CARMAT announces its placement in receivership procedure

CARMAT publishes its 2024 half-year results and provides an update on its outlook
 

• 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

Paris, September 6, 2024 – 7:00 am CEST

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.”

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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.

Paris, September 3, 2024 – 5:45 pm (CEST)

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 announced its participation in the following scientific and investor conferences during the 2^nd half of 2024:

• 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

Paris, April 24, 2024 – 7.00 am CEST

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.”

Paris, April 4, 2024 – 6:00 pm CEST

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”), announces today its participation in the following scientific and investor conferences during the second quarter of 2024:

Scientific Conferences

• 44^th ISHLT Annual Meeting

April 10 to 13, 2024 (Prague, Czech Republic)

Scientific Conference of the International Society of Heart and Lung Transplantation (ISHLT); one of the largest events dedicated to the treatment of advanced heart and lung diseases. The CARMAT team will be present on stand 36.

For more information, click here.

• Mechanical Circulatory Support (MCS) Master-Class 2024

June 7 to 8, 2024 (Turin, Italy)

International Society for Mechanical Circulatory Support (ISMCS) event dedicated to training in implantation techniques for mechanical circulatory support systems. CARMAT proctors will present the Aeson® heart implantation procedure during hands-on sessions.

For more information, click here.

• EACTAIC ECHO Course 2024

June 15 to 18, 2024 (Milan, Italy)

The European Association of Cardiothoracic and Vascular Anesthesia and Intensive Care (EACTAIC) ECHO 2024 course features innovations to enhance the learning experience and promote skills development.

For more information, click here.

Investor Conferences

• Gilbert Dupont Société Générale MidCap Forum

May 16, 2024 (Paris, France)

Investor forum organised by Gilbert Dupont (Société Générale Group), a leading player in the intermediation and financial operations in the French small and mid-cap segment.

• Portzamparc BNP Paribas Mid & Small Caps Seminar

June 12, 2024 (Paris, France)

Mid & Smallcaps conference organised by Portzamparc, BNP Paribas investment banking partner specialising in French small and medium-sized companies.

• 7 Aeson® implants have been performed as part of the study, including 4 over the last 4 weeks
• The pace of implants allows the Company to anticipate the completion of the study in 2025, in line with its objective

Paris, October 23, 2023 – 7:00 am (CEST)

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure (the “Company” or “CARMAT“), announces that it has presented its progress on the EFICAS clinical trial at the 36^th “Journées de La Pitié” national conference on heart and lung transplantation and circulatory assistance, organized by the cardiology institute of the Pitié Salpêtrière hospital from October 18 to 20, 2023 in Paris.

Prof. Christian Latrémouille, Director of Surgical Affairs at CARMAT, provided an update on the latest progress of this large-scale study at a session dedicated to innovations: “Seven Aeson® implants have been performed as part of the study since its initiation in several of the French centers involved. The pace of study enrollment is accelerating, with 4 implants performed over the last 4 weeks. This ramp-up is the result of growing experience in patient selection and attest to the steep learning curve of the surgical procedure. Post-operative patient recovery is increasingly satisfactory, which gives us great confidence in Aeson®’s performance and the success of the study, anticipated to be completed in 2025. I would like to thank all the participating teams for their commitment and look forward to seeing additional centers join us in our efforts to offer as many patients as possible an effective alternative to heart transplant.”

EFICAS is a prospective study designed to include 52 patients eligible for transplants, currently enrolled by a network of 6 French cardiology centers. It will enable CARMAT to gather additional data on the efficacy and safety of its artificial heart, as well as medico-economic data to support the value proposition of the prosthesis, and in particular the reimbursement of the device in France. The primary objective of the study is 180-day post-implantation survival without disabling stroke, or successful heart transplant within 180 days of implantation.

Pr. Lebreton of Pitié Salpêtrière Hospital (AP-HP), Paris, says: “We are delighted to have implanted a first patient with the Aeson® total artificial heart as part of the EFICAS clinical study. The patient is recovering very quickly, and most of his symptoms of advanced heart failure have already disappeared.”

Pr. Obadia of Hôpital Louis Pradel (Hospices Civils de Lyon), principal investigator of the EFICAS study, comments: “With our second Aeson® implant within a month, our learning curve is rapid, and we remain impressed with the device’s performance. The CARMAT team provides excellent support to the hospital teams, before, during and after each implant.”

Pr. Vincentelli of the Lille Regional University Hospital (CHRU), says: “The Aeson® heart is an absolute necessity in the therapeutic arsenal against end-stage heart failure. This total artificial heart has enabled us to safely prepare and wait for heart transplants in young patients who have no longer responded to conventional treatment.”

CARMAT teams also attended the 7^th “Journée” VAD Meeting, organized by the French-speaking coordination for the development of cardiac assistance (COFDAC), on October 19, 2023. This was an opportunity to demonstrate the Aeson® device to VAD coordinators in France, who play a key role in the management of patients on circulatory assistance.

CARMAT completes a €7 million capital increase with several historical financial shareholders  

• Extension of the Company’s cash runway to early 2024
• Active work on other financing solutions and measures to extend this horizon
• Confirmation of Aeson®’s early sales momentum

Paris, October 16, 2023 – 07:00 am (CEST)

CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure (the “Company” or “CARMAT“), today announced the completion of a capital increase for a total amount of €7 million, subscribed in its vast majority by several of its historical financial shareholders (“Capital Increase“).

Stéphane Piat, Chief Executive Officer of CARMAT, comments: “As the early momentum of Aeson® sales bas been confirming in recent weeks, I am delighted by the confidence in our project, demonstrated by three of our long-standing shareholders (Lohas, Santé Holdings and Therabel Invest). Their financial support will enable us to continue the deployment of our strategic plan over the coming months, and particularly to support the acceleration of our sales and our EFICAS clinical trial in France.

We are also very actively working on other financing solutions and measures which, combined with a strict financial discipline, should enable us to further extend our financial visibility.

We are confident in the robustness and safety of our artificial heart, and in its strong potential, and are determined to lead CARMAT to commercial success and profitability, with the support of our teams, shareholders and partners, for the benefit of patients suffering from advanced biventricular heart failure.”