8-K

Date: May 4, 2023

DBV TECHNOLOGIES S.A.

/s/ Sébastien Robitaille

Name: Sébastien Robitaille

Title: Chief Financial Officer

0001193125-23-136025.txt : 20230504 0001193125-23-136025.hdr.sgml : 20230504 20230504164310 ACCESSION NUMBER: 0001193125-23-136025 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20230504 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230504 DATE AS OF CHANGE: 20230504 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DBV Technologies S.A. CENTRAL INDEX KEY: 0001613780 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: I0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36697 FILM NUMBER: 23889550 BUSINESS ADDRESS: STREET 1: 177-181 AVENUE PIERRE BROSSOLETTE CITY: MONTROUGE STATE: I0 ZIP: 92120 BUSINESS PHONE: 33(0)155427878 MAIL ADDRESS: STREET 1: 177-181 AVENUE PIERRE BROSSOLETTE CITY: MONTROUGE STATE: I0 ZIP: 92120 8-K 1 d298404d8k.htm 8-K 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

May 4, 2023

Date of Report (Date of earliest event reported)

DBV Technologies S.A.

(Exact name of registrant as specified in its charter)

France

001-36697

Not applicable

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

177-181 avenue Pierre Brossolette

92120 Montrouge France

Not Applicable

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: +33 1 55 42 78 78

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Ordinary shares, nominal value €0.10 per share	n/a	The Nasdaq Stock Market LLC*
American Depositary Shares, each representing one- half of one ordinary share, nominal value €0.10 per share	DBVT	The Nasdaq Stock Market LLC

*	Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC.

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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. ☐

Item 2.02

Results of Operations and Financial Condition

On May 4, 2023, DBV Technologies S.A. (the “Company”) issued a press release announcing financial results and business highlights for the fiscal quarter ended March 31, 2023. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in Item 2.02 in this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01

Financial Statements and Exhibits

(d) Exhibits


Exhibit No.		Description

99.1		Press Release issued May 4, 2023

104		Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

EX-99.1 2 d298404dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

LOGO

DBV Technologies Reports First Quarter 2023 Financial Results

•

DBV closes Q1 2023 with cash and cash equivalents of $192.3 million.

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today reported financial results for the first quarter of 2023. The quarterly financial statements were approved by the Board of Directors on May 4, 2023.

Financial Highlights for the First Quarter and the Three Months Ended March 31, 2023

The Company’s unaudited consolidated financial statements for the three months ended March 31, 2023, are prepared in accordance with generally accepted accounting principles in the U.S. (“U.S. GAAP”).

Cash and cash Equivalents


(in millions of USD)	Three months ended March 31,
(in millions of USD)	2023	2022

Net cash & cash equivalents at the beginning of the period	209.2	77.3
Net increase/(decrease) in cash & cash equivalents, of which:	(16.9)	(3.2)
Net cash flow used in operating activities	(20.8)	(1.5)
Net cash flow provided by / (used in) investing activities	-	-
Net cash flow provided by / ((used in) financing activities	-	(0.1)
Effect of exchange rate changes on cash & cash equivalents	3.9	(1.6)

Net cash & cash equivalents at the end of the period	192.3	74.1

Cash and cash equivalents amounted to $192.3 million as of March 31, 2023, compared to $209.2 million as of December 31, 2022, which is a net decrease of $16.9 million due to:

LOGO

(1)

$20.8 million of cash used for operations, mainly driven by the impact of the initiation of the VITESSE trial in early March 2023. Cash used for operations increased by $19.3 million compared to the same quarter last year. During the first quarter of 2022, the Company received $20.9 million from French tax authorities as reimbursement of 2019 and 2020 research tax credits.

(2)

Partially offset by a $3.9 million positive impact of changes in exchange rates. The Company’s treasury position, stated in US Dollars, has been impacted by an appreciation of the Euro against the US Dollar during the first quarter of 2023.

Operating Income

In millions of USD

Three months ended March 31,

2023

2022

Variation

Research tax credits

1.8

1.5

+0.3

+20%

Other operating income

0.4

1.0

-0.6

-60%

Operating income

2.2

2.5

-0.3

-12%

Operating income amounts to $2.2 million as of March 31, 2023, compared to $2.5 million as of March 31, 2022, which is a decrease of $0.3 million due to:

(1)

$0.3 million increase in the Research Tax Credit estimate as research and development costs increased during the first quarter in 2023 compared to the same quarter in 2022, mainly due to the initiation of the VITESSE trial.

(2)

Offset by a $0.6 million decrease in other operating income that consists of revenues recognized in advance of the completion of the collaboration agreement with Nestlé Health Science (“NHS”).

Operating Expenses

LOGO




Research & Development	16.0	12.2	+3.8	+31%

Sales & Marketing	0.4	0.5	-0.1	-20%

General & Administrative	6.9	6.6	+0.3	+5%

Operating expenses	23.3	19.3	+4.0	+21%

Operating expenses amounted to $23.3 million as of March 31, 2023, compared to $19.3 million as of March 31, 2022, which is an increase by $4.0 million mainly driven by research and development expenses to support initiation of the VITESSE trial.

Net Loss and Net Loss per Share


	Three months ended March 31,

	2023	2022	Variation

Net income / (loss) (in millions of USD)	(20.5)	(16.7)	-3.8	-23%

Basic / diluted net income / (loss) per share (USD/share)	(0.22)	(0.30)	+0.1	+27%

Net result for the three months ended March 31, 2023 is a loss amounting to $20.5 million, compared to a loss amounting to $16.7 million for the same period in 2022.

On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) is $0.22 for the three months ended March 31, 2023.

CONDENSED STATEMENT OF CONSOLIDATED FINANCIAL POSITION (unaudited)


In millions of USD	March 31, 2023	December 31, 2022

Assets	232.9	246.5

of which cash & cash equivalents	192.3	209.2

Liabilities	53.8	52.1

Shareholders’ equity	179.1	194.5

of which net result	(20.5)	(96.3)

LOGO

CONDENSED STATEMENT OF CONSOLIDATED OPERATIONS AND COMPREHENSIVE LOSS (unaudited)


In millions of USD	Three months ended March 31,
In millions of USD	2023	2022

Revenues	2.2	2.5

Research & Development	(16.0)	(12.2)

Sales & Marketing	(0.4)	(0.5)

General & Administrative	(6.9)	(6.6)

Restructuring income/(expenses)	-

Operating expenses	(23.3)	(19.3)

Finance income/(expenses)	0.6	0,2

Income tax	-	(0.1)



Net gain/(loss)	(20.5)	(16.7)


Basic/diluted net gain/(loss) per share attributable to shareholders	(0.22)	(0.30)

LOGO

CONDENSED STATEMENT OF CONSOLIDATED CASH FLOW (unaudited)


In millions of USD	Three months ended March 31,
In millions of USD	2023	2022



Net cash flows provided / (used) in operating activities	(20.8)	(1.5)

Net cash flows provided / (used) in investing activities	-	-

Net cash flows provided / (used) in financing activities	-	(0.1)

Effect of exchange rate changes on cash & cash equivalents	3.9	(1.6)

Net increase / (decrease) in cash & cash equivalents	(16.9)	(3.2)

Net cash & cash equivalents at the beginning of the period	209.2	77.3



Net cash & cash equivalents at the end of the period	192.3	74.1

About DBV Technologies

DBV Technologies is developing Viaskin^™, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT^™, and is DBV Technologies’ method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV Technologies’ food allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).

Forward Looking Statements

This press release may contain forward-looking statements and estimates, including statements regarding DBV’s financial condition and planned clinical efforts. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks

LOGO

and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, including the impact of the COVID-19 pandemic, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 2, 2023, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.

Investor Contact

Anne Pollak

DBV Technologies

+1 857-529-2363

anne.pollak@dbv-technologies.com

Media Contact

Angela Marcucci

DBV Technologies

+1 646-842-2393

angela.marcucci@dbv-technologies.com

Viaskin and EPIT are trademarks of DBV Technologies.

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Document and Entity Information	May 04, 2023
Document Information [Line Items]
Document Type	8-K
Document Period End Date	May 04, 2023
Entity Registrant Name	DBV Technologies S.A.
Entity Incorporation, State or Country Code	I0
Entity File Number	001-36697
Entity Tax Identification Number	00-0000000
Entity Address, Address Line One	177-181 avenue Pierre Brossolette
Entity Address, Postal Zip Code	92120
Entity Address, City or Town	Montrouge
Entity Address, Country	FR
Country Region	33
City Area Code	1
Local Phone Number	55 42 78 78
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false
Amendment Flag	false
Entity Central Index Key	0001613780
Common Stock [Member]
Document Information [Line Items]
Title of 12(b) Security	Ordinary shares, nominal value €0.10 per share
No Trading Symbol Flag	true
Security Exchange Name	NASDAQ
American Depositary Share [Member]
Document Information [Line Items]
Title of 12(b) Security	American Depositary Shares, each representing one- half of one ordinary share, nominal value €0.10 per share
Security Exchange Name	NASDAQ
Trading Symbol	DBVT

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