☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
June 30, 2022
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
applicableapplicable
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
American Depositary Shares, each representing one-half of one ordinary share, nominal value €0.10 per share | DBVT | The Nasdaq Stock Market LLC | ||
Ordinary shares, nominal value €0.10 per share* | n/a | The Nasdaq Stock Market LLC |
* | Not for trading, but only in connection with the registration of the American Depositary Shares. |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||||||
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |||||||
Emerging growth company | ☐ |
Part I | Financial information | |||||||
Item 1 | ||||||||
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Notes to the Condensed Consolidated Financial Statements (Unaudited) | ||||||||
Item 2 | Management’s Discussion and Analysis of Financial Condition and Results of Operations | |||||||
Item 3 | ||||||||
Item 4 | ||||||||
Part II | ||||||||
Item 1 | ||||||||
Item 1A | ||||||||
Item 2 | ||||||||
Item 3 | ||||||||
Item 4 | ||||||||
Item 5 | ||||||||
Item 6 |
statements regarding
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the sufficiency of existing capital resources;
the implementation of our global restructuring plan,
developments relating to our competitors and our industry, including competing therapies; and
We qualify all of our forward-looking statements by these cautionary statements.
March 31, | December 31, | |||||||||||
Note | 2021 | 2020 | ||||||||||
Assets | ||||||||||||
Current assets : | ||||||||||||
Cash and cash equivalents | 3 | $ | 152,459 | $ | 196,352 | |||||||
Trade receivables | — | 2,230 | ||||||||||
Other current assets | 7,349 | 8,792 | ||||||||||
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Total current assets | 159,809 | 207,375 | ||||||||||
Property, plant, and equipment, net | 21,526 | 24,792 | ||||||||||
Right-of-use assets related to operating leases | 9,168 | 10,104 | ||||||||||
Intangible assets | 32 | 41 | ||||||||||
Other non-current assets | 30,870 | 29,935 | ||||||||||
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Total non-current assets | 61,596 | 64,871 | ||||||||||
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Total Assets | $ | 221,405 | $ | 272,246 | ||||||||
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Liabilities and shareholders’ equity | ||||||||||||
Current liabilities: | ||||||||||||
Trade payables | 4 | $ | 17,176 | $ | 20,338 | |||||||
Short-term operating leases | 3,314 | 3,708 | ||||||||||
Short-term financial debt | 701 | 724 | ||||||||||
Current contingencies | 6 | 4,246 | 5,016 | |||||||||
Other current liabilities | 4 | 13,394 | 22,926 | |||||||||
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Total current liabilities | 38,831 | 52,713 | ||||||||||
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Long-term operating leases | 9,533 | 10,496 | ||||||||||
Long-term financial debt | 350 | 543 | ||||||||||
Non-current contingencies | 6 | 2,229 | 2,527 | |||||||||
Other non-current liabilities | 1,286 | 475 | ||||||||||
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Total non-current liabilities | 13,398 | 14,042 | ||||||||||
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Total Liabilities | $ | 52,229 | $ | 66,754 | ||||||||
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Shareholders’ equity : | ||||||||||||
Ordinary shares, €0.10 par value; 54,936,687 and 54,929,187 shares authorized, and issued as at March 31, 2021 and December 31, 2020, respectively, and 4,100,663 and 4,029,763 shares outstanding as at March 31, 2021 and December 31, 2020, respectively | $ | 6,519 | $ | 6,518 | ||||||||
Additional paid-in capital | 1,153,516 | 1,152,042 | ||||||||||
Treasury stock, 60,588 and 112,302 ordinary shares as of March 31, 2021 and December 31, 2020, respectively, at cost | (681 | ) | (1,169 | ) | ||||||||
Accumulated deficit | (987,992 | ) | (958,543 | ) | ||||||||
Accumulated other comprehensive income | 399 | 484 | ||||||||||
Accumulated currency translation effect | (2,586 | ) | 6,158 | |||||||||
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Total Shareholders’ equity | $ | 169,176 | $ | 205,491 | ||||||||
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Total Liabilities and Shareholder’s equity | $ | 221,405 | $ | 272,246 | ||||||||
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June 30, | December 31, | |||||||||
Note | 2022 | 2021 | ||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | 3 | $ | 247,971 | $ | 77,301 | |||||
Other current assets | 4 | 11,981 | 37,085 | |||||||
Total current assets | 259,953 | 114,386 | ||||||||
Property, plant, and equipment, net | 15,677 | 18,146 | ||||||||
Right-of-use | 5 | 3,146 | 7,336 | |||||||
Intangible assets | 14 | 22 | ||||||||
Other non-current assets | 6,189 | 6,833 | ||||||||
Total non-current assets | 25,025 | 32,338 | ||||||||
Total Assets | $ | 284,978 | $ | 146,723 | ||||||
Liabilities and shareholders’ equity | ||||||||||
Current liabilities: | ||||||||||
Trade payables | 6 | $ | 16,341 | $ | 11,429 | |||||
Short-term operating leases | 5 | 1,968 | 3,003 | |||||||
Short-term financial debt | 156 | 510 | ||||||||
Current contingencies | 9 | 3,189 | 4,095 | |||||||
Other current liabilities | 6 | 8,778 | 12,361 | |||||||
Total current liabilities | 30,431 | 31,397 | ||||||||
Long-term operating leases | 5 | 1,945 | 7,147 | |||||||
Non-current contingencies | 9 | 6,421 | 6,758 | |||||||
Other non-current liabilities | 6 | 1,764 | 2,147 | |||||||
Total non-current liabilities | 10,130 | 16,052 | ||||||||
Total Liabilities | $ | 40,562 | $ | 47,449 | ||||||
Shareholders’ equity: | ||||||||||
Ordinary shares, €0.10 par value; 94,022,679 and 55,095,762 shares authorized, and issued as at June 30, 2022 and December 31, 2021, respectively | $ | 10,708 | $ | 6,538 | ||||||
Additional paid-in capital | 456,447 | 358,115 | ||||||||
Treasury stock, 106,287 and 153,631 ordinary shares as of June 30, 2022 and December 31, 2021, respectively, at cost | (953 | ) | (1,232 | ) | ||||||
Accumulated deficit | (203,050 | ) | (258,528 | ) | ||||||
Accumulated other comprehensive income | 743 | 519 | ||||||||
Accumulated currency translation effect | (19,480 | ) | (6,137 | ) | ||||||
Total Shareholders’ equity | 7 | $ | 244,416 | $ | 99,274 | |||||
Total Liabilities and Shareholders’ equity | $ | 284,978 | $ | 146,723 | ||||||
Three Months Ended March 31, | ||||||||||
Note | 2021 | 2020 | ||||||||
Operating income | 7 | $ | 2,941 | $ | 4,720 | |||||
Operating expenses | ||||||||||
Research and development expenses | (22,164 | ) | (27,532 | ) | ||||||
Sales and marketing expenses | (729 | ) | (7,297 | ) | ||||||
General and administrative expenses | (9,683 | ) | (11,113 | ) | ||||||
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Total Operating expenses | (32,575 | ) | (45,942 | ) | ||||||
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Loss from operations | (29,634 | ) | (41,222 | ) | ||||||
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Financial income | 215 | 309 | ||||||||
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Loss before taxes | (29,419 | ) | (40,913 | ) | ||||||
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Income tax | (30 | ) | — | |||||||
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Net loss | $ | (29,449 | ) | $ | (40,913 | ) | ||||
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Other comprehensive loss | ||||||||||
Foreign currency translation differences, net of taxes | (8,744 | ) | (6,064 | ) | ||||||
Actuarial (losses) gains on employee benefits, net of taxes | (85 | ) | 189 | |||||||
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Comprehensive loss | $ | (38,279 | ) | $ | (46,788 | ) | ||||
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Basic/diluted Net loss per share attributable to shareholders | 11 | $ | (0.54 | ) | $ | (0.79 | ) | |||
Weighted average shares outstanding used in computing per share amounts: | 54,880,776 | 51,802,524 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||
Note | 2022 | 2021 | 2022 | 2021 | ||||||||||||||
Operating income | 10 | $ | 1,529 | $ | (1,488 | ) | $ | 4,074 | $ | 1,453 | ||||||||
Operating expenses | ||||||||||||||||||
Research and development expenses | (18,611 | ) | (20,179 | ) | (30,834 | ) | (42,343 | ) | ||||||||||
Sales and marketing expenses | (1,037 | ) | (1,198 | ) | (1,500 | ) | (1,927 | ) | ||||||||||
General and administrative expenses | (5,704 | ) | (8,269 | ) | (12,334 | ) | (17,951 | ) | ||||||||||
Total Operating expenses | (25,352 | ) | (29,646 | ) | (44,669 | ) | (62,221 | ) | ||||||||||
Loss from operations | (23,823 | ) | (31,134 | ) | (40,595 | ) | (60,768 | ) | ||||||||||
Financial income | 784 | 46 | 936 | 261 | ||||||||||||||
Loss before taxes | (23,039 | ) | (31,088 | ) | (39,659 | ) | (60,507 | ) | ||||||||||
Income tax | — | 434 | (87 | ) | 404 | |||||||||||||
Net loss | $ | (23,039 | ) | $ | (30,654 | ) | $ | (39,746 | ) | $ | (60,103 | ) | ||||||
Foreign currency translation differences, net of taxes | (11,394 | ) | 2,788 | (13,327 | ) | (5,956 | ) | |||||||||||
Actuarial gains (losses) on employee benefits, net of taxes | 200 | 48 | 224 | (38 | ) | |||||||||||||
Total comprehensive loss | $ | (34,234 | ) | $ | (27,818 | ) | $ | (52,849 | ) | $ | (66,097 | ) | ||||||
Basic/diluted net loss per share attributable to shareholders | 14 | $ | (0.35 | ) | $ | (0.56 | ) | $ | (0.66 | ) | $ | (1.09 | ) | |||||
Weighted average shares outstanding used in computing per share amounts: | 66,047,949 | 54,904,764 | 60,490,075 | 54,892,794 |
Three Months Ended March 31, | ||||||||||||
Notes | 2021 | 2020 | ||||||||||
Net loss for the period | $ | (29,449 | ) | $ | (40,913 | ) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
Depreciation, amortization and accrued contingencies | 1,483 | 1,548 | ||||||||||
Retirement pension obligations | — | 109 | ||||||||||
Expenses related to share-based payments | 1,433 | 3,073 | ||||||||||
Other elements | (456 | ) | 419 | |||||||||
Changes in operating assets and liabilities: | ||||||||||||
Decrease (increase) in inventories and work in progress | — | (2,402 | ) | |||||||||
Decrease (increase) in trade receivables | 2,101 | — | ||||||||||
Decrease (increase) in other current assets | (417 | ) | 122 | |||||||||
(Decrease) increase in trade payables | (2,567 | ) | (3,212 | ) | ||||||||
(Decrease) increase in other current and non-current liabilities | (7,980 | ) | (8,382 | ) | ||||||||
Change in operating lease liabilities and right of use assets | (353 | ) | (45 | ) | ||||||||
Net cash flow used in operating activities | (36,204 | ) | (49,683 | ) | ||||||||
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Cash flows used in investing activities: | ||||||||||||
Acquisitions of property, plant, and equipment, net from proceeds | (184 | ) | (816 | ) | ||||||||
Acquisitions of intangible assets | — | (114 | ) | |||||||||
Acquisitions of non-current financial assets | (1 | ) | — | |||||||||
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Net cash flows used in investing activities | (185 | ) | (930 | ) | ||||||||
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Cash flows provided by financing activities: | ||||||||||||
(Decrease) increase in conditional advances | (164 | ) | 7 | |||||||||
Treasury shares | 578 | (412 | ) | |||||||||
Capital increases, net of transaction costs | 42 | 151,023 | ||||||||||
Other cash flows related to financing activities | (17 | ) | (7 | ) | ||||||||
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Net cash flows provided by financing activities | 440 | 150,611 | ||||||||||
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Effect of exchange rate changes on cash and cash equivalents | (7,944 | ) | (5,811 | ) | ||||||||
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Net (decrease) / increase in cash and cash equivalents | (43,893 | ) | 94,187 | |||||||||
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Net Cash and cash equivalents at the beginning of the period | 196,352 | 193,255 | ||||||||||
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Net cash and cash equivalents at the end of the period | 3 | $ | 152,459 | $ | 287,442 | |||||||
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Six Months Ended June 30, | ||||||||||
Notes | 2022 | 2021 | ||||||||
Net loss for the period | $ | (39,746 | ) | $ | (60,103 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||
Depreciation, amortization and accrued contingencies | 1,249 | 8,619 | ||||||||
Retirement pension obligations | 14 | 57 | ||||||||
Expenses related to share-based payments | 8 | 2,441 | 2,527 | |||||||
Other elements | (3 | ) | (843 | ) | ||||||
Changes in operating assets and liabilities: | ||||||||||
Decrease (increase) in trade receivables | — | 2,175 | ||||||||
Decrease (increase) in other current assets | 23,436 | (8,393 | ) | |||||||
(Decrease) increase in trade payables | 5,894 | (3,165 | ) | |||||||
(Decrease) increase in other current and non-current liabilities | (3,040 | ) | (6,608 | ) | ||||||
Change in operating lease liabilities and right of use assets | (1,979 | ) | (769 | ) | ||||||
Net cash flow used in operating activities | (11,733 | ) | (66,503 | ) | ||||||
Cash flows used in investing activities: | ||||||||||
Acquisitions of property, plant, and equipment, net from proceeds | (369 | ) | (13 | ) | ||||||
Proceeds from property, plant, and equipment dispositions | 3 | — | ||||||||
Acquisitions of non-current financial assets | (279 | ) | — | |||||||
Proceeds from non-current financial assets | 426 | — | ||||||||
Net cash flows used in investing activities | (218 | ) | (13 | ) | ||||||
Cash flows provided by financing activities: | ||||||||||
Decrease in conditional advances | (328 | ) | (345 | ) | ||||||
Treasury shares | 279 | 638 | ||||||||
Capital increases, net of transaction costs | 195,270 | 794 | ||||||||
Other cash flows related to financing activities | — | (17 | ) | |||||||
Net cash flows provided by financing activities | 195,221 | 1,071 | ||||||||
Effect of exchange rate changes on cash and cash equivalents | (12,600 | ) | (5,423 | ) | ||||||
Net increase (decrease) in cash and cash equivalents | 170,670 | (70,868 | ) | |||||||
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 | $ | 247,971 | $ | 125,484 | |||||
Ordinary shares | ||||||||||||||||||||||||||||||||
Number of Shares | Amount | Additional paid-in capital | Treasury stock | Accumulated deficit | Accumulated other comprehensive income (loss) | Accumulated currency translation effect | Total Shareholders’ Equity | |||||||||||||||||||||||||
Balance at January 1, 2020 | 47,028,510 | $ | 5,645 | $ | 1,003,595 | $ | (230 | ) | $ | (798,988 | ) | $ | 108 | $ | (16,945 | ) | $ | 193,186 | ||||||||||||||
Net (loss) | — | — | — | — | (40,913 | ) | — | — | (40,913 | ) | ||||||||||||||||||||||
Other comprehensive income (loss) | — | — | — | — | — | 189 | (6,064 | ) | (5,875 | ) | ||||||||||||||||||||||
Issuance of ordinary shares | 7,898,677 | 873 | 150,150 | — | — | — | — | 151,023 | ||||||||||||||||||||||||
Treasury shares | — | — | — | (832 | ) | — | — | — | (832 | ) | ||||||||||||||||||||||
Share-based payments | — | — | 3,073 | — | — | — | 3,073 | |||||||||||||||||||||||||
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Balance at March 31, 2020 | 54,927,187 | $ | 6,518 | $ | 1,156,818 | $ | (1,062 | ) | $ | (839,901 | ) | $ | 297 | $ | (23,009 | ) | $ | 299,662 | ||||||||||||||
Ordinary shares | ||||||||||||||||||||||||||||||||
Number of Shares | Amount | Additional paid-in capital | Treasury stock | Accumulated deficit | Accumulated other comprehensive gain (loss) | Accumulated currency translation effect | Total Shareholders’ Equity | |||||||||||||||||||||||||
Balance at January 1, 2021 | 54,929,187 | $ | 6,518 | $ | 1,152,042 | $ | (1,169 | ) | $ | (958,543 | ) | $ | 484 | $ | 6,158 | $ | 205,491 | |||||||||||||||
Net (loss) | — | — | — | — | (29,449 | ) | — | — | (29,449 | ) | ||||||||||||||||||||||
Other comprehensive (loss) | — | — | — | — | — | (85 | ) | (8,744 | ) | (8,829 | ) | |||||||||||||||||||||
Issuance of ordinary shares | 7 500 | 1 | 42 | — | — | — | — | 42 | ||||||||||||||||||||||||
Treasury shares | — | — | — | 488 | — | — | — | 488 | ||||||||||||||||||||||||
Share-based payments | — | — | 1,433 | — | — | — | — | 1,433 | ||||||||||||||||||||||||
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Balance at March 31, 2021 | 54,936,687 | $ | 6,519 | $ | 1,153,516 | $ | (681 | ) | $ | (987,992 | ) | $ | 399 | $ | (2,586 | ) | $ | 169,176 |
Ordinary shares | ||||||||||||||||||||||||||||||||
Number of Shares | Amount | Additional paid-in capital | Treasury stock | Accumulated deficit | Accumulated other comprehensive income (loss) | Accumulated currency translation effect | Total Shareholders’ Equity | |||||||||||||||||||||||||
Balance at January 1, 2021 | 54,929,187 | $ | 6,518 | $ | 1,152,042 | $ | (1,169 | ) | $ | (958,543 | ) | $ | 484 | $ | 6,158 | $ | 205,491 | |||||||||||||||
Net (loss) | — | — | — | — | (29,449 | ) | — | — | (29,449 | ) | ||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | (85 | ) | (8,744 | ) | (8,829 | ) | |||||||||||||||||||||
Issuance of ordinary shares | 7,500 | 1 | 42 | — | — | — | — | 42 | ||||||||||||||||||||||||
Treasury shares | — | — | — | 488 | — | — | — | 488 | ||||||||||||||||||||||||
Share-based payments | — | — | 1,433 | — | — | — | — | 1,433 | ||||||||||||||||||||||||
Balance at March 31, 2021 | 54,936,687 | $ | 6,519 | $ | 1,153,516 | $ | (681 | ) | $ | (987,992 | ) | $ | 399 | $ | (2,586 | ) | $ | 169,176 | ||||||||||||||
Net (loss) | — | — | — | — | (30,654 | ) | — | — | (30,654 | ) | ||||||||||||||||||||||
Other comprehensive income | — | — | — | — | — | 48 | 2,788 | 2,836 | ||||||||||||||||||||||||
Issuance of ordinary shares | 75,000 | 9 | 464 | — | — | — | — | 473 | ||||||||||||||||||||||||
Insuance 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 |
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 | ) | ||||||||||||||||||||||
Insuance 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 |
2021.
Going concern
Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.
Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its Biologics License Application (“BLA”) for Viaskin™ Peanut, beginning in August 2020, the Company scaled down its other clinical programs and pre-clinical spend to focus on Viaskin™ Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin™ Peanut in the United States and European Union. Based on guidance received from the FDA in January 2021, the Company’s plans to implement such guidance, and expected cost savings from implementation of the global restructuring plan, the Company expects that its current balance of cash and cash equivalents of $152.5 million as of March 31, 2021 will be sufficient to fund its operations for at least the next 12 months.
The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings. As a result of disruptions to the global financial markets as a result of the ongoing COVID-19 pandemic, the Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions. The ongoing COVID-19 pandemic has already caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.
Effective January 1, 2021, the2022
date.
In January 2017, the FASB issued ASU 2017-04, Simplifying the Test for Goodwill Impairment, which modifies the goodwill impairment test and requires an entity to write down the carrying value of goodwill for the amount by which the carrying amount of a reporting unit exceeds its fair value. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The Company does not expect this new standard will have a material impact on its consolidated financial statements.
In January 2020, the Company announced positive topline results of the three-year, open-label extension of its Phase III PEPITES trial, or PEOPLE trial, evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrated long-term clinical benefit as shown by an increase in eliciting dose (“ED”), which may decrease the chance of reacting to an accidental peanut exposure. After three years, the Company observed that 75.9% (107/141) of patients had increased their ED from baseline, and 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein by year three. The safety profile of Viaskin Peanut was consistent with that observed
United States
On August 4, 2020, the Company announced that FDA has issued a Complete Response Letter in which the FDA indicated it could not approve the Viaskin Peanut BLA in its current form. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study. The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data. The FDA did not raise any safety concerns related to Viaskin Peanut.
On January 13, 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. The Company believes the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, the Company proposed potential resolutions to two main concerns identified by the FDAComplete Response Letter received in the CRL: the impact of patch adhesion and the need for patch modifications.August 2020. The FDA agreed with the Company’sits position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patches, thepatch, FDA has
requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years.
On November 2, 2020, The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches
1. | Identify a modified Viaskin patch (which the Company calls mVP). |
2. | Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible. |
3. | Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies: |
a. | PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL |
b. | ‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and Mvp; |
available.
On
Financing
On February 4, 2020,2022.
On March 2, 2020,
Consequently, following partial exercise of the Option, the total number of ordinary shares sold in the global offering was 7,838,687 ordinary shares, including 4,874,268the ordinary shares in issuable upon exercise of
Restructuring
The Company initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanutmay not be offered or sold in the United States and European Union.except pursuant to an effective registration statement or an applicable exemption from the registration requirements. The Company expects full implementationhas agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the organization-wide costs reduction measures to be completed byordinary shares, including the secondordinary shares underlying
The following table summarizes restructuring activities as2022, the Company has cash and cash equivalent to support the Company’s operations several months beyond the projected completion of March 31, 2021 includedVITESSE, the planned Phase 3 clinical study of the modified Viaskin
| ||||
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| ||||
| ||||
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|
older.
aimed primarily at guaranteeing the safety of its employees and the continuation of ongoing clinical trials, in compliance with the directives of the authorities in each country. The Company has experienced a decrease in new patients enrolling in the ongoing clinical studies and it has had to adapt the protocols of its clinical trials because patients remain subject to travel restrictions.
March 31, | December 31, | |||||||
2021 | 2020 | |||||||
Cash | 58,069 | 42,341 | ||||||
Cash equivalents | 94,390 | 154,011 | ||||||
|
|
|
| |||||
Total cash and cash equivalents as reported in the statements of financial position | 152,459 | 196,352 | ||||||
|
|
|
|
equivalents as of June 30, 2022 and December 31, 2021:
June 30, | December 31, | |||||||
2022 | 2021 | |||||||
Cash | 226,674 | 31,427 | ||||||
Cash equivalents | 21,298 | 45,874 | ||||||
Total cash and cash equivalents as reported in the statements of financial position | 247,971 | 77,301 | ||||||
June 30, | December 31, | |||||||
2022 | 2021 | |||||||
Research tax credit | 2,908 | 28,092 | ||||||
Other tax claims | 4,339 | 3,561 | ||||||
Prepaid expenses | 3,773 | 4,149 | ||||||
Other receivables | 961 | 1,283 | ||||||
Total | 11,981 | 37,085 | ||||||
Amount in thousands of US Dollars | ||||
Opening research tax credit receivable as of January 1, 2022 | 28,092 | |||
+ Operating revenue | 3,060 | |||
- Payment received | (27,119 | ) | ||
- Adjustment and currency translation effect | (1,125 | ) | ||
Closing research tax credit receivable as of June 30, 2022 | 2,908 | |||
Of which - Non -current portion | — | |||
Of which - Current portion | 2,908 |
June 30, 2022 | December 31, 2021 | |||||||||||||||||||||||
Real estate | Other assets | Total | Real estate | Other assets | Total | |||||||||||||||||||
Current portion | 2,104 | 50 | 2,154 | 3,361 | 77 | 3,438 | ||||||||||||||||||
Year 2 | 1,843 | 19 | 1,862 | 3,124 | 23 | 3,147 | ||||||||||||||||||
Year 3 | 284 | 11 | 295 | 2,299 | 18 | 2,317 | ||||||||||||||||||
Year 4 | — | — | — | 771 | 1 | 773 | ||||||||||||||||||
Year 5 | — | — | — | 790 | — | 790 | ||||||||||||||||||
Thereafter | — | — | — | 1,220 | — | 1,220 | ||||||||||||||||||
Total minimum lease payments | 4,231 | 80 | 4,311 | 11,565 | 119 | 11,684 | ||||||||||||||||||
Less: Effects of discounting | (363 | ) | (6 | ) | (370 | ) | (1,526 | ) | (8 | ) | (1,534 | ) | ||||||||||||
Present value of operating lease | 3,868 | 73 | 3,941 | 10,039 | 111 | 10,150 | ||||||||||||||||||
Less: current portion | (1,922 | ) | (46 | ) | (1,968 | ) | (2,929 | ) | (74 | ) | (3,003 | ) | ||||||||||||
Long-term operating lease | 1,946 | 27 | 1,973 | 7,110 | 37 | 7,147 | ||||||||||||||||||
Weighted average remaining lease term (years) | 1.79 | — | 4.14 | 2.01 | ||||||||||||||||||||
Weighted average discount rate | 3.14 | % | 1.29 | % | 4.84 | % | 3.32 | % |
June 30, | |||||||
2022 | 2021 | ||||||
Operating lease expense | 950 | 1,698 | |||||
Net termination impact | (1,657 | ) | — |
June 30, | ||||||
2022 | 2021 | |||||
Cash paid for amounts included in the measurement of lease liabilities | — | — | ||||
Operating cash flows from operating leases | 1,079 | 2,077 |
4.1
4.2
Other current
March 31, | December 31, | |||||||
2021 | 2020 | |||||||
Employee related liabilities | 9,245 | 16,661 | ||||||
Deferred income | 3,378 | 4,687 | ||||||
Tax liabilities | 312 | 580 | ||||||
Other debts | 460 | 999 | ||||||
|
|
|
| |||||
Total | 13,394 | 22,926 | ||||||
|
|
|
|
June 30, | December 31, | |||||||||||||||||||||||
2022 | 2021 | |||||||||||||||||||||||
Other current liabilities | Other non-current liabilities | Total | Other current liabilities | Other non-current liabilities | Total | |||||||||||||||||||
Employee related liabilities | 4,135 | 77 | 4,212 | 6,708 | 247 | 6,954 | ||||||||||||||||||
Deferred income | 3,012 | 1,687 | 4,700 | 4,146 | 1,900 | 6,046 | ||||||||||||||||||
Tax liabilities | 400 | — | 400 | 182 | — | 182 | ||||||||||||||||||
Other debts | 1,231 | — | 1,231 | 1,325 | — | 1,325 | ||||||||||||||||||
Total | 8,778 | 1,764 | 10,542 | 12,361 | 2,147 | 14,508 | ||||||||||||||||||
obligations
subscribed in cash at a unit price of €2.90 of share premium) and to be fully paid up at the time of subscription, i.e. a capital increase of a nominal amount of €3,285,566.90 together with a share premium of € 95,281,440.10, i.e. a gross amount of the capital increase of € 98,567,007, and (ii) 28,276,331 prefunded warrants to be subscribed in cash by paying up on the date of issue of € 82,001,359.90 corresponding to the prepayment of the subscription price of the new ordinary shares in the event of exercise of the prefunded warrants, |
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 June 30, 2022 | 28,276,331 | |||
stock units to employees. There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 1413 to the consolidated financial statements included in the Annual Report.
Stock | ||||
Weighted average share price at grant date in € | ||||
Weighted average expected volatility | % | |||
Weighted average risk-free interest rate | ||||
Weighted average expected term (in years) | 6 | |||
Dividend yield | — | |||
Weighted average fair value of |
Number of outstanding | ||||||||||||||||
BSA | BCE | SO | RSUs | |||||||||||||
Balance as of December 31, 2020 | 218,008 | 5,500 | 2,610,510 | 1,118,745 | ||||||||||||
Granted during the period | — | — | 75,600 | 24,900 | ||||||||||||
Forfeited during the period | — | — | (15,400 | ) | (13,700 | ) | ||||||||||
Exercised/released during the period | — | (500 | ) | — | — | |||||||||||
Expired during the period | — | — | — | — | ||||||||||||
|
|
|
|
|
|
|
| |||||||||
Balance as of March 31, 2021 | 218,008 | 5 000 | 2,670,710 | 1,129,945 | ||||||||||||
|
|
|
|
|
|
|
|
Reconciliation of the share-based
Number of outstanding | ||||||||||||
BSA | SO | RSUs | ||||||||||
Balance as of December 31, 2021 | 256,693 | 3,631,210 | 1,240,520 | |||||||||
Granted during the period | — | 19,000 | 3,200 | |||||||||
Forfeited during the period | — | (205,728 | ) | (66,588 | ) | |||||||
Exercised/released during the period | — | (2,125 | ) | (31,910 | ) | |||||||
Expired during the period | — | — | — | |||||||||
Balance as of June 30, 2022 | 256,693 | 3,442,358 | 1,145,223 | |||||||||
Three Months Ended March 31, | ||||||||||||
2021 | 2020 | |||||||||||
Research and development | SO | (376 | ) | (876 | ) | |||||||
RSU | (251 | ) | (392 | ) | ||||||||
Sales and marketing | SO | (49 | ) | (598 | ) | |||||||
RSU | (22 | ) | (2 | ) | ||||||||
General and administrative | SO | (644 | ) | (1,071 | ) | |||||||
RSU | (91 | ) | (133 | ) | ||||||||
|
|
|
| |||||||||
Total share-based compensation expense | (1,433 | ) | (3,073 | ) | ||||||||
|
|
|
|
o
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||||||
Research & development | SO | (290 | ) | (302 | ) | (665 | ) | (678 | ) | |||||||||||
RSU | (185 | ) | 115 | (393 | ) | (136 | ) | |||||||||||||
Sales & marketing | SO | (38 | ) | (63 | ) | (33 | ) | (112 | ) | |||||||||||
RSU | (17 | ) | (26 | ) | (16 | ) | (48 | ) | ||||||||||||
General & administrative | SO | (478 | ) | (709 | ) | (1,176 | ) | (1,353 | ) | |||||||||||
RSU | (70 | ) | (110 | ) | (157 | ) | (201 | ) | ||||||||||||
Total share-based compensation (expens e ) | (1,078 | ) | (1,094 | ) | (2,441 | ) | (2,527 | ) | ||||||||||||
Current
June 30, | December 31, | |||||||
2022 | 2021 | |||||||
Current contingencies | 3,189 | 4,095 | ||||||
Non-current contingencies | 6,421 | 6,758 | ||||||
Total contingencies | 9,610 | 10,853 | ||||||
March 31, | December 31, | |||||||
2021 | 2020 | |||||||
Current contingencies | 4,246 | 5,016 | ||||||
Non-current contingencies | 2,229 | 2,527 | ||||||
|
|
|
| |||||
Total contingencies | 6,474 | 7,542 | ||||||
|
|
|
|
The table below shows movements in contingencies:
Pension retirement obligations | Collaboration agreement - Loss at completion | Other contingencies | Total | |||||||||||||
At January 1, 2021 | 937 | 3,956 | 2,649 | 7,542 | ||||||||||||
Increases in liabilities | — | — | — | — | ||||||||||||
Used liabilities | — | (434 | ) | (515 | ) | (949 | ) | |||||||||
Reversals of unused liabilities | — | — | — | — | ||||||||||||
Net interest related to employee benefits, and unwinding of discount | — | — | — | — | ||||||||||||
Actuarial gains and losses on defined-benefit plans | 85 | — | — | 85 | ||||||||||||
Other effects including currency translation effect | (44 | ) | (164 | ) | 4 | (204 | ) | |||||||||
|
|
|
|
|
|
|
| |||||||||
At March 31, 2021 | 978 | 3,358 | 2,139 | 6,474 | ||||||||||||
|
|
|
|
|
|
|
| |||||||||
Of which current | — | 2,107 | 2,139 | 4,246 | ||||||||||||
Of which non-current | 978 | 1,251 | — | 2,229 |
Pension retirement obligations | Collaboration agreement - Loss at completion | Other contingencies | Total | |||||||||||||
At January 1, 2022 | 1,008 | 9,800 | 45 | 10,853 | ||||||||||||
Increases in liabilities | 14 | — | — | 14 | ||||||||||||
Used liabilities | — | (108 | ) | (44 | ) | (152 | ) | |||||||||
Reversals of unused liabilities | — | — | — | — | ||||||||||||
Net interest related to employee benefits, and unwinding of discount | — | — | — | — | ||||||||||||
Actuarial gains and losses on defined-benefit plans | (224 | ) | — | — | (224 | ) | ||||||||||
Currency translation effect | (73 | ) | (807 | ) | (2 | ) | (882 | ) | ||||||||
At June 30, 2022 | 725 | 8,885 | — | 9,610 | ||||||||||||
Of which Current | — | 3,189 | — | 3,189 | ||||||||||||
Of which Non-current | 725 | 5,696 | — | 6,421 |
Other contingencies are primarily composed of the estimated expenses to be incurred as part of the employee-related costs related to restructuring, as well as estimated cost of refurbishing lease premises (Refer to Note 2, “Significant Events and Transactions—Restructuring contingencies).
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Research tax credit | 1,807 | 2,902 | ||||||
Other operating income | 1,133 | 1,818 | ||||||
|
|
|
| |||||
Total | 2,941 | 4,720 | ||||||
|
|
|
|
three and six months ended June 30, 2022 and 2021:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Research tax credit | 1,491 | 1,870 | 3,060 | 3,677 | ||||||||||||
Other operating income | 37 | (3,358 | ) | 1,014 | (2,225 | ) | ||||||||||
Total | 1,529 | (1,488 | ) | 4,074 | 1,453 | |||||||||||
AllocationJune 30, 2021.
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Research and development expenses | 4,718 | 10,204 | ||||||
Sales and marketing expenses | 518 | 4,197 | ||||||
General and administrative expenses | 3,766 | 4,283 | ||||||
|
|
|
| |||||
Total personnel expenses | 9,002 | 18,684 | ||||||
|
|
|
|
Allocationfunction during the three and six months ended June 30, 2022 and 2021:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Research and Development expenses | 3,097 | 3,393 | 6,172 | 8,111 | ||||||||||||
Sales and Marketing expenses | 344 | 518 | 589 | 1,036 | ||||||||||||
General and Administrative expenses | 2,767 | 2,999 | 5,362 | 6,765 | ||||||||||||
Total personnel expenses | 6,208 | 6,910 | 12,123 | 15,912 | ||||||||||||
Three months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Wages and salaries | 4,454 | 12,872 | ||||||
Social security contributions | 1,332 | 663 | ||||||
Expenses for pension commitments | 402 | 915 | ||||||
Employer contribution to bonus shares | 1,381 | 1,162 | ||||||
Share-based payments | 1,433 | 3,073 | ||||||
|
|
|
| |||||
Total personnel expenses | 9,002 | 18,684 | ||||||
|
|
|
|
nature during the three six months ended June 30, 2022 and 2021:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Wages and salaries | 3,509 | 4,382 | 7,497 | 8,836 | ||||||||||||
Social security contributions | 1,256 | 1,064 | 1,507 | 2,396 | ||||||||||||
Expenses for pension commitments | 211 | 293 | 509 | 695 | ||||||||||||
Employer contribution to bonus shares | 154 | 77 | 170 | 1,458 | ||||||||||||
Share-based payments | 1,078 | 1,094 | 2,441 | 2,527 | ||||||||||||
Total | 6,208 | 6,910 | 12,123 | 15,912 | ||||||||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Non-employee warrants | 225,008 | 225,008 | ||||||
Employee warrants | 75,000 | 82,500 | ||||||
Stock-options | 2,670,710 | 2 835,635 | ||||||
Restricted stock units | 1,129,945 | 696,895 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Non-employee warrants | 256,693 | 256,693 | 256,693 | 256,693 | ||||||||||||
Stock options | 3,442,358 | 2,594,410 | 3,442,358 | 2,594,410 | ||||||||||||
Restricted stock units | 1,145,223 | 1,092,445 | 1,145,223 | 1,092,445 | ||||||||||||
Prefunded warrants | 28,276,331 | — | 28,276,331 | — |
On We believe Viaskin may offer convenient, self-administered,
4. | Identify a modified Viaskin patch (which the Company calls mVP). |
5. | 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. |
6. | 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: |
c. | 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 |
d. | ‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and Mvp; |
During on the first quarterkey elements of the VITESSE protocol. As previously disclosed, the Company will communicate key elements of the VITESSE trial design and projected timelines once this process has concluded.
arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33;4 %, 95 % CI = 22.4% - 44.5 %).
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Operating income | $ | 2,941 | $ | 4,720 | ||||
Operating expenses | ||||||||
Research and development expenses | (22,164 | ) | (27,532 | ) | ||||
Sales and marketing expenses | (729 | ) | (7,297 | ) | ||||
General and administrative expenses | (9,683 | ) | (11,113 | ) | ||||
Restructuring expenses | — | — | ||||||
|
|
|
| |||||
Total Operating expenses | (32,575 | ) | (45,942 | ) | ||||
|
|
|
| |||||
Financial income | 215 | 309 | ||||||
|
|
|
| |||||
Income tax | (30 | ) | — | |||||
|
|
|
| |||||
Net loss | $ | (29,449 | ) | $ | (40,913 | ) | ||
|
|
|
| |||||
Basic/diluted Net loss per share attributable to shareholders | $ | (0.54 | ) | $ | (0.79 | ) |
Comparison of the three months ended March 31, 2021 to the three months ended March 31, 2020
2021.
Three months ended June 30, | ||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||
Operating income | $ | 1,529 | $ | (1,488 | ) | 3,016 | (203 | )% | ||||||||
Operating expenses | ||||||||||||||||
Research and development expenses | (18,611 | ) | (20,179 | ) | 1,568 | (8 | )% | |||||||||
Sales and marketing expenses | (1,037 | ) | (1,198 | ) | 162 | (13 | )% | |||||||||
General and administrative expenses | (5,704 | ) | (8,269 | ) | 2,564 | (31 | )% | |||||||||
Total Operating expenses | (25,352 | ) | (29,646 | ) | 4,309 | (15 | )% | |||||||||
Financial income | 784 | 46 | 737 | * | ||||||||||||
Income tax | — | 434 | (434 | ) | (100 | )% | ||||||||||
Net loss | $ | (23,039 | ) | $ | (30,654 | ) | 7,629 | (25 | )% | |||||||
Basic/diluted Net loss per share attributable to shareholders | $ | (0.35 | ) | $ | (0.56 | ) |
* | Percentage not meaningful |
We generated
Three months ended June 30, | ||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||
Sales | — | — | — | — | ||||||||||||
Other income | 1,529 | (1,488 | ) | 3,016 | (203 | )% | ||||||||||
Research tax credit | 1,491 | 1,870 | (379 | ) | (20 | )% | ||||||||||
Other operating income | 37 | (3,358 | ) | 3,396 | (101 | )% | ||||||||||
Total operating income | 1,529 | (1,488 | ) | 3,016 | (203 | )% | ||||||||||
Three Months Ended March 31 | % change | |||||||||||
2021 | 2020 | 2021 vs 2020 | ||||||||||
Sales | — | — | ||||||||||
Other income | 2,941 | 4,720 | (37.7 | )% | ||||||||
Research tax credit | 1,807 | 2,902 | (37.7 | )% | ||||||||
Other operating income | 1,133 | 1,818 | (37.6 | )% | ||||||||
|
|
|
|
|
| |||||||
Total operating income | 2,941 | 4,720 | (37.7 | )% | ||||||||
|
|
|
|
|
|
We generated operating income of $1.5 million during the three months ended June 30, 2022 compared to $(1.5) million during the three months ended June 30, 2021. The decreaseincrease in operating income is primarily attributable to the decrease ofrevenue recognized under the CIR,Nestlé’s collaboration agreement, as eligible expenses have declined in correlation with Research and Development costs.
As of March 31, 2021, we recorded our collaboration contract income based on our updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. During the three months ended June 30, 2021 negative revenue was recognized under the Nestlé’s collaboration agreement due to delays in new patient enrollment.The decrease in research tax credit is attributable to the decline of eligible expenses in connection with Research and license agreement with Nestlé Health Science. The accrual recorded in the amount of the difference between our current best estimates of costs yet to be incurredDevelopment costs.
Operating Expense
Development Expenses
Three months Ended March 31 | % change | |||||||||||
2021 | 2020 | 2021 vs 2020 | ||||||||||
Research and development expenses | 22,164 | 27,532 | (19.5 | )% | ||||||||
Sales and marketing expenses | 729 | 7,297 | (90.0 | )% | ||||||||
General and administrative expenses | 9,683 | 11,113 | (12.9 | )% | ||||||||
|
|
|
|
|
| |||||||
Total operating expenses | 32,575 | 45,942 | (29.1 | )% | ||||||||
|
|
|
|
|
|
Operating
Three Months Ended June 30, | ||||||||||||||||
Research and Development expenses | 2022 | 2021 | $ change | % change | ||||||||||||
External clinical-related expenses | 11,664 | 9,808 | 1,856 | 19 | % | |||||||||||
Employee-related costs | 2,622 | 3,206 | (584 | ) | (18 | )% | ||||||||||
Share-based payment expenses | 475 | 187 | 289 | 155 | % | |||||||||||
Depreciation, amortization and other costs | 3,850 | 6,978 | (3,128 | ) | (45 | )% | ||||||||||
Total Research and Development expenses | 18,611 | 20,179 | (1,568 | ) | (8 | )% | ||||||||||
Three Months Ended March 31, | % change | |||||||||||
2021 | 2020 | 2021 vs 2020 | ||||||||||
Research and development expenses | 4,718 | 10,204 | (53.8 | )% | ||||||||
Sales and marketing expenses | 518 | 4,197 | (87.7 | )% | ||||||||
General and administrative expenses | 3,766 | 4,283 | (12.1 | )% | ||||||||
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Total personnel expenses | 9,002 | 18,684 | (51.8 | )% | ||||||||
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new organization.
Three Months Ended June 30, | ||||||||||||||||
Sales and Marketing expenses | 2022 | 2021 | $ change | % change | ||||||||||||
External professional services | 399 | 307 | 92 | 30 | % | |||||||||||
Employee-related costs | 289 | 430 | (140 | ) | (33 | )% | ||||||||||
Share-based payment expenses | 55 | 89 | (34 | ) | (38 | )% | ||||||||||
Depreciation, amortization and other costs | 294 | 373 | (79 | ) | (21 | )% | ||||||||||
Total Sales and Marketing expenses | 1,037 | 1,198 | (162 | ) | (13 | )% | ||||||||||
Three Months Ended June 30, | ||||||||||||||||
General and Administrative expenses | 2022 | 2021 | $ change | % change | ||||||||||||
External professional services | 1,771 | 1,922 | (151 | ) | (8 | )% | ||||||||||
Employee-related costs | 2,220 | 2,180 | 40 | 2 | % | |||||||||||
Share-based payment expenses | 548 | 819 | (271 | ) | (33 | )% | ||||||||||
Depreciation, amortization and other costs | 1,166 | 3,348 | (2,182 | ) | (65 | )% | ||||||||||
Total General and Administrative expenses | 5,704 | 8,269 | (2,564 | ) | (31 | )% | ||||||||||
As a result of the ongoing COVID-19 pandemic, we also experienced a decrease in other expenses, in particular tradeshows and travel expenses.
Restructuring
We initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin™ Peanut in the United States and European Union.
We expect full implementation of the restructuring plan to result in a reduction of more than 200 jobs, resulting in a remaining global team of 90 individuals dedicated to the pursuit of innovation and scientific development of novel therapies.
As of March 31, 2021, we had 104 employees. We expect full implementation of the organization-wide costs reduction measures to be completed by the second half of 2021.
The restructuring costs, which were $23.6 million as of December 31, 2020, were mainly comprised of payroll expenses, restructuring-related consulting and legal fees, as well as impairment of facilities and right of use assets following resizing of facilities.
During the three months ended March 31, 2021, the restructuring liability evolved as presented below:
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They were no restructuring costs for three months ended March 31, 2021 and 2020.
Financial income
Our financial income was $0.2 million for the three months ended March 31, 2021 and 2020. This item mainly includes foreign exchange income.
Net loss
Net loss was $29.4 million for the three months ended March 31, 2021, compared to $40.9 million for the three months ended March 31, 2020. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.54$0.35 and $0.79$0.56 for the three months ended June 30, 2022 and 2021, respectively.
Six months ended June 30, | ||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||
Operating income | $ | 4,074 | $ | 1,453 | 2,621 | 180 | % | |||||||||
Operating expenses | ||||||||||||||||
Research and development expenses | (30,834 | ) | (42,343 | ) | 11,509 | (27 | )% | |||||||||
Sales and marketing expenses | (1,500 | ) | (1,927 | ) | 427 | (22 | )% | |||||||||
General and administrative expenses | (12,334 | ) | (17,951 | ) | 5,617 | (31 | )% | |||||||||
Total Operating expenses | (44,669 | ) | (62,221 | ) | 17,552 | (28 | )% | |||||||||
Financial income (expense) | 936 | 261 | 675 | 258 | % | |||||||||||
Income tax | (87 | ) | 404 | (491 | ) | (122 | )% | |||||||||
Net loss | $ | (39,746 | ) | $ | (60,103 | ) | 20,357 | (34 | )% | |||||||
Basic/diluted Net loss per share attributable to shareholders | $ | (0.66 | ) | $ | (1.09 | ) | ||||||||||
Six months ended June 30, | ||||||||||||||||
2022 | 2021 | $ change | % change | |||||||||||||
Sales | — | — | ||||||||||||||
Other income | 4,074 | 1,453 | 2,621 | 180 | % | |||||||||||
Research tax credit | 3,060 | 3,677 | (617 | ) | (17 | )% | ||||||||||
Other operating income | 1,014 | (2,225 | ) | 3,238 | (146 | )% | ||||||||||
Total operating income | 4,074 | 1,453 | 2,621 | 180 | % | |||||||||||
Six Months Ended June 30, | ||||||||||||||||
Research and Development expenses | 2022 | 2021 | $ change | % change | ||||||||||||
External clinical-related expenses | 19,014 | 22,686 | (3,672 | ) | (16 | )% | ||||||||||
Employee-related costs | 5,114 | 7,297 | (2,183 | ) | (30 | )% | ||||||||||
Share-based payment expenses | 1,058 | 814 | 244 | 30 | % | |||||||||||
Depreciation, amortization and other costs | 5,648 | 11,546 | (5,898 | ) | (51 | )% | ||||||||||
Total Research and Development expenses | 30,834 | 42,343 | (11,509 | ) | (27 | )% | ||||||||||
Six Months Ended June 30, | ||||||||||||||||
Sales and Marketing expenses | 2022 | 2021 | $ change | % change | ||||||||||||
External professional services | 521 | 391 | 130 | 33 | % | |||||||||||
Employee-related costs | 539 | 877 | (338 | ) | (39 | )% | ||||||||||
Share-based payment expenses | 49 | 159 | (110 | ) | (69 | )% | ||||||||||
Depreciation, amortization and other costs | 391 | 500 | (109 | ) | (22 | )% | ||||||||||
Total Sales and Marketing expenses | 1,500 | 1,927 | (427 | ) | (22 | )% | ||||||||||
Six Months Ended June 30, | ||||||||||||||||
General and Administrative expenses | 2022 | 2021 | $ change | % change | ||||||||||||
External professional services | 2,879 | 4,210 | (1,330 | ) | (32 | )% | ||||||||||
Employee-related costs | 4,029 | 5,211 | (1,181 | ) | (23 | )% | ||||||||||
Share-based payment expenses | 1,333 | 1,554 | (221 | ) | (14 | )% | ||||||||||
Depreciation, amortization and other costs | 4,093 | 6,977 | (2,884 | ) | (41 | )% | ||||||||||
Total General and Administrative expenses | 12,334 | 17,951 | (5,617 | ) | (31 | )% | ||||||||||
Material Cash Requirements Due by the period Ended June 30, | ||||||||||||||||||||
2023 | 2024 | 2025 | Thereafter | Total | ||||||||||||||||
(Amounts in thousands) | ||||||||||||||||||||
Conditional advances | 156 | — | — | — | 156 | |||||||||||||||
Operating leases | 2,154 | 1,862 | 295 | — | 4,312 | |||||||||||||||
Purchase obligations - Obligations Under the Terms of CRO Agreements | 17,057 | 6,721 | 4,969 | — | 30,586 | |||||||||||||||
Total | 19,367 | 8,583 | 5,264 | — | 35,054 |
represents a $3.5 million cash requirement as of June 30, 2022 which expires March 8, 2024.
Three Months Ended March 31, | % change | |||||||||||
(Amounts in thousands of U.S. Dollars) | 2021 | 2020 | 2021 vs 2020 | |||||||||
Net cash flow used in operating activities | (36,204 | ) | (49,683 | ) | (27.1 | )% | ||||||
Net cash flow used in investing activities | (185 | ) | (930 | ) | (80.1 | )% | ||||||
Net cash flow provided by financing activities | 440 | 150,611 | (99.7 | )% | ||||||||
Effect of exchange rate changes on cash and cash equivalents | (7,944 | ) | (5,811 | ) | (36.7 | )% | ||||||
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Net (decrease) increase in cash and cash equivalents | (43,893 | ) | 94,187 | (146.6 | )% | |||||||
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2021.
Six months ended June 30, | ||||||||||||||||
(Amounts in thousands of U.S. Dollars) | 2022 | 2021 | $ change | % of change | ||||||||||||
Net cash flow used in operating activities | (11,733 | ) | (66,503 | ) | 54,770 | (82 | )% | |||||||||
Net cash flow used in investing activities | (218 | ) | (13 | ) | (206 | ) | 1595 | % | ||||||||
Net cash flow provided by financing activities | 195,222 | 1,071 | 194,151 | * | ||||||||||||
Effect of exchange rate changes on cash and cash equivalents | (12,600 | ) | (5,423 | ) | (7,177 | ) | 132 | % | ||||||||
Net (decrease) increase in cash and cash equivalents | 170,670 | (70,868 | ) | 241,538 | (341 | )% | ||||||||||
* | Percentage not meaningful |
costs paid for $6.3 million.
Based on our current assumptions, we expect that our current cash and cash equivalents will support our operations until the second half of 2022
Contractual Obligations and Other Commitments
There have been no material changes in our contractual obligations and commitments from those disclosed in the Annual Report.
2022.
During the three months ended March 31, 2021,June 30, 2022, we issued 7,500the following unregistered securities:
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 thepre-funded warrants will not have the right to exercise any portion of itspre-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. |
12,896 euros.
Exhibit | Description | Incorporated by Reference | ||||||||||||||||
Schedule / Form | File Number | Exhibit | File Date | |||||||||||||||
3.1 | By-laws (statuts) of the registrant (English translation) | 10-K | 001-36697 | 3.1 | 3/17/2021 | |||||||||||||
31.1 | Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended | |||||||||||||||||
31.2 | Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||||||||||
32.1* | Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended | |||||||||||||||||
101.INS | XBRL Instance Document | |||||||||||||||||
101.SCH | XBRL Taxonomy Extension Schema Document | |||||||||||||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||||||||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | �� | ||||||||||||||||
101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | |||||||||||||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document |
* | 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 incorporation language contained in such filing. |
DBV Technologies S.A. | ||||||
(Registrant) | ||||||
Date: | ||||||
August 1, 2022 | By: | /s/ Daniel Tassé | ||||
Daniel Tassé | ||||||
Chief Executive | ||||||
(Principal Executive Officer) | ||||||
Date: | By: | /s/ Sébastien Robitaille | ||||
Sébastien Robitaille | ||||||
Chief Financial Officer | ||||||
(Principal Financial and Accounting Officer) |