0001193125-21-151704.txt : 20210505 0001193125-21-151704.hdr.sgml : 20210505 20210505160728 ACCESSION NUMBER: 0001193125-21-151704 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 60 CONFORMED PERIOD OF REPORT: 20210331 FILED AS OF DATE: 20210505 DATE AS OF CHANGE: 20210505 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: 21893256 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 d172290d10q.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, 2021

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 30, 2021, the registrant had 54,936,687 ordinary shares, nominal value €0.10 per share, outstanding.

 

 

 


Table of Contents

Table of contents

 

          Page  

Part I

  

Financial information

     1  

Item 1

  

Condensed Consolidated Statements of Financial Position (Unaudited) as of March 31,2021 and December 31, 2020

     1  
  

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three Months Ended March 31, 2021 and 2020

     2  
  

Condensed Consolidated Statements of Cash Flows (Unaudited) for the Three Months Ended March 31, 2021 and 2020

     3  
  

Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Three Months Ended March 31, 2021 and 2020

     4  
  

Notes to the Condensed Consolidated Financial Statements (Unaudited)

     5  

Item 2

  

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

     13  

Item 3

  

Quantitative and Qualitative Disclosures About Market Risk

     17  

Item 4

  

Controls and Procedures

     17  

Part II

  

Other information

     18  

Item 1

  

Legal Proceedings

     18  

Item 1A

  

Risk Factors

     18  

Item 2

  

Unregistered Sales of Equity Securities and Use of Proceeds

     18  

Item 3

  

Defaults Upon Senior Securities

     18  

Item 4

  

Mine Safety Disclosures

     18  

Item 5

  

Other Information

     18  

Item 6

  

Exhibits

     19  


Table of Contents

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS.

This Quarterly Report on Form 10-Q (“Form 10-Q”) contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things:

 

   

statements regarding the impact of the ongoing COVID-19 pandemic and its effects on our operations, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations, other service providers and collaborators with whom we conduct business;

 

   

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 for ViaskinTM Peanut to the U.S. Food and Drug Administration;

 

   

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;

 

   

the implementation of our global restructuring plan, our business model and our other strategic plans for our business, product candidates and technology;

 

   

our ability to manufacture clinical and commercial supplies of our product candidates and comply with regulatory requirements related to the manufacturing of our product candidates;

 

   

our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize Viaskin Peanut and/or our other product candidates, if approved;

 

   

the commercialization of our product candidates, if approved;

 

   

our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut and/or our other product candidates, if approved, and our ability to serve such markets;

 

   

the pricing and reimbursement of our product candidates, if approved;

 

   

the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by physicians, patients, third-party payors and others in the medical community;

 

   

our ability to advance product candidates into, and successfully complete, clinical trials;

 

   

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

 

   

estimates of our expenses, future revenues, capital requirements and our needs for additional financing;

 

   

the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements;

 

   

our ability to maintain and establish collaborations or obtain additional grant funding;

 

   

our financial performance;

 

   

developments relating to our competitors and our industry, including competing therapies; 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 on Form 10-Q, 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, 2020, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2021. 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.

In addition, any forward-looking statement in this Annual Report represents our views only as of the date of this annual report and should not be relied upon as representing our views as of any subsequent date. 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.


Table of Contents

Part I – Financial Information

Item 1. Financial Statements

DBV Technologies S.A.

Condensed Consolidated Statements of Financial Position (unaudited)

(amounts in thousands, except share and per share data)

 

            March 31,     December 31,  
     Note      2021     2020  

Assets

       

Current assets :

       

Cash and cash equivalents

     3      $ 152,459     $ 196,352  

Trade receivables

        —         2,230  

Other current assets

        7,349       8,792  
     

 

 

   

 

 

 

Total current assets

        159,809       207,375  

Property, plant, and equipment, net

        21,526       24,792  

Right-of-use assets related to operating leases

        9,168       10,104  

Intangible assets

        32       41  

Other non-current assets

        30,870       29,935  
     

 

 

   

 

 

 

Total non-current assets

        61,596       64,871  
     

 

 

   

 

 

 

Total Assets

      $ 221,405     $ 272,246  
     

 

 

   

 

 

 

Liabilities and shareholders’ equity

       

Current liabilities:

       

Trade payables

     4      $ 17,176     $ 20,338  

Short-term operating leases

        3,314       3,708  

Short-term financial debt

        701       724  

Current contingencies

     6        4,246       5,016  

Other current liabilities

     4        13,394       22,926  
     

 

 

   

 

 

 

Total current liabilities

        38,831       52,713  
     

 

 

   

 

 

 

Long-term operating leases

        9,533       10,496  

Long-term financial debt

        350       543  

Non-current contingencies

     6        2,229       2,527  

Other non-current liabilities

        1,286       475  
     

 

 

   

 

 

 

Total non-current liabilities

        13,398       14,042  
     

 

 

   

 

 

 

Total Liabilities

      $ 52,229     $ 66,754  
     

 

 

   

 

 

 

Shareholders’ equity :

       

Ordinary shares, €0.10 par value; 54,936,687 and 54,929,187 shares authorized, and issued as at March 31, 2021 and December 31, 2020, respectively, and 4,100,663 and 4,029,763 shares outstanding as at March 31, 2021 and December 31, 2020, respectively

      $ 6,519     $ 6,518  

Additional paid-in capital

        1,153,516       1,152,042  

Treasury stock, 60,588 and 112,302 ordinary shares as of March 31, 2021 and December 31, 2020, respectively, at cost

        (681     (1,169

Accumulated deficit

        (987,992     (958,543

Accumulated other comprehensive income

        399       484  

Accumulated currency translation effect

        (2,586     6,158  
     

 

 

   

 

 

 

Total Shareholders’ equity

      $ 169,176     $ 205,491  
     

 

 

   

 

 

 

Total Liabilities and Shareholder’s equity

      $ 221,405     $ 272,246  
     

 

 

   

 

 

 

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

 

1


Table of Contents

DBV Technologies S.A.

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)

(amounts in thousands, except share and per share data)

 

          Three Months Ended March
31,
 
     Note    2021     2020  

Operating income

   7    $ 2,941     $ 4,720  

Operating expenses

       

Research and development expenses

        (22,164     (27,532

Sales and marketing expenses

        (729     (7,297

General and administrative expenses

        (9,683     (11,113
     

 

 

   

 

 

 

Total Operating expenses

        (32,575     (45,942
     

 

 

   

 

 

 

Loss from operations

        (29,634     (41,222
     

 

 

   

 

 

 

Financial income

        215       309  
     

 

 

   

 

 

 

Loss before taxes

        (29,419     (40,913
     

 

 

   

 

 

 

Income tax

        (30     —    
     

 

 

   

 

 

 

Net loss

      $ (29,449   $ (40,913
     

 

 

   

 

 

 

Other comprehensive loss

       

Foreign currency translation differences, net of taxes

        (8,744     (6,064

Actuarial (losses) gains on employee benefits, net of taxes

        (85     189  
     

 

 

   

 

 

 

Comprehensive loss

      $ (38,279   $ (46,788
     

 

 

   

 

 

 

Basic/diluted Net loss per share attributable to shareholders

   11    $ (0.54   $ (0.79

Weighted average shares outstanding used in computing per share amounts:

        54,880,776       51,802,524  

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

 

2


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DBV Technologies S.A.

Condensed Consolidated Statements of Cash Flows (unaudited)

(amounts in thousands)

 

            Three Months Ended March 31,  
     Notes      2021     2020  

Net loss for the period

      $ (29,449   $ (40,913

Adjustments to reconcile net loss to net cash used in operating activities:

       

Depreciation, amortization and accrued contingencies

        1,483       1,548  

Retirement pension obligations

        —         109  

Expenses related to share-based payments

        1,433       3,073  

Other elements

        (456     419  

Changes in operating assets and liabilities:

       

Decrease (increase) in inventories and work in progress

        —         (2,402

Decrease (increase) in trade receivables

        2,101       —    

Decrease (increase) in other current assets

        (417     122  

(Decrease) increase in trade payables

        (2,567     (3,212

(Decrease) increase in other current and non-current liabilities

        (7,980     (8,382

Change in operating lease liabilities and right of use assets

        (353     (45

Net cash flow used in operating activities

        (36,204     (49,683
     

 

 

   

 

 

 

Cash flows used in investing activities:

       

Acquisitions of property, plant, and equipment, net from proceeds

        (184     (816

Acquisitions of intangible assets

        —         (114

Acquisitions of non-current financial assets

        (1     —    
     

 

 

   

 

 

 

Net cash flows used in investing activities

        (185     (930
     

 

 

   

 

 

 

Cash flows provided by financing activities:

       

(Decrease) increase in conditional advances

        (164     7  

Treasury shares

        578       (412

Capital increases, net of transaction costs

        42       151,023  

Other cash flows related to financing activities

        (17     (7
     

 

 

   

 

 

 

Net cash flows provided by financing activities

        440       150,611  
     

 

 

   

 

 

 

Effect of exchange rate changes on cash and cash equivalents

        (7,944     (5,811
     

 

 

   

 

 

 

Net (decrease) / increase in cash and cash equivalents

        (43,893     94,187  
     

 

 

   

 

 

 

Net Cash and cash equivalents at the beginning of the period

        196,352       193,255  
     

 

 

   

 

 

 

Net cash and cash equivalents at the end of the period

     3      $ 152,459     $ 287,442  
     

 

 

   

 

 

 

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

 

3


Table of Contents

DBV Technologies S.A.

Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited)

(amounts in thousands, except share and per share data)

 

    Ordinary shares                                      
    Number of
Shares
    Amount     Additional
paid-in

capital
    Treasury
stock
    Accumulated
deficit
    Accumulated
other

comprehensive
income
(loss)
    Accumulated
currency
translation
effect
    Total
Shareholders’
Equity
 

Balance at January 1, 2020

    47,028,510     $ 5,645     $ 1,003,595     $ (230   $ (798,988   $ 108     $ (16,945   $ 193,186  

Net (loss)

    —         —         —         —         (40,913     —         —         (40,913

Other comprehensive income (loss)

    —         —         —         —         —         189       (6,064     (5,875

Issuance of ordinary shares

    7,898,677       873       150,150       —         —         —         —         151,023  

Treasury shares

    —         —         —         (832     —         —         —         (832

Share-based payments

    —         —         3,073         —         —         —         3,073  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at March 31, 2020

    54,927,187     $ 6,518     $ 1,156,818     $ (1,062   $ (839,901   $ 297     $ (23,009   $ 299,662  
    Ordinary shares                                      
    Number of
Shares
    Amount     Additional
paid-in
capital
    Treasury
stock
    Accumulated
deficit
    Accumulated
other
comprehensive

gain
(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  

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

 

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NOTES TO THE FINANCIAL STATEMENTS (UNAUDITED)

Note 1: The Company

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or the “group”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.

Basis of Presentation

The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.

The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on March 17, 2021 (the “Annual Report”). The condensed consolidated statement of financial position at December 31, 2020 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, 2020.

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, 2021, 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

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 dImpôt 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. The Company 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. Based on guidance received from the FDA in January 2021, the Company’s plans to implement such guidance, and expected cost savings from implementation of the global restructuring plan, the Company expects that its current balance of cash and cash equivalents of $152.5 million as of March 31, 2021 will be sufficient to fund its operations for at least the next 12 months.

The Company intends to seek additional capital as it prepares for the 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. As a result of disruptions to the global financial markets as a result of the ongoing COVID-19 pandemic, 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.

 

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Accounting Pronouncements adopted in 2021

Effective January 1, 2021, the Company adopted ASU 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. The adoption of ASU 2019-12 did not have a material impact on the Company’s financial position or results of operations.

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.

In January 2017, the FASB issued ASU 2017-04, Simplifying the Test for Goodwill Impairment, which modifies the goodwill impairment test and requires an entity to write down the carrying value of goodwill for the amount by which the carrying amount of a reporting unit exceeds its fair value. 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 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

ViaskinTM Peanut for children ages 4-11

In January 2020, the Company announced positive topline results of the three-year, open-label extension of its Phase III PEPITES trial, or PEOPLE trial, evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrated long-term clinical benefit as shown by an increase in eliciting dose (“ED”), which may decrease the chance of reacting to an accidental peanut exposure. After three years, the Company observed that 75.9% (107/141) of patients had increased their ED from baseline, and 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein by year three. The safety profile of Viaskin Peanut was consistent with that observed in the clinical program to date in over 1,000 patients. During the PEOPLE trial, the most common adverse events were mild to moderate skin reactions localized to the administration site, and there was no epinephrine use deemed related to treatment. No treatment related serious adverse events were reported. One patient experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without anti-anaphylactic treatment. Treatment compliance remained high throughout the study at a mean of 98% over three years of treatment. Low discontinuations due to adverse events were observed.

In February 2020, the FDA announced an Allergenic Products Advisory Committee meeting to be held on May 15, 2020 to discuss the Biologics License Application (BLA) for Viaskin Peanut. On March 16, 2020, the Company announced that the FDA had informed us that during its ongoing review of the Company’s BLA for Viaskin Peanut, it had identified questions regarding efficacy, including the impact of patch-site adhesion. Therefore, the Advisory Committee meeting to discuss the BLA originally scheduled on May 15, 2020 was cancelled.

On August 4, 2020, the Company announced that FDA has issued a Complete Response Letter in which the FDA indicated it could not approve the Viaskin Peanut BLA in its current form. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study. The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data. The FDA did not raise any safety concerns related to Viaskin Peanut.

On January 13, 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 Company believes the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, the Company proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications. The FDA agreed with the Company’s 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 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 modified patches, the FDA has

 

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requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population.

On November 2, 2020, the Company announced that its Marketing Authorization Application, or MAA, for Viaskin Peanut had been validated by the European Medicines Agency, or EMA. The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years. The Company received the first set of questions from the EMA, during the first quarter of 2021, which were consistent with the Company’s expectations and prefiling conversations with the EMA. The Company did not receive questions about the impact of adhesion on efficacy. The EMA’s Committee for Medicinal Products for Human Use will provide a recommendation to the European Commission, or EC, on whether to grant a marketing authorization when its review of the Viaskin Peanut MAA is complete.

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 mg 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.

Financing

On February 4, 2020, the Company announced the closing of an underwritten global offering of an aggregate of 7,500,000 ordinary shares in (i) a public offering of 4,535,581 ordinary shares in the form of 9,071,162 American Depositary Shares (“ADSs”) in the United States, Canada and certain countries outside Europe at a public offering price of $10.25 per ADS (on the basis of an exchange rate of $1.0999 = €1.00), and (ii) an offering exclusively addressed to qualified investors in Europe (including France) of 2,964,419 ordinary shares at an offering price of €18.63 per ordinary share (together, the “Global Offering”).

On March 2, 2020, the Company announced that the underwriters partially exercised their option to purchase 338,687 additional ordinary shares in the form of 677,374 ADSs at an offering price of $10.25 per ADS, before deducting commissions and estimated offering expenses (the “Option”). The Option closed on March 4, 2020.

Consequently, following partial exercise of the Option, the total number of ordinary shares sold in the global offering was 7,838,687 ordinary shares, including 4,874,268 ordinary shares in the form of 9,748,536 ADSs, bringing the total gross proceeds from the global offering to $160.7 million and net proceeds of $150.0 million.

Restructuring

The Company initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanut in the United States and European Union. The Company expects full implementation of the organization-wide costs reduction measures to be completed by the second half of 2021.

The following table summarizes restructuring activities as of March 31, 2021 included in current contingencies and other current liabilities in the statement of financial position:

 

     Restructuring
liabilities
 

Restructuring liability - January 1, 2021

     9,387  

Amounts paid

     (4,854

Other effect including currency translation effect

     (220
  

 

 

 

Restructuring liability - March 31, 2021

     4,313  
  

 

 

 

of which current contingencies

     1,511  

of which other current liabilities

     2,803  

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

 

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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, 2021, 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 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 March 16, 2020.

The Company believes that the allegations contained in the amended complaint are without merit and will 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,  
     2021      2020  

Cash

     58,069        42,341  

Cash equivalents

     94,390        154,011  
  

 

 

    

 

 

 

Total cash and cash equivalents as reported in the statements of financial position

     152,459        196,352  
  

 

 

    

 

 

 

Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.

Note 4: Trade Payables and Other Current Liabilities

4.1 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.

4.2 Other Current Liabilities

Other current liabilities consisted of the following:

 

     March 31,      December 31,  
     2021      2020  

Employee related liabilities

     9,245        16,661  

Deferred income

     3,378        4,687  

Tax liabilities

     312        580  

Other debts

     460        999  
  

 

 

    

 

 

 

Total

     13,394        22,926  
  

 

 

    

 

 

 

 

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The other current liabilities include short-term debt to employees including employee termination allowance and benefits as part of the restructuring (refer to Note 2, “Significant Events and Transactions of the Period – Restructuring”), bonus accruals, and social welfare and tax agency obligations.

Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $3.4 million as of March 31, 2021.

Note 5: Share-Based Payments

The Board of Directors has been authorized by the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), employee warrants (Bons de Souscription de Parts de Créateur d’Entreprise or “BSPCE”) and (Bons de Souscription d’Actions or “BSA”).

During the three months ended March 31, 2021, the Company granted 75,600 stock options and 24,900 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 14 to the consolidated financial statements included in the Annual Report.

 

Stock options fair value assumptions during the three months ended March 31, 2021

 

Weighted average share price at grant date in €

     9.3  

Weighted average expected volatility

     90.9

Weighted average risk-free interest rate

     (0.36 )% 

Weighted average expected term (in years)

     6  

Dividend yield

     —    

Weighted average fair value of stock-options in €

     6.9  

Change in Number of BSA/BCE/SO/RSU

 

     Number of outstanding  
     BSA      BCE      SO     RSUs  

Balance as of December 31, 2020

     218,008        5,500        2,610,510       1,118,745  

Granted during the period

     —          —          75,600       24,900  

Forfeited during the period

     —          —          (15,400     (13,700

Exercised/released during the period

     —          (500      —         —    

Expired during the period

     —          —          —         —    
  

 

 

    

 

 

    

 

 

   

 

 

 

Balance as of March 31, 2021

     218,008        5 000        2,670,710       1,129,945  
  

 

 

    

 

 

    

 

 

   

 

 

 

 

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Reconciliation of the share-based payments expenses with the consolidated statements of operations

 

     Three Months Ended
March 31,
 
     2021      2020  

Research and development

     SO        (376      (876
     RSU        (251      (392

Sales and marketing

     SO        (49      (598
     RSU        (22      (2

General and administrative

     SO        (644      (1,071
     RSU        (91      (133
     

 

 

    

 

 

 

Total share-based compensation expense

        (1,433      (3,073
     

 

 

    

 

 

 

Note 6: Contingencies

Current contingencies and non-current contingencies break down as follows:

 

     March 31,      December 31,  
     2021      2020  

Current contingencies

     4,246        5,016  

Non-current contingencies

     2,229        2,527  
  

 

 

    

 

 

 

Total contingencies

     6,474        7,542  
  

 

 

    

 

 

 

The table below shows movements in contingencies:

 

     Pension retirement
obligations
     Collaboration
agreement -
Loss at
completion
     Other contingencies     Total  

At January 1, 2021

     937        3,956        2,649       7,542  

Increases in liabilities

     —          —          —         —    

Used liabilities

     —          (434      (515     (949

Reversals of unused liabilities

     —          —          —         —    

Net interest related to employee benefits, and unwinding of discount

     —          —          —         —    

Actuarial gains and losses on defined-benefit plans

     85        —          —         85  

Other effects including currency translation effect

     (44      (164      4       (204
  

 

 

    

 

 

    

 

 

   

 

 

 

At March 31, 2021

     978        3,358        2,139       6,474  
  

 

 

    

 

 

    

 

 

   

 

 

 

Of which current

     —          2,107        2,139       4,246  

Of which non-current

     978        1,251        —         2,229  

In 2020 and during the first three months of 2021, the ongoing COVID-19 pandemic impacted the Company’s current clinical trials, including its Phase II clinical trial conducted as part of the development activities pursuant to the collaboration and license agreement with Nestlé Health Science. The Company experienced a decrease in new patients enrolling in this Phase II clinical trial and modified the protocols of the clinical trial. As a result of these delays, the Company expects to incur additional clinical and production costs related to the Phase II clinical trial. Starting the last quarter of the fiscal year 2020, an accrual in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been recorded.

 

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Other contingencies are primarily composed of the estimated expenses to be incurred as part of the employee-related costs related to restructuring, as well as estimated cost of refurbishing lease premises (Refer to Note 2, “Significant Events and Transactions—Restructuring contingencies).

There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 15 to the consolidated financial statements included in the Annual Report.

Note 7: Operating income

The operating income is broken down in the following manner:

 

     Three Months Ended March 31,  
     2021      2020  

Research tax credit

     1,807        2,902  

Other operating income

     1,133        1,818  
  

 

 

    

 

 

 

Total

     2,941        4,720  
  

 

 

    

 

 

 

As of March 31, 2021, 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 8: Allocation of Personnel Expenses

The Company had an average of 121 employees during the three months ended March 31, 2021, in comparison with an average of 311 employees during the three months ended March 31, 2020.

Allocation of Personnel Expenses by Function:

 

    

Three Months Ended March

31,

 
     2021      2020  

Research and development expenses

     4,718        10,204  

Sales and marketing expenses

     518        4,197  

General and administrative expenses

     3,766        4,283  
  

 

 

    

 

 

 

Total personnel expenses

     9,002        18,684  
  

 

 

    

 

 

 

Allocation of Personnel Expenses by Nature:

 

    

Three months Ended March

31,

 
     2021      2020  

Wages and salaries

     4,454        12,872  

Social security contributions

     1,332        663  

Expenses for pension commitments

     402        915  

Employer contribution to bonus shares

     1,381        1,162  

Share-based payments

     1,433        3,073  
  

 

 

    

 

 

 

Total personnel expenses

     9,002        18,684  
  

 

 

    

 

 

 

The decrease in personnel expenses is mainly due to a decreased headcount as well as reductions in accrued bonuses, retention measures and share-based compensation expenses, partly as a result of the 2020 global restructuring plan.

 

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Note 9: Commitments

There have been no significant changes in other commitments from those disclosed in Note 19 to the consolidated financial statements included in the Annual Report.

Note 10: 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 20 to the consolidated financial statements included in the Annual Report.

Note 11: 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, 2021 and 2020, 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, 2021 and 2020 indicated in number of potential shares:

 

     Three Months Ended March 31,  
     2021      2020  

Non-employee warrants

     225,008        225,008  

Employee warrants

     75,000        82,500  

Stock-options

     2,670,710        2 835,635  

Restricted stock units

     1,129,945        696,895  

Note 12: Events after the Close of the Period

The Company evaluated subsequent events that occurred after March 31, 2021, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on April 30, 2021 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.

 

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Item 2.

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

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2020, included in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 17, 2021, 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.

On January 13, 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. We believe the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, we proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications. 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 1/1000 of a 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 modified patches, the FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population. We intend to submit the protocols for the safety and adhesion study and the allergen uptake study to the FDA for review and comments before initiating the trials. We will address details about a new human factor, or HF, validation study and additional CMC data in subsequent interactions with the FDA

During the first quarter of 2021, we received the first set of questions from the European Medicines Agency, or EMA, regarding the Marketing Authorization Application, or MAA, for Viaskin Peanut as a treatment for peanut allergy in children ages 4-11.. The questions were consistent with our expectations and prefiling conversations with the EMA. We did not receive questions about the impact of adhesion on efficacy. The EMA’s Committee for Medicinal Products for Human Use will provide a recommendation to the European Commission, or EC, on whether to grant a marketing authorization when its review of the Viaskin Peanut MAA is complete.

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 Condensed Consolidated Financial Statements in Part I, Item 1 of this Report.

 

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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, 2021 and 2020:

 

     Three Months Ended
March 31,
 
     2021      2020  

Operating income

   $ 2,941      $ 4,720  

Operating expenses

     

Research and development expenses

     (22,164      (27,532

Sales and marketing expenses

     (729      (7,297

General and administrative expenses

     (9,683      (11,113

Restructuring expenses

     —          —    
  

 

 

    

 

 

 

Total Operating expenses

     (32,575      (45,942
  

 

 

    

 

 

 

Financial income

     215        309  
  

 

 

    

 

 

 

Income tax

     (30      —    
  

 

 

    

 

 

 

Net loss

   $ (29,449    $ (40,913
  

 

 

    

 

 

 

Basic/diluted Net loss per share attributable to shareholders

   $ (0.54    $ (0.79

Comparison of the three months ended March 31, 2021 to the three months ended March 31, 2020

Operating Income

We generated operating income of $2.9 million during the three months ended March 31, 2021 compared to $4.7 million during the three months ended March 31, 2020, a decrease of 37.7%. 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  
     2021      2020      2021 vs 2020  

Sales

     —          —       

Other income

     2,941        4,720        (37.7 )% 

Research tax credit

     1,807        2,902        (37.7 )% 

Other operating income

     1,133        1,818        (37.6 )% 
  

 

 

    

 

 

    

 

 

 

Total operating income

     2,941        4,720        (37.7 )% 
  

 

 

    

 

 

    

 

 

 

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, 2021, 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.

Operating Expense

The following table summarizes our operating expense excluding restructuring incurred during the three months ended March 31, 2021 and 2020:

 

     Three months Ended
March 31
     % change  
     2021      2020      2021 vs 2020  

Research and development expenses

     22,164        27,532        (19.5 )% 

Sales and marketing expenses

     729        7,297        (90.0 )% 

General and administrative expenses

     9,683        11,113        (12.9 )% 
  

 

 

    

 

 

    

 

 

 

Total operating expenses

     32,575        45,942        (29.1 )% 
  

 

 

    

 

 

    

 

 

 

 

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Operating expenses for the three months ended March 31, 2021 were $32.6 million compared to $45.9 million for the three months ended March 31, 2020. The $13.4 million decrease in operating expenses is mainly attributable to a decrease in personnel expenses directly related to the workforce reduction we implemented as part of our 2020 global restructuring plan. Personnel expenses decreased by $9.7 million, or 52%, to $9.0 million during the three months ended March 31, 2021 from $18.7 million for the three months ended March 31, 2020. Average headcount decreased 61% between the two periods, from 311 FTEs for the three months ended March 31, 2020 to and 121 FTEs for the three months ended March 31, 2021. By function, the personnel expenses, including share-based payment expenses, decreased as follows:

 

    

Three Months Ended March

31,

     % change  
     2021      2020      2021 vs 2020  

Research and development expenses

     4,718        10,204        (53.8 )% 

Sales and marketing expenses

     518        4,197        (87.7 )% 

General and administrative expenses

     3,766        4,283        (12.1 )% 
  

 

 

    

 

 

    

 

 

 

Total personnel expenses

     9,002        18,684        (51.8 )% 
  

 

 

    

 

 

    

 

 

 

The decrease in other operating expenses was primarily due to the budget discipline measures taken by DBV. In particular, sales and marketing consulting fees dropped by 96.8% or $2.6 million, from $2.7 million for the three months ended March 31, 2020 to $0.1 million for the three months ended March 31, 2021 and general and administrative fees decreased by 43.5% or $1.7 million, from $4.0 million for the three months ended March 31, 2020 to $2.3 million for the three months ended March 31, 2021.

As a result of the ongoing COVID-19 pandemic, we also experienced a decrease in other expenses, in particular tradeshows and travel expenses.

Restructuring

We initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanut in the United States and European Union.

We expect full implementation of the restructuring plan to result in a reduction of more than 200 jobs, resulting in a remaining global team of 90 individuals dedicated to the pursuit of innovation and scientific development of novel therapies.

As of March 31, 2021, we had 104 employees. We expect full implementation of the organization-wide costs reduction measures to be completed by the second half of 2021.

The restructuring costs, which were $23.6 million as of December 31, 2020, were mainly comprised of payroll expenses, restructuring-related consulting and legal fees, as well as impairment of facilities and right of use assets following resizing of facilities.

During the three months ended March 31, 2021, the restructuring liability evolved as presented below:

 

     Restructuring
liabilities
 

Restructuring liability - January 1, 2021

     9,387  

Amounts paid

     (4,854

Other effect including currency translation effect

     (220
  

 

 

 

Restructuring liability - March 31, 2021

     4,313  
  

 

 

 

of which current contingencies

     1,511  

of which other current liabilities

     2,803  

They were no restructuring costs for three months ended March 31, 2021 and 2020.

 

15


Table of Contents

Financial income

Our financial income was $0.2 million for the three months ended March 31, 2021 and 2020. This item mainly includes foreign exchange income.

Net loss

Net loss was $29.4 million for the three months ended March 31, 2021, compared to $40.9 million for the three months ended March 31, 2020. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.54 and $0.79 for three months ended March 31, 2021 and 2020, respectively.

Summary Statement of Cash Flows

The table below summarizes our sources and uses of cash for the three months ended March 21, 2021 and 2020.

 

     Three Months Ended
March 31,
     % change  
(Amounts in thousands of U.S. Dollars)    2021      2020      2021 vs 2020  

Net cash flow used in operating activities

     (36,204      (49,683      (27.1 )% 

Net cash flow used in investing activities

     (185      (930      (80.1 )% 

Net cash flow provided by financing activities

     440        150,611        (99.7 )% 

Effect of exchange rate changes on cash and cash equivalents

     (7,944      (5,811      (36.7 )% 
  

 

 

    

 

 

    

 

 

 

Net (decrease) increase in cash and cash equivalents

     (43,893      94,187        (146.6 )% 
  

 

 

    

 

 

    

 

 

 

Operating Activities

Our net cash flows used in operating activities were $36.2 million and $49.7 million during the three months ended March 31, 2021 and 2020, respectively. Our net cash flows used in operating activities decreased by $13.5 million, or 27.2%, 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, 2021 included $4.9 million in restructuring amounts paid.

Investing Activities

Our net cash flows used in investing activities were $0.2 million and $0.9 million during the three months ended March 21, 2021 and 2020, respectively. Those investments were mainly for our industrial machinery and equipment, which are commissioned in order to support the commercialization of Viaskin Peanut, if approved.

Financing Activities

Our net cash flows provided by financing activities decreased to $0.4 million during the three months ended March 21, 2021 from $150.6 million during the three months ended March 21, 2020. Financing activities consisted mainly of our underwritten global offering in the first quarter of 2020.

Based on our current assumptions, we expect that our current cash and cash equivalents will support our operations until the second half of 2022

Contractual Obligations and Other Commitments

There have been no material changes in our contractual obligations and commitments from those disclosed in the Annual Report.

Off-Balance Sheet Arrangements

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

 

16


Table of Contents

Smaller Reporting Company Status

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

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Our market risks have not changed materially from those disclosed in Item 7A of the Annual Report.

 

Item 4.

Controls and Procedures

Disclosure Controls and Procedures

Based on their evaluation as of March 31, 2021, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

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

Limitation on Effectiveness of Controls and Procedures

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and

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

 

17


Table of Contents

PART II – Other information

 

Item 1.

Legal Proceedings

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

 

Item 1A.

Risk Factors

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, 2021, we granted 75,600 stock options and 24,900 restricted stock units to employees in France and in the United States.

During the three months ended March 31, 2021, we issued 7,500 ordinary shares following the exercise of employee warrants by an employee in France, for proceeds of $42,000.

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

Not applicable.

 

18


Table of Contents

Item 6. Exhibits.

Exhibit Index

 

Exhibit

  

Description

   Incorporated by Reference  
          Schedule
/ Form
     File
Number
     Exhibit      File
Date
 
    3.1    By-laws (statuts) of the registrant (English translation)      10-K        001-36697        3.1        3/17/2021  
  31.1    Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended            
  31.2    Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended            
  32.1*    Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended            
101.INS    XBRL Instance Document            
101.SCH    XBRL Taxonomy Extension Schema Document            
101.CAL    XBRL Taxonomy Extension Calculation Linkbase Document            
101.DEF    XBRL Taxonomy Extension Definition Linkbase Document            
101.LAB    XBRL Taxonomy Extension Labels Linkbase Document            
101.PRE    XBRL Taxonomy Extension Presentation Linkbase Document            

 

*

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 incorporation language contained in such filing.


Table of Contents

SIGNATURES

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

 

    DBV Technologies S.A.
Date: May 5, 2021    
    By:  

/s/ Daniel Tassé

    Daniel Tassé
    Chief Executive Officer)
    (Principal Executive Officer)
Date: May 5, 2021     By:  

/s/ Sébastien Robitaille

    Sébastien Robitaille
    Chief Financial Officer
    (Principal Financial and Accounting Officer)
EX-31.1 2 d172290dex311.htm EX-31.1 EX-31.1

Exhibit 31.1

CERTIFICATION

I, Daniel Tassé, certify that:

 

1.

I have reviewed this Quarterly Report on Form 10-Q of DBV Technologies S.A.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 5, 2021     By:  

/s/ Daniel Tassé

      Daniel Tasse
      Chief Executive Officer
      (Principal Executive Officer)
EX-31.2 3 d172290dex312.htm EX-31.2 EX-31.2

Exhibit 31.2

CERTIFICATION

I, Sébastien Robitaille, certify that:

 

1.

I have reviewed this Quarterly Report on Form 10-Q of DBV Technologies S.A.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 5, 2021     By:  

/s/ Sébastien Robitaille

      Sébastien Robitaille
      Chief Executive Officer
      (Principal Financial and Accounting Officer)
EX-32.1 4 d172290dex321.htm EX-32.1 EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Daniel Tassé, Chief Executive Officer of DBV Technologies S.A. (the “Company”), and Sébastien Robitaille, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:

 

1.

The Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2021, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and

 

2.

The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: May 5, 2021

IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the 5th day of May, 2021.

 

By:  

/s/ Daniel Tasse

    By:  

/s/ Sébastien Robitaille

  Daniel Tasse       Sébastien Robitaille
  Chief Executive Officer       Chief Financial Officer
  (Principal Executive Officer)       (Principal Financial and Accounting Officer)

This certification accompanies the Quarterly Report, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Quarterly Report), irrespective of any general incorporation language contained in such filing.

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(&#8220;DBV Technologies,&#8221; or the &#8220;Company&#8221;, or the &#8220;group&#8221;) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin<div style="font-size: 85%; vertical-align: top;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div>. The Company&#8217;s therapeutic approach is based on epicutaneous immunotherapy, or EPIT<div style="font-size: 85%; vertical-align: top;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div>, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin<div style="font-size: 85%; vertical-align: top;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div>. </div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Basis of Presentation </div></div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">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 (&#8220;U.S. GAAP&#8221;) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation. </div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">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&#8217;s Annual Report on Form <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">10-K</div> filed with the SEC on March&#160;17, 2021 (the &#8220;Annual Report&#8221;). The condensed consolidated statement of financial position at December&#160;31, 2020 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company&#8217;s critical accounting policies are detailed in the Annual Report. The Company&#8217;s critical accounting policies have not changed materially since December&#160;31, 2020. </div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">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&#160;31, 2021, or any other future period. </div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Use of estimates </div></div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The&#160;preparation of the Company&#8217;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. </div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="display:inline;">On an <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">on-going</div> basis, management evaluates its estimates, primarily those related to: (1)&#160;evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestl&#233; Health Science, (2)&#160;research tax credits, (3)&#160;assumptions used in the valuation of right of use assets - operating lease, (4)&#160;impairment of <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">right-of-use</div></div> assets related to leases and property, plant and equipment, (5)&#160;recoverability of the Company&#8217;s net deferred tax assets and related valuation allowance, (6)&#160;assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan and, (7)&#160;estimate of contingencies. </div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Going concern </div></div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">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 (<div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Cr</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">&#233;</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">dit d</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">&#8217;</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Imp</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">&#244;</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">t Recherche</div>). 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. </div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">Following receipt of a Complete Response Letter (&#8220;CRL&#8221;) from the U.S. Food and Drug Administration (&#8220;FDA&#8221;) in connection with its Biologics License Application (&#8220;BLA&#8221;) for Viaskin<div style="font-size: 85%; vertical-align: top;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div> Peanut, beginning in August 2020, the Company scaled down its other clinical programs and <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">pre-clinical</div> spend to focus on Viaskin<div style="font-size: 85%; vertical-align: top;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div> Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin<div style="font-size: 85%; vertical-align: top;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div> Peanut in the United States and European Union. Based on guidance received from the FDA in January 2021, the Company&#8217;s plans to implement such guidance, and expected cost savings from implementation of the global restructuring plan, the Company expects that its current balance of cash and cash equivalents of $152.5&#160;million as of March&#160;31, 2021 will be sufficient to fund its operations for at least the next 12 months. </div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">The Company intends to seek additional capital as it prepares for the 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 <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">non-dilutive</div> financings. As a result of disruptions to the global financial markets as a result of the ongoing <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">COVID-19</div> pandemic, 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 <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">COVID-19</div> 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. </div> <div style="font-size: 1px; margin-top: 18px; margin-bottom: 0px;"><div style="font-size: 1px; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Accounting Pronouncements adopted in 2021 </div></div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;">Effective January&#160;1, 2021, the Company adopted ASU <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2019-12,&#160;Income</div> Taxes (Topic 740)&#8212;Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. The adoption of ASU <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2019-12</div> did not have a material impact on the Company&#8217;s financial position or results of operations. </div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Accounting Pronouncements issued not yet adopted </div></div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="display:inline;">In June 2016, the Financial Accounting Standards Board (&#8220;FASB&#8221;) issued ASU <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2016-13</div> - 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 <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2019-10</div> 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&#160;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. </div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">In January 2017, the FASB issued ASU <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2017-04,&#160;Simplifying</div> the Test for Goodwill Impairment, which modifies the goodwill impairment test and requires an entity to write down the carrying value of goodwill for the amount by which the carrying amount of a reporting unit exceeds its fair value. The FASB has issued ASU <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2019-10</div> 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&#160;1, 2023. The Company does not expect this new standard will have a material impact on its consolidated financial statements. </div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">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&#8217;s Consolidated Financial Statements upon adoption. </div></div> <table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Basis of Presentation </div></div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">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 (&#8220;U.S. GAAP&#8221;) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation. </div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">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&#8217;s Annual Report on Form <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">10-K</div> filed with the SEC on March&#160;17, 2021 (the &#8220;Annual Report&#8221;). The condensed consolidated statement of financial position at December&#160;31, 2020 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company&#8217;s critical accounting policies are detailed in the Annual Report. The Company&#8217;s critical accounting policies have not changed materially since December&#160;31, 2020. </div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">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&#160;31, 2021, or any other future period. </div></div> <table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Use of estimates </div></div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The&#160;preparation of the Company&#8217;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. </div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="display:inline;">On an <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">on-going</div> basis, management evaluates its estimates, primarily those related to: (1)&#160;evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestl&#233; Health Science, (2)&#160;research tax credits, (3)&#160;assumptions used in the valuation of right of use assets - operating lease, (4)&#160;impairment of <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">right-of-use</div></div> assets related to leases and property, plant and equipment, (5)&#160;recoverability of the Company&#8217;s net deferred tax assets and related valuation allowance, (6)&#160;assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan and, (7)&#160;estimate of contingencies. </div></div> <table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Going concern </div></div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">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 (<div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Cr</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">&#233;</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">dit d</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">&#8217;</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Imp</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">&#244;</div><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">t Recherche</div>). 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. </div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">Following receipt of a Complete Response Letter (&#8220;CRL&#8221;) from the U.S. Food and Drug Administration (&#8220;FDA&#8221;) in connection with its Biologics License Application (&#8220;BLA&#8221;) for Viaskin<div style="font-size: 85%; vertical-align: top;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div> Peanut, beginning in August 2020, the Company scaled down its other clinical programs and <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">pre-clinical</div> spend to focus on Viaskin<div style="font-size: 85%; vertical-align: top;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div> Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin<div style="font-size: 85%; vertical-align: top;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div> Peanut in the United States and European Union. Based on guidance received from the FDA in January 2021, the Company&#8217;s plans to implement such guidance, and expected cost savings from implementation of the global restructuring plan, the Company expects that its current balance of cash and cash equivalents of $152.5&#160;million as of March&#160;31, 2021 will be sufficient to fund its operations for at least the next 12 months. </div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">The Company intends to seek additional capital as it prepares for the 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 <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">non-dilutive</div> financings. As a result of disruptions to the global financial markets as a result of the ongoing <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">COVID-19</div> pandemic, 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 <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">COVID-19</div> 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. </div> <table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div style="font-family: times new roman; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Accounting Pronouncements adopted in 2021 </div></div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;">Effective January&#160;1, 2021, the Company adopted ASU <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2019-12,&#160;Income</div> Taxes (Topic 740)&#8212;Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. The adoption of ASU <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2019-12</div> did not have a material impact on the Company&#8217;s financial position or results of operations. </div> <table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Accounting Pronouncements issued not yet adopted </div></div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="display:inline;">In June 2016, the Financial Accounting Standards Board (&#8220;FASB&#8221;) issued ASU <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2016-13</div> - 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 <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2019-10</div> 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&#160;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. </div></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">In January 2017, the FASB issued ASU <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2017-04,&#160;Simplifying</div> the Test for Goodwill Impairment, which modifies the goodwill impairment test and requires an entity to write down the carrying value of goodwill for the amount by which the carrying amount of a reporting unit exceeds its fair value. The FASB has issued ASU <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">2019-10</div> 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&#160;1, 2023. The Company does not expect this new standard will have a material impact on its consolidated financial statements. </div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">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&#8217;s Consolidated Financial Statements upon adoption. </div></div> <table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Note 2: Significant Events and Transactions </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Clinical programs </div></div></div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 2%;"><div style="display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;"><div style="text-decoration:underline;display:inline;">Viaskin</div><div style="text-decoration:underline;display:inline;"><div style="font-size: 85%; vertical-align: top;;vertical-align: super;font-size: smaller;display:inline;">TM</div></div><div style="text-decoration:underline;display:inline;"> Peanut for children ages <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">4-11</div></div> </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">In January 2020, the Company announced positive topline results of the three-year, open-label extension of its Phase III PEPITES trial, or PEOPLE trial, evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrated long-term clinical benefit as shown by an increase in eliciting dose (&#8220;ED&#8221;), which may decrease the chance of reacting to an accidental peanut exposure. After three years, the Company observed that 75.9% (107/141) of patients had increased their ED from baseline, and 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein by year three. The safety profile of Viaskin Peanut was consistent with that observed in the clinical program to date in over 1,000 patients. During the PEOPLE trial, the most common adverse events were mild to moderate skin reactions localized to the administration site, and there was no epinephrine use deemed related to treatment. No treatment related serious adverse events were reported. One patient experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without anti-anaphylactic treatment. Treatment compliance remained high throughout the study at a mean of 98% over three years of treatment. Low discontinuations due to adverse events were observed. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">In February 2020, the FDA announced an Allergenic Products Advisory Committee meeting to be held on May&#160;15, 2020 to discuss the Biologics License Application (BLA) for Viaskin Peanut. On March&#160;16, 2020, the Company announced that the FDA had informed us that during its ongoing review of the Company&#8217;s BLA for Viaskin Peanut, it had identified questions regarding efficacy, including the impact of patch-site adhesion. Therefore, the Advisory Committee meeting to discuss the BLA originally scheduled on May&#160;15, 2020 was cancelled. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">On August&#160;4, 2020, the Company announced that FDA has issued a Complete Response Letter in which the FDA indicated it could not approve the Viaskin Peanut BLA in its current form. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study. The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data. The FDA did not raise any safety concerns related to Viaskin Peanut. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">On January&#160;13, 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 Company believes the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, the Company proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications. The FDA agreed with the Company&#8217;s 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 &#181;g (approximately 1/1000 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 modified patches, the FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years. The FDA also recommended conducting a <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">6-month,</div> well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population.</div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">On November&#160;2, 2020, the Company announced that its Marketing Authorization Application, or MAA, for Viaskin Peanut had been validated by the European Medicines Agency, or EMA. The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years. The Company received the first set of questions from the EMA, during the first quarter of 2021, which were consistent with the Company&#8217;s expectations and prefiling conversations with the EMA. The Company did not receive questions about the impact of adhesion on efficacy. The EMA&#8217;s Committee for Medicinal Products for Human Use will provide a recommendation to the European Commission, or EC, on whether to grant a marketing authorization when its review of the Viaskin Peanut MAA is complete. </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt; margin-left: 2%;"><div style="display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;"><div style="text-decoration:underline;display:inline;">Viaskin Peanut for children ages <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">1-3</div></div> </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">On June&#160;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 <div style="font-family: symbol; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">m</div>g 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. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Financing </div></div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">On February&#160;4, 2020, the Company announced the closing of an underwritten global offering of an aggregate of 7,500,000 ordinary shares in (i)&#160;a public offering of 4,535,581 ordinary shares in the form of 9,071,162 American Depositary Shares (&#8220;ADSs&#8221;) in the United States, Canada and certain countries outside Europe at a public offering price of $10.25 per ADS (on the basis of an exchange rate of $1.0999 = &#8364;1.00), and (ii)&#160;an offering exclusively addressed to qualified investors in Europe (including France) of 2,964,419 ordinary shares at an offering price of &#8364;18.63 per ordinary share (together, the &#8220;Global Offering&#8221;). </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">On March&#160;2, 2020, the Company announced that the underwriters partially exercised their option to purchase 338,687 additional ordinary shares in the form of 677,374 ADSs at an offering price of $10.25 per ADS, before deducting commissions and estimated offering expenses (the &#8220;Option&#8221;). The Option closed on March&#160;4, 2020. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Consequently, following partial exercise of the Option, the total number of ordinary shares sold in the global offering was 7,838,687 ordinary shares, including 4,874,268 ordinary shares in the form of 9,748,536 ADSs, bringing the total gross proceeds from the global offering to $160.7&#160;million and net proceeds of $150.0&#160;million. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Restructuring </div></div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The Company initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanut in the United States and European Union. 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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. </div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">The Company has assessed the impact of the uncertainties created by the pandemic. As of March&#160;31, 2021, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company. 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font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. 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top: 0px;;display:inline;">&#160;&#160;</div></td><td style="vertical-align:bottom;"><div style="margin-top: 0px; margin-bottom: 0px; border-top: 1px solid rgb(0, 0, 0); line-height: normal;">&#160;</div></td><td style="vertical-align:bottom;"><div style="margin-top: 0px; margin-bottom: 0px; border-top: 1px solid rgb(0, 0, 0); line-height: normal;">&#160;</div></td><td><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="vertical-align:bottom;"><div style="margin-top: 0px; margin-bottom: 0px; border-top: 1px solid rgb(0, 0, 0); line-height: normal;">&#160;</div></td><td style="vertical-align:bottom;"><div style="margin-top: 0px; margin-bottom: 0px; border-top: 1px solid rgb(0, 0, 0); line-height: normal;">&#160;</div></td><td><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td></tr><tr style="font-family: times new roman; 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font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The table below shows movements in contingencies: </div></div></div> <div style="font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-size: 12pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></div> <table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-collapse: collapse; border-spacing: 0px;;margin : 0px auto;;text-align:left;;width:92%;"><tr style="font-size: 0px;"><td style="width:53%;"></td><td style="vertical-align:bottom;;width:8%;"></td><td></td><td></td><td></td><td style="vertical-align:bottom;;width:7%;"></td><td></td><td></td><td></td><td style="vertical-align:bottom;;width:7%;"></td><td></td><td></td><td></td><td style="vertical-align:bottom;;width:7%;"></td><td></td><td></td><td></td></tr><tr style="font-family: times new roman; 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top: 0px;;display:inline;">&#160;</div></td><td style="padding-bottom: 1pt;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td colspan="2" style="border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1pt; border-bottom-style: solid;;text-align:center;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Total</div></div></td><td style="padding-bottom: 1pt;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td></tr><tr style="font-family: times new roman; font-size: 10pt; page-break-inside: avoid;"><td style="background-color: rgb(204, 238, 255); font-size: 10pt;;vertical-align:top;"><div style="text-indent: -1em; font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 1em; line-height: normal;"><div style="background-color: rgb(204, 238, 255); letter-spacing: 0px; 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top: 0px;;display:inline;">&#160;</div></td><td style="vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#8212;&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#8212;&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; 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The Company experienced a decrease in new patients enrolling in this Phase II clinical trial and modified the protocols of the clinical trial. As a result of these delays, the Company expects to incur additional clinical and production costs related to the Phase II clinical trial. 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color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 15 to the consolidated financial statements included in the Annual Report. </div></div> <table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">Current contingencies and <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">non-current</div> contingencies break down as follows: </div></div> <div style="font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-size: 12pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></div> <table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; 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top: 0px;;display:inline;">&#160;</div></td><td style="padding-bottom: 1pt;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td colspan="2" style="border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1pt; border-bottom-style: solid;;text-align:center;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Other&#160;contingencies</div></div></td><td style="padding-bottom: 1pt;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="padding-bottom: 1pt;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td colspan="2" style="border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1pt; border-bottom-style: solid;;text-align:center;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Total</div></div></td><td style="padding-bottom: 1pt;;vertical-align:bottom;"><div style="letter-spacing: 0px; 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top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;text-align:right;;vertical-align:bottom;"><div style="background-color: rgb(204, 238, 255); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">3,956</div></div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="background-color: rgb(204, 238, 255); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="background-color: rgb(204, 238, 255); letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="background-color: rgb(204, 238, 255); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="white-space: nowrap; 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top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#8212;&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#8212;&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#8212;&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#8212;&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td></tr><tr style="font-family: times new roman; font-size: 10pt; page-break-inside: avoid;"><td style="background-color: rgb(204, 238, 255); 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top: 0px;;display:inline;">&#8212;&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#8212;&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#8212;&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td></tr><tr style="font-size: 1pt;"><td style="height:8;">&#160;</td><td colspan="4" style="height:8;">&#160;</td><td colspan="4" style="height:8;">&#160;</td><td colspan="4" style="height:8;">&#160;</td><td colspan="4" style="height:8;">&#160;</td></tr><tr style="font-family: times new roman; font-size: 10pt; page-break-inside: avoid;"><td style="background-color: rgb(204, 238, 255); font-size: 10pt;;vertical-align:top;"><div style="text-indent: -1em; font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 1em; line-height: normal;"><div style="background-color: rgb(204, 238, 255); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px; 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letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;text-align:right;;vertical-align:bottom;"><div style="background-color: rgb(204, 238, 255); letter-spacing: 0px; top: 0px;;display:inline;">&#8212;&#160;&#160;</div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="background-color: rgb(204, 238, 255); letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="background-color: rgb(204, 238, 255); letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="background-color: rgb(204, 238, 255); letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;text-align:right;;vertical-align:bottom;"><div style="background-color: rgb(204, 238, 255); 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top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#8212;&#160;&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="white-space: nowrap;;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">85</div></td><td style="white-space: nowrap;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td></tr><tr style="font-family: times new roman; font-size: 10pt; page-break-inside: avoid;"><td style="background-color: rgb(204, 238, 255); 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border-bottom-width: 1pt; border-bottom-style: solid;;text-align:center;;vertical-align:bottom;"><div style="display:inline;"><div style="font-weight:bold;display:inline;">2021</div></div></td><td style="padding-bottom: 1pt;;vertical-align:bottom;"><div style="display:inline;">&#160;</div></td><td style="padding-bottom: 1pt;;vertical-align:bottom;"><div style="display:inline;">&#160;&#160;</div></td><td colspan="2" style="border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1pt; border-bottom-style: solid;;text-align:center;;vertical-align:bottom;"><div style="display:inline;"><div style="font-weight:bold;display:inline;">2020</div></div></td><td style="padding-bottom: 1pt;;vertical-align:bottom;"><div style="display:inline;">&#160;</div></td></tr><tr style="font-family: times new roman; font-size: 10pt; page-break-inside: avoid;"><td style="background-color: rgb(204, 238, 255); font-size: 10pt;;vertical-align:top;"><div style="text-indent: -1em; font-family: &quot;times new roman&quot;; 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margin-bottom: 0pt; border-top: 1px solid rgb(0, 0, 0); line-height: normal;">&#160;</div></td><td style="vertical-align:bottom;"><div style="margin-top: 0pt; margin-bottom: 0pt; border-top: 1px solid rgb(0, 0, 0); line-height: normal;">&#160;</div></td><td><div style="display:inline;">&#160;</div></td><td style="vertical-align:bottom;"><div style="display:inline;">&#160;&#160;</div></td><td style="vertical-align:bottom;"><div style="margin-top: 0pt; margin-bottom: 0pt; border-top: 1px solid rgb(0, 0, 0); line-height: normal;">&#160;</div></td><td style="vertical-align:bottom;"><div style="margin-top: 0pt; margin-bottom: 0pt; border-top: 1px solid rgb(0, 0, 0); line-height: normal;">&#160;</div></td><td><div style="display:inline;">&#160;</div></td></tr><tr style="font-family: times new roman; font-size: 10pt; page-break-inside: avoid;"><td style="background-color: rgb(204, 238, 255); font-size: 10pt;;vertical-align:top;"><div style="text-indent: -1em; font-family: &quot;times new roman&quot;; 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Cover Page - shares
3 Months Ended
Mar. 31, 2021
Apr. 30, 2021
Document Information [Line Items]    
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Mar. 31, 2021  
Document Fiscal Year Focus 2021  
Document Fiscal Period Focus Q1  
Entity Registrant Name DBV Technologies S.A.  
Entity Central Index Key 0001613780  
Current Fiscal Year End Date --12-31  
Entity Current Reporting Status Yes  
Entity Filer Category Non-accelerated Filer  
Entity Interactive Data Current Yes  
Entity Common Stock, Shares Outstanding   54,936,687
Document Quarterly Report true  
Document Transition Report false  
Entity Shell Company false  
Entity Emerging Growth Company false  
Entity Address, Country FR  
Entity Small Business true  
Entity Incorporation, State or Country Code I0  
American Depositary Share [Member]    
Document Information [Line Items]    
Title of 12(b) Security American Depositary Shares, each representing one-half of one ordinary share, nominal value €0.10 per share  
Trading Symbol dbvt  
Security Exchange Name NYSE  
Ordinary Shares [Member]    
Document Information [Line Items]    
Title of 12(b) Security Ordinary shares, nominal value €0.10 per share  
No Trading Symbol Flag true  
Security Exchange Name NYSE  
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Condensed Consolidated Statements of Financial Position - USD ($)
$ in Thousands
Mar. 31, 2021
Dec. 31, 2020
Current assets    
Cash and cash equivalents $ 152,459 $ 196,352
Trade receivables   2,230
Other current assets 7,349 8,792
Total current assets 159,809 207,375
Non-Current assets    
Property, plant, and equipment, net 21,526 24,792
Right-of-use assets related to operating leases 9,168 10,104
Intangible assets 32 41
Other non-current assets 30,870 29,935
Total non-current assets 61,596 64,871
Total Assets 221,405 272,246
Current liabilities    
Trade payables 17,176 20,338
Short-term operating lease 3,314 3,708
Short-term financial debt 701 724
Current contingencies 4,246 5,016
Other current liabilities 13,394 22,926
Total current liabilities 38,831 52,713
Non-Current liabilities    
Long-term operating lease 9,533 10,496
Long-term financial debt 350 543
Non-current contingencies 2,229 2,527
Other non-current liabilities 1,286 475
Total non-current liabilities 13,398 14,042
Total Liabilities 52,229 66,754
Shareholders' equity    
Ordinary shares, €0.10 par value; 54,936,687 and 54,929,187 shares authorized, and issued as at March 31, 2021 and December 31, 2020, respectively, and 4,100,663 and 4,029,763 shares outstanding as at March 31, 2021 and December 31, 2020, respectively 6,519 6,518
Additional paid-in capital 1,153,516 1,152,042
Treasury stock, 60,588 and 112,302 ordinary shares as of March 31, 2021 and December 31, 2020, respectively, at cost (681) (1,169)
Accumulated deficit (987,992) (958,543)
Accumulated other comprehensive income 399 484
Accumulated currency translation effect (2,586) 6,158
Total Shareholders' equity 169,176 205,491
Total Liabilities and Shareholder's equity $ 221,405 $ 272,246
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Condensed Consolidated Statements of Financial Position (Parenthetical) - € / shares
Mar. 31, 2021
Dec. 31, 2020
Treasury stock, common, shares 60,588 112,302
Common Shares [Member]    
Common stock shares par value € 0.10 € 0.10
Common stock shares authorized 54,936,687 54,929,187
Common stock shares issued 54,936,687 54,929,187
Common stock shares outstanding 4,100,663 4,029,763
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Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Revenues    
Operating income $ 2,941 $ 4,720
Operating expenses    
Research and development expenses (22,164) (27,532)
Sales and marketing expenses (729) (7,297)
General and administrative expenses (9,683) (11,113)
Total Operating expenses (32,575) (45,942)
Loss from operations (29,634) (41,222)
Other Income (expenses)    
Financial income 215 309
Loss before taxes (29,419) (40,913)
Income tax (30)  
Net loss (29,449) (40,913)
Foreign currency translation differences, net of taxes (8,744) (6,064)
Actuarial (loss) gains on employee benefits, net of taxes (85) 189
Comprehensive loss $ (38,279) $ (46,788)
Basic/diluted Net loss per share attributable to shareholders $ (0.54) $ (0.79)
Weighted average shares outstanding used in computing per share amounts: 54,880,776 51,802,524
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Condensed Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Statement of Cash Flows [Abstract]    
Net loss for the period $ (29,449) $ (40,913)
Cash flows used in operating activities:    
Depreciation, amortization and accrued contingencies 1,483 1,548
Retirement pension obligations   109
Expenses related to share-based payments 1,433 3,073
Other elements (456) 419
Changes in operating assets and liabilities:    
Decrease (increase) in inventories and work in progress   (2,402)
Decrease (increase) in trade receivables 2,101  
Decrease (increase) in other current assets (417) 122
(Decrease) increase in trade payables (2,567) (3,212)
(Decrease) increase in other current and non-current liabilities (7,980) (8,382)
Change in operating lease liabilities and right of use assets (353) (45)
Net cash flow used in operating activities (36,204) (49,683)
Cash flows used in investing activities :    
Acquisitions of property, plant, and equipment, net from proceeds (184) (816)
Acquisitions of intangible assets   (114)
Acquisitions of non-current financial assets (1)  
Net cash flows used in investing activities (185) (930)
Cash flows provided by financing activities :    
(Decrease) increase in conditional advances (164) 7
Treasury shares 578 (412)
Capital increases, net of transaction costs 42 151,023
Other cash flows related to financing activities (17) (7)
Net cash flows provided by financing activities 440 150,611
Effect of exchange rate changes on cash and cash equivalents (7,944) (5,811)
Net (decrease) / increase in cash and cash equivalents (43,893) 94,187
Net Cash and cash equivalents at the beginning of the period 196,352 193,255
Net cash and cash equivalents at the end of the period $ 152,459 $ 287,442
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Condensed Consolidated Statements of Changes in Shareholders' Equity - USD ($)
$ in Thousands
Total
Common Shares [Member]
Additional Paid-in Capital [Member]
Treasury Stock [Member]
Accumulated Deficit [Member]
Accumulated Other Comprehensive income (loss) [Member]
Accumulated Currency Translation Effect [Member]
Beginning balance at Dec. 31, 2019 $ 193,186 $ 5,645 $ 1,003,595 $ (230) $ (798,988) $ 108 $ (16,945)
Beginning balance (Shares) at Dec. 31, 2019   47,028,510          
Net (loss) (40,913)       (40,913)    
Other comprehensive income (loss) (5,875)         189 (6,064)
Issuance of ordinary shares 151,023 $ 873 150,150        
Issuance of ordinary shares (Shares)   7,898,677          
Treasury shares (832)     (832)      
Share-based payments 3,073   3,073        
Ending balance at Mar. 31, 2020 299,662 $ 6,518 1,156,818 (1,062) (839,901) 297 (23,009)
Ending balance (Shares) at Mar. 31, 2020   54,927,187          
Beginning balance at Dec. 31, 2020 205,491 $ 6,518 1,152,042 (1,169) (958,543) 484 6,158
Beginning balance (Shares) at Dec. 31, 2020   54,929,187          
Net (loss) (29,449)       (29,449)    
Other comprehensive income (loss) (8,829)         (85) (8,744)
Issuance of ordinary shares 42 $ 1 42        
Issuance of ordinary shares (Shares)   7,500          
Treasury shares 488     488      
Share-based payments 1,433   1,433        
Ending balance at Mar. 31, 2021 $ 169,176 $ 6,519 $ 1,153,516 $ (681) $ (987,992) $ 399 $ (2,586)
Ending balance (Shares) at Mar. 31, 2021   54,936,687          
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The Company
3 Months Ended
Mar. 31, 2021
Accounting Policies [Abstract]  
The Company
Note 1: The Company
Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or the “group”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin
. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT
, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin
.
Basis of Presentation
The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.
The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form
10-K
filed with the SEC on March 17, 2021 (the “Annual Report”). The condensed consolidated statement of financial position at December 31, 2020 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, 2020.
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, 2021, 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
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 (
Cr
é
dit d
Imp
ô
t 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. The Company 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. Based on guidance received from the FDA in January 2021, the Company’s plans to implement such guidance, and expected cost savings from implementation of the global restructuring plan, the Company expects that its current balance of cash and cash equivalents of $152.5 million as of March 31, 2021 will be sufficient to fund its operations for at least the next 12 months.
The Company intends to seek additional capital as it prepares for the 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. As a result of disruptions to the global financial markets as a result of the ongoing
COVID-19
pandemic, 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.
 
Accounting Pronouncements adopted in 2021
Effective January 1, 2021, the Company adopted ASU
2019-12, Income
Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. The adoption of ASU
2019-12
did not have a material impact on the Company’s financial position or results of operations.
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.
In January 2017, the FASB issued ASU
2017-04, Simplifying
the Test for Goodwill Impairment, which modifies the goodwill impairment test and requires an entity to write down the carrying value of goodwill for the amount by which the carrying amount of a reporting unit exceeds its fair value. 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 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.
XML 18 R8.htm IDEA: XBRL DOCUMENT v3.21.1
Significant Events and Transactions
3 Months Ended
Mar. 31, 2021
Significant Events And Transactions Disclosure [Abstract]  
Significant Events and Transactions
Note 2: Significant Events and Transactions
Clinical programs
Viaskin
TM
Peanut for children ages
4-11
In January 2020, the Company announced positive topline results of the three-year, open-label extension of its Phase III PEPITES trial, or PEOPLE trial, evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrated long-term clinical benefit as shown by an increase in eliciting dose (“ED”), which may decrease the chance of reacting to an accidental peanut exposure. After three years, the Company observed that 75.9% (107/141) of patients had increased their ED from baseline, and 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein by year three. The safety profile of Viaskin Peanut was consistent with that observed in the clinical program to date in over 1,000 patients. During the PEOPLE trial, the most common adverse events were mild to moderate skin reactions localized to the administration site, and there was no epinephrine use deemed related to treatment. No treatment related serious adverse events were reported. One patient experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without anti-anaphylactic treatment. Treatment compliance remained high throughout the study at a mean of 98% over three years of treatment. Low discontinuations due to adverse events were observed.
In February 2020, the FDA announced an Allergenic Products Advisory Committee meeting to be held on May 15, 2020 to discuss the Biologics License Application (BLA) for Viaskin Peanut. On March 16, 2020, the Company announced that the FDA had informed us that during its ongoing review of the Company’s BLA for Viaskin Peanut, it had identified questions regarding efficacy, including the impact of patch-site adhesion. Therefore, the Advisory Committee meeting to discuss the BLA originally scheduled on May 15, 2020 was cancelled.
On August 4, 2020, the Company announced that FDA has issued a Complete Response Letter in which the FDA indicated it could not approve the Viaskin Peanut BLA in its current form. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study. The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data. The FDA did not raise any safety concerns related to Viaskin Peanut.
On January 13, 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 Company believes the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, the Company proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications. The FDA agreed with the Company’s 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 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 modified patches, the FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years. The FDA also recommended conducting a
6-month,
well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population.
On November 2, 2020, the Company announced that its Marketing Authorization Application, or MAA, for Viaskin Peanut had been validated by the European Medicines Agency, or EMA. The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years. The Company received the first set of questions from the EMA, during the first quarter of 2021, which were consistent with the Company’s expectations and prefiling conversations with the EMA. The Company did not receive questions about the impact of adhesion on efficacy. The EMA’s Committee for Medicinal Products for Human Use will provide a recommendation to the European Commission, or EC, on whether to grant a marketing authorization when its review of the Viaskin Peanut MAA is complete.
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
m
g 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.
Financing
On February 4, 2020, the Company announced the closing of an underwritten global offering of an aggregate of 7,500,000 ordinary shares in (i) a public offering of 4,535,581 ordinary shares in the form of 9,071,162 American Depositary Shares (“ADSs”) in the United States, Canada and certain countries outside Europe at a public offering price of $10.25 per ADS (on the basis of an exchange rate of $1.0999 = €1.00), and (ii) an offering exclusively addressed to qualified investors in Europe (including France) of 2,964,419 ordinary shares at an offering price of €18.63 per ordinary share (together, the “Global Offering”).
On March 2, 2020, the Company announced that the underwriters partially exercised their option to purchase 338,687 additional ordinary shares in the form of 677,374 ADSs at an offering price of $10.25 per ADS, before deducting commissions and estimated offering expenses (the “Option”). The Option closed on March 4, 2020.
Consequently, following partial exercise of the Option, the total number of ordinary shares sold in the global offering was 7,838,687 ordinary shares, including 4,874,268 ordinary shares in the form of 9,748,536 ADSs, bringing the total gross proceeds from the global offering to $160.7 million and net proceeds of $150.0 million.
Restructuring
The Company initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanut in the United States and European Union. The Company expects full implementation of the organization-wide costs reduction measures to be completed by the second half of 2021.
The following table summarizes restructuring activities as of March 31, 2021 included in current contingencies and other current liabilities in the statement of financial position:
 
 
  
Restructuring

liabilities
 
Restructuring liability - January 1, 2021
  
 
9,387
 
Amounts paid
  
 
(4,854
Other effect including currency translation effect
  
 
(220
 
  
 
 
 
Restructuring liability - March 31, 2021
  
 
4,313
 
 
  
 
 
 
of which current contingencies
  
 
1,511
 
of which other current liabilities
  
 
2,803
 
 
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, 2021, 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 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 March 16, 2020.
The Company believes that the allegations contained in the amended complaint are without merit and will 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.
XML 19 R9.htm IDEA: XBRL DOCUMENT v3.21.1
Cash and Cash Equivalents
3 Months Ended
Mar. 31, 2021
Cash and Cash Equivalents [Abstract]  
Cash and Cash Equivalents
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,
 
 
  
2021
 
  
2020
 
Cash
  
 
58,069
 
  
 
42,341
 
Cash equivalents
  
 
94,390
 
  
 
154,011
 
 
  
 
 
 
  
 
 
 
Total cash and cash equivalents as reported in the statements of financial position
  
 
152,459
 
  
 
196,352
 
 
  
 
 
 
  
 
 
Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.
XML 20 R10.htm IDEA: XBRL DOCUMENT v3.21.1
Trade Payables and Other Current Liabilities
3 Months Ended
Mar. 31, 2021
Payables and Accruals [Abstract]  
Trade Payables and Other Current Liabilities
Note 4: Trade Payables and Other Current Liabilities
4.1 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.
4.2 Other Current Liabilities
Other current liabilities consisted of the following:
 
   
March 31,
   
December 31,
 
   
2021
   
2020
 
Employee related liabilities
   9,245    16,661 
Deferred income
   3,378    4,687 
Tax liabilities
   312    580 
Other debts
   460    999 
   
 
 
   
 
 
 
Total
  
 
13,394
 
  
 
22,926
 
   
 
 
   
 
 
 
 
The other current liabilities include short-term debt to employees including employee termination allowance and benefits as part of the restructuring (refer to Note 2, “Significant Events and Transactions of the Period – Restructuring”), bonus accruals, and social welfare and tax agency obligations.
Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $3.4 million as of March 31, 2021.
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Share-Based Payments
3 Months Ended
Mar. 31, 2021
Share-based Payment Arrangement [Abstract]  
Share-Based Payments
Note 5: Share-Based Payments
The Board of Directors has been authorized by the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), employee warrants (
Bons de Souscription de Parts de Créateur d’Entreprise
or “BSPCE”) and (
Bons de Souscription d’Actions
or “BSA”).
During the three months ended March 31, 2021, the Company granted 75,600 stock options and 24,900 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 14 to the consolidated financial statements included in the Annual Report.
 
Stock options fair value assumptions during the three months ended March 31, 2021
 
Weighted average share price at grant date in €
  
 
9.3
 
Weighted average expected volatility
  
 
90.9
Weighted average risk-free interest rate
  
 
(0.36
)% 
Weighted average expected term (in years)
  
 
6
 
Dividend yield
  
 
—  
 
Weighted average fair value of stock-options in €
  
 
6.9
 
Change in Number of BSA/BCE/SO/RSU
 
 
  
Number of outstanding
 
 
  
BSA
 
  
BCE
 
  
SO
 
 
RSUs
 
Balance as of December 31, 2020
  
 
218,008
 
  
 
5,500
 
  
 
2,610,510
 
 
 
1,118,745
 
Granted during the period
  
 
—  
 
  
 
—  
 
  
 
75,600
 
 
 
24,900
 
Forfeited during the period
  
 
—  
 
  
 
—  
 
  
 
(15,400
 
 
(13,700
Exercised/released during the period
  
 
—  
 
  
 
(500
  
 
—  
 
 
 
—  
 
Expired during the period
  
 
—  
 
  
 
—  
 
  
 
—  
 
 
 
—  
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
Balance as of March 31, 2021
  
 
218,008
 
  
 
5 000
 
  
 
2,670,710
 
 
 
1,129,945
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
Reconciliation of the share-based payments expenses with the consolidated statements of operations
 
 
  
Three Months Ended

March 31,
 
 
  
2021
 
  
2020
 
Research and development
  
 
SO
 
  
 
(376
  
 
(876
 
  
 
RSU
 
  
 
(251
  
 
(392
Sales and marketing
  
 
SO
 
  
 
(49
  
 
(598
 
  
 
RSU
 
  
 
(22
  
 
(2
General and administrative
  
 
SO
 
  
 
(644
  
 
(1,071
 
  
 
RSU
 
  
 
(91
  
 
(133
 
  
   
  
 
 
 
  
 
 
 
Total share-based compensation expense
  
   
  
 
(1,433
  
 
(3,073
 
  
   
  
 
 
 
  
 
 
XML 22 R12.htm IDEA: XBRL DOCUMENT v3.21.1
Contingencies
3 Months Ended
Mar. 31, 2021
Loss Contingency [Abstract]  
Contingencies
Note 6: Contingencies
Current contingencies and
non-current
contingencies break down as follows:
 
 
  
March 31,
 
  
December 31,
 
 
  
2021
 
  
2020
 
Current contingencies
  
 
4,246
 
  
 
5,016
 
Non-current
contingencies
  
 
2,229
 
  
 
2,527
 
 
  
 
 
 
  
 
 
 
Total contingencies
  
 
6,474
 
  
 
7,542
 
 
  
 
 
 
  
 
 
The table below shows movements in contingencies:
 
 
  
Pension retirement

obligations
 
  
Collaboration

agreement -

Loss at

completion
 
  
Other contingencies
 
 
Total
 
At January 1, 2021
  
 
937
 
  
 
3,956
 
  
 
2,649
 
 
 
7,542
 
Increases in liabilities
  
 
—  
 
  
 
—  
 
  
 
—  
 
 
 
—  
 
Used liabilities
  
 
—  
 
  
 
(434
  
 
(515
 
 
(949
Reversals of unused liabilities
  
 
—  
 
  
 
—  
 
  
 
—  
 
 
 
—  
 
     
Net interest related to employee benefits, and unwinding of discount
  
 
—  
 
  
 
—  
 
  
 
—  
 
 
 
—  
 
Actuarial gains and losses on defined-benefit plans
  
 
85
 
  
 
—  
 
  
 
—  
 
 
 
85
 
Other effects including currency translation effect
  
 
(44
  
 
(164
  
 
4
 
 
 
(204
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
At March 31, 2021
  
 
978
 
  
 
3,358
 
  
 
2,139
 
 
 
6,474
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
Of which current
  
 
—  
 
  
 
2,107
 
  
 
2,139
 
 
 
4,246
 
Of which
non-current
  
 
978
 
  
 
1,251
 
  
 
—  
 
 
 
2,229
 
In 2020 and during the first three months of 2021, the ongoing
COVID-19
pandemic impacted the Company’s current clinical trials, including its Phase II clinical trial conducted as part of the development activities pursuant to the collaboration and license agreement with Nestlé Health Science. The Company experienced a decrease in new patients enrolling in this Phase II clinical trial and modified the protocols of the clinical trial. As a result of these delays, the Company expects to incur additional clinical and production costs related to the Phase II clinical trial. Starting the last quarter of the fiscal year 2020, an accrual in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been recorded.
Other contingencies are primarily composed of the estimated expenses to be incurred as part of the employee-related costs related to restructuring, as well as estimated cost of refurbishing lease premises (Refer to Note 2, “Significant Events and Transactions—Restructuring contingencies).
There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 15 to the consolidated financial statements included in the Annual Report.
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Operating Income
3 Months Ended
Mar. 31, 2021
Other Income and Expenses [Abstract]  
Operating Income
Note 7: Operating income
The operating income is broken down in the following manner:
 
 
  
Three Months Ended March 31,
 
 
  
2021
 
  
2020
 
Research tax credit
  
 
1,807
 
  
 
2,902
 
Other operating income
  
 
1,133
 
  
 
1,818
 
 
  
 
 
 
  
 
 
 
Total
  
 
2,941
 
  
 
4,720
 
 
  
 
 
 
  
 
 
As of March 31, 2021, 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.
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Allocation of Personnel Expenses
3 Months Ended
Mar. 31, 2021
Operating Expenses [Abstract]  
Allocation of Personnel Expenses
Note 8: Allocation of Personnel Expenses
The Company had an average of 121 employees during the three months ended March 31, 2021, in comparison with an average of 311 employees during the three months ended March 31, 2020.
Allocation of Personnel Expenses by Function:
 
 
  
Three Months Ended March
31,
 
 
  
2021
 
  
2020
 
Research and development expenses
  
 
4,718
 
  
 
10,204
 
Sales and marketing expenses
  
 
518
 
  
 
4,197
 
General and administrative expenses
  
 
3,766
 
  
 
4,283
 
 
  
 
 
 
  
 
 
 
Total personnel expenses
  
 
9,002
 
  
 
18,684
 
 
  
 
 
 
  
 
 
Allocation of Personnel Expenses by Nature:
 
 
  
Three months Ended March
31,
 
 
  
2021
 
  
2020
 
Wages and salaries
  
 
4,454
 
  
 
12,872
 
Social security contributions
  
 
1,332
 
  
 
663
 
Expenses for pension commitments
  
 
402
 
  
 
915
 
Employer contribution to bonus shares
  
 
1,381
 
  
 
1,162
 
Share-based payments
  
 
1,433
 
  
 
3,073
 
 
  
 
 
 
  
 
 
 
Total personnel expenses
  
 
9,002
 
  
 
18,684
 
 
  
 
 
 
  
 
 
 
The decrease in personnel expenses is mainly due to a decreased headcount as well as reductions in accrued bonuses, retention measures and share-based compensation expenses, partly as a result of the 2020 global restructuring plan.
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Commitments
3 Months Ended
Mar. 31, 2021
Commitments and Contingencies Disclosure [Abstract]  
Commitments
Note 9: Commitments
There have been no significant changes in other commitments from those disclosed in Note 19 to the consolidated financial statements included in the Annual Report.
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Relationships with Related Parties
3 Months Ended
Mar. 31, 2021
Related Party Transactions [Abstract]  
Relationships with Related Parties
Note 10: 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 20 to the consolidated financial statements included in the Annual Report.
XML 27 R17.htm IDEA: XBRL DOCUMENT v3.21.1
Loss Per Share
3 Months Ended
Mar. 31, 2021
Earnings Per Share [Abstract]  
Loss Per Share
Note 11: 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, 2021 and 2020, 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, 2021 and 2020 indicated in number of potential shares:
 
   
Three Months Ended March 31,
 
   
2021
   
2020
 
Non-employee
warrants
   225,008    225,008 
Employee warrants
   75,000    82,500 
Stock-options
   2,670,710    2 835,635 
Restricted stock units
   1,129,945    696,895 
XML 28 R18.htm IDEA: XBRL DOCUMENT v3.21.1
Events After the Close of the Fiscal Year
3 Months Ended
Mar. 31, 2021
Subsequent Events [Abstract]  
Events after the Close of the Fiscal Year
Note 12: Events after the Close of the Period
The Company evaluated subsequent events that occurred after March 31, 2021, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on April 30, 2021 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.
XML 29 R19.htm IDEA: XBRL DOCUMENT v3.21.1
The Company (Policies)
3 Months Ended
Mar. 31, 2021
Accounting Policies [Abstract]  
Basis of Presentation
Basis of Presentation
The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.
The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form
10-K
filed with the SEC on March 17, 2021 (the “Annual Report”). The condensed consolidated statement of financial position at December 31, 2020 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, 2020.
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, 2021, or any other future period.
Use of estimates
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
Going concern
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 (
Cr
é
dit d
Imp
ô
t 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. The Company 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. Based on guidance received from the FDA in January 2021, the Company’s plans to implement such guidance, and expected cost savings from implementation of the global restructuring plan, the Company expects that its current balance of cash and cash equivalents of $152.5 million as of March 31, 2021 will be sufficient to fund its operations for at least the next 12 months.
The Company intends to seek additional capital as it prepares for the 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. As a result of disruptions to the global financial markets as a result of the ongoing
COVID-19
pandemic, 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.
Accounting Pronouncements adopted in 2021
Accounting Pronouncements adopted in 2021
Effective January 1, 2021, the Company adopted ASU
2019-12, Income
Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. The adoption of ASU
2019-12
did not have a material impact on the Company’s financial position or results of operations.
Accounting Pronouncements issued not yet adopted
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.
In January 2017, the FASB issued ASU
2017-04, Simplifying
the Test for Goodwill Impairment, which modifies the goodwill impairment test and requires an entity to write down the carrying value of goodwill for the amount by which the carrying amount of a reporting unit exceeds its fair value. 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 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.
XML 30 R20.htm IDEA: XBRL DOCUMENT v3.21.1
Significant Events and Transactions (Tables)
3 Months Ended
Mar. 31, 2021
Significant Events And Transactions Disclosure [Abstract]  
Summary of restructuring reserve
The following table summarizes restructuring activities as of March 31, 2021 included in current contingencies and other current liabilities in the statement of financial position:
 
 
  
Restructuring

liabilities
 
Restructuring liability - January 1, 2021
  
 
9,387
 
Amounts paid
  
 
(4,854
Other effect including currency translation effect
  
 
(220
 
  
 
 
 
Restructuring liability - March 31, 2021
  
 
4,313
 
 
  
 
 
 
of which current contingencies
  
 
1,511
 
of which other current liabilities
  
 
2,803
 
XML 31 R21.htm IDEA: XBRL DOCUMENT v3.21.1
Cash and Cash Equivalents (Tables)
3 Months Ended
Mar. 31, 2021
Cash and Cash Equivalents [Abstract]  
Summary of breakdown of cash and cash equivalents
The following table presents for each reported period, the breakdown of cash and cash equivalents:
 
 
  
March 31,
 
  
December 31,
 
 
  
2021
 
  
2020
 
Cash
  
 
58,069
 
  
 
42,341
 
Cash equivalents
  
 
94,390
 
  
 
154,011
 
 
  
 
 
 
  
 
 
 
Total cash and cash equivalents as reported in the statements of financial position
  
 
152,459
 
  
 
196,352
 
 
  
 
 
 
  
 
 
XML 32 R22.htm IDEA: XBRL DOCUMENT v3.21.1
Trade Payables and Other Current Liabilities (Tables)
3 Months Ended
Mar. 31, 2021
Other Liabilities, Current [Abstract]  
Summary of Other Current Liabilities
Other current liabilities consisted of the following:
 
   
March 31,
   
December 31,
 
   
2021
   
2020
 
Employee related liabilities
   9,245    16,661 
Deferred income
   3,378    4,687 
Tax liabilities
   312    580 
Other debts
   460    999 
   
 
 
   
 
 
 
Total
  
 
13,394
 
  
 
22,926
 
   
 
 
   
 
 
 
XML 33 R23.htm IDEA: XBRL DOCUMENT v3.21.1
Share-Based Payments (Tables)
3 Months Ended
Mar. 31, 2021
Summary of Stock Options Valuation Assumptions
There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 14 to the consolidated financial statements included in the Annual Report.
 
Stock options fair value assumptions during the three months ended March 31, 2021
 
Weighted average share price at grant date in €
  
 
9.3
 
Weighted average expected volatility
  
 
90.9
Weighted average risk-free interest rate
  
 
(0.36
)% 
Weighted average expected term (in years)
  
 
6
 
Dividend yield
  
 
—  
 
Weighted average fair value of stock-options in €
  
 
6.9
 
Summary of RSU Activity
Change in Number of BSA/BCE/SO/RSU
 
 
  
Number of outstanding
 
 
  
BSA
 
  
BCE
 
  
SO
 
 
RSUs
 
Balance as of December 31, 2020
  
 
218,008
 
  
 
5,500
 
  
 
2,610,510
 
 
 
1,118,745
 
Granted during the period
  
 
—  
 
  
 
—  
 
  
 
75,600
 
 
 
24,900
 
Forfeited during the period
  
 
—  
 
  
 
—  
 
  
 
(15,400
 
 
(13,700
Exercised/released during the period
  
 
—  
 
  
 
(500
  
 
—  
 
 
 
—  
 
Expired during the period
  
 
—  
 
  
 
—  
 
  
 
—  
 
 
 
—  
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
Balance as of March 31, 2021
  
 
218,008
 
  
 
5 000
 
  
 
2,670,710
 
 
 
1,129,945
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
Summary of Share-Based Payments Expenses
Reconciliation of the share-based payments expenses with the consolidated statements of operations
 
 
  
Three Months Ended

March 31,
 
 
  
2021
 
  
2020
 
Research and development
  
 
SO
 
  
 
(376
  
 
(876
 
  
 
RSU
 
  
 
(251
  
 
(392
Sales and marketing
  
 
SO
 
  
 
(49
  
 
(598
 
  
 
RSU
 
  
 
(22
  
 
(2
General and administrative
  
 
SO
 
  
 
(644
  
 
(1,071
 
  
 
RSU
 
  
 
(91
  
 
(133
 
  
   
  
 
 
 
  
 
 
 
Total share-based compensation expense
  
   
  
 
(1,433
  
 
(3,073
 
  
   
  
 
 
 
  
 
 
XML 34 R24.htm IDEA: XBRL DOCUMENT v3.21.1
Contingencies (Tables)
3 Months Ended
Mar. 31, 2021
Loss Contingency [Abstract]  
Summary of Current Contingencies and Non-current Contingencies
Current contingencies and
non-current
contingencies break down as follows:
 
 
  
March 31,
 
  
December 31,
 
 
  
2021
 
  
2020
 
Current contingencies
  
 
4,246
 
  
 
5,016
 
Non-current
contingencies
  
 
2,229
 
  
 
2,527
 
 
  
 
 
 
  
 
 
 
Total contingencies
  
 
6,474
 
  
 
7,542
 
 
  
 
 
 
  
 
 
Summary of Movement in Provisions
The table below shows movements in contingencies:
 
 
  
Pension retirement

obligations
 
  
Collaboration

agreement -

Loss at

completion
 
  
Other contingencies
 
 
Total
 
At January 1, 2021
  
 
937
 
  
 
3,956
 
  
 
2,649
 
 
 
7,542
 
Increases in liabilities
  
 
—  
 
  
 
—  
 
  
 
—  
 
 
 
—  
 
Used liabilities
  
 
—  
 
  
 
(434
  
 
(515
 
 
(949
Reversals of unused liabilities
  
 
—  
 
  
 
—  
 
  
 
—  
 
 
 
—  
 
     
Net interest related to employee benefits, and unwinding of discount
  
 
—  
 
  
 
—  
 
  
 
—  
 
 
 
—  
 
Actuarial gains and losses on defined-benefit plans
  
 
85
 
  
 
—  
 
  
 
—  
 
 
 
85
 
Other effects including currency translation effect
  
 
(44
  
 
(164
  
 
4
 
 
 
(204
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
At March 31, 2021
  
 
978
 
  
 
3,358
 
  
 
2,139
 
 
 
6,474
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
Of which current
  
 
—  
 
  
 
2,107
 
  
 
2,139
 
 
 
4,246
 
Of which
non-current
  
 
978
 
  
 
1,251
 
  
 
—  
 
 
 
2,229
 
XML 35 R25.htm IDEA: XBRL DOCUMENT v3.21.1
Operating Income (Tables)
3 Months Ended
Mar. 31, 2021
Other Income and Expenses [Abstract]  
Schedule of operating income
The operating income is broken down in the following manner:
 
 
  
Three Months Ended March 31,
 
 
  
2021
 
  
2020
 
Research tax credit
  
 
1,807
 
  
 
2,902
 
Other operating income
  
 
1,133
 
  
 
1,818
 
 
  
 
 
 
  
 
 
 
Total
  
 
2,941
 
  
 
4,720
 
 
  
 
 
 
  
 
 
XML 36 R26.htm IDEA: XBRL DOCUMENT v3.21.1
Allocation of Personnel Expenses (Tables)
3 Months Ended
Mar. 31, 2021
Operating Expenses [Abstract]  
Summary of Allocation of Personnel Expenses By Function
Allocation of Personnel Expenses by Function:
 
 
  
Three Months Ended March
31,
 
 
  
2021
 
  
2020
 
Research and development expenses
  
 
4,718
 
  
 
10,204
 
Sales and marketing expenses
  
 
518
 
  
 
4,197
 
General and administrative expenses
  
 
3,766
 
  
 
4,283
 
 
  
 
 
 
  
 
 
 
Total personnel expenses
  
 
9,002
 
  
 
18,684
 
 
  
 
 
 
  
 
 
Summary of Allocation of Personnel Expenses By Nature
Allocation of Personnel Expenses by Nature:
 
 
  
Three months Ended March
31,
 
 
  
2021
 
  
2020
 
Wages and salaries
  
 
4,454
 
  
 
12,872
 
Social security contributions
  
 
1,332
 
  
 
663
 
Expenses for pension commitments
  
 
402
 
  
 
915
 
Employer contribution to bonus shares
  
 
1,381
 
  
 
1,162
 
Share-based payments
  
 
1,433
 
  
 
3,073
 
 
  
 
 
 
  
 
 
 
Total personnel expenses
  
 
9,002
 
  
 
18,684
 
 
  
 
 
 
  
 
 
XML 37 R27.htm IDEA: XBRL DOCUMENT v3.21.1
Loss Per Share (Tables)
3 Months Ended
Mar. 31, 2021
Earnings Per Share, Basic and Diluted [Abstract]  
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]
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, 2021 and 2020 indicated in number of potential shares:
 
   
Three Months Ended March 31,
 
   
2021
   
2020
 
Non-employee
warrants
   225,008    225,008 
Employee warrants
   75,000    82,500 
Stock-options
   2,670,710    2 835,635 
Restricted stock units
   1,129,945    696,895 
XML 38 R28.htm IDEA: XBRL DOCUMENT v3.21.1
The Company - Additional Information (Detail) - USD ($)
$ in Thousands
Mar. 31, 2021
Dec. 31, 2020
Mar. 31, 2020
Dec. 31, 2019
Subsidiary or Equity Method Investee [Line Items]        
Cash and cash equivalents $ 152,459 $ 196,352 $ 287,442 $ 193,255
XML 39 R29.htm IDEA: XBRL DOCUMENT v3.21.1
Significant Events and Transactions - Additional Information (Detail)
$ / shares in Units, $ in Thousands
3 Months Ended
Mar. 02, 2020
$ / shares
shares
Feb. 04, 2020
€ / shares
shares
Jan. 31, 2020
patients
Mar. 31, 2021
USD ($)
patients
shares
Mar. 31, 2020
USD ($)
Feb. 04, 2020
$ / shares
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Stockholders' Equity Note, Stock Split, Conversion Ratio   1.0999        
Proceeds From Issuance Of Common Stock | $       $ 150,000    
Stock issued during the period, Value | $       $ 42 $ 151,023  
Common Stock [Member]            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Stock Issued During Period, Shares, New Issues       7,838,687    
Public Offering [member] | Common Stock [Member]            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Stock Issued During Period, Shares, New Issues   7,500,000   4,874,268    
Public Offering [member] | American Depositary Shares            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Stock Issued During Period, Shares, New Issues       9,748,536    
Public Offering [member] | Outside Europe [Member] | Common Stock [Member]            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Stock Issued During Period, Shares, New Issues   4,535,581        
Public Offering [member] | Outside Europe [Member] | American Depositary Shares            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Stock Issued During Period, Shares, New Issues   9,071,162        
Shares Issued, Price Per Share | $ / shares           $ 10.25
Over-Allotment Option | Common Stock [Member]            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Stock Issued During Period, Shares, New Issues 338,687          
Over-Allotment Option | American Depositary Shares            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Stock Issued During Period, Shares, New Issues 677,374          
Shares Issued, Price Per Share | $ / shares $ 10.25          
Global Offering [member]            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Stock issued during the period, Value | $       $ 160,700    
Private Placement [Member]            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Shares Issued, Price Per Share | € / shares   € 18.63        
Stock Issued During Period, Shares, Issued for Services   2,964,419        
ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member]            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Percentage Of Patients Increased ED From Baseline     75.90%      
Number Of Patients Increased ED From Baseline | patients       107    
Number Of Patients | patients       141    
Percentage Of Patients Increased ED Of Minimum Thousand Milligram Peanut Protein By Three Year     51.80% 73.00%    
Number Of Patients Observed For Safety Profile Till Date | patients     1,000      
Treatment Compliance Percentage     98.00%      
Clinical Program Trial Period     6 months      
Minimum | ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member]            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Age Of Child     4 years      
Maximum | ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member]            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Age Of Child     11 years      
XML 40 R30.htm IDEA: XBRL DOCUMENT v3.21.1
Significant Events and Transactions - Summary of restructuring reserve (Detail)
$ in Thousands
3 Months Ended
Mar. 31, 2021
USD ($)
Summary of restructuring reserve  
Restructuring liability - January 1, 2021 $ 9,387
Amounts paid (4,854)
Other effect including currency translation effect (220)
Restructuring liability - March 31, 2021 4,313
of which current contingencies 1,511
of which other current liabilities $ 2,803
XML 41 R31.htm IDEA: XBRL DOCUMENT v3.21.1
Cash and Cash Equivalents - Summary of breakdown of cash and cash equivalents (Detail) - USD ($)
$ in Thousands
Mar. 31, 2021
Dec. 31, 2020
Mar. 31, 2020
Dec. 31, 2019
Cash and Cash Equivalents, at Carrying Value [Abstract]        
Cash $ 58,069 $ 42,341    
Cash equivalents 94,390 154,011    
Total cash and cash equivalent as reported in statement of financial position $ 152,459 $ 196,352 $ 287,442 $ 193,255
XML 42 R32.htm IDEA: XBRL DOCUMENT v3.21.1
Trade Payables and Other Current Liabilities - Additional Information (Detail)
€ in Millions
Mar. 31, 2021
EUR (€)
Nestl Health Science [Member]  
Deferred revenues € 3.4
XML 43 R33.htm IDEA: XBRL DOCUMENT v3.21.1
Trade Payables and Other Current Liabilities - Summary of Other Current Liabilities (Detail) - USD ($)
$ in Thousands
Mar. 31, 2021
Dec. 31, 2020
Other current liabilities $ 13,394 $ 22,926
Employee related liabilities [Member]    
Other current liabilities 9,245 16,661
Deferred income [Member]    
Other current liabilities 3,378 4,687
Tax Liabilities [Member]    
Other current liabilities 312 580
Other Debts [Member]    
Other current liabilities $ 460 $ 999
XML 44 R34.htm IDEA: XBRL DOCUMENT v3.21.1
Share-Based Payments - Summary of Stock Options Valuation Assumptions (Detail)
3 Months Ended
Mar. 31, 2021
€ / shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Dividend yield
Weighted Average [Member]  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Weighted average share price at grant date in € € 9.3
Weighted average expected volatility 90.90%
Weighted average risk-free interest rate (0.36%)
Weighted average expected term (in years) 6 years
Weighted average fair value of stock-options in € € 6.9
XML 45 R35.htm IDEA: XBRL DOCUMENT v3.21.1
Share-Based Payments - Summary of RSU Activity (Detail)
3 Months Ended
Mar. 31, 2021
shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Number of stock options outstanding, Beginning Balance 2,610,510
Number of stock options outstanding, Granted during the period 75,600
Number of stock options outstanding, Forfeited during the period (15,400)
Number of stock options outstanding, Ending Balance 2,670,710
BSA Warrants [Member]  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Number of warrants outstanding, Beginning Balance 218,008
Number of warrants outstanding, Exercised/released during the period 0
Number of warrants outstanding, Ending Balance 218,008
BCE Warrants [Member]  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Number of warrants outstanding, Beginning Balance 5,500
Number of warrants outstanding, Exercised/released during the period (500)
Number of warrants outstanding, Ending Balance 5,000
Restricted Stock Units [Member]  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Number of RSU outstanding, Beginning Balance 1,118,745
Number of RSU outstanding, Granted during the period 24,900
Number of RSU outstanding, Forfeited during the period (13,700)
Number of RSU outstanding, Ending Balance 1,129,945
XML 46 R36.htm IDEA: XBRL DOCUMENT v3.21.1
Share-Based Payments - Summary of Share-Based Payments Expenses (Detail) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments $ (1,433) $ (3,073)
Research and Development expenses [Member] | Employee Stock Option Member    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments (376) (876)
Research and Development expenses [Member] | Restricted Stock Units [Member]    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments (251) (392)
Sales and Marketing expenses [Member] | Employee Stock Option Member    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments (49) (598)
Sales and Marketing expenses [Member] | Restricted Stock Units [Member]    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments (22) (2)
General and Administrative expenses [Member] | Employee Stock Option Member    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments (644) (1,071)
General and Administrative expenses [Member] | Restricted Stock Units [Member]    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments $ (91) $ (133)
XML 47 R37.htm IDEA: XBRL DOCUMENT v3.21.1
Share-Based Payments - Additional Information (Detail)
3 Months Ended
Mar. 31, 2021
shares
Share-Based Payments [Line iteam]  
Number of stock options outstanding, Granted during the period 75,600
Share options [Member] | Employees [Member]  
Share-Based Payments [Line iteam]  
Number of stock options outstanding, Granted during the period 75,600
Restricted Stock Units [Member]  
Share-Based Payments [Line iteam]  
Number of RSU outstanding, Granted during the period 24,900
Restricted Stock Units [Member] | Employees [Member]  
Share-Based Payments [Line iteam]  
Number of RSU outstanding, Granted during the period 24,900
XML 48 R38.htm IDEA: XBRL DOCUMENT v3.21.1
Contingencies - Summary of Current Contingencies and Non-current Contingencies (Detail) - USD ($)
$ in Thousands
Mar. 31, 2021
Dec. 31, 2020
Liability, Defined Benefit Plan [Abstract]    
Current contingencies $ 4,246 $ 5,016
Non-current contingencies 2,229 2,527
Total contingencies $ 6,474 $ 7,542
XML 49 R39.htm IDEA: XBRL DOCUMENT v3.21.1
Contingencies - Summary of Movement in Contingencies (Detail) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2021
Dec. 31, 2020
Contingencies, Beginning balance $ 7,542  
Increases in liabilities 0  
Used liabilities (949)  
Reversals of unused liabilities 0  
Net interest related to employee benefits, and unwinding of discount 0  
Actuarial gains and losses on defined-benefit plans 85  
Other effects including currency translation effect (204)  
Contingencies, Ending balance 6,474  
Of which current 4,246 $ 5,016
Of which non-current 2,229 $ 2,527
Pension retirement obligations [Member]    
Contingencies, Beginning balance 937  
Actuarial gains and losses on defined-benefit plans 85  
Other effects including currency translation effect (44)  
Contingencies, Ending balance 978  
Of which non-current 978  
Collaboration agreement -Loss at completion [Member]    
Contingencies, Beginning balance 3,956  
Used liabilities (434)  
Other effects including currency translation effect (164)  
Contingencies, Ending balance 3,358  
Of which current 2,107  
Of which non-current 1,251  
Other provisions incl. restructuring [Member]    
Contingencies, Beginning balance 2,649  
Increases in liabilities 0  
Used liabilities (515)  
Other effects including currency translation effect 4  
Contingencies, Ending balance 2,139  
Of which current $ 2,139  
XML 50 R40.htm IDEA: XBRL DOCUMENT v3.21.1
Operating Income - Summary of Operating Income (Detail) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Other Income and Expenses [Abstract]    
Research Tax Credit $ 1,807 $ 2,902
Other Operating income 1,133 1,818
Total $ 2,941 $ 4,720
XML 51 R41.htm IDEA: XBRL DOCUMENT v3.21.1
Allocation of Personnel Expenses - Summary of Allocation of Personnel Expenses By Function (Detail) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Research and development expenses $ 22,164 $ 27,532
Sales and marketing expenses 729 7,297
General and administrative expenses 9,683 11,113
Total Operating expenses 32,575 45,942
Expenses by Function [Member]    
Research and development expenses 4,718 10,204
Sales and marketing expenses 518 4,197
General and administrative expenses 3,766 4,283
Total Operating expenses $ 9,002 $ 18,684
XML 52 R42.htm IDEA: XBRL DOCUMENT v3.21.1
Allocation of Personnel Expenses -Summary of Allocation of Personnel Expenses By Nature (Detail) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Share-based payments $ (1,433) $ (3,073)
Total Operating expenses 32,575 45,942
Expenses by Nature [Member]    
Wages and salaries 4,454 12,872
Social security contributions 1,332 663
Expenses for pension commitments 402 915
Employer contribution to bonus shares 1,381 1,162
Share-based payments 1,433 3,073
Total Operating expenses $ 9,002 $ 18,684
XML 53 R43.htm IDEA: XBRL DOCUMENT v3.21.1
Commitments - Additional Information (Detail)
3 Months Ended
Mar. 31, 2021
USD ($)
Disclosure Of Commitments [Line Items]  
Increase (decrease) in other commitments during the period $ 0
XML 54 R44.htm IDEA: XBRL DOCUMENT v3.21.1
Relationships with Related Parties - Additional Information (Detail)
$ in Thousands
3 Months Ended
Mar. 31, 2021
USD ($)
Related Party Transactions [Abstract]  
Increase decrease in related party transactions and changes in nature of the transactions $ 0
XML 55 R45.htm IDEA: XBRL DOCUMENT v3.21.1
Loss Per Share - Summary of the Common Stock Equivalents Which Were Excluded From the Calculation of Diluted Net Loss Per Share (Details) - shares
3 Months Ended
Mar. 31, 2021
Mar. 31, 2020
Non-employee warrants [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 225,008,000 225,008,000
Employee warrants [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 75,000,000 82,500,000
Stock options [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 2,670,710,000 2,835,635,000
Restricted stock units [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 1,129,945,000 696,895,000
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