Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures.
We maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to management, including our chief executive officer (principal executive officer) and chief financial officer (principal financial officer), as appropriate, to allow timely decisions regarding required disclosure.
Our principal executive officer and principal financial officer evaluated the effectiveness of these disclosure controls and procedures and concluded that as of December 31, 2021, our disclosure controls and procedures were effective.
Management’s Report on Internal Control Over Financial Reporting.
Our management is responsible for establishing and maintaining adequate internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) and for the assessment of the effectiveness of our internal control over financial reporting. Under the supervision and with the participation of our chief executive officer (principal executive officer) and chief financial officer (principal financial officer), management assessed the effectiveness of our internal control over financial reporting based upon the framework in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements and can only provide reasonable assurance regarding the reliability of financial reporting and the
100
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preparation of financial statements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
A deficiency in internal control over financial reporting exists when the design or operation of a control does not allow management or employees, in the normal course of performing their assigned functions, to prevent or detect misstatements on a timely basis. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the registrant’s annual or interim financial statements will not be prevented or detected on a timely basis.
Based on this assessment, our management has concluded that our internal control over financial reporting was effective as of December 31, 2021.
As a smaller reporting company, our independent registered accounting firm is not required to issue an attestation report on our internal control over financial reporting.
Changes in Internal Control over Financial Reporting.
There were no changes to our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The information required by this Item 10 will be included in the sections titled “Board of Directors and Corporate Governance” and “Information About Our Executive Officers” in our Proxy Statement and is incorporated herein by reference.
Item 11. Executive Compensation.
The information required by this Item 11 will be included in the sections titled “Executive Compensation” and “Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this Item 12 will be included in the sections titled “Security Ownership of Certain Beneficial Owners and Management” and “Executive Compensation” in our Proxy Statement and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item 13 will be included in the sections titled “Board of Directors and Corporate Governance” and “Certain Relationships and Related Person Transactions” in our Proxy Statement and is incorporated herein by reference.
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Item 14. Principal Accountant Fees and Services.
The information required by this Item 14 will be included in Proposal 5 in the section titled “Audit Fees and Services” in our Proxy Statement and is incorporated herein by reference.
PART IV
Item 15. Exhibits and Financial Statement Schedules.
The financial statements schedules and exhibits filed as part of this Annual Report on Form 10-K are as follows:
(a)(1) Financial Statements
Reference is made to the financial statements included in Item 8 of Part II hereof.
(a)(2) Financial Statement Schedules
All other schedules are omitted because they are not required or the required information is included in the financial statements or notes thereto.
(a)(3) Exhibits
102
Table of Contents
EXHIBIT INDEX
Incorporated by Reference
Exhibit
Description
Schedule/
Form
File Number
Exhibit
File Date
3.1*
By-laws ( statuts ) of the registrant (English translation)
4.1
Form of Deposit Agreement
Form F-1/A
333-198870
4.1
10/15/14
4.2
Form of American Depositary Receipt
Form F-1/A
333-198870
4.1
10/15/14
4.3
Description of Registered Securities
Form 20-F
001-36697
2.3
03/20/20
4.4
Registration Rights Agreement, dated as of March 23, 2018, between the registrant, 667, L.P. and Baker Brothers Life Sciences, L.P.
Form 6-K
001-36697
4.1
03/23/18
10.1
Office Lease between the registrant and GENERALI VIE, dated March 3, 2015 (English translation)
Form 20-F
001-36697
4.2
04/29/15
10.2
Assignment, Development and Co-Ownership Agreement among the registrant, L’Assistance Publique—Hopitaux de Paris and Université Paris Descartes, dated January 7, 2009 (English translation)
Form F-1
333-198870
10.2
09/22/14
10.3#
Development Collaboration and License Agreement between the registrant and NESTEC S.A., dated May 27, 2016
Form 20-F
001-36697
4.14
03/22/17
10.4#
Amendment to Development Collaboration and License Agreement between the registrant and NESTEC S.A., dated July 12, 2018
Form 20-F
001-36697
4.5
04/01/19
10.5†
Form of Indemnification Agreement between the registrant and each of its executive officers and directors
Form F-1/A
333-198870
10.3
10/15/14
10.6†
2013 and 2014 Share Option Plans (English translation)
Form F-1
333-198870
10.4
09/22/14
10.7†
2012, 2013 and 2014 Free Share Plans (English translation)
Form F-1
333-198870
10.5
09/22/14
10.8†
Summary of BSA
Form F-1
333-198870
10.6
09/22/14
10.9†
Summary of BSPCE
Form F-1
333-198870
10.7
09/22/14
10.10†
2015 Share Option Plan (English translation)
Form 20-F
001-36697
4.10
04/28/16
10.11†
2015 Free Share Plans (English translation)
Form 20-F
001-36697
4.11
04/28/16
10.12†
2016 Share Option Plan (English translation)
Form 20-F
001-36697
4.12
03/22/17
10.13†
2016 Free Share Plan (English translation)
Form 20-F
001-36697
4.13
03/22/17
10.14†
2017 Share Option Plan (English translation)
Form 20-F
001-36697
4.14
03/16/18
10.15†
2017 Free Share Plan (English translation)
Form 20-F
001-36697
4.15
03/16/18
103
Table of Contents
Incorporated by Reference
Exhibit
Description
Schedule/
Form
File Number
Exhibit
File Date
10.16†
2018 Share Option Plan (English translation)
Form 20-F
001-36697
4.17
04/01/19
10.17†
2018 Free Share Plan (English translation)
Form 20-F
001-36697
4.18
04/01/19
10.18†
2019 Share Option Plan (English translation)
Form 20-F
001-36697
4.19
03/20/20
10.19†
2019 Free Share Plans (English translation)
Form 20-F
001-36697
4.20
03/20/20
10.20†
2020 Stock Option Plan (English translation)
Form 10-K
001-36697
10.21
03/17/21
10.21†
2020 Free Share Plan (English translation)
Form 10-K
001-36697
10.22
03/17/21
10.22†*
2021 Stock Option Plan (English translation)
10.23†*
2021 Free Share Plan (English translation)
10.24†
Executive Agreement, dated November 29, 2018, between the registrant and Daniel Tassé
Form 10-K
001-36697
10.23
03/17/21
10.25†
First Amendment to the Executive Agreement of Daniel Tassé, dated June 27, 2019, between the registrant and Daniel Tassé
Form 10-K
001-36697
10.24
03/17/21
10.26†
Executive Agreement, dated July 22, 2019, between the registrant and Pharis Mohideen
Form 10-K
001-36697
10.25
03/17/21
10.27†
Letter Agreement, dated June 26, 2019, between the registrant and Sébastien Robitaille (English translation)
Form 10-K
001-36697
10.26
03/17/21
10.28†
Letter Agreement, dated December 1, 2020, between the registrant and Se´bastien Robitaille (English translation)
Form 10-K
001-36697
10.27
03/17/21
21.1
List of subsidiaries of the registrant
Form 20-F
001-36697
8.1
03/20/20
23.1*
Consent of Deloitte & Associés and KPMG S.A.
24.1*
Power of Attorney (included on the signature page of this report).
31.1*
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
31.2*
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
32.1**
Certification by the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS*
Inline XBRL Instance Document
101.SCH*
Inline XBRL Taxonomy Extension Schema Document
104
Table of Contents
Incorporated by Reference
Exhibit
Description
Schedule/
Form
File Number
Exhibit
File Date
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104*
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
*
Filed herewith.
**
Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.
†
Indicates a management contract or any compensatory plan, contract or arrangement.
#
Confidential treatment has been granted from the Securities and Exchange Commission as to certain portions of this document.
105
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
DBV Technologies S.A.
/s/ Daniel Tassé
Name: Daniel Tassé
Title: Chief Executive Officer
(Principal Executive Officer)
Date: March 9, 2022
Each person whose individual signature appears below hereby authorizes and appoints Daniel Tassé and Sebastien Robitaille, and each of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file any and all amendments to this report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his substitute or substitutes may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report on Form 10-K has been signed below by the following persons on behalf of the Registrant in the capacities indicated on March 9, 2022.
Signature
Title
/s/ Daniel Tassé
Daniel Tassé
Chief Executive Officer and Director
( Principal Executive Officer
)
/s/ Sebastién Robitaille
Sebastién Robitaille
Chief Financial Officer
( Principal Financial and Accounting Officer
)
/s/ Michel de Rosen
Michel de Rosen
Director
/s/ Mailys Ferrere
Mailys Ferrere
Director
/s/ Michael J. Goller
Michael J. Goller
Director
/s/ Viviane Monges
Viviane Monges
Director
/s/ Timothy E. Morris
Timothy E. Morris
Director
106
Table of Contents
Signature
Title
/s/ Adora Ndu
Adora Ndu
Director
/s/ Julie O’Neill
Julie O’Neill
Director
/s/ Ravi Madduri Rao
Ravi Madduri Rao
Director
/s/ Daniel Soland
Daniel Soland
Director
107
Table of Contents
Index to Financial Statements
Annual Financial Statements for the Years Ended December 31, 2021 and 2020:
Page
Report of Deloitte & Associés and KPMG S.A., Independent Registered Public Accounting Firms (Deloitte & Associés, Paris-La Défense, France, PCAOB ID No. 1756 ) (KPMG S.A., Paris-La Défense, France , PCAOB ID No. 1253 )
2
Consolidated Statements of Financial Position as of December 31, 2021 and 2020
4
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2021 and 2020
5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2021 and 2020
6
Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2021
and 2020
7
Notes to the Consolidated Financial Statements
8
F-1
Table of Contents
REPORT OF INDPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS
To the Shareholders and Board of Directors of DBV Technologies S.A.
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated statements of financial position of DBV Technologies S.A. and subsidiaries (the “Company”) as of December 31, 2021 and 2020, the related consolidated statements of operations and comprehensive loss, cash flows and changes in shareholders’ equity for each of the two years in the period ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred operating losses and negative cash flows from operations since inception and current cash and cash equivalents are not projected to be sufficient for at least the next twelve months. These matters raise substantial doubt about the ability of the Company to continue as a going concern. Management’s plans in regard to these matters are described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
This matter is also described in the “Critical Audit Matter” section of our report.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are public accounting firms registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
F-2
Table of Contents
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Going Concern—Refer to Note 1 to the consolidated financial statements
Critical Audit Matter Description
As described further in Note 1 to the consolidated financial statements, the Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions.
The Company’s available cash and cash equivalents is not sufficient to support its operating plan for at least the next 12 months from the issuance date of these consolidated financial statements. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern.
We identified the evaluation of the Company’s ability to continue as a going concern and related disclosures as a critical audit matter. This matter required a high degree of auditor judgment and increased effort when performing audit procedures to evaluate (1) the reasonableness of management’s forecasted operating expenses, and (2) the adequacy of the consolidated financial statements disclosure related to the going concern assessment.
How the Critical Audit Matter was Addressed in the Audit
The primary audit procedures we performed to address this critical audit matter included the following:
•
We obtained an understanding and tested the design and implementation of the internal control related to the Company’s going concern assessment;
•
We evaluated the reasonableness of the Company’s forecasted operating expenses by obtaining an understanding of the Company’s operations and strategy, inquiring about the Company’s research and development activities, comparing the forecasted operating expenses to historical operating expenses and assessing expected costs, especially those costs that relate to future clinical trials;
•
We assessed management’s ability to forecast operating expenses by comparing prior year forecasts to actual financial results;
•
We assessed the adequacy of the consolidated financial statements’ disclosure related to the going concern assessment.
/s/ Deloitte & Associés
KPMG S.A.
/s/ Cédric Adens
Partner
We have served as the Company’s auditor since 2011.
We have served as the Company’s auditor since 2020.
Paris-La
Défense, France
March 9
, 202 2
F-3
Table of Contents
DBV Technologies S.A.
Consolidated Statements of Financial Position
(amounts in thousands, except share and per share data)
Year ended December 31,
Note
2021
2020
Assets
Current assets:
Cash and cash equivalents
3
$
77,301
$
196,352
Trade receivables
4
—
2,230
Other current assets
5
37,085
8,792
Total current assets
114,386
207,375
Property, plant, and equipment, net
6
18,146
24,792
Right-of-use
assets related to operating leases
7
7,336
10,104
Intangible assets
22
41
Other non-current
assets
8
6,833
29,935
Total non-current
assets
32,338
64,871
Total Assets
$
146,723
$
272,246
Liabilities and shareholders’ equity
Current liabilities
Trade payables
9
$
11,429
$
20,338
Short-term operating leases
7
3,003
3,708
Short-term financial debt
10
510
724
Current contingencies
14
4,095
5,016
Other current liabilities
9
12,361
22,926
Total current liabilities
31,397
52,713
Long-term operating leases
7
7,147
10,496
Long-term financial debt
10
—
543
Non-current
contingencies
14
6,758
2,527
Other non-current
liabilities
10
2,147
475
Total non-current
liabilities
16,052
14,042
Total liabilities
$
47,449
$
66,754
Shareholders’ equity:
Ordinary shares, € 0.10 par value; 55,095,762 and 54,929,187 shares authorized, and issued as at December 31, 2021 and 2020, respectively, and 5,128,423 and 4,036,263 shares outstanding as at at December 31, 2021 and 2020, respectively
$
6,538
$
6,518
Additional paid-in
capital
358,115
1,152,042
Treasury stock, 153,631 and 102,302 ordinary shares as of December 31, 2021 and 2020, respectively, at cost
( 1,232
)
( 1,169
)
Accumulated deficit
( 258,528
)
( 958,543
)
Accumulated other comprehensive income
519
484
Accumulated currency translation effect
( 6,137
)
6,158
Total shareholders’ equity
12
$
99,274
$
205,491
Total liabilities and shareholders’ equity
$
146,723
$
272,246
The accompanying notes are an integral part of these consolidated financial statements
F- 4
Table of Contents
DBV Technologies S.A.
Consolidated Statements of Operations and Comprehensive Loss
(amounts in thousands, except share and per share data)
Year ended December 31,
Note
2021
2020
Operating income
15
$
5,708
$
11,276
Operating expenses
Research and development expenses
16
( 70,336
)
( 101,607
)
Sales & marketing expenses
16
( 4,387
)
( 9,879
)
General & administrative expenses
16
( 30,520
)
( 35,081
)
Restructuring reversal (expenses)
2,16
920
( 23,552
)
Total Operating expenses
( 104,323
)
( 170,118
)
Loss from operations
( 98,614
)
( 158,842
)
Financial income (expenses)
425
( 724
)
Loss before taxes
( 98,189
)
( 159,566
)
Income tax
17
381
10
Net loss
$
( 97,809
)
$
( 159,555
)
Foreign currency translation differences, net of taxes
( 12,296
)
23,104
Actuarial gains on employee benefits, net of taxes
35
376
Total comprehensive loss
$
( 110,070
)
$
( 136,075
)
Basic/diluted Net loss per share attributable to shareholders
20
$
( 1.78
)
$
( 2.95
)
Weighted average number of shares outstanding used in computing per share amounts:
20
54,916,937
54,092,666
The accompanying notes are an integral part of these consolidated financial statements
F- 5
Table of Contents
DBV Technologies S.A.
Consolidated Statements of Cash Flows
(amounts in thousands)
Year ended December 31,
Notes
2021
2020
Net loss for the period
$
( 97,809
)
$
( 159,555
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation, amortization and accrued contingencies
8,376
10,461
Retirement pension obligations
184
( 436
)
Expenses related to share-based payments
3,122
( 1,130
)
Other elements
656
655
Changes in operating assets and liabilities:
Decrease (increase) in inventories and work in progress
—
2,327
Decrease (increase) in trade receivables
2,150
( 2,070
)
Decrease (increase) in other current assets
( 8,578
)
( 9,275
)
(Decrease) increase in trade payables
( 7,559
)
( 5,082
)
(Decrease) increase in other current and non-current
liabilities
( 7,599
)
( 3,357
)
Change in operating lease liabilities and right of use assets
( 1,185
)
1,854
Net cash flow used in operating activities
( 108,242
)
( 165,607
)
Cash flows used in investing activities:
Acquisitions of property, plant, and equipment
( 910
)
( 2,788
)
Proceeds from property, plant, and equipment dispositions
604
55
Acquisitions of intangible assets
( 8
)
( 29
)
Acquisitions of non-current
financial assets
( 119
)
( 103
)
Net cash flows used in investing activities
( 433
)
( 2,865
)
Cash flows provided by financing activities:
(Decrease) increase in conditional advances
( 689
)
( 303
)
Treasury shares
184
( 563
)
Capital increases, net of transaction costs
794
150,449
Other cash flows related to financing activities
( 15
)
( 36
)
Net cash flows provided by financing activities
274
149,548
Effect of exchange rate changes on cash and cash equivalents
( 10,651
)
22,022
Net (decrease) / increase in cash and cash equivalents
( 119,051
)
3,097
Net cash and cash equivalents at the beginning of the period
196,352
193,255
Net cash and cash equivalents at the end of the period
3
$
77,301
$
196,352
The accompanying notes are an integral part of these consolidated financial statements
F- 6
Table of Contents
DBV Technologies S.A.
Consolidated Statements of Changes in Shareholders’ Equity
(amounts in thousands, except share and per share data)
Ordinary shares
Number of
Shares
Note 12
Amount
Additional
paid-in
capital
Treasury
stock
Acc.
deficit
Acc.
other
comprehensive
income
Acc.
currency
translation
effect
Total
Equity
Balance at January 1, 2020
47,028,510
5,645
1,003,595
( 230
)
( 798,988
)
108
( 16,945
)
193,186
Net (loss)
—
—
—
—
( 159,555
)
—
—
( 159,555
)
Other comprehensive income (loss)
—
—
—
—
—
376
23,104
23,480
Issuance of ordinary shares
7,900,677
873
149,576
—
—
—
—
150,449
Treasury shares
—
—
—
( 939
)
—
—
—
( 939
)
Share-based payments (income) expenses
—
—
( 1,130
)
—
—
—
—
( 1,130
)
Balance at December 31, 2020
54,929,187
$
6,518
$
1,152,042
$
( 1,169
)
$
( 958,543
)
$
484
$
6,158
$
205,491
Net (loss)
( 97,809
)
( 97,809
)
Other comprehensive (loss)
35
( 12,296
)
( 12,261
)
Issuance of ordinary shares
166,575
20
496
515
Issuance of share warrants
—
—
279
—
—
—
—
279
Treasury shares
( 63
)
( 63
)
Share-based payments (income) expenses
3,122
3,122
Allocation of accumulated net losses
—
—
( 797,823
)
—
797,823
—
—
—
Balance at December 31, 2021
55,095,762
$
6,538
$
358,115
$
( 1,232
)
$
( 258,528
)
$
519
$
( 6,137
)
$
99,274
The accompanying notes are an integral part of these consolidated financial statements
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Notes to the Consolidated Financial Statements
Note 1: Nature of the business and principles and accounting methods
Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or “we”, or the “group”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin ™
. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT TM
, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin ™
.
Basis of Presentation
The Company’s consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. (“U.S. GAAP”) and presented in thousands of U.S. Dollars, except for share and per share data and as otherwise noted. Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). We also follow the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern and using the historical cost principle with the exception of certain assets and liabilities that are measured at fair value in accordance with U.S. GAAP. The categories concerned are detailed in the following notes.
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. Intercompany transactions and balances have been eliminated.
The following list presents all entities included in the consolidation scope for the years ended December 31, 2020 and 2021, as well as their country of incorporation and the percentage of ownership interests:
•
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 Australia Pty Ltd. was incorporated in New South Wales, Australia on July 3, 2018 (the “Australian subsidiary”). The share capital of this Australian subsidiary is 100 % owned by DBV Technologies S.A. (“DBV Technologies”).
•
DBV Pharma was incorporated in Paris on December 21, 2018 (the “French subsidiary”). The share capital of this French subsidiary is 100 % owned by DBV Technologies S.A.
On December 31, 2021, the company proceeded to the dissolution of DBV Canada Ltd. This subsidiary was originally incorporated in Ottawa, Ontario on August 13, 2018 (the “Canadian subsidiary”). The share capital of this Canadian subsidiary was 100 % owned by DBV Technologies S.A.
Functional Currency and Translation of Financial Statements in Foreign Currency
The Consolidated Financial Statements are presented in U.S. dollars, which differs from the functional currency of the Company, being the Euro. The statements of financial position of consolidated entities having a functional currency different from the presentation currency are translated at the closing exchange rate (spot exchange rate at the statement of financial position date) and the statements of operations, statements of comprehensive loss and statements of cash flow of such consolidated entities are translated at the weighted average exchange rate. The resulting translation adjustments are included in equity under the caption “Accumulated other comprehensive income (loss)” in the Consolidated Statements of Changes in Shareholders’ Equity.
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Conversion of Foreign Currency Transactions
Foreign currency transactions are converted to functional currency of the entity at the rate of exchange applicable on the transaction date. At period-end,
foreign currency monetary assets and liabilities are converted at the rate of exchange prevailing on that date. The resulting exchange gains or losses are recorded in the entity individual statements of operations in “Financial income (expense)”; they will be recognized in profit or loss on disposal of the net investment.
Use of estimates
The preparation of the Company’s consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. As of December 31, 2021, the ongoing pandemic may make management’s estimates vulnerable to significant changes. Those uncertainties were considered in the assumptions underlying the estimates and judgments used by the Company but a number of estimates have been and will continue to be affected by the ongoing pandemic. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates.
On an on-going
basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right-of-use
assets—operating lease, (4) impairment of right-of-use
assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, and (7) estimate of contingencies.
Going concern
These Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists.
Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.
Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin ™
Peanut, in August 2020, the Company scaled down its other clinical programs and pre-clinical
spend to focus on Viaskin ™
Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin ™
Peanut in the United States and European Union.
In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. In order to respond to the FDA’s requests and recommendations, the Company defined parallel workstreams primarily in order to generate the 6-month
safety and adhesion clinical data to assess a modified Viaskin Peanut patch and demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population.
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Following the submission of the adhesion study’s protocol to the FDA, the Company received an Advice/Information Request letter from the FDA in October 2021, requesting a stepwise approach to the modified Viaskin patch development program and provided partial feedback on this protocol.
In December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback and announced its plan to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach as the most straightforward approach to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. After receiving approval from the FDA for its change in strategy, the protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (“mVP”) patch was completed at the end of February 2022 and has been prepared for FDA submission. The Company is currently engaged in fruitful discussions with FDA in preparation for protocol submission and review. The Company expects to complete protocol submission following further alignment with FDA.
The company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, the Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern.
Based on its current operations, as well as its plans and assumptions as revised pursuant to its change of strategy, announced in December 2021, the Company expects that its balance of cash and cash equivalents of
$ 77.3 million as of December 31, 2021 will be sufficient to fund its operations into the first quarter of 2023.
The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive
financings.
The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to the ongoing COVID-19
pandemic. The ongoing COVID-19
pandemic has already caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.
If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently.
These Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern.
Intangible Assets
Acquired intangible assets are accounted for at acquisition cost less accumulated amortization. Acquired intangible assets are mainly composed of software amortized on a straight-line basis over their estimated useful lives comprised between one and three years . Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. 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.
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Property, Plant, and Equipment
Property, plant, and equipment are recorded at their acquisition cost.
Property, plant, and equipment are depreciated on a straight-line method over the estimated useful lifes of the property. Leasehold improvements are amortized over the shorter of the estimated useful lives of the assets or the remaining lease term.
Depreciation is calculated on a straight-line basis over the assets’ estimated useful lives as follows:
PROPERTY, PLANT, AND EQUIPMENT ITEM PERIOD
DEPRECIATION
Fixtures and leasehold improvements
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
Impairment of assets
The Company periodically reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable or the estimated useful life is no longer appropriate. If indicators of impairment exist and the recoverable value of the asset on an undiscounted cash flow basis is less than the carrying amount, an impairment loss is recorded to the extent the carrying amount exceeds its fair value.
Lease contracts
The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to use, or control the use of, identified property, plant, or equipment for a period of time in exchange for consideration. The Company’s leases are comprised of real estate leases, leases for industrial equipment and leases for office equipment.
The Company’s real estate leases typically include options and features including rent free periods, rent escalation periods, renewal options and early termination options. The lease term is defined contract-by-contract
and corresponds to the non-cancelable
period of the lease taking into account the optional periods that are reasonably certain to be exercised.
The Company recognizes operating lease liabilities based on the present value of the future minimum lease payments over the lease term at commencement date.
The Company does not recognize a lease liability or right of use asset for leases with a term of 12 months or less.
Operating lease right of use assets are presented as operating lease right of use assets on the consolidated balance sheet. To date, the Company has recognized a single lease cost under which the operating lease right of use and liability are amortized on a straight-line basis over the lease term, and categorized within Operating Expense in the Consolidated Statement of Operations. The operating lease cash flows are categorized under Net Cash Used in Operating Activities in the Consolidated Statement of Cash Flows. Variable costs are expensed in the period incurred.
Since the rate implicit in the lease is not readily determinable, the Company uses its incremental borrowing rates based on the information available at commencement date in determining the discount rate used to calculate the present value of lease payments. As the Company has no external borrowings, the incremental borrowing rates are determined using information on indicative borrowing rates that would be available to the Company based on the value, currency and borrowing term provided by financial institutions, adjusted for company and market specific factors.
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Inventories and Work in Progress
Inventories are measured at the lower of cost or net realizable value at production costs calculated using the first-in,
first-out
method. It includes acquisition costs, processing costs and other costs incurred in bringing the inventories to their present location and condition.
Inventories are exclusively composed of work in progress relating to the production of the first batches that may be used for the commercialization.
During the launch phase of a new product, any inventories of that product are written down to zero pending regulatory approval.
Financial Assets and Liabilities
Financial assets, excluding cash and cash equivalents, consist exclusively of other receivables. Other receivables are non-derivative
financial assets with a payment, which is fixed or can be determined, not listed on an active market. They are included in current assets, except those that mature more than twelve months after the reporting date. The recoverable amount of other receivables is estimated whenever there is an indication that the asset may be impaired and at least on each reporting date. If the recoverable amount is lower than the carrying amount, an impairment loss is recognized in the Consolidated Statements of Operations and Comprehensive Loss.
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 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 Company carries its trade receivable at net realizable value. On a periodic basis, the Company evaluates its trade receivable and determines whether to provide an allowance or if any accounts should be written down and charged to expense as a bad debt. The Company generally does not require any security or collateral to support its receivables.
During the years ended December 31, 2021 and December 31, 2020, the Company did no t hold any derivative financial instruments.
Fair Value Measurements
Fair value is defined as an exit price, representing the amount that would be received upon the sale of an asset or payment to transfer a liability in an orderly transaction between market participants. Fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows:
•
Level 1—Quoted market prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.
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•
Level 2—Quoted market prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly. Fair value determined through the use of models or other valuation methodologies.
•
Level 3—Significant unobservable inputs for assets or liabilities that cannot be corroborated by market data. Fair value is determined by the reporting entity’s own assumptions utilizing the best information available and includes situations where there is little market activity for the asset or liability.
The asset’s or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is significant to the fair value measurement. The Company’s policy is to recognize transfers between levels of the fair value hierarchy in the period the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1, 2, or 3 during the periods presented.
The Company considers its cash and cash equivalents, accounts receivable and accounts payable to reflect their fair value given their short maturity and risk profile of the counterparty.
Cash and Cash Equivalents
Cash includes cash on hand and demand deposits with banks. Cash equivalents include short-term, highly liquid investments, with a remaining maturity at the date of purchase of three months or less for which the risk of changes in value is considered to be insignificant. Demand deposits therefore meet the definition of cash equivalents. Cash equivalents are measured at fair value using level 1 and any changes are recognized in the Consolidated Statements of Operations and Comprehensive Loss.
Concentration of Credit Risk
The Company has no significant off-balance
sheet risk, such as foreign currency contracts, options contracts, or other foreign hedging arrangements. Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and other receivables. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and have not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships or entities for which it has a receivable.
Share Capital
Ordinary 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 Consolidated Financial Statements in Shareholders’ Equity as a deduction from the proceeds from the issue, net of tax.
Employee benefits
Depending on the laws and practices of the countries in which the Company operates, employees may be entitled to compensation when they retire or to a pension following their retirement. For state-managed plans and other defined contribution plans, the Company recognizes them as expenses when they become payable, with the Company’s commitment being limited to our contributions.
The liability with respect to defined benefit plans is estimated using the following main assumptions:
•
discount rate;
•
future salary increases;
•
employee turnover; and
•
mortality tables.
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The difference between the amount of the liability 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 (loss) for the portion representing the actuarial gains and losses. Service costs are recognized in profit or loss and are allocated by function.
Actuarial gains and losses result from changes in actuarial assumptions and from differences between assumed and actual experience. Gains and losses recorded in other comprehensive income (loss) are amortized over expected remaining service periods to the extent they exceed 10% of the projected benefit obligation for the defined benefit plan.
The Company’s payments for the defined-contribution plans are recognized as expenses in the Consolidated Statements of Operations and Comprehensive Loss for the period with which they are associated.
Contingencies
An estimated loss from a loss contingency is recognized if the following two conditions are met:
•
information available before the consolidated financial statements are issued indicates that it is probable that an asset had been impaired or a liability had been incurred at the date of the consolidated financial statements; and
•
the amount of loss can be reasonably estimated.
With respect to litigations and claims that may result in a liability to be recognized, we exercise significant judgment in measuring and recognizing a liability or determining exposure to contingent liabilities that are related to pending litigation or other outstanding claims. These judgment and estimates are subject to change as new information becomes available.
Operating Income
The Company accounts for revenue when the amount can be reliably assessed, future economic benefits are likely to benefit the Company, and specific criteria are met for the Company’s business, which is in accordance with ASC 606 for the collaboration agreement with Nestlé Health Science.
Other operating income
Research Tax Credit
The Research Tax Credit ( Crédit d’Impôt Recherche
) 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 receive a tax credit that can be used against the payment of the income 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.
In the fiscal year ended December 31, 2021, the Company recovered its Small and Medium-sized
Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit. The Company will request the immediate reimbursement of the 2021 fiscal year CIR, as well as former tax credit receivables for the 2019 and 2020 fiscal years, which were originally refundable three years after the tax declaration in case the Company wouldn’t have been able to offset it against corporate income tax due.
Collaboration agreement with Nestlé Health Science
The Company enters into research and development collaboration agreements that may consist of non-refundable
upfront payments and milestone payments.
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Non-refundable
upfront payments are deferred and recognized as income over the period of the collaboration agreement.
Milestone payments represent amounts received depending upon the achievement of certain scientific, regulatory, or commercial milestones. They are recognized when the triggering event has occurred, there are no further contingencies or services to be provided with respect to that event, and the co-contracting
party has no right to require refund of payment. The triggering event may be scientific results achieved by the Company or another party to the arrangement, regulatory approvals, or the marketing of products developed under the arrangement.
The Company recognizes income under the percentage-of-completion
method. The Company periodically updates its measurement of progress and updates its cumulative income recognized accordingly. The Company accrues for any excess between costs yet to be incurred and income yet to be recognized for the completion of the performance obligations. Please refer to Note 1 4
“Contingencies”.
Research and Development Expenditures
Research and development expenditures are charged to expense as costs are incurred in performing research and development activities. Research and development costs include all direct costs, including salaries, share-based payments and benefits for research and development personnel, outside consultants, costs of clinical trials, costs related to manufacturing clinical study materials, sponsored research, clinical trials insurance, other outside costs, depreciation, and facility costs related to the development of drug candidates. The Company records upfront, non-refundable
payments made to outside vendors, or other payments made in advance of services performed or goods being delivered, as prepaid expenses, which are expensed as services are performed or the goods are delivered.
Certain research and development projects are, or have been, partially funded by collaboration agreements, and the expenses related to these activities are included in research and development costs. The Company records the related reimbursement of research and development costs under these agreements as income in the period in which such costs are incurred. Please refer to Collaboration agreement with Nestlé Health Science for further detail.
Share-based payments
Since its incorporation, the Company has established several plans for equity compensation issued in the form of employee warrants (bons de souscription de parts de créateur d’entreprise or “BCEs”), stock options (“SO”), and restricted stock units (“RSUs”) granted to employees and/or executives. The company has also established several plans for equity compensation issued in the form of “share warrants” (bons de souscription d’actions or “BSAs”) granted to non-employee
members of the Board of Directors and members of the Scientific Advisory Board.
These awards are measured at their fair value on the date of grant. Except for RSUs, fair value is estimated using Black and Scholes models that require inputs based on certain subjective assumptions, including the expected term of the award, and the conditions of each equity plan. The fair value is amortized in personnel expenses (allocated by function in the Consolidated Statements of Operations and Comprehensive Loss) on a straight-line basis over the requisite service period, and such expense is reduced for estimated forfeitures, with a corresponding increase in shareholders’ equity.
The determination of the requisite service period and the estimate of RSUs awards that are expected to vest depends on the legal interpretation of the RSUs award agreements with employees under the French labor laws and related jurisprudence. Changes in interpretations could significantly impact the accounting for the share-based payments.
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At each closing date, the Company re-assesses
the number of options expected to vest. If applicable, the impacts of such revised estimates are recognized in the Consolidated Statements of Operations and Comprehensive Loss, with a corresponding adjustment in shareholders’ equity.
The awards are not subject to any market conditions.
Income Tax
Income taxes are accounted for under the asset and liability method of accounting. Deferred taxes are recognized for the future tax consequences attributable to temporary differences between the financial reporting carrying amounts and tax bases of assets and liabilities, and on tax losses, using the liability method. Differences are defined as temporary when they are expected to reverse within a foreseeable future. The Company may only recognize deferred tax assets on net operating losses if, based on the projected taxable incomes within the next three years, management determines that it is probable that future taxable profit will be available against which the unused tax losses and tax credits can be utilized. As a result, the measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. If future taxable profits are considerably different from those forecasted that support recording deferred tax assets, the Company will have to revise downwards or upwards the amount of deferred tax assets, which would have a significant impact on the Company’s financial results. Tax assets and liabilities are not discounted. Amounts recognized in the Consolidated Financial Statements are calculated at the level of each tax entity included in the consolidation scope. Deferred tax assets and liabilities are measured using the enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted.
Uncertain tax position
Tax benefits are recognized from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position.
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.
Other Items in the Comprehensive Loss
Comprehensive loss
is comprised of net income(loss) and other comprehensive income (loss). Other comprehensive income (loss) includes changes in equity that are excluded from net income (loss), such as foreign currency translation adjustments. These changes in equity are presented net of tax.
Net Loss Per Share
The Company calculates basic and diluted net loss per ordinary share by dividing the net loss by the weighted-average number of ordinary shares outstanding during the period. For the years ended December 31, 2021 and 2020, the Company has excluded the effects of all potentially dilutive shares, which include outstanding ordinary stock options, warrants to purchase ordinary shares, and restricted stock units, from the weighted-average number of ordinary shares outstanding as their inclusion in the computation for these years would be anti-dilutive due to net losses incurred.
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Subsequent Events
The Consolidated Statements of Financial Position and the Consolidated Statements of Operations and Comprehensive Loss of the Company are adjusted to reflect the subsequent events that alter the amounts related to the situations that existed as of the end of the period covered. The Company has evaluated subsequent events from the balance sheet date through March
9
, 2022, the date at which the consolidated financial statements are issued.
Accounting Pronouncements adopted in 2021
Effective January 1, 2021, the Company adopted ASU 2019-12,
Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. The adoption of ASU 2019-12
did not have a material impact on the Company’s financial position or results of operations.
Accounting Pronouncements issued not yet adopted
In June 2016, the FASB issued ASU 2016-13—Financial
Instruments—Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU 2019-10
which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect that this new standard will have a material impact on its consolidated financial statements.
Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption.
Note 2 Significant Events and Transactions of the Periods
Clinical programs
United States Regulatory History and Current Status
Viaskin Peanut has obtained fast track designation and breakthrough therapy designation in children from the FDA, which are regulatory designations intended to expedite or facilitate the process of reviewing new drugs and biological products that are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.
In August 2019, the Company announced the submission of a BLA to the FDA for Viaskin Peanut for the treatment of peanut allergy in children 4 to 11 years of age.
In October 2019, the Company announced that the FDA accepted for review the BLA for its investigational Viaskin ™
Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.
In February 2020, the FDA announced an Allergenic Products Advisory Committee meeting to be held on May 15, 2020 to discuss the BLA for Viaskin Peanut. On March 16, 2020, the Company announced that the FDA had informed it that during its ongoing review of the Company’s BLA for Viaskin Peanut, it had identified questions regarding efficacy, including the impact of patch-site adhesion. Therefore, the Advisory Committee meeting to discuss the BLA originally scheduled on May 15, 2020 was cancelled.
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In August 2020, the Company received a Complete Response Letter, or CRL, in which the FDA indicated it could not approve the Viaskin Peanut BLA in its current form. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study. The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data. The FDA did not raise any safety concerns related to Viaskin Peanut.
In
January 2021, the Company
received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 m
g (approximately 1/1000 of
one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11.
The Company named that assessment EQUAL, which stands for Equivalence in Uptake of Alergen. The FDA also recommended conducting a 6 -month,
well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.
Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:
1.
Identify a modified Viaskin patch (which the Company calls mVP).
2.
Generate the 6-month
safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible.
3.
Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies:
a.
PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL
b.
‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and mVP.
In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, to identify the one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, the Company selected the modified patch to advance to further clinical testing in the intended patient population. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is approximately 50% larger in size relative to the current patch and circular in shape.
In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and on October 14, 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conducts allergen uptake comparison
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studies (i.e., ‘EQUAL in Adults’, EQUAL), and submits the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study. The FDA’s explanation was that the results from the allergen uptake studies might affect the design of the STAMP study.
After careful review of the FDA’s information requests and consideration of all other options, in December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback. The Company estimated that the FDA’s newly proposed sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the 6-month
safety and adhesion study. The Company does not believe this approach to be in the best interest of patients due to the significant time delays associated with FDA review of a resource dependent (non-PDUFA)
product. As such, in December 2021, the Company announced it plans to initiate a pivotal Phase III—placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The study will also include updates to the Instructions for Use (IFU). The Company considers this approach the most straightforward to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA has confirmed its change in strategy is agreeable via oral and written exchanges. The protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (“mVP”) patch was completed at the end of February 2022 and has been prepared for FDA submission. The Company is currently engaged in discussions with FDA in preparation for protocol submission and review. The Company expects to complete protocol submission following further alignment with FDA.
European Union Regulatory History and Current Status
In November 2020, the Company announced that its Marketing Authorization Application, or MAA, for Viaskin Peanut had been validated by the European Medicines Agency, or EMA. The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years. Following the MAA validation, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, will review the application and provide a recommendation to the European Commission, or EC, on whether to grant a marketing authorization. On March 11, 2021, the Company announced that it had received the EMA’s Day 120 questions, which were consistent with both its expectations and pre-
filing conversations with the EMA. The Company did not receive questions about the impact of adhesion on efficacy.
In August 2021, the Company announced it has received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.
In December 2021, the Company announced it has withdrawn the Marketing Authorization Application for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by positive data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301).
The decision to withdraw was based on the view of CHMP that the data available to date from a single pivotal study were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believe data from a second Viaskin Peanut pivotal study will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intend to resubmit the MAA when that data set is available.
Viaskin Peanut for children ages 1-3
In June 2020, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effect after 12 months of therapy, as assessed by a double-blind placebo- controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not
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statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 m
g dose in this age group, which is the dose being studied in Part B of the study. Enrollment of Part B of EPITOPE was complete in first quarter of 2021, and top-line results are expected mid-year 2022.
Financing
In February 2020, the Company announced the closing of an underwritten global offering of an aggregate of 7,500,000 ordinary shares in (i) a public offering of 4,535,581 ordinary shares in the form of 9,071,162 American Depositary Shares (“ADSs”) in the United States, Canada and certain countries outside Europe at a public offering price of $ 10.25 per ADS (on the basis of an exchange rate of $ 1.0999 = €1.00), and (ii) an offering exclusively addressed to qualified investors in Europe (including France) of 2,964,419 ordinary shares at an offering price of € 18.63 per ordinary share (together, the “Global Offering”).
In March 2020, the Company announced that the underwriters partially exercised their option to purchase 338,687 additional ordinary shares in the form of 677,374 ADSs at an offering price of $ 10.25 per ADS, before deducting commissions and estimated offering expenses (the “Option”). The Option closed on March 4, 2020.
Consequently, following partial exercise of the Option, the total number of ordinary shares sold in the global offering was 7,838,687 ordinary shares, including 4,874,268 ordinary shares in the form of 9,748,536 ADSs, bringing the total gross proceeds from the global offering to $ 160.7 million and net proceeds of $ 150.0 million.
Restructuring
The Company initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin ™
Peanut in the United States and European Union. Full implementation of the organization-wide costs reduction measures was completed during the second half of 2021. The full implementation of the restructuring plan resulted in a reduction of more than 200 jobs and in a remaining global team of about 90 people dedicated to the pursuit of innovation and scientific development of novel therapies.
The restructuring costs were mainly comprised of payroll expenses, restructuring-related consulting and legal fees, as well as impairment of facilities and right of use assets following resizing of facilities.
The following table summarizes restructuring effects as of December 31, 2021 and 2020 included in the Statement of Operations and Comprehensive Loss:
December 31,
2021
2020
Employee-related expenses (income)
( 920
)
19,194
Effects of restructuring on leases
—
2,028
Other restructuring costs
—
2,330
Total restructuring costs
( 920
)
23,552
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The following table summarizes restructuring activities as of December 31, 2021 included in current contingencies and other current liabilities on the statement of consolidated financial position:
(Amounts in thousands of U.S. Dollars)
Restructuring
liabilities
Restructuring liability —
January 1, 2020
—
Restructuring costs
23,552
Restructuring costs —
non cash items
( 2,028
)
Amounts paid
( 12,137
)
Restructuring liability —
December 31, 2020
9,387
of which current contingencies
1,993
of which other current liabilities
7,394
Restructuring
liabilities
Restructuring liability —
January 1, 2021
9,387
Restructuring costs
—
Amounts paid
( 7,747
)
Reversal of contingencies
( 920
)
Other effect including currency translation effect
( 282
)
Restructuring liability —
December 31, 2021
438
of which current contingencies
—
of which other current liabilities
438
The reversal of contingencies is mainly comprised of unused accruals related to payroll.
COVID-19
Pandemic
On March 11, 2020, the World Health Organization declared COVID-19
a pandemic. This global health crisis led many countries to impose national containment measures and travel bans. In view of this exceptional situation, the Company decided to take all measures aimed primarily at guaranteeing the safety of its employees and the continuation of ongoing clinical trials, in compliance with the directives of the authorities in each country. The Company has experienced a decrease in new patients enrolling in the ongoing clinical studies and it has had to adapt the protocols of its clinical trials because patients remain subject to travel restrictions.
The Company has assessed the impact of the uncertainties created by the pandemic, such as the duration of the outbreak, the efficacy of vaccines and the evolution of variations strains of COVID-19,
travel restrictions, social distancing requirements and business restrictions in the United States, France and other countries. As of December 31, 2021, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company. The Company continues to update these estimates and assumptions as the situation evolves. The effects of the COVID-19
pandemic are presented in the relevant line items of the Consolidated Statement of Financial Position and the Consolidated Statement of Operations and Comprehensive Loss according to the function or nature of the income or expense.
Legal Proceedings
A class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis Ito-Stone
v. DBV Technologies, et al., Case No. 2:19-cv-00525.
The complaint, as amended, alleged that the Company and its former Chief Executive Officer, its current Chief Executive Officer, its former Deputy Chief Executive Officer, and its former Chief Business officer violated certain federal
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securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5
promulgated thereunder. The plaintiffs seek unspecified damages on behalf of a purported class of persons that purchased the Company’s securities between February 14, 2018 and August 4, 2020 and also held the Company’s securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020.
A hearing was held on July 29, 2021 in the U.S. District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. As the dismissal was without prejudice, the Plaintiffs replead their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court. The company moved to dismiss third amended complaint on December 10, 2021.
The Company believes that the allegations contained in the amended complaint are without merit and will continue to defend the case vigorously. The Company believes this complaint will not have a material adverse effect on the Company’s consolidated financial position, results of operations or liquidity.
Note 3 Cash and Cash Equivalents
The following table presents for each reported period, the breakdown of cash and cash equivalents:
December 31,
2021
2020
Cash
31,427
42,341
Cash equivalent
45,874
154,011
Total cash and cash equivalent as reported in statement of financial position
77,301
196,352
Bank overdrafts
—
—
Total net cash and cash equivalents as reported in the statement of cash flow
77,301
196,352
Cash equivalents are immediately convertible into cash at no or insignificant cost on demand. They are measured using level 1 fair value measurements.
Note 4 Trade Receivables
All the trade receivables have payment terms of less than one year. As of December 31, 2020, the receivables balance corresponds exclusively to the amounts due under the license and collaboration agreement with Nestlé Health Science, which have been settled during the year 2021.
Note 5 Other Current Assets
Other current assets consisted of the following:
December 31,
2021
2020
Research tax credit
28,092
—
Other tax claims
3,561
5,049
Prepaid expenses
4,149
3,162
Other receivables
1,282
581
Total
37,085
8,792
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Research tax credit
In the fiscal year ended December 31, 2021, the Company recovered its Small and Medium-sized
Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit. The Company will request the immediate reimbursement of the 2021 fiscal year CIR, as well as former tax credit receivables, which were originally refundable three years after the tax declaration in case the Company wouldn’t have been able to offset it against corporate income tax due.
The variance in Research Tax Credit during the two years disclosed is presented as follow:
Amount in
thousands of
US Dollars
Opening balance sheet receivable as of January 1, 2020
10,969
+ 2020 fiscal year research tax credit
9,930
- Payment received
—
- Currency translation effect
1,751
Closing balance sheet receivable as of December 31, 2020
22,650
Of which —
Non-current
portion
22,650
Of which —
Current portion
—
Amount in
thousands
of
US Dollars
Opening balance sheet receivable as of January 1, 2021
22,650
+ 2021 fiscal year research tax credit
7,505
- Payment received
—
- Adjustment and currency translation effect
( 2,063
)
Closing balance sheet receivable as of December 31, 2021
28,092
Of which —Non
-current
portion
—
Of which —Current
portion
28,092
The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of rental and insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.
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Note 6 Property, Plant, and Equipment
Property and equipment, net consisted of the following:
1/1/2020
Currency
translation
effect
Increase
Decrease
12/31/2020
Laboratory equipment
13,966
1,830
7,544
( 268
)
23,072
Building fixtures
6,530
595
697
( 55
)
7,767
Office equipment
908
46
16
—
970
Computer equipment
1,903
104
215
( 377
)
1,846
Property, plant, and equipment in progress
12,813
755
2,732
( 8,473
)
7,828
Total, gross
36,120
3,330
11,205
( 9,173
)
41,482
Less accumulated amortization and depreciation
( 11,101
)
( 1,225
)
( 4,364
)
—
( 16,690
)
Total, net
25,019
2,105
6,841
( 9,173
)
24,792
1/1/2021
Currency
translation
effect
Increase
Decrease
12/31/2021
Laboratory equipment
23,072
( 1,783
)
853
( 708
)
21,434
Building fixtures
7,767
( 408
)
48
( 3,449
)
3,958
Office equipment
970
( 39
)
—
( 67
)
864
Computer equipment
1,846
( 92
)
9
( 464
)
1,299
Property, plant, and equipment in progress
7,828
( 477
)
( 2,960
)
4,390
Total, gross
41,482
( 2,799
)
910
( 7,648
)
31,945
Less accumulated amortization and depreciation
( 16,690
)
1,109
( 4,437
)
6,219
( 13,799
)
Total, net
24,792
( 1,690
)
( 3,527
)
( 1,429
)
18,146
The depreciation and amortization expense for each of
the years ended December 31, 2021 and 2020 was $ 4.4 million .
Laboratory equipment increase in 2021 is mainly driven by commissioning of industrial equipment.
Note 7 Lease contracts
Future minimum lease payments under the Company’s operating leases’ right of use as of December 31, 2021 and 2020, are as follows:
December 31, 2021
December 31, 2020
Real
estate
Other
assets
Total
Real
estate
Other
assets
Total
Current portion
3,361
77
3,438
4,196
88
4,284
Year 2
3,124
23
3,147
3,481
82
3,562
Year 3
2,299
18
2,317
3,182
23
3,206
Year 4
771
1
773
2,388
18
2,406
Year 5
790
—
790
771
1
773
Thereafter
1,220
—
1,220
2,011
—
2,011
Total minimum lease payments
11,565
119
11,684
16,029
212
16,241
Less: Effects of discounting
( 1,526
)
( 8
)
( 1,534
)
( 2,020
)
( 16
)
( 2,037
)
Present value of operating lease
10,039
111
10,150
14,009
196
14,205
Less: current portion
( 2,929
)
( 74
)
( 3,003
)
( 3,628
)
( 80
)
( 3,708
)
Long-term operating lease
7,110
37
7,147
10,381
116
10,496
Weighted average remaining lease term (years)
4.14
2.01
5.01
2.73
Weighted average discount rate
4.84
%
3.32
%
4.62
%
3.32
%
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The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was:
December 31,
2021
2020
Operating lease expense
3,027
4,531
Restructuring expense
—
2,028
Supplemental cash flow information related to operating leases is as
follows for the period December 31, 2021 and 2020:
December 31,
2021
2020
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
2,879
3,898
Note 8 Other non-current
assets
Other non-current
assets consisted of the following:
December 31,
2021
2020
Research tax credit
—
22,650
Pledged securities
3,969
4,299
Deposits and other non-current
financial assets
2,665
2,704
Liquidity contract
199
281
Total other non-current
assets
6,833
29,935
The non-current
assets are composed of security deposits paid to premises lessors, pledged securities not used as of December 31, 2021 and the liquidity contract.
Under the liquidity contract, 153,631 treasury shares were allocated as a reduction of Shareholders’ Equity as at December 31, 2021 with the cash balance being maintained in financial assets.
Note 9 Trade payables and Other Current Liabilities
Trade Payables
No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal year presented.
Other Current Liabilities
Other current liabilities consisted of the following:
December 31,
2021
2020
Social debt
6,708
16,661
Deferred income
4,146
4,687
Tax liabilities
182
580
Other debts
1,325
999
Total
12,361
22,926
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The other current liabilities include short-term debt related to employees’ bonus accruals, as well as social welfare and tax agencies. As of December 31, 2020, the other current liabilities also included employee termination allowance and benefits as part of the restructuring (Refer to Note 2, “Significant Events and Transactions of the Periods—Restructuring”),
Deferred income mainly includes deferred incomes from the collaboration agreement with Nestlé Health Science, which amounted to $ 4.1 million as of December 31, 2021.
Note 10 Financial debt and Other Non-Current
Liabilities
Financial debt—Conditional Advances
The table below presents the details of the debts recorded on the statement of financial position by the type of conditional advance:
BPI
advance
Balance sheet debt at start of period 01/01/2020
1,458
Repayments
( 303
)
Other including currency translation effect
112
Balance sheet debt as at 12/31/2020
1,267
Of which —
Non-current
portion
543
Of which —
Current portion
724
Stated interest rate
No
Discount rate
3.2
%
Maturity (in years)
2 - 7
BPI
advance
Balance sheet debt at start of period 01/01/2021
1,267
Repayments
( 689
)
Other including currency translation effect
( 68
)
Balance sheet debt as at 12/31/2021
510
Of which —
Non-current
portion
—
Of which —
Current portion
510
Stated interest rate
No
Discount rate
3.2
%
Maturity (in years)
2 - 7
The changes appearing in “Other transactions” are comprised of the effect of discounting conditional advances.
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.
BpiFrance Financement Interest Free Loan
In 2014, BpiFrance Financement granted an interest-free Innovation loan to DBV Technologies to help financing the pharmaceutical development of Viaskin ™
Milk. This amount was received in a single disbursement on November 27, 2014.
The initial planned repayment was scheduled in 20 quarterly repayments, starting on June 30, 2017. In 2020, due to the COVID-19
pandemic, Bpifrance postponed the repayments for a 6 -month
period. Repayment will end during the third quarter of 2022.
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Due dates of liabilities
The following table shows the maturity of the Company’s liabilities (except leases disclosed in Note 7—“Lease contract”):
Carrying
2022
2023
Thereafter
Short-term financial debt —
Conditional advances
510
510
—
—
Other liabilities
14,508
12,361
2,147
—
Supplier accounts payable and related payables
11,429
11,429
—
—
Total liabilities
26,446
24,299
2,147
—
As detailed in Note 9, the current portion of other liabilities mainly includes social security and deferred incomes from the collaboration agreement with Nestlé Health Science.
Note 11 Fair value measurement
The Company reports assets and liabilities recorded at fair value on the Company’s consolidated balance sheets based upon the level of judgment associated with inputs used to measure their fair value.
The fair value measurement level within the fair value hierarchy for a particular asset or liability is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.
Financial instruments not measured at fair value on the Company’s consolidated statement of financial position, but which require disclosure of their fair values include cash and cash equivalents, accounts receivable, deposits, liquidity contract, accounts payable and conditional advances. The fair values of these financial instruments are deemed to approximate their carrying amount.
The fair values of cash and cash equivalents, accounts receivable, deposits, liquidity contract and accounts payable are categorized as Level 1. The fair value of conditional advance was categorized as Level 2 and was estimated based on a discounted cash flow method using the effective interest rate. For the interest-free conditional advances, the discount rate applied is equal to the rate of fungible treasury bonds over the time period that corresponds to the time period of the repayment of the advances. As of December 31, 2021, the fair value of conditional advances was $ 0.5 million.
There has been no transfer between levels of the fair value hierarchy during the years ended December 31, 2020 and 2021.
Note 12 Share Capital Issued
The share capital, as of December 31, 2021, is set at the sum of € 5,509,576 ($ 6,537,591 converted at historical rates). It is divided into 55,095,762 fully authorized, subscribed and paid-up
shares with a nominal value of € 0.10 .
This number does not reflect ordinary shares issuable upon exercise or settlement of non-employee
warrants (“BSA”), employee warrants (“BCE”), stock options (“SO”) and restricted stock units (“RSU”) granted to both employees and non-employees
of the Company.
All the shares give their owners the right to a proportional share of the income and the net assets of the Company.
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The table below presents the changes in the share capital of the Company as of December 31, 2020 and 2021:
(Amounts in thousands of U.S. Dollars except share and per share data)
Date
Nature of the transactions
Share capital
*
Additional paid-in
capital
Number of shares
Balance as of January 1, 2020
5,645
1,003,595
47,028,510
1/16/2020
Capital increase by employee warrants
4
292
35,000
1/16/2020
Capital increase by stock options
3
140
24,990
02/04/2020
Capital increase by global offering
829
153,580
7,500,000
02/04/2020
Fees charged to share premium
—
( 9,265
)
—
03/04/2020
Capital increase by global offering
38
6,985
338,687
03/04/2020
Fees charged to share premium
—
( 421
)
—
9/30/2020
Fees charged to share premium
—
( 1,735
)
—
11/25/2020
Capital increase by RSU
—
—
2,000
12/31/2020
Share-based payments
—
( 1,130
)
—
Balance as of December 31, 2020
6,518
1,152,042
54,929,187
02/22/2021
Capital increase by employee warrants
1
46
7,500
05/12/2021
Capital increase by employee warrants
1
62
10,200
05/17/2021
Capital increase by employee warrants
1
64
10,500
05/18/2021
Capital increase by employee warrants
1
66
10,800
05/19/2021
Retained earnings charged on share premium
( 797,823
)
05/21/2021
Capital increase by employee warrants
1
68
11,100
05/26/2021
Capital increase by employee warrants
3
129
21,000
05/28/2021
Capital increase by employee warrants
1
70
11,400
06/10/2021
Issuance of share warrants
279
10/07/2021
Capital increase by ordinary shares
2
( 2
)
20,000
11/24/2021
Capital increase by ordinary shares
7
( 7
)
58,675
12/20/2021
Capital increase by ordinary shares
1
( 1
)
5,400
12/31/2021
Share-based payments
3,122
Balance as of December 31, 2021
6,538
358,115
55,095,762
*
Conversion in U.S. Dollars at historical rates
In May 2021, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2020 have been allocated to additional paid-in
capital in the amount of € 695,575,130 ($ 797,822,881 converted at historical rates).
Note 13 Share-Based Payments
The Board of Directors has been authorized by the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), and non-employee
warrants (Bons de Souscription d’Actions or “BSA”), as follows:
Share-based
payments
instrument
General meeting of
shareholders
Board of directors
meeting
Grant date
Number granted
BSA
12/9/11
9/25/12
9/25/12
30,000
BSA
6/4/13
7/25/13
7/25/13
73,000
SO
12/9/11
9/18/13
9/18/13
518,000
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BSA
6/3/14
3/24/15
3/24/15
10,000
SO
6/3/14
6/23/15
6/23/15
120,000
BSA
6/23/15
11/19/15
11/19/15
22,500
BSA
6/23/15
12/15/15
2/15/16
90,000
SO
6/3/14
4/6/16
4/21/16
33,000
SO
6/3/14
6/21/16
6/21/16
110,000
BSA
6/21/16
6/21/16
8/21/16
20,000
SO
6/3/14
6/21/16
9/15/16
9,300
SO
6/3/14
6/21/16
10/17/16
16,500
BSA
6/21/16
12/9/16
2/9/16
59,000
SO
6/3/14
6/21/16
12/9/16
74,960
RSU
9/21/15
3/14/17
3/14/17
22,500
RSU
9/21/15
4/20/17
4/20/17
24,000
BSA
6/15/17
6/15/17
8/15/17
9,000
SO
6/3/14
6/15/17
6/15/17
126,000
SO
6/15/17
6/15/17
6/15/17
111,600
SO
6/15/17
6/15/17
9/15/17
52,600
SO
6/15/17
11/17/17
12/5/17
625,200
BSA
6/15/17
5/2/18
7/2/18
44,000
RSU
6/22/18
6/22/18
6/22/18
486,153
RSU
6/22/18
9/6/18
9/6/18
450
SO
6/22/18
9/6/18
9/6/18
65,000
SO
6/22/18
6/22/18
10/15/18
76,700
RSU
6/22/18
11/1/18
11/1/18
57,000
SO
6/22/18
11/29/18
11/29/18
350,000
RSU
6/22/18
12/12/18
12/12/18
16,250
RSU
6/22/18
12/12/18
12/17/18
3,000
SO
6/22/18
3/4/19
3/20/19
547,100
RSU
6/22/18
5/10/19
5/10/19
100,000
SO
5/24/19
5/24/19
5/24/19
150,000
SO
5/24/19
7/1/19
7/1/19
403,400
SO
5/24/19
7/1/19
7/22/19
75,000
RSU
5/24/19
10/11/19
10/11/19
40,000
SO
5/24/19
10/11/19
1/15/20
94,500
RSU
5/24/19
10/11/19
3/16/20
5,000
RSU
4/20/20
4/20/20
4/29/20
20,000
RSU
4/20/20
11/24/20
11/24/20
475,000
SO
4/20/20
11/24/20
11/24/20
1,216,200
RSU
4/20/20
3/23/21
3/23/21
24,900
SO
4/20/20
3/23/21
3/23/21
75,200
RSU
5/19/21
5/19/21
5/19/21
20,000
BSA
5/19/21
5/19/21
6/3/21
39,185
RSU
5/19/21
11/22/21
11/22/21
257,300
SO
5/19/21
11/22/21
11/22/21
1,107,300
In the following tables in Notes 13.1 to 13.4, exercise prices, grant date share fair values and fair value per equity instruments are provided in euros, as the Company is incorporated in France and the euro is the currency used for the
grants.
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Table of Contents
13.1 Non-
employee warrants
The Company’s board of directors has been authorized by the shareholders’ general meeting to grant BSAs to non-employee’s
members of the Board of Directors and members of the Scientific Advisory Board.
The BSAs
plans granted by the Board of Directors until 2018 are similar in their nature and conditions, except for the exercise price that is comprised between € 5.13 and € 69.75 .
During the year ended December 31, 2021, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the Company offered the directors the opportunity to subscribe for warrants to purchase ordinary shares on May 19, 2021, and on June 3, 2021, the directors subscribed for warrants to purchase an aggregate of 39,185 ordinary shares. These warrants have a contractual life of 4 years from their date of issuance and are not subject to a performance condition. Unless otherwise decided by the Board of Directors, these warrants may be exercised at any time prior to their expiration, provided that the beneficiary still holds a seat on the Board of Directors at the time of exercise, and subject to applicable French laws and regulations applicable to companies whose securities are listed on a regulated stock market. The fair value of the warrants has been estimated using the Cox-Ross
Rubinstein binomial option pricing model .
Warrant fair value assumptions during the year ended December 31, 2021
Weighted average share price at grant date (
in €)
10.75
Weighted average expected volatility
90.0
%
Weighted average risk-free interest rate
( 0.53
)%
Weighted average expected term (in years)
3.21
Dividend yield
—
Weighted average fair value of warrants (
in €)
—
The following table summarizes all BSA activity during the year ended December 31, 2020:
Number of
warrants
outstanding
Weighted-
average
exercise price
(in Euros)
Weighted-
average
remaining
contractual
term (in
years)
Aggregate
intrinsic value (in
thousands of
Euros)
Balance as of December 31, 2019
218,008
52.78
6.36
244.6
Granted during the period
—
—
—
—
Forfeited during the period
—
—
—
—
Exercised during the period
—
—
—
—
Expired during the period
—
—
—
—
Balance as of December 31, 2020
218,008
52.78
5.36
—
Warrants exercisable as of December 31, 2020
218,008
52.78
5.36
—
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Table of Contents
The following table summarizes all BSA warrants activity during the year ended December 31, 2021:
Number of
warrants
outstanding
Weighted-
average
exercise price
(in Euros)
Weighted-
average
remaining
contractual
term (in
years)
Aggregate
intrinsic value (in
thousands of
Euros)
Balance as of December 31, 2020
218,008
52.78
5.36
—
Granted during the period
39,185
9.18
—
—
Forfeited during the period
—
—
—
—
Exercised during the period
—
—
—
—
Expired during the period
( 500
)
5.13
—
—
Balance as of December 31, 2021
256,693
47.51
4.35
—
Warrants exercisable as of December 31, 2021
256,693
47.51
4.35
—
13.2 Employee warrants
The Company’s Board of Directors has been authorized by the shareholders’ general meeting to grant BSPCE warrants (Bons de Souscription de Parts de Créateur d’Entreprise or “BSPCE”) to employees. The Company no longer grants BCE warrants since 2011.
The following table summarizes all BSPCE warrants activity during the year ended December 31, 2020:
Number of
warrants
outstanding
Weighted-
average
exercise price
in Euros
Weighted-
average
remaining
contractual
term (in years)
Aggregate
intrinsic value
in thousands
of Euros
Balance as of December 31, 2019
7,166
5.13
1.47
1,558.2
Granted during the period
—
—
—
—
Forfeited during the period
—
—
—
—
Exercised during the period
( 1,666
)
5.13
—
—
Expired during the period
—
—
—
—
Balance as of December 31, 2020
5,500
5.13
0.47
—
Warrants exercisable as of December 31, 2020
5,500
5.13
0.47
—
The following table summarizes all BSPCE warrants activity during the year ended December 31, 2021:
Number of
warrants
outstanding
Weighted-
average
exercise price
in Euros
Weighted-
average
remaining
contractual
term (in years)
Aggregate
intrinsic value
in thousands
of Euros
Balance as of December 31, 2020
5,500
5.13
0.47
—
Granted during the period
—
—
—
—
Forfeited during the period
—
—
—
—
Exercised during the period
( 5,500
)
5.13
—
—
Expired during the period
—
—
—
—
Balance as of December 31, 2021
—
—
—
—
Warrants exercisable as of December 31, 2021
—
—
—
—
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Table of Contents
There were no
BSPCE
warrants grants during the years ended December 31
, 2021
and 2020
.
13.3 Stock options
The Company’s Board of Directors has been authorized by the shareholders’ general meeting to grant SOs to employees.
The different stock options plans granted by the Board of Directors are similar in their nature and conditions, except for the exercise price that is comprised between € 4.16 and € 74.22 .
All SO issued have a ten-year contractual
life. SO are expensed in accordance with the following vesting conditions:
•
Before June 22, 2018 and after January 15, 2020, SO granted mainly vest over four years at a rate of 25 % upon the first anniversary of the issuance date and 12.5 % every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors’ decisions),
•
Between June 22, 2018 and January 15, 2020, SO may be exercised by the beneficiary once both of the following conditions have been met:
•
Service condition: 25% upon the first anniversary of the issuance date and 12.5% every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific contractual clause or board of directors’ decisions), and,
•
Performance condition: approval of Viaskin ™
Peanut by the US Food and Drug Administration,
Performance conditions which are other than market conditions, 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. Estimated achievement of performance conditions is reviewed at each reporting date.
The Company also applied a forfeiture rate for each grant according to its respective characteristics and composition. This forfeiture rate is reviewed at each reporting date.
The following table summarizes all stock options activity during the year ended December 31, 2020:
Number of SO
outstanding
Weighted-average
exercise price in
Euros
Weighted-average
remaining
contractual term
(in years)
Aggregate
intrinsic value
in thousands
of Euros
Balance as of December 31, 2019
3,002,045
29.89
8.21
7,286.3
Granted during the period
1,310,700
5.54
—
—
Forfeited during the period
( 1,667,235
)
28.49
—
—
Exercised during the period
( 35,000
)
7.57
—
—
Expired during the period
—
—
—
—
Balance as of December 31, 2020
2,610,510
18.75
8.17
198.8
Options exercisable as of December 31, 2020
580,023
38.79
4.94
—
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Table of Contents
The following table summarizes all stock options activity during the year ended December 31, 2021:
Number of SO
outstanding
Weighted-average
exercise price in
Euros
Weighted-average
remaining
contractual term
(in years)
Aggregate
intrinsic value
in thousands
of Euros
Balance as of December 31, 2020
2,610,510
18.75
8.17
198.8
Granted during the period
1,182,900
6.09
—
—
Forfeited during the period
( 162,200
)
4.89
—
—
Exercised during the period
—
—
—
—
Expired during the period
—
—
—
—
Balance as of December 31, 2021
3,631,210
15.25
7.96
Options exercisable as of December 31, 2021
878,560
29.50
5.43
—
Stock options have been granted during the years ended December 31, 2021 and 2020. The weighted-average exercise price of SO granted during the year ended December 31, 2021 was € 6.09 per share.
As of December 31, 2021, there was € 10.1 million ($ 11.4 million converted at closing rate) of unrecognized SO expense that is expected to be recognized over a weighted-average period of 2.9 years.
Fair value of stock options
Determining the fair value of the share-based payments at the grant date requires judgment. The Company calculated the fair value of stock options instruments on the grant date using the Black-Scholes option pricing model. The Black-Scholes model requires the input of highly subjective assumptions, including the expected volatility, expected term, risk-free interest rate and dividend yield.
Exercise price
The exercise price of the Company’s stock awards is based on the fair market value of our ordinary shares.
Risk-free interest rate
The risk-free interest rate is based on French government bonds (GFRN) with a maturity corresponding to the stock options maturity.
Expected term
The Company determines the expected term based on the average period the stock options are expected to remain outstanding.
Expected Volatility
The Company determines the expected volatility based on the historical data period corresponding to the stock options expected maturity.
Expected Dividend yield
The Company has never declared or paid any cash dividends, and it does not presently plan to pay cash dividends in the foreseeable future. Consequently, the Company uses an expected dividend yield of zero.
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Table of Contents
The Company estimated the following assumptions for the calculation of the fair value of the stock options:
Assumptions per year ended, December 31,
Stock options per grant date
Prior to
2017
2017
2018
2019
2020
2021
Weighted average shares price at grant date in €
36.69
45.49
31.86
15.26
5.54
5.71
Weighted average expected volatility
45.4
%
41.8
%
47.1
%
70.8
%
87.3
%
90.2
%
Weighted average risk-free interest rate
1.0
%
( 0.1
)%
0.3
%
( 0.1
)%
( 0.5
)%
( 0.06
)%
Weighted average expected term (in years)
6.7
6.0
6.0
6.0
6.0
6.0
Dividend yield
0
0
0
0
0
0
Weighted average fair value of stock-options (in €)
17.66
17.16
13.67
9.65
3.90
4/17
13.4 Restricted stock units
The Company’s board of directors has been authorized by the shareholders’ general meeting to grant
RSUs to employees.
RSUs are measured based on the fair market value of the underlying stock on the date of grant and recognized as an expense on a straight-line basis in accordance with the following vesting conditions:
•
Before May 31, 2019, the vesting of RSUs granted is subject to the expiration of the presence condition of one ( 1 ) or two ( 2 ) years (except in specific board of directors’ decisions). The release of RSUs for these plans is subject to the achievement of performance conditions (submission of a BLA to U.S. FDA for Viaskin ™
Peanut, approval of Viaskin ™
Peanut by the U.S. FDA, first sale of Viaskin ™
Peanut in the United States);
•
Between May 31, 2019 and November 23, 2020, the vesting of RSUs is subject either to the expiration of the presence condition of two (2) years only, or to the dual condition of expiration of the presence condition and achievement of the performance condition (date of approval of Viaskin ™
Peanut by the U.S. FDA);
•
Since November 24, 2020, RSUs vest over four years at a rate of 25 % upon the first anniversary of the issuance date and 12.5 % every 6 months thereafter, subject to the beneficiary being still employed by the Company (except in specific board of directors’ decisions).
Performance conditions, which are other than market conditions, 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. Estimated achievement of performance conditions is reviewed at each reporting date.
RSU plans may be subject to a conservation period under French governing laws.
The Company applied a forfeiture rate for each grant according to its respective characteristics and composition. This forfeiture rate is reviewed at each reporting date.
The following table summarizes all RSUs activity for the year ended December 31, 2020:
Number of
RSU
outstanding
Weighted
average grant
date fair
value in
Euros
Balance as of December 31, 2019
692,145
30.55
Granted during the period
500,000
4.56
Forfeited during the period
( 71,400
)
7.29
Released during the period
( 2,000
)
68.07
Expired during the period
—
—
Balance as of December 31, 2020
1,118,745
20.35
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Table of Contents
The service conditions have been met in 2020 for the plan granted on May 10, 2019 with a total fair value of € 1.3 million.
The following table summarizes all RSUs activity for the year ended December 31, 2021:
Number of
RSU
outstanding
Weighted
average grant
date fair
value in
Euros
Balance as of December 31, 2020
1,118,745
20.35
Granted during the period
302,200
6.13
Forfeited during the period
( 96,350
)
6.74
Released during the period
( 84,075
)
8.20
Expired during the period
—
—
Balance as of December 31, 2021
1,240,520
18.77
The plan granted on May 10, 2019 vested in 2020 with a total fair value of € 1,288 thousands. This plan is not included in the previous table since the RSUs will be released, and shares issued once the performance condition will be achieved (approval of Viaskin ™
Peanut by the U.S. FDA).
As of December 31, 2021, there was € 2.5 million ($ 2.8 million converted at closing rate) of unrecognized RSUs compensation expense that is expected to be recognized over a weighted-average period of 2.4 years.
13.5 Reconciliation of the share-based payment expenses with the Consolidated Statements of Operations and Comprehensive Loss
December 31,
2021
2020
Research and development
SO
( 759
)
190
RSU
( 887
)
( 806
)
Sales and marketing
SO
( 209
)
2,141
RSU
( 104
)
( 24
)
General and administrative
SO
( 841
)
( 119
)
RSU
( 322
)
( 253
)
Total share-based compensation (expense) income
( 3,122
)
1,130
As of December 31, 2020, reversal of share-based payments expenses was mainly due to the restructuring plan announced on June 26, 2020 which led to significant reduction in the Company’s workforce.
Note 14 Contingencies
Non-current
contingencies and current contingencies break down as follows:
December 31,
2021
2020
Current contingencies
4,095
5,016
Non-current
contingencies
6,758
2,527
Total contingencies
10,853
7,542
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Table of Contents
The table below shows movements
in contingencies:
Pension retirement
obligations
Collaboration
agreement—Loss at
completion
Other contingencies
Total
At January 1, 2020
1,656
—
724
2,380
Increases in liabilities
—
3,683
2,466
6,149
Used liabilities
—
—
( 724
)
( 724
)
Reversals of unused liabilities
( 443
)
—
—
( 443
)
Net interest related to employee benefits, and unwinding of discount
8
—
—
8
Actuarial gains and losses on defined-benefit plans
( 376
)
—
—
( 376
)
Currency translation effect
93
274
183
550
At December 31, 2020
937
3,956
2,649
7,542
Of which Current
—
2,366
2,649
5,016
Of which Non-current
937
1,590
—
2,527
At January 1, 2021
937
3,956
2,649
7,542
Increases in liabilities
181
6,420
47
6,649
Used liabilities
—
—
( 1,634
)
( 1,634
)
Reversals of unused liabilities
—
—
( 920
)
( 920
)
Net interest related to employee benefits, and unwinding of discount
3
—
—
3
Actuarial gains and losses on defined-benefit plans
( 35
)
—
—
( 35
)
Currency translation effect
( 78
)
( 577
)
( 98
)
( 753
)
At December 31, 2021
1,008
9,800
45
10,853
Of which Current
—
4,049
45
4,095
Of which Non-current
1,008
5,750
—
6,758
The Company does not hold any plan assets for any
of the
periods presented.
As of December 31, 2021, the Company updated its measurement of progress of the Phase 2 clinical trial (“PII”) conducted as part of the collaboration and license agreement with Nestlé and updated the cumulative income recognized. The Company has recorded an accrual in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and incomes yet to be recognized for the completion of the PII.
As of December 31, 2020, other contingencies were mainly composed of the estimated to be incurred as part of the social costs related to restructuring, as well as estimated cost of refurbishment on lease premises (Refer to Note 2, “Significant Events and Transactions of the Periods—Restructuring contingencies”).
F
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Table of Contents
As part of the estimation of the retirement commitments, the following assumptions were used for all categories of employees:
December 31,
2021
2020
% Social security contributions
50.0
%
50.0
%
Salary increases
2.0
%
2.0
%
Discount rate—Iboxx Corporates AA 10+
0.98
%
0.34
%
Expected staff turnover
10.0
%
10.0
%
Estimated retirement age
65
65
Life table
TGH05-TGF05
Collective agreement
National Collective Agreement of the pharmaceutical industry
Note 15 Operating Income
The operating income is broken down in the following manner:
December 31,
2021
2020
Research tax credit
7,505
9,930
Other operating income
( 1,797
)
1,346
Total
5,708
11,276
On May 31, 2016, the Company announced its entry into an exclusive global collaboration with Nestlé Health Science to develop MAG1C, a ready-to-use
and standardized atopy patch test tool for the diagnosis of cow’s milk protein allergy in infants and toddlers. Under the terms of the exclusive collaboration, the Company is responsible for leading the development activities of MAG1C up through a pivotal Phase III clinical program, and if appropriate regulatory approvals are received, Nestlé Health Science will support the commercialization of MAG1C globally, while prioritizing certain agreed-upon countries. The Company entered into an amendment with Nestlé Health Science on July 12, 2018. 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 that the Company received in July 2016.
In 2020 and 2021, the ongoing COVID-19
pandemic impacted the Company’s current clinical trials, including the Phase II clinical trial conducted as part of the development activities pursuant to the collaboration and license agreement with Nestlé Health Science. The Company experienced difficulties in enrolling new patients in this Phase II clinical trial and modified the protocols of the clinical trial. As a result of the accumulation of recruitment delays, the Company expects to incur additional clinical and production costs related to the Phase II clinical trial.
As of December 31, 2021, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of the Phase II clinical trial conducted as part of the agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly.
Note 16 Allocation of Personnel Expenses
The Company had 101 average employees for the year ended December 31, 2021, in comparison with 270 employees for the year ended December 31, 2020.
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Table of Contents
Allocation of Personnel Expenses by Function:
December 31,
2021
2020
Research and Development expenses
14,596
25,703
Sales and Marketing expenses
1,885
5,217
General and Administrative expenses
9,357
9,906
Restructuring*
5,296
12,066
Total personnel expenses
31,135
52,891
*
Restructuring personnel expenses excluding effect of accrual for the year ended December 31, 2020 and reversal for the year ended December 31, 2021.
Allocation of Personnel Expenses by Nature:
December 31,
2021
2020
Wages and salaries
18,017
43,330
Social security contributions
8,407
9,510
Expenses for pension commitments
1,366
2,151
Employer contribution to bonus shares
223
( 970
)
Share-based payments
3,122
( 1,130
)
Total
31,135
52,891
The decrease in personnel expenses is mainly due to a decrease in headcount as well as accrued bonus, retention measures as part of the global restructuring plan.
Note 17 Income Tax
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 26.5 % as of December 31, 2021 and 28 % as of December 31, 2020 (excluding additional contributions):
December 31,
2021
2020
(Loss) before taxes
( 98,189
)
( 159,566
)
Theoritical company tax rate
26.50
%
28.00
%
Nominal tax expense
26,020
44,678
Increase/decrease in tax expense arising from:
Research tax credit
1,990
2,781
Share-based compensation
( 104
)
( 3,505
)
Other permanent differences
( 86
)
2,756
Non recognition of deferred tax assets mainly related to tax losses
( 25,882
)
( 41,881
)
Other differences
( 1,557
)
( 4,818
)
Effective tax expenses—current
381
10
Effective tax expenses—deferred
—
—
Effective tax rate
( 0.39
)%
( 0.01
)%
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Table of Contents
Deferred Tax Assets
Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The significant components of the Company’s deferred tax assets are comprised of the following:
December 31,
2021
2020
Deferred tax assets:
Net operating loss carryforwards
263,086
290,914
Share-based compensation
5,521
4,070
Personnel-related accruals
376
667
Pension retirement obligations
252
262
Leases
518
84
Other
2,760
1,346
Total deferred tax assets
272,513
297,343
Less : Valuation allowance
( 272,513
)
( 297,343
)
Net deferred tax assets
—
—
Note 18 Commitments
Purchase Obligations
The Company has signed agreements with several contract research organizations (CRO) and part of the ongoing clinical studies for Viaskin ™
Peanuts and Viaskin ™
Milk products, the Company. As of December 31, 2021, we had non-cancellable
contractual obligations with CRO until year ended 2024 for $ 30.3 million.
Letter of Credit and Collateral
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 leased premises in Bagneux for an amount of € 400 thousand (equivalent to $ 491 thousand at closing exchange rate).
A letter of credit has also been signed by the Company in April 2016 for $ 143 thousand to ensure the lease of its premises of its United States subsidiary. This credit note has been extended in 2020 and 2021.
A letter of credit was also signed by the Company in May 2017 for $ 300 thousand to secure the lease of its premises of its United States subsidiary. In 2015, the Company took a term deposit for a sum of € 228 thousand (equivalent to $ 259 thousand at closing exchange rate).
A Certificate of Deposit, for an initial amount of $ 250 thousand was signed in order to guarantee an American Express credit cards program in the United States.
Royalty Payments
On January 7, 2009, the Company entered into an assignment, development and co-ownership
agreement with Public Welfare-Hospitals of Paris (L’Assistance Publique—Hopitaux de Paris), or AP-HP,
and Université Paris-Descartes, or UPD, by which the Company agreed to terms of co-
ownership with AP-HP
and UPD of certain U.S. and foreign patents and patent applications, referred to herein as the shared patents. The Company, and any licensees or sublicensees the Company designates, have the exclusive right to commercial uses of the shared patents. AP-HP
and UPD agreed to use the shared patents only for internal research purposes and not to license the shared patents to any third party. Upon commercialization of any product covered by the shared patents, which the Company expects would include its Viaskin ™
product candidates, the Company will be obligated to
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Table of Contents
pay AP-HP
and UPD a percentage of net sales as a royalty. This royalty varies depending on the particular patent used in the product and is in the
low single digits. Additionally, if the Company licenses any of the shared patents to a third party and a licensee commercializes products covered by such shared patents, the Company will be obligated to pay AP-HP
and UPD a percentage in the low single digits of the money it receives from its licensee. If the Company does not sell any of its product candidates covered by the shared patents within 30 months from the date it first markets such product
candidates, AP-HP
may, upon six months’ notice and subject to certain exceptions, convert its exclusive right to the commercial use of the shared patents to a non-exclusive
right. Any party may terminate the license in the event of another party’s substantial breach which remains uncured after six months of receiving written notice of such breach. The agreement will also terminate in the event the Company ceases operations or is subject to a dissolution or bankruptcy proceedings. Absent early termination, the agreement will automatically terminate upon the expiration of the last shared patent. In the event the agreement is terminated, the Company would no longer have the exclusive right to commercial use of the shared patents, though it would retain its shared ownership rights. In addition, its ownership stake in certain jointly made improvements covered by the shared patents would survive termination of the agreement. The longest lived patent rights licensed to the Company under the agreement are currently expected to expire in 2033. To date, this agreement has not had an impact on the Company’s financial statements.
Note 19 Relationships with Related Parties
The compensation amounts for 2021 presented below, which were awarded to the Directors and Officers of the Company totaled $ 7 million. The recipients of this compensation are “related parties” under applicable French law and may not be considered executive officers or related parties under comparable SEC and Nasdaq rules and regulations applicable to the Company.
December 31,
2021
2020
Short-term benefits
5,128
5,226
Post-employment benefits
67
34
Termination benefits
280
829
Share-based payments
1,556
2,209
Total
7,031
8,297
The methods for the valuation of the benefit related to share-based payments are presented in Note 13 Share-Based Payments.
Amounts payable to related parties as of December31, 2021 and 2020 are as follows:
December 31,
2021
2020
Compensation
1,820
2,049
Pension obligations
156
122
Total
1,976
2,172
As of December 31, 2020, the amount of compensation included severance pay for Executive Committee members in connection with the restructuring announcement in June 2020.
Note 20 Loss Per Share
The basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the course of the fiscal year. As the Company was in a loss position for the years ended December 31, 2021 and 2020, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive given the Company’s net loss.
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The computations for basic and diluted loss per share were as follows (in thousands of U.S. Dollars except per share data):
December 31,
2021
2020
Net loss
( 97,809
)
( 159,555
)
Weighted average number of ordinary shares
54,916,937
54,092,666
Basic and diluted net loss per share attributable to ordinary
shareholders ($/share)
( 1.78
)
( 2.95
)
The following is a summary of the ordinary share equivalents which were excluded from the calculation of diluted net loss per share for the periods indicated in number of potential shares:
December 31,
2021
2020
Non-employee
warrants
256,693
225,008
Employee warrants
—
82,500
Stock-options
3,631,210
2,610,510
Restricted stock units
1,240,520
1,118,245
Note 21 Events after the Close of the Fiscal Year
In January 2022, the company entered into a termination agreement for its U.S. office in Summit, NJ, following the resizing of its facility use. The agreement provides for the termination of the lease effective on February 1, 2022, in exchange for a one-time
lump sum early termination fee. Right of use and related lease debt will be adjusted in the 2022 financial period.
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