| 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 |
| State or other jurisdiction of incorporation or organization |
(I.R.S. Employer Identification No.) |
| 177-181 avenue Pierre Brossolette |
||
(Address of principal executive offices) |
(Zip Code) |
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
one-half of one ordinary share, nominal value €0.10 per share |
||||
n/a |
| * | |
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
| ☒ | Smaller reporting company | |||||
| Emerging growth company | ||||||
Page |
||||||
| Part I | 4 | |||||
| Item 1 | Condensed Consolidated Statements of Financial Position (Unaudited) as of September 30, 2021 and December 31, 2020 | 4 | ||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Nine Months Ended September 30, 2021 and 2020 | 5 | |||||
| Condensed Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2021 and 2020 | 6 | |||||
| Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Nine Months Ended September 30, 2021 and 2020 | 7 | |||||
| Notes to the Financial Statements (Unaudited) | 9 | |||||
| Item 2 | 21 | |||||
| Item 3 | 31 | |||||
| Item 4 | 31 | |||||
| Part II | 32 | |||||
| Item 1 | 32 | |||||
| Item 1A | 32 | |||||
| Item 2 | 32 | |||||
| Item 3 | 32 | |||||
| Item 4 | 32 | |||||
| Item 5 | 32 | |||||
| Item 6 | 33 | |||||
| • | the impact of the ongoing COVID-19 pandemic, including the emergence of new variant strains of COVID-19, and its effects on our operations, research and development, clinical trials and ability to obtain financing and potential disruption in the operations and business of third-party manufacturers, contract research organizations, other service providers and collaborators with whom we conduct business; |
| • | our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated re-submission of a Biologics License Application (“BLA”) for ViaskinTM Peanut to the U.S. Food and Drug Administration; |
| • | the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs; |
| • | the sufficiency of existing capital resources; |
| • | our business model and our other strategic plans for our business, product candidates and technology; |
| • | our ability to manufacture clinical and commercial supplies of our product candidates and comply with regulatory requirements related to the manufacturing of our product candidates; |
| • | our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize Viaskin Peanut and/or our other product candidates, if approved; |
| • | the commercialization of our product candidates, if approved; |
| • | our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut and/or our other product candidates, if approved, and our ability to serve such markets; |
| • | the pricing and reimbursement of our product candidates, if approved; |
| • | the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by physicians, patients, third-party payors and others in the medical community; |
| • | our ability to advance product candidates into, and successfully complete, clinical trials; |
| • | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; |
| • | estimates of our expenses, future revenues, capital requirements and our needs for additional financing; |
| • | the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; |
| • | our ability to maintain and establish collaborations or obtain additional grant funding; |
| • | our financial performance; |
| • | developments relating to our competitors and our industry, including competing therapies; and |
| • | other risks and uncertainties, including those listed under the caption Risk Factors in our most recent Annual Report on Form 10-K and in any subsequent Quarterly Reports on Form 10-Q. |
September 30, |
December 31, |
|||||||||||
Note |
2021 |
2020 |
||||||||||
| Assets |
|
|
||||||||||
| Current assets: |
|
|
||||||||||
| Cash and cash equivalents |
|
3 |
|
$ | $ | |||||||
| Trade receivables |
|
|
— | |||||||||
| Other current assets |
|
|
||||||||||
| |
|
|
|
|
|
|||||||
| Total current assets |
|
|
||||||||||
| Property, plant, and equipment, net |
|
|
||||||||||
| Right-of-use |
|
|
||||||||||
| Intangible assets |
|
|
||||||||||
| Other non-current assets |
|
|
||||||||||
| |
|
|
|
|
|
|||||||
| Total non-current assets |
|
|
||||||||||
| |
|
|
|
|
|
|||||||
| Total Assets |
|
|
$ |
$ |
||||||||
| |
|
|
|
|
|
|||||||
| Liabilities and shareholders’ equity |
|
|
||||||||||
| Current liabilities: |
|
|
||||||||||
| Trade payables |
|
4 |
|
$ | $ | |||||||
| Short-term operating leases |
|
|
||||||||||
| Short-term financial debt |
|
|
||||||||||
| Current contingencies |
|
7 |
|
|||||||||
| Other current liabilities |
|
4 |
|
|||||||||
| |
|
|
|
|
|
|||||||
| Total current liabilities |
|
|
||||||||||
| |
|
|
|
|
|
|||||||
| Long-term operating leases |
|
|
||||||||||
| Long-term financial debt |
|
|
— | |||||||||
| Non-current contingencies |
|
7 |
|
|||||||||
| Other non-current liabilities |
|
4 |
|
|||||||||
| |
|
|
|
|
|
|||||||
| Total non-current liabilities |
|
|
||||||||||
| |
|
|
|
|
|
|||||||
| Total Liabilities |
|
|
$ |
$ |
||||||||
| |
|
|
|
|
|
|||||||
| Shareholders’ equity: |
|
|
||||||||||
| Ordinary shares, € |
|
|
$ | $ | ||||||||
| Additional paid-in capital |
|
|
||||||||||
| Treasury stock, |
|
|
( |
) | ( |
) | ||||||
| Accumulated deficit |
|
|
( |
) | ( |
) | ||||||
| Accumulated other comprehensive income |
|
|
||||||||||
| Accumulated currency translation effect |
|
|
( |
) | ||||||||
| |
|
|
|
|
|
|||||||
| Total Shareholders’ equity |
|
5 |
|
$ |
$ |
|||||||
| |
|
|
|
|
|
|||||||
| Total Liabilities and Shareholders’ E quity |
|
|
$ |
$ |
||||||||
| |
|
|
|
|
|
|||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||||
Note |
2021 |
2020 |
2021 |
2020 |
||||||||||||||||
Operating income |
8 |
$ |
$ |
$ |
$ |
|||||||||||||||
Operating expenses |
||||||||||||||||||||
Research and development expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Sales and marketing expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
General and administrative expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Restructuring expenses |
— | — | ( |
) | ||||||||||||||||
Total Operating expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Loss from operations |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Financial income (expense) |
( |
) | ( |
) | ||||||||||||||||
Loss before taxes |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Income tax |
— | ( |
) | ( |
) | |||||||||||||||
Net loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||||||
Other comprehensive loss |
||||||||||||||||||||
Foreign currency translation differences, net of taxes |
( |
) | ( |
) | ||||||||||||||||
Actuarial gains (losses) on employee benefits, net of taxes |
( |
) | ( |
) | ( |
) | ||||||||||||||
Comprehensive loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||||||
Basic/diluted net loss per share attributable to shareholders |
12 |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | |||||||
Weighted average shares outstanding used in computing per share amounts: |
||||||||||||||||||||
Nine Months Ended September 30, |
||||||||||||
Notes |
2021 |
2020 |
||||||||||
| Net loss for the period |
|
$ |
( |
) |
$ |
( |
) | |||||
| Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
| Depreciation, amortization and accrued contingencies |
|
|||||||||||
| Retirement pension obligations |
|
( |
) | |||||||||
| Expenses related to share-based payments |
|
6 |
( |
) | ||||||||
| Other elements |
|
|||||||||||
| Changes in operating assets and liabilities: |
|
|||||||||||
| Decrease (increase) in inventories and work in progress |
|
— | ||||||||||
| Decrease (increase) in trade receivables |
|
( |
) | |||||||||
| Decrease (increase) in other current assets |
|
( |
) | ( |
) | |||||||
| (Decrease) increase in trade payables |
|
( |
) | ( |
) | |||||||
| (Decrease) increase in other current and non-current liabilities |
|
( |
) | ( |
) | |||||||
| Change in operating lease liabilities and right—of—use assets |
|
( |
) | ( |
) | |||||||
| Net cash flow used in operating activities |
|
( |
) |
( |
) | |||||||
| |
|
|
|
|
||||||||
| Cash flows provided by (used in) investing activities: |
|
|||||||||||
| Acquisitions of property, plant, and equipment, net from proceeds |
|
( |
) | |||||||||
| Acquisitions of intangible assets |
|
( |
) | ( |
) | |||||||
| Acquisitions of non-current financial assets |
|
( |
) | |||||||||
| |
|
|
|
|
||||||||
| Net cash flows provided by (used in) investing activities | |
( |
) | |||||||||
| |
|
|
|
|
||||||||
| Cash flows (used in) provided by financing activities: |
|
|||||||||||
| (Decrease) increase in conditional advances |
|
( |
) | ( |
) | |||||||
| Treasury shares |
|
( |
) | ( |
) | |||||||
| Capital increases, net of transaction costs |
|
|||||||||||
| Other cash flows related to financing activities |
|
( |
) | ( |
) | |||||||
| |
|
|
|
|
||||||||
Net cash flows (used in) provided by financing activities |
|
( |
) |
|||||||||
| |
|
|
|
|
||||||||
| Effect of exchange rate changes on cash and cash equivalents |
|
( |
) | |||||||||
| |
|
|
|
|
||||||||
| Net (decrease) increase in cash and cash equivalents |
|
( |
) |
|||||||||
| |
|
|
|
|
||||||||
| Net Cash and cash equivalents at the beginning of the period |
|
|||||||||||
| |
|
|
|
|
||||||||
| Net cash and cash equivalents at the end of the period |
|
3 |
$ |
$ |
||||||||
| |
|
|
|
|
||||||||
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 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive income (loss) |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
| Issuance of ordinary shares |
— | — | — | — | ||||||||||||||||||||||||||||
| Treasury shares |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
| Share-based payments |
— | — | — | — | — | |||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Balance at March 31, 2020 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive income (loss) |
— | — | — | — | — | ( |
) |
|||||||||||||||||||||||||
| Treasury shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Share-based payments |
— | — | ( |
) | — | — | — | — | ( |
) | ||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Balance at June 30, 2020 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive income (loss) |
— | — | — | — | — | ( |
) | |||||||||||||||||||||||||
| Issuance of ordinary shares |
— | — | ( |
) | — | — | — | — | ( |
) | ||||||||||||||||||||||
| Treasury shares |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
| Share-based payments |
— | — | ( |
) | — | — | — | — | ( |
) | ||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Balance at September 30, 2020 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||||
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 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
$ |
|||||||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive loss |
— | — | — | — | — | ( |
) | ( |
) | ( |
) | |||||||||||||||||||||
| Issuance of ordinary shares |
— | — | — | — | ||||||||||||||||||||||||||||
| Treasury shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Balance at March 31, 2021 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive income |
— | — | — | — | ||||||||||||||||||||||||||||
| Issuance of ordinary shares |
— | — | — | — | ||||||||||||||||||||||||||||
| Issuance of warrants |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Treasury shares |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
| Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Allocation of accumulated net losses |
— | — | ( |
) | — | — | — | — | ||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Balance at June 30, 2021 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
$ |
|||||||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive income (loss) |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
| Treasury shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Balance at September 30, 2021 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
Restructuring liabilities |
||||
| Restructuring liability—January 1, 2021 |
||||
| Amounts paid |
( |
) | ||
| Other effect including currency translation effect |
( |
) | ||
| |
|
|||
| Restructuring liability – September 30, 2021 |
||||
| |
|
|||
| of which current contingencies |
||||
| of which other current liabilities |
||||
September 30, |
December 31, |
|||||||
2021 |
2020 |
|||||||
| Cash |
||||||||
| Cash equivalents |
||||||||
| |
|
|
|
|||||
| Total cash and cash equivalents as reported in the statements of financial position |
||||||||
| |
|
|
|
|||||
September 30, |
December 31, |
|||||||
2021 |
2020 |
|||||||
| Other current liabilities |
||||||||
| Other non-current liabilities |
||||||||
| |
|
|
|
|||||
| Total |
||||||||
| |
|
|
|
|||||
September 30, |
December 31, |
|||||||||||||||
2021 |
2020 |
|||||||||||||||
Other current liabilities |
Other non-current liabilities |
Total | Total | |||||||||||||
| Employee related liabilities |
||||||||||||||||
| Deferred income |
||||||||||||||||
| Tax liabilities |
— |
|||||||||||||||
| Other debts |
— |
|||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Stock option fair value assumptions during the nine months ended September 30, 2021 |
||||
| Weighted average share price at grant date in € |
||||
| Weighted average expected volatility |
||||
| Weighted average risk-free interest rate |
( |
|||
| Weighted average expected term (in years) |
||||
| Dividend yield |
||||
| Weighted average fair value of stock options in € |
||||
| Warrant fair value assumptions during the nine months ended September 30, 2021 |
||||
| Weighted average share price at grant date in € |
||||
| Weighted average expected volatility |
||||
| Weighted average risk-free interest rate |
( |
|||
| Weighted average expected term (in years) |
||||
| Dividend yield |
||||
| Weighted average fair value of warrants in € |
||||
Number of outstanding |
||||||||||||||||
BSA |
BSPCE |
SO |
RSU |
|||||||||||||
| Balance as of December 31, 2020 |
||||||||||||||||
| Granted during the period |
— | |||||||||||||||
| Forfeited during the period |
— | — | ( |
) | ( |
) | ||||||||||
| Exercised/released during the period |
( |
) | — | — | ||||||||||||
| Expired during the period |
( |
) | — | — | — | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Balance as of September 30, 2021 |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||||||
| Research & development |
SO | ( |
) | ( |
) | ( |
) | |||||||||||||
| RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
| Sales & marketing |
SO | ( |
) | ( |
) | |||||||||||||||
| RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
| General & administrative |
SO | ( |
) | ( |
) | |||||||||||||||
| RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| Total share-based compensation (expense) |
( |
) |
( |
) |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
September 30, |
December 31, |
|||||||
2021 |
2020 |
|||||||
| Current contingencies |
||||||||
| Non-current contingencies |
||||||||
| |
|
|
|
|||||
| Total contingencies |
||||||||
| |
|
|
|
|||||
Pension retirement obligations |
Collaboration agreement— Loss at completion |
Other contingencies |
Total |
|||||||||||||
| At January 1, 2021 |
||||||||||||||||
| Increases in liabilities |
||||||||||||||||
| Used liabilities |
— | ( |
) | ( |
) | |||||||||||
| Reversals of unused liabilities |
— | — | — | |||||||||||||
| Net interest related to employee benefits, and unwinding of discount |
— | — | — | |||||||||||||
| Actuarial gains and losses on defined-benefit plans |
— | — | ||||||||||||||
| Other effects including currency translation effect |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
| At September 30, 2021 |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Of which current |
— |
|||||||||||||||
| Of which non-current |
— |
|||||||||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
| Research tax credit |
||||||||||||||||
| Other operating ( incomeloss ) |
( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
| Research and development expenses |
||||||||||||||||
| Sales and marketing expenses |
||||||||||||||||
| General and administrative expenses |
||||||||||||||||
| Restructuring expenses |
( |
) | ||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total personnel expenses |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
| Wages and salaries |
||||||||||||||||
| Social security contributions |
||||||||||||||||
| Expenses for pension commitments |
||||||||||||||||
| Employer contribution to bonus shares |
( |
) | ||||||||||||||
| Share-based payments |
( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
| Non-employee warrants |
||||||||||||||||
| Employee warrants |
||||||||||||||||
| Stock options |
||||||||||||||||
| Restricted stock units |
||||||||||||||||
Three months ended September 30, |
$ change |
% change |
||||||||||||||
2021 |
2020 |
|||||||||||||||
| Operating income |
$ |
1,323 |
$ |
4,158 |
$ |
(2,836 |
) |
(68 |
%) | |||||||
| Operating expenses |
||||||||||||||||
| Research and development expenses |
(16,320 | ) | (25,751 | ) | 9,430 | (37 | %) | |||||||||
| Sales and marketing expenses |
(1,072 | ) | (1,595 | ) | 524 | (33 | %) | |||||||||
| General and administrative expenses |
(8,299 | ) | (6,863 | ) | (1,437 | ) | 21 | % | ||||||||
| Restructuring expenses |
— | 286 | (286 | ) | 100 | % | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total Operating expenses |
(25,691 | ) |
(33,923 | ) |
8,232 | (24 | %) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Financial income (expense) |
336 | (1,184 | ) | 1,519 | (128 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Income tax |
— | (7 | ) | 7 | (100 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ |
(24,033 |
) |
$ |
(30,955 |
) |
$ |
6,922 |
(22 |
%) | ||||||
| |
|
|
|
|
|
|
|
|||||||||
Three months ended September 30, |
$ change |
% change |
||||||||||||||
2021 |
2020 |
|||||||||||||||
| Sales |
— | — | — | — | ||||||||||||
| Other income |
1,323 | 4,158 | (2,836 | ) | (68 | %) | ||||||||||
| Research tax credit |
1,647 |
1,815 |
(168 |
) |
(9 |
%) | ||||||||||
| Other operating (loss) income |
(324 |
) |
2,344 |
(2,668 |
) |
(114 |
%) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total operating income |
1,323 |
4,158 |
(2,836 |
) |
(68 |
%) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Three Months Ended September 30, |
$ change |
% change |
||||||||||||||
| Research and development expenses |
2021 |
2020 |
||||||||||||||
| External clinical-related expenses |
8,633 | 5,175 | 3,458 | 67 | % | |||||||||||
| Employee-related costs |
3,228 | 5,876 | (2,648 | ) | (45 | %) | ||||||||||
| Share-based payment expenses |
933 | 108 | 825 | * | ||||||||||||
| Depreciation, amortization and other costs |
3,526 | 14,592 | (11,066 | ) | (76 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total Research and development expenses |
16,320 |
25,751 |
(9,430 |
) |
(37 |
%) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Three Months Ended September 30, |
$ change |
% change |
||||||||||||||
Sales and Marketing expenses |
2021 |
2020 |
||||||||||||||
| External professional services |
379 | (239 | ) | 619 | (258 | %) | ||||||||||
| Employee-related costs |
405 | 2,336 | (1,931 | ) | (83 | %) | ||||||||||
| Share-based payment expenses (income) |
87 | (182 | ) | 269 | (148 | %) | ||||||||||
| Depreciation, amortization and other costs |
200 | (320 | ) | 520 | (163 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total Sales and Marketing expenses |
1,072 |
1,595 |
(524 |
) |
(33 |
%) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Three Months Ended September 30, |
$ change |
% change |
||||||||||||||
General and Administrative expenses |
2021 |
2020 |
||||||||||||||
| External professional services |
2,216 | 1,663 | 552 | 33 | % | |||||||||||
| Employee-related costs |
2,052 | 1,571 | 482 | 31 | % | |||||||||||
| Share-based payment expenses |
530 | — | 531 | * | ||||||||||||
| Depreciation, amortization and other costs |
3,501 | 3,629 | (128 | ) | (4 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total General and Administrative expenses |
8,299 |
6,863 |
1,437 |
21 |
% | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| *Percentage | not meaningful |
Nine months ended September 30, |
$ change |
% change |
||||||||||||||
2021 |
2020 |
|||||||||||||||
| Operating income |
$ |
2,776 |
$ |
12,488 |
$ |
(9,713 |
) |
(78 |
%) | |||||||
| Operating expenses |
||||||||||||||||
| Research and development expenses |
(58,663 | ) | (75,214 | ) | 16,551 | (22 | %) | |||||||||
| Sales and marketing expenses |
(2,999 | ) | (8,114 | ) | 5,115 | (63 | %) | |||||||||
| General and administrative expenses |
(26,250 | ) | (26,838 | ) | 587 | (2 | %) | |||||||||
| Restructuring expenses |
— | (21,003 | ) | 21,003 | (100 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total Operating expenses |
(87,912 |
) |
(131,169 |
) |
43,257 |
( 33 |
%) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Financial income (expense) |
597 | (1,380 | ) | 1,977 | (143 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Income tax |
404 | (10 | ) | 414 | * | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ |
(84,136 |
) |
$ |
(120,071 |
) |
$ |
35,935 |
(30 |
%) | ||||||
| |
|
|
|
|
|
|
|
|||||||||
| * | Percentage not meaningful |
Nine Months ended September 30, |
$ change |
% change |
||||||||||||||
2021 |
2020 |
|||||||||||||||
| Sales |
— | — | ||||||||||||||
| Other income |
2,776 | 12,488 | (9,713 | ) | (78 | %) | ||||||||||
| Research tax credit |
5,324 |
7,615 |
(2,291 |
) |
(30 |
%) | ||||||||||
| Other operating (loss) income |
(2,549 |
) |
4,873 |
(7,422 |
) |
(152 |
%) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total operating income |
2,776 |
12,488 |
(9,713 |
) |
(78 |
%) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Nine Months Ended September 30, |
$ change |
% change |
||||||||||||||
Research and development expenses |
2021 |
2020 |
||||||||||||||
| External clinical-related expenses |
31,319 | 34,494 | (3,175 | ) | (9 | %) | ||||||||||
| Employee-related costs |
10,525 | 18,810 | (8,284 | ) | (44 | %) | ||||||||||
| Share-based payment expenses (income) |
1,747 | (516 | ) | 2,263 | (439 | %) | ||||||||||
| Depreciation, amortization and other costs |
15,072 | 22,427 | (7,355 | ) | (33 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total Research and development expenses |
58,663 |
75,214 |
(16,551 |
) |
(22 |
%) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Nine Months Ended September 30, |
$ change |
% change |
||||||||||||||
Sales and Marketing expenses |
2021 |
2020 |
||||||||||||||
| External professional services |
771 | 2,881 | (2,111 | ) | (73 | %) | ||||||||||
| Employee-related costs |
1,282 | 7,038 | (5,757 | ) | (82 | %) | ||||||||||
| Share-based payment expenses (income) |
246 | (2,052 | ) | 2,298 | (112 | %) | ||||||||||
| Depreciation, amortization and other costs |
700 | 246 | 454 | 185 | % | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total Sales and Marketing expenses |
2,999 |
8,114 |
(5,115 |
) |
(63 |
%) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Nine Months Ended September 30, |
$ change |
% change |
||||||||||||||
General and Administrative expenses |
2021 |
2020 |
||||||||||||||
| External professional services |
6,425 | 10,517 | (4,092 | ) | (39 | %) | ||||||||||
| Employee-related costs |
7,263 | 7,026 | 237 | 3 | % | |||||||||||
| Share-based payment expenses (income) |
2,084 | (397 | ) | 2,482 | 625 | % | ||||||||||
| Depreciation, amortization and other costs |
10,478 | 9,693 | 785 | 8 | % | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total General and Administrative expenses |
26,250 |
26,838 |
(587 |
) |
(2 |
%) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| * | Percentage not meaningful |
Nine Months ended September 30, |
$ change |
% of change |
||||||||||||||
(Amounts in thousands of U.S. Dollars) |
2021 |
2020 |
||||||||||||||
| Net cash flow used in operating activities |
(89,452 | ) | (132,076 | ) | 42,624 | (32 | %) | |||||||||
| Net cash flow provided by (used in) investing activities |
41 | (2,232 | ) | 2,273 | (102 | %) | ||||||||||
| Net cash flow (used in) provided by financing activities |
(103 | ) | 149,624 | (149,726 | ) | (100 | %) | |||||||||
| Effect of exchange rate changes on cash and cash equivalents |
(8,643 | ) | 12,834 | (21,477 | ) | (167 | %) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net (decrease) increase in cash and cash equivalents |
(98,157 |
) |
28,150 |
(126,307 |
) |
(449 |
%) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
Equity |
||||
capital |
||||
| (Amounts in thousands of U.S. Dollars) |
||||
| Nine months ended September 30, 2020 |
$ | 150,010 | ||
| Nine months ended September 30, 2021 |
— | |||
| |
|
|||
| Total |
$ |
150,010 |
||
| |
|
|||
Exhibit |
Description |
Incorporated by Reference | ||||||||
| Schedule / Form |
File Number |
Exhibit |
File Date | |||||||
| 31.1 | Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||
| 31.2 | Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||
| 32.1* | Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended | |||||||||
| 101.INS | Inline XBRL Instance Document | |||||||||
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |||||||||
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |||||||||
| 101.LAB | Inline XBRL Taxonomy Extension Labels Linkbase Document | |||||||||
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||
| 104 | Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101. | |||||||||
| * | Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing. |
| DBV Technologies S.A. (Registrant) | ||||||
| Date: October 26, 2021 | By: /s/ Daniel Tassé | |||||
| Daniel Tassé | ||||||
Chief Executive Officer | ||||||
(Principal Executive Officer) | ||||||
| Date: October 26, 2021 | By: /s/ Sébastien Robitaille | |||||
| Sébastien Robitaille | ||||||
Chief Financial Officer | ||||||
(Principal Financial and Accounting Officer) |
Exhibit 31.1
Certification by the Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Daniel Tasse, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of DBV Technologies S.A.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: October 26, 2021
| /s/ Daniel Tasse | ||
| Daniel Tasse | ||
| Chief Executive Officer | ||
| (Principal Executive Officer) | ||
Exhibit 31.2
Certification by the Chief Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Sébastien Robitaille, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of DBV Technologies S.A.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: October 26, 2021
| /s/ Sebastien Robitaille | ||
| Sébastien Robitaille | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting Officer) | ||
Exhibit 32.1
Certification by the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Daniel Tasse, Chief Executive Officer of DBV Technologies S.A. (the “Company”), and Sébastien Robitaille, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:
| 1. | The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2021, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and |
| 2. | The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: October 26, 2021
| /s/ Daniel Tasse | /s/ Sébastien Robitaille | |
| Daniel Tasse | Sébastien Robitaille | |
| Chief Executive Officer | Chief Financial Officer | |
| (Principal Executive Officer) | (Principal Financial and Accounting Officer) |
This certification accompanies the Quarterly Report, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Quarterly Report), irrespective of any general incorporation language contained in such filing.
Condensed Consolidated Statements of Financial Position (Parenthetical) - € / shares |
Sep. 30, 2021 |
Dec. 31, 2020 |
|---|---|---|
| Treasury stock, common, shares | 75,400 | 112,302 |
| Common Shares [Member] | ||
| Common stock shares par value | € 0.10 | € 0.10 |
| Common stock shares authorized | 55,011,687 | 54,929,187 |
| Common stock shares issued | 55,011,687 | 54,929,187 |
| Common stock shares outstanding | 3,946,548 | 4,029,763 |
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
| Revenues | ||||
| Operating income | $ 1,323 | $ 4,158 | $ 2,776 | $ 12,488 |
| Operating expenses | ||||
| Research and development expenses | (16,320) | (25,751) | (58,663) | (75,214) |
| Sales and Marketing expenses | (1,072) | (1,595) | (2,999) | (8,114) |
| General and administrative expenses | (8,299) | (6,863) | (26,250) | (26,838) |
| Restructuring expenses | 286 | (21,003) | ||
| Total Operating expenses | (25,691) | (33,923) | (87,912) | (131,169) |
| Loss from operations | (24,368) | (29,765) | (85,137) | (118,681) |
| Other Income (expenses) | ||||
| Financial income (expense) | 336 | (1,184) | 597 | (1,380) |
| Loss before taxes | (24,033) | (30,948) | (84,540) | (120,061) |
| Income tax | (7) | 404 | (10) | |
| Net loss | (24,033) | (30,955) | (84,136) | (120,071) |
| Foreign currency translation differences, net of taxes | (3,728) | 13,196 | (9,684) | 13,495 |
| Actuarial gains (losses) on employee benefits, net of taxes | 28 | (75) | (10) | (113) |
| Comprehensive loss | $ (27,733) | $ (17,834) | $ (93,830) | $ (106,688) |
| Basic/diluted net loss per share attributable to shareholders | $ (0.44) | $ (0.56) | $ (1.53) | $ (2.23) |
| Weighted average shares outstanding used in computing per share amounts: | 54,947,354 | 54,843,843 | 54,911,278 | 53,852,176 |
Condensed Consolidated Statements of Changes in Shareholders' Equity - USD ($) $ in Thousands |
Total |
Common Shares [Member] |
Additional Paid-in Capital [Member] |
Treasury Stock [Member] |
Accumulated Deficit [Member] |
Accumulated Other Comprehensive income (loss) [Member] |
Accumulated Currency Translation Effect [Member] |
|---|---|---|---|---|---|---|---|
| Beginning balance at Dec. 31, 2019 | $ 193,186 | $ 5,645 | $ 1,003,595 | $ (230) | $ (798,988) | $ 108 | $ (16,945) |
| Beginning balance (Shares) at Dec. 31, 2019 | 47,028,510 | ||||||
| Net (loss) | (40,913) | (40,913) | |||||
| Other comprehensive income (loss) | (5,875) | 189 | (6,064) | ||||
| Issuance of ordinary shares | 151,023 | $ 873 | 150,150 | ||||
| Issuance of ordinary shares (Shares) | 7,898,677 | ||||||
| Treasury shares | (832) | (832) | |||||
| Share-based payments | 3,073 | 3,073 | |||||
| Ending balance at Mar. 31, 2020 | 299,662 | $ 6,518 | 1,156,818 | (1,062) | (839,901) | 297 | (23,009) |
| Ending balance (Shares) at Mar. 31, 2020 | 54,927,187 | ||||||
| Beginning balance at Dec. 31, 2019 | 193,186 | $ 5,645 | 1,003,595 | (230) | (798,988) | 108 | (16,945) |
| Beginning balance (Shares) at Dec. 31, 2019 | 47,028,510 | ||||||
| Net (loss) | (120,071) | ||||||
| Ending balance at Sep. 30, 2020 | 233,099 | $ 6,518 | 1,150,309 | (1,214) | (919,058) | (5) | (3,450) |
| Ending balance (Shares) at Sep. 30, 2020 | 54,927,187 | ||||||
| Beginning balance at Mar. 31, 2020 | 299,662 | $ 6,518 | 1,156,818 | (1,062) | (839,901) | 297 | (23,009) |
| Beginning balance (Shares) at Mar. 31, 2020 | 54,927,187 | ||||||
| Net (loss) | (48,203) | (48,203) | |||||
| Other comprehensive income (loss) | 6,136 | (227) | 6,363 | ||||
| Treasury shares | 107 | 107 | |||||
| Share-based payments | (5,964) | (5,964) | |||||
| Ending balance at Jun. 30, 2020 | 251,739 | $ 6,518 | 1,150,855 | (955) | (888,103) | 70 | (16,646) |
| Ending balance (Shares) at Jun. 30, 2020 | 54,927,187 | ||||||
| Net (loss) | (30,955) | (30,955) | |||||
| Other comprehensive income (loss) | 13,121 | (75) | 13,196 | ||||
| Issuance of ordinary shares | (472) | (472) | |||||
| Treasury shares | (260) | (260) | |||||
| Share-based payments | (74) | (74) | |||||
| Ending balance at Sep. 30, 2020 | 233,099 | $ 6,518 | 1,150,309 | (1,214) | (919,058) | (5) | (3,450) |
| Ending balance (Shares) at Sep. 30, 2020 | 54,927,187 | ||||||
| Beginning balance at Dec. 31, 2020 | 205,491 | $ 6,518 | 1,152,042 | (1,169) | (958,543) | 484 | 6,158 |
| Beginning balance (Shares) at Dec. 31, 2020 | 54,929,187 | ||||||
| Net (loss) | (29,449) | (29,449) | |||||
| Other comprehensive income (loss) | (8,829) | (85) | (8,744) | ||||
| Issuance of ordinary shares | 42 | $ 1 | 42 | ||||
| Issuance of ordinary shares (Shares) | 7,500 | ||||||
| Treasury shares | 488 | 488 | |||||
| Share-based payments | 1,433 | 1,433 | |||||
| Ending balance at Mar. 31, 2021 | 169,176 | $ 6,519 | 1,153,516 | (681) | (987,992) | 399 | (2,586) |
| Ending balance (Shares) at Mar. 31, 2021 | 54,936,687 | ||||||
| Beginning balance at Dec. 31, 2020 | 205,491 | $ 6,518 | 1,152,042 | (1,169) | (958,543) | 484 | 6,158 |
| Beginning balance (Shares) at Dec. 31, 2020 | 54,929,187 | ||||||
| Net (loss) | (84,136) | ||||||
| Ending balance at Sep. 30, 2021 | 116,892 | $ 6,529 | 359,081 | (810) | (244,856) | 474 | (3,526) |
| Ending balance (Shares) at Sep. 30, 2021 | 55,011,687 | ||||||
| Beginning balance at Mar. 31, 2021 | 169,176 | $ 6,519 | 1,153,516 | (681) | (987,992) | 399 | (2,586) |
| Beginning balance (Shares) at Mar. 31, 2021 | 54,936,687 | ||||||
| Net (loss) | (30,654) | (30,654) | |||||
| Other comprehensive income (loss) | 2,836 | 0 | 48 | 2,788 | |||
| Issuance of ordinary shares | 473 | $ 9 | 464 | ||||
| Issuance of ordinary shares (Shares) | 75,000 | ||||||
| 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 | |||||
| Ending balance at Jun. 30, 2021 | 143,019 | $ 6,529 | 357,530 | (866) | (220,823) | 446 | 203 |
| Ending balance (Shares) at Jun. 30, 2021 | 55,011,687 | ||||||
| Net (loss) | (24,033) | (24,033) | |||||
| Other comprehensive income (loss) | (3,701) | 28 | (3,728) | ||||
| Treasury shares | 56 | 56 | |||||
| Share-based payments | 1,551 | 1,551 | |||||
| Ending balance at Sep. 30, 2021 | $ 116,892 | $ 6,529 | $ 359,081 | $ (810) | $ (244,856) | $ 474 | $ (3,526) |
| Ending balance (Shares) at Sep. 30, 2021 | 55,011,687 |
The Company |
9 Months Ended |
|---|---|
Sep. 30, 2021 | |
| Accounting Policies [Abstract] | |
| The Company | Note 1: The Company Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or the “group”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin ™ . The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT™ , a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin™ . Basis of Presentation The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. The amounts are presented in thousands unless otherwise indicated. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation. The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on March 17, 2021 (the “Annual Report”). The condensed consolidated statement of financial position at December 31, 2020 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2020. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2021, or any other future period. Use of estimates The preparation of the Company’s condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates. On an on-going basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right-of-use assets—operating lease, (4) impairment of right-of-use 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 ( 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. Crédit d’Impôt Recherche ). Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin ™ Peanut, 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 the Company’s plans to address the guidance received from the FDA in January 2021 and additional feedback received in October 2021 regarding the protocol for STAMP (Safety, Tolerability and Adhesion of Modified Patches), and its expected cost savings from implementation of the global restructuring plan, the Company expects that its balance of cash and cash equivalents of $98.2 million as of September 30, 2021 will be sufficient to fund its operations into the third quarter of 2022. As of the date of the filing, the Company’s available cash is not projected to be sufficient to support its operating plan for the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern. 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. 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, including as a result of disruptions to the global financial markets due to the ongoing COVID-19 pandemic. 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. If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts, or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently. These interim financial statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists. Accounting Pronouncements adopted in 2021 Effective January 1, 2021, the Company adopted ASU 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. The adoption of ASU 2019-12 did not have a material impact on the Company’s financial position or results of operations. Accounting Pronouncements issued not yet adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13—Financial Instruments—Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. 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 guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard will have a material impact on its consolidated financial statements. Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption. |
Significant Events and Transactions |
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Significant Events And Transactions Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Significant Events and Transactions | Note 2: Significant Events and Transactions Clinical programs Viaskin TM Peanut for children ages 4-11 in the United States In January 2020, the Company announced positive topline results of the three-year, open-label extension of its Phase III PEPITES trial (the “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 in the clinical program to date in over 1,000 patients. During the PEOPLE trial, the most common adverse events were mild to moderate skin reactions localized to the administration site, and there was no epinephrine use deemed related to treatment. No treatment related serious adverse events were reported. One patient experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without anti-anaphylactic treatment. Treatment compliance remained high throughout the study at a mean of 98% over three years of treatment. Low discontinuations due to adverse events were observed. In February 2020, the FDA announced an Allergenic Products Advisory Committee meeting to be held on May 15, 2020 to discuss the BLA for Viaskin Peanut. On March 16, 2020, the Company announced that the FDA had informed the Company that during its ongoing review of the Company’s BLA for Viaskin Peanut, it had identified questions regarding efficacy, including the impact of patch-site adhesion. Therefore, the Advisory Committee meeting to discuss the BLA originally scheduled on May 15, 2020 was cancelled. In August 2020, the Company announced that the FDA has issued a Complete Response Letter (“CRL”) 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 (“CMC”) data. The FDA did not raise any safety concerns related to Viaskin Peanut. In January 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. In exchanges with the FDA, the Company proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications. The FDA agreed with the Company’s 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 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 modified patches, the FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population. In the second quarter of 2021, the Company completed CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches in order to identify the top performers. Based on the adhesion parameters studied, the Company was pleased to learn that all modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the current Viaskin Peanut patch. The Company then selected two modified patches that performed best out of the five modified patches studied for further development. The difference between the two selected patches is their shape—one is circular and the other is rectangular with rounded corners. They are both approximately 50% larger than the current patch but maintain the same structure of the occlusion chamber (i.e., foam ring and backing). The Company also conducted advisory boards with patient caregivers and key opinion leaders to obtain qualitative feedback on the consumer experience with both patches. I n the second quarter of 2021, the Company initiated PREQUAL, a Phase 1 study in healthy adult volunteers to optimize the allergen sample collection methodologies and validate the assays DBV intends to use in EQUAL (EQuivalence in Uptake of ALergen) to demonstrate the protein uptake comparability of the modified patch (mVP) to the reference or current patch (cVP). The Company submitted the protocol for STAMP, the 6-month adhesion and safety study of the modified patch, to the FDA on May 6, 2021, and received feedback from the FDA on October 14, 2021. The FDA has requested a stepwise approach to DBV’s modified Viaskin Peanut (mVP) development program. The FDA would like to review the data from DBV’s protein uptake release study prior to providing additional comments on the STAMP protocol design. In its communication, the FDA st ated that guidance is forthcoming on how best to demonstrate the protein uptake comparability of the mVP to the reference or current patch (cVP). The STAMP trial will not be initiated until DBV receives complete feedback from the FDA. Viaskin TM Peanut for children ages 4-11 in Europe In November 2020, the Company announced that its Marketing Authorization Application (“MAA”) for Viaskin Peanut had been validated by the European Medicines Agency (“EMA”). The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years. The Company received the first set of questions from the EMA, during the first quarter of 2021, which were consistent with the Company’s expectations and prefiling conversations with the EMA. The Company did not receive questions about the impact of adhesion on efficacy. The EMA’s Committee for Medicinal Products for Human Use will provide a recommendation to the European Commission (“EC”) on whether to grant a marketing authorization when its review of the Viaskin Peanut MAA is complete. In July 2021, the Company received from the EMA a Day 180 list of outstanding issues. The review of the Viaskin Peanut MAA is progressing according to established EMA processes and ongoing conversations with the EMA. Many of EMA’s Objections and Major Objections have been answered; one Major Objection remained. DBV is preparing its responses to the Day 180 letter and evaluating how to best address the Objections, including the remaining Major Objection which questions the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study. Further exchanges with EMA are anticipated. DBV estimates the EMA could issue its decision on potential marketing authorization for Viaskin Peanut in the first quarter of 2022. Viaskin Peanut for children ages 1-3 I n June 2020, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 µg dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in the first quarter of 202 1. Financing In February 2020, the Company announced the closing of an underwritten global offering of an aggregate of 7,500,000 ordinary shares in (i) a public offering of 4,535,581 ordinary shares in the form of 9,071,162 American Depositary Shares (“ADSs”) in the United States, Canada and certain countries outside Europe at a public offering price of $10.25 per ADS (on the basis of an exchange rate of $1.0999 = €1.00), and (ii) an offering exclusively addressed to qualified investors in Europe (including France) of 2,964,419 ordinary shares at an offering price of €18.63 per ordinary share (together, the “Global Offering”). In March 2020, the Company announced that the underwriters partially exercised their option to purchase 338,687 additional ordinary shares in the form of 677,374 ADSs at an offering price of $10.25 per ADS, before deducting commissions and estimated offering expenses (the “Option”). The Option closed on March 4, 2020. Consequently, following partial exercise of the Option, the total number of ordinary shares sold in the global offering was 7,838,687 ordinary shares, including 4,874,268 ordinary shares in the form of 9,748,536 ADSs, bringing the total gross proceeds from the global offering to $160.7 million and net proceeds of $150.0 million. Restructuring The Company initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanut in the United States and European Union. The Company expects full implementation of the organization-wide costs reduction measures to be completed in the second half of 2021. The following table summarizes restructuring activities as of September 30, 2021 included in current contingencies and other current liabilities in the statement of financial position:
COVID-19 Pandemic On March 11, 2020, the World Health Organization declared COVID-19 a pandemic. This global health crisis led many countries to impose national containment measures and travel bans. In view of this exceptional situation, the Company decided to take all measures 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. The Company has assessed the impact of the uncertainties created by the pandemic, such as the duration of the outbreak, the efficacy of vaccines and the evolution of variations strains of COVID-19, travel restrictions, social distancing requirements and business restrictions in the United States, France and other countries. As of September 30, 2021, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company. The Company continues to update these estimates and assumptions as the situation evolves. The effects of the COVID-19 pandemic are presented in the relevant line items of the condensed consolidated statement of financial position and the condensed consolidated statement of operations according to the function or nature of the income or expense.Legal Proceedings A class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis Ito-Stone v. DBV Technologies, et al., Case No. 2:19-cv-00525. 10b-5 promulgated thereunder. The plaintiffs seek unspecified damages on behalf of a purported class of persons that purchased the Company’s securities between February 14, 2018 and August 4, 2020 and also held the Company’s securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020.A hearing was held on July 29, 2021 in the U.S. District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. As the dismissal was without prejudice, the Plaintiffs repled their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court. The Company believes that the allegations contained in the amended complaint are without merit and will continue to defend the case vigorously. The Company believes this complaint will not have a material adverse effect on the Company’s consolidated financial position, results of operations or liquidity. |
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Cash and Cash Equivalents |
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash and Cash Equivalents [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash and Cash Equivalents | Note 3: Cash and Cash Equivalents The following tables summarize the cash and cash equivalents as of September 30, 2021 and December 31, 2020:
Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements. |
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Trade Payables and Other Current Liabilities |
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| Payables and Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Trade Payables and Other Current Liabilities | Note 4: Trade Payables and Other Current Liabilities 4.1 Trade Payables No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented. 4.2 Other Liabilities The following tables summarize the other liabilities as of September 30, 2021 and December 31, 2020:
The following table summarizes the other liabilities by nature as of September 30, 2021 and December 31, 2020:
The other current liabilities include debt to employees including employee termination allowance and benefits as part of the restructuring (refer to Note 2, “Significant Events and Transactions of the Period – Restructuring”), bonus accruals, and social welfare and tax agency obligations. Deferred income from the collaboration agreement with Nestlé Health Science amounted to $6.9 million as of September 30, 2021. |
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Shareholders' equity |
9 Months Ended |
|---|---|
Sep. 30, 2021 | |
| Stockholders' Equity Note [Abstract] | |
| Shareholders' equity | Note 5: Shareholders’ equity The share capital as of September 30, 2021 is set at the sum of €5,501,168.70 ($6,528,543 converted at historical rates). It is divided into 55,011,687 fully authorized, subscribed and paid-up shares with a par value of €0.10.During the nine months ended September 30, 2021, the capital increase of approximately $10,000 is linked to the issuance of an aggregate of 82,500 shares pursuant to the exercise of warrants. Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2020 have been allocated to additional
paid-in capital in the amount of €695,575,130.36 ($797,822,881 converted at historical rates). |
Share-Based Payments |
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| Share-based Payment Arrangement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-Based Payments | Note 6: Share-Based Payments The Board of Directors has been authorized by the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options (“SO”), employee warrants ( Bons de Souscription de Parts de Créateur d’Entreprise non-employee warrants (Bons de Souscription d’Actions During the nine months ended September 30, 2021, the Company granted 75,600 stock options and 44,900 restricted stock units to employees. There have been no changes in the vesting conditions and method of valuation of the SO and RSU from that disclosed in Note 14 to the consolidated financial statements included in the Annual Report.
During the nine months ended September 30, 2021, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the Company offered the directors the opportunity to subscribe for warrants to purchase ordinary shares on May 19, 2021, and on
June 3, 2021, the directors subscribed for warrants to purchase an aggregate of 39,185 ordinary shares. These warrants have a contractual life of 4 years from their date of issuance and are not subject to a performance condition. Unless otherwise decided by the Board of Directors, these warrants may be exercised at any time prior to their expiration, provided that the beneficiary still holds a seat on the Board of Directors at the time of exercise, and subject to applicable French laws and regulations applicable to companies whose securities are listed on a regulated stock market. The fair value of the warrants has been estimated unsing the Cox-Ross Rubinstein binomial option pricing model.
The changes in number of BSA/BSPCE/SO/RSU are as follows:
Share-based payments expenses reflected in the condensed consolidated statements of operations is as follows:
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Contingencies |
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| Loss Contingency [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Contingencies | Note 7: Contingencies The following tables summarize the contingencies as of September 30, 2021 and December 31, 2020:
The changes in contingencies are as follows:
In 2020 and during the first nine months of 2021, the ongoing COVID-19 pandemic impacted the Company’s current clinical trials, including the Phase II clinical trial conducted as part of the development activities pursuant to the collaboration and license agreement with Nestlé Health Science. The Company experienced difficulties in enrolling new patients in this Phase II clinical trial (“PII”) and modified the protocols of the clinical trial. As a result of the accumulation of recruitment delays, the Company expects to incur additional clinical and production costs related to the Phase II clinical trial. As of September 30, 2021, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of the Phase II clinical trial conducted as part of the agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly. 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”). There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 15 to the consolidated financial statements included in the Annual Report. |
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Operating Income |
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| Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Operating Income | Note 8: Operating income The following table summarizes the operating income during the three and nine months ended September 30, 2021 and 2020:
In 2020 and during the first nine months of 2021, the ongoing COVID-19 pandemic im pacted the Company’s current clinical trials, including the Phase II clinical trial conducted as part of the development activities pursuant to the collaboration and license agreement with Nestlé Health Science. The Company experienced difficulties in enrolling new patients in this Phase II clinical trial and modified the protocols of the clinical trial. As a result of the accumulation of recruitment delays, the Company expects to incur additional clinical and production costs related to the Phase II clinical trial. As of September 30, 2021, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of the Phase II clinical trial conducted as part of the agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly. |
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Allocation of Personnel Expenses |
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| Operating Expenses [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of Personnel Expenses | Note 9: Allocation of Personnel Expenses The Company had an average of 105 employees during the nine months ended September 30, 2021, in comparison with an average of 291 employees during the nine months ended September 30, 2020. The following table summarizes the allocation of personnel expenses by function during the three and nine months ended September 30, 2021 and 2020:
The following table summarizes the allocation of personnel expenses by nature during the three nine months ended September 30, 2021 and 2020:
The decrease in personnel expenses is mainly due to a decreased headcount as a result of the 2020 global restructuring plan. |
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Commitments |
9 Months Ended |
|---|---|
Sep. 30, 2021 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Commitments | Note 10: Commitments There have been no significant changes in other commitments from those disclosed in Note 19 to the consolidated financial statements included in the Annual Report. |
Relationships with Related Parties |
9 Months Ended |
|---|---|
Sep. 30, 2021 | |
| Related Party Transactions [Abstract] | |
| Relationships with Related Parties | Note 11: Relationships with Related Parties The Company’s related parties consist of executive officers, directors and beneficial owners of five percent (5%) or more of any class of our voting securities, including any of their immediate family members and any entity owned or controlled by such persons. As of September 30, 2021, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not changed significantly since December 31, 2020. Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the Company offered its directors the opportunity to subscribe for warrants to purchase ordinary shares on May 19, 2021, and on June 3, 2021, the directors subscribed for warrants to purchase an aggregate Share-Based Payments There were no other new significant related-party transactions during the period nor any change in the nature of the transactions from those described in Note 20 to the consolidated financial statements included in the Annual Report. |
Loss Per Share |
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| Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Loss Per Share | Note 12: Loss Per Share Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three and nine month periods ended September 30, 2021 and 2020, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss. The ordinary share equivalents at September 30, 2021 and 2020 excluded from the calculation of diluted net loss per share for the three months and nine months ended September 30, 2021 and 2020 (in number of potential shares) are set forth here below:
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Events After The Close Of The Period |
9 Months Ended |
|---|---|
Sep. 30, 2021 | |
| Subsequent Events [Abstract] | |
| Events after the Close of the Period | Note 13: Events after the Close of the Period The Company evaluated subsequent events that occurred after September 30, 2021, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on October 26, 2021 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements. |
The Company (Policies) |
9 Months Ended |
|---|---|
Sep. 30, 2021 | |
| Accounting Policies [Abstract] | |
| Basis of Presentation | Basis of Presentation The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. The amounts are presented in thousands unless otherwise indicated. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation. The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on March 17, 2021 (the “Annual Report”). The condensed consolidated statement of financial position at December 31, 2020 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2020. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2021, or any other future period. |
| Use of estimates | Use of estimates The preparation of the Company’s condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates. On an on-going basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right-of-use assets—operating lease, (4) impairment of right-of-use |
| Going concern | 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 ( 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. Crédit d’Impôt Recherche ). Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin ™ Peanut, 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 the Company’s plans to address the guidance received from the FDA in January 2021 and additional feedback received in October 2021 regarding the protocol for STAMP (Safety, Tolerability and Adhesion of Modified Patches), and its expected cost savings from implementation of the global restructuring plan, the Company expects that its balance of cash and cash equivalents of $98.2 million as of September 30, 2021 will be sufficient to fund its operations into the third quarter of 2022. As of the date of the filing, the Company’s available cash is not projected to be sufficient to support its operating plan for the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern. 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. 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, including as a result of disruptions to the global financial markets due to the ongoing COVID-19 pandemic. 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. If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts, or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently. These interim financial statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists. |
| Accounting Pronouncements adopted in 2021 | Accounting Pronouncements adopted in 2021 Effective January 1, 2021, the Company adopted ASU
2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. The adoption of ASU 2019-12 did not have a material impact on the Company’s financial position or results of operations. |
| Accounting Pronouncements issued not yet adopted | Accounting Pronouncements issued not yet adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13—Financial Instruments—Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. 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 guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard will have a material impact on its consolidated financial statements. Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption. |
Significant Events and Transactions (Tables) |
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Significant Events And Transactions Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of restructuring reserve | The following table summarizes restructuring activities as of September 30, 2021 included in current contingencies and other current liabilities in the statement of financial position:
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Cash and Cash Equivalents (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash and Cash Equivalents [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of breakdown of cash and cash equivalents | The following tables summarize the cash and cash equivalents as of September 30, 2021 and December 31, 2020:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trade Payables and Other Current Liabilities (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Liabilities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Other Liabilities | The following tables summarize the other liabilities as of September 30, 2021 and December 31, 2020:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Other Liabilities by Nature | The following table summarizes the other liabilities by nature as of September 30, 2021 and December 31, 2020:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Payments (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Stock Options Valuation Assumptions | There have been no changes in the vesting conditions and method of valuation of the SO and RSU from that disclosed in Note 14 to the consolidated financial statements included in the Annual Report.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Fair Value of the Warrants has been Estimated Unsing the Cox-Ross Rubinstein Binomial Option Pricing Model | The fair value of the warrants has been estimated unsing the Cox-Ross Rubinstein binomial option pricing model.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of RSU Activity | The changes in number of BSA/BSPCE/SO/RSU are as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Share-Based Payments Expenses | Share-based payments expenses reflected in the condensed consolidated statements of operations is as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Contingencies (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Loss Contingency [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Current Contingencies and Non-current Contingencies | The following tables summarize the contingencies as of September 30, 2021 and December 31, 2020:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Movement in Provisions | The changes in contingencies are as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Operating Income (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of operating income | The following table summarizes the operating income during the three and nine months ended September 30, 2021 and 2020:
|
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Allocation of Personnel Expenses (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Operating Expenses [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Allocation of Personnel Expenses By Function | The following table summarizes the allocation of personnel expenses by function during the three and nine months ended September 30, 2021 and 2020:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Allocation of Personnel Expenses By Nature | The following table summarizes the allocation of personnel expenses by nature during the three nine months ended September 30, 2021 and 2020:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Loss Per Share (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Earnings Per Share, Basic and Diluted [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | The ordinary share equivalents at September 30, 2021 and 2020 excluded from the calculation of diluted net loss per share for the three months and nine months ended September 30, 2021 and 2020 (in number of potential shares) are set forth here below:
|
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The Company - Additional Information (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
Sep. 30, 2020 |
Dec. 31, 2019 |
|---|---|---|---|---|
| Subsidiary or Equity Method Investee [Line Items] | ||||
| Cash and cash equivalents | $ 98,195 | $ 196,352 | $ 221,404 | $ 193,255 |
Significant Events and Transactions - Summary of restructuring reserve (Detail) $ in Thousands |
9 Months Ended |
|---|---|
|
Sep. 30, 2021
USD ($)
| |
| Summary of restructuring reserve | |
| Restructuring liability - January 1, 2021 | $ 9,387 |
| Amounts paid | (7,024) |
| Other effect including currency translation effect | (238) |
| Restructuring liability – September 30, 2021 | 2,125 |
| of which current contingencies | 950 |
| of which other current liabilities | $ 1,175 |
Cash and Cash Equivalents - Summary of breakdown of cash and cash equivalents (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
Sep. 30, 2020 |
Dec. 31, 2019 |
|---|---|---|---|---|
| Cash and Cash Equivalents, at Carrying Value [Abstract] | ||||
| Cash | $ 33,928 | $ 42,341 | ||
| Cash equivalents | 64,267 | 154,011 | ||
| Total cash and cash equivalent as reported in statement of financial position | $ 98,195 | $ 196,352 | $ 221,404 | $ 193,255 |
Trade Payables and Other Current Liabilities - Additional Information (Detail) $ in Millions |
Sep. 30, 2021
USD ($)
|
|---|---|
| Nestl Health Science [Member] | |
| Deferred revenues | $ 6.9 |
Trade Payables and Other Current Liabilities - Summary of Other Liabilities (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
|---|---|---|
| Other Liabilities [Abstract] | ||
| Other current liabilities | $ 12,659 | $ 22,926 |
| Other non-current liabilities | 4,292 | 475 |
| Total | $ 16,951 | $ 23,402 |
Trade Payables and Other Current Liabilities - Summary of Other Liabilities by Nature (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
|---|---|---|
| Schedule Of Other Liabilities, By Nature [Line Items] | ||
| Other current liabilities | $ 12,659 | $ 22,926 |
| Other non-current liabilities | 4,292 | 475 |
| Total | 16,951 | 23,402 |
| Employee related liabilities [Member] | ||
| Schedule Of Other Liabilities, By Nature [Line Items] | ||
| Other current liabilities | 6,748 | |
| Other non-current liabilities | 1,674 | |
| Total | 8,422 | 17,136 |
| Deferred income [Member] | ||
| Schedule Of Other Liabilities, By Nature [Line Items] | ||
| Other current liabilities | 4,291 | |
| Other non-current liabilities | 2,618 | |
| Total | 6,909 | 4,687 |
| Tax Liabilities [Member] | ||
| Schedule Of Other Liabilities, By Nature [Line Items] | ||
| Other current liabilities | 149 | |
| Total | 149 | 580 |
| Other Debts [Member] | ||
| Schedule Of Other Liabilities, By Nature [Line Items] | ||
| Other current liabilities | 1,471 | |
| Total | $ 1,471 | $ 999 |
Shareholders' equity - Additional Information (Detail) |
9 Months Ended | 12 Months Ended | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
Sep. 30, 2021
USD ($)
shares
|
Dec. 31, 2020
USD ($)
|
Dec. 31, 2020
EUR (€)
|
Sep. 30, 2021
EUR (€)
€ / shares
shares
|
Jun. 30, 2021
USD ($)
|
Mar. 31, 2021
USD ($)
|
Sep. 30, 2020
USD ($)
|
Jun. 30, 2020
USD ($)
|
Mar. 31, 2020
USD ($)
|
Dec. 31, 2019
USD ($)
|
|
| Class of Stock [Line Items] | ||||||||||
| Share capital | $ | $ 116,892,000 | $ 205,491,000 | $ 143,019,000 | $ 169,176,000 | $ 233,099,000 | $ 251,739,000 | $ 299,662,000 | $ 193,186,000 | ||
| Warrant [Member] | ||||||||||
| Class of Stock [Line Items] | ||||||||||
| Stock Issued During Period, Value, Stock Options Exercised | $ | $ 10,000 | |||||||||
| Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | shares | 82,500 | |||||||||
| Share Capital | ||||||||||
| Class of Stock [Line Items] | ||||||||||
| Share capital | $ 6,528,543,000 | € 5,501,168,700 | ||||||||
| Nominal value | € / shares | € 0.10 | |||||||||
| Share capital authorized | shares | 55,011,687 | 55,011,687 | ||||||||
| Adjustments to Additional Paid in Capital, Dividends in Excess of Retained Earnings | $ 797,822,881 | € 695,575,130.36 | ||||||||
Share-Based Payments - Summary of Stock Options Valuation Assumptions (Detail) |
9 Months Ended |
|---|---|
|
Sep. 30, 2021
€ / shares
| |
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
| Weighted average share price at grant date in € | € 10.75 |
| Weighted average risk-free interest rate | (0.53%) |
| Weighted average expected term (in years) | 3 years 2 months 15 days |
| Dividend yield | |
| Weighted average fair value of stock options in € | € 0 |
| Weighted Average [Member] | |
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
| Weighted average share price at grant date in € | € 9.3 |
| Weighted average expected volatility | 90.90% |
| Weighted average risk-free interest rate | (0.36%) |
| Weighted average expected term (in years) | 6 years |
| Weighted average fair value of stock options in € | € 6.9 |
Share-Based Payments - Summary of Fair Value of the Warrants has been Estimated Unsing the Cox-Ross Rubinstein Binomial Option Pricing Model (Detail) |
9 Months Ended |
|---|---|
|
Sep. 30, 2021
€ / shares
| |
| Schedule Of Share Based Payment Award Fair Value Of Warrants Valuation Assumptions [Line Items] | |
| Weighted average share price at grant date in € | € 10.75 |
| Weighted average expected volatility | 90.00% |
| Weighted average risk-free interest rate | (0.53%) |
| Weighted average expected term (in years) | 3 years 2 months 15 days |
| Dividend yield | |
| Weighted average fair value of warrants in € | € 0 |
Share-Based Payments - Additional Information (Detail) - shares |
9 Months Ended | ||
|---|---|---|---|
Sep. 03, 2021 |
May 19, 2021 |
Sep. 30, 2021 |
|
| Share-Based Payments [Line iteam] | |||
| Number of stock options outstanding, Granted during the period | 75,600 | ||
| Warrants Remaining contractual life | 4 years | ||
| Director [Member] | Warrant [Member] | |||
| Share-Based Payments [Line iteam] | |||
| Stock Issued During Period, Shares, Issued for Services | 39,185 | 39,185 | |
| Share options [Member] | Employees [Member] | |||
| Share-Based Payments [Line iteam] | |||
| Number of stock options outstanding, Granted during the period | 75,600 | ||
| Restricted Stock Units [Member] | |||
| Share-Based Payments [Line iteam] | |||
| Number of RSU outstanding, Granted during the period | 44,900 | ||
| Restricted Stock Units [Member] | Employees [Member] | |||
| Share-Based Payments [Line iteam] | |||
| Number of RSU outstanding, Granted during the period | 44,900 |
Contingencies - Summary of Current Contingencies and Non-current Contingencies (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
|---|---|---|
| Liability, Defined Benefit Plan [Abstract] | ||
| Current contingencies | $ 5,633 | $ 5,016 |
| Non-current contingencies | 7,629 | 2,527 |
| Total contingencies | $ 13,262 | $ 7,542 |
Operating Income - Summary of Operating Income (Detail) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
| Other Income and Expenses [Abstract] | ||||
| Research Tax Credit | $ 1,647 | $ 1,815 | $ 5,324 | $ 7,615 |
| Other Operating (loss) income | (324) | 2,344 | (2,549) | 4,873 |
| Total | $ 1,323 | $ 4,158 | $ 2,776 | $ 12,488 |
Allocation of Personnel Expenses - Summary of Allocation of Personnel Expenses By Function (Detail) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
| Research and development expenses | $ 16,320 | $ 25,751 | $ 58,663 | $ 75,214 |
| Sales and marketing expenses | 1,072 | 1,595 | 2,999 | 8,114 |
| General and administrative expenses | 8,299 | 6,863 | 26,250 | 26,838 |
| Restructuring expenses | (286) | 21,003 | ||
| Total Operating expenses | 25,691 | 33,923 | 87,912 | 131,169 |
| Expenses by Function [Member] | ||||
| Research and development expenses | 4,161 | 5,984 | 12,272 | 18,294 |
| Sales and marketing expenses | 492 | 2,154 | 1,528 | 4,987 |
| General and administrative expenses | 2,583 | 1,570 | 9,347 | 6,628 |
| Restructuring expenses | 0 | (231) | 0 | 6,792 |
| Total Operating expenses | $ 7,236 | $ 9,477 | $ 23,148 | $ 36,701 |
Allocation of Personnel Expenses -Summary of Allocation of Personnel Expenses By Nature (Detail) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
| Share-based payments | $ (1,551) | $ 74 | $ (4,078) | $ 2,965 |
| Total Operating expenses | 25,691 | 33,923 | 87,912 | 131,169 |
| Expenses by Nature [Member] | ||||
| Wages and salaries | 3,793 | 7,021 | 12,629 | 33,121 |
| Social security contributions | 1,110 | 933 | 3,505 | 5,669 |
| Expenses for pension commitments | 286 | 617 | 981 | 1,116 |
| Employer contribution to bonus shares | 497 | 981 | 1,955 | (241) |
| Share-based payments | 1,551 | (74) | 4,078 | (2,965) |
| Total Operating expenses | $ 7,236 | $ 9,477 | $ 23,148 | $ 36,701 |
Commitments - Additional Information (Detail) |
9 Months Ended |
|---|---|
|
Sep. 30, 2021
USD ($)
| |
| Disclosure Of Commitments [Line Items] | |
| Increase (decrease) in other commitments during the period | $ 0 |
Relationships with Related Parties - Additional Information (Detail) - USD ($) $ in Thousands |
9 Months Ended | ||
|---|---|---|---|
Sep. 03, 2021 |
May 19, 2021 |
Sep. 30, 2021 |
|
| Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||
| Increase decrease in related party transactions and changes in nature of the transactions | $ 0 | ||
| Director [Member] | Warrant [Member] | |||
| Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||
| Stock Issued During Period, Shares, Issued for Services | 39,185 | 39,185 |