☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
France | Not applicable | |
State or other jurisdiction of incorporation or organization | (I.R.S. Employer Identification No.) |
177-181 avenue Pierre Brossolette92120 Montrouge France | ||
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
American Depositary Shares, each representing one-half ofone ordinary share, nominal value €0.10 per share | DBVT | The Nasdaq Stock Market LLC | ||
Ordinary shares, nominal value €0.10 per | 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 | ☐ |
Table of contents
Part I | 1 | |||||
Item 1 | Condensed Consolidated Statements of Financial Position (Unaudited) as of | 1 | ||||
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three | 2 | |||||
Condensed Consolidated Statements of Cash Flows (Unaudited) for the | 3 | |||||
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the | 4 | |||||
5 | ||||||
Item 2 | 15 | |||||
Item 3 | 21 | |||||
Item 4 | 21 | |||||
Part II | 22 | |||||
Item 1 | 22 | |||||
Item 1A | 22 | |||||
Item 2 | 22 | |||||
Item 3 | 22 | |||||
Item 4 | 23 | |||||
Item 5 | 23 | |||||
Item 6 | 24 |
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™“Viaskin™”, “EPIT™“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
SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS.
This Quarterly Report contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended or Securities Act,(the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, or Exchange Act.(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:
• | 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 ViaskinTM Peanut to the U.S. Food and Drug Administration, or the FDA; |
the timing and anticipated results of 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;
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 ongoing COVID-19 pandemic including the emergence of new variant strains of COVID-19, 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, 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, 2021,2022, filed with the Securities and Exchange Commission, or the SEC on March 9, 2022. Additional information is also included on our Current Report on Form 8-K, filed with the SEC on June 13, 2022.2, 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 Quarterly 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 Quarterly 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
September 30, | December 31, | |||||||||||
Note | 2022 | 2021 | ||||||||||
Assets | ||||||||||||
Current assets: | ||||||||||||
Cash and cash equivalents | 3 | $ | 212,670 | $ | 77,301 | |||||||
Other current assets | 4 | 13,025 | 37,085 | |||||||||
Total current assets | 225,695 | 114,386 | ||||||||||
Property, plant, and equipment, net | 14,429 | 18,146 | ||||||||||
Right-of-use | 5 | 2,614 | 7,336 | |||||||||
Intangible assets | 11 | 22 | ||||||||||
Other non-current assets | 5,368 | 6,833 | ||||||||||
Total non-current assets | 22,422 | 32,338 | ||||||||||
Total Assets | $ | 248,117 | $ | 146,723 | ||||||||
Liabilities and shareholders' equity | ||||||||||||
Current liabilities: | ||||||||||||
Trade payables | 6 | $ | 15,369 | $ | 11,429 | |||||||
Short-term operating leases | 5 | 1,381 | 3,003 | |||||||||
Short-term financial debt | — | 510 | ||||||||||
Current contingencies | 9 | 3,026 | 4,095 | |||||||||
Other current liabilities | 6 | 8,615 | 12,361 | |||||||||
Total current liabilities | 28,391 | 31,397 | ||||||||||
Long-term operating leases | 5 | 1,423 | 7,147 | |||||||||
Non-current contingencies | 9 | 5,272 | 6,758 | |||||||||
Other non-current liabilities | 6 | 979 | 2,147 | |||||||||
Total non-current liabilities | 7,674 | 16,052 | ||||||||||
Total Liabilities | $ | 36,065 | $ | 47,449 | ||||||||
Shareholders’ equity: | ||||||||||||
Ordinary shares, €0.10 par value; 94,025,441 and 55,095,762 shares authorized, and issued as at September 30, 2022 and December 31, 2021, respectively | $ | 10,709 | $ | 6,538 | ||||||||
Additional paid-in capital | 456,884 | 358,115 | ||||||||||
Treasury stock, 137,101 and 153,631 ordinary shares as of September 30, 2022 and December 31, 2021, respectively, at cost | (1,083 | ) | (1,232 | ) | ||||||||
Accumulated deficit | (220,337 | ) | (258,528 | ) | ||||||||
Accumulated other comprehensive income | 783 | 519 | ||||||||||
Accumulated currency translation effect | (34,904 | ) | (6,137 | ) | ||||||||
Total Shareholders’ equity | 7 | $ | 212,052 | $ | 99,274 | |||||||
Total Liabilities and Shareholders’ equity | $ | 248,117 | $ | 146,723 | ||||||||
March 31, | December 31, | |||||||||
Note | 2023 | 2022 | ||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | 3 | $ | 192,289 | $ | 209,194 | |||||
Other current assets | 4 | 17,946 | 13,880 | |||||||
Total current assets | 210,236 | 223,074 | ||||||||
Property, plant, and equipment, net | 14,786 | 15,096 | ||||||||
Right-of-use | 5 | 2,127 | 2,513 | |||||||
Intangible assets | 10 | 10 | ||||||||
Other non-current assets | 5,771 | 5,824 | ||||||||
Total non-current assets | 22,693 | 23,444 | ||||||||
Total Assets | $ | 232,929 | $ | 246,518 | ||||||
Liabilities and shareholders’ equity | ||||||||||
Current liabilities: | ||||||||||
Trade payables | 6 | $ | 19,938 | $ | 14,473 | |||||
Short-term operating leases | 5 | 1,923 | 1,894 | |||||||
Current contingencies | 9 | 4,142 | 3,944 | |||||||
Other current liabilities | 6 | 6,776 | 9,210 | |||||||
Total current liabilities | 32,778 | 29,521 | ||||||||
Long-term operating leases | 5 | 680 | 1,127 | |||||||
Non-current contingencies | 9 | 15,989 | 16,680 | |||||||
Other non-current liabilities | 6 | 4,387 | 4,735 | |||||||
Total non-current liabilities | 21,056 | 22,543 | ||||||||
Total Liabilities | $ | 53,834 | $ | 52,064 | ||||||
Shareholders’ equity: | ||||||||||
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 | ||||||
Additional paid-in capital | 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 | ) | ||||||
Total Shareholders’ equity | 7 | $ | 179,094 | $ | 194,453 | |||||
Total Liabilities and Shareholders’ equity | $ | 232,929 | $ | 246,518 | ||||||
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 | 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, 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 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||
Note | 2022 | 2021 | 2022 | 2021 | ||||||||||||||
Operating income | 10 | $ | 2,074 | $ | 1,323 | $ | 6,148 | $ | 2,776 | |||||||||
Operating expenses | ||||||||||||||||||
Research and development expenses | (15,096 | ) | (16,320 | ) | (45,930 | ) | (58,663 | ) | ||||||||||
Sales and marketing expenses | (159 | ) | (1,072 | ) | (1,659 | ) | (2,999 | ) | ||||||||||
General and administrative expenses | (4,839 | ) | (8,299 | ) | (17,173 | ) | (26,250 | ) | ||||||||||
Total Operating expenses | (20,094 | ) | (25,691 | ) | (64,762 | ) | (87,912 | ) | ||||||||||
Loss from operations | (18,020 | ) | (24,368 | ) | (58,614 | ) | (85,137 | ) | ||||||||||
Financial income | 732 | 336 | 1,668 | 597 | ||||||||||||||
Loss before taxes | (17,287 | ) | (24,033 | ) | (56,946 | ) | (84,540 | ) | ||||||||||
Income tax (expense) | — | — | (87 | ) | 404 | |||||||||||||
Net loss | $ | (17,287 | ) | $ | (24,033 | ) | $ | (57,033 | ) | $ | (84,136 | ) | ||||||
Foreign currency translation differences, net of taxes | (15,425 | ) | (3,728 | ) | (28,752 | ) | (9,684 | ) | ||||||||||
Actuarial gains (losses) on employee benefits, net of taxes | 41 | 28 | 264 | (10 | ) | |||||||||||||
Total comprehensive loss | $ | (32,672 | ) | $ | (27,733 | ) | $ | (85,520 | ) | $ | (93,830 | ) | ||||||
Basic/diluted net loss per share attributable to shareholders | 14 | $ | (0.18 | ) | $ | (0.44 | ) | $ | (0.79 | ) | $ | (1.53 | ) | |||||
Weighted average shares outstanding used in computing per sha re amounts: | 93,905,050 | 54,947,354 | 71,779,572 | 54,911,278 |
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 |
Nine Months Ended September 30, | ||||||||||||
Notes | 2022 | 2021 | ||||||||||
Net loss for the period | $ | (57,033 | ) | $ | (84,136 | ) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
Depreciation, amortization and accrued contingencies | 1,140 | 9,705 | ||||||||||
Retirement pension obligations | 58 | 127 | ||||||||||
Expenses related to share-based payments | 8 | 3,416 | 4,078 | |||||||||
Other elements | (3 | ) | 1,214 | |||||||||
Changes in operating assets and liabilities: | ||||||||||||
Decrease (increase) in trade receivables | — | 2,174 | ||||||||||
Decrease (increase) in other current assets | 20,900 | (9,036 | ) | |||||||||
(Decrease) increase in trade payables | 5,699 | (7,135 | ) | |||||||||
(Decrease) increase in other current and non-current liabilities | (3,405 | ) | (5,497 | ) | ||||||||
Change in operating lease liabilities and right of use assets | (2,554 | ) | (946 | ) | ||||||||
Net cash flow used in operating activities | (31,781 | ) | (89,452 | ) | ||||||||
Cash flows used in investing activities: | ||||||||||||
Acquisitions of property, plant, and equipment | (742 | ) | — | |||||||||
Proceeds from property, plant, and equipment dispositions | 3 | 46 | ||||||||||
Acquisition of intangible assets | — | (8 | ) | |||||||||
Acquisitions of non-current financial assets | (149 | ) | — | |||||||||
Proceeds from non-current financial assets | 822 | 3 | ||||||||||
Net cash flows used in investing activities | (66 | ) | 41 | |||||||||
Cash flows provided by financing activities: | ||||||||||||
Decrease in conditional advances | (479 | ) | (518 | ) | ||||||||
Treasury shares | 149 | (359 | ) | |||||||||
Capital increases, net of transaction costs | 194,732 | 794 | ||||||||||
Other cash flows related to financing activities | — | (21 | ) | |||||||||
Net cash flows provided by financing activities | 194,403 | (103 | ) | |||||||||
Effect of exchange rate changes on cash and cash equivalents | (27,186 | ) | (8,643 | ) | ||||||||
Net increase (decrease) in cash and cash equivalents | 135,369 | (98,157 | ) | |||||||||
Net Cash and cash equivalents at the beginning of the period | 77,301 | 196,352 | ||||||||||
Net cash and cash equivalents at the end of the period | 3 | $ | 212,670 | $ | 98,195 | |||||||
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, 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 | ||||||||||||||||||||||||
Balance at March 31, 2021 | 54,936,687 | $ | 6,519 | $ | 1,153,516 | $ | (681 | ) | $ | (987,992 | ) | $ | 399 | $ | (2,586 | ) | $ | 169,176 | ||||||||||||||
Net (loss) | — | — | — | — | (30,654 | ) | — | — | (30,654 | ) | ||||||||||||||||||||||
Other comprehensive income | — | — | — | — | — | 48 | 2,788 | 2,836 | ||||||||||||||||||||||||
Issuance of ordinary shares | 75,000 | 9 | 464 | — | — | — | — | 473 | ||||||||||||||||||||||||
Issuance of warrants | 279 | 279 | ||||||||||||||||||||||||||||||
Treasury shares | — | — | (185 | ) | — | — | — | (185 | ) | |||||||||||||||||||||||
Share-based payments | — | — | 1,094 | — | — | — | 1,094 | |||||||||||||||||||||||||
Allocation of accumulated net losses | — | — | (797,823 | ) | — | 797,823 | — | — | — | |||||||||||||||||||||||
Balance at June 30, 2021 | 55,011,687 | $ | 6,529 | $ | 357,530 | $ | (866 | ) | $ | (220,823 | ) | $ | 446 | $ | 203 | $ | 143,019 | |||||||||||||||
Net (loss) | — | — | — | — | (24,033 | ) | — | — | (24,033 | ) | ||||||||||||||||||||||
Other comprehensive income | — | — | — | — | — | 28 | (3,728 | ) | (3,701 | ) | ||||||||||||||||||||||
Treasury shares | — | — | 56 | — | — | — | 56 | |||||||||||||||||||||||||
Share-based payments | — | — | 1,551 | — | — | — | 1,551 | |||||||||||||||||||||||||
Balance at September 30, 2021 | 55,011,687 | $ | 6,529 | $ | 359,081 | $ | (810 | ) | $ | (244,856 | ) | $ | 474 | $ | (3,526 | ) | $ | 116,892 | ||||||||||||||
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 loss | — | — | — | — | — | 24 | (1,933 | ) | (1,909 | ) | ||||||||||||||||||||||
Issuance of ordinary shares | 775 | 1 | — | — | — | — | — | 1 | ||||||||||||||||||||||||
Treasury shares | — | — | — | 40 | — | — | — | 40 | ||||||||||||||||||||||||
Share-based payments | — | — | 1,363 | — | — | — | — | 1,363 | ||||||||||||||||||||||||
Other changes | — | — | — | — | 15 | (15 | ) | — | ||||||||||||||||||||||||
Balance at March 31, 2022 | 55,096,537 | $ | 6,539 | $ | 359,478 | $ | (1,193 | ) | $ | (275,219 | ) | $ | 543 | $ | (8,086 | ) | $ | 82,062 | ||||||||||||||
Net (loss) | — | — | — | — | (23,039 | ) | — | — | (23,039 | ) | ||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | 200 | (11,394 | ) | (11,194 | ) | ||||||||||||||||||||||
Issuance of ordinary shares | 38,926,142 | 4,170 | 103,007 | — | — | — | — | 107,176 | ||||||||||||||||||||||||
Issuance of warrants | — | — | 88,094 | — | — | — | — | 88,094 | ||||||||||||||||||||||||
Treasury shares | — | — | — | 240 | — | — | — | 240 | ||||||||||||||||||||||||
Share-based payments | — | — | 1,078 | — | — | — | — | 1,078 | ||||||||||||||||||||||||
Allocation of accumulated net losses | — | — | (95,209 | ) | — | 95,209 | — | — | — | |||||||||||||||||||||||
Balance at June 30, 2022 | 94,022,679 | $ | 10,708 | $ | 456,447 | $ | (953 | ) | $ | (203,050 | ) | $ | 743 | $ | (19,480 | ) | $ | 244,416 | ||||||||||||||
Net (loss) | — | — | — | — | (17,287 | ) | — | — | (17,287 | ) | ||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | 41 | (15,425 | ) | (15,384 | ) | ||||||||||||||||||||||
Issuance of ordinary shares | 2 762 | 1 | (540 | ) | — | — | — | — | (539 | ) | ||||||||||||||||||||||
Treasury shares | — | — | — | (130 | ) | — | — | — | (130 | ) | ||||||||||||||||||||||
Share-based payments | — | — | 976 | — | — | — | — | 976 | ||||||||||||||||||||||||
Balance at September 30, 2022 | 94 025 441 | $ | 10,709 | $ | 456,884 | $ | (1,083 | ) | $ | (220,337 | ) | $ | 783 | $ | (34,904 | ) | $ | 212,052 | ||||||||||||||
1. | Identify a modified Viaskin patch |
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 EQUAL. The data collection phase of the trial is complete, and the data analysis phase is ongoing. |
b. | ‘EQUAL in adults’—a second Phase |
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 |
September 30, | December 31, | |||||||
2022 | 2021 | |||||||
Cash | 167,916 | 31,427 | ||||||
Cash equivalents | 44,754 | 45,874 | ||||||
Total cash and cash equivalents as reported in the statements of financial position | 212,670 | 77,301 | ||||||
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 | ||||||
September 30, | December 31, | |||||||
2022 | 2021 | |||||||
Research tax credit | 4,094 | 28,092 | ||||||
Other tax claims | 3,636 | 3,561 | ||||||
Prepaid expenses | 4,107 | 4,149 | ||||||
Other receivables | 1,188 | 1,283 | ||||||
Total | 13,025 | 37,085 | ||||||
Amount in thousands of US Dollars | ||||
Opening research tax credit receivable as of January 1, | 5,792 | |||
+ Operating revenue | ||||
- Payment received | ||||
- Adjustment and currency translation effect | ||||
Closing research tax credit receivable as of | ||||
Of which - Non-current portion | — | |||
Of which - Current portion |
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 | % |
September 30, 2022 | December 31, 2021 | |||||||||||||||||||||||
Real estate | Other assets | Total | Real estate | Other assets | Total | |||||||||||||||||||
Current portion | 1,504 | 34 | 1,538 | 3,361 | 77 | 3,438 | ||||||||||||||||||
Year 2 | 1,874 | 18 | 1,891 | 3,124 | 23 | 3,147 | ||||||||||||||||||
Year 3 | 103 | 6 | 109 | 2,299 | 18 | 2,317 | ||||||||||||||||||
Year 4 | — | — | — | 771 | 1 | 773 | ||||||||||||||||||
Year 5 | — | — | — | 790 | — | 790 | ||||||||||||||||||
Thereafter | — | — | — | 1,220 | — | 1,220 | ||||||||||||||||||
Total minimum lease payments | 3,481 | 58 | 3,538 | 11,565 | 119 | 11,684 | ||||||||||||||||||
Less: Effects of discounting | (729 | ) | (5 | ) | (734 | ) | (1,526 | ) | (8 | ) | (1,534 | ) | ||||||||||||
Present value of operating lease | 2,752 | 52 | 2,804 | 10,039 | 111 | 10,150 | ||||||||||||||||||
Less: current portion | (1,350 | ) | (31 | ) | (1,381 | ) | (2,929 | ) | (74 | ) | (3,003 | ) | ||||||||||||
Long-term operating lease | 1,402 | 22 | 1,423 | 7,110 | 37 | 7,147 | ||||||||||||||||||
Weighted average remaining lease term (years) | 1.80 | — | 4.14 | 2.01 | ||||||||||||||||||||
Weighted average discount rate | 3.50 | % | 0.9 | % | 4.84 | % | 3.32 | % |
September 30, | March 31, | |||||||||||||||
2022 | 2021 | 2023 | 2022 | |||||||||||||
Operating lease expense | 1,373 | 2,480 | ||||||||||||||
Operating lease expense / (income) | 446 | 507 | ||||||||||||||
Net termination impact | (1,657 | ) | — | (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 |
September 30, | ||||||||
2022 | 2021 | |||||||
Cash paid for amounts included in the measurement of lease liabilities | — | — | ||||||
Operating cash flows from operating leases | 1,533 | 2,845 |
September 30, | December 31, | March 31 | December 31, | |||||||||||||||||||||||||||||||||||||||||||||
2022 | 2021 | 2023 | 2022 | |||||||||||||||||||||||||||||||||||||||||||||
Other current liabilities | Other non- current liabilities | Total | Other current liabilities | Other non- current liabilities | Total | Other current liabilities | Other non- current liabilities | Total | Other current liabilities | Other non- current liabilities | Total | |||||||||||||||||||||||||||||||||||||
Employee related liabilities | 4,666 | 54 | 4,719 | 6,708 | 247 | 6,954 | 4,189 | 11 | 4,200 | 5,872 | 45 | 5,917 | ||||||||||||||||||||||||||||||||||||
Deferred income | 2,911 | 926 | 3,836 | 4,146 | 1,900 | 6,046 | 2 193 | 4 375 | 6,568 | 2,137 | 4,690 | 6,828 | ||||||||||||||||||||||||||||||||||||
Tax liabilities | 405 | — | 405 | 182 | — | 182 | 97 | — | 97 | 69 | — | 69 | ||||||||||||||||||||||||||||||||||||
Other debts | 634 | — | 634 | 1,325 | — | 1,325 | 297 | — | 297 | 1,131 | — | 1,131 | ||||||||||||||||||||||||||||||||||||
Total | 8,615 | 979 | 9,594 | 12,361 | 2,147 | 14,508 | 6 776 | 4 387 | 11,162 | 9,210 | 4,735 | 13,945 | ||||||||||||||||||||||||||||||||||||
warrants | ||||
Number of outstanding | Number of outstanding | |||||||||||||||||||||||
BSA | SO | RSUs | BSA | SO | RSUs | |||||||||||||||||||
Balance as of December 31, 2021 | 256,693 | 3,631,210 | 1,240,520 | |||||||||||||||||||||
Balance as of December 31, 2022 | 251,693 | 5,306,569 | 1,589,081 | |||||||||||||||||||||
Granted during the period | — | 154,500 | 69,900 | — | 59,200 | 35,800 | ||||||||||||||||||
Forfeited during the period | — | (238,715 | ) | (92,326 | ) | — | (47,200 | ) | (30,769 | ) | ||||||||||||||
Exercised/released during the period | — | (5,613 | ) | (32,159 | ) | — | — | (10,174 | ) | |||||||||||||||
Expired during the period | (5,000 | ) | — | — | — | — | — | |||||||||||||||||
Balance as of September 30, 2022 | 251,693 | 3,541,383 | 1,185,936 | |||||||||||||||||||||
Balance as of March 31, 2023 | 251,693 | 5,318,569 | 1,583,938 | |||||||||||||||||||||
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 | ) | ||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||||||
Research & development | SO | (337 | ) | (273 | ) | (1,002 | ) | (952 | ) | |||||||||||
RSU | (201 | ) | (660 | ) | (594 | ) | (795 | ) | ||||||||||||
Sales & marketing | SO | 30 | (60 | ) | (3 | ) | (172 | ) | ||||||||||||
RSU | 20 | (27 | ) | 4 | (75 | ) | ||||||||||||||
General & administrative | SO | (423 | ) | (439 | ) | (1,599 | ) | (1,791 | ) | |||||||||||
RSU | (66 | ) | (92 | ) | (223 | ) | (293 | ) | ||||||||||||
Total share-based compensation (expense) | (976 | ) | (1,551 | ) | (3,416 | ) | (4,078 | ) | ||||||||||||
September 30, | December 31, | March 31, | December 31, | |||||||||||||
2022 | 2021 | 2023 | 2022 | |||||||||||||
Current contingencies | 3,026 | 4,095 | 4,142 | 3,944 | ||||||||||||
Non-current contingencies | 5,272 | 6,758 | 15,989 | 16,680 | ||||||||||||
Total contingencies | 8,298 | 10,853 | 20,131 | 20,625 | ||||||||||||
Pension retirement obligations | Collaboration agreement - Loss at completion | Other contingencies | Total | Pension retirement obligations | Collaboration agreement - Loss at completion | Other contingencies | Total | |||||||||||||||||||||||||
At January 1, 2022 | 1,008 | 9,800 | 45 | 10,853 | ||||||||||||||||||||||||||||
At January 1, 2023 | 790 | 19,835 | — | 20,625 | ||||||||||||||||||||||||||||
Increases in liabilities | 58 | — | — | 58 | — | — | 170 | 170 | ||||||||||||||||||||||||
Used liabilities | — | (889 | ) | (43 | ) | (932 | ) | — | — | — | — | |||||||||||||||||||||
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 | (264 | ) | — | — | (264 | ) | 82 | — | — | 82 | ||||||||||||||||||||||
Currency translation effect | (123 | ) | (1,291 | ) | (3 | ) | (1,417 | ) | 16 | 374 | 2 | 392 | ||||||||||||||||||||
At September 30, 2022 | 678 | 7,620 | — | 8,298 | ||||||||||||||||||||||||||||
At March 31, 2023 | 853 | 19,106 | 172 | 20,131 | ||||||||||||||||||||||||||||
Of which Current | — | 3,026 | — | 3,026 | — | 3,970 | 172 | 4,142 | ||||||||||||||||||||||||
Of which Non-current | 678 | 4,594 | — | 5,272 | 853 | 15,135 | — | 15,989 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | Three Months Ended March 31, | ||||||||||||||||||||
2023 | 2022 | |||||||||||||||||||||||
Research tax credit | 1,407 | 1,647 | 4,467 | 5,324 | 1,765 | 1,569 | ||||||||||||||||||
Other operating income | 668 | (324 | ) | 1,681 | (2,549 | ) | 429 | 976 | ||||||||||||||||
Total | 2,074 | 1,323 | 6,148 | 2,776 | 2,194 | 2,546 | ||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | Three Months Ended March 31, | ||||||||||||||||||||
2023 | 2022 | |||||||||||||||||||||||
Research and Development expenses | 3,186 | 4,161 | 9,357 | 12,272 | 4,006 | 3,075 | ||||||||||||||||||
Sales and Marketing expenses | 138 | 492 | 727 | 1,528 | 165 | 245 | ||||||||||||||||||
General and Administrative expenses | 1,598 | 2,583 | 6,961 | 9,347 | 3,100 | 2,595 | ||||||||||||||||||
Total personnel expenses | 4,922 | 7,236 | 17,045 | 23,148 | 7,272 | 5,915 | ||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | Three Months Ended March 31, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | 2023 | 2022 | |||||||||||||||||||
Wages and salaries | 3,505 | 3,793 | 11,001 | 12,629 | 4,438 | 3,987 | ||||||||||||||||||
Social security contributions | 634 | 1,110 | 2,141 | 3,505 | 699 | 251 | ||||||||||||||||||
Expenses for pension commitments | 214 | 286 | 723 | 981 | 258 | 297 | ||||||||||||||||||
Employer contribution to bonus shares | (406 | ) | 497 | (236 | ) | 1,955 | 244 | 16 | ||||||||||||||||
Share-based payments | 976 | 1,551 | 3,416 | 4,078 | 1,632 | 1,363 | ||||||||||||||||||
Total | 4,922 | 7,236 | 17,045 | 23,148 | 7,272 | 5,915 | ||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | Three Months Ended March 31, | ||||||||||||||||||||
2023 | 2022 | |||||||||||||||||||||||
Non-employee warrants | 251,693 | 256,693 | 251,693 | 256,693 | 251,693 | 256,693 | ||||||||||||||||||
Stock options | 3,541,383 | 2,585,710 | 3,541,383 | 2,585,710 | 5,318,569 | 3,471,808 | ||||||||||||||||||
Restricted stock units | 1,185,936 | 1,104,145 | 1,185,936 | 1,104,145 | 1,583,938 | 1,183,633 | ||||||||||||||||||
Prefunded warrants | 28,276,331 | — | 28,276,331 | — | 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, 2021,2022, included in our Annual Report on Form 10-K for the year ended December 31, 2021,2022, filed with the Securities and Exchange Commission on March 9, 2022,2, 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 EPIT
Our most advanced clinical program is Viaskin Peanut.
On March 7, 2023, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigationscreening of the 250 Pg dosefirst patient in this age group, which is the dose being studied in Part BVITESSE. Screening of the study. Enrollment for Part B of EPITOPE was completedlast patient is anticipated in the first quarter of 2022.
On April 19, 2023, the treatment responder criteria after 12 months, as compared to 33.5% of subjects inCompany outlined the placebo arm (difference in response rates = 33.4 %, 95 % CI = 22.4% - 44.5 %).
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 the Consolidated Financial Statements in Part I, Item 1 of our Annual Report.
Business trends and Results of Operations
Comparison of the Three Months Ended September 30,March 31, 2023 and 2022 and 2021
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 September 30, 2022March 31, 2023 and 2021.2022.
16
Three months ended September 30, | ||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||
Operating income | $ | 2,074 | $ | 1,323 | 751 | 57 | % | |||||||||
Operating expenses | ||||||||||||||||
Research and development expenses | (15,096 | ) | (16,320 | ) | 1,224 | (8 | %) | |||||||||
Sales and marketing expenses | (159 | ) | (1,072 | ) | 913 | (85 | %) | |||||||||
General and administrative expenses | (4,839 | ) | (8,299 | ) | 3,460 | (42 | %) | |||||||||
Total Operating expenses | (20,094 | ) | (25,691 | ) | 5,597 | (22 | %) | |||||||||
Financial income | 732 | 336 | 396 | 118 | % | |||||||||||
Income tax | — | — | — | — | ||||||||||||
Net loss | $ | (17,287 | ) | $ | (24,033 | ) | 6,745 | (28 | %) | |||||||
Basic/diluted Net loss per share attributable to shareholders | $ | (0.18 | ) | $ | (0.44 | ) |
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 | % | ||||||||
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Total Operating expenses | (23,359 | ) | (19,317 | ) | (4,042 | ) | 21 | % | ||||||||
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Financial income | 605 | 152 | 453 | 298 | % | |||||||||||
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Income tax | — | (87 | ) | 87 | (100 | %) | ||||||||||
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Net loss | $ | (20,561 | ) | $ | (16,706 | ) | (3,854 | ) | 23 | % | ||||||
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Basic/diluted Net loss per share attributable to shareholders | $ | (0.22 | ) | $ | (0.30 | ) |
Operating Income
The following table summarizes our operating income during the three months ended September 30, 2022March 31, 2023 and 2021:
Three months ended September 30, | $ change | % change | ||||||||||||||
2022 | 2021 | |||||||||||||||
Sales | — | — | — | — | ||||||||||||
Other income | 2,074 | 1,323 | 751 | 57 | % | |||||||||||
Research tax credit | 1,407 | 1,647 | (240 | ) | (15 | %) | ||||||||||
Other operating income | 668 | (324 | ) | 992 | (306 | %) | ||||||||||
Total operating income | 2,074 | 1,323 | 751 | 57 | % | |||||||||||
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 | %) | ||||||||||
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Total operating income | 2,194 | 2,546 | (352 | ) | (14 | %) | ||||||||||
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Our operating income is primarily generated from the French research tax credit (
Operating Expenses
Since inception, our operating expenses have consisted primarily of research and development activities, general and administration costs and sales and marketing costs.
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the three months ended September 30, 2022March 31, 2023 and 2021:2022:
Three Months Ended March 31, | ||||||||||||||||
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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Three Months Ended September 30, | ||||||||||||||||
Research and Development expenses | 2022 | 2021 | $ change | % change | ||||||||||||
External clinical-related expenses | 11,136 | 8,633 | 2,503 | 29 | % | |||||||||||
Employee-related costs | 2,648 | 3,228 | (581 | ) | (18 | %) | ||||||||||
Share-based payment expenses | 538 | 933 | (395 | ) | (42 | %) | ||||||||||
Depreciation, amortization and other costs | 774 | 3,526 | (2,752 | ) | (78 | %) | ||||||||||
Total Research and Development expenses | 15,096 | 16,320 | (1,224 | ) | (8 | %) | ||||||||||
Research and Development expenses decreasedincreased by $1.2$3.8 million for the three months ended September 30, 2022,March 31, 2023, compared to the three
months ended September 30, 2021,March 31, 2022, primarily due to a decrease in depreciation, amortization and following the loss at completion recorded on the Phase II clinical trial conducted as part of the Nestlé agreement for the three months ended September 30, 2021. The increase in external clinical-related expenses, ismainly driven by the launchhigher costs of work onrecruitment of patient in VITESSE protocol. We have also continued to practice financial discipline and implemented further cost containment strategies.
Employee-related costs, excluding share-based payment expenses, decreasedincreased by $1.0$0.8 million for the three months ended September 30, 2022March 31, 2023 compared to the three months ended September 30, 2021March 31, 2022 mostly due to EUR/USD exchange variation and workforce reduction.
Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended September 30, 2022March 31, 2023 and 2021:
Three Months Ended September 30, | $ change | % change | ||||||||||||||
Sales and Marketing expenses | 2022 | 2021 | ||||||||||||||
Personnel expenses | 138 | 492 | (354 | ) | (72 | %) | ||||||||||
External professional services and other costs | 20 | 580 | (559 | ) | (96 | %) | ||||||||||
Total Sales and Marketing expenses | 159 | 1,072 | (913 | ) | (85 | %) | ||||||||||
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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Sales and marketing expenses amounted to $0.2$0.4 million for the three months ended September 30, 2022,March 31, 2023, compared to $1.1$0.5 million for the three months ended September 30, 2021.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the three months ended September 30, 2022March 31, 2023 and 2021:
Three Months Ended September 30, | $ change | % change | ||||||||||||||
General and Administrative expenses | 2022 | 2021 | ||||||||||||||
External professional services | 1,292 | 2,216 | (924 | ) | (42 | %) | ||||||||||
Employee-related costs | 1,110 | 2,052 | (942 | ) | (46 | %) | ||||||||||
Share-based payment expenses | 488 | 530 | (42 | ) | (8 | %) | ||||||||||
Depreciation, amortization and other costs | 1,949 | 3,501 | (1,552 | ) | (44 | %) | ||||||||||
Total General and Administrative expenses | 4,839 | 8,299 | (3,460 | ) | (42 | %) | ||||||||||
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 decreasedincreased by $3.5$0.3 million for the three months ended September 30, 2022,March 31, 2023, compared to the three months ended September 30, 2021March 31, 2022 primarily due to a decrease in depreciation, amortization and other costs as we continued to practice financial discipline(mainly driven by the decrease in Directors and implemented further cost containment strategies.
Financial income (expense)
Our financial income was approximately $0.7$0.6 million for the three months ended September 30, 2022,March 31, 2023, compared to a financial income of $0.3$0.2 million for the three months ended September 30, 2021.March 31, 2022. This item mainly includes foreign exchange income.
Income tax
We did not have any income tax profit or expense for the three months ended September 30, 2022 nor 2021.
Net loss
Net loss was $17.3$20.6 million for the three months ended September 30, 2022,March 31, 2023, compared to $24.0$16.7 million for the three months ended September 30, 2021.March 31, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.18$0.22 and $0.44$0.30 for the three months ended September 30,March 31, 2023 and 2022, and 2021, respectively.
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Nine months ended September 30, | $ change | % change | ||||||||||||||
2022 | 2021 | |||||||||||||||
Operating income | $ | 6,148 | $ | 2,776 | 3,373 | 122 | % | |||||||||
Operating expenses | ||||||||||||||||
Research and development expenses | (45,930 | ) | (58,663 | ) | 12,733 | (22 | )% | |||||||||
Sales and marketing expenses | (1,659 | ) | (2,999 | ) | 1,340 | (45 | )% | |||||||||
General and administrative expenses | (17,173 | ) | (26,250 | ) | 9,077 | (35 | )% | |||||||||
Total Operating expenses | (64,762 | ) | (87,912 | ) | 23,150 | (26 | )% | |||||||||
Financial income | 1,668 | 597 | 1,071 | 179 | % | |||||||||||
Income tax (expense) | (87 | ) | 404 | (491 | ) | (122 | )% | |||||||||
Net loss | $ | (57,033 | ) | $ | (84,136 | ) | 27,103 | (32 | )% | |||||||
Basic/diluted Net loss per share attributable to shareholders | $ | (0.79 | ) | $ | (1.53 | ) |
Nine months ended September 30, | $ change | % change | ||||||||||||||
2022 | 2021 | |||||||||||||||
Sales | — | — | ||||||||||||||
Other income | 6,148 | 2,776 | 3,373 | 122 | % | |||||||||||
Research tax credit | 4,467 | 5,324 | (857 | ) | (16 | %) | ||||||||||
Other operating income | 1,681 | (2,549 | ) | 4,230 | (166 | %) | ||||||||||
Total operating income | 6,148 | 2,776 | 3,373 | 122 | % | |||||||||||
Nine Months Ended September 30, | ||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||
Research and Development expenses | ||||||||||||||||
External clinical-related expenses | 30,150 | 31,319 | (1,169 | ) | (4 | %) | ||||||||||
Employee-related costs | 7,761 | 10,525 | (2,764 | ) | (26 | %) | ||||||||||
Share-based payment expenses | 1,596 | 1,747 | (151 | ) | (9 | %) | ||||||||||
Depreciation, amortization and other costs | 6,423 | 15,072 | (8,649 | ) | (57 | %) | ||||||||||
Total Research and Development expenses | 45,930 | 58,663 | (12,733 | ) | (22 | %) | ||||||||||
Nine Months Ended September 30, | ||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||
Sales and Marketing expenses | ||||||||||||||||
Personnel expenses | 727 | 1,528 | (801 | ) | (52 | %) | ||||||||||
External professional services and other costs | 932 | 1,471 | (538 | ) | (37 | %) | ||||||||||
Total Sales and Marketing expenses | 1,659 | 2,999 | (1,340 | ) | (45 | %) | ||||||||||
Nine Months Ended September 30, | ||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||
General and Administrative expenses | ||||||||||||||||
External professional services | 4,171 | 6,425 | (2,255 | ) | (35 | %) | ||||||||||
Employee-related costs | 5,139 | 7,263 | (2,124 | ) | (29 | %) | ||||||||||
Share-based payment expenses | 1,822 | 2,084 | (263 | ) | (13 | %) | ||||||||||
Depreciation, amortization and other costs | 6,042 | 10,478 | (4,436 | ) | (42 | %) | ||||||||||
Total General and Administrative expenses | 17,173 | 26,250 | (9,077 | ) | (35 | %) | ||||||||||
Liquidity and Capital Resources
Financial Condition
On September 30, 2022,March 31, 2023, we had $212.7$192.3 million in cash and cash equivalents compared to $77.3$209.2 million of cash and cash equivalents on December 31, 2021.2022. 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 $31.8$20.8 and $89.5$1.5 million for the ninethree months ended September 30,March 31, 2023 and 2022, and 2021, respectively. For the ninethree months ended September 30, 2022,March 31, 2023, we recorded a net loss of $57$20.6 million. Our net cash flows provided by financing activities increased to $194.4 millionwas nil during the ninethree months ended September 30, 2022 fromMarch 31, 2023 compared to $(0.1) million during the ninethree months ended September 30, 2021. Financing activities consisted mainly of our global offering in the second quarter ofMarch 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 is projected to be sufficient to support our operating plan for at least the next 12 months.
In May 2022, the Company announced that pursuantwe established an At-The-Market (“ATM”) program to the Company’s ATM program, it had issuedoffer and completed sales of new Ordinary Shares in the form of ADSs, forsell, including with unsolicited investors who have expressed an interest, a total gross amount of $15.3 million.
We intend to 28,276,331 Ordinary Shares.
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 due to the ongoing COVID-19 pandemic.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.
Material Cash Requirements Due by the period Ended September 30, | ||||||||||||||||||||
2023 | 2024 | 2025 | Thereafter | Total | ||||||||||||||||
(Amounts in thousands) | ||||||||||||||||||||
Operating leases | 1,381 | 1,423 | — | — | 2,804 | |||||||||||||||
Purchase obligations - Obligations Under the Terms of CRO Agreements | 12,411 | 36,234 | 7,805 | — | 56,450 | |||||||||||||||
Total | 13,791 | 37,657 | 7,805 | — | 59,254 |
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$3.4 million cash requirement as of September 30,December 31, 2022 which expires March 8, 2024.
Our primary U.S. office is located in North America that were initially intended to support our U.S. subsidiary as well as future commercialization needs. We lease 3,780 square feet of office space in Tower 49,Basking Ridge, New York, New York. This lease is for a period of 65 months and expires on February 25, 2023.Jersey. In light of our global restructuring, the current stage of regulatory interactions regarding Viaskin Peanut, and the ongoing COVID-19 pandemic,March 2022, we entered into a sublease agreement of this office space in June 2021. The NYC office represents a $0.2 million cash requirement as of September 30, 2022 until the first quarter of 2023.
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. Expenses associated with
There have been no material changes in our purchase obligations from those disclosed in the ongoing trials amounted globally to $125.9 million. As of September 30, 2022, the amount we are still obligated to pay in connection with these contracts through 2025 is $56.4 million.
Summary Statement of Cash Flows
The table below summarizes our sources and uses of cash for the ninethree months ended September 30, 2022March 31, 2023 and 2021.
Nine months ended September 30, | ||||||||||||||||
(Amounts in thousands of U.S. Dollars) | 2022 | 2021 | $ change | % of change | ||||||||||||
Net cash flow used in operating activities | (31,781 | ) | (89,452 | ) | 57,671 | (64 | %) | |||||||||
Net cash flow used in investing activities | (66 | ) | 41 | (107 | ) | (262 | %) | |||||||||
Net cash flow provided by financing activities | 194,403 | (103 | ) | 194,506 | * | |||||||||||
Effect of exchange rate changes on cash and cash equivalents | (27,186 | ) | (8,643 | ) | (18,543 | ) | 215 | % | ||||||||
Net (decrease) increase in cash and cash equivalents | 135,369 | (98,157 | ) | 233,527 | (238 | %) | ||||||||||
Three months ended arch 31, | ||||||||||||||||
(Amounts in thousands of U.S. Dollars) | 2023 | 2022 | $ change | % of change | ||||||||||||
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 | 3,909 | (1,594 | ) | 5,503 | (345 | %) | ||||||||||
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Net (decrease) increase in cash and cash equivalents | (16,905 | ) | (3,194 | ) | (13,711 | ) | 429 | % | ||||||||
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Operating Activities
Our net cash flows used in operating activities were $31.8$20.8 million and $89.5$1.5 million during the ninethree months ended September 30,March 31, 2023 and 2022, and 2021, respectively. DuringThe variance of $19.4 million is mainly driven by the nine months period ended September 30, 2022, we received $21.1reimbursement of $20.9 million of research tax credit’s reimbursementcredits for the 2019 2020 and 20212020 fiscal year. Excluding research tax credit reimbursement, our net cash flows used in operating activities decreased by $31.3 million, or 35%, mainly due to cost containment measures and to the workforce reduction following full implementation of the new organization
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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.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Annual Report.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Based on its evaluation as of September 30, 2022,March 31, 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'sSEC’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'smanagement’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.
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PART II – Other information
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.
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 below, therein 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 ninethree months ended September 30, 2022,March 31, 2023, we issued the following unregistered securities:
On March 23, 2023, the issuance of |
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.
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Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Not applicable.
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Item 6. Exhibits.
Exhibit Index
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 incorporate language contained in such filing. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registration has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
DBV Technologies S.A. | ||||||||
(Registrant) | ||||||||
Date: | By: | /s/ Daniel Tassé | ||||||
Daniel Tassé | ||||||||
Chief Executive Officer | ||||||||
(Principal Executive Officer) | ||||||||
Date: | By: | /s/ Sébastien Robitaille | ||||||
Sébastien Robitaille | ||||||||
Chief Financial Officer | ||||||||
(Principal Financial and Accounting Officer) |
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