DBVT 10-Q
DBV Technologies S.A. (DBVT)
10-Q
2022-11-03
For: 2022-09-30
View Original
Added on
April 10, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2022
or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 001-36697
(Exact name of registrant as specified in its charter)
applicable | ||
State or other jurisdiction of incorporation or organization |
(I.R.S. Employer Identification No.) |
177-181 avenue Pierre Brossolette |
||
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code +33 1 55 42 78 78
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
| American Depositary Shares, each representing one-half ofone ordinary share, nominal €0.10 per share |
||||
Ordinary shares, nominal value €0.10 per share * |
n/a |
| * |
Securities registered pursuant to section 12(g) of the Act: None.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
☐ |
Accelerated filer |
☐ | |||
Non-accelerated filer |
☒ | Smaller reporting company | ||||
| Emerging growth company | ||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No
As of November 3, 2022, the registrant
had
ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.
Table of contents
| Part I | 3 | |||
| Item 1 | Condensed Consolidated Statements of Financial Position (Unaudited) as of September 30, 2022 and December 31, 2021 | 3 | ||
| Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Nine Months Ended September 30, 2022 and 2021 | 4 | |||
| Condensed Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2022 and 2021 | 5 | |||
| Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Nine Months Ended September 30, 2022 and 2021 | 6 | |||
| 8 | ||||
| Item 2 | 21 | |||
| Item 3 | 33 | |||
| Item 4 | 33 | |||
| Part II | 34 | |||
| Item 1 | 34 | |||
| Item 1A | 34 | |||
| Item 2 | 34 | |||
| Item 3 | 35 | |||
| Item 4 | 35 | |||
| Item 5 | 35 | |||
| Item 6 | 36 |
Unless the context otherwise requires, we use the terms “DBV”, “DBV Technologies,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q, or Quarterly Report, to refer to DBV Technologies S.A. and, where appropriate, its consolidated subsidiaries. “Viaskin™”, “EPIT™” and our other registered and common law trade names, trademarks and service marks are the property of DBV Technologies S.A. or our subsidiaries. All other trademarks, trade names and service marks appearing in this Quarterly Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report may be referred to without the
®
and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto. SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS.
This Quarterly Report contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended or Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or 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:
| • | the impact of the ongoing COVID-19 pandemic, including the emergence of new variant strains of COVID-19, and its effects on our operations, research and development, clinical trials and ability to obtain financing and potential disruption in the operations and business of third-party manufacturers, contract research organizations, or CROs, other service providers and collaborators with whom we conduct business; |
| • | our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated re-submission of a Biologics License Application, or a BLA, for Viaskin TM Peanut to the U.S. Food and Drug Administration, or the FDA; |
| • | the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs; |
| • | our business model and our other strategic plans for our business, product candidates and technology; |
| • | our ability to manufacture clinical and commercial supplies of our product candidates and comply with regulatory requirements related to the manufacturing of our product candidates; |
| • | our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize Viaskin Peanut and/or our other product candidates, if approved; |
| • | the commercialization of our product candidates, if approved; |
| • | our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut and/or our other product candidates, if approved, and our ability to serve such markets; |
| • | the pricing and reimbursement of our product candidates, if approved; |
| • | the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by physicians, patients, third-party payors and others in the medical community; |
| • | our ability to advance product candidates into, and successfully complete, clinical trials; |
| • | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; |
| • | estimates of our expenses, future revenues, capital requirements and our needs for additional financing; |
| • | the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; |
| • | our ability to maintain and establish collaborations or obtain additional grant funding; |
1
| • | our financial performance; 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, 2021, filed with the Securities and Exchange Commission, or the SEC on March 9, 2022. Additional information is also included on our Current Report on Form 8-K, filed with the SEC on June 13, 2022. 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.
2
Part I - Financial Information
Item 1. Financial Statements
DBV Technologies S.A.
Condensed Consolidated Statements of Financial Position (unaudited)
(amounts in thousands, except share and per share data)
September 30, |
December 31, |
|||||||||||
Note |
2022 |
2021 |
||||||||||
| Assets |
||||||||||||
| Current assets: |
||||||||||||
| Cash and cash equivalents |
3 |
$ |
$ | |||||||||
| Other current assets |
4 |
|||||||||||
| |
|
|
|
|||||||||
| Total current assets |
||||||||||||
| Property, plant, and equipment, net |
||||||||||||
| Right-of-use |
5 |
|||||||||||
| Intangible assets |
||||||||||||
| Other non-current assets |
||||||||||||
| |
|
|
|
|||||||||
| Total non-current assets |
||||||||||||
| |
|
|
|
|||||||||
| Total Assets |
$ |
$ |
||||||||||
| |
|
|
|
|||||||||
| Liabilities and shareholders' equity |
||||||||||||
| Current liabilities: |
||||||||||||
| Trade payables |
6 |
$ |
$ | |||||||||
| Short-term operating leases |
5 |
|||||||||||
| Short-term financial debt |
||||||||||||
| Current contingencies |
9 |
|||||||||||
| Other current liabilities |
6 |
|||||||||||
| |
|
|
|
|||||||||
| Total current liabilities |
||||||||||||
| |
|
|
|
|||||||||
| Long-term operating leases |
5 |
|||||||||||
| Non-current contingencies |
9 |
|||||||||||
| Other non-current liabilities |
6 |
|||||||||||
| |
|
|
|
|||||||||
| Total non-current liabilities |
||||||||||||
| |
|
|
|
|||||||||
| Total Liabilities |
$ |
$ |
||||||||||
| |
|
|
|
|||||||||
| Shareholders’ equity: |
||||||||||||
| Ordinary shares, € |
$ |
$ | ||||||||||
| Additional paid-in capital |
||||||||||||
| Treasury stock, |
( |
) |
( |
) | ||||||||
| Accumulated deficit |
( |
) |
( |
) | ||||||||
| Accumulated other comprehensive income |
||||||||||||
| Accumulated currency translation effect |
( |
) |
( |
) | ||||||||
| |
|
|
|
|||||||||
| Total Shareholders’ equity |
7 |
$ |
$ |
|||||||||
| |
|
|
|
|||||||||
| Total Liabilities and Shareholders’ equity |
$ |
$ |
||||||||||
| |
|
|
|
|||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
DBV Technologies S.A.
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(amounts in thousands, except share and per share data)
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||
Note |
2022 |
2021 |
2022 |
2021 |
||||||||||||||
Operating income |
10 |
$ |
$ |
$ |
$ |
|||||||||||||
Operating expenses |
||||||||||||||||||
Research and development expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Sales and marketing expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
General and administrative expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Total Operating expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Loss from operations |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||
Financial income |
||||||||||||||||||
Loss before taxes |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||
Income tax (expense) |
( |
) | ||||||||||||||||
Net loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||||
Foreign currency translation differences, net of taxes |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Actuarial gains (losses) on employee benefits, net of taxes |
( |
) | ||||||||||||||||
Total comprehensive loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||||
Basic/diluted net loss per share attributable to shareholders |
14 |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | |||||
Weighted average shares outstanding used in computing per sha re amounts: |
||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
DBV Technologies S.A.
Condensed Consolidated Statements of Cash Flows (unaudited)
(amounts in thousands)
Nine Months Ended September 30, |
||||||||||||
Notes |
2022 |
2021 |
||||||||||
| Net loss for the period |
|
|
$ |
( |
) |
$ |
( |
) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
||||||||||
| Depreciation, amortization and accrued contingencies |
|
|
||||||||||
| Retirement pension obligations |
|
|
||||||||||
| Expenses related to share-based payments |
|
8 |
|
|||||||||
| Other elements |
|
|
( |
) | ||||||||
| Changes in operating assets and liabilities: |
|
|
||||||||||
| Decrease (increase) in trade receivables |
|
|
||||||||||
| Decrease (increase) in other current assets |
|
|
( |
) | ||||||||
| (Decrease) increase in trade payables |
|
|
( |
) | ||||||||
| (Decrease) increase in other current and non-current liabilities |
|
|
( |
) | ( |
) | ||||||
| Change in operating lease liabilities and right of use assets |
|
|
( |
) | ( |
) | ||||||
| Net cash flow used in operating activities |
|
|
( |
) |
( |
) | ||||||
| |
|
|
|
|
|
|||||||
| Cash flows used in investing activities: |
|
|
||||||||||
| Acquisitions of property, plant, and equipment |
|
|
( |
) | ||||||||
| Proceeds from property, plant, and equipment dispositions |
|
|
||||||||||
| Acquisition of intangible assets |
|
|
( |
) | ||||||||
| Acquisitions of non-current financial assets |
|
|
( |
) | ||||||||
| Proceeds from non-current financial assets |
|
|
||||||||||
| |
|
|
|
|
|
|||||||
| Net cash flows used in investing activities |
|
|
( |
) |
||||||||
| |
|
|
|
|
|
|||||||
| Cash flows provided by financing activities: |
|
|
||||||||||
| Decrease in conditional advances |
|
|
( |
) | ( |
) | ||||||
| Treasury shares |
|
|
( |
) | ||||||||
| Capital increases, net of transaction costs |
|
|
||||||||||
| Other cash flows related to financing activities |
|
|
( |
) | ||||||||
| |
|
|
|
|
|
|||||||
| Net cash flows provided by financing activities |
|
|
( |
) | ||||||||
| |
|
|
|
|
|
|||||||
| Effect of exchange rate changes on cash and cash equivalents |
|
|
( |
) | ( |
) | ||||||
| |
|
|
|
|
|
|||||||
| Net increase (decrease) in cash and cash equivalents |
|
|
( |
) | ||||||||
| |
|
|
|
|
|
|||||||
| Net Cash and cash equivalents at the beginning of the period |
|
|
||||||||||
| |
|
|
|
|
|
|||||||
| Net cash and cash equivalents at the end of the period |
|
3 |
|
$ |
$ |
|||||||
| |
|
|
|
|
|
|||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
DBV Technologies S.A.
Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited)
(amounts in thousands, except share and per share
data)
Ordinary shares |
||||||||||||||||||||||||||||||||
Number of Shares |
Amount |
Additional paid-in capital |
Treasury stock |
Accumulated deficit |
Accumulated other comprehensive income (loss) |
Accumulated currency translation effect |
Total Shareholders’ Equity |
|||||||||||||||||||||||||
| Balance at January 1, 2021 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
$ |
|||||||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive loss |
— | — | — | — | — | ( |
) | ( |
) | ( |
) | |||||||||||||||||||||
| Issuance of ordinary shares |
— | — | — | — | ||||||||||||||||||||||||||||
| Treasury shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Balance at March 31, 2021 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive income |
— | — | — | — | — | |||||||||||||||||||||||||||
| Issuance of ordinary shares |
— | — | — | — | ||||||||||||||||||||||||||||
| Issuance of warrants |
||||||||||||||||||||||||||||||||
| Treasury shares |
— | — | ( |
) | — | — | — | ( |
) | |||||||||||||||||||||||
| Share-based payments |
— | — | — | — | — | |||||||||||||||||||||||||||
| Allocation of accumulated net losses |
— | — | ( |
) | — | — | — | — | ||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Balance at June 30, 2021 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
$ |
|||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive income |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
| Treasury shares |
— | — | — | — | — | |||||||||||||||||||||||||||
| Share-based payments |
— | — | — | — | — | |||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Balance at September 30, 2021 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
DBV Technologies S.A.
Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited) (continued)
(amounts in thousands, except share and per share data)
Ordinary shares |
||||||||||||||||||||||||||||||||
Number of Shares |
Amount |
Additional paid-in capital |
Treasury stock |
Accumulated deficit |
Accumulated other comprehensive income (loss) |
Accumulated currency translation effect |
Total Shareholders’ Equity |
|||||||||||||||||||||||||
| Balance at January 1, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
| Issuance of ordinary shares |
— | — | — | — | — | |||||||||||||||||||||||||||
| Treasury shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Other changes |
— | — | — | — | ( |
) | — | |||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Balance at March 31, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
| Issuance of ordinary shares |
— | — | — | — | ||||||||||||||||||||||||||||
| Issuance of warrants |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Treasury shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| Allocation of accumulated net losses |
— | — | ( |
) | — | — | — | — | ||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Balance at June 30, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Net (loss) |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
| Other comprehensive loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||
| Issuance of ordinary shares |
( |
) | — | — | — | — | ( |
) | ||||||||||||||||||||||||
| Treasury shares |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
| Share-based payments |
— | — | — | — | — | — | ||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
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|
|
|||||||||||||||||
| Balance at September 30, 2022 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
7
NOTES TO THE FINANCIAL STATEMENTS (UNAUDITED)
Note 1: The Company
Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or the “group”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin™. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT™, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin™.
Basis of Presentation
The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.
The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on March 9, 2022 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2021 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2021.
Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2022, or any other future period.
Use of estimates
The preparation of the Company’s condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates.
On an on-going basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets - operating lease, (4) impairment of right-of-use assets related to leases and property, plant and equipment, (5) recoverability of the Company's net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, and (7) estimate of contingencies.
Accounting Pronouncements adopted in 2022
The Company has not adopted any new accounting pronouncements in 2022 to date.
Accounting Pronouncements issued not yet adopted
In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13 - Financial Instruments - Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard will have a material impact on its consolidated financial statements.
Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption.
8
Note 2: Significant Events and Transactions
Clinical programs
Viaskin
TM
Peanut for children ages 4-11 in the United States In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the Complete Response Letter received in August 2020. The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a 6 -month, well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.
Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:
1. |
Identify a modified Viaskin patch (“mVP”). |
2. |
Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible. |
3. |
Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies: |
a. |
PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays the Company intends to use in EQUAL |
b. |
‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and mVP; |
In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, to identify the one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, the Company selected the modified patch to advance to further clinical testing in the intended patient population. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape.
In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and in October 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study.
After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 letter. The Company estimated that the FDA’s newly proposed stepwise approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the 6-month safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy is agreeable via oral and written exchanges.
9
The new Phase 3 pivotal study for modified Viaskin Peanut has been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), which means “speed” in French.
In May 2022, the Company announced that the FDA granted it a Type C meeting to align on the protocol and the study protocol was submitted to the FDA as part of Type C meeting briefing package.
On September 9, 2022, the Company announced the initiation of the Phase 3 study, using the modified Viaskin™ Peanut Patch, in peanut-allergic children ages 4 to 7 years.
On September 21, 2022, the Company announced it received feedback from the U.S. FDA in the form of a partial clinical hold on its VITESSE Phase 3 clinical study. In the partial clinical hold letter, the FDA specifies changes to elements of the VITESSE protocol with the intent for the trial to support a future BLA submission. The modifications noted within the FDA’s communication address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment. The Company has not yet begun the screening or recruitment of subjects in the VITESSE study. The partial clinical hold is specific to VITESSE and does not impact any other ongoing its clinical studies. The Company expects to provide additional updates following consultation with the FDA.
Viaskin Peanut for children ages 4-11 - European Union Regulatory History and Current Status
In August 2021, the Company announced its receipt from the EMA of the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.
In December 2021, the Company announced it had withdrawn the Marketing Authorization Application for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by positive data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301). The decision to withdraw was based on the view of EMA Committee for Medicinal Products for Human Use (CHMP) that the data available to date from a single pivotal study were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believes data from a second Viaskin Peanut pivotal study will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intends to resubmit the MAA when that data set is available.
Viaskin Peanut for children ages 1-3
10
In June 2020, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 Pg dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2022.
In June 2022, the Company announced that its pivotal Phase III trial EPITOPE, assessing the safety and efficacy of Viaskin™ Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33.4 %, 95 % CI = 22.4% - 44.5 %).
The Company intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population.
Financing
In May 2022, the Company announced that pursuant to the Company’s program established in May 2022 (the “ATM Program”), it had issued and completed sales of new ordinary shares (the “Ordinary Shares”) in form of American Depositary Shares (“ADSs”), for a total gross amount of $15.3 million. In this context, 6,036,238 new Ordinary Shares in form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.27 dollar per ADS (i.e., a subscription price per Ordinary Share of 2.41 euro based on the USD/EUR exchange rate of 1.0531 dollar for 1 euro, as published by the European Central Bank on May 4, 2022) and each ADS giving the right to receive
At-The-Market
one-half
of one ordinary share of the Company. In June 2022, the Company announced an aggregate $194 million private investment in public equity (PIPE) financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 ordinary shares, as well as 28,276,331 ordinary shares. The ordinary shares were sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22 ), and the 2.90 (corresponding to $3.11 ) per 0.10 exercise price for each such 194 million (corresponding to €181 million), before deducting private placement expenses.
pre-funded
warrants to purchase up to pre-funded
warrants were sold to the purchasers at a pre-funded
price of €pre-funded
warrant, which equals the per share price for the ordinary shares less the remaining €pre-funded
warrant. Gross proceeds from the PIPE financing total approximately $The ordinary shares, including the ordinary shares issuable upon exercise of the pre-funded warrants from the PIPE financing, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. In connection with the PIPE financing, the Company entered into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which the Company filed has a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of 59,269,629 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants.
COVID-19
Pandemic On March 11, 2020, the World Health Organization declared
COVID-19
a pandemic. This global health crisis led many countries to impose national containment measures and travel bans. In view of this exceptional situation, the Company decided to take all measures aimed primarily at guaranteeing the safety of its employees and the continuation of ongoing clinical trials, in compliance with the directives of the authorities in each country. The Company has experienced a decrease in new patients enrolling in the ongoing clinical studies and it has had to adapt the protocols of its clinical trials because patients remain subject to travel restrictions. The Company has assessed the impact of the uncertainties created by the pandemic. As of September 30, 2022, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company. The Company continues to update these estimates and assumptions as the situation evolves. The effects of the COVID-19 pandemic are presented in the relevant line items of the condensed consolidated statement of financial position and the condensed consolidated statement of operations according to the function or nature of the income or expense, and Comprehensive Loss.
Legal Proceedings
A class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis Ito-Stone v. DBV Technologies, et al., Case No. 2:19-cv-00525. The complaint alleged that the Company and its former Chief Executive
11
Officer, its current Chief Executive Officer, and its former Deputy Chief Executive Officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The plaintiffs seek unspecified damages on behalf of a purported class of purchasers of the Company’s securities between February 14, 2018 and August 4, 2020 and also held the Company’s securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020.
A hearing was held on July 29, 2021 in the U.S. District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. As the dismissal was without prejudice, the Plaintiffs replead their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court. The company moved to dismiss third amended complaint on December 10, 2021.
On July 29, 2022 the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs have 30 days to appeal the dismissal of the Third Amended Complaint. The Plaintiffs failed to file an appeal of the dismissal of the Third Amended Complaint within the 30-day period and this matter is resolved with finality.
12
Note 3: Cash and Cash Equivalents
The following tables summarize the cash and cash equivalents as of September 30, 2022 and December 31,
2021:
September 30, |
December 31, |
|||||||
2022 |
2021 |
|||||||
Cash |
||||||||
Cash equivalents |
||||||||
Total cash and cash equivalents as reported in the statements of financial position |
||||||||
Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.
Note 4 Other Current Assets
Other current assets consisted of the following:
September 30, |
December 31, |
|||||||
2022 |
2021 |
|||||||
Research tax credit |
||||||||
Other tax claims |
||||||||
Prepaid expenses |
||||||||
Other receivables |
||||||||
Total |
||||||||
Research tax credit
In the fiscal year ended December 31, 2021, the Company recovered its Small and
Medium-sized
Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit. During the nine months period ended September 30, 2022, the Company received the reimbursement of the 2019, 2020 and 2021 fiscal year research tax credit.
The variance in Research Tax Credit is presented as
follows:
Amount in thousands of US Dollars |
||||
Opening research tax credit receivable as of January 1, 2022 |
||||
+ Operating revenue |
||||
- Payment received |
( |
) | ||
- Adjustment and currency translation effect |
( |
) | ||
Closing research tax credit receivable as of September 30, 2022 |
||||
Of which - Non-current portion |
||||
Of which - Current portion |
||||
1
3
The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.
Note 5 Lease contracts
Future minimum lease payments under the Company's operating leases’ right of use as of September 30, 2022 and December 31, 2021, are as follows:
September 30, 2022 |
December 31, 2021 |
|||||||||||||||||||||||
Real estate |
Other assets |
Total |
Real estate |
Other assets |
Total |
|||||||||||||||||||
Current portion |
||||||||||||||||||||||||
Year 2 |
||||||||||||||||||||||||
Year 3 |
||||||||||||||||||||||||
Year 4 |
— | — | — | |||||||||||||||||||||
Year 5 |
— | — | — | — | ||||||||||||||||||||
Thereafter |
— | — | — | — | ||||||||||||||||||||
Total minimum lease payments |
||||||||||||||||||||||||
Less: Effects of discounting |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Present value of operating lease |
||||||||||||||||||||||||
Less: current portion |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Long-term operating lease |
||||||||||||||||||||||||
Weighted average remaining lease term (years) |
— | |||||||||||||||||||||||
Weighted average discount rate |
% | % | % | % | ||||||||||||||||||||
The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the condensed consolidated statement of operations and comprehensive loss was:
September 30, |
||||||||
2022 |
2021 |
|||||||
Operating lease expense |
||||||||
Net termination impact |
( |
) | — | |||||
In January 2022, the company entered into a termination agreement for its U.S. office in Summit, NJ, following the resizing of its facility use. The Company recognized an income of $1.2 million as of June 30, 2022 due to the early termination of its Summit, NJ lease, offset by the payment of a 1.5 million.
one-time
lump sum early termination fee of $On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months .
The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. Right of use and related lease debt have been recorded starting April 1, 2022 for a gross amount
of 0.4 million.
$
1
4
Supplemental cash flow information related to operating leases is as follows for the period September 30, 2022 and
2021:
September 30, |
||||||||
2022 |
2021 |
|||||||
| Cash paid for amounts included in the measurement of lease liabilities |
— | — | ||||||
| Operating cash flows from operating leases |
||||||||
Note 6: Trade Payables and Other Current Liabilities
6.1 Trade Payables
No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented.
6.2 Other Liabilities
The following tables summarize the other liabilities as of September 30, 2022 and December 31,
2021:
September 30, |
December 31, |
|||||||||||||||||||||||
2022 |
2021 |
|||||||||||||||||||||||
Other current liabilities |
Other non- current liabilities |
Total |
Other current liabilities |
Other non- current liabilities |
Total |
|||||||||||||||||||
| Employee related liabilities |
||||||||||||||||||||||||
| Deferred income |
||||||||||||||||||||||||
| Tax liabilities |
||||||||||||||||||||||||
| Other debts |
||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Total |
||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
The other current liabilities include short-term debt to employees including social welfare and tax agency obligations.
Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $3.8 million as of September 30, 2022.
Note 7: Shareholders’ equity
The share capital as of September 30, 2022 is set at the sum of €9,402,544 ($10,708,725 converted at historical rates). It is divided into 94,025,441 fully authorized, subscribed and 0.10 .
paid-up
shares with a par value of €Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022 (the “SH General Meeting”), the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2021 have been allocated to additional
paid-in
capital. Pursuant to the authorization granted by the SH General Meeting, the Board of Directors, at its meeting of June 9, 2022 (the “Board General
Meeting”):
| • | decided, within the framework of the PIPE financing the principle of a capital increase in cash with cancellation of preferential subscription rights, reserved for categories of persons meeting which set out the characteristics included in the 18th resolution of the Board General Meeting, through the issuance of Ordinary Shares and warrants to subscribe for Ordinary Shares, for a maximum amount of nd resolution of the Board General Meeting; |
1
5
| • | granted a number of authorizations for the purpose of carrying out the i |
| • | sub-delegated its authority to the Chief Executive Officer for the purpose of implementing the financing. |
The Chief Executive Officer, acting pursuant to the sub-delegations of authority granted by the Board of Directors of the Company on June 8, 2022, after receiving the favorable opinion of the Pricing Committee established by the Board of Directors, has, on June 9, 2022 :
| • | decided, making use of the 18 th resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L. 225-128 of French Commercial Code, an amount of € |
| • | decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € pre-financed price released in advance at the time of the subscription of the prefunded warrants ), being specified that this amount does not take into account the nominal value of the ordinary shares to be issued in order to preserve the rights of the holders of securities giving access to the capital issued or to be issued, in accordance with the legal and regulatory provisions and the contractual stipulations providing for other cases of adjustment if necessary; |
| • | determined the list of beneficiaries (designated within each of the categories of persons defined in the 18 th resolution of the Board General Meeting) and the number of New Ordinary Shares and warrants allocated to each of them under the conditions defined in the 18th resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the PIPE financing. |
The Company has assessed the
pre-funded
warrants for appropriate equity or liability classification. During this assessment, the Company determined the pre-funded
warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815. The 2022 Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the 2022 Warrants do not provide any guarantee of value or return.
Accordingly, the
pre-funded
warrants are classified as equity and accounted for as a component of additional paid-in
capital at the time of issuance. The changes in number of outstanding prefunded warrants are as follows:
Prefunded warrants |
||||
| Balance as of December 31, 2021 |
||||
| Granted during the period |
||||
| Forfeited during the period |
||||
| Exercised/released during the period |
||||
| Expired during the period |
||||
| |
|
|||
| Balance as of September 30, 2022 |
||||
| |
|
|||
1
6
Note 8: Share-Based Payments
The Board of Directors has been authorized by the SH General Meeting to grant restricted stock units (“RSU”), stock options plan (“SO”) and or “BSA”).
non-employee
warrants (Bons de Souscription d’Actions
During the nine months ended September 30, 2022, the Company granted 154,500 stock options and 69,900 restricted stock units to employees. There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 13 to the consolidated financial statements included in the Annual Report.
| Stock option fair value assumptions during the nine months ended September 30, 2022 |
||||
| Weighted average share price at grant date in € |
||||
| Weighted average expected volatility |
% | |||
| Weighted average risk-free interest rate |
% | |||
| Weighted average expected term (in years) |
||||
| Dividend yield |
||||
| Weighted average fair value of stock options in € |
||||
Change in Number of BSA/SO/RSU:
Number of outstanding |
||||||||||||
BSA |
SO |
RSUs |
||||||||||
| Balance as of December 31, 2021 |
||||||||||||
| Granted during the period |
— | |||||||||||
| Forfeited during the period |
— | ( |
) | ( |
) | |||||||
| Exercised/released during the period |
( |
) | ( |
) | ||||||||
| Expired during the period |
( |
) | — | |||||||||
| |
|
|
|
|
|
|||||||
| Balance as of September 30, 2022 |
||||||||||||
| |
|
|
|
|
|
|||||||
Share-based payments exp
e
nses reflected in the condensed consolidated statements of operations is as follows:
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||||||
| Research & development |
SO | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
| RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
| Sales & marketing |
SO | ( |
) | ( |
) | ( |
) | |||||||||||||
| RSU | ( |
) | ( |
) | ||||||||||||||||
| General & administrative |
SO | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
| RSU | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| Total share-based compensation (expense) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
1
7
Note 9: Contingencies
The following tables summarize the contingencies as of September 30, 2022 and December 31, 2021:
September 30, |
December 31, |
|||||||
2022 |
2021 |
|||||||
| Current contingencies |
||||||||
| Non-current contingencies |
||||||||
| |
|
|
|
|||||
| Total contingencies |
||||||||
| |
|
|
|
|||||
The changes in contingencies are as follows:
Pension retirement obligations |
Collaboration agreement - Loss at completion |
Other contingencies |
Total |
|||||||||||||
| At January 1, 2022 |
||||||||||||||||
| Increases in liabilities |
||||||||||||||||
| Used liabilities |
— | ( |
) | ( |
) | ( |
) | |||||||||
| Reversals of unused liabilities |
— | — | ||||||||||||||
| Net interest related to employee benefits, and unwinding of discount |
— | — | — | |||||||||||||
| Actuarial gains and losses on defined-benefit plans |
( |
) | — | — | ( |
) | ||||||||||
| Currency translation effect |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
| At September 30, 2022 |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Of which Current |
— |
— |
||||||||||||||
| Of which Non-current |
— |
|||||||||||||||
In 2021 and during the first nine months of 2022, the Company updated its measurement of progress of the Phase 2 clinical trial (“PII”) conducted as part of the collaboration and license agreement with Nestlé and updated the cumulative income recognized. The Company has recorded an accrual in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and incomes yet to be recognized for the completion of the PII.
There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 14 to the consolidated financial statements included in the Annual Report.
Note 10: Operating income
The following table summarizes the operating income during the three and six months ended September 30, 2022 and 2021:
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
| Research tax credit |
||||||||||||||||
| Other operating income |
( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
As of September 30, 2022, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of
1
8
the Phase II clinical trial conducted as part of the agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly.
Note 11: Allocation of Personnel Expenses
The Company had an average of 85 employees during the nine months ended September 30, 2022, in comparison with an average of 105 employees during the nine months ended September 30, 2021.
The following table summarizes the allocation of personnel expenses by function during the three and nine months ended September 30, 2022 and 2021:
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
| Research and Development expenses |
||||||||||||||||
| Sales and Marketing expenses |
||||||||||||||||
| General and Administrative expenses |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total personnel expenses |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
The following table summarizes the allocation of personnel expenses by nature during the three and nine months ended September 30, 2022 and 2021:
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
| Wages and salaries |
||||||||||||||||
| Social security contributions |
||||||||||||||||
| Expenses for pension commitments |
||||||||||||||||
| Employer contribution to bonus shares |
( |
) | ( |
) | ||||||||||||
| Share-based payments |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
The decrease in personnel expenses is mainly due to a decrease in headcount following the full implementation of the new organization.
Note 12: Commitments
There have been no significant changes in other commitments from those disclosed in Note 18 to the consolidated financial statements included in the Annual Report.
Note 13: Relationships with Related Parties
The Company’s related parties consist exclusively of the members of the Board of Directors and the members of the Executive Committee. As of September 30, 2022, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not changed significantly since December 31, 2021.
There were no new significant related-party transactions during the period nor any change in the nature of the transactions from those described in Note 19 to the consolidated financial statements included in the Annual Report.
1
9
Note 14: Loss Per Share
Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three and nine months periods ended September 30, 2022 and 2021, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss.
The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three and six months ended September 30, 2022 and 2021 indicated in number of potential shares:
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
| Non-employee warrants |
||||||||||||||||
| Stock options |
||||||||||||||||
| Restricted stock units |
||||||||||||||||
| Prefunded warrants |
||||||||||||||||
Note 15: Events after the Close of the Period
The Company evaluated subsequent events that occurred after September 30, 2022, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on November 3, 2022 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.
20
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, 2021, included in our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission on March 9, 2022, 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
TM
, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin. We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, as it targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat patients, including infants and 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. Our most advanced clinical program is Viaskin Peanut. Viaskin
TM
Peanut for children ages 4-11 in the United States In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the Complete Response Letter received in August 2020. The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches
Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:
| 1. | Identify a modified Viaskin patch (“mVP”). |
| 2. | Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible. |
| 3. | Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies: |
| a. | PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays the Company intends to use in EQUAL |
| b. | ‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and mVP; |
In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, to identify the one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, the Company selected the modified patch to advance to
21
further clinical testing in the intended patient population. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape.
In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and in October 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study.
After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 letter. The Company estimated that the FDA’s newly proposed stepwise approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the 6-month safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy is agreeable via oral and written exchanges.
The new Phase 3 pivotal study for modified Viaskin Peanut has been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), which means “speed” in French.
In May 2022, the Company announced that the FDA granted it a Type C meeting to align on the protocol and the study protocol was submitted to the FDA as part of the Type C meeting briefing package.
On September 9, 2022, the Company announced the initiation of the Phase 3 study, using the modified Viaskin™ Peanut Patch, in peanut-allergic children ages 4 to 7 years.
On September 21, 2022, the Company announced it received feedback from the U.S. FDA in the form of a partial clinical hold on its VITESSE Phase 3 clinical study. In the partial clinical hold letter, the FDA specifies changes to elements of the VITESSE protocol with the intent for the trial to support a future BLA submission. The modifications noted within the FDA’s communication address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment. The Company has not yet begun the screening or recruitment of subjects in the VITESSE study. The partial clinical hold is specific to VITESSE and does not impact any other ongoing its clinical studies. The Company expects to provide additional updates following consultation with the FDA.
22
Viaskin Peanut for children ages 4-11 - European Union Regulatory History and Current Status
In August 2021, the Company announced its receipt from the EMA of the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.
In December 2021, the Company announced it had withdrawn the Marketing Authorization Application for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by positive data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301). The decision to withdraw was based on the view of EMA Committee for Medicinal Products for Human Use (CHMP) that the data available to date from a single pivotal study were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believes data from a second Viaskin Peanut pivotal study will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intends to resubmit the MAA when that data set is available.
Viaskin Peanut for children ages 1-3
In June 2020, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 Pg dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2022.
In June 2022, The Company announced that its pivotal Phase III trial EPITOPE, assessing the safety and efficacy of Viaskin™ Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33.4 %, 95 % CI = 22.4% - 44.5 %).
DBV intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population.
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 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 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 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.
Business trends and Results of Operations
Comparison of the Three Months Ended September 30, 2022 and 2021
The following table summarizes our results of operations, derived from our 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 September 30, 2022 and 2021.
23
Three months ended September 30, |
||||||||||||||||
2022 |
2021 |
$ change |
% change |
|||||||||||||
| Operating income |
$ |
2,074 |
$ |
1,323 |
751 |
57 |
% | |||||||||
| Operating expenses |
||||||||||||||||
| Research and development expenses |
(15,096 | ) | (16,320 | ) | 1,224 | (8 | %) | |||||||||
| Sales and marketing expenses |
(159 | ) | (1,072 | ) | 913 | (85 | %) | |||||||||
| General and administrative expenses |
(4,839 | ) | (8,299 | ) | 3,460 | (42 | %) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total Operating expenses |
(20,094 | ) | (25,691 | ) | 5,597 | (22 | %) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Financial income |
732 | 336 | 396 | 118 | % | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Income tax |
— | — | — | — | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ |
(17,287 |
) |
$ |
(24,033 |
) |
6,745 |
(28 |
%) | |||||||
| |
|
|
|
|
|
|
|
|||||||||
| Basic/diluted Net loss per share attributable to shareholders |
$ |
(0.18 |
) |
$ |
(0.44 |
) |
||||||||||
Operating Income
The following table summarizes our operating income during the three months ended September 30, 2022 and 2021:
Three months ended September 30, |
$ change |
% change |
||||||||||||||
2022 |
2021 |
|||||||||||||||
| Sales |
— | — | — | — | ||||||||||||
| Other income |
2,074 | 1,323 | 751 | 57 | % | |||||||||||
| Research tax credit |
1,407 |
1,647 |
(240 | ) | (15 | %) | ||||||||||
| Other operating income |
668 |
(324 |
) |
992 | (306 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total operating income |
2,074 |
1,323 |
751 |
57 |
% | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Our operating income is primarily generated from the French research tax credit (, or “CIR”), and by the revenue recognized under our collaboration agreement with Nestlé Health Science. We generated operating income of $2.1 million during the three months ended September 30, 2022 compared to $ 1.3 million during the three months ended September 30, 2021. The increase in operating income is primarily attributable to the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. During the three months ended September 30, 2021 negative revenue was recognized under the Nestlé’s collaboration agreement due to delays in new patient enrollment. The decrease in research tax credit is attributable to the decrease in eligible costs in connection with Research and Development costs.
Crédit d’Iimpôt Recherche
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the three months ended September 30, 2022 and 2021:
Three Months Ended September 30, |
||||||||||||||||
Research and Development expenses |
2022 |
2021 |
$ change |
% change |
||||||||||||
| External clinical-related expenses |
11,136 | 8,633 | 2,503 | 29 | % | |||||||||||
| Employee-related costs |
2,648 | 3,228 | (581 | ) | (18 | %) | ||||||||||
| Share-based payment expenses |
538 | 933 | (395 | ) | (42 | %) | ||||||||||
| Depreciation, amortization and other costs |
774 | 3,526 | (2,752 | ) | (78 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total Research and Development expenses |
15,096 |
16,320 |
(1,224 |
) |
(8 |
%) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Research and Development expenses decreased by $1.2 million for the three months ended September 30, 2022, compared to the three
24
months ended September 30, 2021, primarily due to a decrease in depreciation, amortization and following the loss at completion recorded on the Phase II clinical trial conducted as part of the Nestlé agreement for the three months ended September 30, 2021. The increase in external clinical-related expenses is driven by the launch of work on VITESSE protocol. We have also continued to practice financial discipline and implemented further cost containment strategies.
Employee-related costs, excluding share-based payment expenses, decreased by $1.0 million for the three months ended September 30, 2022 compared to the three months ended September 30, 2021 mostly due to EUR/USD exchange variation and workforce reduction.
25
Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the three months ended September 30, 2022 and 2021:
Three Months Ended September 30, |
$ change |
% change |
||||||||||||||
Sales and Marketing expenses |
2022 |
2021 |
||||||||||||||
| Personnel expenses |
138 | 492 | (354 | ) | (72 | %) | ||||||||||
| External professional services and other costs |
20 | 580 | (559 | ) | (96 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total Sales and Marketing expenses |
159 |
1,072 |
(913 |
) |
(85 |
%) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Sales and marketing expenses amounted to $0.2 million for the three months ended September 30, 2022, compared to $1.1 million for the three months ended September 30, 2021.
Employee-related costs decreased by $0.3 million for the three months ended September 30, 2022, compared to the three months ended September 30, 2021 due to the workforce reduction following full implementation of the new organization.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the three months ended September 30, 2022 and 2021:
Three Months Ended September 30, |
$ change |
% change |
||||||||||||||
General and Administrative expenses |
2022 |
2021 |
||||||||||||||
| External professional services |
1,292 | 2,216 | (924 | ) | (42 | %) | ||||||||||
| Employee-related costs |
1,110 | 2,052 | (942 | ) | (46 | %) | ||||||||||
| Share-based payment expenses |
488 | 530 | (42 | ) | (8 | %) | ||||||||||
| Depreciation, amortization and other costs |
1,949 | 3,501 | (1,552 | ) | (44 | %) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total General and Administrative expenses |
4,839 |
8,299 |
(3,460 |
) |
(42 |
%) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
General and Administrative expenses decreased by $3.5 million for the three months ended September 30, 2022, compared to the three months ended September 30, 2021 primarily due to a decrease in depreciation, amortization and other costs as we continued to practice financial discipline and implemented further cost containment strategies.
Financial income (expense)
Our financial income was approximately $0.7 million for the three months ended September 30, 2022, compared to a financial income of $0.3 million for the three months ended September 30, 2021. This item mainly includes foreign exchange income.
Income tax
We did not have any income tax profit or expense for the three months ended September 30, 2022 nor 2021.
Net loss
Net loss was $17.3 million for the three months ended September 30, 2022, compared to $24.0 million for the three months ended September 30, 2021. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.18 and $0.44 for the three months ended September 30, 2022 and 2021, respectively.
26
Business trends and Results of Operations
Comparison of the Nine Months Ended September 30, 2022 and 2021
The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the nine months ended September 30, 2022 and 2021.
Nine months ended September 30, |
$ change |
% change |
||||||||||||||
2022 |
2021 |
|||||||||||||||
| Operating income |
$ |
6,148 |
$ |
2,776 |
3,373 |
122 |
% | |||||||||
| Operating expenses |
||||||||||||||||
| Research and development expenses |
(45,930 | ) | (58,663 | ) | 12,733 | (22 | )% | |||||||||
| Sales and marketing expenses |
(1,659 | ) | (2,999 | ) | 1,340 | (45 | )% | |||||||||
| General and administrative expenses |
(17,173 | ) | (26,250 | ) | 9,077 | (35 | )% | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total Operating expenses |
(64,762 | ) | (87,912 | ) | 23,150 | (26 | )% | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Financial income |
1,668 | 597 | 1,071 | 179 | % | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Income tax (expense) |
(87 | ) | 404 | (491 | ) | (122 | )% | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ |
(57,033 |
) |
$ |
(84,136 |
) |
27,103 |
(32 |
)% | |||||||
| |
|
|
|
|
|
|
|
|||||||||
| Basic/diluted Net loss per share attributable to shareholders |
$ |
(0.79 |
) |
$ |
(1.53 |
) |
||||||||||
Operating Income
The following table summarizes our operating income during the nine months ended September 30, 2022 and 2021:
Nine months ended September 30, |
$ change |
% change |
||||||||||||||
2022 |
2021 |
|||||||||||||||
| Sales |
— | — | ||||||||||||||
| Other income |
6,148 | 2,776 | 3,373 | 122 | % | |||||||||||
| Research tax credit |
4,467 |
5,324 |
(857 |
) |
(16 |
%) | ||||||||||
| Other operating income |
1,681 |
(2,549 |
) |
4,230 |
(166 |
%) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total operating income |
6,148 |
2,776 |
3,373 |
122 |
% | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Our operating income was primarily generated from the French research tax credit (or “CIR”) and from revenue recognized under our collaboration agreement with Nestlé Health Science. We generated operating income of $6.1 million during the nine months ended September 30, 2022, compared to $2.8 million during the nine months ended September 30, 2021.
Crédit d’Impôt Recherche
The increase in operating income is primarily attributable to the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. During the nine months ended September 30, 2021 negative revenue was recognized under the Nestlé’s collaboration agreement due to delays in new patient enrollment. The decrease in research tax credit is attributable to the decline in eligible expenses in connection with Research and Development costs.
27
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the nine months ended September 30, 2022 and 2021:
Nine Months Ended September 30, |
||||||||||||||||
2022 |
2021 |
$ change |
% change |
|||||||||||||
Research and Development expenses |
||||||||||||||||
External clinical-related expenses |
30,150 | 31,319 | (1,169 | ) | (4 | %) | ||||||||||
Employee-related costs |
7,761 | 10,525 | (2,764 | ) | (26 | %) | ||||||||||
Share-based payment expenses |
1,596 | 1,747 | (151 | ) | (9 | %) | ||||||||||
Depreciation, amortization and other costs |
6,423 | 15,072 | (8,649 | ) | (57 | %) | ||||||||||
Total Research and Development expenses |
45,930 |
58,663 |
(12,733 |
) |
(22 |
%) | ||||||||||
Research and Development expenses decreased by $12.7 million for the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021 primarily due to a decrease in external clinical-related expenses as main component of the work on clinical studies such as REALISE and EPITOPE has been finalized during the year 2021. We have also continued to practice financial discipline and implemented further cost containment strategies.
Employee-related costs, excluding share-based payments expenses, decreased by $2.8 million for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021 due to the workforce reduction following full implementation of the new organization.
The decrease in depreciation, amortization and other costs was primarily due to the loss at completion recorded on the Phase II clinical trial conducted as part of Nestlé agreement.
Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2022 and 2021:
Nine Months Ended September 30, |
||||||||||||||||
2022 |
2021 |
$ change |
% change |
|||||||||||||
Sales and Marketing expenses |
||||||||||||||||
Personnel expenses |
727 | 1,528 | (801 | ) | (52 | %) | ||||||||||
External professional services and other costs |
932 | 1,471 | (538 | ) | (37 | %) | ||||||||||
Total Sales and Marketing expenses |
1,659 |
2,999 |
(1,340 |
) |
(45 |
%) | ||||||||||
Sales and marketing expenses decreased by $1.3 million for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021, primarily due to a decrease in employee-related costs.
Personnel expenses, decreased by $0.8 million for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021 due to the workforce reduction following full implementation of the new organization.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2022 and 2021:
Nine Months Ended September 30, |
||||||||||||||||
2022 |
2021 |
$ change |
% change |
|||||||||||||
General and Administrative expenses |
||||||||||||||||
External professional services |
4,171 | 6,425 | (2,255 | ) | (35 | %) | ||||||||||
Employee-related costs |
5,139 | 7,263 | (2,124 | ) | (29 | %) | ||||||||||
Share-based payment expenses |
1,822 | 2,084 | (263 | ) | (13 | %) | ||||||||||
Depreciation, amortization and other costs |
6,042 | 10,478 | (4,436 | ) | (42 | %) | ||||||||||
Total General and Administrative expenses |
17,173 |
26,250 |
(9,077 |
) |
(35 |
%) | ||||||||||
28
General and Administrative expenses decreased by $9.1 million for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021, primarily due to a decrease of depreciation, amortization and other costs. We have continued to practice financial discipline and implemented further cost containment strategies.
The decrease in employee-related costs, excluding share-based payment expenses, is directly related to the workforce reduction following full implementation of the new organization
.
Financial income (expense)
Our financial income was $1.7 million for the nine months ended September 30, 2022, compared to a financial income of $0.6 million for the nine months ended September 30, 2021. This item mainly includes foreign exchange income (expense).
Income tax
Our income tax expense was $87,000 for the nine months ended September 30, 2022, compared to a US Tax income of $404,000 for the nine months ended September 30, 2021.
Net loss
Net loss was $57.0 million for the nine months ended September 30, 2022, compared to $84.1 million for the nine months ended September 30, 2021. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.79 and $1.53 for the nine months ended September 30, 2022 and 2021, respectively.
Liquidity and Capital Resources
Financial Condition
On September 30, 2022, we had $212.7 million in cash and cash equivalents compared to $77.3 million of cash and cash equivalents on December 31, 2021. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $31.8 and $89.5 million for the nine months ended September 30, 2022 and 2021, respectively. For the nine months ended September 30, 2022, we recorded a net loss of $57 million. Our net cash flows provided by financing activities increased to $194.4 million during the nine months ended September 30, 2022 from $(0.1) million during the nine months ended September 30, 2021. Financing activities consisted mainly of our global offering in the second quarter of 2022.
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. 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.
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.
29
As of the date of the filing, our available cash is projected to be sufficient to support our operating plan for at least the next 12 months.
In May 2022, the Company announced that pursuant to the Company’s ATM program, it had issued and completed sales of new Ordinary Shares in the form of ADSs, for a total gross amount of $15.3 million.
In June 2022, the Company announced an aggregate $194 million PIPE financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 Ordinary Shares, as well as pre-funded warrants to purchase up to 28,276,331 Ordinary Shares.
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 due to the ongoing COVID-19 pandemic. 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.
The following table presents our material cash requirements for future periods:
Material Cash Requirements Due by the period Ended September 30, |
||||||||||||||||||||
2023 |
2024 |
2025 |
Thereafter |
Total |
||||||||||||||||
(Amounts in thousands) |
||||||||||||||||||||
Operating leases |
1,381 | 1,423 | — | — | 2,804 | |||||||||||||||
Purchase obligations - Obligations Under the Terms of CRO Agreements |
12,411 | 36,234 | 7,805 | — | 56,450 | |||||||||||||||
Total |
13,791 | 37,657 | 7,805 | — | 59,254 | |||||||||||||||
The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. The table does not include obligations under agreements that we can cancel without a significant penalty.
Future events could cause actual payments to differ from these estimates.
Conditional advances
In 2014, BpiFrance Financement granted an interest-free Innovation loan to DBV Technologies to help finance the pharmaceutical development of Viaskin™ Milk. This amount was received in a single disbursement on November 27, 2014. In 2020, due to the COVID-19 pandemic, Bpifrance postponed the repayments for a 6-month period. Repayment ended during the third quarter of 2022.
Operating leases
Our corporate headquarters are located in Montrouge, France. Our principal offices occupy a 4,470 square meter facility, pursuant to a lease agreement dated March 3, 2015 and represents a $3 million cash requirement as of September 30, 2022 which expires March 8, 2024.
We also have facilities in North America that were initially intended to support our U.S. subsidiary as well as future commercialization needs. We lease 3,780 square feet of office space in Tower 49, New York, New York. This lease is for a period of 65 months and expires on February 25, 2023. In light of our global restructuring, the current stage of regulatory interactions regarding Viaskin Peanut, and the ongoing COVID-19 pandemic, we entered into a sublease agreement of this office space in June 2021. The NYC office represents a $0.2 million cash requirement as of September 30, 2022 until the first quarter of 2023.
On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. The principal offices occupy a 5,799 square meter facility, and represents a $0.4 million cash requirement as of September 30, 2022 which expires May 1, 2025.
30
Purchase obligations - Obligations Under the Terms of CRO Agreements
In connection with the launch of our clinical trials for Viaskin Peanut and Viaskin Milk, we signed agreements with several contract research organizations. Expenses associated with the ongoing trials amounted globally to $125.9 million. As of September 30, 2022, the amount we are still obligated to pay in connection with these contracts through 2025 is $56.4 million.
31
Summary Statement of Cash Flows
The table below summarizes our sources and uses of cash for the nine months ended September 30, 2022 and 2021.
Nine months ended September 30, |
||||||||||||||||
(Amounts in thousands of U.S. Dollars) |
2022 |
2021 |
$ change |
% of change |
||||||||||||
Net cash flow used in operating activities |
(31,781 | ) | (89,452 | ) | 57,671 | (64 | %) | |||||||||
Net cash flow used in investing activities |
(66 | ) | 41 | (107 | ) | (262 | %) | |||||||||
Net cash flow provided by financing activities |
194,403 | (103 | ) | 194,506 | * | |||||||||||
Effect of exchange rate changes on cash and cash equivalents |
(27,186 | ) | (8,643 | ) | (18,543 | ) | 215 | % | ||||||||
Net (decrease) increase in cash and cash equivalents |
135,369 |
(98,157 |
) |
233,527 |
(238 |
%) | ||||||||||
| * | Percentage not meaningful |
Operating Activities
Our net cash flows used in operating activities were $31.8 million and $89.5 million during the nine months ended September 30, 2022 and 2021, respectively. During the nine months period ended September 30, 2022, we received $21.1 million of research tax credit’s reimbursement for the 2019, 2020 and 2021 fiscal year. Excluding research tax credit reimbursement, our net cash flows used in operating activities decreased by $31.3 million, or 35%, mainly due to cost containment measures and to the workforce reduction following full implementation of the new organizationCash flows used in operating activities for the nine months ended September 30, 2021 included restructuring costs paid for $0.7 million.
.
Financing Activities
Our net cash flows provided by financing activities increased to $194.4 million during the nine months ended September 30, 2022 from $103,000 during the nine months ended September 30, 2021. Financing activities consisted mainly of our global offering in the second quarter of 2022.
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.
32
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our market risks have not changed materially from those disclosed in item 7A of the Annual Report.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Based on its evaluation as of September 30, 2022, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting identified in management's evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitation on Effectiveness of Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error of fraud may occur and not be detected.
33
PART II – Other information
Item 1. Legal Proceedings
See “Note 2: Significant Events and Transactions – Legal Proceedings” in the notes to the condensed consolidated financial statements included elsewhere in this Report.
Item 1A. Risk Factors
Except as set forth below, there have been no material changes in our risk factors from those disclosed in the Annual Report.
Future sales of ordinary shares or ADSs by existing shareholders could depress the market price of the ADSs.
As of December 31, 2021, 55,095,762 Ordinary Shares were issued and outstanding. Sales of a substantial number of shares of our Ordinary Shares or ADSs in the public market, or the perception that these sales might occur, could depress the market price of our securities and could impair our ability to raise capital through the sale of additional equity securities. A substantial number of our shares are now generally freely tradable, subject, in the case of sales by our affiliates, to the volume limitations and other provisions of Rule 144 under the Securities Act. If holders of these shares sell, or indicate an intent to sell, substantial amounts of our securities in the public market, the trading price of our securities could decline significantly.
In June 2022, we completed a $194 million PIPE financing from the sale of (i) 32,855,669 Ordinary Shares, nominal value €0.10 per share at a price per Ordinary Share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022), and (ii) pre-funded warrants to purchase an aggregate of 28,276,331 Ordinary Shares (the “Warrant Shares”) at a pre-funded price per pre-funded warrant of €2.90 (corresponding to $3.11), which equals the per share price of the Ordinary Shares less the exercise price of €0.10 per pre-funded warrant. Each pre-funded warrant has an exercise price of €0.10 per Warrant Share. Pursuant to a registration rights agreement (the “Registration Rights Agreement”) with the investors, the Company filed a registration statement with the SEC registering the resale of 59,269,629 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants. The Company also filed a registration statement with the SEC registering the resale of 11,593,170 ordinary shares by Entities affiliated with Baker Bros. Advisors, issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants. As a result, subject to certain beneficial ownership limitations contained in the pre-funded warrants, these shares are freely tradable, without restriction, in the public market. In addition, the exercise of some or all of the pre-funded warrants will increase the number of our outstanding ordinary shares, which may dilute the ownership percentage or voting power of our shareholders.
In addition, we have filed a registration statement with the SEC to register the Ordinary Shares that may be issued under our equity incentive plans. The Ordinary Shares subject to outstanding options under our equity incentive plans, Ordinary Shares reserved for future issuance under our equity incentive plans and Ordinary Shares subject to outstanding warrants will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations. Sales of a large number of the shares issued under these plans in the public market could have an adverse effect on the market price of our securities.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
During the nine months ended September 30, 2022, we issued the following unregistered securities:
| • | On March 23, 2022, the issuance of an aggregate of 775 ordinary shares to a non-U.S. employee upon settlement of RSUs; |
| • | On May 19, 2022, the issuance of an aggregate of 5,000 ordinary shares to a non-U.S. employee upon settlement of RSUs; |
| • | On May 24, 2022, the issuance of an aggregate of 26,135 ordinary shares to a non-U.S. employee upon settlement of RSUs; |
| • | Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022, the Company offered the opportunity to subscribe for warrants to purchase ordinary shares on May 12, 2022, and on June 9, 2022, the Chief Executive Officer authorized a capital increase for an amount of €3,285,566.90 through the issue of (i) 32,855,669 New Shares with a per value of €0.10 each and (ii) the issuance of 28,276,331 prefunded warrants, with cancellation of shareholders' preferential subscription rights in favor of Braidwell LP, funds advised by Baker Bros. Advisors LP and BpiFrance Participations SA, existing shareholders of the Company and Venrock Healthcare Capital Partners. |
| • | On June 8, 2022, we entered into a securities purchase agreement with certain institutional and accredited investors pursuant to which we agreed to issue and sell to the investors i) 32,855,669 ordinary shares, nominal value €0.10 per share, at a price per ordinary share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022), and (ii) pre-funded warrants to purchase an aggregate of 28,276,331 ordinary shares (the “Warrant |
34
Shares”) at a pre-funded price per pre-funded warrant of €2.90 (corresponding to $3.11), which equals the per share price of the ordinary shares less the exercise price of €0.10 per Pre-Funded Warrant. Each Pre-Funded Warrant has an exercise price of €0.10 per Warrant Share. The Pre-Funded Warrants are exercisable at any time after their original issuance and will expire ten years following their issuance. The exercise price and number of shares of ordinary shares issuable upon exercise of the warrants may be adjusted in certain circumstances, including stock splits, stock dividends, reclassifications and the like. The pre-funded warrants issued in the PIPE provide that the holder of the pre-funded warrants will not have the right to exercise any portion of its pre-funded warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of ordinary shares outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”). The holder may increase or decrease the Beneficial Ownership Limitation, provided, however, that the holder may only increase the Beneficial Ownership Limitation by (i) obtaining authorization from the French Ministry of Economy in the event the Beneficial Ownership Limitation is being raised above 9.99%, and (ii) by providing 61 days’ notice to the Company, except that in no event will the Beneficial Ownership Limitation exceed 19.99%. The securities issued by us pursuant to the securities purchase agreement and to be issued upon exercise of the warrants were not registered under the Securities Act of 1933, as amended, or the Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Pursuant to the Registration Rights Agreement, the Company filed a registration statement with the Securities and Exchange Commission registering the resale of 59,269,629 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants. |
| • | On June 10, 2022, the issuance of 3,100 ordinary shares to a non-U.S. employee upon exercise of 3,100 SO at an exercise price of 4.16 euros per SO, for aggregate proceeds to the Company of 12,896 euros. |
| • | On July 8, 2022, the issuance of 2,513 ordinary shares to a U.S. employee upon exercise of 2,513 SO at an exercise price of 4.16 euros per SO, for aggregate proceeds to the Company of 10,454 euros. |
| • | On September 23, 2022, the issuance of an aggregate of 249 ordinary shares to a non-U.S. employee upon settlement of RSUs. |
None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Regulation S promulgated under Section 5 of the Securities Act, as transactions by an issuer not involving any public offering or as offerings made to non-U.S. resident employees pursuant to an employee benefit plan established and administered in accordance with the law of a country other than the United States (namely, the Republic of France) and in accordance with that country’s practices and documentation. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Not applicable.
35
Item 6. Exhibits.
Exhibit Index
Incorporated by Reference | ||||||||||
Exhibit |
Description |
Schedule/ Form |
File Number |
Exhibit |
File Date | |||||
| 3.1 | By-laws (status) of the registrant (English translation) | |||||||||
| 31.1 | Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended | |||||||||
| 31.2 | Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||
| 32.1* | Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended | |||||||||
| 101.INS | XBRL Instance Document | |||||||||
| 101.SCH | XBRL Taxonomy Extension Schema Document | |||||||||
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | |||||||||
| 101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | |||||||||
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||
| 104 | Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101. | |||||||||
| * | Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, (whether made before or after the date of the Form 10-Q), irrespective of any general incorporate language contained in such filing. |
36
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registration has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
DBV Technologies S.A. |
||||||||
| (Registrant) | ||||||||
Date: November 3, 2022 |
By: |
/s/ Daniel Tassé |
||||||
| Daniel Tassé | ||||||||
Chief Executive Officer | ||||||||
(Principal Executive Officer) | ||||||||
Date: November 3, 2022 |
By: |
/s/ Sébastien Robitaille |
||||||
| Sébastien Robitaille | ||||||||
Chief Financial Officer | ||||||||
(Principal Financial and Accounting Officer) | ||||||||
37