| ☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
2023
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
92120
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
American Depositary Shares, each representing one-half of one ordinary share, nominal value€0.10 per share | DBVT | The Nasdaq Stock Market LLC | ||
Ordinary shares, nominal value €0.10 per share* | n/a | The Nasdaq Stock Market LLC |
| * | Not for trading, but only in connection with the registration of the American Depositary Shares. |
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |||
| Emerging growth company | ☐ | |||||
Part I | 1 | |||||
Item 1 | 1 | |||||
| 2 | ||||||
| 3 | ||||||
| 4 | ||||||
Notes to the Condensed Consolidated Financial Statements (Unaudited) | 5 | |||||
Item 2 | Management’s Discussion and Analysis of Financial Condition and Results of Operations | |||||
Item 3 | ||||||
Item 4 | ||||||
Part II | ||||||
Item 1 | ||||||
Item 1A | ||||||
Item 2 | ||||||
Item 3 | ||||||
Item 4 | �� | |||||
Item 5 | ||||||
Item 6 | ||||||
Unless the context otherwise requires, we use the terms “DBV”, “DBV Technologies,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q, or Quarterly Report, to refer to DBV Technologies S.A. and, where appropriate, its consolidated subsidiaries. “Viaskin™”, “EPIT™” and our other registered and common law trade names, trademarks and service marks are the property of DBV Technologies S.A. or our subsidiaries. All other trademarks, trade names and service marks appearing in this Quarterly Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.
SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS.
This Quarterly Report on Form 10-Q (“Form 10-Q”) contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things:
statements regarding the impact of the ongoing COVID-19 pandemic and its effects on our operations, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations, other service providers and collaborators with whom we conduct business;
| • | our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated re-submission of a Biologics License Application, or a BLA, for ViaskinTMPeanut to the U.S. Food and Drug |
the initiation, timing progress and anticipated results of our pre-clinical studies and clinical trials, and our research and development programs;interactions with regulatory agencies;
| • | the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs; |
the sufficiency of existing capital resources;
the implementation of our global restructuring plan, our business model and our other strategic plans for our business, product candidates and technology;
our ability to manufacture clinical and commercial supplies of our product candidates and comply with regulatory requirements related to the manufacturing of our product candidates;
our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize Viaskin Peanut and/or our other product candidates, if approved;
the commercialization of our product candidates, if approved;
our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut and/or our other product candidates, if approved, and our ability to serve such markets;
the pricing and reimbursement of our product candidates, if approved;
the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by physicians, patients, third-party payors and others in the medical community;
our ability to advance product candidates into, and successfully complete, clinical trials;
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
estimates of our expenses, future revenues, capital requirements and our needs for additional financing;
the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements;
our ability to maintain and establish collaborations or obtain additional grant funding;
1
our financial performance;
developments relating to our competitors and our industry, including competing therapies;
the impact of the COVID-19 pandemic and its effects on our operations, research and development, clinical trials and ability to obtain financing and potential disruption in the operations and business of third-party manufacturers, contract research organizations, or CROs, other service providers and collaborators with whom we conduct business; and
other risks and uncertainties, including those listed under the caption “Risk Factors.”
Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, on Form 10-Q, these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. These risks, uncertainties and other factors are described in greater detail under the caption “Risk Factors” in Part I. Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020,2022, filed with the Securities and Exchange Commission, (“SEC”)or the SEC on March 17, 2021.2, 2023. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement. We qualify all of our forward-looking statements by these cautionary statements.
In addition, any forward-looking statement in this AnnualQuarterly Report, including statements that “we believe” and similar statements, reflect our beliefs and opinions on the relevant subject and represents our views only as of the date of this annual reportQuarterly Report and should not be relied upon as representing our views as of any subsequent date. These statements are based upon information available to us as of the date of this Quarterly Report and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
2
Assets Current assets : Cash and cash equivalents Trade receivables Other current assets Total current assets Property, plant, and equipment, net Right-of-use assets related to operating leases Intangible assets Other non-current assets Total non-current assets Total Assets Liabilities and shareholders’ equity Current liabilities: Trade payables Short-term operating leases Short-term financial debt Current contingencies Other current liabilities Total current liabilities Long-term operating leases Long-term financial debt Non-current contingencies Other non-current liabilities Total non-current liabilities Total Liabilities Shareholders’ equity : Ordinary shares, €0.10 par value; 54,936,687 and 54,929,187 shares authorized, and issued as at March 31, 2021 and December 31, 2020, respectively, and 4,100,663 and 4,029,763 shares outstanding as at March 31, 2021 and December 31, 2020, respectively Additional paid-in capital Treasury stock, 60,588 and 112,302 ordinary shares as of March 31, 2021 and December 31, 2020, respectively, at cost Accumulated deficit Accumulated other comprehensive income Accumulated currency translation effect Total Shareholders’ equity Total Liabilities and Shareholder’s equity – - March 31, December 31, Note 2021 2020 3 $ 152,459 $ 196,352 — 2,230 7,349 8,792 159,809 207,375 21,526 24,792 9,168 10,104 32 41 30,870 29,935 61,596 64,871 $ 221,405 $ 272,246 4 $ 17,176 $ 20,338 3,314 3,708 701 724 6 4,246 5,016 4 13,394 22,926 38,831 52,713 9,533 10,496 350 543 6 2,229 2,527 1,286 475 13,398 14,042 $ 52,229 $ 66,754 $ 6,519 $ 6,518 1,153,516 1,152,042 (681 ) (1,169 ) (987,992 ) (958,543 ) 399 484 (2,586 ) 6,158 $ 169,176 $ 205,491 $ 221,405 $ 272,246 Cash and cash equivalents $ 192,289 $ 209,194 Other current assets 17,946 13,880 Property, plant, and equipment, net 14,786 15,096 2,127 2,513 Intangible assets 10 10 5,771 5,824 Trade payables $ 19,938 $ 14,473 Short-term operating leases 1,923 1,894 Current contingencies 4,142 3,944 Other current liabilities 6,776 9,210 Long-term operating leases 680 1,127 15,989 16,680 4,387 4,735 Ordinary shares, €0.10 par value; 94,147,319 and 94,137,145 shares authorized, and issued as of March 31, 2023 and December 31, 2022, respectively $ 10,721 $ 10,720 459,852 458,221 Treasury stock, 157,654 and 149,793 ordinary shares as of March 31, 2023 and December 31, 2022, respectively, at cost (1,123 ) (1,109 ) Accumulated deficit (280,138 ) (259,578 ) Accumulated other comprehensive income 698 781 Accumulated currency translation effect (10,915 ) (14,581 )
| Three Months Ended March 31, | ||||||||||
| Note | 2021 | 2020 | ||||||||
Operating income | 7 | $ | 2,941 | $ | 4,720 | |||||
Operating expenses | ||||||||||
Research and development expenses | (22,164 | ) | (27,532 | ) | ||||||
Sales and marketing expenses | (729 | ) | (7,297 | ) | ||||||
General and administrative expenses | (9,683 | ) | (11,113 | ) | ||||||
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Total Operating expenses | (32,575 | ) | (45,942 | ) | ||||||
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| |||||||
Loss from operations | (29,634 | ) | (41,222 | ) | ||||||
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| |||||||
Financial income | 215 | 309 | ||||||||
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| |||||||
Loss before taxes | (29,419 | ) | (40,913 | ) | ||||||
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| |||||||
Income tax | (30 | ) | — | |||||||
|
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| |||||||
Net loss | $ | (29,449 | ) | $ | (40,913 | ) | ||||
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| |||||||
Other comprehensive loss | ||||||||||
Foreign currency translation differences, net of taxes | (8,744 | ) | (6,064 | ) | ||||||
Actuarial (losses) gains on employee benefits, net of taxes | (85 | ) | 189 | |||||||
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| |||||||
Comprehensive loss | $ | (38,279 | ) | $ | (46,788 | ) | ||||
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Basic/diluted Net loss per share attributable to shareholders | 11 | $ | (0.54 | ) | $ | (0.79 | ) | |||
Weighted average shares outstanding used in computing per share amounts: | 54,880,776 | 51,802,524 | ||||||||
Three Months Ended March 31, | ||||||||||
Note | 2023 | 2022 | ||||||||
Operating income | 10 | $ | 2,194 | $ | 2,546 | |||||
Operating expenses | ||||||||||
| Research and development expenses | (16,037 | ) | (12,223 | ) | ||||||
| Sales and marketing expenses | (434 | ) | (464 | ) | ||||||
| General and administrative expenses | (6,889 | ) | (6,630 | ) | ||||||
Total Operating expenses | (23,359 | ) | (19,317 | ) | ||||||
Loss from operations | (21,165 | ) | (16,771 | ) | ||||||
| Financial income(expenses) | 605 | 152 | ||||||||
Loss before taxes | (20,561 | ) | (16,619 | ) | ||||||
| Income tax (expense) | — | (87 | ) | |||||||
Net loss | $ | (20,561 | ) | $ | (16,706 | ) | ||||
| Foreign currency translation differences, net of taxes | 3,666 | (1,933 | ) | |||||||
| Actuarial gains (losses) on employee benefits, net of taxes | (82 | ) | 24 | |||||||
Total comprehensive loss | $ | (16,977 | ) | $ | (18,615 | ) | ||||
| Basic/diluted Net loss per share attributable to shareholders | 14 | $ | (0.22 | ) | $ | (0.30 | ) | |||
| Weighted average shares outstanding used in computing per share amounts: | 93,970,598 | 54,932,192 | ||||||||
| Three Months Ended March 31, | ||||||||||||
| Notes | 2021 | 2020 | ||||||||||
Net loss for the period | $ | (29,449 | ) | $ | (40,913 | ) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
Depreciation, amortization and accrued contingencies | 1,483 | 1,548 | ||||||||||
Retirement pension obligations | — | 109 | ||||||||||
Expenses related to share-based payments | 1,433 | 3,073 | ||||||||||
Other elements | (456 | ) | 419 | |||||||||
Changes in operating assets and liabilities: | ||||||||||||
Decrease (increase) in inventories and work in progress | — | (2,402 | ) | |||||||||
Decrease (increase) in trade receivables | 2,101 | — | ||||||||||
Decrease (increase) in other current assets | (417 | ) | 122 | |||||||||
(Decrease) increase in trade payables | (2,567 | ) | (3,212 | ) | ||||||||
(Decrease) increase in other current and non-current liabilities | (7,980 | ) | (8,382 | ) | ||||||||
Change in operating lease liabilities and right of use assets | (353 | ) | (45 | ) | ||||||||
Net cash flow used in operating activities | (36,204 | ) | (49,683 | ) | ||||||||
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Cash flows used in investing activities: | ||||||||||||
Acquisitions of property, plant, and equipment, net from proceeds | (184 | ) | (816 | ) | ||||||||
Acquisitions of intangible assets | — | (114 | ) | |||||||||
Acquisitions of non-current financial assets | (1 | ) | — | |||||||||
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Net cash flows used in investing activities | (185 | ) | (930 | ) | ||||||||
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Cash flows provided by financing activities: | ||||||||||||
(Decrease) increase in conditional advances | (164 | ) | 7 | |||||||||
Treasury shares | 578 | (412 | ) | |||||||||
Capital increases, net of transaction costs | 42 | 151,023 | ||||||||||
Other cash flows related to financing activities | (17 | ) | (7 | ) | ||||||||
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Net cash flows provided by financing activities | 440 | 150,611 | ||||||||||
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Effect of exchange rate changes on cash and cash equivalents | (7,944 | ) | (5,811 | ) | ||||||||
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Net (decrease) / increase in cash and cash equivalents | (43,893 | ) | 94,187 | |||||||||
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Net Cash and cash equivalents at the beginning of the period | 196,352 | 193,255 | ||||||||||
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Net cash and cash equivalents at the end of the period | 3 | $ | 152,459 | $ | 287,442 | |||||||
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Three Months Ended March 31, | ||||||||||
Notes | 2023 | 2022 | ||||||||
Net loss for the period | $ | (20,561 | ) | $ | (16,706 | ) | ||||
Adjustments to reconcile net loss to net cash flow provided by (used in) operating activities: | ||||||||||
| Depreciation, amortization and accrued contingencies | (228 | ) | (599 | ) | ||||||
| Retirement pension obligations | (35 | ) | (9 | ) | ||||||
| Expenses related to share-based payments | 8 | 1,632 | 1,363 | |||||||
| Other elements | — | (3 | ) | |||||||
Changes in operating assets and liabilities: | ||||||||||
| Decrease (increase) in other current assets | (3,098 | ) | 20,458 | |||||||
| (Decrease) increase in trade payables | 4,478 | (19 | ) | |||||||
(Decrease) increase in other current and non-current liabilities | (2,989 | ) | (4,118 | ) | ||||||
| Change in operating lease liabilities and right of use assets | (42 | ) | (1,849 | ) | ||||||
| Net cash flow provided by (used in) operating activities | (20,841 | ) | (1,483 | ) | ||||||
| Cash flows provided by (used in) investing activities: | ||||||||||
| Acquisitions of property, plant, and equipment | (111 | ) | (131 | ) | ||||||
| Proceeds from property, plant, and equipment dispositions | — | 3 | ||||||||
Acquisitions of non-current financial assets | — | (40 | ) | |||||||
Proceeds from non-current financial assets dispositions | 153 | 179 | ||||||||
| Net cash flows provided by (used in) investing activities | 42 | 11 | ||||||||
| Cash flows provided by (used in) financing activities: | ||||||||||
| (Decrease) increase in conditional advances | — | (168 | ) | |||||||
| Treasury shares | (14 | ) | 40 | |||||||
| Net cash flows provided by (used in) financing activities | (14 | ) | (129 | ) | ||||||
| Effect of exchange rate changes on cash and cash equivalents | 3,909 | (1,594 | ) | |||||||
Net increase (decrease) in cash and cash equivalents | (16,905 | ) | (3,194 | ) | ||||||
| Net Cash and cash equivalents at the beginning of the period | 209,194 | 77,301 | ||||||||
Net cash and cash equivalents at the end of the period | 3 | $ | 192,289 | $ | 74,107 | |||||
| Ordinary shares | ||||||||||||||||||||||||||||||||
| Number of Shares | Amount | Additional paid-in capital | Treasury stock | Accumulated deficit | Accumulated other comprehensive income (loss) | Accumulated currency translation effect | Total Shareholders’ Equity | |||||||||||||||||||||||||
Balance at January 1, 2020 | 47,028,510 | $ | 5,645 | $ | 1,003,595 | $ | (230 | ) | $ | (798,988 | ) | $ | 108 | $ | (16,945 | ) | $ | 193,186 | ||||||||||||||
Net (loss) | — | — | — | — | (40,913 | ) | — | — | (40,913 | ) | ||||||||||||||||||||||
Other comprehensive income (loss) | — | — | — | — | — | 189 | (6,064 | ) | (5,875 | ) | ||||||||||||||||||||||
Issuance of ordinary shares | 7,898,677 | 873 | 150,150 | — | — | — | — | 151,023 | ||||||||||||||||||||||||
Treasury shares | — | — | — | (832 | ) | — | — | — | (832 | ) | ||||||||||||||||||||||
Share-based payments | — | — | 3,073 | — | — | — | 3,073 | |||||||||||||||||||||||||
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Balance at March 31, 2020 | 54,927,187 | $ | 6,518 | $ | 1,156,818 | $ | (1,062 | ) | $ | (839,901 | ) | $ | 297 | $ | (23,009 | ) | $ | 299,662 | ||||||||||||||
| Ordinary shares | ||||||||||||||||||||||||||||||||
| Number of Shares | Amount | Additional paid-in capital | Treasury stock | Accumulated deficit | Accumulated other comprehensive gain (loss) | Accumulated currency translation effect | Total Shareholders’ Equity | |||||||||||||||||||||||||
Balance at January 1, 2021 | 54,929,187 | $ | 6,518 | $ | 1,152,042 | $ | (1,169 | ) | $ | (958,543 | ) | $ | 484 | $ | 6,158 | $ | 205,491 | |||||||||||||||
Net (loss) | — | — | — | — | (29,449 | ) | — | — | (29,449 | ) | ||||||||||||||||||||||
Other comprehensive (loss) | — | — | — | — | — | (85 | ) | (8,744 | ) | (8,829 | ) | |||||||||||||||||||||
Issuance of ordinary shares | 7 500 | 1 | 42 | — | — | — | — | 42 | ||||||||||||||||||||||||
Treasury shares | — | — | — | 488 | — | — | — | 488 | ||||||||||||||||||||||||
Share-based payments | — | — | 1,433 | — | — | — | — | 1,433 | ||||||||||||||||||||||||
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Balance at March 31, 2021 | 54,936,687 | $ | 6,519 | $ | 1,153,516 | $ | (681 | ) | $ | (987,992 | ) | $ | 399 | $ | (2,586 | ) | $ | 169,176 | ||||||||||||||
Ordinary shares | ||||||||||||||||||||||||||||||||
Number of Shares | Amount | Additional paid-in capital | Treasury stock | Accumulated deficit | Accumulated other comprehensive income (loss) | Accumulated currency translation effect | Total Shareholders’ Equity | |||||||||||||||||||||||||
Balance at January 1, 2022 | 55,095,762 | $ | 6,538 | $ | 358,115 | $ | (1,232 | ) | $ | (258,528 | ) | $ | 519 | $ | (6,137 | ) | $ | 99,274 | ||||||||||||||
Net (loss) | — | — | — | — | (16,706 | ) | — | — | (16,706 | ) | ||||||||||||||||||||||
Other comprehensive income (loss) | — | — | — | — | — | 24 | (1,933 | ) | (1,909 | ) | ||||||||||||||||||||||
Insuance of ordinary shares | 775 | 1 | — | — | — | — | — | 1 | ||||||||||||||||||||||||
Treasury shares | — | — | — | 40 | — | — | — | 40 | ||||||||||||||||||||||||
Share-based payments | — | — | 1,363 | — | — | — | — | 1,363 | ||||||||||||||||||||||||
Other change in equity | — | — | — | — | 15 | (15 | ) | — | ||||||||||||||||||||||||
Balance at March 31, 2022 | 55,096,537 | $ | 6,539 | $ | 359,478 | $ | (1,193 | ) | $ | (275,219 | ) | $ | 543 | $ | (8,086 | ) | $ | 82,062 | ||||||||||||||
Ordinary shares | ||||||||||||||||||||||||||||||||
Number of Shares | Amount | Additional paid-in capital | Treasury stock | Accumulated deficit | Accumulated other comprehensive income (loss) | Accumulated currency translation effect | Total Shareholders’ Equity | |||||||||||||||||||||||||
Balance at January 1, 2023 | 94,137,145 | $ | 10,720 | $ | 458,221 | $ | (1,109 | ) | $ | (259,578 | ) | $ | 781 | $ | (14,581 | ) | $ | 194,453 | ||||||||||||||
Net (loss) | — | — | — | — | (20,561 | ) | — | — | (20,561 | ) | ||||||||||||||||||||||
Other comprehensive income (loss) | — | — | — | — | — | (82 | ) | 3,666 | 3,584 | |||||||||||||||||||||||
Insuance of ordinary shares | 10 174 | 1 | (1 | ) | — | — | — | — | — | |||||||||||||||||||||||
Treasury shares | — | — | — | (14 | ) | — | — | — | (14 | ) | ||||||||||||||||||||||
Share-based payments | — | — | 1,632 | — | — | — | — | 1,632 | ||||||||||||||||||||||||
Balance at March 31, 2023 | 94,147,319 | $ | 10,721 | $ | 459,852 | $ | (1,123 | ) | $ | (280,138 | ) | $ | 698 | $ | (10,915 | ) | $ | 179,094 | ||||||||||||||
2022.
Going concern
Since its inception, the Company has primarily funded its operations with equity financings,contingencies 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(8) estimate of its first product in the United States and in the European Union, if approved.
Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its Biologics License Application (“BLA”) for Viaskin™ Peanut, beginning in August 2020, the Company scaled down its other clinical programs and pre-clinical spend to focus on Viaskin™ Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin™ Peanut in the United States and European Union. Based on guidance received from the FDA in January 2021, the Company’s plans to implement such guidance, and expected cost savings from implementation of the global restructuring plan, the Company expects that its current balance of cash and cash equivalents of $152.5 million as of March 31, 2021 will be sufficient to fund its operations for at least the next 12 months.
The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings. As a result of disruptions to the global financial markets as a result of the ongoing COVID-19 pandemic, the Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions. The ongoing COVID-19 pandemic has already caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.
Effective January 1, 2021, the Company adopted ASU 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. The adoption of ASU 2019-12 did not have a material impact on the Company’s financial position or results of operations.
Accounting Pronouncements issued not yet adopted
2023
In January 2017, the FASB
yet adopted
ViaskinTM Peanut for children ages 4-11
In February 2020, the FDA announced an Allergenic Products Advisory Committee meeting to be held on May 15, 2020 to discuss the Biologics License Application (BLA) for Viaskin Peanut. On March 16, 2020, the Company announced that the FDA had informed us that during its ongoing review of the 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.
On August 4, 2020, the Company announced that FDA has issued a Complete Response Letter in which the FDA indicated it could not approve the Viaskin Peanut BLA in its current form. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study. The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data. The FDA did not raise any safety concerns related to Viaskin Peanut.
On January 13, 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. The Company believes the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, the Company proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications.Complete Response Letter. The FDA agreed with the Company’sits 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 order to confirm the consistency of efficacy data between the existing and a modified patches, thepatch, FDA has
requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years.4-11. The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess thea modified Viaskin Peanut patch in the intended patient population.
The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.
| 1. | Identify a modified Viaskin patch (which the Company calls “mVP”). |
| 2. | Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible. |
| 3. | Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional Phase 1 clinical trials in healthy adult volunteers: |
| a. | PREQUAL, a Phase 1 study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL. The data collection phase of the trial is complete, and the data analysis phase is ongoing. |
| b. | ‘EQUAL in adults’—a second Phase 1 trial with adult healthy volunteers to compare the allergen uptake of cVP and mVP; |
available.
On
Financing
revised trial protocol.
Consequently, following partial exercise of the Option, the total number of ordinary shares soldtopline results in the global offering was 7,838,687 ordinary shares, including 4,874,268 ordinary sharesfirst half in 2025.
Restructuring
our business activities. The Company initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanut in the United States and European Union. The Company expects full implementation of the organization-wide costs reduction measures to be completed by the second half of 2021.
The following table summarizes restructuring activities as of March 31, 2021 included in current contingencies and other current liabilities in the statement of financial position:
| ||||
| ||||
| ||||
| ||||
| ||||
| ||||
COVID-19 Pandemic
On March 11, 2020, the World Health Organization declared COVID-19 a pandemic. This global health crisis led many countries to impose national containment measures and travel bans. In view of this exceptional situation, the Company decided to take all measures
aimed primarily at guaranteeing the safety of its employees and the continuation of ongoing clinical trials, in compliance with the directives of the authorities in each country. The Company has experienced a decrease in new patients enrolling in the ongoing clinical studies and it has had to adapt the protocols of its clinical trials because patients remainis not currently subject to travel restrictions.
The Company has assessed the impactany material legal proceedings.
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
Cash | 58,069 | 42,341 | ||||||
Cash equivalents | 94,390 | 154,011 | ||||||
|
|
|
| |||||
Total cash and cash equivalents as reported in the statements of financial position | 152,459 | 196,352 | ||||||
|
|
|
| |||||
equivalents as of March 31, 2023 and December 31, 2022:
March 31, | December 31, | |||||||
2023 | 2022 | |||||||
Cash | 36,811 | 30,104 | ||||||
Cash equivalents | 155,478 | 179,090 | ||||||
Total cash and cash equivalents as reported in the statements of financial position | 192,289 | 209,194 | ||||||
Bank overdrafts | — | — | ||||||
Total cash and cash equivalents as reported in the statements of cash flows | 192,289 | 209,194 | ||||||
March 31, | December 31, | |||||||
2023 | 2022 | |||||||
Research tax credit | 7,695 | 5,792 | ||||||
Other tax claims | 5,109 | 3,903 | ||||||
Prepaid expenses | 2,352 | 2,680 | ||||||
Other receivables | 2,790 | 1,504 | ||||||
Total | 17,946 | 13,880 | ||||||
Amount in thousands of US Dollars | ||||
Opening research tax credit receivable as of January 1, 2023 | 5,792 | |||
+ Operating revenue | 1,765 | |||
- Payment received | — | |||
- Adjustment and currency translation effect | 138 | |||
Closing research tax credit receivable as of March 31, 2023 | 7,695 | |||
Of which - Non-current portion | — | |||
Of which - Current portion | 7,695 | |||
March 31, 2023 | December 31, 2022 | |||||||||||||||||||||||
Real estate | Other assets | Total | Real estate | Other assets | Total | |||||||||||||||||||
Current portion | 1,917 | 76 | 1,993 | 1,972 | 79 | 2,051 | ||||||||||||||||||
Year 2 | 746 | 63 | 809 | 1,168 | 74 | 1,243 | ||||||||||||||||||
Year 3 | 26 | — | 26 | 65 | 6 | 71 | ||||||||||||||||||
Thereafter | — | — | — | — | — | — | ||||||||||||||||||
Total minimum lease payments | 2,689 | 139 | 2,828 | 3,204 | 160 | 3,364 | ||||||||||||||||||
Less: Effects of discounting | (209 | ) | (14 | ) | (225 | ) | (325 | ) | (17 | ) | (343 | ) | ||||||||||||
Present value of operating lease | 2,480 | 125 | 2,603 | 2,879 | 143 | 3,021 | ||||||||||||||||||
Less: current portion | (1,852 | ) | (72 | ) | (1,923 | ) | (1,823 | ) | (71 | ) | (1,894 | ) | ||||||||||||
Long-term operating lease | 628 | 53 | 680 | 1,055 | 72 | 1,127 | ||||||||||||||||||
Weighted average remaining lease term (years) | 1.18 | — | 1.40 | — | ||||||||||||||||||||
Weighted average discount rate | 2.93 | % | 2.45 | % | 3.00 | % | 2.45 | % | ||||||||||||||||
March 31, | ||||||||
2023 | 2022 | |||||||
Operating lease expense / (income) | 446 | 507 | ||||||
Net termination impact | (81 | ) | (1,657 | ) | ||||
March 31 | ||||||||
2023 | 2022 | |||||||
Cash paid for amounts included in the measurement of lease liabilities | ||||||||
Operating cash flows for operating leases | 496 | 583 | ||||||
4.1
4.2
Other current
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
Employee related liabilities | 9,245 | 16,661 | ||||||
Deferred income | 3,378 | 4,687 | ||||||
Tax liabilities | 312 | 580 | ||||||
Other debts | 460 | 999 | ||||||
|
|
|
| |||||
Total | 13,394 | 22,926 | ||||||
|
|
|
| |||||
March 31 | December 31, | |||||||||||||||||||||||
2023 | 2022 | |||||||||||||||||||||||
Other current liabilities | Other non- current liabilities | Total | Other current liabilities | Other non- current liabilities | Total | |||||||||||||||||||
Employee related liabilities | 4,189 | 11 | 4,200 | 5,872 | 45 | 5,917 | ||||||||||||||||||
Deferred income | 2 193 | 4 375 | 6,568 | 2,137 | 4,690 | 6,828 | ||||||||||||||||||
Tax liabilities | 97 | — | 97 | 69 | — | 69 | ||||||||||||||||||
Other debts | 297 | — | 297 | 1,131 | — | 1,131 | ||||||||||||||||||
Total | 6 776 | 4 387 | 11,162 | 9,210 | 4,735 | 13,945 | ||||||||||||||||||
stock units to employees.
| ||||
| ||||
| ||||
| ||||
| ||||
| ||||
| ||||
| Number of outstanding | ||||||||||||||||
| BSA | BCE | SO | RSUs | |||||||||||||
Balance as of December 31, 2020 | 218,008 | 5,500 | 2,610,510 | 1,118,745 | ||||||||||||
Granted during the period | — | — | 75,600 | 24,900 | ||||||||||||
Forfeited during the period | — | — | (15,400 | ) | (13,700 | ) | ||||||||||
Exercised/released during the period | — | (500 | ) | — | — | |||||||||||
Expired during the period | — | — | — | — | ||||||||||||
|
|
|
|
|
|
|
| |||||||||
Balance as of March 31, 2021 | 218,008 | 5 000 | 2,670,710 | 1,129,945 | ||||||||||||
|
|
|
|
|
|
|
| |||||||||
Reconciliation of the share-based
Number of outstanding | ||||||||||||
BSA | SO | RSUs | ||||||||||
Balance as of December 31, 2022 | 251,693 | 5,306,569 | 1,589,081 | |||||||||
Granted during the period | — | 59,200 | 35,800 | |||||||||
Forfeited during the period | — | (47,200 | ) | (30,769 | ) | |||||||
Exercised/released during the period | — | — | (10,174 | ) | ||||||||
Expired during the period | — | — | — | |||||||||
Balance as of March 31, 2023 | 251,693 | 5,318,569 | 1,583,938 | |||||||||
| Three Months Ended March 31, | ||||||||||||
| 2021 | 2020 | |||||||||||
Research and development | SO | (376 | ) | (876 | ) | |||||||
| RSU | (251 | ) | (392 | ) | ||||||||
Sales and marketing | SO | (49 | ) | (598 | ) | |||||||
| RSU | (22 | ) | (2 | ) | ||||||||
General and administrative | SO | (644 | ) | (1,071 | ) | |||||||
| RSU | (91 | ) | (133 | ) | ||||||||
|
|
|
| |||||||||
Total share-based compensation expense | (1,433 | ) | (3,073 | ) | ||||||||
|
|
|
| |||||||||
Note 6: Contingencies
Current contingencies and non-current contingencies break down is as follows:
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
Current contingencies | 4,246 | 5,016 | ||||||
Non-current contingencies | 2,229 | 2,527 | ||||||
|
|
|
| |||||
Total contingencies | 6,474 | 7,542 | ||||||
|
|
|
| |||||
Three Months Ended March 31, | ||||||||||||
2023 | 2022 | |||||||||||
Research & development | SO | (429 | ) | (375 | ) | |||||||
| RSU | (258 | ) | (208 | ) | ||||||||
Sales & marketing | SO | (27 | ) | 5 | ||||||||
| RSU | (8 | ) | 1 | |||||||||
General & administrative | SO | (797 | ) | (698 | ) | |||||||
| RSU | (113 | ) | (87 | ) | ||||||||
Total share-based compensation (expense) | (1,632 | ) | (1,363 | ) | ||||||||
March 31, | December 31, | |||||||
2023 | 2022 | |||||||
Current contingencies | 4,142 | 3,944 | ||||||
Non-current contingencies | 15,989 | 16,680 | ||||||
Total contingencies | 20,131 | 20,625 | ||||||
| Pension retirement obligations | Collaboration agreement - Loss at completion | Other contingencies | Total | |||||||||||||
At January 1, 2021 | 937 | 3,956 | 2,649 | 7,542 | ||||||||||||
Increases in liabilities | — | — | — | — | ||||||||||||
Used liabilities | — | (434 | ) | (515 | ) | (949 | ) | |||||||||
Reversals of unused liabilities | — | — | — | — | ||||||||||||
Net interest related to employee benefits, and unwinding of discount | — | — | — | — | ||||||||||||
Actuarial gains and losses on defined-benefit plans | 85 | — | — | 85 | ||||||||||||
Other effects including currency translation effect | (44 | ) | (164 | ) | 4 | (204 | ) | |||||||||
|
|
|
|
|
|
|
| |||||||||
At March 31, 2021 | 978 | 3,358 | 2,139 | 6,474 | ||||||||||||
|
|
|
|
|
|
|
| |||||||||
Of which current | — | 2,107 | 2,139 | 4,246 | ||||||||||||
Of which non-current | 978 | 1,251 | — | 2,229 | ||||||||||||
contingencies are as follows:
Pension retirement obligations | Collaboration agreement - Loss at completion | Other contingencies | Total | |||||||||||||
At January 1, 2023 | 790 | 19,835 | — | 20,625 | ||||||||||||
Increases in liabilities | — | — | 170 | 170 | ||||||||||||
Used liabilities | — | — | — | — | ||||||||||||
Reversals of unused liabilities | (35 | ) | (1,103 | ) | — | (1,138 | ) | |||||||||
Net interest related to employee benefits, and unwinding of discount | — | — | — | — | ||||||||||||
Actuarial gains and losses on defined-benefit plans | 82 | — | — | 82 | ||||||||||||
Currency translation effect | 16 | 374 | 2 | 392 | ||||||||||||
At March 31, 2023 | 853 | 19,106 | 172 | 20,131 | ||||||||||||
Of which Current | — | 3,970 | 172 | 4,142 | ||||||||||||
Of which Non-current | 853 | 15,135 | — | 15,989 | ||||||||||||
Other contingencies are primarily composed
periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 1513 to the consolidated financial statements included in the Annual Report.
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
Research tax credit | 1,807 | 2,902 | ||||||
Other operating income | 1,133 | 1,818 | ||||||
|
|
|
| |||||
Total | 2,941 | 4,720 | ||||||
|
|
|
| |||||
As ofthree months ended March 31, 2021, the Company recorded its collaboration contract’s income based on its updated measurement2023 and 2022:
Three Months Ended March 31, | ||||||||
2023 | 2022 | |||||||
Research tax credit | 1,765 | 1,569 | ||||||
Other operating income | 429 | 976 | ||||||
Total | 2,194 | 2,546 | ||||||
Allocation2022.
Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
Research and development expenses | 4,718 | 10,204 | ||||||
Sales and marketing expenses | 518 | 4,197 | ||||||
General and administrative expenses | 3,766 | 4,283 | ||||||
|
|
|
| |||||
Total personnel expenses | 9,002 | 18,684 | ||||||
|
|
|
| |||||
Allocationfunction during the three ended March 31, 2023 and 2022:
Three Months Ended March 31, | ||||||||
2023 | 2022 | |||||||
Research and Development expenses | 4,006 | 3,075 | ||||||
Sales and Marketing expenses | 165 | 245 | ||||||
General and Administrative expenses | 3,100 | 2,595 | ||||||
Total personnel expenses | 7,272 | 5,915 | ||||||
Three months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
Wages and salaries | 4,454 | 12,872 | ||||||
Social security contributions | 1,332 | 663 | ||||||
Expenses for pension commitments | 402 | 915 | ||||||
Employer contribution to bonus shares | 1,381 | 1,162 | ||||||
Share-based payments | 1,433 | 3,073 | ||||||
|
|
|
| |||||
Total personnel expenses | 9,002 | 18,684 | ||||||
|
|
|
| |||||
nature during the three months ended March 31, 2023 and 2022:
Three Months Ended March 31, | ||||||||
2023 | 2022 | |||||||
Wages and salaries | 4,438 | 3,987 | ||||||
Social security contributions | 699 | 251 | ||||||
Expenses for pension commitments | 258 | 297 | ||||||
Employer contribution to bonus shares | 244 | 16 | ||||||
Share-based payments | 1,632 | 1,363 | ||||||
Total | 7,272 | 5,915 | ||||||
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
Non-employee warrants | 225,008 | 225,008 | ||||||
Employee warrants | 75,000 | 82,500 | ||||||
Stock-options | 2,670,710 | 2 835,635 | ||||||
Restricted stock units | 1,129,945 | 696,895 | ||||||
Three Months Ended March 31, | ||||||||
2023 | 2022 | |||||||
Non-employee warrants | 251,693 | 256,693 | ||||||
Stock options | 5,318,569 | 3,471,808 | ||||||
Restricted stock units | 1,583,938 | 1,183,633 | ||||||
Prefunded warrants | 28,276,331 | — | ||||||
|
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2020,2022, included in our Annual Report on Form 10-K for the year ended December 31, 2020,2022, filed with the Securities and Exchange Commission on March 17, 2021,2, 2023, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report.
Overview
We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy, or EPITTM™, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, as itdifferentiated. Viaskin targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat patients, including infants and children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved.
Our most advanced clinical program is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in nine clinical trials, including four Phase 2 trials and three completed Phase 3 trials. We recently completed a Phase 3 trial of Viaskin Peanut in children ages one to three with peanut allergy and we also have an ongoing Phase 3 trial of Viaskin Peanut in children ages four to seven with peanut allergy.
On January 13, 2021,March 7, 2023, the Company received written responses fromannounced screening of the FDA to questions providedfirst patient in VITESSE. Screening of the last patient is anticipated in the Type A meeting requestfirst half in 2024 and topline results in the first half in 2025.
On April 19, 2023, the Company submitted in October 2020 followingoutlined the CRL. We believe the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, we proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications. The FDA agreed with our position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of a peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and modified patches, the FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population. We intend to submit the protocols for the safety and adhesion study and the allergen uptake study to the FDA for review and comments before initiating the trials. We will address details about a new human factor, or HF, validation study and additional CMC data in subsequent interactions with the FDA
During the first quarter of 2021, we received the first set of questions from the European Medicines Agency, or EMA, regarding the Marketing Authorization Application, or MAA, for Viaskin Peanut as a treatment for peanut allergy in children ages 4-11..1-3 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified criteria for success for the primary endpoint, not requesting any additional efficacy study. The questions were consistent with our expectationsFDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and prefiling conversations with the EMA. We did not receive questions about the impact of adhesion on efficacy. The EMA’s Committeewill include updated instructions for Medicinal Products for Human Use will provide a recommendation to the European Commission, or EC, on whether to grant a marketing authorization when its review of the Viaskin Peanut MAA is complete.use.
15
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report. Our significant accounting policies are more fully described in Note 1 of the Notes to Condensedthe Consolidated Financial Statements in Part I, Item 1 of thisour Annual Report.
Business trends and Results of Operations
The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the three months ended March 31, 20212023 and 2020:2022.
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
Operating income | $ | 2,941 | $ | 4,720 | ||||
Operating expenses | ||||||||
Research and development expenses | (22,164 | ) | (27,532 | ) | ||||
Sales and marketing expenses | (729 | ) | (7,297 | ) | ||||
General and administrative expenses | (9,683 | ) | (11,113 | ) | ||||
Restructuring expenses | — | — | ||||||
|
|
|
| |||||
Total Operating expenses | (32,575 | ) | (45,942 | ) | ||||
|
|
|
| |||||
Financial income | 215 | 309 | ||||||
|
|
|
| |||||
Income tax | (30 | ) | — | |||||
|
|
|
| |||||
Net loss | $ | (29,449 | ) | $ | (40,913 | ) | ||
|
|
|
| |||||
Basic/diluted Net loss per share attributable to shareholders | $ | (0.54 | ) | $ | (0.79 | ) | ||
Comparison of the three months ended March 31, 2021 to the three months ended March 31, 202016
| Three months ended March 31, | ||||||||||||||||
| 2023 | 2022 | $ change | % change | |||||||||||||
Operating income | $ | 2,194 | $ | 2,546 | (352 | ) | (14 | %) | ||||||||
Operating expenses | ||||||||||||||||
Research and development expenses | (16,037 | ) | (12,223 | ) | (3,814 | ) | 31 | % | ||||||||
Sales and marketing expenses | (434 | ) | (464 | ) | 30 | (7 | %) | |||||||||
General and administrative expenses | (6,889 | ) | (6,630 | ) | (259 | ) | 4 | % | ||||||||
|
|
|
|
|
|
|
| |||||||||
Total Operating expenses | (23,359 | ) | (19,317 | ) | (4,042 | ) | 21 | % | ||||||||
|
|
|
|
|
|
|
| |||||||||
Financial income | 605 | 152 | 453 | 298 | % | |||||||||||
|
|
|
|
|
|
|
| |||||||||
Income tax | — | (87 | ) | 87 | (100 | %) | ||||||||||
|
|
|
|
|
|
|
| |||||||||
Net loss | $ | (20,561 | ) | $ | (16,706 | ) | (3,854 | ) | 23 | % | ||||||
|
|
|
|
|
|
|
| |||||||||
Basic/diluted Net loss per share attributable to shareholders | $ | (0.22 | ) | $ | (0.30 | ) | ||||||||||
Operating Income
We generatedThe following table summarizes our operating income of $2.9 million during the three months ended March 31, 2021 compared to $4.7 million during the three months ended March 31, 2020, a decrease of 37.7%. This2023 and 2022:
| Three months ended March 31, | $ change | % change | ||||||||||||||
| 2023 | 2022 | |||||||||||||||
Sales | — | — | — | — | ||||||||||||
Other income | 2,194 | 2,546 | (352 | ) | (14 | %) | ||||||||||
Research tax credit | 1,765 | 1,569 | 196 | 12 | % | |||||||||||
Other operating income | 429 | 976 | (548 | ) | (56 | %) | ||||||||||
|
|
|
|
|
|
|
| |||||||||
Total operating income | 2,194 | 2,546 | (352 | ) | (14 | %) | ||||||||||
|
|
|
|
|
|
|
| |||||||||
Our operating income was mainlyis primarily generated from the French research tax credit (créCrédit d’impôd’Impôt recherche)Recherche, or CIR,“CIR”), and by the revenue recognized under our collaboration agreement with Nestlé Health Science.
| Three Months Ended March 31 | % change | |||||||||||
| 2021 | 2020 | 2021 vs 2020 | ||||||||||
Sales | — | — | ||||||||||
Other income | 2,941 | 4,720 | (37.7 | )% | ||||||||
Research tax credit | 1,807 | 2,902 | (37.7 | )% | ||||||||
Other operating income | 1,133 | 1,818 | (37.6 | )% | ||||||||
|
|
|
|
|
| |||||||
Total operating income | 2,941 | 4,720 | (37.7 | )% | ||||||||
|
|
|
|
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We generated operating income of $2.2 million during the three months ended March 31, 2023 compared to $ 2.6 million during the three months ended March 31, 2022. The decrease in operating income is primarily attributable to the decrease ofrevenue recognized under the CIR,Nestlé’s collaboration agreement, as eligible expenses have declined in correlation with Research and Development costs.
As of March 31, 2021, we recorded our collaboration contract income based on our updated the measurement of progress of the Phase II2 clinical trial conducted as part of the collaborationagreement. The increase in research tax credit is attributable to the increase in eligible costs in connection with Research and license agreement with Nestlé Health Science. The accrual recorded in the amountDevelopment costs.
Operating Expenses
Since inception, our operating expenses have consisted primarily of the difference between our current best estimates ofresearch and development activities, general and administration costs yet to be incurred and income yet to be recognized for the completion of the Phase II clinical has been updated accordingly.sales and marketing costs.
Operating ExpenseResearch and Development Expenses
The following table summarizes our operating expense excluding restructuringresearch and development expenses incurred during the three months ended March 31, 20212023 and 2020:2022:
| Three months Ended March 31 | % change | |||||||||||
| 2021 | 2020 | 2021 vs 2020 | ||||||||||
Research and development expenses | 22,164 | 27,532 | (19.5 | )% | ||||||||
Sales and marketing expenses | 729 | 7,297 | (90.0 | )% | ||||||||
General and administrative expenses | 9,683 | 11,113 | (12.9 | )% | ||||||||
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Total operating expenses | 32,575 | 45,942 | (29.1 | )% | ||||||||
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| Research and Development expenses | 2023 | 2022 | $ change | % change | ||||||||||||
External clinical-related expenses | 10,471 | 7,350 | 3,121 | 42 | % | |||||||||||
Employee-related costs | 3,319 | 2,492 | 827 | 33 | % | |||||||||||
Share-based payment expenses | 687 | 583 | 104 | 18 | % | |||||||||||
Depreciation, amortization and other costs | 1,559 | 1,799 | (239 | ) | (69 | %) | ||||||||||
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Total Research and Development expenses | 16,039 | 12,224 | 3,813 | 31 | % | |||||||||||
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OperatingResearch and Development expenses for the three months ended March 31, 2021 were $32.6 million compared to $45.9increased by $3.8 million for the three months ended March 31, 2020. The $13.4 million decrease in operating expenses is mainly attributable to a decrease in personnel expenses directly related2023, compared to the workforce reduction we implemented as part of our 2020 global restructuring plan. Personnel expenses decreased by $9.7 million, or 52%, to $9.0 million during the three
months ended March 31, 2021 from $18.72022, primarily due to the increase in external clinical-related expenses, mainly driven by higher costs of recruitment of patient in VITESSE Phase 3 clinical trial.
Employee-related costs, excluding share-based payment expenses, increased by $0.8 million for the three months ended March 31, 2020. Average headcount decreased 61% between the two periods, from 311 FTEs for2023 compared to the three months ended March 31, 20202022 mostly due to the recruitment of US employees partially offset by the departure of non-US employees.
Sales and 121 FTEs forMarketing expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended March 31, 2021. By function, the personnel expenses, including share-based payment expenses, decreased as follows:2023 and 2022:
Three Months Ended March 31, | % change | |||||||||||
| 2021 | 2020 | 2021 vs 2020 | ||||||||||
Research and development expenses | 4,718 | 10,204 | (53.8 | )% | ||||||||
Sales and marketing expenses | 518 | 4,197 | (87.7 | )% | ||||||||
General and administrative expenses | 3,766 | 4,283 | (12.1 | )% | ||||||||
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Total personnel expenses | 9,002 | 18,684 | (51.8 | )% | ||||||||
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| Three Months Ended March 31, | $ change | % change | ||||||||||||||
| Sales and Marketing expenses | 2023 | 2022 | ||||||||||||||
Personnel expenses (incl. share-based payment expenses) | 165 | 245 | (80 | ) | (33 | %) | ||||||||||
External professional services and other costs | 269 | 219 | (50 | ) | 23 | % | ||||||||||
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Total Sales and Marketing expenses | 434 | 464 | (30 | ) | (7 | %) | ||||||||||
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The decrease in other operating expenses was primarily due to the budget discipline measures taken by DBV. In particular, salesSales and marketing consulting fees dropped by 96.8% or $2.6 million, from $2.7expenses amounted to $0.4 million for the three months ended March 31, 20202023, compared to $0.1$0.5 million for the three months ended March 31, 20212022.
General and Administrative expenses
The following table summarizes our general and administrative fees decreasedexpenses incurred during the three months ended March 31, 2023 and 2022:
| Three Months Ended March 31, | $ change | % change | ||||||||||||||
| General and Administrative expenses | 2023 | 2022 | ||||||||||||||
External professional services | 1,706 | 1,108 | 598 | 54 | % | |||||||||||
Employee-related costs | 2,190 | 1,810 | 380 | 21 | % | |||||||||||
Share-based payment expenses | 910 | 786 | 124 | 16 | % | |||||||||||
Depreciation, amortization and other costs | 2,082 | 2,927 | (844 | ) | (29 | %) | ||||||||||
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Total General and Administrative expenses | 6,889 | 6,630 | 259 | 4 | % | |||||||||||
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General and Administrative expenses increased by 43.5% or $1.7 million, from $4.0$0.3 million for the three months ended March 31, 20202023, compared to $2.3the three months ended March 31, 2022 primarily due to a decrease in depreciation, amortization and other costs (mainly driven by the decrease in Directors and Officers insurance premium) and an increase in external professional services.
Financial income (expense)
Our financial income was approximately $0.6 million for the three months ended March 31, 2021.
As2023, compared to a result of the ongoing COVID-19 pandemic, we also experienced a decrease in other expenses, in particular tradeshows and travel expenses.
Restructuring
We initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin™ Peanut in the United States and European Union.
We expect full implementation of the restructuring plan to result in a reduction of more than 200 jobs, resulting in a remaining global team of 90 individuals dedicated to the pursuit of innovation and scientific development of novel therapies.
As of March 31, 2021, we had 104 employees. We expect full implementation of the organization-wide costs reduction measures to be completed by the second half of 2021.
The restructuring costs, which were $23.6 million as of December 31, 2020, were mainly comprised of payroll expenses, restructuring-related consulting and legal fees, as well as impairment of facilities and right of use assets following resizing of facilities.
During the three months ended March 31, 2021, the restructuring liability evolved as presented below:
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They were no restructuring costs for three months ended March 31, 2021 and 2020.
Financial income
Our financial income wasof $0.2 million for the three months ended March 31, 2021 and 2020.2022. This item mainly includes foreign exchange income.the financial income on our financial assets.
Income tax
We did not have any income tax profit or expense for the three months ended March 31, 2023 compared to an expense of $0.1 for the three months ended March 31, 2022.
Net loss
Net loss was $29.4$20.6 million for the three months ended March 31, 2021,2023, compared to $40.9$16.7 million for the three months ended March 31, 2020.2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.54$0.22 and $0.79$0.30 for the three months ended March 31, 20212023 and 2020,2022, respectively.
18
Liquidity and Capital Resources
Financial Condition
On March 31, 2023, we had $192.3 million in cash and cash equivalents compared to $209.2 million of cash and cash equivalents on December 31, 2022. Based on its current operations, plans and assumptions, the Company expects that its balance of cash and cash equivalents will be sufficient to fund its operations for at least the next 12 months. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $20.8 and $1.5 million for the three months ended March 31, 2023 and 2022, respectively. For the three months ended March 31, 2023, we recorded a net loss of $20.6 million. Our net cash flows provided by financing activities was nil during the three months ended March 31, 2023 compared to $(0.1) million during the three months ended March 31, 2022.
Our financial statements have been prepared on a going concern basis assuming that we will be successful in our financing objectives. As such, no adjustments have been made to the financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern.
Sources of Liquidity and Material Cash Requirements
We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt.
We fund short-term cash requirements primarily from payments associated with research tax credits (Crédit d’Impôt Recherche).
In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached. The Company intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes.
We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all. If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.
Operating leases
Our corporate headquarters are located in Montrouge, France. Our principal offices occupy a 4,470 square meter facility, pursuant to a lease agreement dated March 3, 2015 and represents a $3.4 million cash requirement as of December 31, 2022 which expires March 8, 2024.
Our primary U.S. office is located in Basking Ridge, New Jersey. In March 2022, we entered into a lease agreement, commencing on April 1, 2022 and effective for 38 months, for an office of 5,799 square feet in Basking Ridge, New Jersey. The Basking Ridge office represent a $0.4 million cash requirement as of December 31, 2022 which expires June 1, 2025.
There have been no material changes in our operating leases from those disclosed in the Annual Report.
Purchase obligations - Obligations Under the Terms of CRO Agreements
In connection with the launch of our clinical trials for Viaskin Peanut and Viaskin Milk, we signed agreements with several contract research organizations.
There have been no material changes in our purchase obligations from those disclosed in the Annual Report.
Summary Statement of Cash Flows
The table below summarizes our sources and uses of cash for the three months ended March 21, 202131, 2023 and 2020.2022.
| Three Months Ended March 31, | % change | Three months ended arch 31, | ||||||||||||||||||||||||||
| (Amounts in thousands of U.S. Dollars) | 2021 | 2020 | 2021 vs 2020 | 2023 | 2022 | $ change | % of change | |||||||||||||||||||||
Net cash flow used in operating activities | (36,204 | ) | (49,683 | ) | (27.1 | )% | ||||||||||||||||||||||
Net cash flow used in investing activities | (185 | ) | (930 | ) | (80.1 | )% | ||||||||||||||||||||||
Net cash flow provided by financing activities | 440 | 150,611 | (99.7 | )% | ||||||||||||||||||||||||
Net cash flow provided by (used in) operating activities | (20,841 | ) | (1,483 | ) | (19,359 | ) | 1,306 | % | ||||||||||||||||||||
Net cash flow provided by (used in) investing activities | 42 | 11 | 31 | 273 | % | |||||||||||||||||||||||
Net cash flow provided by (used in) financing activities | (14 | ) | (129 | ) | 114 | (89 | %) | |||||||||||||||||||||
Effect of exchange rate changes on cash and cash equivalents | (7,944 | ) | (5,811 | ) | (36.7 | )% | 3,909 | (1,594 | ) | 5,503 | (345 | %) | ||||||||||||||||
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Net (decrease) increase in cash and cash equivalents | (43,893 | ) | 94,187 | (146.6 | )% | (16,905 | ) | (3,194 | ) | (13,711 | ) | 429 | % | |||||||||||||||
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Operating Activities
Our net cash flows used in operating activities were $36.2$20.8 million and $49.7$1.5 million during the three months ended March 31, 20212023 and 2022, respectively. The variance of $19.4 million is mainly driven by the reimbursement of $20.9 million of research tax credits for the 2019 and 2020 respectively. Our net cash flows used in operating activities decreased by $13.5 million, or 27.2%, mainly due to the budget discipline measures we took, in particular the decrease in personnel expenses, which was directly related to the workforce reduction we implemented as part of our global restructuring plan. Cash flows used in operating activities for the three months ended March 31, 2021 included $4.9 million in restructuring amounts paid.fiscal year.
Investing Activities
Our net cash flows used in investing activities were $0.2 million and $0.9 million during the three months ended March 21, 2021 and 2020, respectively. Those investments were mainly for our industrial machinery and equipment, which are commissioned in order to support the commercialization of Viaskin Peanut, if approved.
Financing Activities
Our net cash flows provided by financing activities decreased to $0.4 million during the three months ended March 21, 2021 from $150.6 million during the three months ended March 21, 2020. Financing activities consisted mainly of our underwritten global offering in the first quarter of 2020.
Based on our current assumptions, we expect that our current cash and cash equivalents will support our operations until the second half of 2022
Contractual Obligations and Other Commitments
There have been no material changes in our contractual obligations and commitments from those disclosed in the Annual Report.
Off-Balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements and do not have variable interests in variable interest entities.19
Smaller Reporting Company Status
We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
20
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Our market risks have not changed materially from those disclosed in Item 7A3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Annual Report.Exchange Act and are not required to provide the information required under this item.
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Item 4. Controls and Procedures
Disclosure Controls and Procedures
Based on theirits evaluation as of March 31, 2021,2023, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitation on Effectiveness of Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and
procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error of fraud may occur and not be detected.
Item 1. Legal Proceedings |
See “Note 2: Significant Events and Transactions – Legal Proceedings” in the notes to the condensed consolidated financial statements included elsewhere in this Report.
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Item 1A. Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report. There have been no material changes in our risk factors from those disclosed in the Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
During the three months ended March 31, 2021, we granted 75,600 stock options and 24,900 restricted stock units to employees in France and in the United States.
During the three months ended March 31, 2021,2023, we issued 7,500 ordinary sharesthe following the exercise of employee warrants by an employee in France, for proceeds of $42,000.unregistered securities:
| • | On March 23, 2023, the issuance of an aggregate of 10,174 ordinary shares to US and non-U.S. employees upon settlement of RSUs; |
None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Regulation S promulgated under Section 5 of the Securities Act, as transactions by an issuer not involving any public offering or as offerings made to non-U.S. resident employees pursuant to an employee benefit plan established and administered in accordance with the law of a country other than the United States (namely, the Republic of France) and in accordance with that country’s practices and documentation. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.
Item 3. Defaults Upon Senior Securities |
None.
22
Item 4. Mine Safety Disclosures |
Not applicable.
Item 5. Other Information |
Not applicable.
Exhibit Index
Exhibit | Description | Incorporated by Reference | ||||||||||||||||
| Schedule / Form | File Number | Exhibit | File Date | |||||||||||||||
| 3.1 | By-laws (statuts) of the registrant (English translation) | 10-K | 001-36697 | 3.1 | 3/17/2021 | |||||||||||||
| 31.1 | Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended | |||||||||||||||||
| 31.2 | Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||||||||||
| 32.1* | Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended | |||||||||||||||||
| 101.INS | XBRL Instance Document | |||||||||||||||||
| 101.SCH | XBRL Taxonomy Extension Schema Document | |||||||||||||||||
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||||||||||
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | �� | ||||||||||||||||
| 101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | |||||||||||||||||
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||||||||||
Incorporated by Reference | ||||||||||
| Exhibit | Description | Schedule/ | File Number | Exhibit | File Date | |||||
| 3.1 | By-laws (status) of the registrant (English translation) | |||||||||
| 31.1 | Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended | |||||||||
| 31.2 | Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||
| 32.1* | Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||
| 101.INS | XBRL Instance Document | |||||||||
| 101.SCH | XBRL Taxonomy Extension Schema Document | |||||||||
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | |||||||||
| 101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | |||||||||
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||
| 104 | Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101. | |||||||||
| * | Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, (whether made before or after the date of the Form 10-Q), irrespective of any general |
24
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrantregistration has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| DBV Technologies S.A. | ||||||
| (Registrant) | ||||||
| Date: May | ||||||
| 4, 2023 | By: | /s/ Daniel Tassé | ||||
| Daniel Tassé | ||||||
| Chief Executive | ||||||
| (Principal Executive Officer) | ||||||
| Date: May | By: | /s/ Sébastien Robitaille | ||||
| Sébastien Robitaille | ||||||
| Chief Financial Officer | ||||||
| (Principal Financial and Accounting Officer) | ||||||
25