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 |
applicable | ||
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 | ||
American Depositary Shares, each representing one-half ofone ordinary share, nominal €0.10 per share |
||||
Ordinary shares, nominal value €0.10 per share * |
n/a |
* |
Large accelerated filer |
☐ |
Accelerated filer |
☐ | |||
Non-accelerated filer |
☒ | Smaller reporting company | ||||
Emerging growth company |
Part I | 3 | |||
Item 1 | Condensed Consolidated Statements of Financial Position (Unaudited) as of September 30, 2022 and December 31, 2021 | 3 | ||
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Nine Months Ended September 30, 2022 and 2021 | 4 | |||
Condensed Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2022 and 2021 | 5 | |||
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Nine Months Ended September 30, 2022 and 2021 | 6 | |||
8 | ||||
Item 2 | 21 | |||
Item 3 | 33 | |||
Item 4 | 33 | |||
Part II | 34 | |||
Item 1 | 34 | |||
Item 1A | 34 | |||
Item 2 | 34 | |||
Item 3 | 35 | |||
Item 4 | 35 | |||
Item 5 | 35 | |||
Item 6 | 36 |
• | 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, or CROs, 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, or a BLA, for Viaskin TM Peanut to the U.S. Food and Drug Administration, or the FDA; |
• | the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs; |
• | 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; and |
• | other risks and uncertainties, including those listed under the caption “Risk Factors.” |
September 30, |
December 31, |
|||||||||||
Note |
2022 |
2021 |
||||||||||
Assets |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
3 |
$ |
$ | |||||||||
Other current assets |
4 |
|||||||||||
|
|
|
|
|||||||||
Total current assets |
||||||||||||
Property, plant, and equipment, net |
||||||||||||
Right-of-use |
5 |
|||||||||||
Intangible assets |
||||||||||||
Other non-current assets |
||||||||||||
|
|
|
|
|||||||||
Total non-current assets |
||||||||||||
|
|
|
|
|||||||||
Total Assets |
$ |
$ |
||||||||||
|
|
|
|
|||||||||
Liabilities and shareholders' equity |
||||||||||||
Current liabilities: |
||||||||||||
Trade payables |
6 |
$ |
$ | |||||||||
Short-term operating leases |
5 |
|||||||||||
Short-term financial debt |
||||||||||||
Current contingencies |
9 |
|||||||||||
Other current liabilities |
6 |
|||||||||||
|
|
|
|
|||||||||
Total current liabilities |
||||||||||||
|
|
|
|
|||||||||
Long-term operating leases |
5 |
|||||||||||
Non-current contingencies |
9 |
|||||||||||
Other non-current liabilities |
6 |
|||||||||||
|
|
|
|
|||||||||
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 |
7 |
$ |
$ |
|||||||||
|
|
|
|
|||||||||
Total Liabilities and Shareholders’ equity |
$ |
$ |
||||||||||
|
|
|
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||
Note |
2022 |
2021 |
2022 |
2021 |
||||||||||||||
Operating income |
10 |
$ |
$ |
$ |
$ |
|||||||||||||
Operating expenses |
||||||||||||||||||
Research and development expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Sales and marketing expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
General and administrative expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Total Operating expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Loss from operations |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||
Financial income |
||||||||||||||||||
Loss before taxes |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||
Income tax (expense) |
( |
) | ||||||||||||||||
Net loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||||
Foreign currency translation differences, net of taxes |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Actuarial gains (losses) on employee benefits, net of taxes |
( |
) | ||||||||||||||||
Total comprehensive loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||||
Basic/diluted net loss per share attributable to shareholders |
14 |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | |||||
Weighted average shares outstanding used in computing per sha re amounts: |
Nine Months Ended September 30, |
||||||||||||
Notes |
2022 |
2021 |
||||||||||
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 |
|
8 |
|
|||||||||
Other elements |
|
|
( |
) | ||||||||
Changes in operating assets and liabilities: |
|
|
||||||||||
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 used in investing activities: |
|
|
||||||||||
Acquisitions of property, plant, and equipment |
|
|
( |
) | ||||||||
Proceeds from property, plant, and equipment dispositions |
|
|
||||||||||
Acquisition of intangible assets |
|
|
( |
) | ||||||||
Acquisitions of non-current financial assets |
|
|
( |
) | ||||||||
Proceeds from non-current financial assets |
|
|
||||||||||
|
|
|
|
|
|
|||||||
Net cash flows used in investing activities |
|
|
( |
) |
||||||||
|
|
|
|
|
|
|||||||
Cash flows provided by financing activities: |
|
|
||||||||||
Decrease in conditional advances |
|
|
( |
) | ( |
) | ||||||
Treasury shares |
|
|
( |
) | ||||||||
Capital increases, net of transaction costs |
|
|
||||||||||
Other cash flows related to financing activities |
|
|
( |
) | ||||||||
|
|
|
|
|
|
|||||||
Net cash flows provided by financing activities |
|
|
( |
) | ||||||||
|
|
|
|
|
|
|||||||
Effect of exchange rate changes on cash and cash equivalents |
|
|
( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Net increase (decrease) 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, 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 |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
Treasury shares |
— | — | — | — | — | |||||||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | |||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at September 30, 2021 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares |
||||||||||||||||||||||||||||||||
Number of Shares |
Amount |
Additional paid-in capital |
Treasury stock |
Accumulated deficit |
Accumulated other comprehensive income (loss) |
Accumulated currency translation effect |
Total Shareholders’ Equity |
|||||||||||||||||||||||||
Balance at January 1, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Other comprehensive loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
Issuance of ordinary shares |
— | — | — | — | — | |||||||||||||||||||||||||||
Treasury shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Other changes |
— | — | — | — | ( |
) | — | |||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at March 31, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Other comprehensive loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
Issuance of ordinary shares |
— | — | — | — | ||||||||||||||||||||||||||||
Issuance of warrants |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Treasury shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Allocation of accumulated net losses |
— | — | ( |
) | — | — | — | — | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at June 30, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Other comprehensive loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
Issuance of ordinary shares |
( |
) | — | — | — | — | ( |
) | ||||||||||||||||||||||||
Treasury shares |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at September 30, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1. |
Identify a modified Viaskin patch (“mVP”). |
2. |
Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible. |
3. |
Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies: |
a. |
PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays the Company intends to use in EQUAL |
b. |
‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and mVP; |
September 30, |
December 31, |
|||||||
2022 |
2021 |
|||||||
Cash |
||||||||
Cash equivalents |
||||||||
Total cash and cash equivalents as reported in the statements of financial position |
||||||||
September 30, |
December 31, |
|||||||
2022 |
2021 |
|||||||
Research tax credit |
||||||||
Other tax claims |
||||||||
Prepaid expenses |
||||||||
Other receivables |
||||||||
Total |
||||||||
Amount in thousands of US Dollars |
||||
Opening research tax credit receivable as of January 1, 2022 |
||||
+ Operating revenue |
||||
- Payment received |
( |
) | ||
- Adjustment and currency translation effect |
( |
) | ||
Closing research tax credit receivable as of September 30, 2022 |
||||
Of which - Non-current portion |
||||
Of which - Current portion |
September 30, 2022 |
December 31, 2021 |
|||||||||||||||||||||||
Real estate |
Other assets |
Total |
Real estate |
Other assets |
Total |
|||||||||||||||||||
Current portion |
||||||||||||||||||||||||
Year 2 |
||||||||||||||||||||||||
Year 3 |
||||||||||||||||||||||||
Year 4 |
— | — | — | |||||||||||||||||||||
Year 5 |
— | — | — | — | ||||||||||||||||||||
Thereafter |
— | — | — | — | ||||||||||||||||||||
Total minimum lease payments |
||||||||||||||||||||||||
Less: Effects of discounting |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Present value of operating lease |
||||||||||||||||||||||||
Less: current portion |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Long-term operating lease |
||||||||||||||||||||||||
Weighted average remaining lease term (years) |
— | |||||||||||||||||||||||
Weighted average discount rate |
% | % | % | % |
September 30, |
||||||||
2022 |
2021 |
|||||||
Operating lease expense |
||||||||
Net termination impact |
( |
) | — |
September 30, |
||||||||
2022 |
2021 |
|||||||
Cash paid for amounts included in the measurement of lease liabilities |
— | — | ||||||
Operating cash flows from operating leases |
September 30, |
December 31, |
|||||||||||||||||||||||
2022 |
2021 |
|||||||||||||||||||||||
Other current liabilities |
Other non- current liabilities |
Total |
Other current liabilities |
Other non- current liabilities |
Total |
|||||||||||||||||||
Employee related liabilities |
||||||||||||||||||||||||
Deferred income |
||||||||||||||||||||||||
Tax liabilities |
||||||||||||||||||||||||
Other debts |
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total |
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
• | decided, within the framework of the PIPE financing the principle of a capital increase in cash with cancellation of preferential subscription rights, reserved for categories of persons meeting which set out the characteristics included in the 18th resolution of the Board General Meeting, through the issuance of Ordinary Shares and warrants to subscribe for Ordinary Shares, for a maximum amount of nd resolution of the Board General Meeting; |
• | granted a number of authorizations for the purpose of carrying out the i |
• | sub-delegated its authority to the Chief Executive Officer for the purpose of implementing the financing. |
• | decided, making use of the 18 th resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L. 225-128 of French Commercial Code, an amount of € |
• | decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € pre-financed price released in advance at the time of the subscription of the prefunded warrants ), being specified that this amount does not take into account the nominal value of the ordinary shares to be issued in order to preserve the rights of the holders of securities giving access to the capital issued or to be issued, in accordance with the legal and regulatory provisions and the contractual stipulations providing for other cases of adjustment if necessary; |
• | determined the list of beneficiaries (designated within each of the categories of persons defined in the 18 th resolution of the Board General Meeting) and the number of New Ordinary Shares and warrants allocated to each of them under the conditions defined in the 18th resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the PIPE financing. |
Prefunded warrants |
||||
Balance as of December 31, 2021 |
||||
Granted during the period |
||||
Forfeited during the period |
||||
Exercised/released during the period |
||||
Expired during the period |
||||
|
|
|||
Balance as of September 30, 2022 |
||||
|
|
Stock option fair value assumptions during the nine months ended September 30, 2022 |
||||
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 € |
Number of outstanding |
||||||||||||
BSA |
SO |
RSUs |
||||||||||
Balance as of December 31, 2021 |
||||||||||||
Granted during the period |
— | |||||||||||
Forfeited during the period |
— | ( |
) | ( |
) | |||||||
Exercised/released during the period |
( |
) | ( |
) | ||||||||
Expired during the period |
( |
) | — | |||||||||
|
|
|
|
|
|
|||||||
Balance as of September 30, 2022 |
||||||||||||
|
|
|
|
|
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||||||
Research & development |
SO | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Sales & marketing |
SO | ( |
) | ( |
) | ( |
) | |||||||||||||
RSU | ( |
) | ( |
) | ||||||||||||||||
General & administrative |
SO | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Total share-based compensation (expense) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
|
|
|
|
|
|
|
|
September 30, |
December 31, |
|||||||
2022 |
2021 |
|||||||
Current contingencies |
||||||||
Non-current contingencies |
||||||||
|
|
|
|
|||||
Total contingencies |
||||||||
|
|
|
|
Pension retirement obligations |
Collaboration agreement - Loss at completion |
Other contingencies |
Total |
|||||||||||||
At January 1, 2022 |
||||||||||||||||
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 |
( |
) | — | — | ( |
) | ||||||||||
Currency translation effect |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
At September 30, 2022 |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Of which Current |
— |
— |
||||||||||||||
Of which Non-current |
— |
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Research tax credit |
||||||||||||||||
Other operating income |
( |
) | ( |
) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
||||||||||||||||
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Research and Development expenses |
||||||||||||||||
Sales and Marketing expenses |
||||||||||||||||
General and Administrative expenses |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total personnel expenses |
||||||||||||||||
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
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, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Non-employee warrants |
||||||||||||||||
Stock options |
||||||||||||||||
Restricted stock units |
||||||||||||||||
Prefunded warrants |
1. | Identify a modified Viaskin patch (“mVP”). |
2. | Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible. |
3. | Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies: |
a. | PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays the Company intends to use in EQUAL |
b. | ‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and mVP; |
Three months ended September 30, |
||||||||||||||||
2022 |
2021 |
$ change |
% change |
|||||||||||||
Operating income |
$ |
2,074 |
$ |
1,323 |
751 |
57 |
% | |||||||||
Operating expenses |
||||||||||||||||
Research and development expenses |
(15,096 | ) | (16,320 | ) | 1,224 | (8 | %) | |||||||||
Sales and marketing expenses |
(159 | ) | (1,072 | ) | 913 | (85 | %) | |||||||||
General and administrative expenses |
(4,839 | ) | (8,299 | ) | 3,460 | (42 | %) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Operating expenses |
(20,094 | ) | (25,691 | ) | 5,597 | (22 | %) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Financial income |
732 | 336 | 396 | 118 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Income tax |
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss |
$ |
(17,287 |
) |
$ |
(24,033 |
) |
6,745 |
(28 |
%) | |||||||
|
|
|
|
|
|
|
|
|||||||||
Basic/diluted Net loss per share attributable to shareholders |
$ |
(0.18 |
) |
$ |
(0.44 |
) |
Three months ended September 30, |
$ change |
% change |
||||||||||||||
2022 |
2021 |
|||||||||||||||
Sales |
— | — | — | — | ||||||||||||
Other income |
2,074 | 1,323 | 751 | 57 | % | |||||||||||
Research tax credit |
1,407 |
1,647 |
(240 | ) | (15 | %) | ||||||||||
Other operating income |
668 |
(324 |
) |
992 | (306 | %) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating income |
2,074 |
1,323 |
751 |
57 |
% | |||||||||||
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
||||||||||||||||
Research and Development expenses |
2022 |
2021 |
$ change |
% change |
||||||||||||
External clinical-related expenses |
11,136 | 8,633 | 2,503 | 29 | % | |||||||||||
Employee-related costs |
2,648 | 3,228 | (581 | ) | (18 | %) | ||||||||||
Share-based payment expenses |
538 | 933 | (395 | ) | (42 | %) | ||||||||||
Depreciation, amortization and other costs |
774 | 3,526 | (2,752 | ) | (78 | %) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Research and Development expenses |
15,096 |
16,320 |
(1,224 |
) |
(8 |
%) | ||||||||||
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
$ change |
% change |
||||||||||||||
Sales and Marketing expenses |
2022 |
2021 |
||||||||||||||
Personnel expenses |
138 | 492 | (354 | ) | (72 | %) | ||||||||||
External professional services and other costs |
20 | 580 | (559 | ) | (96 | %) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Sales and Marketing expenses |
159 |
1,072 |
(913 |
) |
(85 |
%) | ||||||||||
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
$ change |
% change |
||||||||||||||
General and Administrative expenses |
2022 |
2021 |
||||||||||||||
External professional services |
1,292 | 2,216 | (924 | ) | (42 | %) | ||||||||||
Employee-related costs |
1,110 | 2,052 | (942 | ) | (46 | %) | ||||||||||
Share-based payment expenses |
488 | 530 | (42 | ) | (8 | %) | ||||||||||
Depreciation, amortization and other costs |
1,949 | 3,501 | (1,552 | ) | (44 | %) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total General and Administrative expenses |
4,839 |
8,299 |
(3,460 |
) |
(42 |
%) | ||||||||||
|
|
|
|
|
|
|
|
Nine months ended September 30, |
$ change |
% change |
||||||||||||||
2022 |
2021 |
|||||||||||||||
Operating income |
$ |
6,148 |
$ |
2,776 |
3,373 |
122 |
% | |||||||||
Operating expenses |
||||||||||||||||
Research and development expenses |
(45,930 | ) | (58,663 | ) | 12,733 | (22 | )% | |||||||||
Sales and marketing expenses |
(1,659 | ) | (2,999 | ) | 1,340 | (45 | )% | |||||||||
General and administrative expenses |
(17,173 | ) | (26,250 | ) | 9,077 | (35 | )% | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Operating expenses |
(64,762 | ) | (87,912 | ) | 23,150 | (26 | )% | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Financial income |
1,668 | 597 | 1,071 | 179 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Income tax (expense) |
(87 | ) | 404 | (491 | ) | (122 | )% | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss |
$ |
(57,033 |
) |
$ |
(84,136 |
) |
27,103 |
(32 |
)% | |||||||
|
|
|
|
|
|
|
|
|||||||||
Basic/diluted Net loss per share attributable to shareholders |
$ |
(0.79 |
) |
$ |
(1.53 |
) |
Nine months ended September 30, |
$ change |
% change |
||||||||||||||
2022 |
2021 |
|||||||||||||||
Sales |
— | — | ||||||||||||||
Other income |
6,148 | 2,776 | 3,373 | 122 | % | |||||||||||
Research tax credit |
4,467 |
5,324 |
(857 |
) |
(16 |
%) | ||||||||||
Other operating income |
1,681 |
(2,549 |
) |
4,230 |
(166 |
%) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating income |
6,148 |
2,776 |
3,373 |
122 |
% | |||||||||||
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
||||||||||||||||
2022 |
2021 |
$ change |
% change |
|||||||||||||
Research and Development expenses |
||||||||||||||||
External clinical-related expenses |
30,150 | 31,319 | (1,169 | ) | (4 | %) | ||||||||||
Employee-related costs |
7,761 | 10,525 | (2,764 | ) | (26 | %) | ||||||||||
Share-based payment expenses |
1,596 | 1,747 | (151 | ) | (9 | %) | ||||||||||
Depreciation, amortization and other costs |
6,423 | 15,072 | (8,649 | ) | (57 | %) | ||||||||||
Total Research and Development expenses |
45,930 |
58,663 |
(12,733 |
) |
(22 |
%) | ||||||||||
Nine Months Ended September 30, |
||||||||||||||||
2022 |
2021 |
$ change |
% change |
|||||||||||||
Sales and Marketing expenses |
||||||||||||||||
Personnel expenses |
727 | 1,528 | (801 | ) | (52 | %) | ||||||||||
External professional services and other costs |
932 | 1,471 | (538 | ) | (37 | %) | ||||||||||
Total Sales and Marketing expenses |
1,659 |
2,999 |
(1,340 |
) |
(45 |
%) | ||||||||||
Nine Months Ended September 30, |
||||||||||||||||
2022 |
2021 |
$ change |
% change |
|||||||||||||
General and Administrative expenses |
||||||||||||||||
External professional services |
4,171 | 6,425 | (2,255 | ) | (35 | %) | ||||||||||
Employee-related costs |
5,139 | 7,263 | (2,124 | ) | (29 | %) | ||||||||||
Share-based payment expenses |
1,822 | 2,084 | (263 | ) | (13 | %) | ||||||||||
Depreciation, amortization and other costs |
6,042 | 10,478 | (4,436 | ) | (42 | %) | ||||||||||
Total General and Administrative expenses |
17,173 |
26,250 |
(9,077 |
) |
(35 |
%) | ||||||||||
Material Cash Requirements Due by the period Ended September 30, |
||||||||||||||||||||
2023 |
2024 |
2025 |
Thereafter |
Total |
||||||||||||||||
(Amounts in thousands) |
||||||||||||||||||||
Operating leases |
1,381 | 1,423 | — | — | 2,804 | |||||||||||||||
Purchase obligations - Obligations Under the Terms of CRO Agreements |
12,411 | 36,234 | 7,805 | — | 56,450 | |||||||||||||||
Total |
13,791 | 37,657 | 7,805 | — | 59,254 |
Nine months ended September 30, |
||||||||||||||||
(Amounts in thousands of U.S. Dollars) |
2022 |
2021 |
$ change |
% of change |
||||||||||||
Net cash flow used in operating activities |
(31,781 | ) | (89,452 | ) | 57,671 | (64 | %) | |||||||||
Net cash flow used in investing activities |
(66 | ) | 41 | (107 | ) | (262 | %) | |||||||||
Net cash flow provided by financing activities |
194,403 | (103 | ) | 194,506 | * | |||||||||||
Effect of exchange rate changes on cash and cash equivalents |
(27,186 | ) | (8,643 | ) | (18,543 | ) | 215 | % | ||||||||
Net (decrease) increase in cash and cash equivalents |
135,369 |
(98,157 |
) |
233,527 |
(238 |
%) | ||||||||||
* | Percentage not meaningful |
• | On March 23, 2022, the issuance of an aggregate of 775 ordinary shares to a non-U.S. employee upon settlement of RSUs; |
• | On May 19, 2022, the issuance of an aggregate of 5,000 ordinary shares to a non-U.S. employee upon settlement of RSUs; |
• | On May 24, 2022, the issuance of an aggregate of 26,135 ordinary shares to a non-U.S. employee upon settlement of RSUs; |
• | Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022, the Company offered the opportunity to subscribe for warrants to purchase ordinary shares on May 12, 2022, and on June 9, 2022, the Chief Executive Officer authorized a capital increase for an amount of €3,285,566.90 through the issue of (i) 32,855,669 New Shares with a per value of €0.10 each and (ii) the issuance of 28,276,331 prefunded warrants, with cancellation of shareholders' preferential subscription rights in favor of Braidwell LP, funds advised by Baker Bros. Advisors LP and BpiFrance Participations SA, existing shareholders of the Company and Venrock Healthcare Capital Partners. |
• | On June 8, 2022, we entered into a securities purchase agreement with certain institutional and accredited investors pursuant to which we agreed to issue and sell to the investors i) 32,855,669 ordinary shares, nominal value €0.10 per share, at a price per ordinary share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022), and (ii) pre-funded warrants to purchase an aggregate of 28,276,331 ordinary shares (the “Warrant |
Shares”) at a pre-funded price per pre-funded warrant of €2.90 (corresponding to $3.11), which equals the per share price of the ordinary shares less the exercise price of €0.10 per Pre-Funded Warrant. Each Pre-Funded Warrant has an exercise price of €0.10 per Warrant Share. The Pre-Funded Warrants are exercisable at any time after their original issuance and will expire ten years following their issuance. The exercise price and number of shares of ordinary shares issuable upon exercise of the warrants may be adjusted in certain circumstances, including stock splits, stock dividends, reclassifications and the like. The pre-funded warrants issued in the PIPE provide that the holder of the pre-funded warrants will not have the right to exercise any portion of its pre-funded warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of ordinary shares outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”). The holder may increase or decrease the Beneficial Ownership Limitation, provided, however, that the holder may only increase the Beneficial Ownership Limitation by (i) obtaining authorization from the French Ministry of Economy in the event the Beneficial Ownership Limitation is being raised above 9.99%, and (ii) by providing 61 days’ notice to the Company, except that in no event will the Beneficial Ownership Limitation exceed 19.99%. The securities issued by us pursuant to the securities purchase agreement and to be issued upon exercise of the warrants were not registered under the Securities Act of 1933, as amended, or the Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Pursuant to the Registration Rights Agreement, the Company filed a registration statement with the Securities and Exchange Commission registering the resale of 59,269,629 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants. |
• | On June 10, 2022, the issuance of 3,100 ordinary shares to a non-U.S. employee upon exercise of 3,100 SO at an exercise price of 4.16 euros per SO, for aggregate proceeds to the Company of 12,896 euros. |
• | On July 8, 2022, the issuance of 2,513 ordinary shares to a U.S. employee upon exercise of 2,513 SO at an exercise price of 4.16 euros per SO, for aggregate proceeds to the Company of 10,454 euros. |
• | On September 23, 2022, the issuance of an aggregate of 249 ordinary shares to a non-U.S. employee upon settlement of RSUs. |
Incorporated by Reference | ||||||||||
Exhibit |
Description |
Schedule/ Form |
File Number |
Exhibit |
File Date | |||||
3.1 | By-laws (status) of the registrant (English translation) | |||||||||
31.1 | Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended | |||||||||
31.2 | Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||
32.1* | Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||
101.INS | XBRL Instance Document | |||||||||
101.SCH | XBRL Taxonomy Extension Schema Document | |||||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | |||||||||
101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | |||||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||
104 | Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101. |
* | Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, (whether made before or after the date of the Form 10-Q), irrespective of any general incorporate language contained in such filing. |
DBV Technologies S.A. |
||||||||
(Registrant) | ||||||||
Date: November 3, 2022 |
By: |
/s/ Daniel Tassé |
||||||
Daniel Tassé | ||||||||
Chief Executive Officer | ||||||||
(Principal Executive Officer) | ||||||||
Date: November 3, 2022 |
By: |
/s/ Sébastien Robitaille |
||||||
Sébastien Robitaille | ||||||||
Chief Financial Officer | ||||||||
(Principal Financial and Accounting Officer) |