DBV Technologies Reports Interim Financial Results for the First Half of 2016
(Thomson Reuters ONE) -
Press Release
Montrouge, France, July 28, 2016
DBV Technologies Reports
Interim Financial Results for the First Half of 2016
DBV Technologies, (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market:
DBVT), a clinical-stage specialty biopharmaceutical company, announced today its
interim financial results for the first half of 2016. The full interim financial
report (regulated information) is available on DBV's website in the Investor
Relations section. The 2016 half-year financial statements were subject to a
limited review by the Company's external auditors.
2016 First Half Year Results
Selected financial information (IFRS as adopted by the European Union - subject
to limited review procedures by external auditors)
In thousands of euros H1 2015 H1 2016
Total income 3,170 4,750
R&D expenses (12,500) (32,892)
S&M expenses - (5,450)
G&A expenses (5,495) (15,783)
Operating (loss) (14,917) (49,376)
Net (loss) (14,478) (49,443)
Net loss per share (in ? per share) (0.74) (2.03)
Net cash flow from operating activities (12,441) (30,123)
Net cash flow from investment activities (804) (5,607)
Net cash Flows from financing activities 3,178 1,078
Net cash flow (10,067) (34,653)
Cash position 104,535 288,761
Total income was ?3.2 million and ?4.8 million for the first half of 2015 and
2016, respectively. This income was primarily generated from research tax
credits.
Research & Development expenses were ?12.5 million and ?32.9 million for the
first half of 2015 and 2016, respectively. This change reflects:
* an increase of research and development activities with respect to the
Company's pre-clinical research and clinical development including, in
particular, the cost of service providers incurred in connection with:
* the Phase III trial, PEPITES, of Viaskin® Peanut, for which the patient
recruitment objective was achieved in the first half of 2016,
* the initialization of the SMILEE study, a Phase IIa clinical trial of
the safety and efficacy of Viaskin Milk in pediatric patient populations
with milk-induced eosinophilic esophagitis, and;
* the follow-up trial of the Phase I/II trial MILES for Viaskin® Milk;
* acceleration in the hiring of research and development personnel to support
the Company's ongoing programs and an associated increase in share-based
compensation expenses with respect to equity awards granted in the second of
half 2015 and the first half of 2016;
Sales & Marketing expenses amounted ?5.5 million in the first half of 2016 and
mainly include payroll for the US staff and fees to prepare the launch and
commercialization of Viaskin Peanut in North America, if approved. The Company
did not have any sales and marketing expenses in the first half of 2015.
General & Administrative expenses were ?5.5 million and ?15.8 million in the
first half of 2015 and 2016, respectively. This change reflects increased
investment in the Company's administrative and management functions, an increase
in share-based compensation expenses with respect to equity awards granted
during the second of half 2015 and the first half of 2016, as well as an
increase in professional and insurance fees.
The Company's net loss for the first six months of 2016 was ?(49.4) million,
compared to ?(14.5) million for the corresponding 2015 period. Net loss per
share (based on the number of weighted average number of shares outstanding)
were ?(0.74) and ?(2.03) for the first half of 2015 and 2016, respectively.
Net cash flow used in operating activities for the first half of 2015 and 2016
was ?(12.4) million and ?(30.1) million, respectively, with the increase
primarily fueled by increasing efforts in R&D.
Net cash flow used in investment activities increased from ?(0.8) million for
the first half of 2015 to ?(5.6) million for the first half 2016, with the
increase primarily due to the relocation of global corporate headquarters to
Montrouge, France, and the purchase of tools and equipment for industrial
manufacturing prototypes for product candidates.
Net cash flow from financing activities was ?3.2 million for the first half of
2015 and ?1.1 million for the first half of 2016, primarily attributable to the
exercise of equity instruments in both periods.
DBV Technologies expects to announce its cash position on November 3, 2016,
before the opening of the Euronext market in Paris, France.
About DBV Technologies
DBV Technologies developed Viaskin®, a 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 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. DBV's 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 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 B 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
Forward Looking Statements
This press release may contain forward-looking statements and estimates. These
forward-looking statements and estimates are not promises or guarantees and
involve substantial risks and uncertainties. At this stage, the products of the
Company 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, the
risk that historical preclinical results may not be predictive of future
clinical trial results, and the risk that historical clinical trial results may
not be predictive of future trial results. A further list and description of
these risks, uncertainties and other risks can be found in the Company's
regulatory filings with the French Autorité des Marchés Financiers, the
Company's Securities and Exchange Commission filings and reports, including in
the Company's Annual Report on Form 20-F for the year ended December 31, 2015
and future filings and reports by the Company. 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. DBV
Technologies undertakes no obligation to update or revise the information
contained in this Press Release, whether as a result of new information, future
events or circumstances or otherwise.
DBV Technologies Contact
Susanna Mesa
Senior Vice President, Strategy
+1 212-271-0861
susanna.mesa(at)dbv-technologies.com
Media Contacts
Erinn White, Centron PR
+1 646-722-8822
ewhite(at)centronpr.com
Media Contacts, Europe
Caroline Carmagnol, Alize RP - Relation Presse
+33 (0)6 64 18 99 59
caroline(at)alizerp.com
PDF Version:
http://hugin.info/156437/R/2031083/755648.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: DBV Technologies via GlobeNewswire
[HUG#2031083]
Unternehmensinformation / Kurzprofil:
Datum: 28.07.2016 - 07:30 Uhr
Sprache: Deutsch
News-ID 485869
Anzahl Zeichen: 9794
contact information:
Town:
Bagneux
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 286 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DBV Technologies Reports Interim Financial Results for the First Half of 2016"
steht unter der journalistisch-redaktionellen Verantwortung von
DBV Technologies (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
