- 6 Aeson® artificial hearts marketed to date
- Enrollment of the first cohort of 3 patients in the EFS1 in the
USA finalized
- Cash position of €58 million at June 30, 2021, covering the
Company’s activities through to mid-2022
- Videoconference with Stéphane Piat today at 5 pm Paris
time
Regulatory News:
CARMAT (FR0010907956, ALCAR), the designer and developer of the
world’s most advanced total artificial heart, aiming to provide a
therapeutic alternative to people suffering from end-stage
biventricular heart failure, today reports its results for the
first half of the year to June 30, 20212 and issues an update on
its latest progress and main strategic objectives.
Stéphane Piat, Chief Executive Officer of CARMAT,
commented: “Following the granting of CE marking in December
2020, CARMAT dedicated most of its resources to preparing the
commercial launch in Europe, initiating the EFS in the US and
strengthening its supply chain. Despite the constraints associated
with the COVID-19 pandemic, CARMAT achieved key milestones: since
July, 6 patients in leading German and Italian hospitals did
benefit from Aeson®, the world’s first physiological artificial
heart, in a commercial setting. CARMAT also successfully completed
the enrollment of the first cohort of 3 patients in the EFS study,
with some of the largest and renowned American cardiology centers
such as Duke University Hospital, paving the way to the evaluation
of our device in the US, the world’s largest medical device market.
The very positive feedback regarding the implantations of Aeson® in
both commercial and clinical trials settings is further
demonstrating our confidence that our device represents a valid
alternative to heart transplants. We anticipate that around a dozen
European centers, primarily in Germany, will be commercially active
by the end of 2021. In order to support this momentum, CARMAT has
also been working on ramping up its production activities, which
should allow the company to manufacture Aeson® prostheses at an
increasing pace in order to appropriately supply hospitals that
would like to offer our unique technology to their patients”.
Simplified income statement (€
millions)
30/06/2021
(6 months)
30/06/2020
(6 months)
Sales
0.0
0.0
Net Operating income (expense)
-25.5
-20.6
Net Financial income (expense)
-1.5
-1.0
Non-recurring items
0.0
0.0
Research tax credit
+0.7
+0.8
Net Profit (Loss)
-26.4
-20.8
CARMAT did not generate any sales during the first half of 2021.
The first sales were recorded from the beginning of the third
quarter of this year and amount to c. €2 million to date.
In the first half of 2021, CARMAT dedicated most of its efforts
and resources to:
- prepare for the commercial launch of its
Aeson® artificial heart3 in Europe, notably with the training of
“client” centers; - prepare for the initiation of the EFS (Early
Feasibility Study) in the United States, with the first cohort of 3
patients implanted in the 3rd quarter 2021; - prepare for the
EFICAS study in France with the objective to include the first
patients in the 4th quarter 2021; - prepare for the post-market
surveillance (PMS) of the device; - ramp up the pace of production
with around 8 to 10 prostheses now assembled every month; -
continue its actions to strengthen and secure its production
supplies.
This sustained activity increased the operating expenses leading
to a net operating loss of €25.5 million in for the first half of
2021.
Taking into account the net financial loss (-€1.5 million),
non-recurring items and the Research Tax Credit (+€0.7 million),
the net loss amounts to €26.4 million for the first half of 2021,
compared to a net loss of €20.8 million for the first half of
2020.
- Cash position and financial structure
The cash position was
strengthened to €57.9 million at June 30, 2021, compared to €36.0
million at December 31, 2020.
The €21.9 million increase in
the first half of 2021 results from the following cash
flows:
(€ millions)
30/06/2021
(6 months)
30/06/2020
(6 months)
Cash flow from operating activities
-29.4
-19.8
Cash flow from investment activities
-1.0
-0.4
Cash flow from financing activities
+52.3
+10.0
Change in cash position
+21.9
-10.2
The cash flow from operating activities was negative at €29.4
million. The increase compared to the first half of 2020 is mainly
due to higher operating expenses mainly driven by the increasing
pace of production and the inventory build-up to cope with the
commercial launch in Europe, and the preparation of the EFS and
EFICAS clinical studies.
The positive cash flow from financing activities of €52.3
million was mainly driven by:
- the fundraising of €55.7 million by way of
a public offering with a priority subscription period for existing
shareholders and a global offering, that was completed in March; -
the payment of the first tranche of €0.3 million of a total grant
of €1.4 million4 obtained as part of the French Governmental
“Industrial recovery plan – Strategic sectors”; - the use of the
contingent equity line subscribed with Kepler Cheuvreux for €0.3
million.
CARMAT is funded until mid-2022, based on its current business
plan and available financial resources, notably:
- the cash position at June 30, 2021; - the
€13 million granted by the French State to partially finance the
EFICAS study (this sum will be received throughout the duration of
the study); - the drawdown, planned in Q4 2021, of the remaining
€10.0 million tranche of the €30 million conditional loan granted
by the European Investment Bank, since all conditions to draw down
this third tranche are already fulfilled.
- H1 2021 highlights and recent achievements
Commercialization of Aeson® in Europe
Following the CE marking granted in December 2020 with the “BTT”
(bridge to transplant) indication, the company was able to achieve
its first commercial sales in Europe with 6 implants performed so
far, including 4 in German hospitals and 2 in Naples (the Azienda
Ospedaliera dei Colli hospital in Naples was the first one to
implant Aeson® in a commercial setting on July 15, 2021).
The CE marking enables CARMAT to market its Aeson® artificial
heart throughout the European Union and in some other countries
that recognize this certification. During the second half of 2021,
the Company will focus on marketing its device in Germany, the
European largest market, and will address one or two other EU
markets, including Italy, in a more opportunistic manner.
Following strong positive feedback from leading cardiology
centers, CARMAT expects to have, by the end of 2021, around a dozen
European centers trained and commercially active, mostly in
Germany.
Expansion of the clinical plan and initiation of the EFS in
the United States
EFS in the United States
The EFS is a clinical study with a two-step protocol approved by
the FDA (Food & Drug Administration) including a report to be
issued on the progress of the first cohort of 3 patients after 60
days, before the additional 7 patients can be enrolled. The primary
endpoint of the study is 180 days survival after the implant or a
successful natural heart transplant within 180 days of the
implant.
On July 15, 2021, CARMAT announced the initiation of its EFS in
the United States with a first implant of the Aeson® heart
performed on July 12, 2021 at Duke University Hospital (North
Carolina), one of the top American cardiology centers. Two
additional implants have since been performed at UofL Health -
Jewish Hospital by physicians from the University of Louisville
(Kentucky).
With these 3 implants, the first cohort of the study is
completed and CARMAT is planning for the second cohort with an
additional 7 implants.
PIVOTAL study in Europe
At June 30, 2021, a total of 15 patients had been enrolled
within the framework of the PIVOTAL study, the positive interim
results of which contributed to CARMAT being granted CE marking for
its device as a bridge to transplant in December 2020.
The Company intends to continue enrolments in this study in
order to achieve the initial indicative target of 20 patients by
the end of the first half of 20225.
EFICAS study in France
The EFICAS study, which will cover 52 implants in France, will
allow CARMAT to collect both additional data on the efficacy and
safety of its artificial heart and medico-economic data to support
its value proposition and the device’s reimbursement, notably in
France.
During the first half of 2021, the Company submitted a dossier
in order to be able to use the most recent version of its
artificial heart in this study. Due to regulatory timelines, CARMAT
is therefore planning to start enrolling patients in the fourth
quarter of 2021.
Ramping up of production
During the first half of 2021, CARMAT continued to implement its
plan to ramp up production and build up inventories, as well as to
enhance the reliability of its production processes at the
Bois-d’Arcy (France) plant. Furthermore, CARMAT continued and
intensified its efforts to secure its industrial supplies. The
industrial headcount increased by 20, from 61 at the end of 2020 to
81 at June 30, 2021.
Change in governance
The Annual Shareholders Meeting of May 12, 2021 approved the
appointment of Florent Battistella, David Coti and John B.
Hernandez as new directors. Following the stepping down of Truffle
Capital from the CARMAT Board, the Board thus includes 12 members,
8 of them independent.
CARMAT also strengthened its leadership structure with the
appointment of Professor Christian Latrémouille as Director of
Surgical Affairs in February 2021 and, more recently, the
appointment of Ivo Simundic as Sales Director for the DACH region
to support the deployment of the Aeson® artificial heart in
Germany, Austria and Switzerland.
In the second half of 2021, CARMAT intends to continue focusing
its efforts and resources on its strategic priorities:
- commercialize Aeson® in Europe, following
the first sales recorded in July, - perform additional implants
within the Early Feasibility Study framework in the United States,
- perform the first implants within the framework of the EFICAS
study in France, - ramp-up the production of the device, and
continue to improve processes and secure all supplies.
Given the gradual improvement in the COVID-19 situation, CARMAT
does not anticipate any major adverse impact in the second half of
2021, but it closely monitors this situation, both in France and in
other countries where the Company, its suppliers and customers
operate. CARMAT could have to adjust its development prospects,
should the situation deteriorate.
The Company would like to inform the public that, notably in
accordance with good medical practice and subject to regulatory
obligations or specific circumstances, it will not systematically
communicate on individual Aeson® implantations, whether performed
in a commercial set-up or as part of its clinical studies, or on
the health condition of patients who have benefited from implants.
However, the Company is planning to communicate when it reaches
significant milestones and when it publishes its financial
results.
- Join a video conference with Stéphane Piat today at 5:00 pm
CEST
Log in by clicking on this link:
https://us02web.zoom.us/webinar/register/WN_yT_wDB12Sd-7J5azUi34RQ
- The link above allows you to register for the virtual meeting
via Zoom. You will then receive a confirmation email containing the
link to access the meeting.
- If you do not have the Zoom application, it will automatically
download when you log in to the webinar.
- At any time during the presentation, you can submit your
question via the webinar platform. It will be queued for the
Q&A session.
●●●
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.
●●●
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.21-0076. 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 Early Feasibility Study 2 First-half results were approved by
the Board on September 13, 2021 and have been the subject of a
limited review by the statutory auditors. The 2021 half-year
financial report was published today and is available on the
Company’s website. 3 The Aeson® artificial heart consists of an
implantable prosthesis and its portable external supply system to
which it is continuously connected. 4 the remaining €1.1 million
will be received in two steps in 2022 and 2023, depending on the
progress of the industrial projects which are subsidized. 5 The
initial enrollment target for this study was 20 patients, a figure
that could be revised up or down during the study. The primary
endpoint of this study is 6-month survival with the CARMAT heart or
a successful heart transplant within 6 months of the device being
implanted. The granting of CE marking did not a priori require a
specific number of implantations and/or a predetermined success
rate. In accordance with good clinical practice and subject to
regulatory obligations or special circumstances, CARMAT does not
provide individual details of implantations or patients’ condition.
To date, 15 patients have been implanted within the framework of
the study. Of these 15 patients, 11 have successfully reached the
study’s primary endpoint (7 having survived for more than 6 months
after receiving the CARMAT heart and 4 having had a successful
heart transplant within 6 months of receiving the device), a
success rate of over 73%.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210914005916/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 1 44 54 36 66
carmat@alizerp.com
NewCap Financial Communication & Investor
Relations
Dusan Oresansky Quentin Massé Tel.: +33 1 44 71 94
92 carmat@newcap.eu
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