Table of Contents
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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 March 31, 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 May
2
, 2023, the registrant had 94,147,319 ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.
 
 
 

Table of Contents

Table of contents

 

Part I

   Financial information      1  

Item 1

   Condensed Consolidated Statements of Financial Position (Unaudited) as of March 31, 2023 and December 31, 2022      1  
  Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three Months Ended March 31, 2023 and 2022      2  
  Condensed Consolidated Statements of Cash Flows (Unaudited) for the Three Months Ended March 31, 2023 and 2022      3  
  Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Three Months Ended March 31, 2023 and 2022      4  
  Notes to the Condensed Consolidated Financial Statements (Unaudited)      5  

Item 2

   Management’s Discussion and Analysis of Financial Condition and Results of Operations      15  

Item 3

   Quantitative and Qualitative Disclosures About Market Risk      21  

Item 4

   Controls and Procedures      21  

Part II

   Other Information      22  

Item 1

   Legal Proceedings      22  

Item 1A

   Risk Factors      22  

Item 2

   Unregistered Sales of Equity Securities and Use of Proceeds      22  

Item 3

   Defaults Upon Senior Securities      22  

Item 4

   Mine Safety Disclosures      23  

Item 5

   Other Information      23  

Item 6

   Exhibits      24  

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;

 

1

Table of Contents
  •  

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.

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)
 
         
March 31,
    
December 31,
  
    
Note
   
2023
    
2022
  
Assets
                      
Current assets:
                      
Cash and cash equivalents
   
3
    $ 192,289     $ 209,194  
Other current assets
   
4
      17,946       13,880  
         
 
 
    
 
 
  
Total current assets
        
 
210,236
 
  
 
223,074
 
Property, plant, and equipment, net
           14,786       15,096  
Right-of-use
assets related to operating leases
   
5
      2,127       2,513  
Intangible assets
           10       10  
Other
non-current
assets
           5,771       5,824  
         
 
 
    
 
 
  
Total
non-current
assets
        
 
22,693
 
  
 
23,444
 
         
 
 
    
 
 
  
Total Assets
        
$
232,929
 
  
$
246,518
 
         
 
 
    
 
 
  
Liabilities and shareholders’ equity
                      
Current liabilities:
                      
Trade payables
   
6
    $ 19,938     $ 14,473  
Short-term operating leases
   
5
      1,923       1,894  
Current contingencies
   
9
      4,142       3,944  
Other current liabilities
   
6
      6,776       9,210  
         
 
 
    
 
 
  
Total current liabilities
        
 
32,778
 
  
 
29,521
 
         
 
 
    
 
 
  
Long-term operating leases
   
5
      680       1,127  
Non-current
contingencies
   
9
      15,989       16,680  
Other
non-current
liabilities
   
6
      4,387       4,735  
         
 
 
    
 
 
  
Total
non-current
liabilities
        
 
21,056
 
  
 
22,543
 
         
 
 
    
 
 
  
Total Liabilities
        
$
53,834
 
  
$
52,064
 
         
 
 
    
 
 
  
Shareholders’ equity:
                      
Ordinary shares, €0.10 par value; 94,147,319 and 94,137,145 shares authorized, and issued as of March 31, 2023 and December 31, 2022, respectively
         $ 10,721     $ 10,720  
Additional
paid-in
capital
           459,852       458,221  
Treasury stock, 157,654 and 149,793 ordinary shares as of March 31, 2023 and December 31, 2022, respectively, at cost
           (1,123 )      (1,109 ) 
Accumulated deficit
           (280,138 )      (259,578 ) 
Accumulated other comprehensive income
           698       781  
Accumulated currency translation effect
           (10,915 )      (14,581 ) 
         
 
 
    
 
 
  
Total Shareholders’ equity
   
7
   
$
179,094
 
  
$
194,453
 
         
 
 
    
 
 
  
Total Liabilities and Shareholders’ equity
        
$
232,929
 
  
$
246,518
 
         
 
 
    
 
 
  
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
1
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
March 31,
  
    
Note
   
2023
    
2022
  
Operating income
   
10
   
$
2,194
 
  
$
2,546
 
Operating expenses
                      
Research and development expenses
           (16,037 )      (12,223 ) 
Sales and marketing expenses
           (434 )      (464 ) 
General and administrative expenses
           (6,889 )      (6,630 ) 
         
 
 
    
 
 
  
Total Operating expenses
        
 
(23,359
) 
  
 
(19,317
) 
         
 
 
    
 
 
  
Loss from operations
        
 
(21,165
) 
  
 
(16,771
) 
         
 
 
    
 
 
  
Financial income(expenses)
           605       152  
         
 
 
    
 
 
  
Loss before taxes
        
 
(20,561
) 
  
 
(16,619
) 
         
 
 
    
 
 
  
Income tax (expense)
           —         (87 ) 
         
 
 
    
 
 
  
Net loss
        
$
(20,561
) 
  
$
(16,706
) 
         
 
 
    
 
 
  
Foreign currency translation differences, net of taxes
           3,666       (1,933 ) 
Actuarial gains (losses) on employee benefits, net of taxes
           (82 )      24  
         
 
 
    
 
 
  
Total comprehensive loss
        
$
(16,977
) 
  
$
(18,615
) 
         
 
 
    
 
 
  
Basic/diluted Net loss per share attributable to shareholders
   
14
   
$
(0.22
) 
  
$
(0.30
) 
Weighted average shares outstanding used in computing per share amounts:
           93,970,598       54,932,192  
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
2
DBV Technologies S.A.
Condensed Consolidated Statements of Cash Flows (unaudited)
(amounts in thousands)
 
         
Three Months Ended March 31,
  
    
Notes
   
2023
    
2022
  
Net loss for the period
        
$
(20,561
) 
  
$
(16,706
) 
Adjustments to reconcile net loss to net cash flow provided by (used in) operating activities:
                      
Depreciation, amortization and accrued contingencies
           (228 )      (599 ) 
Retirement pension obligations
           (35 )      (9 ) 
Expenses related to share-based payments
   
8
      1,632       1,363  
Other elements
           —         (3 ) 
Changes in operating assets and liabilities:
                      
Decrease (increase) in other current assets
           (3,098 )      20,458  
(Decrease) increase in trade payables
           4,478       (19 ) 
(Decrease) increase in other current and
non-current
liabilities
           (2,989 )      (4,118 ) 
Change in operating lease liabilities and right of use assets
           (42 )      (1,849 ) 
Net cash flow provided by (used in) operating activities
        
 
(20,841
) 
  
 
(1,483
) 
         
 
 
    
 
 
  
Cash flows provided by (used in) investing activities:
                      
Acquisitions of property, plant, and equipment
           (111 )      (131 ) 
Proceeds from property, plant, and equipment dispositions
           —         3  
Acquisitions of
non-current
financial assets
           —         (40 ) 
Proceeds from
non-current
financial assets dispositions
           153       179  
         
 
 
    
 
 
  
Net cash flows provided by (used in) investing activities
        
 
42
 
  
 
11
 
         
 
 
    
 
 
  
Cash flows provided by (used in) financing activities:
                      
(Decrease) increase in conditional advances
           —         (168 ) 
Treasury shares
           (14 )     40  
         
 
 
    
 
 
  
Net cash flows provided by (used in) financing activities
        
 
(14
) 
  
 
(129
) 
         
 
 
    
 
 
  
Effect of exchange rate changes on cash and cash equivalents
           3,909       (1,594 ) 
         
 
 
    
 
 
  
Net increase (decrease) in cash and cash equivalents
        
 
(16,905
) 
  
 
(3,194
) 
         
 
 
    
 
 
  
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
   
$
192,289
 
  
$
74,107
 
         
 
 
    
 
 
  
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
3
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 ) 
Insuance 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
 
 
                                                                 
    
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  
Insuance 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
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
4
NOTES TO THE 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.
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.
 
5
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 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 1 trial with adult healthy volunteers to compare the allergen uptake of cVP and mVP;
In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches. The Company completed CHAMP in the second quarter of 2021. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and 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.
 
6
In 2022, the Company announced the new Phase 3 pivotal study for modified Viaskin Peanut (mvP) patch would be in younger
(4-7
years old) and more sensitive children with peanut allergy.
On September 7, 2022, the Company announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages
4-7
years with peanut allergy. We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional review Board (IRB)/Ethics Committee (EC) approval.
On September 21, 2022, the Company announced it received feedback from the U.S. FDA in the form of a partial clinical hold on VITESSE . In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and
start-up
activities for prompt study launch once the partial clinical hold was lifted.
On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol.

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.
European Union Regulatory History and Current Status
On August 2, 2021, the Company announced its 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 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.
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 the FDA provided written responses regarding the regulatory path for Viaskin Peanut in toddlers ages 1-3 years old with a confirmed peanut allergy. In February 2023 the Company submitted a pre-BLA Meeting request to FDA and the Agency granted DBV’s request as a written response only. In the written responses received, the Agency confirmed that the Company’s Phase 3 EPITOPE study met the pre-specified criteria for success for the primary endpoint. The FDA did not request an additional efficacy study to support a future BLA but requires that DBV conduct an additional safety study in 1 – 3-year-olds using the original Viaskin Peanut patch to augment the safety data collected from the Phase 3 EPITOPE study. The new safety study is intended to bring the safety database in 1–3-year-olds close to 600 patients on active treatment which is consistent with FDA’s position in support of the Company’s dossier in 4–7-year-olds. The safety study will not require a food challenge for study participation, will generate patch adhesion data, and will include updated instructions for use.
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.
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.
 
7
Note 3: Cash and Cash Equivalents
The following tables summarize the cash and cash equivalents as of March 31, 2023 and December 31, 2022:
 
    
March 31,
     
December 31,
  
    
2023
     
2022
  
Cash
      36,811        30,104  
Cash equivalents
      155,478        179,090  
    
 
 
     
 
 
  
Total cash and cash equivalents as reported in the statements of financial position
   
 
192,289
 
   
 
209,194
 
    
 
 
     
 
 
  
Bank overdrafts
      —          —    
    
 
 
     
 
 
  
Total cash and cash equivalents as reported in the statements of cash flows
   
 
192,289
 
   
 
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:
 
    
March 31,
     
December 31,
  
    
2023
     
2022
  
Research tax credit
      7,695        5,792  
Other tax claims
      5,109        3,903  
Prepaid expenses
      2,352        2,680  
Other receivables
      2,790        1,504  
    
 
 
     
 
 
  
Total
   
 
17,946
 
   
 
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
      1,765  
- Payment received
      —    
- Adjustment and currency translation effect
      138  
    
 
 
  
Closing research tax credit receivable as of March 31, 2023
   
 
7,695
 
    
 
 
  
Of which -
Non-current
portion
   
 
—  
 
Of which - Current portion
   
 
7,695
 
 
8
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 clini
cal stu
dies.
Note 5 Lease contracts
Future minimum lease payments under the Company’s operating leases’ right of use as of March 31, 2023 and December 31, 2022, are as follows:
 
    
March 31, 2023
    
December 31, 2022
  
    
Real estate
    
Other
assets
    
Total
    
Real estate
    
Other
assets
    
Total
  
Current portion
      1,917       76       1,993       1,972       79       2,051  
Year 2
      746       63       809       1,168       74       1,243  
Year 3
      26       —         26       65       6       71  
Thereafter
      —         —         —         —         —         —    
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Total minimum lease payments
   
 
2,689
 
  
 
139
 
  
 
2,828
 
  
 
3,204
 
  
 
160
 
  
 
3,364
 
Less: Effects of discounting
      (209 )      (14 )      (225 )      (325 )      (17 )      (343 ) 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Present value of operating lease
   
 
2,480
 
  
 
125
 
  
 
2,603
 
  
 
2,879
 
  
 
143
 
  
 
3,021
 
Less: current portion
      (1,852 )      (72 )      (1,923 )      (1,823 )      (71 )      (1,894 ) 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Long-term operating lease
   
 
628
 
  
 
53
 
  
 
680
 
  
 
1,055
 
  
 
72
 
  
 
1,127
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Weighted average remaining lease term (years)
      1.18       —                 1.40       —            
Weighted average discount rate
      2.93 %      2.45 %              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 condensed consolidated statement of operations and
comprehe
nsive loss was:
 
    
March 31,
  
  
2023
     
2022
  
Operating lease expense / (income)
      446        507  
Net termination impact
      (81 )       (1,657 ) 
 
9
Supplemental cash flow information related to operating leases is as follows for the period March 31, 2023 and 2022:
 
    
March 31
  
  
2023
     
2022
  
Cash paid for amounts included in the measurement of lease liabilities
                  
Operating cash flows for operating leases
      496        583  
Note 6: Trade Payables and Other Liabilities
6.1 Trade Payables
No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented.
6.2 Other Liabilities
The following tables summarize the other liabilities as of March 31, 2023 and December 31, 2022:
 
    
March 31
     
December 31,
  
    
2023
     
2022
  
    
Other
 current

liabilities
     
Other
 non-
current

liabilities
     
Total
     
Other
 current

liabilities
     
Other
 non-

current

liabilities
     
Total
  
Employee related liabilities
      4,189        11        4,200        5,872        45        5,917  
Deferred income
     
2 193
        4 375        6,568        2,137        4,690        6,828  
Tax liabilities
      97        —          97        69        —          69  
Other debts
      297        —          297        1,131        —          1,131  
    
 
 
     
 
 
     
 
 
     
 
 
     
 
 
     
 
 
  
Total
   
 
6 776
 
   
 
4 387
 
   
 
11,162
 
   
 
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 March 31, 2023 is set at the sum of €9,414,731.90 ($
10,721
thousands converted at historical rates). It is divided into 94,147,319 fully authorized, subscribed and
paid-up
shares with a par value of €0.10.
 
10
Note 8: Share-Based Payments
The Board of Directors has been authorized by the SH General Meeting to grant restricted stock units (“RSU”), stock options plan (“SO”) and
non-employee
warrants (
Bons de Souscription d’Actions
or “BSA”).
During the three months ended March 31, 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
      —          (47,200 )       (30,769 ) 
Exercised/released during the period
      —          —          (10,174 ) 
Expired during the period
      —          —          —    
    
 
 
     
 
 
     
 
 
  
Balance as of March 31, 2023
   
 
251,693
 
   
 
5,318,569
 
   
 
1,583,938
 
    
 
 
     
 
 
     
 
 
  
Share-based payments expenses reflected in the condensed consolidated statements of operations is as follows:
 
    
Three Months Ended
March 31,
  
    
2023
     
2022
  
Research & development
      SO        (429 )       (375 ) 
       RSU        (258 )       (208 ) 
Sales & marketing
      SO        (27 )       5  
       RSU        (8 )       1  
General & administrative
      SO        (797 )       (698 ) 
       RSU        (113 )       (87 ) 
             
 
 
     
 
 
  
Total share-based compensation (expense)
            
 
(1,632
) 
   
 
(1,363
) 
             
 
 
     
 
 
  
 
11
Note 9: Contingencies
The following tables summarize the contingencies as of March 31, 2023 and December 31, 2022:
 
    
March 31,
     
December 31,
  
    
2023
     
2022
  
Current contingencies
      4,142        3,944  
Non-current
contingencies
      15,989        16,680  
    
 
 
     
 
 
  
Total contingencies
   
 
20,131
 
   
 
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
      —          —          170        170  
Used liabilities
      —          —          —          —    
Reversals of unused liabilities
      (35 )       (1,103 )       —          (1,138 ) 
Net interest related to employee benefits, and unwinding of discount
      —          —          —          —    
Actuarial gains and losses on defined-benefit plans
      82        —          —          82  
Currency translation effect
      16        374        2        392  
    
 
 
     
 
 
     
 
 
     
 
 
  
At March 31, 2023
   
 
853
 
   
 
19,106
 
   
 
172
 
   
 
20,131
 
    
 
 
     
 
 
     
 
 
     
 
 
  
Of which Current
   
 
—  
 
   
 
3,970
 
   
 
172
 
   
 
4,142
 
Of which
Non-current
   
 
853
 
   
 
15,135
 
   
 
—  
 
   
 
15,989
 
In 2022 and during the first three 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 has recorded an accrual in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and incomes yet to be recognized for the completion of the PII.
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.
Note 10: Operating income
The following table summarizes the operating income during the three months ended March 31, 2023 and 2022:
 
    
Three Months Ended
March 31,
  
    
2023
     
2022
  
Research tax credit
      1,765        1,569  
Other operating income
      429        976  
    
 
 
     
 
 
  
Total
   
 
2,194
 
   
 
2,546
 
    
 
 
     
 
 
  
 
12
Note 11: Allocation of Personnel Expenses
The Company had an average of 88 employees during the three months ended March 31, 2023, in comparison with an average of 88 employees during the three months ended March 31, 2022.
The following table summarizes the allocation of personnel expenses by function during the three ended March 31, 2023 and 2022:
 
    
Three Months Ended
March 31,
  
    
2023
     
2022
  
Research and Development expenses
      4,006        3,075  
Sales and Marketing expenses
      165        245  
General and Administrative expenses
      3,100        2,595  
    
 
 
     
 
 
  
Total personnel expenses
   
 
7,272
 
   
 
5,915
 
    
 
 
     
 
 
  
The following table summarizes the allocation of personnel expenses by nature during the three months ended March 31, 2023 and 2022:
 
    
Three Months Ended
March 31,
  
    
2023
     
2022
  
Wages and salaries
      4,438        3,987  
Social security contributions
      699        251  
Expenses for pension commitments
      258        297  
Employer contribution to bonus shares
      244        16  
Share-based payments
      1,632        1,363  
    
 
 
     
 
 
  
Total
   
 
7,272
 
   
 
5,915
 
    
 
 
     
 
 
  
The increase in personnel expenses is mainly
due
to the recruitment of US employees partially offset by the departure of
non-US
employees and charges related to share-base payments.
Note 12: Commitments
There have been no significant changes in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report.
Note 13: Relationships with Related Parties
There were no new significant related-party transactions during the period nor any change in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report.
 
13
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 months ended March 31, 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 months ended March 31, 2023 and 2022 indicated in number of potential shares:
 
    
Three Months Ended
March 31,
  
    
2023
     
2022
  
Non-employee
warrants
      251,693        256,693  
Stock options
      5,318,569        3,471,808  
Restricted stock units
      1,583,938        1,183,633  
Prefunded warrants
      28,276,331        —    
Note 15: Events after the Close of the Period
The Company evaluated subsequent events that occurred after March 31, 2023, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on May 4, 2023 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.
 
 
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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 EPIT™, 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.

 

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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 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 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 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.

Business trends and Results of Operations

Comparison of the Three Months Ended March 31, 2023 and 2022

The following table summarizes our results of operations, derived from our 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 March 31, 2023 and 2022.

 

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Table of Contents
     Three months ended
March 31,		                
     2023      2022      $ change      % change  

Operating income

    $ 2,194      $ 2,546        (352 )       (14 %) 

Operating expenses

            

Research and development expenses

      (16,037 )       (12,223 )       (3,814 )       31 % 

Sales and marketing expenses

      (434 )       (464 )       30        (7 %) 

General and administrative expenses

      (6,889 )       (6,630 )       (259 )       4 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Total Operating expenses

      (23,359 )       (19,317 )       (4,042 )       21 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Financial income

      605        152        453        298 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Income tax

      —          (87 )       87        (100 %) 
  

 

 

     

 

 

     

 

 

     

 

 

  

Net loss

    $ (20,561 )     $ (16,706 )       (3,854 )       23 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Basic/diluted Net loss per share attributable to shareholders

    $ (0.22 )     $ (0.30 )       

Operating Income

The following table summarizes our operating income during the three months ended March 31, 2023 and 2022:

 

     Three months ended
March 31,		      $ change      % change  
     2023      2022                

Sales

      —          —          —          —    

Other income

      2,194        2,546        (352 )       (14 %) 

Research tax credit

      1,765        1,569        196        12 % 

Other operating income

      429        976        (548 )       (56 %) 
  

 

 

     

 

 

     

 

 

     

 

 

  

Total operating income

      2,194        2,546        (352 )       (14 %) 
  

 

 

     

 

 

     

 

 

     

 

 

  

Our operating income is primarily generated from the French research tax credit (Crédit d’Impôt Recherche, or “CIR”), and by the revenue recognized under our collaboration agreement with Nestlé Health Science. We generated operating income of $2.2 million during the three months ended March 31, 2023 compared to $ 2.6 million during the three months ended March 31, 2022. The decrease in operating income is primarily attributable to the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase 2 clinical trial conducted as part of the agreement. The increase in research tax credit is attributable to the increase in eligible costs in connection with Research and Development costs.

Operating Expenses

Since inception, our operating expenses have consisted primarily of research and development activities, general and administration costs and sales and marketing costs.

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the three months ended March 31, 2023 and 2022:

 

     Three Months Ended
March 31,		                
Research and Development expenses    2023      2022      $ change      % change  

External clinical-related expenses

      10,471        7,350        3,121        42 % 

Employee-related costs

      3,319        2,492        827        33 % 

Share-based payment expenses

      687        583        104        18 % 

Depreciation, amortization and other costs

      1,559        1,799        (239 )       (69 %) 
  

 

 

     

 

 

     

 

 

     

 

 

  

Total Research and Development expenses

      16,039        12,224        3,813        31 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

 

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Research and Development expenses increased by $3.8 million for the three months ended March 31, 2023, compared to the three

months ended March 31, 2022, primarily due to the increase in external clinical-related expenses, mainly driven by higher costs of recruitment of patient in VITESSE Phase 3 clinical trial.

Employee-related costs, excluding share-based payment expenses, increased by $0.8 million for the three months ended March 31, 2023 compared to the three months ended March 31, 2022 mostly due to the recruitment of US employees partially offset by the departure of non-US employees.

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the three months ended March 31, 2023 and 2022:

 

     Three Months Ended
March 31,		      $ change      % change  
Sales and Marketing expenses    2023      2022  

Personnel expenses (incl. share-based payment expenses)

      165        245        (80 )       (33 %) 

External professional services and other costs

      269        219        (50 )       23 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Total Sales and Marketing expenses

      434        464        (30 )       (7 %) 
  

 

 

     

 

 

     

 

 

     

 

 

  

Sales and marketing expenses amounted to $0.4 million for the three months ended March 31, 2023, compared to $0.5 million for the three months ended March 31, 2022.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the three months ended March 31, 2023 and 2022:

 

     Three Months Ended
March 31,		      $ change      % change  
General and Administrative expenses    2023      2022  

External professional services

      1,706        1,108        598        54 % 

Employee-related costs

      2,190        1,810        380        21 % 

Share-based payment expenses

      910        786        124        16 % 

Depreciation, amortization and other costs

      2,082        2,927        (844 )       (29 %) 
  

 

 

     

 

 

     

 

 

     

 

 

  

Total General and Administrative expenses

      6,889        6,630        259        4 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

General and Administrative expenses increased by $0.3 million for the three months ended March 31, 2023, compared to the three months ended March 31, 2022 primarily due to a decrease in depreciation, amortization and other costs (mainly driven by the decrease in Directors and Officers insurance premium) and an increase in external professional services.

Financial income (expense)

Our financial income was approximately $0.6 million for the three months ended March 31, 2023, compared to a financial income of $0.2 million for the three months ended March 31, 2022. This item mainly includes the financial income on our financial assets.

Income tax

We did not have any income tax profit or expense for the three months ended March 31, 2023 compared to an expense of $0.1 for the three months ended March 31, 2022.

Net loss

Net loss was $20.6 million for the three months ended March 31, 2023, compared to $16.7 million for the three months ended March 31, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.22 and $0.30 for the three months ended March 31, 2023 and 2022, respectively.

 

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Liquidity and Capital Resources

Financial Condition

On March 31, 2023, we had $192.3 million in cash and cash equivalents compared to $209.2 million of cash and cash equivalents on December 31, 2022. Based on its current operations, plans and assumptions, the Company expects that its balance of cash and cash equivalents will be sufficient to fund its operations for at least the next 12 months. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $20.8 and $1.5 million for the three months ended March 31, 2023 and 2022, respectively. For the three months ended March 31, 2023, we recorded a net loss of $20.6 million. Our net cash flows provided by financing activities was nil during the three months ended March 31, 2023 compared to $(0.1) million during the three months ended March 31, 2022.

Our financial statements have been prepared on a going concern basis assuming that we will be successful in our financing objectives. As such, no adjustments have been made to the 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.

We fund short-term cash requirements primarily from payments associated with research tax credits (Crédit d’Impôt Recherche).

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 intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes.

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.

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 $3.4 million cash requirement as of December 31, 2022 which expires March 8, 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 $0.4 million cash requirement as of December 31, 2022 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 three months ended March 31, 2023 and 2022.

 

     Three months ended
arch 31,		                
(Amounts in thousands of U.S. Dollars)    2023      2022      $ change      % of
change		  

Net cash flow provided by (used in) operating activities

      (20,841 )       (1,483 )       (19,359 )       1,306 % 

Net cash flow provided by (used in) investing activities

      42        11        31        273 % 

Net cash flow provided by (used in) financing activities

      (14 )       (129 )       114        (89 %) 

Effect of exchange rate changes on cash and cash equivalents

      3,909        (1,594 )       5,503        (345 %) 
  

 

 

     

 

 

     

 

 

     

 

 

  

Net (decrease) increase in cash and cash equivalents

      (16,905 )       (3,194 )       (13,711 )       429 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Operating Activities

Our net cash flows used in operating activities were $20.8 million and $1.5 million during the three months ended March 31, 2023 and 2022, respectively. The variance of $19.4 million is mainly driven by the reimbursement of $20.9 million of research tax credits for the 2019 and 2020 fiscal year.

 

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Table of Contents

Smaller Reporting Company Status

We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

 

20

Table of Contents

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Item 4. Controls and Procedures

Disclosure Controls and Procedures

Based on its evaluation as of March 31, 2023, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Limitation on Effectiveness of Controls and Procedures

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error of fraud may occur and not be detected.

 

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Table of Contents

PART II – Other information

Item 1. Legal Proceedings

See “Note 2: Significant Events and Transactions – Legal Proceedings” in the notes to the condensed consolidated financial statements included elsewhere in this Report.

Item 1A. Risk Factors

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report. There have been no material changes in our risk factors from those disclosed in the Annual Report.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

During the three months ended March 31, 2023, we issued the following unregistered securities:

 

  •  

On March 23, 2023, the issuance of an aggregate of 10,174 ordinary shares to US and non-U.S. employees upon settlement of RSUs;

None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Regulation S promulgated under Section 5 of the Securities Act, as transactions by an issuer not involving any public offering or as offerings made to non-U.S. resident employees pursuant to an employee benefit plan established and administered in accordance with the law of a country other than the United States (namely, the Republic of France) and in accordance with that country’s practices and documentation. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.

Item 3. Defaults Upon Senior Securities

None.

 

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Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Not applicable.

 

23

Table of Contents

Item 6. Exhibits.

Exhibit Index

 

         

Incorporated by Reference

Exhibit   

Description

   

Schedule/
Form

   

File

Number

   

Exhibit

   

File

Date

3.1    By-laws (status) of the registrant (English translation)            
31.1    Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended            
31.2    Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended            
32.1*    Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended            
101.INS    XBRL Instance Document            
101.SCH    XBRL Taxonomy Extension Schema Document            
101.CAL    XBRL Taxonomy Extension Calculation Linkbase Document            
101.DEF    XBRL Taxonomy Extension Definition Linkbase Document            
101.LAB    XBRL Taxonomy Extension Labels Linkbase Document            
101.PRE    XBRL Taxonomy Extension Presentation Linkbase Document            
104    Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101.            

 

*

Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, (whether made before or after the date of the Form 10-Q), irrespective of any general incorporate language contained in such filing.

 

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Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registration has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

    DBV Technologies S.A.
    (Registrant)
Date: May 4, 2023     By:  

/s/ Daniel Tassé

    Daniel Tassé
    Chief Executive Officer
    (Principal Executive Officer)
Date: May 4, 2023     By:  

/s/ Sébastien Robitaille

    Sébastien Robitaille
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

 

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