DBV Technologies S.A 10-Q for FY2024 Q2
DBV Technologies S.A. (DBVT)
About this 10-Q
DBV Technologies S.A filed this 10-Q on July 30, 2024, covering the quarter ended June 30, 2024 (FY2024 Q2).
Headline figures
Quarter ended June 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $1.16M
- down 49.3% from $2.29M a year earlier
- Net loss
- $33.12M
- compared with a net loss of $24.24M a year earlier
- Diluted EPS
- -$0.34
- compared with -$0.26 a year earlier
Table of Contents
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
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.
Table of Contents
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
Table of Contents
Note |
June 30, 2024 |
December 31, 2023 |
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Assets |
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Current assets : |
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Cash and cash equivalents |
3 |
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Other current assets |
4 |
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Total current assets |
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Property, plant, and equipment, net |
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Right-of-use |
5 |
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Intangible assets |
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Other non-current assets |
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Total non-current assets |
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Total Assets |
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Liabilities and shareholders’ equity |
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Current liabilities: |
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Trade payables |
6 |
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Short-term operating leases |
5 |
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Current contingencies |
9 |
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Other current liabilities |
6 |
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Total current liabilities |
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Long-term operating leases |
5 |
|||||||||||
Non-current contingencies |
9 |
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Other non-current liabilities |
6 |
|||||||||||
Total non-current liabilities |
||||||||||||
Total Liabilities |
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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 |
||||||||||||||||
Table of Contents
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.
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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 |
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| 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 | )% | |||||||||
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| Total Operating expenses |
(35,003 | ) | (27,364 | ) | (7,639 | ) | 27.9 | % | ||||||||
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| Financial income (expense) |
726 | 846 | (120 | ) | (14.2 | )% | ||||||||||
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| Income tax |
— | (13 | ) | 13 | (100.0 | )% | ||||||||||
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| Net loss |
(33,116 | ) | (24,243 | ) | (8,873 | ) | 36.6 | % | ||||||||
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| Basic/diluted Net loss per share attributable to shareholders |
(0.34 | ) | (0.26 | ) | ||||||||||||
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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 | )% | ||||||||||
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| 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 | )% | ||||||||||
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| Total Research and Development expenses |
25,374 | 17,616 | 7,758 | 44.0 | % | |||||||||||
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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 | % | |||||||||||
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| Total Sales & Marketing expenses |
986 | 516 | 470 | 91.0 | % | |||||||||||
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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 | % | ||||||||||
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| Total General & Administrative expenses |
8,643 | 9,231 | (588 | ) | -6.4 | % | ||||||||||
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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.
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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 |
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| 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 | % | ||||||||
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| Total Operating expenses |
(64,968 | ) | (50,723 | ) | (14,244 | ) | 28.1 | % | ||||||||
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| Financial income |
1,986 | 1,450 | 536 | 37.0 | % | |||||||||||
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| Income tax |
(48 | ) | (13 | ) | (35 | ) | 273.6 | % | ||||||||
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| Net loss |
(60,461 | ) | (44,804 | ) | (15,657 | ) | 34.9 | % | ||||||||
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| Basic/diluted Net loss per share attributable to shareholders |
(0.63 | ) | (0.48 | ) | ||||||||||||
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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 | )% | ||||||||||
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| Total operating income |
2,568 | 4,482 | (1,914 | ) | (43 | )% | ||||||||||
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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 | % | |||||||||||
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| Total Research and Development expenses |
46,777 | 33,653 | 13,123 | 39 | % | |||||||||||
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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 | % | |||||||||||
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| Total Sales & Marketing expenses |
1,744 | 950 | 794 | 83.6 | % | |||||||||||
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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 | % | ||||||||||
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| Total General & Administrative expenses |
16,447 | 16,120 | 327 | 2.0 | % | |||||||||||
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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.
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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.
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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 | )% | |||||||||
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| Net (decrease) increase in cash and cash equivalents |
(75,154 | ) | (35,232 | ) | (39,922 | ) | 113.3 | % | ||||||||
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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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Exhibit 3.1
BY-LAWS
(updated by decision of the CEO on May 24, 2024)
DBV Technologies
Limited Company lNith share capital of€ 9,649,307.80
107, avenue de la République - 92320 Châtillon, France
Nanterre Trade and Companies Register No. 441 772 522
I. - CHARACTERISTIC FEATURES OF THE COMPANY
Article 1 - Form
The Company was incorporated in the form of a French Limited Company (Société Anonyme) with a Board of Directors.
Article 2 - Name
The name of the Company is: “DBV Technologies”.
Article 3 - Registered office
The registered office is located at: 107, avenue de la République, 92320 Châtillon, France.
Article 4 - Corporate Purpose
The Company’s corporate purpose in France and in all countries is:
| • | the development of any innovative medical products, including any drugs, or diagnostic or treatment products; |
| • | the study, research, development, industrial manufacturing, and marketing of said products; |
| • | the use and development of any patents or licenses relating to these products, and generally speaking any commercial, investment or real estate, financial or other transactions that are directly or indirectly related to the corporate purpose in whole or in part, or to any other similar or related purpose, and that may promote the operation and commercial development of the Company. |
Article 5 - Term
The Company’s term is ninety-nine years as from its registration in the Trade and Companies Register.
Article 6 - Share capital
The share capital has been set at € 9,649,307.80.
It is divided into 96,493,078 ordinary shares with a par value of 10-euro cents (€0.10) each. All of the shares have been fully subscribed, and their full amount paid up in cash.
Article 7 - Changes to the share capital
I. The share capital may be increased either via the issue of new shares, or by increasing the par value of the existing shares.
The new shares will be paid for in cash, or via a contribution in kind, offset against liquid and due receivables, or via the incorporation of profits, reserves, or share premiums into the share capital, either as the result of a merger or demerger, or following the exercise of a right attached to transferable securities granting entitlement to the share capital, including payment of the corresponding amounts, where applicable.
The new equity securities will be issued either at their par value, or at that amount plus a share premium.
Only the Extraordinary General Meeting of Shareholders has the power to decide on increasing the share capital, based on a report from the Board of Directors containing the disclosures required by law.
However, the Extraordinary General Meeting of Shareholders may delegate this power to the Board of Directors under the conditions determined by law. The Board of Directors has the requisite powers to perform a capital increase in one or several installments, to determine its terms and conditions, to record its completion, and to amend the By-Laws accordingly within the limits of the powers so granted by the Extraordinary General Meeting of Shareholders.
If the General Meeting of Shareholders decides to increase the share capital, it may delegate the powers required to perform the transaction to the Board of Directors. If a delegation of power or of authority is used, the Board of Directors will draw up a supplementary report at the next Ordinary General Meeting of Shareholders.
If the capital increase is performed via the incorporation of profits, reserves, or share premiums, the Extraordinary General Meeting of Shareholders will take decisions under the quorum and majority conditions provided for Ordinary General Meetings of Shareholders. In this case, it may decide that rights amounting to fractional shares may neither be traded nor transferred, and that the corresponding equity securities must be sold. The proceeds from the sale will be allocated to the holders in proportion to their rights.
A capital increase by increasing the par value of the shares can only be decided with the shareholders’ unanimous consent, except if it results from the incorporation of profits, reserves, or share premiums into the share capital.
Shareholders will have a preferential right to subscribe to the cash shares issued in order to perform a capital increase, in proportion to the number of shares that they hold. The shares purchased as a result of exercising this right will be shares in the same class as the one for the shares giving rise to said right, together with the shares resulting from the purchase of other transferable securities than shares.
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The shareholders may sell all or some of their subscription rights throughout the subscription period. These rights will be tradable if they are stripped from shares that are themselves tradable. Otherwise, they may be sold under the same conditions as the actual shares.
Shareholders may waive their preferential subscription right on an individual basis.
The Extraordinary General Meeting of Shareholders that decides on the capital increase may waive the preferential subscription right under the conditions and limits determined by law, and rule to that effect on the reports prepared by the Board of Directors and the Statutory Auditors under the conditions determined by the laws and regulations in effect.
If the Extraordinary General Meeting of Shareholders, or the Board of Directors in the event of a delegation of authority, has expressly decided to do so, any shares that have not been subscribed on an irrevocable basis will be allotted to shareholders who subscribed to a higher number of shares on a revocable basis than the number to which they were able to subscribe on a preferential basis, in proportion to the subscription rights that they hold, and within the limits of their request, in any event.
If, for any reason, subscriptions have not absorbed the full amount of the capital increase, the Board of Directors may use the options provided for below, or only some of them, in the order that it determines:
| (i) | limiting the capital increase to the amount of the subscriptions, subject to the general condition that it amounts to at least three quarters of the increase decided upon, and that this option was not expressly excluded by the Extraordinary General Meeting of Shareholders at the time of issue; |
| (ii) | allocating the balance of the shares if the Extraordinary General Meeting of Shareholders has not decided otherwise; |
| (iii) | opening the subscription process to the public if the Extraordinary General Meeting of Shareholders has expressly authorized it. |
If subscriptions have not absorbed the entire capital increase following the exercise of these options, or three-quarters of the increase in the case provided for under (i) above, the capital increase will not be performed.
However, the Board of Directors may automatically limit the capital increase to the amount raised in all cases where the unsubscribed shares account for less than 3% of the capital increase.
In the event of a capital increase with or without preferential subscription rights, the Extraordinary General Meeting of Shareholders may provide that the number of securities may be increased by up to 15% of the initial issue, at the same price as the one used for the initial issue within a period of thirty days following the close of the subscription period.
If the capital increase creates fractions of shares, shareholders who have an insufficient number of subscription or allotment rights must make arrangements to purchase or sell the rights required to obtain the delivery of a whole number of new shares.
| II. | The Extraordinary General Meeting of Shareholders (or the Board of Directors in the event of a delegation of authority) may also authorize or decide on a capital decrease, subject to the rights of creditors, where applicable. |
Decreasing the share capital below the legal limit can only be decided under the condition precedent of a capital increase intended to return the share capital to an amount that is at least equal to the minimum legal threshold, unless the Company turns itself into a company with another legal form. Otherwise, any interested party may apply to the courts to have the Company wound up. The court may not order the Company to be wound up if the amount of the share capital has been restored to the statutory minimum by the day when it rules on the substance of the case.
Article 8 - Financial year
The financial year runs from January 1 to December 31.
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II. - ADMINISTRATION OF THE COMPANY
Article 9 - Executive Management exercise method
The executive management of the Company is the responsibility either of the Chairman of the Board of Directors or of another individual appointed by the Board of Directors bearing the title of Chief Executive Officer.
The Board of Directors chooses between the two Executive Management exercise methods based on the unanimous vote of all of its members.
Where responsibility for the Company’s Executive Management is held by the Chairman of the Board of Directors, the following provisions concerning the role of Chief Executive Officer apply.
A. The Board of Directors
Article 10 - Composition of the Board of Directors
The Company is governed by a Board of Directors that consists of between 3 and 18 directors.
The Directors are appointed by the General Meeting of Shareholders, deliberating under the quorum and majority conditions for Ordinary General Meetings of Shareholders.
The term of office for the Directors appointed during the term of the company is three (3) years. This term expires at the end of the meeting convened to approve the financial statements for the year just ended, and which is held in the year during which their term of office expires.
By way of exception and in order to allow exclusively for the implementation or maintenance of the staggered terms of office of Directors, the ordinary General Meeting of Shareholders may appoint one or more members of the Board for a term of two (2) years or one (1) year.
The Directors may be dismissed at any time and without any good reason by the General Meeting of Shareholders, deliberating under the quorum and majority conditions for Ordinary General Meetings of Shareholders.
The number of Directors aged over eighty cannot exceed one third of the Board members.
Article 11 - Board Discussions
The Board of Directors meets as often as is required by the Company’s interests at the invitation of the Chairman of the Board of Directors, at the registered office or the place specified in the notice of meeting. The invitation may be issued by any means five days in advance: it may also be issued orally and immediately if all of the Directors and non-voting Board members agree.
The Board of Directors may also make decisions by written consultation of the directors under the conditions provided by law. The Board of Directors may also, at the discretion of its Chairman, make the following decisions by written consultation:
| • | cooptation following (i) a death, (ii) a resignation, (iii) when the number of directors has fallen below the statutory minimum, or (iv) when the gender balance is no longer respected; |
| • | authorization of sureties, endorsements and guarantees given by the Company; |
| • | transfer of the registered office in the same department; |
| • | amendment of the articles of association to bring them into line with the conditions laid down by law; |
| • | convening of the General Meeting. |
In the event of a written consultation, the Chairman sends to each director, alternatively (i) by registered letter with acknowledgement of receipt, (ii) by e-mail with acknowledgement of receipt, the text of the proposed decisions as well as all documents useful for his information.
The directors have a period of five calendar days (ending at 11:59 p.m., Paris time, on the last day of this period) from the date of dispatch of the draft decisions to express their vote in writing. The reply is sent alternatively (i) by registered letter with acknowledgement of receipt, (ii) by e-mail with acknowledgement of receipt, to the attention of the Chairman of the Board of Directors, at the Company’s registered office, if any.
The Board of Directors may only validly deliberate on a written consultation if at least half of its members have replied within the time limit indicated above. Decisions are taken by a majority of the votes of the members who have replied, each member having one vote.
If it has not met for over two months, at least one quarter of the members of the Board of Directors may ask the Chairman to convene the Board based on a determined agenda. The Chief Executive Officer or a Director may also ask the Chairman to convene the Board of Directors based on a determined agenda. The Chairman will be bound by any such requests.
An attendance register will be kept, and minutes will be drawn up following each meeting. The Board may only validly take decisions if at least half of its members are present.
Except where the choice of the method for exercising Executive Management is concerned, decisions will be taken based on a majority vote of the Directors present or represented. The Chairman will have a casting vote in the event that the vote is split.
The Directors and any individuals asked to attend the Board of Directors’ meetings are required to exercise discretion with respect to information of a confidential nature, and which is provided as such by the Chairman of the Board of Directors.
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Article 12 - The Board’s powers
The Board of Directors determines the Company’s guidelines, and ensures their implementation. Subject to the powers specifically assigned to General Meetings of Shareholders, and within the limits of the corporate purpose, the Board will deal with any matter involving the proper operation of the Company, and settle any matters concerning it through its discussions.
The Board of Directors carries out the controls and verifications that it considers appropriate. Every Director will receive all of the information required to fulfill their assignment, and may ask for the disclosure of any documents that they consider useful.
Article 13 - The Chairman of the Board of Directors
The Board of Directors elects a Chairman, who must be a private individual, from among its members, and determines their remuneration, in accordance with applicable law. The Chairman is appointed for a period that may not exceed the length of their term of office as a Director. They are eligible for re- election. The Board of Directors may dismiss the Chairman at any time. Any provisions to the contrary will be considered void.
No one aged 75 or over may be appointed as Chairman. If the incumbent Chairman reaches this age during a financial year, their duties will automatically end following the Ordinary General Meeting of Shareholders convened to approve the financial statements for that financial year.
The Chairman organizes and directs the work undertaken by the Board, and accounts for it at the General Meeting of Shareholders. They ensure that the Company’s bodies operate properly, and especially that the Directors are in a position to fulfill their assignment.
Article 14 - Non-Voting Board Members
The General Meeting of Shareholders may appoint one or two non-voting Board members for the Company who are private individuals, regardless of whether they are shareholders; they will be aged 65 at most on the day of their appointment.
Non-voting Board members are appointed for a period of two (2) years. Their assignment ends after the General Meeting of Shareholders that has approved the financial statements for the year just ended, and held in the year during which their term of office expires.
Non-voting Board members do not receive any remuneration. They may receive allowances determined by the Board of Directors in order to reimburse the expenses that they are required to incur as part of the normal performance of their duties. If the Board delegates a specific assignment to the non-voting Board members or to one of them, they may allocate them an allowance in proportion to the importance of the assignment entrusted to them, as well as a budget for performing said assignment. Non- voting Board members are invited to all of the Board of Directors’ meetings and to all of the General Meeting of Shareholders, and take part in the discussions in an advisory capacity. Non-voting Board members perform a general and permanent advisory and supervisory role at the Company. However, they may not interfere in the management of the Company under any circumstances, or, in general, replace its legal bodies.
B. The Executive Management
Article 15 - Chief Executive Officers and Deputy Chief Executive Officers
The executive management of the Company is the responsibility of a private individual appointed by the Board of Directors bearing the title of Chief Executive Officer, under the Company’s responsibility.
The Board of Directors may appoint one or more private individuals responsible for assisting the Chief Executive Officer, who will bear the title of Deputy Chief Executive Officer, on the recommendation of the Chief Executive Officer. The number of Deputy Chief Executive Officers cannot exceed five.
The Chief Executive Officer may be dismissed by the Board of Directors at any time. The same applies to the Deputy Chief Executive Officers, on the recommendation of the Chief Executive Officer. If the dismissal is not on justified grounds, it may result in the payment of damages and interest.
Where the Chief Executive Officer ceases, or is otherwise prevented from performing their duties, the Deputy Chief Executive Officers will retain their positions and their assignments until a new Chief Executive Officer is appointed, unless the Board decides otherwise.
The Board of Directors determines the compensation paid to the Chief Executive Officer and the Deputy Chief Executive Officers, in accordance with applicable law.
Article 16 - Powers of the Chief Executive Officer and Deputy Chief Executive Officers
The Chief Executive Officer is granted very extensive powers to act in the Company’s name in all circumstances. They exercise the powers within the limit of the corporate purpose, and subject to those that the law and these By-Laws expressly assign to General Meeting of Shareholders and to the Board of Directors.
They represent the Company in its dealings with third parties. The Company will be committed even by the Chief Executive Officer’s actions that do not relate to the corporate purpose, unless it proves that the third party was aware that the action exceeded that purpose, or could not ignore this fact in view of the circumstances. The sole publication of the By-Laws does not amount to sufficient proof.
The Board of Directors determines the scope and term of the powers granted to the Deputy Chief Executive Officers, with the Chief Executive Officer’s consent. The Deputy Chief Executive Officers have the same powers as the Chief Executive Officer where third parties are concerned.
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III. - GENERAL MEETING OF SHAREHOLDERS
Article 17 - General Meeting of Shareholders
The duly constituted General Meeting of Shareholders represents the entire body of shareholders.
Its decisions, which are taken in accordance with the law and the By-Laws, are binding on all of the shareholders, even if they are absent, disagree, or are incapable. There are three forms of meetings, depending on the purpose of the resolutions put forward:
| • | Ordinary General Meetings; |
| • | Extraordinary General Meetings; |
| • | Special Meetings that bring together the holders of shares in a given class. |
Article 18 - Invitations
The Meetings are convened by the Board of Directors. They may also be convened by the Statutory Auditor or by a court representative, under the conditions and in accordance with the procedures provided for by law.
Meetings are convened by the liquidator(s) during the liquidation period.
The Meetings are held at the registered office or at any other location specified in the notice of meeting.
A notice of meeting is published in the Bulletin des Annonces Légales Obligatoires (French Official Gazette, or BALO) at least thirty-five days before a Meeting is held. In addition to the information relating to the Company, the notice specifies the agenda for the Meeting, and the wording of the draft resolutions that will be put forward. Requests to enter points or draft resolutions on the agenda must be addressed to the Company under the conditions provided for by the regulations in effect.
The Meetings are held at the registered office or at any other location specified in the notice of meeting.
Subject to specific legal provisions, the invitation is issued at least fifteen days before the date of the Meeting by a notice inserted in a legal gazette published in the Department where the registered office is located, as well as in the BALO.
The holders of registered shares must be convened under the conditions provided for by the regulations in force.
The notice of meeting must also specify the conditions under which shareholders may vote by post, and the places where, and terms and conditions according to which, they may obtain postal vote forms.
The notice of meeting may be sent, where applicable, with a proxy form and a postal voting form, under the conditions specified in Article 21 of these Articles of Association, or with a postal voting form only, under the conditions specified in Article 21 of these Articles of Association.
Where a Meeting has been unable to take decisions as a result of failing to achieve the quorum required, a second Meeting will be convened, subject to specific legal provisions, at least ten days in advance, in the forms provided for by the regulations in effect.
Article 19 - Agenda
The agenda for Meetings will be prepared by the person convening the meeting.
One or several shareholders, who represent at least the percentage of the share capital specified by law, and acting in accordance with the legal conditions and timeframes, have the option to request the inclusion of points or draft resolutions on the agenda for the Meeting, via registered letter with a request for acknowledgment of receipt.
The Meeting may not discuss an issue that has not been entered on the agenda, which cannot be altered at the time of the second invitation. However, it may dismiss one or several members of the Board of Directors, and replace them in all circumstances.
Article 20 - Participation of Shareholders in Meetings
Any shareholder may participate, personally or by proxy, in the meetings upon proof of identity and ownership of his or her shares, in accordance with the procedures provided for by the laws and regulations in force.
Article 21 - Postal and proxy voting
Postal voting is carried out in accordance with the terms and conditions laid down by the legal and regulatory provisions. In particular, any shareholder may send postal voting forms either in paper form or, if the Board of Directors decides to do so and publishes the decision in the notice of meeting, by electronic means, before the meetings. Proxy forms may be sent either in paper form or by electronic means before the meetings.
If the Board of Directors decides at the time of convening the meeting to allow the transmission of voting or proxy forms by electronic means, the electronic signature of these forms may result from a reliable process for identifying the shareholder, guaranteeing its link with the remote form to which its signature is attached. The vote thus expressed before the meeting by this electronic means, as well as the acknowledgement of receipt given, will be considered as non-revocable writings and opposable to all. The proxy is however revocable in the same way as those required for the appointment of the proxy. In the event of a transfer of ownership of securities occurring before midnight (Paris time) on the second business day preceding the meeting, the Company will invalidate or modify accordingly, as the case may be, the proxy or the vote cast before the meeting by this electronic means.
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Article 22 - Attendance sheet
An attendance sheet containing the information specified by law will be kept at each Meeting.
This attendance sheet, duly initialed by the shareholders present and the proxies, and the shareholders attending via video-conference or another means of telecommunication, in accordance with the legal and regulatory requirements, and to which the powers granted to each representative are appended, together with the postal voting forms, will be certified as accurate by the Meeting Bureau.
The Meetings will be chaired by the Chairman of the Board of Directors. Otherwise, the Meeting will elect its own Chairman.
The tellers’ duties will be performed by two shareholders who are present and agree to do so, and who represent the highest number of votes, both on their own behalf and as proxies.
The Bureau formed in this way will appoint a secretary, who may be chosen from outside the shareholders.
Article 23 - Voting rights attached to shares
The voting right attached to the shares is proportional to the percentage of the total share capital that they represent. Each equity share or dividend share will grant entitlement to one vote. Fully paid-up shares for which proof can be provided that they have been registered in the name of the same shareholder for at least two years do not benefit from double voting rights.
Article 24 - Minutes
The decisions taken at the Meetings will be recorded in minutes that are drawn up in a special ledger held at the registered office, and signed by the members of the Bureau.
Copies or excerpts of the minutes of the decisions will be certified either by the Chairman of the Board of Directors or by the Meeting Secretary. They will be validly certified by the liquidator(s) in the event of liquidation proceedings.
Article 25 - Disclosure of documents
Any shareholder has the right to obtain disclosure of, and the Board of Directors is required to send or make available to them, the documents required to enable them to form an opinion in full knowledge of the facts, and to make an informed judgment on the Company’s management and operations.
The nature of these documents, and the conditions for sending them or making them available to the shareholders are determined by the regulations in effect.
Every shareholder or their representative may seek the assistance of an expert registered on one of the lists drawn up by the courts, in order to exercise their right of disclosure.
The exercise of the right of disclosure entails the right to take copies, except where records are concerned.
Article 26 - Ordinary General Meeting of Shareholders
The Ordinary General Meeting of Shareholders takes all of the decisions that exceed the powers of the Board of Directors and which do not fall within the remit of the Extraordinary General Meeting of Shareholders.
The Meeting is convened at least once a year, within a period of six months following the end of each financial year, in order to approve the financial statements for that year, subject to this period being extended by an order from the Presiding Judge of the Commercial Court ruling at the request of the Board of Directors.
The Meeting is convened on an extraordinary basis every time that this appears to be in the Company’s interests.
When convened for the first time, the Ordinary General Meeting of Shareholders may only validly deliberate if the shareholders present, represented, or who have voted by post hold at least one fifth of the shares to which voting rights are attached.
No quorum is required if the meeting is convened for a second time and the original agenda has not been amended.
The Ordinary General Meeting of Shareholders decides by a majority of the votes expressed by the shareholders present, represented or voting by mail. The expressed votes do not include those attached to shares for which the shareholder has not taken part in the vote, has abstained or has voted blank or null.
Article 27 - Extraordinary General Meeting of Shareholders
Only the Extraordinary General Meeting of Shareholders is authorized to amend all of the provisions of the By-Laws, and to specifically decide on turning the Company into a company with another legal form. It cannot, however increase the shareholders’ undertakings, except in the case of transactions resulting from a duly executed reverse share split.
The Extraordinary General Meeting of Shareholders may only validly deliberate if the shareholders present, represented or who have voted by post hold at least one quarter of the shares with voting rights at the time of the first invitation, and one fifth of the shares with voting rights at the time of the second invitation. If the second quorum is not achieved, the second Meeting may be postponed to a date no later than two months after the date on which it was convened.
The Meeting passes resolutions based on a two-thirds majority vote expressed by the shareholders who are present, represented, or have voted by post, or who are attending the Meeting via video- conference or another means of telecommunication, in accordance with the legal and regulatory provisions.
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As a legal exemption to the above provisions, a General Meeting of Shareholders that decides on a capital increase via the capitalization of reserves, profits, or share premiums may pass resolutions under the same quorum and majority conditions as an Ordinary General Meeting of Shareholders.
Furthermore, where the Extraordinary General Meeting of Shareholders is required to discuss the approval of a contribution in kind or the granting of a particular benefit, the shares held by the individual making the contribution or the beneficial owner will not be taken into account to calculate the majority. The individual making the contribution or the beneficial owner will not have a vote, either on their own behalf, or as a proxy.
Article 28 - Special Meeting
If there are several share classes, no change may be made to the rights attached to shares in one of these classes without a due vote at an Extraordinary General Meeting of Shareholders open to all shareholders and, furthermore, without an equally compliant vote at a Special Meeting open only to the holders of shares in the class in question.
Special Meetings may only validly discuss matters if the shareholders present, represented, who have voted by post, or who are attending the Meeting via video-conference or via another means of telecommunication in accordance with the legal and regulatory provisions, hold at least one third of the shares with voting rights, where an amendment to those rights is planned, on the first invitation, and one fifth of the shares on the second invitation. Otherwise, the second Special Meeting may be postponed to a date no later than two months after the date on which it was convened.
Special Meetings pass resolutions based on a two-thirds majority of the expressed votes of the shareholders present or represented.
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IV. - THE COMPANY’S SECURITIES
Article 29 - Payment for the shares
At least 25% of the par value of shares subscribed in cash must be paid at the time of subscription, together with the full share premium, where applicable.
The balance must be paid in one or several installments, as called by the Board of Directors, and within a period of five years from the date on which the capital increase was finalized.
Calls for funds are made known to the shareholders via a notice published in the BALO fifteen (15) days in advance.
If the shareholder does not make the required payments on the amount of the shares to which they have subscribed at the times determined by the Board of Directors, these payments will automatically bear interest payable to the Company at the legal rate determined in Article L. 313-2 of the French Monetary and Financial Code, as from the end of the month following the date when they are due, without any requirement for a court application or letter of notice. Furthermore, shares for which the required payments have not been made at the end of a period of 30 days as from the sending of a letter of notice to the defaulting shareholder, to which no reply has been received, will no longer grant the right to attend General Meetings of Shareholders and to vote at those Meetings, and will be deducted from the quorum calculation. The right to dividends, and the preferential right to subscribe to capital increases attached to the shares will be suspended. These rights will be recovered once the capital and interest amounts due have been paid. The shareholder may then request the payment of dividends that have not expired, and exercise their preferential subscription right, if the determined timeframe for exercising that right has not expired.
The share capital must be fully paid up before any issue of new shares to be paid for in cash.
Article 30 - Form of the shares - Management of the securities accounts
The shares may be in registered or bearer form, if the legislation allows, depending on the shareholder’s choice.
Issued shares give rise to a registration in individual accounts in the name of each shareholder opened by the Company or any authorized intermediary. These accounts are held under the conditions and in accordance with the procedures provided for by the legal and regulatory provisions.
In order to identify the owners of bearer shares, the company may, under the conditions provided for by the legal and regulatory provisions in force, request, at any time, information concerning the owners of its shares and securities conferring immediate or future voting rights at its own General Meetings of Shareholders.
Article 31 - Transfer of the shares
Shares registered on an account are transferred from account to account.
Cash shares are freely tradable as from the completion of the capital increase. Shares resulting from contributions are freely tradable as from the completion of the capital increase, i.e. the date of the Meeting or of the meeting of the Board of Directors acting on a delegation of authority, which approved the contributions, in the event of a contribution in kind during the term of the company.
The transfer of ownership will result from their registration on the purchaser’s account, on the date and under the conditions determined by law and the applicable regulations, where applicable.
The shares will be freely tradable, subject to the provisions provided for by law.
Article 32 - Crossing of thresholds
Any private individual or legal entity referred to in Articles L. 233-7, L. 233-9, and L. 223-10 of the French Commercial Code who comes to directly or indirectly hold a number of shares representing a percentage of the Company’s share capital or voting rights higher than or equal to 2.5% or a multiple of that percentage, either on a stand-alone basis or in concert, must inform the Company of the total number of shares, voting rights, and securities granting access to the share capital or to voting rights immediately or in the future that they hold, via registered letter with a request for an acknowledgment of receipt sent to the registered office within a period of four trading days, prior to the market close as from the point when they crossed said percentage threshold(s).
The disclosure obligation provided for above also applies under the same conditions when each threshold mentioned above is crossed downwards.
If they have not been reported under the conditions specified above, shares or voting rights that exceed the percentage that should have been reported will be stripped of their voting rights at General Meetings of Shareholders at any Meeting that may be held until the expiry of a two-year period following the date when the notice of interest was made compliant, in accordance with Article L. 233-14 of the French Commercial Code, if a failure to report has been observed, and if one or several shareholders holding an interest of at least 2.5% have made a request recorded in the minutes of the General Meeting of Shareholders.
The above reports will apply notwithstanding the reports on the crossing of thresholds provided for by the legal or regulatory provisions in effect.
Article 33 - Rights and obligations attached to the shares
Each share entitles the holder to a share in the Company’s profits and assets, in proportion to the amount of capital that it represents. Furthermore, each share entitles the holder to vote and be represented at General Meetings of Shareholders under legal and statutory provisions. Shareholders will only be liable up to the amount of the par value of the shares that they hold; any calls for funds above that amount are prohibited. Ownership of a share automatically entails adherence to the Company’s By-Laws and to the decisions of the General Meeting of Shareholders.
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Heirs, creditors, assigns, or other representatives of a shareholder will not be entitled to request seizure of the Company’s assets or securities, or ask for them to be shared out or sold at auction, nor interfere in administrative acts relating to the Company in order to exercise their rights; they must refer to the company records and to the resolutions of the General Meeting of Shareholders.
Whenever it is necessary to hold several shares in order to exercise a given right, such as in the case of an exchange, reverse share split or allotment of shares, or an increase or decrease in the share capital, or a merger or other corporate transaction, the holders of single shares, or of a lower number of shares than required, may only exercise these rights if they personally arrange for the consolidation, and potentially the purchase or sale of the shares required.
However, in the event of the exchange of securities following a merger or demerger transaction, a capital decrease, a reverse share split or share split, and the mandatory conversion of bearer shares to registered shares, or of the distribution of securities charged to the reserves relating to a capital decrease, or the distribution or allotment of bonus shares, based solely on a decision by the Board of Directors, the Company may sell securities that the beneficiaries have requested to be delivered to them, as long as it has carried out the publication formalities provided for in the regulations at least two years beforehand.
As from the sale, the old securities or the old rights to distributions or allotments will be canceled, as and when required, and their holders will only be able to claim the cash allocation of the net proceeds of the sale of the unclaimed securities.
Article 34 - Beneficial & Bare ownership
The shares are indivisible as regards the Company.
Joint owners of shares are required to have themselves represented to the Company by just one of them, who will be considered as the sole owner, or by a single proxy; in the event of disagreement, the single proxy may be appointed by a court at the request of the first joint owner to do so.
Unless the Company has been notified of an agreement to the contrary, the beneficial owners of shares will validly represent the bare owners with the Company. Voting rights will be held by the beneficial owner at Ordinary General Meetings of Shareholders and by the bare owner at Extraordinary General Meetings of Shareholders.
Unless otherwise agreed between the parties, the preferential subscription right attached to securities belongs to the bare owner where the shares are encumbered by a usufruct interest.
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V. - COMPANY FINANCIAL STATEMENTS
Article 35. - Preparation and approval of the company financial statements
| a) | The Board of Directors will draw up an inventory and the annual financial statements at the end of each financial year, and will then prepare the management report. |
Where applicable, the Board of Directors will prepare and publish the consolidated financial statements, together with the report regarding the management of the Group.
| b) | The Ordinary General Meeting of Shareholders will approve the annual company financial statements within a period of six months following the financial year- end, after familiarizing itself with the management report and the report prepared by the Statutory Auditors; the consolidated financial statements and the report regarding the management of the Group will be presented at that Meeting, if required. |
All information measures will be taken in compliance with the law and the regulations.
Article 36 - Audit of the financial statements
The financial statements will be audited by one or several incumbent, and, where applicable, alternate Statutory Auditors, under the conditions determined by Articles L. 225-218 of the French Commercial Code.
Article 37 - Allocation of the amounts available for distribution
Following the approval of the financial statements, and the recording of the existence of amounts available for distribution, the Ordinary General Meeting of Shareholders will determine the share of these amounts allotted to the shareholders in the form of a dividend; this dividend will be charged to the distributable profit for the year as a priority.
The procedures for paying the dividends or interim dividends are determined by the General Meeting of Shareholders. Write -down differences are not available for distribution.
If required, the Meeting will allocate the non-distributed portion of the profit for the financial year available for distribution in the proportions that it determines, either to one or several reserves, which may be general or special, which remain at its disposal, or to the “retained earnings” account.
Any losses will be carried forward, unless the Meeting decides to offset them against existing reserves.
VI. - LIQUIDATION OF THE COMPANY
Article 38 - Liquidation
Once it has been wound up, the Company will be liquidated under the conditions determined by the French Commercial Code.
Unless the Ordinary General Meeting of Shareholders decides otherwise, the liquidator or liquidators will pursue any ongoing business until it is completed.
The net proceeds of the liquidation, following the settlement of the liabilities and payroll expenses, and repayment to the shareholders of the non-amortized par value of their shares, will be divided between the shareholders, taking the rights of the different share categories into account, where applicable.
VII. - MISCELLANEOUS ITEMS
Article 39 - Powers
All powers will be granted to the bearers of original copies of these By-Laws, or of copies or excerpts certified as original, in order to carry out all formalities.
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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 c) registrant’s internal control over financial reporting. |
Date: July 30, 2024
| /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, Virginie Boucinha , 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 30, 2024
| /s/ Virginie Boucinha |
| Virginie Boucinha |
| 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 Virginie Boucinha, 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, 2024, 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 30, 2024
| /s/ Daniel Tassé |
/s/ Virginie Boucinha | |||
| Daniel Tassé Chief Executive Officer (Principal Executive Officer) |
Virginie Boucinha 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.