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 |
N/A | |
(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 | ☐ | |||
Non-accelerated filer |
☒ | Smaller reporting company | ||||
| Emerging growth company | ||||||
Table of contents
Unless the context otherwise requires, we use the terms “DBV”, “DBV Technologies,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q, or Quarterly Report, to refer to DBV Technologies S.A. and, where appropriate, its consolidated subsidiaries. “Viaskin™”, “EPIT™” and our other registered and common law trade names, trademarks and service marks are the property of DBV Technologies S.A. or our subsidiaries. All other trademarks, trade names and service marks appearing in this Quarterly Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.
SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS.
This Quarterly Report contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things:
| • | 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 ViaskinTM Peanut to the U.S. Food and Drug Administration, or the FDA; |
| • | the timing and anticipated results of interactions with regulatory agencies; |
| • | 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; |
| • | the impact of the COVID-19 pandemic 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; and |
| • | other risks and uncertainties, including those listed under the caption “Risk Factors.” |
Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. These risks, uncertainties and other factors are described in greater detail under the caption “Risk Factors” in Part I. Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission, or the SEC on March 2, 2023. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement. We qualify all of our forward-looking statements by these cautionary statements.
1
In addition, any forward-looking statement in this Quarterly Report, including statements that “we believe” and similar statements, reflect our beliefs and opinions on the relevant subject and represents our views only as of the date of this Quarterly Report and should not be relied upon as representing our views as of any subsequent date. These statements are based upon information available to us as of the date of this Quarterly Report and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
2
June 30, |
December 31, |
|||||||||||
Note |
2023 |
2022 |
||||||||||
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 |
|||||||||||
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, € of June 30, 2023 and December 31, 2022, respectively |
$ | $ | ||||||||||
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 June 30, |
Six Months Ended June 30, |
|||||||||||||||||||
Note |
2023 |
2022 |
2023 |
2022 |
||||||||||||||||
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 (expenses) |
||||||||||||||||||||
Loss before taxes |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Income tax |
( |
) | ( |
) | ( |
) | ||||||||||||||
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 share amounts: |
||||||||||||||||||||
Six Months Ended June 30, |
||||||||||||
Notes |
2023 |
2022 |
||||||||||
Net loss for the period |
$ |
( |
) |
$ |
( |
) | ||||||
Adjustments to reconcile net loss to net cash flow provided by (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 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 provided by (used in) operating activities |
( |
) |
( |
) | ||||||||
Cash flows provided by (used in) investing activities: |
||||||||||||
Acquisitions of property, plant, and equipment, net from proceeds |
( |
) | ( |
) | ||||||||
Proceeds from property, plant, and equipment dispositions |
||||||||||||
Acquisitions of non-current financial assets |
( |
) | ( |
) | ||||||||
Proceeds from non-current financial assets dispositions |
||||||||||||
Net cash flows provided by (used in) investing activities |
( |
) |
( |
) | ||||||||
Cash flows provided by (used in) 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 (used in) 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, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Other comprehensive income (loss) |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
Issuance of ordinary shares |
— | — | — | — | ||||||||||||||||||||||||||||
Treasury shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Other change in equity |
— | — | — | — | — | ( |
) | — | ||||||||||||||||||||||||
Balance at March 31, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Other comprehensive income (loss) |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
Issuance of ordinary shares |
— | — | — | — | ||||||||||||||||||||||||||||
Issuance of warrants |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Treasury shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Allocation of accumulated net losses |
— | — | ( |
) | — | — | — | — | ||||||||||||||||||||||||
Balance at June 30, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
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, 2023 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Other comprehensive income (loss) |
— | — | — | — | — | ( |
) | |||||||||||||||||||||||||
Issuance of ordinary shares |
( |
) | — | — | — | — | ||||||||||||||||||||||||||
Treasury shares |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Balance at March 31, 2023 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Other comprehensive income (loss) |
— | — | — | — | — | ( |
) | ( |
) | ( |
) | |||||||||||||||||||||
Issuance of ordinary shares |
— | — | — | — | ||||||||||||||||||||||||||||
Treasury shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Allocation of accumulated net losses |
— | — | ( |
) | — | — | — | — | ||||||||||||||||||||||||
Balance at June 30, 2023 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
| 1. | Identify a modified Viaskin patch (which the Company calls “mVP”). |
| 2. | Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible. |
| 3. | Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional Phase 1 clinical trials in healthy adult volunteers: |
| a. | PREQUAL, a Phase 1 study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL . The data collection phase of the trial is complete, and the data analysis phase is ongoing. |
| b. | ‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and mVP; |
June 30, |
December 31, |
|||||||
2023 |
2022 |
|||||||
Cash |
||||||||
Cash equivalents |
||||||||
Total cash and cash equivalents as reported in the statements of financial position |
||||||||
Bank overdrafts |
||||||||
Total cash and cash equivalents as reported in the statements of cash flows |
||||||||
June 30, 2023 |
December 31, 2022 |
|||||||
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, 2023 |
||||
+ Operating revenue |
||||
- Payment received |
||||
- Adjustment and currency translation effect |
||||
Closing research tax credit receivable as of June 30, 2023 |
||||
Of which - Non-current portion |
||||
Of which - Current portion |
||||
June 30, 2023 |
December 31, 2022 |
|||||||||||||||||||||||
Real estate |
Other assets |
Total |
Real estate |
Other assets |
Total |
|||||||||||||||||||
Current portion |
||||||||||||||||||||||||
Year 2 |
||||||||||||||||||||||||
Year 3 |
— | |||||||||||||||||||||||
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 |
% | % | % | % | ||||||||||||||||||||
June 30, |
||||||||
2023 |
2022 |
|||||||
Operating lease expense / (income) |
||||||||
Net termination impact |
( |
) | ( |
) | ||||
June 30, |
||||||||
2023 |
2022 |
|||||||
Cash paid for amounts included in the measurement of lease liabilities |
||||||||
Operating cash outflows related to operating leases |
||||||||
June 30, |
December 31, |
|||||||||||||||||||||||
2023 |
2022 |
|||||||||||||||||||||||
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 |
||||||||||||||||||||||||
Number of outstanding |
||||||||||||
BSA |
SO |
RSUs |
||||||||||
Balance as of December 31, 2022 |
||||||||||||
Granted during the period |
— | |||||||||||
Forfeited during the period |
— | ( |
) | ( |
) | |||||||
Exercised/released during the period |
— | — | ( |
) | ||||||||
Expired during the period |
— | — | — | |||||||||
Balance as of June 30, 2023 |
||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||||||||||
Research & development |
SO | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
| RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Sales & marketing |
SO | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
| RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
General & administrative |
SO | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
| RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Total share-based compensation (expense) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
June 30, |
December 31, |
|||||||
2023 |
2022 |
|||||||
Current contingencies |
||||||||
Non-current contingencies |
||||||||
Total contingencies |
||||||||
Pension retirement obligations |
Collaboration agreement - Loss at completion |
Other contingencies |
Total |
|||||||||||||
At January 1, 2023 |
— |
|||||||||||||||
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 June 30, 2023 |
||||||||||||||||
Of which Current |
— |
|||||||||||||||
Of which Non-current |
— |
|||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||||||
Research tax credit |
||||||||||||||||
Other operating income |
||||||||||||||||
Total |
||||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||||||
Research and Development expenses |
||||||||||||||||
Sales and Marketing expenses |
||||||||||||||||
General and Administrative expenses |
||||||||||||||||
Total personnel expenses |
||||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||||||
Wages and salaries |
||||||||||||||||
Social security contributions |
||||||||||||||||
Expenses for pension commitments |
||||||||||||||||
Employer contribution to bonus shares |
( |
) | ||||||||||||||
Share-based payments |
||||||||||||||||
Total |
||||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||||||
Non-employee warrants |
||||||||||||||||
Stock options |
||||||||||||||||
Restricted stock units |
||||||||||||||||
Prefunded warrants |
||||||||||||||||
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2022, included in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 2, 2023, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report.
Overview
We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy, or EPITTM, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, Viaskin targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved.
Our most advanced clinical program is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in nine clinical trials, including four Phase 2 trials and three completed Phase 3 trials. We recently completed a Phase 3 trial of Viaskin Peanut in children ages one to three with peanut allergy and we also have an ongoing Phase 3 trial of Viaskin Peanut in children ages four to seven with peanut allergy.
On March 7, 2023, the Company announced screening of the first patient in VITESSE. Screening of the last patient is anticipated in the first half in 2024 and topline results in the first half in 2025.
On April 19, 2023, the Company outlined the regulatory path for Viaskin Peanut in children 1-3 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use.
On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory efforts for VP in toddlers ages 1-3 years old with a confirmed peanut allergy.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report. Our significant accounting policies are more fully described in Note 1 of the Notes to the Consolidated Financial Statements in Part I, Item 1 of our Annual Report.
17
Business trends and Results of Operations
Comparison of the Three Months Ended June 30, 2023 and 2022
The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the three months ended June 30, 2023 and 2022.
| Three months ended June 30, | ||||||||||||||||
| 2023 | 2022 | $ change | % change | |||||||||||||
| Operating income |
$ | 2,288 | $ | 1,529 | 759 | 50 | % | |||||||||
| Operating expenses |
||||||||||||||||
| Research and development expenses |
(17,616 | ) | (18,611 | ) | 995 | (5 | )% | |||||||||
| Sales and marketing expenses |
(516 | ) | (1,037 | ) | 520 | (50 | )% | |||||||||
| General and administrative expenses |
(9,231 | ) | (5,704 | ) | (3,527 | ) | 62 | % | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Operating expenses |
(27,364 | ) | (25,352 | ) | (2,012 | ) | 8 | % | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Financial income (expenses) |
846 | 784 | 62 | 8 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Income tax |
(13 | ) | — | (13 | ) | — | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ | (24,243 | ) | $ | (23,039 | ) | (1,204 | ) | 5 | % | ||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Basic/diluted Net loss per share attributable to shareholders |
$ | (0.26 | ) | $ | (0.35 | ) | ||||||||||
Operating Income
The following table summarizes our operating income during the three months ended June 30, 2023 and 2022:
| Three months ended June 30, | ||||||||||||||||
| 2023 | 2022 | $ change | % change | |||||||||||||
| Sales |
— | — | — | — | ||||||||||||
| Other income |
2,288 | 1,529 | 759 | 50 | % | |||||||||||
| Research tax credit |
1,975 | 1,491 | 484 | 32 | % | |||||||||||
| Other operating income |
312 | 37 | 275 | 734 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating income |
2,288 | 1,529 | 759 | 50 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Our operating income is primarily generated from the French research tax credit (Crédit d’Impôt Recherche, or “CIR”), and revenues recognized as part of our collaboration agreement with Nestlé Health Science. We generated operating income of $2.3 million during the three months ended June 30, 2023 compared to $1.5 million during the three months ended June 30, 2022.
The increase in operating income was primarily due to the increase by $0.5 million in French research tax credit as the eligible employee-related costs increased to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.
In addition, other operating income increased by $0.3 million for the three months ended June 30, 2023, compared to the three months ended June 30, 2022, after we updated the measurement of progress of the Phase 2 clinical trial conducted as part of the Nestlé’s collaboration agreement.
Operating Expenses
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the three months ended June 30, 2023 and 2022:
18
| Three Months Ended June 30, | ||||||||||||||||
| Research and Development expenses | 2023 | 2022 | $ change | % change | ||||||||||||
| External clinical-related expenses |
11,421 | 11,664 | (243 | ) | (2 | )% | ||||||||||
| Employee-related costs (excl. share-based payments) |
3,278 | 2,622 | 656 | 25 | % | |||||||||||
| Share-based payment expenses |
736 | 475 | 261 | 55 | % | |||||||||||
| Depreciation, amortization and other costs |
2,181 | 3,850 | (1,669 | ) | (43 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Research and Development expenses |
17,616 | 18,611 | (995 | ) | 50 | % | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Research and Development expenses decreased by $1.0 million for the three months ended June 30, 2023, compared to the three months ended June 30, 2022, primarily due to the reversal of $1.1 million of the loss at completion recorded as other costs on the Phase 2 clinical trial conducted as part of the collaboration agreement with Nestlé. During the three months ended June 30, 2022, the loss at completion was impacted by additional clinical and production costs following increasing timing to achieve upcoming milestones. During the three months ended June 30, 2023, there were no changes to the timing to completion.
In addition external clinical expenses decreased by $0.2 million as a result of differences in phasing of on-going clinical trials between the three months ended June 30, 2022 and the three months ended June 30, 2023.
Decreases in impacts of the loss at completion and in external clinical-related expenses were partially offset by the increase by $0.7 million in employee-related costs (excl. share-based payments) to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.
Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended June 30, 2023 and 2022:
| Three Months Ended June 30, | ||||||||||||||||
| Sales and Marketing expenses | 2023 | 2022 | $ change | % change | ||||||||||||
| External professional services |
80 | 399 | (319 | ) | (80 | )% | ||||||||||
| Employee-related costs (excl. share-based payments) |
173 | 289 | (116 | ) | (40 | )% | ||||||||||
| Share-based payment expenses |
35 | 55 | (20 | ) | (36 | )% | ||||||||||
| Depreciation, amortization and other costs |
229 | 294 | (65 | ) | (22 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Sales and Marketing expenses |
516 | 1,037 | (520 | ) | (50 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Sales and marketing expenses decreased by $0.5 million for the three months ended June 30, 2023, compared to the three months ended June 30, 2022, due to a decrease of external professional services and employee-related costs.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the three months ended June 30, 2023 and 2022:
| Three Months Ended June 30, | ||||||||||||||||
| General and Administrative expenses | 2023 | 2022 | $ change | % change | ||||||||||||
| External professional services |
3,806 | 1,771 | 2,034 | 115 | % | |||||||||||
| Employee-related costs (excl. share-based payments) |
1,814 | 2,220 | (405 | ) | (18 | )% | ||||||||||
| Share-based payment expenses |
1,043 | 548 | 496 | 91 | % | |||||||||||
| Depreciation, amortization and other costs |
2,568 | 1,166 | 1,402 | 120 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total General and Administrative expenses |
9,231 | 5,704 | 3,527 | 62 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
General and Administrative expenses increased by $3.5 million for the three months ended June 30, 2023, compared to the three months ended June 30, 2022, mainly due to one-time costs associated with financing activities, organizational planning, market research and planning activities. In addition, we recorded a provision amounting to $0.7 million as of June 30, 2023, as our best estimate of costs to be incurred if the Montrouge office lease agreement is not renewed at its July 2024 terms.
19
Financial income (expense)
Our financial income was $0.8 million for the three months ended June 30, 2023, compared to a financial income of $0.8 million for the three months ended June 30, 2022. This item mainly includes the financial income on our financial assets.
Income tax
Our income tax expense was nil for the three months ended June 30, 2023 and June 30, 2022.
Net loss
Net loss was $24.2 million for the three months ended June 30, 2023, compared to $23 million for the three months ended June 30, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.26 and $0.35 for the three months ended June 30, 2023 and 2022, respectively.
Comparison of the Six Months Ended June 30, 2023 and 2022
The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the six months ended June 30, 2023 and 2022.
| Six months ended June 30, | ||||||||||||||||
| 2023 | 2022 | $ change | % change | |||||||||||||
| Operating income |
$ | 4,482 | $ | 4,074 | 407 | 10 | % | |||||||||
| Operating expenses |
||||||||||||||||
| Research and development expenses |
(33,653 | ) | (30,834 | ) | (2,819 | ) | 9 | % | ||||||||
| Sales and marketing expenses |
(950 | ) | (1,500 | ) | 551 | (37 | )% | |||||||||
| General and administrative expenses |
(16,120 | ) | (12,334 | ) | (3,786 | ) | 31 | % | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Operating expenses |
(50,723 | ) | (44,669 | ) | (6,054 | ) | 14 | % | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Financial income (expense) |
1,450 | 936 | 515 | 55 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Income tax |
(13 | ) | (87 | ) | 74 | (85 | )% | |||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ | (44,804 | ) | $ | (39,746 | ) | (5,058 | ) | 13 | % | ||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Basic/diluted Net loss per share attributable to shareholders |
$ | (0.48 | ) | $ | (0.66 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Operating Income
The following table summarizes our operating income during the six months ended June 30, 2023 and 2022:
| Six months ended June 30, | ||||||||||||||||
| 2023 | 2022 | $ change | % change | |||||||||||||
| Sales |
— | — | ||||||||||||||
| Other income |
4,482 | 4,074 | 407 | 10 | % | |||||||||||
| Research tax credit |
3,741 | 3,060 | 680 | 22 | % | |||||||||||
| Other operating income |
741 | 1,014 | (273 | ) | (27 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating income |
4,482 | 4,074 | 407 | 10 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Our operating income consisted of the French research tax credit (Crédit d’Impôt Recherche, or “CIR”), and revenues recognized as part of our collaboration agreement with Nestlé Health Science. We generated operating income of $4.5 million during the six months ended June 30, 2023 compared to $4.1 million during the six months ended June 30, 2022.
The increase in operating income was due to the increase by $0.7 million in the French research tax credit as both eligible employee-related costs and eligible external clinical-related expenses increased to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.
20
The increase in research tax credit was partially offset by the decrease by $0.3 million in other operating income for the six months ended June 30, 2023, compared to the six months ended June 30, 2022, after we updated the measurement of progress of the Phase 2 clinical trial conducted as part of the Nestlé’s collaboration agreement.
Operating Expenses
Research and Development Expenses
The following table summarizes our R&D expenses incurred during the six months ended June 30, 2023 and 2022:
| Six Months Ended June 30, | ||||||||||||||||
| Research and Development expenses | 2023 | 2022 | $ change | % change | ||||||||||||
| External clinical-related expenses |
21,892 | 19,014 | 2,878 | 15 | % | |||||||||||
| Employee-related costs (excl. share-based payments) |
6,598 | 5,114 | 1,484 | 29 | % | |||||||||||
| Share-based payment expenses |
1,423 | 1,058 | 365 | 34 | % | |||||||||||
| Depreciation, amortization and other costs |
3,741 | 5,648 | (1,908 | ) | (34 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Research and Development expenses |
33,653 | 30,834 | 2,819 | 9 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Research and Development expenses increased by $2.8 million for the six months ended June 30, 2023, compared to the six months ended June 30, 2022, primarily due to the increase by $2.9 million and by $1.5 million in external clinical-related expenses and in employee-related costs (excl. share-based payments) respectively, to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.
Increases in both external clinical-related expenses and employee-related costs were partially offset by the reversal of $1.1 million of the loss at completion recorded as other costs on the Phase 2 clinical trial conducted as part of the collaboration agreement with Nestlé. During the six months ended June 30, 2022, the loss at completion was impacted by additional clinical and production costs following increasing timing to achieve upcoming milestones. During the six months ended June 30, 2023, there were no changes to the timing to completion.
Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2023 and 2022:
| Six Months Ended June 30, | ||||||||||||||||
| Sales and Marketing expenses | 2023 | 2022 | $ change | % change | ||||||||||||
| External professional services |
348 | 521 | (173 | ) | (33 | )% | ||||||||||
| Employee-related costs (excl. share-based payments) |
303 | 539 | (237 | ) | (44 | )% | ||||||||||
| Share-based payment expenses |
70 | 49 | 21 | 41 | % | |||||||||||
| Depreciation, amortization and other costs |
229 | 391 | (162 | ) | (41 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Sales and Marketing expenses |
950 | 1,500 | (551 | ) | (37 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Sales and marketing expenses decreased by $ 0.6 million for the six months ended June 30, 2023, compared to the six months ended June 30, 2022, primarily due to a decrease of external professional services and employee-related costs.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2023 and 2022:
| Six Months Ended June 30, | ||||||||||||||||
| General and Administrative expenses | 2023 | 2022 | $ change | % change | ||||||||||||
| External professional services |
5,512 | 2,879 | 2,633 | 91 | % | |||||||||||
| Employee-related costs (excl. share-based payments) |
4,005 | 4,029 | (25 | ) | (1 | )% | ||||||||||
| Share-based payment expenses |
1,954 | 1,333 | 620 | 47 | % | |||||||||||
| Depreciation, amortization and other costs |
4,650 | 4,093 | 557 | 14 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total General and Administrative expenses |
16,120 | 12,334 | 3,786 | 31 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
21
General and Administrative expenses increased by $3.8 million for the six months ended June 30, 2023, compared to the six months ended June 30, 2022, mainly due to one-time costs associated with financing activities, organizational planning, market research and planning activities. In addition, we recorded a provision amounting to $0.7 million as of June 30, 2023, as our best estimate of costs to be incurred if the Montrouge office lease agreement is not renewed at its July 2024 terms.
Financial income (expense)
Our financial income was $1.5 million for the six months ended June 30, 2023, compared to a financial income of $0.9 million for the six months ended June 30, 2022. This item mainly includes financial income on our financial assets.
Income tax
Our income tax expense was nil for the six months ended June 30, 2023 and June 30, 2022.
Net loss
Net loss was $ 44.8 million for the six months ended June 30, 2023, compared to $39.7 million for the six months ended June 30, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.48 and $0.66 for the six months ended June 30, 2023 and 2022, respectively.
Liquidity and Capital Resources
Financial Condition
On June 30, 2023, we had $174 million in cash and cash equivalents compared to $209.2 million of cash and cash equivalents on December 31, 2022. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $ 46.4 million and $11.7 million for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, we recorded a net loss of $ 44.8 million. Our net cash flows provided by financing activities decreased to $7.8 million during the six months ended June 30, 2023 from $195.2 million during the six months ended June 30, 2022 due to more important financing operations in first semester of 2022 (May 2022 ATM and June 2022 PIPE) compared to 2023 (June 2023 ATM).
Our condensed consolidated financial statements have been prepared on a going concern basis assuming that based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents at closing date will be sufficient to fund our operations for at least the next 12 months. As such, no adjustments have been made to the condensed consolidated financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern.
Sources of Liquidity and Material Cash Requirements
We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt.
Payments associated with Research tax credits (Crédit d’Impôt Recherche) contribute to fund our short-term cash requirements. We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our 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.
In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company. The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached. The Company’s intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Peanut platform and for working capital and other general corporate purposes.
Pursuant to the ATM program, the Company issued and completed sales of new Ordinary Shares in the form of ADSs for a total gross amount of $15.3 million on May 4, 2022, and of $7.8 million on June 14, 2023. Respectively, 6,036,238 and 2,052,450 new Ordinary Shares in the form of ADSs were issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM issuance”), at a unit subscription price of $1.27 and $1.90 per ADS, each ADS giving the right to receive one-half of one ordinary share of the Company.
22
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all. If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.
Operating leases
Our corporate headquarters are located in Montrouge, France. Our principal offices occupy a 4,470 square meter facility, pursuant to a lease agreement dated March 3, 2015, and represents a $0.8 million cash requirement as of June 30, 2023 which expires July 31, 2024.
Our primary U.S. office is located in Basking Ridge, New Jersey. In March 2022, we entered into a lease agreement, commencing on April 1, 2022 and effective for 38 months, for an office of 5,799 square feet in Basking Ridge, New Jersey. The Basking Ridge office represent a $0.1 million cash requirement as of June 30, 2023 which expires June 1, 2025.
There have been no material changes in our operating leases from those disclosed in the Annual Report.
Purchase obligations - Obligations Under the Terms of CRO Agreements
In connection with the launch of our clinical trials for Viaskin Peanut and Viaskin Milk, we signed agreements with several contract research organizations.
There have been no material changes in our purchase obligations from those disclosed in the Annual Report.
Summary Statement of Cash Flows
The table below summarizes our sources and uses of cash for the six months ended June 30, 2023 and 2022.
| Six months ended June 30, | ||||||||||||||||
| (Amounts in thousands of U.S. Dollars) | 2023 | 2022 | $ change | % of change | ||||||||||||
| Net cash flow used in operating activities |
(46,394 | ) | (11,733 | ) | (34,661 | ) | 295 | % | ||||||||
| Net cash flow used in investing activities |
(299 | ) | (218 | ) | (80 | ) | 37 | % | ||||||||
| Net cash flow provided by financing activities |
7,793 | 195,222 | (187,429 | ) | (96 | )% | ||||||||||
| Effect of exchange rate changes on cash and cash equivalents |
3,668 | (12,600 | ) | 16,268 | (129 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net (decrease) increase in cash and cash equivalents |
(35,232 | ) | 170,670 | (205,903 | ) | (121 | )% | |||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Operating Activities
Our net cash flows used in operating activities were $46.4 million and $11.7 million during the six months ended June 30, 2023 and 2022, respectively. Our net cash flows used in operating activities increased by $ 34.7 million, mainly due to the repayment in 2022 of the research tax credit receivable relating to fiscal years 2019 to 2021 for €24.8 million (corresponding to $28.1 million on the basis of 2021 closing exchange rate). The increase is also explained by the change in trade payables during the six months period ended June 30, 2023 compared to the six months period ended June 30, 2022.
Investing Activities
Our net cash flows used in investing activities were $0.3 million and $0.2 million during the six months ended June 30, 2023 and 2022, respectively.
Financing Activities
Our net cash flows provided by financing activities was $ 7.8 million during the six months ended June 30, 2023 that consisted of the ATM in June 2023 compared to $195.2 million during the six months ended June 30, 2022, that consisted of the May 2022 ATM and the June 2022 PIPE.
23
Off-Balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements and do not have variable interests in variable interest entities.
Smaller Reporting Company Status
We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Based on its evaluation as of June 30, 2023, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitation on Effectiveness of Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error of fraud may occur and not be detected.
PART II – Other information
Item 1. Legal Proceedings
See “Note 2: Significant Events and Transactions – Legal Proceedings” in the notes to the condensed consolidated financial statements included elsewhere in this Report.
24
Item 1A. Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report. There have been no material changes in our risk factors from those disclosed in the Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
During the six months ended June 30, 2023, we issued the following unregistered securities:
| • | On March 23, 2023, the issuance of an aggregate of 10,174 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; |
| • | On May 19, 2023, the issuance of an aggregate of 2,500 ordinary shares to a non-U.S. employee upon settlement of RSUs; |
| • | On May 22, 2023, the issuance of an aggregate of 14,364 ordinary shares to non-U.S. employees upon settlement of RSUs; and |
| • | On May 24, 2023, the issuance of an aggregate of 34,321 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs. |
None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Regulation S promulgated under Section 5 of the Securities Act, as transactions by an issuer not involving any public offering or as offerings made to non-U.S. resident employees pursuant to an employee benefit plan established and administered in accordance with the law of a country other than the United States (namely, the Republic of France) and in accordance with that country’s practices and documentation. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Not applicable.
Item 6. Exhibits.
Exhibit Index
| Exhibit | Description |
Incorporated by Reference | ||||||||||||||||
| Schedule/ Form |
File Number |
Exhibit | File Date |
|||||||||||||||
| 3.1 | By-laws (statuts) of the registrant (English translation) | 10-Q | 001-36697 | 3.1 | 5/04/23 | |||||||||||||
| 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 | |||||||||||||||||
25
| Exhibit | Description |
Incorporated by Reference | ||||||||||||||||
| Schedule/ Form |
File Number |
Exhibit | File Date |
|||||||||||||||
| 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. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| DBV Technologies S.A. | ||||||
| (Registrant) | ||||||
| Date: July 31, 2023 | By: | /s/ Daniel Tassé | ||||
| Daniel Tassé | ||||||
| Chief Executive Officer | ||||||
| (Principal Executive Officer) | ||||||
| Date: July 31, 2023 | By: | /s/ Sébastien Robitaille | ||||
| Sébastien Robitaille | ||||||
| Chief Financial Officer | ||||||
| (Principal Financial and Accounting Officer) | ||||||
26
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 Tassé, 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: July 31, 2023
| /s/ Daniel Tassé |
| Daniel Tassé |
| 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: July 31, 2023
| /s/ Sébastien 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. 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 Tassé, 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 June 30, 2023, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) and 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: July 31, 2023
| /s/ Daniel Tassé |
/s/ Sébastien Robitaille | |||
| Daniel Tassé Chief Executive Officer (Principal Executive Officer) |
Sébastien Robitaille Chief Financial 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 |
Jun. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Treasury stock, common, shares | 149,972 | 149,793 |
| Common Shares [Member] | ||
| Common stock shares par value | € 0.1 | € 0.1 |
| Common stock shares authorized | 96,250,954 | 94,137,145 |
| Common stock shares issued | 96,250,954 | 94,137,145 |
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Operating income | $ 2,288 | $ 1,529 | $ 4,482 | $ 4,074 |
| Operating expenses | ||||
| Research and development expenses | (17,616) | (18,611) | (33,653) | (30,834) |
| Sales and marketing expenses | (516) | (1,037) | (950) | (1,500) |
| General and administrative expenses | (9,231) | (5,704) | (16,120) | (12,334) |
| Total Operating expenses | (27,364) | (25,352) | (50,723) | (44,669) |
| Loss from operations | (25,076) | (23,823) | (46,242) | (40,595) |
| Financial income(expenses) | 846 | 784 | 1,450 | 936 |
| Loss before taxes | (24,230) | (23,039) | (44,791) | (39,659) |
| Income tax | (13) | 0 | (13) | (87) |
| Net loss | (24,243) | (23,039) | (44,804) | (39,746) |
| Foreign currency translation differences, net of taxes | (221) | (11,394) | 3,445 | (13,327) |
| Actuarial gains (losses) on employee benefits, net of taxes | (10) | 200 | (92) | 224 |
| Total comprehensive loss | $ (24,475) | $ (34,234) | $ (41,452) | $ (52,849) |
| Basic net loss per share attributable to shareholders | $ (0.26) | $ (0.35) | $ (0.48) | $ (0.66) |
| Weighted average number of shares outstanding used in computing per share amounts: | 94,324,889 | 66,047,949 | 94,150,141 | 60,490,075 |
| Diluted net loss per share attributable to shareholders | $ (0.26) | $ (0.35) | $ (0.48) | $ (0.66) |
| Weighted average number of shares outstanding used in computing per share amounts: | 94,324,889 | 66,047,949 | 94,150,141 | 60,490,075 |
The Company |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| 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. 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 2, 2023 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2022 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, 2022. 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, 2023, 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 Accounting Pronouncements adopted in 2023 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. Adoption of this new standard did not have a material impact on the consolidated financial statements. In October 2021, the FASB issued ASU 2021-08, which amends ASC 805 to require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination. This amendment is effective for public business entities for the fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Adoption of this new standard has no impact on the consolidated financial statements. Accounting Pronouncements issued not yet adopted 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 |
6 Months Ended | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | ||||||||||||||||
| Significant Events And Transactions of the Period Disclsure [Abstract] | ||||||||||||||||
| Significant Events and Transactions | Note 2: Significant Events and Transactions Clinical programs United States Regulatory History and Current Status 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 receipt of the Complete Response Letter. The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches. Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:
In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches. The Company completed CHAMP in the second quarter of 2021. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape. In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and on October 14, 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study. The FDA’s explanation was that the results from the allergen uptake studies might affect the design of the STAMP study. After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback. The Company estimated that the FDA’s newly proposed sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the 6-month safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy is agreeable via oral and written exchanges. In 2022, the Company announced the new Phase 3 pivotal study for modified Viaskin Peanut (mVP) patch would be in younger (4-7 years old) and more sensitive children with peanut allergy. On September 7, 2022, the Company announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 years with peanut allergy. We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval. On September 21, 2022, the Company announced it received feedback from the U.S. FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and start-up activities for prompt study launch once the partial clinical hold was lifted. On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol. On March 2, 2023, the Company announced the completion of EVOLVE, a 12-week caregiver and patient user experience study of the mVP patch in 50 peanut allergic children ages 4–11-years old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the mVP patch. The study concluded that the updated IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the mVP patch. In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion scores. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated in the first half in 2024 and topline results in the first half in 2025. On April 19, 2023, the Company outlined the regulatory path for Viaskin Peanut in children 1-3 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use. Viaskin Peanut for children ages 4-11—European Union Regulatory History and Current Status On August 2, 2021, the Company announced it received from the European Medicines Agency (“EMA”) of the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study. On December 20, 2021, the Company announced it had withdrawn the Marketing Authorization Application (“MAA”) for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301). The decision to withdraw was based on the view of EMA Committee for Medicinal Products for Human Use (CHMP) that the data available to date from a single pivotal clinical trial were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believes data from a second Viaskin Peanut pivotal clinical trial will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intends to resubmit the MAA when that data set is available. Viaskin Peanut for children ages 1-3 In 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 2021. In June 2022, the Company announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms respectively. Enrollment was balance for age and baseline disease characteristics between the active and placebo treatment arms. On April 19, 2023, the Company announced it will begin a new safety study after it received confirmation from the FDA that the EPITOPE study meets the pre-specified On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory efforts for VP in toddlers ages 1-3 years old with a confirmed peanut allergy. Viaskin Peanut for Children ages 4-7 On September 7, 2022, the Company announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 years with peanut allergy. We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval. On September 21, 2022, the Company announced we had received feedback from the FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and start-up activities for prompt study launch once the partial clinical hold was lifted. On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE trial. Screening of the last patient is anticipated in the first half in 2024 and topline results in the first half in 2025. Financing In June 2023, the Company issued and completed sales of new ordinary shares (the “Ordinary Shares”) in the form of American Depositary Shares (“ADSs”), for a total gross amount of $7.8 million, under the At-The-Market the form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.90 dollar per ADS (i.e., a subscription price per Ordinary Share of 3.52 euro based on the USD/EUR exchange rate of 1.0809 dollar for 1 euro, as published by the European Central Bank on June 14, 2023) and each ADS giving the right to receive one-half of one ordinary share of the Company. Legal Proceedings From time to time, the Company may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The Company is not currently subject to any material legal proceedings. |
Cash and Cash Equivalents |
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| 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 June 30, 2023 and December 31, 2022:
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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Other Current Assets |
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| Other Current Assets | Note 4 Other Current Assets Other current assets consisted of the following:
Research tax credit The variance in Research Tax Credit is presented as follows:
Before currency translation effect, the balance in research tax credit as of June 30, 2023, consisted of $5.8 million research tax credit for the 2022 fiscal year filed with the tax authorities and yet to be reimbursed, and $3.7 million estimated research tax credit for the first six months of the 2023 fiscal year. The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies. |
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Lease contracts |
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| Lessee Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lease contracts | Note 5 Lease contracts Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2023 and December 31, 2022, are as follows:
The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was:
Supplemental cash flow information related to operating leases is as follows for the period June 30, 2023 and 2022:
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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 6: Trade Payables and Other Current Liabilities 6.1 Trade Payables Trade payables increased by $4.6 million as of June 30, 2023, compared to December 31, 2022. 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 period presented. 6.2 Other Liabilities The following tables summarize the other liabilities as of June 30, 2023 and December 31, 2022:
The Employee related liabilities include short-term debt to employees including social welfare and tax agency obligations. Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science.
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Shareholders' equity |
6 Months Ended |
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Jun. 30, 2023 | |
| Stockholders' Equity Note [Abstract] | |
| Shareholders' equity | Note 7: Shareholders’ equity The share capital as of June 30, 2023 is set at the sum of €9,625,095.40 ($10,952 thousands converted at historical rates). It is divided into 96,250,954 fully authorized, subscribed and paid-up ordinary shares with a par value of €0.10. Pursuant to the authorization granted by the General Meeting of the Shareholders held on April 12, 2023 (the “SH General Meeting”), the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2022, have been allocated to additional
paid-in capital. |
Share-Based Payments |
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| Share-based Payment Arrangement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-Based Payments | Note 8: 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 plan (“SO”), and non-employee warrants (Bons de Souscription d’Actions During the six months ended June 30, 2023, the Company granted 59,200 stock options and 35,800 restricted stock units to employees. There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report. Change in Number of BSA/SO/RSU:
Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:
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| Loss Contingency [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Contingencies | Note 9: Contingencies The following tables summarize the contingencies as of June 30, 2023 and December 31, 2022:
The changes in contingencies are as follows:
The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 13 to the consolidated financial statements included in the Annual Report. In 2022 and during the first six months of 2023, the Company updated its measurement of progress of the Phase 2 clinical trial (“PII”) conducted as part of the collaboration and license agreement with Nestlé Health Sciences and updated the cumulative income recognized. The Company recognized a reversal of $1.1 million of the loss for completion recorded in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and income yet to be recognized for the completion of the PII. The other contingencies mainly consisted of a provision for refurbishment amounting to the best estimate of costs to be incurred in case the Montrouge office lease agreement is not renewed at its July 2024 term. |
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| Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Operating Income | Note 10: Operating income The following table summarizes the operating income during the three and six months ended June 30, 2023 and 2022:
The increase in operating income was primarily due to the increase in the research and development costs eligible to research tax credit in France. The Company recognizes as other operating income accrued revenues based on its updated measurement of progress of the Phase 2 clinical trial conducted as part of the collaboration agreement with Nestlé. Moreover, the loss for completion 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 2 clinical trial was updated accordingly as of June 30, 2023 (see note 9 related to contingencies). |
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Allocation of Personnel Expenses |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Operating Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Allocation of Personnel Expenses | Note 11: Allocation of Personnel Expenses The Company had an average of 88 employees during the six months ended June 30, 2023, in comparison with an average of 87 employees during the six months ended June 30, 2022. The following table summarizes the allocation of personnel expenses by function during the three and six months ended June 30, 2023 and 2022:
The following table summarizes the allocation of personnel expenses by nature during the three and six months ended June 30, 2023 and 2022:
The increase in personnel expenses was mainly due to recruitment of US employees partially offset by the departure of
non-US employees, and the increase of charges related to share-base payments. |
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Commitments |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Commitments | Note 12: Commitments There were no significant changes in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report.
|
Relationships with Related Parties |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| Related Party Transactions [Abstract] | |
| Relationships with Related Parties | Note 13: Relationships with Related Parties The Company’s related parties exclusively consisted of the members of the Board of Directors and the members of the Executive Committee. As of June 30, 2023, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not significantly changed since December 31, 2022. There were no new significant related-party transactions during the period nor any changes in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report.
|
Loss Per Share |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Loss Per Share | Note 14: 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 six-month periods ended June 30, 2023 and 2022, 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 following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three and six months ended June 30, 2023 and 2022 indicated in number of potential shares:
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Events After the Close of the Period |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| Subsequent Events [Abstract] | |
| Events After the Close of the Period | Note 15: Events after the Close of the Period The Company evaluated subsequent events that occurred after June 30, 2023, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on July 28, 2023, and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.
|
The Company (Policies) |
6 Months Ended |
|---|---|
Jun. 30, 2023 | |
| 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. 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 2, 2023 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2022 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, 2022. 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, 2023, 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 |
| Accounting Pronouncements adopted in 2023 | Accounting Pronouncements adopted in 2023 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. Adoption of this new standard did not have a material impact on the consolidated financial statements. In October 2021, the FASB issued ASU 2021-08, which amends ASC 805 to require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination. This amendment is effective for public business entities for the fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Adoption of this new standard has no impact on the consolidated financial statements. |
| Accounting Pronouncements issued not yet adopted | Accounting Pronouncements issued not yet adopted 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.
|
Cash and Cash Equivalents (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash and Cash Equivalents [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash and Cash Equivalents | The following tables summarize the cash and cash equivalents as of June 30, 2023 and December 31, 2022:
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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Other Current Assets (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Current Assets [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Other Current Asset | Other current assets consisted of the following:
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| Summary of Research Tax Credit | The variance in Research Tax Credit is presented as follows:
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Lease contracts (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lessee Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Operating Leases Future Minimum Payments Receivable | Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2023 and December 31, 2022, are as follows:
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| Summary of Rent expenses | Rent expense presented in the consolidated statement of operations and comprehensive loss was:
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| Summary of Supplemental cash flow information related to our operating leases | Supplemental cash flow information related to operating leases is as follows for the period June 30, 2023 and 2022:
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Trade Payables and Other Current Liabilities (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Liabilities, Current [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Other Liabilities | The following tables summarize the other liabilities as of June 30, 2023 and December 31, 2022:
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Share-Based Payments (Tables) |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of RSU Activity | Change in Number of BSA/SO/RSU:
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| Summary of Share-Based Payments Expenses | Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:
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Contingencies (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Loss Contingency [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Current Contingencies and Non-current Contingencies | The following tables summarize the contingencies as of June 30, 2023 and December 31, 2022:
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| Summary of Movement in Provisions | The changes in contingencies are as follows:
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Operating Income (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of operating income | The following table summarizes the operating income during the three and six months ended June 30, 2023 and 2022:
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Allocation of Personnel Expenses (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 six months ended June 30, 2023 and 2022:
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| Summary of Allocation of Personnel Expenses By Nature | The following table summarizes the allocation of personnel expenses by nature during the three and six months ended June 30, 2023 and 2022:
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Loss Per Share (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Earnings Per Share, Basic [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three and six months ended June 30, 2023 and 2022 indicated in number of potential shares:
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Cash and Cash Equivalents - Summary of breakdown of cash and cash equivalents (Detail) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Cash and Cash Equivalents, at Carrying Value [Abstract] | ||
| Cash | $ 24,111 | $ 30,104 |
| Cash equivalents | 149,850 | 179,090 |
| Total cash and cash equivalents as reported in the statements of financial position | 173,961 | 209,194 |
| Bank overdrafts | 0 | 0 |
| Total cash and cash equivalents as reported in the statements of cash flows | $ 173,961 | $ 209,194 |
Other Current Assets - Summary of Other Current Asset (Detail) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Other Assets [Abstract] | ||
| Research tax credit | $ 9,662 | $ 5,792 |
| Other tax claims | 5,851 | 3,903 |
| Prepaid expenses | 4,494 | 2,680 |
| Other receivables | 1,571 | 1,504 |
| Total | $ 21,578 | $ 13,880 |
Other Current Assets - Summary Of Research Tax Credit (Detail) $ in Thousands |
6 Months Ended |
|---|---|
|
Jun. 30, 2023
USD ($)
| |
| Tax Credit Carryforward [Line Items] | |
| Opening balance | $ 5,792 |
| + Operating revenue | 3,741 |
| - Payment received | 0 |
| - Adjustment and currency translation effect | 130 |
| Closing balance | 9,662 |
| Of which - Non-current portion | 0 |
| Of which - Current portion | $ 9,662 |
Other Current Assets - Additional Information (Detail) - USD ($) $ in Millions |
6 Months Ended | 12 Months Ended |
|---|---|---|
Jun. 30, 2023 |
Dec. 31, 2022 |
|
| Research Tax Credit Carryforward [Member] | ||
| Other Current Assets [Line Items] | ||
| Tax credit carryforward amount before currency translation | $ 3.7 | $ 5.8 |
Lease contracts - Summary of Rent expenses (Detail) - Rent Expenses [Member] - USD ($) $ in Thousands |
6 Months Ended | |
|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Operating lease expense / (income) | $ 1,543 | $ 950 |
| Net termination impact | $ (920) | $ (1,657) |
Lease contracts - Summary of Supplemental cash flow information related to our operating leases (Detail) - USD ($) $ in Thousands |
6 Months Ended | |
|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Cash Flow, Operating Activities, Lessee [Abstract] | ||
| Operating cash outflows related to operating leases | $ 963 | $ 1,079 |
Trade Payables and Other Current Liabilities - Summary of Other Liabilities by Nature (Detail) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Other current liabilities | $ 7,258 | $ 9,210 |
| Other non-current liabilities | 3,987 | 4,735 |
| Total | 11,245 | 13,945 |
| Employee Related Liabilities [Member] | ||
| Other current liabilities | 4,374 | 5,872 |
| Other non-current liabilities | 0 | 45 |
| Total | 4,374 | 5,917 |
| Deferred Incomes [Member] | ||
| Other current liabilities | 2,264 | 2,137 |
| Other non-current liabilities | 3,987 | 4,690 |
| Total | 6,251 | 6,828 |
| Tax Liabilities [Member] | ||
| Other current liabilities | 187 | 69 |
| Other non-current liabilities | 0 | 0 |
| Total | 187 | 69 |
| Other Debts [Member] | ||
| Other current liabilities | 433 | 1,131 |
| Other non-current liabilities | 0 | 0 |
| Total | $ 433 | $ 1,131 |
Trade Payables and Other Current Liabilities - Additional Information (Detail) - USD ($) $ in Thousands |
6 Months Ended | |
|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Increase decrease in trade payables current | $ 3,419 | $ 5,894 |
| Increase in Current Trade Payables [Member] | ||
| Increase decrease in trade payables current | $ 4,600 | |
Shareholders' equity - Additional Information (Detail) € / shares in Units, $ in Thousands |
Jun. 30, 2023
USD ($)
shares
|
Jun. 30, 2023
EUR (€)
€ / shares
shares
|
Mar. 31, 2023
USD ($)
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Dec. 31, 2022
USD ($)
|
Jun. 30, 2022
USD ($)
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Mar. 31, 2022
USD ($)
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Dec. 31, 2021
USD ($)
|
|---|---|---|---|---|---|---|---|
| Class of Stock [Line Items] | |||||||
| Share capital | $ | $ 164,240 | $ 179,094 | $ 194,453 | $ 244,416 | $ 82,062 | $ 99,274 | |
| Share Capital [Member] | |||||||
| Class of Stock [Line Items] | |||||||
| Share capital authorized | shares | 96,250,954 | 96,250,954 | |||||
| Nominal value | € / shares | € 0.1 | ||||||
| Share capital | $ 10,952 | € 9,625,095.4 |
Share-Based Payments - Additional Information (Detail) |
6 Months Ended |
|---|---|
|
Jun. 30, 2023
shares
| |
| Share options [Member] | |
| Share-Based Payments [Line iteam] | |
| Number of stock options outstanding, Granted during the period | 59,200 |
| Restricted Stock Units [Member] | |
| Share-Based Payments [Line iteam] | |
| Number of RSU outstanding, Granted during the period | 35,800 |
Contingencies - Summary of Current Contingencies and Non-current Contingencies (Detail) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Liability, Defined Benefit Plan [Abstract] | ||
| Current contingencies | $ 5,076 | $ 3,944 |
| Non-current contingencies | 15,731 | 16,680 |
| Total contingencies | $ 20,807 | $ 20,625 |
Contingencies - Additional Information (Detail) $ in Thousands |
6 Months Ended |
|---|---|
|
Jun. 30, 2023
USD ($)
| |
| Loss contingency reversal amount | $ (1,083) |
| Collaboration And License Agreement [Member] | |
| Loss contingency reversal amount | $ 1,100 |
Operating Income - Summary of Operating Income (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Other Income and Expenses [Abstract] | ||||
| Research tax credit | $ 1,975 | $ 1,491 | $ 3,741 | $ 3,060 |
| Other operating income | 312 | 37 | 741 | 1,014 |
| Total | $ 2,288 | $ 1,529 | $ 4,482 | $ 4,074 |
Allocation of Personnel Expenses - Summary of Allocation of Personnel Expenses By Function (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Research and Development expenses | $ 17,616 | $ 18,611 | $ 33,653 | $ 30,834 |
| Sales and Marketing expenses | 516 | 1,037 | 950 | 1,500 |
| General and Administrative expenses | 9,231 | 5,704 | 16,120 | 12,334 |
| Total Operating expenses | 27,364 | 25,352 | 50,723 | 44,669 |
| Expenses by Function [Member] | ||||
| Research and Development expenses | 4,014 | 3,097 | 8,020 | 6,172 |
| Sales and Marketing expenses | 208 | 344 | 373 | 589 |
| General and Administrative expenses | 2,858 | 2,767 | 5,958 | 5,362 |
| Total Operating expenses | $ 7,079 | $ 6,208 | $ 14,351 | $ 12,123 |
Allocation of Personnel Expenses -Summary of Allocation of Personnel Expenses By Nature (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Share-based payments | $ (1,814) | $ (1,078) | $ (3,446) | $ (2,441) |
| Total Operating expenses | 27,364 | 25,352 | 50,723 | 44,669 |
| Expenses by Nature [Member] | ||||
| Wages and salaries | 4,078 | 3,509 | 8,516 | 7,497 |
| Social security contributions | 1,185 | 1,256 | 1,884 | 1,507 |
| Expenses for pension commitments | 246 | 211 | 504 | 509 |
| Employer contribution to bonus shares | (244) | 154 | 0 | 170 |
| Share-based payments | 1,814 | 1,078 | 3,446 | 2,441 |
| Total Operating expenses | $ 7,079 | $ 6,208 | $ 14,351 | $ 12,123 |
Commitments - Additional Information (Detail) |
6 Months Ended |
|---|---|
|
Jun. 30, 2023
USD ($)
| |
| Disclosure Of Commitments [Line Items] | |
| Increase (decrease) in other commitments during the period | $ 0 |
Relationships with Related Parties - Additional Information (Detail) $ in Thousands |
6 Months Ended |
|---|---|
|
Jun. 30, 2023
USD ($)
| |
| Related Party Transactions [Abstract] | |
| Increase decrease in related party transactions and changes in nature of the transactions | $ 0 |