Report of Foreign Issuer (6-k)
September 07 2018 - 9:05AM
Edgar (US Regulatory)
UNITED STATES SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
6-K
REPORT OF
FOREIGN PRIVATE ISSUER
PURSUANT TO RULE
13a-16
OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of September 2018
Commission File Number:
001-36697
DBV TECHNOLOGIES S.A.
(Translation of registrants name into English)
177-181
avenue Pierre Brossolette
92120 Montrouge France
(Address of principal executive office)
Indicate by check mark whether
the registrant files or will file annual reports under cover of Form
20-F
or Form
40-F:
☒ Form
20-F ☐ Form
40-F
Indicate by check mark if the registrant is submitting the Form
6-K
in paper as permitted by Regulation
S-T
Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form
6-K
in paper as permitted by Regulation
S-T
Rule 101(b)(7): ☐
EXHIBIT LIST
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Exhibit
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Description
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99.1
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Press Release dated September 7, 2018.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
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DBV TECHNOLOGIES S.A.
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Date: September 7, 2018
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By:
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/s/ David Schilansky
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Name:
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David Schilansky
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Title:
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Deputy Chief Executive Officer
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Exhibit 99.1
DBV Technologies Reports First Half 2018 Financial Results
DBV Technologies (Euronext: DBV ISIN: FR0010417345 Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today
reported first half 2018 financial results. The interim financial report is available on the Investor Relations section of the Companys website,
https://www.dbv-technologies.com/investor-relations/
. First half 2018 financial statements were subject to a limited review by the Companys external auditors.
Cash Position:
cash and cash equivalents as of June 30, 2018, were 202.2 million, compared to 137.9 million as of
December 31, 2017, an increase of 64.4 million. The increase in the cash position is attributable to the increase in the net cash from financing activities pursuant to the Companys March 2018 public offering.
Operating Income:
operating income was 7.3 million for the first half 2018 compared to 7.6 million for the prior-year period. In
the first half 2018, as well as in the first half 2017, income was primarily generated from the Companys Research Tax Credit (Crédit Impôt Recherche) and by income recognized under the collaboration agreement with Nestlé
Health Science.
Research
& Development Expenses:
research and development expenses decreased
by 2.6 million, or 4.9%, to 49.9 million in the first half 2018, compared to 52.5 million in the first half 2017, reflecting the decrease in expenses following the completion of the Phase III and Phase II
clinical trials of Viaskin Peanut and Viaskin Milk, respectively, as well as a decrease in manufacturing expenses due to the completion of a new manufacturing machine in the first half 2017. During the first half 2018, the Company continued to
increase its R&D activity for both
pre-clinical
research and clinical development, as well as reinforcing the teams dedicated to R&D.
Sales
& Marketing Expenses:
sales and marketing expenses were 9.7 million for the first half 2018
compared to 8.5 million for the first half 2017, reflecting an increase of 1.2 million, or 14.1%, compared to the prior-year period. The increase in sales and marketing expenses resulted from an increase in expenses
related to the potential commercialization of Viaskin Peanut in North America, if approved, as well as an increase in share-based compensation.
General
& Administrative
Expenses:
general and administrative expenses were 21.1 million for the first half 2018, compared to 17.7 million for the first half 2017. The increase in general and administrative expenses was primarily attributable
to an increase in personnel-related expenses as a result of increased global employee headcount and increased costs associated with legal and professional services, partially offset by decreases in share-based compensation.
Net Loss:
net loss was (72.1) million for the first half 2018, compared to (72.5) million for the first half 2017. Loss
per share (based on the weighted average number of shares outstanding over the period) was (2.60) and (2.94) in first half 2018 and 2017, respectively.
About DBV Technologies
DBV Technologies is developing
Viaskin
®
, a proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT
®
, DBVs method of delivering biologically active compounds to the immune system through intact skin. With this new class of self-administered and
non-invasive
product candidates, the company is dedicated to safely transforming the care of food allergic patients, for whom there are no approved treatments. DBVs food allergies programs include
ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of Viaskin Egg. DBV is also pursuing a human
proof-of-concept
clinical study of
Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases. DBV Technologies has global headquarters in Montrouge, France and New York, NY. Company shares
are traded on segment A of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and traded on the Nasdaq Global Select Market in the form of American Depositary Shares (each representing
one-half
of one ordinary share) (Ticker: DBVT). For more information on DBV Technologies, please visit our website:
www.dbv-technologies.com
DBV Investor Relations Contact
Sara Blum Sherman
Senior Director, Investor Relations & Strategy
+1 212-271-0740
sara.sherman@dbv-technologies.com
DBV Media Contact
Raul Damas
Partner, Brunswick Group
+1-212-333-3810
DBV@brunswickgroup.com
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