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CARMAT

Interim / Quarterly Report Sep 25, 2023

1179_ir_2023-09-25_1b8fc1fb-1737-4fba-9488-d9a7319928e6.pdf

Interim / Quarterly Report

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French joint-stock corporation (société anonyme) with share capital of €913,743.76 Registered office: 36, avenue de l'Europe Immeuble l'Etendard Energy III 78140 Vélizy Villacoublay, France Registered in the Versailles Trade and Companies Register under no. 504 937 905

2023 INTERIM FINANCIAL REPORT

SIX MONTHS ENDED JUNE 30, 2023

1 DECLARATION BY THE PERSON RESPONSIBLE FOR THE
INTERIM FINANCIAL REPORT AT JUNE
30, 2023______
3
2 REVIEW OF OPERATIONS
_________
4
2.1 SUMMARY OF THE INTERIM FINANCIAL STATEMENTS AT JUNE 30, 20234
2.2 SIGNIFICANT EVENTS OF FIRST-HALF 2023 AND RECENT DEVELOPMENTS6
2.2.1 Implementing the industrial plan 6
2.2.2 Commercial development6
2.2.3 Clinical studies and US market access 6
2.2.4
2.2.5
Financial structure 7
Changes in the Company's governance7
2.2.6 Impact of the Covid-19 situation and the conflict in Ukraine8
2.3 NEXT STEPS8
2.4 MAIN RISK FACTORS 8
3 2023 INTERIM FINANCIAL STATEMENTS_______ 9
3.1 BALANCE SHEET 9
3.2 INCOME STATEMENT11
4 NOTES TO THE 2023 INTERIM FINANCIAL STATEMENTS __
12
4.1 SIGNIFICANT EVENTS DURING THE PERIOD 12
4.2 SIGNIFICANT ACCOUNTING POLICIES12
4.2.1
4.2.2
General principles and conventions 12
Additional information 14
4.3 ADDITIONAL INFORMATION ON THE BALANCE SHEET17
4.3.1 Movements in non-current assets 17
4.3.2 Movements in depreciation and amortization18
4.3.3 Movements in inventories18
4.3.4
4.3.5
Movements in provisions 19
Receivables and payables by maturity19
4.3.6 Share capital20
4.3.7 Other balance sheet details25
4.4 ADDITIONAL INFORMATION ON THE INCOME STATEMENT 27
4.4.1 Sales27
4.4.2 Operating grants27
4.4.3 Applied research and development costs 27
4.4.4
4.4.5
Research tax credit27
Non-recurring income and expenses27
4.4.6 Information on related companies27
4.5 FINANCIAL COMMITMENTS AND OTHER INFORMATION 28
4.5.1
4.5.2
Financial commitments28
Other information 29

1 DECLARATION BY THE PERSON RESPONSIBLE FOR THE INTERIM FINANCIAL REPORT AT JUNE 30, 2023

I hereby declare that, to the best of my knowledge, the financial statements presented for the six months ended June 30, 2023 were prepared in accordance with applicable accounting standards, and give a true and fair view of the assets, liabilities, financial position and results of the Company, and that the interim review of operations on pages 4 to 7 presents a true and fair view of the significant events that took place during the first half of the year, their impact on the financial statements and the main transactions between related parties, along with a description of the principal risks and uncertainties for the remaining six months of the year.

Stéphane Piat Chief Executive Officer, Carmat

2 REVIEW OF OPERATIONS

2.1 SUMMARY OF THE INTERIM FINANCIAL STATEMENTS AT JUNE 30, 2023

2023 2022 2022
Income statement 6 months 12 months 6 months
ended ended ended
(in millions of euros) June 30, 2023 Dec. 31, 2022 June 30, 2022
Revenue 0.6 0.3 0.0
Net operating expense (25.9) (51.9) (25.1)
Net financial expense (1.7) (3.8) (1.9)
Net non-recurring income 0.0 0.0 0.0
Research and innovation tax credit 1.0 2.1 0.9
Net loss (26.7) (53.7) (26.0)
Balance sheet
(in millions of euros) June 30, 2023 Dec. 31, 2022 June 30, 2022
Total assets 64.5 85.2 81.0
Total equity (24.5) 2.0 0.2
(Net cash)/Net debt* 32.7 3.9 6.4
Cash flow statement 6 months 12 months 6 months
ended ended ended
(in millions of euros) June 30, 2023 Dec. 31, 2022 June 30, 2022
Cash and cash equivalents at beginning of period 51.4 39.2 39.2
Net cash used in operating activities (30.7) (54.4) (30.5)
Net cash used in investing activities (1.6) (2.0) (1.1)
Net cash from financing activities 4.7 68.6 39.8
Cash and cash equivalents at end of period 23.8 51.4 47.4

First-half 2023 earnings

Carmat generated €0.6 million in revenue in the first half of 2023, corresponding to the sale of three Aeson® hearts – two for commercial implants and one for an implant as part of the EFICAS clinical study.

Despite demands arising from hospitals, Aeson® implants were held back by the fact that only a small number of Aeson® artificial hearts were available during 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 June, enabling output to gradually return to normal over the summer.

In the first six months of the year, Carmat's efforts and resources were predominantly focused on:

  • extending its Bois d'Arcy's manufacturing site, which will enable the Company to increase its production capacity to 500 hearts a year by the end of 2023;
  • training more medical centers (25 centers trained to date for commercial implants) and preparing for the launch of Aeson® in eight new countries;
  • ramping up for the EFICAS clinical study in France as from the second half of the year;
  • continuing discussions with the FDA with a view to ultimately gaining market access for Aeson® in the United States.

Despite the outlay required for the above projects, the Company maintained tight control over its operating expenses, enabling it to keep its operating loss broadly stable at €25.9 million versus €25.1 million in first-half 2022.

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 flows and financial structure

Cash and financing

At June 30, 2023, the Company had €23.8 million in cash and cash equivalents, versus €51.4 million at December 31, 2022.

Cash flows from operating and investing activities represented a net cash outflow of €32.3 million, up slightly on the first-half 2022 net outflow of €31.6 million, particularly due to the increase in industrial capital expenditure.

Concerning financing, in the six months ended June 30, 2023, the Company received the following funds:

  • €0.7 million corresponding to the second tranche of the total €1.4 million "CAP23" grant1 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 Carmat at end-2022 for its winning proposal in the European Union's "EIC Accelerator" funding program2;
  • the first €3.3 million tranche of the €13.2 million blended financing package3 awarded to Carmat in April 2023 (see Section 2.1.3) under the "France 2030" plan.

Also in the first half of 2023, as planned, Carmat began to repay its government-guaranteed loans4, making the first half-yearly repayment in April in an amount of €0.6 million.

Based on the Company's current business plan and taking into account the amounts required to honor all of its contractual repayment maturities, Carmat's confirmed financial resources5 should enable it to fund its business until end-October 2023. 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 date6.

Net debt
(in thousands of euros)
(Net cash)/Net debt June 30, 2023
Long-term financial liabilities (>12 months) 39 773
Short-term financial liabilities (<12 months) 16 806
Total financial liabilities [a] 56 579
Cash and cash equivalents [b] 23 846
(Net cash)/Net debt [a-b] 32 733

At June 30, 2023, the Company's net debt stood at €32.7 million. Short-term financial liabilities include (i) an aggregate €2.0 million payable in the fourth quarter of 2023 (mainly corresponding to repayments due under governmentguaranteed loans7), and (ii) an aggregate €14.9 million payable in the first half of 2024 (mostly relating to the repayment of the first tranche – drawn down in January 2019 – of the loan taken out with the EIB, as well as repayments due under government-guaranteed loans8).

8 Third half-yearly installment due on the government-guaranteed loan taken out with BNP Paribas.

1 The remaining balance of this grant (€0.3 million) is due in 2024.

2 The remaining balance of this grant is due in 2024.

3 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 four tranches over 2023-2026. The second tranche is due in 2024.

4 Two government-guaranteed loans representing a principal amount of €5 million each, taken out in the fourth quarter of 2020 with BNP Paribas and Bpifrance.

5 Including cash and cash equivalents at June 30, 2023 and the €0.9 million balance of the 2022 research tax credit due to be received by the end of October 2023.

6 See Section 4.2.1 for the factors underlying the going concern principle used by the Board of Directors.

7 Second half-yearly installment due on the government-guaranteed loan taken out with BNP Paribas, and the first annual installment due on the government-guaranteed loan taken out with Bpifrance.

2.2.1 IMPLEMENTING 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 ten 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 the supplier portfolio

Carmat's manufacturing output relies on a large number of suppliers and subcontractors. As it ramps up its production, one of the key factors for the Company's success will be to develop its supplier portfolio in order to work only with highly reliable partners capable of producing the required volumes at a competitive price, and which meet the strict quality requirements specific to the implantable medical devices market. In order to achieve this goal, Carmat has drawn up an ambitious multi-year roadmap, which it began to action in several tangible ways in the first half of 2023. For example, it entered into a new partnership agreement with France-based Vygon for developing the connector conduits of the Aeson® artificial heart and stepped up its partnership with the Swiss company MPS for producing the motor pump. These initiatives enable Carmat to both strengthen its supply continuity and reduce the production cost of the prosthesis.

Increase in production capacity

During the first half of 2023 the Company also began work on expanding its production capacity, in particular by extending its cleanroom and creating additional production facilities at the Bois d'Arcy site. In view of the current progress of the works, the Company is standing by its objective of reaching a production capacity of 500 hearts a year by the end of 2023.That capacity could represent a potential yearly turnover of 100 M€. Carmat's aim is to subsequently double its production capacity again, to 1,000 hearts a year, by 2027.

2.2.2 COMMERCIAL DEVELOPMENT

Hospital training and geographic expansion

During the period, the Company continued to actively train hospitals in order to reach its target of 30 medical centers trained for commercial implants by the end of 2023. To date, an overall 40 centers are trained, including 25 for commercial implants and the other 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.

From the second half of 2023, the Company plans to make the Aeson® artificial heart commercially available in eight more countries – both in Europe (Greece, Slovenia, Croatia, Serbia, Austria and Switzerland) and outside Europe (Israel and Saudi Arabia) – in addition to the two countries in which the device has already been sold for commercial implants (Germany and Italy). 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 got back to normal, the Company forecasts sales revenue between €4 million and €6 million in the second half of 2023.

2.2.3 CLINICAL STUDIES AND US MARKET ACCESS

Continuation of the EFICAS clinical study in France

In early January 2023, Carmat announced the first Aeson® implant as part of the EFICAS study. The 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 medicoeconomic data that can be used to support the value proposition and obtain reimbursement of the device.

The 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 has received €13 million in funding from the French National Innovation Fund9 to partially finance this study.During the first half of 2023, the Company continued in-depth discussion with the FDA (Food & Drug Administration).

Optimized US market access strategy

In order to optimize Aeson®'s access to the US market, CARMAT intends to rely on data collected from both EFS10 and the on-going EFICAS study in France, which could enable CARMAT to avoid conducting a substantial pivotal study in the United States.

Given both EFS and EFICAS' current schedules, and all other elements it is aware of, Carmat anticipates, should both studies be successful, to apply for Premarket Approval ("PMA") by the end of 2026.

Publication of a scientific article on the first U.S. 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.

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 five months of support on the Aeson® device, the patient was successfully bridged to transplant, and has made a full recovery.

2.2.4 FINANCIAL STRUCTURE

€13.2 million non-dilutive blended financing package obtained under the "France 2030" plan

In April 2023, the Company obtained a €13.2 million blended financing package under the "France 2030" plan, consisting of a €7.9 million grant and a €5.3 million repayable advance. This financing will be used to help drive the increase in annual production capacity of Aeson® artificial hearts to 1,000 per year within five years, and to reduce the production cost of the device.

The package is split into four tranches, with each tranche becoming 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 due in 2024.

Carmat is also actively working on various financing options in order to extend in the short term its cash runway beyond October 2023 (see Section 2.1).

2.2.5 CHANGES IN THE COMPANY'S GOVERNANCE

The Combined Shareholders' Meeting held on May 11, 2023 ratified the appointment of Thérabel Invest – represented by Laurent Kirsch – as a corporate director of the Company for a three-year term. Laurent Kirsch brings to the Board his extensive experience in the healthcare industry, including at international level, as well as his financial expertise. At the date of this report, the Board of Directors was chaired by Alexandre Conroy and comprised 12 directors, nine of whom are independent.

10 The EFS is a feasibility study with a sample size of 10 patients eligible for a heart transplant. The EFS design provides for two successive cohorts of three and seven patients. The first cohort was completed during the second half of 2021.The initiation of the second cohort is subject to receiving the go-ahead from the FDA. Carmat expects the EFS to resume in the second half of 2024.

9 The funds will be received as and when the implants are performed during the study.

2.2.6 IMPACT OF THE COVID-19 SITUATION AND THE CONFLICT IN UKRAINE

Covid-19 did not have any perceptible direct impact on Carmat's business in the first half of 2023. The same applies to the situation in Ukraine. Barring any significant changes in events relating to Covid and/or Ukraine, Carmat will no longer report on these two situations.

2.3 NEXT STEPS

Strong ramp-up in sales from 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 their "screening" to identify patients, in view of both commercial implants, and implants in the EFICAS clinical study.

In view of 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 €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 (Greece, Slovenia, Croatia, Serbia, Austria, Switzerland, Israel and Saudi Arabia).

Confirmation of 2023 key objectives

In light of its first-half achievements and recent developments, Carmat reiterates its confidence in reaching the key 2023 objectives from its strategic roadmap:

  • successful sales development in Europe;
  • annual production capacity of 500 hearts by the end of the year;
  • 30 centers trained for commercial implants by the end of the year;
  • 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.

2.4 MAIN RISK FACTORS

Risk factors are discussed in detail in Chapter 2 of the 2022 Universal Registration Document filed with the French Financial Markets Authority (Autorité des marchés financiers – AMF) under number D. 23-0323. To date, the Company is not aware of any significant changes in these risk factors.

The Company would also like to draw the attention of readers to Section 4.2.1 of this report, particularly the assumptions underlying the going concern basis of accounting adopted by the Board of Directors in the preparation of the Company's financial statements for the six months ended June 30, 2023.

3 2023 INTERIM FINANCIAL STATEMENTS

Note that the legal provisions applicable to Carmat, whose shares are traded on Euronext Growth, do not require the issuance of an audit report by the Statutory Auditors on the interim financial statements.

3.1 BALANCE SHEET

June 30, 2023 Dec. 31, 2022
Assets (in thousands of euros) Gross Depreciation,
amortization and
impairment
Net Net
UNCALLED SUBSCRIBED CAPITAL (TOTAL I)
Non-current assets
Intangible assets (notes 4.3.1 and 4.3.2)
Start-up costs
Development costs
Licenses, patents and similar rights 2,073 2,073 0 0
Goodwill(1)
Intangible assets not yet available for use
Advances and downpayments
Property, plant and equipment (notes 4.3.1 and 4.3.2)
Land
Buildings
Technical plant, equipment and tooling 13,417 9,588 3,828 3,903
Other property, plant and equipment 3,427 2,267 1,160 1,288
Property, plant and equipment in progress 2,476 2,476 1,508
Advances and downpayments
Financial assets(2) (notes 4.3.1 and 4.3.2)
Equity-accounted investments
Other equity interests
Other long-term investments
Loans
Other financial assets 1,024 0 1,023 737
TOTAL II 22,417 13,929 8,488 7,436
Current assets
Inventories and work in progress (note 4.3.3)
Raw materials, supplies 7,131 452 6,679 5,562
Work in progress - goods 1,954 760 1,194 307
Semi-finished and finished goods 15,905 9,562 6,343 5,372
Goods for resale 7,045 7,045 6,195
Advances and downpayments on orders 5,318 5,318 3,994
Receivables(3)
Trade notes and accounts receivable 420 420 140
Other receivables (note 4.3.5) 3,863 පිළි 3,765 3,520
Share capital subscribed, called and unpaid 0
Marketable securities 0
Cash instruments 0
Cash 23,846 23,846 51,427
Prepaid expenses(3) (note 4.3.7.4) 1,355 1,355 1,248
TOTAL III 66,837 10,872 55,965 77,764
ACCRUAL ACCOUNTS
Deferred loan issuance costs (IV) 0
Bond redemption premiums (V) 0
Unrealized foreign exchange losses (VI) 36 36 37
Grand total (I+II+III+IV+V+VI) 89,290 24,801 64,489 85,237
(1) Including lease rights.
(2) Of which are due in less than one year. 108 344
(3) Of which are due in more than one vear

EQUITY (note 4.3.6)
Share capital (of which paid-up: €913,744) 914 907
Additional paid-in capital 2,115 69,730
Revaluation adjustments
Reserves
Legal reserve
Statutory or contractual reserves
Untaxed reserves
Other reserves 106 87
Retained earnings/(Losses carried forward) (1,228) (15,228)
Net loss for the period (26,673) (53,681)
Grants 226 154
Tax-driven provisions
TOTAL I (24,540) 1,969
OTHER EQUITY
Proceeds from issues of equity securities
Conditional advances (note 4.3.7.1) 15,825 14,507
TOTAL II 15,825 14,507
PROVISIONS
Provisions for contingencies 186 140
Provisions for losses (notes 4.3.4 and 4.3.7.6) ഒക്ട 1,029
TOTAL III 1,181 1,168
LIABILITIES (1)
Debt
Convertible bonds
Other bonds
Bank loans and borrowings 46,670 46,098
Bank overdrafts
Sundry loans and borrowings (note 4.3.5) 60,809 9,260
Advances and downpayments received on orders in progress
Accounts payable (note 4.3.5)
Trade notes and accounts payable 6,665 6,526
Tax and social security payables 5,667 5,704
Amounts payable on non-current assets and other
Other payables
ACCRUAL ACCOUNTS
Prepaid income 11 (note 4.3.7.4) 3,102
TOTAL IV 72,013 67,587
Unrealized foreign exchange gains 10 6
TOTAL V 10 6
Grand total (I+II+III+IV+V) 64,489 85,237
14 Liabilities and prepaid income due in less than one year. 19,137 14,867

3.2 INCOME STATEMENT

Income statement (in thousands of euros) 6 months ended
June 30, 2023
6 months ended
June 30, 2022
12 months ended
Dec. 31, 2022
France Export Total Total Total
OPERATING INCOME
Sale of goods for resale 3 7
Production sold - goods 133 420 ല്ലാ - 338
Production sold - services
NET REVENUE 133 420 553 3 345
Inventoried production 1,905 (1,970) (3,094)
Capitalized production
Operating grants 6 123 132
Reversals of impairment, depreciation/amortization and provisions,
expense transfers
7,681 9,774 11,587
Other income 25 17 27
TOTAL OPERATING INCOME (I) 10,169 7,947 8,997
OPERATING EXPENSES
Purchases of goods for resale 901 1,936 3,148
Change in inventories (goods for resale) (851) (1,870) (2,948)
Purchases of raw materials and other supplies 4,010 3,366 7,504
Change in inventories (raw materials and other supplies) (1,211) (998) (1,238)
Other purchases and external expenses 12,389 11,795 22,353
Taxes, duties and other levies 200 247 471
Wages and salaries 8,062 7,541 14,713
Social security contributions 3,668 3,240 6,187
Depreciation/amortization and impairment
of non-current assets: depreciation/amortization (note 4.3.2) 825 762 1,680
of non-current assets: impairment
of current assets: impairment 7,284 6,566 7,786
Additions to provisions (note 4.3.4) 287 143 611
Other expenses 498 301 652
TOTAL OPERATING EXPENSES (II) 36,063 33,028 60,919
1 - NET OPERATING EXPENSE (I-II) (25,894) (25,081) (51,922)
SHARE IN INCOME FROM JOINT VENTURES
Income allocated or loss transferred (III)
Loss incurred or income transferred (IV)
FINANCIAL INCOME
Investment income
Income from other marketable securities and non-current asset
receivables
Other interest income 262
Reversals of impairment and provisions, expense transfers 0
Foreign exchange gains 1 13 25
Net income on sales of marketable securities - -
TOTAL (V) 263 13 25
FINANCIAL EXPENSES
Depreciation/amortization, impairment and provisions 0
Interest expense 1,990 1,882 3,820
Foreign exchange losses 12 17 E2
Net expenses on sales of marketable securities
TOTAL (VI) 2,003 1,900 3,872
2 - Net financial expense (V-VI) (1,739) (1,887) (3,848)
3 - Recurring expense before tax (I-II+III-IV+V-VI)
Non-recurring income (note 4.4.5)
(27,633) (26,968) (55,770)
Non-recurring income on management transactions 42 ಕಿರಿ 92
Non-recurring income on corporate actions 38 110 142
Reversals of impairment and provisions, expense transfers
TOTAL (VII) 80 200 234
NON-RECURRING EXPENSES (NOTE 4.4.5)
Non-recurring expenses on management transactions 36 25 ട്‌വ
Non-recurring expenses on corporate actions 38 77 90
Depreciation/amortization, impairment and provisions 0 67 67
TOTAL (VII) 74 169 208
4 - NET NON-RECURRING INCOME (VII-VIII) 6 30 27
Employee profit-sharing (DX) - - -
Income tax (X) (note 4.4.4) (854) (947) (2,062)
TOTAL INCOME (I+III+V+VII) 10,512 8,160 ૭,255
TOTAL EXPENSES (II+IV+VI+VI+VIII+IX+X) 37,185 34,151 62,937
5 - NET LOSS (TOTAL INCOME - TOTAL EXPENSES) (26,673) (25,990) (53,681)

4 NOTES TO THE 2023 INTERIM FINANCIAL STATEMENTS

The following sections contain notes to the balance sheet at June 30, 2023, which shows total assets of €64.489 million, and to the income statement for the six months then ended, presented in list form and showing €0.6 million in revenue and a net loss of €26.673 million.

The reporting period covers the six months from January 1, 2023 to June 30, 2023.

The notes and tables presented below are an integral part of the financial statements for the six months ended June 30, 2023, as authorized for issue by the Board of Directors on September 21, 2023. They are presented in thousands of euros unless otherwise stated.

4.1 SIGNIFICANT EVENTS DURING THE PERIOD

Activity

Carmat generated €0.6 million in revenue in the first half of 2023, corresponding to the sale of three Aeson® artificial hearts – two for commercial implants in Italy and Germany and one for an implant as part of the EFICAS clinical study in France.

Supply problems slowed down the Company's planned ramp-up in production, resulting in only a very limited number of prostheses being available for implantation during the period. The vast majority of these difficulties were resolved by the end of June, enabling the Company to now forecast an output of 60 to 70 artificial hearts in 2023, and revenue of €4 million to €6 million in the second half of 2023.

During the first half of 2023, the Company also began work on expanding its production capacity, which will enable it to raise its capacity to 500 hearts a year by the end of 2023.

Financing

During the period, the Company received a total of €5.1 million in financing (grants and a repayable advance), including €3.3 million for the first tranche of a €13.2 million blended financing package awarded during the first half of 2023 under the "France 2030" plan. The total €13.2 million in financing will be received in four tranches over 2023-2026.

Also in the first half of 2023, the Company began its repayments of the €5 million government-guaranteed loan taken out in the fourth quarter of 2020 with BNP Paribas.

Based on the Company's current business plan and taking into account the amounts required to honor all of its contractual repayment maturities, Carmat's confirmed financial resources11 should enable it to fund its business until end-October 2023. The Company is actively working on various financing options in order to secure in the short term the financial resources it requires in order to continue as a going concern beyond that date12.

Net loss

The Company reported a €26.7 million net loss for the first half of 2023, on a par with the €26.0 million net loss recorded for first-half 2022.

SIGNIFICANT EVENTS AFTER THE REPORTING DATE

No events occurred after the reporting date that are liable to alter the presentation or valuation of the interim financial statements as authorized for issue by the Board of Directors on September 21, 2023.

4.2 SIGNIFICANT ACCOUNTING POLICIES

The methods used for measuring accounting items for the period remain unchanged from the previous period.

4.2.1 GENERAL PRINCIPLES AND CONVENTIONS

The Company's financial statements have been prepared in accordance with French generally accepted accounting rules and principles as set out in the French General Chart of Accounts (ANC Standard 2014-03 on the Chart of Accounts issued by the French accounting standards-setter – Autorité des Normes Comptable [ANC]). The historical cost method is used as the basis for measuring accounting items.

12 See Section 4.2.1 for the factors underlying the going concern principle used by the Board of Directors.

11 Including cash and cash equivalents at June 30, 2023 and the €0.9 million balance of the 2022 research tax credit due to be received by the end of October 2023.

The accounting conventions have been applied in accordance with the provisions of the French Commercial Code (Code de commerce), the Accounting Decree of November 29, 1983 and the CRC regulations concerning the new French General Chart of Accounts applicable at the end of the reporting period.

The financial statements for the six months ended June 30, 2023 have been prepared in accordance with French generally accepted accounting principles, including the principles of prudence and accrual-based accounting. They are presented on a going concern basis and accounting methods have been applied consistently from one period to the next.

Going concern basis

Given its stage of development, Carmat is not yet cashflow positive, and based on its current business plan, does not expect to be self-financing for several years yet. At this stage, it is therefore dependent on external financing (capital increases, borrowings, grants and other types of financing).

Based purely on its current confirmed financial resources, the Company can fund its business activity (on the basis of its updated business plan) until the end of October 2023 without the need for any further financing.

The Company's confirmed financial resources include13:

  • €23.8 million in cash and cash equivalents at June 30, 2023;
  • the €0.9 million balance of the 2022 research tax credit due to be received by October 2023.

Carmat's updated business plan for the second half of 2023 is based on the assumptions that the Company will:

  • meet all contractual maturities of its loans, and more generally all maturities of its operating payables;
  • face no major disruptions in its production chain, therefore enabling the production and availability of a sufficient number of implantable prostheses to ensure sales levels and the continuation of the planned clinical trials (corresponding to revenues of €4 to €6 million in the second half of 2023).

If the Company is unable to access any additional financing, it would have a funding shortfall starting in November 2023, which could reach between €10 million and €15 million by December 31, 2023, and then grow by around €30 million14 and €20 million in the first and second quarters of 2024, respectively.

Based on the progress of its project, the results of its clinical trials, the CE marking obtained in December 2020, the volumes of Aeson® sales already achieved, the positive feedback it has received and the interest shown by the medical community for its device, as well as its output potential and all other information in its possession, the Company considers that, as things stand, the probability that it will be unable to source the funds it needs to continue as a going concern is fairly low. However, such a risk cannot be completely ruled out, particularly in view of the current geopolitical, economic and financial context, which could in the short term make it more difficult for Carmat to secure the financing it requires. In addition, securing such financing is partly contingent on the Company successfully rolling out its business plan, especially in terms of sales growth.

The Company has an ongoing active investor relations policy targeting both French and international investors, and is constantly on the lookout for new financing opportunities (equity, government support and other types of financing). It believes it can count on the support of a number of its main existing shareholders, and could, if necessary, temporarily reduce its cash-burn by implementing cost-saving measures. It also believes that as its production levels are now back on track, its sales momentum will gain significant pace as from the fourth quarter of 2023.

The Company expects to be able to gradually extend its cash runway to 12 months. This will take place over several stages: first, by completing in the very short-term transactions on which it is currently working actively and which should enable it to strengthen its equity and therefore continue as a going concern beyond October 2023; and subsequently by launching other complementary initiatives allowing it to extend its cash runway to at least mid-2024. On the basis on the above, the Board of Directors considered it appropriate to adopt the going concern basis of accounting in the preparation of these financial statements. However, it is not certain that the Company will have access to these financings.

This gives rise to significant uncertainty that could cast doubt on the Company's ability to continue as a going concern. Indeed, if the Company is unable to secure the funds it needs, it may not be able to pay its debts and realize its assets in the normal course of its business.

14 Including €15 million for repayment of the first tranche drawn down in 2019 on the loan taken out in 2018 with the EIB.

13 As a winner of the European Union's EIC Accelerator program, in December 2022, the Company was also awarded optional equity financing of up to €15 million, subject to an agreement between the two parties. As this amount is not certain, it has not been factored in the Company's funding horizon. In view of its discussions with EIC, which are still open, the Company thinks the probability of getting this amount is low.

4.2.2 ADDITIONAL INFORMATION

4.2.2.1 Applied research and development costs

Research and development costs are recognized as expenses in the year in which they are incurred.

4.2.2.2 Intangible assets

Patents, licenses and other intangible assets have been measured at their acquisition cost, excluding the expenses incurred in acquiring them.

The methods and periods of amortization used are as follows:

Category Method Useful life
Licenses and software Straight line 1 to 3 years
Patents Straight line 15 years

4.2.2.3 Property, plant and equipment

The gross value of property, plant and equipment corresponds to their initial book value, inclusive of any expenditure required to render the items usable, excluding costs incurred in their acquisition.

The methods and periods of depreciation used are as follows:

Category Method Useful life
Fixtures and fittings Straight line 9 to 10 years
Technical plant Straight line 3 to 10 years
Equipment and tooling Straight line 2 to 6 years
Furniture Straight line 8 years
IT equipment Straight line 3 years

4.2.2.4 Financial assets

- Other financial assets

In 2010, the Company entered into a liquidity agreement, the purpose of which was to improve the liquidity of transactions and regularize the Carmat share price, without impeding the normal operation of the market and without misleading third parties. To this end, the Company made €300,000 available.

Treasury shares acquired through the implementation of this liquidity agreement are recorded under financial assets. If necessary, an impairment loss is recognized based on Carmat's share price at the end of the reporting period.

Other financial assets are composed of the following:

  • guarantee deposits paid, which are shown at face value;
  • the unused balance of sums made available under the liquidity agreement for the acquisition of treasury shares.

4.2.2.5 Receivables and payables

Receivables and payables are measured at face value. Where applicable, receivables are impaired via provisions to take into account any collection difficulties they may potentially face. Any provisions for impairment are determined by comparison between the acquisition value and the probable realizable value.

4.2.2.6 Revenue

Sales are recognized when ownership is transferred to the customer.

4.2.2.7 Translation differences and foreign exchange gains and losses

Payables and receivables in foreign currencies are measured at the reporting date exchange rate. Any resulting translation differences are recorded in the balance sheet under "Unrealized foreign exchange gains" or "Unrealized foreign exchange losses", as appropriate.

A provision is booked for the full amount of any unrealized foreign exchange losses.

Unrealized gains are not recorded in the income statement.

Foreign exchange gains and losses on trade receivables and payables are recognized as operating income or expenses.

4.2.2.8 Inventories

According to the French Commercial Code and Chart of Accounts (Article 211-7), inventories are assets that meet the following criteria:

  • they are identifiable items that will generate future economic benefits, are controlled by the company, and their cost can be measured reliably;
  • they are held for sale in the ordinary course of business or in the form of materials or supplies to be consumed in the production process or in the rendering of services.

The Company's inventories and work in progress comprise goods, raw materials and other supplies, semi-finished and finished goods, and work in progress in the production process.

Inventories and work in progress were recognized as an asset on Carmat's balance sheet for the first time on December 31, 2020. They were previously expensed in the year in which they were purchased or produced, as the Company was still in the clinical phase and could not expect them to generate any future economic benefits.

Inventories and work in progress are measured at the reporting date using the methods set out in the French Chart of Accounts. Items are monitored individually and are clearly identifiable. An impairment provision is recognized if their realizable value falls below their carrying amount.

Impairment is calculated taking the following factors into account:

  • the life cycle of items of inventory and work in progress (obsolete or short shelf-life items, damaged items or items that do not meet the requisite quality standards, etc.);

  • the different outlook for inventory items, distinguishing between items intended for sale and items intended for other, non-revenue-generating activities (e.g., clinical trials, training, tests, etc.). Inventories intended for other activities are fully written down.

When the recoverable amount at the period-end (fair value for finished goods and goods for resale and value in use for work in progress and raw materials) is less than the carrying amount, a provision for impairment is recognized for the difference.

Impairment provisions are recognized by inventory category.

4.2.2.9 Cash in euros

Cash on hand or at bank is recorded at face value.

4.2.2.10 Cash in foreign currencies

Cash in foreign currencies is converted into euros at the exchange rate prevailing at the reporting date. Translation differences are recognized directly in profit or loss for the period as foreign exchange gains and losses.

4.2.2.11 Cash and cash equivalents

For the purposes of the cash flow statement, cash and cash equivalents are defined as being:

  • the sum of the "Cash instruments" and "Cash" items on the assets side of the balance sheet, to the extent that cash instruments are available in the very short term and do not present a risk of a loss in value in the event of a change in interest rates;
  • less the "Bank overdrafts" item on the liabilities side of the balance sheet.

4.2.2.12 Repayable advances made by public bodies

Advances received from public bodies to finance the Company's operations and repayable subject to conditions are shown in liabilities under "Other equity – Conditional advances". The corresponding interest is shown in balance sheet liabilities under "Sundry loans and borrowings".

4.2.2.13 Grants

Grants received are included in the balance sheet at the time of payment under "Tax and social security payables" or "Prepaid income".

  • When the milestones defined in the relevant contracts are achieved, they are recorded:
    • either directly in income for the period as an operating grant for the portion covering operating expenses; or
    • in the balance sheet as an investment grant for the portion relating to investments; a portion will then be recorded as non-recurring income as and when the investments concerned by the grant are amortized.

4.2.2.14 Retirement benefits

Future payments in respect of benefits granted to employees are measured according to an actuarial method (method 2 based on IAS 19 as amended published in June 2011, in compliance with ANC recommendation no. 2013-02 dated November 7, 2013), taking account of assumptions concerning changes in salaries, retirement age and mortality. The resulting amounts are then discounted to present value and entitlement capped according to the collective bargaining agreement for the metallurgy industry. These obligations are covered by provisions recorded as liabilities in the balance sheet.

4.2.2.15 Provisions for losses

In addition to the legal guarantee of conformity provided for in Article 1604 of the French Civil Code and the warranty against hidden defects provided for in Article 1641 of said Code, the Company may grant customers, within the framework of its commercial offer, a commercial warranty which consists of the free supply of a certain number of replacement components, under certain limited contractually defined terms and for a contractually defined limited period of time.

The Company therefore records a provision for losses at the time the product is sold, in accordance with the principle set out in the French Chart of Accounts of matching income and expenses. The amount of the provision is based on the contractually defined terms of the warranty and statistical considerations.

The provision is subsequently written back as necessary, to the extent of the expenses actually incurred in connection with the implementation of the warranty and/or when the warranty is extinguished.

A 20% social security levy on the value of free shares granted is payable by the Company when the shares vest for their beneficiaries. The Company therefore records a provision for losses for this amount prorated over the vesting period (i.e., the period between the grant date and the vesting date of the shares). The provision is reversed when the social security levy is paid.

4.2.2.16 Sub-contracting expenses

The progress of third-party sub-contracting agreements for certain services is assessed at the end of each reporting period in order to allow the cost of services already rendered to be recorded under accrued expenses.

4.2.2.17 Share issue costs

In application of the reference method (ANC 2018-01), share issue costs are recorded in the balance sheet as deductions from the share premium.

4.2.2.18 Borrowing costs

Borrowing costs are expensed as incurred.

4.3 ADDITIONAL INFORMATION ON THE BALANCE SHEET

4.3.1 MOVEMENTS IN NON-CURRENT ASSETS

(in thousands of euros)

Gross value Increases
at start of
period
Line to line
transfers
Acquisitions
Licenses, patents and similar rights(1) 2 073
Intangible assets not yet available for use
TOTAL 2 073
Technical plant, equipment and industrial tooling(2) 12 807 501 108
General plant, sundry fixtures and fittings 2 870
Office and IT equipment, furniture 545 12
Property, plant and equipment in progress 1 508 1 470
TOTAL 17 730 501 1 590
Other financial assets(3) 738 2 310
TOTAL 738 2 310
Grand total 20 540 501 3 900
Decreases Revaluation of
Line to
line
transfers
Disposals –
Retirements
Gross value at
end of period
original value
at end of
period
Licenses, patents and similar rights(1) 2 073
Intangible assets not yet available for use
TOTAL 2 073
Technical plant, equipment and industrial tooling(2) 13 416
General plant, sundry fixtures and fittings 2 870
Office and IT equipment, furniture 557
Property, plant and equipment in progress 501 2 477
TOTAL 501 19 320
Other financial assets(3) 2 024 1 024
TOTAL 2 024 1 024
Grand total 501 2 024 22 417

(1) This item includes a sum of €411,284, recognized in respect of the share of the contribution in kind of €960,000 made on September 30, 2008, corresponding to the contribution of patents.

(2) This item includes the commissioning of the clean room at a total cost of €943,582. The item also includes a sum of €548,716 recognized in respect of the share of the contribution in kind of €960,000 made on September 30, 2008, corresponding to the contribution of equipment and tooling.

(3) This item includes the 9,477 treasury shares held in connection with the liquidity agreement, valued at €0.069 million, the liquidities not invested in treasury shares at the end of the period under the liquidity agreement for €0.040 million, and guarantee deposits of €0.916 million, comprising deposits under premises lease contracts.

4.3.2 MOVEMENTS IN DEPRECIATION AND AMORTIZATION

(in thousands of euros)
Positions and movements for the period
Value at start
of period
Additions for
the period
Decreases
Reversals
Value at end
of period
Licenses, patents and similar rights 2,073 2,073
TOTAL 2,073 2,073
Technical plant, equipment and industrial tooling 8,905 684 9,588
General plant, sundry fixtures and fittings 1,672 112 1,784
Office and IT equipment, furniture 455 29 483
TOTAL 11,031 825 11,856
Grand total 13,104 825 13,929

4.3.3 MOVEMENTS IN INVENTORIES

(in thousands of euros)
Inventories – gross value Value at start of
period
Increases Decreases Value at end
of period
Raw materials, supplies 5 920 3 074 1 862 7,131
Work in progress – goods 807 1 954 807 1,954
Semi-finished and finished goods 15 147 6 106 5 348 15,905
Goods for resale 6 195 919 69 7,045
TOTAL 28 069 12 053 8 086 32,036

(in thousands of euros)

Inventories – impairment(1) Value at start of
period
Additions for the
period
Decreases
Reversals
Value at end
of period
Raw materials, supplies 358 205 111 452
Work in progress – goods 500 760 500 760
Semi-finished and finished goods 9 775 6 287 6 500 9
562
Goods for resale 0
TOTAL 10 634 7 251 7 111 10
774

(1) Impairment for the period breaks down by as follows by type:

- impairment related to the life cycle of items of inventory (€7.4 million);

- Impairment related to net realizable value (€3.0 million);

- additional impairment related to quality issues identified at the end of 2021 (€0.3 million).

A 10-point change in the portion of inventories intended for non-revenue-generating activities (clinical trials, training, R&D tests) would have a €1.0 million impact on the amount of impairment related to estimated intended use.

(in thousands of euros)

Provisions Value at start
of period
Increases
Additions
Decreases
Reversals
Value at end
of period
Sundry risks(1) 102 70 22 150
Foreign exchange losses 37 36 37 36
Pension and similar obligations 336 55 390
Payroll taxes on AGAP free preference shares 693 127 215 605
TOTAL 1,168 288 274 1,182
Impairment of inventories and work in progress 10,634 7,251 7,111 10,774
Impairment of other receivables 319 33 254 98
TOTAL 10,953 7,284 7,365 10,871
Grand total 12,121 7,572 7,640 12,053
Of which operational additions and reversals: 7,572 7,640

(1) This amount essentially comprises:

- provisions for employee disputes and breach of contract;

- provisions for commercial guarantees (see note 4.3.7.6).

4.3.5 RECEIVABLES AND PAYABLES BY MATURITY

(in thousands of euros)
Trade receivables
Gross amount Due within
1 year
Due beyond
1 year
Trade receivables 420 420
Total 420 420
(in thousands of euros)
Other receivables
Gross amount Due within
1 year
Due beyond
1 year
Social security receivables 83 83
Income tax(1) 1,948 994 954
Value-added tax 1,811 1,811
Other taxes, duties and levies
Sundry receivables 20 20
Total 3,863 2,909 954

(1) Income tax receivable corresponds to the research tax credit for the first half of 2023, plus the balance of the 2022 research tax credit that remains due.

(in thousands of euros)
Payables
Gross amount Due within
1 year
Due in 1 to
5 years
Due beyond 5
years
Bank loans and borrowings(1) 46,670 16,806 29,864
Sundry loans and borrowings(2) 9,909 495 9,414
Trade notes and accounts payable 6,665 6,665
Staff and related payables 2,583 2,583
Social security payables 2,277 2,277
Value-added tax 78 78
Other taxes, duties and levies 728 728
Total 68,910 29,137 30,359 9,414

(1) This amount corresponds to bank loans (see details below) and accrued interest payable to banks.

(2) This amount corresponds to the accrued interest expected at the year-end on the repayable advances.

(in thousands of euros)
Breakdown of bank loans and borrowings
Gross amount Due within
1 year
Due beyond
1 year
EIB loan – principal(1) 30,000 10,000 20,000
EIB loan – accrued interest 7,115 4,216 2,899
BPI government-guaranteed loan – principal 5,000 1,250 3,750
BPI government-guaranteed loan – accrued interest 66 66
BNP Paribas government-guaranteed loan – principal 4,484 1,269 3,215
BNP Paribas government-guaranteed loan – accrued
interest
6 6
Total 46,670 16,806 29,864

(1) Loan from the European Investment Bank (EIB): the EIB loan contract provides for certain information and operational commitments (such as limitations on authorized debt, authorized external growth operations, transfers of assets, etc.), the non-compliance of which would allow the EIB, if it deemed it necessary, to demand an early repayment of the loan. The occurrence of certain changes in the shareholding structure or a change in management not approved beforehand by the EIB would also allow the latter, if deemed necessary following discussions with the Company, to demand an early repayment of the loan. To date, Carmat complies with all of the commitments required by the EIB.

4.3.6 SHARE CAPITAL Classes of shares Par value in euros Number of shares Opening Created Canceled Redeemed Closing Ordinary shares 0.04 22,641,279 164,067 22,805,346 Preference shares 0.04 34,190 4,058 (200) 38,048 Total 22,675,469 168,125 (200) 22,843,394

Changes in the Company's share capital in the first half of 2023 are detailed in note 4.3.6.1 below.

Changes in equity
4.3.6.1

4.3.6.2 Other securities giving access to the share capital – Stock options

The 46,000 stock options granted on December 3, 2016, and the 46,000 stock options granted on April 1, 2019 (all exercisable for new ordinary shares) were forfeited on March 31, 2023 following the end of the beneficiary's directorship and employment contract. Consequently, there were no longer any outstanding stock options at June 30, 2023.

4.3.6.3 Other securities giving access to the share capital – Free shares

Free shares awarded during the period

The free share plan (AGA June 2023-01, AGA June 2023-02 and AGA June 2023-03) of June 26, 2023 led to the award of 636,962 ordinary shares (including 250,989 under the AGA June 2023-01, 194,463 under the AGA June 2023-02 and 191,330 under the AGA June 2023-03). These shares vest on the following dates: June 26, 2024 for the AGA June 2023- 01 shares, which are subject to a two-year lock-up period; June 26, 2025 for the AGA June 2023-02 shares, which are subject to a one-year lock-up period; and June 26, 2024 for the AGA June 2023-03 shares, which are not subject to a lock-up period.

The preference share plan (AGAP 2023) of June 26, 2023 led to the award of 2,171 AGAP 2023 preference shares. Of these shares, 1,995 vest on June 26, 2024 and the remaining 176 vest on June 27, 2026. All of the shares can be converted into a maximum of 100 ordinary shares each as from June 26, 2026, based on the achievement of performance conditions.

Summary table of free shares

AGAP/AGA
shares
awarded
AGAP/AGA
shares
forfeited
AGAP/AGA
shares
vested
AGAP
shares
vested
and
already
converted
into
ordinary
shares
AGAP
shares to
be
converted
into
ordinary
shares
Number of
ordinary
shares
issued
Maximum
number of
ordinary
shares yet
to be
issued (a)
Net
number of
new
shares
that may
be created
(b)
AGAP 2017-03
(SM of April 27,
2017)
3,490 3,490 2,230 1,260 116,950 59,400 58,320
AGAP 2018-01
(SM of April 5,
2018)
580 580 200 380 20,000 38,000 37,620
AGAP 2018-02
(SM of April 5,
2018)
11,500 200 11,300 1,150 10,150 14,500 151,750 141,600
AGAP 2018-03
(SM of April 5,
2018)
740 740 740 55,500 54,760
AGAP 2019-01
(SM of March 28,
2019)
8,000 120 7,260 7,880 78,800 71,540
AGAP 2019-02
(SM of March 28,
2019)
8,000 120 7880 7,680 2,000 76,800 69,120
AGAP 2019-03
(SM of March 28,
2019)
3,600 60 3,540 3,540 0 0
AGAP 2020-01
(SM of March 30,
2020)
2,360 2,160 2,360 236,000 233,840
AGAP 2020-02
(SM of March 30,
2020)
900 820 900 90,000 89,180
AGA 2021-02
(SM of May 12,
2021)
58,500 58,500 N/A N/A 58,500 0 0
AGA 2021-03
(SM of May 12,
2021)
117,500 0 N/A N/A 0 117,500 117,500
AGA 2022-01
(SM of May 12,
2021)
5,980 5,980 N/A N/A 5,980 0 0
AGA 2022-02
(SM of May 12,
2021)
8,970 0 N/A N/A 0 8,970 8,970
AGA 2022-03
(SM of May 12,
2021)
19,850 0 N/A N/A 0 19,850 19,850
AGAP 2022
(SM of May 11,
2022)
4,654 0 4,258 4,654 0 465,400 461,142

AGAP/AGA
shares
awarded
AGAP/AGA
shares
forfeited
AGAP/AGA
shares
vested
AGAP
shares
vested and
already
converted
into
ordinary
shares
AGAP
shares to
be
converted
into
ordinary
shares
Number
of
ordinary
shares
issued
Maximum
number of
ordinary
shares yet
to be
issued (a)
Net number
of new
shares that
may be
created (b)
AGA June 22-01
(SM of May 11,
2022)
97,587 N/A N/A 97,587 0 0
AGA June 22-02
(SM of May 11,
2022)
97,587 N/A N/A 0 97,587 97,587
AGA June 22-03
(SM of May 11,
2022)
124,816 N/A N/A 0 124,816 124,816
AGA June 23-01
(SM of May 11,
2023)
250,989 0 0 N/A N/A 250,989 250,989
AGA June 23-02
(SM of May 11,
2023)
194,643 0 0 N/A N/A 194,643 194,643
AGA June 23-03
(SM of May 11,
2023)
191,330 0 0 N/A N/A 191,330 191,330
AGAP 2023
(SM of May 11,
2023)
2,171 0 0 0 0 217,100 217,100
Total 1,213,747 315,517 2,474,435 2,439,907

(a) Assuming that (i) all AGAP shares awarded and not forfeited are converted into ordinary shares, less any ordinary shares already issued, and (ii) all AGA shares awarded vest for their beneficiaries, less those already vested.

(b) Representing a maximum dilution of 10.7% compared to the existing capital.

4.3.6.4 Other securities giving access to the share capital – Share warrants (BSA)

Share warrants awarded during the period

20,000 share warrants were awarded on February 21, 2023 to the Chairman of the Board of Directors, Alexandre Conroy, who subscribed for all of these warrants in June 2023, at a price of €4.523 per warrant.

6,000 share warrants were awarded on June 26, 2023 to Thérabel Invest, an independent corporate director of the Company, which subscribed for all of these warrants after the end of the reporting period, on August 29, 2023, at a price of €3.318 per warrant.

Summary table of BSA share warrants

Issued Subscribed Forfeited Reserve Exercised Balance % of
existing
share
capital
Expiry
date
BSA 2017
(SM of April 27,
2017)
12,000 12,000 12,000 0.05% May 15,
2027
BSA 2018
(SM of April 5,
2018)
10,000 10,000 10,000 0.04% June 11,
2028
BSA 2019
(SM of March 28,
2019)
6,000 6,000 6,000 0.03% June 24,
2029
BSA 2021
(SM of May 12,
2021)
12,000 12,000 12,000 0.05% June 14,
2031
BSA Feb. 2023
(SM of May 11,
2022)
20,000 20,000 20,000 0.09% Feb. 21,
2033
BSA June 2023
(SM of May 11,
2022)
6,000 0 6,000 0.03% May 11,
2033

4.3.7 OTHER BALANCE SHEET DETAILS

4.3.7.1 Conditional advances

The "Conditional advances" line item comprises (i) repayable advances received from Bpifrance, which totaled €14,507,309 at June 30, 2023, with a contractual interest rate of 5.59%, and (ii) the "Plan Santé 2030" repayable advance amounting to €1,317,937, granted in April 2023, with a contractual interest rate of 3.56%.

The interest accrued, calculated using the capitalization method, stood at €9.909 million at the period-end and is recorded in liabilities under "Sundry loans and borrowings".

4.3.7.2 Accrued income

(in thousands of euros)
Amount of accrued income included in the following balance sheet items
Value
Other receivables 81
Total 81

4.3.7.3 Accrued expenses

(in thousands of euros)
Amount of accrued expenses included in the following balance sheet items
Value
Royalties 8
Bank loans and borrowings 17,096
Sundry loans and borrowings 9,909
Trade notes and accounts payable 3,642
Tax and social security payables 3,764
Total 34,418

4.3.7.4 Prepaid expenses and income

(in thousands of euros)
Prepaid expenses
Value
Operating expenses 1,355
Total 1,355

Prepaid expenses include the portion of rent, software license fees, insurance premiums and other fees already paid but relating to the period after June 30, 2023.

(in thousands of euros)
Prepaid income
Value
Operating income 3 102
Total 3 102

Prepaid income includes:

  • the first tranche (€1.1 million) of the total €2.5 million grant awarded to Carmat at end-2022 for its winning proposal in the European Union's "EIC Accelerator" funding program;
  • the grant part of the first tranche (€2.0 million) of the €13.2 million blended financing package awarded to Carmat in April 2023 under the "France 2030" plan (see Section 2.1.3).

4.3.7.5 Information on related companies

The following balance sheet items include sums in connection with related companies:

(in thousands of euros)
Trade notes and accounts payable 14

The related companies taken into account, which are all part of Airbus Group, are as follows:

  • Matra Défense;

  • Ségula Matra Automotive.

4.3.7.6 Provisions for losses

Preference shares

At June 30, 2023, a provision for losses of €0.605 million had been recorded for the 20% social security levy due on free shares awarded but not yet vested. This levy is payable when the shares vest.

The calculation assumptions used to determine the amount of the provision are as follows:

  • determination of an estimated percentage of achievement for each of the performance criteria for the free preference shares (AGAP);

  • value of an ordinary share: €7.21 (closing price on June 30, 2023);

  • employer contribution rate: 20%.

Commercial warranty

As part of its commercial offer, the Company may grant customers a "commercial warranty" (free replacement of a certain number of replacement components for a given period, under certain limited contractually defined conditions).

The corresponding provision amounted to €0.022 million at June 30, 2023.

4.4 ADDITIONAL INFORMATION ON THE INCOME STATEMENT

4.4.1 SALES

The Company recorded €0.553 million in revenue for the first half of 2023, corresponding to the sale of three Aeson® prostheses.

4.4.2 OPERATING GRANTS

The Company recognized income of €0.006 million in first-half 2023 corresponding to "young-apprentice" grants received.

4.4.3 APPLIED RESEARCH AND DEVELOPMENT COSTS

Research and development expenditure represented €7.512 million in first-half 2023.

4.4.4 RESEARCH TAX CREDIT

The income statement for the first half of 2023 shows a research tax credit for an estimated €0.954 million, calculated using the same methods as in prior years.

4.4.5 NON-RECURRING INCOME AND EXPENSES

(in thousands of euros)
Description
6 months
ended
June 30, 2023
12 months
ended
Dec. 31, 2022
6 months
ended
June 30, 2022
Non-recurring income
• Various adjustments 42 92 90
• Portion of investment grants transferred to income 21 71
• Disposal of assets
• Disposal of treasury shares 17 142 39
Total 80 234 200
Non-recurring expenses
• Various adjustments 34 50 23
• Disposal of assets
• Disposal of treasury shares 38 90 77
• Fines and penalties 1 2
• Non-recurring depreciation/amortization 67 67
Total 74 208 170

4.4.6 INFORMATION ON RELATED COMPANIES

The following income statement items include sums in connection with related companies:
(in thousands of euros)
Description
6 months ended
June 30, 2023
Other purchases and external expenses 90

The related companies taken into account, which are all part of Airbus Group, are as follows:

  • Matra Electronique.

4.5 FINANCIAL COMMITMENTS AND OTHER INFORMATION

4.5.1 FINANCIAL COMMITMENTS

4.5.1.1 Commitments given

The Company has received a €14,507,309 repayable advance under the framework agreement with Bpifrance, on which the accrued interest amounted to €9,908,873 at the reporting date. This amount is repayable to Bpifrance subject to achieving cumulative revenue of at least €38,000,000. The Bpifrance agreement also provides for supplementary payments if certain conditions are met; consequently, the total amount repayable could exceed the amount of the advance initially granted, up to a limit of €50,000,000.

In April 2023, Carmat was granted a €13.2 million blended financing package under the "France 2030" plan, including a €5.3 million advance that is repayable if the project is successful. Out of this €5.3 million, €1.3 million has already been received and was therefore recognized on the liabilities side of the balance sheet at June 30, 2023 (under "Conditional advances"). No interest was recognized for the first half of 2023 as the amount was received on the last day of the six-month reporting period.

On June 24, 2008, the Company signed a royalties agreement with Professor Alain Carpentier and Matra Défense, which was amended on February 5, 2010. Under this agreement, the Company has undertaken to pay to Professor Alain Carpentier and Matra Défense 2% of the net sales proceeds of the Carmat artificial heart manufactured and distributed by Carmat, with this amount to be divided between the two beneficiaries in proportion to their respective shares in the capital of the Company on the date it was established. These royalties will be payable every six months within 30 days of the end of each six-month period, commencing after the first marketing of the Carmat artificial heart post-CE marking in Europe and FDA marketing authorization in the United States, and ending upon expiration of the patents shown in the appendices to the agreement. The Company is also authorized to repurchase, at any time, the right to benefit from these royalties for a sum of €30,000,000, less any royalties already paid under the agreement, with this total sum being divided between the two beneficiaries in proportion to their respective shares in the share capital of the Company on the date it was established. This amount of €30,000,000 is indexed to the Producer Price Index of the Business Services Industry – euro zone orthopedic and orthopedic equipment. The rights allocated to Professor Alain Carpentier and to Matra Défense in this way are non-transferable.

In connection with the €30 million EIB loan granted to Carmat in December 2018, the Company and the EIB signed a royalties agreement providing for the payment of additional compensation to the EIB depending on the commercial performance of the Company. This agreement is valid for 13 years from the year in which Carmat's cumulative sales amount to €500,000 (in practice, this corresponds to 2021). The Company can decide to terminate the royalties agreement at any time by paying a lump sum (net of any royalties already paid), based on the amount borrowed and the year during which the decision is taken.

Upon the occurrence of certain events (in particular should the EIB demand the early repayment of the loan or should a new shareholder reach 33% of the voting rights of Carmat), the EIB could, if deemed necessary, demand from the Company an advance payment of royalties up to a certain percentage of the amount of the loan effectively used (this percentage would range from 100% of the borrowed amount if the event occurs during the first four years of the financial agreement to 160% if the event occurs after the eleventh year). An amount of €8,209 due for first-half 2023 under this royalties agreement was recognized in the period.

4.5.1.2 Commitments received

None.

4.5.1.3 Pension and retirement benefit obligations

The Company has not signed any specific agreements on retirement benefit obligations. These are therefore limited to the lump-sum payment due on retirement as provided for in the applicable collective bargaining agreement.

In application of the reference method 1 in ANC recommendation 2013-02, the provision for retirement benefit obligations was recognized at June 30, 2022.

The overall amount of the provision was €0.390 million at the reporting date, an increase of €0.055 million in the period.

4.5.2 OTHER INFORMATION

(in thousands of euros) June 30, 2023 6 months ended 6 months ended 12 months ended
June 30, 2022
Dec. 31, 2022
NET OPERATING EXPENSE (25,894) (25,081) (51,922)
ELIMINATION OF INCOME AND EXPENSES WITH NO CASH IMPACT
Depreciation amortization and provisions 8,046 7,539 10,077
Reversals of depreciation/amortization and provisions (7,290) (9,774) (11,561)
Gains or losses on disposals of assets
Operating items with no cash or financial impact 9 (71) 5
NON-OPERATING INCOME VITH AN IMPACT ON CASH OR CASH FLOV FROM
OPERATIONS
(2) 1,140 2,074
CASH FLOW FROM OPERATIONS BEFORE CHANGE IN VORKING CAPITAL (25,130) (26,247) (51,327)
Tax and social security payables 37 (562) 876
Trade payables 139 (1,323) (1,847)
Other payables 14
Prepaid income 0
Inventories and work in progress (3,967) (898) (1,093)
Advances and downpayments paid on orders (1,324) 139 (328)
Other receivables (278) (1,014) (101)
Trade receivables (26) 200 70
Prepaid expenses (107) (589) (638)
CHANGE IN VORKING CAPITAL (5,526) (4,047) (3,047)
NET CASH USED IN OPERATING ACTIVITIES (30,656) (30,293) (54,375)
Acquisitions of property, plant and equipment and intangible assets (1,590) (1,114) (1,748)
Proceeds from disposals of property, plant and equipment and intangible assets
Other changes in non-ourrent assets રેન્ડ (242)
NET CASH USED IN INVESTING ACTIVITIES (1,590) (1,079) (1,990)
Capital increase 7 39,510 69,046
Increase in repayable advances 1,318
Repayment of repayable advances (including interest)
New borrowings
Repayment of bank loans and borrowings (including interest) (771) (153) (481)
Subscription of BSA share warrants 90
Grants received 3,801 242
Dividends paid
Purchaseldisposal of treasury shares11 22 (22) 37
Interest received 198
NET CASH FROM FINANCING ACTIVITIES 4,665 39,548 68,601
CHANGE IN CASH AND CASH EQUIVALENTS (27,581) 8,176 12,237
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 51,427 39,191 39,191
CASH AND CASH EQUIVALENTS AT END OF PERIOD (23,846) 47,367 51,427
(1) Linder the liguidity agreement.

4.5.2.1 Cash flow statement

4.5.2.2 Information on executives

4.5.2.2.1 Advances and loans to management

No loans or advances were made to executives of the Company during the period (disclosure required in accordance with Article R.123-197 of the French Commercial Code).

4.5.2.2.2 Management compensation

Total compensation paid to members of the Board of Directors in their capacity as directors amounted to €0.064 million for the period and is shown within "Other expenses" in the income statement.

Total compensation paid to the Chairman of the Board of Directors and the Chief Executive Officer was €0.628 million for the period and breaks down as follows:

(in thousands of euros)
Management compensation
6 months
ended
June 30, 2023
6 months
ended
June 30, 2022
Gross salaries 289 268
Benefits in kind 5 5
Bonuses 334 155
Total compensation 628 428

4.5.2.3 Increases and decreases in future tax liabilities

(in thousands of euros)
Description of temporary differences
Value
Tax loss carryforwards 433,159

This amount comprises:

  • the tax loss generated in fiscal years prior to 2022, amounting to €374.240 million;
  • the tax loss generated in 2022 in an amount of €58.919 million.

It does not include the tax loss recorded for the first half of 2023.

Salaried staff June 30, 2023 June 30, 2022
Managers 135 128
Supervisors and technicians 38 35
Administrative employees 4 8
Total(1) 177 171

(1) Excluding temporary workers.

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