0001193125-23-058479.txt : 20230303 0001193125-23-058479.hdr.sgml : 20230303 20230302182906 ACCESSION NUMBER: 0001193125-23-058479 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 18 CONFORMED PERIOD OF REPORT: 20230302 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230303 DATE AS OF CHANGE: 20230302 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: 23700849 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 d408746d8k.htm 8-K 8-K
00-0000000 true false 0001613780 0001613780 2023-03-02 2023-03-02 0001613780 us-gaap:CommonStockMember 2023-03-02 2023-03-02 0001613780 dei:AdrMember 2023-03-02 2023-03-02

 

 

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

March 2, 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 March 2, 2023, DBV Technologies S.A. (the “Company”) issued a press release announcing the full year financial results and business update for the year ended December 31, 2022. 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 7.01

Regulation FD Disclosure

On March 2, 2023, the Company issued a press release announcing the filing of its Annual Report on Form 10-K for the year ended December 31, 2022 with the Securities and Exchange Commission and its Universal Registration Document for the year ended December 31, 2022 with the French market authority. A copy of the press release is being furnished as Exhibit 99.2 to this Current Report on Form 8-K.

The information contained in Item 7.01 in this Current Report on Form 8-K (including Exhibit 99.2) is being furnished and shall not be deemed “filed” for purposes of Section 18 of 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 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 March 2, 2023
99.2    Press Release issued March 2, 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.

 

Date: March 2, 2023   DBV TECHNOLOGIES S.A.
    By:  

/s/ Sébastien Robitaille

    Name:   Sébastien Robitaille
    Title:   Chief Financial Officer
EX-99.1 2 d408746dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

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Montrouge, France, March 2, 2023

DBV Technologies Reports Full Year 2022 Financial Results and Business Update

 

   

DBV completed EVOLVE, a 12-week caregiver and patient user experience study of the modified Viaskin Peanut patch in peanut-allergic children ages 4 – 11 years old

 

   

DBV had $209.2 million in Cash and Cash Equivalents at December 31, 2022.

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today reported financial results for the full year 2022. The audit procedures have been substantially completed by the Company’s statutory auditors and financials – prepared under both US GAAP and IFRS for the purpose of Form 10-K and Universal Registration Document respectively – were approved by the Board of Directors on March 2, 2023.

EVOLVE

DBV completed EVOLVE, a 12-week caregiver and patient user experience study of the modified Viaskin Peanut patch in 50 peanut allergic children ages 4 – 11-years old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the modified Viaskin Peanut patch. The study concluded that the updated Viaskin Peanut IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the modified Viaskin Peanut patch.

In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion scores. As previously announced, VITESSE will assess patch adhesion of the modified Viaskin Peanut patch and DBV will include a statistical test of adhesion in the VITESSE statistical analysis plan. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA application.

Financial Highlights for the Full Year 2022

The Company’s annual consolidated financial statements are prepared in accordance with both generally accepted accounting principles in the U.S. (“US GAAP”) and International Financial Reporting Standards (“IFRS”) as adopted by the European Union. Unless otherwise indicated, the financial figures in the Full Year 2022 Financial Highlights are presented under both U.S GAAP and IFRS financial statements, and commented using U.S. GAAP financial statements. Differences between US GAAP and IFRS consolidated financial statements are mainly due to discrepancies arising from the application of lease accounting standards.


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Cash and Cash Equivalents

 

     US GAAP      IFRS  
     Year ended December 31,      Year ended December 31,  
In millions of USD    2022      2021      2022      2021  

Net cash & cash equivalents at the beginning of the period

     77,3        196,4        77,3        196,4  

Net increase / (decrease) in cash & cash equivalents, of which:

     131,9        (119,1      131,9        (119,1

Net cash flow used in operating activities

     (55,7      (108,2      (51,4      (104,1

Net cash flow used in investing activities

     (0,1 )        (0,4 )        (0,1 )        (0,4 )  

Net cash flow provided by / (used in) financing activities

     194,1        0,3        189,9        (3,9 )  

Effect of exchange rate changes on cash & cash equivalents

     (6,5 )        (10,7      (6,5 )        (10,7
  

 

 

    

 

 

    

 

 

    

 

 

 

Net cash & cash equivalents at the end of the period

     209,2        77,3        209,2        77,3  
  

 

 

    

 

 

    

 

 

    

 

 

 

Cash and cash equivalents amount to $209,2 million as of December 31, 2022, compared to $77,3 million as of December 31, 2021, which is an increase by $131,9 million due to:

 

(1)

$194,1 million due to financing activities, mainly from ATM Program in May 2022 ($14,1 million, net of transaction costs), then from private investment in public equity ($180,4 million, net of transaction costs);

 

(2)

$26,1 million reimbursed by French tax administration for research tax credits related to years 2019, 2020, and 2021;

And partially offset by :

 

(3)

$81,8 million of cash used for operations, before $26,1 million reimbursement of research tax credits. This is a decrease of 24% compared to prior year reflecting the cost containment measures that has been continuously maintained since their implementation in 2020.


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     US GAAP      IFRS  
In millions of USD    FY22     FY21     FY20      FY22     FY21     FY20  

Net cash flow used in operating activities

     55,7       108,2       165,6        51,4       104,1       160.9  

Reimbursements of Research Tax Credits

     26,1       —         —          26,1       —         —    

Net cash flow used in operating activities, excluding reimbursements of Research Tax Credits

     81,8       108,2       165,6        77,5       104,1       160,9  

Compared to prior year

     -26,4       -57,4          -26,6       -56,8    
     -24     -35        -26     -35  

 

(4)

$6,5 million negative impact of changes in exchange rates.

The Company’s treasury position, stated in US Dollars, has benefited in the last quarter from a change in the Euro to US Dollar exchange rate. The company’s activities and expenditures in the fourth quarter were in line with expectations and continue to reflect DBV’s expense discipline.

Operating Income

 

     US GAAP     IFRS  
     Year ended December 31,     Year ended December 31,  
In millions of USD    2022     2021     Variation     2022     2021     Variation  

Research tax credits

     5,7       7,5       -1,8        -24     5,7       7,5       -1,8        -24

Other operating income

     (0,9     (1,8     +0,9        -51     (0,9     (1,8     +0,9        -51
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 

Produits opérationnels

     4,8       5,7       -0,9        -15     4,8       5,7       -0,9        -15
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 

Operating income amounts to $4,8 million as of December 31, 2022, compared to $5,7 million as of December 31, 2021, which is a decrease by $0,9 million due to:

 

  (1)

A decrease in 2022 research tax credit by $1.8 million compared to 2021. This reflects the impact of the global restructuring plan initiated in 2020 and completed in 2021 which has impacted the expenses eligible to the research tax credit.

 

  (2)

Partially offset by the variance in other operating income that consists of revenues recognized in advance of the completion of the collaboration agreement with Nestlé Health Science (“NHS”).


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Operating Expenses

 

     US GAAP     IFRS  
In millions of USD    Year ended December 31,     Year ended December 31,  
   2022      2021     Variation     2022      2021     Variation  

Research & Development

     75,5        70,3       +5,2        +7     75,2        70,1       +5,1        +7

Sales & Marketing

     1,6        4,4       -2,8        -63     1,6        4,4       -2,8        -65

General & Administrative

     24,3        30,5       -6,2        -20     24,2        30,4       -6,1        -20

Restructuring

     —          (0,9     +0,9        -100     —          (0,9     +0,9        -100
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

Total operating expenses

     101,5        104,3       -2,8        -3     101,0        104,0       -2,9        -3
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

including personnel expenses

     24,0        31,1       -7,1        -23     24,0        31,1       -7,1        -23 % 

Operating expenses amount to $101,5 million as of December 31, 2022, compared to $104,3 million as of December 31, 2021, which is a decrease by $2,8 million mainly due to the decrease in personnel expenses as a result of the global restructuring plan that was announced in 2020 and completed in the course of 2021. The average number of employees was 86 for the year ended December 31, 2022, compared to 101 and 270 for the years ended December 31, 2021 and 2020 respectively.

This reduction in our operating expenses also reflects the strict financial discipline maintained across all services to focus our resources on the support of our clinical trial objectives.

Net Loss and Net Loss per Share

 

     US GAAP     IFRS  
     Year ended December 31,     Year ended December 31,  
     2022     2021     Variation     2022     2021     Variation  

Net (loss) in millions of USD

     (96,3     (97,8     +1,5        -2     (96,0     (98,1     +2,0        -2

Basic / diluted net (loss) per share in USD

     (1,24     (1,78     +0,5        -30     (1,24     (1,79     +0,6        -31

Net result for the year ended December 31, 2022, is a loss amounting to $96,3 million compared to a loss amounting to $97,8 million for the year ended December 31, 2021.

On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) is $1.24 for the year ended December 31, 2022.


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Conference Call Information DBV will host a conference call and live audio webcast today, Thursday, March 2, 2023, at 5:00 p.m. ET to report fourth quarter 2022 financial results and provide a

business update.

Attendees may access the call via the below teleconferencing numbers and asking to join the DBV Technologies call:

 

   

United States: 1-866-777-2509

 

   

International: 1-412-317-5413

A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/ A replay of the presentation will also be available on DBV’s website after the event


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CONDENSED STATEMENT OF CONSOLIDATED FINANCIAL POSITION

 

     US GAAP     IFRS  
     Year ended December 31,     Year ended December 31,  
In millions of USD    2022     2021     2022     2021  

Assets

     246,5       146,7       246,5       146,3  

of which cash & cash equivalents

     209,2       77,3       209,2       77,3  

Liabilities

     52,1       47,4       52,0       47,3  

Shareholders’ equity

     194,5       99,3       194,5       99,0  

of which net result

     (96,3     (97,8     (96,0     (98,1

CONDENSED STATEMENT OF CONSOLIDATED OPERATIONS AND COMPREHENSIVE LOSS

 

     US GAAP     IFRS  
In millions of USD    Year ended December 31,     Year ended December 31,  
   2022     2021     2022     2021  

Revenues

     4,8       5,7       4,8       5,7  

Research & Development

     (75,5     (70,3     (75,2     (70,1

Sales & Marketing

     (1,6     (4,4     (1,6     (4,4

General & Administrative

     (24,3     (30,5     (24,2     (30,4

Restructuring income/(expenses)

     —         0,9       —         0,9  

Operating expenses

     (101,5     (104,3     (101,0     (104,0

Finance income/(expenses)

     0,4       0,4       0,3       (0,2

Income tax

     (0,1     0,4       (0,1     0,4  

Net gain/(loss)

     (96,3     (97,8     (96,0     (98,1

Résultat de base et dilué par action ($/action)

     (1,24     (1,78     (1,24     (1,79


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CONDENSED STATEMENT OF CONSOLIDATED CASH FLOW

 

     US GAAP     IFRS  
     Year ended December 31,     Year ended December 31,  
In millions of USD    2022     2021     2022     2021  

Net cash flows provided / (used) in operating activities

     (55,7     (108,2     (51,4     (104,1

Net cash flows provided / (used) in investing activities

     (0,1     (0,4     (0,1 )       (0,4 )  

Net cash flows provided / (used) in financing activities

     194,1       0,3       189,9       (3,9 )  

Effect of exchange rate changes on cash & cash equivalents (US GAAP presentation)

     (6,5     (10,7    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net increase / (decrease) in cash & cash equivalents

     131,9       (119,1     138,4       (108,4 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash & cash equivalents at the beginning of the period

     77,3       196,4       77,3       196,4  

Effect of exchange rate changes on cash & cash equivalents (IFRS presentation)

         (6,5 )       (10,7
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash & cash equivalents at the end of the period

     209,2       77,3       209,2       77,3  
  

 

 

   

 

 

   

 

 

   

 

 

 

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 forecast of its cash runway, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies, and the outcome of any litigation. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s


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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.

EX-99.2 3 d408746dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

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Montrouge, France, March 2, 2023

DBV Technologies announces filing of 2022 Annual Report on Form 10-K and 2022 Universal Registration Document

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company (the “Company”), today announced the filing of its Annual Report on Form 10-K for the year ended December 31, 2022, with the U.S. Securities and Exchange Commission (“SEC”) and the filing of its 2022 Universal Registration Document (“URD”) for the year ended December 31, 2022 with the French market authority, “Autorité des Marchés Financiers” (“AMF”).

These documents can be accessed on the Investors section of the Company’s website at www.dbv-technologies.com. In addition, the URD is available on the AMF’s website at www.amf-france.org and the Form 10-K is available on the SEC’s website at www.sec.gov.

Printed copies of both documents are available, free of charge, at the Company’s headquarters and registered office located at 177-181 avenue Pierre Brossolette 92120 Montrouge, France.

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, DBV’s 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’s food allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Summit, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).

Investor Contact

Anne Pollak

DBV Technologies

+1 857-529-2363

anne.pollak@dbv-technologies.com


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Media Contact

Angela Marcucci

DBV Technologies

+1 646-842-2393

angela.marcucci@dbv-technologies.com

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Document and Entity Information
Mar. 02, 2023
Document Information [Line Items]  
Document Type 8-K
Document Period End Date Mar. 02, 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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