☒ | 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 BrossoletteMontrouge France | 92120 | ||
(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 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 | ||||||||
Part I | ||||||||
Item 1 | ||||||||
Item 2 | ||||||||
Item 3 | ||||||||
Item 4 | ||||||||
Part II | ||||||||
Item 1 | ||||||||
Item 1A | ||||||||
Item 2 | ||||||||
Item 3 | ||||||||
Item 4 | ||||||||
Item 5 | ||||||||
Item 6 |
September 30, | December 31, | March 31, | December 31, | |||||||||||||||||||
Note | 2021 | 2020 | Note | 2022 | 2021 | |||||||||||||||||
Assets | ||||||||||||||||||||||
Current assets: | ||||||||||||||||||||||
Cash and cash equivalents | 3 | $ | 98,195 | $ | 196,352 | 3 | $ | 74,107 | $ | 77,301 | ||||||||||||
Trade receivables | — | 2,230 | ||||||||||||||||||||
Other current assets | 11,943 | 8,792 | 4 | 16,329 | 37,085 | |||||||||||||||||
Total current assets | 110,138 | 207,375 | 90,437 | 114,386 | ||||||||||||||||||
Property, plant, and equipment, net | 19,273 | 24,792 | 17,196 | 18,146 | ||||||||||||||||||
Right-of-use | 7,876 | 10,104 | ||||||||||||||||||||
Right | 5 | 3,356 | 7,336 | |||||||||||||||||||
Intangible assets | 26 | 41 | 18 | 22 | ||||||||||||||||||
Other non-current assets | 33,612 | 29,935 | 6,575 | 6,833 | ||||||||||||||||||
Total non-current assets | 60,786 | 64,871 | 27,144 | 32,338 | ||||||||||||||||||
Total Assets | $ | 170,924 | $ | 272,246 | $ | 117,581 | $ | 146,723 | ||||||||||||||
Liabilities and shareholders’ equity | ||||||||||||||||||||||
Current liabilities: | ||||||||||||||||||||||
Trade payables | 4 | $ | 12,170 | $ | 20,338 | 6 | $ | 11,416 | $ | 11,429 | ||||||||||||
Short-term operating leases | 2,657 | 3,708 | 5 | 2,034 | 3,003 | |||||||||||||||||
Short-term financial debt | 695 | 724 | 333 | 510 | ||||||||||||||||||
Current contingencies | 7 | 5,633 | 5,016 | 8 | 3,529 | 4,095 | ||||||||||||||||
Other current liabilities | 4 | 12,659 | 22,926 | 6 | 8,719 | 12,361 | ||||||||||||||||
Total current liabilities | 33,814 | 52,713 | 26,031 | 31,397 | ||||||||||||||||||
Long-term operating leases | 8,298 | 10,496 | 5 | 2,268 | 7,147 | |||||||||||||||||
Long-term financial debt | — | 543 | ||||||||||||||||||||
Non-current contingencies | 7 | 7,629 | 2,527 | 8 | 5,758 | 6,758 | ||||||||||||||||
Other non-current liabilities | 4 | 4,292 | 475 | 1,461 | 2,147 | |||||||||||||||||
Total non-current liabilities | 20,218 | 14,042 | ||||||||||||||||||||
Total current liabilities | 9,488 | 16,052 | ||||||||||||||||||||
Total Liabilities | $ | 54,033 | $ | 66,754 | $ | 35,519 | $ | 47,449 | ||||||||||||||
Shareholders’ equity: | ||||||||||||||||||||||
Ordinary shares, €0.10 par value; 55,011,687 and 54,929,187 shares authorized, and issued as at September 30, 2021 and December 31, 2020, respectively, and 3,946,548 and 4,029,763 shares outstanding as at September 30, 2021 and December 31, 2020, respectively | $ | 6,529 | $ | 6,518 | ||||||||||||||||||
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 | 359,081 | 1,152,042 | 359,478 | 358,115 | ||||||||||||||||||
Treasury stock, 75,400 and 112,302 ordinary shares as of September 30, 2021 and December 31, 2020, respectively, at cost | (810 | ) | (1,169 | ) | ||||||||||||||||||
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 | (244,856 | ) | (958,543 | ) | (275,219 | ) | (258,528 | ) | ||||||||||||||
Accumulated other comprehensive income | 474 | 484 | 543 | 519 | ||||||||||||||||||
Accumulated currency translation effect | (3,526 | ) | 6,158 | (8,086 | ) | (6,137 | ) | |||||||||||||||
Total Shareholders’ equity | 5 | $ | 116,892 | $ | 205,491 | $ | 82,062 | $ | 99,274 | |||||||||||||
Total Liabilities and Shareholders’ E quity | $ | 170,924 | $ | 272,246 | ||||||||||||||||||
Total Liabilities and s hareholder’s equity | $ | 117,581 | $ | 146,723 | ||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | Three months Ended March 31, | ||||||||||||||||||||||||||||||
Note | 2021 | 2020 | 2021 | 2020 | Note | 2022 | 2021 | |||||||||||||||||||||||||
Operating income | 8 | $ | 1,323 | $ | 4,158 | $ | 2,776 | $ | 12,488 | 9 | $ | 2,546 | $ | 2,941 | ||||||||||||||||||
Operating expenses | ||||||||||||||||||||||||||||||||
Research and development expenses | (16,320 | ) | (25,751 | ) | (58,663 | ) | (75,214 | ) | (12,223 | ) | (22,164 | ) | ||||||||||||||||||||
Sales and marketing expenses | (1,072 | ) | (1,595 | ) | (2,999 | ) | (8,114 | ) | (464 | ) | (729 | ) | ||||||||||||||||||||
General and administrative expenses | (8,299 | ) | (6,863 | ) | (26,250 | ) | (26,838 | ) | (6,630 | ) | (9,683 | ) | ||||||||||||||||||||
Restructuring expenses | — | 286 | — | (21,003 | ) | |||||||||||||||||||||||||||
Total Operating expenses | (25,691 | ) | (33,923 | ) | (87,912 | ) | (131,169 | ) | (19,317 | ) | (32,575 | ) | ||||||||||||||||||||
Loss from operations | (24,368 | ) | (29,765 | ) | (85,137 | ) | (118,681 | ) | (16,771 | ) | (29,634 | ) | ||||||||||||||||||||
Financial income (expense) | 336 | (1,184 | ) | 597 | (1,380 | ) | ||||||||||||||||||||||||||
Financial income | 152 | 215 | ||||||||||||||||||||||||||||||
Loss before taxes | (24,033 | ) | (30,948 | ) | (84,540 | ) | (120,061 | ) | (16,619 | ) | (29,419 | ) | ||||||||||||||||||||
Income tax | — | (7 | ) | 404 | (10 | ) | (87 | ) | (30 | ) | ||||||||||||||||||||||
Net loss | $ | (24,033 | ) | $ | (30,955 | ) | $ | (84,136 | ) | $ | (120,071 | ) | $ | (16,706) | $ | (29,449) | ||||||||||||||||
Other comprehensive loss | ||||||||||||||||||||||||||||||||
Foreign currency translation differences, net of taxes | (3,728 | ) | 13,196 | (9,684 | ) | 13,495 | (1,933 | ) | (8,744 | ) | ||||||||||||||||||||||
Actuarial gains (losses) on employee benefits, net of taxes | 28 | (75 | ) | (10 | ) | (113 | ) | |||||||||||||||||||||||||
Actuarial gains (loss) on employee benefits, net of taxes | 24 | (85 | ) | |||||||||||||||||||||||||||||
Comprehensive loss | $ | (27,733 | ) | $ | (17,834 | ) | $ | (93,830 | ) | $ | (106,688 | ) | ||||||||||||||||||||
Total comprehensive loss | $ | (18,615 | ) | $ | (38,279 | ) | ||||||||||||||||||||||||||
Basic/diluted net loss per share attributable to shareholders | 12 | $ | (0.44 | ) | $ | (0.56 | ) | $ | (1.53 | ) | $ | (2.23 | ) | 13 | $ | (0.30 | ) | $ | (0.54 | ) | ||||||||||||
Weighted average shares outstanding used in computing per share amounts: | 54,947,354 | 54,843,843 | 54,911,278 | 53,852,176 | ||||||||||||||||||||||||||||
Weighted average number of shares outstanding used in computing per share amounts: | 54,932,192 | 54,880,776 |
Nine Months Ended September 30, | ||||||||||||
Notes | 2021 | 2020 | ||||||||||
Net loss for the period | $ | (84,136 | ) | $ | (120,071 | ) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
Depreciation, amortization and accrued contingencies | 9,705 | 18,360 | ||||||||||
Retirement pension obligations | 127 | (650 | ) | |||||||||
Expenses related to share-based payments | 6 | 4,078 | (2,965 | ) | ||||||||
Other elements | 1,214 | 789 | ||||||||||
Changes in operating assets and liabilities: | ||||||||||||
Decrease (increase) in inventories and work in progress | — | 2,292 | ||||||||||
Decrease (increase) in trade receivables | 2,174 | (1,974 | ) | |||||||||
Decrease (increase) in other current assets | (9,036 | ) | (9,591 | ) | ||||||||
(Decrease) increase in trade payables | (7,135 | ) | (6,760 | ) | ||||||||
(Decrease) increase in other current and non-current liabilities | (5,497 | ) | (11,372 | ) | ||||||||
Change in operating lease liabilities and right—of—use assets | (946 | ) | (136 | ) | ||||||||
Net cash flow used in operating activities | (89,452 | ) | (132,076 | ) | ||||||||
Cash flows provided by (used in) investing activities: | ||||||||||||
Acquisitions of property, plant, and equipment, net from proceeds | 46 | (2,200 | ) | |||||||||
Acquisitions of intangible assets | (8 | ) | (20 | ) | ||||||||
Acquisitions of non-current financial assets | 3 | (12 | ) | |||||||||
Net cash flows provided by (used in) investing activities | 41 | (2,232 | ) | |||||||||
Cash flows (used in) provided by financing activities: | ||||||||||||
(Decrease) increase in conditional advances | (518 | ) | (138 | ) | ||||||||
Treasury shares | (359 | ) | (766 | ) | ||||||||
Capital increases, net of transaction costs | 794 | 150,551 | ||||||||||
Other cash flows related to financing activities | (21 | ) | (24 | ) | ||||||||
Net cash flows (used in) provided by financing activities | (103 | ) | 149,624 | |||||||||
Effect of exchange rate changes on cash and cash equivalents | (8,643 | ) | 12,834 | |||||||||
Net (decrease) increase in cash and cash equivalents | (98,157 | ) | 28,150 | |||||||||
Net Cash and cash equivalents at the beginning of the period | 196,352 | 193,255 | ||||||||||
Net cash and cash equivalents at the end of the period | 3 | $ | 98,195 | $ | 221,404 | |||||||
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 | 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 | 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 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at January 1, 2021 | 54,929,187 | $ | 6,518 | $ | 1,152,042 | $ | (1,169 | ) | $ | (958,543 | ) | $ | 484 | $ | 6,158 | $ | 205,491 | |||||||||||||||||||||||||||||||||||||||||||||||
Net (loss) | — | — | — | — | (40,913 | ) | — | — | (40,913 | ) | — | — | — | — | (29,449 | ) | — | — | (29,449 | ) | ||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income (loss) | — | — | — | — | — | 189 | (6,064 | ) | (5,875 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | (85 | ) | (8,744 | ) | (8,829 | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares | 7,898,677 | 873 | 150,150 | — | — | — | — | 151,023 | 7,500 | 1 | 42 | — | — | — | — | 42 | ||||||||||||||||||||||||||||||||||||||||||||||||
Treasury shares | — | — | — | (832 | ) | — | — | — | (832 | ) | — | — | — | 488 | — | — | — | 488 | ||||||||||||||||||||||||||||||||||||||||||||||
Share-based payments | — | — | 3,073 | — | — | — | 3,073 | — | — | 1,433 | — | — | — | — | 1,433 | |||||||||||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2020 | 54,927,187 | $ | 6,518 | $ | 1,156,818 | $ | (1,062 | ) | $ | (839,901 | ) | $ | 297 | $ | (23,009 | ) | $ | 299,662 | ||||||||||||||||||||||||||||||||||||||||||||||
Net (loss) | — | — | — | — | (48,203 | ) | — | — | (48,203 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income (loss) | — | — | — | — | — | (227 | ) | 6,363 | 6,136 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Treasury shares | — | — | — | 107 | — | — | — | 107 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based payments | — | — | (5,964 | ) | — | — | — | — | (5,964 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2020 | 54,927,187 | $ | 6,518 | $ | 1,150,855 | $ | (955 | ) | $ | (888,103 | ) | $ | 70 | $ | (16,646 | ) | $ | 251,739 | ||||||||||||||||||||||||||||||||||||||||||||||
Net (loss) | — | — | — | — | (30,955 | ) | — | — | (30,955 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income (loss) | — | — | — | — | — | (75 | ) | 13,196 | 13,121 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares | — | — | (472 | ) | — | — | — | — | (472 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Treasury shares | — | — | — | (260 | ) | — | — | — | (260 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based payments | — | — | (74 | ) | — | — | — | — | (74 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2020 | 54,927,187 | $ | 6,518 | $ | 1,150,309 | $ | (1,214 | ) | $ | (919,058 | ) | $ | (5 | ) | $ | (3,450 | ) | $ | 233,099 | |||||||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2021 | 54,936,687 | $ | 6,519 | $ | 1,153,516 | $ | (681 | ) | $ | (987,992 | ) | $ | 399 | $ | (2,586 | ) | $ | 169,176 |
Ordinary shares | 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 | 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 | |||||||||||||||||||||||||||||||||||||||||||||||
Balance at January 1, 2022 | 55,095,762 | $ | 6,538 | $ | 358,115 | $ | (1,232 | ) | $ | (258,528 | ) | $ | 519 | $ | (6,137 | ) | $ | 99,274 | ||||||||||||||||||||||||||||||||||||||||||||||
Net (loss) | — | — | — | — | (29,449 | ) | — | — | (29,449 | ) | — | — | — | — | (16,706 | ) | — | — | (16,706 | ) | ||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | (85 | ) | (8,744 | ) | (8,829 | ) | — | — | — | — | — | 24 | (1,933 | ) | (1,909 | ) | |||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares | 7,500 | 1 | 42 | — | — | — | — | 42 | 775 | 1 | 0 | — | — | — | — | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||
Treasury shares | — | — | — | 488 | — | — | — | 488 | — | — | — | 40 | — | — | — | 40 | ||||||||||||||||||||||||||||||||||||||||||||||||
Share-based payments | — | — | 1,433 | — | — | — | — | 1,433 | — | — | 1,363 | — | — | — | — | 1,363 | ||||||||||||||||||||||||||||||||||||||||||||||||
Other changes | — | — | — | — | 15 | (15 | ) | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 | — | — | — | 0 | — | 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 (loss) | — | — | — | — | — | 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 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2022 | 55,096,537 | $ | 6,539 | $ | 359,478 | $ | (1,193 | ) | $ | (275,219 | ) | $ | 543 | $ | (8,086 | ) | $ | 82,062 |
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; |
7 liabilities | ||||
September 30, | December 31, | March 31, | December 31, | |||||||||||||
2021 | 2020 | 2022 | 2021 | |||||||||||||
Cash | 33,928 | 42,341 | 29,145 | 31,427 | ||||||||||||
Cash equivalents | 64,267 | 154,011 | 44,963 | 45,874 | ||||||||||||
Total cash and cash equivalents as reported in the statements of financial position | 98,195 | 196,352 | 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 |
September 30, | December 31, | |||||||
2021 | 2020 | |||||||
Other current liabilities | 12,659 | 22,926 | ||||||
Other non-current liabilities | 4,292 | 475 | ||||||
Total | 16,951 | 23,402 | ||||||
September 30, | December 31, | March 31, | December 31, | |||||||||||||||||||||
2021 | 2020 | 2022 | 2021 | |||||||||||||||||||||
Other current liabilities | Other non-current liabilities | Total | Total | |||||||||||||||||||||
Employee related liabilities | 6,748 | 1,674 | 8,422 | 17,136 | ||||||||||||||||||||
Social security | 3,995 | 6,708 | ||||||||||||||||||||||
Deferred income | 4,291 | 2,618 | 6,909 | 4,687 | 3,794 | 4,146 | ||||||||||||||||||
Tax liabilities | 149 | — | 149 | 580 | 137 | 182 | ||||||||||||||||||
Other debts | 1,471 | — | 1,471 | 999 | 793 | 1,325 | ||||||||||||||||||
Total | 12,659 | 4,292 | 16,951 | 23,402 | 8,719 | 12,361 | ||||||||||||||||||
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, | ||||||||||
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, | |||||||
2022 | 2021 | |||||||
Current contingencies | 3,529 | 4,095 | ||||||
Non-current contingencies | 5,758 | 6,758 | ||||||
�� | ||||||||
Total contingencies | 9,288 | 10,853 | ||||||
Number of outstanding | ||||||||||||||||
BSA | BSPCE | SO | RSU | |||||||||||||
Balance as of December 31, 2020 | 218,008 | 5,500 | 2,610,510 | 1,118,745 | ||||||||||||
Granted during the period | 39,185 | — | 75,600 | 44,900 | ||||||||||||
Forfeited during the period | — | — | (100,400 | ) | (59,500 | ) | ||||||||||
Exercised/released during the period | 0 | (5,500 | ) | — | — | |||||||||||
Expired during the period | (500 | ) | — | — | — | |||||||||||
Balance as of September 30, 2021 | 256,693 | 0 | 2,585,710 | 1,104,145 | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||||||
Research & development | SO | (273 | ) | (6 | ) | (952 | ) | 1,144 | ||||||||||||
RSU | (660 | ) | (102 | ) | (795 | ) | (628 | ) | ||||||||||||
Sales & marketing | SO | (60 | ) | 186 | (172 | ) | 2,063 | |||||||||||||
RSU | (27 | ) | (4 | ) | (75 | ) | (12 | ) | ||||||||||||
General & administrative | SO | (439 | ) | 25 | (1,791 | ) | 609 | |||||||||||||
RSU | (92 | ) | (24 | ) | (293 | ) | (211 | ) | ||||||||||||
Total share-based compensation (expense) | (1,551 | ) | 74 | (4,078 | ) | 2,965 | ||||||||||||||
September 30, | December 31, | |||||||
2021 | 2020 | |||||||
Current contingencies | 5,633 | 5,016 | ||||||
Non-current contingencies | 7,629 | 2,527 | ||||||
Total contingencies | 13,262 | 7,542 | ||||||
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, 2021 | 937 | 3,956 | 2,649 | 7,542 | ||||||||||||||||||||||||||||
At January 1, 2022 | 1,008 | 9,800 | 45 | 10,853 | ||||||||||||||||||||||||||||
Increases in liabilities | 127 | 7,334 | 478 | 7,940 | 0 | 0 | 0 | 0 | ||||||||||||||||||||||||
Used liabilities | — | 0 | (1,601 | ) | (1,601 | ) | — | (1,286 | ) | (45 | ) | (1,331 | ) | |||||||||||||||||||
Reversals of unused liabilities | — | — | — | 0 | (9 | ) | — | — | (9 | ) | ||||||||||||||||||||||
Net interest related to employee benefits, and unwinding of discount | — | — | — | 0 | — | — | — | 0 | ||||||||||||||||||||||||
Actuarial gains and losses on defined-benefit plans | 10 | — | — | 10 | (24 | ) | — | — | (24 | ) | ||||||||||||||||||||||
Other effects including currency translation effect | (57 | ) | (458 | ) | (113 | ) | (629 | ) | ||||||||||||||||||||||||
Currency translation effect | (20 | ) | (181 | ) | — | (202 | ) | |||||||||||||||||||||||||
At September 30, 2021 | 1,016 | 10,832 | 1,413 | 13,262 | ||||||||||||||||||||||||||||
At March 31, 2022 | 955 | 8,332 | 0 | 9,288 | ||||||||||||||||||||||||||||
Of which current | — | 4,220 | 1,413 | 5,633 | ||||||||||||||||||||||||||||
Of which non-current | 1,016 | 6,612 | — | 7,629 | ||||||||||||||||||||||||||||
Of which Current | — | 3,529 | 0 | 3,529 | ||||||||||||||||||||||||||||
Of which Non-current | 955 | 4,803 | — | 5,758 |
Three Months Ended September 30, | Nine Months Ended September 30, | Three months Ended March 31, | ||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | 2022 | 2021 | |||||||||||||||||||
Research tax credit | 1,647 | 1,815 | 5,324 | 7,615 | 1,569 | 1,807 | ||||||||||||||||||
Other operating ( incomeloss ) | (324 | ) | 2,344 | (2,549 | ) | 4,873 | ||||||||||||||||||
Other operating income | 976 | 1,133 | ||||||||||||||||||||||
Total | 1,323 | 4,158 | 2,776 | 12,488 | 2,546 | 2,941 | ||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Research and development expenses | 4,161 | 5,984 | 12,272 | 18,294 | ||||||||||||
Sales and marketing expenses | 492 | 2,154 | 1,528 | 4,987 | ||||||||||||
General and administrative expenses | 2,583 | 1,570 | 9,347 | 6,628 | ||||||||||||
Restructuring expenses | 0 | (231 | ) | 0 | 6,792 | |||||||||||
Total personnel expenses | 7,236 | 9,477 | 23,148 | 36,701 | ||||||||||||
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 September 30, | Nine Months Ended September 30, | Three months Ended March 31, | ||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | 2022 | 2021 | |||||||||||||||||||
Wages and salaries | 3,793 | 7,021 | 12,629 | 33,121 | 3,987 | 4,454 | ||||||||||||||||||
Social security contributions | 1,110 | 933 | 3,505 | 5,669 | 251 | 1,332 | ||||||||||||||||||
Expenses for pension commitments | 286 | 617 | 981 | 1,116 | 297 | 402 | ||||||||||||||||||
Employer contribution to bonus shares | 497 | 981 | 1,955 | (241 | ) | 16 | 1,381 | |||||||||||||||||
Share-based payments | 1,551 | (74 | ) | 4,078 | (2,965 | ) | 1,363 | 1,433 | ||||||||||||||||
Total | 7,236 | 9,477 | 23,148 | 36,701 | 5,915 | 9,002 | ||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | Three months EndedMarch 31, | ||||||||||||||||||||
2022 | 2021 | |||||||||||||||||||||||
Non-employee warrants | 256,693 | 225,008 | 256,693 | 225,008 | 256,693 | 225,008 | ||||||||||||||||||
Employee warrants | 0 | 82,500 | 0 | 82,500 | 0 | 75,000 | ||||||||||||||||||
Stock options | 2,585,710 | 1,596,512 | 2,585,710 | 1,596,512 | ||||||||||||||||||||
Stock-options | 3,471,808 | 2,670,710 | ||||||||||||||||||||||
Restricted stock units | 1,104,145 | 713,345 | 1,104,145 | 713,345 | 1,183,633 | 1,129,945 |
Item 2. |
1. | Identify a modified Viaskin patch (which we call mVP). |
2. | Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which we expected to be the longest component of the mVP clinical plan. We prioritized the STAMP protocol submission so we could begin the clinical trial 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, we outlined our proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional Phase I clinical trials in healthy adult volunteers: |
a. | PREQUAL, a Phase I trial with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL. The data collection phase of the trial is complete, and the data analysis phase is ongoing. |
b. | ‘EQUAL in adults,’ a second Phase I trial with adult healthy volunteers to compare the allergen uptake of cVP and mVP. |
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 |
Three months ended September 30, | $ change | % change | ||||||||||||||
2021 | 2020 | |||||||||||||||
Operating income | $ | 1,323 | $ | 4,158 | $ | (2,836 | ) | (68 | %) | |||||||
Operating expenses | ||||||||||||||||
Research and development expenses | (16,320 | ) | (25,751 | ) | 9,430 | (37 | %) | |||||||||
Sales and marketing expenses | (1,072 | ) | (1,595 | ) | 524 | (33 | %) | |||||||||
General and administrative expenses | (8,299 | ) | (6,863 | ) | (1,437 | ) | 21 | % | ||||||||
Restructuring expenses | — | 286 | (286 | ) | 100 | % | ||||||||||
Total Operating expenses | (25,691 | ) | (33,923 | ) | 8,232 | (24 | %) | |||||||||
Financial income (expense) | 336 | (1,184 | ) | 1,519 | (128 | %) | ||||||||||
Income tax | — | (7 | ) | 7 | (100 | %) | ||||||||||
Net loss | $ | (24,033 | ) | $ | (30,955 | ) | $ | 6,922 | (22 | %) | ||||||
Three months ended September 30, | $ change | % change | ||||||||||||||
2021 | 2020 | |||||||||||||||
Sales | — | — | — | — | ||||||||||||
Other income | 1,323 | 4,158 | (2,836 | ) | (68 | %) | ||||||||||
Research tax credit | 1,647 | 1,815 | (168 | ) | (9 | %) | ||||||||||
Other operating (loss) income | (324 | ) | 2,344 | (2,668 | ) | (114 | %) | |||||||||
Total operating income | 1,323 | 4,158 | (2,836 | ) | (68 | %) | ||||||||||
Three Months Ended September 30, | $ change | % change | ||||||||||||||
Research and development expenses | 2021 | 2020 | ||||||||||||||
External clinical-related expenses | 8,633 | 5,175 | 3,458 | 67 | % | |||||||||||
Employee-related costs | 3,228 | 5,876 | (2,648 | ) | (45 | %) | ||||||||||
Share-based payment expenses | 933 | 108 | 825 | * | ||||||||||||
Depreciation, amortization and other costs | 3,526 | 14,592 | (11,066 | ) | (76 | %) | ||||||||||
Total Research and development expenses | 16,320 | 25,751 | (9,430 | ) | (37 | %) | ||||||||||
Three Months Ended September 30, | $ change | % change | ||||||||||||||
Sales and Marketing expenses | 2021 | 2020 | ||||||||||||||
External professional services | 379 | (239 | ) | 619 | (258 | %) | ||||||||||
Employee-related costs | 405 | 2,336 | (1,931 | ) | (83 | %) | ||||||||||
Share-based payment expenses (income) | 87 | (182 | ) | 269 | (148 | %) | ||||||||||
Depreciation, amortization and other costs | 200 | (320 | ) | 520 | (163 | %) | ||||||||||
Total Sales and Marketing expenses | 1,072 | 1,595 | (524 | ) | (33 | %) | ||||||||||
Three Months Ended September 30, | $ change | % change | ||||||||||||||
General and Administrative expenses | 2021 | 2020 | ||||||||||||||
External professional services | 2,216 | 1,663 | 552 | 33 | % | |||||||||||
Employee-related costs | 2,052 | 1,571 | 482 | 31 | % | |||||||||||
Share-based payment expenses | 530 | — | 531 | * | ||||||||||||
Depreciation, amortization and other costs | 3,501 | 3,629 | (128 | ) | (4 | %) | ||||||||||
Total General and Administrative expenses | 8,299 | 6,863 | 1,437 | 21 | % | |||||||||||
Nine months ended September 30, | $ change | % change | ||||||||||||||
2021 | 2020 | |||||||||||||||
Operating income | $ | 2,776 | $ | 12,488 | $ | (9,713 | ) | (78 | %) | |||||||
Operating expenses | ||||||||||||||||
Research and development expenses | (58,663 | ) | (75,214 | ) | 16,551 | (22 | %) | |||||||||
Sales and marketing expenses | (2,999 | ) | (8,114 | ) | 5,115 | (63 | %) | |||||||||
General and administrative expenses | (26,250 | ) | (26,838 | ) | 587 | (2 | %) | |||||||||
Restructuring expenses | — | (21,003 | ) | 21,003 | (100 | %) | ||||||||||
Total Operating expenses | (87,912 | ) | (131,169 | ) | 43,257 | ( 33 | %) | |||||||||
Financial income (expense) | 597 | (1,380 | ) | 1,977 | (143 | %) | ||||||||||
Income tax | 404 | (10 | ) | 414 | * | |||||||||||
Net loss | $ | (84,136 | ) | $ | (120,071 | ) | $ | 35,935 | (30 | %) | ||||||
Nine Months ended September 30, | $ change | % change | ||||||||||||||
2021 | 2020 | |||||||||||||||
Sales | — | — | ||||||||||||||
Other income | 2,776 | 12,488 | (9,713 | ) | (78 | %) | ||||||||||
Research tax credit | 5,324 | 7,615 | (2,291 | ) | (30 | %) | ||||||||||
Other operating (loss) income | (2,549 | ) | 4,873 | (7,422 | ) | (152 | %) | |||||||||
Total operating income | 2,776 | 12,488 | (9,713 | ) | (78 | %) | ||||||||||
Nine Months Ended September 30, | $ change | % change | ||||||||||||||
Research and development expenses | 2021 | 2020 | ||||||||||||||
External clinical-related expenses | 31,319 | 34,494 | (3,175 | ) | (9 | %) | ||||||||||
Employee-related costs | 10,525 | 18,810 | (8,284 | ) | (44 | %) | ||||||||||
Share-based payment expenses (income) | 1,747 | (516 | ) | 2,263 | (439 | %) | ||||||||||
Depreciation, amortization and other costs | 15,072 | 22,427 | (7,355 | ) | (33 | %) | ||||||||||
Total Research and development expenses | 58,663 | 75,214 | (16,551 | ) | (22 | %) | ||||||||||
Nine Months Ended September 30, | $ change | % change | ||||||||||||||
Sales and Marketing expenses | 2021 | 2020 | ||||||||||||||
External professional services | 771 | 2,881 | (2,111 | ) | (73 | %) | ||||||||||
Employee-related costs | 1,282 | 7,038 | (5,757 | ) | (82 | %) | ||||||||||
Share-based payment expenses (income) | 246 | (2,052 | ) | 2,298 | (112 | %) | ||||||||||
Depreciation, amortization and other costs | 700 | 246 | 454 | 185 | % | |||||||||||
Total Sales and Marketing expenses | 2,999 | 8,114 | (5,115 | ) | (63 | %) | ||||||||||
Nine Months Ended September 30, | $ change | % change | ||||||||||||||
General and Administrative expenses | 2021 | 2020 | ||||||||||||||
External professional services | 6,425 | 10,517 | (4,092 | ) | (39 | %) | ||||||||||
Employee-related costs | 7,263 | 7,026 | 237 | 3 | % | |||||||||||
Share-based payment expenses (income) | 2,084 | (397 | ) | 2,482 | 625 | % | ||||||||||
Depreciation, amortization and other costs | 10,478 | 9,693 | 785 | 8 | % | |||||||||||
Total General and Administrative expenses | 26,250 | 26,838 | (587 | ) | (2 | %) | ||||||||||
Nine Months ended September 30, | $ change | % of change | ||||||||||||||
(Amounts in thousands of U.S. Dollars) | 2021 | 2020 | ||||||||||||||
Net cash flow used in operating activities | (89,452 | ) | (132,076 | ) | 42,624 | (32 | %) | |||||||||
Net cash flow provided by (used in) investing activities | 41 | (2,232 | ) | 2,273 | (102 | %) | ||||||||||
Net cash flow (used in) provided by financing activities | (103 | ) | 149,624 | (149,726 | ) | (100 | %) | |||||||||
Effect of exchange rate changes on cash and cash equivalents | (8,643 | ) | 12,834 | (21,477 | ) | (167 | %) | |||||||||
Net (decrease) increase in cash and cash equivalents | (98,157 | ) | 28,150 | (126,307 | ) | (449 | %) | |||||||||
Equity | ||||
capital | ||||
(Amounts in thousands of U.S. Dollars) | ||||
Nine months ended September 30, 2020 | $ | 150,010 | ||
Nine months ended September 30, 2021 | — | |||
Total | $ | 150,010 | ||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
Item 4. |
Item 1. |
Item 1A. | Risk Factors |
Item 2. |
Item 3. | Defaults Upon Senior Securities |
Item 4. | Mine Safety Disclosures |
Item 5. | Other Information |
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 | |||||||||
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 Officer | ||||||||
(Principal Executive Officer) |
Date: | May , 2022 | By: | /s/ Sébastien Robitaille | ||||||
Sébastien Robitaille | |||||||||
Chief Financial Officer | |||||||||
(Principal Financial and Accounting Officer) |