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.) | |
N/A | ||
(Address of principal executive offices) |
(Zip Code) | |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
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 Viaskin Peanut to the U.S. Food and Drug Administration, or the FDA; |
| • | the timing and anticipated results of interactions with regulatory agencies; |
| • | the design, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs; |
| • | 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 funding; |
| • | our financial performance; |
| • | developments relating to our competitors and our industry, including competing therapies; and |
| • | other risks and uncertainties, including those listed under the caption “Risk Factors.” |
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, 2023, filed with the Securities and Exchange Commission, or the SEC, on March 7, 2024. 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.
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.
1
Note |
June 30, 2024 |
December 31, 2023 |
||||||||||
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, € |
||||||||||||
Additional paid-in capital |
||||||||||||
Treasury stock |
( |
) | ( |
) | ||||||||
Accumulated deficit |
( |
) | ( |
) | ||||||||
Accumulated other comprehensive income |
||||||||||||
Accumulated currency translation effect |
( |
) | ( |
) | ||||||||
Total Shareholders’ equity |
7 |
|||||||||||
Total Liabilities and Shareholder’s equity |
||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||||||
Note |
2024 |
2023 |
2024 |
2023 |
||||||||||||||||
Operating income |
10 |
|||||||||||||||||||
Operating expenses |
11 |
|||||||||||||||||||
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 (expense) |
( |
) | ( |
) | ( |
) | ||||||||||||||
Net loss |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Foreign currency translation differences, net of taxes |
( |
) | ( |
) | ( |
) | ||||||||||||||
Actuarial gains (losses) on employee benefits, net of taxes |
( |
) | ( |
) | ||||||||||||||||
Total comprehensive loss |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Basic/diluted Net loss per share attributable to shareholders |
14 |
( |
) |
( |
) |
( |
) |
( |
) | |||||||||||
Weighted average shares outstanding used in computing per share amounts: |
||||||||||||||||||||
Six Months Ended June 30, |
||||||||||||
Notes |
2024 |
2023 |
||||||||||
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 |
( |
) | ( |
) | ||||||||
Proceeds from property, plant, and equipment dispositions |
||||||||||||
Acquisitions of non-current financial assets |
( |
) | ||||||||||
Proceeds of non-current financial assets dispositions |
||||||||||||
Net cash flows provided by (used in) investing activities |
( |
) |
( |
) | ||||||||
Cash flows provided by (used in) financing activities : |
||||||||||||
(Decrease) increase in conditional advances |
||||||||||||
Treasury shares |
( |
) | ||||||||||
Capital increases, net of transaction costs |
||||||||||||
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, 2023 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||
Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Other comprehensive income (loss) |
— | — | — | — | — | ( |
) | |||||||||||||||||||||||||
Issuance of ordinary shares |
( |
) | — | — | — | — | ||||||||||||||||||||||||||
Treasury shares |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Other change in equity |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||
Balance at March 31, 2023 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||
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, 2023 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||
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, 2024 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||
Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Other comprehensive income (loss) |
— | — | — | — | — | ( |
) | ( |
) | ( |
) | |||||||||||||||||||||
Issuance of ordinary shares |
— | — | — | — | ||||||||||||||||||||||||||||
Treasury shares |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Balance at March 31, 2024 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||
Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Other comprehensive income (loss) |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
Issuance of ordinary shares |
( |
) | — | — | — | — | ||||||||||||||||||||||||||
Treasury shares |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Allocation of accumulated net losses |
— | — | ( |
) | — | — | — | — | ||||||||||||||||||||||||
Balance at June 30, 2024 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||
June 30, |
December 31, |
|||||||
2024 |
2023 |
|||||||
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, 2024 |
December 31, 2023 |
|||||||
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, 2024 |
||||
+ Operating income |
||||
- Payment received |
||||
- Adjustment and currency translation effect |
( |
) | ||
Closing research tax credit receivable as of June 30, 2024 |
||||
Of which - Non-current portion |
||||
Of which - Current portion |
||||
June 30, 2024 |
December 31, 2023 |
|||||||||||||||||||||||
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 lease liabilities |
||||||||||||||||||||||||
Less: current portion |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Long-term lease liabilities |
||||||||||||||||||||||||
Weighted average remaining lease term (years) |
||||||||||||||||||||||||
Weighted average discount rate |
% | % | % | % | ||||||||||||||||||||
June 30, |
||||||||
2024 |
2023 |
|||||||
Operating lease expense / (income) |
||||||||
Net termination impact |
( |
) | ( |
) | ||||
Net restructuring impact |
||||||||
June 30, |
||||||||
2024 |
2023 |
|||||||
Cash paid for amounts included in the measurement of lease liabilities |
— | — | ||||||
Operating cash flows from operating leases |
||||||||
June 30, |
December 31, |
|||||||||||||||||||||||
2024 |
2023 |
|||||||||||||||||||||||
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, 2023 |
||||||||||||
Granted during the period |
— | |||||||||||
Forfeited during the period |
— | ( |
) | ( |
) | |||||||
Exercised/released during the period |
— | — | ( |
) | ||||||||
Expired during the period |
— | — | — | |||||||||
Balance as of June 30, 2024 |
||||||||||||
Three Months Ended March 31, |
Six Months Ended June 30, |
|||||||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||||||
Research & development |
SO | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
| RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Sales & marketing |
SO | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
| RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
General & administrative |
SO | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
| RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Total share-based compensation (expense) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
June 30, |
December 31, |
|||||||
2024 |
2023 |
|||||||
Current contingencies |
||||||||
Non-current contingencies |
||||||||
Total contingencies |
||||||||
Pension retirement obligations |
Collaboration agreement |
Other contingencies |
Total |
|||||||||||||
At January 1, 2024 |
||||||||||||||||
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, 2024 |
||||||||||||||||
Of which current |
||||||||||||||||
Of which non-current |
||||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Research tax credit |
||||||||||||||||
Other operating income |
||||||||||||||||
Total |
||||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Research and Development expenses |
||||||||||||||||
Sales & Marketing expenses |
||||||||||||||||
General & Administrative expenses |
||||||||||||||||
Total personnel expenses |
||||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
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, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
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, 2023, included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 7, 2024, 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 EPIT, 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 specialized antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen that accumulates in the outer layer of the skin, and then migrate to the skin-draining lymph nodes 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 product candidate is Viaskin Peanut, evaluated as a potential immunotherapy for children with peanut allergy in eleven clinical trials, including four Phase 2 trials and four completed Phase 3 trials. We are advancing two separate Viaskin Peanut product candidates in parallel to support two potential Biologics License Applications (BLAs) in two distinct age groups: one in toddlers ages one through three with the original (square) patch, and one in children ages four through seven with the modified (circular) patch.
Currently, we have an ongoing Phase 3 efficacy and safety trial (VITESSE) to evaluate the modified Viaskin Peanut patch in children ages four through seven with peanut allergy. Screening of the last subject is anticipated by the end of the third quarter of 2024 with topline results anticipated in the third quarter of 2025. We also have an ongoing Phase 3 open-label extension to the EPITOPE trial (our completed Phase 3 efficacy and safety trial conducted in peanut-allergic toddlers which met its clinical endpoints), with 3-year results anticipated later this year, as well as two planned Phase 3 supplementary safety studies, one in peanut-allergic children ages four through seven, and one in peanut-allergic toddlers, ages one through three The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to the FDA on November 9, 2023. The Company received comments and queries to the protocol from the FDA on March 11, 2024. Since March, the Company and the FDA have been engaged in ongoing dialogue related to the program. Much of the ongoing dialogue has focused on patch wear-time experience. To address the FDA’s protocol queries, the Company submitted to the FDA on June 28, 2024, a proposed labeling approach, informed by the EPITOPE efficacy data. The proposed labeling approach focuses on the user experience during the first 90 days on treatment. The Company is awaiting feedback on the labeling proposal following FDA review.
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.
15
Business trends and Results of Operations
Comparison of the Three Months Ended June 30, 2024 and 2023
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, 2024 and 2023.
| Three months ended June 30, | ||||||||||||||||
| 2024 | 2023 | $ change | % of change | |||||||||||||
| Operating income |
1,161 | 2,288 | (1,126 | ) | (49.2 | )% | ||||||||||
| Operating expenses |
||||||||||||||||
| Research and development expenses |
(25,374 | ) | (17,616 | ) | (7,758 | ) | 44.0 | % | ||||||||
| Sales and marketing expenses |
(986 | ) | (516 | ) | (470 | ) | 91.0 | % | ||||||||
| General and administrative expenses |
(8,643 | ) | (9,231 | ) | 588 | (6.4 | )% | |||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Operating expenses |
(35,003 | ) | (27,364 | ) | (7,639 | ) | 27.9 | % | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Financial income (expense) |
726 | 846 | (120 | ) | (14.2 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Income tax |
— | (13 | ) | 13 | (100.0 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss |
(33,116 | ) | (24,243 | ) | (8,873 | ) | 36.6 | % | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Basic/diluted Net loss per share attributable to shareholders |
(0.34 | ) | (0.26 | ) | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Operating Income
The following table summarizes our operating income during the three months ended June 30, 2024 and 2023:
| Three months ended June 30, | ||||||||||||||||
| 2024 | 2023 | $ change | % of change | |||||||||||||
| Sales |
— | — | — | — | % | |||||||||||
| Other income |
1,161 | 2,288 | (1,126 | ) | (49.2 | )% | ||||||||||
| Research tax credit |
1,161 | 1,975 | (814 | ) | (41.2 | )% | ||||||||||
| Other operating income |
— | 312 | (312 | ) | (100.0 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating income |
1,161 | 2,288 | (1,126 | ) | (49.2 | )% | ||||||||||
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|
|
|
|
|
|
|
|||||||||
Until the end of 2023, our operating income was composed of both the French research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC. Following the termination of the Collaboration Agreement on October 30, 2023, our operating income is now exclusively generated by the French research tax credit which explains why Other operating income was nil for the three months ended June 30, 2024 compared to $.3 million for the three months ended June 30, 2023.
Research tax credit decreased by $0.8 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023 primarily due to a greater proportion of studies activities carried out in North America and therefore not eligible to the French Research tax credit.
Operating Expenses
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the three months ended June 30, 2024 and 2023:
| Three months ended June 30 | ||||||||||||||||
| Research and Development expenses | 2024 | 2023 | $ change | % of change | ||||||||||||
| External clinical-related expenses |
18,466 | 11,421 | 7,045 | 61.7 | % | |||||||||||
| Employee-related costs |
4,481 | 3,278 | 1,203 | 36.7 | % | |||||||||||
| Share-based payment expenses |
696 | 736 | (40 | ) | (5.4 | )% | ||||||||||
| Depreciation, amortization and other costs |
1,731 | 2,181 | (450 | ) | (20.6 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Research and Development expenses |
25,374 | 17,616 | 7,758 | 44.0 | % | |||||||||||
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|
|
|
|
|
|||||||||
16
Research and Development expenses increased by $7.8 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023, due to an increase in external clinical-related expenses by $7.0 million, reflecting the progress on patient enrollment in VITESSE Phase 3 clinical trial after the initiation of the study with the first patient screened in March 2023 and the preparatory activities for the COMFORT studies in preparation for and anticipation of initiation after FDA alignment.
Employee-related costs, excluding share-based payments, increased by $1.2 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023 due to the recruitment of 17 internal resources in Medical, Quality and Regulatory Affairs mostly based in the U.S.
Depreciation, amortization and other costs decreased by $0.5 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023, due to no longer requiring onerous contract provisioning following the termination of the Collaboration Agreement with NESTEC.
Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended June 30, 2024 and 2023:
| Three Months Ended June 30, | ||||||||||||||||
| Sales & Marketing expenses | 2024 | 2023 | $ change | % of change | ||||||||||||
| Personnel expenses (incl.share-based payment expenses) |
253 | 208 | 46 | 22.1 | % | |||||||||||
| External professional services and other costs |
375 | 80 | 295 | 370.1 | % | |||||||||||
| Depreciation, amortization and other costs |
358 | 229 | 129 | 56.2 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Sales & Marketing expenses |
986 | 516 | 470 | 91.0 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Sales and marketing expenses have increased by $0.5 million during the three months ended June 30, 2024, compared to the three months ended June 30, 2023 to support pre-commercialization activities for Viaskin Peanut in North America.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the three months ended June 30, 2024 and 2023:
| Three Months Ended June 30, | ||||||||||||||||
| General & Administrative expenses | 2024 | 2023 | $ change | % of change | ||||||||||||
| External professional services |
3,162 | 3,806 | (644 | ) | -16.9 | % | ||||||||||
| Employee-related costs |
2,614 | 1,814 | 800 | 44.1 | % | |||||||||||
| Share-based payment expenses |
799 | 1,043 | (244 | ) | -23.4 | % | ||||||||||
| Depreciation, amortization and other costs |
2,067 | 2,568 | (500 | ) | -19.5 | % | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total General & Administrative expenses |
8,643 | 9,231 | (588 | ) | -6.4 | % | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
General and Administrative expenses decreased by $0.6 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023 as a result of (1) an optimization and rationalization of external professional services and (2) the decrease of depreciation, amortization and other costs primarily explained by the provision reversal on the Montrouge office revamping following the non-renewal of the related lease agreement.
These were partially offset by an increase of $0.8 million in employee-related costs (excluding share-based payment) related to the hiring of 7 internal resources to support recruitment, project management, information solutions and legal and intellectual property activities.
Financial income (expense)
Our financial income was $0.7 million for the three months ended June 30, 2024, compared to a financial income of $0.8 million for the three months ended June 30, 2023. This item mainly includes the financial income on our financial assets and foreign exchange result.
Income tax
Our income tax expense was nil for the three months ended June 30, 2024 compared to $13 thousand for the three months ended June 30, 2023.
17
Net loss
Net loss was $33.1 million for the three months ended June 30, 2024, compared to $24.2 million for the three months ended June 30, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.34 and $0.26 for the three months ended June 30, 2024 and 2023, respectively.
Comparison of the Six Months Ended June 30, 2024 and 2023
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, 2024 and 2023.
| Six Months Ended June 30, | ||||||||||||||||
| 2024 | 2023 | $ change | % of change | |||||||||||||
| Operating income |
2,568 | 4,482 | (1,914 | ) | (42.7 | )% | ||||||||||
| Operating expenses |
||||||||||||||||
| Research and development expenses |
(46,777 | ) | (33,653 | ) | (13,123 | ) | 39.0 | % | ||||||||
| Sales and marketing expenses |
(1,744 | ) | (950 | ) | (794 | ) | 83.6 | % | ||||||||
| General and administrative expenses |
(16,447 | ) | (16,120 | ) | (327 | ) | 2.0 | % | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Operating expenses |
(64,968 | ) | (50,723 | ) | (14,244 | ) | 28.1 | % | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Financial income |
1,986 | 1,450 | 536 | 37.0 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Income tax |
(48 | ) | (13 | ) | (35 | ) | 273.6 | % | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss |
(60,461 | ) | (44,804 | ) | (15,657 | ) | 34.9 | % | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Basic/diluted Net loss per share attributable to shareholders |
(0.63 | ) | (0.48 | ) | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Operating Income
The following table summarizes our operating income during the six months ended June 30, 2024 and 2023:
| Six Months Ended June 30, | ||||||||||||||||
| 2024 | 2023 | $ change | % of change | |||||||||||||
| Sales |
— | — | — | — | % | |||||||||||
| Other income |
2,568 | 4,482 | (1,914 | ) | (43 | )% | ||||||||||
| Research tax credit |
2,568 | 3,741 | (1,173 | ) | (31 | )% | ||||||||||
| Other operating income |
— | 741 | (741 | ) | (100 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating income |
2,568 | 4,482 | (1,914 | ) | (43 | )% | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
During the six months ended June 30, 2024 we generated an Operating Income of $2.6 million compared to $4.5 million during the six months ended June 30, 2023.
Until the end of 2023, our operating income was composed of both the French research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC. Following the termination of the Collaboration Agreement on October 30, 2023, our operating income is now exclusively composed of the French research tax credit. Other operating income was nil for the six months ended June 30, 2024 compared to $0.7 million for the six months ended June 30, 2023.
Research tax credit decreased by $1.2 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023 primarily due to the fact that a greater proportion of clinical studies activities were carried out in North America and were therefore not eligible to the French Research tax credit.
Operating Expenses
Research and Development Expenses
The following table summarizes our R&D expenses incurred during the six months ended June 30, 2024 and 2023:
| Six Months Ended June 30, | ||||||||||||||||
| Research and Development expenses | 2024 | 2023 | $ change | % of change | ||||||||||||
| External clinical-related expenses |
32,492 | 21,892 | 10,599 | 48 | % | |||||||||||
| Employee-related costs |
8,759 | 6,598 | 2,161 | 33 | % | |||||||||||
| Share-based payment expenses |
1,466 | 1,423 | 43 | 3 | % | |||||||||||
| Depreciation, amortization and other costs |
4,060 | 3,741 | 319 | 9 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Research and Development expenses |
46,777 | 33,653 | 13,123 | 39 | % | |||||||||||
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|
|
|
|
|
|
|
|
|||||||||
18
Research and Development expenses increased by $13.1 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023, essentially due to external clinical-related expenses surging by $10.6 million from both patient enrollment in VITESSE Phase 3 clinical trial sustainable increase after the initiation of the study with the first patient screened in March 2023 and the preparatory activities for the COMFORT studies in preparation for and anticipation of initiation after FDA alignment.
Employee-related costs, excluding share-based payments, increased by $2.2 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023 due to the recruitment of 17 internal resources in Medical, Quality and Regulatory Affairs, mostly based in the U.S.
Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2024 and 2023:
| Six Months Ended June 30, | ||||||||||||||||
| Sales & Marketing expenses | 2024 | 2023 | $ change | % of change | ||||||||||||
| Personnel expenses (incl.share-based payment expenses) |
587 | 373 | 215 | 57.6 | % | |||||||||||
| External professional services and other costs |
567 | 348 | 219 | 62.8 | % | |||||||||||
| Depreciation, amortization and other costs |
589 | 229 | 360 | 157.4 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total Sales & Marketing expenses |
1,744 | 950 | 794 | 83.6 | % | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Sales and marketing expenses increased by $0.8 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023, primarily to support pre-commercialization activities for Viaskin Peanut in North America.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2024 and 2023:
| Six Months Ended June 30, | ||||||||||||||||
| General & Administrative expenses | 2024 | 2023 | $ change | % of change | ||||||||||||
| External professional services |
5,595 | 5,512 | 83 | 1.5 | % | |||||||||||
| Employee-related costs |
4,694 | 4,005 | 689 | 17.2 | % | |||||||||||
| Share-based payment expenses |
1,956 | 1,954 | 3 | 0.1 | % | |||||||||||
| Depreciation, amortization and other costs |
4,203 | 4,650 | (447 | ) | -9.6 | % | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total General & Administrative expenses |
16,447 | 16,120 | 327 | 2.0 | % | |||||||||||
|
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|
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|
|
|
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|
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General and Administrative expenses remain flat thanks to the optimization of External professional services.
Employee-related costs (excluding share-based payment) increased by $0.7 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023 mainly due to the hiring of 7 employees to support recruitments, project management, information solutions and legal and intellectual property activities.
This increase is partially offset by a decrease in Depreciation, amortization and other costs for $0.4 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023 primarily due to the provision reversal on the Montrouge office revamping.
Financial income (expense)
Our financial income was $2.0 million for the six months ended June 30, 2024, compared to a financial income of $1.5 million for the six months ended June 30, 2023. This item mainly includes financial income on our financial assets and a favorable foreign exchange result..
Income tax
Our income tax expense was $48 thousand for the six months ended June 30, 2024 compared to $13 thousand for the six months ended June 30, 2023.
Net loss
Net loss was $60.5 million for the six months ended June 30, 2024, compared to $44.8 million for the six months ended June 30, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.63 and $0.48 for the six months ended June 30, 2024 and 2023, respectively.
19
Liquidity and Capital Resources
Financial Condition
On June 30, 2024, we had $66.2 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023.
Based on its current operations, plans and assumptions, the Company expects that its balance of cash and cash equivalents will be sufficient to fund its operations into the first quarter 2025.
As of the date of filing, our available cash is not projected to be sufficient to support our operating plan for at least the next 12 months. As such, there is substantial doubt regarding our ability to continue as a going concern.
We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $69.8 million and $46.4 million for the six months ended June 30, 2024 and 2023, respectively. For the six months ended June 30, 2024, we recorded a net loss of $60.5 million. Our net cash flows provided by financing activities decreased to $0.1 million during the six months ended June 30, 2024 from $7.8 million during the six months ended June 30, 2023 yielded by our ATM.
Our financial statements have been prepared on a going concern basis assuming that we will be successful in our financing objectives. As such, no adjustments have been made to the 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.
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 ordinary share of the Company. The ATM program was intended to be effective through the expiration on July 16, 2024 of the Company’s existing registration statement registering the ADSs to be issued under the ATM program. The Company’s intent was 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.
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.
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 Châtillon, France. Our principal offices occupy a 2,447 square meter facility, pursuant to a lease agreement dated November, 2023 and represents $0.8 million cash requirement as of June 30, 2024 until March, 2033.
The lease agreement for the office occupying 4,470 square meter facility in Montrouge, France, signed on March 3, 2015, with an effective date of August 1, 2025, expired on May 31, 2024. Associated lease termination costs were reflected in the Company’s financial accounts in the Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024.
Our primary U.S. office is located in Warren, New Jersey. In February 2024, we entered into a sublease agreement, commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet in Warren, New Jersey. The Warren office represent a $0.1 million cash requirement as of June 30, 2024 which expires December 31, 2029.
We also have facilities in North America that were intended to support our U.S. operations. We lease 5,799 square feet in Basking Ridge, New Jersey, which commenced on April 1, 2022 and is effective for 38 months.
The Company transitioned to its new offices location in Warren NJ and Châtillon France in April 2024.
There have been no material changes in our operating leases from those disclosed in the Annual Report except the impact of the new lease in Warren NJ for $1.7 million.
Purchase obligations - Obligations Under the Terms of CRO Agreements
In preparation of the launch of our clinical trials for Viaskin Peanut, we signed agreements with several contract research organizations. As of , June 30, 2024 expenses associated with the ongoing trials amounted globally to $162.4 million compared to $114.4 million as of December 31, 2023.
20
Summary Statement of Cash Flows
The table below summarizes our sources and uses of cash for the six months ended June 30, 2024 and 2023.
| Six Months Ended June 30, | ||||||||||||||||
| (Amounts in thousands of U.S. Dollars) | 2024 | 2023 | $ change | % of change | ||||||||||||
| Net cash flow provided by (used in) operating activities |
(69,765 | ) | (46,394 | ) | (23,371 | ) | 50.4 | % | ||||||||
| Net cash flow provided by (used in) investing activities |
(1,441 | ) | (299 | ) | (1,142 | ) | 382.2 | % | ||||||||
| Net cash flow provided by (used in) financing activities |
(95 | ) | 7,793 | (7,888 | ) | (101.2 | )% | |||||||||
| Effect of exchange rate changes on cash and cash equivalents |
(3,853 | ) | 3,668 | (7,521 | ) | (205.1 | )% | |||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net (decrease) increase in cash and cash equivalents |
(75,154 | ) | (35,232 | ) | (39,922 | ) | 113.3 | % | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Operating Activities
Our net cash flows used in operating activities were $69.8 million and $46.4 million during the six months ended June 30, 2024 and 2023, respectively. Our net cash flows used in operating activities increased by $23.4 million . The variance is mainly driven by the increase in (1) external clinical related expenses by $6.6 million, (2) R&D activities to support clinical trials progress through Regulatory Affairs, Medical Affairs and Operations activities by $8.2 million and (3) internal employees’ compensation increase by $3.1 million with the hiring of 24 additional internal resources.
Investing Activities
Our net cash flows used in investing activities were $1.4 million and $0.3 million during the six months ended June 30, 2024 and 2023 respectively. The variance includes capitalized costs for the headquarters move to Châtillon in April 2024 which amounted to $1.8 million.
Financing Activities
Our net cash flows from financing activities were $95 thousand for the six months ended June 30, 2024 compared to $7.8 million for the six months ended June 30, 2023 from the ATM.
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, 2024, 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.
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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.
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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 Quarterly Report.
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, 2024,we issued the following unregistered securities:
| • | On March 23, 2024, the issuance of an aggregate of 2,599 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; |
| • | On May 12, 2024, the issuance of an aggregate of 1,600 ordinary shares to U.S. employees upon settlement of RSUs; |
| • | On May 19, 2024, the issuance of an aggregate of 2,500 ordinary shares to U.S. employees upon settlement of RSUs; |
| • | On May 22, 2024, the issuance of an aggregate of 22,112 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; and |
| • | On May 24, 2024, the issuance of an aggregate of 32,497 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
During the six months ended June 30, 2024, none of our directors and officers (as defined in Rule16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted or terminated any contracts, instructions, or written plans for the purchase or sale of the Company’s securities.
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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) | |||||||||||||||||
| 31.1 | Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended | |||||||||||||||||
| 31.2 | Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||||||||||
| 32.1* | Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||||||||||
| 101.INS | XBRL Instance Document | |||||||||||||||||
| 101.SCH | XBRL Taxonomy Extension Schema Document | |||||||||||||||||
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||||||||||
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | |||||||||||||||||
| 101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | |||||||||||||||||
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||||||||||
| 104 | Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101. | |||||||||||||||||
| * | Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporate language contained in such filing. |
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 30, 2024 | By: | /s/ Daniel Tassé | ||||
| Daniel Tassé | ||||||
| Chief Executive Officer | ||||||
| (Principal Executive Officer) | ||||||
| Date: July 30, 2024 | By: | /s/ Virginie Boucinha | ||||
| Virginie Boucinha | ||||||
| Chief Financial Officer | ||||||
| (Principal Financial and Accounting Officer) | ||||||
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