,
versus respectively three and fourteen in the first half and in the
second half of 2023. The rate of Aeson® implants reached four per
month in the second quarter, doubling from two hearts per month in
the first quarter.
In the first six months of 2024, CARMAT generated €3.3 million
in revenue7, which means that it has already exceeded its full-year
revenue for 2023 (€2.8 million).
Sales were generated for the first time in Poland, bringing the
number of countries in which CARMAT has a commercial activity to
three (Germany, Italy and Poland). A total of nine hospitals
carried out their first Aeson® implants in the first half of 2024 –
four in Germany, three in France and two in Poland.
This very positive trend reflects the encouraging take-up of
CARMAT’s artificial heart therapy in Europe.
Very good momentum for the EFICAS clinical study
In the first six months of 2024, 13 Aeson® implants were
performed as part of the EFICAS clinical study in France,
corresponding to a rate of more than two implants per month.
This brought the total number of Aeson® implants performed under
this study to 24 at June 30, 2024, paving the way for the
completion, in the short-term, of half of the target number of
patient recruitments, which represents 52 patients in total.
All of the French centers taking part in the study8, a total of
10, had already referred patients, and nine of them had performed
at least one implant.
As a reminder, EFICAS is the largest clinical study ever
conducted by CARMAT and will allow the company to collect
additional data on safety and performance of its Aeson® heart, as
well as medico-economic data to support its value proposition. The
Company anticipates publishing the study results in the last
quarter of 2025.
This study is instrumental to report Aeson® clinical results
scientifically on a significant sample size of patients, and thus
facilitate the communication and dissemination of these results
across the medical community.
In view of this, the Company believes that the publication will
lead to a strong and sustained acceleration in the take-up of
Aeson® artificial hearts in Europe.
EFICAS is a key study both for securing social security
reimbursement of Aeson® in France and for supporting CARMAT’s
application for Premarket Approval (PMA) (marketing authorization
in the United States issued by the FDA – Food & Drug
Administration), which the Company expects to receive in 2027.
Continued international business development
Europe and Middle East
In the first half of 2024, CARMAT trained nine new hospitals to
perform Aeson® commercial implants, expanding its network to 42
centers in 14 different countries9. The Company is therefore well
on track to meet its target of 50 trained hospitals by the end of
2024.
Out of these 42 centers, three-quarters were active in
first-half 2024, i.e., they had already submitted patient files to
CARMAT to assess their eligibility for implantation.
In addition, five countries in Europe (Switzerland, Austria,
Slovenia, Croatia and Greece) and one in the Middle East (Israel)
were activated and therefore ready to perform implants. The Company
plans to activate more countries in Europe in the second half of
the year.
United States
Discussions with the FDA (the U.S. Food & Drug
Administration) continued during the period, with a view to
commencing the second cohort of seven patients in the EFS10.
Based on all of the information available, the Company expects
this to happen in Q1 2025, and still foresees the commercial launch
of Aeson® in the United States taking place during the second half
of 2027.
Production ramp-up
Thanks to its expanded production capacity, with a second
production facility coming on stream at its Bois-d'Arcy site at the
end of 2023, as well as its growing supplier base and the
experience it has built up over the last few years, the Company had
a continuous production output in the first half of 2024, enabling
it to meet demand without any difficulties, while keeping up an
inventory level of more than 20 Aeson® hearts.
CARMAT intends to continue to implement its industrial roadmap
aimed at continuously improving its production processes, securing
its supplies, gradually reducing the production cost for its
artificial heart, and aligning its capacity development with
demand.
Changes in the Company’s governance
On June 24, 2024, Pierre Bastid, having served on the Company’s
Board as a director since 2018, was appointed as Chairman of the
Board of Directors, replacing Alexandre Conroy, who resigned for
personal reasons.
A seasoned industrialist and entrepreneur, Pierre Bastid has
subscribed for shares in each of the capital increases carried out
by the Company since 2016 and holds 13.1% of CARMAT’s share
capital11 via the Lohas and Les Bastidons entities.
CARMAT’s Board has now 10 directors, including five independent
directors.
2024 Objectives
For the second half of 2024, the Company forecasts a sales trend
which would reach a yearly turnover within a range of €8 million to
€12 million, to be compared with revenue of around €14 million
previously communicated. This forecast reflects a better
understanding of the market access dynamics and seasonality, as
well as two summer months during which the level of surgical
activity remained limited across Europe.
Regarding the other key objectives for 2024, the Company
confirms it is on track to achieve them by the end of the year,
namely:
- a patient recruitment rate of around 75% in
the EFICAS clinical study, - c. fifty centers trained for
commercial implants, - a c. 20% reduction in cash burn (operations
and investments) versus 2023, - filing to resume the EFS study
(United States).
Key catalysts anticipated in 2025 to support short and
medium-term development
In 2025, the Company anticipates four key drivers to support its
short and medium-term development:
- Q1 2025: initiation of the second cohort of
patients in the EFS study in the United States, - H1 2025:
publication in a scientific journal of the Aeson® clinical results
for patients previously under “ECLS12“, - H2 2025: resumption of
the PIVOTAL study in Europe for a cohort of patients not eligible
for heart transplant, to target the “Destination Therapy”
indication, - Q4 2025: publication of the results of the EFICAS
study (52 patients).
In the short term, continued development
in Europe supported by scientific publications
With over 70 patients having received an implant since Aeson®
was created, CARMAT has built up substantial clinical experience.
This testifies to the technology's unique performance and safety
profile, particularly given that the Company tends to treat
patients at an increasingly severe stage of the disease.
In the coming months, the Company intends to carry-on with the
gradual spread of its therapy across Europe, in the
bridge-to-transplant indication for which Aeson® is currently
approved, by building on this clinical experience, but also on the
growing reputation of Aeson®, supported in particular by a ripple
effect between centers, and spontaneous positive communication by
physicians and hospitals performing implants.
Aeson® sales’ growth should then accelerate significantly
following the publication of Aeson® clinical results in patients
previously under ECLS, anticipated in Q1 2025, and EFICAS study
results in Q4 2025.
In the medium term, heading towards the US
market and the Destination Therapy
In the medium term, the Company continues to target access to
the US market, as well as the Destination Therapy (DT) indication
(or so called “permanent implant”), which would allow patients to
remain under Aeson® support with no subsequent heart transplant. In
terms of addressable market, the Destination Therapy represents one
of the biggest opportunities in cardiology.
The anticipated launch, in Q1 2025, of the second cohort of
patients in the US EFS study, and the expected resumption in H2
2025 of the European PIVOTAL study with a cohort of patients not
eligible for heart transplant, are important milestones to
ultimately get Aeson® approved for this strategic indication.
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 it contains do not
constitute an offer to sell or subscribe, or the solicitation of an
order to buy or subscribe, CARMAT shares in any country.
This press release may contain forward-looking statements about
the Company's objectives and prospects. These forward-looking
statements are based on the current estimates and expectations of
the Company's management, and are subject to risk factors and
uncertainties, including those described in its universal
registration document filed with the Autorité des Marchés
Financiers (AMF) under number D.24-0374 and available on CARMAT's
website, as updated in the Company's 2024 half-year financial
report published today.
Readers' attention is particularly drawn to the fact that the
Company's current financing horizon is limited to the end of
September 2024 and that, given its financing requirements and
outstanding dilutive instruments, the Company's shareholders are
likely to experience significant dilution of their stake in the
Company in the short term. The Company is also subject to other
risks 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,
changes in technology and the competitive environment, regulatory
developments, industrial risks and all risks associated with
managing the Company's growth. The forward-looking statements
contained in this press release may not be achieved due to these or
other unknown risk factors and uncertainties, or factors which the
Company does not currently consider material and specific.
Aeson® is an active implantable medical device commercially
available in the European Union and other CE-marked countries. The
Aeson® total artificial heart is intended to replace the ventricles
of the native heart and is indicated as a bridge to transplantation
in patients with 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
benefit from heart transplantation within 180 days of implantation.
The implant decision and surgical procedure must be carried out by
healthcare professionals trained by the manufacturer. The
documentation (clinician's manual, patient's manual and alarm
booklet) must be read carefully to learn about the characteristics
of Aeson® and the information required for patient selection and
proper use (contraindications, precautions, side effects) of
Aeson®. In the United States, Aeson® is currently available
exclusively as part of a feasibility clinical trial approved by the
Food & Drug Administration (FDA).
________________________________ 1 Cash flow from operating and
investing activities 2 The interim financial statements were
approved by the Board of Directors on September 5, 2024; The
statutory auditor's limited review procedures are currently in
progress. The 2024 half-year financial report is published today
and can be consulted on the Company's website. 3 See the press
release published by the Company on July 5, 2024 about this equity
financing. 4 Including the €2.2 million received in early July 2024
in connection with the Vester Finance equity financing line. 5 See
Section 4.2.1 for the factors underlying the going concern
principle used by the Board of Directors. 6 See the press release
on the agreement published by the Company on March 22, 2024. 7
Including €1.1m in the first quarter and €2.2m in the second
quarter. 8 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. 9 Germany, Italy, Poland,
Switzerland, Israel, Slovenia, Saudi Arabia, Serbia, Croatia,
Austria, Denmark, Netherlands, Czech Republic and Greece. 10 The
first cohort of seven patients was finalized in the second half of
2021. 11 At June 30, 2024. 12 ECLS = Extra-Corporal Life
Support
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240905480690/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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