0001193125-23-199175.txt : 20230731 0001193125-23-199175.hdr.sgml : 20230731 20230731163601 ACCESSION NUMBER: 0001193125-23-199175 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 70 CONFORMED PERIOD OF REPORT: 20230630 FILED AS OF DATE: 20230731 DATE AS OF CHANGE: 20230731 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DBV Technologies S.A. CENTRAL INDEX KEY: 0001613780 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: I0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-36697 FILM NUMBER: 231127833 BUSINESS ADDRESS: STREET 1: 177-181 AVENUE PIERRE BROSSOLETTE CITY: MONTROUGE STATE: I0 ZIP: 92120 BUSINESS PHONE: 33(0)155427878 MAIL ADDRESS: STREET 1: 177-181 AVENUE PIERRE BROSSOLETTE CITY: MONTROUGE STATE: I0 ZIP: 92120 10-Q 1 d515836d10q.htm FORM 10-Q Form 10-Q
Table of Contents
falseQ20001613780--12-3100-0000000 0001613780 2023-06-30 0001613780 2022-12-31 0001613780 2022-04-01 2022-06-30 0001613780 2023-01-01 2023-06-30 0001613780 2022-01-01 2022-06-30 0001613780 2023-04-01 2023-06-30 0001613780 2023-07-31 0001613780 2022-01-01 2022-03-31 0001613780 2023-01-01 2023-03-31 0001613780 2021-12-31 0001613780 2022-03-31 0001613780 2022-06-30 0001613780 2023-03-31 0001613780 us-gaap:CommonStockMember 2022-12-31 0001613780 us-gaap:RealEstateMember 2022-12-31 0001613780 dbvt:OtherAssetMember 2022-12-31 0001613780 dbvt:TaxLiabilitiesMember 2022-12-31 0001613780 dbvt:OtherDebtsMember 2022-12-31 0001613780 dbvt:EmployeeRelatedLiabilitiesMember 2022-12-31 0001613780 dbvt:DeferredRevenueMember 2022-12-31 0001613780 us-gaap:CommonStockMember 2023-06-30 0001613780 us-gaap:RealEstateMember 2023-06-30 0001613780 dbvt:OtherAssetMember 2023-06-30 0001613780 dbvt:TaxLiabilitiesMember 2023-06-30 0001613780 dbvt:OtherDebtsMember 2023-06-30 0001613780 dbvt:EmployeeRelatedLiabilitiesMember 2023-06-30 0001613780 dbvt:DeferredRevenueMember 2023-06-30 0001613780 dbvt:CollaborationAgreementLossAtCompletionMember 2023-06-30 0001613780 dbvt:OtherProvisionsInclRestructuringMember 2023-06-30 0001613780 us-gaap:PostemploymentRetirementBenefitsMember 2023-06-30 0001613780 dbvt:AmericanDepositarySharesMember 2023-06-30 0001613780 dbvt:ShareCapitalMember 2023-06-30 0001613780 dbvt:ExpensesByFunctionMember 2022-01-01 2022-06-30 0001613780 dbvt:ExpensesByNatureMember 2022-01-01 2022-06-30 0001613780 dbvt:NonemployeewarrantsMember 2022-01-01 2022-06-30 0001613780 us-gaap:EmployeeStockOptionMember 2022-01-01 2022-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember 2022-01-01 2022-06-30 0001613780 dbvt:PrefundedWarrantsMember 2022-01-01 2022-06-30 0001613780 dbvt:RentExpensesMember 2022-01-01 2022-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember us-gaap:SellingAndMarketingExpenseMember 2022-01-01 2022-06-30 0001613780 us-gaap:GeneralAndAdministrativeExpenseMember us-gaap:EmployeeStockOptionMember 2022-01-01 2022-06-30 0001613780 us-gaap:GeneralAndAdministrativeExpenseMember us-gaap:RestrictedStockUnitsRSUMember 2022-01-01 2022-06-30 0001613780 us-gaap:ResearchAndDevelopmentExpenseMember us-gaap:EmployeeStockOptionMember 2022-01-01 2022-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember us-gaap:ResearchAndDevelopmentExpenseMember 2022-01-01 2022-06-30 0001613780 us-gaap:SellingAndMarketingExpenseMember us-gaap:EmployeeStockOptionMember 2022-01-01 2022-06-30 0001613780 dbvt:ExpensesByFunctionMember 2022-04-01 2022-06-30 0001613780 dbvt:ExpensesByNatureMember 2022-04-01 2022-06-30 0001613780 dbvt:NonemployeewarrantsMember 2022-04-01 2022-06-30 0001613780 us-gaap:EmployeeStockOptionMember 2022-04-01 2022-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember 2022-04-01 2022-06-30 0001613780 dbvt:PrefundedWarrantsMember 2022-04-01 2022-06-30 0001613780 us-gaap:RetainedEarningsMember 2022-04-01 2022-06-30 0001613780 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-04-01 2022-06-30 0001613780 us-gaap:AccumulatedTranslationAdjustmentMember 2022-04-01 2022-06-30 0001613780 us-gaap:CommonStockMember 2022-04-01 2022-06-30 0001613780 us-gaap:AdditionalPaidInCapitalMember 2022-04-01 2022-06-30 0001613780 us-gaap:TreasuryStockMember 2022-04-01 2022-06-30 0001613780 us-gaap:ResearchAndDevelopmentExpenseMember us-gaap:EmployeeStockOptionMember 2022-04-01 2022-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember us-gaap:SellingAndMarketingExpenseMember 2022-04-01 2022-06-30 0001613780 us-gaap:GeneralAndAdministrativeExpenseMember us-gaap:EmployeeStockOptionMember 2022-04-01 2022-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember us-gaap:GeneralAndAdministrativeExpenseMember 2022-04-01 2022-06-30 0001613780 us-gaap:ResearchAndDevelopmentExpenseMember us-gaap:RestrictedStockUnitsRSUMember 2022-04-01 2022-06-30 0001613780 us-gaap:SellingAndMarketingExpenseMember us-gaap:EmployeeStockOptionMember 2022-04-01 2022-06-30 0001613780 dbvt:ExpensesByFunctionMember 2023-01-01 2023-06-30 0001613780 dbvt:ExpensesByNatureMember 2023-01-01 2023-06-30 0001613780 dbvt:NonemployeewarrantsMember 2023-01-01 2023-06-30 0001613780 us-gaap:EmployeeStockOptionMember 2023-01-01 2023-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember 2023-01-01 2023-06-30 0001613780 dbvt:PrefundedWarrantsMember 2023-01-01 2023-06-30 0001613780 dbvt:RentExpensesMember 2023-01-01 2023-06-30 0001613780 dbvt:OtherProvisionsInclRestructuringMember 2023-01-01 2023-06-30 0001613780 us-gaap:PostemploymentRetirementBenefitsMember 2023-01-01 2023-06-30 0001613780 dbvt:CollaborationAgreementLossAtCompletionMember 2023-01-01 2023-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember 2023-01-01 2023-06-30 0001613780 us-gaap:ResearchAndDevelopmentExpenseMember us-gaap:EmployeeStockOptionMember 2023-01-01 2023-06-30 0001613780 us-gaap:SellingAndMarketingExpenseMember us-gaap:RestrictedStockUnitsRSUMember 2023-01-01 2023-06-30 0001613780 us-gaap:GeneralAndAdministrativeExpenseMember us-gaap:EmployeeStockOptionMember 2023-01-01 2023-06-30 0001613780 us-gaap:GeneralAndAdministrativeExpenseMember us-gaap:RestrictedStockUnitsRSUMember 2023-01-01 2023-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember us-gaap:ResearchAndDevelopmentExpenseMember 2023-01-01 2023-06-30 0001613780 us-gaap:SellingAndMarketingExpenseMember us-gaap:EmployeeStockOptionMember 2023-01-01 2023-06-30 0001613780 dei:AdrMember 2023-01-01 2023-06-30 0001613780 us-gaap:CommonStockMember 2023-01-01 2023-06-30 0001613780 dbvt:CollaborationAndLicenseAgreementMember 2023-01-01 2023-06-30 0001613780 dbvt:IncreaseInCurrentTradePayablesMember 2023-01-01 2023-06-30 0001613780 us-gaap:ResearchMember 2023-01-01 2023-06-30 0001613780 us-gaap:EmployeeStockOptionMember 2023-01-01 2023-06-30 0001613780 dbvt:ExpensesByFunctionMember 2023-04-01 2023-06-30 0001613780 dbvt:ExpensesByNatureMember 2023-04-01 2023-06-30 0001613780 dbvt:NonemployeewarrantsMember 2023-04-01 2023-06-30 0001613780 us-gaap:EmployeeStockOptionMember 2023-04-01 2023-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember 2023-04-01 2023-06-30 0001613780 dbvt:PrefundedWarrantsMember 2023-04-01 2023-06-30 0001613780 us-gaap:RetainedEarningsMember 2023-04-01 2023-06-30 0001613780 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-04-01 2023-06-30 0001613780 us-gaap:AccumulatedTranslationAdjustmentMember 2023-04-01 2023-06-30 0001613780 us-gaap:CommonStockMember 2023-04-01 2023-06-30 0001613780 us-gaap:AdditionalPaidInCapitalMember 2023-04-01 2023-06-30 0001613780 us-gaap:TreasuryStockMember 2023-04-01 2023-06-30 0001613780 us-gaap:ResearchAndDevelopmentExpenseMember us-gaap:EmployeeStockOptionMember 2023-04-01 2023-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember us-gaap:SellingAndMarketingExpenseMember 2023-04-01 2023-06-30 0001613780 us-gaap:GeneralAndAdministrativeExpenseMember us-gaap:EmployeeStockOptionMember 2023-04-01 2023-06-30 0001613780 us-gaap:GeneralAndAdministrativeExpenseMember us-gaap:RestrictedStockUnitsRSUMember 2023-04-01 2023-06-30 0001613780 us-gaap:RestrictedStockUnitsRSUMember us-gaap:ResearchAndDevelopmentExpenseMember 2023-04-01 2023-06-30 0001613780 us-gaap:SellingAndMarketingExpenseMember us-gaap:EmployeeStockOptionMember 2023-04-01 2023-06-30 0001613780 us-gaap:RetainedEarningsMember 2022-01-01 2022-03-31 0001613780 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-01-01 2022-03-31 0001613780 us-gaap:AccumulatedTranslationAdjustmentMember 2022-01-01 2022-03-31 0001613780 us-gaap:CommonStockMember 2022-01-01 2022-03-31 0001613780 us-gaap:AdditionalPaidInCapitalMember 2022-01-01 2022-03-31 0001613780 us-gaap:TreasuryStockMember 2022-01-01 2022-03-31 0001613780 us-gaap:RetainedEarningsMember 2023-01-01 2023-03-31 0001613780 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-01-01 2023-03-31 0001613780 us-gaap:AccumulatedTranslationAdjustmentMember 2023-01-01 2023-03-31 0001613780 us-gaap:CommonStockMember 2023-01-01 2023-03-31 0001613780 us-gaap:AdditionalPaidInCapitalMember 2023-01-01 2023-03-31 0001613780 us-gaap:TreasuryStockMember 2023-01-01 2023-03-31 0001613780 srt:MinimumMember dbvt:ViaskintmClinicalProgramForChildrenAgedBetweenFourToElevenMember 2020-01-31 2020-01-31 0001613780 dbvt:ViaskintmClinicalProgramForChildrenAgedBetweenFourToElevenMember srt:MaximumMember 2020-01-31 2020-01-31 0001613780 dbvt:ViaskintmClinicalProgramForChildrenAgedBetweenFourToElevenMember 2020-01-31 2020-01-31 0001613780 dbvt:AmericanDepositarySharesMember 2023-06-01 2023-06-30 0001613780 us-gaap:ResearchMember 2022-01-01 2022-12-31 0001613780 us-gaap:CommonStockMember 2022-06-30 0001613780 us-gaap:AdditionalPaidInCapitalMember 2022-06-30 0001613780 us-gaap:TreasuryStockMember 2022-06-30 0001613780 us-gaap:RetainedEarningsMember 2022-06-30 0001613780 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-06-30 0001613780 us-gaap:AccumulatedTranslationAdjustmentMember 2022-06-30 0001613780 us-gaap:PostemploymentRetirementBenefitsMember 2022-12-31 0001613780 dbvt:CollaborationAgreementLossAtCompletionMember 2022-12-31 0001613780 us-gaap:RestrictedStockUnitsRSUMember 2022-12-31 0001613780 us-gaap:RestrictedStockUnitsRSUMember 2023-06-30 0001613780 dbvt:BSAWarrantsMember 2022-12-31 0001613780 dbvt:BSAWarrantsMember 2023-06-30 0001613780 us-gaap:EmployeeStockOptionMember 2022-12-31 0001613780 us-gaap:EmployeeStockOptionMember 2023-06-30 0001613780 us-gaap:AdditionalPaidInCapitalMember 2023-06-30 0001613780 us-gaap:TreasuryStockMember 2023-06-30 0001613780 us-gaap:RetainedEarningsMember 2023-06-30 0001613780 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-06-30 0001613780 us-gaap:AccumulatedTranslationAdjustmentMember 2023-06-30 0001613780 us-gaap:CommonStockMember 2021-12-31 0001613780 us-gaap:AdditionalPaidInCapitalMember 2021-12-31 0001613780 us-gaap:TreasuryStockMember 2021-12-31 0001613780 us-gaap:RetainedEarningsMember 2021-12-31 0001613780 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-12-31 0001613780 us-gaap:AccumulatedTranslationAdjustmentMember 2021-12-31 0001613780 us-gaap:CommonStockMember 2022-03-31 0001613780 us-gaap:AdditionalPaidInCapitalMember 2022-03-31 0001613780 us-gaap:TreasuryStockMember 2022-03-31 0001613780 us-gaap:RetainedEarningsMember 2022-03-31 0001613780 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-03-31 0001613780 us-gaap:AccumulatedTranslationAdjustmentMember 2022-03-31 0001613780 us-gaap:AdditionalPaidInCapitalMember 2022-12-31 0001613780 us-gaap:TreasuryStockMember 2022-12-31 0001613780 us-gaap:RetainedEarningsMember 2022-12-31 0001613780 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-12-31 0001613780 us-gaap:AccumulatedTranslationAdjustmentMember 2022-12-31 0001613780 us-gaap:CommonStockMember 2023-03-31 0001613780 us-gaap:AdditionalPaidInCapitalMember 2023-03-31 0001613780 us-gaap:TreasuryStockMember 2023-03-31 0001613780 us-gaap:RetainedEarningsMember 2023-03-31 0001613780 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-03-31 0001613780 us-gaap:AccumulatedTranslationAdjustmentMember 2023-03-31 iso4217:USD xbrli:shares utr:Year utr:Month xbrli:pure iso4217:EUR iso4217:EUR xbrli:shares iso4217:USD xbrli:shares

 
 
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 June 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
 
Not applicable
State or other jurisdiction of
incorporation or organization
 
(I.R.S. Employer
Identification No.)
   
177-181
avenue Pierre Brossolette
92120 Montrouge France
 
N/A
(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
one-half
of one ordinary share, nominal value €0.10 per share
 
DBVT
 
The Nasdaq Stock Market LLC
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 July 31, 2023, the registrant had 96,250,954 ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.
 
 
 


Table of Contents

Table of contents

 

Part I

  Financial information      3  

Item 1

  Condensed Consolidated Statements of Financial Position (Unaudited) as of June 30, 2023 and December 31, 2022      3  
  Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Six Months Ended June 30, 2023 and 2022      4  
  Condensed Consolidated Statements of Cash Flows (Unaudited) for the Six Months Ended June 30, 2023 and 2022      5  
  Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Six Months Ended June 30, 2023 and 2022      6  
  Notes to the Condensed Consolidated Financial Statements (Unaudited)      7  

Item 2

  Management’s Discussion and Analysis of Financial Condition and Results of Operations      17  

Item 3

  Quantitative and Qualitative Disclosures About Market Risk      24  

Item 4

  Controls and Procedures      24  

Part II

  Other Information      24  

Item 1

  Legal Proceedings      24  

Item 1A

  Risk Factors      25  

Item 2

  Unregistered Sales of Equity Securities and Use of Proceeds      25  

Item 3

  Defaults Upon Senior Securities      25  

Item 4

  Mine Safety Disclosures      25  

Item 5

  Other Information      25  

Item 6

  Exhibits      25  

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.


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;

 

   

the impact of the COVID-19 pandemic and its effects on our operations, research and development, clinical trials and ability to obtain financing and potential disruption in the operations and business of third-party manufacturers, contract research organizations, or CROs, other service providers and collaborators with whom we conduct business; 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.

 

1


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.

 

 

2


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)
 
           
June 30,
   
December 31,
 
    
Note
    
2023
   
2022
 
Assets
                         
Current assets:
                         
Cash and cash equivalents
  
 
3
 
   $ 173,961     $ 209,194  
Other current assets
  
 
4
 
     21,578       13,880  
             
 
 
   
 
 
 
Total current assets
           
 
195,539
 
 
 
223,074
 
Property, plant, and equipment, net
              14,135       15,096  
Right-of-use
assets related to operating leases
  
 
5
 
     1,832       2,513  
Intangible assets
              68       10  
Other
non-current
assets
              5,944       5,824  
             
 
 
   
 
 
 
Total
non-current
assets
           
 
21,979
 
 
 
23,444
 
             
 
 
   
 
 
 
Total Assets
           
$
217,518
 
 
$
246,518
 
             
 
 
   
 
 
 
Liabilities and shareholders’ equity
                         
Current liabilities:
                         
Trade payables
  
 
6
 
   $ 19,094     $ 14,473  
Short-term operating leases
  
 
5
 
     1,944       1,894  
Current contingencies
  
 
9
 
     5,076       3,944  
Other current liabilities
  
 
6
 
     7,258       9,210  
             
 
 
   
 
 
 
Total current liabilities
           
 
33,373
 
 
 
29,521
 
             
 
 
   
 
 
 
Long-term operating leases
  
 
5
 
     187       1,127  
Non-current
contingencies
  
 
9
 
     15,731       16,680  
Other
non-current
liabilities
  
 
6
 
     3,987       4,735  
             
 
 
   
 
 
 
Total
non-current
liabilities
           
 
19,905
 
 
 
22,543
 
             
 
 
   
 
 
 
Total Liabilities
           
$
53,277
 
 
$
52,064
 
             
 
 
   
 
 
 
Shareholders’ equity:
                         
Ordinary shares, €0.10 par value; 96,250,954 and 94,137,145 shares authorized, and issued as
of
 June 30, 2023 and December 31, 2022, respectively
            $ 10,952     $ 10,720  
Additional
paid-in
capital
              375,759       458,221  
Treasury stock, 149,972 and 149,793 ordinary shares as of June 30, 2023 and December 31, 2022, respectively, at cost
              (1,082     (1,109
Accumulated deficit
              (210,940     (259,578
Accumulated other comprehensive income
              687       781  
Accumulated currency translation effect
              (11,136     (14,581
             
 
 
   
 
 
 
Total Shareholders’ equity
  
 
7
 
  
$
164,240
 
 
$
194,453
 
             
 
 
   
 
 
 
Total Liabilities and Shareholders’ equity
           
$
217,518
 
 
$
246,518
 
             
 
 
   
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
3

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 June 30,
   
Six Months Ended
June 30,
 
    
Note
    
2023
   
2022
   
2023
   
2022
 
Operating income
  
 
10
 
  
$
2,288
 
 
$
1,529
 
 
$
4,482
 
 
$
4,074
 
Operating expenses
                                         
Research and development expenses
              (17,616     (18,611     (33,653     (30,834
Sales and marketing expenses
              (516     (1,037     (950     (1,500
General and administrative expenses
              (9,231     (5,704     (16,120     (12,334
             
 
 
   
 
 
   
 
 
   
 
 
 
Total Operating expenses
           
 
(27,364
 
 
(25,352
 
 
(50,723
 
 
(44,669
             
 
 
   
 
 
   
 
 
   
 
 
 
Loss from operations
           
 
(25,076
 
 
(23,823
 
 
(46,242
 
 
(40,595
             
 
 
   
 
 
   
 
 
   
 
 
 
Financial income (expenses)
              846       784       1,450       936  
             
 
 
   
 
 
   
 
 
   
 
 
 
Loss before taxes
           
 
(24,230
 
 
(23,039
 
 
(44,791
 
 
(39,659
             
 
 
   
 
 
   
 
 
   
 
 
 
Income tax
              (13           (13     (87
             
 
 
   
 
 
   
 
 
   
 
 
 
Net loss
           
$
(24,243
 
$
(23,039
 
$
(44,804
 
$
(39,746
             
 
 
   
 
 
   
 
 
   
 
 
 
Foreign currency translation differences, net of taxes
              (221     (11,394     3,445       (13,327
Actuarial gains (losses) on employee benefits, net of taxes
              (10     200       (92     224  
             
 
 
   
 
 
   
 
 
   
 
 
 
Total comprehensive loss
           
$
(24,475
 
$
(34,234
 
$
(41,452
 
$
(52,849
             
 
 
   
 
 
   
 
 
   
 
 
 
Basic/diluted net loss per share attributable to shareholders
  
 
14
 
  
$
(0.26
 
$
(0.35
 
$
(0.48
 
$
(0.66
Weighted average shares outstanding used in computing per share amounts:
              94,324,889       66,047,949       94,150,141       60,490,075  
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
4

DBV Technologies S.A.
Condensed Consolidated Statements of Cash Flows (unaudited)
(amounts in thousands)
 
           
Six Months
Ended June 30,
 
    
Notes
    
2023
   
2022
 
Net loss for the period
           
$
(44,804
 
$
(39,746
Adjustments to reconcile net loss to net cash flow provided by (used in) operating activities:
                         
Depreciation, amortization and accrued contingencies
              369       1,249  
Retirement pension obligations
              11       14  
Expenses related to share-based payments
  
 
8
 
     3,446       2,441  
Other elements
              23       (3
Changes in operating assets and liabilities:
                         
Decrease (increase) in other current assets
              (6,481     23,436  
(Decrease) increase in trade payables
              3,419       5,894  
(Decrease) increase in other current and
non-current
liabilities
              (2,913     (3,040
Change in operating lease liabilities and right of use assets
              535       (1,979
Net cash flow provided by (used in) operating activities
           
 
(46,394
 
 
(11,733
             
 
 
   
 
 
 
Cash flows provided by (used in) investing activities:
                         
Acquisitions of property, plant, and equipment, net from proceeds
              (275     (369
Proceeds from property, plant, and equipment dispositions
                       3  
Acquisitions of
non-current
financial assets
              (27     (279
Proceeds from
non-current
financial assets dispositions
              4       426  
             
 
 
   
 
 
 
Net cash flows provided by (used in) investing activities
           
 
(299
 
 
(218
             
 
 
   
 
 
 
Cash flows provided by (used in) financing activities:
                         
Decrease in conditional advances
                       (328
Treasury shares
              27       279  
Capital increases, net of transaction costs
              7,766       195,270  
Other cash flows related to financing activities
                           
             
 
 
   
 
 
 
Net cash flows provided by (used in) financing activities
           
 
7,793
 
 
 
195,221
 
             
 
 
   
 
 
 
Effect of exchange rate changes on cash and cash equivalents
              3,668       (12,600
             
 
 
   
 
 
 
Net increase (decrease) in cash and cash equivalents
           
 
(35,232
 
 
170,670
 
             
 
 
   
 
 
 
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
 
  
$
173,961
 
 
$
247,971
 
             
 
 
   
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
5

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
 
 
    
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
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
6

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.
 
7

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 Current Status
In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following 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.
Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:
 
  1.
Identify a modified Viaskin patch (which the Company calls “mVP”).
 
  2.
Generate the
6-month
safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible.
 
  3.
Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional Phase 1 clinical trials in healthy adult volunteers:
 
  a.
PREQUAL, a Phase 1 study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL
.
The data collection phase of the trial is complete, and the data analysis phase is ongoing.
 
  b.
‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and mVP;
In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches. The Company completed CHAMP in the second quarter of 2021. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and 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.
 
8

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 Institution
al
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.
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 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 will also generate patch adhesion data and will include updated instructions for use.
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.
 
9

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 in 2024 and topline results in the first half in 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, 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.
 
10

Note 3: Cash and Cash Equivalents
The following tables summarize the cash and cash equivalents as of June 30, 2023 and December 31, 2022:
 
    
June 30,
    
December 31,
 
    
2023
    
2022
 
Cash
     24,111        30,104  
Cash equivalents
     149,850        179,090  
    
 
 
    
 
 
 
Total cash and cash equivalents as reported in the statements of financial position
  
 
173,961
 
  
 
209,194
 
    
 
 
    
 
 
 
Bank overdrafts
                   
    
 
 
    
 
 
 
Total cash and cash equivalents as reported in the statements of cash flows
  
 
173,961
 
  
 
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:
 
 
  
June 30,
2023
 
  
December 31,
2022
 
Research tax credit
     9,662        5,792  
Other tax claims
     5,851        3,903  
Prepaid expenses
     4,494        2,680  
Other receivables
     1,571        1,504  
    
 
 
    
 
 
 
Total
  
 
21,578
 
  
 
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
     3,741  
- Payment received
         
- Adjustment and currency translation effect
     130  
    
 
 
 
Closing research tax credit receivable as of June 30, 2023
  
 
9,662
 
    
 
 
 
Of which -
Non-current
portion
         
Of which - Current portion
     9,662  
Before currency translation effect, the balance in research tax credit as of June 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 $3.7 million estimated research tax credit for the first six 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.
 
11

Note 5 Lease contracts
Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2023 and December 31, 2022, are as follows:
 
    
June 30, 2023
   
December 31, 2022
 
    
Real estate
   
Other
assets
   
Total
   
Real estate
   
Other
assets
   
Total
 
Current portion
     1,886       74       1,961       1,972       79       2,051  
Year 2
     291       43       334       1,168       74       1,243  
Year 3
              —                  65       6       71  
Thereafter
                                                      
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total minimum lease payments
  
 
2,177
 
 
 
118
 
 
 
2,295
 
 
 
3,204
 
 
 
160
 
 
 
3,364
 
Less: Effects of discounting
     (153     (10     (163     (325     (17     (343
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Present value of operating lease
  
 
2,024
 
 
 
107
 
 
 
2,131
 
 
 
2,879
 
 
 
143
 
 
 
3,021
 
Less: current portion
     (1,873     (72     (1,944     (1,823     (71     (1,894
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Long-term operating lease
  
 
151
 
 
 
36
 
 
 
187
 
 
 
1,055
 
 
 
72
 
 
 
1,127
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Weighted average remaining lease term (years)
     0.95       —                 1.40       —            
Weighted average discount rate
     2.90     2.50             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:
 
    
June 30,
 
    
2023
    
2022
 
Operating lease expense / (income)
     1,543        950  
Net termination impact
     (920      (1,657
Supplemental cash flow information related to operating leases is as follows for the period June 30, 2023 and 2022:
 
    
June 30,
 
    
2023
    
2022
 
Cash paid for amounts included in the measurement of lease liabilities
                 
Operating cash outflows related to operating leases
     963        1,079  
Note 6: Trade Payables and Other Current Liabilities
6.1 Trade Payables
Trade payables increased by $4.6 million as of June 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.
 
12

6.2 Other Liabilities
The following tables summarize the other liabilities as of June 30, 2023 and December 31, 2022:
 
    
June 30,
    
December 31,
 
    
2023
    
2022
 
    
Other
 current

liabilities
    
Other
 non-current

liabilities
     Total     
Other
 current

liabilities
    
Other
 non-current

liabilities
     Total  
Employee related liabilities
     4,374                  4,374        5,872        45        5,917  
Deferred income
     2,264        3,987        6,251        2,137        4,690        6,828  
Tax liabilities
     187                  187        69                  69  
Other debts
     433                  433        1,131                  1,131  
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
Total
  
 
7,258
 
  
 
3,987
 
  
 
11,245
 
  
 
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 June 30, 2023 is set at the sum of €9,625,095.40 ($10,952 thousands converted at historical rates). It is divided into 96,250,954 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.
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 six months ended June 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
     —          (75,200      (54,444
Exercised/released during the period
     —          —          (61,359
Expired during the period
     —          —          —    
    
 
 
    
 
 
    
 
 
 
Balance as of June 30, 2023
  
 
251,693
 
  
 
5,290,569
 
  
 
1,509,078
 
    
 
 
    
 
 
    
 
 
 
 
13

Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:
 
           
Three Months
Ended June 30,
   
Six Months
Ended June 30,
 
           
2023
   
2022
   
2023
   
2022
 
Research & development
     SO        (465     (290     (894     (665
       RSU        (271     (185     (529     (393
Sales & marketing
     SO        (27     (38     (54     (33
       RSU        (8     (17     (17     (16
General & administrative
     SO        (925     (478     (1,722     (1,176
       RSU        (118     (70     (231     (157
             
 
 
   
 
 
   
 
 
   
 
 
 
Total share-based compensation (expense)
           
 
(1,814
 
 
(1,078
 
 
(3,446
 
 
(2,441
             
 
 
   
 
 
   
 
 
   
 
 
 
Note 9: Contingencies
The following tables summarize the contingencies as of June 30, 2023 and December 31, 2022:
 
    
June 30,
    
December 31,
 
    
2023
    
2022
 
Current contingencies
     5,076        3,944  
Non-current
contingencies
     15,731        16,680  
    
 
 
    
 
 
 
Total contingencies
  
 
20,807
 
  
 
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
     11        —          780        791  
Used liabilities
     —          —          —              
Reversals of unused liabilities
     —          (1,083      —          (1,083
Net interest related to employee benefits, and unwinding of discount
     —          —          —              
Actuarial gains and losses on defined-benefit plans
     93        —          —          93  
Currency translation effect
     15        366                  381  
    
 
 
    
 
 
    
 
 
    
 
 
 
At June 30, 2023
  
 
909
 
  
 
19,118
 
  
 
780
 
  
 
20,807
 
    
 
 
    
 
 
    
 
 
    
 
 
 
Of which Current
  
 
—  
 
  
 
4,296
 
  
 
780
 
  
 
5,076
 
Of which
Non-current
  
 
909
 
  
 
14,822
 
  
 
—  
 
  
 
15,731
 
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 six months of 2023, the Company updated its measurement of progress of the Phase 2 clinical trial (“PII”) conducted as part of the collaboration and license agreement with Nestlé Health Sciences and updated the cumulative income recognized. The Company recognized a reversal of $1.1 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.
 
14

Note 10: Operating income
The following table summarizes the operating income during the three and six months ended June 30, 2023 and 2022:
 
    
Three Months Ended
June 30,
    
Six Months Ended
June 30,
 
    
2023
    
2022
    
2023
    
2022
 
Research tax credit
     1,975        1,491        3,741        3,060  
Other operating income
     312        37        741        1,014  
    
 
 
    
 
 
    
 
 
    
 
 
 
Total
  
 
2,288
 
  
 
1,529
 
  
 
4,482
 
  
 
4,074
 
    
 
 
    
 
 
    
 
 
    
 
 
 
The increase in operating income 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 June 30, 2023 (see note 9 related to contingencies).
Note 11: Allocation of Personnel Expenses
The Company had an average of 88 employees during the six months ended June 30, 2023, in comparison with an average of 87 employees during the six months ended June 30, 2022.
The following table summarizes the allocation of personnel expenses by function during the three and six months ended June 30, 2023 and 2022:
 
    
Three Months
Ended June 30,
    
Six Months
Ended June 30,
 
    
2023
    
2022
    
2023
    
2022
 
Research and Development expenses
     4,014        3,097        8,020        6,172  
Sales and Marketing expenses
     208        344        373        589  
General and Administrative expenses
     2,858        2,767        5,958        5,362  
    
 
 
    
 
 
    
 
 
    
 
 
 
Total personnel expenses
  
 
7,079
 
  
 
6,208
 
  
 
14,351
 
  
 
12,123
 
    
 
 
    
 
 
    
 
 
    
 
 
 
The following table summarizes the allocation of personnel expenses by nature during the three and six months ended June 30, 2023 and 2022:
 
    
Three Months
Ended June 30,
    
Six Months
Ended June 30,
 
    
2023
    
2022
    
2023
    
2022
 
Wages and salaries
     4,078        3,509        8,516        7,497  
Social security contributions
     1,185        1,256        1,884        1,507  
Expenses for pension commitments
     246        211        504        509  
Employer contribution to bonus shares
     (244      154               170  
Share-based payments
     1,814        1,078        3,446        2,441  
    
 
 
    
 
 
    
 
 
    
 
 
 
Total
  
 
7,079
 
  
 
6,208
 
  
 
14,351
 
  
 
12,123
 
    
 
 
    
 
 
    
 
 
    
 
 
 
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 consolidated financial statements included in the Annual Report.
 
15

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 June 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
six-month
periods ended June 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 six months ended June 30, 2023 and 2022 indicated in number of potential shares:
 
    
Three Months Ended
June 30,
    
Six Months Ended
June 30,
 
    
2023
    
2022
    
2023
    
2022
 
Non-employee
warrants
     251,693        256,693        251,693        256,693  
Stock options
     5,290,569        3,442,358        5,290,569        3,442,358  
Restricted stock units
     1,509,078        1,145,223        1,509,078        1,145,223  
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 June 30, 2023, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on July 28, 2023, and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.
 
16


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 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 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.

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.

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.

 

17


Table of Contents

Business trends and Results of Operations

Comparison of the Three Months Ended June 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 June 30, 2023 and 2022.

 

     Three months ended June 30,                
     2023      2022      $ change      % change  

Operating income

   $ 2,288      $ 1,529        759        50

Operating expenses

           

Research and development expenses

     (17,616      (18,611      995        (5 )% 

Sales and marketing expenses

     (516      (1,037      520        (50 )% 

General and administrative expenses

     (9,231      (5,704      (3,527      62
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Operating expenses

     (27,364      (25,352      (2,012      8
  

 

 

    

 

 

    

 

 

    

 

 

 

Financial income (expenses)

     846        784        62        8
  

 

 

    

 

 

    

 

 

    

 

 

 

Income tax

     (13      —          (13      —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Net loss

   $ (24,243    $ (23,039      (1,204 )       5
  

 

 

    

 

 

    

 

 

    

 

 

 

Basic/diluted Net loss per share attributable to shareholders

   $ (0.26    $ (0.35      

Operating Income

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

 

     Three months ended June 30,                
     2023      2022      $ change      % change  

Sales

     —          —          —          —    

Other income

     2,288        1,529        759        50

Research tax credit

     1,975        1,491        484        32

Other operating income

     312        37        275        734
  

 

 

    

 

 

    

 

 

    

 

 

 

Total operating income

     2,288        1,529        759        50
  

 

 

    

 

 

    

 

 

    

 

 

 

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 $2.3 million during the three months ended June 30, 2023 compared to $1.5 million during the three months ended June 30, 2022.

The increase in operating income was primarily due to the increase by $0.5 million in French research tax credit as the eligible employee-related costs 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.

In addition, other operating income increased by $0.3 million for the three months ended June 30, 2023, compared to the three months ended June 30, 2022, after we updated the measurement of progress of the Phase 2 clinical trial conducted as part of the Nestlé’s collaboration agreement.

Operating Expenses

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the three months ended June 30, 2023 and 2022:

 

18


Table of Contents
     Three Months Ended June 30,                
Research and Development expenses    2023      2022      $ change      % change  

External clinical-related expenses

     11,421        11,664        (243      (2 )% 

Employee-related costs (excl. share-based payments)

     3,278        2,622        656        25

Share-based payment expenses

     736        475        261        55

Depreciation, amortization and other costs

     2,181        3,850        (1,669      (43 )% 
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Research and Development expenses

     17,616        18,611        (995      50
  

 

 

    

 

 

    

 

 

    

 

 

 

Research and Development expenses decreased by $1.0 million for the three months ended June 30, 2023, compared to the three months ended June 30, 2022, primarily due to the reversal of $1.1 million of the loss at completion recorded as other costs on the Phase 2 clinical trial conducted as part of the collaboration agreement with Nestlé. During the three months ended June 30, 2022, the loss at completion was impacted by additional clinical and production costs following increasing timing to achieve upcoming milestones. During the three months ended June 30, 2023, there were no changes to the timing to completion.

In addition external clinical expenses decreased by $0.2 million as a result of differences in phasing of on-going clinical trials between the three months ended June 30, 2022 and the three months ended June 30, 2023.

Decreases in impacts of the loss at completion and in external clinical-related expenses were partially offset by the increase by $0.7 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 June 30, 2023 and 2022:

 

     Three Months Ended June 30,                
Sales and Marketing expenses    2023      2022      $ change      % change  

External professional services

     80        399        (319      (80 )% 

Employee-related costs (excl. share-based payments)

     173        289        (116      (40 )% 

Share-based payment expenses

     35        55        (20      (36 )% 

Depreciation, amortization and other costs

     229        294        (65      (22 )% 
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Sales and Marketing expenses

     516        1,037        (520      (50 )% 
  

 

 

    

 

 

    

 

 

    

 

 

 

Sales and marketing expenses decreased by $0.5 million for the three months ended June 30, 2023, compared to the three months ended June 30, 2022, due to a decrease of external professional services and employee-related costs.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the three months ended June 30, 2023 and 2022:

 

     Three Months Ended June 30,                
General and Administrative expenses    2023      2022      $ change      % change  

External professional services

     3,806        1,771        2,034        115

Employee-related costs (excl. share-based payments)

     1,814        2,220        (405      (18 )% 

Share-based payment expenses

     1,043        548        496        91

Depreciation, amortization and other costs

     2,568        1,166        1,402        120
  

 

 

    

 

 

    

 

 

    

 

 

 

Total General and Administrative expenses

     9,231        5,704        3,527        62
  

 

 

    

 

 

    

 

 

    

 

 

 

General and Administrative expenses increased by $3.5 million for the three months ended June 30, 2023, compared to the three months ended June 30, 2022, mainly due to one-time costs associated with financing activities, organizational planning, market research and planning activities. In addition, we recorded a provision amounting to $0.7 million as of June 30, 2023, as our best estimate of costs to be incurred if the Montrouge office lease agreement is not renewed at its July 2024 terms.

 

19


Table of Contents

Financial income (expense)

Our financial income was $0.8 million for the three months ended June 30, 2023, compared to a financial income of $0.8 million for the three months ended June 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 June 30, 2023 and June 30, 2022.

Net loss

Net loss was $24.2 million for the three months ended June 30, 2023, compared to $23 million for the three months ended June 30, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.26 and $0.35 for the three months ended June 30, 2023 and 2022, respectively.

Comparison of the Six Months Ended June 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 six months ended June 30, 2023 and 2022.

 

     Six months ended June 30,                
     2023      2022      $ change      % change  

Operating income

   $ 4,482      $ 4,074        407        10

Operating expenses

           

Research and development expenses

     (33,653      (30,834      (2,819      9

Sales and marketing expenses

     (950      (1,500      551        (37 )% 

General and administrative expenses

     (16,120      (12,334      (3,786      31
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Operating expenses

     (50,723      (44,669      (6,054      14
  

 

 

    

 

 

    

 

 

    

 

 

 

Financial income (expense)

     1,450        936        515        55
  

 

 

    

 

 

    

 

 

    

 

 

 

Income tax

     (13      (87      74        (85 )% 
  

 

 

    

 

 

    

 

 

    

 

 

 

Net loss

   $ (44,804    $ (39,746      (5,058      13
  

 

 

    

 

 

    

 

 

    

 

 

 

Basic/diluted Net loss per share attributable to shareholders

   $ (0.48    $ (0.66      
  

 

 

    

 

 

    

 

 

    

 

 

 

Operating Income

The following table summarizes our operating income during the six months ended June 30, 2023 and 2022:

 

     Six months ended June 30,                
     2023      2022      $ change      % change  

Sales

     —          —          

Other income

     4,482        4,074        407        10

Research tax credit

     3,741        3,060        680        22

Other operating income

     741        1,014        (273      (27 )% 
  

 

 

    

 

 

    

 

 

    

 

 

 

Total operating income

     4,482        4,074        407        10
  

 

 

    

 

 

    

 

 

    

 

 

 

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 $4.5 million during the six months ended June 30, 2023 compared to $4.1 million during the six months ended June 30, 2022.

The increase in operating income was due to the increase by $0.7 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.

 

20


Table of Contents

The increase in research tax credit was partially offset by the decrease by $0.3 million in other operating income for the six months ended June 30, 2023, compared to the six months ended June 30, 2022, after we updated the measurement of progress of the Phase 2 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 six months ended June 30, 2023 and 2022:

 

     Six Months Ended June 30,                
Research and Development expenses    2023      2022      $ change      % change  

External clinical-related expenses

     21,892        19,014        2,878        15

Employee-related costs (excl. share-based payments)

     6,598        5,114        1,484        29

Share-based payment expenses

     1,423        1,058        365        34

Depreciation, amortization and other costs

     3,741        5,648        (1,908      (34 )% 
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Research and Development expenses

     33,653        30,834        2,819        9
  

 

 

    

 

 

    

 

 

    

 

 

 

Research and Development expenses increased by $2.8 million for the six months ended June 30, 2023, compared to the six months ended June 30, 2022, primarily due to the increase by $2.9 million and by $1.5 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 $1.1 million of the loss at completion recorded as other costs on the Phase 2 clinical trial conducted as part of the collaboration agreement with Nestlé. During the six months ended June 30, 2022, the loss at completion was impacted by additional clinical and production costs following increasing timing to achieve upcoming milestones. During the six months ended June 30, 2023, there were no changes to the timing to completion.

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2023 and 2022:

 

     Six Months Ended June 30,                
Sales and Marketing expenses    2023      2022      $ change      % change  

External professional services

     348        521        (173      (33 )% 

Employee-related costs (excl. share-based payments)

     303        539        (237      (44 )% 

Share-based payment expenses

     70        49        21        41

Depreciation, amortization and other costs

     229        391        (162      (41 )% 
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Sales and Marketing expenses

     950        1,500        (551      (37 )% 
  

 

 

    

 

 

    

 

 

    

 

 

 

Sales and marketing expenses decreased by $ 0.6 million for the six months ended June 30, 2023, compared to the six months ended June 30, 2022, primarily due to a decrease of external professional services and employee-related costs.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2023 and 2022:

 

     Six Months Ended June 30,                
General and Administrative expenses    2023      2022      $ change      % change  

External professional services

     5,512        2,879        2,633        91

Employee-related costs (excl. share-based payments)

     4,005        4,029        (25      (1 )% 

Share-based payment expenses

     1,954        1,333        620        47

Depreciation, amortization and other costs

     4,650        4,093        557        14
  

 

 

    

 

 

    

 

 

    

 

 

 

Total General and Administrative expenses

     16,120        12,334        3,786        31
  

 

 

    

 

 

    

 

 

    

 

 

 

 

21


Table of Contents

General and Administrative expenses increased by $3.8 million for the six months ended June 30, 2023, compared to the six months ended June 30, 2022, mainly due to one-time costs associated with financing activities, organizational planning, market research and planning activities. In addition, we recorded a provision amounting to $0.7 million as of June 30, 2023, as our best estimate of costs to be incurred if the Montrouge office lease agreement is not renewed at its July 2024 terms.

Financial income (expense)

Our financial income was $1.5 million for the six months ended June 30, 2023, compared to a financial income of $0.9 million for the six months ended June 30, 2022. This item mainly includes financial income on our financial assets.

Income tax

Our income tax expense was nil for the six months ended June 30, 2023 and June 30, 2022.

Net loss

Net loss was $ 44.8 million for the six months ended June 30, 2023, compared to $39.7 million for the six months ended June 30, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.48 and $0.66 for the six months ended June 30, 2023 and 2022, respectively.

Liquidity and Capital Resources

Financial Condition

On June 30, 2023, we had $174 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 $ 46.4 million and $11.7 million for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, we recorded a net loss of $ 44.8 million. Our net cash flows provided by financing activities decreased to $7.8 million during the six months ended June 30, 2023 from $195.2 million during the six months ended June 30, 2022 due to more important financing operations in first semester of 2022 (May 2022 ATM and June 2022 PIPE) compared to 2023 (June 2023 ATM).

Our 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 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.

 

22


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 $0.8 million cash requirement as of June 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 June 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 six months ended June 30, 2023 and 2022.

 

     Six months ended June 30,