Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 26, 2021 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | DBV TECHNOLOGIES S.A. | |
Entity Central Index Key | 0001613780 | |
Entity File Number | 001-36697 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Address, Postal Zip Code | 92120 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Interactive Data Current | Yes | |
Entity Common Stock, Shares Outstanding | 55,011,687 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Address, Country | FR | |
Entity Small Business | true | |
Entity Incorporation, State or Country Code | I0 | |
Entity Address, Address Line One | 177-181 avenue Pierre Brossolette | |
Entity Address, City or Town | Montrouge | |
City Area Code | 33 | |
Local Phone Number | 1 55 42 78 78 | |
Entity Tax Identification Number | 00-0000000 | |
American Depositary Share [Member] | ||
Document Information [Line Items] | ||
Title of 12(b) Security | American Depositary Shares, each representing one-half of one ordinary share, nominal value €0.10 per share | |
Trading Symbol | DBVT | |
Security Exchange Name | NASDAQ | |
Ordinary Shares [Member] | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Ordinary shares, nominal value €0.10 per share | |
No Trading Symbol Flag | true | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Financial Position - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 98,195 | $ 196,352 |
Trade receivables | 2,230 | |
Other current assets | 11,943 | 8,792 |
Total current assets | 110,138 | 207,375 |
Non-Current assets | ||
Property, plant, and equipment, net | 19,273 | 24,792 |
Right-of-use assets related to operating leases | 7,876 | 10,104 |
Intangible assets | 26 | 41 |
Other non-current assets | 33,612 | 29,935 |
Total non-current assets | 60,786 | 64,871 |
Total Assets | 170,924 | 272,246 |
Current liabilities: | ||
Trade payables | 12,170 | 20,338 |
Short-term operating leases | 2,657 | 3,708 |
Short-term financial debt | 695 | 724 |
Current contingencies | 5,633 | 5,016 |
Other current liabilities | 12,659 | 22,926 |
Total current liabilities | 33,814 | 52,713 |
Non-Current liabilities | ||
Long-term operating leases | 8,298 | 10,496 |
Long-term financial debt | 543 | |
Non-current contingencies | 7,629 | 2,527 |
Other non-current liabilities | 4,292 | 475 |
Total non-current liabilities | 20,218 | 14,042 |
Total Liabilities | 54,033 | 66,754 |
Shareholders' equity : | ||
Ordinary shares, €0.10 par value; 55,011,687 and 54,929,187 shares authorized, and issued as at September 30, 2021 and December 31, 2020, respectively, and 3,946,548 and 4,029,763 shares outstanding as at September 30, 2021 and December 31, 2020, respectively | 6,529 | 6,518 |
Additional paid-in capital | 359,081 | 1,152,042 |
Treasury stock, 75,400 and 112,302 ordinary shares as of September 30, 2021 and December 31, 2020, respectively, at cost | (810) | (1,169) |
Accumulated deficit | (244,856) | (958,543) |
Accumulated other comprehensive income | 474 | 484 |
Accumulated currency translation effect | (3,526) | 6,158 |
Total Shareholders' equity | 116,892 | 205,491 |
Total Liabilities and Shareholders' Equity | $ 170,924 | $ 272,246 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Financial Position (Parenthetical) - € / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Treasury stock, common, shares | 75,400 | 112,302 |
Common Shares [Member] | ||
Common stock shares par value | € 0.10 | € 0.10 |
Common stock shares authorized | 55,011,687 | 54,929,187 |
Common stock shares issued | 55,011,687 | 54,929,187 |
Common stock shares outstanding | 3,946,548 | 4,029,763 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenues | ||||
Operating income | $ 1,323 | $ 4,158 | $ 2,776 | $ 12,488 |
Operating expenses | ||||
Research and development expenses | (16,320) | (25,751) | (58,663) | (75,214) |
Sales and Marketing expenses | (1,072) | (1,595) | (2,999) | (8,114) |
General and administrative expenses | (8,299) | (6,863) | (26,250) | (26,838) |
Restructuring expenses | 286 | (21,003) | ||
Total Operating expenses | (25,691) | (33,923) | (87,912) | (131,169) |
Loss from operations | (24,368) | (29,765) | (85,137) | (118,681) |
Other Income (expenses) | ||||
Financial income (expense) | 336 | (1,184) | 597 | (1,380) |
Loss before taxes | (24,033) | (30,948) | (84,540) | (120,061) |
Income tax | (7) | 404 | (10) | |
Net loss | (24,033) | (30,955) | (84,136) | (120,071) |
Foreign currency translation differences, net of taxes | (3,728) | 13,196 | (9,684) | 13,495 |
Actuarial gains (losses) on employee benefits, net of taxes | 28 | (75) | (10) | (113) |
Comprehensive loss | $ (27,733) | $ (17,834) | $ (93,830) | $ (106,688) |
Basic/diluted net loss per share attributable to shareholders | $ (0.44) | $ (0.56) | $ (1.53) | $ (2.23) |
Weighted average shares outstanding used in computing per share amounts: | 54,947,354 | 54,843,843 | 54,911,278 | 53,852,176 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Statement of Cash Flows [Abstract] | ||
Net loss for the period | $ (84,136) | $ (120,071) |
Cash flows used in operating activities: | ||
Depreciation, amortization and accrued contingencies | 9,705 | 18,360 |
Retirement pension obligations | 127 | (650) |
Expenses related to share-based payments | 4,078 | (2,965) |
Other elements | 1,214 | 789 |
Changes in operating assets and liabilities: | ||
Decrease (increase) in inventories and work in progress | 2,292 | |
Decrease (increase) in trade receivables | 2,174 | (1,974) |
Decrease (increase) in other current assets | (9,036) | (9,591) |
(Decrease) increase in trade payables | (7,135) | (6,760) |
(Decrease) increase in other current and non-current liabilities | (5,497) | (11,372) |
Change in operating lease liabilities and right—of—use assets | (946) | (136) |
Net cash flow used in operating activities | (89,452) | (132,076) |
Cash flows provided by (used in) investing activities: | ||
Acquisitions of property, plant, and equipment, net from proceeds | 46 | (2,200) |
Acquisitions of intangible assets | (8) | (20) |
Acquisitions of non-current financial assets | 3 | (12) |
Net cash flows provided by (used in) investing activities | 41 | (2,232) |
Cash flows (used in) provided by financing activities: | ||
(Decrease) increase in conditional advances | (518) | (138) |
Treasury shares | (359) | (766) |
Capital increases, net of transaction costs | 794 | 150,551 |
Other cash flows related to financing activities | (21) | (24) |
Net cash flows (used in) provided by financing activities | (103) | 149,624 |
Effect of exchange rate changes on cash and cash equivalents | (8,643) | 12,834 |
Net (decrease) increase in cash and cash equivalents | (98,157) | 28,150 |
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 | $ 98,195 | $ 221,404 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Changes in Shareholders' Equity - USD ($) $ in Thousands | Total | Common Shares [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive income (loss) [Member] | Accumulated Currency Translation Effect [Member] |
Beginning balance at Dec. 31, 2019 | $ 193,186 | $ 5,645 | $ 1,003,595 | $ (230) | $ (798,988) | $ 108 | $ (16,945) |
Beginning balance (Shares) at Dec. 31, 2019 | 47,028,510 | ||||||
Net (loss) | (40,913) | (40,913) | |||||
Other comprehensive income (loss) | (5,875) | 189 | (6,064) | ||||
Issuance of ordinary shares | 151,023 | $ 873 | 150,150 | ||||
Issuance of ordinary shares (Shares) | 7,898,677 | ||||||
Treasury shares | (832) | (832) | |||||
Share-based payments | 3,073 | 3,073 | |||||
Ending balance at Mar. 31, 2020 | 299,662 | $ 6,518 | 1,156,818 | (1,062) | (839,901) | 297 | (23,009) |
Ending balance (Shares) at Mar. 31, 2020 | 54,927,187 | ||||||
Beginning balance at Dec. 31, 2019 | 193,186 | $ 5,645 | 1,003,595 | (230) | (798,988) | 108 | (16,945) |
Beginning balance (Shares) at Dec. 31, 2019 | 47,028,510 | ||||||
Net (loss) | (120,071) | ||||||
Ending balance at Sep. 30, 2020 | 233,099 | $ 6,518 | 1,150,309 | (1,214) | (919,058) | (5) | (3,450) |
Ending balance (Shares) at Sep. 30, 2020 | 54,927,187 | ||||||
Beginning balance at Mar. 31, 2020 | 299,662 | $ 6,518 | 1,156,818 | (1,062) | (839,901) | 297 | (23,009) |
Beginning balance (Shares) at Mar. 31, 2020 | 54,927,187 | ||||||
Net (loss) | (48,203) | (48,203) | |||||
Other comprehensive income (loss) | 6,136 | (227) | 6,363 | ||||
Treasury shares | 107 | 107 | |||||
Share-based payments | (5,964) | (5,964) | |||||
Ending balance at Jun. 30, 2020 | 251,739 | $ 6,518 | 1,150,855 | (955) | (888,103) | 70 | (16,646) |
Ending balance (Shares) at Jun. 30, 2020 | 54,927,187 | ||||||
Net (loss) | (30,955) | (30,955) | |||||
Other comprehensive income (loss) | 13,121 | (75) | 13,196 | ||||
Issuance of ordinary shares | (472) | (472) | |||||
Treasury shares | (260) | (260) | |||||
Share-based payments | (74) | (74) | |||||
Ending balance at Sep. 30, 2020 | 233,099 | $ 6,518 | 1,150,309 | (1,214) | (919,058) | (5) | (3,450) |
Ending balance (Shares) at Sep. 30, 2020 | 54,927,187 | ||||||
Beginning balance at Dec. 31, 2020 | 205,491 | $ 6,518 | 1,152,042 | (1,169) | (958,543) | 484 | 6,158 |
Beginning balance (Shares) at Dec. 31, 2020 | 54,929,187 | ||||||
Net (loss) | (29,449) | (29,449) | |||||
Other comprehensive income (loss) | (8,829) | (85) | (8,744) | ||||
Issuance of ordinary shares | 42 | $ 1 | 42 | ||||
Issuance of ordinary shares (Shares) | 7,500 | ||||||
Treasury shares | 488 | 488 | |||||
Share-based payments | 1,433 | 1,433 | |||||
Ending balance at Mar. 31, 2021 | 169,176 | $ 6,519 | 1,153,516 | (681) | (987,992) | 399 | (2,586) |
Ending balance (Shares) at Mar. 31, 2021 | 54,936,687 | ||||||
Beginning balance at Dec. 31, 2020 | 205,491 | $ 6,518 | 1,152,042 | (1,169) | (958,543) | 484 | 6,158 |
Beginning balance (Shares) at Dec. 31, 2020 | 54,929,187 | ||||||
Net (loss) | (84,136) | ||||||
Ending balance at Sep. 30, 2021 | 116,892 | $ 6,529 | 359,081 | (810) | (244,856) | 474 | (3,526) |
Ending balance (Shares) at Sep. 30, 2021 | 55,011,687 | ||||||
Beginning balance at Mar. 31, 2021 | 169,176 | $ 6,519 | 1,153,516 | (681) | (987,992) | 399 | (2,586) |
Beginning balance (Shares) at Mar. 31, 2021 | 54,936,687 | ||||||
Net (loss) | (30,654) | (30,654) | |||||
Other comprehensive income (loss) | 2,836 | 0 | 48 | 2,788 | |||
Issuance of ordinary shares | 473 | $ 9 | 464 | ||||
Issuance of ordinary shares (Shares) | 75,000 | ||||||
Issuance of warrants | 279 | 279 | |||||
Treasury shares | (185) | (185) | |||||
Share-based payments | 1,094 | 1,094 | |||||
Allocation of accumulated net losses | (797,823) | 797,823 | |||||
Ending balance at Jun. 30, 2021 | 143,019 | $ 6,529 | 357,530 | (866) | (220,823) | 446 | 203 |
Ending balance (Shares) at Jun. 30, 2021 | 55,011,687 | ||||||
Net (loss) | (24,033) | (24,033) | |||||
Other comprehensive income (loss) | (3,701) | 28 | (3,728) | ||||
Treasury shares | 56 | 56 | |||||
Share-based payments | 1,551 | 1,551 | |||||
Ending balance at Sep. 30, 2021 | $ 116,892 | $ 6,529 | $ 359,081 | $ (810) | $ (244,856) | $ 474 | $ (3,526) |
Ending balance (Shares) at Sep. 30, 2021 | 55,011,687 |
The Company
The Company | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
The Company | 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 ™ ™ ™ 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. The amounts are presented in thousands unless otherwise indicated. 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 Company’s Annual Report on Form 10-K 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 Company’s 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 s right-of-use 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 Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin ™ pre-clinical ™ ™ Based on the Company’s plans to address the guidance received from the FDA in January 2021 and additional feedback received in October 2021 regarding the protocol for STAMP (Safety, Tolerability and Adhesion of Modified Patches), and its expected cost savings from implementation of the global restructuring plan, the Company expects that its balance of cash and cash equivalents of $98.2 million as of September 30, 2021 will be sufficient to fund its operations into the third quarter of 2022. As of the date of the filing, the Company’s available cash is not projected to be sufficient to support its operating plan for the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern. 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 The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to the ongoing COVID-19 COVID-19 If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts, or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently. These interim financial statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists. Accounting Pronouncements adopted in 2021 Effective January 1, 2021, the Company adopted ASU 2019-12, Income 2019-12 Accounting Pronouncements issued not yet adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13—Financial 2019-10 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. |
Significant Events and Transact
Significant Events and Transactions | 9 Months Ended |
Sep. 30, 2021 | |
Significant Events And Transactions Disclosure [Abstract] | |
Significant Events and Transactions | Note 2: Significant Events and Transactions Clinical programs Viaskin TM 4-11 In January 2020, the Company announced positive topline results of the three-year, open-label extension of its Phase III PEPITES trial (the “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 BLA for Viaskin Peanut. On March 16, 2020, the Company announced that the FDA had informed the Company that during its ongoing review of the Company’s BLA for Viaskin Peanut, it had identified questions regarding efficacy, including the impact of patch-site adhesion. Therefore, the Advisory Committee meeting to discuss the BLA originally scheduled on May 15, 2020 was cancelled. In August 2020, the Company announced that the FDA has issued a Complete Response Letter (“CRL”) in which the FDA indicated it could not approve the Viaskin Peanut BLA in its current form. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study. The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls (“CMC”) data. The FDA did not raise any safety concerns related to Viaskin Peanut. In January 2021, 6-month, In the second quarter of 2021, the Company completed CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches in order to identify the top performers. Based on the adhesion parameters studied, the Company was pleased to learn that all modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the current Viaskin Peanut patch. The Company then selected two modified patches that performed best out of the five modified patches studied for further development. The difference between the two selected patches is their shape—one is circular and the other is rectangular with rounded corners. They are both approximately 50% larger than the current patch but maintain the same structure of the occlusion chamber (i.e., foam ring and backing). The Company also conducted advisory boards with patient caregivers and key opinion leaders to obtain qualitative feedback on the consumer experience with both patches. I n the second quarter of 2021, the Company initiated PREQUAL, a Phase 1 study in healthy adult volunteers to optimize the allergen sample collection methodologies and validate the assays DBV intends to use in EQUAL (EQuivalence in Uptake of ALergen) to demonstrate the protein uptake comparability of the modified patch (mVP) to the reference or current patch (cVP). The Company submitted the protocol for STAMP, the 6-month n its communication, the FDA st ated that guidance is forthcoming on how best to demonstrate the protein uptake comparability of the mVP to the reference or current patch (cVP). The STAMP trial will not be initiated until DBV receives complete feedback from the FDA. Viaskin TM 4-11 In November 2020, the Company announced that its Marketing Authorization Application (“MAA”) for Viaskin Peanut had been validated by the European Medicines Agency (“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 Company’s expectations and prefiling conversations with the EMA. The Company did not receive questions about the impact of adhesion on efficacy. The EMA’s Committee for Medicinal Products for Human Use will provide a recommendation to the European Commission (“EC”) on whether to grant a marketing authorization when its review of the Viaskin Peanut MAA is complete. In July 2021, the Company received from the EMA a Day 180 list of outstanding issues. The review of the Viaskin Peanut MAA is progressing according to established EMA processes and ongoing conversations with the EMA. Many of EMA’s Objections and Major Objections have been answered; one Major Objection remained. DBV is preparing its responses to the Day 180 letter and evaluating how to best address the Objections, including the remaining Major Objection which questions the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study. Further exchanges with EMA are anticipated. DBV estimates the EMA could issue its decision on potential marketing authorization for Viaskin Peanut in the first quarter of 2022. Viaskin Peanut for children ages 1-3 I n June 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 µg 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 202 1. Financing In February 2020, the Company announced the closing of an underwritten global offering of an aggregate of 7,500,000 ordinary shares in (i) a public offering of 4,535,581 ordinary shares in the form of 9,071,162 American Depositary Shares (“ADSs”) in the United States, Canada and certain countries outside Europe at a public offering price of $10.25 per ADS (on the basis of an exchange rate of $1.0999 = €1.00), and (ii) an offering exclusively addressed to qualified investors in Europe (including France) of 2,964,419 ordinary shares at an offering price of €18.63 per ordinary share (together, the “Global Offering”). In March 2020, the Company announced that the underwriters partially exercised their option to purchase 338,687 additional ordinary shares in the form of 677,374 ADSs at an offering price of $10.25 per ADS, before deducting commissions and estimated offering expenses (the “Option”). The Option closed on March 4, 2020. Consequently, following partial exercise of the Option, the total number of ordinary shares sold in the global offering was 7,838,687 ordinary shares, including 4,874,268 ordinary shares in the form of 9,748,536 ADSs, bringing the total gross proceeds from the global offering to $160.7 million and net proceeds of $150.0 million. Restructuring The Company initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanut in the United States and European Union. The Company expects full implementation of the organization-wide costs reduction measures to be completed in the second half of 2021. The following table summarizes restructuring activities as of September 30, 2021 included in current contingencies and other current liabilities in the statement of financial position: Restructuring Restructuring liability—January 1, 2021 9,387 Amounts paid (7,024 ) Other effect including currency translation effect (238 ) Restructuring liability – September 30, 2021 2,125 of which current contingencies 950 of which other current liabilities 1,175 COVID-19 On March 11, 2020, the World Health Organization declared COVID-19 The Company has assessed the impact of the uncertainties created by the pandemic, such as the duration of the outbreak, the efficacy of vaccines and the evolution of variations strains of COVID-19, COVID-19 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 2:19-cv-00525. 10b-5 A hearing was held on July 29, 2021 in the U.S. District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. As the dismissal was without prejudice, the Plaintiffs repled their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court. The Company believes that the allegations contained in the amended complaint are without merit and will continue to defend the case vigorously. The Company believes this complaint will not have a material adverse effect on the Company’s consolidated financial position, results of operations or liquidity. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 9 Months Ended |
Sep. 30, 2021 | |
Cash and Cash Equivalents [Abstract] | |
Cash and Cash Equivalents | Note 3: Cash and Cash Equivalents The following tables summarize the cash and cash equivalents as of September 30, 2021 and December 31, 2020: September 30, December 31, 2021 2020 Cash 33,928 42,341 Cash equivalents 64,267 154,011 Total cash and cash equivalents as reported in the statements of financial position 98,195 196,352 Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements. |
Trade Payables and Other Curren
Trade Payables and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Payables and Accruals [Abstract] | |
Trade Payables and Other Current Liabilities | 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 Liabilities The following tables summarize the other liabilities as of September 30, 2021 and December 31, 2020: September 30, December 2021 2020 Other current liabilities 12,659 22,926 Other non-current liabilities 4,292 475 Total 16,951 23,402 The following table summarizes the other liabilities by nature as of September 30, 2021 and December 31, 2020: September 30, December 2021 2020 Other current Other non-current Total Total Employee related liabilities 6,748 1,674 8,422 17,136 Deferred income 4,291 2,618 6,909 4,687 Tax liabilities 149 — 149 580 Other debts 1,471 — 1,471 999 Total 12,659 4,292 16,951 23,402 The other current liabilities include 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 from the collaboration agreement with Nestlé Health Science amounted to $6.9 million as of September 30, 2021. |
Shareholders' equity
Shareholders' equity | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders' Equity Note [Abstract] | |
Shareholders' equity | Note 5: Shareholders’ equity The share capital as of September 30, 2021 is set at the sum of €5,501,168.70 ($6,528,543 converted at historical rates). It is divided into 55,011,687 fully authorized, subscribed and paid-up During the nine months ended September 30, 2021, the capital increase of approximately $10,000 is linked to the issuance of an aggregate of 82,500 shares pursuant to the exercise of warrants. Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2020 have been allocated to additional paid-in |
Share-Based Payments
Share-Based Payments | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Payments | Note 6: 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 (“SO”), employee warrants ( Bons de Souscription de Parts de Créateur d’Entreprise non-employee Bons de Souscription d’Actions During the nine months ended September 30, 2021, the Company granted 75,600 stock options and 44,900 restricted stock units to employees. There have been no changes in the vesting conditions and method of valuation of the SO and RSU from that disclosed in Note 14 to the consolidated financial statements included in the Annual Report. Stock option fair value assumptions during the nine months ended September 30, 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 During the nine months ended September 30, 2021, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the Company offered the directors the opportunity to subscribe for warrants to purchase ordinary shares on May 19, 2021, and on June Cox-Ross Warrant fair value assumptions during the nine months ended September 30, 2021 Weighted average share price at grant date in € 10.75 Weighted average expected volatility 90.0% Weighted average risk-free interest rate (0.53)% Weighted average expected term (in years) 3.21 Dividend yield — Weighted average fair value of warrants in € — The changes in number of BSA/BSPCE/SO/RSU are as follows: Number of outstanding BSA BSPCE SO RSU Balance as of December 31, 2020 218,008 5,500 2,610,510 1,118,745 Granted during the period 39,185 — 75,600 44,900 Forfeited during the period — — (100,400 ) (59,500 ) Exercised/released during the period — (5,500 ) — — Expired during the period (500 ) — — — Balance as of September 30, 2021 256,693 — 2,585,710 1,104,145 Share-based payments expenses reflected in the condensed consolidated statements of operations is as follows: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research & development SO (273 ) (6 ) (952 ) 1,144 RSU (660 ) (102 ) (795 ) (628 ) Sales & marketing SO (60 ) 186 (172 ) 2,063 RSU (27 ) (4 ) (75 ) (12 ) General & administrative SO (439 ) 25 (1,791 ) 609 RSU (92 ) (24 ) (293 ) (211 ) Total share-based compensation (expense) (1,551 ) 74 (4,078 ) 2,965 |
Contingencies
Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Loss Contingency [Abstract] | |
Contingencies | Note 7: Contingencies The following tables summarize the contingencies as of September 30, 2021 and December 31, 2020: September 30, December 31, 2021 2020 Current contingencies 5,633 5,016 Non-current contingencies 7,629 2,527 Total contingencies 13,262 7,542 The changes in contingencies are as follows: Pension Collaboration Loss at Other Total At January 1, 2021 937 3,956 2,649 7,542 Increases in liabilities 127 7,334 478 7,940 Used liabilities — — (1,601 ) (1,601 ) Reversals of unused liabilities — — — — Net interest related to employee benefits, and unwinding of discount — — — — Actuarial gains and losses on defined-benefit plans 10 — — 10 Other effects including currency translation effect (57 ) (458 ) (113 ) (629 ) At September 30, 2021 1,016 10,832 1,413 13,262 Of which current — 4,220 1,413 5,633 Of which non-current 1,016 6,612 — 7,629 In 2020 and during the first nine months of 2021, the ongoing COVID-19 As of September 30, 2021, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of the Phase II clinical trial conducted as part of the agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly. 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 Transactions—Restructuring”). 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. |
Operating Income
Operating Income | 9 Months Ended |
Sep. 30, 2021 | |
Other Income and Expenses [Abstract] | |
Operating Income | Note 8: Operating income The following table summarizes the operating income during the three and nine months ended September 30, 2021 and 2020: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research tax credit 1,647 1,815 5,324 7,615 Other operating ( loss (324 ) 2,344 (2,549 ) 4,873 Total 1,323 4,158 2,776 12,488 In 2020 and during the first nine months of 2021, the ongoing COVID-19 m As of September 30, 2021, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of the Phase II clinical trial conducted as part of the agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly. |
Allocation of Personnel Expense
Allocation of Personnel Expenses | 9 Months Ended |
Sep. 30, 2021 | |
Operating Expenses [Abstract] | |
Allocation of Personnel Expenses | Note 9: Allocation of Personnel Expenses The Company had an average of 105 employees during the nine months ended September 30, 2021, in comparison with an average of 291 employees during the nine months ended September 30, 2020. The following table summarizes the allocation of personnel expenses by function during the three and nine months ended September 30, 2021 and 2020: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research and development expenses 4,161 5,984 12,272 18,294 Sales and marketing expenses 492 2,154 1,528 4,987 General and administrative expenses 2,583 1,570 9,347 6,628 Restructuring expenses — (231 ) — 6,792 Total personnel expenses 7,236 9,477 23,148 36,701 The following table summarizes the allocation of personnel expenses by nature during the three nine months ended September 30, 2021 and 2020: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Wages and salaries 3,793 7,021 12,629 33,121 Social security contributions 1,110 933 3,505 5,669 Expenses for pension commitments 286 617 981 1,116 Employer contribution to bonus shares 497 981 1,955 (241 ) Share-based payments 1,551 (74 ) 4,078 (2,965 ) Total 7,236 9,477 23,148 36,701 The decrease in personnel expenses is mainly due to a decreased headcount as a result of the 2020 global restructuring plan. |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Note 10: 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. |
Relationships with Related Part
Relationships with Related Parties | 9 Months Ended |
Sep. 30, 2021 | |
Related Party Transactions [Abstract] | |
Relationships with Related Parties | Note 11: Relationships with Related Parties The Company’s related parties consist of executive officers, directors and beneficial owners of five percent (5%) or more of any class of our voting securities, including any of their immediate family members and any entity owned or controlled by such persons. As of September 30, 2021, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not changed significantly since December 31, 2020. Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the Company offered its directors the opportunity to subscribe for warrants to purchase ordinary shares on May 19, 2021, and on June 3, 2021, the directors subscribed for warrants to purchase an aggregate Share-Based Payments There were no other 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. |
Loss Per Share
Loss Per Share | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Loss Per Share | Note 12: 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 and nine month periods ended September 30, 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 Company’s net loss. The ordinary share equivalents at September 30, 2021 and 2020 excluded from the calculation of diluted net loss per share for the three months and nine months ended September 30, 2021 and 2020 (in number of potential shares) are set forth here below: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Non-employee warrants 256,693 225,008 256,693 225,008 Employee warrants — 82,500 — 82,500 Stock options 2,585,710 1,596,512 2,585,710 1,596,512 Restricted stock units 1,104,145 713,345 1,104,145 713,345 |
Events After The Close Of The P
Events After The Close Of The Period | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events [Abstract] | |
Events after the Close of the Period | Note 13: Events after the Close of the Period The Company evaluated subsequent events that occurred after September 30, 2021, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on October 26, 2021 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements. |
The Company (Policies)
The Company (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 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. The amounts are presented in thousands unless otherwise indicated. 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 Company’s Annual Report on Form 10-K 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 | Use of estimates The preparation of the Company’s 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 s 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 Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin ™ pre-clinical ™ ™ Based on the Company’s plans to address the guidance received from the FDA in January 2021 and additional feedback received in October 2021 regarding the protocol for STAMP (Safety, Tolerability and Adhesion of Modified Patches), and its expected cost savings from implementation of the global restructuring plan, the Company expects that its balance of cash and cash equivalents of $98.2 million as of September 30, 2021 will be sufficient to fund its operations into the third quarter of 2022. As of the date of the filing, the Company’s available cash is not projected to be sufficient to support its operating plan for the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern. 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 The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to the ongoing COVID-19 COVID-19 If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts, or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently. These interim financial statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists. |
Accounting Pronouncements adopted in 2021 | Accounting Pronouncements adopted in 2021 Effective January 1, 2021, the Company adopted ASU 2019-12, Income 2019-12 |
Accounting Pronouncements issued not yet adopted | Accounting Pronouncements issued not yet adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13—Financial 2019-10 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. |
Significant Events and Transa_2
Significant Events and Transactions (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Significant Events And Transactions Disclosure [Abstract] | |
Summary of restructuring reserve | The following table summarizes restructuring activities as of September 30, 2021 included in current contingencies and other current liabilities in the statement of financial position: Restructuring Restructuring liability—January 1, 2021 9,387 Amounts paid (7,024 ) Other effect including currency translation effect (238 ) Restructuring liability – September 30, 2021 2,125 of which current contingencies 950 of which other current liabilities 1,175 |
Cash and Cash Equivalents (Tabl
Cash and Cash Equivalents (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Cash and Cash Equivalents [Abstract] | |
Summary of breakdown of cash and cash equivalents | The following tables summarize the cash and cash equivalents as of September 30, 2021 and December 31, 2020: September 30, December 31, 2021 2020 Cash 33,928 42,341 Cash equivalents 64,267 154,011 Total cash and cash equivalents as reported in the statements of financial position 98,195 196,352 |
Trade Payables and Other Curr_2
Trade Payables and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Other Liabilities [Abstract] | |
Summary of Other Liabilities | The following tables summarize the other liabilities as of September 30, 2021 and December 31, 2020: September 30, December 2021 2020 Other current liabilities 12,659 22,926 Other non-current liabilities 4,292 475 Total 16,951 23,402 |
Summary of Other Liabilities by Nature | The following table summarizes the other liabilities by nature as of September 30, 2021 and December 31, 2020: September 30, December 2021 2020 Other current Other non-current Total Total Employee related liabilities 6,748 1,674 8,422 17,136 Deferred income 4,291 2,618 6,909 4,687 Tax liabilities 149 — 149 580 Other debts 1,471 — 1,471 999 Total 12,659 4,292 16,951 23,402 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Stock Options Valuation Assumptions | There have been no changes in the vesting conditions and method of valuation of the SO and RSU from that disclosed in Note 14 to the consolidated financial statements included in the Annual Report. Stock option fair value assumptions during the nine months ended September 30, 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 |
Summary of Fair Value of the Warrants has been Estimated Unsing the Cox-Ross Rubinstein Binomial Option Pricing Model | The fair value of the warrants has been estimated unsing the Cox-Ross Warrant fair value assumptions during the nine months ended September 30, 2021 Weighted average share price at grant date in € 10.75 Weighted average expected volatility 90.0% Weighted average risk-free interest rate (0.53)% Weighted average expected term (in years) 3.21 Dividend yield — Weighted average fair value of warrants in € — |
Summary of RSU Activity | The changes in number of BSA/BSPCE/SO/RSU are as follows: Number of outstanding BSA BSPCE SO RSU Balance as of December 31, 2020 218,008 5,500 2,610,510 1,118,745 Granted during the period 39,185 — 75,600 44,900 Forfeited during the period — — (100,400 ) (59,500 ) Exercised/released during the period — (5,500 ) — — Expired during the period (500 ) — — — Balance as of September 30, 2021 256,693 — 2,585,710 1,104,145 |
Summary of Share-Based Payments Expenses | Share-based payments expenses reflected in the condensed consolidated statements of operations is as follows: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research & development SO (273 ) (6 ) (952 ) 1,144 RSU (660 ) (102 ) (795 ) (628 ) Sales & marketing SO (60 ) 186 (172 ) 2,063 RSU (27 ) (4 ) (75 ) (12 ) General & administrative SO (439 ) 25 (1,791 ) 609 RSU (92 ) (24 ) (293 ) (211 ) Total share-based compensation (expense) (1,551 ) 74 (4,078 ) 2,965 |
Contingencies (Tables)
Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Loss Contingency [Abstract] | |
Summary of Current Contingencies and Non-current Contingencies | The following tables summarize the contingencies as of September 30, 2021 and December 31, 2020: September 30, December 31, 2021 2020 Current contingencies 5,633 5,016 Non-current contingencies 7,629 2,527 Total contingencies 13,262 7,542 |
Summary of Movement in Provisions | The changes in contingencies are as follows: Pension Collaboration Loss at Other Total At January 1, 2021 937 3,956 2,649 7,542 Increases in liabilities 127 7,334 478 7,940 Used liabilities — — (1,601 ) (1,601 ) Reversals of unused liabilities — — — — Net interest related to employee benefits, and unwinding of discount — — — — Actuarial gains and losses on defined-benefit plans 10 — — 10 Other effects including currency translation effect (57 ) (458 ) (113 ) (629 ) At September 30, 2021 1,016 10,832 1,413 13,262 Of which current — 4,220 1,413 5,633 Of which non-current 1,016 6,612 — 7,629 |
Operating Income (Tables)
Operating Income (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Other Income and Expenses [Abstract] | |
Schedule of operating income | The following table summarizes the operating income during the three and nine months ended September 30, 2021 and 2020: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research tax credit 1,647 1,815 5,324 7,615 Other operating ( loss (324 ) 2,344 (2,549 ) 4,873 Total 1,323 4,158 2,776 12,488 |
Allocation of Personnel Expen_2
Allocation of Personnel Expenses (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Operating Expenses [Abstract] | |
Summary of Allocation of Personnel Expenses By Function | The following table summarizes the allocation of personnel expenses by function during the three and nine months ended September 30, 2021 and 2020: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Research and development expenses 4,161 5,984 12,272 18,294 Sales and marketing expenses 492 2,154 1,528 4,987 General and administrative expenses 2,583 1,570 9,347 6,628 Restructuring expenses — (231 ) — 6,792 Total personnel expenses 7,236 9,477 23,148 36,701 |
Summary of Allocation of Personnel Expenses By Nature | The following table summarizes the allocation of personnel expenses by nature during the three nine months ended September 30, 2021 and 2020: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Wages and salaries 3,793 7,021 12,629 33,121 Social security contributions 1,110 933 3,505 5,669 Expenses for pension commitments 286 617 981 1,116 Employer contribution to bonus shares 497 981 1,955 (241 ) Share-based payments 1,551 (74 ) 4,078 (2,965 ) Total 7,236 9,477 23,148 36,701 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share, Basic and Diluted [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | The ordinary share equivalents at September 30, 2021 and 2020 excluded from the calculation of diluted net loss per share for the three months and nine months ended September 30, 2021 and 2020 (in number of potential shares) are set forth here below: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Non-employee warrants 256,693 225,008 256,693 225,008 Employee warrants — 82,500 — 82,500 Stock options 2,585,710 1,596,512 2,585,710 1,596,512 Restricted stock units 1,104,145 713,345 1,104,145 713,345 |
The Company - Additional Inform
The Company - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Subsidiary or Equity Method Investee [Line Items] | ||||
Cash and cash equivalents | $ 98,195 | $ 196,352 | $ 221,404 | $ 193,255 |
Significant Events and Transa_3
Significant Events and Transactions - Additional Information (Detail) $ / shares in Units, $ in Thousands | Mar. 02, 2020$ / sharesshares | Feb. 04, 2020$ / sharesshares | Jan. 31, 2020patients | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Sep. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Sep. 30, 2021USD ($)patientsshares | Feb. 04, 2020€ / shares |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 1.0999 | ||||||||
Proceeds From Issuance Of Common Stock | $ | $ 150,000 | ||||||||
Stock issued during the period, Value | $ | $ 473 | $ 42 | $ (472) | $ 151,023 | |||||
Common Stock [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 7,838,687 | ||||||||
Public Offering [member] | Common Stock [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 7,500,000 | 4,874,268 | |||||||
Public Offering [member] | American Depositary Shares | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 9,748,536 | ||||||||
Public Offering [member] | Outside Europe [Member] | Common Stock [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 4,535,581 | ||||||||
Public Offering [member] | Outside Europe [Member] | American Depositary Shares | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 9,071,162 | ||||||||
Shares Issued, Price Per Share | $ / shares | $ 10.25 | ||||||||
Over-Allotment Option | Common Stock [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 338,687 | ||||||||
Over-Allotment Option | American Depositary Shares | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 677,374 | ||||||||
Shares Issued, Price Per Share | $ / shares | $ 10.25 | ||||||||
Global Offering [member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Stock issued during the period, Value | $ | $ 160,700 | ||||||||
Private Placement [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Shares Issued, Price Per Share | € / shares | € 18.63 | ||||||||
Stock Issued During Period, Shares, Issued for Services | 2,964,419 | ||||||||
ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Percentage Of Patients Increased ED From Baseline | 75.90% | ||||||||
Number Of Patients Increased ED From Baseline | patients | 107 | ||||||||
Number Of Patients | patients | 141 | ||||||||
Percentage Of Patients Increased ED Of Minimum Thousand Milligram Peanut Protein By Three Year | 51.80% | 73.00% | |||||||
Number Of Patients Observed For Safety Profile Till Date | patients | 1,000 | ||||||||
Treatment Compliance Percentage | 98.00% | ||||||||
Clinical Program Trial Period | 6 months | ||||||||
Minimum | ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Age Of Child | 4 years | ||||||||
Maximum | ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Age Of Child | 11 years |
Significant Events and Transa_4
Significant Events and Transactions - Summary of restructuring reserve (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Summary of restructuring reserve | |
Restructuring liability - January 1, 2021 | $ 9,387 |
Amounts paid | (7,024) |
Other effect including currency translation effect | (238) |
Restructuring liability – September 30, 2021 | 2,125 |
of which current contingencies | 950 |
of which other current liabilities | $ 1,175 |
Cash and Cash Equivalents - Sum
Cash and Cash Equivalents - Summary of breakdown of cash and cash equivalents (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Cash and Cash Equivalents, at Carrying Value [Abstract] | ||||
Cash | $ 33,928 | $ 42,341 | ||
Cash equivalents | 64,267 | 154,011 | ||
Total cash and cash equivalent as reported in statement of financial position | $ 98,195 | $ 196,352 | $ 221,404 | $ 193,255 |
Trade Payables and Other Curr_3
Trade Payables and Other Current Liabilities - Additional Information (Detail) $ in Millions | Sep. 30, 2021USD ($) |
Nestl Health Science [Member] | |
Deferred revenues | $ 6.9 |
Trade Payables and Other Curr_4
Trade Payables and Other Current Liabilities - Summary of Other Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Other Liabilities [Abstract] | ||
Other current liabilities | $ 12,659 | $ 22,926 |
Other non-current liabilities | 4,292 | 475 |
Total | $ 16,951 | $ 23,402 |
Trade Payables and Other Curr_5
Trade Payables and Other Current Liabilities - Summary of Other Liabilities by Nature (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Schedule Of Other Liabilities, By Nature [Line Items] | ||
Other current liabilities | $ 12,659 | $ 22,926 |
Other non-current liabilities | 4,292 | 475 |
Total | 16,951 | 23,402 |
Employee related liabilities [Member] | ||
Schedule Of Other Liabilities, By Nature [Line Items] | ||
Other current liabilities | 6,748 | |
Other non-current liabilities | 1,674 | |
Total | 8,422 | 17,136 |
Deferred income [Member] | ||
Schedule Of Other Liabilities, By Nature [Line Items] | ||
Other current liabilities | 4,291 | |
Other non-current liabilities | 2,618 | |
Total | 6,909 | 4,687 |
Tax Liabilities [Member] | ||
Schedule Of Other Liabilities, By Nature [Line Items] | ||
Other current liabilities | 149 | |
Total | 149 | 580 |
Other Debts [Member] | ||
Schedule Of Other Liabilities, By Nature [Line Items] | ||
Other current liabilities | 1,471 | |
Total | $ 1,471 | $ 999 |
Shareholders' equity - Addition
Shareholders' equity - Additional Information (Detail) | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2021USD ($)shares | Dec. 31, 2020USD ($) | Dec. 31, 2020EUR (€) | Sep. 30, 2021EUR (€)€ / sharesshares | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Class of Stock [Line Items] | ||||||||||
Share capital | $ | $ 116,892,000 | $ 205,491,000 | $ 143,019,000 | $ 169,176,000 | $ 233,099,000 | $ 251,739,000 | $ 299,662,000 | $ 193,186,000 | ||
Warrant [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Stock Issued During Period, Value, Stock Options Exercised | $ | $ 10,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | shares | 82,500 | |||||||||
Share Capital | ||||||||||
Class of Stock [Line Items] | ||||||||||
Share capital | $ 6,528,543,000 | € 5,501,168,700 | ||||||||
Nominal value | € / shares | € 0.10 | |||||||||
Share capital authorized | shares | 55,011,687 | 55,011,687 | ||||||||
Adjustments to Additional Paid in Capital, Dividends in Excess of Retained Earnings | $ 797,822,881 | € 695,575,130.36 |
Share-Based Payments - Summary
Share-Based Payments - Summary of Stock Options Valuation Assumptions (Detail) | 9 Months Ended |
Sep. 30, 2021€ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted average share price at grant date in € | € 10.75 |
Weighted average risk-free interest rate | (0.53%) |
Weighted average expected term (in years) | 3 years 2 months 15 days |
Dividend yield | |
Weighted average fair value of stock options in € | € 0 |
Weighted Average [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted average share price at grant date in € | € 9.3 |
Weighted average expected volatility | 90.90% |
Weighted average risk-free interest rate | (0.36%) |
Weighted average expected term (in years) | 6 years |
Weighted average fair value of stock options in € | € 6.9 |
Share-Based Payments - Summar_2
Share-Based Payments - Summary of Fair Value of the Warrants has been Estimated Unsing the Cox-Ross Rubinstein Binomial Option Pricing Model (Detail) | 9 Months Ended |
Sep. 30, 2021€ / shares | |
Schedule Of Share Based Payment Award Fair Value Of Warrants Valuation Assumptions [Line Items] | |
Weighted average share price at grant date in € | € 10.75 |
Weighted average expected volatility | 90.00% |
Weighted average risk-free interest rate | (0.53%) |
Weighted average expected term (in years) | 3 years 2 months 15 days |
Dividend yield | |
Weighted average fair value of warrants in € | € 0 |
Share-Based Payments - Summar_3
Share-Based Payments - Summary of RSU Activity (Detail) | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of stock options outstanding, Granted during the period | 75,600 |
Number of stock options outstanding, Beginning Balance | 2,610,510 |
Number of stock options outstanding, Forfeited during the period | (100,400) |
Number of stock options outstanding, Ending Balance | 2,585,710 |
BSA Warrants [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted average grant date fair value, Expired during the period | $ / shares | $ (500) |
Number of warrants outstanding, Beginning Balance | 218,008 |
Number of stock options outstanding, Granted during the period | 39,185 |
Number of warrants outstanding, Exercised/released during the period | 0 |
Number of warrants outstanding, Ending Balance | 256,693 |
BCE Warrants [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of warrants outstanding, Beginning Balance | 5,500 |
Number of warrants outstanding, Exercised/released during the period | (5,500) |
Number of warrants outstanding, Ending Balance | 0 |
Restricted Stock Units [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of RSU outstanding, Beginning Balance | 1,118,745 |
Number of RSU outstanding, Granted during the period | 44,900 |
Number of RSU outstanding, Forfeited during the period | (59,500) |
Number of RSU outstanding, Ending Balance | 1,104,145 |
Share-Based Payments - Summar_4
Share-Based Payments - Summary of Share-Based Payments Expenses (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | $ (1,551) | $ 74 | $ (4,078) | $ 2,965 |
Research & Development expenses [Member] | Employee Stock Option Member | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (273) | (6) | (952) | 1,144 |
Research & Development expenses [Member] | Restricted Stock Units [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (660) | (102) | (795) | (628) |
Sales & Marketing expenses [Member] | Employee Stock Option Member | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (60) | 186 | (172) | 2,063 |
Sales & Marketing expenses [Member] | Restricted Stock Units [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (27) | (4) | (75) | (12) |
General & Administrative expenses [Member] | Employee Stock Option Member | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (439) | 25 | (1,791) | 609 |
General & Administrative expenses [Member] | Restricted Stock Units [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | $ (92) | $ (24) | $ (293) | $ (211) |
Share-Based Payments - Addition
Share-Based Payments - Additional Information (Detail) - shares | Sep. 03, 2021 | May 19, 2021 | Sep. 30, 2021 |
Share-Based Payments [Line iteam] | |||
Number of stock options outstanding, Granted during the period | 75,600 | ||
Warrants Remaining contractual life | 4 years | ||
Director [Member] | Warrant [Member] | |||
Share-Based Payments [Line iteam] | |||
Stock Issued During Period, Shares, Issued for Services | 39,185 | 39,185 | |
Share options [Member] | Employees [Member] | |||
Share-Based Payments [Line iteam] | |||
Number of stock options outstanding, Granted during the period | 75,600 | ||
Restricted Stock Units [Member] | |||
Share-Based Payments [Line iteam] | |||
Number of RSU outstanding, Granted during the period | 44,900 | ||
Restricted Stock Units [Member] | Employees [Member] | |||
Share-Based Payments [Line iteam] | |||
Number of RSU outstanding, Granted during the period | 44,900 |
Contingencies - Summary of Curr
Contingencies - Summary of Current Contingencies and Non-current Contingencies (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Liability, Defined Benefit Plan [Abstract] | ||
Current contingencies | $ 5,633 | $ 5,016 |
Non-current contingencies | 7,629 | 2,527 |
Total contingencies | $ 13,262 | $ 7,542 |
Contingencies - Summary of Move
Contingencies - Summary of Movement in Contingencies (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | |
Contingencies, Beginning balance | $ 7,542 | |
Increases in liabilities | 7,940 | |
Used liabilities | (1,601) | |
Reversals of unused liabilities | 0 | |
Net interest related to employee benefits, and unwinding of discount | 0 | |
Actuarial gains and losses on defined-benefit plans | 10 | |
Other effects including currency translation effect | (629) | |
Contingencies, Ending balance | 13,262 | |
Of which current | 5,633 | $ 5,016 |
Of which non-current | 7,629 | $ 2,527 |
Pension retirement obligations [Member] | ||
Contingencies, Beginning balance | 937 | |
Increases in liabilities | 127 | |
Actuarial gains and losses on defined-benefit plans | 10 | |
Other effects including currency translation effect | (57) | |
Contingencies, Ending balance | 1,016 | |
Of which non-current | 1,016 | |
Collaboration agreement -Loss at completion [Member] | ||
Contingencies, Beginning balance | 3,956 | |
Increases in liabilities | 7,334 | |
Used liabilities | 0 | |
Other effects including currency translation effect | (458) | |
Contingencies, Ending balance | 10,832 | |
Of which current | 4,220 | |
Of which non-current | 6,612 | |
Other provisions incl. restructuring [Member] | ||
Contingencies, Beginning balance | 2,649 | |
Increases in liabilities | 478 | |
Used liabilities | (1,601) | |
Other effects including currency translation effect | (113) | |
Contingencies, Ending balance | 1,413 | |
Of which current | $ 1,413 |
Operating Income - Summary of O
Operating Income - Summary of Operating Income (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Other Income and Expenses [Abstract] | ||||
Research Tax Credit | $ 1,647 | $ 1,815 | $ 5,324 | $ 7,615 |
Other Operating (loss) income | (324) | 2,344 | (2,549) | 4,873 |
Total | $ 1,323 | $ 4,158 | $ 2,776 | $ 12,488 |
Allocation of Personnel Expen_3
Allocation of Personnel Expenses - Summary of Allocation of Personnel Expenses By Function (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Research and development expenses | $ 16,320 | $ 25,751 | $ 58,663 | $ 75,214 |
Sales and marketing expenses | 1,072 | 1,595 | 2,999 | 8,114 |
General and administrative expenses | 8,299 | 6,863 | 26,250 | 26,838 |
Restructuring expenses | (286) | 21,003 | ||
Total Operating expenses | 25,691 | 33,923 | 87,912 | 131,169 |
Expenses by Function [Member] | ||||
Research and development expenses | 4,161 | 5,984 | 12,272 | 18,294 |
Sales and marketing expenses | 492 | 2,154 | 1,528 | 4,987 |
General and administrative expenses | 2,583 | 1,570 | 9,347 | 6,628 |
Restructuring expenses | 0 | (231) | 0 | 6,792 |
Total Operating expenses | $ 7,236 | $ 9,477 | $ 23,148 | $ 36,701 |
Allocation of Personnel Expen_4
Allocation of Personnel Expenses -Summary of Allocation of Personnel Expenses By Nature (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based payments | $ (1,551) | $ 74 | $ (4,078) | $ 2,965 |
Total Operating expenses | 25,691 | 33,923 | 87,912 | 131,169 |
Expenses by Nature [Member] | ||||
Wages and salaries | 3,793 | 7,021 | 12,629 | 33,121 |
Social security contributions | 1,110 | 933 | 3,505 | 5,669 |
Expenses for pension commitments | 286 | 617 | 981 | 1,116 |
Employer contribution to bonus shares | 497 | 981 | 1,955 | (241) |
Share-based payments | 1,551 | (74) | 4,078 | (2,965) |
Total Operating expenses | $ 7,236 | $ 9,477 | $ 23,148 | $ 36,701 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Disclosure Of Commitments [Line Items] | |
Increase (decrease) in other commitments during the period | $ 0 |
Relationships with Related Pa_2
Relationships with Related Parties - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 03, 2021 | May 19, 2021 | Sep. 30, 2021 |
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||
Increase decrease in related party transactions and changes in nature of the transactions | $ 0 | ||
Director [Member] | Warrant [Member] | |||
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||
Stock Issued During Period, Shares, Issued for Services | 39,185 | 39,185 |
Loss Per Share - Summary of the
Loss Per Share - Summary of the Common Stock Equivalents Which Were Excluded From the Calculation of Diluted Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Non-employee warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 256,693 | 225,008 | 256,693 | 225,008 |
Employee warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 0 | 82,500 | 0 | 82,500 |
Stock options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 2,585,710 | 1,596,512 | 2,585,710 | 1,596,512 |
Restricted stock units [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,104,145 | 713,345 | 1,104,145 | 713,345 |