20-F/A 1 d525684d20fa.htm 20-F/A 20-F/A
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 20-F/A

(Amendment No. 1)

 

 

(Mark One)

REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

 

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2016

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to                     

OR

 

SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report

Commission File Number 001-36697

 

 

DBV TECHNOLOGIES S.A.

(Exact name of registrant as specified in its charter and translation of registrant’s name into English)

 

 

France

(Jurisdiction of incorporation or organization)

177-181 avenue Pierre Brossolette

92120 Montrouge France

(Address of principal executive offices)

Dr. Pierre-Henri Benhamou

Chairman and Chief Executive Officer

DBV Technologies S.A.

177-181 avenue Pierre Brossolette

92120 Montrouge France

Tel: +33 1 55 42 78 78 Fax: +33 1 43 26 10 83

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

 

Title of each class

 

Name of each exchange on which registered

American Depositary Shares, each representing one-half of one ordinary share, nominal value €0.10 per share   The Nasdaq Stock Market LLC
Ordinary shares, nominal value €0.10 per share*   The Nasdaq Stock Market LLC*

 

* Not for trading, but only in connection with the registration of the American Depositary Shares.

Securities registered or to be registered pursuant to Section 12(g) of the Act. None

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

Ordinary shares, nominal value €0.10 per share: 24,648,828 as of December 31, 2016

 

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    ☒  Yes    ☐  No

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.    ☐  Yes    ☒  No

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).    ☐  Yes    ☒  No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer  ☒            Accelerated filer  ☐            Non-accelerated filer  ☐            Emerging growth company  ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

 

U.S. GAAP  ☐

    

International Financial Reporting Standards as issued

by the International Accounting Standards Board  ☒

   Other  ☐

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, 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. ☐

† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.    ☐  Item 17    ☐  Item 18

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    ☐  Yes    ☒  No

 

 

 


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EXPLANATORY NOTE

This Amendment No. 1 (“Amendment No. 1”) to our Annual Report on Form 20-F for the year ended December 31, 2016, originally filed with the U.S. Securities and Exchange Commission (“SEC”) on March 22, 2017 (the “Form 20-F”), is being filed solely for the purpose of amending Items 17 and 19 of the Form 20-F to include a revised audit report of Deloitte & Associés, relating to our financial statements as of December 31, 2014, 2015 and 2016 appearing in the Form 20-F. The revised audit report states that our financial statements are in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.

Pursuant to Rule 12b-15 under the Securities Exchange Act of 1934, as amended, this Amendment No. 1 also contains new certifications pursuant to Section 302 and 906 of the Sarbanes-Oxley Act of 2002.

No other changes have been made to the Form 20-F. The Form 20-F, as amended by this Amendment No. 1, speaks as of the original filing date of the Form 20-F, does not reflect events that may have occurred subsequent to the original filing date of the Form 20-F, and does not modify or update in any way the disclosures made in the Form 20-F.


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PART III

Item 17. Financial Statements.

See pages F-1 through F-61 of this Annual Report on Form 20-F.

Item 18. Financial Statements.

Not applicable.

Item 19. Exhibits

 

Exhibit

  

Description

12.1*    Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
12.2*    Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
13.1**    Certification by the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
13.2**    Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

  * Filed herewith.
** Furnished herewith.


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Index to Financial Statements

 

     Page  
Annual Financial Statements for the Years Ended December 31, 2014, 2015 and 2016:   
Report of Deloitte & Associés, Independent Registered Public Accounting Firm      F-2  
Report of Deloitte & Associés, Independent Registered Public Accounting Firm (ICFR)      F-3  
Consolidated Statements of Financial Position as of December 31, 2014, 2015 and 2016      F-4  
Consolidated Statements of (Loss) for the Years Ended December 31, 2014, 2015 and 2016      F-5  
Consolidated Statements of Comprehensive (Loss) for the Years Ended December 31, 2014, 2015 and 2016      F-6  
Consolidated Statements of Cash Flows for the Years Ended December 31, 2014, 2015 and 2016      F-7  
Consolidated Statements of Shareholders’ Equity for the Years Ended December 31, 2014, 2015 and 2016      F-8  
Notes to the Consolidated Financial Statements      F-9  

 

F-1


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Report of Independent Registered Public Accounting Firm

To the Board of Directors and Shareholders of DBV Technologies S.A.

Paris, France

We have audited the accompanying statements of consolidated financial position of DBV Technologies S.A. and subsidiary (the “Company”) as of December 31, 2014, 2015 and 2016, and the related consolidated statements of (loss), comprehensive (loss), shareholders’ equity, and cash flows for each of the three years in the period ended December 31, 2016. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, such consolidated financial statements present fairly, in all material respects, the financial position of DBV Technologies SA and subsidiary as of December 31, 2014, 2015 and 2016, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2016, in conformity with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company’s internal control over financial reporting as of December 31, 2016, based on the criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 22, 2017 expressed an unqualified opinion on the Company’s internal control over financial reporting.

/s/ Deloitte & Associés

Represented by Julien Razungles

Neuilly-sur-Seine, France

March 22, 2017

 

F-2


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Report of Independent Registered Public Accounting Firm

Internal Control Over Financial Reporting

To the Board of Directors and Shareholders of DBV Technologies S.A.

Paris, France

We have audited the internal control over financial reporting of DBV Technologies S.A. and subsidiary (the “Company”) as of December 31, 2016, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on that risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

A company’s internal control over financial reporting is a process designed by, or under the supervision of, the company’s principal executive and principal financial officers, or persons performing similar functions, and effected by the company’s board of directors, management, and other personnel 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. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2016, based on the criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated financial statements as of and for the year ended December 31, 2016, of the Company and our report dated March 22, 2017 expressed an unqualified opinion on those financial statements.

/s/ Deloitte & Associés

Represented by Julien Razungles

Neuilly-sur-Seine, France

March 22, 2017

 

F-3


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DBV TECHNOLOGIES S.A.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(Amounts in thousands of Euros)

 

     Note      Year Ended December 31,  
        2014     2015     2016  
ASSETS          

Non-current assets

         

Intangible assets

     4        29       94       96  

Property, plant, and equipment

     5        2,225       5,581       12,482  

Other non-current financial assets

     6        1,596       2,711       2,745  
     

 

 

   

 

 

   

 

 

 

Total non-current assets

        3,850       8,387       15,323  
     

 

 

   

 

 

   

 

 

 

Current assets

         

Inventories

     7        124       —         —    

Customer accounts receivable

     8        136       —         1,250  

Other current assets

     8        6,723       11,512       14,454  

Cash and cash equivalents

     9        114,583       323,381       256,473  
     

 

 

   

 

 

   

 

 

 

Total current assets

        121,566       334,893       272,177  
     

 

 

   

 

 

   

 

 

 

TOTAL ASSETS

        125,416       343,280       287,500  
     

 

 

   

 

 

   

 

 

 
     Note      Year Ended December 31,  
        2014     2015     2016  
LIABILITIES          

Shareholders’ equity

         

Share capital

     10        1,916       2,421       2,465  

Premiums related to the share capital

        163,877       403,910       405,882  

Reserve

        (26,336     (39,580     (50,968

Net (loss)

        (24,012     (44,674     (114,531
     

 

 

   

 

 

   

 

 

 

Total shareholders’ equity

        115,445       322,076       242,849  

Non-current liabilities

         

Long-term financial debt

     11        3,888       4,693       4,049  

Non-current provisions

     12        531       490       853  

Other non-current liabilities

     11        —         —         10,746  
     

 

 

   

 

 

   

 

 

 

Total non-current liabilities

        4,419       5,183       15,649  
     

 

 

   

 

 

   

 

 

 

Current liabilities

         

Bank overdrafts

        28       —         —    

Short-term financial debt

     11        213       149       591  

Supplier accounts payable

     13        1,875       10,034       13,720  

Other current liabilities

     13        3,436       5,838       14,692  

Total current liabilities

        5,552       16,021       29,002  
     

 

 

   

 

 

   

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

        125,416       343,280       287,500  
     

 

 

   

 

 

   

 

 

 

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

 

F-4


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DBV TECHNOLOGIES S.A.

CONSOLIDATED STATEMENTS OF (LOSS)

(Amounts in thousands of Euros except per share data)

 

     Note      Year Ended December 31,  
        2014     2015     2016  

Operating income

         

Revenues

     15        211       202       —    

Other income

     15        4,551       5,964       9,084  

Total income

        4,762       6,166       9,084  

Operating expenses

         

Cost of goods sold

        (136     (128     —    

Research and development

     16/17        (21,143     (34,234     (78,828

Sales and marketing

     16/17        (13     (491     (11,282

General and administrative

     16/17        (8,105     (16,859     (35,005

Total expenses

        (29,397     (51,712     (125,115

Operating (loss)

        (24,636     (45,546     (116,031

Financial revenues

     18        727       1,018       1,516  

Financial expenses

     18        (103     (146     (16

Financial (loss)

        624       871       1,500  

Income tax

     19        —         —         —    

Net (loss)

        (24,012     (44,674     (114,531

Basic/diluted earnings (loss) per share (€/share)

     22        (1.49     (2.08     (4.68

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

 

F-5


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DBV TECHNOLOGIES S.A.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS)

(Amounts in thousands of Euros)

 

     Year Ended December 31,  
     2014     2015     2016  

Net (loss)

     (24,012     (44,674     (114,531

Other comprehensive income:

      

Actuarial gains and losses on employee benefits, net of corporate tax

     (153     166       (249

Profit (loss) directly recognized in shareholders’ equity

     (153     166       (249

Other items in the total profit (loss) to be recycled subsequently to the net profit (loss)

     (26     (90     (743
  

 

 

   

 

 

   

 

 

 

Total comprehensive income (loss)

     (24,191     (44,598     (115,523

In accordance with IAS 1 Presentation of Financial Statements (2007) (IAS 1), the Group, as defined in Note 2, presents a combined statement of other elements of comprehensive (loss).

The Group does not hold any financial assets available for sale and non-current financial assets are measured at historical cost which approximates fair value; therefore, no change in fair value is reflected in the consolidated statement of comprehensive (loss).

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

 

F-6


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DBV TECHNOLOGIES S.A

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Amounts in thousands of Euros)

 

     Note      2014     2015     2016  

Cash flows from operating activities

       

Net (loss) for the period

        (24,012     (44,674     (114,531

Reconciliation of the net (loss) and the cash used for the operating activities:

       

Amortization and depreciation

        515       1,073       1,349  

Retirement pension obligations

        86       125       115  

Expenses related to share-based payments

        4,639       10,419       34,353  

Other elements

        —         296       147  
     

 

 

   

 

 

   

 

 

 

Operating cash flows before change in working capital

        (18,770     (32,761     (78,566
     

 

 

   

 

 

   

 

 

 

Inventories

        (117     124       —    

Customer accounts receivable

        (125     136       (1,250

Other current assets

        (1,702     (4,870     (2,931

Supplier accounts payable

        (424     8,236       3,645  

Other current and non current liabilities

        578       2,372       19,564  

Change in working capital requirement

        (1,789     5,998       19,028  
     

 

 

   

 

 

   

 

 

 

Net cash flow used in operating activities

        (20,560     (26,763     (59,538
     

 

 

   

 

 

   

 

 

 

Cash flows used in investment activities

         

Acquisitions of property, plant, and equipment

     5        (941     (4,360     (7,992

Acquisitions of intangible assets

     4        (31     (148     (215

Acquisitions of non-current financial assets

        (124     (839     (93
     

 

 

   

 

 

   

 

 

 

Net cash flows used in investment activities

        (1,096     (5,347     (8,300
     

 

 

   

 

 

   

 

 

 

Cash flows from financing activities:

       

Increase in conditional advances

     11        3,128       865       —    

(Decrease) in conditional advances

     11        (128     (192     (275

Treasury shares

        (889     (175     (54

Capital increases, net of transaction costs

     10        94,643       240,538       2,016  

Other cash flows related to financing activities

        54       (21     (21
     

 

 

   

 

 

   

 

 

 

Net cash flows from financing activities:

        96,808       241,014       1,666  
     

 

 

   

 

 

   

 

 

 

(Decrease) / increase in cash

        75,152       208,904       (66,172

Net cash and cash equivalents at the beginning of the period

        39,403       114,555       323,381  
     

 

 

   

 

 

   

 

 

 

Impact of exchange rate fluctuations

        —         (78     (735
     

 

 

   

 

 

   

 

 

 

Net cash and cash equivalents at the close of the period

     9        114,555       323,381       256,473  
     

 

 

   

 

 

   

 

 

 

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

 

F-7


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DBV TECHNOLOGIES S.A.

CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

(Amounts in thousands of Euros except number of shares)

 

     Share capital
Shares of common stock
                           
     Number
of Shares
     Amount      Premiums
Related to the
Share Capital
     Reserve     Profit
(loss)
    Total
Share-holders’
Equity
 

At January 1, 2014

     15,088,298        1,509        69,641        (11,449     (19,306     40,395  

Net (loss)

                (24,012     (24,012

Foreign exchange translation

               

(Loss) directly recognized in shareholders’ equity

              (179       (179
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Total (loss) directly recognized in shareholders’ equity

              (179     (24,012     (24,191

Allocation of prior (loss)

              (19,306     19,306       —    

Increase in capital

     4,072,363        407        94,204            94,611  

Treasury shares

              (41       (41

Issue of share warrants

           32            32  

Share-based payments

              4,639         4,639  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

At December 31, 2014

     19,160,661        1,916        163,877        (26,336     (24,012     115,445  

Net (loss)

     —          —          —          —         (44,674     (44,674

Foreign exchange translation

     —          —          —          (90     —         (90

(Loss) directly recognized in shareholders’ equity

     —          —          —          166       —         166  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Total (loss) directly recognized in shareholders’ equity

              76       (44,674     (44,598

Allocation of prior (loss)

     —          —          —          (24,012     24,012       —    

Increase in capital

     5,044,468        504        239,892        —         —         240,396  

Treasury shares

     —          —          —          273       —         273  

Issue of share warrants

     —          —          142        —         —         142  

Share-based payments

     —          —          —          10,419       —         10,419  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

At December 31, 2015

     24,205,129        2,421        403,910        (39,580     (44,674     322,076  

Net (loss)

     —          —          —          —         (114,531     (114,531

Foreign exchange translation

     —          —          —          (743     —         (743

(Loss) directly recognized in shareholders’ equity

     —          —          —          (249     —         (249
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Total (loss) directly recognized in shareholders’ equity

              (992     (114,531     (115,523

Allocation of prior (loss)

     —          —          —          (44,674     44,674       —    

Increase in capital

     443,699        44        1,395        —         —         1,439  

Treasury shares

     —          —          —          (74     —         (74

Issue of share warrants

     —          —          577        —         —         577  

Share-based payments

     —          —          —          34,353       —         34,353  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

At December 31, 2016

     24,648,828        2,465        405,882        (50,968     (114,531     242,849  

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

 

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NOTES TO THE FINANCIAL STATEMENTS

Note 1: The Company

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy, specifically in young children.

The Company historically marketed a ready-to-use diagnostic product to detect cow’s milk protein allergy (“CMPA”) in children called Diallertest® Milk, which was launched in France in 2004. This product was distributed in France only, by a commercial partner, under a temporary exception status from French regulatory authorities which, without such temporary exception, marketing of the product would not be allowed. During the second half of 2015, the Company discontinued its commercial partnership with respect to the product and ceased commercial sales of Diallertest Milk. The Company did not generate any revenue from sales of Diallertest Milk in 2016 and has discontinued any further commercialization of the product.

DBV Technologies is also 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.

Viaskin® Peanut is the first specific immunotherapy product developed by DBV Technologies. Solid preclinical data have already been published. Pharmacological development was achieved through a vast network of collaborative efforts in the United States and in Europe. A tolerance study (Phase Ib) conducted in the United States demonstrated the safety and high level of tolerance of Viaskin® Peanut in patients with peanut allergies, and the U.S. Food and Drug Administration (“FDA”) granted a Fast Track designation to the product. In France, the French Health Product Safety Agency (Agence française de sécurité sanitaire des produits de santé, AFSSAPS) authorized an efficacy study sponsored by the Paris Region Public Hospitals (Assistance Publique – Hôpitaux de Paris, AP/HP). In 2012, an efficacy study (Phase IIb) was launched in the United States and Europe. The topline results for the studies were published during the second 2014 semester. Peanut EPIT Efficacy and Safety Study (“PEPITE”), a Phase III clinical study, began during the last 2015 quarter and the Company has reached its patient recruitment objective for the clinical study at the end of the first half 2016. In August 2016, the Company launched the REAL Life Use and Safety of EPIT (“REALISE”) study, which is designed to evaluate the use and safety of Viaskin Peanut 250 µg in routine clinical practice in approximately 335 peanut allergic patients four to 11 years of age. Results from both PEPITES and REALISE are expected during the second half of 2017.

Viaskin® Milk is the second product developed in specific immunotherapy for the treatment of CMPA in children two to 17 years of age, and received fast track designation from the FDA in September 2016. In 2014, a clinical efficacy study using Viaskin® Milk was launched. In June 2015, the Company completed Part A of the Viaskin® Milk Efficacy and Safety Phase I/II study. No safety concern was observed during Part A of the study and the Company has begun enrolling cow’s milk-allergic subjects in the Part B (Phase II) of the study to evaluate the safety and efficacy of three doses of Viaskin® Milk in children ages 2-17.

In November 2015, in partnership with the Company, the Children’s Hospital of Philadelphia initiated an investigator-sponsored multi-center, double-blind, placebo-controlled, randomized trial to study safety and efficacy of Viaskin Milk in pediatric patient populations with milk-induced Eosinophilic Esophagitis (“EoE”).

The Company is also developing a third product candidate, Viaskin Egg, for the treatment of hen’s egg allergy. In the first half of 2015, the Company began pre-clinical work for this product candidate with the goal of initiating a clinical program if these studies are successful.

Main events in 2016

1. PARTNERSHIPS

In May 2016, the Company announced that it has entered into an exclusive global collaboration with Nestlé Health Science for the development and, if approved, commercialization of MAG1C, an innovative, ready-to-use and standardized atopy patch test for the diagnosis of CMPA in infants and toddlers.

Under the terms of the agreement, the Company will be eligible to receive up to €100 million in development, clinical, regulatory and commercial milestones, including an upfront payment of €10 million. The Company will be responsible for performing development activities up through a pivotal Phase III clinical program, following which Nestlé Health Science has the exclusive right to commercialize the product globally, if approved. As of December 31, 2016, the Company recorded a deferred revenue balance with respect to payments received under its collaboration with Nestlé Health Science, which the Company will recognize over the service obligation period. Deferred revenue is included in other current and non-current liabilities, as applicable.

 

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On September 6, 2016, the Company, BioNet-Asia Co. Ltd. and the Geneva University Hospitals (HUG) announced that the first subject was enrolled in a proof-of-concept Phase I clinical trial testing Viaskin rPT in the reactivation of immunity against Bordetella pertussis (whooping cough) in healthy adults. This pertussis vaccination program intends to test the ability of the Company’s needleless and adjuvant-free patch technology, Viaskin, to epicutaneously deliver two doses of BioNet’s genetically detoxified, recombinant pertussis toxin (rPT) to boost immunity against whooping cough.

On November 17, 2016, the Company, BioNet-Asia and Geneva University Hospitals announced the completion of the dosing in the first cohort of the Phase I trial of Viaskin rPT for booster vaccination against Bordetella pertussis. The independent Data and Safety Monitoring Board expressed no safety concerns with Viaskin rPT 25 µg in the first subject cohort. Based on this review, dosing with Viaskin rPT 50 µg has been initiated in the second subject cohort.

2. CLINICAL PROGRAMS

On June 27, 2016, the Company announced completion of recruitment in its global Phase III study of Viaskin Peanut for the treatment of peanut allergic children. Recruitment in PEPITES exceeded initial expectations, with a total of 500 patients screened. As a result, the Company increased its initial randomization target of 330 patients to at least 350 patients. Viaskin Peanut is the Company’s lead product candidate, which is based on epicutaneous immunotherapy (“EPIT”), a proprietary technology platform that can deliver biologically active compounds to the immune system through the skin.

On August 1, 2016, the Company announced the expansion of a clinical program of Viaskin Peanut for the treatment of peanut allergy. REALISE is a Phase III trial designed to assess the use and safety of Viaskin Peanut 250 µg in routine clinical practice and is expected to enroll approximately 335 peanut allergic patients four to 11 years of age. Results from both PEPITES and REALISE are expected during the second half of 2017.

On September 21, 2016, the Company announced that the FDA granted Fast Track designation for Viaskin Milk, the Company’s investigational treatment for pediatric patients two years of age and older with Immunoglobulin E (“IgE”)-mediated CMPA, currently under clinical investigation in a Phase IIb trial. There are currently no approved treatments for CMPA, the most common food allergy in infants and young children. Fast Track is a process designed by the FDA to facilitate the development, expedite the review of drugs to treat serious conditions and fill an unmet medical need.

On October 24, 2016, the Company announced topline results from the two-year OLFUS-VIPES study supporting the durable effect and favorable safety profile of Viaskin Peanut for the treatment of peanut-allergic children.

On October 26, 2016, the Company announced the publication of positive Viaskin Peanut data from the National Institute of Allergy and Infectious Disease-sponsored Phase II academic study in the Journal of Allergy and Clinical Immunology.

3. CHANGE IN THE GROUP’S EXECUTIVE COMMITTEE MEMBERSHIP AND BOARD MEMBERS

The Company announced the appointment of Lucia Septién, M.D., as Chief Medical Officer. Dr. Septién will provide strategic input and oversight into the Company’s clinical development programs and medical affairs. In partnership with Dr. Hugh Sampson and Laurent Martin, the Company’s Chief Scientific Officer and Chief Development Officer, respectively, Dr. Septién will be instrumental in the advancement of the Company’s lead product candidate, Viaskin Peanut, through its Phase III trial to appropriate regulatory submissions. Dr Septién will also have a key role in accelerating the development of other Viaskin product candidates in and beyond food allergies. Dr. Septién is a new member of the executive committee of the Company.

On June 21, 2016, the Company announced the appointments of Claire Giraut and Maïlys Ferrere to its Board of Directors, effective immediately pursuant to their election at the Company’s ordinary shareholders’ general meeting. Claire Giraut will serve on the Board’s Audit Committee. With these additions, the Company’s Board is now comprised of seven directors.

 

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Note 2: General Information and Statement of Compliance

Preliminary remarks

DBV Technologies Inc. was incorporated in Delaware on April 7, 2014 (the “US subsidiary”). The share capital of this US subsidiary is 100% owned by DBV Technologies S.A. (“DBV Technologies”).

General principles

The accompanying consolidated financial statements and related notes (the “Financial Statements”) present the operations of DBV Technologies S.A. and its US subsidiary (the “Group”) as of December 31, 2016. The Company is a corporate venture under French law (société anonyme) and its registered office is located at 177/181 avenue Pierre Brossolette, 92210 Montrouge at December 31, 2016.

Our Financial Statements as of December 31, 2016 have been prepared under the responsibility of DBV Technologies’ management. The Financial Statements were approved by the Board of Directors of DBV Technologies on March 14, 2017.

All amounts are expressed in thousands of euros, unless stated otherwise.

For consolidation purposes, both DBV Technologies S.A. and the US subsidiary have prepared individual financial statements for the periods ended December 31, 2014, December 31, 2015 and December 31, 2016.

Statement of Compliance

Our Financial Statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standard Board (“IASB”) and whose application is mandatory for the year ended December 31, 2016. Comparative figures are presented for December 31, 2014 and 2015.

Due to the listing of the Company’s ordinary shares on the Euronext Paris and in accordance with the European Union’s regulation No. 1606/2002 of July 19, 2002, the financial statements of the Group are also prepared in accordance with IFRS, as adopted by the European Union (“EU”).

The following amendments are mandatorily effective for annual periods beginning on or after January 1st, 2016:

 

    Amendments to IAS 16 / IAS 38 – Clarification of acceptable methods of depreciation and amortization

 

    Amendments to IAS 1 – Disclosure initiative

 

    Amendments to IFRS11 – Acquisition of an interest in a joint operation

 

    Amendments to IAS 28, IFRS 10, IFRS 12, Investment entities: applying the consolidation exception

 

    Amendments to IAS 16 / IAS 41 – Bearer plants

 

    Amendments to IAS 27 – Equity method in separate financial statements

 

    IFRS 14 – Regulatory Deferral Accounts

 

    Amendments to IFRSs Annual Improvements to IFRSs 2012-2014 Cycle

These amendments have not had any impact on the Financial Statements as of December 31, 2016.

As of December 31, 2016, there is no difference in the IFRS published and mandated by the IASB and EU, with the exception of the following specific accounting principles which the EU has not yet adopted at the end of 2016:

 

    IFRS 14 – Regulatory Deferral Accounts

This amendment has not had any impact on the Financial Statements as of December 31, 2016.

As a result, the Financial Statements comply with IFRS as published by the IASB and as adopted by the EU.

IFRS include International Financial Reporting Standards (“IFRS”), International Accounting Standards (the “IAS”), as well as the interpretations issued by the Standing Interpretations Committee (the “SIC”), and the International Financial Reporting Interpretations Committee (“IFRIC”). The main accounting methods used to prepare the Financial Statements are described below. These methods were used for all years presented.

There is no new standard, amendment to standards, or interpretation applicable with effect on the period ending December 31, 2016 that have an impact on the Financial Statements or on their presentation.

 

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New and revised standards and amendments that may be relevant to the Company’s operations but are not yet effective:

 

    IFRS 9 – Financial Instruments

 

    IFRS 15 – Revenue from Contracts with Customers

 

    IFRS 16 – Leases

 

    Amendment to IAS 7 – Statement of Cash flows

 

    Amendments to IAS 12 – Recognition of deferred tax assets for unrealised losses

 

    Amendments to IFRS 2 – Classification and measurement of share-based payment transactions

 

    Amendements to IFRS 10 and IAS 28 – Sale or contribution of assets between an Investor and its associate or Joint Venture

Management is in the process of evaluating the impact of these standards and amendments and is therefore, not currently able to estimate reliably the impact of their adoption on the Company’s results on financial position or cash flows.

The accounting policies and measurement principles adopted for the Financial Statements as of and for the year ended December 31, 2016 are the same as those used as of and for the years ended December 31, 2014 and 2015.

Note 3: Accounting Principles

Methods of consolidation

The Financial Statements incorporate the standalone financial statements of DBV Technologies S.A and US subsidiary which is controlled by the Company. Control is achieved when the Company:

 

    has power over the subsidiary;

 

    is exposed, or has rights, to variable returns from its involvement with the subsidiary; and

 

    has the ability to use its power to affect its returns.

The Company reassesses whether or not it controls a subsidiary if facts and circumstances indicate that there are changes to one or more of the three elements of control listed above.

Consolidation of subsidiaries begins when the Company obtains control over the subsidiary and ceases when the Company loses control over the subsidiary.

Profit or loss and each component of other comprehensive income are attributed to the owners of the Company and to the non- controlling interests. Total comprehensive income of subsidiaries is attributed to the owners of the Company and to the non-controlling interests even if this results in the non-controlling interests having a deficit balance.

When necessary, adjustments are made to the financial statements of subsidiaries to align their accounting policies with the Group’s accounting policies.

All intragroup assets and liabilities, equity, income, expenses and cash flows relating to transactions between members of the Group are neutralized in consolidation.

Translation of financial statements in foreign currencies

In preparing the financial statements of each individual group entity, transactions in currencies other than the entity’s functional currency are recognized at the rates of exchange prevailing at the dates of the transactions. At the end of each reporting period, monetary items denominated in foreign currencies are retranslated at the rates prevailing at that date. Non-monetary items carried at fair value that are denominated in foreign currencies are retranslated at the rates prevailing at the date when the fair value was determined.

For the purpose of presenting these consolidated financial statements, the assets and liabilities of the Group’s foreign operations are translated into euros using exchange rates prevailing at the end of each reporting period. Income and expense items are translated at the average exchange rates at the dates of the transactions. Exchange differences arising, if any, are recognized in other comprehensive income and accumulated in equity.

 

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3.1 Intangible Assets

In application of the provisions in IAS 38 Intangible Assets (“IAS 38”), intangible assets acquired are recorded as assets on the Consolidated Statements of Financial Position at their acquisition cost.

Research and Development Expenses

Research expenses are recorded in the Financial Statements as expenses.

In accordance with IAS 38, development expenses are recorded in the Financial Statements as intangible assets only if all the following criteria are met:

 

  (a) technical feasibility necessary for the completion of the development project;

 

  (b) intention on the part of the Company to complete the project and to utilize it;

 

  (c) capacity to utilize the intangible asset;

 

  (d) proof of the probability of future economic benefits associated with the asset;

 

  (e) availability of the technical, financial, and other resources for completing the project; and

 

  (f) reliable evaluation of the development expenses.

Because of the risks and uncertainties related to regulatory authorizations and to the research and development process, the Company believes that the six criteria stipulated by IAS 38 are only fulfilled once the Market Access Authorization has been obtained from the competent authorities.

The application of this principle has resulted in all development costs being expensed as incurred.

Software

The costs related to the acquisition of licenses to software are posted to assets on the basis of the costs incurred to acquire and to implement the software in question.

They are amortized using the straight-line method over a period of one to three years depending on the anticipated period of use.

3.2 Property, Plant, and Equipment

Property, plant, and equipment are recorded at their acquisition cost or, if applicable, at their production cost.

Property, plant, and equipment are depreciated on the basis of the straight-line method over the estimated use period of the property. The fixtures of property rented are depreciated over the term of their own lifetime or of the term of the rental agreement, whichever is shorter.

The depreciation periods used are the following:

 

PROPERTY, PLANT, AND EQUIPMENT ITEM

   DEPRECIATION PERIOD  

Fixtures and improvements in structures

     9 years  

Research and development / production tools

     5 years  

Research equipment and technical facilities

     5 years  

Computer equipment

     3 years  

Office equipment and furniture

     5 years  

3.3 Financial Assets

In accordance with IAS 39 (Financial Instruments: Recognition and Measurement) and IAS 32 (Financial Instruments: Presentation), the Company has adopted the following classification for non-derivative financial assets, based on the type of asset and on management intention at the date of initial recognition. The designation and classification of such financial assets are subsequently reassessed at the end of each reporting period.

Non-derivative financial assets are recognized on the date when the Company becomes party to the contractual terms of the asset. On initial recognition, financial assets are measured at fair value, plus direct transaction costs in the case of financial assets not classified as fair value through profit or loss.

 

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Classification, presentation and subsequent measurement of non-derivative financial assets are as follows:

Assets Owned Until Their Maturity

These securities are exclusively fixed income or determinable income and have fixed maturities, other than loans and accounts receivable, that the Company has the intention and the ability to keep until maturity. After their initial posting at their fair value, they are valued and posted to the accounts at the cost amortized on the basis of the effective interest rate (“EIR”) method.

The assets owned until their maturity are monitored for any objective indication of impairment. A financial asset is impaired if its book value is greater than its recoverable amount as estimated during impairment tests. The impairment is recorded to the income statement.

Loans and Receivables

Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are presented in current assets with loans with a maturity of less than 12 months are presented within “other current assets” and with trade receivables presented within “accounts receivable.” Loans with a maturity of more than 12 months are presented as “long- term loans and advances” within “other non-current assets.” Those financial assets are measured at amortized cost using the effective interest method.

The loans and receivables are monitored for any objective indication of impairment. A financial asset is impaired if its book value is greater than its recoverable amount as estimated during impairment tests. The impairment is recorded in the Consolidated Statements of (Loss).

The loans and receivables also include the deposits and guarantees, which are classified under “Non-current financial assets” in the Consolidated Statements of Financial Position.

Assets at Fair Value Per the Consolidated Statements of (Loss)

These assets are classified on the balance sheet in the following line items: Other non-current assets, Current financial assets and Cash and cash equivalents.

Financial assets at fair value through profit or loss comprise assets held for trading (financial assets acquired principally for the purpose of reselling them in the near term, usually within less than 12 months), and financial instruments designated as fair value through profit and loss on initial recognition in accordance with the conditions for application of the fair value option.

Realized and unrealized foreign exchange gains and losses on financial assets in currencies other than the euro are recognized in the income statement in Financial income or Financial expenses.

Assets Available for Sale

The assets available for sale include, primarily, securities that do not meet the criteria of the definition of the other categories of financial assets. They are measured at their fair value, and the changes in value are recorded in the Consolidated Statements of Changes in Shareholders’ Equity.

The fair value corresponds to the market price for those securities that are listed on the stock exchange or to an estimate of the use value for unlisted securities, determined on the basis of the financial criteria most appropriate for the specific situation of each security. When there is an objective indication of the impairment of these securities, the accumulated impairment that has been recorded in the Consolidated Statements of Changes in Shareholders’ Equity is recognized in the Consolidated Statement (Loss).

3.4 Recoverable Amount of the Intangible Assets and Property, Plant, and Equipment

The property, plant, and equipment and intangible assets that have an established lifetime are subjected to an impairment test when the recoverability of their book value is called into question by the existence of indications of impairment. An impairment is posted to the accounts up to the amount of the excess of the book value over the recoverable value of the asset. The recoverable value of an asset corresponds to its fair value minus the costs of sale or its use value, whichever is higher.

 

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3.5 Inventories and Work in Progress

Inventories are recorded at their cost or at their net liquidation value, if the latter is lower. In the latter case, the impairment is posted to income or loss. The inventories are valued on the basis of the “first-in, first-out” (“FIFO”) method.

3.6 Share Capital

Common shares are classified under Shareholders’ Equity. The costs of share capital transactions that are directly attributable to the issue of new shares or options are recorded in the Financial Statements in Shareholders’ Equity as a deduction from the revenue from the issue, net of tax.

3.7 Payments in Shares

Since its incorporation, the Company has established several plans for compensation paid in equity instruments in the form of employee warrants (bons de souscription de parts de créateur d’entreprise orBSPCEs”) granted to employees and/or executives and in the form of “share warrants” (bons de souscription d’actions or “BSAs”) granted to non-employee members of the Board of Directors and scientific consultants.

Pursuant to IFRS 2 Share-based payment (“IFRS 2”), the cost of the transactions paid with equity instruments is posted to the accounts as an expense in exchange for an increase in the Shareholders’ Equity for the period during which the rights to be benefited from the equity instruments are acquired.

The Company has applied IFRS 2 to all equity instruments granted since 2002 to its employees, members of the Board of Directors, other individuals, or to companies.

The options are not subject to any market conditions. The characteristics of the options are presented in Note 17.

3.8 Recognition and measurement of Financial Liabilities

Financial Liabilities at Amortized Cost

Borrowings and other financial liabilities are valued initially at their fair value and then at the amortized cost, calculated on the basis of the effective interest rate (“EIR”) method.

The transaction expenses that are directly attributable to the acquisition or to the issue of a financial liability reduce that financial liability. These expenses are then amortized over the lifetime of the liability, on the basis of the EIR.

The EIR is the rate that equalizes the anticipated flow of future cash outflows with the current net book value of the financial liability in order to deduct its amortized cost therefrom.

Liabilities at Fair Value per the Consolidated Statements of (Loss)

The liabilities at fair value per the Consolidated Statements of (Loss) are valued at their fair value.

3.9 Subsidies and Conditional Advances

Subsidies

The Company receives assistance in the form of subsidies, which are grants that are not repayable by the Company. The subsidies are recognized when there is reasonable assurance that:

 

    the Company will comply with the conditions attached to the subsidies, and

 

    the subsidies will be received.

Subsidies that are upfront non-refundable payments are presented as deferred revenue and recognized ratably through income over the duration of the research program to which the subsidy relates.

A public subsidy that is to be received (e.g. from OSEO, the French Agency for Innovation) either as compensation for expenses or for losses already incurred, or for immediate financial support of the Company without associated expenses or losses, is recognized as other income ratably over the duration of the funded project.

Conditional advances

The Company also receives from time to time assistance in the form of conditional advances, which are advances repayable in whole or in part based upon acknowledgment by the funder of a technical or commercial success of the related project by the funding entity. The details concerning the conditional advances are provided in Note 11.

 

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The amount resulting from the deemed benefit of the interest-free nature of the award is considered a subsidy for accounting purposes. This deemed benefit is determined by applying a discount rate equal to the rate of fungible treasury bonds over the time period that corresponds to the time period of the repayment of the advances.

In the event of a change in payment schedule of the stipulated repayments of the conditional advances, the Company makes a new calculation of the net book value of the debt resulting from the discounting of the expected new future cash flows. The adjustment that results therefrom is recognized in the income statement for the fiscal year during which the modification is recognized.

The conditional advances that can be subject to this type of modification are the with Compagnie Française d’Assurance pour le Commerce Extérieur (“COFACE”) advances presented in Note 11.

3.10 Provisions

Provisions for Risks and Expenses

The provisions for risks and lawsuits correspond to the commitments resulting from lawsuits and various risks whose due dates and amounts are uncertain.

A provision is posted to the accounts when the Company has a legal or implicit obligation to a third party resulting from a past event, concerning which it is likely or certain that it will cause an outflow of resources to that third party, without consideration that is anticipated to be at least equivalent to the latter, and that the future outflows of liquid assets can be estimated reliably.

The amount recorded in the accounts as a provision is the best estimation of the expenses necessary to extinguish the obligation.

Pension Retirement Obligations

The employees of the Company receive the retirement benefits stipulated by law in France:

 

    obtaining a compensation paid by the Company to employees upon their retirement (defined-benefit plan);

 

    payment of retirement pensions by the Social Security agencies, which are financed by the contributions made by companies and employees (defined-contribution plans).

For the defined-benefit plans, the costs of the retirement benefits are estimated by using the projected credit unit method. According to this method, the cost of the retirement pensions is recognized in the Consolidated Statement of (Loss) so that it is distributed uniformly over the term of the services of the employees. The retirement benefit commitments are valued at the current value of the future payments estimated using, for the discounting, the market rate based on the long-term obligations of the first-category companies with a term that corresponds to that estimated for the payment of the services provided.

The Company relies on external actuaries to conduct an annual review of the valuation of these plans.

The difference between the amount of the provision at the beginning of a fiscal year and at the close of that year is recognized through profit or loss for the portion representing the costs of services rendered and through other comprehensive income for the portion representing the actual gains and losses.

The Company’s payments for the defined-contribution plans are recognized as expenses on the income statement of the period with which they are associated.

3.11 Revenue

The revenue of the Company resulted in previous years mainly from the sale of the product Diallertest, a kit for diagnosing the allergy to proteins in cow’s milk. During the second half of 2015, the Company discontinued its commercial partnership with respect to the product and ceased selling Diallertest Milk.

The Company recognizes revenue when the amount can be measured reliably, when it is likely that the future economic advantages will benefit the Company, and when the specific criteria are met for the business activity of the Company. For product sales, the sales revenue is recognized upon delivery.

 

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3.12 Other Income

Subsidies

Since it was formed, because of its innovative character, the Company has received a certain number of sources of assistance or subsidies from the central government or from local public authorities such as OSEO or the Banque Publique d’Investissement, intended to finance its operations or the recruitment of specific personnel.

When the grant of the subsidy is reasonably certain, these subsidies are recognized as “Other income” during the calendar year over which the corresponding expenses or expenditures were recorded.

Research Tax Credit

The Research Tax Credit (Crédit d’Impôt Recherche, CIR) is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific research. Companies that prove that they have expenditures that meet the required criteria (research expenditures located in France or, since January 1, 2005, within the European Community or in another State that is a party to the Agreement on the European Economic Area that has concluded a tax treaty with France that contains an administrative assistance clause) receive a tax credit that can be used for the payment of the corporate tax due for the fiscal year in which the expenditures were made and the next three fiscal years, or, as applicable, can be reimbursed for the excess portion. The expenditures taken into account for the calculation of the research tax credit involve only research expenses.

The Company has received the Research Tax Credit annually since it was formed.

The Company received the reimbursement of the 2013 Research Tax Credit for an amount of €3.3 million during the year 2014. The Company received the reimbursement of the 2014 Research Tax Credit for an amount of €4.3 million during the year 2015.

The Company received the reimbursement of the 2015 Research Tax Credit for an amount of €5.7 million during the year 2016.

The Company will request the reimbursement of the 2016 Research Tax Credit for an amount of €7.2 million during the year 2017, under the community tax rules for small and medium firms in compliance with the regulatory texts applicable.

Collaboration agreement with Nestlé Health Science

On May 31, 2016, the Company announced its entry into an exclusive global collaboration with Nestlé Health Science to develop MAG1C, a ready-to-use and standardized atopy patch test tool for the diagnosis of cow’s milk protein allergy in infants and toddlers. Under the terms of the exclusive collaboration, the Company is responsible for leading the development activities of MAG1C up through a pivotal Phase III clinical program, and if the appropriate regulatory approvals are received, Nestlé Health Science will support the commercialization of MAG1C globally. The Company is eligible to receive up to €100.0 million in potential development, clinical, regulatory and commercial milestones, inclusive of a non-refundable upfront payment of €10.0 million, received in July 2016.

In accordance with International Accounting Standard 18, upfront payments and milestones received under the Company’s collaboration agreement are deferred and recognized over the service period obligation. Upon entry into the collaboration agreement, the Company’s management estimated the expected service period obligation, as well as the cost involved in the project. Upfront payments and milestones are recognized on a straight line basis or, if the associated costs can be reliably estimated, based on the cost incurred under the project. Periodically, the Company reassesses the estimated time and cost to complete the project and adjusts the time period over which the revenue is deferred accordingly. If the outcome of a contract cannot be estimated reliably, revenue is recognized only to the extent of costs incurred that it is probable will be recoverable, in accordance with International Accounting Standard 11.

As of December 31, 2016, the Company recorded a deferred revenue balance with respect to payments received under its collaboration with Nestlé Health Science, which the Company will recognize over the service obligation period. Deferred revenue is included in other current and non-current liabilities, as applicable.

3.13 Rental Agreements

The rental agreements involving property, plant, and equipment are classified as finance lease agreements when the Company bears a substantial portion of all the benefits and risks inherent in the ownership of the property. The assets that are covered under financing lease agreements are capitalized as of the beginning date of the rental agreement on the basis of the fair value of the rented asset or the discounted values of the future minimum payments, whichever is lower. Each rental payment is distributed between the debt and the financial cost in such a manner as to determine a constant interest rate on the principal that remains due. The corresponding rental obligations, net of the financial expenses, are classified as financial liabilities. The portion of the financial expense that corresponds to the interest is recognized as an expense over the term of the agreement. The property, plant, or equipment acquired within the framework of a finance lease agreement is amortized over the use period or the term of the lease agreement, whichever is shorter.

The rental agreements for which a significant portion of the risks and advantages is preserved by the lessor are classified as ordinary rental agreements. The payments made for these ordinary rental agreements, net of any incentive measures, are recognized as expenses on the income statement in a linear manner over the term of the agreement.

3.14 Taxes

Income Tax

Deferred taxes are recognized for all the temporary differences arising from the difference between the tax basis and the accounting basis of the assets and liabilities that appear in the financial statements. The primary temporary differences are related to the tax losses that can be carried forward or backward. The tax rates that have been ratified by a legal text as of the closing date are utilized to determine the deferred taxes.

 

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The deferred tax assets are recorded in the accounts only to the extent that it is likely that the future profits will be sufficient to absorb the losses that can be carried forward or backward. Considering its stage of development, which does not allow income projections judged to be sufficiently reliable to be made, the Company has not recognized deferred tax assets in relation to tax losses carryforward in the Consolidated Statements of Financial Position.

3.15 Segment Information

The Company operates in a single operating segment: the conducting of research and development of epicutaneous immunotherapy products in order to market them in the future. The assets, liabilities, and operating losses recognized are primarily located in France.

3.16 Other Items in the Comprehensive (or Loss)

The revenue and expense items for the period that are not posted in the Consolidated Statements of (Loss) as stipulated by the applicable standards are presented, as necessary, under the rubric “Other items in the comprehensive (or loss).”

3.17 Use of Estimates

The preparation of our Financial Statements requires the management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses. Estimates and assumptions are based on historical experience and other factors that management believes to be reasonable under the circumstances. Estimates and assumptions are measured on an ongoing basis. Actual results may differ from these estimates.

These estimates and judgments mainly involve:

 

    a valuation of the fair value of the employee warrants (BSPCEs) granted to employees and/or executives and share warrants (BSAs) granted to non-employee members of the Board of Directors and scientific consultants and to service providers, performed on the basis of actuarial models; these models require the use by the Company of certain calculation assumptions such as the expected volatility of the security;

 

    an estimate of the Research Tax Credit based on internal and external expenses incurred by the Company during the year. Only eligible research expenses are included in the calculation of the research tax credit; and

 

    an estimate of the repayments of the conditional advances obtained by Company from public institutions. The anticipated repayments of the conditional advances are analyzed at each reporting period.

3.18 Presentation of Financial Assets and Financial Liabilities Measured at Fair Value

In accordance with the amendments to IFRS 7, financial instruments are presented in three categories based on a hierarchical method used to determine their fair value:

 

    level 1: fair value calculated using quoted prices in an active market for identical assets and liabilities;

 

    level 2: fair value calculated using valuation techniques based on observable market data such as prices of similar assets and liabilities or parameters quoted in an active market;

 

    level 3: fair value calculated using valuation techniques based wholly or partly on unobservable inputs such as prices in an inactive market or a valuation based on multiples for unlisted securities.

3.19 Subsequent events

The Consolidated Statements of Financial Position and the Consolidated Statements of (Loss) of the Company are adjusted to reflect the subsequent events that alter the amounts related to the situations that exist as of the closing date. The adjustments are made until the date the financial statements are approved and authorized for issuance by the Board of Directors.

 

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Note 4: Intangible Assets

The intangible assets are broken down as follows:

 

     December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Patents, licenses, trademarks

     46        54        196  

Software

     162        302        376  
  

 

 

    

 

 

    

 

 

 

Total, gross

     208        356        572  
  

 

 

    

 

 

    

 

 

 

Accumulated amortization of patents, licenses, and trademarks

     38        53        125  

Accumulated depreciation of software packages

     141        210        351  
  

 

 

    

 

 

    

 

 

 

Accumulated amortization and depreciation

     179        262        476  
  

 

 

    

 

 

    

 

 

 

Total, net

     29        94        96  
  

 

 

    

 

 

    

 

 

 

The increase of the gross value of intangible assets only correspond to acquisitions for a global amount of €216 thousands.

There has been no recognition of impairment losses in application of IAS 36 Impairment of Assets for the calendar years presented.

Note 5: Property, Plant, and Equipment

 

     1/1/2014      Increase      Decrease      12/31/2014  
     (Amounts in thousands of Euros)  

Laboratory equipment

     1,372        886        —          2,257  

Building fixtures

     922        8        —          930  

Office equipment

     215        —          —          215  

Computer equipment

     274        48        —          322  

Other property, plant, and equipment

     51        —          —          51  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total, gross

     2,834        941        —          3,775  
  

 

 

    

 

 

    

 

 

    

 

 

 

Accumulated depreciation of laboratory equipment

     670        246        —          916  

Accumulated depreciation of the building fixtures

     179        107        —          286  

Accumulated depreciation of office equipment

     92        34        —          126  

Accumulated depreciation of computer equipment

     159        64        —          222  

Accumulated depreciation of other property, plant, and equipment

     —          —          —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total accumulated amortization and depreciation

     1,099        451        —          1,550  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total, net

     1,734        491        —          2,225  
  

 

 

    

 

 

    

 

 

    

 

 

 
     1/1/2015        Increase        Decrease        12/31/2015  
     (Amounts in thousands of Euros)  

Laboratory equipment

     2,257        467        (368      2,357  

Building fixtures

     930        8        —          938  

Office equipment

     215        24        (30      209  

Computer equipment

     322        244        (95      470  

Property, plant, and equipment in progress

     51        3,622        —          3,672  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total, gross

     3,775        4,365        (493      7,646  
  

 

 

    

 

 

    

 

 

    

 

 

 

Accumulated depreciation of laboratory equipment

     916        382        (349      948  

Accumulated depreciation of the building fixtures

     286        496        —          782  

Accumulated depreciation of office equipment

     126        35        (30      131  

Accumulated depreciation of computer equipment

     222        78        (95      205  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total accumulated amortization and depreciation

     1,550        990        (475      2,065  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total, net

     2,225        3,375        (18      5,581  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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Table of Contents
        
     1/1/2016      Increase      Decrease      12/31/2016  
     (Amounts in thousands of Euros)  

Laboratory equipment

     2,357        740        —          3,097  

Building fixtures

     938        3,672        —          4,610  

Office equipment

     209        398        —          607  

Computer equipment

     470        516        —          986  

Property, plant, and equipment in progress

     3,672        2,713        —          6,385  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total, gross

     7,646        8,039        —          15,685  
  

 

 

    

 

 

    

 

 

    

 

 

 

Accumulated depreciation of laboratory equipment

     948        557        —          1,505  

Accumulated depreciation of the building fixtures

     782        327        —          1,109  

Accumulated depreciation of office equipment

     131        81        —          212  

Accumulated depreciation of computer equipment

     205        172        —          377  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total accumulated amortization and depreciation

     2,065        1,137        —          3,203  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total, net

     5,581        6,901        —          12,482  
  

 

 

    

 

 

    

 

 

    

 

 

 

Over the three years presented, the acquisitions correspond primarily to building fixtures and to laboratory and production equipment and material. The increase in property, plant and equipment in progress item is related to costs incurred for building out the Company’s new corporate headquarters located at Montrouge, as well as the purchase of materials for the conception and tuning of the new industrial machines (Gen 4.0 and Cut Pack, for example).

Note 6: Non-Current Financial Assets

 

     December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Deposits

     100        716        824  

Pledged securities

     385        611        611  

Liquidity contract

     1,111        1,384        1,310  
  

 

 

    

 

 

    

 

 

 

Total non-current financial assets

     1,596        2,711        2,745  
  

 

 

    

 

 

    

 

 

 

The non-current financial assets are composed of security deposits paid to the lessor and of open-ended mutual funds (sociétés d’investissement à capital variable, “SICAVs”) pledged as guarantees of the ordinary rental agreements and the liquidity contract.

Under the liquidity contract, 3,747 treasury shares were allocated as a reduction of Shareholders’ Equity as at December 31, 2016 with the cash balance being maintained in financial assets. The share capital is divided in 24,648,828 shares including these 3,747 treasury shares.

Note 7: Inventories

 

     December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Inventories of raw materials

     124        69        69  

Depreciation of inventories (charged to income statement)

     —          (69      (69
  

 

 

    

 

 

    

 

 

 

Total net value of the inventories

     124        —          —    
  

 

 

    

 

 

    

 

 

 

 

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The inventories and work in progress involved the Diallertest Milk product. The Company discontinued its commercial partnership with respect to the product during the second half of 2015.

Note 8: Customer Accounts Receivable

8.1 Customer Accounts Receivable

 

     December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Accounts receivable

     149        13        1,263  

Valuation allowance (charged to income statement)

     (13      (13      (13
  

 

 

    

 

 

    

 

 

 

Total net value of accounts receivable

     136        —          1,250  
  

 

 

    

 

 

    

 

 

 

All the customer accounts receivable have payment terms of less than one year.

As of December 31, 2016, the accounts receivable correspond primarily to the amounts due under collaboration agreement with Nestlé Health Science. As of December 31, 2014 and 2015, accounts receivable and related receivables correspond primarily to the sales of Diallertest®. Milk. The Company discontinued its commercial partnership with respect to the product in the second half of 2015.

 

            Additions                
(in thousands of euros)    Balance at
beginning
of period
     Charged to      Charged to             Balance at
end of
period
 

Description— 2014

      Income
statement
     Other
accounts
     Reversal     

Valuation allowance deducted from account receivables

     13        —        —        —        13  
            Additions                
     Balance at
beginning
of period
     Charged to      Charged to             Balance at
end of
period
 

Description— 2015

      Income
statement
     Other
accounts
     Reversal     

Valuation allowance deducted from account receivables

     13      —          —          —        13  
            Additions                
     Balance at
beginning
of period
     Charged to      Charged to             Balance at
end of
period
 

Description— 2016

      Income
statement
     Other
accounts
     Reversal     

Valuation allowance deducted from account receivables

     13                           13  

8.2 Other current assets

The other current assets are broken down as follows:

 

     December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Research tax credit

     4,340        5,702        7,228  

Other tax claims

     1,023        2,550        2,618  

Other receivables

     423        1,409        1,883  

Prepaid expenses

     938        1,850        2,725  
  

 

 

    

 

 

    

 

 

 

Total

     6,723        11,512        14,454  
  

 

 

    

 

 

    

 

 

 

 

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The other tax debt claims are primarily related to the deductible VAT as well as the reimbursement of VAT that has been requested.

As of December 31, 2016, 2015 and 2014, prepaid expenses are comprised primarily of rental and insurance expenses, upfront payments deferred over clinical studies period, as well as scientific fees. Their variation is linked to an increase in insurance premiums following the Company’s U.S. public offering on Nasdaq in 2014 and the July 2015 follow-on fundraising, as well as an increase in upfront payments which are recognized over the term of the ongoing clinical studies.

Research Tax Credit

The Company benefits from the provisions in Articles 244 quater B and 49 septies F of the French Tax Code related to the Research Tax Credit. In compliance with the principles described in Note 3.13, the Research Tax Credit is posted to the accounts as “Other Income” during the year with which the eligible research expenditures are associated.

The changes in this Research Tax Credit over the last three years are presented as follows:

 

     Amounts in thousands of Euros  

Opening Balance Sheet Receivable as of January 1, 2014

     3,312  

+ Other income

     4,340  

- Payment received

     (3,312

- Adjustment

     —    
  

 

 

 

Closing Balance Sheet Receivable as of December 31, 2014

     4,340  
  

 

 

 
     Amounts in thousands of Euros  

Opening Balance Sheet Receivable as of January 1, 2015

     4,340  

+ Other income

     5,702  

- Payment received

     (4,322

- Adjustment

     (18
  

 

 

 

Closing Balance Sheet Receivable as of December 31, 2015

     5,702  
  

 

 

 
     Amounts in thousands of Euros  

Opening Balance Sheet Receivable as of January 1, 2016

     5,702  

+ Other income

     7,228  

- Payment received

     (5,702

- Adjustment

     —    
  

 

 

 

Closing Balance Sheet Receivable as of December 31, 2016

     7,228  
  

 

 

 

 

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The adjustments to the amount of the receivable in 2015 reflect the penalties related to the tax inspection of the 2014 Research Tax Credit that occurred in 2015.

Following a tax inspection led by the French tax authorities on fiscal years 2012, 2013 and 2014, the Company received on July 4, 2016 a proposition of adjustments primarily affecting the Research Tax credit. The proposed adjustment amounts to €0,9 million.

The Company, advised by its counsels, has sent a response to dispute the proposed reassessment. No provision has been recorded in the consolidated financial statement as of December 31, 2016.

Note 9: Cash and Cash Equivalents

The cash and cash equivalents item is broken down as follows:

 

     December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Cash

     108        178,895        146,374  

Cash equivalents term deposits

     114,475        144,486        110,100  
  

 

 

    

 

 

    

 

 

 

Total cash and cash equivalents as reported in statement of financial position

     114,583        323,381        256,473  
  

 

 

    

 

 

    

 

 

 

Bank overdrafts

     (28      —          —    
  

 

 

    

 

 

    

 

 

 

Total net cash and cash equivalents as reported in the statement of cash flow

     114,555        323,381        256,473  
  

 

 

    

 

 

    

 

 

 

Cash equivalents are immediately convertible into cash at no cost. They are measured using level 1 fair value measurements.

As of December 31, 2015, the increase in cash and cash equivalents mainly related to the net proceeds received as part of our July 2015 fundraising.

Note 10: Capital

10.1 Share Capital Issued

The share capital, as of December 31, 2016, is set at the sum of €2,464,882.80. It is divided into 24,648,828 fully authorized, subscribed and paid-up shares with a nominal value of €0.10.

This number does not include share warrants (“BSA”), employee warrants (“BSPCE”), stock-options (“SO”) and performance shares (“AGA”) granted to certain investors and to certain natural persons, both employees and non-employees of the Company.

All the shares give their owners the right to a proportional share of the income and the net assets of the Company.

 

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Table of Contents

The table below presents the historical changes in the share capital of the Company as of December 31 2014, 2015 and 2016:

 

Date

  

Nature of the Transactions

   Share Capital      Share premium      Number of
Shares
     Nominal
value
 
   Balance as of January 1, 2014    K€ 1,508.8      K€ 69,640.9        15,088,298      0.10  

01/23/2014

  

Capital increase by issuance of common shares

   K€ 3.8      K€ 189.4        37,650      0.10  

02/11/2014

  

Capital increase by issuance of common shares

   K€ 0.5      K€ 41.2        5,000      0.10  

04/02/2014

  

Capital increase by incorporation of reserve

   K€ 24.2      K€ (24.2)        242,484      0.10  

06/11/2014

  

Capital increase by issuance of common shares

   K€ 4.5      K€ 226.4        45,000      0.10  

06/13/2014

  

Capital increase by issuance of common shares

   K€ 4.0      K€ 169.2        40,005      0.10  

06/18/2014

  

Capital increase by issuance of common shares

   K€ 1.0      K€ 44.6        9,750      0.10  

06/19/2014

  

Capital increase by issuance of common shares

   K€ 0.1      K€ 5.1        1,005      0.10  

07/25/2014

  

Capital increase by incorporation of reserve

   K€ 4.5      K€ (4.5)        44,693      0.10  

09/19/2014

  

Capital increase by incorporation of reserve

   K€ 25.7      K€ (25.7)        257,418      0.10  

10/03/2014

  

Capital increase by issuance of common shares

   K€ 2.3      K€ 105        22,965      0.10  

10/22/2014

  

Capital increase by issuance of common shares

   K€ 307.5      K€ 104,231.9        3,074,686      0.10  

11/01/2014

  

Capital increase by incorporation of reserve

   K€ 25.7      K€ (25.7)        257,422      0.10  

11/30/2014

  

Capital increase by issuance of common shares

   K€ 1.8      K€ 97        17,560      0.10  

11/30/2014

  

Capital increase by issuance of common shares

   K€ 1.7      K€ 83.3        16,725      0.10  

12/31/2014

  

Issue of share subscription warrants

      K€ 32.3         0.10  

12/31/2014

  

Fees charged to share premium 2014

      K€ (10,909.1)        
     

 

 

    

 

 

    

 

 

    

 

 

 
  

Balance as of December 31, 2014

   K€ 1,916.1      K€ 163,876.8        19,160,661      0.10  

Date

  

Nature of the Transactions

   Share Capital      Share premium      Number of
Shares
     Nominal
value
 
  

Balance as of January 1, 2015

   K€ 1,916.1      K€ 163,876.8        19,160,661      0.10  

01/06/2015

  

Capital increase by issuance of common shares

   K€ 0.4      K€ 18.9        3,750      0.10  

01/07/2015

  

Capital increase by issuance of common shares

   K€ 1.0      K€ 59.0        10,000      0.10  

01/22/2015

  

Capital increase by incorporation of reserve

   K€ 3.5      K€ (3.5)        35,360      0.10  

01/30/2015

  

Capital increase by issuance of common shares

   K€ 9.8      K€ 476.8        97,720      0.10  

02/03/2015

  

Capital increase by issuance of common shares

   K€ 0.8      K€ 37.7        7,500      0.10  

02/13/2015

  

Capital increase by issuance of common shares

   K€ 3.8      K€ 188.6        37,500      0.10  

02/17/2015

  

Capital increase by issuance of common shares

   K€ 2.0      K€ 100.6        19,995      0.10  

03/04/2015

  

Capital increase by issuance of common shares

   K€ 1.0      K€ 59        10,000      0.10  

03/26/2015

  

Capital increase by issuance of common shares

   K€ 5.0      K€ 400        50,000      0.10  

04/07/2015

  

Capital increase by issuance of common shares

   K€ 4.0      K€ 169.2        40,005      0.10  

04/09/2015

  

Capital increase by issuance of common shares

   K€ 15.0      K€ 692.1        150,375      0.10  

04/28/2015

  

Capital increase by issuance of common shares

   K€ 1.4      K€ 77.1        14,290      0.10  

05/05/2015

  

Issue of share subscription warrants

   K€      K€ 43        

05/11/2015

  

Capital increase by issuance of common shares

   K€ 2.0      K€ 100.7        20,010      0.10  

06/23/2015

  

Capital increase by issuance of common shares

   K€ 59.1      K€ 27,029.4        590,543      0.10  

06/23/2015

  

Capital Decrease

   K€ (58.6)      K€ (26,823.4)        (586,048)      0.10  

07/20/2015

  

Capital increase by issuance of common shares

   K€ 414.0      K€ 254,932.9        4,140,000      0.10  

07/24/2015

  

Capital increase by issuance of common shares

   K€ 1.6      K€ 79.2        15,750      0.10  

07/25/2015

  

Capital increase by incorporation of reserve

   K€ 28.6      K€ (28.6)        286,338      0.10  

07/28/2015

  

Capital increase by issuance of common shares

   K€ 1.7      K€ 91.5        17,000      0.10  

09/18/2015

  

Capital increase by issuance of common shares

   K€ 0.3      K€ 46.7        2,500      0.10  

10/07/2015

  

Capital increase by issuance of common shares

   K€ 4.8      K€ 241.2        47,955      0.10  

12/10/2015

  

Capital increase by issuance of common shares

   K€ 1.8      K€ 146.9        17,500      0.10  

12/10/2015

  

Issue of share subscription warrants

   K€      K€ 99.2        

12/14/2015

  

Capital increase by issuance of common shares

   K€ 1.6      K€ 69.5        16,425      0.10  

12/31/2015

  

Fees charged to share premium

   K€      K€ (18,269.7)        
     

 

 

    

 

 

    

 

 

    

 

 

 
   Balance as of December 31, 2015    K€ 2,420.5      K€ 403,910.4        24,205,129      0.10  

 

F-24


Table of Contents

Date

  

Nature of the Transactions

   Share
Capital
     Share
premium
     Number of
Shares
     Nominal
value
 
  

Balance as of January 1, 2016

   K€ 2,420.5      K€ 403,910.4        24,205,129      0.10  

01/05/16

  

Capital increase by issuance of common shares

   K€ 0.6      K€ 32.7        6,495     

02/16/16

  

Issue of share subscription warrants

   K€      K€ 471.1         0.10  

04/06/16

  

Capital increase by incorporation of reserve

   K€ 10.2      K€ (10.2)        101,829      0.10  

05/27/16

  

Capital increase by issuance of common shares

   K€ 0.2      K€ 7.5        1,500      0.10  

06/03/16

  

Capital increase by issuance of common shares

   K€ 15.6      K€ (15.6)        156,000      0.10  

06/06/16

  

Capital increase by issuance of common shares

   K€ 6.0      K€ 301.2        59,890      0.10  

06/10/16

  

Capital increase by issuance of common shares

   K€ 3.5      K€ 176.0        34,985      0.10  

07/18/16

  

Capital increase by issuance of common shares

   K€  2.0      K€  100.7        20,010      0.10  

08/21/16

  

Issue of share subscription warrants

   K€      K€ 106          

08/04/16

  

Capital increase by issuance of common shares

   K€ 1.0      K€ 50.4        10,020      0.10  

08/24/16

  

Capital increase by issuance of common shares

   K€ 0.7      K€ 37.1        7,380      0.10  

08/30/16

  

Capital increase by issuance of common shares

   K€ 0.4      K€ 66.2        3,500      0.10  

08/31/16

  

Capital increase by issuance of common shares

   K€ 0.4      K€ 66.2        3,500      0.10  

09/01/16

  

Capital increase by issuance of common shares

   K€ 0.4      K€ 66.2        3,500      0.10  

09/02/16

  

Capital increase by issuance of common shares

   K€ 0.4      K€ 66.2        3,500      0.10  

09/05/16

  

Capital increase by issuance of common shares

   K€ 0.4      K€ 66.2        3,500      0.10  

09/06/16

  

Capital increase by issuance of common shares

   K€ 0.4      K€ 66.2        3,500      0.10  

09/06/16

  

Capital increase by issuance of common shares

   K€ 0.4      K€ 66.2        3,500      0.10  

09/08/16

  

Capital increase by issuance of common shares

   K€ 0.4      K€ 66.2        3,500      0.10  

09/09/16

  

Capital increase by issuance of common shares

   K€ 0.4      K€ 66.2        3,500      0.10  

09/12/16

  

Capital increase by issuance of common shares

   K€ 0.4      K€ 66.2        3,500      0.10  

09/12/16

  

Capital increase by issuance of common shares

   K€ 0.5      K€ 23.1        4,590      0.10  

11/25/16

  

Capital increase by issuance of common shares

   K€ 0.6      K€ 30.2        6,000      0.10  
     

 

 

    

 

 

    

 

 

    

 

 

 
  

Balance as of December 31, 2016

   K€ 2,464.9      K€ 405,882.5        24,648,828      0.10  

No fees and banks commissions related to share capital increases in 2016 were posted in deduction of the share premium. In 2015, the fees and banks commissions related to share capital increases amounted to €18.3 million.

On July 20, 2015, the Company announced the closing of its underwritten public offering of 4,140,000 ordinary shares in the form of 8,280,000 American Depositary Shares (ADSs) at a price to the public of $34.00 per ADS, before underwriting discounts and commissions, which included an additional 1,080,000 ADSs sold pursuant to the full exercise of the underwriters’ option to purchase additional ADSs. Each ADS represents the right to receive one-half of one ordinary share.

As part of the public offering completed in July 2015, share capital increased by the issuance of 4,140,000 shares (€414 thousands) with a corresponding increase of €236.9 million in share premium (€254.9 million gross, or €236.9 million net after deduction of fees and expenses of €18.0 million).

Initial public offering on the NASDAQ Global Market

On October 22, 2014, the Company announced the pricing of its global offering of 2,673,641 common shares, of which 2,138,913 ordinary shares represented by 4,277,826 ADSs at the subscription price of $21.64 per ADS, as part of a public offering conducted in the United States, Canada and some countries outside of France, and 534,728 common shares at a price of €34 per share, under a concurrent private placement conducted by leaders banks and international sales agents in France and in some countries outside the United States and Canada.

As part of the initial public offering completed in October 2014, share capital increased by the issuance of 3,074,686 shares €(307,468) with a corresponding increase of €93,403,561 in share premium (€104,231,855 gross, or €93,403,561 net after deduction of fees and expenses for €10,828,294.23).

 

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Table of Contents

10.2 Share Warrants and Employee Warrants

The Company has issued share warrants (BSAs), employee warrants (BSPCEs), performance shares (AGAs) and stock-options (SO) as follows:

 

Date

   Type      Number of
warrants
issued as of
12/31/2014
     Number of
warrants
null and
void as of
12/31/2014
     Number of
warrants
null and
outstanding
as of
12/31/2014
     Maximum
number of

shares to
be issued
     Strike price
per share
 

12/07/2007

     BSA        1,717        572        1,145        17,175      4.33  

01/21/2009

     BSA/BSPCE        16,380        —          13,713        205,695      4.33  

01/21/2009

     BSPCE        2,296        —          —          —        4.33  

06/25/2010

     BSA        1,825        —          1,825        27,375      4.33  

01/28/2011

     BSA        10,039        7,529        —          —        5.13  

06/24/2011

     BSA/BSPCE        32,000        —          28,933        433,995      5.13  

11/22/2011

     BSA/BSPCE        11,377        —          9,373        140,595      5.13  

01/17/2012

     BSA        89,835        —          89,835        89,835      5.13  

04/02/2012

     AGA        669,796        —          —          —        —    

07/25/2012

     AGA        134,081        —          —          —        —    

09/25/2012

     BSA        30,000        —          25,000        25,000      8.59  

11/28/2012

     AGA        35,360        —          35,360        35,360      —    

07/25/2013

     BSA        73,000        —          70,500        70,500      8.10  

09/12/2013

     AGA        501,500        —          420,000        420,000      —    

09/18/2013

     SO        518,000        —          471,000        471,000      7.57  

06/03/2014

     BSA        10,000        —          10,000        10,000      18.79  

06/03/2014

     AGA        186,000        —          186,000        186,000      —    

06/03/2014

     SO        75,000        —          75,000        75,000      19.01  
     

 

 

    

 

 

    

 

 

    

 

 

    

Total

        2,398,206        8,101        1,437,684        2,207,530     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Date

   Type      Number of
warrants
issued as of
12/31/2015
     Number of
warrants
null and
void as of
12/31/2015
     Number of
warrants
null and
outstanding
as of
12/31/2015
     Maximum
number of
shares to
be issued
     Strike price
per share
 

12/07/2007

     BSA        1,717        572        859        12,885      4.33  

01/21/2009

     BSA/BSPCE        16,380        —          4,041        60,615      4.33  

01/21/2009

     BSPCE        2,296        —          —          —        4.33  

06/25/2010

     BSA        1,825        —          730        10,950      4.33  

01/28/2011

     BSA        10,039        7,529        —          —        5.13  

06/24/2011

     BSA/BSPCE        32,000        —          13,465        201,975      5.13  

11/22/2011

     BSA/BSPCE        11,377        —          2,509        37,635      5.13  

01/17/2012

     BSA        89,835        —          89,835        89,835      5.13  

04/02/2012

     AGA        669,796        1,860      —          —        —    

07/25/2012

     AGA        134,081        —          —          —        —    

09/25/2012

     BSA        30,000        —          10,000        10,000      8.59  

11/28/2012

     AGA        35,360        —          —          —        —    

07/25/2013

     BSA        73,000        —          13,000        13,000      8.10  

09/12/2013

     AGA        501,500        113,333      101,829        101,829      —    

09/18/2013

     SO        518,000        47,000      471,000        471,000      7.57  

06/03/2014

     BSA        10,000        —          5,000        5,000      18.79  

06/03/2014

     AGA        186,000        30,000      156,000        156,000      —    

06/03/2014

     SO        75,000        —          75,000        75,000      19.01  

03/24/2015

     BSA        10,000        —          10,000        10,000      43.00  

06/23/2015

     SO        120,000        —          120,000        120,000      48.90

09/30/2015

     AGA        708,500        —          708,500        708,500      —    

11/19/2015

     SO        195,000        —          195,000        195,000      66.06  

11/19/2015

     BSA        22,500        7,500      15,000        15,000      66.06

12/15/2015

     AGA        42,000        —          42,000        42,000      —    
     

 

 

    

 

 

    

 

 

    

 

 

    

Total

        3,496,206        207,794        2,033,768        2,336,224     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

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Table of Contents

Date

   Type      Number of
warrants
issued as of
12/31/2016
     Number of
warrants
null and
void as of
12/31/2016
     Number of
warrants
null and
outstanding
as of
12/31/2016
     Maximum
number of
shares to
be issued
     Strike price
per share
 

12/07/2007

     BSA        1,717        572        859        12,885      4.33  

01/21/2009

     BSA/BSPCE        16,380        —          2,997        44,955      4.33  

01/21/2009

     BSPCE        2,296        —          —          —        4.33  

06/25/2010

     BSA        1,825        —          730        10,950      4.33  

01/28/2011

     BSA        10,039        7,529        —          —        5.13  

06/24/2011

     BSA/BSPCE        32,000        —          10,440        156,600      5.13  

11/22/2011

     BSA/BSPCE        11,377        —          2,509        37,635      5.13  

01/17/2012

     BSA        89,835        —          —          —        5.13  

04/02/2012

     AGA        669,796        1,860        —          —        —    

07/25/2012

     AGA        134,081        —          —          —        —    

09/25/2012

     BSA        30,000        —          10,000        10,000      8.59  

11/28/2012

     AGA        35,360        —          —          —        —    

07/25/2013

     BSA        73,000        —          13,000        13,000      8.10  

09/12/2013

     AGA        501,500        113,333        —          —        —    

09/18/2013

     SO        518,000        47,000        471,000        471,000      7.57  

06/03/2014

     BSA        10,000        —          5,000        5,000      18.79  

06/03/2014

     AGA        186,000        30,000        —          —        —    

06/03/2014

     SO        75,000        —          40,000        40,000      19.01  

03/24/2015

     BSA        10,000        —          10,000        10,000      43.00  

06/23/2015

     SO        120,000        —          120,000        120,000      48.90  

09/30/2015

     AGA        708,500        13,000        695,500        695,500      —    

11/19/2015

     SO        195,000        25,000        170,000        170,000      66.06  

11/19/2015

     BSA        22,500        7,500      15,000        15,000      66.06  

12/15/2015

     AGA        42,000        6,000        36,000        36,000      —    

12/15/2015

     BSA        90,000        16,500        73,500        73,500      64.14  

01/04/2016

     SO        75,000        —          75,000        75,000      65.68  

04/06/2016

     AGA        63.750        5,000        58,750        58,750      —    

04/21/2016

     SO        33,000        —          33,000        33,000      62.82  

05/02/2016

     SO        22,000        —          22,000        22,000      59.04  

06/21/2016

     SO        110,000        —          110,000        110,000      53.96  

06/21/2016

     BSA        20,000        —          20,000        20,000      52.97  

06/21/2016

     AGA        208,000        —          208,000        208,000      —    

08/01/2016

     SO        10,000        —          10,000        10,000      62.24  

09/15/2016

     SO        9,300        —          9,300        9,300      62.80  

10/17/2016

     SO        16,500        —          16,500        16,500      64.39  

10/27/2016

     AGA        15,000        —          15,000        15,000      —    

11/15/2016

     SO        8,300        —          8,300        8,300      68.33  

12/09/2016

     SO        74,960        —          74,960        74,960      69.75  

12/09/2016

     AGA        23,600        —          23,600        23,600      —    
     

 

 

    

 

 

    

 

 

    

 

 

    

Total

        4,275,616        273,294        2,360,945        2,606,435     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

The totals presented above do not include the warrants cancelled prior to December 31, 2009.

As part of the initial public offering on Euronext, the nominal value of the shares underwent a fifteen-for-one share split following the decision of the Combined General Meeting of December 9, 2011.

The impact of the share-based payments on the net (loss) is presented in Note 16.

 

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Table of Contents

Note 11: Financial and Other Non-Current Liabilities

11.1 Conditional Advances

The conditional advances from public institutions are subject to contracts with OSEO and COFACE.

As of December 31, 2015, the Company had two advance contracts with OSEO Innovation, and a contract with COFACE. These advances do not bear interest and are 100% repayable at their nominal value in the event of technical and/or commercial success. The 3rd OSEO advance and the COFACE advance do not bear interest.

The agreement with COFACE terminated on December 31, 2016, generating an exceptional income of €146 thousand corresponding to allowances which could not be reimbursed along with Company takings, and which therefore remain acquitted to the Company.

The Company also benefited from a third grant from BpiFrance Financement in November 2014.

The portion of the conditional advances for terms longer than one year is classified as non-current liabilities, while the portion for terms of less than one year is classified as current liabilities.

The table below presents the details of the debts recorded on the statement of financial position by the type of conditional advance:

 

     3rd OSEO
contract
    4th OSEO
contract
    BPI
advance
    COFACE     Total  

Balance sheet debt at start of period 01/01/2014

     504       792       —         146       1,443  

+ receipts

     128       —         3,000       —         3,128  

- repayments

     (128     —         —         —         (128

+/- other transactions

     2       13       (416     5       (396
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance sheet debt as at 12/31/2014

     507       805       2,584       151       4,047  

Of which-non-current portion

             3,855  

Of which-current portion

             192  

Stated interest rate

     No       2.05     No       No    

Discount rate

     0.4%-1.9     1.5%-1.8     3.20     4.25  

Maturity (in years)

     0-3       7-9       2-7       0    
     3rd OSEO
contract
    4th OSEO
Contract
    BPI
advance
    COFACE     Total  
          

Balance sheet debt at start of period 01/01/2015

     507       805       2,584       151       4,047  

+ receipts

     —         865       —         —         865  

- repayments

     (192     —         —         —         (192

+/- other transactions

     3       (2     82       5       89  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance sheet debt as at 12/31/2015

     318       1,669       2,666       156       4,809  

Of which-non-current portion

             4,681  

Of which-current portion

             128  

Stated interest rate

     No       2.05     No       No    

Discount rate

     0.4%-1.9     1.5%-1.8     3.20     4.25  

Maturity (in years)

     0-3       7-9       2-7       0    

 

     3rd OSEO
contract
    4th OSEO
contract
    BPI
advance
    COFACE     Total  

Balance sheet debt at start of period 01/01/2016

     318       1,669       2,666       156       4,809  

+ receipts

     —         —         —         —         —    

- repayments

     (128     —         —         (147     (275

+/- other transactions

     2       16       85       (9     95  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance sheet debt as at 12/31/2016

     192       1,684       2,751       —         4,628  

Of which-non-current portion

             4,049  

Of which-current portion

             578  

Stated interest rate

     No       2.05     No       No    

Discount rate

     0.4%-1.9     1.5%-1.8     3.20     4.25  

Maturity (in years)

     0-3       7-9       2-7       0    

 

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Table of Contents

The changes appearing in “Other transactions” are comprised of the effect of discounting conditional advances.

Second OSEO Advance

On January 10, 2005, DBV Technologies obtained from OSEO a repayable financial assistance for innovation in the amount of €600,000 for a project to design a high-speed industrial machine for the production and development of second-generation patches intended for the detection of various allergies. The principal steps of this advance are the following:

 

    €300,000 were paid to the Company in 2005 upon the signing of the contract;

 

    €180,000 were paid to the Company in 2008;

 

    the balance of €120,000 was received in 2010.

The terms of repayment are the following:

 

    the first repayment of €140,000 made in 2011;

 

    the second repayment in the amount of €200,000 made in 2012;

 

    the third and final repayment in the amount of €260,000 made in 2013.

Third OSEO Advance

In 2011, the Company was notified by OSEO Innovation of a new grant in the form of a conditional advance of up to €640,000 to finance the development of its program to treat the allergy to proteins in cow’s milk.

The amount of the assistance was paid as follows:

 

    €256,000 after the contract was signed;

 

    €256,000 from June 30, 2012 upon a call for funds;

 

    the balance of €128,000 after confirmation of the end of the program notified on December 31, 2013.

The first payment of €256,000 was received in 2011.

The second payment of €256,000 was received in 2013.

The final balance of €128,000 has been received in 2014.

In the event of technical or commercial success of the program, the repayment schedule will be the following:

 

    €64,000 no later than September 30, 2014;

 

    €64,000 no later than December 31, 2014;

 

    €64,000 no later than March 31, 2015;

 

    €64,000 no later than June 30, 2015;

 

    €32,000 no later than September 30, 2015;

 

    €32,000 no later than December 31, 2015;

 

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Table of Contents
    €32,000 no later than March 31, 2016;

 

    €32,000 no later than June 30, 2016;

 

    €32,000 no later than September 30, 2016;

 

    €32,000 no later than December 31, 2016;

 

    €32,000 no later than March 31, 2017;

 

    €32,000 no later than June 30, 2017;

 

    €32,000 no later than September 30, 2017;

 

    €32,000 no later than December 31, 2017;

 

    €32,000 no later than March 31, 2018;

 

    €32,000 no later than June 30, 2018.

Regardless of the outcome of the development program, a fixed sum of €256,000 must be repaid in four quarterly instalments of €64,000 beginning on September 30, 2014.

Fourth OSEO Advance

In 2013, OSEO has provided assistance in the form of conditional advances for €3,206,162 to the Company as part of a collaborative research and clinical development in mite allergy in young children. ImmunaVia, the program, will be funded according to the following schedule, subject to the progress of the program:

 

    €903,500 paid in April 2013;

 

    €903,500 in October 2014;

 

    €918,000 in October 2015;

 

    €481,162 in April 2018.

The funds which were to be paid in October 2014 were finally received on January 22, 2015 for an amount of €864,989.

Such conditional advance bears interest at an annual rate of 2.05%. In case of technical or commercial success of the project, the repayment schedule, for a total amount of €3,750,000 (including interest), is as follows:

 

    €400,000 on or before June 30, 2021;

 

    €800,000 on or before June 30, 2022;

 

    €1,100,000 no later than June 30, 2023;

 

    €1,450,000 no later than June 30, 2024.

Furthermore, the financing program includes additional payment by OSEO to the Company for a total of €1,919,056 in non- refundable subsidies.

BpiFrance Financement Interest-Free Loan

In 2014, BpiFrance Financement granted an interest-free Innovation loan of €3,000,000 to DBV Technologies to help financing the pharmaceutical development of Viaskin Milk. This amount was received in a single disbursement on November 27, 2014.

The planned repayment schedule is as follows:

 

    €150,000 on June 30, 2017;

 

    €150,000 on September 30, 2017;

 

    €150,000 on December 31, 2017;

 

    €150,000 on March 31, 2018;

 

    €150,000 on June 30, 2018;

 

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Table of Contents
    €150,000 on September 30, 2018;

 

    €150,000 on December 31, 2018;

 

    €150,000 on March 31, 2019;

 

    €150,000 on June 30, 2019;

 

    €150,000 on September 30, 2019;

 

    €150,000 on December 31, 2019;

 

    €150,000 on March 31, 2020;

 

    €150,000 on June 30, 2020;

 

    €150,000 on September 30, 2020;

 

    €150,000 on December 31, 2020;

 

    €150,000 on March 31, 2021;

 

    €150,000 on June 30, 2021;

 

    €150,000 on September 30, 2021;

 

    €150,000 on December 31, 2021;

 

    €150,000 on March 31, 2022;

COFACE Advance

On September 6, 2007, DBV Technologies signed a prospecting insurance contract with Compagnie Française d’Assurance pour le Commerce Extérieur (“COFACE”) in order to promote its Diallertest product internationally. Under the terms of that contract, the Company received conditional advances of up to €147 thousands. DBV Technologies must repay these advances in amounts of up to 7% of its revenue from the export sales of its Diallertest product, until April 30, 2017.

The agreement with COFACE was terminated on December 31, 2016, and has generated an income of €147 thousand as the Company discontinued the commercialization of Diallertest® products during the second half of 2015.

As of December 31, 2015, the remaining amount was €156 thousand compared to €151 thousands on December 31, 2014.

11.2 Other non-current liabilities

Other non-current liabilities mainly include non-current part of deferred revenue from the collaboration agreement the Company entered into with Nestlé Healthcare and non-current part of accrual for employers’ contribution on free share plans.

11.3 Due Dates of the Financial Liabilities and other current and non current liabilities

Due dates of the financial liabilities recognized as of December 31, 2014:

 

     Gross
amount
     Less than
One year
     One to
Five Years
     More
than Five
Years
 
     (Amounts in thousands of Euros)  

Non-current conditional advances

     3,855        —          1,940        1,914  

Non-current financial rent debts

     33        —          33        —    

Current conditional advances

     192        192        —          —    

Current financial rent debts

     21        21        —          —    

Supplier accounts payable and related payables

     1,875        1,875        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities and current and non current liabilities

     5,976        2,087        1,974        1,914  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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Due dates of the financial liabilities recognized as of December 31, 2015:

 

     Gross
amount
     Less than
One year
     One to
Five Years
     More
than Five
Years
 
     (Amounts in thousands of Euros)  

Non-current conditional advances

     4,681        —          2,378        2,302  

Non-current financial rent debts

     12        —          12        —    

Current conditional advances

     128        128        —          —    

Current financial rent debts

     21        21        —          —    

Supplier accounts payable and related payables

     10,034        10,034        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities and current and non current liabilities

     14,876        10,183        2,391        2,302  
  

 

 

    

 

 

    

 

 

    

 

 

 

As detailed in Note 13, other current liabilities mainly include social security and tax liabilities and are mainly due in less than one year from the reporting date.

Due dates of the financial liabilities recognized as of December 31, 2016:

 

     Gross
amount
     Less than
One year
     One to
Five Years
     More
than Five
Years
 
     (Amounts in thousands of Euros)  

Non-current conditional advances

     4,049        —          2,531        1,518  

Non-current financial rent debts

     —          —          —          —    

Other non-current liabilities

     10,746        —          10,370        377  

Current conditional advances

     578        578        —          —    

Current financial rent debts

     12        12        —          —    

Other current liabilities

     14,692        14,692        —          —    

Supplier accounts payable and related payables

     13,720        13,720        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities and current and non current liabilities

     43,798        29,003        12,900        1,895  
  

 

 

    

 

 

    

 

 

    

 

 

 

As detailed in Note 13, other current liabilities mainly include social security and current part of deferred revenues from the collaboration agreement with Nestlé Healthcare as well as subsidies and conditional advances.

Note 12: Non-Current Provisions

 

     December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Pension retirement obligations

     531        490        853  

Total

     531        490        853  

 

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Commitments for Compensation Payable to Employees Upon Their Retirement

 

    

Amounts in

thousands
of Euros

 

As of January 1, 2014

     (291

Costs of services rendered (operating expense)

     (75

Interest expense (finance expense)

     (12

Benefit paid

      

Actuarial losses

     (153
  

 

 

 

As of December 31, 2014

     (531

Costs of services rendered (operating expense)

     (116

Interest expense (finance expense)

     (9

Benefit paid

      

Actuarial gains

     166  
  

 

 

 

As of December 31, 2015

     (490

Costs of services rendered (operating expense)

     (104

Interest expense (finance expense)

     (10

Benefit paid

      

Actuarial gains

     (249
  

 

 

 

As of December 31, 2016

     (853
  

 

 

 

As part of the estimation of the retirement commitments, the following assumptions were used for all categories of employees:

 

     December 31,  
     2014     2015     2016  

% social security contributions

     50.0     50.0     50.0

Salary increases

     4.0     2.0     2.0

Discount rate

     1.30     2.08     1.31

Assumptions for the year ended December 31, 2014:

 

    Retirement age: 64 years old (managers); 62 years old (non-managers);

 

    Terms of retirement: voluntary retirement;

 

    Life table: TGH05-TGF05;

 

    Collective agreement: Convention Collective Nationale de l’Industrie Pharmaceutique (National Collective Agreement in the Pharmaceutical Industry);

 

    Turn-over of the personnel declining with age.

The discount rates come from the corporate AA zero coupon yield curve.

Assumptions for the years ended December 31, 2015 and December 31, 2016:

 

    Retirement age: 65 years old;

 

    Terms of retirement: voluntary retirement;

 

    Life table: INSEE 2010;

 

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    Collective agreement: Convention Collective Nationale de l’Industrie Pharmaceutique (National Collective Agreement in the Pharmaceutical Industry);

 

    Turn-over of the personnel declining with age.

The discount rates come from the corporate AA zero coupon yield curve.

No employee has retired during the last three fiscal years presented.

Note 13: Supplier Accounts Payable and Other Current Liabilities

13.1 Supplier Accounts Payable

No discounting was performed on the supplier accounts payable to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal year presented.

 

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13.2 Other Current Liabilities

 

     December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Social security

     2,160        4,464        10,794  

Tax liabilities

     114        388        504  

Other debts

     110        195        146  

Deferred revenues

     1,052        791        3,248  
  

 

 

    

 

 

    

 

 

 

Total

     3,436        5,838        14,692  
  

 

 

    

 

 

    

 

 

 

The other liabilities include the short-term debts to employees, as well as social welfare and tax agencies. Deferred revenues include subsidies, conditional advances and current part of deferred revenues from the collaboration agreement with Nestlé Healthcare.

Note 14: Financial Instruments Recognized in the Consolidated Statements of Financial Position and Related Effect on the Consolidated Statements of (Loss)

 

2014

   Book value
in the
Consolidated
Statements
of Financial
Position
     Fair value
through
Consolidated
Statements
of (Loss) (3)
     Loans and
receivables (1)
     Debt At
amortized
cost (2)
     Fair value  

Financial assets

              

Long-term financial assets

     1,596        1,496        100        —          1,596  

Customer accounts receivables and related receivables

     136        —          136        —          136  

Other current financial assets

     241        —          241        —          241  

Cash and cash equivalents

     114,583        114,583        —          —          114,583  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

     116,556        116,079        477        —          116,556  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Financial liabilities

              

Long-term conditional advances

     3,855        —          —          3,855        3,855  

Long term financial rent debt

     33        —          —          33        33  

Short-term conditional advances

     192        —          —          192        192  

Short term financial rent debt

     21        —          —          21        21  

Account payable and other liabilities

     5,311        —          —          5,311        5,311  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

     9,412        —          —          9,412        9,412  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

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2015

   Book value
in the
Consolidated
Statements
of Financial
Position
     Fair value
through
Consolidated
Statements
of (Loss) (3)
     Loans and
receivables (1)
     Debt At
amortized
cost (2)
     Fair value  

Financial assets

              

Long-term financial assets

     2,711        1,365        1,346        —          2,711  

Customer accounts receivables and related receivables

     —          —          —          —          —    

Other current financial assets

     333        —          333        —          333  

Cash and cash equivalents

     323,381        323,381        —          —          323,381  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

     326,425        324,746        1,679        —          326,425  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Financial liabilities

              

Long-term conditional advances

     4,681        —          —          4,681        4,681  

Long term financial rent debt

     12        —          —          12        12  

Short-term conditional advances

     128        —          —          128        128  

Short term financial rent debt

     21        —          —          21        21  

Account payable and other liabilities

     15,872        —          —          15,872        15,872  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

     20,714        —          —          20,714        20,714  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

2016

   Book value
in the
Consolidated
Statements
of Financial
Position
     Fair value
through
Consolidated
Statements
of (Loss) (3)
     Loans and
receivables (1)
     Debt At
amortized
cost (2)
     Fair value  

Financial assets

              

Long-term financial assets

     2,745        1,310        1,435        —          2,745  

Customer accounts receivables and related receivables

     1,250        —          1,250        —          1,250  

Other current financial assets

     516        —          516        —          516  

Cash and cash equivalents

     256,473        256,473        —          —          256,473  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

     260,985        257,783        3,202        —          260,985  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Financial liabilities

              

Long-term conditional advances

     4,049        —          —          4,049        4,049  

Long term financial rent debt

     —          —          —          —          —    

Other long-term liabilities

     10,746        —          —          10,746        10,746  

Short-term conditional advances

     578        —          —          578        578  

Short term financial rent debt

     12        —          —          12        12  

Other short-term liabilities

     14,692        —          —          14,692        14,692  

Account payable and other liabilities

     13,720        —          —          13,720        13,720  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

     43,798        —          —          43,798        43,798  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) The fair value of “loans and receivables” corresponds to the value reported in the Consolidated Statements of Financial Position (value at the transaction date and then tested for impairment on each reporting date).
(2) The book amount of financial liabilities measured at amortized cost was deemed to be a reasonable estimation of fair value.
(3) The fair value of financial assets held for trading is determined based on Level 1 fair value measurements and corresponds to the market value of the assets.

Note 15: Operating Income

The operating income is broken down in the following manner:

 

     December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Revenues

     211        202        —    

Research tax credit

     4,340        5,685        7,228  

Subsidies

     211        279        303  

Other operating income

     —          —          1,554  
  

 

 

    

 

 

    

 

 

 

Total

     4,762        6,166        9,084  
  

 

 

    

 

 

    

 

 

 

 

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The revenues of the Company are composed of the sales of Diallertest® products whose commercialization was discontinued during the second half of 2015.

As of December 31, 2016, the Company also recorded as other income a portion of the upfront fee and milestones agreed under the contract with Nestlé which are deferred over the service obligation period.

Note 16: Operating Expenses

The research and development expenses are broken down as follows:

 

     December 31,  
Research and development expenses    2014      2015      2016  
     (Amounts in thousands of Euros)  

Personnel expenses

     7,703        13,268        32,777  

Sub-contracting, collaboration, and consultants

     10,703        15,325        34,413  

Research supplies

     937        911        1,234  

Rental

     255        1,094        1,903  

Conferences, travel expenses

     665        1,233        2,387  

Depreciation and amortization

     466        1,000        1,141  

Maintenance and service costs

     22        77        1,325  

Small equipments and other supplies

     249        795        2,675  

Others

     143        531        973  
  

 

 

    

 

 

    

 

 

 

Total research and development expenses

     21,143        34,234        78,828  
  

 

 

    

 

 

    

 

 

 

The sales and marketing expenses are broken down as follows:

 

     December 31,  
Sales and marketing expenses    2014      2015      2016  
     (Amounts in thousands of Euros)  

Personnel expenses

     —          133        4,954  

Fees

     —          339        4,447  

Communication and travel expenses

     13        20        1,393  

Others

     —          —          487  
  

 

 

    

 

 

    

 

 

 

Total sales and marketing expenses

     13        491        11,282  
  

 

 

    

 

 

    

 

 

 

By nature, the breakdown of general and administrative expenses is as follows:

 

     December 31,  
General and administrative expenses    2014      2015      2016  
     (Amounts in thousands of Euros)  

Personnel expenses

     5,109        8,768        22,613  

Fees

     1,166        4,234        7,701  

Rental

     204        305        501  

Insurance policies

     230        1,239        1,853  

Communication and travel expenses

     633        1,010        1,136  

Depreciation and amortization

     111        74        181  

Others

     652        1,229        1,020  
  

 

 

    

 

 

    

 

 

 

Total general and administrative expenses

     8,105        16,859        35,005  
  

 

 

    

 

 

    

 

 

 

 

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Personnel Expenses

The Company had 164 employees at December 31, 2016, in comparison with 91 employees at December 31, 2015 and 56 employees at December 31, 2014.

The personnel expenses are broken down as follows:

 

     December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Wages and salaries

     4,883        7,243        14,651  

Social security contributions

     3,203        3,193        3,903  

Expenses for pension commitments

     87        116        982  

Employer contribution to bonus shares

     —          1,198        6,456  

Share-based payments

     4,639        10,419        34,353  
  

 

 

    

 

 

    

 

 

 

Total

     12,812        22,168        60,345  
  

 

 

    

 

 

    

 

 

 

The increase in personnel expenses is partly due to the growth of the Company’s employees and the increase of the share-based payments linked to the global plans put in place during the second semester of 2015 and in 2016 (see Note 17).

Note 17: Share-Based Payments

The Board of Directors has been authorized by the general meeting of the shareholders to grant employee warrants (Bons de Souscription de Parts de Créateur d’Entreprise or “BSPCE”), (Bons de Createurs d’Entreprise or “BCE”) and (Bons de Souscription d’Actions or “BSA”), Free shares and to implement share options plans as follows:

 

    With the authorization of the General Meeting of Shareholders on January 21, 2009, the Board of Directors issued 2,296 BCEX (“BCEX”);

 

    With the authorization of the General Meeting of Shareholders on June 14, 2007, December 16, 2010 and December 9, 2011, the Board of Directors issued 194,552 BSA (“BSA”);

 

    With the authorization of the General Meeting of Shareholders on January 21, 2009, the Board of Directors issued 10,716 BSA (“BSA2”);

 

    With the authorization of the General Meeting of Shareholders on January 21, 2009, the Board of Directors issued 5,358 BCE (“BCE4”);

 

    With the authorization of the General Meeting of Shareholders on December 16, 2010, the Board of Directors issued 19,377 BSA (“BSA2010”);

 

    With the authorization of the General Meeting of Shareholders on January 21, 2009, the Board of Directors issued 2,131 BSA (“BSAX”);

 

    With the authorization of the General Meeting of Shareholders on December 16, 2010, the Board of Directors issued 34,039 BSPCE (“BSPCE2010”);

 

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    With the authorization of the General Meeting of Shareholders on December 9, 2011, the Board of Directors issued 518,000 options (“OPTIONS 2013”);

 

    With the authorization of the General Meeting of Shareholders on December 9, 2011, the Board of Directors issued 1,340,737 Free shares (“Free shares”);

 

    With the authorization of the General Meeting of Shareholders on June 4, 2013, the Board of Directors issued 73,000 BSA;

 

    With the authorization of the General Meeting of Shareholders on June 3, 2014, the Board of Directors issued 20,000 BSA;

 

    With the authorization of the General Meeting of Shareholders on June 3, 2014, the Board of Directors issued 749,060 options;

 

    With the authorization of the General Meeting of Shareholders on June 3, 2014, the Board of Directors issued 186,000 free shares;

 

    With the authorization of the General Meeting of Shareholders on June 23, 2015, the Board of Directors issued 88,500 BSA;

 

    With the authorization of the General Meeting of Shareholders on September 21, 2015, the Board of Directors granted 1,060,850 Free shares;

 

    With the authorization of the General Meeting of Shareholders on June 21, 2016, the Board of Directors issued 20,000 BSA and granted 59,000 additional BSA whish only 34,008 have been issued as of February 9, 2017.

17.1 BCEX

The BCEX may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to one fourth (1/4) of the BCEX on the first anniversary of the date of grant;

 

    up to one fourth (1/4) of the BCEX on the second anniversary of the date of grant;

 

    up to one fourth (1/4) of the BCEX on the third anniversary of the date of grant;

 

    up to one fourth (1/4) of the BCEX on the fourth anniversary of the date of grant;

 

    at the latest within ten (10) years from the date of grant.

By a decision by the Board of Directors meeting held on November 22, 2011, the BCEX warrants became exercisable beginning on the date of the first quotation of the shares of the Company on the Euronext regulated market in Paris.

Details of BCEX

 

Date of grant (Board of Directors)

   01/21/2009     01/21/2009     01/21/2009     01/21/2009  

Vesting period (years)

     1       2       3       4  

Plan expiration date

     01/20/2019       01/20/2019       01/20/2019       01/20/2019  

Number of BCEX granted

     574       574       574       574  

Share entitlement per BCEX(1)

     15       15       15       15  

Exercise price

     70       70       70       70  

Valuation method used

     Black and Scholes  

Grant date share fair value

     70       70       70       70  

Expected volatility

     40     40     40     40

Average life of BCEX

     5.5       6.0       6.5       7.0  

Discount rate(2)

     2.71     2.98     2.98     3.11

Expected dividends

     0     0     0     0

Performance conditions

     NA       NA       NA       NA  

Fair value per BCEX

     28.64       30.25       31.46       31.87  

 

(1) The number of shares takes into account an exercise parity adjusted by the division by 15 of the nominal value of the shares decided by the general meeting on December 9, 2011; each BCEX warrant now gives the right to subscribe to 15 new shares instead of 1 new share. For the same reason, the exercise price of each BCE plan was adjusted as a result and is thus equal to 1/15th of the price initially determined by the general meeting that authorized each of the plans.
(2) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of BCEX.

 

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Change in Number of BCEX Outstanding

 

     Year ended December 31,  
Number of BCEX    2014      2015      2016  

Balance at beginning of period

     2,296        —          —    

Granted during the period

     —          —          —    

Forfeited during the period

     —          —          —    

Exercised during the period

     2,296        —          —    

Expired during the period

     —          —          —    

Balance at end of period

     —          —          —    

Breakdown of the Closing Balance

 

    Year ended December 31,  
    2014     2015     2016  
Number of BCEX   Outstanding     Exercisable     Outstanding     Exercisable     Outstanding     Exercisable  

BCEX with exercise price of €70

    —         —         —         —       —       —  

Total

    —       —       —       —       —       —  

17.2 BSA

Date of Grant 12/07/2007

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to one fourth (1/4) of the BSA on the first anniversary of the date of grant;

 

    up to one fourth (1/4) of the BSA on the second anniversary of the date of grant;

 

    up to one fourth (1/4) of the BSA on the third anniversary of the date of grant;

 

    up to one fourth (1/4) of the BSA on the fourth anniversary of the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

Date of Grant 01/17/2012

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 89,835 BSA (all the BSA) on January 17, 2016; and

 

    at the latest within ten (10) years from the date of grant.

Date of Grant 09/25/2012

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 30,000 BSA (all the BSA) on the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

Date of Grant 07/25/2013

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 73,000 BSA (all the BSA) on the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

 

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Date of Grant 06/03/2014

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 10,000 BSA (all the BSA) on the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

Date of Grant 03/24/2015

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 10,000 BSA (all the BSA) on the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

Date of Grant 11/19/2015

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 15,000 BSA (all the BSA) on the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

Date of Grant 12/15/2015

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 73,500 BSA (all the BSA) on the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

Date of Grant 06/21/2016

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 20,000 BSA (all the BSA) on the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

Details of BSA

 

Date of grant (Board of Directors)

  12/07/2007     12/07/2007     12/07/2007     12/07/2007     01/17/2012     01/17/2012     01/17/2012     01/17/2012  

Vesting period (years)

    1       2       3       4       1       2       3       4  

Plan expiration date

    12/08/2017       12/08/2017       12/08/2017       12/08/2017       01/17/2022       01/17/2022       01/17/2022       01/17/2022  

Number of BSA granted

    431       431       428       427       22,459       22,459       22,459       22,458  

Share entitlement per BSA(1)

    15       15       15       15       1       1       1       1  

Exercise price

    65       65       65       65       5.13       5.13       5.13       5.13  

Valuation method used

    Black and Scholes  

Grant date share fair value

    65       65       65       65       5.13       5.13       5.13       5.13  

Expected volatility

    40     40     40     40     40     40     40     40

Average life of BSA

    4.5       5.0       5.5       6.0       5.5       6.0       6.5       7.0  

Discount rate(2)

    4.06     4.09     4.09     4.10     2.33     2.33     2.61     2.61

Expected dividends

    0     0     0     0     0     0     0     0

Performance conditions

    NA       NA       NA       NA       NA       NA       NA       NA  

Fair value per BSA

    22.18       23.62       24.95       26.22       2.05       2.14       2.26       2.34  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

(1) The number of shares takes into account an exercise parity adjusted by the division by 15 of the nominal value of the shares decided by the general meeting on December 9, 2011; each BSA warrant now gives the right to subscribe to 15 new shares instead of 1 new share. For the same reason, the exercise price of each BSA plan was adjusted as a result and is thus equal to 1/15th of the price initially determined by the general meeting that authorized each of the plans.

 

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(2) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of BSA.

 

Date of grant (Board of Directors)

  09/25/2012     09/25/2012     09/25/2012     09/25/2012     07/25/2013     06/03/2014  

Vesting period (years)

    1       2       3       4       0       0  

Plan expiration date

    09/25/2022       09/25/2022       09/25/2022       09/25/2022       07/25/2023       06/03/2024  

Number of BSA granted

    7 500       7 500       7 500       7 500       73 000       10 000  

Share entitlement per BSA(1)

    1       1       1       1       1       1  

Exercise price

    8.59       8.59       8.59       8.59       8.1       18.79  

Valuation method used

    Black and Scholes  

Grant date share fair value

    8.4       8.4       8.4       8.4       8.15       19.01  

Expected volatility

    40     40     40     40     40     40

Average life of BSA

    5.5       6.0       6.5       7.0       5.0       5.0  

Discount rate(2)

    1.21     1.21     1.53     1.53     1.16     0.71

Expected dividends

    0     0     0     0     0     0

Performance conditions

    NA       NA       NA       NA       NA       NA  

Fair value per BSA

    2.29       2.43       2.61       2.74       2.18       4.98  

 

(1) The number of shares takes into account an exercise parity adjusted by the division by 15 of the nominal value of the shares decided by the general meeting on December 9, 2011; each BSA warrant now gives the right to subscribe to 15 new shares instead of 1 new share. For the same reason, the exercise price of each BSA plan was adjusted as a result and is thus equal to 1/15th of the price initially determined by the general meeting that authorized each of the plans.

 

(2) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of BSA.

 

Date of grant (Board of Directors)

   03/24/2015     11/19/2015     12/15/2015     06/21/2016  

Vesting period (years)

        

Plan expiration date

     03/24/2025       11/19/2025       12/15/2015       06/21/2016  

Number of BSA granted

     10,000       15,000       90,000 (2)      20,000  

Share entitlement per BSA

     1       1       1       1  

Exercise price

     43.00       66.06       64,14       52.97  

Valuation method used

     Black and Scholes  

Grant date share fair value

     43       66.06       42.61       61.25  

Expected volatility

     36     50.91     51     47

Average life of BSA

     5.0       5.0       5.0       5.0  

Discount rate(1)

     0.68     0.81     -0.09     -0.41

Expected dividends

     0     0     0     0

Performance conditions

     NA       NA       NA       NA  

Fair value per BSA

     9.90       22.60       7.28       21.59  

 

(1) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of BSA.
(2) The final subscription date for the BSAs issued in December 2015 was February 15, 2016. At February 15, 2016, 73,500 BSAs were subscribed and 16,500 BSAs were cancelled.

Change in Number of BSA Outstanding

 

     Year ended December 31,  
Number of BSA    2014      2015      2016  

Balance at beginning of period

     193,980        196,480        143,694  

Granted during the period

     10,000        25,000        93,500  

Forfeited during the period

     —        —        —  

Exercised during the period

     7,500        77,786        89,835

Expired during the period

     —        —        —  

Balance at end of period

     196,480        143,694        147,359  

 

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Breakdown of the Closing Balance

 

    Year ended December 31,  
    2014     2015     2016  
Number of BSA   Outstanding     Exercisable     Outstanding     Exercisable     Outstanding     Exercisable  

BSA2010 with exercise price of €65

    1,145       1,145       859       859       859       859  

BSA2010 with exercise price of €5.13

    89,835       —         89,835       —         —         —    

BSA2010 with exercise price of €8.59

    25,000       25,000       10,000       10,000       10,000       10,000  

BSA2010 with exercise price of €8.1

    70,500       70,500       13,000       13,000       13,000       13,000  

BSA2010 with exercise price of €18.79

    10,000       10,000     5,000       5,000       5,000       5,000  

BSA with exercise price of €43.00

    —         —         10,000       10,000       10,000       10,000  

BSA with exercise price of €66.06

    —         —         15,000       15,000       15,000       15,000  

BSA with exercise price of €64.14

    —         —         —         —         73,500       73,500  

BSA with exercise price of €52.97

    —         —         —         —         20,000       20,000  

Total

    196,480       106,645       143,694       53,859       147,359       147,359  

17.3 BSA 2

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 4,822 BSA on the date of grant;

 

    up to 2,680 BSA on the first anniversary of the date of grant;

 

    up to 1,072 BSA on the second anniversary of the date of grant;

 

    up to 1,072 BSA on the third anniversary of the date of grant;

 

    up to 1,070 BSA on the fourth anniversary of the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

By a decision by the Board of Directors meeting held on November 22, 2011, the BSA2 warrants became exercisable beginning on the date of the first quotation of the shares of the Company on the Euronext regulated market in Paris.

Details of BSA2

 

Date of grant (Board of Directors)

  01/21/2009     01/21/2009     01/21/2009     01/21/2009     01/21/2009  

Vesting period (years)

    0       1       2       3       4  

Plan expiration date

    01/20/2019       01/20/2019       01/20/2019       01/20/2019       01/20/2019  

Number of BSA2 granted

    4,822       2,680       1,072       1,072       1,070  

Share entitlement per BSA2(1)

    15       15       15       15       15  

Exercise price

    65       65       65       65       65  

Valuation method used

    Black and Scholes  

Grant date share fair value

    70       70       70       70       70  

Expected volatility

    40     40     40     40     40

Average life of BSA2

    5.0       5.5       6.0       6.5       7.0  

Discount rate(2)

    2.71     2.71     2.98     2.98     3.11

Expected dividends

    0     0     0     0     0

Performance conditions

    NA       NA       NA       NA       NA  

Fair value per BSA2

    29.05       30.32       31.89       33.05       33.45  

 

(1) The number of shares takes into account an exercise parity adjusted by the division by 15 of the nominal value of the shares decided by the general meeting on December 9, 2011; each BSA2 warrant now gives the right to subscribe to 15 new shares instead of 1 new share. For the same reason, the exercise price of each BSA2 plan was adjusted as a result and is thus equal to 1/15th of the price initially determined by the general meeting that authorized each of the plans.
(2) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of BSA2.

 

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Change in Number of BSA 2 Outstanding

 

     Year ended December 31  
Number of BSA2    2014      2015      2016  

Balance at beginning of period

     10,716        8,049        —    

Granted during the period

     —          —          —    

Forfeited during the period

     —          —          —    

Exercised during the period

     2,667        8,049        —    

Expired during the period

     —          —          —    

Balance at end of period

     8,049        —          —    

Breakdown of the Closing Balance

 

     Year ended December 31,  
     2014      2015      2016  
Number of BSA2    Outstanding      Exercisable      Outstanding      Exercisable      Outstanding      Exercisable  

BSA2 with exercise price of €65

     8,049        8,049        —          —          —          —    

Total

     8,049        8,049        —          —          —          —    

17.4 BCE 4

The BCE4 may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 2,411 BCE4 on the date of grant;

 

    up to 1,340 BCE4 on the first anniversary of the date of grant;

 

    up to 536 BCE4 on the second anniversary of the date of grant;

 

    up to 536 BCE4 on the third anniversary of the date of grant;

 

    up to 535 BSA on the fourth anniversary of the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

By a decision by the Board of Directors meeting held on November 22, 2011, the BCE4 warrants became exercisable beginning on the date of the first quotation of the shares of the Company on the Euronext regulated market in Paris.

Details of BCE4

 

Date of grant (Board of Directors)

  01/21/2009     01/21/2009     01/21/2009     01/21/2009     01/21/2009  

Vesting period (years)

    0       1       2       3       4  

Plan expiration date

    01/20/2019       01/20/2019       01/20/2019       01/20/2019       01/20/2019  

Number of BCE4 granted

    2,411       1,340       536       536       535  

Share entitlement per BCE4(1)

    15       15       15       15       15  

Exercise price

    65       65       65       65       65  

Valuation method used

    Black and Scholes  

Grant date share fair value

    70       70       70       70       70  

Expected volatility

    40     40     40     40     40

Average life of BCE4

    5.0       5.5       6.0       6.5       7.0  

Discount rate(2)

    2.71     2.71     2.98     2.98     3.11

Expected dividends

    0     0     0     0     0

Performance conditions

    NA       NA       NA       NA       NA  

Fair value per BCE4

    29.06       30.33       31.90       33.06       34.35  

 

(1) The number of shares takes into account an exercise parity adjusted by the division by 15 of the nominal value of the shares decided by the general meeting on December 9, 2011; each BCE4 warrant now gives the right to subscribe to 15 new shares instead of 1 new share. For the same reason, the exercise price of each BCE4 plan was adjusted as a result and is thus equal to 1/15th of the price initially determined by the general meeting that authorized each of the plans.
(2) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of BCE4.

 

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Change in Number of BCE4 Outstanding

 

     Year ended December 31,  
Number of BCE4    2014      2015      2016  

Balance at beginning of period

     5,358        5,358        2,691  

Granted during the period

     —        —        —  

Forfeited during the period

     —        —        —  

Exercised during the period

     —        2,667        —    

Expired during the period

     —        —        —  

Balance at end of period

     5,358        2,691        2,691  

Breakdown of the Closing Balance

 

     Year ended December 31,  
     2014      2015      2016  
Number of BCE4    Outstanding      Exercisable      Outstanding      Exercisable      Outstanding      Exercisable  

BCE4 with exercise price of €65

     5,358        5,358        2,691        2,691        2,691        2,691  

Total

     5,358        5,358        2,691        2,691        2,691        2,691  

17.5 BSA2010

Date of Grant 01/28/2011

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 2,510 BSA on the 12/23/2011;

 

    up to 2,510 BSA on the 12/23/2012;

 

    up to 2,510 BSA on the 12/23/2013;

 

    up to 2,509 BSA on the 12/23/2014; and

 

    at the latest before the 01/28/2021.

Date of Grant 06/24/2011

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to one fourth (1/4) of the BSA on the 12/23/2011;

 

    up to one fourth (1/4) of the BSA on the 12/23/2012;

 

    up to one fourth (1/4) of the BSA on the 12/23/2013;

 

    up to one fourth (1/4) of the BSA on the 12/23/2014; and

 

    at the latest before the 11/22/2021.

Date of Grant 11/22/2011

The BSA may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 335 BSA on the 11/22/2012;

 

    up to 335 BSA on the 11/22/2013;

 

    up to 334 BSA on the 11/22/2014;

 

    up to 334 BSA on the 11/22/2015; and

 

    at the latest before the 11/22/2021.

 

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Details of BSA2010

 

Date of grant (Board of Directors)

  01/28/2011     01/28/2011     01/28/2011     01/28/2011     06/24/2011     06/24/2011     06/24/2011     06/24/2011  

Vesting period (years)

    0.9       1.9       2.9       3.9       0.5       1.5       2.5       3.5  

Plan expiration date

    01/27/2021       01/27/2021       01/27/2021       01/27/2021       11/22/2021       11/22/2021       11/22/2021       11/22/2021  

Number of BSA2010 granted

    2,510       2,510       2,510       2,509       2,000       2,000       2,000       2,000  

Share entitlement per BSA2010(1)

    15       15       15       15       15       15       15       15  

Exercise price

    77       77       77       77       77       77       77       77  

Valuation method used

   
Black and Scholes
 

Grant date share fair value

    77       77       77       77       77       77       77       77  

Expected volatility

    40     40     40     40     40     40     40     40

Average life of BSA2010

    5.5       6.0       6.5       7.0       5.5       6.0       6.5       7.0  

Discount rate(2)

    2.70     2.82     2.82     3.04     2.55     2.68     2.68     2.87

Expected dividends

    0     0     0     0     0     0     0     0

Performance conditions

    NA       NA       NA       NA       NA       NA       NA       NA  

Fair value per BSA2010

    31.33       32.90       34.23       35.84       31.15       32.70       34.02       35.57  

 

(1) The number of shares takes into account an exercise parity adjusted by the division by 15 of the nominal value of the shares decided by the general meeting on December 9, 2011; each BSA2010 warrant now gives the right to subscribe to 15 new shares instead of 1 new share. For the same reason, the exercise price of each BSA2010 plan was adjusted as a result and is thus equal to 1/15th of the price initially determined by the general meeting that authorized each of the plans.
(2) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of BSA2010.

 

Date of grant (Board of Directors)

   11/22/2011     11/22/2011     11/22/2011     11/22/2011  

Vesting period (years)

     1.0       2.0       3.0       4.0  

Plan expiration date

     11/22/2021       11/22/2021       11/22/2021       11/22/2021  

Number of BSA2010 granted

     335       335       334       334  

Share entitlement per BSA(1)

     15       15       15       15  

Exercise price

     77       77       77       77  

Valuation method used

     Black and Scholes  

Grant date share fair value

     77       77       77       77  

Expected volatility

     40     40     40     40

Average life of BSA

     5.5       6.0       6.5       7.0  

Discount rate(2)

     2.23     2.60     2.60     2.85

Expected dividends

     0     0     0     0

Performance conditions

     NA       NA       NA       NA  

Fair value per BSA

     30.70       32.58       33.89       35.54  

 

(1) The number of shares takes into account an exercise parity adjusted by the division by 15 of the nominal value of the shares decided by the general meeting on December 9, 2011; each BSA2010 warrant now gives the right to subscribe to 15 new shares instead of 1 new share. For the same reason, the exercise price of each BSA2010 plan was adjusted as a result and is thus equal to 1/15th of the price initially determined by the general meeting that authorized each of the plans.
(2) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of BSA2010.

Change in Number of BSA2010 Outstanding

 

     Year ended December 31,  
Number of BSA    2014      2015      2016  

Balance at beginning of period

     11,848        8,334        1,044  

Granted during the period

     —        —        —  

Forfeited during the period

     —        —        —  

Exercised during the period

     3,514        7,290        434  

Expired during the period

     —        —        —  

Balance at end of period

     8,334        1,044        610  

 

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Breakdown of the Closing Balance

 

     Year ended December 31,  
     2014      2015      2016  
Number of BSA2010    Outstanding      Exercisable      Outstanding      Exercisable      Outstanding      Exercisable  

BSA2010 with exercise price of €77

     8,334        8,000        1,044        1,044        610        610  

Total

     8,334        8,000        1,044        1,044        610        610  

17.6 BSAX

Date of Grant 01/21/2009 and 06/25/2010

The BSAX may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to one fourth (1/4) of the BSAX on the first anniversary of the date of grant;

 

    up to one fourth (1/4) of the BSAX on the second anniversary of the date of grant;

 

    up to one fourth (1/4) of the BSAX on the third anniversary of the date of grant;

 

    up to one fourth (1/4) of the BSAX on the fourth anniversary of the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

By a decision by the Board of Directors meeting held on November 22, 2011, the BSAX warrants became exercisable beginning on the date of the first quotation of the shares of the Company on the Euronext regulated market in Paris.

Details of BSAX

 

Date of grant (Board of Directors)

   01/21/2009     01/21/2009     01/21/2009     21/01/2009     06/25/2010     06/25/2010     06/25/2010     06/25/2010  

Vesting period (years)

     1       2       3       4       1       2       3       4  

Plan expiration date

     01/20/2019       01/20/2019       01/20/2019       01/20/2019       06/24/2020       06/24/2020       06/24/2020       06/24/2020  

Number of BSAX granted

     77       77       77       75       457       457       456       455  

Share entitlement per BSAX(1)

     15       15       15       15       15       15       15       15  

Exercise price

     65       65       65       65       65       65       65       65  

Valuation method used

     Black and Scholes  

Grant date share fair value

     70       70       70       70       70       70       70       70  

Expected volatility

     40     40     40     40     40     40     40     40

Average life of BSAX

     5.5       6.0       6.5       7.0       5.5       6.0       6.5       7.0  

Discount rate(2)

     2.71     2.98     2.98     3.11     2.04     2.23     2.23     2.50

Expected dividends

     0     0     0     0     0     0     0     0

Performance conditions

     NA       NA       NA       NA       NA       NA       NA       NA  

Fair value per BSAX

     30.32       31.89       33.05       33.45       29.47       30.88       31.99       33.44  

 

(1) The number of shares takes into account an exercise parity adjusted by the division by 15 of the nominal value of the shares decided by the general meeting on December 9, 2011; each BSAX warrant now gives the right to subscribe to 15 new shares instead of 1 new share. For the same reason, the exercise price of each BSAX plan was adjusted as a result and is thus equal to 1/15th of the price initially determined by the general meeting that authorized each of the plans.
(2) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of BSAX.

 

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Change in Number of BSAX Outstanding

 

     Year ended December 31,  
Number of BSAX    2014      2015      2016  

Balance at beginning of period

     2,131        2,131        1,036  

Granted during the period

     —        —        —  

Forfeited during the period

     —        —        —  

Exercised during the period

     —        1,095        —    

Expired during the period

     —        —        —  

Balance at end of period

     2,131        1,036        1,036  

Breakdown of the Closing Balance

 

     Year ended December 31,  
     2014      2015      2016  
Number of BSAX    Outstanding      Exercisable      Outstanding      Exercisable      Outstanding      Exercisable  

BSAX with exercise price of €65

     2,131        2,131        1,036        1,036        1,036        1,036  

Total

     2,131        2,131        1,036        1,036        1,036        1,036  

17.7 BCE2010

Date of Grant 06/24/2011

The BCE may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to one fourth (1/4) of the BCE on the 12/23/2011;

 

    up to one fourth (1/4) of the BCE on the 12/23/2012;

 

    up to one fourth (1/4) of the BCE on the 12/23/2013;

 

    up to one fourth (1/4) of the BCE on the 12/23/2014; and

 

    at the latest within before the 11/22/2021.

Date of Grant 11/22/2011

The BSPCE may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to one fourth (1/4) of the BSPCE on the 11/22/2012;

 

    up to one fourth (1/4) of the BSPCE on the 11/22/2013;

 

    up to one fourth (1/4) of the BSPCE on the 11/22/2014;

 

    up to one fourth (1/4) of the BSPCE on the 11/22/2015; and

 

    at the latest within before the 11/22/2021.

Details of BCE2010

 

Date of grant (Board of Directors)

   06/24/2011     06/24/2011     06/24/2011     06/24/2011     11/22/2011     11/22/2011     11/22/2011     11/22/2011  

Vesting period (years)

     0.5       1.5       2.5       3.5       1       2       3       4  

Plan expiration date

     11/22/2021       11/22/2021       11/22/2021       11/22/2021       11/22/2021       11/22/2021       11/22/2021       11/22/2021  

Number of BCE2010 granted

     6,000       6,000       6,000       6,000       2,510       2,510       2,510       2,509  

Share entitlement per BCE2010(1)

     15       15       15       15       15       15       15       15  

Exercise price

     77       77       77       77       77       77       77       77  

Valuation method used

     Black and Scholes  

Grant date share fair value

     77       77       77       77       77       77       77       77  

Expected volatility

     40     40     40     40     40     40     40     40

Average life of BCE2010

     5.5       6.0       6.5       7.0       5.4       5.9       6.4       6.9  

 

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Date of grant (Board of Directors)

   06/24/2011     06/24/2011     06/24/2011     06/24/2011     11/22/2011     11/22/2011     11/22/2011     11/22/2011  

Discount rate(2)

     2.55     2.68     2.68     2.87     2.05     2.42     2.42     2.66

Expected dividends

     0     0     0     0     0     0     0     0

Performance conditions

     NA       NA       NA       NA       NA       NA       NA       NA  

Fair value per BCE2010

     31.16       32.71       34.03       35.58       30.42       32.29       33.58       35.2  

 

(1) The number of shares takes into account an exercise parity adjusted by the division by 15 of the nominal value of the shares decided by the general meeting on December 9, 2011; each BCE2010 warrant now gives the right to subscribe to 15 new shares instead of 1 new share. For the same reason, the exercise price of each BCE2010 plan was adjusted as a result and is thus equal to 1/15th of the price initially determined by the general meeting that authorized each of the plans.
(2) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of BCE2010.

 

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Change in Number of BCE2010 Outstanding

 

     Year ended December 31,  
Number of BCE2010    2014      2015      2016  

Balance at beginning of period

     34,039        29,972        15,974  

Granted during the period

     —        —        —  

Forfeited during the period

     —        —        —  

Exercised during the period

     4,067        13,998        3,635  

Expired during the period

     —        —        —  

Balance at end of period

     29,972        15,974        12,339  

Breakdown of the Closing Balance

 

     Year ended December 31,  
     2014      2015      2016  
Number of BCE2010    Outstanding      Exercisable      Outstanding      Exercisable      Outstanding      Exercisable  

BCE2010 with exercise price of €77.00

     29,972        27,463        15,974        15,974        12,339        12,339  

Total

     29,972        27,463        15,974        15,974        12,339        12,339  

17.8 OPTIONS

Grant of 09/18/2013

The share options may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 518,000 SO (all the SO) on the fourth anniversary of the date of grant; and

 

    at the latest within ten (10) years from the date of grant.

Grant of 06/03/2014

The share options may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 75,000 SO (all the SO) on the 06/04/2016; and

 

    at the latest before the 06/03/2024.

Grant of 06/23/2015

The share options may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 30,000 SO on the 06/24/2016;

 

    up to 30,000 additional SO on the 06/24/2017;

 

    up to 30,000 additional SO on the 06/24/2018;

 

    up to 30,000 additional SO on the 06/24/2019;

 

    at the latest before the 06/24/2025.

Grant of 09/30/2015

The 195,000 share options may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 25% of the SO on the 09/30/2016;

 

    up to additional 25% of the SO on the 09/30/2017;

 

    up to additional 25% of the SO on the 09/30/2018;

 

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    up to additional 25% of the SO on the 09/30/2019;

 

    at the latest before the 09/30/2025.

Grant of 12/15/2015

The 75,000 share options may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 25% of the SO on the 12/15/2016;

 

    up to additional 25% of the SO on the 12/15/2017;

 

    up to additional 25% of the SO on the 12/15/2018;

 

    up to additional 25% of the SO on the 12/15/2019;

 

    at the latest before the 12/15/2025.

Grant of 04/06/2016

The 55,000 share options may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 8,250 SO on the 04/021/2017;

 

    up to additional 8,250 SO on the 04/21/2018;

 

    up to additional 8,250 SO on the 04/21/2019;

 

    up to additional 8,250 SO on the 04/21/2020;

 

    up to 5,500 SO on the 05/02/2017;

 

    up to additional 5,500 SO on the 05/02/2018;

 

    up to additional 5,500 SO on the 05/02/2019;

 

    up to additional 5,500 SO on the 05/02/2020;

 

    at the latest before 10 years of the date of the Grant.

Grant of 06/21/2016

The 154,100 share options may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 25% of the SO as of one year after the Grant date;

 

    up to additional 12.5% of the SO as of 18 months after the Grant date;

 

    up to additional 12.5% of the SO as of 24 months after the Grant date;

 

    up to additional 12.5% of the SO as of 30 months after the Grant date;

 

    up to additional 12.5% of the SO as of 36 months after the Grant date;

 

    up to additional 12.5% of the SO as of 42 months after the Grant date;

 

    up to additional 12.5% of the SO as of 48 months after the Grant date;

 

    at the latest before 10 years of the date of the Grant.

Grant of 12/09/2016

The 74,960 share options may be exercised by the beneficiary on the basis of the following vesting schedule:

 

    up to 18,740 SO as of one year after the Grant date;

 

    up to additional 9,370 SO as of 18 months after the Grant date;

 

    up to additional 9,370 SO as of 24 months after the Grant date;

 

    up to additional 9,370 SO as of 30 months after the Grant date;

 

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  up to additional 9,370 SO as of 36 months after the Grant date;

 

  up to additional 9,370 SO as of 42 months after the Grant date;

 

  up to additional 9,370 SO as of 48 months after the Grant date;

 

  at the latest before 10 years of the date of the Grant.

Details of SO

 

Date of grant (Board of Directors)

   09/18/2013     06/03/2014     06/23/2015     11/19/2015     01/04/2016     04/21/2016     05/02/2016  

Vesting period (years)

     4       2       1-4       1-4       1-4       1-4       1-4  

Plan expiration date

     09/18/2023       06/03/2024       06/23/2025       11/19/2025       01/04/2026       04/21/2026       05/02/2026  

Number of SO granted

     518,000       75,000       120,000       195,000       75,000       33,000       22,000  

Share entitlement per SO

     1       1       1       1       1       1       1  

Exercise price

     7.57       19.01       48.9       66.06       65.68       62.82       59.04  

Valuation method used

     Black and Scholes  

Grant date share fair value

     7.9       19.01       48.9       66.06       65.68       62.82       58.62  

Expected volatility

     40     40     51     51     49.3%-49.8     49.4%-50.7     49.3%-50.6

Average life of SO

     7       6       7       7       5-7       5-7       5-7  

Discount rate(1)

     1.72     0.89     0.89     0.81     0.39     0.04     0.10

Expected dividends

     0         0     0     0     0     0

Performance conditions

     NA       NA       NA       NA       NA       NA       NA  

Fair value per SO

     3.57       7.46       25.28       34.05       29.5-32.6       28.3-30.9       26.4-28.8  

 

(1) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of SO.

 

Date of grant (Board of Directors)

   06/21/2016     08/01/2016     09/15/2016     10/17/2016     11/15/2016     12/09/2016  

Vesting period (years)

     1-4       1-4       1-4       1-4       1-4       1-4  

Plan expiration date

     06/21/2026       08/01/2026       09/15/2016       10/17/2026       11/15/2026       12/09/2026  

Number of SO granted

     110,000       10,000       9,300       16,500       8,300       74,960  

Share entitlement per SO

     1       1       1       1       1       1  

Exercise price

     53.96       62.24       62.8       64.39       68.33       69.75  

Valuation method used

     Black and Scholes  

Grant date share fair value

     52.97       62.24       62.8       64.39       68.33       69.75  

Expected volatility

     49.1%-50.3     48.8%-49.8     48.6%-49.4     48.0%-48.9     47.8%-48.8     47.7%-48.5

Average life of SO

     5-7       5-7       5-7       5-7       5-7       5-7  

Discount rate(1)

     -0.01     -0.25     -0.18    

-0.32

0.15

% - 

   

-0.11

+0.16


   

-0.2

+0.18


Expected dividends

                         0

Performance conditions

     NA       NA       NA       NA       NA       NA  

Fair value per SO

     23.4-25.5       27.3-29.9       27.4-30.1       27.6-30.6       29.4-32.7       29.7-33.4  

 

(1) Based on French government bonds (GFRN) with a maturity corresponding to the maturity of SO.

 

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Change in Number of SO Outstanding

 

     December 31,  
Number of SO    2014      2015      2016  

Balance at beginning of period

     518,000        546,000        861,000  

Granted during the period

     75,000        315,000        359,060  

Forfeited during the period

     47,000        —          25,000  

Exercised during the period

     —        —        35,000  

Expired during the period

     —        —        —  

Balance at end of period

     546,000        861,000        1,160,060  

Breakdown of the Closing Balance

 

     Year ended December 31,  
     2014      2015      2016  
Number of SO    Outstanding      Exercisable      Outstanding      Exercisable      Outstanding      Exercisable  

SO with exercise price of €7.57

     471,000        —        471,000        —        471,000        —  

SO with exercise price of €19.01

     75,000      —        75,000        —        40,000        40,000

SO with exercise price of €48.90

     —        —        120,000        —        120,000        45,000

SO with exercise price of €66.06

     —        —        195,000        —        170,000        —  

SO with exercise price of €65.68

     —        —        —          —        75,000        —  

SO with exercise price of €62.82

     —        —        —          —        33,000        —  

SO with exercise price of €59.04

     —        —        —          —        22,000        —  

SO with exercise price of €53.96

     —        —        —          —        110,000        —  

SO with exercise price of €62.24

     —        —        —          —        10,000        —  

SO with exercise price of €62.80

     —        —        —          —        9,300        —  

SO with exercise price of €64.39

     —        —        —          —        16,500        —  

SO with exercise price of €68.33

     —        —        —          —        8,300        —  

SO with exercise price of €69.75

     —        —        —          —        74,960        —  

Total

     546,000        —        861,000        —        1,160,000        85,000

The exercise prices, anticipated lifetime, and fair value of the underlying shares based on the share price on the Euronext market on the grant date of the warrants were used for the valuation of each category of compensation in shares.

17.9 FREE SHARES

The free shares are subject to a two-year vesting period.

Details of Free Shares

 

Date of grant (Board of Directors)

  04/02/2012     07/25/2012     11/28/2012     07/25/2013&09/12/2013     06/03/2014  

Vesting period (years)

    2       2       2       2       2  

Number of free shares granted

    669,796       134,081       35,360       501,500       186,000  

Share entitlement per free share (1)

    1       1       1       1       1  

Grant date share fair value

    8.86       8.20       8.70       7.96       19.01  

Expected dividends

    0     0     0     0     0

Performance conditions

    Yes (1)      Yes (1)      No       Yes (2)      Yes (3) 

Expected turnover during the vesting period

    1     1     1     1     1

Date of grant (Board of Directors)

  09/30/2015     12/15/2015        

Vesting period (years)

    2       2    

Number of free shares granted

    708,500       42,000    

Share entitlement per free share (1)

    1       1    

Grant date share fair value

    62.99       64.14    

Expected dividends

    0     0  

Performance conditions

    Yes (4)      Yes (4)   

Expected turnover during the vesting period

    0     0  

 

(1) The acquisition of free shares is contingent for certain individuals (the “Key Managers”), including Dr. Benhamou, upon the achievement of the three performance criteria below:

 

    One-third of the shares allocated to Key Managers will only be acquired from the later of the two following dates (i) expiry of a period of two years from the date of allocation and (ii) inclusion of the 100th patient in the VIPES phase II study.

 

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    One-third of the shares allocated to Key Managers will only be acquired from the later of the two following dates (i) expiry of a period of two years from the date of allocation and (ii) achievement of the principal evaluation criterion in the VIPES phase II study.

 

    One-third of the shares allocated to Key Managers will only be acquired from the later of the two following dates (i) expiry of a period of two years from the date of allocation and (ii) inclusion of the first patient in the Viaskin Milk phase II study.

 

(2) The acquisition of free shares is contingent for the Key Managers, including Dr. Benhamou, upon the achievement of the three performance criteria below:

 

    One-third of the shares allocated to Key Managers will only be acquired from the later of the two following dates (i) expiry of a period of two years from the date of allocation and (ii) inclusion of the 100th patient in the Viaskin Peanut phase III study a maximum of twelve (12) months after the inclusion of the first patient in the study.

 

    One-third of the shares allocated to Key Managers will only be acquired from the later of the two following dates (i) expiry of a period of two years from the date of allocation and (ii) approval by the FDA of a protocol for the Phase III trial of Viaskin Peanut.

 

    One-third of the shares allocated to Key Managers will only be acquired from the later of the two following dates (i) expiry of a period of two years from the date of allocation and (ii) an increase of at least fifty (50) per cent for five (5) consecutive days of the Company’s share price compared with the closing price of the Company’s shares listed on Euronext Paris on the day of the adoption of the 2013 free share allocation plan, or July 25, 2013.

It is specified that in the event of a change of control of the Company (as defined in Article L. 233-3 of the Commercial Code), the performance criteria will be considered as definitively achieved.

 

(3) The acquisition of free shares is contingent for the Key Managers, including Dr. Benhamou, upon the achievement of the two performance criteria below:

 

    Half of the shares allocated to Key Managers will only be acquired from the later of the two following dates (i) expiry of a period of two years from the date of allocation and (ii) inclusion of the 100th patient in the Viaskin Peanut phase III study a maximum of twelve (12) months after the inclusion of the first patient in the study.

 

    Half of the shares allocated to Key Managers will only be acquired from the later of the two following dates (i) expiry of a period of two years from the date of allocation and (ii) approval by the FDA of a protocol for the Phase III trial of Viaskin Peanut.

 

(4) The acquisition of free shares is contingent for all the employees, including Dr. Benhamou, upon the achievement of the three performance criteria below:

 

    One third of the shares will only be acquired from the later of the following two dates : (i) the end of the 2 year vesting period which runs from September 30, 2015 and (ii) achievement of the primary efficacy endpoint of the Phase III ‘Pepites’ trial for Viaskin Peanut;

 

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    One third of the shares will only be acquired from the later of the following two dates : (i) the end of the 2 year vesting period which runs from September 30, 2015 and (ii) achievement of the primary efficacy endpoint of the Phase II ‘Miles’ trial for Viaskin Milk;

 

    One third of the shares will only be acquired from until the later of the following two dates: (i) the end of the 2 year vesting period which runs from September 30, 2015 and (ii) the beginning of clinical testing of another product candidate from the Viaskin platform.

 

Board of Directors Grant date

   04/06/2016     06/21/2016     08/16/2016     09/01/2016     10/27/2016     12/09/2016  

Vesting period (years)

     2       2       2       2       2       2  

Number of free shares granted

     63,750       193,000       10,000       5,000       15,000       23,600  

Share entitlement per free share

     1       1       1       1       1       1  

Grant date share fair value

     62.40       52.97       60.68       61.49       67.44       69.75  

Expected dividends

     0     0     0     0     0     0

Performance conditions

     yes (1)      yes (1)      yes (1)      yes (1)      yes (2)      yes (2) 

Expected turnover during the vesting period

     0     0     0     0     0     0

 

(1) The acquisition of free shares is contingent for all the employees, including Dr. Benhamou, upon the achievement of the three performance criteria below:

 

    One third of the shares will only be acquired from the later of the following two dates: (i) the end of the 2 year vesting period which runs from Grant Date and (ii) achievement of the primary efficacy endpoint of the Phase III ‘Pepites’ trial for Viaskin Peanut;

 

    One third of the shares will only be acquired from the later of the following two dates: (i) the end of the 2 year vesting period which runs from Grant Date and (ii) achievement of the primary efficacy endpoint of the Phase II ‘Miles’ trial for Viaskin Milk;

 

    One third of the shares will only be acquired from until the later of the following two dates: (i) the end of the 2 year vesting period which runs from Grant date and (ii) the beginning of clinical testing of another product candidate from the Viaskin platform.

 

(2) The acquisition of free shares is contingent for key and new employees upon the achievement of the two performance criteria below:

 

    Half of the shares will only be acquired from the later of the following two dates: (i) the end of the 2 year vesting period which runs from Grant Date and (ii) achievement of the primary efficacy endpoint of the Phase III ‘Pepites’ trial for Viaskin Peanut;

 

    Half of the shares will only be acquired from the later of the following two dates: (i) the end of the 2 year vesting period which runs from Grant Date and (ii) achievement of the primary efficacy endpoint of the Phase II ‘Miles’ trial for Viaskin Milk.

Performance conditions other than market conditions, which are taken into account by adjusting the number of equity instruments included in the measurement of the transaction amount, but are not taken into account when estimating the fair value of the shares.

Change in Number of Free Shares Outstanding

 

     Year ended December 31,  
Number of Free shares    2014      2015      2016  

Balance at beginning of period

     1,340,737        641,360        1,008,329  

Granted during the period

     186,000        750,500        310,350  

Forfeited during the period

     83,360        61,833        24,000  

Exercised during the period

     802,017        321,698        257,829  

Expired during the period

     —          —        —    

Balance at end of period

     641,360        1,008,329        1,036,850  

 

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Note 18: Financial Revenue and Expenses

The financial income and expenses are broken down as follows:

 

     Year ended December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Financial revenues

     727        1,018        1,516  

Financial expenses

     (103      (146      (16
  

 

 

    

 

 

    

 

 

 

Total

     624        871        1,500  
  

 

 

    

 

 

    

 

 

 

The financial income mainly includes capital gains on the disposals of investment securities. The foreign exchange losses and the expenses related to the accretion of the OSEO, BpiFrance and COFACE advances are classified as financial expenses in the Consolidated Statements of (Loss).

Note 19: Income Tax Expense

As mentioned in Note 3.13—Accounting Principles—Other Income, the French Research Tax Credit is not included in the line item “Income taxes” but included in the line item “Other Income.”

Reconciliation between the Effective and Nominal Income Tax Expense

The following table shows the reconciliation between the effective and nominal tax expense at the nominal standard French rate of 33.33% (excluding additional contributions):

 

     Year ended December 31,  
     2014     2015     2016  
     (Amounts in thousands of Euros)  

(Loss) before taxes

     (24,012     (44,674     (114,531

Theoretical group tax rate

     33,33     33,33     33,33

Nominal tax expense

     8,003       14,890       38,173  

Increase/decrease in tax expense arising from:

      

Permanent differences (1)

     3,636       6,089       —    

Research tax credit

     1,446       1,895       2,409  

Share-based compensation

     (1,546     (3,473     (11,451

Non recognition of deferred tax assets related to tax losses and temporary differences

     (11,458     (19,211     (29,195

Other differences

     (81     190       64  

Effective tax expenses

     0       0       0  

Effective tax rate

     0     0     0

 

(1) The significant balance of permanent differences is mainly affected by transaction costs on capital increases occurred in 2014 and 2015. These transaction costs are booked in equity and are subject to a tax deduction.

 

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Deferred Tax Assets and Liabilities

As mentioned in Note 3.15, the Company has not recognized deferred tax assets in the Consolidated Statements of Financial Position. The amount of the losses carried forward at the end of December 2016 is €246.4 million including €230 million for DBV Technologies S.A.

Note 20: Commitments

Obligations Under the Terms of the Ordinary Rental Agreements

The principal offices of the Company occupy a 4,770 square meter facility consisting of office and laboratory space, pursuant to a lease agreement dated March 9, 2015, which expires on March 8, 2024. The Company also has a second facility in Bagneux, France, which was its former corporate headquarters. This facility consists of 1,479 square meters of office and laboratory space and is used primarily by the Company’s industrial and production teams. This lease expires on May 31, 2020.

The Company has an office in North America to support the U.S. subsidiary as well as future commercialization needs. The Company subleases 3,913 square feet of office space in New York, New York. This sublease is for an initial period of 25 months and expires on June 30, 2017. The Company expects to enter into a similar lease agreement in the New York City area prior to end of this sublease.

The Company also leases a commercial facility of 8,919 square feet in Summit, New Jersey, which is intended to support the manufacturing needs through the launch and commercialization of Viaskin Peanut in North America, if the appropriate regulatory approvals are received. This lease commenced on September 19, 2016 for a period of eight years and four months. This lease includes extension options of two to five-year periods.

The amount of future rents and charges in that capacity breaks down as follows at December 31, 2016:

 

     12/31/2016  

2017

     2,298  

2018

     2,156  

2019

     2,162  

2020

     1,936  

2021

     1,776  

2022

     1,782  

2023

     1,789  

2024

     1,228  
  

 

 

 

Total

     15,128  
  

 

 

 

In July 2014, the Company signed a lease agreement for laboratory equipment. The future rental payments as at December 31, 2016 are as follows:

 

    2017: €12,466.

The Company has signed various ordinary rental agreements for office equipment and vehicles. The future rental payments as at December 31, 2016 are as follows:

 

    2017: €56,431;

 

    2018: €53,295;

 

    2019 : €13,639;

 

    2020 : €6,955.

 

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Obligations Under the Terms of Other Agreements

The Company signed with its bank CIC an acquisition contract of monetary market fund “SICAV CM-CIC” pledged as a guarantee for the ordinary rental agreements of the premises of Bagneux for an amount of €0.4 million.

The Company also signed a letter of credit to ensure the sub-lease of its premises of its New York subsidiary company for $164 thousand due on March 17, 2016. This credit note has been extended for an additional year.

A letter of credit has also been signed by the Company in April 2016 for $143 thousands to ensure the lease of its premises of its Summit (NJ) subsidiary.

In addition, the Company took a term deposit for a sum of €227 thousand over 3 years.

As it has sub-contracted several important functions, the Company has been required to conclude, within the framework of its current operations, sub-contracting contracts or short- or medium-term delegation contracts with various third parties, in France and abroad, which include various obligations that are usual in these circumstances.

Within the context of launching its clinical studies for Viaskin Peanuts and Viaskin Milk products, the Company signed agreements with several contract research organizations (CRO).

The ongoing studies amount globally to €77.8 million.

As of December 31, 2016, the amount remaining to pay as part of these contracts until year ended 2021 is €54.1 million.

On January 7, 2009, the Company entered into an assignment, development and co-ownership agreement with Public Welfare-Hospitals of Paris (L’Assistance Publique—Hopitaux de Paris), or AP-HP, and Université Paris-Descartes, or UPD, by which the Company agreed to terms of co- ownership with AP-HP and UPD of certain U.S. and foreign patents and patent applications, referred to herein as the shared patents. The Company, and any licensees or sublicensees the Company designates, have the exclusive right to commercial uses of the shared patents. AP-HP and UPD agreed to use the shared patents only for internal research purposes and not to license the shared patents to any third party. Upon commercialization of any product covered by the shared patents, which the Company expects would include its Viaskin product candidates, the Company will be obligated to pay AP-HP and UPD a percentage of net sales as a royalty. This royalty varies depending on the particular patent used in the product and is in the low single digits. Additionally, if the Company licenses any of the shared patents to a third party and a licensee commercializes products covered by such shared patents, the Company will be obligated to pay AP-HP and UPD a percentage in the low single digits of the money it receives from its licensee. If the Company does not sell any of its product candidates covered by the shared patents within 30 months from the date it first markets such product candidates, AP-HP may, upon six months’ notice and subject to certain exceptions, convert its exclusive right to the commercial use of the shared patents to a non-exclusive right. Any party may terminate the license in the event of another party’s substantial breach which remains uncured after six months of receiving written notice of such breach. The agreement will also terminate in the event the Company ceases operations or is subject to a dissolution or bankruptcy proceedings. Absent early termination, the agreement will automatically terminate upon the expiration of the last shared patent. In the event the agreement is terminated, the Company would no longer have the exclusive right to commercial use of the shared patents, though it would retain its shared ownership rights. In addition, its ownership stake in certain jointly made improvements covered by the shared patents would survive termination of the agreement. The longest lived patent rights licensed to the Company under the agreement are currently expected to expire in 2028. To date, this agreement has not had an impact on the Company’s financial statements.

Note 21: Relationships with Related Parties

The compensation amounts for 2016 presented below, which were awarded to the members of the Board of Directors and the Executive Committee of the Company totals €16.9 million.

Following the reorganization of the Company at the beginning of 2015, the Company henceforth considered the members of the Executive Committee to be related parties.

Amounts in thousands of euros:

 

     December 31,  
     2014      2015      2016  

Members of the Board of Directors

     433        605        714  

Executive Committee

     887        1,768        2,268  

Directors’ fees

     40        195        195  

Share-based payments to members of the Board of Directors

     2,771        4,637        13,714  

Total

     4,131        7,205        16,891  

 

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The methods for the valuation of the benefit related to share-based payments are presented in Note 17.

Effective January 2017, the Company entered into a consulting agreement with Dan Soland, one of its directors pursuant to which he has agreed to provide consulting services to the Company, upon its request, related to the review of our commercialization strategy. No related expense was recorded as an expense for 2016, as the agreement will start in 2017. The initial term of the agreement is for one year, subject to renewal upon mutual agreement. Mr. Soland will receive a lump sum of €45,000, to be paid by us on a semi-annual basis.

A schedule of amounts payable to related parties as of December 31, in thousands of euros:

 

     December 31,  
     2014      2015      2016  

Compensation

     345        674        767  

Directors’ fees

     40        195        195  

Pension obligations

     159        233        342  

Total

     544        1,102        1,304  

Note 22: Earnings Per Share

Taking into account the division of the nominal value of shares of the Company by 15, which was decided by the annual general meeting on December 9, 2011 the amount of shares is adjusted, and multiplying it by 15, for all the outstanding shares presented. The basic earnings per share is calculated by dividing the net income going to the shareholders of the Company by the weighted average number of common shares outstanding during the course of the fiscal year. The weighted average number of shares was 16,086,247 in 2014. The weighted average number of shares was 21,522,342 in 2015. The weighted average number of shares was 24,454,850 in 2016.

The instruments that entitle their holders to a portion of the share capital on a deferred basis (BSAs, BSPCEs) are considered to be anti-dilutive (1,437,684 instruments in 2014, 2,033,768 instruments in 2015 and 2,360,945 instruments in 2016, corresponding respectively to 2,207,530, 2,336,224 and 2,606,435 ordinary shares to be issued). These instruments are presented in detail in Note 17. Therefore, the diluted earnings per share are identical to the basic earnings per share.

 

     December 31,  
     2014      2015      2016  
     (Amounts in thousands of Euros)  

Net income of the reporting period

     (24,012      (44,674      (114,531

Adjusted weighted average number of outstanding shares

     16,086,247        21,522,342        24,454,850  
  

 

 

    

 

 

    

 

 

 

Basic / Diluted earnings per share (€/share)

     (1.49      (2.08      (4.68
  

 

 

    

 

 

    

 

 

 

Note 23: Management of Financial Risks

The principal financial instruments of the Company are comprised of financial assets, cash, and investment securities. The purpose of managing these instruments is to allow the business activities of the Company to be financed. It is not the Company’s policy to subscribe to financial instruments for speculative purposes. The Company does not utilize derivatives.

The principal risks to which the Company is exposed are liquidity risk, interest rate risk and credit risk.

 

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Liquidity Risk

The Company could need to strengthen its shareholders’ equity or rely on additional financing in order to ensure its development.

Since it was formed, the Company has financed its growth by reinforcing its shareholders’ equity through a succession of increases in the share capital, obtaining public assistance in support of innovation, and reimbursements of Research Tax Credit claims, but has never utilized bank loans. Therefore, the Company is not exposed to a liquidity risk resulting from the implementation of any early repayment clauses in loan agreements for such borrowings.

As of this date, the Company does not believe that it is exposed to a short-term liquidity risk, considering the cash and cash equivalents that the Company has available as of December 31, 2016 is €256 million, which is mainly composed of cash and term deposits that are convertible into cash immediately without penalties in case of a need for cash.

Significant research and development efforts and expenditures related to clinical studies have been initiated since the start-up of the Company’s business, which has thus far generated negative operating cash flows.

The Company will continue to have significant financing requirements in the future for the development of its technology, the continuation of its clinical development program, and the equipment for its own pharmaceutical laboratory, as well as for the production and marketing of its products in the future. It is possible that the company will find itself unable to self-finance its growth, which would compel it to seek other sources of financing, particularly through new increases in share capital.

The level of the financing requirements of the Company and how they are phased out over time depend on factors that are largely beyond the control of the Company such as:

 

    higher costs and slower progress than anticipated for its research and development and clinical studies programs;

 

    the costs of preparing, filing, defending, and maintaining its patents and other intellectual property rights;

 

    higher costs and longer time periods than anticipated for obtaining the regulatory authorizations for the marketing of its products as well as for gaining access to insurance reimbursement for them, including the time required to prepare the applications to the competent authorities;

 

    costs for responding to changes in the Viaskin® technology and for conducting the manufacturing and marketing on some or all of its products; and

 

    new opportunities to develop new products or to acquire technologies, products, or companies.

It is possible that the Company will be unable to obtain additional capital when it needs it, or that such capital may not be available on financial terms that are acceptable to the Company. If the necessary funds are not available, the Company could have to:

 

    delay, reduce, or eliminate the number or the scope of its pre-clinical and clinical trials;

 

    grant licenses to its technologies to partners or third parties; or

 

    conclude new collaboration agreements on terms less favorable to it than those that it could have obtained in a different context.

In addition, to the extent that the Company raises capital by issuing new shares, the investment of its shareholders could be diluted. Furthermore, financing by debt, to the extent that it is available, could also include restrictive conditions for the Company and its shareholders.

The occurrence of one or more of these risks could have a material adverse effect on the Company, its business, its financial position, its earnings, its development, and its prospects.

Interest Rate Risk

The Company’s exposure to interest-rate risk primarily involves investment securities. These are composed of money market funds and time deposit accounts. Changes in interest rates have a direct impact on the rate of return on these investments and the cash flows generated.

The Company has no variable rate debt. The repayment flows of its debts are not subject to interest rate risk.

The repayment of the conditional advances may vary depending on whether or not objectives are attained. The change in the flows of the anticipated repayments is treated in the income statement (Note 3.10).

 

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As of this date, the Company has not contracted borrowings from credit institutions and, therefore, has only very low exposure to interest rate risk.

Credit Risk

The credit risk related to the cash, the cash equivalents, and the current financial instruments is not significant in light of the quality of the co-contracting financial institutions.

Fair Value

The fair value of financial instruments traded on an active market, such as the securities available for sale, is based on the market rate as of the closing date. The market prices used for the financial assets owned by the Company are the bid prices in effect on the market as of the valuation date.

The nominal value, less the provisions for depreciation, of the accounts receivable and current debts, is presumed to approximate the fair value of those items.

Foreign Exchange Risk

The Company is exposed to a very insignificant foreign exchange risk inherent in some of its supplies obtained in the United States, which have been invoiced in US dollars. As of this date, the company does not make sales revenue in dollars or in any other currency other than the euro; the Company does not receive any full or partial mechanical endorsement. The exposure to currencies other than the U.S. dollar is negligible.

For 2014, 2015 and 2016, less than 12%, respectively, of our purchases and other external expenses have been made in U.S. dollars, generating a negligible net annual foreign exchange loss of €24 thousands in 2014 and net foreign exchange gain of €79 thousands in 2015 and €682 thousands in 2016.

In light of these insignificant amounts, the Company has not adopted, at this stage, a hedging mechanism in order to protect its business activity against fluctuations in exchange rates. The Company cannot rule out the possibility that a significant increase in its business, particularly in the United States, may result in greater exposure to exchange rate risk and should thus consider adopting an appropriate policy for hedging against these risks.

Note 24: Events After the Close of the Fiscal Year

The Company evaluated subsequent events that occurred after December 31, 2016 through the date of the Board of Directors which authorized the issuance of the Consolidated Financial Statements and determined that there are no significant events that require adjustments or disclosure in such Consolidated Financial Statements.

 

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SIGNATURES

The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this Amendment No. 1 to the annual report on its behalf.

 

DBV TECHNOLOGIES S.A.

/s/ Dr. Pierre-Henri Benhamou

By:   Dr. Pierre-Henri Benhamou
Title:  

Chief Executive Officer

(Principal Executive Officer)

Date: January 29, 2018