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Index to Financial Statements Page Annual Financial Statements for the Years Ended

Key Takeaway: Index to Financial Statements Page Annual Financial Statements for the Years Ended December 31, 2016, 2017 and 2018: Report of Deloitte & Associ s, Independent Registered Public Accounting Firm 2 Report of Deloitte & Associ s, Independent Registered Public Accounting F

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Index to Financial Statements
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Annual Financial Statements for the Years Ended December 31, 2016, 2017 and 2018:
Report of Deloitte & Associ s, Independent Registered Public Accounting Firm 2
Report of Deloitte & Associ s, Independent Registered Public Accounting Firm (ICFR) 3
Consolidated Statements of Financial Position as of December 31, 2016, 2017 and 2018 4
Consolidated Statements of (Loss) for the Years Ended December 31, 2016, 2017 and 2018 5
Consolidated Statements of Comprehensive (Loss) for the Years Ended December 31, 2016, 2017 and 2018 6
Consolidated Statements of Cash Flows for the Years Ended December 31, 2016, 2017 and 2018 7
Consolidated Statements of Changes in Shareholders Equity for the Years Ended December 31, 2016, 2017 and 2018 8
Notes to the Consolidated Financial Statements 9
Report of Independent Registered Public Accounting Firm
To the Shareholders and Board of Directors of DBV Technologies SA
Opinion on the Financial Statements
accompanying consolidated statements of financial position of DBV Technologies S.A. and subsidiaries (the Company ) as of December 31, 2018 and 2017, and the related consolidated statements of (loss), comprehensive (loss), cash flows
and shareholders equity, for each of the three years in the period ended December 31, 2018, and the related notes (collectively referred to as the financial statements ). In our opinion, the financial statements present fairly,
in all material respects, the financial position of the Company as of December 31, 2018 and 2017, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2018, in conformity with
International Financial Reporting Standards as issued by the International Accounting Standards Board.
We have also audited, in accordance with the
standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company s internal control over financial reporting as of December 31, 2018, based on criteria established in Internal Control Integrated
Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated April 1, 2019, expressed an unqualified opinion on the Company s internal control over financial reporting.
The accompanying financial statements have
been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the financial statements, the Company has incurred operating losses and negative cash flows from operations since inception and current cash and cash
equivalents on hand are not projected to be sufficient to support the Company s current operating plan. 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 also described in Note 3. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
These financial statements are the
responsibility of the Company s management. Our responsibility is to express an opinion on the Company s financial statements based on our audits. We are a public accounting firm registered with the 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 financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the 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 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 financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Deloitte & Associ s
Paris-La D fense, France
April 1, 2019
We have served as the Company s auditor since 2011.
Report of Independent Registered Public Accounting Firm
Internal Control Over Financial Reporting
To the Shareholders and Board of Directors of DBV Technologies SA
Opinion on Internal Control over Financial Reporting
have audited the internal control over financial reporting of DBV Technologies S.A. and subsidiaries (the Company ) as of December 31, 2018, based on criteria established in Internal Control Integrated Framework
(2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31,
2018, based on criteria established in Internal Control Integrated Framework (2013) issued by COSO.
We have also audited, in accordance
with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2018 of the Company and our report dated April 1, 2019, expressed an
unqualified opinion on those financial statements and included an explanatory paragraph regarding the Company s ability to continue as a going concern.
The Company s management is
responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management s Annual Report on Internal
Control over Financial Reporting. Our responsibility is to express an opinion on the Company s internal control over financial reporting based on our audit. We are a public accounting firm registered with the 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material
weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a
reasonable basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company s internal control over financial reporting includes those policies and procedures that
(1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as
necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors
of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. 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.
/s/ Deloitte & Associ s
Paris-La D fense, France
April 1, 2019
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(Amounts in thousands of Euros)
Year Ended December 31,
Note 2016 2017 2018
ASSETS
Non-Current assets
Intangible assets 4 96 123 29
Property, plant, and equipment 5 12,482 17,808 20,219
Other non-current financial assets 6 2,745 3,012 6,033
Total non-current assets 15,323 20,942 26,281
Current assets
Inventories 7 1,566
Customer accounts receivable and related receivables 8 1,250 1,265
Other current assets 8 14,454 17,721 21,131
Cash and cash equivalents 9 256,473 137,880 122,770
Total current assets 272,177 156,865 145,468
TOTAL ASSETS 287,500 177,807 171,749
Year Ended December 31,
Note 2016 2017 2018
LIABILITIES AND SHAREHOLDERS EQUITY
Shareholders equity
Share Capital 10 2,465 2,499 3,016
Premiums related to the Share Capital 405,882 406,709 539,292
Reserves (50,968 ) (131,592 ) (254,946 )
Net (loss) (114,531 ) (147,693 ) (166,076 )
Total shareholders equity 242,849 129,923 121,286
Non-current liabilities
Long-term financial debt 11 4,049 1,825 1,278
Non-current provisions 12 853 1,260 1,536
Other non-current liabilities 11 10,746 8,869 4,105
Total non-current liabilities 15,649 11,954 6,919
Current liabilities
Bank overdrafts
Short-term financial debt 11 591 2,325 1,201
Current provisions 913 1,270
Supplier accounts payable 13 13,720 16,941 28,567
Other current liabilities 13 14,692 15,751 12,506
Total current liabilities 29,002 35,930 43,543
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY 287,500 177,807 171,749
The accompanying notes form an integral part of these consolidated financial statements.
CONSOLIDATED STATEMENTS OF (LOSS)
(Amounts in thousands of Euros except share and per share data)
Year Ended December 31,
Note 2016 2017 2018
Operating income
Revenues 15
Other income 15 9,084 11,909 14,537
Total income 9,084 11,909 14,537
Operating expenses
Cost of goods sold
Research & Development 16/17 (78,828 ) (105,232 ) (107,171 )
Sales & Marketing 16/17 (11,282 ) (15,824 ) (32,169 )
General & Administrative 16/17 (35,005 ) (35,837 ) (41,399 )
Total expenses (125,115 ) (156,892 ) (180,739 )
Operating (loss) (116,031 ) (144,983 ) (166,202 )
Financial revenues 18 1,516 616 493
Financial expenses 18 (16 ) (3,325 ) (351 )
Financial profit (loss) 1,500 (2,709 ) 141
Income tax 19 (0 ) (1 ) (15 )
Net (loss) (114,531 ) (147,693 ) (166,076 )
Basic/diluted (loss) per share ( /share) 22 (4.68 ) (5.97 ) (5.74 )
The accompanying notes form an integral part of these consolidated financial statements.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS)
(Amounts in thousands of Euros)
Year Ended December 31,
2016 2017 2018
Net (loss) (114,531 ) (147,693 ) (166,076 )
Actuarial gains and losses on employee benefits, net of corporate tax (249 ) (177 ) 19
Profit (loss) directly recognized in shareholders equity (249 ) (177 ) 19
Other comprehensive income (743 ) 3,280 (683 )
Total comprehensive (loss) (115,523 ) (144,590 ) (166,740 )
In accordance with IAS 1 Presentation of Financial Statements, the Group, as defined in Note 2, presents a combined
statement of other elements of comprehensive (loss).
The accompanying notes form an integral part of these consolidated financial
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands of Euros)
Note 2016 2017 2018
K K K
Net (loss) for the period (114,531 ) (147,693 ) (166,076 )
Reconciliation of the net (loss) and the cash used for the operating activities:
Cash flows used in operating activities:
Amortization and provision 1,349 2,926 2,830
Retirement pension obligations 115 230 295
Expenses related to share-based payments 34,353 30,781 25,904
Other elements 147 130 752
Operating cash flows before change in working capital (78,566 ) (113,626 ) (136,294 )
Inventories (1,566 )
Customer accounts receivable (1,250 ) 3 1,229
Other current assets (2,931 ) (3,458 ) (2,591 )
Supplier accounts payable 3,645 3,333 9,095
Other current and non-current liabilities 19,564 (566 ) (6,493 )
Change in working capital requirement 19,028 (687 ) (326 )
Net cash flow used in operating activities (59,538 ) (114,314 ) (136,620 )
Cash flows used in investing activities:
Acquisitions of property, plant, and equipment 5 (7,992 ) (7,246 ) (4,710 )
Acquisitions of intangible assets 4 (215 ) (299 ) (41 )
Acquisitions of non-current financial assets (93 ) (289 ) (3,890 )
Net cash flows used in investing activities (8,300 ) (7,834 ) (8,641 )
Cash flows provided by financing activities:
(Decrease) in conditional advances 11 (275 ) (578 ) (1,800 )
Treasury shares (54 ) (25 ) (479 )
Capital increases, net of transaction costs 10 2,016 861 133,099
Other cash flows related to financing activities (21 ) 28 (144 )
Net cash flows provided by financing activities 1,666 286 130,676
(Decrease) in cash (66,172 ) (121,863 ) (14,586 )
Net Cash and cash equivalents at the beginning of the period 323,381 256,473 137,880
Impact of exchange rate fluctuations (735 ) 3,269 (525 )
Net cash and cash equivalents at the close of the period 9 256,473 137,880 122,770
The accompanying notes form an integral part of these consolidated financial statements.
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS EQUITY
(Amounts in thousands of Euros except for the number of shares)
Share capital Shares of Common Stock
Number of Shares Amount Premiums related to the Share Capital Reserve Profit (loss) Total Share- holders Equity
At January 1, 2016 24,205,129 2,421 403,910 (39,580 ) (44,674 ) 322,076
Net (loss) (114,531 ) (114,531 )
Foreign exchange translation (743 ) (743 )
Profit directly recognized in shareholders equity (249 ) (249 )
Total (loss) directly recognized in shareholders equity (992 ) (114,531 ) (115,523 )
Allocation of prior (loss) (44,674 ) 44,674
Increase in capital 443,699 44 1,395 1,439
Treasury shares (74 ) (74 )
Issue of share warrants 577 577
Share-based payments 34,353 34,353
At December 31, 2016 24,648,828 2,465 405,882 (50,968 ) (114,531 ) 242,849
Net (loss) (147,693 ) (147,693 )
Foreign exchange translation 3,280 3,280
(Loss) directly recognized in shareholders equity (177 ) (177 )
Total (loss) directly recognized in shareholders equity 3,103 (147,693 ) (144,590 )
Allocation of prior (loss) (114,531 ) 114,531
Increase in capital 341,994 34 536 571
Treasury shares 23 23
Issue of share warrants 290 290
Share-based payments 30,781 30,781
At December 31, 2017 24,990,822 2,499 406,709 (131,592 ) (147,693 ) 129,923
Net (loss) (166,076 ) (166,076 )
Foreign exchange translation (683 ) (683 )
(Loss) directly recognized in shareholders equity 19 19
Total (loss) directly recognized in shareholders equity (665 ) (166,076 ) (166,740 )
Allocation of prior (loss) (147,693 ) 147,693
Increase in capital 5,166,955 517 132,419 132,936
Treasury shares (900 ) (900 )
Issue of share warrants 164 164
Share-based payments 25,904 25,904
At December 31, 2018 30,157,777 3,016 539,292 (254,946 ) (166,076 ) 121,286
The accompanying notes form an integral part of these consolidated financial statements.
NOTES TO THE FINANCIAL STATEMENTS
Incorporated in 2002 under the laws
of France, DBV Technologies S.A. ( DBV Technologies, or the Company ) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called
Viaskin . The Company s therapeutic approach is based on epicutaneous immunotherapy, or EPIT , a proprietary method of delivering
biologically active compounds to the immune system through intact skin using Viaskin .
The Company s lead product candidate, Viaskin Peanut, has completed a global Phase III program
for the treatment of peanut-allergic patients 4 to 11 years of age. In October 2018, the Company announced its submission of a Biologics License Application ( BLA ) to the U.S. Food and Drug Administration ( FDA ) for Viaskin Peanut for the treatment of peanut allergy in children 4 to 11 years of age. On December 19, 2018, the Company announced that, after discussions with the U.S. FDA, the Company voluntarily
withdrew its Biologics License Application ( BLA ) for Viaskin Peanut in children 4 to 11 years of age.. On February 13, 2019, the Company announced that it expects to resubmit
its BLA to the FDA for Viaskin Peanut for the treatment of peanut-allergic children 4 to 11 years of age in the third quarter of 2019.
In August 2017, the Company initiated Part A of the EPITOPE (EPIT in Toddlers with Peanut Allergy)
trial, a Phase III trial of Viaskin Peanut in peanut-allergic toddlers ages one to three. EPITOPE is a two-part, pivotal Phase III clinical trial
assessing the safety and efficacy of Viaskin Peanut 250 g for the treatment of peanut-allergic toddlers one to three years of age. In September 2018, the Company announced that the
independent data safety and monitoring board ( DSMB ) completed its review of Part A of EPITOPE and recommended that the dose of Viaskin Peanut 250 g be evaluated in Part B.
On October 26, 2018, the Company announced that the first patient was enrolled in Part B of EPITOPE. This trial is the second Phase III clinical program currently investigating the use of
Viaskin Peanut for the treatment of patients with peanut allergy.
The Company is developing its second product candidate, Viaskin Milk, for the treatment of cow s milk protein allergy, or CMPA, in children two to 17 years of age, which received fast track designation from the FDA in September 2016. In November 2014,
the Company initiated a multi-center, double-blind, placebo-controlled, randomized Phase I/II trial to study the safety and efficacy of Viaskin Milk in 198 patients with Immunoglobulin E, or
IgE, mediated CMPA, which the Company refers to as the Milk Efficacy and Safety, or MILES, trial. In June 2015, we announced completion of Part A of the MILES study, or Phase I, and we launched Part B, or Phase II, in October 2015. In February 2018,
the Company announced preliminary results from Part B of the MILES study. Following analyses of the data, the 300 g dose was identified as the dose with the greatest observed clinical activity for children (intent-to-treat, p=0.042). The Company believes these preliminary results support further advancement of the Viaskin Milk program and intends to
discuss findings with regulatory authorities to determine the design of future studies. All patients in the open-label extension trial are being switched to the 300 g dose for treatment of up to 24 months.
In February 2015, the Company announced the development of a third product candidate, Viaskin Egg,
for the treatment of patients suffering from hen s egg allergy. Preclinical development for Viaskin Egg commenced in the first half of 2015 and is currently ongoing.
Other Viaskin application
In addition to our development programs in food allergies, we are exploring the use of our Viaskin
technology for the treatment of inflammatory and autoimmune diseases with high unmet medical need. Human proof-of-concept trials are ongoing with Viaskin in Eosinophilic Esophagitis (EoE) and as a booster vaccination against Bordetella pertussis (whooping cough) in healthy adults. The Company s other earlier stage research programs include
vaccination for respiratory syncytial virus, as well as potential treatments for celiac disease and type I diabetes.
Last updated: Apr 1, 2019