0001193125-22-136833.txt : 20220502 0001193125-22-136833.hdr.sgml : 20220502 20220502162743 ACCESSION NUMBER: 0001193125-22-136833 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 69 CONFORMED PERIOD OF REPORT: 20220331 FILED AS OF DATE: 20220502 DATE AS OF CHANGE: 20220502 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DBV Technologies S.A. CENTRAL INDEX KEY: 0001613780 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: I0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-36697 FILM NUMBER: 22882379 BUSINESS ADDRESS: STREET 1: 177-181 AVENUE PIERRE BROSSOLETTE CITY: MONTROUGE STATE: I0 ZIP: 92120 BUSINESS PHONE: 33(0)155427878 MAIL ADDRESS: STREET 1: 177-181 AVENUE PIERRE BROSSOLETTE CITY: MONTROUGE STATE: I0 ZIP: 92120 10-Q 1 d337003d10q.htm 10-Q 10-Q
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM
10-Q
 
 
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 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 applicable
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 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, 2022, the registrant had
 55,096,537 ordinary
shares, nominal value €0.10 per share, outstanding including treasury shares
.
 
 
 

Table of contents
 
 
 
 
  
Page
 
Part I
 
  
 
1
 
Item 1
 
  
 
1
 
 
  
 
2
 
 
  
 
3
 
 
  
 
4
 
 
 
  
5
 
Item 2
 
  
 
15
 
Item 3
 
  
 
20
 
Item 4
 
  
 
21
 
Part II
 
  
 
22
 
Item 1
 
  
 
22
 
Item 1A
 
  
 
22
 
Item 2
 
  
 
22
 
Item 3
 
  
 
22
 
Item 4
 
  
 
22
 
Item 5
 
  
 
22
 
Item 6
 
  
 
23
 
Unless the context otherwise requires, we use the terms “DBV,” “DBV Technologies,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q 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 prospectus 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.

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.”
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. 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.

Part I – Financial Information
Item 1. Financial Statements
DBV Technologies S.A.
Condensed Consolidated Statements of Financial Position (unaudited)
(amounts in thousands, except share and per share data)
 
         
March 31,
   
December 31,
 
    
Note
  
2022
   
2021
 
Assets
                     
Current assets:
                     
Cash and cash equivalents
  
3
   $ 74,107     $ 77,301  
Other current assets
  
4
     16,329       37,085  
         
 
 
   
 
 
 
Total current assets
       
 
90,437
 
 
 
114,386
 
Property, plant, and equipment, net
          17,196       18,146  
Right
 
of
 
use
assets related to operating leases
  
5
     3,356       7,336  
Intangible assets
          18       22  
Other
non-current
assets
          6,575       6,833  
         
 
 
   
 
 
 
Total
non-current
assets
       
 
27,144
 
 
 
32,338
 
         
 
 
   
 
 
 
Total Assets
       
$
117,581
 
 
$
146,723
 
         
 
 
   
 
 
 
Liabilities and shareholders’ equity
                     
Current liabilities:
                     
Trade payables
  
6
   $ 11,416     $ 11,429  
Short-term operating leases
  
5
     2,034       3,003  
Short-term financial debt
          333       510  
Current contingencies
  
8
     3,529       4,095  
Other current liabilities
  
6
     8,719       12,361  
         
 
 
   
 
 
 
Total current liabilities
       
 
26,031
 
 
 
31,397
 
         
 
 
   
 
 
 
Long-term operating leases
  
5
     2,268       7,147  
Non-current
contingencies
  
8
     5,758       6,758  
Other
non-current
liabilities
          1,461       2,147  
         
 
 
   
 
 
 
Total current liabilities
       
 
9,488
 
 
 
16,052
 
         
 
 
   
 
 
 
Total Liabilities
       
$
35,519
 
 
$
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  
Additional
paid-in
capital
          359,478       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
Accumulated deficit
          (275,219     (258,528
Accumulated other comprehensive income
          543       519  
Accumulated currency translation effect
          (8,086     (6,137
         
 
 
   
 
 
 
Total Shareholders’ equity
       
$
82,062
 
 
$
99,274
 
         
 
 
   
 
 
 
Total Liabilities and
s
hareholder’s equity
       
$
117,581
 
 
$
146,723
 
         
 
 
   
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
1

DBV Technologies S.A.
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(amounts in thousands, except share and per share data)
 
           
Three months Ended

March 31,
 
    
Note
    
2022
   
2021
 
Operating income
  
 
9
 
  
$
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
             
 
 
   
 
 
 
Loss from operations
           
 
(16,771
 
 
(29,634
             
 
 
   
 
 
 
Financial income
              152       215  
             
 
 
   
 
 
 
Loss before taxes
           
 
(16,619
 
 
(29,419
             
 
 
   
 
 
 
Income tax
              (87     (30
             
 
 
   
 
 
 
Net loss
           
$
(16,706)
 
 
$
(29,449)
 
             
 
 
   
 
 
 
Foreign currency translation differences, net of taxes
              (1,933     (8,744
Actuarial gains (loss) on employee benefits, net of taxes
              24       (85
             
 
 
   
 
 
 
Total comprehensive loss
           
$
(18,615
 
$
(38,279
             
 
 
   
 
 
 
Basic/diluted net loss per share attributable to shareholders
  
 
13
 
  
$
(0.30
 
$
(0.54
       
Weighted average number of shares outstanding used in computing per share amounts:
              54,932,192       54,880,776  
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
2

DBV Technologies S.A.
Condensed Consolidated Statements of Cash Flows (unaudited)
(amounts in thousands)
 
         
Three months Ended March 31,
 
    
Notes
  
2022
   
2021
 
Net loss for the period
                     
Adjustments to reconcile net loss to net cash used in operating activities:
       
$
(16,706
 
$
(29,449
Depreciation, amortization and accrued contingencies
          (599     1,483  
Retirement pension obligations
          (9         
Expenses related to share-based payments
          1,363       1,433  
Other elements
          (3     (456
Changes in operating assets and liabilities:
                     
Decrease (increase) in trade receivables
                   2,101  
Decrease (increase) in other current assets
          20,458       (417
(Decrease) increase in trade payables
          (19     (2,567
(Decrease) increase in other current and
non-current
liabilities
          (4,118     (7,980
Change in operating lease liabilities and right of use assets
          (1,849     (353
         
 
 
   
 
 
 
Net cash flow used in operating activities
       
 
(1,483
 
 
(36,204
         
 
 
   
 
 
 
Cash flows provided by (used in) investing activities:
                     
Acquisitions of property, plant, and equipment
          (131     (184
Proceeds from property, plant and equipment dispositions
          3           
Acquisitions of
non-current
financial assets
          (40     (1
Proceeds from
non-current
financial assets
          179           
         
 
 
   
 
 
 
Net cash flows provided by (used in) investing activities
       
 
11
 
 
 
(185
         
 
 
   
 
 
 
Cash flows (used in) provided by financing activities:
                     
(Decrease) in conditional advances
          (168     (164
Treasury shares
          40       578  
Capital increases, net of transaction costs
                   42  
Other cash flows related to financing activities
                   (17
         
 
 
   
 
 
 
Net cash flows (used in) provided by financing activities
       
 
(129
 
 
440
 
         
 
 
   
 
 
 
Effect of exchange rate changes on cash and cash equivalents
          (1,594     (7,944
         
 
 
   
 
 
 
Net decrease in cash and cash equivalents
       
 
(3,194
 
 
(43,893
         
 
 
   
 
 
 
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
 
         
 
 
   
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
3

DBV Technologies S.A.
Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited)
(amounts in thousands, except share and per share data)
 
    
Ordinary shares
                                       
    
Number of

Shares
    
Amount
    
Additional

paid-in

capital
    
Treasury

stock
   
Accumulated

deficit
   
Accumulated

other

comprehensive

income (loss)
   
Accumulated

currency

translation

effect
   
Total

Shareholders’

Equity
 
Balance at January 1, 2021
  
 
54,929,187
 
  
$
6,518
 
  
$
1,152,042
 
  
$
(1,169
 
$
(958,543
 
$
484
 
 
$
6,158
 
 
$
205,491
 
Net (loss)
     —          —          —          —         (29,449     —         —         (29,449
Other comprehensive loss
     —          —          —          —         —         (85     (8,744     (8,829
Issuance of ordinary shares
     7,500        1        42        —         —         —         —         42  
Treasury shares
     —          —          —          488       —         —         —         488  
Share-based payments
     —          —          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
 
 
    
Ordinary shares
                                       
    
Number of

Shares
    
Amount
    
Additional

paid-in

capital
    
Treasury

stock
   
Accumulated

deficit
   
Accumulated

other

comprehensive

income (loss)
   
Accumulated

currency

translation

effect
   
Total

Shareholders’

Equity
 
Balance at January 1, 2022
  
 
55,095,762
 
  
$
6,538
 
  
$
358,115
 
  
$
(1,232
 
$
(258,528
 
$
519
 
 
$
(6,137
 
$
99,274
 
Net (loss)
     —          —          —          —         (16,706     —         —         (16,706
Other comprehensive loss
     —          —          —          —         —         24       (1,933     (1,909
Issuance of ordinary shares
     775        1                  —         —         —         —         1  
Treasury shares
     —          —          —          40       —         —         —         40  
Share-based payments
     —          —          1,363        —         —         —         —         1,363  
Other changes
     —          —          —          —         15               (15     —    
    
 
 
    
 
 
    
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance at March 31, 2022
  
 
55,096,537
 
  
$
6,539
 
  
   $
359,478
 
  
$
(1,193
 
$
(275,219
 
$
543
  
 
$
(8,086
 
$
82,062
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
4

NOTES TO THE FINANCIAL STATEMENTS (UNAUDITED)
Note 1: The Company
Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or the “group”) is a
clinical-stage
specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin
. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT
, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin
.
Basis of Presentation
The condensed consolidated financial statements of the Company and its
wholly-owned
subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and presented in thousands of U.S. Dollars, except for share and per share data and as otherwise noted. 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 - operating lease, (4) impairment of
right
 
of
 
use
assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan 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 adopt 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 - Financial Instruments - Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU
2019-10
which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an
other-than-temporary
impairment had been recognized before the effective date. 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.
Note 2: Significant Events and Transactions
Clinical programs
Viaskin Peanut for children ages 4-11 - 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. The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250
µg
(approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages
4-11.
The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a
6-month,
well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches
Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:
1. Identify a modified Viaskin patch (which the Company calls mVP).
 
6

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. The Company estimated that the FDA’s newly proposed sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the
6-month
safety and adhesion study. 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 plans to initiate a pivotal Phase
3
—placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children ages 4-11. The study will also include updates to the Instructions for Use (IFU). The Company considers this trial the most straightforward to demonstrate effectiveness, safety, and improved adhesion of the modified Viaskin Peanut system. The FDA has confirmed the Company’s change in strategy is agreeable via oral and written exchanges. 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 Company
has been granted a Type C meeting by the FDA in the second quarter of 2022 to align on the new Phase
3
study protocol.
Viaskin Peanut for children ages 4-11 - European Union Regulatory History and Current Status
In August 2021, the Company announced it has received from the EMA 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
On 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 2021 and
top-line
results are expected by the end of the second quarter of 2022.
 
7

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, 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.
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 3 Cash and Cash Equivalents
The following table presents for each reported period, the breakdown of cash and cash equivalents:
 
    
March 31,
    
December 31,
 
    
2022
    
2021
 
Cash
     29,145        31,427  
Cash equivalents
     44,963        45,874  
    
 
 
    
 
 
 
Total cash and cash equivalents as reported in the statements of financial position
  
 
74,107
 
  
 
77,301
 
    
 
 
    
 
 
 
Bank overdrafts
                   
    
 
 
    
 
 
 
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

Note 4 Other Current Assets
Other current assets consisted of the following:
 
    
March 31,
    
December 31,
 
    
2022
    
2021
 
Research tax credit
     8,430        28,092  
Other tax claims
     3,696        3,561  
Prepaid expenses
     3,386        4,149  
Other receivables
     817        1,283  
    
 
 
    
 
 
 
Total
  
 
16,329
 
  
 
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 three months period ended March 31, 2022, the Company received the reimbursement of the 2019 and 2020 fiscal year research tax credit.
The variance in Research Tax Credit is presented as follow:
 
    
Amount in

thousands of US

Dollars
 
Opening research tax credit receivable as of January 1, 2022
     28,092  
+ Operating revenue
     1,569  
- Payment received
     (20,874
- Adjustment and currency translation effect
     (358
    
 
 
 
Closing research tax credit receivable as of March 31, 2022
  
 
8,430
 
    
 
 
 
Of which -
Non-current
portion
         
Of which - Current portion
  
 
8,430
 
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

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

assets
   
Total
   
Real estate
   
Other

assets
   
Total
 
Current portion
     2,159       66       2,225       3,361       77       3,438  
Year 2
     1,803       18       1,821       3,124       23       3,147  
Year 3
     605       15       620       2,299       18       2,317  
Year 4
     —         —         —         771       1       773  
Year 5
     —         —         —         790       —         790  
Thereafter
     —         —         —         1,220       —         1,220  
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total minimum lease payments
  
 
4,567
 
 
 
99
 
 
 
4,666
 
 
 
11,565
 
 
 
119
 
 
 
11,684
 
Less: Effects of discounting
     (358     (7     (365     (1,526     (8     (1,534
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Present value of operating lease
  
 
4,209
 
 
 
92
 
 
 
4,302
 
 
 
10,039
 
 
 
111
 
 
 
10,150
 
Less: current portion
     (1,973     (61     (2,034     (2,929     (74     (3,003
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Long-term operating lease
  
 
2,236
 
 
 
31
 
 
 
2,268
 
 
 
7,110
 
 
 
37
 
 
 
7,147
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Weighted average remaining lease term (years)
     2.21       1.87               4.14       2.01          
Weighted average discount rate
     3.51     3.32             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  
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, 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. 
Supplemental cash flow information related to operating leases is as follows for the period March 31, 2022 and 2021:
 
    
March 31,
 
    
2022
    
2021
 
Cash paid for amounts included in the measurement of lease liabilities
                 
Operating cash flows from operating leases
     583        1,025  
Note 6 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 current liabilities consisted of the following:
 
    
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
 
    
 
 
    
 
 
 
The other current liabilities include short-term debt to employees including social welfare and tax agency obligations.
Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $3.8 million as of March 31, 2022.
Note 7 Share-Based Payments
The Board of Directors has been authorized by the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options
 
(“SO”) and (Bons de Souscription d’Actions or “BSA”). During the three months ended March 31, 2022, the Company did not grant any stock options and restricted stock.
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
to the consolidated financial statements included in the Annual Report.
Change in Number of BSA/SO/RSU:

 
 
  
Number of outstanding
 
  
BSA
 
  
SO
 
  
RSUs
 
Balance as of December 31, 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
               —          (775
Expired during the period
     —          —              
    
 
 
    
 
 
    
 
 
 
Balance as of March 31, 2022
  
 
256,693
 
  
 
3,471,808
 
  
 
1,183,633
 
    
 
 
    
 
 
    
 
 
 
Reconciliation of the share-based payments expenses with the consolidated statements of operations
 
    
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
         
 
 
    
 
 
 
 
11

Note 8 Contingencies
Current 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:
 
    
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
                                       
Used liabilities
     —          (1,286      (45      (1,331
Reversals of unused liabilities
     (9      —          —          (9
Net interest related to employee benefits, and unwinding of discount
     —          —          —              
Actuarial gains and losses on defined-benefit plans
     (24      —          —          (24
Currency translation effect
     (20      (181      —          (202
    
 
 
    
 
 
    
 
 
    
 
 
 
At March 31, 2022
  
 
955
 
  
 
8,332
 
  
 
  
 
  
 
9,288
 
    
 
 
    
 
 
    
 
 
    
 
 
 
Of which Current
  
 
—  
 
  
 
3,529
 
  
 
  
 
  
 
3,529
 
Of which
Non-current
  
 
955
 
  
 
4,803
 
  
 
—  
 
  
 
5,758
 
In 2021 and during the first three 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 9 Operating income
The operating income is broken down in the following manner:
 
    
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

As of March 31, 2022, the Company recorded its collaboration contract’s income 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. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and income
yet
to be recognized for the completion of the Phase II clinical trial has been updated accordingly.
Note 10 Allocation of Personnel Expenses
The Company had an average of 88 employees during the three months ended March 31, 2022, in comparison with an average of 121 employees during the three months ended March 31, 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
 
    
 
 
    
 
 
 
Allocation of Personnel Expenses by Nature:
 
    
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
 
    
 
 
    
 
 
 
The decrease in personnel expenses is mainly due to a decreased headcount following the implementation of a new organization.
Note 11 Commitments
There have been no significant changes in other commitments from those disclosed in Note 18 to the consolidated financial statements included in the Annual Report.
Note 12 Relationships with Related Parties
There were no new significant
related-party
transactions during the period nor any change in the nature of the transactions from those described in Note 19 to the consolidated financial statements included in the Annual Report.
 
13

Note 13 Loss Per Share
Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three months ended March 31, 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.
The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three months ended March 31, 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
               75,000  
Stock-options
     3,471,808        2,670,710  
Restricted stock units
     1,183,633        1,129,945  
Note 14 Events after the Close of the Period
The Company evaluated subsequent events that occurred after March 31, 2022, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on April 29, 2022.
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.
 
14

Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 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, 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.
Following receipt of a CRL from the FDA in connection with our BLA 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 in the United States and European Union.
In January 2021, we received written responses from the FDA to questions provided in the Type A meeting request we submitted in October 2020 following the CRL. The FDA agreed with our 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 1/1,000 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.
We 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. We later named this clinical trial STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.
Based on the January 2021 FDA feedback, we defined three parallel workstreams:
 
1.
Identify a modified Viaskin patch (which we call mVP).
 
2.
Generate the
6-month
safety and adhesion clinical data FDA requested via STAMP, which we expected to be the longest component of the mVP clinical plan. We prioritized the STAMP protocol submission so we could begin the clinical trial 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, we outlined our 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:
 
  a.
PREQUAL, a Phase I trial with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL. The data collection phase of the trial is complete, and the data analysis phase is ongoing.
 
  b.
‘EQUAL in adults,’ a second Phase I trial with adult healthy volunteers to compare the allergen uptake of cVP and mVP.
In March 2021, we 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. We completed CHAMP in the second quarter of 2021. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and based on the results of CHAMP, we then selected two modified patches that performed best out of the five modified patches studied for further development. We 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, we submitted our proposed STAMP protocol to the FDA, and on October 14, 2021, we 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 we conduct allergen uptake comparison trials (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 trials might affect the design of the STAMP study.
After careful review of the FDA’s information requests, in December 2021, we decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback. We estimated that the FDA’s newly proposed sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the
6-month
safety and adhesion study. As such, in December 2021, we announced we plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). We consider 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”) change in strategy is agreeable via oral and written exchanges. 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 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 collaboration and license agreement with Nestlé Health Science. The accrual recorded in the amount of the difference between our current best estimates of costs yet to be incurred and income yet to be recognized for the completion of the Phase II clinical has been updated accordingly.
 
16

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 Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 9, 2022.
Smaller Reporting Company Status
We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our voting and
non-voting
ordinary shares held by
non-affiliates
is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and
non-voting
ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
 
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
As a “smaller reporting company” as defined by Item 10 of Regulation S-K, the Company is not required to provide the information required by this item.
 
20

Item 4.
Controls and Procedures
Disclosure Controls and Procedures
Based on their evaluation as of March 31, 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 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.
 
21

PART II – Other Information
 
Item 1.
Legal Proceedings
See “Note 2: Significant Events and Transactions – Legal Proceedings” in the notes to the condensed consolidated financial statements included elsewhere in this Report.
 
Item 1A.
Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “ Risk Factors” of our Annual Report. There have been no material changes in our risk factors from those disclosed in the Annual Report.
 
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
During the three months ended March 31, 2022, we did not grant any stock options and restricted stock units to employees in France and in the United States.
During the three months ended March 31, 2022, we issued an aggregate of 775 ordinary shares to a non-U.S. employee upon settlement of RSUs.
None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Regulation S promulgated under Section 5 of the Securities Act, as transactions by an issuer not involving any public offering or as offerings made to
non-U.S.
resident employees pursuant to an employee benefit plan established and administered in accordance with the law of a country other than the United States (namely, the Republic of France) and in accordance with that country’s practices and documentation. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.
 
Item 3.
Defaults Upon Senior Securities
None.
 
Item 4.
Mine Safety Disclosures
Not applicable.
 
Item 5.
Other Information
None
 
22

Item 6. Exhibits.
Exhibit Index
 
Exhibit
  
Description
  
Incorporated by Reference
         
Schedule
/ Form
  
File
Number
  
Exhibit
  
File
Date
    3.1    By-laws (statuts) of the registrant (English translation)            
  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    Inline 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.SCH    Inline XBRL Taxonomy Extension Schema Document            
101.CAL    Inline XBRL Taxonomy Extension Calculation Linkbase Document            
101.DEF    Inline XBRL Taxonomy Extension Definition Linkbase Document            
101.LAB    Inline XBRL Taxonomy Extension Labels Linkbase Document            
101.PRE    Inline XBRL Taxonomy Extension Presentation Linkbase Document            
104    Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101.            
 
*
Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, (whether made before or after the date of the
Form 10-Q),
irrespective of any general incorporate language contained in such filing.
 
 
23

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registration has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
   
DBV Technologies S.A.
    (Registrant)
Date: May     , 2022     By:  
/s/ Daniel Tassé
      Daniel Tassé
     
Chief Executive Officer
     
(Principal Executive Officer)
Date: May     , 2022     By:  
/s/ Sébastien Robitaille
      Sébastien Robitaille
     
Chief Financial Officer
     
(Principal Financial and Accounting Officer)
 
24
EX-3.1 2 d337003dex31.htm EX-3.1 EX-3.1

Exhibit 3.1

BY-LAWS

(updated by decision of the CEO on March 23, 2022)

DBV Technologies

Limited Company with share capital of €5,509,653.70

177-181 avenue Pierre Brossolette - 92120 Montrouge, France

Nanterre Trade and Companies Register No. 441 772 522

 

1


I. - CHARACTERISTIC FEATURES OF THE COMPANY

Article 1 - Form

The Company was incorporated in the form of a French Limited Company (Société Anonyme) with a Board of Directors.

Article 2 - Name

The name of the Company is: “DBV Technologies”

Article 3 - Registered office

The registered office is located at: 177-181 avenue Pierre Brossolette - 92120 Montrouge, France

Article 4 - Corporate Purpose

The Company’s corporate purpose in France and in all countries is:

 

   

the development of any innovative medical products, including any drugs, or diagnostic or treatment products;

 

   

the study, research, development, industrial manufacturing, and marketing of said products;

 

   

the use and development of any patents or licenses relating to these products, and generally speaking any commercial, investment or real estate, financial or other transactions that are directly or indirectly related to the corporate purpose in whole or in part, or to any other similar or related purpose, and that may promote the operation and commercial development of the Company.

Article 5 - Term

The Company’s term is ninety-nine years as from its registration in the Trade and Companies Register.

Article 6 - Share capital

The share capital has been set at €5,509,653.70.

It is divided into 55,096,537 ordinary shares with a par value of 10-euro cents (€0.10) each. All of the shares have been fully subscribed, and their full amount paid up in cash.

Article 7 - Changes to the share capital

I. The share capital may be increased either via the issue of new shares, or by increasing the par value of the existing shares.

 

2


The new shares will be paid for in cash, or via a contribution in kind, offset against liquid and due receivables, or via the incorporation of profits, reserves, or share premiums into the share capital, either as the result of a merger or demerger, or following the exercise of a right attached to transferable securities granting entitlement to the share capital, including payment of the corresponding amounts, where applicable.

The new equity securities will be issued either at their par value, or at that amount plus a share premium.

Only the Extraordinary General Meeting of Shareholders has the power to decide on increasing the share capital, based on a report from the Board of Directors containing the disclosures required by law.

However, the Extraordinary General Meeting of Shareholders may delegate this power to the Board of Directors under the conditions determined by law. The Board of Directors has the requisite powers to perform a capital increase in one or several installments, to determine its terms and conditions, to record its completion, and to amend the By-Laws accordingly within the limits of the powers so granted by the Extraordinary General Meeting of Shareholders.

If the General Meeting of Shareholders decides to increase the share capital, it may delegate the powers required to perform the transaction to the Board of Directors.

If a delegation of power or of authority is used, the Board of Directors will draw up a supplementary report at the next Ordinary General Meeting of Shareholders.

If the capital increase is performed via the incorporation of profits, reserves, or share premiums, the Extraordinary General Meeting of Shareholders will take decisions under the quorum and majority conditions provided for Ordinary General Meetings of Shareholders. In this case, it may decide that rights amounting to fractional shares may neither be traded nor transferred, and that the corresponding equity securities must be sold. The proceeds from the sale will be allocated to the holders in proportion to their rights.

A capital increase by increasing the par value of the shares can only be decided with the shareholders’ unanimous consent, except if it results from the incorporation of profits, reserves, or share premiums into the share capital.

Shareholders will have a preferential right to subscribe to the cash shares issued in order to perform a capital increase, in proportion to the number of shares that they hold. The shares purchased as a result of exercising this right will be shares in the same class as the one for the shares giving rise to said right, together with the shares resulting from the purchase of other transferable securities than shares.

The shareholders may sell all or some of their subscription rights throughout the subscription period. These rights will be tradable if they are stripped from shares that are themselves tradable. Otherwise, they may be sold under the same conditions as the actual shares.

Shareholders may waive their preferential subscription right on an individual basis.

The Extraordinary General Meeting of Shareholders that decides on the capital increase may waive the preferential subscription right under the conditions and limits determined by law, and rule to that effect on the reports prepared by the Board of Directors and the Statutory Auditors under the conditions determined by the laws and regulations in effect.

If the Extraordinary General Meeting of Shareholders, or the Board of Directors in the event of a delegation of authority, has expressly decided to do so, any shares that have not been subscribed on an irrevocable basis will be allotted to shareholders who subscribed to a higher number of shares on a revocable basis than the number to which they were able to subscribe on a preferential basis, in proportion to the subscription rights that they hold, and within the limits of their request, in any event.

 

3


If, for any reason, subscriptions have not absorbed the full amount of the capital increase, the Board of Directors may use the options provided for below, or only some of them, in the order that it determines:

 

(i)

limiting the capital increase to the amount of the subscriptions, subject to the general condition that it amounts to at least three quarters of the increase decided upon, and that this option was not expressly excluded by the Extraordinary General Meeting of Shareholders at the time of issue;

 

(ii)

allocating the balance of the shares if the Extraordinary General Meeting of Shareholders has not decided otherwise;

 

(iii)

opening the subscription process to the public if the Extraordinary General Meeting of Shareholders has expressly authorized it.

If subscriptions have not absorbed the entire capital increase following the exercise of these options, or three-quarters of the increase in the case provided for under (i) above, the capital increase will not be performed.

However, the Board of Directors may automatically limit the capital increase to the amount raised in all cases where the unsubscribed shares account for less than 3% of the capital increase.

In the event of a capital increase with or without preferential subscription rights, the Extraordinary General Meeting of Shareholders may provide that the number of securities may be increased by up to 15% of the initial issue, at the same price as the one used for the initial issue within a period of thirty days following the close of the subscription period.

If the capital increase creates fractions of shares, shareholders who have an insufficient number of subscription or allotment rights must make arrangements to purchase or sell the rights required to obtain the delivery of a whole number of new shares.

II. The Extraordinary General Meeting of Shareholders (or the Board of Directors in the event of a delegation of authority) may also authorize or decide on a capital decrease, subject to the rights of creditors, where applicable.

Decreasing the share capital below the legal limit can only be decided under the condition precedent of a capital increase intended to return the share capital to an amount that is at least equal to the minimum legal threshold, unless the Company turns itself into a company with another legal form. Otherwise, any interested party may apply to the courts to have the Company wound up. The court may not order the Company to be wound up if the amount of the share capital has been restored to the statutory minimum by the day when it rules on the substance of the case.

Article 8 - Financial year

The financial year runs from January 1 to December 31.

II. - ADMINISTRATION OF THE COMPANY

Article 9 - Executive Management exercise method

The executive management of the Company is the responsibility either of the Chairman of the Board of Directors or of another individual appointed by the Board of Directors bearing the title of Chief Executive Officer.

The Board of Directors chooses between the two Executive Management exercise methods based on the unanimous vote of all of its members.

Where responsibility for the Company’s Executive Management is held by the Chairman of the Board of Directors, the following provisions concerning the role of Chief Executive Officer apply.

 

4


A. The Board of Directors

Article 10 - Composition of the Board of Directors

The Company is governed by a Board of Directors that consists of between 3 and 18 directors.

The Directors are appointed by the General Meeting of Shareholders, deliberating under the quorum and majority conditions for Ordinary General Meetings of Shareholders.

The term of office for the Directors appointed during the term of the company is three (3) years. This term expires at the end of the meeting convened to approve the financial statements for the year just ended, and which is held in the year during which their term of office expires.

By way of exception and in order to allow exclusively for the implementation or maintenance of the staggered terms of office of Directors, the ordinary General Meeting of Shareholders may appoint one or more members of the Board for a term of two (2) years or one (1) year.

The Directors may be dismissed at any time and without any good reason by the General Meeting of Shareholders, deliberating under the quorum and majority conditions for Ordinary General Meetings of Shareholders.

The number of Directors aged over eighty cannot exceed one third of the Board members.

Article 11 - Board Discussions

The Board of Directors meets as often as is required by the Company’s interests at the invitation of the Chairman of the Board of Directors, at the registered office or the place specified in the notice of meeting. The invitation may be issued by any means five days in advance: it may also be issued orally and immediately if all of the Directors and non-voting Board members agree.

The Board of Directors may also make decisions by written consultation of the directors under the conditions provided by law.

If it has not met for over two months, at least one quarter of the members of the Board of Directors may ask the Chairman to convene the Board based on a determined agenda. The Chief Executive Officer or a Director may also ask the Chairman to convene the Board of Directors based on a determined agenda. The Chairman will be bound by any such requests.

An attendance register will be kept, and minutes will be drawn up following each meeting. The Board may only validly take decisions if at least half of its members are present.

Except where the choice of the method for exercising Executive Management is concerned, decisions will be taken based on a majority vote of the Directors present or represented. The Chairman will have a casting vote in the event that the vote is split.

The Directors and any individuals asked to attend the Board of Directors’ meetings are required to exercise discretion with respect to information of a confidential nature, and which is provided as such by the Chairman of the Board of Directors.

Article 12 - The Board’s powers

The Board of Directors determines the Company’s guidelines, and ensures their implementation. Subject to the powers specifically assigned to General Meetings of Shareholders, and within the limits of the corporate purpose, the Board will deal with any matter involving the proper operation of the Company, and settle any matters concerning it through its discussions.

 

5


The Board of Directors carries out the controls and verifications that it considers appropriate. Every Director will receive all of the information required to fulfill their assignment, and may ask for the disclosure of any documents that they consider useful.

Article 13 - The Chairman of the Board of Directors

The Board of Directors elects a Chairman, who must be a private individual, from among its members, and determines their remuneration, in accordance with applicable law. The Chairman is appointed for a period that may not exceed the length of their term of office as a Director. They are eligible for re-election. The Board of Directors may dismiss the Chairman at any time. Any provisions to the contrary will be considered void.

No one aged 75 or over may be appointed as Chairman. If the incumbent Chairman reaches this age during a financial year, their duties will automatically end following the Ordinary General Meeting of Shareholders convened to approve the financial statements for that financial year.

The Chairman organizes and directs the work undertaken by the Board, and accounts for it at the General Meeting of Shareholders. They ensure that the Company’s bodies operate properly, and especially that the Directors are in a position to fulfill their assignment.

Article 14 - Non-Voting Board Members

The General Meeting of Shareholders may appoint one or two non-voting Board members for the Company who are private individuals, regardless of whether they are shareholders; they will be aged 65 at most on the day of their appointment.

Non-voting Board members are appointed for a period of two (2) years. Their assignment ends after the General Meeting of Shareholders that has approved the financial statements for the year just ended, and held in the year during which their term of office expires.

Non-voting Board members do not receive any remuneration. They may receive allowances determined by the Board of Directors in order to reimburse the expenses that they are required to incur as part of the normal performance of their duties. If the Board delegates a specific assignment to the non-voting Board members or to one of them, they may allocate them an allowance in proportion to the importance of the assignment entrusted to them, as well as a budget for performing said assignment. Non-voting Board members are invited to all of the Board of Directors’ meetings and to all of the General Meeting of Shareholders, and take part in the discussions in an advisory capacity. Non-voting Board members perform a general and permanent advisory and supervisory role at the Company. However, they may not interfere in the management of the Company under any circumstances, or, in general, replace its legal bodies.

B. The Executive Management

Article 15 - Chief Executive Officers and Deputy Chief Executive Officers

The executive management of the Company is the responsibility of a private individual appointed by the Board of Directors bearing the title of Chief Executive Officer, under the Company’s responsibility.

The Board of Directors may appoint one or more private individuals responsible for assisting the Chief Executive Officer, who will bear the title of Deputy Chief Executive Officer, on the recommendation of the Chief Executive Officer. The number of Deputy Chief Executive Officers cannot exceed five.

The Chief Executive Officer may be dismissed by the Board of Directors at any time. The same applies to the Deputy Chief Executive Officers, on the recommendation of the Chief Executive Officer. If the dismissal is not on justified grounds, it may result in the payment of damages and interest.

Where the Chief Executive Officer ceases, or is otherwise prevented from performing their duties, the Deputy Chief Executive Officers will retain their positions and their assignments until a new Chief Executive Officer is appointed, unless the Board decides otherwise.

 

6


The Board of Directors determines the compensation paid to the Chief Executive Officer and the Deputy Chief Executive Officers, in accordance with applicable law.

Article 16 - Powers of the Chief Executive Officer and Deputy Chief Executive Officers

The Chief Executive Officer is granted very extensive powers to act in the Company’s name in all circumstances. They exercise the powers within the limit of the corporate purpose, and subject to those that the law and these By-Laws expressly assign to General Meeting of Sharehol