- Cash position of €45.3 million at June 30, 2020, covering the
next major stages of its project
- Despite the COVID-19 crisis, CARMAT still on track to meet key
deadlines:
- CE marking expected by the end of 2020, allowing a commercial
launch in 2021
- Implants within the framework of the feasibility study in the
United States expected to begin by the end of 2020
- Videoconference with Stéphane Piat at 6.30 pm Paris time
today
Regulatory News:
This replaces the announcement made at 5:45 PM on September 9
due to the following corrections: Instead of: “The Company also has
access to a €21.9 million contingent equity line with
Kepler-Cheuvreux that may be used until September 26, 2020,
although the Company does not intend to make use of this line.”,
please read: “The Company also has access to a €21.9 million
contingent equity line with Kepler-Cheuvreux that may be used until
September 27, 2021, although the Company does not intend to
make use of this line.”
CARMAT Reports Its 2020 Half-year Results
and Issues an Update on Its Activities and Outlook
CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and
developer of the world’s most advanced total artificial heart,
aiming to provide a therapeutic alternative for people suffering
from end-stage biventricular heart failure, today reports its
results for the first half of the year to June 30, 20201 and issues
an update on its activities and development prospects.
Stéphane Piat, Chief Executive Officer of CARMAT, said:
“The first half of 2020 was unusual because of the COVID-19
pandemic that affected healthcare systems around the world. For
CARMAT, the impact was insofar limited as our activities in France
continued with limited hindrances and in strict compliance with the
health and safety measures imposed by the authorities. During the
first half of the year, we continued our work to ramp up production
and enhance the reliability of production processes at our
Bois-d’Arcy plant, with a particular emphasis on securing supplies
with a view to the commercial phase. On a clinical level, with the
gradual easing of restrictions in Europe from mid-May 2020,
Rigshopitalet in Denmark was able to perform its first implantation
of our device, thus taking the total number of patients in the
PIVOTAL study to 13. Given the persistence of the COVID-19
situation and the resulting procurement problems encountered by
certain suppliers, CARMAT is now expecting to complete enrollment
in the PIVOTAL study by the end of the first quarter of 2021. This
delay does not jeopardize the timeframe of the submission and
review of the CE marking dossier making it possible for this CE
marking to be granted by the end of 2020. We are also continuing to
hold discussions with the FDA and various stakeholders in the U.S.
feasibility study to enable patient enrollment to begin before the
end of 2020 as planned, subject to the public health emergency
improving. The “Forfait Innovation” dossier was definitively
approved by the French National Authority for Health (HAS) in
April, budgetary discussions initiated with the Ministry of Health
and Solidarity have entered their final phase and official
notification of the decision should be published in the coming
weeks. Today, given what we have achieved in recent months and
despite the ongoing pandemic context, we are confirming our
development strategy and, with a cash position of €45.3 million,
have the necessary resources to meet our project’s key
milestones.”
Simplified income statement (€
millions)
30/06/2020
(6 months)
30/06/2019
(6 months)
Net sales
0.0
0.0
Other operating income
0.3
0.7
Operating expenses
-20.9
-24.4
Operating profit/loss
-20.6
-23.7
Financial profit/loss
-1.0
-0.8
Non-recurring items
0.0
0.0
Research tax credit
+0.8
+0.5
Net profit/loss
-20.8
-24.0
As its total artificial heart project is still in clinical
development, CARMAT generated no sales in the first half of
2020.
Over the first half of 2020, operating expenses totaled €20.9
million and were mainly allocated to:
- production activities: ramping up of production and further
work to enhance the reliability of production processes at the
Bois-d’Arcy plant; continuation and intensification of actions to
secure supplies, including the set-up of “double-sourcing” for key
suppliers; - the finalization of the product’s commercial
configuration, including improvements identified during the
research and clinical development phases; - preparation for
commercialization in Europe from a regulatory (CE marking process),
marketing and commercial perspective, but also from an operational
perspective (logistics, IT systems, sales administration, etc.); -
the pursuance of clinical activities: ongoing PIVOTAL study in
Europe, but also preparation for the launch of the Early
Feasibility Study (EFS) in the United States.
These expenses were down by 14% compared with the first half of
2019. This decrease was firstly because a large part of R&D
activities within the framework of the CE marking process and
approval to initiate the EFS in the United States were carried out
in 2019, and secondly because there was a slight slowdown in
spending in the first half of 2020, notably as a result of the
COVID-19 crisis.
The first half of 2020 thus saw a net loss of €20.8 million,
versus a loss of €24.0 million at June 30, 2019, once a financial
loss of -€1.0 million and Research Tax Credit of +€0.8 million are
taken into account.
- Financial structure at June 30, 2020
The Company had a cash position of €45.3 million at June 30,
2020, versus €55.5 million at December 31, 2019. The €10.2 million
decrease compared to end-2019 was a result of the following cash
flows:
(€ millions)
30/06/2020
(6 months)
Cash flow from operating activities
-19.8
Cash flow from investment activities
-0.4
Cash flow from financing activities
+10.0
Change in cash position
-10.2
In May 2020, the Company drew down the second tranche of €10
million of the conditional loan granted in December 2018 by the EIB
(European Investment Bank); the Company has the flexibility to draw
down the final tranche of €10 million at any time until December
17, 2021.
The Company also has access to a €21.9 million contingent equity
line with Kepler-Cheuvreux that may be used until September 27,
2021, although the Company does not intend to make use of this
line.
These financial resources should allow CARMAT to successfully
take its project through to CE marking and its commercial launch,
whilst continuing its clinical development.
- H1 2020 highlights and recent developments
Clinical development and European market access
The COVID-19 pandemic resulted in difficult (or even impossible,
as in Kazakhstan) access to hospitals and a suboptimal organization
of implant procedures. Within this context, only one implant could
be carried out in Denmark during the first half of 2020, taking the
total number of implants performed within the framework of the
PIVOTAL study to 13 (10 in the first cohort, now closed, and 3 in
the ongoing second cohort).
The context of the pandemic that is still present today has also
led to sourcing problems with certain suppliers of components, and
CARMAT is now expecting to complete enrollment (20 patients in
total) by the end of the first quarter of 2021. In this respect,
over the summer, the Company submitted authorization requests
aiming to expand the PIVOTAL study to four new centers in
France.
Regarding the market access procedure, CARMAT has agreed, with
the DEKRA notified body, to a detailed schedule for the filing and
review of its dossier that would make it possible to obtain CE
marking by the end of 2020 despite the delay resulting from the
COVID-19 situation.
To date, the prosthesis has achieved, within the framework of
the PIVOTAL study, almost 8 years of cumulative continuous support
considering all patients who have benefited from the
prosthesis.
Over the summer, CARMAT also announced the publication of the
successful bridge-to-transplant experience performed during the
PIVOTAL study on patients in the first cohort in the Journal of
Heart and Lung Transplantation, the most recognized peer-reviewed
journal in the field of transplantation.
US market access
In February 2020, CARMAT received full approval from the FDA
(Food & Drug Administration) to undertake a clinical
feasibility study in the United States on 10 patients eligible for
a transplant.
Following this approval, in May, the Centers for Medicare &
Medicaid Services (CMS) approved coverage of the CARMAT device and
routine care items and services supplied to patients within the
framework of this study.
The various steps (ethics committee approval, execution of
contracts with the centers participating in the study, training of
personnel, logistics, etc.) necessary to initiate the study made
good progress over the first half of the year. Subject to the
evolution of the COVID-19 crisis, and notably of travel
restrictions in the United States and the ability to get access to
participating hospitals, the first implant within the framework of
the EFS should take place before the end of 2020, as expected.
Forfait Innovation in France
In April 2020, the French National Authority for Health (HAS)
confirmed its positive opinion regarding the financing by special
exemption of the CARMAT total artificial heart within the framework
of the EFICAS study, a prospective, multicenter, non-randomized
study to be undertaken on 52 patients in France. This study has
already received approval from the French National Agency for
Medicine and Health Product Safety (ANSM) and the Île-de-France
Patient Protection Committee (CPP).
Following these validations, budget discussions were initiated
with the Ministry of Health and Solidarity and continued until
August because of the COVID-19 context. The Ministry’s decision is
expected in the coming weeks.
Factoring the estimated impacts of the COVID-19 pandemic on the
areas of development detailed above, CARMAT intends to focus its
resources on the following strategic priorities:
- obtain CE marking by the end of 2020;
- initiate implants within the framework of the EFS in the United
States by the end of 2020;
- complete the enrollment of the PIVOTAL study’s second patient
cohort by the end of the first quarter of 2021;
- reach a budget agreement with the Ministry of Health regarding
the EFICAS study in France in the coming weeks, with implants
beginning by the second quarter of 2021;
- ramp up production, along with the continuous improvement of
processes; and secure supplies with a view to the commercial launch
expected in 2021.
CARMAT is continuing to closely monitor the COVID-19 situation
in France and abroad and, depending on its evolution, may have to
reassess its impact and adjust the Company’s development
prospects.
- Participate in a videoconference with Stéphane Piat from 6.30
pm Paris time today (in French)
Go to the following link:
https://us02web.zoom.us/webinar/register/WN_qvqA2XcNRGWHvUUjy7cLVg
- The above link will enable you to register for the Zoom virtual
meeting.
- You will subsequently receive a confirmation email with the
link to access the meeting.
- If you do not have the Zoom app, it will download automatically
when you log in.
- At any time during the presentation, you can send in your
question via the webinar platform. It will be put in a queue/line
for the Q&A session.
●●●
About CARMAT: the world’s most advanced total artificial
heart project
A credible response to end-stage heart failure: CARMAT
aims to eventually provide a response to a major public health
issue associated with heart disease, the world’s leading cause of
death: chronic and acute heart failure. By pursuing the development
of its total artificial heart, composed of the implantable
bioprosthesis and its portable external power supply system to
which it is connected, CARMAT intends to overcome the well-known
shortfall in heart transplants for the tens of thousands of people
suffering from irreversible end-stage heart failure, the most
seriously affected of the 20 million patients with this progressive
disease in Europe and the United States.
The result of combining two types of unique expertise:
the medical expertise of Professor Carpentier, known throughout the
world for inventing Carpentier-Edwards® heart valves, which are the
most used in the world, and the technological expertise of Airbus
Group, world aerospace leader.
The first physiological artificial heart: given its size,
the use of highly biocompatible materials, its unique
self-regulation system and its pulsatile nature, the CARMAT total
artificial heart could, assuming the clinical trials are
successful, potentially save the lives of thousands of patients
each year with no risk of rejection and with a good quality of
life.
A project leader acknowledged at a European level: with
the backing of the European Commission, CARMAT has been granted the
largest subsidy ever given to an SME by Bpifrance; a total of €33
million.
Strongly committed, prestigious founders and
shareholders: Matra Défense SAS (subsidiary of the Airbus
Group), Professor Alain Carpentier, the Centre Chirurgical Marie
Lannelongue, Truffle Capital, a leading European venture capital
firm, ALIAD (Air Liquide’s venture capital investor), CorNovum (an
investment holding company held 50-50 by Bpifrance and the French
State), the family offices of Pierre Bastid (Lohas), of Dr.
Antonino Ligresti (Santé Holdings S.R.L.), of the Gaspard family
(Corely Belgium SPRL and Bratya SPRL) and of M. Pierre-Edouard
Stérin (BAD 21 SPRL), Groupe Therabel as well as the thousands of
institutional and individual shareholders who have placed their
trust in CARMAT.
For more information: www.carmatsa.com
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 contains
forward‐looking statements that relate to the Company’s objectives.
Such forward‐looking statements are based solely on the current
expectations and assumptions of the Company’s management and
involve risk and uncertainties. Potential risks and uncertainties
include, without limitation, whether the Company will be successful
in implementing its strategies, whether there will be continued
growth in the relevant market and demand for the Company’s
products, new products or technological developments introduced by
competitors, and risks associated with managing growth. 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.
No guarantee can be given as to any of the events anticipated by
the forward-looking statements, which are subject to inherent
risks, including those described in the Universal registration
document filed with the Autorité des Marchés Financiers on March
13, 2020 under number D.20-0126 as well as changes in economic
conditions, the financial markets or the markets in which CARMAT
operates. In particular, no guarantee can be given concerning the
Company’s ability to finalize the development, validation and
industrialization of the prosthesis and the equipment required for
its use, to manufacture the prostheses, satisfy the requirements of
the ANSM, enroll patients, obtain satisfactory clinical results,
perform the clinical trials and tests required for CE marking and
to obtain the CE mark. CARMAT products are currently exclusively
used within the framework of clinical trials.
------------------------------------------------
1 First-half accounts were approved by the Board on September 7,
2020 and have been the subject of a limited review by the statutory
auditors. The 2020 half-year financial report was published today
and is available on the Company’s website.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200922005869/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 Investor Relations & Strategic
Communication
Dusan Oresansky Emmanuel Huynh Tel.: +33 1 44 71
94 94 carmat@newcap.eu
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