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 registrants 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 issuers 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
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.
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
* | Filed herewith. |
** | Furnished herewith. |
F-1
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 Companys 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 Companys 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 Companys internal control over financial reporting.
/s/ Deloitte & Associés
Represented by Julien Razungles
Neuilly-sur-Seine, France
March 22, 2017
F-2
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 Companys 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 Managements Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Companys 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 companys internal control over financial reporting is a process designed by, or under the supervision of, the companys principal executive and principal financial officers, or persons performing similar functions, and effected by the companys 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 companys 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 companys 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
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 | |||||||||||||
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|
|
|
|
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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 | |||||||||||||
|
|
|
|
|
|
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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 | |||||||||||||
|
|
|
|
|
|
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
125,416 | 343,280 | 287,500 | |||||||||||||
|
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|
|
|
The accompanying notes form an integral part of these consolidated financial statements.
F-4
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
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 | ) | ||||||
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|
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|
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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
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 | |||||||||||||
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Operating cash flows before change in working capital |
(18,770 | ) | (32,761 | ) | (78,566 | ) | ||||||||||
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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 | ||||||||||||
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Net cash flow used in operating activities |
(20,560 | ) | (26,763 | ) | (59,538 | ) | ||||||||||
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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 | ) | ||||||||||
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Net cash flows used in investment activities |
(1,096 | ) | (5,347 | ) | (8,300 | ) | ||||||||||
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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 | ) | |||||||||||
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Net cash flows from financing activities: |
96,808 | 241,014 | 1,666 | |||||||||||||
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(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 | |||||||||||||
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Impact of exchange rate fluctuations |
| (78 | ) | (735 | ) | |||||||||||
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Net cash and cash equivalents at the close of the period |
9 | 114,555 | 323,381 | 256,473 | ||||||||||||
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The accompanying notes form an integral part of these consolidated financial statements.
F-7
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 | ) | ||||||||||||||||||||
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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 | ||||||||||||||||||||||
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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 | ||||||||||||||||||
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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 | ||||||||||||||||||
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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 | ) | ||||||||||||||||
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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 | ||||||||||||||||||
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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.
F-8
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 cows 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 Companys 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 cows 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 Childrens 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 hens 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 Companys needleless and adjuvant-free patch technology, Viaskin, to epicutaneously deliver two doses of BioNets 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 Companys 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 Companys 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 GROUPS 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 Companys clinical development programs and medical affairs. In partnership with Dr. Hugh Sampson and Laurent Martin, the Companys Chief Scientific Officer and Chief Development Officer, respectively, Dr. Septién will be instrumental in the advancement of the Companys 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 Companys ordinary shareholders general meeting. Claire Giraut will serve on the Boards Audit Committee. With these additions, the Companys 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 Companys ordinary shares on the Euronext Paris and in accordance with the European Unions 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 Companys 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 Companys 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 Groups 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 entitys 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 Groups 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 dentreprise or BSPCEs) granted to employees and/or executives and in the form of share warrants (bons de souscription dactions 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 dAssurance 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 Companys 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 cows 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 dInvestissement, 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 dImpôt 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 cows 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 Companys collaboration agreement are deferred and recognized over the service period obligation. Upon entry into the collaboration agreement, the Companys 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.
F-18
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 | |||||||||||
|
|
|
|
|
|
|
|
F-19
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 Companys 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 dinvestissement 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 | | | |||||||||
|
|
|
|
|
|
F-20
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 | |||||||||
|
|
|
|
|
|
F-21
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 Companys 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 | |||
|
|
F-22
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.
F-23
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
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).
F-25
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 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
F-26
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.
F-27
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 |
F-28
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 cows 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; |
F-29
| 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; |
F-30
| 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 dAssurance 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 | ||||||||||||
|
|
|
|
|
|
|
|
F-31
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 |
F-32
Commitments for Compensation Payable to Employees Upon Their Retirement
Amounts in thousands |
||||
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 lIndustrie 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; |
F-33
| Collective agreement: Convention Collective Nationale de lIndustrie 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.
F-34
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 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
F-35
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 | |||||||||
|
|
|
|
|
|
F-36
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 | |||||||||
|
|
|
|
|
|
F-37
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 Companys 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 dEntreprise or BSPCE), (Bons de Createurs dEntreprise or BCE) and (Bons de Souscription dActions 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); |
F-38
| 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. |
F-39
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. |
F-40
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. |
F-41
(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 |
F-42
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. |
F-43
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. |
F-44
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. |
F-45
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 |
F-46
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. |
F-47
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 |
F-48
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. |
F-49
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; |
F-50
| 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; |
F-51
| 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 | % | 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 | % | 0 | % | 0 | % | 0 | % | 0 | % | 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. |
F-52
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. |
F-53
| 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 Companys share price compared with the closing price of the Companys 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; |
F-54
| 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 |
F-55
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 3.13Accounting PrinciplesOther 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. |
F-56
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 Companys 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 | |||
|
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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. |
F-57
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 (LAssistance PubliqueHopitaux 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 partys 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 Companys 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 |
F-58
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 | |||||||||
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Basic / Diluted earnings per share (/share) |
(1.49 | ) | (2.08 | ) | (4.68 | ) | ||||||
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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 Companys 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.
F-59
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 Companys 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 Companys 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).
F-60
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.
F-61
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
Exhibit 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
I, Pierre-Henri Benhamou, certify that:
1. | I have reviewed this Amendment No. 1 to the Annual Report on Form 20-F of DBV Technologies S.A.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; and |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report. |
Date: January 29, 2018 | ||
/s/ Pierre-Henri Benhamou | ||
Name: | Pierre-Henri Benhamou | |
Title: | Chief Executive Officer (Principal Executive Officer) |
Exhibit 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
I, David Schilansky, certify that:
1. | I have reviewed this Amendment No. 1 to the Annual Report on Form 20-F of DBV Technologies S.A.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; and |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report. |
Date: January 29, 2018 | ||
/s/ David Schilansky | ||
Name: | David Schilansky | |
Title: | Deputy Chief Executive Officer (Principal Financial Officer) |
Exhibit 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
In connection with the filing of this Amendment No. 1 to the Annual Report of DBV Technologies S.A. (the Company) on Form 20-F for the fiscal year ended December 31, 2016 as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Pierre-Henri Benhamou, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: January 29, 2018 | ||
/s/ Pierre-Henri Benhamou | ||
Name: | Pierre-Henri Benhamou | |
Title: | Chief Executive Officer (Principal Executive Officer) |
Exhibit 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
In connection with the filing of this Amendment No. 1 to the Annual Report of DBV Technologies S.A. (the Company) on Form 20-F for the fiscal year ended December 31, 2016 as filed with the Securities and Exchange Commission on the date hereof (the Report), I, David Schilansky, Deputy Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: January 29, 2018 | ||
/s/ David Schilansky | ||
Name: | David Schilansky | |
Title: | Deputy Chief Executive Officer (Principal Financial Officer) |