DBVT filing — read by section

10-Q 
 
 Table of Contents 

 UNITED STATES 

 SECURITIES AND EXCHANGE COMMISSION 

 Washington, D.C. 20549 

 FORM 10-Q 
 
 (Mark One) 

 ☒ 
 
 QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 

 For the quarterly period ended September 30, 2023 

 or 

 ☐ 
 
 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 

 For the transition period from      

 to      

 Commission file number 001-36697 
 
 DBV TECHNOLOGIES S.A. 

 (Exact name of registrant as specified in its charter) 

 France 

 State or other jurisdiction of

 incorporation or organization

 Not applicable 

 (I.R.S. Employer

 Identification No.)

 177-181
 avenue Pierre Brossolette 

 N/A

 92120 Montrouge France (Address of principal executive offices)
 
 (Zip Code)

 Registrant’s telephone number, including area code + 33 1 55 42 78 78 

 Securities registered pursuant to Section 12(b) of the Act: 

 Title of each class

 Trading

 Symbol(s)

 Name of each exchange

 on which registered

 American Depositary Shares, each representing 

 DBVT 

 The Nasdaq Stock Market LLC 

 one-half
 of one ordinary share, nominal value

 €0.10 per share

 Ordinary shares, nominal value €0.10 per share *

 n/a

 The Nasdaq Stock Market LLC 

 *
 
 Not for trading , but only in connection with the registration of the American Depositary Shares. 

 Securities
 
 registered pursuant to section 12(g) of the Act: None. 

 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒  Yes  ☐ No 

 Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T
 (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒  Yes  ☐ No 

 Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated
 filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2
 of the Exchange Act. 

 Large accelerated filer
 
 ☐
 
 Accelerated filer
 
 ☐
 
 Non-accelerated
 filer 
 
 ☒
 
 Smaller reporting company
 
 ☒ 
 
 Emerging growth company
 
 ☐ 
 
 If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ 

 Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2
 of the Act). ☐ Yes  ☒  No 

 As of October 31, 2023, the registrant had 96,288,553 ordinary shares, nominal value €0.10 per share, outstanding including treasury shares. 
 
 Table of Contents 

 Table of contents 
 
 Part I 
 
 Financial information 
 
 5 
 
 Item 1 
 
 Condensed Consolidated Statements of Financial Position (Unaudited) as of September 30, 2023 and December 31, 2022 
 
 5 
 
 Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Nine Months Ended September 30,2023 and 2022 
 
 6 
 
 Condensed Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2023 and 2022 
 
 7 
 
 Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Nine Months Ended September 30, 2023 and 2022 
 
 8 
 
 Notes to the Condensed Consolidated Financial Statements (Unaudited) 
 
 9 
 
 Item 2 
 
 Management’s Discussion and Analysis of Financial Condition and Results of Operations 
 
 19 
 
 Item 3 
 
 Quantitative and Qualitative Disclosures About Market Risk 
 
 26 
 
 Item 4 
 
 Controls and Procedures 
 
 26 
 
 Part II 
 
 Other Information 
 
 26 
 
 Item 1 
 
 Legal Proceedings 
 
 26 
 
 Item 1A 
 
 Risk Factors 
 
 27 
 
 Item 2 
 
 Unregistered Sales of Equity Securities and Use of Proceeds 
 
 27 
 
 Item 3 
 
 Defaults Upon Senior Securities 
 
 27 
 
 Item 4 
 
 Mine Safety Disclosures 
 
 27 
 
 Item 5 
 
 Other Information 
 
 27 
 
 Item 6 
 
 Exhibits 
 
 27 
 
 Unless the context otherwise requires, we use the terms “DBV”, “DBV Technologies,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q, or Quarterly Report, to refer to DBV Technologies S.A. and, where appropriate, its consolidated subsidiaries. “Viaskin ™ ”, “EPIT ™ ” and our other registered and common law trade names, trademarks and service marks are the property of DBV Technologies S.A. or our subsidiaries. All other trademarks, trade names and service marks appearing in this Quarterly Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto. 

 2 

 Table of Contents 

 SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS. 

 This Quarterly Report contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things: 

 • 
 
 our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated re-submission
 of a Biologics License Application, or a BLA, for ViaskinTM Peanut to the U.S. Food and Drug Administration, or the FDA; 
 
 • 
 
 the timing and anticipated results of interactions with regulatory agencies; 

 • 
 
 the initiation, timing, progress and results of our pre-clinical
 studies and clinical trials, and our research and development programs; 
 
 • 
 
 the sufficiency of existing capital resources; 

 • 
 
 our business model and our other strategic plans for our business, product candidates and technology; 

 • 
 
 our ability to manufacture clinical and commercial supplies of our product candidates and comply with regulatory requirements related to the manufacturing of our product candidates; 

 • 
 
 our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize Viaskin Peanut and/or our other product candidates, if approved; 

 • 
 
 the commercialization of our product candidates, if approved; 

 • 
 
 our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut and/or our other product candidates, if approved, and our ability to serve such markets; 

 • 
 
 the pricing and reimbursement of our product candidates, if approved; 

 • 
 
 the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by physicians, patients, third- party payors and others in the medical community; 

 • 
 
 our ability to advance product candidates into, and successfully complete, clinical trials; 

 • 
 
 the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; 

 • 
 
 estimates of our expenses, future revenues, capital requirements and our needs for additional financing; 

 • 
 
 the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; 

 • 
 
 our ability to maintain and establish collaborations or obtain additional grant funding; 

 • 
 
 our financial performance; 

 • 
 
 developments relating to our competitors and our industry, including competing therapies; and 

 • 
 
 other risks and uncertainties, including those listed under the caption “Risk Factors.” 

 Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward- looking statement. These risks, uncertainties and other factors are described in greater detail under the caption “Risk Factors” in Part I. Item 1A of our Annual Report on Form 10-K
 for the year ended December 31, 2022, filed with the Securities and Exchange Commission, or the SEC on March 2, 2023. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement. We qualify all of our forward-looking statements by these cautionary statements. 
 
 3 

 Table of Contents 
 In addition, any forward-looking statement in this Quarterly Report, including statements that “we believe” and similar statements, reflect our beliefs and opinions on the relevant subject and represents our views only as of the date of this Quarterly Report and should not be relied upon as representing our views as of any subsequent date. These statements are based upon information available to us as of the date of this Quarterly Report and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. 

 4 

 Table of Contents 
 Part I – Financial Information 

 Item 1. Financial Statements 

 DBV Technologies S.A. 

 Condensed Consolidated Statements of Financial Position (unaudited) 

 (amounts in thousands, except share and per share data) 

 September 30,
 
 December 31,
 
 Notes
 
 2023
 
 2022
 
 Assets
 
 Current assets:
 
 Cash and cash equivalents
 
 3 
 
 $ 
 149,135 
 
 $ 
 209,194 
 
 Other current assets
 
 4 
 
 20,136 
 
 13,880 
 
 Total current assets
 
 169,270 
 
 223,074 
 
 Property, plant, and equipment, net
 
 13,094 
 
 15,096 
 
 Right-of-use

 assets related to operating leases
 
 5 
 
 1,389 
 
 2,513 
 
 Intangible assets
 
 61 
 
 10 
 
 Other non-current
 assets
 
 5,970 
 
 5,824 
 
 Total non-current
 assets
 
 20,513 
 
 23,444 
 
 Total Assets
 
 $ 
 189,783 
 
 $ 
 246,518 
 
 Liabilities and shareholders’ equity
 
 Current liabilities:
 
 Trade payables
 
 6 
 
 $ 
 16,654 
 
 $ 
 14,473 
 
 Short-term operating leases
 
 5 
 
 1,522 
 
 1,894 
 
 Current contingencies
 
 9 
 
 4,596 
 
 3,944 
 
 Other current liabilities
 
 6 
 
 8,671 
 
 9,210 
 
 Total current liabilities
 
 31,443 
 
 29,521 
 
 Long-term operating leases
 
 5 
 
 94 
 
 1,127 
 
 Non-current
 contingencies
 
 9 
 
 11,553 
 
 16,680 
 
 Other non-current
 liabilities
 
 6 
 
 2,702 
 
 4,735 
 
 Total non-current
 liabilities
 
 14,349 
 
 22,543 
 
 Total Liabilities
 
 $ 
 45,792 
 
 $ 
 52,064 
 
 Shareholders’ equity:
 
 Ordinary shares, € 0.10 par value; 96,253,553 and 94,137,145 shares authorized, and issued as of 
September 30, 2023 and December 31, 2022, respectively
 
 $ 
 10,953 
 
 $ 
 10,720 
 
 Additional paid-in
 capital
 
 376,249 
 
 458,221 
 
 Treasury stock, 175,481 and 149,793 ordinary shares as of September 30, 2023 and December 31, 2022, respectively, at cost
 
 ( 1,163 
 ) 
 
 ( 1,109 
 ) 

 Accumulated deficit
 
 ( 227,677 
 ) 
 
 ( 259,578 
 ) 

 Accumulated other comprehensive income
 
 761 
 
 781 
 
 Accumulated currency translation effect
 
 ( 15,132 
 ) 
 
 ( 14,581 
 ) 

 Total Shareholders’ equity
 
 7 
 
 $ 
 143,991 
 
 $ 
 194,453 
 
 Total Liabilities and Shareholders’ equity
 
 $ 
 189,783 
 
 $ 
 246,518 
 
 The accompanying notes are an integral part of these condensed consolidated financial statements. 
 
 5

 Table of Contents 
 
 DBV Technologies S.A. 

 Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) 

 (amounts in thousands, except share and per share data) 

 Three Months Ended September 30,
 
 Nine Months Ended
September 30,
 
 Notes
 
 2023
 
 2022
 
 2023
 
 2022
 
 Operating income
 
 10 
 
 $ 
 2,372 
 
 $ 
 2,074 
 
 $ 
 6,853 
 
 $ 
 6,148 
 
 Operating expenses
 
 Research and development expenses
 
 ( 13,795 
 ) 
 
 ( 15,096 
 ) 
 
 ( 47,448 
 ) 
 
 ( 45,930 
 ) 

 Sales and marketing expenses
 
 ( 663 
 ) 
 
 ( 159 
 ) 
 
 ( 1,613 
 ) 
 
 ( 1,659 
 ) 

 General and administrative expenses
 
 ( 6,184 
 ) 
 
 ( 4,839 
 ) 
 
 ( 22,304 
 ) 
 
 ( 17,173 
 ) 

 Total Operating expenses
 
 ( 20,642 
 ) 
 
 ( 20,094 
 ) 
 
 ( 71,365 
 ) 
 
 ( 64,762 
 ) 

 Loss from operations
 
 ( 18,270 
 ) 
 
 ( 18,020 
 ) 
 
 ( 64,512 
 ) 
 
 ( 58,614 
 ) 

 Financial income (expenses)
 
 1,534 
 
 732 
 
 2,984 
 
 1,668 
 
 Loss before taxes
 
 ( 16,736 
 ) 
 
 ( 17,287 
 ) 
 
 ( 61,527 
 ) 
 
 ( 56,946 
 ) 

 Income tax
 
 —   
 
 —   
 
 ( 13 
 ) 
 
 ( 87 
 ) 

 Net loss
 
 $ 
 ( 16,736 
 ) 
 
 $ 
 ( 17,287 
 ) 
 
 $ 
 ( 61,540 
 ) 
 
 $ 
 ( 57,033 
 ) 

 Foreign currency translation differences, net of taxes
 
 ( 3,996 
 ) 
 
 ( 15,425 
 ) 
 
 ( 551 
 ) 
 
 ( 28,752 
 ) 

 Actuarial gains (losses) on employee benefits, net of taxes
 
 73 
 
 41 
 
 ( 19 
 ) 
 
 264 
 
 Total comprehensive loss
 
 $ 
 ( 20,659 
 ) 
 
 $ 
 ( 32,672 
 ) 
 
 $ 
 ( 62,111 
 ) 
 
 $ 
 ( 85,520 
 ) 

 Basic/diluted net loss per share attributable to shareholders
 
 14 
 
 $ 
 ( 0.17 
 ) 
 
 $ 
 ( 0.18 
 ) 
 
 $ 
 ( 0.65 
 ) 
 
 $ 
 ( 0.79 
 ) 

 Weighted average shares outstanding used in computing per share amounts:
 
 96,075,540 
 
 93,905,050 
 
 94,801,569 
 
 71,779,572 
 
 The accompanying notes are an integral part of these condensed consolidated financial statements. 
 
 6

 Table of Contents 
 
 DBV Technologies S.A. 

 Condensed Consolidated Statements of Cash Flows (unaudited) 

 (amounts in thousands) 

 Nine Months
Ended September 30,
 
 Notes
 
 2023
 
 2022
 
 Net loss for the period
 
 $ 
 ( 61,540 
 ) 
 
 $ 
 ( 57,033 
 ) 

 Adjustments to reconcile net loss to net cash flow provided by (used in) operating activities:
 
 Depreciation, amortization and accrued contingencies
 
 ( 3,072 
 ) 
 
 1,140 
 
 Retirement pension obligations
 
 58 
 
 58 
 
 Expenses related to share-based payments
 
 8 
 
 4,800 
 
 3,416 
 
 Other elements
 
 23 
 
 ( 3 
 ) 

 Changes in operating assets and liabilities:
 
 Decrease (increase) in other current assets
 
 ( 5,850 
 ) 
 
 20,900 
 
 (Decrease) increase in trade payables
 
 1,691 
 
 5,699 
 
 (Decrease) increase in other current and non-current
 liabilities
 
 ( 2,547 
 ) 
 
 ( 3,405 
 ) 

 Change in operating lease liabilities and right of use assets
 
 471 
 
 ( 2,554 
 ) 

 Net cash flow provided by (used in) operating activities
 
 ( 65,967 
 ) 
 
 ( 31,781 
 ) 

 Cash flows provided by (used in) investing activities:
 
 Acquisitions of property, plant, and equipment, net from proceeds
 
 ( 325 
 ) 
 
 ( 742 
 ) 

 Proceeds from property, plant, and equipment dispositions
 
 —   
 
 3 
 
 Acquisitions of non-current
 financial assets
 
 ( 54 
 ) 
 
 ( 149 
 ) 

 Proceeds from non-current
 financial assets dispositions
 
 ( 242 
 ) 
 
 822 
 
 Net cash flows provided by (used in) investing activities
 
 ( 621 
 ) 
 
 ( 66 
 ) 

 Cash flows provided by (used in) financing activities:
 
 Decrease in conditional advances
 
 —   
 
 ( 479 
 ) 

 Treasury shares
 
 54 
 
 149 
 
 Capital increases, net of transaction costs
 
 6,902 
 
 194,732 
 
 Other cash flows related to financing activities
 
 —   
 
 —   
 
 Net cash flows provided by (used in) financing activities
 
 6,956 
 
 194,403 
 
 Effect of exchange rate changes on cash and cash equivalents
 
 ( 427 
 ) 
 
 ( 27,186 
 ) 

 Net increase (decrease) in cash and cash equivalents
 
 ( 60,059 
 ) 
 
 135,369 
 
 Net Cash and cash equivalents at the beginning of the period
 
 209,194 
 
 77,301 
 
 Net cash and cash equivalents at the end of the period
 
 3 
 
 $ 
 149,135 
 
 $ 
 212,670 
 
 The accompanying notes are an integral part of these condensed consolidated financial statements. 
 
 7

 Table of Contents 
 
 DBV Technologies S.A. 

 Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited) 

 (amounts in thousands, except share and per share data) 

 Ordinary shares
 
 Number of
Shares
 
 Amount
 
 Additional
paid-in
capital
 
 Treasury
stock
 
 Accumulated
deficit
 
 Accumulated
other
comprehensive
income (loss)
 
 Accumulated
currency
translation
effect
 
 Total
Shareholders’
Equity
 
 Balance at January 1, 2022
 
 55,095,762 
 
 $ 
 6,538 
 
 $ 
 358,115 
 
 $ 
 ( 1,232 
 ) 
 
 $ 
 ( 258,528 
 ) 
 
 $ 
 519 
 
 $ 
 ( 6,137 
 ) 
 
 $ 
 99,274 
 
 Net (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 ( 16,706 
 ) 
 
 —  
 
 —  
 
 ( 16,706 
 ) 

 Other comprehensive income (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 24 
 
 ( 1,933 
 ) 
 
 ( 1,909 
 ) 

 Issuance of ordinary shares
 
 775 
 
 1 
 
 —   
 
 —  
 
 —  
 
 —  
 
 —  
 
 1 
 
 Treasury shares
 
 —  
 
 —  
 
 —  
 
 40 
 
 —  
 
 —  
 
 —  
 
 40 
 
 Share-based payments
 
 —  
 
 —  
 
 1,363 
 
 —  
 
 —  
 
 —  
 
 —  
 
 1,363 
 
 Other change in equity
 
 —  
 
 —  
 
 —  
 
 —  
 
 15 
 
 —  
 
 ( 15 
 ) 
 
 —  
 
 Balance at March 31, 2022
 
 55,096,537 
 
 $ 
 6,539 
 
 $ 
 359,478 
 
 $ 
 ( 1,193 
 ) 
 
 $ 
 ( 275,219 
 ) 
 
 $ 
 543 
 
 $ 
 ( 8,086 
 ) 
 
 $ 
 82,062 
 
 Net (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 ( 23,039 
 ) 
 
 —  
 
 —  
 
 ( 23,039 
 ) 

 Other comprehensive income (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 200 
 
 ( 11,394 
 ) 
 
 ( 11,194 
 ) 

 Issuance of ordinary shares
 
 38,926,142 
 
 4,170 
 
 103,007 
 
 —  
 
 —  
 
 —  
 
 —  
 
 107,176 
 
 Issuance of warrants
 
 —  
 
 —  
 
 88,094 
 
 —  
 
 —  
 
 —  
 
 —  
 
 88,094 
 
 Treasury shares
 
 —  
 
 —  
 
 —  
 
 240 
 
 —  
 
 —  
 
 —  
 
 240 
 
 Share-based payments
 
 —  
 
 —  
 
 1,078 
 
 —  
 
 —  
 
 —  
 
 —  
 
 1,078 
 
 Allocation of accumulated net losses
 
 —  
 
 —  
 
 ( 95,209 
 ) 
 
 —  
 
 95,209 
 
 —  
 
 —  
 
 —  
 
 Balance at June 30, 2022
 
 94,022,679 
 
 $ 
 10,708 
 
 $ 
 456,447 
 
 $ 
 ( 953 
 ) 
 
 $ 
 ( 203,050 
 ) 
 
 $ 
 743 
 
 $ 
 ( 19,480 
 ) 
 
 $ 
 244,416 
 
 Net (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 ( 17,287 
 ) 
 
 —  
 
 —  
 
 ( 17,287 
 ) 

 Other comprehensive income (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 41 
 
 ( 15,425 
 ) 
 
 ( 15,384 
 ) 

 Issuance of ordinary shares
 
 2,762 
 
 1 
 
 ( 539 
 ) 
 
 —  
 
 —  
 
 —  
 
 —  
 
 ( 539 
 ) 

 Issuance of warrants
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 Treasury shares
 
 —  
 
 —  
 
 —  
 
 ( 130 
 ) 
 
 —  
 
 —  
 
 —  
 
 ( 130 
 ) 

 Share-based payments
 
 —  
 
 —  
 
 976 
 
 —  
 
 —  
 
 —  
 
 —  
 
 976 
 
 Allocation of accumulated net losses
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 Balance at September 30, 2022
 
 94,025,441 
 
 $ 
 10,709 
 
 $ 
 456,884 
 
 $ 
 ( 1,083 
 ) 
 
 $ 
 ( 220,337 
 ) 
 
 $ 
 783 
 
 $ 
 ( 34,904 
 ) 
 
 $ 
 212,052 
 
 Ordinary shares
 
 Number of
Shares
 
 Amount
 
 Additional
paid-in
capital
 
 Treasury
stock
 
 Accumulated
deficit
 
 Accumulated
other
comprehensive
income (loss)
 
 Accumulated
currency
translation
effect
 
 Total
Shareholders’
Equity
 
 Balance at January 1, 2023
 
 94,137,145 
 
 $ 
 10,720 
 
 $ 
 458,221 
 
 $ 
 ( 1,109 
 ) 
 
 $ 
 ( 259,578 
 ) 
 
 $ 
 781 
 
 $ 
 ( 14,581 
 ) 
 
 $ 
 194,453 
 
 Net (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 ( 20,561 
 ) 
 
 —  
 
 —  
 
 ( 20,561 
 ) 

 Other comprehensive income (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 ( 82 
 ) 
 
 3,666 
 
 3,584 
 
 Issuance of ordinary shares
 
 10,174 
 
 1 
 
 ( 1 
 ) 
 
 —  
 
 —  
 
 —  
 
 —  
 
 —   
 
 Treasury shares
 
 —  
 
 —  
 
 —  
 
 ( 14 
 ) 
 
 —  
 
 —  
 
 —  
 
 ( 14 
 ) 

 Share-based payments
 
 —  
 
 —  
 
 1,632 
 
 —  
 
 —  
 
 —  
 
 —  
 
 1,632 
 
 Balance at March 31, 2023
 
 94,147,319 
 
 $ 
 10,721 
 
 $ 
 459,852 
 
 $ 
 ( 1,123 
 ) 
 
 $ 
 ( 280,138 
 ) 
 
 $ 
 698 
 
 $ 
 ( 10,915 
 ) 
 
 $ 
 179,094 
 
 Net (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 ( 24,243 
 ) 
 
 —  
 
 —  
 
 ( 24,243 
 ) 

 Other comprehensive income (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 ( 10 
 ) 
 
 ( 221 
 ) 
 
 ( 232 
 ) 

 Issuance of ordinary shares
 
 2,103,635 
 
 231 
 
 7,535 
 
 —  
 
 —  
 
 —  
 
 —  
 
 7,766 
 
 Treasury shares
 
 —  
 
 —  
 
 —  
 
 42 
 
 —  
 
 —  
 
 —  
 
 42 
 
 Share-based payments
 
 —  
 
 —  
 
 1,814 
 
 —  
 
 —  
 
 —  
 
 —  
 
 1,814 
 
 Allocation of accumulated net losses
 
 —  
 
 —  
 
 ( 93,441 
 ) 
 
 —  
 
 93,441 
 
 —  
 
 —  
 
 —  
 
 Balance at June 30, 2023
 
 96,250,954 
 
 $ 
 10,952 
 
 $ 
 375,759 
 
 $ 
 ( 1,082 
 ) 
 
 $ 
 ( 210,940 
 ) 
 
 $ 
 687 
 
 $ 
 ( 11,136 
 ) 
 
 $ 
 164,240 
 
 Net (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 ( 16,736 
 ) 
 
 —  
 
 —  
 
 ( 16,736 
 ) 

 Other comprehensive income (loss)
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 73 
 
 ( 3,996 
 ) 
 
 ( 3,922 
 ) 

 Issuance of ordinary shares
 
 2,599 
 
 1 
 
 ( 864 
 ) 
 
 —  
 
 —  
 
 —  
 
 —  
 
 ( 864 
 ) 

 Treasury shares
 
 —  
 
 —  
 
 —  
 
 ( 81 
 ) 
 
 —  
 
 —  
 
 —  
 
 ( 81 
 ) 

 Share-based payments
 
 —  
 
 —  
 
 1,354 
 
 —  
 
 —  
 
 —  
 
 —  
 
 1,354 
 
 Allocation of accumulated net losses
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 —  
 
 Balance at September 30, 2023
 
 96,253,553 
 
 $ 
 10,953 
 
 $ 
 376,249 
 
 $ 
 ( 1,163 
 ) 
 
 $ 
 ( 222,676 
 ) 
 
 $ 
 761 
 
 $ 
 ( 15,132 
 ) 
 
 $ 
 143,991 
 
 The accompanying notes are an integral part of these condensed consolidated financial statements. 
 
 8

 Table of Contents 
 
 NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 

 Note 1: The Company 
 Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, 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 ™
, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin ™
. 
 Basis of Presentation 
 The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation. 
 The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K
 filed with the SEC on March 2, 2023 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2022 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2022. 
 Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2023, or any other future period. 
 Use of estimates 
 The preparation of the Company’s condensed 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. 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, (7) estimate of contingencies, and (8) estimate of employee benefits obligations. 

 Accounting Pronouncements adopted in 2023 
 In June 2016, the Financial Accounting Standards Board (“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. Adoption of this new standard did not have a material impact on the consolidated financial statements. 
 In October 2021, the FASB issued ASU 2021-08,
 which amends ASC 805 to require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination. This amendment is effective for public business entities for the fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Adoption of this new standard has no impact on the consolidated financial statements. 
 
 9 

 Table of Contents 
 Accounting Pronouncements issued not yet adopted 
 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. 
 Note 2: Significant Events and Transactions 

 Clinical programs 

 United
 
 States
 
 Regulatory
 
 History
 
 and
 
 Cur
 r
 ent
 
 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 receipt of the Complete Response Letter. 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 1/1000 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 study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches. 
 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 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 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 conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit 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. 
 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 is agreeable via oral and written exchanges. 
 
 10 

 Table of Contents 
 
 In 2022, the Company announced the new Phase 3 pivotal study for modified Viaskin Peanut (mVP) patch would be in younger (4-7
 years old) and more sensitive children with peanut allergy. 
 On September 7, 2022, the Company 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. 
 On September 21, 2022, the Company announced it received feedback from the U.S. 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, the Company 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. The Company further announced it plans to initiate a separate, 
 
 six
-month 
 safety study in approximately 275 additional subject s
, randomized 3:1 active versus placebo, to supplement the safety data generated by the VITESSE trial, resulting in a safety database of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut. 
 On March 2, 2023, the Company announced the completion of EVOLVE, a 12-week
 caregiver and patient user experience study of the mVP patch in 50 peanut allergic children ages 4–11-years
 old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the mVP patch. The study concluded that the updated IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the mVP patch. In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion scores. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA. 
 On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated in the first half of 2024 and topline results in the first half of 2025. 

 On April 19, 2023, the Company outlined the regulatory path for Viaskin Peanut in children 1-3
 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified
 criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use. 
 On July 31, 2023, the Company announced receipt of feedback from FDA on the two supplemental safety studies, COMFORT Children and COMFORT Toddlers. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 – 3 -years
 and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT Children safety study will enroll peanut allergic children ages 4 – 7 -years
 and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study. FDA agreed with a 6 -month
 study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study. The Company expects both COMFORT studies will assess adhesion using the same tools and measurements that were established in VITESSE. 
 
 Viaskin Peanut for children ages 4-11—European Union Regulatory History and Current Status
 
 On August 2, 2021, the Company announced it received from the European Medicines Agency (“EMA”) of 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 had withdrawn the Marketing Authorization Application (“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 EMA Committee for Medicinal Products for Human Use (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 believes 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 intends 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 effects 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 for Part B of EPITOPE was completed in the first quarter of 2021. 

 11 

 Table of Contents 
 In June 2022, the Company 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 balance for age and baseline disease characteristics between the active and placebo treatment arms. 

 On April 19, 2023, the Company announced it will begin a new safety study after it received confirmation from the FDA that the EPITOPE study meets the pre-specified
 criteria for success for the primary endpoint, with no additional efficacy study requested. This safety study will increase the safety data collected from EPITOPE in support of a BLA. It will also generate patch adhesion data and will include updated instructions for use. 

 On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in 

 an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory efforts for VP in toddlers ages 1-3
 years old with a confirmed peanut allergy. 

 Viaskin Peanut
 for Children ages 4-7

 On September 7, 2022, the Company 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. 

 On September 21, 2022, the Company 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, the Company 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. 

 On March 7, 2023, the Company announced that the first patient was screened in the VITESSE trial. Screening of the last patient is anticipated in the first half of 2024 and topline results in the first half of 2025. 

 Financing 

 In June 2023, the Company issued and completed sales of new ordinary shares (the “Ordinary Shares”) in the form of American Depositary Shares (“ADSs”), for a total gross amount of $ 7.8 million (and a net amount of $ 6.9 million after $ 0.9 capital 
increase fees imputation), under the At-The-Market

 (“ATM”) program established in May 2022. In this context, 2,052,450 new Ordinary Shares in the 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 1.90 dollar per ADS (i.e., a subscription price per Ordinary Share of 3.52 euro based on the USD/EUR exchange rate of 1.0809 dollar for 1 euro, as published by the European Central Bank on June 14, 2023) and each ADS giving the right to receive one-half
 of one ordinary share of the Company. 
 Legal Proceedings 
 From time to time, the Company may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The Company is not currently subject to any material legal proceedings. 
 
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 Table of Contents 

 Note 3: Cash and Cash Equivalents 
 The following tables summarize the cash and cash equivalents as of September 30, 2023 and December 31, 2022: 
 
 September 30,
 2023 
 
 December 31,
 2022 
 
 Cash
 
 18,927 
 
 30,104 
 
 Cash equivalents
 
 130,208 
 
 179,090 
 
 Total cash and cash equivalents as reported in the statements of financial position
 
 149,135 
 
 209,194 
 
 Bank overdrafts
 
 —   
 
 —   
 
 Total cash and cash equivalents as reported in the statements of cash flows
 
 149,135 
 
 209,194 
 
 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: 
 
 September 30,
 2023 
 
 December 31,
 2022 
 
 Research tax credit
 
 10,622 
 
 5,792 
 
 Other tax claims
 
 4,571 
 
 3,903 
 
 Prepaid expenses
 
 3,195 
 
 2,680 
 
 Other receivables
 
 1,748 
 
 1,504 
 
 Total
 
 20,136 
 
 13,880 
 
 Research tax credit
 
 The variance in Research Tax Credit is presented as follows: 
 
 Amount in
thousands of
US Dollars
 
 Opening research tax credit receivable as of January 1, 2023
 
 5,792 
 
 + Operating revenue
 
 4,978 
 
 - Payment received
 
 —   
 
 - Adjustment and currency translation effect
 
 ( 148 
 ) 

 Closing research tax credit receivable as of September 30, 2023
 
 10,622 
 
 Of which - Non-current
 portion
 
 —   
 
 Of which - Current portion
 
 10,622 
 
 Before currency translation effect, the balance in research tax credit as of September 30, 2023, consisted of $ 5.8 million research tax credit for the 2022 fiscal year filed with the tax authorities and yet to be reimbursed, and $ 5.0 million estimated research tax credit for the first nine months of the 2023 fiscal year. 
 The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. 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. 
 
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 Table of Contents 
 Note 5 Lease contracts 
 Future minimum lease payments under the Company’s operating leases’ right of use as of September 30, 2023 and December 31, 2022, are as follows: 
 
 September 30, 2023
 
 December 31, 2022
 
 Other
 
 Other
 
 Real estate
 
 assets
 
 Total
 
 Real estate
 
 assets
 
 Total
 
 Current portion
 
 1,592 
 
 73 
 
 1,665 
 
 1,972 
 
 79 
 
 2,051 
 
 Year 2
 
 103 
 
 24 
 
 127 
 
 1,168 
 
 74 
 
 1,243 
 
 Year 3
 
 —   
 
 —  
 
 —   
 
 65 
 
 6 
 
 71 
 
 Thereafter
 
 —   
 
 —   
 
 —   
 
 —   
 
 —   
 
 —   
 
 Total minimum lease payments
 
 1,695 
 
 97 
 
 1,792 
 
 3,204 
 
 160 
 
 3,364 
 
 Less: Effects of discounting
 
 ( 167 
 ) 
 
 ( 9 
 ) 
 
 ( 176 
 ) 
 
 ( 325 
 ) 
 
 ( 17 
 ) 
 
 ( 343 
 ) 

 Present value of operating lease
 
 1,528 
 
 88 
 
 1,616 
 
 2,879 
 
 143 
 
 3,021 
 
 Less: current portion
 
 ( 1,451 
 ) 
 
 ( 71 
 ) 
 
 ( 1,522 
 ) 
 
 ( 1,823 
 ) 
 
 ( 71 
 ) 
 
 ( 1,894 
 ) 

 Long-term operating lease
 
 77 
 
 17 
 
 94 
 
 1,055 
 
 72 
 
 1,127 
 
 Weighted average remaining lease term (years)
 
 0.72 
 
 —  
 
 1.40 
 
 —  
 
 Weighted average discount rate
 
 2.84 
 % 
 
 2.48 
 % 
 
 3.00 
 % 
 
 2.45 
 % 
 
 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: 
 
 September 30, 
 
 2023 
 
 2022 
 
 Operating lease expense
 
 1,223 
 
 1,373 
 
 Net termination impact
 
 ( 92 
 ) 
 
 ( 1,657 
 ) 

 Supplemental cash flow information related to operating leases is as follows for the period September 30, 2023 and 2022: 
 
 September 30, 
 
 2023 
 
 2022 
 
 Cash paid for amounts included in the measurement of lease liabilities
 
 Operating cash outflows related to operating leases
 
 1,410 
 
 1,533 
 
 Note 6: Trade Payables and Other Current Liabilities 

 6.1 Trade Payables 

 Trade 

 payables increased by $ 2.2 million as of September 30, 2023, compared to December 31, 2022. 
 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 period presented. 
 
 1 4
 
 Table of Contents 
 
 6.2 Other Liabilities 

 The following tables summarize the other liabilities as of September 30, 2023 and December 31, 2022: 

 September 30,
 
 December 31,
 
 2023
 
 2022
 
 Other current
liabilities
 
 Other non-current

liabilities
 
 Total
 
 Other current
liabilities
 
 Other non-current

liabilities
 
 Total
 
 Employee related liabilities
 
 5,557 
 
 —   
 
 5,557 
 
 5,872 
 
 45 
 
 5,917 
 
 Deferred income
 
 2,286 
 
 2,702 
 
 4,988 
 
 2,137 
 
 4,690 
 
 6,828 
 
 Tax liabilities
 
 193 
 
 —   
 
 193 
 
 69 
 
 —   
 
 69 
 
 Other debts
 
 635 
 
 —   
 
 635 
 
 1,131 
 
 —   
 
 1,131 
 
 Total
 
 8,671 
 
 2,702 
 
 11,372 
 
 9,210 
 
 4,735 
 
 13,945 
 
 The Employee related liabilities include short-term debt to employees including social welfare and tax agency obligations. Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science.
 Note 7: Shareholders’ equity 

 The share capital as of September 30, 2023 is set at the amount 
of € 9,625,355.30 ($ 10,953 thousands converted at historical rates). It is divided into 96,253,553 fully authorized, subscribed and paid-up
 ordinary shares with a par value of € 0.10 . 
 Pursuant to the authorization granted by the General Meeting of the Shareholders held on April 12, 2023 (the “SH General Meeting”), the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2022, have been allocated to additional paid-in
 capital for € 88,091,118.04 . 

 Note 8: 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”). 

 During 

the nine months ended September 30, 2023, the Company granted 59,200 stock options and 35,800 restricted stock units to employees. There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report. 
 Change in Number of BSA/SO/RSU: 

 Number of outstanding
 
 BSA
 
 SO
 
 RSUs
 
 Balance as of December 31, 2022
 
 251,693 
 
 5,306,569 
 
 1,589,081 
 
 Granted during the period
 
 —  
 
 59,200 
 
 35,800 
 
 Forfeited during the period
 
 —  
 
 ( 128,700 
 ) 
 
 ( 123,382 
 ) 

 Exercised/released during the period
 
 —  
 
 —  
 
 ( 66,883 
 ) 

 Expired during the period
 
 —  
 
 —  
 
 —  
 
 Balance as of September 30, 2023
 
 251,693 
 
 5,237,069 
 
 1,434,616 
 
 1 5
 
 Table of Contents 
 Share-based payments expense reflected in the condensed consolidated statements of operations is as follows: 
 
 Three Months
Ended September 30,
 
 Nine Months
Ended September
 
 30,
 
 2023
 
 2022
 
 2023
 
 2022
 
 Research & development
 
 SO 
 
 ( 376 
 ) 
 
 ( 337 
 ) 
 
 ( 1,272 
 ) 
 
 ( 1,002 
 ) 

 RSU 
 
 ( 85 
 ) 
 
 ( 201 
 ) 
 
 ( 614 
 ) 
 
 ( 594 
 ) 

 Sales & marketing
 
 SO 
 
 ( 25 
 ) 
 
 30 
 
 ( 78 
 ) 
 
 ( 3 
 ) 

 RSU 
 
 ( 8 
 ) 
 
 20 
 
 ( 25 
 ) 
 
 4 
 
 General & administrative
 
 SO 
 
 ( 747 
 ) 
 
 ( 423 
 ) 
 
 ( 2,473 
 ) 
 
 1,599 
 ) 

 RSU 
 
 ( 106 
 ) 
 
 ( 66 
 ) 
 
 ( 337 
 ) 
 
 ( 223 
 ) 

 Total share-based compensation (expense)
 
 ( 1,345 
 ) 
 
 ( 976 
 ) 
 
 ( 4,800 
 ) 
 
 ( 3,416 
 ) 

 Note 9: Contingencies 

 The following tables summarize the contingencies as of September 30, 2023 and December 31, 2022: 

 September 30,
 2023 
 
 December 31,
 2022 
 
 Current contingencies
 
 4,596 
 
 3,944 
 
 Non-current
 contingencies
 
 11,553 
 
 16,680 
 
 Total contingencies
 
 16,149 
 
 20,625 
 
 The changes in contingencies are as follows: 
 
 Pension
 retirement
 obligations 
 
 Collaboration
 agreement -
 Loss at
 completion 
 
 Other
 contingencies 
 
 Total 
 
 At January 1, 2023
 
 790 
 
 19,835 
 
 —  
 
 20,625 
 
 Increases in liabilities
 
 58 
 
 —  
 
 796 
 
 854 
 
 Used liabilities
 
 —  
 
 —  
 
 —  
 
 —   
 
 Reversals of unused liabilities
 
 —  
 
 ( 5,325 
 ) 
 
 —  
 
 ( 5,325 
 ) 

 Net interest related to employee benefits, and unwinding of discount
 
 —  
 
 —  
 
 —  
 
 —   
 
 Actuarial gains and losses on defined-benefit plans
 
 19 
 
 —  
 
 —  
 
 19 
 
 Currency translation effect
 
 ( 7 
 ) 
 
 ( 16 
 ) 
 
 —   
 
 ( 24 
 ) 

 At September 30, 2023
 
 860 
 
 14,494 
 
 796 
 
 16,149 
 
 Of which Current
 
 —  
 
 3,801 
 
 796 
 
 4,596 
 
 Of which Non-current

 860 
 
 10,693 
 
 —  
 
 11,553 
 
 The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 13 to the consolidated financial statements included in the Annual Report. 
 In 2022 and during the first nine months of 2023, the Company updated its measurement of progress of the Phase 2 clinical trial conducted as part of the collaboration and license agreement with Nestlé Health Sciences and updated the cumulative income recognized. The Company recognized a reversal of $ 5.3 million of the loss for completion recorded in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and income yet to be recognized for the completion of the PII. 
 The other contingencies mainly consisted of a provision for refurbishment amounting to the best estimate of costs to be incurred in case the Montrouge office lease agreement is not renewed at its July 2024 term expiration. 

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 Table of Contents 

 Note 10: Operating income 

 The following table summarizes the operating income during the three and nine months ended September 30, 2023 and 2022: 

 Three Months Ended
September 30,
 
 Nine Months Ended
September 30,
 
 2023
 
 2022
 
 2023
 
 2022
 
 Research tax credit
 
 1,237 
 
 1,407 
 
 4,978 
 
 4,467 
 
 Other operating income
 
 1,134 
 
 668 
 
 1,875 
 
 1,681 
 
 Total
 
 2,372 
 
 2,074 
 
 6,853 
 
 6,148 
 
 The increase in operating income for the nine months period was primarily due to the increase in the research and development costs eligible to research tax credit in France. 

 The Company recognizes as other operating income accrued revenues based on its updated measurement of progress of the Phase 2 clinical trial conducted as part of the collaboration agreement with Nestlé. Moreover, the loss for completion 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 was updated accordingly as of September 30, 2023 (see note 9 related to contingencies). 

 Note 11: Allocation of Personnel Expenses 

 The Company had an average of 97
 employees during the nine months ended September 30, 2023, in comparison with an average of 85
 employees during the nine months ended September 30, 2022. 

 The following table summarizes the allocation of personnel expenses by function during the three and nine months ended September 30, 2023 and 2022: 

 Three Months
Ended September 30,
 
 Nine Months
Ended September 30,
 
 2023
 
 2022
 
 2023
 
 2022
 
 Research and Development expenses
 
 3,663 
 
 3,186 
 
 11,684 
 
 9,357 
 
 Sales and Marketing expenses
 
 187 
 
 138 
 
 557 
 
 727 
 
 General and Administrative expenses
 
 2,876 
 
 1,598 
 
 8,834 
 
 6,961 
 
 Total personnel expenses
 
 6,724 
 
 4,922 
 
 21,075 
 
 17,045 
 
 The following table summarizes the allocation of personnel expenses by nature during the three and nine months ended September 30, 2023 and 2022: 

 Three Months
Ended September 30,
 
 Nine Months
Ended September 30,
 
 2023
 
 2022
 
 2023
 
 2022
 
 Wages and salaries
 
 4,175 
 
 3,505 
 
 12,691 
 
 11,001 
 
 Social security contributions
 
 962 
 
 634 
 
 2,846 
 
 2,141 
 
 Expenses for pension commitments
 
 234 
 
 214 
 
 738 
 
 723 
 
 Employer contribution to bonus shares
 
 —   
 
 ( 406 
 ) 
 
 —   
 
 ( 236 
 ) 

 Share-based payments
 
 1,353 
 
 976 
 
 4,800 
 
 3,416 
 
 Total
 
 6,724 
 
 4,922 
 
 21,075 
 
 17,045 
 
 The increase in personnel expenses was mainly due to recruitment of US employees partially offset by the departure of non-US
 employees, and the increase of charges related to share-base payments. 

 Note 12: Commitments 

 There were no significant changes in other commitments from those disclosed in Note 17 to the consoli date
d financial statements included in the Annual Report. 

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 Table of Contents 
 Note 13: Relationships with Related Parties 
 The Company’s related parties exclusively consisted of the members of the Board of Directors and the members of the Executive Committee. As of September 30, 2023, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not significantly changed since December 31, 2022. 
 There were no new significant related-party transactions during the period nor any changes in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report. 
 Note 14: Loss Per Share 

 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 period. As the Company was in a loss position for each of the three- and nine-month periods ended September 30, 2023 and 2022, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss. 
 The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three and nine months ended September 30, 2023 and 2022 indicated in number of potential shares: 
 
 Three Months Ended
 September 30, 
 
 Nine Months Ended
 September 30, 
 
 2023 
 
 2022 
 
 2023 
 
 2022 
 
 Non-employee
 warrants
 
 251,693 
 
 251,693 
 
 251,693 
 
 251,693 
 
 Stock options
 
 5,237,069 
 
 3,541,383 
 
 5,237,069 
 
 3,541,383 
 
 Restricted stock units
 
 1,434,616 
 
 1,185,936 
 
 1,434,616 
 
 1,185,936 
 
 Prefunded warrants
 
 28,276,331 
 
 28,276,331 
 
 28,276,331 
 
 28,276,331 
 
 Note 15: Events after the Close of the Period 

 The Company evaluated subsequent events that occurred after September 30, 2023, through the d
ate the condensed consolidated financial statements were issued after their approval by the Board of Directors on October 31, 2023, and determined that there were significant events that
 require disclosure in such condensed consolidated financial statements: 

 On October 16 th
, 2023, the Company has announced the appointment of Virginie Boucinha as CFO effective as of November 6 th
, 2023, in replacement of Sébastien Robitaille leaving as of November 17 th
, 2023. 
 The Company and Nestlé Health Science entered into a termination letter agreement, effective October 30, 2023, terminating the collaboration agreement between the two parties and the PII clinical study. According to this agreement, upfront and milestones 1 to 3 are definitively acquired by DBV. The termination agreement may have other contractual and accounting consequences, due to the end of the study, including, potential impacts of termination with some related parties which the Company is currently assessing and will be accounted for as of December 31, 2023. 
 
 1 8

 Table of Contents 

 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 
 You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2022, included in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 2, 2023, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report. 
 Overview 
 We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy, or EPITTM, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, Viaskin targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved. 
 Our most advanced clinical program is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in nine clinical trials, including four Phase 2 trials and three completed Phase 3 trials. We recently completed a Phase 3 trial of Viaskin Peanut in children ages one to three with peanut allergy and we also have an ongoing Phase 3 trial of Viaskin Peanut in children ages four to seven with peanut allergy. 
 On December 23, 2022, the Company announced it plans to initiate a separate, six-month safety study in approximately 275 additional subjects, randomized 3:1 active versus placebo, to supplement the safety data generated by the VITESSE trial, resulting in a safety database of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut (COMFORT Children). 
 On March 7, 2023, the Company announced screening of the first patient in VITESSE. Screening of the last patient is anticipated in the first half in 2024 and topline results in the first half in 2025. 
 On April 19, 2023, the Company outlined the regulatory path for Viaskin Peanut in children 1-3 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study (COMFORT Toddlers) will also generate patch adhesion data and will include updated instructions for use. 
 On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory efforts for VP in toddlers ages 1-3 years old with a confirmed peanut allergy. 
 On July 31, 2023, the Company announced receipt of feedback from FDA on the two supplemental safety studies, COMFORT Children and COMFORT Toddlers. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 – 3-years and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT Children safety study will enroll peanut allergic children ages 4 – 7-years and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study. The FDA agreed with a 6-month study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study. The Company expects both COMFORT studies will assess adhesion using the same tools and measurements that were established in VITESSE. 
 Critical Accounting Policies and Significant Judgments and Estimates 
 Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. 

 19 

 Table of Contents 

 There have been no new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report. Our significant accounting policies are more fully described in Note 1 of the Notes to the Consolidated Financial Statements in Part I, 
 Item 1 of our Annual Report. 
 Business trends and Results of Operations 
 Comparison of the Three Months Ended September 30, 2023 and 2022 
 The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the three months ended September 30, 2023 and 2022. 
 
 Three months ended September 30, 
 
 2023 
 
 2022 
 
 $ change 
 
 % change 
 
 Operating income
 
 $ 
 2,372 
 
 $ 
 2,074 
 
 297 
 
 14 
 % 

 Operating expenses
 
 Research and development expenses
 
 (13,795 
 ) 
 
 (15,096 
 ) 
 
 1,301 
 
 (9 
 )% 

 Sales and marketing expenses
 
 (663 
 ) 
 
 (159 
 ) 
 
 (504 
 ) 
 
 318 
 % 

 General and administrative expenses
 
 (6,184 
 ) 
 
 (4,839 
 ) 
 
 (1,345 
 ) 
 
 28 
 % 

 Total Operating expenses
 
 (20,642 
 ) 
 
 (20,094 
 ) 
 
 (548 
 ) 
 
 3 
 % 

 Financial income (expenses)
 
 1,534 
 
 732 
 
 802 
 
 110 
 % 

 Income tax
 
 —  
 
 —  
 
 —  
 
 —  
 
 Net loss
 
 $ 
 (16,736 
 ) 
 
 $ 
 (17,287 
 ) 
 
 551 
 
 (3 
 %) 

 Basic/diluted Net loss per share attributable to shareholders
 
 $ 
 (0.17 
 ) 
 
 $ 
 (0.18 
 ) 
 
 Operating Income 
 The following table summarizes our operating income during the three months ended September 30, 2023 and 2022: 
 
 Three months ended September 30, 
 
 2023 
 
 2022 
 
 $ change 
 
 % change 
 
 Sales
 
 —  
 
 —  
 
 —  
 
 —  
 
 Other income
 
 2,372 
 
 2,074 
 
 297 
 
 14 
 % 

 Research tax credit
 
 1,237 
 
 1,407 
 
 (169 
 ) 
 
 (12 
 %) 

 Other operating income
 
 1,134 
 
 668 
 
 467 
 
 70 
 % 

 Total operating income
 
 2,372 
 
 2,074 
 
 297 
 
 14 
 % 

 Our operating income is primarily generated from the French research tax credit (Crédit d’Impôt Recherche, or “CIR”), and revenues recognized as part of our collaboration agreement with Nestlé Health Science. We generated operating income of $2.4 million during the three months ended September 30, 2023 compared to $2.1 million during the three months ended September 30, 2022. 
 The increase in operating income is primarily attributable to the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. 
 Operating Expenses 
 Research and Development Expenses 
 The following table summarizes our research and development expenses incurred during the three months ended September 30, 2023 and 2022: 

 20 

 Table of Contents 

 Three Months
Ended September 30, 
 
 Research and Development expenses 
 
 2023 
 
 2022 
 
 $ change 
 
 % change 
 
 External clinical-related expenses
 
 12,277 
 
 11,136 
 
 1,141 
 
 10 
 % 

 Employee-related costs (excl. share-based payments)
 
 3,203 
 
 2,648 
 
 555 
 
 21 
 % 

 Share-based payment expenses
 
 460 
 
 538 
 
 (78 
 ) 
 
 (14 
 %) 

 Depreciation, amortization and other costs
 
 (2,145 
 ) 
 
 774 
 
 (2,920 
 ) 
 
 (377 
 %) 

 Total Research and Development expenses
 
 13,795 
 
 15,096 
 
 (1,301 
 ) 
 
 (9 
 %) 

 Research and Development expenses decreased by $1.3 million for the three months ended September 30, 2023, compared to the three months ended September 30, 2022, primarily due to the reversal of $4.2 million of the loss at completion recorded as depreciation, amortization and other costs on the Phase II clinical trial conducted as part of the collaboration agreement with Nestlé. During the three months ended September 30, 2023, there was a reduction of costs to be engaged to follow the achievement of upcoming milestones. 
 Decreases in impacts of the loss at completion were partially offset by the increase by $1.1 million in external clinical-related expenses as a result of differences in phasing of on-going clinical trials between the three months ended September 30, 2022 and the three months ended September 30, 2023 and the increase by $0.6 million in employee-related costs (excl. share-based payments) to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA. 
 Sales and Marketing expenses 
 The following table summarizes our sales and marketing expenses incurred during the three months ended September 30, 2023 and 2022: 
 
 Three Months Ended September 30, 
 
 Sales and Marketing expenses 
 
 2023 
 
 2022 
 
 $ change 
 
 % change 
 
 External professional services
 
 343 
 
 (279 
 ) 
 
 621 
 
 (223 
 )% 

 Employee-related costs (excl. share-based payments)
 
 152 
 
 188 
 
 (37 
 ) 
 
 (19 
 %) 

 Share-based payment expenses
 
 32 
 
 (50 
 ) 
 
 82 
 
 (165 
 %) 

 Depreciation, amortization and other costs
 
 136 
 
 299 
 
 (163 
 ) 
 
 (55 
 %) 

 Total Sales and Marketing expenses
 
 663 
 
 159 
 
 504 
 
 318 
 % 

 Sales and marketing expenses increased by $0.5 million for the three months ended September 30, 2023, compared to the three months ended September 30, 2022, due to an increase of external professional services. 
 General and Administrative expenses 
 The following table summarizes our general and administrative expenses incurred during the three months ended September 30, 2023 and 2022: 
 
 Three Months Ended September 30, 
 
 General and Administrative expenses 
 
 2023 
 
 2022 
 
 $ change 
 
 % change 
 
 External professional services
 
 840 
 
 1,292 
 
 (451 
 ) 
 
 (35 
 %) 

 Employee-related costs (excl. share-based payments)
 
 2,024 
 
 1,110 
 
 914 
 
 82 
 % 

 Share-based payment expenses
 
 853 
 
 489 
 
 364 
 
 74 
 % 

 Depreciation, amortization and other costs
 
 2,467 
 
 1,949 
 
 518 
 
 27 
 % 

 Total General and Administrative expenses
 
 6,184 
 
 4,839 
 
 1,345 
 
 28 
 % 

 General and Administrative expenses increased by $1.3 million for the three months ended September 30, 2023, compared to the three months ended September 30, 2022, mainly due to increase by $0.9 million in employee-related costs (excluding share-based payments) to support General and Administrative expenses activities explained by the average number of employees increase. In addition, we recorded a provision amounting to $0.8 million as of September 30, 2023, as our best estimate of costs to be incurred if the Montrouge office lease agreement is not renewed at its July 2024 term expiration. 
 
 21 

 Table of Contents 

 Financial income (expense) 
 Our financial income was $1.5 million for the three months ended September 30, 2023, compared to a financial income of $0.7 million for the three months ended September 30, 2022. This item mainly includes the financial income on our financial assets. 
 Income tax 
 Our income tax expense was nil for the three months ended September 30, 2023 and September 30, 2022. 
 Net loss 
 Net loss was $16.7 million for the three months ended September 30, 2023, compared to $17.3 million for the three months ended September 30, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.17 and $0.18 for the three months ended September 30, 2023 and 2022, respectively. 
 Comparison of the Nine Months Ended September 30, 2023 and 2022 
 The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the nine months ended September 30, 2023 and 2022. 
 
 Nine months ended September 30, 
 
 2023 
 
 2022 
 
 $ change 
 
 % change 
 
 Operating income
 
 $ 
 6,853 
 
 $ 
 6,148 
 
 705 
 
 11 
 % 

 Operating expenses
 
 Research and development expenses
 
 (47,448 
 ) 
 
 (45,930 
 ) 
 
 (1,518 
 ) 
 
 3 
 % 

 Sales and marketing expenses
 
 (1,613 
 ) 
 
 (1,659 
 ) 
 
 46 
 
 (3) 
 % 

 General and administrative expenses
 
 (22,304 
 ) 
 
 (17,173 
 ) 
 
 (5,130 
 ) 
 
 30 
 % 

 Total Operating expenses
 
 (71,365 
 ) 
 
 (64,762 
 ) 
 
 (6,602 
 ) 
 
 10 
 % 

 Financial income (expense)
 
 2,984 
 
 1,668 
 
 1,316 
 
 79 
 % 

 Income tax
 
 (13 
 ) 
 
 (87 
 ) 
 
 74 
 
 (85) 
 % 

 Net loss
 
 $ 
 (61,540 
 ) 
 
 $ 
 (57,033 
 ) 
 
 (4,507 
 ) 
 
 8 
 % 

 Basic/diluted Net loss per share attributable to shareholders
 
 $ 
 (0.65 
 ) 
 
 $ 
 (0.79 
 ) 
 
 Operating Income 
 The following table summarizes our operating income during the nine months ended September 30, 2023 and 2022: 
 
 Nine months ended September 30, 
 
 2023 
 
 2022 
 
 $ change 
 
 % change 
 
 Sales
 
 —  
 
 —  
 
 Other income
 
 6,853 
 
 6,148 
 
 ,705 
 
 11 
 % 

 Research tax credit
 
 4,978 
 
 4,467 
 
 ,511 
 
 11 
 % 

 Other operating income
 
 1,875 
 
 1,681 
 
 ,194 
 
 12 
 % 

 Total operating income
 
 6,853 
 
 6,148 
 
 ,705 
 
 11 
 % 

 Our operating income consisted of the French research tax credit (Crédit d’Impôt Recherche, or “CIR”), and revenues recognized as part of our collaboration agreement with Nestlé Health Science. We generated operating income of $6.9 million during the nine months ended September 30, 2023 compared to $6.1 million during the nine months ended September 30, 2022. 
 The increase in operating income was mainly due to the increase by $0.5 million in the French research tax credit as both eligible employee-related costs and eligible external clinical-related expenses increased to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA. 
 
 22 

 Table of Contents 

 The other operating income increased by $0.2 million for nine months ended September 30, 2023, after we updated the measurement of progress of the Phase II clinical trial conducted as part of the Nestlé’s collaboration agreement. 
 Operating Expenses 
 Research and Development Expenses 
 The following table summarizes our R&D expenses incurred during the nine months ended September 30, 2023 and 2022: 
 
 Nine Months Ended September 30, 
 
 Research and Development expenses 
 
 2023 
 
 2022 
 
 $ change 
 
 % change 
 
 External clinical-related expenses
 
 34,170 
 
 30,150 
 
 4,020 
 
 13 
 % 

 Employee-related costs (excl. share-based payments)
 
 9,797 
 
 7,761 
 
 2,036 
 
 26 
 % 

 Share-based payment expenses
 
 1,886 
 
 1,596 
 
 290 
 
 18 
 % 

 Depreciation, amortization and other costs
 
 1,595 
 
 6,423 
 
 (4,827 
 ) 
 
 (75 
 %) 

 Total Research and Development expenses
 
 47,448 
 
 45,930 
 
 1,518 
 
 3 
 % 

 Research and Development expenses increased by $1.5 million for the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022, mainly due to the increase by $4.0 million and by $2.0 million in external clinical-related expenses and in employee-related costs (excl. share- based payments) respectively, to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA. 
 Increases in both external clinical-related expenses and employee-related costs were partially offset by the reversal of $5.3 million of the loss at completion recorded as other costs on the Phase II clinical trial conducted as part of the collaboration agreement with Nestlé. During the nine months ended September 30, 2022, the loss at completion was impacted by additional clinical and production costs following increasing timing to achieve upcoming milestones. During the nine months ended September 30, 2023, there were reduction of costs to be engaged to follow the achievement of upcoming milestones. 
 Sales and Marketing expenses 
 The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2023 and 2022: 
 
 nine Months Ended September 30, 
 
 Sales and Marketing expenses 
 
 2023 
 
 2022 
 
 $ change 
 
 % change 
 
 External professional services
 
 691 
 
 243 
 
 449 
 
 185 
 % 

 Employee-related costs (excl. share-based payments)
 
 454 
 
 728 
 
 (274 
 ) 
 
 (38 
 %) 

 Share-based payment expenses
 
 103 
 
 (1 
 ) 
 
 104 
 
 (10815 
 %) 

 Depreciation, amortization and other costs
 
 365 
 
 690 
 
 (325 
 ) 
 
 (47 
 %) 

 Total Sales and Marketing expenses
 
 1,613 
 
 1,659 
 
 (46 
 ) 
 
 (3 
 )% 

 Sales and marketing expenses decreased by $ 0.05 million for the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022, mainly due to a decrease of employee-related costs following departures in the US and other costs offset by an increase of external professional services to support Sales and Marketing activities. 
 General and Administrative expenses 
 The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2023 and 2022: 
 
 Nine Months Ended September 30, 
 
 General and Administrative expenses 
 
 2023 
 
 2022 
 
 $ change 
 
 % change 
 
 External professional services
 
 6,352 
 
 4,171 
 
 2,182 
 
 52 
 % 

 Employee-related costs (excl. share-based payments)
 
 6,023 
 
 5,139 
 
 884 
 
 17 
 % 

 Share-based payment expenses
 
 2,811 
 
 1,822 
 
 989 
 
 54 
 % 

 Depreciation, amortization and other costs
 
 7,117 
 
 6,042 
 
 1,075 
 
 18 
 % 

 Total General and Administrative expenses
 
 22,304 
 
 17,173 
 
 5,130 
 
 30 
 % 

 23 

 Table of Contents 

 General and Administrative expenses increased by $5.1 million for the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022, mainly due to an increase by $2.2 million for one-time costs associated with financing activities, organizational planning, market research and planning activities. In addition, we recorded an increase by $0.9 million in employee-related costs to support General and Administrative activities and a provision amounting to $0.8 million as of September 30, 2023, as our best estimate of costs to be incurred if the Montrouge office lease agreement is not renewed at its July 2024 term expiration. 
 Financial income (expense) 
 Our financial income was $3.0 million for the nine months ended September 30, 2023, compared to a financial income of $1.7 million for the nine months ended September 30, 2022. This item mainly includes financial income on our financial assets. 
 Income tax 
 Our income tax expense was nil for the nine months ended September 30, 2023 and September 30, 2022. 
 Net loss 
 Net loss was $ 61.5 million for the nine months ended September 30, 2023, compared to $57.0 million for the nine months ended September 30, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.65 and $0.79 for the nine months ended September 30, 2023 and 2022, respectively. 
 Liquidity and Capital Resources 
 Financial Condition 
 On September 30, 2023, we had $149.1 million in cash and cash equivalents compared to $209.2 million of cash and cash equivalents on December 31, 2022. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $66.0 million and $31.8 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, we recorded a net loss of $ 61.5 million. Our net cash flows provided by financing activities were $7.0 million during the nine months ended September 30, 2023 that consisted of the ATM program compared to $194.4 million during the nine months ended September 30, 2022, that consisted of the May 2022 ATM and June 2022 PIPE offering. 
 Our unaudited condensed consolidated financial statements have been prepared on a going concern basis assuming that based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents at closing date will be sufficient to fund our operations for at least the next 12 months. As such, no adjustments have been made to the unaudited condensed consolidated financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern. 
 Sources of Liquidity and Material Cash Requirements 
 We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt. 
 Payments associated with Research tax credits (Crédit d’Impôt Recherche) contribute to fund our short-term cash requirements. We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our 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. 
 In May 2022, we established an At-The-Market (“ATM”) program 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”), each ADS representing one-half of one ordinary share of the Company. The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached. 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 Peanut platform and for working capital and other general corporate purposes. 
 Pursuant to the ATM program, the Company issued and completed sales of new Ordinary Shares in the form of ADSs for a total gross amount of $15.3 million on May 4, 2022, and of $7.8 million on June 14, 2023. Respectively, 6,036,238 and 2,052,450 new Ordinary Shares in the form of ADSs were 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 and $1.90 per ADS, each ADS giving the right to receive one-half of one ordinary share of the Company. 

 24 

 Table of Contents 

 We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all. If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently. 
 Operating leases 
 Our corporate headquarters are located in Montrouge, France. Our principal offices occupy a 4,470 square meter facility, pursuant to a lease agreement dated March 3, 2015, and represents a $1.2 million cash requirement as of September 30, 2023 which expires July 31, 2024. 
 Our primary U.S. office is located in Basking Ridge, New Jersey. In March 2022, we entered into a lease agreement, commencing on April 1, 2022 and effective for 38 months, for an office of 5,799 square feet in Basking Ridge, New Jersey. The Basking Ridge office represent a $0.1 million cash requirement as of September 30, 2023 which expires June 1, 2025. 
 There have been no material changes in our operating leases from those disclosed in the Annual Report. 
 Purchase obligations - Obligations Under the Terms of CRO Agreements 
 In connection with the launch of our clinical trials for Viaskin Peanut and Viaskin Milk, we signed agreements with several contract research organizations. 
 There have been no material changes in our purchase obligations from those disclosed in the Annual Report. 
 Summary Statement of Cash Flows 
 The table below summarizes our sources and uses of cash for the nine months ended September 30, 2023 and 2022. 
 
 Nine months ended September 30, 
 
 (Amounts in thousands of U.S. Dollars) 
 
 2023 
 
 2022 
 
 $ change 
 
 % of change 
 
 Net cash flow used in operating activities
 
 (65,967 
 ) 
 
 (31,781 
 ) 
 
 (34,186 
 ) 
 
 108 
 % 

 Net cash flow used in investing activities
 
 (621 
 ) 
 
 (66 
 ) 
 
 (555 
 ) 
 
 839 
 % 

 Net cash flow provided by financing activities
 
 6,956 
 
 194,403 
 
 (187,447 
 ) 
 
 -96 
 % 

 Effect of exchange rate changes on cash and cash equivalents
 
 (427 
 ) 
 
 (27,186 
 ) 
 
 26,759 
 
 -98 
 % 

 Net (decrease) increase in cash and cash equivalents
 
 (60,059 
 ) 
 
 135,369 
 
 (195,429 
 ) 
 
 -144 
 % 

 Operating Activities 
 Our net cash flows used in operating activities were $66.0 million and $31.8 million during the nine months ended September 30, 2023 and 2022, respectively. Our net cash flows used in operating activities increased by $ 34.2 million, mainly due to the repayment in 2022 of the research tax credit receivable relating to fiscal years 2019 to 2021 for €24.8 million (corresponding to $28.1 million on the basis of 2021 closing exchange rate). The increase is also explained by the change in trade payables during the nine months period ended September 30, 2023 compared to the nine months period ended September 30, 2022. 
 Investing Activities 
 Our net cash flows used in investing activities were $0.6 million and $0.1 million during the nine months ended September 30, 2023 and 2022, respectively. 
 Financing Activities 
 Our net cash flows provided by financing activities was $7.0 million during the nine months ended September 30, 2023 that consisted of the ATM in June 2023 compared to $194.4 million during the nine months ended September 30, 2022, that consisted of our May 2022 ATM and June 2022 PIPE offering in second quarter of 2022. 
 
 25 

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 Off-Balance Sheet Arrangements 
 We have not entered into any off-balance sheet arrangements and do not have variable interests in variable interest entities. 
 Smaller Reporting Company Status 
 We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter. 
 Item 3. Quantitative and Qualitative Disclosures About Market Risk 
 We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item. 
 Item 4. Controls and Procedures 
 Disclosure Controls and Procedures 
 Based on its evaluation as of September 30, 2023, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. 
 Changes in Internal Control Over Financial Reporting 
 There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 
 Limitation on Effectiveness of Controls and Procedures 
 Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost- effective control system, misstatements due to error of fraud may occur and not be detected. 
 PART II – Other information 
 Item 1. Legal Proceedings 
 See “Note 2: Significant Events and Transactions – Legal Proceedings” in the notes to the condensed consolidated financial statements included elsewhere in this Report. 
 
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 Item 1A. Risk Factors 
 Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report. There have been no material changes in our risk factors from those disclosed in the Annual Report. 
 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 
 During the nine months ended September 30, 2023, we issued the following unregistered securities: 
 
 • 
 
 On March 23, 2023, the issuance of an aggregate of 10,174 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; and 
 
 • 
 
 On May 19, 2023, the issuance of an aggregate of 2,500 ordinary shares to a non-U.S. employee upon settlement of RSUs; and 
 
 • 
 
 On May 22, 2023, the issuance of an aggregate of 14,364 ordinary shares to non-U.S. employees upon settlement of RSUs; and 
 
 • 
 
 On May 24, 2023, the issuance of an aggregate of 34,321 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; and 
 
 • 
 
 On September 23, 2023, the issuance of an aggregate of 2,599 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs. 
 
 None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Regulation S promulgated under Section 5 of the Securities Act, as transactions by an issuer not involving any public offering or as offerings made to non-U.S. resident employees pursuant to an employee benefit plan established and administered in accordance with the law of a country other than the United States (namely, the Republic of France) and in accordance with that country’s practices and documentation. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising. 
 Item 3. Defaults Upon Senior Securities 
 None. 
 Item 4. Mine Safety Disclosures 
 Not applicable. 
 Item 5. Other Information 
 Not applicable. 
 Item 6. Exhibits. 
 Exhibit Index 
 
 Exhibit
 
 Description
 
 Incorporated by Reference 

 Schedule/
Form 
 
 File
Number 
 
 Exhibit 
 
 File
Date 

 3.1 
 
 By-laws (statuts) of the registrant (English translation) 
 
 10-Q 
 
 001-
 36697
 
 3.1 
 
 5/04/23 

 31.1 
 
 Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended 
 
 31.2 
 
 Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended 
 
 32.1* 
 
 Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended 
 
 101.INS 
 
 XBRL Instance Document 
 
 101.SCH 
 
 XBRL Taxonomy Extension Schema Document 
 
 101.CAL 
 
 XBRL Taxonomy Extension Calculation Linkbase Document 
 
 27 

 Table of Contents 

 Exhibit
 
 Description
 
 Incorporated by Reference 
 
 Schedule/
Form 
 
 File
Number 
 
 Exhibit 
 
 File
Date 
 
 101.DEF 
 
 XBRL Taxonomy Extension Definition Linkbase Document 
 
 101.LAB 
 
 XBRL Taxonomy Extension Labels Linkbase Document 
 
 101.PRE 
 
 XBRL Taxonomy Extension Presentation Linkbase Document 
 
 104 
 
 Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101. 
 
 * 
 Furnished herewith and not deemed to be “filed” for purposes of Section 18 of 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-Q), irrespective of any general incorporate language contained in such filing. 
 
 SIGNATURES 
 Pursuant to the requirements 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. 

 (Registrant) 

 Date: October 31, 2023 
 
 By: 
 
 /s/ Daniel Tassé
 
 Daniel Tassé 

 Chief Executive Officer 

 (Principal Executive Officer) 

 Date: October 31, 2023 
 
 By: 
 
 /s/ Sébastien Robitaille
 
 Sébastien Robitaille 

 Chief Financial Officer 

 (Principal Financial and Accounting Officer) 

 28
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.
DBV Technologies S.A. 10-Q
