UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
FORM
10-Q
 
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,September 30, 2023
or
 
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
     
to
     
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.)
France
State or other jurisdiction of
incorporation or organization
Not applicable
(I.R.S. Employer
Identification No.)
177-181
avenue Pierre Brossolette
92120 Montrouge France
 
N/A
(Address92120 Montrouge France (Address of principal executive offices)
 
(Zip Code)
Registrant’s telephone number, including area code +33 1 55 42 78 78
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
 
Trading
Symbol(s)
 
Name of each exchange
on which registered
American Depositary Shares, each representing
DBVT
The Nasdaq Stock Market LLC
one-half
of one ordinary share, nominal value
€0.10 per share
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.
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
,October 31, 2023, the registrant had 94,147,31996,288,553 ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.
 
 
 

Table of contents

 

Part I

 Financial information   15 

Item 1

 Condensed Consolidated Statements of Financial Position (Unaudited) as of March 31,September 30, 2023 and December 31, 2022   15 
 Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Nine Months Ended March 31, 2023September 30,2023 and 2022   26 
 Condensed Consolidated Statements of Cash Flows (Unaudited) for the ThreeNine Months Ended March 31,September 30, 2023 and 2022   37 
 Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the ThreeNine Months Ended March 31,September 30, 2023 and 2022   48 
 Notes to the Condensed Consolidated Financial Statements (Unaudited)   59 

Item 2

 Management’s Discussion and Analysis of Financial Condition and Results of Operations   1519 

Item 3

 Quantitative and Qualitative Disclosures About Market Risk   2126 

Item 4

 Controls and Procedures   2126 

Part II

 Other Information   2226 

Item 1

 Legal Proceedings   2226 

Item 1A

 Risk Factors   2227 

Item 2

 Unregistered Sales of Equity Securities and Use of Proceeds   2227 

Item 3

 Defaults Upon Senior Securities   2227 

Item 4

 Mine Safety Disclosures   2327 

Item 5

 Other Information   2327 

Item 6

 Exhibits   2427 

Unless the context otherwise requires, we use the terms “DBV”, “DBV Technologies,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q, or Quarterly Report, to refer to DBV Technologies S.A. and, where appropriate, its consolidated subsidiaries. “Viaskin™”, “EPIT™” and our other registered and common law trade names, trademarks and service marks are the property of DBV Technologies S.A. or our subsidiaries. All other trademarks, trade names and service marks appearing in this Quarterly Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.

2

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;

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 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-partythird- 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

our financial performance;

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

and

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-lookingforward- looking statement. These risks, uncertainties and other factors are described in greater detail under the caption “Risk Factors” in Part I. Item 1A of our Annual Report on Form
10-K
for the year ended December 31, 2022, filed with the Securities and Exchange Commission, or the SEC on March 2, 2023. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement. We qualify all of our forward-looking statements by these cautionary statements.

3
Table of Contents
In addition, any forward-looking statement in this Quarterly Report, including statements that “we believe” and similar statements, reflect our beliefs and opinions on the relevant subject and represents our views only as of the date of this Quarterly Report and should not be relied upon as representing our views as of any subsequent date. These statements are based upon information available to us as of the date of this Quarterly Report and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

2

4
Table of Contents
Part I -
– Financial
Information
Item 1. Financial Statements
DBV Technologies S.A.
Condensed Consolidated Statements of Financial Position (unaudited)
(amounts in thousands, except share and per share data)
 
      
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
 
             

       September 30,  December 31, 
   Notes   2023  2022 
Assets              
Current assets:              
Cash and cash equivalents   3   $149,135  $209,194 
Other current assets   4    20,136   13,880 
               
Total current assets        169,270   223,074 
Property, plant, and equipment, net        13,094   15,096 
Right-of-use
assets related to operating leases
   5    1,389   2,513 
Intangible assets        61   10 
Other
non-current
assets
        5,970   5,824 
               
Total
non-current
assets
        20,513   23,444 
               
Total Assets       $189,783  $246,518 
               
Liabilities and shareholders’ equity              
Current liabilities:              
Trade payables   6   $16,654  $14,473 
Short-term operating leases   5    1,522   1,894 
Current contingencies   9    4,596   3,944 
Other current liabilities   6    8,671   9,210 
               
Total current liabilities        31,443   29,521 
               
Long-term operating leases   5    94   1,127 
Non-current
contingencies
   9    11,553   16,680 
Other
non-current
liabilities
   6    2,702   4,735 
               
Total
non-current
liabilities
        14,349   22,543 
               
Total Liabilities       $45,792  $52,064 
               
Shareholders’ equity:              
Ordinary shares, €0.10 par value; 96,253,553 and 94,137,145 shares authorized, and issued as of
September 30, 2023 and December 31, 2022, respectively		       $10,953  $10,720 
Additional
paid-in
capital
        376,249   458,221 
Treasury stock, 175,481 and 149,793 ordinary shares as of September 30, 2023 and December 31, 2022, respectively, at cost        (1,163)   (1,109) 
Accumulated deficit        (227,677)   (259,578) 
Accumulated other comprehensive income        761   781 
Accumulated currency translation effect        (15,132)   (14,581) 
               
Total Shareholders’ equity   7   $143,991  $194,453 
               
Total Liabilities and Shareholders’ equity       $189,783  $246,518 
 
 
 
 
 
 
 
 
 
 
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
1
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Table of Contents
DBV Technologies S.A.
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(amounts in thousands, except share and per share data)
 
      
Three Months Ended
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 

   Three Months Ended September 30,  Nine Months Ended
September 30,		 
   Notes   2023  2022  2023  2022 
Operating income   10   $2,372  $2,074  $6,853  $6,148 
Operating expenses                      
Research and development expenses        (13,795)   (15,096)   (47,448)   (45,930) 
Sales and marketing expenses        (663)   (159)   (1,613)   (1,659) 
General and administrative expenses        (6,184)   (4,839)   (22,304)   (17,173) 
                       
Total Operating expenses        (20,642)   (20,094)   (71,365)   (64,762) 
                       
Loss from operations        (18,270)   (18,020)   (64,512)   (58,614) 
                       
Financial income (expenses)        1,534   732   2,984   1,668 
                       
Loss before taxes        (16,736)   (17,287)   (61,527)   (56,946) 
                       
Income tax        —    —    (13)   (87) 
                       
Net loss       $(16,736)  $(17,287)  $(61,540)  $(57,033) 
                       
Foreign currency translation differences, net of taxes        (3,996)   (15,425)   (551)   (28,752) 
Actuarial gains (losses) on employee benefits, net of taxes        73   41   (19)   264 
Total comprehensive loss       $(20,659)  $(32,672)  $(62,111)  $(85,520) 
                       
Basic/diluted net loss per share attributable to shareholders   14   $(0.17)  $(0.18)  $(0.65)  $(0.79) 
                       
Weighted average shares outstanding used in computing per share amounts:        96,075,540   93,905,050   94,801,569   71,779,572 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
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Table of Contents
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
 
             

   Nine Months
Ended September 30,		 
   Notes   2023  2022 
Net loss for the period       $(61,540)   $(57,033) 
Adjustments to reconcile net loss to net cash flow provided by (used in) operating activities:               
Depreciation, amortization and accrued contingencies        (3,072)    1,140 
Retirement pension obligations        58    58 
Expenses related to share-based payments   8    4,800    3,416 
Other elements        23    (3) 
Changes in operating assets and liabilities:               
Decrease (increase) in other current assets        (5,850)    20,900 
(Decrease) increase in trade payables        1,691    5,699 
(Decrease) increase in other current and
non-current
liabilities
        (2,547)    (3,405) 
Change in operating lease liabilities and right of use assets        471    (2,554) 
Net cash flow provided by (used in) operating activities        (65,967)    (31,781) 
                
Cash flows provided by (used in) investing activities:               
Acquisitions of property, plant, and equipment, net from proceeds        (325)    (742) 
Proceeds from property, plant, and equipment dispositions        —     3 
Acquisitions of
non-current
financial assets
        (54)    (149) 
Proceeds from
non-current
financial assets dispositions
        (242)    822 
                
Net cash flows provided by (used in) investing activities        (621)    (66) 
                
Cash flows provided by (used in) financing activities:               
Decrease in conditional advances        —     (479) 
Treasury shares        54    149 
Capital increases, net of transaction costs        6,902    194,732 
Other cash flows related to financing activities        —     —  
                
Net cash flows provided by (used in) financing activities        6,956    194,403 
                
Effect of exchange rate changes on cash and cash equivalents        (427)    (27,186) 
                
Net increase (decrease) in cash and cash equivalents        (60,059)    135,369 
                
Net Cash and cash equivalents at the beginning of the period        209,194    77,301 
                
Net cash and cash equivalents at the end of the period   3   $ 149,135   $ 212,670 
                
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
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Table of Contents
DBV Technologies S.A.
Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited)
(amounts in thousands, except share and per share data)

   Ordinary shares                     
   Number of
Shares		   Amount   Additional
paid-in
capital		  Treasury
stock		  Accumulated
deficit		  Accumulated
other
comprehensive
income (loss)		   Accumulated
currency
translation
effect		  Total
Shareholders’
Equity		 
Balance at January 1, 2022  55,095,762  $6,538  $358,115  $(1,232)  $(258,528)  $519  $(6,137)  $99,274 
Net (loss)  —    —    —    —    (16,706)   —    —    (16,706) 
Other comprehensive income (loss)  —    —    —    —    —    24   (1,933)   (1,909) 
Issuance of ordinary shares  775   1   —    —    —    —    —    1 
Treasury shares  —    —    —    40   —    —    —    40 
Share-based payments  —    —    1,363   —    —    —    —    1,363 
Other change in equity  —    —    —    —    15   —    (15)   —  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance at March 31, 2022  55,096,537  $6,539  $359,478  $(1,193)  $(275,219)  $543  $(8,086)  $82,062 
Net (loss)  —    —    —    —    (23,039)   —    —    (23,039) 
Other comprehensive income (loss)  —    —    —    —    —    200   (11,394)   (11,194) 
Issuance of ordinary shares  38,926,142   4,170   103,007   —    —    —    —    107,176 
Issuance of warrants  —    —    88,094   —    —    —    —    88,094 
Treasury shares  —    —    —    240   —    —    —    240 
Share-based payments  —    —    1,078   —    —    —    —    1,078 
Allocation of accumulated net losses  —    —    (95,209)   —    95,209   —    —    —  
                                 
Balance at June 30, 2022  94,022,679  $10,708  $456,447  $(953)  $ (203,050)  $743  $ (19,480)  $ 244,416 
Net (loss)  —    —    —    —    (17,287)   —    —    (17,287) 
Other comprehensive income (loss)  —    —    —    —    —    41   (15,425)   (15,384) 
Issuance of ordinary shares  2,762   1   (539)   —    —    —    —    (539) 
Issuance of warrants  —    —    —    —    —    —    —    —  
Treasury shares  —    —    —    (130)   —    —    —    (130) 
Share-based payments  —    —    976   —    —    —    —    976 
Allocation of accumulated net losses  —    —    —    —    —    —    —    —  
                                 
Balance at September 30, 2022  94,025,441  $10,709  $456,884  $(1,083)  $(220,337)  $ 783  $(34,904)  $212,052 
                                 
 
                                 
   
Ordinary shares
                      
   
Number of
Shares
   
Amount
   
Additional
paid-in

capital
   
Treasury
stock
  
Accumulated
deficit
  
Accumulated
other
comprehensive
income (loss)
   
Accumulated
currency
translation
effect
  
Total
Shareholders’
Equity
 
Balance at January 1, 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 
Issuance of ordinary shares  10,174   1   (1)   —    —    —    —    —  
Treasury shares  —    —    —    (14)   —    —    —    (14) 
Share-based payments  —    —    1,632   —    —    —    —    1,632 
                                 
Balance at March 31, 2023  94,147,319  $10,721  $459,852  $(1,123)  $ (280,138)  $698  $ (10,915)  $179,094 
Net (loss)  —    —    —    —    (24,243)   —    —    (24,243) 
Other comprehensive income (loss)  —    —    —    —    —    (10)   (221)   (232) 
Issuance of ordinary shares  2,103,635   231   7,535   —    —    —    —    7,766 
Treasury shares  —    —    —    42   —    —    —    42 
Share-based payments  —    —    1,814   —    —    —    —    1,814 
Allocation of accumulated net losses  —    —    (93,441)   —    93,441   —    —    —  
                                 
Balance at June 30, 2023  96,250,954  $10,952  $375,759  $(1,082)  $ (210,940)  $687  $ (11,136)  $164,240 
Net (loss)  —    —    —    —    (16,736)   —    —    (16,736) 
Other comprehensive income (loss)  —    —    —    —    —    73   (3,996)   (3,922) 
Issuance of ordinary shares  2,599   1   (864)   —    —    —    —    (864) 
Treasury shares  —    —    —    (81)   —    —    —    (81) 
Share-based payments  —    —    1,354   —    —    —    —    1,354 
Allocation of accumulated net losses  —    —    —    —    —    —    —    —  
                                 
Balance at September 30, 2023  96,253,553  $10,953  $376,249  $(1,163)  $ (222,676)  $761  $ (15,132)  $143,991 
                                 
                                 
   
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.
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4
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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
2016-132016-13—Financial
- Financial Instruments - 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.
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Table of Contents
Accounting Pronouncements issued not yet adopted
Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption.
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Table of Contents
Note 2: Significant Events and Transactions
Clinical programs
United
States
Regulatory
History
and Current
Cur
r
ent
Status
In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following receipt of the Complete Response Letter. The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a
6-month,
well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.
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.
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Table of Contents
In 2022, the Company announced the new Phase 3 pivotal study for modified Viaskin Peanut (mvP)(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 reviewReview 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 .VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and
start-up
activities for prompt study launch once the partial clinical hold was lifted.
On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol.

The Company further announced it plans to initiate a separate,
six
-month
safety study in approximately 275 additional subject
s
, randomized 3:1 active versus placebo, to supplement the safety data generated by the VITESSE trial, resulting in a safety database of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut.
On March 2, 2023, the Company announced the completion of EVOLVE, a
12-week
caregiver and patient user experience study of the mVP patch in 50 peanut allergic children ages
4–11-years
old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the mVP patch. The study concluded that the updated IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the mVP patch. In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion scores. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA.
On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated in the first half inof 2024 and topline results in the first half inof 2025.
On April 19, 2023, the Company outlined the regulatory path for Viaskin Peanut in children
1-3
years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the
pre-specified
criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use.
On July 31, 2023, the Company announced receipt of feedback from FDA on the two supplemental safety studies, COMFORT Children and COMFORT Toddlers. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 –
3-years
and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT Children safety study will enroll peanut allergic children ages 4 –
7-years
and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study. FDA agreed with a
6-month
study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study. The Company expects both COMFORT studies will assess adhesion using the same tools and measurements that were established in VITESSE.
Viaskin Peanut for children ages 4-11—European Union Regulatory History and Current Status
On August 2, 2021, the Company announced itsit received from the European Medicines Agency (EMA)(“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)(“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.
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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 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 metmeets the
pre-specified
criteria for success for the primary endpoint. The FDA did not request anendpoint, with no additional efficacy study to support a future BLA but requires that DBV conduct an additionalrequested. This safety study in 1 – 3-year-olds using the original Viaskin Peanut patch to augmentwill increase 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 studya BLA. It will not require a food challenge for study participation, willalso 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 inof 2024 and topline results in the first half inof 2025.
Financing
In June 2023, the Company issued and completed sales of new ordinary shares (the “Ordinary Shares”) in the form of American Depositary Shares (“ADSs”), for a total gross amount of $7.8 million (and a net amount of $6.9 million after $0.9
capital
increase fees imputation), under the
At-The-Market
(“ATM”) program established in May 2022. In this context, 2,052,450 new Ordinary Shares in the form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.90 dollar per ADS (i.e., a subscription price per Ordinary Share of 3.52 euro based on the USD/EUR exchange rate of 1.0809 dollar for 1 euro, as published by the European Central Bank on June 14, 2023) and each ADS giving the right to receive
one-half
of one ordinary share of the Company.
Legal Proceedings
From time to time, the Company may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The Company is not currently subject to any material legal proceedings.
 
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Note 3: Cash and Cash Equivalents
The following tables summarize the cash and cash equivalents as of March 31,September 30, 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
 
   September 30,
2023		   December 31,
2022		 
Cash   18,927    30,104 
Cash equivalents   130,208    179,090 
           
Total cash and cash equivalents as reported in the statements of financial position   149,135    209,194 
           
Bank overdrafts   —     —  
           
Total cash and cash equivalents as reported in the statements of cash flows   149,135    209,194 
Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.
Note 4 Other Current Assets
Other current assets consisted of the following:
 
  
March 31,
   
December 31,
 
  
2023
   
2022
   September 30,
2023		   December 31,
2022		 
Research tax credit
   7,695    5,792    10,622    5,792 
Other tax claims
   5,109    3,903    4,571    3,903 
Prepaid expenses
   2,352    2,680    3,195    2,680 
Other receivables
   2,790    1,504    1,748    1,504 
  
 
   
 
         
Total
  
 
17,946
 
  
 
13,880
 
   20,136    13,880 
  
 
   
 
         
Research tax credit
The variance in Research Tax Credit is presented as follows:
 

   
Amount in
thousands of
US
Dollars
 
Opening research tax credit receivable as of January 1, 2023
5,792
+ Operating revenue
   1,7655,792
+ Operating revenue4,978
- Payment received— 
- Adjustment and currency translation effect(148) 
Closing research tax credit receivable as of September 30, 202310,622
 
Of which -
- Payment receivedNon-current
portion
   —  
- 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
10,622
8
TableBefore currency translation effect, the balance in research tax credit as of ContentsSeptember 30, 2023, consisted of $5.8 million research tax credit for the 2022 fiscal year filed with the tax authorities and yet to be reimbursed, and $5.0 million estimated research tax credit for the first nine months of the 2023 fiscal year.
The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing cliniclinical studies.
cal stu
dies.
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Note 5 Lease contracts
Future minimum lease payments under the Company’s operating leases’ right of use as of March 31,September 30, 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%     

   September 30, 2023  December 31, 2022 
   Other  Other 
   Real estate  assets  Total  Real estate  assets  Total 
Current portion   1,592   73   1,665   1,972   79   2,051 
Year 2   103   24   127   1,168   74   1,243 
Year 3   —    —    —    65   6   71 
Thereafter   —    —    —    —    —    —  
                          
Total minimum lease payments   1,695   97   1,792   3,204   160   3,364 
Less: Effects of discounting   (167)   (9)   (176)   (325)   (17)   (343) 
                          
Present value of operating lease   1,528   88   1,616   2,879   143   3,021 
Less: current portion   (1,451)   (71)   (1,522)   (1,823)   (71)   (1,894) 
                          
Long-term operating lease   77   17   94   1,055   72   1,127 
                          
Weighted average remaining lease term (years)   0.72   —        1.40   —      
Weighted average discount rate   2.84%   2.48%       3.00%   2.45%     
The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the condensed consolidated statement of operations and
comprehe
nsive comprehensive loss was:
 
   
March 31,
 
  
2023
   
2022
 
Operating lease expense / (income)
   446    507 
Net termination impact
   (81)    (1,657) 
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   September 30, 
   2023   2022 
Operating lease expense   1,223    1,373 
Net termination impact   (92)    (1,657) 
Supplemental cash flow information related to operating leases is as follows for the period March 31,September 30, 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 
   September 30, 
   2023   2022 
Cash paid for amounts included in the measurement of lease liabilities          
Operating cash outflows related to operating leases   1,410    1,533 
Note 6: Trade Payables and Other Current Liabilities
6.1 Trade Payables
Trade
payables increased by $2.2 million as of September 30, 2023, compared to December 31, 2022.
No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented.
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6.2 Other Liabilities
The following tables summarize the other liabilities as of March 31,September 30, 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
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 

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

liabilities
   Total   Other current
liabilities		   
Other non-current

liabilities
   Total 
Employee related liabilities   5,557    —     5,557    5,872    45    5,917 
Deferred income   2,286    2,702    4,988    2,137    4,690    6,828 
Tax liabilities   193    —     193    69    —     69 
Other debts   635    —     635    1,131    —     1,131 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total   8,671    2,702    11,372    9,210    4,735    13,945 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Employee related liabilities include short-term debt to employees including social welfare and tax agency obligations.
Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science.
Note 7: Shareholders’ equity
The share capital as of March 31,September 30, 2023 is set at the sum
amount
of €9,414,731.90€9,625,355.30 ($
10,721
10,953 thousands converted at historical rates). It is divided into 94,147,31996,253,553 fully authorized, subscribed and
paid-up
ordinary shares with a par value of €0.10.
Pursuant to the authorization granted by the General Meeting of the Shareholders held on April 12, 2023 (the “SH General Meeting”), the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2022, have been allocated to additional
paid-in
capital for €88,091,118.04.
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Note 8:
Share-Based
Payments
The Board of Directors has been authorized by the SH General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), and
non-employee
warrants (
Bons(Bons de Souscription d’Actions
or “BSA”).
During
the threenine months ended March 31,September 30, 2023, the Company granted 59,200 stock options and 35,800 restricted stock units to employees.
There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report.
Change in Number of BSA/SO/RSU:
 
   
Number of outstanding
 
   
BSA
   
SO
   
RSUs
 
Balance as of December 31, 2022
  
 
251,693
 
  
 
5,306,569
 
  
 
1,589,081
 
Granted during the period
   —      59,200    35,800 
Forfeited during the period
   —      (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
 
   
 
 
   
 
 
   
 
 
 
   Number of outstanding 
   BSA   SO  RSUs 
Balance as of December 31, 2022   251,693    5,306,569    1,589,081 
Granted during the period   —     59,200    35,800 
Forfeited during the period   —     (128,700)   (123,382)
Exercised/released during the period   —     —     (66,883)
Expired during the period   —     —     —  
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance as of September 30, 2023   251,693    5,237,069   1,434,616 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Share-based payments expensesexpense 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
   Three Months
Ended September 30,		  Nine Months
Ended September		 
             30, 
       2023  2022  2023  2022 
Research & development   SO    (376)   (337)   (1,272)   (1,002) 
    RSU    (85)   (201)   (614)   (594) 
Sales & marketing   SO    (25)   30   (78)   (3) 
    RSU    (8)   20   (25)   4 
General & administrative   SO    (747)   (423)   (2,473)   1,599) 
    RSU    (106)   (66)   (337)   (223) 
                       
Total share-based compensation (expense)        (1,345)   (976)   (4,800)   (3,416) 
                       
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Note 9: Contingencies
The following tables summarize the contingencies as of March 31,September 30, 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
 
   
 
 
   
 
 
 
   September 30,
2023		   December 31,
2022		 
Current contingencies   4,596    3,944 
Non-current
contingencies
   11,553    16,680 
           
Total contingencies   16,149    20,625 
           
The changes in contingencies are as follows:
 
   
Pension
retirement
obligations
   
Collaboration
agreement -
Loss at
completion
   
Other

contingencies
   
Total
 
At January 1, 2023
  
 
790
 
  
 
19,835
 
  
 
—  
 
  
 
20,625
 
Increases in liabilities
   —      —      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.
   Pension
retirement
obligations		   Collaboration
agreement -
Loss at
completion		   Other
contingencies		   Total 
At January 1, 2023   790    19,835    —     20,625 
Increases in liabilities   58    —     796    854 
Used liabilities   —     —     —     —  
Reversals of unused liabilities   —     (5,325)    —     (5,325) 
Net interest related to employee benefits, and unwinding of discount   —     —     —     —  
Actuarial gains and losses on defined-benefit plans   19    —     —     19 
Currency translation effect   (7)    (16)    —     (24) 
                     
At September 30, 2023   860    14,494    796    16,149 
                     
Of which Current   —     3,801    796    4,596 
Of which
Non-current
   860    10,693    —     11,553 
The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 13 to the consolidated financial statements included in the Annual Report.
In 2022 and during the first nine months of 2023, the Company updated its measurement of progress of the Phase 2 clinical trial conducted as part of the collaboration and license agreement with Nestlé Health Sciences and updated the cumulative income recognized. The Company recognized a reversal of $5.3 million of the loss for completion recorded in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and income yet to be recognized for the completion of the PII.
The other contingencies mainly consisted of a provision for refurbishment amounting to the best estimate of costs to be incurred in case the Montrouge office lease agreement is not renewed at its July 2024 term expiration.
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Note 10: Operating income
The following table summarizes the operating income during the three and nine months ended March 31,September 30, 2023 and 2022:
 

  Three Months Ended
September 30,		   Nine Months Ended
September 30,		 
  
Three Months Ended
March 31,
   2023   2022   2023   2022 
  
2023
   
2022
 
Research tax credit
   1,765    1,569    1,237    1,407    4,978    4,467 
Other operating income
   429    976    1,134    668    1,875    1,681 
  
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
Total
  
 
2,194
 
  
 
2,546
 
   2,372    2,074    6,853    6,148 
  
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
The increase in operating income for the nine months period was primarily due to the increase in the research and development costs eligible to research tax credit in France.
12
The Company recognizes as other operating income accrued revenues based on its updated measurement of progress of the Phase 2 clinical trial conducted as part of the collaboration agreement with Nestlé. Moreover, the loss for completion recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase 2 clinical trial was updated accordingly as of September 30, 2023 (see note 9 related to contingencies).
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Note 11: Allocation of Personnel Expenses
The Company had an average of 88
97
employees during the threenine months ended March 31,September 30, 2023, in comparison with an average of 88
85
employees during the threenine months ended March 31,September 30, 2022.
The following table summarizes the allocation of personnel expenses by function during the three and nine months ended March 31,September 30, 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
 
   
 
 
   
 
 
 

   Three Months
Ended September 30,		   Nine Months
Ended September 30,		 
   2023   2022   2023   2022 
Research and Development expenses   3,663    3,186    11,684    9,357 
Sales and Marketing expenses   187    138    557    727 
General and Administrative expenses   2,876    1,598    8,834    6,961 
                     
Total personnel expenses   6,724    4,922    21,075    17,045 
                     
The following table summarizes the allocation of personnel expenses by nature during the three and nine months ended March 31,September 30, 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
 
   
 
 
   
 
 
 

   Three Months
Ended September 30,		   Nine Months
Ended September 30,		 
   2023   2022   2023   2022 
Wages and salaries   4,175    3,505    12,691    11,001 
Social security contributions   962    634    2,846    2,141 
Expenses for pension commitments   234    214    738    723 
Employer contribution to bonus shares   —     (406)    —     (236) 
Share-based payments   1,353    976    4,800    3,416 
                     
Total   6,724    4,922    21,075    17,045 
                     
The increase in personnel expenses iswas mainly
due
to the 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 have beenwere no significant changes in other commitments from those disclosed in Note 17 to the consolidatedconsoli
date
d financial statements included in the
Annual Report.
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Note 13: Relationships with Related Parties
The Company’s related parties exclusively consisted of the members of the Board of Directors and the members of the Executive Committee. As of September 30, 2023, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not significantly changed since December 31, 2022.
There were no new significant related-party transactions during the period nor any changechanges in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report.
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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 monthsthree- and nine-month periods ended March 31,September 30, 2023 and 2022, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss.
The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three and nine months ended March 31,September 30, 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    —   
   Three Months Ended
September 30,		   Nine Months Ended
September 30,		 
   2023   2022   2023   2022 
Non-employee
warrants
   251,693    251,693    251,693    251,693 
Stock options   5,237,069    3,541,383    5,237,069    3,541,383 
Restricted stock units   1,434,616    1,185,936    1,434,616    1,185,936 
Prefunded warrants   28,276,331    28,276,331    28,276,331    28,276,331 
Note 15: Events after the Close of the Period
The Company evaluated subsequent events that occurred after March 31,September 30, 2023, through
the dated
ate the condensed consolidated financial statements were issued after their approval by the Board of Directors on May 4,October 31, 2023, and determined that there are nowere significant events
that
require adjustments or disclosure in such condensed consolidated financial statements.statements:
On October 16
th
, 2023, the Company has announced the appointment of Virginie Boucinha as CFO effective as of November 6
th
, 2023, in replacement of Sébastien Robitaille leaving as of November 17
th
, 2023.
The Company and Nestlé Health Science entered into a termination letter agreement, effective October 30, 2023, terminating the collaboration agreement between the two parties and the PII clinical study. According to this agreement, upfront and milestones 1 to 3 are definitively acquired by DBV. The termination agreement may have other contractual and accounting consequences, due to the end of the study, including, potential impacts of termination with some related parties which the Company is currently assessing and will be accounted for as of December 31, 2023.

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14

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™,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.differentiated, Viaskin targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved.

Our most advanced clinical program is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in nine clinical trials, including four Phase 2 trials and three completed Phase 3 trials. We recently completed a Phase 3 trial of Viaskin Peanut in children ages one to three with peanut allergy and we also have an ongoing Phase 3 trial of Viaskin Peanut in children ages four to seven with peanut allergy.

On December 23, 2022, the Company announced it plans to initiate a separate, six-month safety study in approximately 275 additional subjects, randomized 3:1 active versus placebo, to supplement the safety data generated by the VITESSE trial, resulting in a safety database of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut (COMFORT Children).

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

On April 19, 2023, the Company outlined the regulatory path for Viaskin Peanut in children 1-3 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study (COMFORT Toddlers) will also generate patch adhesion data and will include updated instructions for use.

On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory efforts for VP in toddlers ages 1-3 years old with a confirmed peanut allergy.

15On July 31, 2023, the Company announced receipt of feedback from FDA on the two supplemental safety studies, COMFORT Children and COMFORT Toddlers. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 – 3-years and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT Children safety study will enroll peanut allergic children ages 4 – 7-years and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study. The FDA agreed with a 6-month study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study. The Company expects both COMFORT studies will assess adhesion using the same tools and measurements that were established in VITESSE.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

19

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,September 30, 2023 and 2022

The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the three months ended March 31,September 30, 2023 and 2022.

 

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

Operating income

  $2,372   $2,074    297    14% 

Operating expenses

        

Research and development expenses

   (13,795)    (15,096)    1,301    (9)% 

Sales and marketing expenses

   (663)    (159)    (504)    318% 

General and administrative expenses

   (6,184)    (4,839)    (1,345)    28% 
    

 

 

   

 

 

   

 

 

 

Total Operating expenses

   (20,642)    (20,094)    (548)    3% 
    

 

 

   

 

 

   

 

 

 

Financial income (expenses)

   1,534    732    802    110% 
    

 

 

   

 

 

   

 

 

 

Income tax

   —     —     —     —  
    

 

 

   

 

 

   

 

 

 

Net loss

  $(16,736)   $(17,287)    551    (3%) 
    

 

 

   

 

 

   

 

 

 

Basic/diluted Net loss per share attributable to shareholders

  $(0.17)   $(0.18)     

16

   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,September 30, 2023 and 2022:

 

  Three months ended
March 31,		   $ change   % change   Three months ended September 30,     
  2023   2022           2023   2022   $ change   % change 

Sales

   —      —      —      —      —     —     —     —  

Other income

   2,194    2,546    (352)    (14%)    2,372    2,074    297    14% 

Research tax credit

   1,765    1,569    196    12%    1,237    1,407    (169)    (12%) 

Other operating income

   429    976    (548)    (56%)    1,134    668    467    70% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total operating income

   2,194    2,546    (352)    (14%)    2,372    2,074    297    14% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Our operating income is primarily generated from the French research tax credit (Cré(Crédit d’Impôt Recherche,, or “CIR”), and by the revenuerevenues recognized underas part of our collaboration agreement with Nestlé Health Science. We generated operating income of $2.2$2.4 million during the three months ended March 31,September 30, 2023 compared to $ 2.6$2.1 million during the three months ended March 31,September 30, 2022.

The decreaseincrease 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 2II 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,September 30, 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% 
  

 

 

   

 

 

   

 

 

   

 

 

 

1720

   Three Months
Ended September 30,		     
Research and Development expenses  2023   2022   $ change   % change 

External clinical-related expenses

   12,277    11,136    1,141    10% 

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

   3,203    2,648    555    21% 

Share-based payment expenses

   460    538    (78)    (14%) 

Depreciation, amortization and other costs

   (2,145)    774    (2,920)    (377%) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Research and Development expenses

   13,795    15,096    (1,301)    (9%) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Research and Development expenses increaseddecreased by $3.8$1.3 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,September 30, 2023, compared to the three months ended March 31,September 30, 2022, mostlyprimarily due to the recruitmentreversal of US employees$4.2 million of the loss at completion recorded as depreciation, amortization and other costs on the Phase II clinical trial conducted as part of the collaboration agreement with Nestlé. During the three months ended September 30, 2023, there was a reduction of costs to be engaged to follow the achievement of upcoming milestones.

Decreases in impacts of the loss at completion were partially offset by the departureincrease by $1.1 million in external clinical-related expenses as a result of differences in phasing of non-USon-going employees.clinical trials between the three months ended September 30, 2022 and the three months ended September 30, 2023 and the increase by $0.6 million in employee-related costs (excl. share-based payments) to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the three months ended March 31,September 30, 2023 and 2022:

 

  Three Months Ended
March 31,		   $ change   % change   Three Months Ended September 30,     
Sales and Marketing expenses  2023   2022   2023   2022   $ change   % change 

Personnel expenses (incl. share-based payment expenses)

   165    245    (80)    (33%) 

External professional services and other costs

   269    219    (50)    23% 

External professional services

   343    (279)    621    (223)% 

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

   152    188    (37)    (19%) 

Share-based payment expenses

   32    (50)    82    (165%) 

Depreciation, amortization and other costs

   136    299    (163)    (55%) 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total Sales and Marketing expenses

   434    464    (30)    (7%)    663    159    504    318% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Sales and marketing expenses amounted to $0.4 million for the three months ended March 31, 2023, compared toincreased by $0.5 million for the three months ended March 31, 2022.September 30, 2023, compared to the three months ended September 30, 2022, due to an increase of external professional services.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the three months ended March 31,September 30, 2023 and 2022:

 

  Three Months Ended
March 31,		   $ change   % change   Three Months Ended September 30,     
General and Administrative expenses  2023   2022   2023   2022   $ change   % change 

External professional services

   1,706    1,108    598    54%    840    1,292    (451)    (35%) 

Employee-related costs

   2,190    1,810    380    21% 

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

   2,024    1,110    914    82% 

Share-based payment expenses

   910    786    124    16%    853    489    364    74% 

Depreciation, amortization and other costs

   2,082    2,927    (844)    (29%)    2,467    1,949    518    27% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total General and Administrative expenses

   6,889    6,630    259    4%    6,184    4,839    1,345    28% 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

General and Administrative expenses increased by $0.3$1.3 million for the three months ended March 31,September 30, 2023, compared to the three months ended March 31,September 30, 2022, primarilymainly due to a decreaseincrease by $0.9 million in depreciation, amortizationemployee-related costs (excluding share-based payments) to support General and other costs (mainly drivenAdministrative expenses activities explained by the decrease in Directors and Officers insurance premium) and an increase in external professional services.average number of employees increase. In addition, we recorded a provision amounting to $0.8 million as of September 30, 2023, as our best estimate of costs to be incurred if the Montrouge office lease agreement is not renewed at its July 2024 term expiration.

21

Financial income (expense)

Our financial income was approximately $0.6$1.5 million for the three months ended March 31,September 30, 2023, compared to a financial income of $0.2$0.7 million for the three months ended March 31,September 30, 2022. This item mainly includes the financial income on our financial assets.

Income tax

We did not have anyOur income tax profit or expense was nil for the three months ended March 31,September 30, 2023 compared to an expense of $0.1 for the three months ended March 31,and September 30, 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,September 30, 2023, compared to $17.3 million for the three months ended September 30, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.22$0.17 and $0.30$0.18 for the three months ended March 31,September 30, 2023 and 2022, respectively.

Comparison of the Nine Months Ended September 30, 2023 and 2022

18The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the nine months ended September 30, 2023 and 2022.

   Nine months ended September 30,     
   2023   2022   $ change   % change 

Operating income

  $6,853   $6,148    705    11% 

Operating expenses

        

Research and development expenses

   (47,448)    (45,930)    (1,518)    3% 

Sales and marketing expenses

   (1,613)    (1,659)    46    (3)% 

General and administrative expenses

   (22,304)    (17,173)    (5,130)    30% 
  

 

 

   

 

 

     

 

 

 

Total Operating expenses

   (71,365)    (64,762)    (6,602)    10% 
  

 

 

   

 

 

     

 

 

 

Financial income (expense)

   2,984    1,668    1,316    79% 
  

 

 

   

 

 

     

 

 

 

Income tax

   (13)    (87)    74    (85)% 
  

 

 

   

 

 

     

 

 

 

Net loss

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

 

 

   

 

 

     

 

 

 

Basic/diluted Net loss per share attributable to shareholders

  $(0.65)   $(0.79)     
  

 

 

   

 

 

     

Operating Income

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

   Nine months ended September 30,     
   2023   2022   $ change   % change 

Sales

   —     —      

Other income

   6,853    6,148    ,705    11% 

Research tax credit

   4,978    4,467    ,511    11% 

Other operating income

   1,875    1,681    ,194    12% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating income

   6,853    6,148    ,705    11% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Our operating income consisted of the French research tax credit (Crédit d’Impôt Recherche, or “CIR”), and revenues recognized as part of our collaboration agreement with Nestlé Health Science. We generated operating income of $6.9 million during the nine months ended September 30, 2023 compared to $6.1 million during the nine months ended September 30, 2022.

The increase in operating income was mainly due to the increase by $0.5 million in the French research tax credit as both eligible employee-related costs and eligible external clinical-related expenses increased to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.

22

The other operating income increased by $0.2 million for nine months ended September 30, 2023, after we updated the measurement of progress of the Phase II clinical trial conducted as part of the Nestlé’s collaboration agreement.

Operating Expenses

Research and Development Expenses

The following table summarizes our R&D expenses incurred during the nine months ended September 30, 2023 and 2022:

   Nine Months Ended September 30,     
Research and Development expenses  2023   2022   $ change   % change 

External clinical-related expenses

   34,170    30,150    4,020    13% 

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

   9,797    7,761    2,036    26% 

Share-based payment expenses

   1,886    1,596    290    18% 

Depreciation, amortization and other costs

   1,595    6,423    (4,827)    (75%) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Research and Development expenses

   47,448    45,930    1,518    3% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Research and Development expenses increased by $1.5 million for the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022, mainly due to the increase by $4.0 million and by $2.0 million in external clinical-related expenses and in employee-related costs (excl. share- based payments) respectively, to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.

Increases in both external clinical-related expenses and employee-related costs were partially offset by the reversal of $5.3 million of the loss at completion recorded as other costs on the Phase II clinical trial conducted as part of the collaboration agreement with Nestlé. During the nine months ended September 30, 2022, the loss at completion was impacted by additional clinical and production costs following increasing timing to achieve upcoming milestones. During the nine months ended September 30, 2023, there were reduction of costs to be engaged to follow the achievement of upcoming milestones.

Sales and Marketing expenses

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

   nine Months Ended September 30,     
Sales and Marketing expenses  2023   2022   $ change   % change 

External professional services

   691    243    449    185% 

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

   454    728    (274)    (38%) 

Share-based payment expenses

   103    (1)    104    (10815%) 

Depreciation, amortization and other costs

   365    690    (325)    (47%) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Sales and Marketing expenses

   1,613    1,659    (46)    (3)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Sales and marketing expenses decreased by $ 0.05 million for the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022, mainly due to a decrease of employee-related costs following departures in the US and other costs offset by an increase of external professional services to support Sales and Marketing activities.

General and Administrative expenses

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

   Nine Months Ended September 30,     
General and Administrative expenses  2023   2022   $ change   % change 

External professional services

   6,352    4,171    2,182    52% 

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

   6,023    5,139    884    17% 

Share-based payment expenses

   2,811    1,822    989    54% 

Depreciation, amortization and other costs

   7,117    6,042    1,075    18% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total General and Administrative expenses

   22,304    17,173    5,130    30% 
  

 

 

   

 

 

   

 

 

   

 

 

 
                 

23

General and Administrative expenses increased by $5.1 million for the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022, mainly due to an increase by $2.2 million for one-time costs associated with financing activities, organizational planning, market research and planning activities. In addition, we recorded an increase by $0.9 million in employee-related costs to support General and Administrative activities and a provision amounting to $0.8 million as of September 30, 2023, as our best estimate of costs to be incurred if the Montrouge office lease agreement is not renewed at its July 2024 term expiration.

Financial income (expense)

Our financial income was $3.0 million for the nine months ended September 30, 2023, compared to a financial income of $1.7 million for the nine months ended September 30, 2022. This item mainly includes financial income on our financial assets.

Income tax

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

Net loss

Net loss was $ 61.5 million for the nine months ended September 30, 2023, compared to $57.0 million for the nine months ended September 30, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.65 and $0.79 for the nine months ended September 30, 2023 and 2022, respectively.

Liquidity and Capital Resources

Financial Condition

On March 31,September 30, 2023, we had $192.3$149.1 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$66.0 million and $1.5$31.8 million for the threenine months ended March 31,September 30, 2023 and 2022, respectively. For the three months ended March 31,As of September 30, 2023, we recorded a net loss of $20.6$ 61.5 million. Our net cash flows provided by financing activities was nil during the three months ended March 31, 2023 compared to $(0.1)were $7.0 million during the threenine months ended March 31, 2022.September 30, 2023 that consisted of the ATM program compared to $194.4 million during the nine months ended September 30, 2022, that consisted of the May 2022 ATM and June 2022 PIPE offering.

Our unaudited condensed consolidated financial statements have been prepared on a going concern basis assuming that based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents at closing date will be successful insufficient to fund our financing objectives.operations for at least the next 12 months. As such, no adjustments have been made to the unaudited condensed consolidated financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern.

Sources of Liquidity and Material Cash Requirements

We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt.

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

In May 2022, we established an At-The-Market (“ATM”) program contribute 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 existingfund our short-term 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.

requirements. We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.

In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company. The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached. The Company’s intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Peanut platform and for working capital and other general corporate purposes.

Pursuant to the ATM program, the Company issued and completed sales of new Ordinary Shares in the form of ADSs for a total gross amount of $15.3 million on May 4, 2022, and of $7.8 million on June 14, 2023. Respectively, 6,036,238 and 2,052,450 new Ordinary Shares in the form of ADSs were issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM issuance”), at a unit subscription price of $1.27 and $1.90 per ADS, each ADS giving the right to receive one-half of one ordinary share of the Company.

24

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$1.2 million cash requirement as of December 31, 2022September 30, 2023 which expires March 8,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 $0.4$0.1 million cash requirement as of December 31, 2022September 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 threenine months ended March 31,September 30, 2023 and 2022.

 

  Three months ended
arch 31,		           Nine months ended September 30,     
(Amounts in thousands of U.S. Dollars)  2023   2022   $ change   % of
change		   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%) 

Net cash flow used in operating activities

   (65,967)    (31,781)    (34,186)    108% 

Net cash flow used in investing activities

   (621)    (66)    (555)    839% 

Net cash flow provided by financing activities

   6,956    194,403    (187,447)    -96% 

Effect of exchange rate changes on cash and cash equivalents

   3,909    (1,594)    5,503    (345%)    (427)    (27,186)    26,759    -98% 
  

 

   

 

   

 

   

 

     

 

   

 

   

 

 

Net (decrease) increase in cash and cash equivalents

   (16,905)    (3,194)    (13,711)    429%    (60,059)    135,369    (195,429)    -144% 
  

 

   

 

   

 

   

 

     

 

   

 

   

 

 

Operating Activities

Our net cash flows used in operating activities were $20.8$66.0 million and $1.5$31.8 million during the threenine months ended March 31,September 30, 2023 and 2022, respectively. Our net cash flows used in operating activities increased by $ 34.2 million, mainly due to the repayment in 2022 of the research tax credit receivable relating to fiscal years 2019 to 2021 for €24.8 million (corresponding to $28.1 million on the basis of 2021 closing exchange rate). The variance of $19.4 millionincrease is mainly drivenalso explained by the reimbursementchange in trade payables during the nine months period ended September 30, 2023 compared to the nine months period ended September 30, 2022.

Investing Activities

Our net cash flows used in investing activities were $0.6 million and $0.1 million during the nine months ended September 30, 2023 and 2022, respectively.

Financing Activities

Our net cash flows provided by financing activities was $7.0 million during the nine months ended September 30, 2023 that consisted of $20.9the ATM in June 2023 compared to $194.4 million during the nine months ended September 30, 2022, that consisted of research tax credits for the 2019our May 2022 ATM and 2020 fiscal year.June 2022 PIPE offering in second quarter of 2022.

 

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Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet arrangements and do not have variable interests in variable interest entities.

Smaller Reporting Company Status

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

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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,September 30, 2023, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

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

Limitation on Effectiveness of Controls and Procedures

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

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PART II – Other information

Item 1. Legal Proceedings

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

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Item 1A. Risk Factors

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

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

During the threenine months ended March 31,September 30, 2023, we issued the following unregistered securities:

 

 • 

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

•

On May 19, 2023, the issuance of an aggregate of 2,500 ordinary shares to a non-U.S. employee upon settlement of RSUs; and

•

On May 22, 2023, the issuance of an aggregate of 14,364 ordinary shares to non-U.S. employees upon settlement of RSUs; and

•

On May 24, 2023, the issuance of an aggregate of 34,321 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; and

•

On September 23, 2023, the issuance of an aggregate of 2,599 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs.

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

Item 3. Defaults Upon Senior Securities

None.

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Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Not applicable.

23

Item 6. Exhibits.

Exhibit Index

 

Exhibit

  

Description

  Incorporated by Reference
      Schedule/
Form		  File
Number		  Exhibit  File
Date
3.1  By-laws (statuts) of the registrant (English translation)  10-Q  001-

36697

  3.1  5/04/23
31.1  Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended        
31.2  Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended        
32.1*  Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended         
101.INS  XBRL Instance Document        
101.SCH  XBRL Taxonomy Extension Schema Document        
101.CAL  XBRL Taxonomy Extension Calculation Linkbase Document        

27

Incorporated by ReferenceExhibit

Exhibit  

Description

  

Schedule/
Form

Incorporated by Reference
  

File

Number

  

Exhibit

Schedule/
Form		 

File

Date

3.1File
Number		 By-laws (status) of the registrant (English translation)Exhibit File
Date		 
31.1Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended
31.2Certificate 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.INSXBRL Instance Document
101.SCHXBRL Taxonomy Extension Schema Document
101.CALXBRL 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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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrationregistrant 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,October 31, 2023  By: 

/s/ Daniel Tassé

  Daniel Tassé
  Chief Executive Officer
  (Principal Executive Officer)
Date: May 4,October 31, 2023  By: 

/s/ Sébastien Robitaille

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

 

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