DBV Technologies S.A. 10-K

Item 9A. Controls and Procedures. Evaluation of Disclosure Controls and Procedures. We maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to management, including our chief executive officer (principal executive officer) and chief financial officer (principal financial officer), as appropriate, to allow timely decisions regarding required disclosure. Our principal executive officer and principal financial officer evaluated the effectiveness of these disclosure controls and procedures and concluded that as of December 31, 2022, our disclosure controls and procedures were effective. Management’s Report on Internal Control Over Financial Reporting. Our management is responsible for establishing and maintaining adequate internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) and for the assessment of the effectiveness of our internal control over financial reporting. Under the supervision and with the participation of our chief executive officer (principal executive officer) and chief financial officer (principal financial officer), management assessed the effectiveness of our internal control over financial reporting based upon the framework in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements and can only provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements. Also, projections of any evaluation of effectiveness to future periods are 110 Table of Contents subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. A deficiency in internal control over financial reporting exists when the design or operation of a control does not allow management or employees, in the normal course of performing their assigned functions, to prevent or detect misstatements on a timely basis. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the registrant’s annual or interim financial statements will not be prevented or detected on a timely basis. Based on this assessment, our management has concluded that our internal control over financial reporting was effective as of December 31, 2022. As a smaller reporting company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financial reporting. Changes in Internal Control over Financial Reporting. There were no changes to our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended December 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Item 9B. Other Information. None. Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. Not applicable. PART III Item 10. Directors, Executive Officers and Corporate Governance. The information required by this Item 10 will be included in the sections titled “Board of Directors and Corporate Governance” and “Information About Our Executive Officers” in our Proxy Statement and is incorporated herein by reference. Item 11. Executive Compensation. The information required by this Item 11 will be included in the sections titled “Executive Compensation” (excluding the information under the subheading “Pay Versus Performance”) and “Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. The information required by this Item 12 will be included in the sections titled “Security Ownership of Certain Beneficial Owners and Management” and “Executive Compensation” in our Proxy Statement and is incorporated herein by reference. 111 Table of Contents Item 13. Certain Relationships and Related Transactions, and Director Independence. The information required by this Item 13 will be included in the sections titled “Board of Directors and Corporate Governance” and “Certain Relationships and Related Person Transactions” in our Proxy Statement and is incorporated herein by reference. Item 14. Principal Accountant Fees and Services. The information required by this Item 14 will be included in Proposal 5 in the section titled “Audit Fees and Services” in our Proxy Statement and is incorporated herein by reference. PART IV Item 15. Exhibits and Financial Statement Schedules. The financial statements schedules and exhibits filed as part of this Annual Report on Form 10-K are as follows: (a)(1) Financial Statements Reference is made to the financial statements included in Item 8 of Part II hereof. (a)(2) Financial Statement Schedules All other schedules are omitted because they are not required or the required information is included in the financial statements or notes thereto. (a)(3) Exhibits 112 Table of Contents EXHIBIT INDEX Incorporated by Reference Exhibit Description Schedule/ Form File Number Exhibit File Date 3.1* By-laws ( statuts ) of the registrant (English translation) 4.1 Form of Deposit Agreement Form F-1/A 333-198870 4.1 10/15/14 4.2 Form of American Depositary Receipt Form F-1/A 333-198870 4.1 10/15/14 4.3 Description of Registered Securities Form 20-F 001-36697 2.3 03/20/20 4.4 Registration Rights Agreement, dated as of March 23, 2018, between the registrant, 667, L.P. and Baker Brothers Life Sciences, L.P. Form 6-K 001-36697 4.1 03/23/18 4.5 Registration Rights Agreement, dated as of June 8, 2022, between the registrant and the Investors named therein. Form 8-K 001-36697 10.2 06/13/22 4.6 Securities Purchase Agreement, dated as of June 8, 2022, between the registrant and the Subscribers named therein. Form 8-K 001-36697 10.1 06/13/22 10.1 Office Lease between the registrant and GENERALI VIE, dated March 3, 2015 (English translation) Form 20-F 001-36697 4.2 04/29/15 10.2 Assignment, Development and Co-Ownership Agreement among the registrant, L’Assistance Publique—Hopitaux de Paris and Université Paris Descartes, dated January 7, 2009 (English translation) Form F-1 333-198870 10.2 09/22/14 10.3# Development Collaboration and License Agreement between the registrant and NESTEC S.A., dated May 27, 2016 Form 20-F 001-36697 4.14 03/22/17 10.4# Amendment to Development Collaboration and License Agreement between the registrant and NESTEC S.A., dated July 12, 2018 Form 20-F 001-36697 4.5 04/01/19 10.5† Form of Indemnification Agreement between the registrant and each of its executive officers and directors Form F-1/A 333-198870 10.3 10/15/14 10.6† 2013 and 2014 Share Option Plans (English translation) Form F-1 333-198870 10.4 09/22/14 10.7† 2012, 2013 and 2014 Free Share Plans (English translation) Form F-1 333-198870 10.5 09/22/14 10.8† Summary of BSA Form F-1 333-198870 10.6 09/22/14 10.9† Summary of BSPCE Form F-1 333-198870 10.7 09/22/14 10.10† 2015 Share Option Plan (English translation) Form 20-F 001-36697 4.10 04/28/16 10.11† 2015 Free Share Plans (English translation) Form 20-F 001-36697 4.11 04/28/16 113 Table of Contents Incorporated by Reference Exhibit Description Schedule/ Form File Number Exhibit File Date 10.12† 2016 Share Option Plan (English translation) Form 20-F 001-36697 4.12 03/22/17 10.13† 2016 Free Share Plan (English translation) Form 20-F 001-36697 4.13 03/22/17 10.14† 2017 Share Option Plan (English translation) Form 20-F 001-36697 4.14 03/16/18 10.15† 2017 Free Share Plan (English translation) Form 20-F 001-36697 4.15 03/16/18 10.16† 2018 Share Option Plan (English translation) Form 20-F 001-36697 4.17 04/01/19 10.17† 2018 Free Share Plan (English translation) Form 20-F 001-36697 4.18 04/01/19 10.18† 2019 Share Option Plan (English translation) Form 20-F 001-36697 4.19 03/20/20 10.19† 2019 Free Share Plans (English translation) Form 20-F 001-36697 4.20 03/20/20 10.20† 2020 Stock Option Plan (English translation) Form 10-K 001-36697 10.21 03/17/21 10.21† 2020 Free Share Plan (English translation) Form 10-K 001-36697 10.22 03/17/21 10.22† 2021 Stock Option Plan (English translation) Form 10-K 001-36697 10.22 03/9/22 10.23† 2021 Free Share Plan (English translation) Form 10-K 001-36697 10.23 03/9/22 10.24†* 2022 Stock Option Plan (English translation) 10.25†* 2022 Free Share Plan (English translation) 10.26† Executive Agreement, dated November 29, 2018, between the registrant and Daniel Tassé Form 10-K 001-36697 10.23 03/17/21 10.27† First Amendment to the Executive Agreement of Daniel Tassé, dated June 27, 2019, between the registrant and Daniel Tassé Form 10-K 001-36697 10.24 03/17/21 10.28† Executive Agreement, dated July 22, 2019, between the registrant and Pharis Mohideen Form 10-K 001-36697 10.25 03/17/21 10.29† Letter Agreement, dated June 26, 2019, between the registrant and Sébastien Robitaille (English translation) Form 10-K 001-36697 10.26 03/17/21 10.30† Letter Agreement, dated December 1, 2020, between the registrant and Se´bastien Robitaille (English translation) Form 10-K 001-36697 10.27 03/17/21 21.1 List of subsidiaries of the registrant Form 20-F 001-36697 8.1 03/20/20 23.1* Consent of Deloitte & Associés 23.2* Consent of KPMG S.A. 24.1* Power of Attorney (included on the signature page of this report). 31.1* Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 114 Table of Contents Incorporated by Reference Exhibit Description Schedule/ Form File Number Exhibit File Date 31.2* Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32.1** Certification by the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 101.INS* Inline XBRL Instance Document 101.SCH* Inline XBRL Taxonomy Extension Schema Document 101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document 101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document 104* Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) * Filed herewith. ** Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing. † Indicates a management contract or any compensatory plan, contract or arrangement. # Confidential treatment has been granted from the Securities and Exchange Commission as to certain portions of this document. 115 Table of Contents 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 2, 2023 Each person whose individual signature appears below hereby authorizes and appoints Daniel Tassé and Sebastien Robitaille, 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 2, 2023. Signature Title /s/ Daniel Tassé Daniel Tassé Chief Executive Officer and Director ( Principal Executive Officer ) /s/ Sebastién Robitaille Sebastién Robitaille 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 116 Table of Contents Signature Title /s/ Adora 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 117 Table of Contents Index to Financial Statements Annual Financial Statements for the Years Ended December 31, 2022 and 2021: 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 ) 2 Consolidated Statements of Financial Position as of December 31, 2022 and 2021 5 Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2022 and 2021 6 Consolidated Statements of Cash Flows for the Years Ended December 31, 2022 and 2021 7 Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2022 and 2021 8 Notes to the Consolidated Financial Statements 9 F-1 Table of Contents 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, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, cash flows and changes in shareholders’ equity for each of the years in the two-year period ended December 31, 2022, 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, 2022 and 2021, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America. 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. F-2 Table of Contents Critical Audit Matters The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that (1) relate 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 matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate. Pre-funded warrants—Refer to Note 11 to the consolidated financial statements Critical Audit Matter Description As described in Note 11 to the consolidated financial statements, the Company proceeded with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, an amount of €3,285,566.90, through the issuance of (i) 32,855,669 new ordinary shares at a price per ordinary share of €3.00 (corresponding to $3.22) including a €2.90 share premium and (ii) prefunded warrants to purchase 28,276,331 new ordinary shares at a pre-funded price of €2.90 (corresponding to $3.11) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such pre-funded warrant. The Company determined that the pre-funded warrants are freestanding instruments that meet the criteria for classification as equity. We identified the assessment of the accounting classification of the pre-funded warrants issued during the year as a critical audit matter. The accounting requirements related to the classification of financial instruments as debt or equity are complex. A slight variation in the interpretation of terms and conditions of the pre-funded warrants could result in the pre-funded warrants being classified as a liability, which would also impact the statement of operations, as the subsequent accounting for pre-funded warrants treated as liabilities is significantly different from those classified as equity. This matter required a high degree of auditor judgment to analyze the terms and conditions of the pre-funded warrants agreement to ensure management’s interpretation of the relevant terms and conditions of the pre-funded warrants agreement led to an appropriate application of the accounting standards. How the Critical Audit Matter was Addressed in the Audit The audit procedure we performed to address this critical audit matter included the following: reading the pre-funded warrant agreement and the Company’s analysis and comparing our interpretation of the terms and conditions of the warrant agreement with the analysis performed by management. Income and provision for loss at completion - Contract with Nestlé Health Science — Refer to Notes 13 and 14 to the consolidated financial statements Critical Audit Matter Description As described further in Notes 13 and 14 to the consolidated financial statements, on May 31, 2016, the Company entered into an exclusive global collaboration agreement with Nestlé Health Science to develop MAG1C, a ready-to-use and standardized atopy patch test tool for the diagnosis of cow’s milk protein allergy in infants and toddlers. Under the terms of the exclusive collaboration, the Company is responsible for leading the development activities of MAG1C up through a pivotal Phase III clinical program. As described in Note 1, the Company recognizes income under the percentage-of-completion method, and periodically updates its measurement of progress and its cumulative income accordingly. The Company uses F-3 Table of Contents costs incurred as the input method to determine progress. The Company accrues for any excess between costs yet to be incurred and income yet to be recognized for the completion of the performance obligations. As a consequence, the accounting for this contract involves estimates related to evaluation of costs to be incurred and the determination of the timeline for the Phase II clinical trial and Phase III clinical program. As of December 31, 2022, the Company recorded its collaboration agreement’s revenues based on its updated measurement of progress of the Phase II clinical trial conducted as part of the agreement. Given the Company has experienced difficulties in enrolling new patients in this Phase II clinical trial, the Company expects to incur additional clinical and production costs related to the Phase II clinical trial as well as delays in achievement of upcoming milestones. As a result, revenues were reversed for an amount of $874 thousand and a loss provision of $19,835 thousand was recorded for the year-then-ended. We identified the evaluation of the costs to be incurred and estimated loss at completion for the collaboration agreement with Nestlé Health Science as a critical audit matter. Given estimates are necessary to determine total costs to complete for each clinical phase and milestone of the collaboration agreement, auditing such estimates required complex audit judgment to evaluate the estimated costs to achieve the performance obligations. 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 compared the transaction prices to the consideration expected to be received based on the milestones defined within the collaboration agreement and any amendment or modification that were agreed to with Nestlé Health Science. • For a selection of transactions, we tested the accuracy of costs actually incurred for the collaboration agreement in the current year by agreeing the amounts to invoices. • We evaluated the estimate of total costs to be incurred by: ○ Evaluating the global timeline of the clinical study defined by management as part of their budget process to assess if it is consistent with the external assumptions from the Contract Research Organization (CRO) as related to the recruitment of patients. ○ Evaluating the estimates prepared by management to assess if they are consistent with the approved cash trajectory and budget approved by the Company’s Board of Directors. ○ Performing a look-back analysis by comparing prior year costs to be incurred estimated by management to the actual prior year costs recorded by the Company to identify potential management bias. ○ Evaluating management’s ability to achieve the estimate of total costs and profit or loss by performing inquiries with the Company’s project manager. /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 March 2, 2023 F- 4 Table of Contents DBV Technologies S.A. Consolidated Statements of Financial Position (amounts in thousands, except share and per share data) Year ended December 31, Note 2022 2021 Assets Current assets: Cash and cash equivalents 3 $ 209,194 $ 77,301 Trade receivables — — Other current assets 4 13,880 37,085 Total current assets 223,074 114,386 Property, plant, and equipment, net 5 15,096 18,146 Right-of-use assets related to operating leases 6 2,513 7,336 Intangible assets 10 22 Other non-current assets 7 5,824 6,833 Total non-current assets 23,444 32,338 Total Assets $ 246,518 $ 146,723 Liabilities and shareholders’ equity Current liabilities Trade payables 8 $ 14,473 $ 11,429 Short-term operating leases 6 1,894 3,003 Short-term financial debt 9 — 510 Current contingencies 13 3,944 4,095 Other current liabilities 8 9,210 12,361 Total current liabilities 29,521 31,397 Long-term operating leases 6 1,127 7,147 Long-term financial debt — — Non-current contingencies 13 16,680 6,758 Other non-current liabilities 9 4,735 2,147 Total non-current liabilities 22,543 16,052 Total liabilities $ 52,064 $ 47,449 Shareholders’ equity: Ordinary shares, € 0.10 par value; 94,137,145 and 55,095,762 shares authorized, and issued as at December 31, 2022 and 2021, respectively $ 10,720 $ 6,538 Additional paid-in capital 458,221 358,115 Treasury stock, 149,793 and 153,631 ordinary shares as of December 31, 2022 and 2021, respectively, at cost ( 1,109 ) ( 1,232 ) Accumulated deficit ( 259,578 ) ( 258,528 ) Accumulated other comprehensive income 781 519 Accumulated currency translation effect ( 14,581 ) ( 6,137 ) Total shareholders’ equity 11 $ 194,453 $ 99,274 Total liabilities and shareholders’ equity $ 246,518 $ 146,723 The accompanying notes are an integral part of these consolidated financial statements F- 5 Table of Contents DBV Technologies S.A. Consolidated Statements of Operations and Comprehensive Loss (amounts in thousands, except share and per share data) Year ended December 31, Note 2022 2021 Operating income 14 $ 4,844 $ 5,708 Operating expenses Research and development expenses 15 ( 75,543 ) ( 70,336 ) Sales & marketing expenses 15 ( 1,608 ) ( 4,387 ) General & administrative expenses 15 ( 24,324 ) ( 30,520 ) Restructuring reversal (expenses) 15 — 920 Total Operating expenses ( 101,475 ) ( 104,323 ) Loss from operations ( 96,631 ) ( 98,614 ) Financial income (expenses) 427 425 Loss before taxes ( 96,204 ) ( 98,189 ) Income tax 16 ( 70 ) 381 Net loss $ ( 96,274 ) $ ( 97,809 ) Foreign currency translation differences, net of taxes ( 8,429 ) ( 12,296 ) Actuarial gains on employee benefits, net of taxes 262 35 Total comprehensive loss $ ( 104,441 ) $ ( 110,070 ) Basic/diluted Net loss per share attributable to shareholders 19 $ ( 1.24 ) $ ( 1.78 ) Weighted average number of shares outstanding used in computing per share amounts: 19 77,384,133 54,916,937 The accompanying notes are an integral part of these consolidated financial statements F- 6 Table of Contents DBV Technologies S.A. Consolidated Statements of Cash Flows (amounts in thousands) Year ended December 31, Notes 2022 2021 Net loss for the period $ ( 96,274 ) $ ( 97,809 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation, amortization and accrued contingencies 13,162 8,376 Retirement pension obligations 105 184 Expenses related to share-based payments 5,026 3,122 Other elements ( 7 ) 656 Changes in operating assets and liabilities: Decrease (increase) in inventories and work in progress — — Decrease (increase) in trade receivables — 2,150 Decrease (increase) in other current assets 20,961 ( 8,578 ) (Decrease) increase in trade payables 3,456 ( 7,559 ) (Decrease) increase in other current and non-current liabilities 152 ( 7,599 ) Change in operating lease liabilities and right of use assets ( 2,249 ) ( 1,185 ) Net cash flow used in operating activities ( 55,666 ) ( 108,242 ) Cash flows used in investing activities: Acquisitions of property, plant, and equipment ( 754 ) ( 910 ) Proceeds from property, plant, and equipment dispositions 8 604 Acquisitions of intangible assets — ( 8 ) Acquisitions of non-current financial assets ( 123 ) ( 119 ) Proceeds from non-current financial assets dispositions 770 — Net cash flows used in investing activities ( 100 ) ( 433 ) Cash flows provided by financing activities: (Decrease) increase in conditional advances ( 474 ) ( 689 ) Treasury shares 123 184 Capital increases, net of transaction costs 194,471 794 Other cash flows related to financing activities — ( 15 ) Net cash flows provided by financing activities 194,120 274 Effect of exchange rate changes on cash and cash equivalents ( 6,461 ) ( 10,651 ) Net (decrease) / increase in cash and cash equivalents 131,893 ( 119,051 ) Net cash and cash equivalents at the beginning of the period 77,301 196,352 Net cash and cash equivalents at the end of the period 3 $ 209,194 $ 77,301 The accompanying notes are an integral part of these consolidated financial statements F- 7 Table of Contents DBV Technologies S.A. Consolidated Statements of Changes in Shareholders’ Equity (amounts in thousands, except share and per share data) Ordinary shares Additional paid-in capital Treasury stock Acc. deficit Acc. other comprehensive income Acc. currency translation effect Total Equity Number of Shares Note 12 Amount Balance at January 1, 2021 54,929,187 $ 6,518 $ 1,152,042 $ ( 1,169 ) $ ( 958,543 ) $ 484 $ 6,158 $ 205,491 Net (loss) ( 97,809 ) ( 97,809 ) Other comprehensive (loss) 35 ( 12,296 ) ( 12,261 ) Issuance of ordinary shares 166,575 20 496 515 Issuance of share warrants — — 279 — — — — 279 Treasury shares ( 63 ) ( 63 ) Share-based payments (income) expenses 3,122 3,122 Allocation of accumulated net losses — — ( 797,823 ) — 797,823 — — — Balance at December 31, 2021 55,095,762 $ 6,538 $ 358,115 $ ( 1,232 ) $ ( 258,528 ) $ 519 $ ( 6,137 ) $ 99,274 Net (loss) ( 96,274 ) ( 96,274 ) Other comprehensive (loss) 262 ( 8,429 ) ( 8,167 ) Issuance of ordinary shares 39,041,383 4,182 102,194 106,377 Issuance of share warrants — — 88,094 — — — — 88,094 Treasury shares 123 123 Share-based payments (income) expenses 5,026 5,026 Allocation of accumulated net losses ( 95,209 ) 95,209 — Other change in equity — — — — 15 — ( 15 ) — Balance at December 31, 2022 94,137,145 $ 10,720 $ 458,221 $ ( 1,109 ) $ ( 259,578 ) $ 781 $ ( 14,581 ) $ 194,453 The accompanying notes are an integral part of these consolidated financial statements F- 8 Table of Contents Notes to the Consolidated Financial Statements Note 1: Nature of the business and principles and accounting methods Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or “we”, or the “group”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin ™ . The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT TM , a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin ™ . Basis of Presentation The Company’s consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. (“U.S. GAAP”) and presented in thousands of U.S. Dollars, except for share and per share data and as otherwise noted. Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). We also follow the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern and using the historical cost principle with the exception of certain assets and liabilities that are measured at fair value in accordance with U.S. GAAP. The categories concerned are detailed in the following notes. Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. Intercompany transactions and balances have been eliminated. The following list presents all entities included in the consolidation scope for the years ended December 31, 2021 and 2022, as well as their country of incorporation and the percentage of ownership interests: • DBV Technologies Inc. was incorporated in Delaware on April 7, 2014 (the “US subsidiary”). The share capital of this US subsidiary is 100 % owned by DBV Technologies S.A. • DBV Australia Pty Ltd. was incorporated in New South Wales, Australia on July 3, 2018 (the “Australian subsidiary”). The share capital of this Australian subsidiary is 100 % owned by DBV Technologies S.A. (“DBV Technologies”). • DBV Pharma was incorporated in Paris on December 21, 2018 (the “French subsidiary”). The share capital of this French subsidiary is 100 % owned by DBV Technologies S.A. On December 31, 2021, the company proceeded to the dissolution of DBV Canada Ltd. This subsidiary was originally incorporated in Ottawa, Ontario on August 13, 2018 (the “Canadian subsidiary”). The share capital of this Canadian subsidiary was 100 % owned by DBV Technologies S.A. Functional Currency and Translation of Financial Statements in Foreign Currency The Consolidated Financial Statements are presented in U.S. dollars, which differs from the functional currency of the Company, being the Euro. The statements of financial position of consolidated entities having a functional currency different from the presentation currency are translated at the closing exchange rate (spot exchange rate at the statement of financial position date) and the statements of operations, statements of comprehensive loss and statements of cash flow of such consolidated entities are translated at the weighted average exchange rate. The resulting translation adjustments are included in equity under the caption “Accumulated other comprehensive income (loss)” in the Consolidated Statements of Changes in Shareholders’ Equity. F- 9 Table of Contents Conversion of Foreign Currency Transactions Foreign currency transactions are converted to functional currency of the entity at the rate of exchange applicable on the transaction date. At period-end, foreign currency monetary assets and liabilities are converted at the rate of exchange prevailing on that date. The resulting exchange gains or losses are recorded in the entity individual statements of operations in “Financial income (expense)”; they will be recognized in profit or loss on disposal of the net investment. Use of estimates The preparation of the Company’s consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. As of December 31, 2022, the ongoing pandemic may make management’s estimates vulnerable to significant changes. Those uncertainties were considered in the assumptions underlying the estimates and judgments used by the Company but a number of estimates have been and will continue to be affected by the ongoing pandemic. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates. On an on-going basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right-of-use assets—operating lease, (4) impairment of right-of-use assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, and (7) estimate of contingencies. Going concern These Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). 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. Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin ™ Peanut, in August 2020, the Company scaled down its other clinical programs and pre-clinical spend to focus on Viaskin ™ Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin ™ Peanut in the United States and European Union. In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. In order to respond to the FDA’s requests and recommendations, the Company defined parallel workstreams primarily in order to generate the 6-month safety and adhesion clinical data to assess a modified Viaskin Peanut patch and demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population. F- 10 Table of Contents Following the submission of the adhesion study’s protocol to the FDA, the Company received an Advice/Information Request letter from the FDA in October 2021, requesting a stepwise approach to the modified Viaskin patch development program and provided partial feedback on this protocol. In December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback and announced its plan to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach as the most straightforward approach to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. After receiving approval from the FDA for its change in strategy, the protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (“mVP”) patch was completed at the end of February 2022 and has been prepared for FDA submission. In May 2022, the Company established an At-The-Market (“ATM”) program allowing to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $ 100 million of American Depositary Shares (“ADSs”). The Company’s intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes. In June 2022, the Company announced that its pivotal Phase 3 trial EPITOPE, assessing the safety and efficacy of Viaskin Peanut treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint, with a statistically significant treatment effect. The Company also indicated continuing productive dialogue with the FDA on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut-allergic children ages 4 to 7 years. During the same month, the Company announced private placement financing (“PIPE”) amounting to $ 194 million. In September 2022, after announcing initiating, the Company received a partial clinical hold letter from the FDA on its VITESSE Phase 3 clinical study. Within the FDA’s communication, the modifications address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment. In December 2022, the Company received confirmation from the FDA that it lifted the partial clinical hold on its VITESSE Phase 3 clinical study. The Company indicated the updated protocol will be submitted to study sites for subsequent Institutional Review Boards and Ethics Committees approval. Based on its current operations, plans and assumptions as revised pursuant to 2022 announcements related to EPITOPE P hase 3 study topline results and VITESSE P hase 3 partial clinical hold lift, as well as ATM and PIPE financings, the Company expects that its balance of cash and cash equivalents of $ 209.2 million as of December 31, 202 2 will be sufficient to fund its operations for at least the next 12 months. The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings. 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, including as a result of disruptions to the global financial markets due to the ongoing COVID-19 pandemic and conflict in Ukraine. The ongoing COVID-19 pandemic and conflict in Ukraine have already caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all. F-1 1 Table of Contents If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently. These Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern. Intangible Assets Acquired intangible assets are accounted for at acquisition cost less accumulated amortization. Acquired intangible assets are mainly composed of software amortized on a straight-line basis over their estimated useful lives comprised between one and three years . Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The costs related to the acquisition of licenses to software are posted to assets on the basis of the costs incurred to acquire and to implement the software. Property, Plant, and Equipment Property, plant, and equipment are recorded at their acquisition cost. Property, plant, and equipment are depreciated on a straight-line method over the estimated useful lives of the property. Leasehold improvements are amortized over the shorter of the estimated useful lives of the assets or the remaining lease term. Depreciation is calculated on a straight-line basis over the assets’ estimated useful lives as follows: PROPERTY, PLANT, AND EQUIPMENT ITEM PERIOD DEPRECIATION Laboratory equipment and technical facilities 3 to 10 years Building fixtures and leasehold improvements 5 to 9 years Office equipment and furniture 5 years Computer equipment 3 years Impairment of assets The Company periodically reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable or the estimated useful life is no longer appropriate. If indicators of impairment exist and the recoverable value of the asset on an undiscounted cash flow basis is less than the carrying amount, an impairment loss is recorded to the extent the carrying amount exceeds its fair value. Lease contracts The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to use, or control the use of, identified property, plant, or equipment for a period of time in exchange for consideration. The Company’s leases are comprised of real estate leases, leases for industrial equipment and leases for office equipment. The Company’s real estate leases typically include options and features including rent free periods, rent escalation periods, renewal options and early termination options. The lease term is defined contract-by-contract and corresponds to the non-cancelable period of the lease taking into account the optional periods that are reasonably certain to be exercised. F-1 2 Table of Contents The Company recognizes operating lease liabilities based on the present value of the future minimum lease payments over the lease term at commencement date. The Company does not recognize a lease liability or right of use asset for leases with a term of 12 months or less. Operating lease right of use assets are presented as operating lease right of use assets on the consolidated balance sheet. To date, the Company has recognized a single lease cost under which the operating lease right of use and liability are amortized on a straight-line basis over the lease term, and categorized within Operating Expense in the Consolidated Statement of Operations. The operating lease cash flows are categorized under Net Cash Used in Operating Activities in the Consolidated Statement of Cash Flows. Variable costs are expensed in the period incurred. Since the rate implicit in the lease is not readily determinable, the Company uses its incremental borrowing rates based on the information available at commencement date in determining the discount rate used to calculate the present value of lease payments. As the Company has no external borrowings, the incremental borrowing rates are determined using information on indicative borrowing rates that would be available to the Company based on the value, currency and borrowing term provided by financial institutions, adjusted for company and market specific factors. Inventories and Work in Progress Inventories are measured at the lower of cost or net realizable value at production costs calculated using the first-in, first-out method. It includes acquisition costs, processing costs and other costs incurred in bringing the inventories to their present location and condition. Inventories are exclusively composed of work in progress relating to the production of the first batches that may be used for the commercialization. During the launch phase of a new product, any inventories of that product are written down to zero pending regulatory approval. Financial Assets and Liabilities Financial assets, excluding cash and cash equivalents, consist exclusively of other receivables. Other receivables are non-derivative financial assets with a payment, which is fixed or can be determined, not listed on an active market. They are included in current assets, except those that mature more than twelve months after the reporting date. The recoverable amount of other receivables is estimated whenever there is an indication that the asset may be impaired and at least on each reporting date. If the recoverable amount is lower than the carrying amount, an impairment loss is recognized in the Consolidated Statements of Operations and Comprehensive Loss. The Company also receives from time-to-time assistance in the form of conditional advances, which are advances repayable in whole or in part based upon acknowledgment by the funder of a technical or commercial success of the related project by the funding entity. The amount resulting from the deemed benefit of the interest-free nature of the award is considered a subsidy for accounting purposes. This deemed benefit is determined by applying a discount rate equal to the rate of fungible treasury bonds over the time period that corresponds to the time period of the repayment of the advances. In the event of a change in payment schedule of the stipulated repayments of the conditional advances, the Company makes a new calculation of the net book value of the debt resulting from the discounting of the expected new future cash flows. The adjustment that results therefrom is recognized in the income statement for the fiscal year during which the modification is recognized. F-1 3 Table of Contents The Company carries its trade receivable at net realizable value. On a periodic basis, the Company evaluates its trade receivable and determines whether to provide an allowance or if any accounts should be written down and charged to expense as a bad debt. The Company generally does not require any security or collateral to support its receivables. During the years ended December 31, 2022 and December 31, 2021, the Company did no t hold any derivative financial instruments. Fair Value Measurements Fair value is defined as an exit price, representing the amount that would be received upon the sale of an asset or payment to transfer a liability in an orderly transaction between market participants. Fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows: • Level 1—Quoted market prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. • Level 2—Quoted market prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly. Fair value determined through the use of models or other valuation methodologies. • Level 3—Significant unobservable inputs for assets or liabilities that cannot be corroborated by market data. Fair value is determined by the reporting entity’s own assumptions utilizing the best information available and includes situations where there is little market activity for the asset or liability. The asset’s or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is significant to the fair value measurement. The Company’s policy is to recognize transfers between levels of the fair value hierarchy in the period the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, 2, or 3 during the periods presented. The Company considers its cash and cash equivalents, accounts receivable and accounts payable to reflect their fair value given their short maturity and risk profile of the counterparty. Cash and Cash Equivalents Cash includes cash on hand and demand deposits with banks. Cash equivalents include short-term, highly liquid investments, with a remaining maturity at the date of purchase of three months or less for which the risk of changes in value is considered to be insignificant. Demand deposits therefore meet the definition of cash equivalents. Cash equivalents are measured at fair value using level 1 and any changes are recognized in the Consolidated Statements of Operations and Comprehensive Loss. Concentration of Credit Risk The Company has no significant off-balance sheet risk, such as foreign currency contracts, options contracts, or other foreign hedging arrangements. Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and other receivables. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and have not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships or entities for which it has a receivable. F-1 4 Table of Contents Share Capital Ordinary shares are classified under Shareholders’ Equity. The costs of share capital transactions that are directly attributable to the issue of new shares or options are recorded in the Consolidated Financial Statements in Shareholders’ Equity as a deduction from the proceeds from the issue, net of tax. Employee benefits Depending on the laws and practices of the countries in which the Company operates, employees may be entitled to compensation when they retire or to a pension following their retirement. For state-managed plans and other defined contribution plans, the Company recognizes them as expenses when they become payable, with the Company’s commitment being limited to our contributions. The liability with respect to defined benefit plans is estimated using the following main assumptions: • discount rate; • future salary increases; • employee turnover; and • mortality tables. The difference between the amount of the liability at the beginning of a fiscal year and at the close of that year is recognized through profit or loss for the portion representing the costs of services rendered and through other comprehensive income (loss) for the portion representing the actuarial gains and losses. Service costs are recognized in profit or loss and are allocated by function. Actuarial gains and losses result from changes in actuarial assumptions and from differences between assumed and actual experience. Gains and losses recorded in other comprehensive income (loss) are amortized over expected remaining service periods to the extent they exceed 10% of the projected benefit obligation for the defined benefit plan. The Company’s payments for the defined-contribution plans are recognized as expenses in the Consolidated Statements of Operations and Comprehensive Loss for the period with which they are associated. Contingencies An estimated loss from a loss contingency is recognized if the following two conditions are met: • information available before the consolidated financial statements are issued indicates that it is probable that an asset had been impaired or a liability had been incurred at the date of the consolidated financial statements; and • the amount of loss can be reasonably estimated. With respect to litigations and claims that may result in a liability to be recognized, we exercise significant judgment in measuring and recognizing a liability or determining exposure to contingent liabilities that are related to pending litigation or other outstanding claims. These judgment and estimates are subject to change as new information becomes available. Operating Income The Company accounts for revenue when the amount can be reliably assessed, future economic benefits are likely to benefit the Company, and specific criteria are met for the Company’s business, which is in accordance with ASC 606 for the collaboration agreement with Nestlé Health Science. F-1 5 Table of Contents Other operating income Research Tax Credit The Research Tax Credit ( Crédit d’Impôt Recherche ) is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific research. Companies that prove that they have expenditures that meet the required criteria receive a tax credit that can be used against the payment of the income tax due for the fiscal year in which the expenditures were made and the next three fiscal years, or, as applicable, can be reimbursed for the excess portion. The expenditures taken into account for the calculation of the research tax credit involve only research expenses. In the fiscal year ended December 31, 2021, the Company recovered its Small and Medium-sized Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit. During the year ended December 31, 2022, the Company received the reimbursement of $ 26.1 million of the 2019, 2020 and 2021 fiscal year research tax credit. Collaboration agreement with Nestlé Health Science The Company entered into research and development collaboration agreements that may consist of non-refundable upfront payments and milestone payments. Non-refundable upfront payments are deferred and recognized as income over the period of the collaboration agreement. Milestone payments represent amounts received depending upon the achievement of certain scientific, regulatory, or commercial milestones. They are recognized when the triggering event has occurred, there are no further contingencies or services to be provided with respect to that event, and the co-contracting party has no right to require refund of payment. The triggering event may be scientific results achieved by the Company or another party to the arrangement, regulatory approvals, or the marketing of products developed under the arrangement. The Company recognizes income under the percentage-of-completion method, using costs incurred as the input method to determine progress towards the achievement of each milestone, and recognizing revenue based on costs incurred to date plus the estimate of margin at completion of the milestone. The Company periodically updates its measurement of progress and updates its cumulative income recognized accordingly. The Company accrues for any excess between costs yet to be incurred and income yet to be recognized for the completion of the performance obligations. Please refer to Note 13 “Contingencies”. Research and Development Expenditures Research and development expenditures are charged to expense as costs are incurred in performing research and development activities. Research and development costs include all direct costs, including salaries, share-based payments and benefits for research and development personnel, outside consultants, costs of clinical trials, costs related to manufacturing clinical study materials, sponsored research, clinical trials insurance, other outside costs, depreciation, and facility costs related to the development of drug candidates. The Company records upfront, non-refundable payments made to outside vendors, or other payments made in advance of services performed or goods being delivered, as prepaid expenses, which are expensed as services are performed or the goods are delivered. Certain research and development projects are, or have been, partially funded by collaboration agreements, and the expenses related to these activities are included in research and development costs. The Company records the related reimbursement of research and development costs under these agreements as income in the period in which such costs are incurred. Please refer to Collaboration agreement with Nestlé Health Science for further detail. F-1 6 Table of Contents Share-based payments Since its incorporation, the Company has established several plans for equity compensation issued in the form of employee warrants (bons de souscription de parts de créateur d’entreprise or “BCEs”), stock options (“SO”), and restricted stock units (“RSUs”) granted to employees and/or executives. The company has also established several plans for equity compensation issued in the form of “share warrants” (bons de souscription d’actions or “BSAs”) granted to non-employee members of the Board of Directors and members of the Scientific Advisory Board. These awards are measured at their fair value on the date of grant. Except for RSUs, fair value is estimated using Black and Scholes models that require inputs based on certain subjective assumptions, including the expected term of the award, and the conditions of each equity plan. The fair value is amortized in personnel expenses (allocated by function in the Consolidated Statements of Operations and Comprehensive Loss) on a straight-line basis over the requisite service period, and such expense is reduced for estimated forfeitures, with a corresponding increase in shareholders’ equity. The determination of the requisite service period and the estimate of RSUs awards that are expected to vest depends on the legal interpretation of the RSUs award agreements with employees under the French labor laws and related jurisprudence. Changes in interpretations could significantly impact the accounting for the share-based payments. At each closing date, the Company re-assesses the number of options expected to vest. If applicable, the impacts of such revised estimates are recognized in the Consolidated Statements of Operations and Comprehensive Loss, with a corresponding adjustment in shareholders’ equity. The awards are not subject to any market conditions. Income Tax Income taxes are accounted for under the asset and liability method of accounting. Deferred taxes are recognized for the future tax consequences attributable to temporary differences between the financial reporting carrying amounts and tax bases of assets and liabilities, and on tax losses, using the liability method. Differences are defined as temporary when they are expected to reverse within a foreseeable future. The Company may only recognize deferred tax assets on net operating losses if, based on the projected taxable incomes within the next three years, management determines that it is probable that future taxable profit will be available against which the unused tax losses and tax credits can be utilized. As a result, the measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. If future taxable profits are considerably different from those forecasted that support recording deferred tax assets, the Company will have to revise downwards or upwards the amount of deferred tax assets, which would have a significant impact on the Company’s financial results. Tax assets and liabilities are not discounted. Amounts recognized in the Consolidated Financial Statements are calculated at the level of each tax entity included in the consolidation scope. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. Uncertain tax position Tax benefits are recognized from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. F-1 7 Table of Contents Segment Information The Company operates in a single operating segment: the conducting of research and development of epicutaneous immunotherapy products in order to market them in the future. The assets, liabilities, and operating losses recognized are primarily located in France. Other Items in the Comprehensive Loss Comprehensive loss is comprised of net income(loss) and other comprehensive income (loss). Other comprehensive income (loss) includes changes in equity that are excluded from net income (loss), such as foreign currency translation adjustments. These changes in equity are presented net of tax. Net Loss Per Share The Company calculates basic and diluted net loss per ordinary share by dividing the net loss by the weighted-average number of ordinary shares outstanding during the period. For the years ended December 31, 2022 and 2021, the Company has excluded the effects of all potentially dilutive shares, which include outstanding ordinary stock options, warrants to purchase ordinary shares, and restricted stock units, from the weighted-average number of ordinary shares outstanding as their inclusion in the computation for these years would be anti-dilutive due to net losses incurred. Subsequent Events The Consolidated Statements of Financial Position and the Consolidated Statements of Operations and Comprehensive Loss of the Company are adjusted to reflect the subsequent events that alter the amounts related to the situations that existed as of the end of the period covered. The Company has evaluated subsequent events from the balance sheet date through March 2, 2023, the date at which the consolidated financial statements are issued. Accounting Pronouncements adopted in 2022 The Company has not adopted any new accounting pronouncements in 2022 to date. Accounting Pronouncements issued not yet adopted In June 2016, the FASB issued ASU 2016-13—Financial Instruments—Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect that this new standard will have a material impact on its consolidated financial statements. Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption. F-1 8 Table of Contents Note 2 Significant Events and Transactions of the Periods Clinical programs United States Regulatory History and Current Status In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1,000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 - 11 . The Company named that assessment EQUAL, which stands for Equivalence in Uptake of Allergen. The FDA also recommended conducting a 6 -month, well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this clinical trial STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches. Based on the January 2021 FDA feedback, the Company defined three parallel workstreams: 1. Identify a modified Viaskin patch (which the Company calls mVP). 2. Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the clinical trial as soon as possible. 3. Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional Phase 1 clinical trials in healthy adult volunteers: a. PREQUAL, a Phase 1 trial with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL. The data collection phase of the trial is complete, and the data analysis phase is ongoing. b. ‘EQUAL in adults’—a second Phase 1 trial with adult healthy volunteers to compare the allergen uptake of cVP and mVP. In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches . The Company completed CHAMP in the second quarter of 2021. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and based on the results of CHAMP, the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is approximately 50% larger in size relative to the current patch and circular in shape. In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and on October 14, 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conducts allergen uptake comparison trials (i.e., ‘EQUAL in Adults’, EQUAL), and submits the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study. The FDA’s explanation was that the results from the allergen uptake studies might affect the design of the STAMP study. F-1 9 Table of Contents After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback. The Company estimated that the FDA’s newly proposed sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the 6-month safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy was agreeable via oral and written exchanges. In 2022, the Company announced the new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch would be in younger (4-7 years old) and more sensitive children with peanut allergy. European Union Regulatory History and Current Status On August 2, 2021, the Company announced it has received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study. On December 20, 2021, the Company announced it has withdrawn the MAA for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301). The decision to withdraw was based on the view of CHMP that the data available to date from a single pivotal clinical trial were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believe data from a second Viaskin Peanut pivotal clinical trial will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intend to resubmit the MAA when that data set is available. Viaskin Peanut for Children ages 1-3 In June 2020, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effect after 12 months of therapy, as assessed by a double-blind placebo- controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 µg dose in this age group, which is the dose being studied in Part B of the study. Enrollment of Part B of EPITOPE was complete in first quarter of 2021. In June 2022, we announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms, respectively. Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms. The Company intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population. Viaskin Peanut for Children ages 4-7 On September 7, 2022, we announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 years with peanut allergy. We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval. F- 20 Table of Contents On September 21, 2022, we announced we had received feedback from the FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and start-up activities for prompt study launch once the partial clinical hold was lifted. On December 23, 2022, we announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol. Financing In May 2022, the Company announced that pursuant to the Company’s At-The-Market program established in May 2022 (the “ATM Program”), it had issued and completed sales of new ordinary shares (the “Ordinary Shares”) in form of American Depositary Shares (“ADSs”), for a total gross amount of $ 15.3 million ($ 14.1 million net of transaction costs). In this context , 6,036,238 new Ordinary Shares in form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.27 dollar per ADS (i.e., a subscription price per Ordinary Share of 2.41 euro based on the USD/EUR exchange rate of 1.0531 dollar for 1 euro, as published by the European Central Bank on May 4 , 2022) and each ADS giving the right to receive one-half of one ordinary share of the Company. In June 2022, the Company announced an aggregate $ 194 million ($ 180.4 million net of transaction costs) private investment in public equity (PIPE) financing (corresponding to € 181 million on the basis of an exchange rate of $ 1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 ordinary shares, as well as pre-funded warrants to purchase up to 28,276,331 ordinary shares. The ordinary shares were sold to the purchasers at a price per ordinary share of € 3.00 (corresponding to $ 3.22 ), and the pre-funded warrants were sold to the purchasers at a pre-funded price of € 2.90 (corresponding to $ 3.11 ) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining € 0.10 exercise price for each such pre-funded warrant. Gross proceeds from the PIPE financing total approximately $ 194 million (corresponding to € 181 million), before deducting private placement expenses. The ordinary shares, including the ordinary shares issuable upon exercise of the pre-funded warrants from the PIPE financing, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. In connection with the PIPE financing, the Company entered into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which the Company has filed a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resal e of 59,269,629 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants. COVID-19 Pandemic On March 11, 2020, the World Health Organization declared COVID-19 a pandemic. During the COVID-19 pandemic, the Company experienced a decrease in new patients enrolling in the ongoing clinical studies and had to adapt the protocols of its clinical trials because patients were subject to travel restrictions and other containment measures. The Company has continued to assess the impact of the COVID-19 pandemic and uncertainties created by the pandemic on our business and the conduct of our clinical. As of December 31, 2022, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company. The Company continues to update these estimates and assumptions as the situation evolves. The effects of the F-2 1 Table of Contents COVID-19 pandemic are presented in the relevant line items of the Consolidated Statement of Financial Position and the Consolidated Statement of Operations and Comprehensive Loss according to the function or nature of the income or expense. Legal Proceedings From time to time, we may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. We are not currently subject to any material legal proceedings. Class Action Complaint Dismissal A class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis Ito-Stone v. DBV Technologies, et al., Case No. 2:19-cv-00525. The complaint, as amended, alleged that the Company and its former Chief Executive Officer, its current Chief Executive Officer, its former Deputy Chief Executive Officer, and its former Chief Business officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The plaintiffs seek unspecified damages on behalf of a purported class of persons that purchased the Company’s securities between February 14, 2018 and August 4, 2020 and also held the Company’s securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020. A hearing was held on July 29, 2021 in the U.S. District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. As the dismissal was without prejudice, the Plaintiffs replead their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court. The company moved to dismiss third amended complaint on December 10, 2021. On July 29, 2022, the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Compliant with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs had 30 days to appeal the dismissal of the Third Amended Complaint. This Plaintiffs failed to file an appeal of the dismissal of the Third Amended Complaint within the 30-day period and this matter is resolved with finality. Note 3 Cash and Cash Equivalents The following table presents for each reported period, the breakdown of cash and cash equivalents: December 31, 2022 2021 Cash 30,104 31,427 Cash equivalent s 179,090 45,874 Total cash and cash equivalent s as reported in statement of financial position 209,194 77,301 Bank overdrafts — — Total net cash and cash equivalents as reported in the statement of cash flow 209,194 77,301 F-2 2 Table of Contents Cash equivalents are immediately convertible into cash at no or insignificant cost on demand. They are measured using level 1 fair value measurements. Note 4 Other Current Assets Other current assets consisted of the following: December 31, 2022 2021 Research tax credit 5,792 28,092 Other tax claims 3,903 3,561 Prepaid expenses 2,680 4,149 Other receivables 1,504 1,282 Total 13,880 37,085 The other tax claims are primarily related to deductible VAT. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies. Research tax credit In the fiscal year ended December 31, 2021, the Company recovered its Small and Medium-sized Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit. During the year ended December 31, 2022, the Company received the reimbursement of $ 26.1 million of the 2019, 2020 and 2021 fiscal year research tax credit. The variance in Research Tax Credit during the two years disclosed is presented as follow: Amount in thousands of US Dollars Opening balance sheet receivable as of January 1, 2021 22,650 + 2021 fiscal year research tax credit 7,505 - Payment received — - Adjustment and currency translation effect ( 2,063 ) Closing balance sheet receivable as of December 31, 2021 28,092 Of which—Non-current portion — Of which—Current portion 28,092 F-2 3 Table of Contents Amount in thousands of US Dollars Opening balance sheet receivable as of January 1, 2022 28,092 + 2022 fiscal year research tax credit 5,718 - Payment received ( 26,117 ) - Adjustment and currency translation effect ( 1,901 ) Closing balance sheet receivable as of December 31, 2022 5,792 Of which—Non-current portion — Of which—Current portion 5,792 Note 5 Property, Plant, and Equipment Property and equipment, net consisted of the following: 1/1/2021 Currency translation effect Increase Decrease 12/31/2021 Laboratory equipment 23,072 ( 1,783 ) 853 ( 708 ) 21,434 Building fixtures 7,767 ( 408 ) 48 ( 3,449 ) 3,958 Office equipment 970 ( 39 ) — ( 67 ) 864 Computer equipment 1,846 ( 92 ) 9 ( 464 ) 1,299 Property, plant, and equipment in progress 7,828 ( 477 ) ( 2,960 ) 4,390 Total, gross 41,482 ( 2,799 ) 910 ( 7,648 ) 31,945 Less accumulated amortization and depreciation ( 16,690 ) 1,109 ( 4,437 ) 6,219 ( 13,799 ) Total, net 24,792 ( 1,690 ) ( 3,527 ) ( 1,429 ) 18,146 1/1/2022 Currency translation effect Increase Decrease Relassification 12/31/2022 Laboratory equipment 21,434 ( 1,246 ) — — 270 20,459 Building fixtures 3,958 ( 196 ) 55 ( 604 ) 3,214 Office equipment 864 ( 25 ) 74 ( 428 ) 485 Computer equipment 1,299 ( 65 ) 16 — 8 1,258 Property, plant, and equipment in progress 4,390 ( 252 ) 608 — ( 278 ) 4,468 Total, gross 31,945 ( 1,783 ) 754 ( 1,032 ) — 29,884 Less accumulated amortization and depreciation ( 13,799 ) 703 ( 2,723 ) 1,031 — ( 14,788 ) Total, net 18,146 ( 1,080 ) ( 1,968 ) ( 1 ) — 15,096 The depreciation and amortization expense for each of the years ended December 31, 2022 and 2021 was $ 2.7 million and $ 4.4 million respectively. Laboratory equipment increase in 2021 was mainly driven by commissioning of industrial equipment. F-2 4 Table of Contents Note 6 Lease contracts Future minimum lease payments under the Company’s operating leases’ right of use as of December 31, 2022 and 2021, are as follows: December 31, 2022 December 31, 2021 Real estate Other assets Total Real estate Other assets Total Current portion 1,972 79 2,051 3,361 77 3,438 Year 2 1,168 74 1,243 3,124 23 3,147 Year 3 65 6 71 2,299 18 2,317 Year 4 — — — 771 1 773 Year 5 — — — 790 — 790 Thereafter — — — 1,220 — 1,220 Total minimum lease payments 3,204 160 3,364 11,565 119 11,684 Less: Effects of discounting ( 325 ) ( 17 ) ( 343 ) ( 1,526 ) ( 8 ) ( 1,534 ) Present value of operating lease 2,879 143 3,021 10,039 111 10,150 Less: current portion ( 1,823 ) ( 71 ) ( 1,894 ) ( 2,929 ) ( 74 ) ( 3,003 ) Long-term operating lease 1,055 72 1,127 7,110 37 7,147 Weighted average remaining lease term (years) 1.40 — 4.14 2.01 Weighted average discount rate 3.00 % 2.45 % 4.84 % 3.32 % The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was: December 31, 2022 2021 Operating lease expense 1,800 3,027 Net termination impact ( 1,657 ) — In January 2022, the company entered into a termination agreement for its U.S. office in Summit, NJ, following the resizing of its facility use. The Company recognized an income of $ 1.2 million as of June 30, 2022 due to the early termination of its Summit, NJ lease, offset by the payment of a one-time lump sum early termination fee of $ 1.5 million. On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months . The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. Right of use and related lease debt have been recorded starting April 1, 2022 for a gross amount of $ 0.4 million. Supplemental cash flow information related to operating leases is as follows for the period December 31, 2022 and 2021: December 31, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases 2,195 2,879 F-2 5 Table of Contents Note 7 Other non-current assets Other non-current assets consisted of the following: December 31, 2022 2021 FX facility collateral account 3,739 3,969 Deposits, pledged securities and other non-current financial assets 1,773 2,665 Liquidity contract 312 199 Total other non-current assets 5,824 6,833 The other non-current assets are composed of security deposits paid to premises lessors, pledged securities, the liquidity contract and a collateral account to guarantee a FX facility not used as of December 31, 2022. Under the liquidity contract, 149,793 treasury shares were allocated as a reduction of Shareholders’ Equity as at December 31, 2022 with the cash balance being maintained in financial assets. Note 8 Trade payables and Other Current Liabilities Trade Payables No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal year presented. Other Current Liabilities Other current liabilities consisted of the following: December 31, 2022 2021 Social debt 5,872 6,708 Deferred income 2,137 4,146 Tax liabilities 69 182 Other debts 1,131 1,325 Total 9,210 12,361 The other current liabilities include short-term debt related to employees’ bonus accruals, as well as social welfare and tax agencies. Deferred income mainly includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $ 2.1 million as of December 31, 2022. F-2 6 Table of Contents Note 9 Financial debt and Other Non-Current Liabilities Financial debt—Conditional Advances The table below presents the details of the debts recorded on the statement of financial position by the type of conditional advance: BPI advance Balance sheet debt at start of period 01/01/2021 1,267 Repayments ( 689 ) Other movements ( 68 ) Balance sheet debt as at 12/31/2021 510 Of which—Non-current portion — Of which—Current portion 510 Stated interest rate No Discount rate 3.2 % Maturity (in years) 2 - 7 BPI advance Balance sheet debt at start of period 01/01/2022 510 Repayments ( 474 ) Other movements ( 36 ) Balance sheet debt as at 12/31/2022 — Stated interest rate No Discount rate 3.2 % Maturity (in years) 2 - 7 The changes appearing in “Other movements” are comprised of the effect of discounting conditional advances. BpiFrance Financement Interest Free Loan The Company has been granted until September 2022 a € 3.0 million interest-free Innovation loan from BpiFrance Financement to help financing the pharmaceutical development of Viaskin ™ Milk. This amount was received in a single disbursement on November 27, 2014. Due dates of liabilities The following table shows the maturity of the Company’s liabilities (except leases disclosed in Note 7—“Lease contract”): Carrying 2023 2024 Thereafter Other liabilities 13,945 9,210 4,735 — Supplier accounts payable and related payables 14,473 14,473 — — Total liabilities 28,418 23,683 4,735 — As detailed in Note 8, the current portion of other liabilities mainly includes social security and deferred incomes from the collaboration agreement with Nestlé Health Science. Note 10 Fair value measurement The Company reports assets and liabilities recorded at fair value on the Company’s consolidated balance sheets based upon the level of judgment associated with inputs used to measure their fair value. F-2 7 Table of Contents The fair value measurement level within the fair value hierarchy for a particular asset or liability is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs. Financial instruments not measured at fair value on the Company’s consolidated statement of financial position, but which require disclosure of their fair values include cash and cash equivalents, accounts receivable, deposits, liquidity contract, accounts payable and conditional advances. The fair values of these financial instruments are deemed to approximate their carrying amount. The fair values of cash and cash equivalents, accounts receivable, deposits, liquidity contract and accounts payable are categorized as Level 1. The fair value of conditional advance was categorized as Level 2 and was estimated based on a discounted cash flow method using the effective interest rate. For the interest-free conditional advances, the discount rate applied is equal to the rate of fungible treasury bonds over the time period that corresponds to the time period of the repayment of the advances. There has been no transfer between levels of the fair value hierarchy during the years ended December 31, 2021 and 2022. Note 11 Share Capital Issued The share capital, as of December 31, 2022, is set at the sum of € 9,413,715 ($ 10,720,399 converted at historical rates). It is divided into 94,137,145 fully authorized, subscribed and paid-up shares with a nominal value of € 0.10 . This number does not reflect ordinary shares issuable upon exercise or settlement of non-employee warrants (“BSA”), stock options (“SO”) and restricted stock units (“RSU”) granted to both employees and non-employees of the Company. All the shares give their owners the right to a proportional share of the income and the net assets of the Company. Pursuant to the authorization granted by the SH General Meeting, the Board of Directors, at its meeting of June 9, 2022 (the “Board General Meeting”): • decided, within the framework of the PIPE financing the principle of a capital increase in cash with cancellation of preferential subscription rights, reserved for categories of persons meeting the characteristics set out in the 18 th resolution of the Board General Meeting, through the issuance of Ordinary Shares and warrants to subscribe for Ordinary Shares, for a maximum amount of 6,113,200 New Ordinary Shares, corresponding to the maximum issue ceiling under the 22 nd resolution of the Board General Meeting; • granted a number of authorizations for the purpose of carrying out the issuance; • sub-delegated its authority to the Chief Executive Officer for the purpose of implementing the financing. The Chief Executive Officer, acting pursuant to the sub-delegations of authority granted by the Board of Directors of the Company on June 8, 2022, after receiving the favorable opinion of the Pricing Committee established by the Board of Directors, has, on June 9, 2022: • decided, making use of the 18 th resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L. 225-128 of French Commercial Code, an amount of € 3,285,566.90 , through the issuance of (i) 32,855,669 New Ordinary Shares, to be subscribed in cash at a unit price of € 2.90 of share premium) and to be fully paid up at the time of subscription, i.e. a F-2 8 Table of Contents capital increase of a nominal amount of € 3,285,566.90 together with a share premium of € 95,281,440.10 , i.e. a gross amount of the capital increase of € 98,567,007 , and (ii) 28,276,331 prefunded warrants to be subscribed in cash by paying up on the date of issue of € 82,001,359.90 corresponding to the prepayment of the subscription price of the new ordinary shares in the event of exercise of the prefunded warrants, • decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € 2,827,633.10 , by issuing a maximum of 28,276,331 ordinary shares, with a value of € 0.10 to be subscribed in cash at the price of € 0.10 euro (without share premium), and to be fully paid up at the time of subscription, i.e. a capital increase of a maximum nominal amount of € 2,827,633.10 (and a share premium corresponding to the amount of the pre-financed price released in advance at the time of the subscription of the prefunded warrants ), being specified that this amount does not take into account the nominal value of the ordinary shares to be issued in order to preserve the rights of the holders of securities giving access to the capital issued or to be issued, in accordance with the legal and regulatory provisions and the contractual stipulations providing for other cases of adjustment if necessary; • determined the list of beneficiaries (designated within each of the categories of persons defined in the 18 th resolution of the Board General Meeting) and the number of New Ordinary Shares and warrants allocated to each of them under the conditions defined in the 18th resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the PIPE financing. The Company has assessed the pre-funded warrants for appropriate equity or liability classification. During this assessment, the Company determined the pre-funded warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815. The 2022 Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the 2022 Warrants do not provide any guarantee of value or return. Accordingly, the pre-funded warrants are classified as equity and accounted for as a component of additional paid-in capital at the time of issuance. The changes in number of outstanding prefunded warrants are as follows: Prefunded warrants Balance as of December 31, 2021 — Granted during the period 28,276,331 Forfeited during the period — Exercised/released during the period — Expired during the period — Balance as of December 31, 2022 28,276,331 F-2 9 Table of Contents The table below presents the changes in the share capital of the Company as of December 31, 2021 and 2022: (Amounts in thousands of U.S. Dollars except share and per share data) Date Nature of the transactions Share capital* Additional paid-in capital Number of shares Balance as of December 31, 2020 6,518 1,152,042 54,929,187 02/22/2021 Capital increase by employee warrants 1 46 7,500 05/12/2021 Capital increase by employee warrants 1 62 10,200 05/17/2021 Capital increase by employee warrants 1 64 10,500 05/18/2021 Capital increase by employee warrants 1 66 10,800 05/19/2021 Retained earnings charged on share premium ( 797,823 ) 05/21/2021 Capital increase by employee warrants 1 68 11,100 05/26/2021 Capital increase by employee warrants 3 129 21,000 05/28/2021 Capital increase by employee warrants 1 70 11,400 06/10/2021 Issuance of share warrants 279 10/07/2021 Capital increase by ordinary shares 2 ( 2 ) 20,000 11/24/2021 Capital increase by ordinary shares 7 ( 7 ) 58,675 12/20/2021 Capital increase by ordinary shares 1 ( 1 ) 5,400 12/31/2021 Share-based payments 3,122 Balance as of December 31, 2021 6,538 358,115 55,095,762 03/23/2022 Capital increase by ordinary shares 0 ( 0 ) 775 05/10/2022 Capital increase by ATM program 637 13,442 6,036,238 05/12/2022 Retained earnings charged on share premium ( 95,209 ) 05/19/2022 Capital increase by employee warrants 1 ( 1 ) 5,000 05/24/2022 Capital increase by employee warrants 3 ( 3 ) 26,135 06/09/2022 Capital increase by ordinary shares 3,530 88,743 32,855,669 06/09/2022 Capital increase by share warrants 88,094 06/10/2022 Capital increase by employee warrants 0 13 3,100 07/08/2022 Capital increase by employee warrants 0 10 2,513 09/23/2022 Capital increase by ordinary shares 0 ( 0 ) 249 11/19/2022 Capital increase by ordinary shares 0 ( 0 ) 2,500 11/22/2022 Capital increase by ordinary shares 3 ( 3 ) 30,625 11/24/2022 Capital increase by ordinary shares 8 ( 8 ) 78,579 12/31/2021 Share-based payments 5,026 Balance as of December 31, 2022 10,720 458,220 94,137,145 * Conversion in U.S. Dollars at historical rates In May 2022, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022, the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2021 have been allocated to additional paid-in capital in the amount o f € 81.2 million ($ 95.2 million converted at historical rates). F- 30 Table of Contents Note 12 Share-Based Payments The Board of Directors has been authorized by the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), and non-employee warrants (Bons de Souscription d’Actions or “BSA”), as follows: Share-based payments instrument General meeting of shareholders Board of directors meeting Grant date Number granted BSA 12/9/11 9/25/12 9/25/12 30,000 BSA 6/4/13 7/25/13 7/25/13 73,000 SO 12/9/11 9/18/13 9/18/13 518,000 BSA 6/3/14 3/24/15 3/24/15 10,000 SO 6/3/14 6/23/15 6/23/15 120,000 BSA 6/23/15 11/19/15 11/19/15 22,500 BSA 6/23/15 12/15/15 2/15/16 90,000 SO 6/3/14 4/6/16 4/21/16 33,000 SO 6/3/14 6/21/16 6/21/16 110,000 BSA 6/21/16 6/21/16 8/21/16 20,000 SO 6/3/14 6/21/16 9/15/16 9,300 SO 6/3/14 6/21/16 10/17/16 16,500 BSA 6/21/16 12/9/16 2/9/16 59,000 SO 6/3/14 6/21/16 12/9/16 74,960 RSU 9/21/15 3/14/17 3/14/17 22,500 RSU 9/21/15 4/20/17 4/20/17 24,000 BSA 6/15/17 6/15/17 8/15/17 9,000 SO 6/3/14 6/15/17 6/15/17 126,000 SO 6/15/17 6/15/17 6/15/17 111,600 SO 6/15/17 6/15/17 9/15/17 52,600 SO 6/15/17 11/17/17 12/5/17 625,200 BSA 6/15/17 5/2/18 7/2/18 44,000 RSU 6/22/18 6/22/18 6/22/18 486,153 RSU 6/22/18 9/6/18 9/6/18 450 SO 6/22/18 9/6/18 9/6/18 65,000 SO 6/22/18 6/22/18 10/15/18 76,700 RSU 6/22/18 11/1/18 11/1/18 57,000 SO 6/22/18 11/29/18 11/29/18 350,000 RSU 6/22/18 12/12/18 12/12/18 16,250 RSU 6/22/18 12/12/18 12/17/18 3,000 SO 6/22/18 3/4/19 3/20/19 547,100 RSU 6/22/18 5/10/19 5/10/19 100,000 SO 5/24/19 5/24/19 5/24/19 150,000 SO 5/24/19 7/1/19 7/1/19 403,400 SO 5/24/19 7/1/19 7/22/19 75,000 RSU 5/24/19 10/11/19 10/11/19 40,000 SO 5/24/19 10/11/19 1/15/20 94,500 RSU 5/24/19 10/11/19 3/16/20 5,000 RSU 4/20/20 4/20/20 4/29/20 20,000 RSU 4/20/20 11/24/20 11/24/20 475,000 SO 4/20/20 11/24/20 11/24/20 1,216,200 RSU 4/20/20 3/23/21 3/23/21 24,900 SO 4/20/20 3/23/21 3/23/21 75,200 RSU 5/19/21 5/19/21 5/19/21 20,000 F-3 1 Table of Contents BSA 5/19/21 5/19/21 6/3/21 39,185 RSU 5/19/21 11/22/21 11/22/21 257,300 SO 5/19/21 11/22/21 11/22/21 1,107,300 RSU 5/19/21 5/12/22 5/12/22 3,200 SO 5/19/21 5/12/22 5/12/22 19,000 RSU 5/12/22 7/29/22 7/29/22 66,700 SO 5/12/22 7/29/22 7/29/22 135,500 RSU 5/12/22 11/21/22 11/21/22 519,650 SO 5/12/22 11/21/22 11/21/22 1,771,786 In the following tables related to share-based payments, exercise prices, grant date share fair values and fair value per equity instruments are provided i n euros, as the Company is incorporated in France and the euro is the currency used for the grants. 12.1 Non-employee warrants The Company’s board of directors has been authorized by the shareholders’ general meeting to grant BSAs to non-employee’s members of the Board of Directors and members of the Scientific Advisory Board. The BSAs plans granted by the Board of Directors until 2018 are similar in their nature and conditions, except for the exercise price that is comprised between € 5.13 and € 69.75 . During the year ended December 31, 2021, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the Company offered the directors the opportunity to subscribe for warrants to purchase ordinary shares on May 19, 2021, and on June 3, 2021, the directors subscribed for warrants to purchase an aggregate of 39,185 ordinary shares. These warrants have a contractual life of 4 years from their date of issuance and are not subject to a performance condition. Unless otherwise decided by the Board of Directors, these warrants may be exercised at any time prior to their expiration, provided that the beneficiary still holds a seat on the Board of Directors at the time of exercise, and subject to applicable French laws and regulations applicable to companies whose securities are listed on a regulated stock market. The fair value of the warrants has been estimated using the Cox-Ross Rubinstein binomial option pricing model. Warrant fair value assumptions during the year ended December 31, 2021 Weighted average share price at grant date (in €) 10.75 Weighted average expected volatility 90.0 % Weighted average risk-free interest rate ( 0.53 )% Weighted average expected term (in years) 3.21 Dividend yield — Weighted average fair value of warrants (in €) — F- 3 2 Table of Contents The following table summarizes all BSA activity during the year ended December 31, 2021: Number of warrants outstanding Weighted- average exercise price (in Euros) Weighted- average remaining contractual term (in years) Aggregate intrinsic value (in thousands of Euros) Balance as of December 31, 2020 218,008 52.78 5.36 — Granted during the period 39,185 9.18 — — Forfeited during the period — — — — Exercised during the period — — — — Expired during the period ( 500 ) 5.13 — — Balance as of December 31, 2021 256,693 47.51 4.35 — Warrants exercisable as of December 31, 2021 256,693 47.51 4.35 — The following table summarizes all BSA warrants activity during the year ended December 31, 2022: Number of warrants outstanding Weighted- average exercise price (in Euros) Weighted- average remaining contractual term (in years) Aggregate intrinsic value (in thousands of Euros) Balance as of December 31, 2021 256,693 47.51 4.35 — Granted during the period — — — — Forfeited during the period — — — — Exercised during the period — — — — Expired during the period ( 5,000 ) 8.59 — — Balance as of December 31, 2022 251,693 48.29 4.36 — Warrants exercisable as of December 31, 2022 251,693 48.29 4.36 — 12.2 Employee warrants As of December 31, 2022, no more BSPCE / BCE warrants (Bons de Souscription de Parts de Créateur d’Entreprise or “BSPCE”) are exercisable. 12.3 Stock options The Company’s Board of Directors has been authorized by the shareholders’ general meeting to grant SOs to employees. The different stock options plans granted by the Board of Directors are similar in their nature and conditions, except for the exercise price that is comprised between € 2.61 and € 74.22 . All SO issued have a ten-year contractual life. SO are expensed in accordance with the following vesting conditions: • Before June 22, 2018 and after January 15, 2020, SO granted mainly vest over four years at a rate of 25 % upon the first anniversary of the issuance date and 12.5 % every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors’ decisions), F- 3 3 Table of Contents • Between June 22, 2018 and January 15, 2020, SO may be exercised by the beneficiary once both of the following conditions have been met: • Service condition: 25% upon the first anniversary of the issuance date and 12.5% every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors’ decisions), and, • Performance condition: approval of Viaskin ™ Peanut by the US Food and Drug Administration, Performance conditions which are other than market conditions, are taken into account by adjusting the number of equity instruments included in the measurement of the transaction amount but are not taken into account when estimating the fair value of the shares. Estimated achievement of performance conditions is reviewed at each reporting date. The Company also applied a forfeiture rate for each grant according to its respective characteristics and composition. This forfeiture rate is reviewed at each reporting date. The following table summarizes all stock options activity during the year ended December 31, 2021: Number of SO outstanding Weighted- average exercise price in Euros Weighted- average remaining contractual term (in years) Aggregate intrinsic value in thousands of Euros Balance as of December 31, 2020 2,610,510 18.75 8.17 198.8 Granted during the period 1,182,900 6.09 — — Forfeited during the period ( 162,200 ) 4.89 — — Exercised during the period — — — — Expired during the period — — — — Balance as of December 31, 2021 3,631,210 15.25 8.67 Options exercisable as of December 31, 2021 878,560 29.50 6.13 — The following table summarizes all stock options activity during the year ended December 31, 2022: Number of SO outstanding Weighted- average exercise price in Euros Weighted- average remaining contractual term (in years) Aggregate intrinsic value in thousands of Euros Balance as of December 31, 2021 3,631,210 15.25 8.67 Granted during the period 1,926,286 3.12 — — Forfeited during the period ( 238,715 ) 12.22 — — Exercised during the period 5,613 4.16 — — Expired during the period — — — — Balance as of December 31, 2022 5,313,169 11.00 8.41 Options exercisable as of December 31, 2022 1,331,508 20.20 6.69 — As of December 31, 2022, there was € 9.3 million ($ 9.9 million converted at closing rate) of unrecognized SO expense that is expected to be recognized over a weighted-average period of 3.4 years. F- 3 4 Table of Contents Fair value of stock options Determining the fair value of the share-based payments at the grant date requires judgment. The Company calculated the fair value of stock options instruments on the grant date using the Black-Scholes option pricing model. The Black-Scholes model requires the input of highly subjective assumptions, including the expected volatility, expected term, risk-free interest rate and dividend yield. Exercise price The exercise price of the Company’s stock awards is based on the fair market value of our ordinary shares. Risk-free interest rate The risk-free interest rate is based on French government bonds (GFRN) with a maturity corresponding to the stock options maturity. Expected term The Company determines the expected term based on the average period the stock options are expected to remain outstanding. Expected Volatility The Company determines the expected volatility based on the historical data period corresponding to the stock options expected maturity. Expected Dividend yield The Company has never declared or paid any cash dividends, and it does not presently plan to pay cash dividends in the foreseeable future. Consequently, the Company uses an expected dividend yield of zero. The Company estimated the following assumptions for the calculation of the fair value of the stock options: Assumptions per year ended, December 31, Stock options per grant date Prior to 2017 2017 2018 2019 2020 2021 2022 Weighted average shares price at grant date in € 36.69 45.49 31.86 15.26 5.54 5.71 2.33 Weighted average expected volatility 45.4 % 41.8 % 47.1 % 70.8 % 87.3 % 90.2 % 98.9 % Weighted average risk-free interest rate 1.0 % ( 0.1 )% 0.3 % ( 0.1 )% ( 0.5 )% ( 0.06 )% 2.2 % Weighted average expected term (in years) 6.7 6 6 6 6 6 6 Dividend yield 0 0 0 0 0 0 0 Weighted average fair value of stock-options (in €) 17.66 17.16 13.67 9.65 3.90 4.17 2.23 12.4 Restricted stock units The Company’s board of directors has been authorized by the shareholders’ general meeting to grant RSUs to employees. F-3 5 Table of Contents RSUs are measured based on the fair market value of the underlying stock on the date of grant and recognized as an expense on a straight-line basis in accordance with the following vesting conditions: • Before May 31, 2019, the vesting of RSUs granted is subject to the expiration of the presence condition of one ( 1 ) or two ( 2 ) years (except in specific board of directors’ decisions). The release of RSUs for these plans is subject to the achievement of performance conditions (submission of a BLA to U.S. FDA for Viaskin ™ Peanut, approval of Viaskin ™ Peanut by the U.S. FDA, first sale of Viaskin ™ Peanut in the United States); • Between May 31, 2019 and November 23, 2020, the vesting of RSUs is subject either to the expiration of the presence condition of two (2) years only, or to the dual condition of expiration of the presence condition and achievement of the performance condition (date of approval of Viaskin ™ Peanut by the U.S. FDA); • Since November 24, 2020, RSUs vest over four years at a rate of 25 % upon the first anniversary of the issuance date and 12.5 % every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific board of directors’ decisions). Performance conditions, which are other than market conditions, are taken into account by adjusting the number of equity instruments included in the measurement of the transaction amount but are not taken into account when estimating the fair value of the shares. Estimated achievement of performance conditions is reviewed at each reporting date. RSU plans may be subject to a conservation period under French governing laws. The Company applied a forfeiture rate for each grant according to its respective characteristics and composition. This forfeiture rate is reviewed at each reporting date. The following table summarizes all RSUs activity for the year ended December 31, 2021: Number of RSU outstanding Weighted average grant date fair value in Euros Balance as of December 31, 2020 1,118,745 20.35 Granted during the period 302,200 6.13 Forfeited during the period ( 96,350 ) 6.74 Released during the period ( 84,075 ) 8.20 Expired during the period — — Balance as of December 31, 2021 1,240,520 18.77 The following table summarizes all RSUs activity for t h e year ended December 31, 2022: Number of RSU outstanding Weighted average grant date fair value in Euros Balance as of December 31, 2021 1,240,520 18.77 Granted during the period 589,550 2.67 Forfeited during the period ( 92 326 ) 4.96 Released during the period ( 118,967 ) 5.15 Expired during the period — — Balance as of December 31, 2022 1,618,778 14.69 F-3 6 Table of Contents As of December 31, 2022, there was € 2.6 million ($ 2.8 million converted at closing rate) of unrecognized RSUs compensation expense that is expected to be recognized over a weighted-average period of 3.4 years. 12.5 Reconciliation of the share-based payment expenses with the Consolidated Statements of Operations and Comprehensive Loss December 31, 2022 2021 Research and development SO ( 1 462 ) ( 759 ) RSU ( 841 ) ( 887 ) Sales and marketing SO ( 31 ) ( 209 ) RSU ( 4 ) ( 104 ) General and administrative SO ( 2,374 ) ( 841 ) RSU ( 315 ) ( 322 ) Total share-based compensation (expense) income ( 5,026 ) ( 3,122 ) Note 13 Contingencies Non-current contingencies and current contingencies break down as follows: December 31, 2022 2021 Current contingencies 3,944 4,095 Non-current contingencies 16,680 6,758 Total contingencies 20,625 10,853 The table below shows movements in contingencies: Pension retirement obligations Collaboration agreement—Loss at completion Other contingencies Total At January 1, 2021 937 3,956 2,649 7,542 Increases in liabilities 181 6,420 47 6,649 Used liabilities — — ( 1,634 ) ( 1,634 ) Reversals of unused liabilities — — ( 920 ) ( 920 ) Net interest related to employee benefits, and unwinding of discount 3 — — 3 Actuarial gains and losses on defined-benefit plans ( 35 ) — — ( 35 ) Currency translation effect ( 78 ) ( 577 ) ( 98 ) ( 753 ) At December 31, 2021 1,008 9,800 45 10,853 Of which Current — 4,049 45 4,095 Of which Non-current 1,008 5,750 — 6,758 F-3 7 Table of Contents Pension retirement obligations Collaboration agreement—Loss at completion Other contingencies Total At January 1, 2022 1,008 9,800 45 10,853 Increases in liabilities 105 12,455 — 12,560 Used liabilities — — ( 42 ) ( 42 ) Reversals of unused liabilities — ( 1,984 ) — ( 1,984 ) Net interest related to employee benefits, and unwinding of discount — — — — Actuarial gains and losses on defined-benefit plans ( 262 ) — — ( 262 ) Currency translation effect ( 61 ) ( 436 ) ( 3 ) ( 500 ) At December 31, 2022 790 19,835 — 20,625 Of which Current — 3,944 — 3,944 Of which Non-current 790 15,891 — 16,680 The Company does not hold any plan assets for any of the periods presented. As of December 31, 2022, the Company updated its measurement of progress of the Phase 2 clinical trial (“PII”) conducted as part of the collaboration and license agreement with Nestlé and updated the cumulative income recognized. The Company has recorded an accrual in the amount of the excess between the Company’s current best e stimates of costs yet to be incurred and income yet to be recognized for the completion of the PII. As part of the estimation of the retirement commitments, the following assumptions were used for all categories of employees: December 31, 2022 2021 % Social security contributions 50.0 % 50.0 % Salary increases 2.0 % 2.0 % Discount rate—Iboxx Corporates AA 10+ 3.77 % 0.98 % Expected staff turnover 10.0 % 10.0 % Estimated retirement age 65 65 Life table TGH05-TGF05 Collective agreement National Collective Agreement of the pharmaceutical industry Note 14 Operating Income The operating income is broken down in the following manner: December 31, 2022 2021 Research tax credit 5,718 7,505 Other operating income ( 874 ) ( 1,797 ) Total 4,844 5,708 On May 31, 2016, the Company announced its entry into an exclusive global collaboration with Nestlé Health Science to develop MAG1C, a ready-to-use and standardized atopy patch test tool for the diagnosis of cow’s milk protein allergy in infants and toddlers. Under the terms of the exclusive collaboration, the Company is responsible for leading the development activities of MAG1C up through a pivotal Phase 3 clinical program, and if appropriate regulatory approvals are received, Nestlé Health Science will support the commercialization of F-3 8 Table of Contents MAG1C globally, while prioritizing certain agreed-upon countries. The Company entered into an amendment with Nestlé Health Science on July 12, 2018. The Company is eligible to receive up to € 100.0 million in potential development, clinical, regulatory and commercial milestones, inclusive of a non-refundable upfront payment of € 10.0 million that the Company received in July 2016. The Company’s current clinical trials, including the Phase 2 clinical trial conducted as part of the development activities pursuant to the Development, Collaboration and License agreement with Nestlé Health Science, have been impacted by the Covid-19 pandemic, among other factors. The Company has experienced difficulties in enrolling new patients in this Phase 2 clinical trial notwithstanding the implementation of a protocol amendment and various other strategies to improve recruitment. As a result of the accumulation of recruitment delays, the Company expects to incur additional clinical and production costs related to the Phase 2 clinical trial as well as delays in achievement of upcoming milestones. As of December 31, 2022, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of the Phase 2 clinical trial conducted as part of the agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase 2 clinical trial has been updated accordingly. Note 15 Allocation of Personnel Expenses The Company had 86 average employees for the year ended December 31, 2022, in comparison with 101 employees for the year ended December 31, 2021. Allocation of Personnel Expenses by Function: December 31, 2022 2021 Research and Development expenses 13,055 14,596 Sales and Marketing expenses 914 1,885 General and Administrative expenses 10,008 9,357 Restructuring* — 5,296 Total personnel expenses 23,977 31,135 * Restructuring personnel expenses excluding reversal for the year ended December 31, 2021. Allocation of Personnel Expenses by Nature: December 31, 2022 2021 Wages and salaries 14,802 18,017 Social security contributions 3,206 8,630 Expenses for pension commitments 943 1,366 Share-based payments 5,026 3,122 Total 23,977 31,135 The decrease in personnel expenses is mainly due to a decrease in headcount as well as accrued bonus, retention measures as part of the global restructuring plan. F-3 9 Table of Contents Note 16 Income Tax Reconciliation between the Effective and Nominal Income Tax Expense The following table shows the reconciliation between the effective and nominal tax expense at the nominal standard French rate 25 % as of December 31, 2022 and 26.5 % as of December 31, 2021 (excluding additional contributions): December 31, 2022 2021 (Loss) before taxes ( 96,204 ) ( 98,189 ) Theoretical company tax rate 25.00 % 26.50 % Nominal tax expense 24,051 26,020 Increase/decrease in tax expense arising from: Research tax credit 1,430 1,990 Share-based compensation ( 784 ) ( 104 ) Other permanent differences ( 100 ) ( 86 ) Non recognition of deferred tax assets mainly related to tax losses ( 24,746 ) ( 25,882 ) Other differences 79 ( 1,557 ) Effective tax expenses—current ( 70 ) 381 Effective tax expenses—deferred — — Effective tax rate ( 0.07 )% 0.39 % Deferred Tax Assets Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The significant components of the Company’s deferred tax assets are comprised of the following: December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards 273,964 263,086 Share-based compensation 1,102 5,521 Personnel-related accruals 389 376 Pension retirement obligations 197 252 Leases 6 518 Other 5,248 2,760 Total deferred tax assets 280,907 272,513 Less: Valuation allowance ( 280,907 ) ( 272,513 ) Net deferred tax assets — — Note 17 Commitments Purchase Obligations The Company has signed agreements with several contract research organizations (CRO) and part of the ongoing clinical studies for Viaskin ™ Peanuts and Viaskin ™ Milk products. As of December 31, 2022, expenses associated with the ongoing trials amounted globally to $ 161.6 million, and we had non-cancellable contractual obligations with CRO until year ended 2025 amounting to $ 48.7 million. F- 40 Table of Contents Letter of Credit and Collateral A letter of credit was signed by the Company in May 2017 for $ 0.3 million to secure the lease of its premises of its United States subsidiary in New York. A collateral of the same amount was signed in order to pledge against this letter of credit. A Certificate of Deposit, for an initial amount of $ 0.25 million was signed in order to guarantee an American Express credit cards program in the United States. In 2015, the Company took a term deposit for a sum of € 0.23 million (equivalent to $ 0.24 million at closing exchange rate). Note 18 Relationships with Related Parties The compensation amounts for 2022 presented below, which were awarded to the Directors and Officers of the Company totaled $ 8 million. The recipients of this compensation are “related parties” under applicable French law and may not be considered executive officers or related parties under comparable SEC and Nasdaq rules and regulations applicable to the Company. December 31, 2022 2021 Short-term benefits 4,625 5,128 Post-employment benefits 33 67 Termination benefits 24 280 Share-based payments 3,355 1,556 Total 8,037 7,031 The methods for the valuation of the benefit related to share-based payments are presented in Note 12 Share-Based Payments. Amounts payable to related parties as of December 31, 2022 and 2021 are as follows: December 31, 2022 2021 Compensation 2,009 1,820 Pension obligations 83 156 Total 2,092 1,976 Note 19 Loss Per Share The basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the course of the fiscal year. As the Company was in a loss position for the years ended December 31, 2022 and 2021, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive given the Company’s net loss. F-41 Table of Contents The computations for basic and diluted loss per share were as follows (in thousands of U.S. Dollars except share and per share data): December 31, 2022 2021 Net loss ( 96,274 ) ( 97,809 ) Weighted average number of ordinary shares 77,384,133 54,916,937 Basic and diluted net loss per share attributable to ordinary shareholders ($/share) ( 1.24 ) ( 1.78 ) The following is a summary of the ordinary share equivalents which were excluded from the calculation of diluted net loss per share for the periods indicated in number of potential shares: December 31, 2022 2021 Non-employee warrants 251,693 256,693 Employee warrants — — Stock-options 5,313,169 3,631,210 Restricted stock units 1,618,778 1,240,520 Prefunded warrants 28,276,331 — Note 20 Events after the Close of the Fiscal Year There are no significant events that require adjustments or disclosure in the consolidated financial statements. F-42