☒ | 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 ofone ordinary share, nominal value €0.10 per share | DBVT | The Nasdaq Stock Market LLC | ||
Ordinary shares, nominal value €0.10 per * | n/a | The Nasdaq Stock Market LLC |
* | Not for trading, but only in connection with the registration of the American Depositary Shares. |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||||||
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |||||||
Emerging growth company | ☐ |
Part I | ||||||
3 | ||||||
Item 1 | ||||||
3 | ||||||
4 | ||||||
5 | ||||||
6 | ||||||
8 | ||||||
Item 2 | 21 | |||||
Item 3 | 33 | |||||
Item 4 | 33 | |||||
Part II | 34 | |||||
Item 1 | 34 | |||||
Item 1A | 34 | |||||
Item 2 | 34 | |||||
Item 3 | 35 | |||||
Item 4 | 35 | |||||
Item 5 | 35 | |||||
36 |
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 | ||||||
September 30, | December 31, | |||||||||||
Note | 2022 | 2021 | ||||||||||
Assets | ||||||||||||
Current assets: | ||||||||||||
Cash and cash equivalents | 3 | $ | 212,670 | $ | 77,301 | |||||||
Other current assets | 4 | 13,025 | 37,085 | |||||||||
Total current assets | 225,695 | 114,386 | ||||||||||
Property, plant, and equipment, net | 14,429 | 18,146 | ||||||||||
Right-of-use | 5 | 2,614 | 7,336 | |||||||||
Intangible assets | 11 | 22 | ||||||||||
Other non-current assets | 5,368 | 6,833 | ||||||||||
Total non-current assets | 22,422 | 32,338 | ||||||||||
Total Assets | $ | 248,117 | $ | 146,723 | ||||||||
Liabilities and shareholders' equity | ||||||||||||
Current liabilities: | ||||||||||||
Trade payables | 6 | $ | 15,369 | $ | 11,429 | |||||||
Short-term operating leases | 5 | 1,381 | 3,003 | |||||||||
Short-term financial debt | — | 510 | ||||||||||
Current contingencies | 9 | 3,026 | 4,095 | |||||||||
Other current liabilities | 6 | 8,615 | 12,361 | |||||||||
Total current liabilities | 28,391 | 31,397 | ||||||||||
Long-term operating leases | 5 | 1,423 | 7,147 | |||||||||
Non-current contingencies | 9 | 5,272 | 6,758 | |||||||||
Other non-current liabilities | 6 | 979 | 2,147 | |||||||||
Total non-current liabilities | 7,674 | 16,052 | ||||||||||
Total Liabilities | $ | 36,065 | $ | 47,449 | ||||||||
Shareholders’ equity: | ||||||||||||
Ordinary shares, €0.10 par value; 94,025,441 and 55,095,762 shares authorized, and issued as at September 30, 2022 and December 31, 2021, respectively | $ | 10,709 | $ | 6,538 | ||||||||
Additional paid-in capital | 456,884 | 358,115 | ||||||||||
Treasury stock, 137,101 and 153,631 ordinary shares as of September 30, 2022 and December 31, 2021, respectively, at cost | (1,083 | ) | (1,232 | ) | ||||||||
Accumulated deficit | (220,337 | ) | (258,528 | ) | ||||||||
Accumulated other comprehensive income | 783 | 519 | ||||||||||
Accumulated currency translation effect | (34,904 | ) | (6,137 | ) | ||||||||
Total Shareholders’ equity | 7 | $ | 212,052 | $ | 99,274 | |||||||
Total Liabilities and Shareholders’ equity | $ | 248,117 | $ | 146,723 | ||||||||
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 September 30, | Nine Months Ended September 30, | |||||||||||||||||
Note | 2022 | 2021 | 2022 | 2021 | ||||||||||||||
Operating income | 10 | $ | 2,074 | $ | 1,323 | $ | 6,148 | $ | 2,776 | |||||||||
Operating expenses | ||||||||||||||||||
Research and development expenses | (15,096 | ) | (16,320 | ) | (45,930 | ) | (58,663 | ) | ||||||||||
Sales and marketing expenses | (159 | ) | (1,072 | ) | (1,659 | ) | (2,999 | ) | ||||||||||
General and administrative expenses | (4,839 | ) | (8,299 | ) | (17,173 | ) | (26,250 | ) | ||||||||||
Total Operating expenses | (20,094 | ) | (25,691 | ) | (64,762 | ) | (87,912 | ) | ||||||||||
Loss from operations | (18,020 | ) | (24,368 | ) | (58,614 | ) | (85,137 | ) | ||||||||||
Financial income | 732 | 336 | 1,668 | 597 | ||||||||||||||
Loss before taxes | (17,287 | ) | (24,033 | ) | (56,946 | ) | (84,540 | ) | ||||||||||
Income tax (expense) | — | — | (87 | ) | 404 | |||||||||||||
Net loss | $ | (17,287 | ) | $ | (24,033 | ) | $ | (57,033 | ) | $ | (84,136 | ) | ||||||
Foreign currency translation differences, net of taxes | (15,425 | ) | (3,728 | ) | (28,752 | ) | (9,684 | ) | ||||||||||
Actuarial gains (losses) on employee benefits, net of taxes | 41 | 28 | 264 | (10 | ) | |||||||||||||
Total comprehensive loss | $ | (32,672 | ) | $ | (27,733 | ) | $ | (85,520 | ) | $ | (93,830 | ) | ||||||
Basic/diluted net loss per share attributable to shareholders | 14 | $ | (0.18 | ) | $ | (0.44 | ) | $ | (0.79 | ) | $ | (1.53 | ) | |||||
Weighted average shares outstanding used in computing per sha re amounts: | 93,905,050 | 54,947,354 | 71,779,572 | 54,911,278 |
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 | |||||
Nine Months Ended September 30, | ||||||||||||
Notes | 2022 | 2021 | ||||||||||
Net loss for the period | $ | (57,033 | ) | $ | (84,136 | ) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
Depreciation, amortization and accrued contingencies | 1,140 | 9,705 | ||||||||||
Retirement pension obligations | 58 | 127 | ||||||||||
Expenses related to share-based payments | 8 | 3,416 | 4,078 | |||||||||
Other elements | (3 | ) | 1,214 | |||||||||
Changes in operating assets and liabilities: | ||||||||||||
Decrease (increase) in trade receivables | — | 2,174 | ||||||||||
Decrease (increase) in other current assets | 20,900 | (9,036 | ) | |||||||||
(Decrease) increase in trade payables | 5,699 | (7,135 | ) | |||||||||
(Decrease) increase in other current and non-current liabilities | (3,405 | ) | (5,497 | ) | ||||||||
Change in operating lease liabilities and right of use assets | (2,554 | ) | (946 | ) | ||||||||
Net cash flow used in operating activities | (31,781 | ) | (89,452 | ) | ||||||||
Cash flows used in investing activities: | ||||||||||||
Acquisitions of property, plant, and equipment | (742 | ) | — | |||||||||
Proceeds from property, plant, and equipment dispositions | 3 | 46 | ||||||||||
Acquisition of intangible assets | — | (8 | ) | |||||||||
Acquisitions of non-current financial assets | (149 | ) | — | |||||||||
Proceeds from non-current financial assets | 822 | 3 | ||||||||||
Net cash flows used in investing activities | (66 | ) | 41 | |||||||||
Cash flows provided by financing activities: | ||||||||||||
Decrease in conditional advances | (479 | ) | (518 | ) | ||||||||
Treasury shares | 149 | (359 | ) | |||||||||
Capital increases, net of transaction costs | 194,732 | 794 | ||||||||||
Other cash flows related to financing activities | — | (21 | ) | |||||||||
Net cash flows provided by financing activities | 194,403 | (103 | ) | |||||||||
Effect of exchange rate changes on cash and cash equivalents | (27,186 | ) | (8,643 | ) | ||||||||
Net increase (decrease) in cash and cash equivalents | 135,369 | (98,157 | ) | |||||||||
Net Cash and cash equivalents at the beginning of the period | 77,301 | 196,352 | ||||||||||
Net cash and cash equivalents at the end of the period | 3 | $ | 212,670 | $ | 98,195 | |||||||
Ordinary shares | ||||||||||||||||||||||||||||||||
Number of Shares | Amount | Additional paid-in capital | Treasury stock | Accumulated deficit | Accumulated other comprehensive income (loss) | Accumulated currency translation effect | Total Shareholders’ Equity | |||||||||||||||||||||||||
Balance at January 1, 2021 | 54,929,187 | $ | 6,518 | $ | 1,152,042 | $ | (1,169 | ) | $ | (958,543 | ) | $ | 484 | $ | 6,158 | $ | 205,491 | |||||||||||||||
Net (loss) | — | — | — | — | (29,449 | ) | — | — | (29,449 | ) | ||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | (85 | ) | (8,744 | ) | (8,829 | ) | |||||||||||||||||||||
Issuance of ordinary shares | 7,500 | 1 | 42 | — | — | — | — | 42 | ||||||||||||||||||||||||
Treasury shares | — | — | — | 488 | — | — | — | 488 | ||||||||||||||||||||||||
Share-based payments | — | — | 1,433 | — | — | — | — | 1,433 | ||||||||||||||||||||||||
Balance at March 31, 2021 | 54,936,687 | $ | 6,519 | $ | 1,153,516 | $ | (681 | ) | $ | (987,992 | ) | $ | 399 | $ | (2,586 | ) | $ | 169,176 |
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, 2022 | 55,095,762 | $ | 6,538 | $ | 358,115 | $ | (1,232 | ) | $ | (258,528 | ) | $ | 519 | $ | (6,137 | ) | $ | 99,274 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at January 1, 2021 | 54,929,187 | $ | 6,518 | $ | 1,152,042 | $ | (1,169 | ) | $ | (958,543 | ) | $ | 484 | $ | 6,158 | $ | 205,491 | |||||||||||||||||||||||||||||||||||||||||||||||
Net (loss) | — | — | — | — | (16,706 | ) | — | — | (16,706 | ) | — | — | — | — | (29,449 | ) | — | — | (29,449 | ) | ||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | 24 | (1,933 | ) | (1,909 | ) | — | — | — | — | — | (85 | ) | (8,744 | ) | (8,829 | ) | |||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares | 775 | 1 | 0 | — | — | — | — | 1 | 7,500 | 1 | 42 | — | — | — | — | 42 | ||||||||||||||||||||||||||||||||||||||||||||||||
Treasury shares | — | — | — | 40 | — | — | — | 40 | — | — | — | 488 | — | — | — | 488 | ||||||||||||||||||||||||||||||||||||||||||||||||
Share-based payments | — | — | 1,363 | — | — | — | — | 1,363 | — | — | 1,433 | — | — | — | — | 1,433 | ||||||||||||||||||||||||||||||||||||||||||||||||
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 | ||||||||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2021 | 54,936,687 | $ | 6,519 | $ | 1,153,516 | $ | (681 | ) | $ | (987,992 | ) | $ | 399 | $ | (2,586 | ) | $ | 169,176 | ||||||||||||||||||||||||||||||||||||||||||||||
Net (loss) | — | — | — | — | (30,654 | ) | — | — | (30,654 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income | — | — | — | — | — | 48 | 2,788 | 2,836 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares | 75,000 | 9 | 464 | — | — | — | — | 473 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of warrants | 279 | 279 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Treasury shares | — | — | (185 | ) | — | — | — | (185 | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based payments | — | — | 1,094 | — | — | — | 1,094 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Allocation of accumulated net losses | — | — | (797,823 | ) | — | 797,823 | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2021 | 55,011,687 | $ | 6,529 | $ | 357,530 | $ | (866 | ) | $ | (220,823 | ) | $ | 446 | $ | 203 | $ | 143,019 | |||||||||||||||||||||||||||||||||||||||||||||||
Net (loss) | — | — | — | — | (24,033 | ) | — | — | (24,033 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income | — | — | — | — | — | 28 | (3,728 | ) | (3,701 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Treasury shares | — | — | 56 | — | — | — | 56 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based payments | — | — | 1,551 | — | — | — | 1,551 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2021 | 55,011,687 | $ | 6,529 | $ | 359,081 | $ | (810 | ) | $ | (244,856 | ) | $ | 474 | $ | (3,526 | ) | $ | 116,892 | ||||||||||||||||||||||||||||||||||||||||||||||
Ordinary shares | ||||||||||||||||||||||||||||||||
Number of Shares | Amount | Additional paid-in capital | Treasury stock | Accumulated deficit | Accumulated other comprehensive income (loss) | Accumulated currency translation effect | Total Shareholders’ Equity | |||||||||||||||||||||||||
Balance at January 1, 2022 | 55,095,762 | $ | 6,538 | $ | 358,115 | $ | (1,232 | ) | $ | (258,528 | ) | $ | 519 | $ | (6,137 | ) | $ | 99,274 | ||||||||||||||
Net (loss) | — | — | — | — | (16,706 | ) | — | — | (16,706 | ) | ||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | 24 | (1,933 | ) | (1,909 | ) | ||||||||||||||||||||||
Issuance of ordinary shares | 775 | 1 | — | — | — | — | — | 1 | ||||||||||||||||||||||||
Treasury shares | — | — | — | 40 | — | — | — | 40 | ||||||||||||||||||||||||
Share-based payments | — | — | 1,363 | — | — | — | — | 1,363 | ||||||||||||||||||||||||
Other changes | — | — | — | — | 15 | (15 | ) | — | ||||||||||||||||||||||||
Balance at March 31, 2022 | 55,096,537 | $ | 6,539 | $ | 359,478 | $ | (1,193 | ) | $ | (275,219 | ) | $ | 543 | $ | (8,086 | ) | $ | 82,062 | ||||||||||||||
Net (loss) | — | — | — | — | (23,039 | ) | — | — | (23,039 | ) | ||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | 200 | (11,394 | ) | (11,194 | ) | ||||||||||||||||||||||
Issuance of ordinary shares | 38,926,142 | 4,170 | 103,007 | — | — | — | — | 107,176 | ||||||||||||||||||||||||
Issuance of warrants | — | — | 88,094 | — | — | — | — | 88,094 | ||||||||||||||||||||||||
Treasury shares | — | — | — | 240 | — | — | — | 240 | ||||||||||||||||||||||||
Share-based payments | — | — | 1,078 | — | — | — | — | 1,078 | ||||||||||||||||||||||||
Allocation of accumulated net losses | — | — | (95,209 | ) | — | 95,209 | — | — | — | |||||||||||||||||||||||
Balance at June 30, 2022 | 94,022,679 | $ | 10,708 | $ | 456,447 | $ | (953 | ) | $ | (203,050 | ) | $ | 743 | $ | (19,480 | ) | $ | 244,416 | ||||||||||||||
Net (loss) | — | — | — | — | (17,287 | ) | — | — | (17,287 | ) | ||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | 41 | (15,425 | ) | (15,384 | ) | ||||||||||||||||||||||
Issuance of ordinary shares | 2 762 | 1 | (540 | ) | — | — | — | — | (539 | ) | ||||||||||||||||||||||
Treasury shares | — | — | — | (130 | ) | — | — | — | (130 | ) | ||||||||||||||||||||||
Share-based payments | — | — | 976 | — | — | — | — | 976 | ||||||||||||||||||||||||
Balance at September 30, 2022 | 94 025 441 | $ | 10,709 | $ | 456,884 | $ | (1,083 | ) | $ | (220,337 | ) | $ | 783 | $ | (34,904 | ) | $ | 212,052 | ||||||||||||||
1. | Identify a modified Viaskin patch (“mVP”). |
2. | Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible. |
3. | Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies: |
a. | PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays |
b. | ‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and |
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 | ||||||
September 30, | December 31, | |||||||
2022 | 2021 | |||||||
Cash | 167,916 | 31,427 | ||||||
Cash equivalents | 44,754 | 45,874 | ||||||
Total cash and cash equivalents as reported in the statements of financial position | 212,670 | 77,301 | ||||||
March 31, | December 31, | |||||||
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 | ||||||
September 30, | December 31, | |||||||
2022 | 2021 | |||||||
Research tax credit | 4,094 | 28,092 | ||||||
Other tax claims | 3,636 | 3,561 | ||||||
Prepaid expenses | 4,107 | 4,149 | ||||||
Other receivables | 1,188 | 1,283 | ||||||
Total | 13,025 | 37,085 | ||||||
Amount in thousands of US Dollars | ||||
Opening research tax credit receivable as of January 1, 2022 | 28,092 | |||
+ Operating revenue | ||||
- Payment received | ( | ) | ||
- Adjustment and currency translation effect | ( | ) | ||
Closing research tax credit receivable as of | ||||
Of which - Non-current portion | ||||
Of which - Current portion |
March 31, 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 | % |
September 30, 2022 | December 31, 2021 | |||||||||||||||||||||||
Real estate | Other assets | Total | Real estate | Other assets | Total | |||||||||||||||||||
Current portion | 1,504 | 34 | 1,538 | 3,361 | 77 | 3,438 | ||||||||||||||||||
Year 2 | 1,874 | 18 | 1,891 | 3,124 | 23 | 3,147 | ||||||||||||||||||
Year 3 | 103 | 6 | 109 | 2,299 | 18 | 2,317 | ||||||||||||||||||
Year 4 | — | — | — | 771 | 1 | 773 | ||||||||||||||||||
Year 5 | — | — | — | 790 | — | 790 | ||||||||||||||||||
Thereafter | — | — | — | 1,220 | — | 1,220 | ||||||||||||||||||
Total minimum lease payments | 3,481 | 58 | 3,538 | 11,565 | 119 | 11,684 | ||||||||||||||||||
Less: Effects of discounting | (729 | ) | (5 | ) | (734 | ) | (1,526 | ) | (8 | ) | (1,534 | ) | ||||||||||||
Present value of operating lease | 2,752 | 52 | 2,804 | 10,039 | 111 | 10,150 | ||||||||||||||||||
Less: current portion | (1,350 | ) | (31 | ) | (1,381 | ) | (2,929 | ) | (74 | ) | (3,003 | ) | ||||||||||||
Long-term operating lease | 1,402 | 22 | 1,423 | 7,110 | 37 | 7,147 | ||||||||||||||||||
Weighted average remaining lease term (years) | 1.80 | — | 4.14 | 2.01 | ||||||||||||||||||||
Weighted average discount rate | 3.50 | % | 0.9 | % | 4.84 | % | 3.32 | % |
March 31, | ||||||||
2022 | 2021 | |||||||
Operating lease expense / (income) | (1,150 | ) | 847 |
September 30, | ||||||||
2022 | 2021 | |||||||
Operating lease expense | 1,373 | 2,480 | ||||||
Net termination impact | (1,657 | ) | — |
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, | ||||||||
2022 | 2021 | |||||||
Cash paid for amounts included in the measurement of lease liabilities | — | — | ||||||
Operating cash flows from operating leases | 1,533 | 2,845 |
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 | ||||||
September 30, | December 31, | |||||||||||||||||||||||
2022 | 2021 | |||||||||||||||||||||||
Other current liabilities | Other non- current liabilities | Total | Other current liabilities | Other non- current liabilities | Total | |||||||||||||||||||
Employee related liabilities | 4,666 | 54 | 4,719 | 6,708 | 247 | 6,954 | ||||||||||||||||||
Deferred income | 2,911 | 926 | 3,836 | 4,146 | 1,900 | 6,046 | ||||||||||||||||||
Tax liabilities | 405 | — | 405 | 182 | — | 182 | ||||||||||||||||||
Other debts | 634 | — | 634 | 1,325 | — | 1,325 | ||||||||||||||||||
Total | 8,615 | 979 | 9,594 | 12,361 | 2,147 | 14,508 | ||||||||||||||||||
Prefunded warrants | ||||
Balance as of December 31, 2021 | — | |||
Granted during the period | 28,276,331 | |||
Forfeited during the period | — | |||
Exercised/released during the period | — | |||
Expired during the period | — | |||
Balance as of September 30, 2022 | 28,276,331 | |||
Stock option fair value assumptions during the nine months ended September 30, 2022 | ||||
Weighted average share price at grant date in € | 4.3 | |||
Weighted average expected volatility | 93.6 | % | ||
Weighted average risk-free interest rate | 0.89 | % | ||
Weighted average expected term (in years) | 6 | |||
Dividend yield | — | |||
Weighted average fair value of stock options in € | 3.3 |
Number of outstanding | ||||||||||||
BSA | SO | RSUs | ||||||||||
Balance as of December 31, 2021 | 256,693 | 3,631,210 | 1,240,520 | |||||||||
Granted during the period | — | 154,500 | 69,900 | |||||||||
Forfeited during the period | — | (238,715 | ) | (92,326 | ) | |||||||
Exercised/released during the period | — | (5,613 | ) | (32,159 | ) | |||||||
Expired during the period | (5,000 | ) | — | — | ||||||||
Balance as of September 30, 2022 | 251,693 | 3,541,383 | 1,185,936 | |||||||||
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 | ) | ||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||||||
Research & development | SO | (337 | ) | (273 | ) | (1,002 | ) | (952 | ) | |||||||||||
RSU | (201 | ) | (660 | ) | (594 | ) | (795 | ) | ||||||||||||
Sales & marketing | SO | 30 | (60 | ) | (3 | ) | (172 | ) | ||||||||||||
RSU | 20 | (27 | ) | 4 | (75 | ) | ||||||||||||||
General & administrative | SO | (423 | ) | (439 | ) | (1,599 | ) | (1,791 | ) | |||||||||||
RSU | (66 | ) | (92 | ) | (223 | ) | (293 | ) | ||||||||||||
Total share-based compensation (expense) | (976 | ) | (1,551 | ) | (3,416 | ) | (4,078 | ) | ||||||||||||
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, 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 |
September 30, | December 31, | |||||||
2022 | 2021 | |||||||
Current contingencies | 3,026 | 4,095 | ||||||
Non-current contingencies | 5,272 | 6,758 | ||||||
Total contingencies | 8,298 | 10,853 | ||||||
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 | 58 | — | — | 58 | ||||||||||||
Used liabilities | — | (889 | ) | (43 | ) | (932 | ) | |||||||||
Reversals of unused liabilities | — | — | — | — | ||||||||||||
Net interest related to employee benefits, and unwinding of discount | — | — | — | — | ||||||||||||
Actuarial gains and losses on defined-benefit plans | (264 | ) | — | — | (264 | ) | ||||||||||
Currency translation effect | (123 | ) | (1,291 | ) | (3 | ) | (1,417 | ) | ||||||||
At September 30, 2022 | 678 | 7,620 | — | 8,298 | ||||||||||||
Of which Current | — | 3,026 | — | 3,026 | ||||||||||||
Of which Non-current | 678 | 4,594 | — | 5,272 |
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 | ||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Research tax credit | 1,407 | 1,647 | 4,467 | 5,324 | ||||||||||||
Other operating income | 668 | (324 | ) | 1,681 | (2,549 | ) | ||||||||||
Total | 2,074 | 1,323 | 6,148 | 2,776 | ||||||||||||
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, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Research and Development expenses | 3,186 | 4,161 | 9,357 | 12,272 | ||||||||||||
Sales and Marketing expenses | 138 | 492 | 727 | 1,528 | ||||||||||||
General and Administrative expenses | 1,598 | 2,583 | 6,961 | 9,347 | ||||||||||||
Total personnel expenses | 4,922 | 7,236 | 17,045 | 23,148 | ||||||||||||
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 September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Wages and salaries | 3,505 | 3,793 | 11,001 | 12,629 | ||||||||||||
Social security contributions | 634 | 1,110 | 2,141 | 3,505 | ||||||||||||
Expenses for pension commitments | 214 | 286 | 723 | 981 | ||||||||||||
Employer contribution to bonus shares | (406 | ) | 497 | (236 | ) | 1,955 | ||||||||||
Share-based payments | 976 | 1,551 | 3,416 | 4,078 | ||||||||||||
Total | 4,922 | 7,236 | 17,045 | 23,148 | ||||||||||||
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 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Non-employee warrants | 251,693 | 256,693 | 251,693 | 256,693 | ||||||||||||
Stock options | 3,541,383 | 2,585,710 | 3,541,383 | 2,585,710 | ||||||||||||
Restricted stock units | 1,185,936 | 1,104,145 | 1,185,936 | 1,104,145 | ||||||||||||
Prefunded warrants | 28,276,331 | — | 28,276,331 | — |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
1. | Identify a modified Viaskin patch |
2. | Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which |
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, |
a. | PREQUAL, a Phase I |
b. | ‘EQUAL in |
Three months ended September 30, | ||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||
Operating income | $ | 2,074 | $ | 1,323 | 751 | 57 | % | |||||||||
Operating expenses | ||||||||||||||||
Research and development expenses | (15,096 | ) | (16,320 | ) | 1,224 | (8 | %) | |||||||||
Sales and marketing expenses | (159 | ) | (1,072 | ) | 913 | (85 | %) | |||||||||
General and administrative expenses | (4,839 | ) | (8,299 | ) | 3,460 | (42 | %) | |||||||||
Total Operating expenses | (20,094 | ) | (25,691 | ) | 5,597 | (22 | %) | |||||||||
Financial income | 732 | 336 | 396 | 118 | % | |||||||||||
Income tax | — | — | — | — | ||||||||||||
Net loss | $ | (17,287 | ) | $ | (24,033 | ) | 6,745 | (28 | %) | |||||||
Basic/diluted Net loss per share attributable to shareholders | $ | (0.18 | ) | $ | (0.44 | ) |
Three months ended | ||||||||
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 September 30, | $ change | % change | ||||||||||||||
2022 | 2021 | |||||||||||||||
Sales | — | — | — | — | ||||||||||||
Other income | 2,074 | 1,323 | 751 | 57 | % | |||||||||||
Research tax credit | 1,407 | 1,647 | (240 | ) | (15 | %) | ||||||||||
Other operating income | 668 | (324 | ) | 992 | (306 | %) | ||||||||||
Total operating income | 2,074 | 1,323 | 751 | 57 | % | |||||||||||
Three months Ended March 31 | % change | |||||||||||
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 | Three Months Ended September 30, | |||||||||||||||||||||||||||||
Research and Development expenses | 2022 | 2021 | 2022 | 2021 | $ change | % change | ||||||||||||||||||||||||||
External clinical-related expenses | 7,350 | 12,878 | (5,528 | ) | (43 | %) | 11,136 | 8,633 | 2,503 | 29 | % | |||||||||||||||||||||
Employee-related costs | 2,492 | 4,091 | (1,599 | ) | (39 | %) | 2,648 | 3,228 | (581 | ) | (18 | %) | ||||||||||||||||||||
Share-based payment expenses | 583 | 627 | (45 | ) | (7 | %) | 538 | 933 | (395 | ) | (42 | %) | ||||||||||||||||||||
Depreciation, amortization and other costs | 1,799 | 4,568 | (2,769 | ) | (61 | %) | 774 | 3,526 | (2,752 | ) | (78 | %) | ||||||||||||||||||||
Total Research and Development expenses | 12,223 | 22,164 | (9,941 | ) | (45 | %) | 15,096 | 16,320 | (1,224 | ) | (8 | %) | ||||||||||||||||||||
Three Months Ended September 30, | $ change | % change | ||||||||||||||
Sales and Marketing expenses | 2022 | 2021 | ||||||||||||||
Personnel expenses | 138 | 492 | (354 | ) | (72 | %) | ||||||||||
External professional services and other costs | 20 | 580 | (559 | ) | (96 | %) | ||||||||||
Total Sales and Marketing expenses | 159 | 1,072 | (913 | ) | (85 | %) | ||||||||||
Three Months Ended September 30, | $ change | % change | ||||||||||||||
General and Administrative expenses | 2022 | 2021 | ||||||||||||||
External professional services | 1,292 | 2,216 | (924 | ) | (42 | %) | ||||||||||
Employee-related costs | 1,110 | 2,052 | (942 | ) | (46 | %) | ||||||||||
Share-based payment expenses | 488 | 530 | (42 | ) | (8 | %) | ||||||||||
Depreciation, amortization and other costs | 1,949 | 3,501 | (1,552 | ) | (44 | %) | ||||||||||
Total General and Administrative expenses | 4,839 | 8,299 | (3,460 | ) | (42 | %) | ||||||||||
Nine months ended September 30, | $ change | % change | ||||||||||||||
2022 | 2021 | |||||||||||||||
Operating income | $ | 6,148 | $ | 2,776 | 3,373 | 122 | % | |||||||||
Operating expenses | ||||||||||||||||
Research and development expenses | (45,930 | ) | (58,663 | ) | 12,733 | (22 | )% | |||||||||
Sales and marketing expenses | (1,659 | ) | (2,999 | ) | 1,340 | (45 | )% | |||||||||
General and administrative expenses | (17,173 | ) | (26,250 | ) | 9,077 | (35 | )% | |||||||||
Total Operating expenses | (64,762 | ) | (87,912 | ) | 23,150 | (26 | )% | |||||||||
Financial income | 1,668 | 597 | 1,071 | 179 | % | |||||||||||
Income tax (expense) | (87 | ) | 404 | (491 | ) | (122 | )% | |||||||||
Net loss | $ | (57,033 | ) | $ | (84,136 | ) | 27,103 | (32 | )% | |||||||
Basic/diluted Net loss per share attributable to shareholders | $ | (0.79 | ) | $ | (1.53 | ) |
Nine months ended September 30, | $ change | % change | ||||||||||||||
2022 | 2021 | |||||||||||||||
Sales | — | — | ||||||||||||||
Other income | 6,148 | 2,776 | 3,373 | 122 | % | |||||||||||
Research tax credit | 4,467 | 5,324 | (857 | ) | (16 | %) | ||||||||||
Other operating income | 1,681 | (2,549 | ) | 4,230 | (166 | %) | ||||||||||
Total operating income | 6,148 | 2,776 | 3,373 | 122 | % | |||||||||||
Nine Months Ended September 30, | ||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||
Research and Development expenses | ||||||||||||||||
External clinical-related expenses | 30,150 | 31,319 | (1,169 | ) | (4 | %) | ||||||||||
Employee-related costs | 7,761 | 10,525 | (2,764 | ) | (26 | %) | ||||||||||
Share-based payment expenses | 1,596 | 1,747 | (151 | ) | (9 | %) | ||||||||||
Depreciation, amortization and other costs | 6,423 | 15,072 | (8,649 | ) | (57 | %) | ||||||||||
Total Research and Development expenses | 45,930 | 58,663 | (12,733 | ) | (22 | %) | ||||||||||
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 | %) | ||||||||||
Nine Months Ended September 30, | ||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||
Sales and Marketing expenses | ||||||||||||||||
Personnel expenses | 727 | 1,528 | (801 | ) | (52 | %) | ||||||||||
External professional services and other costs | 932 | 1,471 | (538 | ) | (37 | %) | ||||||||||
Total Sales and Marketing expenses | 1,659 | 2,999 | (1,340 | ) | (45 | %) | ||||||||||
Three months ended March 31, | $ change | % change | Nine Months Ended September 30, | |||||||||||||||||||||||||||||
General & Administrative expenses | 2022 | 2021 | ||||||||||||||||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||||||||||||||||||
General and Administrative expenses | ||||||||||||||||||||||||||||||||
External professional services | 1,108 | 2,287 | (1,179 | ) | (52 | %) | 4,171 | 6,425 | (2,255 | ) | (35 | %) | ||||||||||||||||||||
Employee-related costs | 1,810 | 3,031 | (1,221 | ) | (40 | %) | 5,139 | 7,263 | (2,124 | ) | (29 | %) | ||||||||||||||||||||
Share-based payment expenses | 786 | 735 | 51 | 7 | % | 1,822 | 2,084 | (263 | ) | (13 | %) | |||||||||||||||||||||
Depreciation, amortization and other costs | 2,927 | 3,630 | (702 | ) | (19 | %) | 6,042 | 10,478 | (4,436 | ) | (42 | %) | ||||||||||||||||||||
Total General & Administrative expenses | 6,630 | 9,683 | (3,052 | ) | (32 | %) | ||||||||||||||||||||||||||
Total General and Administrative expenses | 17,173 | 26,250 | (9,077 | ) | (35 | %) | ||||||||||||||||||||||||||
Material Cash Requirements Due by the period Ended March 31, | Material Cash Requirements Due by the period Ended September 30, | |||||||||||||||||||||||||||||||||||||||
2023 | 2024-2025 | 2026-2027 | Thereafter | Total | 2023 | 2024 | 2025 | Thereafter | Total | |||||||||||||||||||||||||||||||
(Amounts in thousands) | (Amounts in thousands) | |||||||||||||||||||||||||||||||||||||||
Conditional advances | 333 | — | — | — | 333 | |||||||||||||||||||||||||||||||||||
Operating leases | 2,034 | 2,268 | — | — | 4,302 | 1,381 | 1,423 | — | — | 2,804 | ||||||||||||||||||||||||||||||
Purchase obligations - Obligations Under the Terms of CRO Agreements | 20,785 | 8,825 | 3,457 | — | 33,067 | 12,411 | 36,234 | 7,805 | — | 56,450 | ||||||||||||||||||||||||||||||
Total | 23,152 | 11,094 | 3,457 | — | 37,703 | 13,791 | 37,657 | 7,805 | — | 59,254 |
Three months ended March 31, | % change | Nine months ended September 30, | ||||||||||||||||||||||||||
(Amounts in thousands of U.S. Dollars) | 2022 | 2021 | 2022 | 2021 | $ change | % of change | ||||||||||||||||||||||
Net cash flow used in operating activities | (1,483 | ) | (36,204 | ) | (96 | %) | (31,781 | ) | (89,452 | ) | 57,671 | (64 | %) | |||||||||||||||
Net cash flow provided by (used in) investing activities | 11 | (185 | ) | (106 | %) | |||||||||||||||||||||||
Net cash flow (used in) provided by financing activities | (129 | ) | 440 | (129 | %) | |||||||||||||||||||||||
Net cash flow used in investing activities | (66 | ) | 41 | (107 | ) | (262 | %) | |||||||||||||||||||||
Net cash flow provided by financing activities | 194,403 | (103 | ) | 194,506 | * | |||||||||||||||||||||||
Effect of exchange rate changes on cash and cash equivalents | (1,594 | ) | (7,944 | ) | (80 | %) | (27,186 | ) | (8,643 | ) | (18,543 | ) | 215 | % | ||||||||||||||
Net (decrease) increase in cash and cash equivalents | (3,194 | ) | (43,893 | ) | (93 | %) | 135,369 | (98,157 | ) | 233,527 | (238 | %) | ||||||||||||||||
Item 4. Controls and Procedures |
Item 1. Legal Proceedings |
Item 1A. Risk Factors |
As of December 31, 2021, 55,095,762 Ordinary Shares were issued and outstanding. Sales of a substantial number of shares of our Ordinary Shares or ADSs in the public market, or the perception that these sales might occur, could depress the market price of our securities and could impair our ability to raise capital through the sale of additional equity securities. A substantial number of our shares are now generally freely tradable, subject, in the case of sales by our affiliates, to the volume limitations and other provisions of Rule 144 under the Securities Act. If holders of these shares sell, or indicate an intent to sell, substantial amounts of our securities in the public market, the trading price of our securities could decline significantly. In June 2022, we completed a $194 million PIPE financing from the sale of (i) 32,855,669 Ordinary Shares, nominal value €0.10 per share at a price per Ordinary Share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022), and (ii) pre-funded warrants to purchase an aggregate of 28,276,331 Ordinary Shares (the “Warrant Shares”) at a pre-funded price per pre-funded warrant of €2.90 (corresponding to $3.11), which equals the per share price of the Ordinary Shares less the exercise price of €0.10 per pre-funded warrant. Each pre-funded warrant has an exercise price of €0.10 per Warrant Share. Pursuant to a registration rights agreement (the “Registration Rights Agreement”) with the investors, the Company filed a registration statement with the SEC registering the resale of 59,269,629 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants. The Company also filed a registration statement with the SEC registering the resale of 11,593,170 ordinary shares by Entities affiliated with Baker Bros. Advisors, issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants. As a result, subject to certain beneficial ownership limitations contained in the pre-funded warrants, these shares are freely tradable, without restriction, in the public market. In addition, the exercise of some or all of the pre-funded warrants will increase the number of our outstanding ordinary shares, which may dilute the ownership percentage or voting power of our shareholders. In addition, we have filed a registration statement with the SEC to register the Ordinary Shares that may be issued under our equity incentive plans. The Ordinary Shares subject to outstanding options under our equity incentive plans, Ordinary Shares reserved for future issuance under our equity incentive plans and Ordinary Shares subject to outstanding warrants will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations. Sales of a large number of the shares issued under these plans in the public market could have an adverse effect on the market price of our securities. | Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
Shares”) at a pre-funded price per pre-funded warrant of €2.90 (corresponding to $3.11), which equals the per share price of the ordinary shares less the exercise price of €0.10 per Pre-Funded Warrant. Each Pre-Funded Warrant has an exercise price of €0.10 per Warrant Share. The Pre-Funded Warrants are exercisable at any time after their original issuance and will expire ten years following their issuance. The exercise price and number of shares of ordinary shares issuable upon exercise of the warrants may be adjusted in certain circumstances, including stock splits, stock dividends, reclassifications and the like. The pre-funded warrants issued in the PIPE provide that the holder of the pre-funded warrants will not have the right to exercise any portion of its pre-funded warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of ordinary shares outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”). The holder may increase or decrease the Beneficial Ownership Limitation, provided, however, that the holder may only increase the Beneficial Ownership Limitation by (i) obtaining authorization from the French Ministry of Economy in the event the Beneficial Ownership Limitation is being raised above 9.99%, and (ii) by providing 61 days’ notice to the Company, except that in no event will the Beneficial Ownership Limitation exceed 19.99%. The securities issued by us pursuant to the securities purchase agreement and to be issued upon exercise of the warrants were not registered under the Securities Act of 1933, as amended, or the Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Pursuant to the Registration Rights Agreement, the Company filed a registration statement with the Securities and Exchange Commission registering the resale of 59,269,629 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants. |
Item 3. Defaults Upon Senior Securities |
Not applicable. Item 5. Other Information |
Incorporated by Reference | ||||||||||
Exhibit | Description | |||||||||
Form | File Number | Exhibit | File Date | |||||||
3.1 | By-laws | |||||||||
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 | |||||||||
101.INS | ||||||||||
101.SCH | ||||||||||
101.CAL | ||||||||||
101.DEF | ||||||||||
101.LAB | ||||||||||
101.PRE | ||||||||||
104 | Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101. |
* | Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, (whether made before or after the date of the Form 10-Q), irrespective of any general incorporate language contained in such filing. |
DBV Technologies S.A. | ||||||||||
(Registrant) | ||||||||||
Date: | By: | /s/ Daniel Tassé | ||||||||
Daniel Tassé | ||||||||||
Chief Executive Officer | ||||||||||
(Principal Executive Officer) | ||||||||||
Date: | By: | /s/ Sébastien Robitaille | ||||||||
Sébastien Robitaille | ||||||||||
Chief Financial Officer | ||||||||||
(Principal Financial and Accounting Officer) |