DBV Technologies SA
For the period ended Dec 31, 2023. Filed Mar 7, 2024.
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FY2023 · Filed Mar 7, 2024
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Signatures
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
DBV Technologies S.A.
/s/ Daniel Tassé
Name: Daniel Tassé
Title: Chief Executive Officer
(Principal Executive Officer)
Date: March 7, 2024
Each person whose individual signature appears below hereby authorizes and appoints Daniel Tassé and Virginie Boucinha, and each of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file any and all amendments to this report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his substitute or substitutes may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report on Form 10-K has been signed below by the following persons on behalf of the Registrant in the capacities indicated on March 7, 2024.
| Signature | Title |
|---|---|
| /s/ Daniel Tassé Daniel Tassé | Chief Executive Officer and Director (Principal Executive Officer) |
| /s/ Virginie Boucinha Virginie Boucinha | Chief Financial Officer (Principal Financial and Accounting Officer) |
| /s/ Michel de Rosen Michel de Rosen | Director |
| /s/ Mailys Ferrere Mailys Ferrere | Director |
| /s/ Michael J. Goller Michael J. Goller | Director |
| /s/ Danièle Guyot-Caparros Danièle Guyot-Caparros | Director |
| /s/ Timothy E. Morris Timothy E. Morris | Director |
| Signature | Title |
|---|---|
| /s/ Ador Ndu Adora Ndu | Director |
| /s/ Julie O’Neill Julie O’Neill | Director |
| /s/ Ravi Madduri Rao Ravi Madduri Rao | Director |
| /s/ Daniel Soland Daniel Soland | Director |
Index to Financial Statements
Annual Financial Statements for the Years Ended December 31, 2023 and 2022:
| Page | ||
| Report of Deloitte & Associés and KPMG S.A., Independent Registered Public Accounting Firms (Deloitte & Associés, Paris-La Défense, France, PCAOB ID No. 1756) (KPMG S.A., Paris-La Défense, France, PCAOB ID No. 1253) | F-2 | |
|---|---|---|
| Consolidated Statements of Financial Position as of December 31, 2023 and 2022 | F-4 | |
| Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2023 and 2022 | F-5 | |
| Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022 | F-6 | |
| Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2023 and 2022 | F-7 | |
| Notes to the Consolidated Financial Statements | F-8 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS
To the Shareholders and Board of Directors of DBV Technologies S.A.
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated statements of financial position of DBV Technologies S.A. and subsidiaries (the “Company”) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, cash flows and changes in shareholders’ equity for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred operating losses and negative cash flows from operations since inception and current cash and cash equivalents are not sufficient for at least the next twelve months. These matters raise substantial doubt about the ability of the Company to continue as a going concern. Management’s plans in regard to these matters are described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
This matter is also described in the “Critical Audit Matter” section of our report.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are public accounting firms registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Going Concern – Refer to Note 1 to the consolidated financial statements
Critical Audit Matter Description
As described further in Note 1 to the consolidated financial statements, the Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions.
The Company’s available cash and cash equivalents are not sufficient to support its operating plan for at least the next twelve months from the issuance date of these consolidated financial statements. As such, substantial doubt exists regarding the Company’s ability to continue as a going concern.
We identified the evaluation of the Company’s ability to continue as a going concern and related disclosures as a critical audit matter. This matter required a high degree of auditor judgment and increased effort when performing audit procedures to evaluate (1) the reasonableness of management’s forecasted operating expenses, and (2) the adequacy of the consolidated financial statements disclosure related to the going concern assessment.
How the Critical Audit Matter was Addressed in the Audit
The primary audit procedures we performed to address this critical audit matter included the following:
| • | We evaluated the design of the internal control related to the Company’s going concern assessment; |
| • | We evaluated the reasonableness of the Company’s forecasted operating expenses by inquiring of senior management to gain an understanding of the Company’s operations, strategy, and research and development activities, compared the forecasted operating expenses to historical operating expenses and challenged expected costs, especially those costs that relate to future clinical trials; |
| • | We assessed management’s ability to forecast operating expenses and cash flows by comparing prior year forecasts to actual financial results; |
| • | We assessed the adequacy of the consolidated financial statements’ disclosure related to the going concern assessment by comparing it to the audit evidence obtained. |
| /s/ Deloitte & Associés | KPMG S.A. |
|---|---|
| /s/ Cédric Adens | |
| Partner | |
| We have served as the Company’s auditor since 2011. | We have served as the Company’s auditor since 2020. |
| Paris-La Défense, France | |
F-
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