- Revenue of €0.6 million in H1 2023, negatively impacted by
supply disruptions
- Production back to normal since the summer: inventory of c. 20
Aeson® hearts to date
- 40 hospitals trained to date, 25 of them for commercial
implants
- 8 additional countries in the process of commercial
activation
- Sales forecast of €4 to 6 million for the second half of
2023
- Increase in the annual production capacity to 500 Aeson®
prostheses, currently being finalized to enable strong and
sustained sales growth
- Cash position of €23.8 million as of June 30, 2023
- Several financing options being actively explored to extend
cash runway beyond end-October 2023
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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, today reports its results for the
first half of the year to June 30, 20231 and issues an update on
its strategic progress and achievements.
Stéphane Piat, Chief Executive Officer of CARMAT,
commented: “During the first half of 2023, the production
ramp-up we were anticipating was significantly disrupted by supply
issues. Due to the lack of a sufficient number of devices, we were
late in generating the demand from hospitals, hence limited
revenues in the first half of the year.
With production returning to normal during the summer, 25
centers have been trained for commercial implants, and we continue
to activate operations in eight more countries. Moreover, we have
identified a substantial number of eligible candidates for Aeson®
across active centers. This positions us favorably to achieve
substantial sales growth in a sustainable manner, with projected
revenues in the range of €4 to 6 million in the second half of
2023.
We are progressing well in extending our Bois-d’Arcy
manufacturing site, which is set to increase our nominal production
capacity to 500 hearts annually by the end of 2023. This expansion
opens the door to potential annual revenues of €100 million,
reflecting our determination to scale effectively.
We are diligently working to secure in the near term the
necessary financial resources to sustain our activities going
forward. This includes accelerating the pace of implantations to
align with our strategic goals.
Since restart in November last year, Aeson® has supported
patients for more than 500 days in aggregate and performed as
expected. We want to emphasize our unwavering confidence in our
therapy and its potential to make a profound impact on patients
with advanced heart failure. We are resolute in our commitment to
success, supported by our teams, loyal shareholders, and partners.
Together, we aim to establish CARMAT as a leader in addressing
advanced heart failure, a vast and critical market.”
Simplified income statement (€
millions)
30/06/2023
(6 months)
30/06/2022
(6 months)
Revenue
0.6
0.0
Net operating expense
-25.9
-25.1
Net financial expense
-1.7
-1.9
Net non-recurring income
0.0
0.0
Research and innovation tax credit
+1.0
+0.9
Net loss
-26.7
-26.0
The Company generated €0.6 million in revenue in the first half
of 2023, corresponding to the sale of 3 Aeson® artificial hearts, 2
for commercial implants and one for an implant as part of the
EFICAS clinical study in France.
Despite demands arising from hospitals, Aeson® implants were
held back by the low number of prostheses available over the
period, due to supply problems which delayed the ramp-up in
production initially planned by the Company. The vast majority of
these supply difficulties were resolved by the end of the first
half of the year, enabling output to gradually ramp-up during the
summer.
In the first half of 2023, CARMAT’s efforts and resources were
predominantly focused on:
- extending its Bois-d’Arcy manufacturing
site, which will enable the Company to reach a production capacity
of 500 hearts a year by the end of 2023; - training more centers
(25 centers trained to date for commercial implants) and preparing
for the launch of Aeson® in 8 new countries; - ramping up for the
EFICAS clinical study in France in the second half of the year; -
continuing its discussions with the FDA with a view to ultimately
gaining market access for Aeson® in the United Sates.
Within this context, operating expenses were kept under control,
hence an operating loss of €25.9 million in the first half of 2023,
broadly flat vs that of 2022 (€25.1 million).
After taking into account net financial expense of €1.7 million
and €1.0 million in income from the research tax credit, CARMAT
ended the first half of 2023 with a net loss of €26.7 million
(compared with a €26.0 million net loss in the first six months of
2022).
- Cash position and financial structure
At June 30, 2023, the Company had €23.8 million in cash and cash
equivalents, versus €51.4 million at December 31, 2022.
The change in the cash position over the first half of the year
results from the following cash flows:
(€ millions)
30/06/2023
(6 months)
30/06/2022
(6 months)
Cash flow from operating activities
-30.7
-30.5
Cash flow from investment activities
-1.6
-1.1
Cash flow from financing activities
4.7
39.8
Change in cash position
-27.6
+8.2
In terms of financing, in the first half of 2023, the Company
received the following funds:
- €0.7 million corresponding to the 2nd
tranche of the €1.4 million “CAP23” grant2 awarded to CARMAT as a
winner of the French government’s “Industrial Recovery Plan –
Strategic Sectors” call for projects; - the first tranche (€1.1
million) of the total €2.5 million grant awarded to the Company at
the end of 2022 for its winning proposal in the European Union’s
“EIC Accelerator” funding program3; - the first €3.3 million
tranche of the €13.2 million blended financing package4 awarded to
CARMAT in April 2023 under the “France 2030” plan.
Also, as planned, CARMAT began to repay its
government-guaranteed loans taken out in the final quarter of 2020,
making a first half-yearly repayment of €0.6 million in April.
As of June 30, 2023, the Company’s net financial debt stood at
€32.7 million, breaking down as follows:
(€ millions)
30/06/2023
+ Long-term financial liabilities
39.8
+ Short-term financial liabilities
16.8
- Cash and cash equivalents
23.8
Net financial debt
32.7
Short-term financial liabilities include an aggregate €2.0
million payable in the fourth quarter of 2023, mainly corresponding
to repayments of government-guaranteed loans5, and an aggregate of
€14.9 million payable in the first half of 2024, primarily relating
to the repayment of the first tranche (drawn down in January 2019)
of the loan taken out with the EIB.
Based on its updated business plan, CARMAT’s confirmed financial
resources6 should enable it to fund its activities until the end of
October 2023, while honoring all of its contractual payment
maturities. The Company is actively working on various financing
options to secure, in the short term, the financial resources it
requires to continue as a going concern beyond that date7.
- H1 2023 highlights and recent developments
Implementation of the industrial plan
Ramp-up in production
As the vast majority of supply problems were resolved by the end
of first half 2023, the Company’s production gradually returned to
normal over the summer, allowing CARMAT to hold c.20 prostheses on
shelf to date. Production has continued to gain momentum since
then, and CARMAT now anticipates to manufacture more than 10 hearts
a month between September and December 2023. The Company therefore
expects to reach a total output of 60 to 70 hearts for full-year
2023.
Strengthening of the supplier
portfolio
To support the ramp-up in production, CARMAT has drawn up an
ambitious multi-year roadmap to strengthen its supplier portfolio,
which led to tangible progress in the first half of 2023 with the
signing of a new partnership agreement with French company Vygon
for the prosthesis’ connector conduits8 and the stepping up of its
partnership with Swiss company MPS for producing the motor pump.
These initiatives enable CARMAT to both strengthen its supply
continuity and reduce Aeson®’s production costs.
Increase in the production
capacity
Meanwhile, CARMAT also began work on expanding its production
capacity with, in particular, the extension of its cleanroom and
the creation of additional production facilities at the Bois-d’Arcy
site. The finalization of this work is underway, and the Company
can confirm that it will reach a nominal production capacity of 500
hearts a year by the end of 2023, representing potential annual
revenue of €100 million. By 2027, CARMAT is planning to double its
production capacity again, to 1,000 hearts a year.
Commercial development
Training of hospitals and geographical
expansion
The Company continued to actively train hospitals, in line with
its goal of 30 medical centers trained for commercial implants by
the end of 2023. To date, 40 hospitals have been trained, including
25 for commercial implants and 15 for implants in the EFICAS study
in France and the EFS in the United States.
As part of this, CARMAT also supports the hospitals in getting
appropriate funding for the therapy and can confirm that it is
secured in the vast majority of them.
In addition to the two countries in which the device has already
been sold for commercial implants (Germany and Italy), the Company
is planning to make the heart commercially available in eight more
countries from the second half of 2023, both in Europe (Austria,
Greece, Slovenia, Croatia, Serbia and Switzerland) and outside
Europe (Israel and Saudi Arabia). Hospitals have been trained in
five of these eight new countries so far.
Patient numbers and sales
forecasts
In view of a solid base of trained medical centers where a
substantial number of eligible patients have already been
identified, and given that production has returned to normal, the
Company forecasts sales revenue between €4 million and €6 million
in the second half of 2023.
Continuation of the EFICAS clinical study in France
In early January 2023, CARMAT announced the first Aeson® implant
as part of the EFICAS study. This implant was performed in December
2022 by Professor André Vincentelli and his team at Lille
University Hospital, one of the six centers participating in the
study.
This study, which is expected to get completed in 2025, will
involve a total of 52 patients eligible for a heart transplant in
France. It will allow CARMAT to collect additional data on the
efficacy and safety of its artificial heart, as well as
medico-economic data that can be used to support the value
proposition and obtain the reimbursement of the device.
This study is critical for Aeson®’s future commercial launch and
social security reimbursement in France, but also to support
CARMAT’s application for the Premarket Approval (“PMA”), i.e., the
authorization to market Aeson® in the United States.
CARMAT benefits from €13 million in funding from the French
National Innovation Fund9 to partially finance this study.
Optimized US market access strategy
During the first half of this year, the Company continued its
in-depth discussions with the FDA (the US Food & Drug
Administration).
In order to optimize its US market access strategy, CARMAT
intends to rely on the EFS10 as well as on data collected from the
ongoing EFICAS study in France, which could enable the Company to
avoid having to undertake a substantial PIVOTAL study in the United
States.
Given both the EFS and EFICAS study’s current schedules and all
other elements it is aware of, CARMAT can confirm that it is
expecting – subject to both studies being successful – to apply for
Premarket Approval (“PMA”) by the end of 2026.
Publication of a scientific article in the first US
implantation of the Aeson® artificial heart
In March 2023, an article entitled The First Autoregulated Total
Artificial Heart Implant in the United States was published in the
official journal of the American Society of Thoracic Surgeons. This
article describes the implantation of Aeson® performed at Duke
University Hospital in the summer of 2021 as part of the Early
Feasibility Study (EFS).
It shows that the Aeson® heart delivers notable improvements
compared with other circulatory support devices. These include
enhanced hemocompatibility and autoregulation enabling increased
cardiac output in response to higher filling pressures, while
avoiding complications such as strokes and hemorrhages. After 5
months of support on the Aeson® device, the patient was
successfully bridged to transplant when a human heart became
available and has made a full recovery.
€13.2 million non-dilutive blended financing package obtained
under the “France 2030” plan
In April 2023, CARMAT obtained a €13.2 million blended financing
package (comprising a €7.9 million grant and a €5.3 million
repayable advance) under the “France 2030” plan. This financing
will be used to help drive the increase in the annual production
capacity of Aeson® artificial hearts to 1,000 per year within 5
years and to reduce the production cost of the device.
This package is split into 4 tranches, each of which will become
available over the period from 2023 to 2026 as the project
progresses. The first tranche of €3.3 million was received in June
and the second is anticipated in 2024.
Substantial acceleration in sales expected from the fourth
quarter of 2023
With c. 20 devices available on the shelf and a production
output back to normal (in excess of 10 hearts a month), CARMAT has,
during the past weeks, encouraged its trained centers to very
actively resume patients screening, in view of both commercial
implants, and implants in the EFICAS clinical study in France.
Given the number of patients eligible to Aeson®, already
identified in the active centers, CARMAT anticipates a strong and
imminent ramp-up in sales, and revenues of c. €4 to 6 million in
the second half of the year, which will ideally set the Company for
a significant sales growth in 2024.
This ramp-up will in the coming months, also be sustained by
Aeson® being progressively launched in additional countries,
including 8 where the activation process has already started
(Austria, Greece, Slovenia, Croatia, Serbia, Switzerland, Israel
and Saudi Arabia).
Confirmation of key objectives
In light of its first-half achievements and recent developments,
the Company reiterates its confidence in reaching the key
objectives from its strategic roadmap:
- successful sales development in Europe; -
annual production capacity of 500 hearts by the end of 2023; - 30
centers trained for commercial implants by the end of 2023; -
ramp-up of implants in the EFICAS study in France; - apply for US
"PMA” by the end of 2026.
In the short term, CARMAT also intends to secure financings that
will enable it to extend its cash runway beyond the end of October
2023.
●●●
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 more than 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 to, or a solicitation of
an offer to buy or subscribe to, shares in CARMAT (the “Company”)
in any country. This press release may contain forward‐looking
statements that relate to the Company’s objectives and prospects.
Such forward‐looking statements are based solely on the current
expectations and assumptions of the Company’s management and
involve risk and uncertainties including, without limitation, the
Company’s ability to successfully implement its strategy, the rate
of development of CARMAT’s production and sales, the pace and
results of ongoing and future clinical trials, new products or
technological developments introduced by competitors, changes in
regulations and risks associated with growth management. The
Company’s objectives as mentioned in this press release may not be
achieved for any of these reasons or due to other risks and
uncertainties.
The significant and specific risks pertaining to the Company are
those described in the Universal Registration Document (“Document
d’Enregistrement Universel”) filed with the Autorité des Marchés
Financiers (AMF, the French stock market authorities) under number
D. 23-0323. Readers and investors’ attention is, however, drawn to
the fact that other risks, unknown or not deemed to be significant
or specific, may or could exist.
Aeson® is an active implantable medical device commercially
available in the European Union and other countries that recognize
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 in patients suffering from end-stage
biventricular heart failure (INTERMACS classes 1-4) who are not
amenable to maximal medical therapy or a left ventricular assist
device (LVAD) and are likely to undergo a heart transplant within
180 days of the device being implanted. 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 read
carefully to understand the characteristics of Aeson® and
information necessary for patient selection and the proper use of
Aeson® (contraindications, precautions, side effects). In the
United States, Aeson® is currently exclusively available within the
framework of an Early Feasibility Study authorized by the Food
& Drug Administration (FDA).
1 First-half results were approved by the Board on September 21,
2023, and are currently the subject of a limited review by the
Company’s statutory auditors. The 2023 half-year report was
published today and is available on the Company’s website. 2 The
remaining balance of this grant (€0.3 million) is due in 2024. 3
The remaining balance of this grant is due in 2024. 4 The €13.2
million blended financing package consists of a €7.9 million grant
and a €5.3 million conditional advance, to be received in 4
tranches over 2023-2026. The second tranche is due in 2024. 5
Second half-yearly repayment of the state-guaranteed loan taken out
with BNP Paribas in 2020 and first yearly repayment of the
state-guaranteed loan taken out with Bpifrance in 2020. 6 Including
cash at June 30, 2023 and the €0.9 million balance of the 2022
research tax credit due to be received by end-October 2023. 7 See
Section 4.2.1 of the 2023 half-year financial report for the
factors underlying the going concern principle used by the Board of
Directors. 8 Conduits connecting the prosthesis and the
cardiovascular system. 9 This financing will gradually be received
as and when the implants are performed during the study. 10 The EFS
is a feasibility study on 10 patients eligible for a heart
transplant. The EFS design provides for two successive cohorts of 3
and 7 patients. The first cohort was completed during the second
half of 2021. The initiation of the second cohort is subject to FDA
approval being granted. Given the low number of points still being
discussed with the FDA, the Company is expecting the second cohort
to be initiated during the second half of 2024.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230925204479/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 Quentin Massé Tel.: +33 1 44 71 94
92 carmat@newcap.eu
Carmat (EU:ALCAR)
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