10-Q
1
d172290d10q.htm
10-Q
10-Q
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2021
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
to
Commission file number 001-36697
DBV TECHNOLOGIES S.A.
(Exact name of registrant as specified in its charter)
France
Not applicable
State or other jurisdiction of
incorporation or organization
(I.R.S. Employer
Identification No.)
177-181 avenue Pierre Brossolette
Montrouge France
92120
(Address of principal executive offices)
(Zip Code)
Registrants telephone number, including area code +33 1 55 42 78 78
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange
on which registered
American Depositary Shares, each representing one-half of one ordinary share, nominal value 0.10 per share
DBVT
The Nasdaq Stock Market LLC
Ordinary shares, nominal value 0.10 per share*
n/a
The Nasdaq Stock Market LLC
*
Not for trading, but only in connection with the registration of the American Depositary Shares.
Securities registered pursuant to section 12(g) of the Act: None.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90
days. ☒ Yes ☐ No
Indicate by check mark whether the
registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such
shorter period that the registrant was required to submit such files). ☒ Yes ☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of large accelerated filer, accelerated filer, smaller reporting
company, and emerging growth company in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended
transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Act). ☐ Yes ☒ No
As of April 30, 2021, the
registrant had 54,936,687 ordinary shares, nominal value 0.10 per share, outstanding.
Table of Contents
Table of contents
Page
Part I
Financial information
1
Item 1
Condensed Consolidated Statements of Financial Position (Unaudited) as of March 31,2021
and December 31, 2020
1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
for the Three Months Ended March 31, 2021 and 2020
2
Condensed Consolidated Statements of Cash Flows (Unaudited) for the Three Months
Ended March 31, 2021 and 2020
3
Condensed Consolidated Statements of Changes in Shareholders Equity (Unaudited)
for the Three Months Ended March 31, 2021 and 2020
4
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
5
Item 2
Managements Discussion and Analysis of Financial Condition and Results
of Operations
13
Item 3
Quantitative and Qualitative Disclosures About Market Risk
17
Item 4
Controls and Procedures
17
Part II
Other information
18
Item 1
Legal Proceedings
18
Item 1A
Risk Factors
18
Item 2
Unregistered Sales of Equity Securities and Use of Proceeds
18
Item 3
Defaults Upon Senior Securities
18
Item 4
Mine Safety Disclosures
18
Item 5
Other Information
18
Item 6
Exhibits
19
Table of Contents
SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS.
This Quarterly Report on Form 10-Q (Form 10-Q) contains
forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended
(the Exchange Act). These statements may be identified by such forward-looking terminology as may, should, expects, intends, plans, anticipates,
believes, estimates, predicts, potential, continue or variations of these words or similar expressions that are intended to identify forward-looking statements, although not all
forward-looking statements contain these words. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially
from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things:
statements regarding the impact of the ongoing COVID-19 pandemic and its
effects on our operations, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations, other service providers and collaborators with whom we
conduct business;
our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect
to our anticipated re-submission of a Biologics License Application for Viaskin TM Peanut to the U.S. Food and Drug Administration;
the initiation, timing, progress and results of our pre-clinical studies
and clinical trials, and our research and development programs;
the sufficiency of existing capital resources;
the implementation of our global restructuring plan, our business model and our other strategic plans for our
business, product candidates and technology;
our ability to manufacture clinical and commercial supplies of our product candidates and comply with regulatory
requirements related to the manufacturing of our product candidates;
our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize
Viaskin Peanut and/or our other product candidates, if approved;
the commercialization of our product candidates, if approved;
our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut
and/or our other product candidates, if approved, and our ability to serve such markets;
the pricing and reimbursement of our product candidates, if approved;
the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by
physicians, patients, third-party payors and others in the medical community;
our ability to advance product candidates into, and successfully complete, clinical trials;
the scope of protection we are able to establish and maintain for intellectual property rights covering our
product candidates and technology;
estimates of our expenses, future revenues, capital requirements and our needs for additional financing;
the potential benefits of strategic collaboration agreements and our ability to enter into strategic
arrangements;
our ability to maintain and establish collaborations or obtain additional grant funding;
our financial performance;
developments relating to our competitors and our industry, including competing therapies; and
other risks and uncertainties, including those listed under the caption Risk Factors.
Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of
activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. These risks, uncertainties and other factors are described in greater detail under the caption Risk
Factors in Part I. Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission (SEC) on March 17, 2021. As a
result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement.
In addition, any forward-looking statement in this Annual Report represents our views only as of the date of this annual report and should not be relied upon
as representing our views as of any subsequent date. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we
specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
Table of Contents
Part I Financial Information
Item 1. Financial Statements
DBV Technologies S.A.
Condensed Consolidated Statements of Financial Position (unaudited)
(amounts in thousands, except share and per share data)
March 31,
December 31,
Note
2021
2020
Assets
Current assets :
Cash and cash equivalents
3
$
152,459
$
196,352
Trade receivables
2,230
Other current assets
7,349
8,792
Total current assets
159,809
207,375
Property, plant, and equipment, net
21,526
24,792
Right-of-use
assets related to operating leases
9,168
10,104
Intangible assets
32
41
Other non-current assets
30,870
29,935
Total non-current assets
61,596
64,871
Total Assets
$
221,405
$
272,246
Liabilities and shareholders equity
Current liabilities:
Trade payables
4
$
17,176
$
20,338
Short-term operating leases
3,314
3,708
Short-term financial debt
701
724
Current contingencies
6
4,246
5,016
Other current liabilities
4
13,394
22,926
Total current liabilities
38,831
52,713
Long-term operating leases
9,533
10,496
Long-term financial debt
350
543
Non-current contingencies
6
2,229
2,527
Other non-current liabilities
1,286
475
Total non-current liabilities
13,398
14,042
Total Liabilities
$
52,229
$
66,754
Shareholders equity :
Ordinary shares, 0.10 par value; 54,936,687 and 54,929,187 shares authorized, and issued as
at March 31, 2021 and December 31, 2020, respectively, and 4,100,663 and 4,029,763 shares outstanding as at March 31, 2021 and December 31, 2020, respectively
$
6,519
$
6,518
Additional paid-in capital
1,153,516
1,152,042
Treasury stock, 60,588 and 112,302 ordinary shares as of March 31, 2021 and December 31,
2020, respectively, at cost
(681
)
(1,169
)
Accumulated deficit
(987,992
)
(958,543
)
Accumulated other comprehensive income
399
484
Accumulated currency translation effect
(2,586
)
6,158
Total Shareholders equity
$
169,176
$
205,491
Total Liabilities and Shareholders equity
$
221,405
$
272,246
The accompanying notes are an integral part of these condensed consolidated financial statements.
1
Table of Contents
DBV Technologies S.A.
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(amounts in thousands, except share and per share data)
Three Months Ended March
31,
Note
2021
2020
Operating income
7
$
2,941
$
4,720
Operating expenses
Research and development expenses
(22,164
)
(27,532
)
Sales and marketing expenses
(729
)
(7,297
)
General and administrative expenses
(9,683
)
(11,113
)
Total Operating expenses
(32,575
)
(45,942
)
Loss from operations
(29,634
)
(41,222
)
Financial income
215
309
Loss before taxes
(29,419
)
(40,913
)
Income tax
(30
)
Net loss
$
(29,449
)
$
(40,913
)
Other comprehensive loss
Foreign currency translation differences, net of taxes
(8,744
)
(6,064
)
Actuarial (losses) gains on employee benefits, net of taxes
(85
)
189
Comprehensive loss
$
(38,279
)
$
(46,788
)
Basic/diluted Net loss per share attributable to shareholders
11
$
(0.54
)
$
(0.79
)
Weighted average shares outstanding used in computing per share amounts:
54,880,776
51,802,524
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Table of Contents
DBV Technologies S.A.
Condensed Consolidated Statements of Cash Flows (unaudited)
(amounts in thousands)
Three Months Ended March 31,
Notes
2021
2020
Net loss for the period
$
(29,449
)
$
(40,913
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation, amortization and accrued contingencies
1,483
1,548
Retirement pension obligations
109
Expenses related to share-based payments
1,433
3,073
Other elements
(456
)
419
Changes in operating assets and liabilities:
Decrease (increase) in inventories and work in progress
(2,402
)
Decrease (increase) in trade receivables
2,101
Decrease (increase) in other current assets
(417
)
122
(Decrease) increase in trade payables
(2,567
)
(3,212
)
(Decrease) increase in other current and non-current
liabilities
(7,980
)
(8,382
)
Change in operating lease liabilities and right of use assets
(353
)
(45
)
Net cash flow used in operating activities
(36,204
)
(49,683
)
Cash flows used in investing activities:
Acquisitions of property, plant, and equipment, net from proceeds
(184
)
(816
)
Acquisitions of intangible assets
(114
)
Acquisitions of non-current financial assets
(1
)
Net cash flows used in investing activities
(185
)
(930
)
Cash flows provided by financing activities:
(Decrease) increase in conditional advances
(164
)
7
Treasury shares
578
(412
)
Capital increases, net of transaction costs
42
151,023
Other cash flows related to financing activities
(17
)
(7
)
Net cash flows provided by financing activities
440
150,611
Effect of exchange rate changes on cash and cash equivalents
(7,944
)
(5,811
)
Net (decrease) / increase in cash and cash equivalents
(43,893
)
94,187
Net Cash and cash equivalents at the beginning of the period
196,352
193,255
Net cash and cash equivalents at the end of the period
3
$
152,459
$
287,442
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Table of Contents
DBV Technologies S.A.
Condensed Consolidated Statements of Changes in Shareholders Equity (unaudited)
(amounts in thousands, except share and per share data)
Ordinary shares
Number of
Shares
Amount
Additional
paid-in
capital
Treasury
stock
Accumulated
deficit
Accumulated
other
comprehensive
income
(loss)
Accumulated
currency
translation
effect
Total
Shareholders
Equity
Balance at January 1, 2020
47,028,510
$
5,645
$
1,003,595
$
(230
)
$
(798,988
)
$
108
$
(16,945
)
$
193,186
Net (loss)
(40,913
)
(40,913
)
Other comprehensive income (loss)
189
(6,064
)
(5,875
)
Issuance of ordinary shares
7,898,677
873
150,150
151,023
Treasury shares
(832
)
(832
)
Share-based payments
3,073
3,073
Balance at March 31, 2020
54,927,187
$
6,518
$
1,156,818
$
(1,062
)
$
(839,901
)
$
297
$
(23,009
)
$
299,662
Ordinary shares
Number of
Shares
Amount
Additional
paid-in
capital
Treasury
stock
Accumulated
deficit
Accumulated
other
comprehensive
gain
(loss)
Accumulated
currency
translation
effect
Total
Shareholders
Equity
Balance at January 1, 2021
54,929,187
$
6,518
$
1,152,042
$
(1,169
)
$
(958,543
)
$
484
$
6,158
$
205,491
Net (loss)
(29,449
)
(29,449
)
Other comprehensive (loss)
(85
)
(8,744
)
(8,829
)
Issuance of ordinary shares
7 500
1
42
42
Treasury shares
488
488
Share-based payments
1,433
1,433
Balance at March 31, 2021
54,936,687
$
6,519
$
1,153,516
$
(681
)
$
(987,992
)
$
399
$
(2,586
)
$
169,176
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Table of Contents
NOTES TO THE FINANCIAL STATEMENTS (UNAUDITED)
Note 1: The Company
Incorporated in 2002 under the laws
of France, DBV Technologies S.A. (DBV Technologies, or the Company, or the group) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel
technology platform called Viaskin . The Companys therapeutic approach is based on epicutaneous immunotherapy, or EPIT , a
proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin .
Basis of Presentation
The condensed consolidated
financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP) and are presented in U.S. dollars.
All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.
The unaudited
condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Companys Annual Report on Form 10-K filed with the SEC on March 17, 2021 (the Annual Report). The condensed consolidated statement of financial position at December 31, 2020 was derived from the audited consolidated
financial statements but does not include all disclosures required by U.S. GAAP. The Companys critical accounting policies are detailed in the Annual Report. The Companys critical accounting policies have not changed materially since
December 31, 2020.
Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have
been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management,
necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2021, or any other future period.
Use of estimates
The preparation of the
Companys condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the
consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances.
The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates.
On an on-going basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement
with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets - operating lease, (4) impairment of
right-of-use assets related to leases and property, plant and equipment, (5) recoverability of the Companys net deferred tax assets and related valuation
allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan and, (7) estimate of contingencies.
Going concern
Since its inception, the Company has
primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits ( Cr é dit
d Imp ô t Recherche ). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.
Following receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in connection with its
Biologics License Application (BLA) for Viaskin Peanut, beginning in August 2020, the Company scaled down its other clinical programs and
pre-clinical spend to focus on Viaskin Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to
progress the clinical development and regulatory review of Viaskin Peanut in the United States and European Union. Based on guidance received from the FDA in January 2021, the Companys
plans to implement such guidance, and expected cost savings from implementation of the global restructuring plan, the Company expects that its current balance of cash and cash equivalents of $152.5 million as of March 31, 2021 will be
sufficient to fund its operations for at least the next 12 months.
The Company intends to seek additional capital as it prepares for the launch of
Viaskin Peanut, if approved, and continues other research and development efforts. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development
agreements and other forms of non-dilutive financings. As a result of disruptions to the global financial markets as a result of the ongoing COVID-19 pandemic, the
Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions. The ongoing COVID-19 pandemic has already caused extreme
volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at
all.
5
Table of Contents
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 Companys financial position or results of operations.
Accounting
Pronouncements issued not yet adopted
In June 2016, the Financial Accounting Standards Board (FASB) issued ASU 2016-13 - Financial Instruments - Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and
requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date
of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt
securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new
standard will have a material impact on its consolidated financial statements.
In January 2017, the FASB issued ASU
2017-04, Simplifying the Test for Goodwill Impairment, which modifies the goodwill impairment test and requires an entity to write down the carrying value of goodwill for the amount by which the carrying
amount of a reporting unit exceeds its fair value. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to
the fiscal year beginning January 1, 2023. The Company does not expect this new standard will have a material impact on its consolidated financial statements.
Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date
are not expected to have a material impact on the Companys Consolidated Financial Statements upon adoption.
Note 2: Significant Events and
Transactions
Clinical programs
Viaskin TM Peanut for children ages
4-11
In January 2020, the Company announced positive topline results of the three-year, open-label
extension of its Phase III PEPITES trial, or PEOPLE trial, evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrated long-term clinical benefit as shown by
an increase in eliciting dose (ED), which may decrease the chance of reacting to an accidental peanut exposure. After three years, the Company observed that 75.9% (107/141) of patients had increased their ED from baseline, and 51.8%
(73/141) of patients reached an ED of at least 1,000 mg peanut protein by year three. The safety profile of Viaskin Peanut was consistent with that observed in the clinical program to date in over 1,000 patients. During the PEOPLE trial, the most
common adverse events were mild to moderate skin reactions localized to the administration site, and there was no epinephrine use deemed related to treatment. No treatment related serious adverse events were reported. One patient experienced one
case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without anti-anaphylactic treatment. Treatment compliance remained high throughout the study at a mean of 98% over three years of
treatment. Low discontinuations due to adverse events were observed.
In February 2020, the FDA announced an Allergenic Products Advisory Committee
meeting to be held on May 15, 2020 to discuss the Biologics License Application (BLA) for Viaskin Peanut. On March 16, 2020, the Company announced that the FDA had informed us that during its ongoing review of the Companys BLA for
Viaskin Peanut, it had identified questions regarding efficacy, including the impact of patch-site adhesion. Therefore, the Advisory Committee meeting to discuss the BLA originally scheduled on May 15, 2020 was cancelled.
On August 4, 2020, the Company announced that FDA has issued a Complete Response Letter in which the FDA indicated it could not approve the Viaskin
Peanut BLA in its current form. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study. The FDA also indicated that supplementary
clinical data would need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data. The FDA did not raise any safety concerns related to Viaskin Peanut.
On January 13, 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in
October 2020 following the CRL. The Company believes the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, the Company proposed potential resolutions to two main concerns identified by the FDA in the CRL: the
impact of patch adhesion and the need for patch modifications. The FDA agreed with the Companys position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current
Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing
and modified patches, the FDA has
6
Table of Contents
requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population.
On November 2, 2020, the Company announced that its Marketing Authorization Application, or MAA, for Viaskin Peanut had been validated by the European
Medicines Agency, or EMA. The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years. The Company received the
first set of questions from the EMA, during the first quarter of 2021, which were consistent with the Companys expectations and prefiling conversations with the EMA. The Company did not receive questions about the impact of adhesion on
efficacy. The EMAs Committee for Medicinal Products for Human Use will provide a recommendation to the European Commission, or EC, on whether to grant a marketing authorization when its review of the Viaskin Peanut MAA is complete.
Viaskin Peanut for children ages 1-3
On June 26, 2020, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effects after 12 months of therapy, as
assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus
placebo. These results validate the ongoing investigation of the 250 m g dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in
the first quarter of 2021.
Financing
On
February 4, 2020, the Company announced the closing of an underwritten global offering of an aggregate of 7,500,000 ordinary shares in (i) a public offering of 4,535,581 ordinary shares in the form of 9,071,162 American Depositary Shares
(ADSs) in the United States, Canada and certain countries outside Europe at a public offering price of $10.25 per ADS (on the basis of an exchange rate of $1.0999 = 1.00), and (ii) an offering exclusively addressed to
qualified investors in Europe (including France) of 2,964,419 ordinary shares at an offering price of 18.63 per ordinary share (together, the Global Offering).
On March 2, 2020, the Company announced that the underwriters partially exercised their option to purchase 338,687 additional ordinary shares in the form
of 677,374 ADSs at an offering price of $10.25 per ADS, before deducting commissions and estimated offering expenses (the Option). The Option closed on March 4, 2020.
Consequently, following partial exercise of the Option, the total number of ordinary shares sold in the global offering was 7,838,687 ordinary shares,
including 4,874,268 ordinary shares in the form of 9,748,536 ADSs, bringing the total gross proceeds from the global offering to $160.7 million and net proceeds of $150.0 million.
Restructuring
The Company initiated a global
restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanut in the United States and European Union. The Company expects full implementation of the
organization-wide costs reduction measures to be completed by the second half of 2021.
The following table summarizes restructuring activities as of
March 31, 2021 included in current contingencies and other current liabilities in the statement of financial position:
Restructuring
liabilities
Restructuring liability - January 1, 2021
9,387
Amounts paid
(4,854
)
Other effect including currency translation effect
(220
)
Restructuring liability - March 31, 2021
4,313
of which current contingencies
1,511
of which other current liabilities
2,803
COVID-19 Pandemic
On March 11, 2020, the World Health Organization declared COVID-19 a pandemic. This global health crisis led many
countries to impose national containment measures and travel bans. In view of this exceptional situation, the Company decided to take all measures
7
Table of Contents
aimed primarily at guaranteeing the safety of its employees and the continuation of ongoing clinical trials, in compliance with the directives of the authorities in each country. The Company has
experienced a decrease in new patients enrolling in the ongoing clinical studies and it has had to adapt the protocols of its clinical trials because patients remain subject to travel restrictions.
The Company has assessed the impact of the uncertainties created by the pandemic. As of March 31, 2021, those uncertainties were taken into account in
the assumptions underlying the estimates and judgments used by the Company. The Company continues to update these estimates and assumptions as the situation evolves. The effects of the COVID-19 pandemic are
presented in the relevant line items of the condensed consolidated statement of financial position and the condensed consolidated statement of operations according to the function or nature of the income or expense.
Legal Proceedings
A class action complaint was
filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis Ito-Stone v. DBV Technologies, et al., Case No. 2:19-cv-00525. The complaint alleged that the Company and its former Chief Executive Officer, its current Chief Executive Officer, and its former Deputy Chief Executive Officer violated certain federal
securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The plaintiffs seek unspecified damages on behalf of a purported class of purchasers of
the Companys securities between February 14, 2018 and March 16, 2020.
The Company believes that the allegations contained in the amended
complaint are without merit and will defend the case vigorously. The Company believes this complaint will not have a material adverse effect on the Companys consolidated financial position, results of operations or liquidity.
Note 3: Cash and Cash Equivalents
The following table
presents for each reported period, the breakdown of cash and cash equivalents:
March 31,
December 31,
2021
2020
Cash
58,069
42,341
Cash equivalents
94,390
154,011
Total cash and cash equivalents as reported in the statements of financial
position
152,459
196,352
Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1
fair value measurements.
Note 4: Trade Payables and Other Current Liabilities
4.1 Trade Payables
No discounting
was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented.
4.2 Other Current Liabilities
Other current liabilities consisted of the following:
March 31,
December 31,
2021
2020
Employee related liabilities
9,245
16,661
Deferred income
3,378
4,687
Tax liabilities
312
580
Other debts
460
999
Total
13,394
22,926
8
Table of Contents
The other current liabilities include short-term debt to employees including employee termination allowance
and benefits as part of the restructuring (refer to Note 2, Significant Events and Transactions of the Period Restructuring), bonus accruals, and social welfare and tax agency obligations.
Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $3.4 million as
of March 31, 2021.
Note 5: Share-Based Payments
The Board of Directors has been authorized by the General Meeting of the Shareholders to grant restricted stock units (RSU), stock options plan
(SO), employee warrants ( Bons de Souscription de Parts de Créateur dEntreprise or BSPCE) and ( Bons de Souscription dActions or BSA).
During the three months ended March 31, 2021, the Company granted 75,600 stock options and 24,900 restricted stock.
There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 14 to the consolidated financial
statements included in the Annual Report.
Stock options fair value assumptions during the three months
ended March 31, 2021
Weighted average share price at grant date in
9.3
Weighted average expected volatility
90.9
%
Weighted average risk-free interest rate
(0.36
)%
Weighted average expected term (in years)
6
Dividend yield
Weighted average fair value of stock-options in
6.9
Change in Number of BSA/BCE/SO/RSU
Number of outstanding
BSA
BCE
SO
RSUs
Balance as of December 31, 2020
218,008
5,500
2,610,510
1,118,745
Granted during the period
75,600
24,900
Forfeited during the period
(15,400
)
(13,700
)
Exercised/released during the period
(500
)
Expired during the period
Balance as of March 31, 2021
218,008
5 000
2,670,710
1,129,945
9
Table of Contents
Reconciliation of the share-based payments expenses with the consolidated statements of operations
Three Months Ended
March 31,
2021
2020
Research and development
SO
(376
)
(876
)
RSU
(251
)
(392
)
Sales and marketing
SO
(49
)
(598
)
RSU
(22
)
(2
)
General and administrative
SO
(644
)
(1,071
)
RSU
(91
)
(133
)
Total share-based compensation expense
(1,433
)
(3,073
)
Note 6: Contingencies
Current contingencies and non-current contingencies break down as follows:
March 31,
December 31,
2021
2020
Current contingencies
4,246
5,016
Non-current contingencies
2,229
2,527
Total contingencies
6,474
7,542
The table below shows movements in contingencies:
Pension retirement
obligations
Collaboration
agreement -
Loss at
completion
Other contingencies
Total
At January 1, 2021
937
3,956
2,649
7,542
Increases in liabilities
Used liabilities
(434
)
(515
)
(949
)
Reversals of unused liabilities
Net interest related to employee benefits, and unwinding of discount
Actuarial gains and losses on defined-benefit plans
85
85
Other effects including currency translation effect
(44
)
(164
)
4
(204
)
At March 31, 2021
978
3,358
2,139
6,474
Of which current
2,107
2,139
4,246
Of which non-current
978
1,251
2,229
In 2020 and during the first three months of 2021, the ongoing COVID-19 pandemic
impacted the Companys current clinical trials, including its Phase II clinical trial conducted as part of the development activities pursuant to the collaboration and license agreement with Nestlé Health Science. The Company experienced
a decrease in new patients enrolling in this Phase II clinical trial and modified the protocols of the clinical trial. As a result of these delays, the Company expects to incur additional clinical and production costs related to the Phase II
clinical trial. Starting the last quarter of the fiscal year 2020, an accrual in the amount of the difference between the Companys current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the
Phase II clinical trial has been recorded.
10
Table of Contents
Other contingencies are primarily composed of the estimated expenses to be incurred as part of the
employee-related costs related to restructuring, as well as estimated cost of refurbishing lease premises (Refer to Note 2, Significant Events and TransactionsRestructuring contingencies).
There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 15 to the consolidated
financial statements included in the Annual Report.
Note 7: Operating income
The operating income is broken down in the following manner:
Three Months Ended March 31,
2021
2020
Research tax credit
1,807
2,902
Other operating income
1,133
1,818
Total
2,941
4,720
As of March 31, 2021, the Company recorded its collaboration contracts income based on its updated measurement of
progress of the Phase II clinical trial conducted as part of the collaboration and license agreement with Nestlé Health Science. The accrual recorded in the amount of the difference between the Companys current best estimates of costs
yet to be incurred and income yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly.
Note 8: Allocation
of Personnel Expenses
The Company had an average of 121 employees during the three months ended March 31, 2021, in comparison with an average of
311 employees during the three months ended March 31, 2020.
Allocation of Personnel Expenses by Function:
Three Months Ended March
31,
2021
2020
Research and development expenses
4,718
10,204
Sales and marketing expenses
518
4,197
General and administrative expenses
3,766
4,283
Total personnel expenses
9,002
18,684
Allocation of Personnel Expenses by Nature:
Three months Ended March
31,
2021
2020
Wages and salaries
4,454
12,872
Social security contributions
1,332
663
Expenses for pension commitments
402
915
Employer contribution to bonus shares
1,381
1,162
Share-based payments
1,433
3,073
Total personnel expenses
9,002
18,684
The decrease in personnel expenses is mainly due to a decreased headcount as well as reductions in accrued bonuses, retention
measures and share-based compensation expenses, partly as a result of the 2020 global restructuring plan.
11
Table of Contents
Note 9: Commitments
There have been no significant changes in other commitments from those disclosed in Note 19 to the consolidated financial statements included in the Annual
Report.
Note 10: Relationships with Related Parties
There were no new significant related-party transactions during the period nor any change in the nature of the transactions from those described in Note 20 to
the consolidated financial statements included in the Annual Report.
Note 11: Loss Per Share
Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares
outstanding during the period. As the Company was in a loss position for each of the three months ended March 31, 2021 and 2020, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were
anti-dilutive as a result of the Companys net loss.
The following is a summary of the ordinary share equivalents that were excluded from the
calculation of diluted net loss per share for each of the three months ended March 31, 2021 and 2020 indicated in number of potential shares:
Three Months Ended March 31,
2021
2020
Non-employee warrants
225,008
225,008
Employee warrants
75,000
82,500
Stock-options
2,670,710
2 835,635
Restricted stock units
1,129,945
696,895
Note 12: Events after the Close of the Period
The Company evaluated subsequent events that occurred after March 31, 2021, through the date the condensed consolidated financial statements were issued
after their approval by the Board of Directors on April 30, 2021 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.
12
Table of Contents
Item 2.
Managements Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with
our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2020, included in our
Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 17, 2021, or the Annual Report. This discussion and other parts of this
Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking
statements. Factors that could cause such differences are discussed in the section of this Report titled Special Note Regarding Forward-Looking Statements and under Item 1A. Risk Factors in the Annual Report.
Overview
We are a clinical-stage specialty
biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy, or
EPIT TM , our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin. We have generated significant data demonstrating that
Viaskins mechanism of action is novel and differentiated, as it targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune
system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat patients, including infants and children, suffering from food allergies, for whom safety is
paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock.
On January 13, 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in
October 2020 following the CRL. We believe the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, we proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch
adhesion and the need for patch modifications. The FDA agreed with our position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut
protein dose of 250 µg (approximately 1/1000 of a peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and modified patches, the FDA has
requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years. The FDA also recommended conducting a 6-month, well-controlled
safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population. We intend to submit the protocols for the safety and adhesion study and the allergen uptake study to the FDA for review and comments before
initiating the trials. We will address details about a new human factor, or HF, validation study and additional CMC data in subsequent interactions with the FDA
During the first quarter of 2021, we received the first set of questions from the European Medicines Agency, or EMA, regarding the Marketing Authorization
Application, or MAA, for Viaskin Peanut as a treatment for peanut allergy in children ages 4-11.. The questions were consistent with our expectations and prefiling conversations with the EMA. We did not
receive questions about the impact of adhesion on efficacy. The EMAs Committee for Medicinal Products for Human Use will provide a recommendation to the European Commission, or EC, on whether to grant a marketing authorization when its review
of the Viaskin Peanut MAA is complete.
Critical Accounting Policies and Significant Judgments and Estimates
Our managements discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements,
which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect
the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our
estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that
are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no
new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report. Our significant accounting policies are more fully described in Note 1 of the Notes to Condensed
Consolidated Financial Statements in Part I, Item 1 of this Report.
13
Table of Contents
The following table summarizes our results of operations, derived from our condensed consolidated financial
statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars for the three months ended March 31, 2021 and 2020:
Three Months Ended
March 31,
2021
2020
Operating income
$
2,941
$
4,720
Operating expenses
Research and development expenses
(22,164
)
(27,532
)
Sales and marketing expenses
(729
)
(7,297
)
General and administrative expenses
(9,683
)
(11,113
)
Restructuring expenses
Total Operating expenses
(32,575
)
(45,942
)
Financial income
215
309
Income tax
(30
)
Net loss
$
(29,449
)
$
(40,913
)
Basic/diluted Net loss per share attributable to shareholders
$
(0.54
)
$
(0.79
)
Comparison of the three months ended March 31, 2021 to the three months ended March 31, 2020
Operating Income
We generated operating income of
$2.9 million during the three months ended March 31, 2021 compared to $4.7 million during the three months ended March 31, 2020, a decrease of 37.7%. This income was mainly generated from the French research tax credit
( crédit dimpôt recherche) , or CIR, and by revenue recognized under our collaboration agreement with Nestlé Health Science.
Three Months Ended March 31
% change
2021
2020
2021 vs 2020
Sales
Other income
2,941
4,720
(37.7
)%
Research tax credit
1,807
2,902
(37.7
)%
Other operating income
1,133
1,818
(37.6
)%
Total operating income
2,941
4,720
(37.7
)%
The decrease in operating income is primarily attributable to the decrease of the CIR, as eligible expenses have declined in
correlation with Research and Development costs.
As of March 31, 2021, we recorded our collaboration contract income based on our updated
measurement of progress of the Phase II clinical trial conducted as part of the collaboration and license agreement with Nestlé Health Science. The accrual recorded in the amount of the difference between our current best estimates of costs
yet to be incurred and income yet to be recognized for the completion of the Phase II clinical has been updated accordingly.
Operating Expense
The following table summarizes our operating expense excluding restructuring incurred during the three months ended March 31, 2021 and 2020:
Three months Ended
March 31
% change
2021
2020
2021 vs 2020
Research and development expenses
22,164
27,532
(19.5
)%
Sales and marketing expenses
729
7,297
(90.0
)%
General and administrative expenses
9,683
11,113
(12.9
)%
Total operating expenses
32,575
45,942
(29.1
)%
14
Table of Contents
Operating expenses for the three months ended March 31, 2021 were $32.6 million compared to
$45.9 million for the three months ended March 31, 2020. The $13.4 million decrease in operating expenses is mainly attributable to a decrease in personnel expenses directly related to the workforce reduction we implemented as part of
our 2020 global restructuring plan. Personnel expenses decreased by $9.7 million, or 52%, to $9.0 million during the three months ended March 31, 2021 from $18.7 million for the three months ended March 31, 2020. Average
headcount decreased 61% between the two periods, from 311 FTEs for the three months ended March 31, 2020 to and 121 FTEs for the three months ended March 31, 2021. By function, the personnel expenses, including share-based payment
expenses, decreased as follows:
Three Months Ended March
31,
% change
2021
2020
2021 vs 2020
Research and development expenses
4,718
10,204
(53.8
)%
Sales and marketing expenses
518
4,197
(87.7
)%
General and administrative expenses
3,766
4,283
(12.1
)%
Total personnel expenses
9,002
18,684
(51.8
)%
The decrease in other operating expenses was primarily due to the budget discipline measures taken by DBV. In particular,
sales and marketing consulting fees dropped by 96.8% or $2.6 million, from $2.7 million for the three months ended March 31, 2020 to $0.1 million for the three months ended March 31, 2021 and general and administrative fees
decreased by 43.5% or $1.7 million, from $4.0 million for the three months ended March 31, 2020 to $2.3 million for the three months ended March 31, 2021.
As a result of the ongoing COVID-19 pandemic, we also experienced a decrease in other expenses, in particular
tradeshows and travel expenses.
Restructuring
We
initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanut in the
United States and European Union.
We expect full implementation of the restructuring plan to result in a reduction of more than 200 jobs, resulting in a
remaining global team of 90 individuals dedicated to the pursuit of innovation and scientific development of novel therapies.
As of March 31, 2021,
we had 104 employees. We expect full implementation of the organization-wide costs reduction measures to be completed by the second half of 2021.
The
restructuring costs, which were $23.6 million as of December 31, 2020, were mainly comprised of payroll expenses, restructuring-related consulting and legal fees, as well as impairment of facilities and right of use assets following
resizing of facilities.
During the three months ended March 31, 2021, the restructuring liability evolved as presented below:
Restructuring
liabilities
Restructuring liability - January 1, 2021
9,387
Amounts paid
(4,854
)
Other effect including currency translation effect
(220
)
Restructuring liability - March 31, 2021
4,313
of which current contingencies
1,511
of which other current liabilities
2,803
They were no restructuring costs for three months ended March 31, 2021 and 2020.
15
Table of Contents
Financial income
Our financial income was $0.2 million for the three months ended March 31, 2021 and 2020. This item mainly includes foreign exchange income.
Net loss
Net loss was $29.4 million for the three
months ended March 31, 2021, compared to $40.9 million for the three months ended March 31, 2020. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.54 and $0.79 for three months
ended March 31, 2021 and 2020, respectively.
Summary Statement of Cash Flows
The table below summarizes our sources and uses of cash for the three months ended March 21, 2021 and 2020.
Three Months Ended
March 31,
% change
(Amounts in thousands of U.S. Dollars)
2021
2020
2021 vs 2020
Net cash flow used in operating activities
(36,204
)
(49,683
)
(27.1
)%
Net cash flow used in investing activities
(185
)
(930
)
(80.1
)%
Net cash flow provided by financing activities
440
150,611
(99.7
)%
Effect of exchange rate changes on cash and cash equivalents
(7,944
)
(5,811
)
(36.7
)%
Net (decrease) increase in cash and cash equivalents
(43,893
)
94,187
(146.6
)%
Operating Activities
Our net cash flows used in operating activities were $36.2 million and $49.7 million during the three months ended March 31, 2021 and 2020,
respectively. Our net cash flows used in operating activities decreased by $13.5 million, or 27.2%, mainly due to the budget discipline measures we took, in particular the decrease in personnel expenses, which was directly related to the
workforce reduction we implemented as part of our global restructuring plan. Cash flows used in operating activities for the three months ended March 31, 2021 included $4.9 million in restructuring amounts paid.
Investing Activities
Our net cash flows used in
investing activities were $0.2 million and $0.9 million during the three months ended March 21, 2021 and 2020, respectively. Those investments were mainly for our industrial machinery and equipment, which are commissioned in order to
support the commercialization of Viaskin Peanut, if approved.
Financing Activities
Our net cash flows provided by financing activities decreased to $0.4 million during the three months ended March 21, 2021 from $150.6 million
during the three months ended March 21, 2020. Financing activities consisted mainly of our underwritten global offering in the first quarter of 2020.
Based on our current assumptions, we expect that our current cash and cash equivalents will support our operations until the second half of 2022
Contractual Obligations and Other Commitments
There have
been no material changes in our contractual obligations and commitments from those disclosed in the Annual Report.
Off-Balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements and do not have variable interests in variable interest
entities.
16
Table of Contents
Smaller Reporting Company Status
We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the
scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market
value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently
completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
Our market risks have not changed materially from those disclosed in Item 7A of the Annual Report.
Item 4.
Controls and Procedures
Disclosure Controls and Procedures
Based on their
evaluation as of March 31, 2021, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e)
under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the SECs rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions
regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting identified in managements evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or
are reasonably likely to materially affect, our internal control over financial reporting.
Limitation on Effectiveness of Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and
procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only
reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to
their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent
limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more
people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated
goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a
cost-effective control system, misstatements due to error of fraud may occur and not be detected.
17
Table of Contents
PART II Other information
Item 1.
Legal Proceedings
See Note 2: Significant Events and Transactions Legal Proceedings in the notes to the condensed consolidated financial statements included
elsewhere in this Report.
Item 1A.
Risk Factors
There have been no material changes in our risk factors from those disclosed in the Annual Report.
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
During the three months ended March 31, 2021, we granted 75,600 stock options and 24,900 restricted stock units to employees in France and in the United
States.
During the three months ended March 31, 2021, we issued 7,500 ordinary shares following the exercise of employee warrants by an employee in
France, for proceeds of $42,000.
None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public
offering. We believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Regulation S promulgated under Section 5 of the Securities Act, as transactions by an
issuer not involving any public offering or as offerings made to non-U.S. resident employees pursuant to an employee benefit plan established and administered in accordance with the law of a country other than
the United States (namely, the Republic of France) and in accordance with that countrys practices and documentation. All recipients had adequate access, through their relationships with us, to information about us. The sales of these
securities were made without any general solicitation or advertising.
Item 3.
Defaults Upon Senior Securities
None.
Item 4.
Mine Safety Disclosures
Not applicable.
Item 5.
Other Information
Not applicable.
18
Table of Contents
Item 6. Exhibits.
Exhibit Index
Exhibit
Description
Incorporated by Reference
Schedule
/ Form
File
Number
Exhibit
File
Date
3.1
By-laws ( statuts ) of the registrant (English translation)
10-K
001-36697
3.1
3/17/2021
31.1
Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended
31.2
Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended
32.1*
Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended
101.INS
XBRL Instance Document
101.SCH
XBRL Taxonomy Extension Schema Document
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
XBRL Taxonomy Extension Labels Linkbase Document
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document
*
Furnished herewith and not deemed to be filed for purposes of Section 18 of the Exchange Act,
and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective
of any general incorporation language contained in such filing.
Table of Contents
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
DBV Technologies S.A.
Date: May 5, 2021
By:
/s/ Daniel Tassé
Daniel Tassé
Chief Executive Officer)
(Principal Executive Officer)
Date: May 5, 2021
By:
/s/ Sébastien Robitaille
Sébastien Robitaille
Chief Financial Officer
(Principal Financial and Accounting Officer)
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.