Table of Contents
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM
10-Q
 
 
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31,June 30, 2022
or
 
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
to
Commission file number
001-36697
 
 
DBV TECHNOLOGIES S.A.
(Exact name of registrant as specified in its charter)
 
 
 
France
 
Not applicableapplicable
State or other jurisdiction of
incorporation or organization
 
(I.R.S. Employer
Identification No.)
  
177-181
avenue Pierre Brossolette
Montrouge France
 
92120
(Address of principal executive offices)
 
(Zip Code)
Registrant’s telephone number, including area code +33 1 55 42 78 78
Securities registered pursuant to Section
 12(b) of the Act:
    
 
Title of each class
 
Trading
Symbol(s)
 
Name of each exchange
on which registered
American Depositary Shares, each representing
one-half
of one ordinary share, nominal value €0.10 per share
 
DBVT
 
The Nasdaq Stock Market LLC
Ordinary shares, nominal value €0.10 per share*
 
n/a
 
The Nasdaq Stock Market LLC
 
*
Not for trading, but only in connection with the registration of the American Depositary Shares.
Securities registered pursuant to section 12(g) of the Act: None.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
☒  Yes            ☐  No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation
S-T
(§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
☒  Yes            ☐  No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging
“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 April 29,August 1
st
, 2022, the registrant had 94,025,192
 55,096,537 ordinary
shares, nominal value €0.10 per share, outstanding including treasury shares
.
shares.
 
 
 
Table of Contents
Table of contents
 
Part I
Financial information   Page3 
Part I
Item 1
 
Financial information
1
Item 1
Condensed Consolidated Statements of Financial Position (Unaudited) as of March 31,June 30, 2022 and December 31, 2021
   13 
 
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Six Months Ended March 31,June 30, 2022 and 2021
   24 
 
Condensed Consolidated Statements of Cash Flows (Unaudited) for the ThreeSix Months Ended March 31,June 30, 2022 and 2021
   35 
 
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the ThreeSix Months Ended March 31,June 30, 2022 and 2021
   46 
 
Notes to the Condensed Consolidated Financial Statements (Unaudited)
  57 
Item 2
 
Management’s Discussion and Analysis of Financial Condition and Results of Operations
   1519 
Item 3
 
Quantitative and Qualitative Disclosures About Market Risk
   2028 
Item 4
 
Controls and Procedures
   2129 
Part II
 
Other Information
   2230 
Item 1
 
Legal Proceedings
   2230 
Item 1A
 
Risk Factors
   2230 
Item 2
 
Unregistered Sales of Equity Securities and Use of Proceeds
30
Item 3
Defaults Upon Senior Securities31
Item 4
Mine Safety Disclosures31
Item 5
Other Information
   2231 
Item 3
6
 
Defaults Upon Senior SecuritiesExhibits
   22
Item 4
Mine Safety Disclosures
22
Item 5
Other Information
22
Item 6
Exhibits
2332 
Unless the context otherwise requires, we use the terms “DBV,”“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 prospectusQuarterly Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q may be referred to without the 
®
 and
™
symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.
Table of Contents
SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS.
This Quarterly Report on Form
10-Q,
or 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 or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or 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:
 
the impact of the ongoing
COVID-19
pandemic, including the emergence of new variant strains of
COVID-19,
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;
 
our ability to continue as a going concern;
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 Viaskin
TM
Peanut to the U.S. Food and Drug Administration, or the FDA;
 
the initiation, timing, progress and results of our
pre-clinical
studies and clinical trials, and our research and development programs;
 
the sufficiency of existing capital resources;
our business model and our other strategic plans for our business, product candidates and technology;
 
our ability to manufacture clinical and commercial supplies of our product candidates and comply with regulatory requirements related to the manufacturing of our product candidates;
 
our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize Viaskin Peanut and/or our other product candidates, if approved;
 
the commercialization of our product candidates, if approved;
 
our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut and/or our other product candidates, if approved, and our ability to serve such markets;
 
the pricing and reimbursement of our product candidates, if approved;
 
the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by physicians, patients, third-party payors and others in the medical community;
 
our ability to advance product candidates into, and successfully complete, clinical trials;
 
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
 
estimates of our expenses, future revenues, capital requirements and our needs for additional financing;
 
the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements;
 
our ability to maintain and establish collaborations or obtain additional grant funding;
 
our financial performance; and
 
other risks and uncertainties, including those listed under the caption “Risk Factors.”
1
Table of Contents
Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. These risks, uncertainties and other factors are described in greater detail under the caption “Risk Factors” in Part I. Item 1A of our Annual Report on Form
10-K
for the year ended December 31, 2021, filed with the Securities and Exchange Commission, or the SEC on March 9, 2022. Additional information is also included on our Current Report on Form
8-K,
filed with the SEC on June 13, 2022. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any
forward-looking
statement. We qualify all of our forward-looking statements by these cautionary statements.
In addition, any forward-looking statement in this Quarterly Report, including statements that “we believe” and similar statements, reflect our beliefs and opinions on the relevant subject and represents our views only as of the date of this Quarterly Report and should not be relied upon as representing our views as of any subsequent date. These statements are based upon information available to us as of the date of this Quarterly Report and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
2
Table of Contents
Part I – Financial Information
Item 1. Financial Statements
DBV Technologies S.A.
Condensed Consolidated Statements of Financial Position (unaudited)
(amounts in thousands, except share and per share data)
 
     
March 31,
 
December 31,
      
June 30,
 
December 31,
 
  
Note
  
2022
 
2021
   
Note
  
2022
 
2021
 
Assets
                
Current assets:
                
Cash and cash equivalents
  
3
  $74,107  $77,301   
3
  $247,971  $77,301 
Other current assets
  
4
   16,329  37,085   
4
   11,981  37,085 
     
 
  
 
      
 
  
 
 
Total current assets
     
 
90,437
 
 
 
114,386
 
     
 
259,953
 
 
 
114,386
 
Property, plant, and equipment, net
      17,196   18,146       15,677   18,146 
Right
of
use
assets related to operating leases
  
5
   3,356  7,336 
Right-of-use
assets related to operating leases
  
5
   3,146  7,336 
Intangible assets
      18   22       14   22 
Other
non-current
assets
      6,575   6,833       6,189   6,833 
     
 
  
 
      
 
  
 
 
Total
non-current
assets
     
 
27,144
 
 
 
32,338
 
     
 
25,025
 
 
 
32,338
 
     
 
  
 
      
 
  
 
 
Total Assets
     
$
117,581
 
 
$
146,723
 
     
$
284,978
 
 
$
146,723
 
     
 
  
 
      
 
  
 
 
Liabilities and shareholders’ equity
                
Current liabilities:
                
Trade payables
  
6
  $11,416  $11,429   
6
  $16,341  $11,429 
Short-term operating leases
  
5
   2,034  3,003   
5
   1,968  3,003 
Short-term financial debt
      333   510       156   510 
Current contingencies
  
8
   3,529  4,095   
9
   3,189  4,095 
Other current liabilities
  
6
   8,719  12,361   
6
   8,778  12,361 
     
 
  
 
      
 
  
 
 
Total current liabilities
     
 
26,031
 
 
 
31,397
 
     
 
30,431
 
 
 
31,397
 
     
 
  
 
      
 
  
 
 
Long-term operating leases
  
5
   2,268  7,147   
5
   1,945  7,147 
Non-current
contingencies
  
8
   5,758  6,758   
9
   6,421  6,758 
Other
non-current
liabilities
      1,461   2,147   
6
   1,764  2,147 
     
 
  
 
      
 
  
 
 
Total current liabilities
     
 
9,488
 
 
 
16,052
 
Total non-current liabilities
     
 
10,130
 
 
 
16,052
 
     
 
  
 
      
 
  
 
 
Total Liabilities
     
$
35,519
 
 
$
47,449
 
     
$
40,562
 
 
$
47,449
 
     
 
  
 
      
 
  
 
 
Shareholders’ equity:
                
Ordinary shares, €0.10 par value; 55,096,537 and 55,095,762
shares authorized, and issued as at March 31, 2022 and December 31, 2021, respectively
     $6,539  $6,538 
Ordinary shares, €0.10 par value; 94,022,679 and 55,095,762 shares authorized, and issued as at June 30, 2022 and December 31, 2021, respectively
     $10,708  $6,538 
Additional
paid-in
capital
      359,478   358,115       456,447   358,115 
Treasury stock, 144,501 and 153,631
ordinary shares as of March 31, 2022 and December 31, 2021, respectively, at cost
      (1,193)   (1,232) 
Treasury stock, 106,287 and 153,631 ordinary shares as of June 30, 2022 and December 31, 2021, respectively, at cost
      (953)   (1,232) 
Accumulated deficit
      (275,219)   (258,528)       (203,050)   (258,528) 
Accumulated other comprehensive income
      543   519       743   519 
Accumulated currency translation effect
      (8,086)   (6,137)       (19,480)   (6,137) 
     
 
  
 
      
 
  
 
 
Total Shareholders’ equity
     
$
82,062
 
 
$
99,274
 
  
7
  
$
244,416
 
 
$
99,274
 
     
 
  
 
      
 
  
 
 
Total Liabilities and
s
hareholder’s equity
     
$
117,581
 
 
$
146,723
 
Total Liabilities and Shareholders’ equity
     
$
284,978
 
 
$
146,723
 
     
 
  
 
      
 
  
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
13
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,
      
Three Months Ended June 30,
 
Six Months Ended 
June 30,
 
  
Note
   
2022
 
2021
   
Note
  
2022
 
2021
 
2022
 
2021
 
Operating income
  
 
9
 
  
$
2,546
 
 
$
2,941
 
  
10
  
$
1,529
 
 
$
(1,488
) 
 
$
4,074
 
 
$
1,453
 
 
Operating expenses
                    
Research and development expenses
      (12,223)   (22,164)       (18,611)   (20,179)   (30,834)   (42,343) 
Sales and marketing expenses
      (464)   (729)       (1,037)   (1,198)   (1,500)   (1,927) 
General and administrative expenses
      (6,630)   (9,683)       (5,704)   (8,269)   (12,334)   (17,951) 
     
 
  
 
      
 
  
 
  
 
  
 
 
Total Operating expenses
     
 
(19,317
) 
 
 
(32,575
) 
     
 
(25,352
) 
 
 
(29,646
) 
 
 
(44,669
) 
 
 
(62,221
) 
     
 
  
 
      
 
  
 
  
 
  
 
 
Loss from operations
     
 
(16,771
) 
 
 
(29,634
) 
     
 
(23,823
) 
 
 
(31,134
) 
 
 
(40,595
) 
 
 
(60,768
) 
     
 
  
 
      
 
  
 
  
 
  
 
 
Financial income
      152   215       784   46   936   261 
     
 
  
 
      
 
  
 
  
 
  
 
 
Loss before taxes
     
 
(16,619
) 
 
 
(29,419
) 
     
 
(23,039
) 
 
 
(31,088
) 
 
 
(39,659
) 
 
 
(60,507
) 
     
 
  
 
      
 
  
 
  
 
  
 
 
Income tax
      (87)   (30)       —     434   (87)   404 
     
 
  
 
      
 
  
 
  
 
  
 
 
Net loss
     
$
(16,706)
 
 
$
(29,449)
 
     
$
(23,039
) 
 
$
(30,654
) 
 
$
(39,746
) 
 
$
(60,103
) 
     
 
  
 
      
 
  
 
  
 
  
 
 
Foreign currency translation differences, net of taxes
      (1,933)   (8,744)       (11,394)   2,788   (13,327)   (5,956) 
Actuarial gains (loss) on employee benefits, net of taxes
      24   (85) 
Actuarial gains (losses) on employee benefits, net of taxes
      200   48   224   (38) 
     
 
  
 
      
 
  
 
  
 
  
 
 
Total comprehensive loss
     
$
(18,615
) 
 
$
(38,279
) 
     
$
(34,234
) 
 
$
(27,818
) 
 
$
(52,849
) 
 
$
(66,097
) 
     
 
  
 
      
 
  
 
  
 
  
 
 
Basic/diluted net loss per share attributable to shareholders  
 
13
 
  
$
(0.30
) 
 
$
(0.54
) 
  
14
  
$
(0.35
) 
 
$
(0.56
) 
 
$
(0.66
) 
 
$
(1.09
) 
 
Weighted average number of shares outstanding used in computing per share amounts:
      54,932,192   54,880,776 
Weighted average shares outstanding used in computing per share amounts:
      66,047,949   54,904,764   60,490,075   54,892,794 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
24
Table of Contents
DBV Technologies S.A.
Condensed Consolidated Statements of Cash Flows (unaudited)
(amounts in thousands)
 
     
Three months Ended March 31,
      
Six Months 
Ended June 30,
 
  
Notes
  
2022
 
2021
   
Notes
  
2022
 
2021
 
Net loss for the period
             
$
(39,746
) 
 
$
(60,103
) 
Adjustments to reconcile net loss to net cash used in operating activities:
     
$
(16,706
) 
 
$
(29,449
) 
Adjustments to reconcile net loss to net cash used in operating activities:
     
Depreciation, amortization and accrued contingencies
      (599)   1,483       1,249   8,619 
Retirement pension obligations
      (9)   0         14   57 
Expenses related to share-based payments
      1,363   1,433   
8
   2,441  2,527 
Other elements
      (3)   (456)       (3)   (843) 
Changes in operating assets and liabilities:
                
Decrease (increase) in trade receivables
      0     2,101       —     2,175 
Decrease (increase) in other current assets
      20,458   (417)       23,436   (8,393) 
(Decrease) increase in trade payables
      (19)   (2,567)       5,894   (3,165) 
(Decrease) increase in other current and
non-current
liabilities
      (4,118)   (7,980)       (3,040)   (6,608) 
Change in operating lease liabilities and right of use assets
      (1,849)   (353)       (1,979)   (769) 
     
 
  
 
 
Net cash flow used in operating activities
     
 
(1,483
) 
 
 
(36,204
) 
     
 
(11,733
) 
 
 
(66,503
) 
     
 
  
 
      
 
  
 
 
Cash flows provided by (used in) investing activities:
        
Acquisitions of property, plant, and equipment
      (131)   (184) 
Proceeds from property, plant and equipment dispositions
      3   0   
Cash flows used in investing activities:
        
Acquisitions of property, plant, and equipment, net from proceeds
      (369)   (13) 
Proceeds from property, plant, and equipment dispositions
      3   —   
Acquisitions of
non-current
financial assets
      (40)   (1)       (279)   —   
Proceeds from
non-current
financial assets
      179   0         426   —   
     
 
  
 
      
 
  
 
 
Net cash flows provided by (used in) investing activities
     
 
11
 
 
 
(185
) 
Net cash flows used in investing activities
     
 
(218
) 
 
 
(13
) 
     
 
  
 
      
 
  
 
 
Cash flows (used in) provided by financing activities:
        
(Decrease) in conditional advances
      (168)   (164) 
Cash flows provided by financing activities:
        
Decrease in conditional advances
      (328)   (345) 
Treasury shares
      40   578       279   638 
Capital increases, net of transaction costs
      0     42       195,270   794 
Other cash flows related to financing activities
      0     (17)       —     (17) 
     
 
  
 
      
 
  
 
 
Net cash flows (used in) provided by financing activities
     
 
(129
) 
 
 
440
 
Net cash flows provided by financing activities
     
 
195,221
 
 
 
1,071
 
     
 
  
 
      
 
  
 
 
Effect of exchange rate changes on cash and cash equivalents
      (1,594)   (7,944)       (12,600)   (5,423) 
     
 
  
 
      
 
  
 
 
Net decrease in cash and cash equivalents
     
 
(3,194
) 
 
 
(43,893
) 
Net increase (decrease) in cash and cash equivalents
     
 
170,670
 
 
 
(70,868
) 
     
 
  
 
      
 
  
 
 
Net cash and cash equivalents at the beginning of the period
      77,301   196,352 
Net Cash and cash equivalents at the beginning of the period
      77,301   196,352 
     
 
  
 
      
 
  
 
 
Net cash and cash equivalents at the end of the period
  
3
  
$
74,107
 
 
$
152,459
 
  
3
  
$
247,971
 
 
$
125,484
 
     
 
  
 
      
 
  
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
35
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
                   
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
   
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, 2021
  
 
54,929,187
 
  
$
6,518
 
  
$
1,152,042
 
  
$
(1,169
) 
 
$
(958,543
) 
 
$
484
 
 
$
6,158
 
 
$
205,491
 
  
 
54,929,187
 
  
$
6,518
 
  
$
1,152,042
 
 
$
(1,169
) 
 
$
(958,543
) 
 
$
484
 
 
$
6,158
 
 
$
205,491
 
Net (loss)
   —      —      —      —     (29,449)   —     —     (29,449)    —      —      —     —     (29,449)   —     —     (29,449) 
Other comprehensive loss
   —      —      —      —     —     (85)   (8,744)   (8,829)    —      —      —     —     —     (85)   (8,744)   (8,829) 
Issuance of ordinary shares
   7,500    1    42    —     —     —     —     42    7,500    1    42   —     —     —     —     42 
Treasury shares
   —      —      —      488   —     —     —     488    —      —      —     488   —     —     —     488 
Share-based payments
   —      —      1,433    —     —     —     —     1,433    —      —      1,433   —     —     —     —     1,433 
  
 
   
 
   
 
   
 
  
 
  
 
  
 
  
 
   
 
   
 
   
 
  
 
  
 
  
 
  
 
  
 
 
Balance at March 31, 2021
  
 
54,936,687
 
  
$
6,519
 
  
$
1,153,516
 
  
$
(681
) 
 
$
(987,992
) 
 
$
399
 
 
$
(2,586
) 
 
$
169,176
 
  
 
54,936,687
 
  
$
6,519
 
  
$
1,153,516
 
 
$
(681
) 
 
$
(987,992
) 
 
$
399
 
 
$
(2,586
) 
 
$
169,176
 
Net (loss)
   —      —      —     —     (30,654)   —     —     (30,654) 
Other comprehensive income
   —      —      —     —     —     48   2,788   2,836 
Issuance of ordinary shares
   75,000    9    464   —     —     —     —     473 
Insuance of warrants
         279               279 
Treasury shares
   —      —         (185)   —     —     —     (185) 
Share-based payments
   —      —      1,094      —     —     —     1,094 
Allocation of accumulated net losses
   —      —      (797,823)   —     797,823   —     —     —   
  
 
   
 
   
 
  
 
  
 
  
 
  
 
  
 
 
Balance at June 30, 2021
  
 
55,011,687
 
  
$
6,529
 
  
$
357,530
 
 
$
(866
) 
 
$
(220,823
) 
 
$
446
 
 
$
203
 
 
$
143,019
 
 
  
Ordinary shares
                   
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
   
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
 
  
 
55,095,762
 
  
$
6,538
 
  
$
358,115
 
 
$
(1,232
) 
 
$
(258,528
) 
 
$
519
 
  
$
(6,137
) 
 
$
99,274
 
Net (loss)
   —      —      —      —     (16,706)   —     —     (16,706)    —      —      —     —     (16,706)   —      —     (16,706) 
Other comprehensive loss
   —      —      —      —     —     24   (1,933)   (1,909)    —      —      —     —     —     24    (1,933)   (1,909) 
Issuance of ordinary shares
   775    1    0      —     —     —     —     1 
Insuance of ordinary shares
   775    1    —     —     —     —      —     1 
Treasury shares
   —      —      —      40   —     —     —     40    —      —      —     40   —     —      —     40 
Share-based payments
   —      —      1,363    —     —     —     —     1,363    —      —      1,363   —     —     —      —     1,363 
Other changes
   —      —      —      —     15     (15)   —      —      —      —     —     15      (15)   —   
  
 
   
 
   
 
   
 
  
 
  
 
  
 
  
 
   
 
   
 
   
 
  
 
  
 
  
 
   
 
  
 
 
Balance at March 31, 2022
  
 
55,096,537
 
  
$
6,539
 
  
   $
359,478
 
  
$
(1,193
) 
 
$
(275,219
) 
 
$
543
  
 
$
(8,086
) 
 
$
82,062
 
  
 
55,096,537
 
  
$
6,539
 
  
$
359,478
 
 
$
(1,193
) 
 
$
(275,219
) 
 
$
543
 
  
$
(8,086
) 
 
$
82,062
 
Net (loss)
   —      —      —     —     (23,039)   —      —     (23,039) 
Other comprehensive 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
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
46
Table of Contents
NOTES TO THE FINANCIAL STATEMENTS (UNAUDITED)
Note 1: The Company
Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or the “group”) is a
clinical-stage
specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin
™
. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT
™
, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin
™
.
Basis of Presentation
The condensed consolidated financial statements of the Company and its
wholly-owned
subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in thousands of U.S. Dollars, except for share and per share data and as otherwise noted.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 9, 2022 (the “Annual Report”). The condensed consolidated statement of financial position at December 31, 2021 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, 2021.
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, 2022, 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 - assets—operating lease, (4) impairment of
right
of
useright-of-use
assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, and (7) estimate of contingencies.
Going concern
These condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists.
Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (
Crédit d’Impôt Recherche
). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.
Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its Biologics License Application (“BLA”) for Viaskin
™
Peanut, beginning in August 2020, the Company scaled down its other clinical programs and
pre-clinical
spend to focus on Viaskin
™
Peanut. In response, the Company implemented a global restructuring plan to provide operational latitude to progress the clinical development and regulatory review of Viaskin
™
Peanut in the United States and European Union. This restructuring plan was completed in the second half of 2021.
In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. In order to respond to the FDA’s requests and recommendations, the Company defined parallel workstreams primarily in order to generate the
6-month
safety and adhesion clinical data to assess a modified Viaskin Peanut patch and demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population.
Following the submission of the adhesion study’s protocol to the FDA, the Company received an Advice/Information Request letter from the FDA in October 2021, requesting a stepwise approach to the modified Viaskin patch development program and provided partial feedback on this protocol. In December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback and announced its plan to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch (mVP) in children ages 4-11. The Company considers this trial as the most straightforward approach to demonstrate effectiveness, safety, and improved adhesion of the modified Viaskin Peanut system. After receiving agreement from the FDA for its change in strategy, the protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (“mVP”) patch was completed at the end of February 2022 
and was submitted to the FDA in April 2022.
The
C
ompany has been granted a Type C meeting by the FDA
, which is expected to be held
in the second quarter of 2022
,
to align on the new Phase
3
study protocol.
The Company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, the Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern.
5
Based on its current operations, as well as its plans and assumptions as revised pursuant to its change of strategy, announced in December 2021, the Company expects that its balance of cash and cash equivalents of $74.1 million as of March 31, 2022 will be sufficient to fund its operations into the first quarter of 2023.
The Company intends to seek additional capital as it prepares for the new pivotal study and launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of
non-dilutive
financings.
The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions. The ongoing
COVID-19
pandemic has already caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.
If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently.
These Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern
Accounting Pronouncements adopted in 2022
The Company
has
not adoptadopted any new accounting pronouncements in 2022
to date.
Accounting Pronouncements issued not yet adopted
In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13 -
2016-13—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. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard will have a material impact on its consolidated financial statements.
Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption.

7
Table of Contents
Note 2: Significant Events and Transactions
Clinical programs
Viaskin
TM
Peanut for children ages
4-11 -
in the United States Regulatory History and Current Status
In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL.Complete Response Letter received in August 2020. 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 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.
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.
6
3.
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 studies:
 
 a.
PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL
 
 b.
‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and Mvp;
In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, to identify the one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, the Company selected the modified patch to advance to further clinical testing in the intended patient population. 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 approximately 50% larger in size relative to the current patch and circular in shape.
In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and
in
October 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, and consideration of all other options, in December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback.letter. The Company estimated that the FDA’s newly proposed sequentialstepwise approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the
6-month
safety and adhesion study. The Company does not believe this approach to be in the best interest of patients due to the significant time delays associated with FDA review of a resource dependent
(non-PDUFA)
product. As such, in December 2021, the Company announced it plansits plan to initiate a pivotal Phase
3
— III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children ages 4-11.in the intended patient population. The studyclinical trial will also include updates to the Instructions for Use (IFU). The Company considers this trialapproach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA has confirmed the Company’s change in strategy is agreeable via oral and written exchanges.
8
Table of Contents
The protocol for the new Phase 3 pivotal study of thefor modified Viaskin Peanut (“mVP”) patch was completed athas been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), which means “speed” in French.
In May 2022, the end of February 2022
Company announced that the FDA granted it a Type C meeting to align on the protocol and the study protocol was submitted to the FDA in April 2022. The Company
has been granted aas part of the the Type C meeting bybriefing package.
DBV continues to engage in productive dialogue with the FDA in the second quarter of 2022 to align on the new Phase
3
studykey elements of the VITESSE protocol.
As previously disclosed, the Company will communicate key elements of the VITESSE trial design and projected timelines once this process has concluded.
Viaskin Peanut for children ages 4-11 -
4-11—European
Union Regulatory History and Current Status
In August 2021, the Company announced it has receivedits receipt from the 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.
In December 2021, the Company announced it has withdrawn the Marketing Authorization Application for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by positive 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 study 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 study 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
OnIn June 26, 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 Pg 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 20212022.
In June 2022, the Company announced that its pivotal Phase III trial EPITOPE, assessing the safety and efficacy of Viaskin
top-line™
results are expectedPeanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33.4 %, 95 % CI = 22.4% - 44.5 %).
DBV intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population.
Financing
In May 2022, the Company announced that pursuant to the Company’s
At-The-Market
program established in May 2022 (the “ATM Program”), it had issued and completed sales of new ordinary shares (the “Ordinary Shares”) in form of American Depositary Shares (“ADSs”), for a total gross amount of $15.3 million. In this context, 6,036,238 new Ordinary Shares in form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.27 dollar per ADS (i.e., a subscription price per Ordinary Share of 2.41 euro based on the USD/EUR exchange rate of 1.0531 dollar for 1 euro, as published by the endEuropean Central Bank on May 4, 2022) and each ADS giving the right to receive
one-half
of one ordinary share of the second quarterCompany).
In June 2022, the Company announced an aggregate $194 million private investment in public equity (PIPE) financing (corresponding to €181 million on the basis of 2022.an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 ordinary shares, as well as
pre-funded
warrants to purchase up to 28,276,331 ordinary shares. The ordinary shares were sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22), and the
pre-funded
warrants were sold to the purchasers at a
pre-funded
price of €2.90 (corresponding to $3.11) per
pre-funded
warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such
pre-funded
warrant. Gross proceeds from the PIPE financing total approximately $194 million (corresponding to €181 million), before deducting private placement expenses.
The ordinary shares, including the ordinary shares issuable upon exercise of
the pre-funded warrants
from the PIPE financing, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the ordinary shares, including the ordinary shares underlying
the pre-funded warrants.
 
7

9
Table of Contents
Following the financing operations carried out in the first half of 2022, the Company has cash and cash equivalent to support the Company’s operations several months beyond the projected completion of VITESSE, the planned Phase 3 clinical study of the modified Viaskin
™
Peanut patch in peanut allergic children ages 4 years and older.
COVID-19
Pandemic
On March 11, 2020, the World Health Organization declared
COVID-19
a pandemic. This global health crisis led many countries to impose national containment measures and travel bans. In view of this exceptional situation, the Company decided to take all measures aimed primarily at guaranteeing the safety of its employees and the continuation of ongoing clinical trials, in compliance with the directives of the authorities in each country. The Company has experienced a decrease in new patients enrolling in the ongoing clinical studies and it has had to adapt the protocols of its clinical trials because patients remain subject to travel restrictions.
The Company has assessed the impact of the uncertainties created by the pandemic. As of March 31,June 30, 2022, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company. The Company continues to update these estimates and assumptions as the situation evolves. The effects of the
COVID-19
pandemic are presented in the relevant line items of the condensed consolidated statement of financial position and the condensed consolidated statement of operations and comprehensive loss according to the function or nature of the income or expense.

Legal Proceedings
A class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis
Ito-Stone
v. DBV Technologies, et al., Case No.
2:19-cv-00525.
The complaint alleged that the Company and its former Chief Executive Officer, its current Chief Executive Officer, and its former Deputy Chief Executive Officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule
10b-5
promulgated thereunder. The plaintiffs seek unspecified damages on behalf of a purported class of purchasers of the Company’s securities between February 14, 2018 and August 4, 2020 and also held the Company’s securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020.
A hearing was held on July 29, 2021 in the U.S. District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. As the dismissal was without prejudice, the Plaintiffs replead their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court. The company moved to dismiss third amended complaint on December 10, 2021.
On July 29, 2022 the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs have 30 days to appeal the dismissal of the Third Amended.
The Company believes that the allegations contained in the amended complaint are without merit and will continue to defend the case vigorously. The Company believes this complaint will not have a material adverse effect on the Company’s consolidated financial position, results of operations or liquidity.
Note 33: Cash and Cash Equivalents
The following table presents for each reported period,tables summarize the breakdown of cash and cash equivalents:equivalents as of June 30, 2022 and December 31, 2021:
 
  
March 31,
   
December 31,
   
June 30,
   
December 31,
 
  
2022
   
2021
   
2022
   
2021
 
Cash
   29,145    31,427    226,674    31,427 
Cash equivalents
   44,963    45,874    21,298    45,874 
  
 
   
 
   
 
   
 
 
Total cash and cash equivalents as reported in the statements of financial position
  
 
74,107
 
  
 
77,301
 
  
 
247,971
 
  
 
77,301
 
  
 
   
 
   
 
   
 
 
Bank overdrafts
   0      0   
  
 
   
 
 
Total net cash and cash equivalents as reported in the statements of cash flows
  
 
74,107
 
  
 
77,301
 
  
 
   
 
 
Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.
8

10
Table of Contents
Note 4 Other Current Assets
Other current assets consisted of the following:
 
  
March 31,
   
December 31,
   
June 30,
   
December 31,
 
  
2022
   
2021
   
2022
   
2021
 
Research tax credit
   8,430    28,092    2,908    28,092 
Other tax claims
   3,696    3,561    4,339    3,561 
Prepaid expenses
   3,386    4,149    3,773    4,149 
Other receivables
   817    1,283    961    1,283 
  
 
   
 
   
 
   
 
 
Total
  
 
16,329
 
  
 
37,085
 
  
 
11,981
 
  
 
37,085
 
  
 
   
 
   
 
   
 
 
Research tax credit
In the fiscal year ended December 31, 2021, the Company recovered its Small and
Medium-sized
Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.
During the threesix months period ended March 31,June 30, 2022, the Company received the reimbursement of the 2019, 2020 and 20202021 fiscal year research tax credit.

The variance in Research Tax Credit is presented as follow:follows:
 
   
Amount in

thousands of US

Dollars
 
Opening research tax credit receivable as of January 1, 2022
   28,092 
+ Operating revenue
   1,5693,060 
- Payment received
   (20,87427,119) 
- Adjustment and currency translation effect
   (3581,125) 
   
 
 
 
Closing research tax credit receivable as of March 31,June 30, 2022
  
 
8,4302,908
 
   
 
 
 
Of
which -
Non-current
portion
0  
Non
Of which - Current -current
portion
  
 
8,430—  
Of
which - Current
portion
2,908
 
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 rental and insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.
9

11
Table of Contents
Note 5 Lease contracts
Future minimum lease payments under the Company’s operating leases’ right of use as of March 31,June 30, 2022 and December 31, 2021, are as follows:
 
  
March 31, 2022
 
December 31, 2021
   
June 30, 2022
 
December 31, 2021
 
  
Real estate
 
Other

assets
 
Total
 
Real estate
 
Other

assets
 
Total
   
Real estate
 
Other

assets
 
Total
 
Real estate
 
Other
assets
 
Total
 
Current portion
   2,159   66   2,225   3,361   77   3,438    2,104   50   2,154   3,361   77   3,438 
Year 2
   1,803   18   1,821   3,124   23   3,147    1,843   19   1,862   3,124   23   3,147 
Year 3
   605   15   620   2,299   18   2,317    284   11   295   2,299   18   2,317 
Year 4
   —     —     —     771   1   773    —     —     —     771   1   773 
Year 5
   —     —     —     790   —     790    —     —     —     790   —     790 
Thereafter
   —     —     —     1,220   —     1,220    —     —     —     1,220   —     1,220 
  
 
  
 
  
 
  
 
  
 
  
 
   
 
  
 
  
 
  
 
  
 
  
 
 
Total minimum lease payments
  
 
4,567
 
 
 
99
 
 
 
4,666
 
 
 
11,565
 
 
 
119
 
 
 
11,684
 
  
 
4,231
 
 
 
80
 
 
 
4,311
 
 
 
11,565
 
 
 
119
 
 
 
11,684
 
Less: Effects of discounting
   (358)   (7)   (365)   (1,526)   (8)   (1,534)    (363)   (6)   (370)   (1,526)   (8)   (1,534) 
  
 
  
 
  
 
  
 
  
 
  
 
   
 
  
 
  
 
  
 
  
 
  
 
 
Present value of operating lease
  
 
4,209
 
 
 
92
 
 
 
4,302
 
 
 
10,039
 
 
 
111
 
 
 
10,150
 
  
 
3,868
 
 
 
73
 
 
 
3,941
 
 
 
10,039
 
 
 
111
 
 
 
10,150
 
Less: current portion
   (1,973)   (61)   (2,034)   (2,929)   (74)   (3,003)    (1,922)   (46)   (1,968)   (2,929)   (74)   (3,003) 
  
 
  
 
  
 
  
 
  
 
  
 
   
 
  
 
  
 
  
 
  
 
  
 
 
Long-term operating lease
  
 
2,236
 
 
 
31
 
 
 
2,268
 
 
 
7,110
 
 
 
37
 
 
 
7,147
 
  
 
1,946
 
 
 
27
 
 
 
1,973
 
 
 
7,110
 
 
 
37
 
 
 
7,147
 
  
 
  
 
  
 
  
 
  
 
  
 
   
 
  
 
  
 
  
 
  
 
  
 
 
Weighted average remaining lease term (years)
   2.21   1.87     4.14   2.01      1.79   —       4.14   2.01   
Weighted average discount rate
   3.51%   3.32%     4.84%   3.32%      3.14%   1.29%     4.84%   3.32%   
The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis.
Rent expense presented in the consolidated statement of operations and comprehensive loss was:
 
   
March 31,
 
   
2022
   
2021
 
Operating lease expense / (income)
   (1,150)    847 
  
June 30,

  
   
2022
 
2021
  
Operating lease expense
   950
 
 
1,698
  
Net termination impact
   (1,657) 
—
  
In January 2022, the company entered into a termination agreement for its U.S. office in Summit, NJ, following the resizing of its facility use. The Company recognized an income
of $1.2 
million
as of March 31,June 30, 2022 due to the early termination of its Summit, NJ lease, offset by the payment of a
one-time
lump sum early termination fee of $1.5 million.
On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. Right of use and related lease debt will be recorded starting April 1, 2022 for a gross amount of 0.4 million.

Supplemental cash flow information related to operating leases is as follows for the period March 31,June 30, 2022 and 2021:
 
  
March 31,
  
June 30,

 
  
2022
   
2021
   
2022
 
2021
 
Cash paid for amounts included in the measurement of lease liabilities
         —   
—
 
Operating cash flows from operating leases
   583    1,025    1,079 
2,077
 

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Note 66: Trade Payables and Other Current Liabilities
6.1 Trade Payables
No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented.
10
6.2 Other Current Liabilities
Other currentThe following tables summarize the other liabilities consistedas of the following:June 30, 2022 and December 31, 2021:
 
   
March 31,
   
December 31,
 
   
2022
   
2021
 
Social security
   3,995    6,708 
Deferred income
   3,794    4,146 
Tax liabilities
   137    182 
Other debts
   793    1,325 
   
 
 
   
 
 
 
Total
  
 
8,719
 
  
 
12,361
 
   
 
 
   
 
 
 
   
June 30,
   
December 31,
 
   
2022
   
2021
 
   
Other current
liabilities
   
Other non-current

liabilities
   Total   
Other current
liabilities
   
Other non-current

liabilities
   Total 
Employee related liabilities
   
4,135
    
77
    4,212    6,708    247    6,954 
Deferred income
   
3,012
    
1,687
    4,700    4,146    1,900    6,046 
Tax liabilities
   
400
    —      400    182    —      182 
Other debts
   
1,231
    —      1,231    1,325    —      1,325 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  
 
8,778
 
  
 
1,764
 
  
 
10,542
 
  
 
12,361
 
  
 
2,147
 
  
 
14,508
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
The other current liabilities include short-term debt to employees including social welfare and tax agency obligations.obligations
.
Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $3.8$4.7 million as of March 31,June 30, 2022.
Note 7: Shareholders’ equity
The share capital as of June 30, 2022 is set at the sum of €9,402,268 ($10,708,445 converted at historical rates). It is divided into 94,022,679 fully authorized, subscribed and
paid-up
shares with a par value of €0.10.
Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022 (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, 2021 have been allocated to additional
paid-in
capital
.
Pursuant to the authorization granted by the SH General Meeting, the Board of Directors, at its meeting of June 9, 2022 (the “Board General Meeting”):
decided, within the framework of the Issuance the principle of a capital increase in cash with cancellation of preferential subscription rights, reserved for categories of persons meeting which set out the characteristics included in the 18
th
resolution of the Board General Meeting, through the issuance of Ordinary Shares and warrants to subscribe for Ordinary Shares, for a maximum amount of 6,113,200 New Ordinary Shares, corresponding to the maximum issue ceiling under the 22
nd
resolution of the Board General Meeting;
granted a number of authorizations for the purpose of carrying out the Issuance;
s
u
b-delegated
its authority to the Chief Executive Officer for the purpose of implementing the financing.
The Chief Executive Officer, acting pursuant to the
sub-delegations
of authority granted by the Board of Directors of the Company on June 8, 2022, after receiving the favorable opinion of the Pricing Committee established by the Board of Directors, has, on June 9, 2022 :
decided, making use of the 18
th
resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L.
225-128
of French Commercial Code, an amount of € 3,285,566.90, through the issuance of (i)
32,855,669
New Ordinary Shares, to be
13
Table of Contents
subscribed in cash at a unit price of €2.90 of share premium) and to be fully paid up at the time of subscription, i.e. a capital increase of a nominal amount of €3,285,566.90 together with a share premium of € 95,281,440.10, i.e. a gross amount of the capital increase of € 98,567,007, and (ii) 28,276,331 prefunded warrants to be subscribed in cash by paying up on the date of issue of € 82,001,359.90 corresponding to the prepayment of the subscription price of the new ordinary shares in the event of exercise of the prefunded warrants,

decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € 2,827,633.10, by issuing a maximum of 28,276,331 ordinary shares, with a value of € 0.10 to be subscribed in cash at the price of € 0.10 euro (without share premium), and to be fully paid up at the time of subscription, i.e. a capital increase of a maximum nominal amount of € 2,827,633.10 (and a share premium corresponding to the amount of the
pre-financed
price released in advance at the time of the subscription of the prefunded warrants ), being specified that this amount does not take into account the nominal value of the ordinary shares to be issued in order to preserve the rights of the holders of securities giving access to the capital issued or to be issued, in accordance with the legal and regulatory provisions and the contractual stipulations providing for other cases of adjustment if necessary;
determined the list of beneficiaries (designated within each of the categories of persons defined in the 18
th
resolution of the Board General Meeting) and the number of New Ordinary Shares and warrants allocated to each of them under the conditions defined in the 18th resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the Issu
e
.
The Company has assessed the
pre-funded
warrants for appropriate equity or liability classification. During this assessment, the Company determined the
pre-funded
warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815.
The 2022 Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the 2022 Warrants do not provide any guarantee of value or return.
Accordingly, the
pre-funded
warrants are classified as equity and accounted for as a component of additional
paid-in
capital at the time of issuance.
The changes in number of outstanding prefunded warrants
are
as follows:
Prefunded
warrants
Balance as of December 31, 2021
—  
Granted during the period
28,276,331
Forfeited during the period
—  
Exercised/released during the period
—  
Expired during the period
—  
Balance as of June 30, 2022
28,276,331
Note 78: 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 (Bons, employee warrants (
Bons de Souscription de Parts de Créateur d’Entreprise
or “BSPCE”) and
non-employee
warrants (
Bons de Souscription d’Actions
or “BSA”).
During the threesix months ended March 31,June 30, 2022, the Company did not grant anygranted 19,000 stock options and 3,200 restricted stock.
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 1
3
13 to the consolidated financial statements included in the Annual Report.
1
4
Table of Contents
Stock option fair value assumptions during the six months ended June 30, 2022
Weighted average share price at grant date in €
2.42
Weighted average expected volatility
92.4% 
Weighted average risk-free interest rate
0.86% 
Weighted average expected term (in years)
6
Dividend yield
—  
Weighted average fair value of stock options in €
1.81
Change in Number of BSA/SO/RSU:

   
Number of outstanding
 
   
BSA
   
SO
   
RSUs
 
Balance as of December 31, 2021
  
 
256,693
 
  
 
3,631,210
 
  
 
1,240,520
 
Granted during the period
   —      19,000    3,200 
Forfeited during the period
   —      (205,728)    (66,588) 
Exercised/released during the period
   —      (2,125)    (31,910) 
Expired during the period
   —      —      —   
   
 
 
   
 
 
   
 
 
 
Balance as of June 30, 2022
  
 
256,693
 
  
 
3,442,358
 
  
 
1,145,223
 
   
 
 
   
 
 
   
 
 
 
   
Number of outstanding
   
BSA
   
SO
   
RSUs
 
Balance as of December 31, 2021
  
 
256,693
   
 
3,631,210
 
  
 
1,240,520
 
Granted during the period
   —      —      —   
Forfeited during the period
   —      (159,403)    (56,113) 
Exercised/released during the period
   0      —      (775) 
Expired during the period
   —      —      0   
   
 
 
   
 
 
   
 
 
 
Balance as of March 31, 2022
  
 
256,693
 
  
 
3,471,808
 
  
 
1,183,633
 
   
 
 
   
 
 
   
 
 
 
Reconciliation of the share-basedShare-based payments expenses withreflected in the condensed consolidated statements of operationso
p
erations is as follow
s
:
 
   
Three months Ended March 31,
 
   
2022
   
2021
 
Research and development
  SO   (375)    (376) 
   RSU   (208)    (251) 
    
Sales and marketing
  SO   5    (49) 
   RSU   1    (22) 
    
General and administrative
  SO   (698)    (644) 
   RSU   (87)    (91) 
      
 
 
   
 
 
 
Total share-based compensation (expense)
     
 
(1,363
) 
  
 
(1,433
) 
      
 
 
   
 
 
 
       
Three Months
Ended June 30,
  
Six Months
Ended June 30,
 
       
2022
  
2021
  
2022
  
2021
 
Research & development
   SO    (290)   (302)   (665)   (678) 
    RSU    (185)   115   (393)   (136) 
Sales & marketing
   SO    (38)   (63)   (33)   (112) 
    RSU    (17)   (26)   (16)   (48) 
General & administrative
   SO    (478)   (709)   (1,176)   (1,353) 
    RSU    (70)   (110)   (157)   (201) 
        
 
 
  
 
 
  
 
 
  
 
 
 
Total share-based compensation (expens
e
)
       
 
(1,078
) 
 
 
(1,094
) 
 
 
(2,441
) 
 
 
(2,527
) 
        
 
 
  
 
 
  
 
 
  
 
 
 
11
Note 89: Contingencies
Current
The following tables summarize the contingencies and
non-current
contingencies break down as follows:
   
March 31,
   
December 31,
 
   
2022
   
2021
 
Current contingencies
   3,529    4,095 
Non-current
contingencies
   5,758    6,758 
 �� 
 
 
   
 
 
 
Total contingencies
  
 
9,288
 
  
 
10,853
 
   
 
 
   
 
 
 
The table below shows movements in contingencies:of June 30, 2022 and December 31, 2021:
 
   
Pension retirement

obligations
   
Collaboration

agreement -

Loss at

completion
   
Other

contingencies
   
Total
 
At January 1, 2022
  
 
1,008
 
  
 
9,800
 
  
 
45
 
  
 
10,853
 
Increases in liabilities
   0      0      0      0   
Used liabilities
   —      (1,286)    (45)    (1,331) 
Reversals of unused liabilities
   (9)    —      —      (9) 
Net interest related to employee benefits, and unwinding of discount
   —      —      —      0   
Actuarial gains and losses on defined-benefit plans
   (24)    —      —      (24) 
Currency translation effect
   (20)    (181)    —      (202) 
   
 
 
   
 
 
   
 
 
   
 
 
 
At March 31, 2022
  
 
955
 
  
 
8,332
 
  
 
0  
 
  
 
9,288
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Of which Current
  
 
—  
 
  
 
3,529
 
  
 
0  
 
  
 
3,529
 
Of which
Non-current
  
 
955
 
  
 
4,803
 
  
 
—  
 
  
 
5,758
 
         
   
June 30,
   
December 31,
 
   
2022
   
2021
 
Current contingencies
   3,189    4,095 
Non-current contingencies
   6,421    6,758 
   
 
 
   
 
 
 
Total contingencies
  
 
9,610
 
  
 
10,853
 
   
 
 
   
 
 
 
15
Table of Contents
The changes in contingencies are as follows:

                 
   
Pension
retirement
obligations
   
Collaboration
agreement -
Loss at
completion
   
Other
contingencies
   
Total
 
                 
At January 1, 2022
  
 
1,008
 
 
 
9,800
 
 
 
45
 
 
 
10,853
 
Increases in liabilities
   14   —     —     14 
Used liabilities
   —     (108)   (44)   (152) 
Reversals of unused liabilities
   —     —     —     —   
Net interest related to employee benefits, and unwinding of discount
   —     —     —     —   
Actuarial gains and losses on defined-benefit plans
   (224)   —     —     (224) 
Currency translation effect
   (73)   (807)   (2)   (882) 
   
 
 
  
 
 
  
 
 
  
 
 
 
At June 30, 2022
  
 
725
 
 
 
8,885
 
 
 
—  
 
 
 
9,610
 
   
 
 
  
 
 
  
 
 
  
 
 
 
Of which Current
   —     
3,189
   —     
3,189
 
Of which
Non-current
   
725
   
5,696
   —     
6,421
 
In 2021 and during the first threesix months of 2022, the Company updated its measurement of progress of the Phase 2 clinical trial (“PII”) conducted as part of the collaboration and license agreement with Nestlé and updated the cumulative income recognized. The Company has recorded an accrual in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and incomes yet to be recognized for the completion of the PII.
There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 14 to the consolidated financial statements included in the Annual Report.
Note 910: Operating income
The following table summarizes the operating income is broken down induring the following manner:three and six months ended June 30, 2022 and 2021:
 
   
Three months Ended March 31,
 
   
2022
   
2021
 
Research tax credit
   1,569    1,807 
Other operating income
   976    1,133 
   
 
 
   
 
 
 
Total
  
 
2,546
 
  
 
2,941
 
   
 
 
   
 
 
 
12
                 
   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2022
   
2021
   
2022
   
2021
 
Research tax credit
   1,491    1,870    3,060    3,677 
Other operating income
   37    (3,358)    1,014    (2,225) 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  
 
1,529
 
  
 
(1,488
) 
  
 
4,074
 
  
 
1,453
 
   
 
 
   
 
 
   
 
 
   
 
 
 
As of March 31,June 30, 2022, the Company recorded its collaboration contract’s incomeagreement’s revenue based on its updated measurement of progress of the Phase II clinical trial conducted as part of the collaboration and license agreement with Nestlé Health Science.agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and income
revenues yet
to be recognized for the completion of the Phase II clinical trial has been updated accordingly.
Note 1011: Allocation of Personnel Expenses
The Company had an average of 8887 employees during the threesix months ended March 31,June 30, 2022, in comparison with an average of 121111 employees during the threesix months ended March 31,June 30, 2021.
Allocation of Personnel Expenses by Function:
 
   
Three months Ended March 31,
 
   
2022
   
2021
 
Research and Development expenses
   3,075    4,718 
Sales and Marketing expenses
   245    518 
General and Administrative expenses
   2,595    3,766 
   
 
 
   
 
 
 
Total personnel expenses
  
 
5,915
 
  
 
9,002
 
   
 
 
   
 
 
 
Allocation1
6
Table of Personnel ExpensesContents
The following table summarizes the allocation of personnel expenses by Nature:function during the three and six months ended June 30, 2022 and 2021:

 
   
Three months Ended March 31,
 
   
2022
   
2021
 
Wages and salaries
   3,987    4,454 
Social security contributions
   251    1,332 
Expenses for pension commitments
   297    402 
Employer contribution to bonus shares
   16    1,381 
Share-based payments
   1,363    1,433 
   
 
 
   
 
 
 
Total
  
 
5,915
 
  
 
9,002
 
   
 
 
   
 
 
 
                 
   
Three Months
Ended June 30,
   
Six Months

Ended June 30,
 
   
2022
   
2021
   
2022
   
2021
 
                 
Research and Development expenses
   3,097    3,393    6,172    8,111 
Sales and Marketing expenses
   344    518    589    1,036 
General and Administrative expenses
   2,767    2,999    5,362    6,765 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total personnel expenses
  
 
6,208
 
  
 
6,910
 
  
 
12,123
 
  
 
15,912
 
   
 
 
   
 
 
   
 
 
   
 
 
 
The following table summarizes the allocation of personnel expenses by nature during the three six months ended June 30, 2022 and 2021:

                 
   
Three Months
Ended June 30,
   
Six Months

Ended June 30,
 
   
2022
   
2021
   
2022
   
2021
 
                 
Wages and salaries
   3,509    4,382    7,497    8,836 
Social security contributions
   1,256    1,064    1,507    2,396 
Expenses for pension commitments
   211    293    509    695 
Employer contribution to bonus shares
   154    77    170    1,458 
Share-based payments
   1,078    1,094    2,441    2,527 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  
 
6,208
 
  
 
6,910
 
  
 
12,123
 
  
 
15,912
 
   
 
 
   
 
 
   
 
 
   
 
 
 
The decrease in personnel expenses is mainly due to a decreaseddecrease in headcount following the full implementation of athe new organization.
Note 1112: Commitments
There have been 0 significant changes in other commitments from those disclosed in Note 18 to the consolidated financial statements included in the Annual Report.
Note 1213: Relationships with Related Parties
The Company’s related parties consist exclusively of the members of the Board of Directors and the members of the Executive Committee. As of June 30, 2022, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not changed significantly since December 31, 2021.
There were 0 new significant
related-party
transactions during the period nor any change in the nature of the transactions from those described in Note 19 to the consolidated financial statements included in the Annual Report.
13
Note 1314: 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 monthsand six month periods ended March 31,June 30, 2022 and 2021, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were
anti-dilutive
as a result of the Company’s net loss.
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7
Table of Contents
The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three and six months ended March 31,June 30, 2022 and 2021 indicated in number of potential shares:
 
   
Three months
Ended
March 31,
 
   
2022
   
2021
 
Non-employee
warrants
   256,693    225,008 
Employee warrants
   0      75,000 
Stock-options
   3,471,808    2,670,710 
Restricted stock units
   1,183,633    1,129,945 

   
Three Months Ended

June 30,
   
Six Months Ended

June 30,
 
   
2022
   
2021
   
2022
   
2021
 
Non-employee warrants
   256,693    256,693    256,693    256,693 
Stock options
   3,442,358    2,594,410    3,442,358    2,594,410 
Restricted stock units
   1,145,223    1,092,445    1,145,223    1,092,445 
Prefunded warrants
   28,276,331    —      28,276,331    —   
Note 1415: Events after the Close of the Period
As previously disclosed, a class action complaint was filed in January 2019 in the U.S. District Court, District of New Jersey, alleging that the Company and certain current and former executive officers violated certain U.S. federal securities laws. Plaintiffs filed a Third Amended Complaint on September 30, 2021. On July 29, 2022 the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs have 30 days to appeal the dismissal of the Third Amended Complaint. The Company believes that the allegations contained in the complaint are without merit and will continue to defend the case vigorously. The Company evaluated no other subsequent events that occurred after March 31,June 30, 2022, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on AprilJuly 29, 2022.2022 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.
On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the
l
andlord and occurred on April 1, 2022. Right of use and related lease debt will be recorded starting April 1, 2022.
 
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Item 2.
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, 2021, included in our Annual Report on Form
10-K
for the year ended December 31, 2021, filed with the Securities and Exchange Commission on March 9, 2022, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report.
Overview
We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy, or EPITTM,EPIT
TM
, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin. We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, as it 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 patients, including infants and 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. Our most advanced clinical program is Viaskin Peanut.
Following receipt of a CRL from the FDA in connection with our BLA
Viaskin
TM
Peanut for Viaskin Peanut, beginning in August 2020, we scaled down our other clinical programs and pre-clinical spend to focus on Viaskin Peanut. We also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin Peanut children ages
4-11
in the United States and European Union.
In January 2021, wethe Company received written responses from the FDA to questions provided in the Type A meeting request wethe Company submitted in October 2020 following the CRL.Complete Response Letter received in August 2020. The FDA agreed with ourits position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1,0001000 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.
WeThe Company named that assessment EQUAL, which stands for Equivalence in Uptake of Allergen.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. WeThe Company later named this clinical trialstudy STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.Patches
Based on the January 2021 FDA feedback, wethe Company defined three parallel workstreams:
 
1.4.
Identify a modified Viaskin patch (which we callthe Company calls mVP).
 
2.5.
Generate the
6-month
safety and adhesion clinical data FDA requested via STAMP, which wethe Company expected to be the longest component of the mVP clinical plan. WeThe Company prioritized the STAMP protocol submission so wethe Company could begin the clinical trialstudy as soon as possible.
 
3.6.
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, wethe Company outlined ourits proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional Phase I clinical trials in healthy adult volunteers:studies:
 
 a.c.
PREQUAL, a Phase I trialstudy 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.EQUAL
 
 b.d.
‘EQUAL in adults,’ adults’—a second Phase I trialstudy with adult healthy volunteers to compare the allergen uptake of cVP and mVP.Mvp;
In March 2021, wethe Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase I trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches. Wepatches, to identify the one or two best-performing patches, which the Company completed CHAMP in the second quarter of 2021. Based on the adhesion parameters studied, the Company selected the modified patch to advance to further clinical testing in the intended patient population. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and based on the results of CHAMP, weCompany then selected two modified patches that performed best out of the five modified patches studied for further development. WeThe Company then selected the circular patch for further development, which is approximately 50% larger in size relative to the current patch and circular in shape.
1
9
Table of Contents
In May 2021, wethe Company submitted ourits proposed STAMP protocol to the FDA, and onin October 14, 2021, wethe 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 wethe Company conduct allergen uptake comparison trialsstudies (i.e., ‘EQUAL in Adults,’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 trials might affect the design of the STAMP study.
After careful review of the FDA’s information requests, in December 2021, wethe Company decided not to pursue the sequentialstepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback. Weletter. The Company estimated that the FDA’s newly proposed sequentialstepwise 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, wethe Company announced weits plan to initiate a pivotal Phase 3III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). We considerThe 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 has confirmed (“mVP”)the Company’s change in strategy is agreeable via oral and written exchanges.
The protocol for the new Phase 3 pivotal study of thefor modified Viaskin Peanut (mVP) patch was completed athas been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), which means “speed” in French.
In May 2022, the end of February 2022Company announced that the FDA granted it a Type C meeting to align on the protocol and the study protocol was submitted to the FDA in April 2022. The Company has been granted a Type C meeting by the FDA , which is expected to be held in the second quarter of 2022, to align on the new Phase 3 study protocol.
15
Business trends and Results of Operations
The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars for the three months ended March 31, 2022 and 2021:
   
Three months ended
 
   
2022
   
2021
 
Operating income
  
$
2,546
 
  
$
2,941
 
Operating expenses
          
Research and development expenses
   (12,223)    (22,164) 
Sales and marketing expenses
   (464)    (729) 
General and administrative expenses
   (6,630)    (9,683) 
   
 
 
   
 
 
 
Total Operating expenses
  
 
(19,317
) 
  
 
(32,575
) 
   
 
 
   
 
 
 
Financial income
   152    215 
   
 
 
   
 
 
 
Income tax
   (87)    (30) 
   
 
 
   
 
 
 
Net loss
  
$
(16,706
) 
  
$
(29,449
) 
   
 
 
   
 
 
 
Basic/diluted Net loss per share attributable to shareholders
  
$
(0.30
) 
  
$
(0.54
) 
Comparison of the three months ended March 31, 2022 to the three months ended March 31, 2021
Operating Income
We generated operating income of $2.5 million during the three months ended March 31, 2022 compared to $2.9 million during the three months ended March 31, 2021, a decrease of 13.4%. This income was mainly generated from the French research tax credit (
crédit d’impôt recherche)
, or CIR, and by revenue recognized under our collaboration agreement with Nestlé Health Science.
   
Three months Ended March

31
   
% change
 
   
2022
   
2021
     
Sales
   —      —     
Other income
   2,546    2,941    (13%) 
Research tax credit
  
 
1,569
 
  
 
1,807
 
   (13%) 
Other operating (loss) income
  
 
976
 
  
 
1,133
 
   (14%) 
  
 
 
   
 
 
   
 
 
 
Total operating income
  
 
2,546
 
  
 
2,941
 
  
 
(13
%) 
  
 
 
   
 
 
   
 
 
 
The decrease in operating income is primarily attributable to the decrease of the CIR, as eligible expenses have declined in correlation with Research and Development costs.
As of March 31, 2022, we recorded our collaboration contract income based on our updated measurement of progress of the Phase II clinical trial conducted as part of the collaborationthe Type C meeting briefing package.
DBV continues to engage in productive dialogue with the FDA on the key elements of the VITESSE protocol. As previously disclosed, the Company will communicate key elements of the VITESSE trial design and license agreement with Nestlé Health Science. The accrual recordedprojected timelines once this process has concluded.
Viaskin Peanut for children ages
4-11
- European Union Regulatory History and Current Status
In August 2021, the Company announced its receipt from the 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 amountprocess. 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 difference betweendata, for example, the clinical relevance and effect size supported by a single pivotal study.
In December 2021, the Company announced it has withdrawn the Marketing Authorization Application for Viaskin Peanut and formally notified the EMA of our current best estimatesdecision. The initial filing was supported by positive 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 costs yetEMA Committee for Medicinal Products for Human Use (CHMP) that the data available to be incurreddate from a single pivotal study 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 study 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 income yetbiomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to be recognizeddemonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 Pg 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 2022.
In June 2022, The Company announced that its pivotal Phase III trial EPITOPE, assessing the safety and efficacy of Viaskin
™
Peanut 250 µg for the completiontreatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjects in the Phase II clinical has been updated accordingly.Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33;4 %, 95 % CI = 22.4% - 44.5 %).
DBV intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population.
 
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Table of Contents
Operating Expense
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the three months ended March 31, 2022 and 2021
:
   
Three months ended March 31,
   
$ change
   
% change
 
Research and Development expenses
  
2022
   
2021
         
External clinical-related expenses
   7,350    12,878    (5,528)    (43%) 
Employee-related costs
   2,492    4,091    (1,599)    (39%) 
Share-based payment expenses
   583    627    (45)    (7%) 
Depreciation, amortization and other costs
   1,799    4,568    (2,769)    (61%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Research and Development expenses
  
 
12,223
 
  
 
22,164
 
  
 
(9,941
) 
  
 
(45
%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Research and development expenses decreased by $9.9 million for the three months ended March 31, 2022, compared to the three months ended March 31, 2021, primarily due to a decrease of $5.5 million in external clinical-related expenses as main component of the work on clinical studies such as REALISE and EPITOPE has been finalized during the year 2021. We have also continued to practice financial diligence and implemented further cost containment strategies.
Employee-related costs, excluding share-based payment expenses, decreased by $1.6 million for the three months ended March 31, 2022, compared to the three months ended March 31, 2021, due to the workforce reduction following full implementation of the new organization.
The decrease in depreciation, amortization and other costs was primarily due to the reversal of loss at completion recorded on the Phase II clinical trial conducted as part of the Nestlé agreement.
Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended March 31, 2022 and 2021:
   
Three months ended March

31,
   
$ change
   
% change
 
Sales & Marketing expenses
  
2022
   
2021
         
Employee-related costs
   245    518    (273)    (53%) 
External professional services
   122    84    38    45% 
Share-based payment expenses
   (5)    71    (76)    (108%) 
Depreciation, amortization and other costs
   102    56    46    82% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Sales & Marketing expenses
  
 
464
 
  
 
729
 
  
 
(265
) 
  
 
(36
%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Sales and marketing expenses decreased by $0.3 million for the three months ended March 31, 2022, compared to the three months ended March 31, 2021, primarily due to a decrease in employee-related costs, partially offset by depreciation and amortization costs.
Employee-related costs, excluding share-based payments expenses, decreased by $0.3 million for the three months ended March 31, 2022, compared to the three months ended March 31, 2021 due to the workforce reduction following full implementation of the new organization.
17
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the three months ended March 31, 2022 and 2021:
   
Three months ended March 31,
   
$ change
   
% change
 
General & Administrative expenses
  
2022
   
2021
         
External professional services
   1,108    2,287    (1,179)    (52%) 
Employee-related costs
   1,810    3,031    (1,221)    (40%) 
Share-based payment expenses
   786    735    51    7% 
Depreciation, amortization and other costs
   2,927    3,630    (702)    (19%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total General & Administrative expenses
  
 
6,630
 
  
 
9,683
 
  
 
(3,052
) 
  
 
(32
%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
General and administrative expenses decreased by $3.1 million for the three months ended March 31, 2022, compared to the three months ended March 31, 2021, primarily due to a decrease in employee-related costs and external professional services as we continued to practice financial diligence and implemented further cost containment strategies.
Employee-related costs, excluding share-based payments expenses, decreased by $1.2 million for the three months ended March 31, 2022, compared to the three months ended March 31, 2021 due to the workforce reduction following full implementation of the new organization.
Financial income
Our financial income was $0.2 million for the three months ended March 31, 2022 and 2021. This item mainly includes foreign exchange income.
Net loss
Net loss was $16.7 million for the three months ended March 31, 2022, compared to $29.4 million for the three months ended March 31, 2021. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.30 and $0.54 for three months ended March 31, 2022 and 2021, respectively.
Liquidity and Capital Resources
Financial Condition
On March 31, 2022, we had $74.1 million in cash and cash equivalents compared to $77.3 million of cash and cash equivalents on December 31, 2021. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $1.5 and $36.2 million for the three months ended March 31, 2022 and 2021, respectively. As of March 31, 2022, we recorded a net loss of $16.7 million.
Based on our current operations, as well as our plans and assumptions as revised pursuant to our change of strategy announced in December 2021, we expect that our balance of cash and cash equivalents of $74.1 million as of March 31, 2022 will be sufficient to fund our operations into the first quarter of 2023. As of the date of the filing, our available cash is not projected to be sufficient to support our operating plan for at least the next 12 months. As such, there is substantial doubt regarding our ability to continue as a going concern.
We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings. We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to the ongoing COVID-19 pandemic. The ongoing COVID-19 pandemic has already caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to 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.
Our financial statements have been prepared on a going concern basis assuming that we will be successful in our financing objectives. As such, no adjustments have been made to the financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern.
Sources and Material Cash Requirements
Based on our current operations, as well as our plans and assumptions as revised pursuant to our change of strategy announced in December 2021, we expect that our balance of cash and cash equivalents of $74.1 million as of March 31, 2022 will be sufficient to fund our operations into the first quarter of 2023.
18
We fund short-term cash requirements primarily from payments associated with research tax credits (
Crédit d’Impôt Recherche
).
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.
As of the date of the filing, our available cash is not projected to be sufficient to support our operating plan for at least the next 12 months. As such, there is substantial doubt regarding our ability to continue as a going concern. We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of
non-dilutive
financings.
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to the ongoing
COVID-19
pandemic. The ongoing
COVID-19
pandemic has already caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to 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.
The following table presents our material cash requirements for future periods:
   
Material Cash Requirements Due by the period Ended
March 31,
 
   
2023
   
2024-2025
   
2026-2027
   
Thereafter
   
Total
 
   
(Amounts in thousands)
 
Conditional advances
   333    —      —      —      333 
Operating leases
   2,034    2,268    —      —      4,302 
Purchase obligations - Obligations Under the Terms of CRO Agreements
   20,785    8,825    3,457    —      33,067 
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
   23,152    11,094    3,457    —      37,703 
The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. The table does not include obligations under agreements that we can cancel without a significant penalty.
Future events could cause actual payments to differ from these estimates.
Conditional advances
In 2014, BpiFrance Financement granted an interest-free Innovation loan to DBV Technologies to help financing the pharmaceutical development of Viaskin
™
Milk. This amount was received in a single disbursement on November 27, 2014. In 2020, due to the
COVID-19
pandemic, Bpifrance postponed the repayments for a
6-month
period. Repayment will end during the third quarter of 2022.
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 $3.9 million cash requirement as of March 31, 2022 which expires March 8, 2024.
We also have facilities in North America that were initially intended to support our U.S. subsidiary as well as future commercialization needs. We lease 3,780 square feet of office space in Tower 49, New York, New York. This lease is for a period of 65 months and expires on February 25, 2023. In light of our global restructuring, the current stage of regulatory interactions regarding Viaskin Peanut, and the ongoing
COVID-19
pandemic, we entered into a sublease agreement of this office space in June 2021. The NYC office represents a $0.3 million cash requirement as of March 31, 2022 until the first quarter of 2023.
On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. Right of use and related lease debt will be recorded starting April 1, 2022.
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. Expenses associated with the ongoing trials amounted globally to $105.5 million. As of March 31, 2022, the amount we are still obligated to pay in connection with these contracts through 2024 is $33.1 million.
19
Cash flows
The table below summarizes our sources and uses of cash for the three months ended March 21, 2022 and 2021:
   
Three months ended March

31,
   
% change
 
(Amounts in thousands of U.S. Dollars)
  
2022
   
2021
     
Net cash flow used in operating activities
   (1,483)    (36,204)    (96%) 
Net cash flow provided by (used in) investing activities
   11    (185)    (106%) 
Net cash flow (used in) provided by financing activities
   (129)    440    
(129
%)
 
Effect of exchange rate changes on cash and cash equivalents
   (1,594)    (7,944)    
(80
%)
 
  
 
 
   
 
 
   
 
 
 
Net (decrease) increase in cash and cash equivalents
  
 
(3,194
) 
  
 
(43,893
) 
  
 
(93
%) 
  
 
 
   
 
 
   
 
 
 
Operating
Activities
Our net cash flows used in operating activities were $1.4 million and $36.2 million during the three months ended March 31, 2022 and 2021, respectively. Our net cash flows used in operating activities decreased by $34.7 million, or 95.9%, mainly due to the budget discipline measures we took, in particular the decrease in personnel expenses, which was directly related to the workforce reduction we implemented as part of our global restructuring plan. Cash flows used in operating activities for the three months ended March 31, 2022 also included $20.9 million of reimbursement of the Research Tax Credit.
Based on our current assumptions, we expect that our current cash and cash equivalents will support our operations into the first quarter of 2023.
Off-Balance
Sheet Arrangements
We have not entered into any
off-balance
sheet arrangements and do not have variable interests in variable interest entities.    
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report. Our significant accounting policies are more fully described in Note 1 of the Notes to the Condensed Consolidated Financial Statements in Part I, Item 1 of our Annual Report on Form 10-KReport.
Business trends and Results of Operations
Comparison of the Three Months Ended June 30, 2022 and 2021
The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the three months ended June 30, 2022 and 2021.
   
Three months ended June 30,
         
   
2022
   
2021
   
$ change
   
% change
 
Operating income
  
$
1,529
 
  
$
(1,488
) 
  
 
3,016
 
  
 
(203
)% 
Operating expenses
                    
Research and development expenses
   (18,611)    (20,179)    1,568    (8)% 
Sales and marketing expenses
   (1,037)    (1,198)    162    (13)% 
General and administrative expenses
   (5,704)    (8,269)    2,564    (31)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total Operating expenses
   (25,352)    (29,646)    4,309    (15)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
Financial income
   784    46    737*      
   
 
 
   
 
 
   
 
 
   
 
 
 
Income tax
   —      434    (434)    (100)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
Net loss
  
$
(23,039
) 
  
$
(30,654
) 
  
 
7,629
 
  
 
(25
)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
Basic/diluted Net loss per share attributable to shareholders
  
$
(0.35
) 
  
$
(0.56
) 
          
*
Percentage not meaningful
Operating Income
The following table summarizes our operating income during the three months ended June 30, 2022 and 2021:
   
Three months ended June 30,
         
   
2022
   
2021
   
$ change
   
% change
 
Sales
   —      —      —      —   
Other income
   1,529    (1,488)    3,016    (203)% 
Research tax credit
  
 
1,491
 
  
 
1,870
 
  
 
(379
) 
  
 
(20
)% 
Other operating income
  
 
37
 
  
 
(3,358
) 
  
 
3,396
 
  
 
(101
)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total operating income
  
 
1,529
 
  
 
(1,488
) 
  
 
3,016
 
  
 
(203
)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
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Our operating income is primarily generated from the French research tax credit (
Cr
é
dit
d
’
Iimp
ô
t
Recherche
, or “CIR”), and by the revenue recognized under our collaboration agreement with Nestlé Health Science. We generated operating income of $1.5 million during the three months ended June 30, 2022 compared to $(1.5) million during the three months ended June 30, 2021. The increase in operating income is primarily attributable to the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. During the three months ended June 30, 2021 negative revenue was recognized under the Nestlé’s collaboration agreement due to delays in new patient enrollment.The decrease in research tax credit is attributable to the decline of eligible expenses in connection with Research and Development costs.
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the three months ended June 30, 2022 and 2021:
   
Three Months Ended June 30,
         
Research and Development expenses
  
2022
   
2021
   
$ change
   
% change
 
External clinical-related expenses
   11,664    9,808    1,856    19% 
Employee-related costs
   2,622    3,206    (584)    (18)% 
Share-based payment expenses
   475    187    289    155% 
Depreciation, amortization and other costs
   3,850    6,978    (3,128)    (45)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Research and Development expenses
  
 
18,611
 
  
 
20,179
 
  
 
(1,568
) 
  
 
(8
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Research and Development expenses decreased by $1.6 million for the three months ended June 30, 2022, compared to the three months ended June 30, 2021, primarily due to an increase in external clinical-related expenses following the launch of work on VITESSE protocol. We have also continued to practice financial discipline and implemented further cost containment strategies.
Employee-related costs, excluding share-based payment expenses, decreased by $0.6 million for the three months ended June 30, 2022 compared to the three months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.
The decrease in depreciation, amortization and other costs was primarily due to the loss at completion recorded on the Phase II clinical trial conducted as part of the Nestlé agreement.
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Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended June 30, 2022 and 2021:
   
Three Months Ended June 30,
         
Sales and Marketing expenses
  
2022
   
2021
   
$ change
   
% change
 
External professional services
   399    307    92    30% 
Employee-related costs
   289    430    (140)    (33)% 
Share-based payment expenses
   55    89    (34)    (38)% 
Depreciation, amortization and other costs
   294    373    (79)    (21)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Sales and Marketing expenses
  
 
1,037
 
  
 
1,198
 
  
 
(162
) 
  
 
(13
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Sales and marketing expenses amounted to $1 million for the three months ended June 30, 2022, compared to $1.2 million for the three months ended June 30, 2021.
Employee-related costs, excluding share-based payments expenses, decreased by $0.1 million for the three months ended June 30, 2022, compared to the three months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the three months ended June 30, 2022 and 2021:
   
Three Months Ended June 30,
         
General and Administrative expenses
  
2022
   
2021
   
$ change
   
% change
 
External professional services
   1,771    1,922    (151)    (8)% 
Employee-related costs
   2,220    2,180    40    2% 
Share-based payment expenses
   548    819    (271)    (33)% 
Depreciation, amortization and other costs
   1,166    3,348    (2,182)    (65)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total General and Administrative expenses
  
 
5,704
 
  
 
8,269
 
  
 
(2,564
) 
  
 
(31
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
General and Administrative expenses decreased by $2.6 million for the three months ended June 30, 2022, compared to the three months ended June 30, 2021 primarily due to a decrease in depreciation, amortization and other costs as we continued to practice financial discipline and implemented further cost containment strategies.
Financial income (expense)
Our financial income was approximately $784,000 for the three months ended June 30, 2022, compared to a financial income of $46,000 for the three months ended June 30, 2021. This item mainly includes foreign exchange income and expenses.
Income tax
Our income tax profit was nil for the three months ended June 30, 2022, compared to $0.1 million for the three months ended June 30, 2021. This profit mainly resulted from U.S. tax refunds.
Net loss
Net loss was $23 million for the three months ended June 30, 2022, compared to $30.7 million for the three months ended June 30, 2021. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.35 and $0.56 for the three months ended June 30, 2022 and 2021, respectively.
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Table of Contents
Business trends and Results of Operations
Comparison of the Six Months Ended June 30, 2022 and 2021
The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the six months ended June 30, 2022 and 2021.
   
Six months ended June 30,
         
   
2022
   
2021
   
$ change
   
% change
 
Operating income
  
$
4,074
 
  
$
1,453
 
  
 
2,621
 
  
 
180
% 
Operating expenses
        
Research and development expenses
   (30,834)    (42,343)    11,509    (27)% 
Sales and marketing expenses
   (1,500)    (1,927)    427    (22)% 
General and administrative expenses
   (12,334)    (17,951)    5,617    (31)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Operating expenses
   (44,669)    (62,221)    17,552    (28)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Financial income (expense)
   936    261    675    258% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Income tax
   (87)    404    (491)    (122)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Net loss
  
$
(39,746
) 
  
$
(60,103
) 
  
 
20,357
 
  
 
(34
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Basic/diluted Net loss per share attributable to shareholders
  
$
(0.66
) 
  
$
(1.09
) 
    
  
 
 
   
 
 
   
 
 
   
 
 
 
Operating Income
The following table summarizes our operating income during the six months ended June 30, 2022 and 2021:
   
Six months ended June 30,
         
   
2022
   
2021
   
$ change
   
% change
 
Sales
   —      —       
Other income
   4,074    1,453    2,621    180% 
Research tax credit
  
 
3,060
 
   3,677    (617)    (17)% 
Other operating income
  
 
1,014
 
   (2,225)    3,238    (146)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total operating income
  
 
4,074
 
  
 
1,453
 
  
 
2,621
 
  
 
180
% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Our operating income was primarily generated from the French research tax credit (
Crédit d’Impôt Recherche
or “CIR”) and from revenue recognized under our collaboration agreement with Nestlé Health Science. We generated operating income of $4.1 million during the six months ended June 30, 2022, compared to $1.5 million during the six months ended June 30, 2021.
The increase in operating income is primarily attributable to the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. During the six months ended June 30, 2021 negative revenue was recognized under the Nestlé’s collaboration agreement due to delays in new patient enrollment.The decrease in research tax credit is attributable to the decline in eligible expenses in connection with Research and Development costs.
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the six months ended June 30, 2022 and 2021:
   
Six Months Ended June 30,
         
Research and Development expenses
  
2022
   
2021
   
$ change
   
% change
 
External clinical-related expenses
   19,014    22,686    (3,672)    (16)% 
Employee-related costs
   5,114    7,297    (2,183)    (30)% 
Share-based payment expenses
   1,058    814    244    30% 
Depreciation, amortization and other costs
   5,648    11,546    (5,898)    (51)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Research and Development expenses
  
 
30,834
 
  
 
42,343
 
  
 
(11,509
) 
  
 
(27
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
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Research and Development expenses decreased by $11.5 million for the six months ended June 30, 2022 compared to the six months ended June 30, 2021 primarily due to a decrease in external clinical-related expenses as main component of the work on clinical studies such as REALISE and EPITOPE has been finalized during the year 2021. We have also continued to practice financial discipline and implemented further cost containment strategies.
Employee-related costs, excluding share-based payments expenses, decreased by $2.2 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.
Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2022 and 2021:
   
Six Months Ended June 30,
         
Sales and Marketing expenses
  
2022
   
2021
   
$ change
   
% change
 
External professional services
   521    391    130    33% 
Employee-related costs
   539    877    (338)    (39)% 
Share-based payment expenses
   49    159    (110)    (69)% 
Depreciation, amortization and other costs
   391    500    (109)    (22)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Sales and Marketing expenses
  
 
1,500
 
  
 
1,927
 
  
 
(427
) 
  
 
(22
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Sales and marketing expenses decreased by $0.4 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021, primarily due to a decrease in employee-related costs.
Employee-related costs, excluding share-based payments expenses, decreased by $0.4 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2022 and 2021:
   
Six Months Ended June 30,
         
General and Administrative expenses
  
2022
   
2021
   
$ change
   
% change
 
External professional services
   2,879    4,210    (1,330)    (32)% 
Employee-related costs
   4,029    5,211    (1,181)    (23)% 
Share-based payment expenses
   1,333    1,554    (221)    (14)% 
Depreciation, amortization and other costs
   4,093    6,977    (2,884)    (41)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total General and Administrative expenses
  
 
12,334
 
  
 
17,951
 
  
 
(5,617
) 
  
 
(31
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
General and Administrative expenses decreased by $5.7 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021, primarily due to a decrease of depreciation, amortization and other costs.
The decrease in employee-related costs, excluding share-based payment expenses, is directly related to the workforce reduction following full implementation of the new organization
.
Financial income (expense)
Our financial income was $0.9 million for the six months ended June 30, 2022, compared to a financial income of $0.3 million for the six months ended June 30, 2021. This item mainly includes foreign exchange income (expense).
Income tax
Our income tax expense was $ 87,000 for the six months ended June 30, 2022. This income tax profit mainly resulted from US tax refunds.
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Table of Contents
Net loss
Net loss was $39.7 million for the six months ended June 30, 2022, compared to $60.1 million for the six months ended June 30, 2021. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.51 and $1.09 for the six months ended June 30, 2022 and 2021, respectively.
Liquidity and Capital Resources
Financial Condition
On June 30, 2022, we had $248 million in cash and cash equivalents compared to $77.3 million of cash and cash equivalents on December 31, 2021. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $12.3 and $66.5 million for the six months ended June 30, 2022 and 2021, filedrespectively. As of June 30, 2022, we recorded a net loss of $23 million.Our net cash flows provided by financing activities increased to $195.2 million during the six months ended June 30, 2022 from $1.1 million during the six months ended June 30, 2021. Financing activities consisted mainly of our underwritten global offering in the second quarter of 2022.
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. 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.
Our financial statements have been prepared on a going concern basis assuming that we will be successful in our financing objectives. As such, no adjustments have been made to the financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern.
Sources of Liquidity and Material Cash Requirements
We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt.
As of the date of the filing, our available cash is projected to be sufficient to support our operating plan for at least the next 12 months.
In May 2022, the Company announced that pursuant to the Company’s ATM program, it had issued and completed sales of new Ordinary Shares in the form of ADSs, for a total gross amount of $15.3 million.
In June 2022, the Company announced an aggregate $194 million PIPE financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 Ordinary Shares, as well as
pre-funded
warrants to purchase up to 28,276,331 Ordinary Shares.
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 due to the ongoing
COVID-19
pandemic. 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.
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Table of Contents
The following table presents our material cash requirements for future periods:
   
Material Cash Requirements Due by the period Ended
June 30,
 
   
2023
   
2024
   
2025
   
Thereafter
   
Total
 
                     
   
(Amounts in thousands)
 
Conditional advances
   156    —      —      —      156 
Operating leases
   2,154    1,862    295    —      4,312 
Purchase obligations - Obligations Under the Terms of CRO Agreements
   17,057    6,721    4,969    —      30,586 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
   19,367    8,583    5,264    —      35,054 
The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. The table does not include obligations under agreements that we can cancel without a significant penalty.
Future events could cause actual payments to differ from these estimates.
Conditional advances
In 2014, BpiFrance Financement granted an interest-free Innovation loan to DBV Technologies to help finance the pharmaceutical development of Viaskin
™
Milk. This amount was received in a single disbursement on November 27, 2014. In 2020, due to the
COVID-19
pandemic, Bpifrance postponed the repayments for a
6-month
period. Repayment will end during the third quarter of 2022.
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 $3.5 million cash requirement as of June 30, 2022 which expires March 8, 2024.
We also have facilities in North America that were initially intended to support our U.S. subsidiary as well as future commercialization needs. We lease 3,780 square feet of office space in Tower 49, New York, New York. This lease is for a period of 65 months and expires on February 25, 2023. In light of our global restructuring, the current stage of regulatory interactions regarding Viaskin Peanut, and the ongoing
COVID-19
pandemic, we entered into a sublease agreement of this office space in June 2021. The NYC office represents a $0.3 million cash requirement as of June 30, 2022 until the first quarter of 2023.
On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. The principal offices occupy a 5,799 square meter facility, and represents a $0.4 million cash requirement as of June 30, 2022 which expires May 1, 2025.
Purchase obligations - Obligations Under the Terms of CRO Agreements
In connection with the Securitieslaunch of our clinical trials for Viaskin Peanut and Exchange Commission (“SEC”) on March 9,Viaskin Milk, we signed agreements with several contract research organizations. Expenses associated with the ongoing trials amounted globally to $105.5 million. As of June 30, 2022, the amount we are still obligated to pay in connection with these contracts through 2024 is $30.6 million.
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Table of Contents
Summary Statement of Cash Flows
The table below summarizes our sources and uses of cash for the six months ended June 30, 2022 and 2021.
   
Six months ended June 30,
         
(Amounts in thousands of U.S. Dollars)
  
2022
   
2021
   
$ change
   
% of change
 
Net cash flow used in operating activities
   (11,733)    (66,503)    54,770    (82)% 
Net cash flow used in investing activities
   (218)    (13)    (206)    1595% 
Net cash flow provided by financing activities
   195,222    1,071    194,151      * 
Effect of exchange rate changes on cash and cash equivalents
   (12,600)    (5,423)    (7,177)    132% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Net (decrease) increase in cash and cash equivalents
  
 
170,670
 
  
 
(70,868
) 
  
 
241,538
 
  
 
(341
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
*
Percentage not meaningful
Operating Activities
Our net cash flows used in operating activities were $11.7 million and $66.5 million during the six months ended June 30, 2022 and 2021, respectively. Our net cash flows used in operating activities increased by $54.8 million, or 82%, mainly due to cost containment measures and to the workforce reduction following full implementation of the new organization
.
Cash flows used in operating activities for the six months ended June 30, 2021 included restructuring costs paid for $6.3 million.
Investing Activities
Our net cash flows used in investing activities was approximately $218,000 and $13,000 during the six months ended June 30, 2022 and 2021, respectively.
Financing Activities
Our net cash flows provided by financing activities increased to $195.2 million during the six months ended June 30, 2022 from $1.1 million during the six months ended June 30, 2021. Financing activities consisted mainly of our underwritten global offering in the second quarter of 2022.
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
non-affiliates
is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our
voting and
non-voting
ordinary shares
held by non-affiliates is less
than $700.0 million measured on the last business day of our second fiscal quarter.
Item 3.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a “smaller reporting company” as defined by Item 10 of Regulation S-K,Our market risks have not changed materially from those disclosed in the Company is not required to provide the information required by this item.Annual Report.
 
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Table of Contents
Item 4.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Based on theirits evaluation as of March 31,June 30, 2022, 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)
and 15d-15(e) under the Exchange Act) were effective to provide
reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules
13a-15(d)
or
15d-15(d)
of the Exchange Act during the period covered by this Quarterly Report on Form
10-Q
that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitation on Effectiveness of Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and
procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error of fraud may occur and not be detected.
 
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PART II – Other Informationinformation
Item 1.
Item 1. Legal Proceedings
See “Note 2: Significant Events and Transactions – Legal Proceedings” in the notes to the condensed consolidated financial statements included elsewhere in this Report.
Item 1A.
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 informationExcept as set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “ Risk Factors” of our Annual Report. Therebelow, there have been no material changes in our risk factors from those disclosed in the Annual Report.
Future sales of ordinary shares or ADSs by existing shareholders could depress the market price of the ADSs.
Item 2.
As of December 31, 2021, 55,095,762 Ordinary Shares were issued and outstanding. Sales of a substantial number of shares of our Ordinary Shares or ADSs in the public market, or the perception that these sales might occur, could depress the market price of our securities and could impair our ability to raise capital through the sale of additional equity securities. A substantial number of our shares are now generally freely tradable, subject, in the case of sales by our affiliates, to the volume limitations and other provisions of Rule 144 under the Securities Act. If holders of these shares sell, or indicate an intent to sell, substantial amounts of our securities in the public market, the trading price of our securities could decline significantly.
In June 2022, we completed a $194 million PIPE financing from the sale of (i) 32,855,669 Ordinary Shares, nominal value €0.10 per share at a price per Ordinary Share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022), and
(ii) pre-funded
warrants to purchase an aggregate of 28,276,331 Ordinary Shares (the “Warrant Shares”) at a
pre-funded
price per
pre-funded
warrant of €2.90 (corresponding to $3.11), which equals the per share price of the Ordinary Shares less the exercise price of €0.10 per
pre-funded
warrant. Each
pre-funded
warrant has an exercise price of €0.10 per Warrant Share. We entered into a registration rights agreement with the investors pursuant to which we agreed to file a registration statement with the SEC registering the resale of the 32,855,669 Ordinary shares and the 28,276,331 Ordinary shares underlying the
pre-funded
warrants issued in the PIPE. Upon the effectiveness of this registration statement and subject to certain beneficial ownership limitations contained in the
pre-funded
warrants, these shares will be freely tradable, without restriction, in the public market. In addition, the exercise of some or all of the
pre-funded
warrants will increase the number of our outstanding ordinary shares, which may dilute the ownership percentage or voting power of our shareholders.
In addition, we have filed a registration statement with the SEC to register the Ordinary Shares that may be issued under our equity incentive plans. The Ordinary Shares subject to outstanding options under our equity incentive plans, Ordinary Shares reserved for future issuance under our equity incentive plans and Ordinary Shares subject to outstanding warrants will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations. Sales of a large number of the shares issued under these plans in the public market could have an adverse effect on the market price of our securities.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
During the three months ended March 31, 2022, we did not grant any stock options and restricted stock units to employees in France and in the United States.
During the threesix months ended March 31,June 30, 2022, we issued the following unregistered securities:
On March 23, 2022, the issuance of an aggregate of 775 ordinary shares to a
non-U.S.
employee upon settlement of RSUs.RSUs;
On May 19, 2022, the issuance of an aggregate of 5,000 ordinary shares to a
non-U.S.
employee upon settlement of RSUs;
On May 24, 2022, the issuance of an aggregate of 26,135 ordinary shares to a
non-U.S.
employee upon settlement of RSUs;
Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022, the Company offered the opportunity to subscribe for warrants to purchase ordinary shares on May 12, 2022, and on June 9, 2022, the Chief Executive Officer authorized a capital increase for an amount of €3,285,566.90 through the issue of (i) 32,855,669 New Shares with a per value of €0.10 each and (ii) the issuance of 28,276,331 prefunded warrants, with cancellation of shareholders’ preferential subscription rights in favor of Braidwell LP, funds advised by Baker Bros. Advisors LP and BpiFrance Participations SA, existing shareholders of the Company and Venrock Healthcare Capital Partners.
On June 8, 2022, we entered into a securities purchase agreement with certain institutional and accredited investors pursuant to which we agreed to issue and sell to the investors i) 32,855,669 ordinary shares, nominal value €0.10 per share, at a price per ordinary share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022),
and (ii) pre-funded warrants
to purchase an aggregate of 28,276,331 ordinary shares (the “Warrant Shares”) at
a pre-funded price
per pre-funded warrant
of €2.90 (corresponding to $3.11), which equals the per share price of the ordinary shares less the exercise price of €0.10
per Pre-Funded Warrant.
Each Pre-Funded Warrant
has an exercise price of €0.10 per Warrant Share.
The Pre-Funded Warrants
are exercisable at any time after their original issuance and will expire ten years
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following their issuance. The exercise price and number of shares of ordinary shares issuable upon exercise of the warrants may be adjusted in certain circumstances, including stock splits, stock dividends, reclassifications and the like. The
pre-funded
warrants issued in the PIPE provide that the holder of the
pre-funded
warrants will not have the right to exercise any portion of its
pre-funded
warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of ordinary shares outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”). The holder may increase or decrease the Beneficial Ownership Limitation, provided, however, that the holder may only increase the Beneficial Ownership Limitation by (i) obtaining authorization from the French Ministry of Economy in the event the Beneficial Ownership Limitation is being raised above 9.99%, and (ii) by providing 61 days’ notice to the Company, except that in no event will the Beneficial Ownership Limitation exceed 19.99%. The securities issued by us pursuant to the securities purchase agreement and to be issued upon exercise of the warrants were not registered under the Securities Act of 1933, as amended, or the Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.
On June 10, 2022, the issuance of 3,100 ordinary shares to a
non-U.S.
employee upon exercise of 3,100 SO at an exercise price of 4.16 euros per SO, for aggregate proceeds to the Company of 12,896 euros.
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.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Item 4.
Not applicable.
Item 5. Other Information
Mine Safety Disclosures
Not applicable.
 
Item 5.
Other Information
None31
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Item 6. Exhibits.
Exhibit Index
 
Exhibit
Description
Incorporated by Reference
Schedule
/ Form
File
Number
Exhibit
File
Date
    3.1By-laws (statuts) of the registrant (English translation)
  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.INSInline XBRL Instance Document - the instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document
101.SCHInline XBRL Taxonomy Extension Schema Document
101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEFInline XBRL Taxonomy Extension Definition Linkbase Document
101.LABInline XBRL Taxonomy Extension Labels Linkbase Document
101.PREInline XBRL Taxonomy Extension Presentation Linkbase Document
104Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101.
Exhibit
  
Description
  
Incorporated by Reference
 
      
Schedule/
Form
   
File
Number
   
Exhibit
   
File
Date
 
1.1  Sales Agreement, dated as of May 2, 2022, by and between DBV Technologies S.A. and Jefferies LLC   Form
8-K
    
001-36697
    1.1    
May 2,
2022		 
 
3.1  Amended and Restated By-laws (statuts) of the registrant (English translation)        
4.1  Terms and Conditions of the Pre-Funded Warrant   Form
8-K
    
001-36697
    





Annex II of
the
Securities
Purchase
Agreement
filed as
Exhibit 10.1		 
 
 
 
 
 
 		   
June 13,
2022		 
 
10.1  Registration Rights Agreement, dated June 8, 2022, by and between DBV Technologies S.A. and the investor parties thereto   Form 8-K    
001-36697
    10.2    
June 13,
2022		 
 
10.2  Securities Purchase Agreement, dated June 8, 2022, by and between DBV Technologies S.A. and the investor parties thereto   Form
8-K
    
001-36697
    10.1    
June 13,
2022		 
 
31.1  Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended        
31.2  Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended        
32.1*  Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended        
101.INS  XBRL Instance Document        
101.SCH  XBRL Taxonomy Extension Schema Document        
101.CAL  XBRL Taxonomy Extension Calculation Linkbase Document        
101.DEF  XBRL Taxonomy Extension Definition Linkbase Document        
101.LAB  XBRL Taxonomy Extension Labels Linkbase Document        
101.PRE  XBRL Taxonomy Extension Presentation Linkbase Document        
104  Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101.        
 
*
Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form
Form 10-Q),
irrespective of any general incorporateincorporation 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     ,August 1, 2022  By: 
/s/ Daniel Tassé
   Daniel Tassé
   
Chief Executive Officer
   
(Principal Executive Officer)
Date: May     ,August 1, 2022  By: 
/s/ Sébastien Robitaille
   Sébastien Robitaille
   
Chief Financial Officer
   
(Principal Financial and Accounting Officer)
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