☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
2022
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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 | ☐ |
Page 1 1 2 3 4 5 1315 1720 1721 1822 1822 1822 1822 1822 1822 1822 1923
statements regarding
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the implementation of our global restructuring plan,
developments relating to our competitors and our industry, including competing therapies; and
statements by these cautionary statements.
March 31, | December 31, | |||||||||||
Note | 2021 | 2020 | ||||||||||
Assets | ||||||||||||
Current assets : | ||||||||||||
Cash and cash equivalents | 3 | $ | 152,459 | $ | 196,352 | |||||||
Trade receivables | — | 2,230 | ||||||||||
Other current assets | 7,349 | 8,792 | ||||||||||
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Total current assets | 159,809 | 207,375 | ||||||||||
Property, plant, and equipment, net | 21,526 | 24,792 | ||||||||||
Right-of-use assets related to operating leases | 9,168 | 10,104 | ||||||||||
Intangible assets | 32 | 41 | ||||||||||
Other non-current assets | 30,870 | 29,935 | ||||||||||
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Total non-current assets | 61,596 | 64,871 | ||||||||||
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Total Assets | $ | 221,405 | $ | 272,246 | ||||||||
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Liabilities and shareholders’ equity | ||||||||||||
Current liabilities: | ||||||||||||
Trade payables | 4 | $ | 17,176 | $ | 20,338 | |||||||
Short-term operating leases | 3,314 | 3,708 | ||||||||||
Short-term financial debt | 701 | 724 | ||||||||||
Current contingencies | 6 | 4,246 | 5,016 | |||||||||
Other current liabilities | 4 | 13,394 | 22,926 | |||||||||
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Total current liabilities | 38,831 | 52,713 | ||||||||||
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Long-term operating leases | 9,533 | 10,496 | ||||||||||
Long-term financial debt | 350 | 543 | ||||||||||
Non-current contingencies | 6 | 2,229 | 2,527 | |||||||||
Other non-current liabilities | 1,286 | 475 | ||||||||||
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Total non-current liabilities | 13,398 | 14,042 | ||||||||||
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Total Liabilities | $ | 52,229 | $ | 66,754 | ||||||||
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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 | $ | 6,519 | $ | 6,518 | ||||||||
Additional paid-in capital | 1,153,516 | 1,152,042 | ||||||||||
Treasury stock, 60,588 and 112,302 ordinary shares as of March 31, 2021 and December 31, 2020, respectively, at cost | (681 | ) | (1,169 | ) | ||||||||
Accumulated deficit | (987,992 | ) | (958,543 | ) | ||||||||
Accumulated other comprehensive income | 399 | 484 | ||||||||||
Accumulated currency translation effect | (2,586 | ) | 6,158 | |||||||||
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Total Shareholders’ equity | $ | 169,176 | $ | 205,491 | ||||||||
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Total Liabilities and Shareholder’s equity | $ | 221,405 | $ | 272,246 | ||||||||
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March 31, | December 31, | |||||||||
Note | 2022 | 2021 | ||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | 3 | $ | 74,107 | $ | 77,301 | |||||
Other current assets | 4 | 16,329 | 37,085 | |||||||
Total current assets | 90,437 | 114,386 | ||||||||
Property, plant, and equipment, net | 17,196 | 18,146 | ||||||||
Right | 5 | 3,356 | 7,336 | |||||||
Intangible assets | 18 | 22 | ||||||||
Other non-current assets | 6,575 | 6,833 | ||||||||
Total non-current assets | 27,144 | 32,338 | ||||||||
Total Assets | $ | 117,581 | $ | 146,723 | ||||||
Liabilities and shareholders’ equity | ||||||||||
Current liabilities: | ||||||||||
Trade payables | 6 | $ | 11,416 | $ | 11,429 | |||||
Short-term operating leases | 5 | 2,034 | 3,003 | |||||||
Short-term financial debt | 333 | 510 | ||||||||
Current contingencies | 8 | 3,529 | 4,095 | |||||||
Other current liabilities | 6 | 8,719 | 12,361 | |||||||
Total current liabilities | 26,031 | 31,397 | ||||||||
Long-term operating leases | 5 | 2,268 | 7,147 | |||||||
Non-current contingencies | 8 | 5,758 | 6,758 | |||||||
Other non-current liabilities | 1,461 | 2,147 | ||||||||
Total current liabilities | 9,488 | 16,052 | ||||||||
Total Liabilities | $ | 35,519 | $ | 47,449 | ||||||
Shareholders’ equity: | ||||||||||
Ordinary shares, €0.10 par value; 55,096,537 and 55,095,762 shares authorized, and issued as at March 31, 2022 and December 31, 2021, respectively | $ | 6,539 | $ | 6,538 | ||||||
Additional paid-in capital | 359,478 | 358,115 | ||||||||
Treasury stock, 144,501 and 153,631 ordinary shares as of March 31, 2022 and December 31, 2021, respectively, at cost | (1,193 | ) | (1,232 | ) | ||||||
Accumulated deficit | (275,219 | ) | (258,528 | ) | ||||||
Accumulated other comprehensive income | 543 | 519 | ||||||||
Accumulated currency translation effect | (8,086 | ) | (6,137 | ) | ||||||
Total Shareholders’ equity | $ | 82,062 | $ | 99,274 | ||||||
Total Liabilities and s hareholder’s equity | $ | 117,581 | $ | 146,723 | ||||||
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 | 2022 | 2021 | ||||||||||
Operating income | 9 | $ | 2,546 | $ | 2,941 | |||||||
Operating expenses | ||||||||||||
Research and development expenses | (12,223 | ) | (22,164 | ) | ||||||||
Sales and marketing expenses | (464 | ) | (729 | ) | ||||||||
General and administrative expenses | (6,630 | ) | (9,683 | ) | ||||||||
Total Operating expenses | (19,317 | ) | (32,575 | ) | ||||||||
Loss from operations | (16,771 | ) | (29,634 | ) | ||||||||
Financial income | 152 | 215 | ||||||||||
Loss before taxes | (16,619 | ) | (29,419 | ) | ||||||||
Income tax | (87 | ) | (30 | ) | ||||||||
Net loss | $ | (16,706) | $ | (29,449) | ||||||||
Foreign currency translation differences, net of taxes | (1,933 | ) | (8,744 | ) | ||||||||
Actuarial gains (loss) on employee benefits, net of taxes | 24 | (85 | ) | |||||||||
Total comprehensive loss | $ | (18,615 | ) | $ | (38,279 | ) | ||||||
Basic/diluted net loss per share attributable to shareholders | 13 | $ | (0.30 | ) | $ | (0.54 | ) | |||||
Weighted average number of shares outstanding used in computing per share amounts: | 54,932,192 | 54,880,776 |
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 | 2022 | 2021 | ||||||||
Net loss for the period | ||||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | $ | (16,706 | ) | $ | (29,449 | ) | ||||
Depreciation, amortization and accrued contingencies | (599 | ) | 1,483 | |||||||
Retirement pension obligations | (9 | ) | 0 | |||||||
Expenses related to share-based payments | 1,363 | 1,433 | ||||||||
Other elements | (3 | ) | (456 | ) | ||||||
Changes in operating assets and liabilities: | ||||||||||
Decrease (increase) in trade receivables | 0 | 2,101 | ||||||||
Decrease (increase) in other current assets | 20,458 | (417 | ) | |||||||
(Decrease) increase in trade payables | (19 | ) | (2,567 | ) | ||||||
(Decrease) increase in other current and non-current liabilities | (4,118 | ) | (7,980 | ) | ||||||
Change in operating lease liabilities and right of use assets | (1,849 | ) | (353 | ) | ||||||
Net cash flow used in operating activities | (1,483 | ) | (36,204 | ) | ||||||
Cash flows provided by (used in) investing activities: | ||||||||||
Acquisitions of property, plant, and equipment | (131 | ) | (184 | ) | ||||||
Proceeds from property, plant and equipment dispositions | 3 | 0 | ||||||||
Acquisitions of non-current financial assets | (40 | ) | (1 | ) | ||||||
Proceeds from non-current financial assets | 179 | 0 | ||||||||
Net cash flows provided by (used in) investing activities | 11 | (185 | ) | |||||||
Cash flows (used in) provided by financing activities: | ||||||||||
(Decrease) in conditional advances | (168 | ) | (164 | ) | ||||||
Treasury shares | 40 | 578 | ||||||||
Capital increases, net of transaction costs | 0 | 42 | ||||||||
Other cash flows related to financing activities | 0 | (17 | ) | |||||||
Net cash flows (used in) provided by financing activities | (129 | ) | 440 | |||||||
Effect of exchange rate changes on cash and cash equivalents | (1,594 | ) | (7,944 | ) | ||||||
Net decrease in cash and cash equivalents | (3,194 | ) | (43,893 | ) | ||||||
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 | $ | 74,107 | $ | 152,459 | |||||
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, 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 |
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 | 0 | — | — | — | — | 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 |
2021.
first quarter of 2023.
Effective January 1, 2021, the2022
date.
In January 2017, the FASB issued ASU 2017-04, Simplifying the Test for Goodwill Impairment, which modifies the goodwill impairment test and requires an entity to write down the carrying value of goodwill for the amount by which the carrying amount of a reporting unit exceeds its fair value. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The Company does not expect this new standard will have a material impact on its consolidated financial statements.
- United States Regulatory History and Current Status
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. 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
requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years.
On November 2, 2020, The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches
a. | PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL |
b. | ‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and Mvp; |
available.
Financing
On February 4, 2020,2021 and
On March 2, 2020, the Company announced that the underwriters partially exercised their option to purchase 338,687 additional ordinary shares in the form of 677,374 ADSs at an offering price of $10.25 per ADS, before deducting commissions and estimated offering expenses (the “Option”). The Option closed on March 4, 2020.
Consequently, following partial exerciseend of the Option, the total numbersecond quarter of ordinary shares sold in the global offering was 7,838,687 ordinary shares, including 4,874,268 ordinary shares in the form of 9,748,536 ADSs, bringing the total gross proceeds from the global offering to $160.7 million and net proceeds of $150.0 million.
Restructuring
The Company initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanut in the United States and European Union. The Company expects full implementation of the organization-wide costs reduction measures to be completed 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:
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2022.
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 remain subject to travel restrictions.
March 31, | December 31, | |||||||
2021 | 2020 | |||||||
Cash | 58,069 | 42,341 | ||||||
Cash equivalents | 94,390 | 154,011 | ||||||
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Total cash and cash equivalents as reported in the statements of financial position | 152,459 | 196,352 | ||||||
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March 31, | December 31, | |||||||
2022 | 2021 | |||||||
Cash | 29,145 | 31,427 | ||||||
Cash equivalents | 44,963 | 45,874 | ||||||
Total cash and cash equivalents as reported in the statements of financial position | 74,107 | 77,301 | ||||||
Bank overdrafts | 0 | 0 | ||||||
Total net cash and cash equivalents as reported in the statements of cash flows | 74,107 | 77,301 | ||||||
March 31, | December 31, | |||||||
2022 | 2021 | |||||||
Research tax credit | 8,430 | 28,092 | ||||||
Other tax claims | 3,696 | 3,561 | ||||||
Prepaid expenses | 3,386 | 4,149 | ||||||
Other receivables | 817 | 1,283 | ||||||
Total | 16,329 | 37,085 | ||||||
Amount in thousands of US Dollars | ||||
Opening research tax credit receivable as of January 1, 2022 | 28,092 | |||
+ Operating revenue | 1,569 | |||
- Payment received | (20,874 | ) | ||
- Adjustment and currency translation effect | (358 | ) | ||
Closing research tax credit receivable as of March 31, 2022 | 8,430 | |||
Of which - Non-current portion | 0 | |||
Of which - Current portion | 8,430 |
March 31, 2022 | December 31, 2021 | |||||||||||||||||||||||
Real estate | Other assets | Total | Real estate | Other assets | Total | |||||||||||||||||||
Current portion | 2,159 | 66 | 2,225 | 3,361 | 77 | 3,438 | ||||||||||||||||||
Year 2 | 1,803 | 18 | 1,821 | 3,124 | 23 | 3,147 | ||||||||||||||||||
Year 3 | 605 | 15 | 620 | 2,299 | 18 | 2,317 | ||||||||||||||||||
Year 4 | — | — | — | 771 | 1 | 773 | ||||||||||||||||||
Year 5 | — | — | — | 790 | — | 790 | ||||||||||||||||||
Thereafter | — | — | — | 1,220 | — | 1,220 | ||||||||||||||||||
Total minimum lease payments | 4,567 | 99 | 4,666 | 11,565 | 119 | 11,684 | ||||||||||||||||||
Less: Effects of discounting | (358 | ) | (7 | ) | (365 | ) | (1,526 | ) | (8 | ) | (1,534 | ) | ||||||||||||
Present value of operating lease | 4,209 | 92 | 4,302 | 10,039 | 111 | 10,150 | ||||||||||||||||||
Less: current portion | (1,973 | ) | (61 | ) | (2,034 | ) | (2,929 | ) | (74 | ) | (3,003 | ) | ||||||||||||
Long-term operating lease | 2,236 | 31 | 2,268 | 7,110 | 37 | 7,147 | ||||||||||||||||||
Weighted average remaining lease term (years) | 2.21 | 1.87 | 4.14 | 2.01 | ||||||||||||||||||||
Weighted average discount rate | 3.51 | % | 3.32 | % | 4.84 | % | 3.32 | % |
March 31, | ||||||||
2022 | 2021 | |||||||
Operating lease expense / (income) | (1,150 | ) | 847 |
March 31, | ||||||||
2022 | 2021 | |||||||
Cash paid for amounts included in the measurement of lease liabilities | ||||||||
Operating cash flows from operating leases | 583 | 1,025 |
4.1
4.2
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, | |||||||
2022 | 2021 | |||||||
Social security | 3,995 | 6,708 | ||||||
Deferred income | 3,794 | 4,146 | ||||||
Tax liabilities | 137 | 182 | ||||||
Other debts | 793 | 1,325 | ||||||
Total | 8,719 | 12,361 | ||||||
During the three months ended March 31, 2021,2022, the Company granted 75,600did not grant any stock options and 24,900 restricted stock.
| ||||
| ||||
| ||||
| ||||
| ||||
| ||||
|
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 | ||||||||||||
|
|
|
|
|
|
|
|
Number of outstanding | ||||||||||||
BSA | SO | RSUs | ||||||||||
Balance as of December 31, 2021 | 256,693 | 3,631,210 | 1,240,520 | |||||||||
Granted during the period | — | — | — | |||||||||
Forfeited during the period | — | (159,403 | ) | (56,113 | ) | |||||||
Exercised/released during the period | 0 | — | (775 | ) | ||||||||
Expired during the period | — | — | 0 | |||||||||
Balance as of March 31, 2022 | 256,693 | 3,471,808 | 1,183,633 | |||||||||
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 | ) | ||||||||
|
|
|
|
Three months Ended March 31, | ||||||||||
2022 | 2021 | |||||||||
Research and development | SO | (375 | ) | (376 | ) | |||||
RSU | (208 | ) | (251 | ) | ||||||
Sales and marketing | SO | 5 | (49 | ) | ||||||
RSU | 1 | (22 | ) | |||||||
General and administrative | SO | (698 | ) | (644 | ) | |||||
RSU | (87 | ) | (91 | ) | ||||||
Total share-based compensation (expense) | (1,363 | ) | (1,433 | ) | ||||||
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 | ||||||
|
|
|
|
March 31, | December 31, | |||||||
2022 | 2021 | |||||||
Current contingencies | 3,529 | 4,095 | ||||||
Non-current contingencies | 5,758 | 6,758 | ||||||
�� | ||||||||
Total contingencies | 9,288 | 10,853 | ||||||
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 |
Pension retirement obligations | Collaboration agreement - Loss at completion | Other contingencies | Total | |||||||||||||
At January 1, 2022 | 1,008 | 9,800 | 45 | 10,853 | ||||||||||||
Increases in liabilities | 0 | 0 | 0 | 0 | ||||||||||||
Used liabilities | — | (1,286 | ) | (45 | ) | (1,331 | ) | |||||||||
Reversals of unused liabilities | (9 | ) | — | — | (9 | ) | ||||||||||
Net interest related to employee benefits, and unwinding of discount | — | — | — | 0 | ||||||||||||
Actuarial gains and losses on defined-benefit plans | (24 | ) | — | — | (24 | ) | ||||||||||
Currency translation effect | (20 | ) | (181 | ) | — | (202 | ) | |||||||||
At March 31, 2022 | 955 | 8,332 | 0 | 9,288 | ||||||||||||
Of which Current | — | 3,529 | 0 | 3,529 | ||||||||||||
Of which Non-current | 955 | 4,803 | — | 5,758 |
Other contingencies are primarily composed of the estimated expenses to be incurred as part of the employee-related costs related to restructuring, as well as estimated cost of refurbishing lease premises (Refer to Note 2, “Significant Events and Transactions—Restructuring contingencies).
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 | ||||||
|
|
|
|
Three months Ended March 31, | ||||||||
2022 | 2021 | |||||||
Research tax credit | 1,569 | 1,807 | ||||||
Other operating income | 976 | 1,133 | ||||||
Total | 2,546 | 2,941 | ||||||
2021.
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 | ||||||
|
|
|
|
Three months Ended March 31, | ||||||||
2022 | 2021 | |||||||
Research and Development expenses | 3,075 | 4,718 | ||||||
Sales and Marketing expenses | 245 | 518 | ||||||
General and Administrative expenses | 2,595 | 3,766 | ||||||
Total personnel expenses | 5,915 | 9,002 | ||||||
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 | ||||||
|
|
|
|
Three months Ended March 31, | ||||||||
2022 | 2021 | |||||||
Wages and salaries | 3,987 | 4,454 | ||||||
Social security contributions | 251 | 1,332 | ||||||
Expenses for pension commitments | 297 | 402 | ||||||
Employer contribution to bonus shares | 16 | 1,381 | ||||||
Share-based payments | 1,363 | 1,433 | ||||||
Total | 5,915 | 9,002 | ||||||
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 EndedMarch 31, | ||||||||
2022 | 2021 | |||||||
Non-employee warrants | 256,693 | 225,008 | ||||||
Employee warrants | 0 | 75,000 | ||||||
Stock-options | 3,471,808 | 2,670,710 | ||||||
Restricted stock units | 1,183,633 | 1,129,945 |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
2020,2021, included in our Annual Report on Form 10-K for the year ended December 31, 2020,2021, filed with the Securities and Exchange Commission on March 17, 2021,9, 2022, 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.EPITTM,EPITTM, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin. We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, as it targets specificOn We believe Viaskin may offer convenient, self-administered,13, 2021, the Companywe received written responses from the FDA to questions provided in the Type A meeting request the Companywe submitted in October 2020 following 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 1/10001,000 of aone 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.thea modified Viaskin Peanut patch in the intended patient population. We later named this clinical trial STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.1. 2. 3. a. b. protocolsallergen uptake comparison data for FDA review and feedback prior to starting the STAMP study. The FDA’s explanation was that the results from the allergen uptake trials might affect the design of the STAMP study.the allergen uptake studywas submitted to the FDA for review and comments before initiating the trials. We will address details aboutin April 2022. The Company has been granted a new human factor, or HF, validation study and additional CMC data in subsequent interactions withType C meeting by the FDADuring , which is expected to be held in the second quarter of 2022, to align on the new Phase 3 study protocol.
Three months ended | ||||||||
2022 | 2021 | |||||||
Operating income | $ | 2,546 | $ | 2,941 | ||||
Operating expenses | ||||||||
Research and development expenses | (12,223 | ) | (22,164 | ) | ||||
Sales and marketing expenses | (464 | ) | (729 | ) | ||||
General and administrative expenses | (6,630 | ) | (9,683 | ) | ||||
Total Operating expenses | (19,317 | ) | (32,575 | ) | ||||
Financial income | 152 | 215 | ||||||
Income tax | (87 | ) | (30 | ) | ||||
Net loss | $ | (16,706 | ) | $ | (29,449 | ) | ||
Basic/diluted Net loss per share attributable to shareholders | $ | (0.30 | ) | $ | (0.54 | ) |
Three months Ended March 31 | % change | |||||||||||
2022 | 2021 | |||||||||||
Sales | — | — | ||||||||||
Other income | 2,546 | 2,941 | (13 | %) | ||||||||
Research tax credit | 1,569 | 1,807 | (13 | %) | ||||||||
Other operating (loss) income | 976 | 1,133 | (14 | %) | ||||||||
Total operating income | 2,546 | 2,941 | (13 | %) | ||||||||
Three months ended March 31, | $ change | % change | ||||||||||||||
Research and Development expenses | 2022 | 2021 | ||||||||||||||
External clinical-related expenses | 7,350 | 12,878 | (5,528 | ) | (43 | %) | ||||||||||
Employee-related costs | 2,492 | 4,091 | (1,599 | ) | (39 | %) | ||||||||||
Share-based payment expenses | 583 | 627 | (45 | ) | (7 | %) | ||||||||||
Depreciation, amortization and other costs | 1,799 | 4,568 | (2,769 | ) | (61 | %) | ||||||||||
Total Research and Development expenses | 12,223 | 22,164 | (9,941 | ) | (45 | %) | ||||||||||
Three months ended March 31, | $ change | % change | ||||||||||||||
Sales & Marketing expenses | 2022 | 2021 | ||||||||||||||
Employee-related costs | 245 | 518 | (273 | ) | (53 | %) | ||||||||||
External professional services | 122 | 84 | 38 | 45 | % | |||||||||||
Share-based payment expenses | (5 | ) | 71 | (76 | ) | (108 | %) | |||||||||
Depreciation, amortization and other costs | 102 | 56 | 46 | 82 | % | |||||||||||
Total Sales & Marketing expenses | 464 | 729 | (265 | ) | (36 | %) | ||||||||||
Three months ended March 31, | $ change | % change | ||||||||||||||
General & Administrative expenses | 2022 | 2021 | ||||||||||||||
External professional services | 1,108 | 2,287 | (1,179 | ) | (52 | %) | ||||||||||
Employee-related costs | 1,810 | 3,031 | (1,221 | ) | (40 | %) | ||||||||||
Share-based payment expenses | 786 | 735 | 51 | 7 | % | |||||||||||
Depreciation, amortization and other costs | 2,927 | 3,630 | (702 | ) | (19 | %) | ||||||||||
Total General & Administrative expenses | 6,630 | 9,683 | (3,052 | ) | (32 | %) | ||||||||||
Material Cash Requirements Due by the period Ended March 31, | ||||||||||||||||||||
2023 | 2024-2025 | 2026-2027 | Thereafter | Total | ||||||||||||||||
(Amounts in thousands) | ||||||||||||||||||||
Conditional advances | 333 | — | — | — | 333 | |||||||||||||||
Operating leases | 2,034 | 2,268 | — | — | 4,302 | |||||||||||||||
Purchase obligations - Obligations Under the Terms of CRO Agreements | 20,785 | 8,825 | 3,457 | — | 33,067 | |||||||||||||||
Total | 23,152 | 11,094 | 3,457 | — | 37,703 |
Three months ended March 31, | % change | |||||||||||
(Amounts in thousands of U.S. Dollars) | 2022 | 2021 | ||||||||||
Net cash flow used in operating activities | (1,483 | ) | (36,204 | ) | (96 | %) | ||||||
Net cash flow provided by (used in) investing activities | 11 | (185 | ) | (106 | %) | |||||||
Net cash flow (used in) provided by financing activities | (129 | ) | 440 | (129 | %) | |||||||
Effect of exchange rate changes on cash and cash equivalents | (1,594 | ) | (7,944 | ) | (80 | %) | ||||||
Net (decrease) increase in cash and cash equivalents | (3,194 | ) | (43,893 | ) | (93 | %) | ||||||
Operating | Activities |
Research Tax Credit.
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. DollarsAnnual Report on Form 10-K for the three monthsyear ended MarchDecember 31, 2021, filed with the Securities and 2020:
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 endedExchange Commission (“SEC”) on March 31, 2021 to the three months ended March 31, 2020
Operating Income
We generated 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%. This income was mainly generated from the French research tax credit (crédit d’impôt recherche), or CIR, and by 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 | )% | ||||||||
|
|
|
|
|
|
The decrease in operating income is primarily attributable to the decrease of the CIR, 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 measurement of progress of the Phase II clinical trial conducted as part of the collaboration and license agreement with Nestlé Health Science. The accrual recorded in the amount of the difference between our current best estimates of costs yet to be incurred and income yet to be recognized for the completion of the Phase II clinical has been updated accordingly.
Operating Expense
The following table summarizes our operating expense excluding restructuring incurred during the three months ended March 31, 2021 and 2020:
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 | )% | ||||||||
|
|
|
|
|
| |||||||
Total operating expenses | 32,575 | 45,942 | (29.1 | )% | ||||||||
|
|
|
|
|
|
Operating expenses for the three months ended March 31, 2021 were $32.6 million compared to $45.9 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 related 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 $18.7 million for the three months ended March 31, 2020. Average headcount decreased 61% between the two periods, from 311 FTEs for the three months ended March 31, 2020 to and 121 FTEs for the three months ended March 31, 2021. By function, the personnel expenses, including share-based payment expenses, decreased as follows:
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 | )% | ||||||||
|
|
|
|
|
| |||||||
Total personnel expenses | 9,002 | 18,684 | (51.8 | )% | ||||||||
|
|
|
|
|
|
The decrease in other operating expenses was primarily due to the budget discipline measures taken by DBV. In particular, sales and marketing consulting fees dropped by 96.8% or $2.6 million, from $2.7 million for the three months ended March 31, 2020 to $0.1 million for the three months ended March 31, 2021 and general and administrative fees decreased by 43.5% or $1.7 million, from $4.0 million for the three months ended March 31, 2020 to $2.3 million for the three months ended March 31, 2021.
As 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:
| ||||
| ||||
| ||||
| ||||
| ||||
|
They were no restructuring costs for three months ended March 31, 2021 and 2020.
Financial income
Our financial income was $0.2 million for the three months ended March 31, 2021 and 2020. This item mainly includes foreign exchange income.
Net loss
Net loss was $29.4 million for the three months ended March 31, 2021, compared to $40.9 million for the three months ended March 31, 2020. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.54 and $0.79 for three months ended March 31, 2021 and 2020, respectively.
Summary Statement of Cash Flows
The table below summarizes our sources and uses of cash for the three months ended March 21, 2021 and 2020.
Three Months Ended March 31, | % change | |||||||||||
(Amounts in thousands of U.S. Dollars) | 2021 | 2020 | 2021 vs 2020 | |||||||||
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 | )% | ||||||||
Effect of exchange rate changes on cash and cash equivalents | (7,944 | ) | (5,811 | ) | (36.7 | )% | ||||||
|
|
|
|
|
| |||||||
Net (decrease) increase in cash and cash equivalents | (43,893 | ) | 94,187 | (146.6 | )% | |||||||
|
|
|
|
|
|
Operating Activities
Our net cash flows used in operating activities were $36.2 million and $49.7 million during the three months ended March 31, 2021 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.
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.
Smaller Reporting Company Status
Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
Our market risks have
Item 4. | Controls and Procedures |
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.2021,2022, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 1. | Legal Proceedings |
Item 1A. | Risk Factors |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
RSUs.
Item 3. | Defaults Upon Senior Securities |
Item 4. | Mine Safety Disclosures |
Item 5. | Other Information |
Not applicable.
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 |
Exhibit | Description | Incorporated by Reference | ||||||||
Schedule / Form | File Number | Exhibit | File Date | |||||||
3.1 | By-laws (statuts) 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 | Inline XBRL Instance Document - the instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document | |||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document | |||||||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |||||||||
101.LAB | Inline XBRL Taxonomy Extension Labels Linkbase Document | |||||||||
101.PRE | Inline 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 |
DBV Technologies S.A. | ||||||
(Registrant) | ||||||
Date: May | ||||||
, 2022 | 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) |