Nature of the business and principles and accounting methods (Policies) | 12 Months Ended |
Dec. 31, 2020 |
Accounting Policies [Abstract] | |
Basis of Presentation | 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. 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 | 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 year ended December 31, 2019 and 2020, 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 Technologies”). • 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 Canada Ltd. was incorporated in Ottawa, Ontario on August 13, 2018 (the “Canadian subsidiary”). The share capital of this Canadian 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. (“DBV Technologies”). |
Functional Currency and Translation of Financial Statements in Foreign Currency | 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. |
Conversion of Foreign Currency Transactions | 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, |
Use of estimates | 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. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates. On an on-going right-of-use |
Going concern | 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 (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 Biologics License Application (BLA) for Viaskin ™ pre-clinical ™ ™ 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 COVID-19 COVID-19 |
Intangible Assets | 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 be impaired. 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. |
Property, Plant, and Equipment | Property, Plant, and Equipment Property, plant, and equipment are recorded at their acquisition cost. Property, plant, and equipment are depreciated on the basis of the straight-line method over the estimated use period 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 | 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 is impaired 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 | 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 option. The lease term is defined contract-by-contract non-cancelable 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, and it does not recognize a lease liability or right of use asset for low value leases. 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 right of use and liability are 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. |
Inventories and Work in Progress | 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 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 and Liabilities Financial assets, excluding cash and cash equivalents, consist exclusively of other receivables. Other receivables are non-derivative The Company also receives from time-to-time 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, 2020 and December 31, 2019, the Company did not hold any derivative financial instruments. |
Fair Value Measurements | 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. • 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 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 Income. |
Concentration of Credit Risk | Concentration of Credit Risk The Company has no significant off-balance 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 | 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 Financial Statements in Shareholders’ Equity as a deduction from the proceeds from the issue, net of tax. |
Employee benefits | 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. 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 resulting 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 higher of the projected benefit obligation for the defined benefit plan. The Company’s payments for the defined-contribution plans are recognized as expenses on the statement of operations of the period with which they are associated. |
Contingencies | Contingencies An estimated loss from a loss contingency is recognized if the following two conditions are met: • information available before the 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 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 | 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. |
Other operating income | Other operating income Research Tax Credit The Research Tax Credit ( Cr é dit d ’ Imp ô t Recherche The repayable portion of the Research Tax Credit in more than one year is recorded in other non-current Collaboration agreement with Nestlé Health Science The Company enters into research and development collaboration agreements that may consist of non-refundable Non-refundable 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 The Company recognizes income under the percentage-of-completion |
Research and Development Expenditures | 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 | 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 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) 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. At each closing date, the Company re-assesses The awards are not subject to any market conditions. In 2020, as the Company re-interpreted the vesting criteria for several RSUs granted in 2017, 2018 and 2019, an immaterial adjustment of the Company’s personnel expenses and net loss has been made in the financial statements prepared in accordance with IFRS, as filed in the Company’s Annual Report on Form 20-F for the year ended December 31, 2019, resulting in an additional expense of €5.2m ($6.2m) and ($0.5m) for the years ended December 31, 2018 and 2019, respectively, with no impact on the total shareholder’s equity for both periods. These financial statements prepared in accordance with U.S. GAAP as of and for the years ended December 31, 2020 and 2019 reflect the re-interpreted |
Income Tax | 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 | 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 | 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 | Other Items in the Comprehensive Loss Comprehensive income 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 | 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, 2020 and 2019, 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 common shares outstanding as their inclusion in the computation for these years would be anti-dilutive due to net losses incurred. |
Subsequent Events | Subsequent Events The Consolidated Statements of Financial Position and the Consolidated Statements of operations 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 1 7 |
Accounting Pronouncements adopted in 2020 | Accounting Pronouncements adopted in 2020 Effective January 1, 2020, the Company adopted ASU 2018-13 2018-13 Effective January 1, 2020, the Company adopted ASU 2018-15 Internal-Use 350-40) internal-use 2018-15 Effective January 1, 2020, the Company adopted ASU 2018-18 2018-18 Effective January 1, 2020, the Company adopted FASB issued ASU 2018 - 14, Compensation - Retirement Benefits - Defined Benefit Plans - General. The purpose of this update is to modify disclosure requirements for Defined Benefit Plans. It removes requirements to disclose the amounts in accumulated other comprehensive income expected to be recognized as components of net periodic benefit cost over the next fiscal year among others. It adds disclosure requirements for the items such as an explanation of the reasons for significant gains and losses related to changes in the benefit obligation for the period. The adoption of ASU 2018-14 |
Accounting Pronouncements issued not yet adopted | Accounting Pronouncements issued not yet adopted In June 2016, the FASB issued ASU 2016-13 2019-10 In January 2017, the FASB issued ASU 2017-04, Simplifying 2019-10 In December 2019, the FASB issued ASU 2019-12, Income 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. |