Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2024 | Jul. 30, 2024 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
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 Filer Category | Non-accelerated Filer | |
Entity Interactive Data Current | Yes | |
Entity Common Stock, Shares Outstanding | 96,498,927 | |
Document Transition Report | false | |
Document Quarterly Report | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Incorporation, State or Country Code | I0 | |
Entity Address, Address Line One | 107 Av. de la République | |
Entity Address, City or Town | Châtillon | |
Entity Address, Postal Zip Code | 92320 | |
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 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 | |
Security Exchange Name | NASDAQ | |
No Trading Symbol Flag | true |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Financial Position - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 66,213 | $ 141,367 |
Other current assets | 23,745 | 17,548 |
Total current assets | 89,958 | 158,915 |
Non-Current assets | ||
Property, plant, and equipment, net | 12,874 | 12,623 |
Right-of-use assets related to operating leases | 5,959 | 5,247 |
Intangible assets | 46 | 58 |
Other non-current assets | 5,353 | 6,144 |
Total non-current assets | 24,232 | 24,071 |
Total Assets | 114,190 | 182,986 |
Current liabilities | ||
Trade payables | 19,818 | 23,302 |
Short-term operating leases | 380 | 1,144 |
Current contingencies | 1,023 | 3,959 |
Other current liabilities | 6,160 | 8,934 |
Total current liabilities | 27,381 | 37,339 |
Non-Current liabilities | ||
Long-term operating leases | 6,783 | 4,526 |
Non-current contingencies | 931 | 935 |
Other non-current liabilities | 0 | 0 |
Total non-current liabilities | 7,714 | 5,461 |
Total Liabilities | 35,095 | 42,799 |
Shareholders' equity: | ||
Ordinary shares, €0.10 par value; 96,493,078 and 96,431,770 shares authorized, and issued as at June 30, 2024 and December 31, 2023, respectively | 10,978 | 10,972 |
Additional paid-in capital | 314,513 | 377,468 |
Treasury stock 303,744, and 222,988 ordinary shares as of June 30, 2024 and December 31, 2023, respectively, at cost | (1,358) | (1,263) |
Accumulated deficit | (232,890) | (238,862) |
Accumulated other comprehensive income | 750 | 742 |
Accumulated currency translation effect | (12,898) | (8,871) |
Total Shareholders' equity | 79,095 | 140,187 |
Total Liabilities and Shareholder's equity | $ 114,190 | $ 182,986 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Financial Position (Parenthetical) - € / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Treasury stock, common, shares | 303,744 | 222,988 |
Common Shares [Member] | ||
Common stock shares par value | € 0.1 | € 0.1 |
Common stock shares authorized | 96,493,078 | 96,431,770 |
Common stock shares issued | 96,493,078 | 96,431,770 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating income | $ 1,161 | $ 2,288 | $ 2,568 | $ 4,482 |
Operating expenses | ||||
Research and development expenses | (25,374) | (17,616) | (46,777) | (33,653) |
Sales and marketing expenses | (986) | (516) | (1,744) | (950) |
General and administrative expenses | (8,643) | (9,231) | (16,447) | (16,120) |
Total Operating expenses | (35,003) | (27,364) | (64,968) | (50,723) |
Loss from operations | (33,842) | (25,076) | (62,400) | (46,242) |
Financial income(expenses) | 726 | 846 | 1,986 | 1,450 |
Loss before taxes | (33,116) | (24,230) | (60,413) | (44,791) |
Income tax (expense) | 0 | (13) | (48) | (13) |
Net loss | (33,116) | (24,243) | (60,461) | (44,804) |
Foreign currency translation differences, net of taxes | (1,001) | (221) | (4,027) | 3,445 |
Actuarial gains (losses) on employee benefits, net of taxes | 67 | (10) | 8 | (92) |
Total comprehensive loss | $ (34,051) | $ (24,475) | $ (64,480) | $ (41,452) |
Basic Net loss per share attributable to shareholders | $ (0.34) | $ (0.26) | $ (0.63) | $ (0.48) |
Weighted average shares outstanding used in computing per share amounts: | 96,170,285 | 94,324,889 | 96,179,388 | 94,150,141 |
Diluted Net loss per share attributable to shareholders | $ (0.34) | $ (0.26) | $ (0.63) | $ (0.48) |
Weighted average shares outstanding used in computing per share amounts: | 96,170,285 | 94,324,889 | 96,179,388 | 94,150,141 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Statement of Cash Flows [Abstract] | ||
Net loss for the period | $ (60,461) | $ (44,804) |
Cash flows used in operating activities: | ||
Depreciation, amortization and accrued contingencies | (1,411) | 369 |
Retirement pension obligations | 33 | 11 |
Expenses related to share-based payments | 3,483 | 3,446 |
Other elements | 0 | 23 |
Changes in operating assets and liabilities: | ||
Decrease (increase) in other current assets | (5,983) | (6,481) |
(Decrease) increase in trade payables | (3,045) | 3,419 |
(Decrease) increase in other current and non-current liabilities | (2,577) | (2,913) |
Change in operating lease liabilities and right of use assets | 197 | 535 |
Net cash flow provided by (used in) operating activities | (69,765) | (46,394) |
Cash flows provided by (used in) investing activities: | ||
Acquisitions of property, plant, and equipment | (2,067) | (275) |
Proceeds from property, plant, and equipment dispositions | 0 | 0 |
Acquisitions of non-current financial assets | 0 | (27) |
Proceeds of non-current financial assets dispositions | 626 | 4 |
Net cash flows provided by (used in) investing activities | (1,441) | (299) |
Cash flows provided by (used in) financing activities: | ||
(Decrease) increase in conditional advances | 0 | 0 |
Treasury shares | (95) | 27 |
Capital increases, net of transaction costs | 0 | 7,766 |
Net cash flows provided by (used in) financing activities | (95) | 7,793 |
Effect of exchange rate changes on cash and cash equivalents | (3,853) | 3,668 |
Net increase (decrease) in cash and cash equivalents | (75,154) | (35,232) |
Net Cash and cash equivalents at the beginning of the period | 141,367 | 209,194 |
Net cash and cash equivalents at the end of the period | $ 66,213 | $ 173,961 |
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, 2022 | $ 194,453 | $ 10,720 | $ 458,221 | $ (1,109) | $ (259,578) | $ 781 | $ (14,581) |
Beginning balance (Shares) at Dec. 31, 2022 | 94,137,145 | ||||||
Net (loss) | (20,561) | (20,561) | |||||
Other comprehensive income (loss) | 3,584 | (82) | 3,666 | ||||
Issuance of ordinary shares | 0 | $ 1 | (1) | ||||
Issuance of ordinary shares (Shares) | 10,174 | ||||||
Treasury shares | (14) | (14) | |||||
Share-based payments | 1,632 | 1,632 | |||||
Ending balance at Mar. 31, 2023 | 179,094 | $ 10,721 | 459,852 | (1,123) | (280,138) | 698 | (10,915) |
Ending balance (Shares) at Mar. 31, 2023 | 94,147,319 | ||||||
Beginning balance at Dec. 31, 2022 | 194,453 | $ 10,720 | 458,221 | (1,109) | (259,578) | 781 | (14,581) |
Beginning balance (Shares) at Dec. 31, 2022 | 94,137,145 | ||||||
Net (loss) | (44,804) | ||||||
Ending balance at Jun. 30, 2023 | 164,240 | $ 10,952 | 375,759 | (1,082) | (210,940) | 687 | (11,136) |
Ending balance (Shares) at Jun. 30, 2023 | 96,250,954 | ||||||
Beginning balance at Mar. 31, 2023 | 179,094 | $ 10,721 | 459,852 | (1,123) | (280,138) | 698 | (10,915) |
Beginning balance (Shares) at Mar. 31, 2023 | 94,147,319 | ||||||
Net (loss) | (24,243) | (24,243) | |||||
Other comprehensive income (loss) | (232) | (10) | (221) | ||||
Issuance of ordinary shares | 7,766 | $ 231 | 7,535 | ||||
Issuance of ordinary shares (Shares) | 2,103,635 | ||||||
Treasury shares | 42 | 42 | |||||
Share-based payments | 1,814 | 1,814 | |||||
Allocation of accumulated net losses | (93,441) | 93,441 | |||||
Ending balance at Jun. 30, 2023 | 164,240 | $ 10,952 | 375,759 | (1,082) | (210,940) | 687 | (11,136) |
Ending balance (Shares) at Jun. 30, 2023 | 96,250,954 | ||||||
Beginning balance at Dec. 31, 2023 | 140,187 | $ 10,972 | 377,468 | (1,263) | (238,862) | 742 | (8,871) |
Beginning balance (Shares) at Dec. 31, 2023 | 96,431,770 | ||||||
Net (loss) | (27,345) | (27,345) | |||||
Other comprehensive income (loss) | (3,084) | (59) | (3,026) | ||||
Issuance of ordinary shares | 0 | $ 0 | 0 | ||||
Issuance of ordinary shares (Shares) | 2,599 | ||||||
Treasury shares | (62) | (62) | |||||
Share-based payments | 1,958 | 1,958 | |||||
Ending balance at Mar. 31, 2024 | 111,654 | $ 10,972 | 379,426 | (1,325) | (266,207) | 683 | (11,897) |
Ending balance (Shares) at Mar. 31, 2024 | 96,434,369 | ||||||
Beginning balance at Dec. 31, 2023 | 140,187 | $ 10,972 | 377,468 | (1,263) | (238,862) | 742 | (8,871) |
Beginning balance (Shares) at Dec. 31, 2023 | 96,431,770 | ||||||
Net (loss) | (60,461) | ||||||
Ending balance at Jun. 30, 2024 | 79,095 | $ 10,978 | 314,513 | (1,358) | (232,890) | 750 | (12,898) |
Ending balance (Shares) at Jun. 30, 2024 | 96,493,078 | ||||||
Beginning balance at Mar. 31, 2024 | 111,654 | $ 10,972 | 379,426 | (1,325) | (266,207) | 683 | (11,897) |
Beginning balance (Shares) at Mar. 31, 2024 | 96,434,369 | ||||||
Net (loss) | (33,116) | (33,116) | |||||
Other comprehensive income (loss) | (934) | 67 | (1,001) | ||||
Issuance of ordinary shares | 0 | $ 6 | (6) | ||||
Issuance of ordinary shares (Shares) | 58,709 | ||||||
Treasury shares | (33) | (33) | |||||
Share-based payments | 1,525 | 1,525 | |||||
Allocation of accumulated net losses | (66,433) | 66,433 | |||||
Ending balance at Jun. 30, 2024 | $ 79,095 | $ 10,978 | $ 314,513 | $ (1,358) | $ (232,890) | $ 750 | $ (12,898) |
Ending balance (Shares) at Jun. 30, 2024 | 96,493,078 |
The Company
The Company | 6 Months Ended |
Jun. 30, 2024 | |
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”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin. 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 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, 2024, 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 right-of-use Going Concern These Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists. Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. The Company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, our available cash and cash equivalents are not projected to be sufficient to support our operating plan for at least the next 12 months. As such, there is substantial doubt regarding our ability to continue as a going concern. Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $66.2 million as of June 30, 2024 will be sufficient to fund our operations into the first quarter 2025. 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 will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements are expected to be funded through debt and equity offerings. 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 any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all. If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently. These condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern. Accounting Pronouncements recently adopted There have been no recently issued accounting standards adopted during the period which had a material impact on the Company’s financial statements. There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows. Accounting Pronouncements issued not yet adopted 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 | 6 Months Ended |
Jun. 30, 2024 | |
Significant Events And Transactions of the Period Disclsure [Abstract] | |
Significant Events and Transactions | Note 2: Significant Events and Transactions Clinical programs United States Regulatory History and Current Status In August 2020, the Company received a Complete Response Letter, or CRL, in which the FDA indicated it could not approve the Viaskin Peanut BLA in its then-current form. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, followed by completion of a new human factors study. In addition, the FDA indicated that supplementary clinical data would need to be generated to support the modified patch. Finally, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data. The FDA did not raise any safety concerns related to Viaskin Peanut. In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request that the Company submitted in October 2020 following receipt of the CRL. The FDA agreed with the Company’s position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously. In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches to confirm consistency of efficacy data between the existing and modified patches. The study was completed in the second quarter of 2021 and the Company selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape. In May 2021, the Company submitted a proposed protocol to the FDA for STAMP (Safety, Tolerability, and Adhesion of Modified Patches), a 6-month After careful review of the FDA’s information requests, the Company decided not to pursue the approach to the development plans for Viaskin Peanut as requested by the FDA. The Company estimated that the FDA’s proposed sequential approach would require at least five rounds of exchanges with the FDA to achieve alignment before initiating STAMP, the 6-month On September 7, 2022, the Company announced the initiation of VITESSE, a Phase 3 pivotal study of the mVP in children ages 4-7 On December 23, 2022, the Company announced that the FDA lifted the partial clinical hold. The FDA confirmed the Company satisfactorily addressed all clinical hold issues and the VITESSE phase 3 clinical study could proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last subject is anticipated by the end of the third quarter of 2024. In June 2022, the Company announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1-3 m On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children 1-3 Pre-BLA pre-specified On July 31, 2023, the Company announced receipt of feedback from FDA on two supplemental safety studies, COMFORT Children and COMFORT Toddlers. The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds The Company also announced on November 9, 2023, 2- year The Company submitted the protocol for its COMFORT Children supplemental safety study in 4-through-7-year-olds 7-years Viaskin Peanut for children ages 4-11—European On December 20, 2021, the Company announced it withdrew the Marketing Authorization Application (“MAA”) for Viaskin Peanut and formally notified the European Medicines Agency (“EMA”) of our decision. The Company believes data from a second Viaskin Peanut pivotal clinical trial will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intends to resubmit the MAA when that data set is available. Viaskin Peanut for children ages 1-3 In June 2020, the Company announced that in Part A of the EPITOPE phase 3 clinical study subject 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 validated the ongoing investigation of the 250 µg dose in this age group, which was the dose studied in Part B of the EPITOPE phase 3 clinical study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2021. In June 2022, the Company announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms respectively. Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms. On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children 1-3 Pre-BLA pre-specified On May 10, 2023, the New England Journal of Medicine (“NEJM”) published results from the EPITOPE phase 3 clinical study that demonstrated EPIT with Viaskin Peanut was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE, called EPOPEX, which showed improvement between months 12 and 24 of treatment with Viaskin Peanut across all efficacy parameters. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023. The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds Viaskin Peanut for Children ages 4-7 On September 7, 2022, the Company announced the initiation of VITESSE, a Phase 3 pivotal study of the mVP in children ages 4-7 On September 21, 2022, the Company announced it received from the FDA a partial clinical hold letter related to certain design elements of VITESSE. The Company announced on December 23, 2022 that the FDA lifted the partial clinical hold. The FDA confirmed the Company satisfactorily addressed all clinical hold issues and the VITESSE phase 3 clinical study could proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE trial. Screening of the last subject is anticipated by the end of the third quarter of 2024. In July 2023, the Company received Type C Meeting Written Responses from the FDA regarding key study design elements for COMFORT Children. Subsequently, in October 2023, the Company received feedback from the FDA addressing the remaining protocol design elements for COMFORT Children. This feedback included language simplification for how Viaskin should be used. The Company submitted the protocol for its COMFORT Children supplemental safety study in 4-through-7-year-olds 7-years ADS Ratio Change & NASDAQ listing market change On May 31st 2024, the Company announced plans to change the ratio of its American Depositary Shares (“ADSs”) to its ordinary shares (the “ADS Ratio”), nominal value €0.10 (ten cents) per share, from the current ADS Ratio of one (1) ADS to one-half For the Company’s ADS holders, the change in the ADS Ratio had the same effect as a one-for-two No fractional new ADSs were issued in connection with the ADS Ratio Change. Instead, fractional entitlements to new ADSs were aggregated and sold by the depositary bank and the net cash proceeds from the sale of the fractional ADS entitlements (after deduction of fees, taxes and expenses) were distributed to the applicable ADS holders by the depositary bank. The ADS Ratio Change had no impact on DBV’s underlying ordinary shares, and no ordinary shares were issued or cancelled in connection with the ADS Ratio Change. In addition, to obtain an additional 180 days period to regain compliance with the NASDAQ minimum bid price requirement, the Company applied to transfer its securities from the NASDAQ Global Select Market to the NASDAQ Capital Market (the “NCM”). On June 18, 2024, the Company was notified by the Listing Qualifications Department that NASDAQ granted the Company’s request to transfer the listing of its ADSs from the NASDAQ Global Select Market tier to the NCM tier, and that NASDAQ granted the Company’s request for a second 180-day Legal Proceedings From time to time, the Company ma y |
Cash and Cash Equivalents
Cash and Cash Equivalents | 6 Months Ended |
Jun. 30, 2024 | |
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 June 30, 2024 and December 31, 2023: June 30, December 31, 2024 2023 Cash 12,688 10,530 Cash equivalents 53,525 130,836 Total cash and cash equivalents as reported in the statements of financial position 66,213 141,367 Bank overdrafts — — Total cash and cash equivalents as reported in the statements of cash flows 66,213 141,367 Cash equivalents are convertible into cash on 32 days notice at no or insignificant cost, on demand. They are measured using level 1 fair value measurements. |
Other Current Assets
Other Current Assets | 6 Months Ended |
Jun. 30, 2024 | |
Other Current Assets [Abstract] | |
Other Current Assets | Note 4: Other Current Assets Other current assets consisted of the following: June 30, December 31, Research tax credit 11,123 8,857 Other tax claims 6,109 5,236 Prepaid expenses 3,090 2,103 Other receivables 3,424 1,353 Total 23,745 17,548 Research tax credit The variance in Research Tax Credit is presented as follows: Amount in Opening research tax credit receivable as of January 1, 2024 8,857 + Operating income 2,568 - Payment received — - Adjustment and currency translation effect (302 ) Closing research tax credit receivable as of June 30, 2024 11,123 Of which - Non-current — Of which - Current portion 11,123 Before currency translation effect, the balance in research tax credit as of June 30, 2024, consisted of $8.9 million research tax credit for the previous fiscal year filed with the tax authorities and yet to be reimbursed, and $2.6 million estimated research tax credit for the first six months of the 2024 fiscal year. The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses include $2.2 million relating to the Services Agreement entered by the Company with Fareva La Vallee, dated March 18, 2024, for the construction of a manufacturing line by Fareva La Vallee for the production and supply of peanut source material for the Company. |
Lease contracts
Lease contracts | 6 Months Ended |
Jun. 30, 2024 | |
Lessee Disclosure [Abstract] | |
Lease contracts | Note 5: Lease contracts Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2024 and December 31, 2023, are as follows: June 30, 2024 December 31, 2023 Real Estate Other Total Real Estate Other Total Current portion 430 50 479 1,205 79 1,284 Year 2 1,207 7 1,213 65 11 75 Year 3 1,252 7 1,259 421 — 421 Thereafter 5,890 12 5,902 5,515 — 5,515 Total minimum lease payments 8,778 75 8,853 7,205 90 7,295 Less: Effects of discounting (1,679 ) (12 ) (1,691 ) (1,617 ) (9 ) (1,626 ) Present value of lease liabilities 7,099 64 7,163 5,588 82 5,670 Less: current portion (339 ) (41 ) (380 ) (1,072 ) (72 ) (1,144 ) Long-term lease liabilities 6,760 23 6,783 4,516 10 4,526 Weighted average remaining lease term (years) 7.90 0.02 7.54 0.00 Weighted average discount rate 5.08 % 0.04 % 4.53 % 2.50 % The increase in $1.7 million dollars in lease obligations due over 1 year results from the new US headquarter lease. The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was: June 30, 2024 2023 Operating lease expense / (income) 1,255 1,543 Net termination impact (70 ) (92 ) Net restructuring impact — — Supplemental cash flow information related to operating leases is as follows for the period June 30, 2024 and 2023: June 30, 2024 2023 Cash paid for amounts included in the measurement of lease liabilities — — Operating cash flows from operating leases 1,019 963 |
Trade payables and Other Liabil
Trade payables and Other Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Trade payables and Other Liabilities | Note 6: Trade Payables and Other Current Liabilities 6.1 Trade Payables Trade payables decreased by $3.5 million as of June 30, 2024, compared to December 31, 2023. 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. 6.2 Other Current Liabilities The following tables summarize the other current liabilities as of June 30, 2024 and December 31, 2023: June 30, December 31, 2024 2023 Other current Other non-current Total Other current Other non-current Total Employee related liabilities 5,530 — 5,530 7,828 — 7,828 Deferred income — — — — — — Tax liabilities 203 — 203 223 — 223 Other debts 427 — 427 883 — 883 Total 6,160 — 6,160 8,934 — 8,934 The Employee related liabilities includes short-term debt to employees including social welfare, tax agency obligations and bonus provision. The variance versus year end is due to bonus accruals. |
Shareholders' equity
Shareholders' equity | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' Equity Note [Abstract] | |
Shareholders' equity | Note 7: Shareholders’ equity The share capital as of June 30, 2024 is set at the sum of €9,649,308 ($10,978 thousand converted paid-up Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 16, 2024 (the “SH General Meeting”), the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2023, have been allocated to additional paid-in l |
Share-Based Payments
Share-Based Payments | 6 Months Ended |
Jun. 30, 2024 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Payments | Note 8: Share-Based Payments The Board of Directors has been authorized at the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), and non-employee Bons de Souscription d’Actions During the six months ended June 30, 2024, the Company granted 534,000 stock options and 124,000 restricted stock units to employees. There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report. Change in Number of BSA/SO/RSU: Number of outstanding BSA SO RSUs Balance as of December 31, 2023 244,693 7,118,691 2,095,517 Granted during the period — 534,000 124,000 Forfeited during the period — (117,600 ) (92,754 ) Exercised/released during the period — — (61,308 ) Expired during the period — — — Balance as of June 30, 2024 244,693 7,535,091 2,065,455 Share-based payments expense reflected in the condensed consolidated statements of operations is as follows: Three Months Six Months 2024 2023 2024 2023 Research & development SO (456 ) (465 ) (969 ) (894 ) RSU (241 ) (271 ) (497 ) (529 ) Sales & marketing SO (20 ) (27 ) (43 ) (54 ) RSU (9 ) (8 ) (18 ) (17 ) General & administrative SO (700 ) (925 ) (1,730 ) (1,722 ) RSU (100 ) (118 ) (226 ) (231 ) Total share-based compensation (expense) (1,525 ) (1,814 ) (3,483 ) (3,447 ) |
Contingencies
Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Loss Contingency [Abstract] | |
Contingencies | Note 9: Contingencies The following tables summarize the contingencies as of June 30, 2024 and December 31, 2023: June 30, December 31, 2024 2023 Current contingencies 1,023 3,959 Non-current 931 935 Total contingencies 1,953 4,894 The changes in contingencies are as follows: Pension Collaboration Other Total At January 1, 2024 935 2,100 1,859 4,894 Increases in liabilities 33 — 72 106 Used liabilities — (1,158 ) (1,130 ) (2,288 ) Reversals of unused liabilities — — (652 ) (652 ) Net interest related to employee benefits, and unwinding of discount — — — — Actuarial gains and losses on defined-benefit plans (8 ) — — (8 ) Currency translation effect (29 ) (54 ) (15 ) (99 ) At June 30, 2024 931 889 134 1,953 Of which current — 889 134 1,023 Of which non-current 931 — — 931 In May 2026, the Company entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Societe des Produits Nestle S.A. (formerly, NESTEC S.A.) (“NESTEC”) under which the COmpany was responsible for leading the development activities of MAG1C up through a pivotal phase 3 clinical program. On October 30, 2023, the Company signed a Mutual Termination Letter Agreement with NESTEC terminating the Collaboration Agreement (the “Collaboration Agreement”) between the parties. As of June 30, 2024, the accrual for ongoing Clinical study completion totals $0.9 million as compated to $2.1 million as of December 31, 2023 representing our best estimate of the remaining expenses related to the ongoing clinical study. An amount of $1.8 million reserved for the refurbishment of the previous Montrouge offices was reversed in the second quarter of 2024. The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 13 to the consolidated financial statements included in the Annual Report. |
Operating Income
Operating Income | 6 Months Ended |
Jun. 30, 2024 | |
Other Income and Expenses [Abstract] | |
Operating Income | Note 10: Operating income The following table summarizes the operating income during the three and six months ended June 30, 2024 and 2023: Three Months Ended Six Months Ended 2024 2023 2024 2023 Research tax credit 1,161 1,975 2,568 3,741 Other operating income — 312 — 741 Total 1,161 2,288 2,568 4,482 Until the end of 2023, our operating income was composed of both the French Research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC. Following the termination of the Collaboration Agreement on October 30, 2023, our operating income is now exclusively generated by the French research tax credit. The decrease in Research tax credit was primarily due to the fact that a greater proportion of studies activities were carried out in North America and were therefore not eligible to the French Research tax credit. |
Operating Expenses
Operating Expenses | 6 Months Ended |
Jun. 30, 2024 | |
Operating Expenses [Abstract] | |
Operating expenses | Note 11: Operating Expenses The Company had an average of 106 employees during the six months ended June 30, 2024, in comparison with an average of 88 employees during the six months ended June 30, 2023. The increase is mainly due to hiring to support development activities and quality activities. The following table summarizes the allocation of personnel expenses by function during the three and six months ended June 30, 2024 and 2023: Three Months Six Months 2024 2023 2024 2023 Research and Development expenses 5,177 4,014 10,225 8,020 Sales & Marketing expenses 233 208 567 373 General & Administrative expenses 3,413 2,858 6,650 5,958 Total personnel expenses 8,824 7,079 17,442 14,351 The following table summarizes the allocation of personnel expenses by nature during the three and six months ended June 30, 2024 and 2023: Three Months Six Months 2024 2023 2024 2023 Wages and salaries 5,540 4,078 10,684 8,516 Social security contributions 1,515 1,185 2,722 1,884 Expenses for pension commitments 244 246 553 504 Employer contribution to bonus shares — (244 ) — — Share-based payments 1,525 1,814 3,483 3,446 Total 8,824 7,079 17,442 14,351 The increase in personnel expenses is due to the recruitment of internal resources mostly based in North America to support development activ it |
Commitments
Commitments | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Note 12: Commitments There were no significant changes in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report. |
Relationships with Related Part
Relationships with Related Parties | 6 Months Ended |
Jun. 30, 2024 | |
Related Party Transactions [Abstract] | |
Relationships with Related Parties | Note 13: Relationships with Related Parties There were no new significant related-party transactions during the period nor any changes in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report. |
Loss Per Share
Loss Per Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Loss Per Share | Note 14: 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 six-month The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three and six months ended June 30, 2024 and 2023 indicated in number of potential shares: Three months ended Six Months 2024 2023 2024 2023 Non-employee 244,693 251,693 244,693 251,693 Stock options 7,535,091 5,290,569 7,535,091 5,290,569 Restricted stock units 2,188,071 1,509,078 2,188,071 1,509,078 Prefunded warrants 28,276,331 28,276,331 28,276,331 28,276,331 |
Events After the Close of the P
Events After the Close of the Period | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events [Abstract] | |
Events after the Close of the Period | Note 15: Events after the Close of the Period The Company evaluated subsequent events that occurred after June 30, 2024, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on July 30, 2024, 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) | 6 Months Ended |
Jun. 30, 2024 | |
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 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, 2024, 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 right-of-use |
Going concern | Going Concern These Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists. Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. The Company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, our available cash and cash equivalents are not projected to be sufficient to support our operating plan for at least the next 12 months. As such, there is substantial doubt regarding our ability to continue as a going concern. Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $66.2 million as of June 30, 2024 will be sufficient to fund our operations into the first quarter 2025. 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 will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements are expected to be funded through debt and equity offerings. 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 any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all. If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently. These condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern. |
Accounting Pronouncements recently adopted | Accounting Pronouncements recently adopted There have been no recently issued accounting standards adopted during the period which had a material impact on the Company’s financial statements. There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows. |
Accounting Pronouncements issued not yet adopted | Accounting Pronouncements issued not yet adopted 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. |
Cash and Cash Equivalents (Tabl
Cash and Cash Equivalents (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Cash and Cash Equivalents [Abstract] | |
Summary of breakdown of cash and cash equivalents | The following tables summarize the cash and cash equivalents as of June 30, 2024 and December 31, 2023: June 30, December 31, 2024 2023 Cash 12,688 10,530 Cash equivalents 53,525 130,836 Total cash and cash equivalents as reported in the statements of financial position 66,213 141,367 Bank overdrafts — — Total cash and cash equivalents as reported in the statements of cash flows 66,213 141,367 |
Other Current Assets (Tables)
Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Other Current Assets [Abstract] | |
Summary of Other Current Asset | Other current assets consisted of the following: June 30, December 31, Research tax credit 11,123 8,857 Other tax claims 6,109 5,236 Prepaid expenses 3,090 2,103 Other receivables 3,424 1,353 Total 23,745 17,548 |
Summary of Research Tax Credit | The variance in Research Tax Credit is presented as follows: Amount in Opening research tax credit receivable as of January 1, 2024 8,857 + Operating income 2,568 - Payment received — - Adjustment and currency translation effect (302 ) Closing research tax credit receivable as of June 30, 2024 11,123 Of which - Non-current — Of which - Current portion 11,123 |
Lease contracts (Tables)
Lease contracts (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Lessee Disclosure [Abstract] | |
Summary of Operating Leases Future Minimum Payments Receivable | Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2024 and December 31, 2023, are as follows: June 30, 2024 December 31, 2023 Real Estate Other Total Real Estate Other Total Current portion 430 50 479 1,205 79 1,284 Year 2 1,207 7 1,213 65 11 75 Year 3 1,252 7 1,259 421 — 421 Thereafter 5,890 12 5,902 5,515 — 5,515 Total minimum lease payments 8,778 75 8,853 7,205 90 7,295 Less: Effects of discounting (1,679 ) (12 ) (1,691 ) (1,617 ) (9 ) (1,626 ) Present value of lease liabilities 7,099 64 7,163 5,588 82 5,670 Less: current portion (339 ) (41 ) (380 ) (1,072 ) (72 ) (1,144 ) Long-term lease liabilities 6,760 23 6,783 4,516 10 4,526 Weighted average remaining lease term (years) 7.90 0.02 7.54 0.00 Weighted average discount rate 5.08 % 0.04 % 4.53 % 2.50 % The increase in $1.7 million dollars in lease obligations due over 1 year results from the new US headquarter lease. |
Summary of Rent expenses | Rent expense presented in the consolidated statement of operations and comprehensive loss was: June 30, 2024 2023 Operating lease expense / (income) 1,255 1,543 Net termination impact (70 ) (92 ) Net restructuring impact — — |
Summary of Supplemental cash flow information related to our operating leases | Supplemental cash flow information related to operating leases is as follows for the period June 30, 2024 and 2023: June 30, 2024 2023 Cash paid for amounts included in the measurement of lease liabilities — — Operating cash flows from operating leases 1,019 963 |
Trade payables and Other Liab_2
Trade payables and Other Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Other Liabilities, Current [Abstract] | |
Summary of Other Current Liabilities | 6.2 Other Current Liabilities The following tables summarize the other current liabilities as of June 30, 2024 and December 31, 2023: June 30, December 31, 2024 2023 Other current Other non-current Total Other current Other non-current Total Employee related liabilities 5,530 — 5,530 7,828 — 7,828 Deferred income — — — — — — Tax liabilities 203 — 203 223 — 223 Other debts 427 — 427 883 — 883 Total 6,160 — 6,160 8,934 — 8,934 |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Summary of RSU Activity | Change in Number of BSA/SO/RSU: Number of outstanding BSA SO RSUs Balance as of December 31, 2023 244,693 7,118,691 2,095,517 Granted during the period — 534,000 124,000 Forfeited during the period — (117,600 ) (92,754 ) Exercised/released during the period — — (61,308 ) Expired during the period — — — Balance as of June 30, 2024 244,693 7,535,091 2,065,455 |
Summary of Share-Based Payments Expenses | Share-based payments expense reflected in the condensed consolidated statements of operations is as follows: Three Months Six Months 2024 2023 2024 2023 Research & development SO (456 ) (465 ) (969 ) (894 ) RSU (241 ) (271 ) (497 ) (529 ) Sales & marketing SO (20 ) (27 ) (43 ) (54 ) RSU (9 ) (8 ) (18 ) (17 ) General & administrative SO (700 ) (925 ) (1,730 ) (1,722 ) RSU (100 ) (118 ) (226 ) (231 ) Total share-based compensation (expense) (1,525 ) (1,814 ) (3,483 ) (3,447 ) |
Contingencies (Tables)
Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Loss Contingency [Abstract] | |
Summary of Non-current Contingencies and Current Contingencies | The following tables summarize the contingencies as of June 30, 2024 and December 31, 2023: June 30, December 31, 2024 2023 Current contingencies 1,023 3,959 Non-current 931 935 Total contingencies 1,953 4,894 |
Summary of Movement in Provisions | The changes in contingencies are as follows: Pension Collaboration Other Total At January 1, 2024 935 2,100 1,859 4,894 Increases in liabilities 33 — 72 106 Used liabilities — (1,158 ) (1,130 ) (2,288 ) Reversals of unused liabilities — — (652 ) (652 ) Net interest related to employee benefits, and unwinding of discount — — — — Actuarial gains and losses on defined-benefit plans (8 ) — — (8 ) Currency translation effect (29 ) (54 ) (15 ) (99 ) At June 30, 2024 931 889 134 1,953 Of which current — 889 134 1,023 Of which non-current 931 — — 931 |
Operating Income (Tables)
Operating Income (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Other Income and Expenses [Abstract] | |
Schedule of operating income | The following table summarizes the operating income during the three and six months ended June 30, 2024 and 2023: Three Months Ended Six Months Ended 2024 2023 2024 2023 Research tax credit 1,161 1,975 2,568 3,741 Other operating income — 312 — 741 Total 1,161 2,288 2,568 4,482 |
Operating Expenses (Tables)
Operating Expenses (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 six months ended June 30, 2024 and 2023: Three Months Six Months 2024 2023 2024 2023 Research and Development expenses 5,177 4,014 10,225 8,020 Sales & Marketing expenses 233 208 567 373 General & Administrative expenses 3,413 2,858 6,650 5,958 Total personnel expenses 8,824 7,079 17,442 14,351 |
Summary of Allocation of Personnel Expenses By Nature | The following table summarizes the allocation of personnel expenses by nature during the three and six months ended June 30, 2024 and 2023: Three Months Six Months 2024 2023 2024 2023 Wages and salaries 5,540 4,078 10,684 8,516 Social security contributions 1,515 1,185 2,722 1,884 Expenses for pension commitments 244 246 553 504 Employer contribution to bonus shares — (244 ) — — Share-based payments 1,525 1,814 3,483 3,446 Total 8,824 7,079 17,442 14,351 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share, Basic [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three and six months ended June 30, 2024 and 2023 indicated in number of potential shares: Three months ended Six Months 2024 2023 2024 2023 Non-employee 244,693 251,693 244,693 251,693 Stock options 7,535,091 5,290,569 7,535,091 5,290,569 Restricted stock units 2,188,071 1,509,078 2,188,071 1,509,078 Prefunded warrants 28,276,331 28,276,331 28,276,331 28,276,331 |
The Company - Additional Inform
The Company - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Subsidiary or Equity Method Investee [Line Items] | ||
Cash and cash equivalents | $ 66,213 | $ 141,367 |
Significant Events and Transa_2
Significant Events and Transactions - Additional Information (Detail) - € / shares | Jul. 31, 2023 | Jun. 30, 2024 |
American Depositary Shares [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Shares Issued, Price Per Share | € 0.1 | |
Minimum [Member] | ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member] | Comfort Children Safety Study [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Age Of Child | 4 years | |
Period for which the study shall be carried out | 4 months | |
Maximum [Member] | ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member] | Comfort Children Safety Study [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Age Of Child | 7 years | |
Period for which the study shall be carried out | 7 years |
Cash and Cash Equivalents - Sum
Cash and Cash Equivalents - Summary of breakdown of cash and cash equivalents (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Cash and Cash Equivalents, at Carrying Value [Abstract] | ||
Cash | $ 12,688 | $ 10,530 |
Cash equivalents | 53,525 | 130,836 |
Total cash and cash equivalents as reported in the statements of financial position | 66,213 | 141,367 |
Bank overdrafts | 0 | 0 |
Total cash and cash equivalents as reported in the statements of cash flows | $ 66,213 | $ 141,367 |
Other Current Assets - Summary
Other Current Assets - Summary of Other Current Asset (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Other Assets [Abstract] | ||
Research tax credit | $ 11,123 | $ 8,857 |
Other tax claims | 6,109 | 5,236 |
Prepaid expenses | 3,090 | 2,103 |
Other receivables | 3,424 | 1,353 |
Total | $ 23,745 | $ 17,548 |
Other Current Assets - Summar_2
Other Current Assets - Summary Of Research Tax Credit (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Tax Credit Carryforward [Line Items] | |
Opening balance | $ 8,857 |
+ Operating income | 2,568 |
- Payment received | 0 |
- Adjustment and currency translation effect | (302) |
Closing balance | 11,123 |
Of which - Non-current portion | 0 |
Of which - Current portion | $ 11,123 |
Other Current Assets - Addition
Other Current Assets - Additional Information (Detail) - USD ($) $ in Millions | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Mar. 18, 2024 | |
Research Tax Credit Carryforward [Member] | |||
Tax credit carryforward amount before currency translation | $ 2.6 | $ 8.9 | |
Construction [Member] | |||
Other Prepaid Expense, Current | $ 2.2 |
Lease contracts - Summary of Op
Lease contracts - Summary of Operating Leases Future Minimum Payments Receivable (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current portion | $ 479 | $ 1,284 |
Year 2 | 1,213 | 75 |
Year 3 | 1,259 | 421 |
Thereafter | 5,902 | 5,515 |
Total minimum lease payments | 8,853 | 7,295 |
Less: Effects of discounting | (1,691) | (1,626) |
Present value of lease liabilities | 7,163 | 5,670 |
Less: current portion | (380) | (1,144) |
Long-term lease liabilities | 6,783 | 4,526 |
Real Estate [Member] | ||
Current portion | 430 | 1,205 |
Year 2 | 1,207 | 65 |
Year 3 | 1,252 | 421 |
Thereafter | 5,890 | 5,515 |
Total minimum lease payments | 8,778 | 7,205 |
Less: Effects of discounting | (1,679) | (1,617) |
Present value of lease liabilities | 7,099 | 5,588 |
Less: current portion | (339) | (1,072) |
Long-term lease liabilities | $ 6,760 | $ 4,516 |
Weighted average remaining lease term (years) | 7 years 10 months 24 days | 7 years 6 months 14 days |
Weighted average discount rate | 5.08% | 4.53% |
Other Asset [Member] | ||
Current portion | $ 50 | $ 79 |
Year 2 | 7 | 11 |
Year 3 | 7 | 0 |
Thereafter | 12 | 0 |
Total minimum lease payments | 75 | 90 |
Less: Effects of discounting | (12) | (9) |
Present value of lease liabilities | 64 | 82 |
Less: current portion | (41) | (72) |
Long-term lease liabilities | $ 23 | $ 10 |
Weighted average remaining lease term (years) | 7 days | 0 years |
Weighted average discount rate | 0.04% | 2.50% |
Lease contracts - Summary of Re
Lease contracts - Summary of Rent expenses (Detail) - Rent Expenses [Member] - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Operating lease expense / (income) | $ 1,255 | $ 1,543 |
Net termination impact | (70) | (92) |
Net restructuring impact | $ 0 | $ 0 |
Lease contracts - Summary of Su
Lease contracts - Summary of Supplemental cash flow information related to our operating leases (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash Flow, Operating Activities, Lessee [Abstract] | ||
Operating cash flows from operating leases | $ 1,019 | $ 963 |
Lease contracts - Additional in
Lease contracts - Additional information (Detail) $ in Millions | 3 Months Ended |
Jun. 30, 2024 USD ($) | |
Increase (Decrease) in Operating Lease Liability | $ 1.7 |
Trade payables and Other Liab_3
Trade payables and Other Liabilities - Summary of Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jul. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2023 |
Other current liabilities | $ 6,160 | $ 8,934 | |
Other non-current liabilities | 0 | 0 | |
Total | 6,160 | 8,934 | |
Employee Related Liabilities [Member] | |||
Other current liabilities | 5,530 | 7,828 | |
Other non-current liabilities | 0 | 0 | |
Total | 5,530 | 7,828 | |
Deferred Incomes [Member] | |||
Other current liabilities | $ 0 | 0 | |
Other non-current liabilities | 0 | 0 | |
Total | $ 0 | 0 | |
Tax Liabilities [Member] | |||
Other current liabilities | 203 | 223 | |
Other non-current liabilities | 0 | 0 | |
Total | 203 | 223 | |
Other Debts [Member] | |||
Other current liabilities | 427 | 883 | |
Other non-current liabilities | 0 | 0 | |
Total | $ 427 | $ 883 |
Shareholders' equity - Addition
Shareholders' equity - Additional Information (Detail) € / shares in Units, € in Thousands, $ in Thousands | Jun. 30, 2024 USD ($) shares | Jun. 30, 2024 EUR (€) € / shares shares | Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Class of Stock [Line Items] | |||||||
Share capital | $ | $ 79,095 | $ 111,654 | $ 140,187 | $ 164,240 | $ 179,094 | $ 194,453 | |
Share capital [Member] | |||||||
Class of Stock [Line Items] | |||||||
Share capital authorized | shares | 96,493,078 | 96,493,078 | |||||
Nominal value | € / shares | € 0.1 | ||||||
Share capital | $ 10,978 | € 9,649,308 |
Share-Based Payments - Summary
Share-Based Payments - Summary of RSU Activity (Detail) | 6 Months Ended |
Jun. 30, 2024 shares | |
BSA Warrants [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of warrants outstanding, Beginning Balance | 244,693 |
Number of warrants outstanding, Ending Balance | 244,693 |
Restricted Stock Units [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of RSU outstanding, Beginning Balance | 2,095,517 |
Number of RSU outstanding, Granted during the period | 124,000 |
Number of RSU outstanding, Forfeited during the period | 92,754 |
Number of RSU outstanding, Released during the period | (61,308) |
Number of RSU outstanding, Ending Balance | 2,065,455 |
Share-based Payment Arrangement, Option [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of stock options outstanding, Beginning Balance | 7,118,691 |
Number of stock options outstanding, Granted during the period | 534,000 |
Number of stock options outstanding, Forfeited during the period | 117,600 |
Number of stock options outstanding, Ending Balance | 7,535,091 |
Share-Based Payments - Summar_2
Share-Based Payments - Summary of Share-Based Payments Expenses (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | $ (1,525) | $ (1,814) | $ (3,483) | $ (3,447) |
Research and Development expenses [Member] | Share options [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (456) | (465) | (969) | (894) |
Research and Development expenses [Member] | Restricted Stock Units [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (241) | (271) | (497) | (529) |
Sales and Marketing expenses [Member] | Share options [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (20) | (27) | (43) | (54) |
Sales and Marketing expenses [Member] | Restricted Stock Units [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (9) | (8) | (18) | (17) |
General and Administrative expenses [Member] | Share options [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | (700) | (925) | (1,730) | (1,722) |
General and Administrative expenses [Member] | Restricted Stock Units [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based payments | $ (100) | $ (118) | $ (226) | $ (231) |
Share-Based Payments - Addition
Share-Based Payments - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2024 shares | |
Share options [Member] | |
Share-Based Payments [Line iteam] | |
Number of stock options outstanding, Granted during the period | 534,000 |
Restricted Stock Units [Member] | |
Share-Based Payments [Line iteam] | |
Number of RSU outstanding, Granted during the period | 124,000 |
Contingencies - Summary of Non
Contingencies - Summary of Non Current Contingencies and Current Contingencies (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Liability, Defined Benefit Plan [Abstract] | ||
Current contingencies | $ 1,023 | $ 3,959 |
Non-current contingencies | 931 | 935 |
Total contingencies | $ 1,953 | $ 4,894 |
Contingencies - Summary of Move
Contingencies - Summary of Movement in Contingencies (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Dec. 31, 2023 | |
Contingencies, Beginning balance | $ 4,894 | |
Increases in liabilities | 106 | |
Used liabilities | (2,288) | |
Reversals of unused liabilities | (652) | |
Net interest related to employee benefits, and unwinding of discount | 0 | |
Actuarial gains and losses on defined-benefit plans | (8) | |
Currency translation effect | (99) | |
Contingencies, Ending balance | 1,953 | |
Of which Current | 1,023 | $ 3,959 |
Of which Non-current | 931 | $ 935 |
Pension retirement obligations [Member] | ||
Contingencies, Beginning balance | 935 | |
Increases in liabilities | 33 | |
Used liabilities | 0 | |
Reversals of unused liabilities | 0 | |
Net interest related to employee benefits, and unwinding of discount | 0 | |
Actuarial gains and losses on defined-benefit plans | (8) | |
Currency translation effect | (29) | |
Contingencies, Ending balance | 931 | |
Of which Current | 0 | |
Of which Non-current | 931 | |
Collaboration agreement -Loss at completion [Member] | ||
Contingencies, Beginning balance | 2,100 | |
Increases in liabilities | 0 | |
Used liabilities | (1,158) | |
Reversals of unused liabilities | 0 | |
Net interest related to employee benefits, and unwinding of discount | 0 | |
Actuarial gains and losses on defined-benefit plans | 0 | |
Currency translation effect | (54) | |
Contingencies, Ending balance | 889 | |
Of which Current | 889 | |
Of which Non-current | 0 | |
Other provisions incl. restructuring [Member] | ||
Contingencies, Beginning balance | 1,859 | |
Increases in liabilities | 72 | |
Used liabilities | (1,130) | |
Reversals of unused liabilities | (652) | |
Net interest related to employee benefits, and unwinding of discount | 0 | |
Actuarial gains and losses on defined-benefit plans | 0 | |
Currency translation effect | (15) | |
Contingencies, Ending balance | 134 | |
Of which Current | 134 | |
Of which Non-current | $ 0 |
Contingencies - Additional Info
Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | ||
Jun. 30, 2024 | Jul. 30, 2024 | Dec. 31, 2023 | |
Accrued Contract Expenses | $ 0.9 | $ 2.1 | |
Montrouge [Member] | |||
Refurbishment Expense Reversal | $ 1.8 |
Operating Income - Summary of O
Operating Income - Summary of Operating Income (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Other Income and Expenses [Abstract] | ||||
Research tax credit | $ 1,161 | $ 1,975 | $ 2,568 | $ 3,741 |
Other operating income | 0 | 312 | 0 | 741 |
Total | $ 1,161 | $ 2,288 | $ 2,568 | $ 4,482 |
Operating Expenses - Summary of
Operating Expenses - Summary of Allocation of Personnel Expenses By Function (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Research and Development expenses | $ 25,374 | $ 17,616 | $ 46,777 | $ 33,653 |
Sales & Marketing expenses | 986 | 516 | 1,744 | 950 |
General & Administrative expenses | 8,643 | 9,231 | 16,447 | 16,120 |
Total Operating expenses | 35,003 | 27,364 | 64,968 | 50,723 |
Expenses by Function [Member] | ||||
Research and Development expenses | 5,177 | 4,014 | 10,225 | 8,020 |
Sales & Marketing expenses | 233 | 208 | 567 | 373 |
General & Administrative expenses | 3,413 | 2,858 | 6,650 | 5,958 |
Total Operating expenses | $ 8,824 | $ 7,079 | $ 17,442 | $ 14,351 |
Operating Expenses - Summary _2
Operating Expenses - Summary of Allocation of Personnel Expenses By Nature (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based payments | $ (1,525) | $ (1,814) | $ (3,483) | $ (3,447) | ||
Total Operating expenses | $ 35,003 | $ 27,364 | 64,968 | 50,723 | ||
Expenses by Nature [Member] | ||||||
Wages and salaries | 5,540 | 4,078 | 10,684 | 8,516 | ||
Social security contributions | 1,515 | 1,185 | 2,722 | 1,884 | ||
Expenses for pension commitments | 244 | 246 | 553 | 504 | ||
Employer contribution to bonus shares | 0 | (244) | 0 | 0 | ||
Share-based payments | 1,525 | 1,814 | 3,483 | 3,446 | ||
Total Operating expenses | $ 8,824 | $ 7,079 | $ 17,442 | $ 14,351 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
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) $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Related Party Transactions [Abstract] | |
Increase decrease in related party transactions and changes in nature of the transactions | $ 0 |
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 (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
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 | 244,693 | 251,693 | 244,693 | 251,693 |
Stock options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 7,535,091 | 5,290,569 | 7,535,091 | 5,290,569 |
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 | 2,188,071 | 1,509,078 | 2,188,071 | 1,509,078 |
Prefunded warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 28,276,331 | 28,276,331 | 28,276,331 | 28,276,331 |