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DBV Technologies reports Full Year 2012 financial results and provides R&D update
BAGNEUX, France --(Business Wire)--
Regulatory News:
DBV Technologies (Paris:DBV) (Euronext: DBV - ISIN: FR0010417345),
creator of Viaskin®, a new standard in the treatment of allergy,
announced today its full year 2012 results, approved by the Board of
Directors on March 1st, 2013. DBV also provided an R&D
update, most notably the 'VIPES' phase IIb clinical study of Viaskin®
Peanut, the largest global trial in desensitization of peanut-allergic
children and adults.
Dr. Pierre-Henri Benhamou, Chairman & CEO of DBV Technologies,
commented: "DBV has dramatically evolved in 2012, with the IPO
providing sufficient financing for our corporate goals. Throughout the
year, we have also met many other important milestones, thrusting DBV
into 2013 on very solid grounds. Clinical development will be a key
focus in 2013, starting today with the achievement of 50% enrollment in
"VIPES". Throughout this year, we also expect significant increase of
pharmaceutical and business development efforts in preparation for
future commercialization."
Full year 2012 results
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Summary financial information (IFRS - reviewed by statutory
auditors)
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In million euros
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2012
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2011
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Total revenues
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2.78
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1.87
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R&D expenses
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(11.58)
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(6.68)
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G&A expenses
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(4.62)
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(2.39)
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Operating result
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(13.50)
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(7.26)
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Net result
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(13.01)
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(7.24)
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EPS (in € per share)
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(1.06)
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(1.03)
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Net cash flow from operating activities
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(10.43)
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(6.13)
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Net cash flow
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26.30
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2.50
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Cash position
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37.83
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11.53
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The Company's total revenues amounted to €2,776,588 and
€1,873,571 in 2012 and 2011 respectively. These revenues were primarily
generated by Research Tax Credits, and to a lesser extent, by the sales
of Diallertest®, as well as by subsidies
received within the framework of the research projects conducted by the
Company. Sales of Diallertest® were slightly up over the period,
to €174,360 in 2012 compared with €126,051 a year earlier, strictly due
to the phasing of orders from DBV 's commercial partner, the overall
demand remaining stable year-on-year.
Research and Development expenses increased significantly by 73%
to reach €11,579,340 compared with €6,675,872 a year earlier. This
increase reflects primarily the preparation of the launch of the Phase
IIb study ('VIPES') which aims to demonstrate Viaskin® Peanut's
efficacy on 220 children, adolescents and adults. Moreover, the Company
reinforced its research and development teams in 2012, in order to lead
simultaneously no less than 5 clinical studies over the next 24 months.
Social contributions and non-cash IFRS2 impacts on share-based
compensations have also led to significantly increase R&D expenses in
2012.
General & Administrative expenses ('G&A') include mainly
management and administrative personnel costs, building costs related to
the headquarters, and certain fees (such as audit, legal, and
consultants' fees). In 2012, G&A expenses reached €4,618,627 compared
with €2,393,583 a year earlier. This strong 93% increase is mainly
explained by social contributions and non-cash IFRS2 impacts on
share-based compensations, as well as communication expenses related to
the listing of the Company.
The net loss in 2012 amounted to €(13,012,000) compared with
€(7,241,157) in 2011. The loss per share issued (based on the weighted
average number of shares outstanding over the period) amounted to
€(1.06) and €(1.03) for 2012 and 2011 respectively.
Net cash flow from operational activities in 2012 and 2011 stood
respectively at €(10,432,549) and €(6,130,146), essentially linked to
increased R&D efforts and social contributions on share-based payments.
Net cash flow from financing activities reached €37,098,822 in
2012 against €9,671,792 a year earlier following the cash receipt of
€37.5 million consecutive to the IPO of the Company on NYSE Euronext in
March 2012.
DBV Technologies will announce its first quarter topline and cash
position on April 15, 2013.
Update on R&D
DBV has published 3 communications at the American Academy of Allergy
Asthma & Immunology (AAAAI) on February 22-28 in San Antonio,
Texas, selected by the Academy as the most remarkable contribution in
food allergy.
The following posters can be found on www.dbv-technologies.com/en/investors/2013/02/20/aaaaai2013en
:
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Epicutaneous ImmunoTherapy (EPIT) is Safe for the Treatment of Peanut
Allergy in Allergic Patients;
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EPIT Prevents Further Sensitization to Peanut in a Model of Mice
Sensitized to Milk;
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Immunotherapy-Induced Regulatory T Cells in Mice Sensitized to Peanut:
Epicutaneous vs Sublingual.
The first patient in the VIPES' study was included in August 2012, and DBV
expects to end the recruitment (last patient, first visit) in June 2013.
VIPES' headline results are expected to be available in the second half
of 2014, with the goal to initiate a phase III study of Viaskin Peanut
in the first half 2015.
VIPES (double-blind, placebo-controlled, randomized phase IIb trial to
evaluate Viaskin® Peanut's efficacy and safety in peanut allergic
patients) is a 12-month, multicenter and multinational study that is
being conducted in Europe and North America, including 6 countries with
a total of 24 centers. The 220 peanut-allergic subjects range from 6 to
55 years of age with a history of immediate hypersensitive reaction to
peanut. VIPES was granted Fast Track designation by the Food and Drug
Administration (FDA).
Other clinical activity updates include:
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DBV is still waiting for the 18-month results of the "Arachild" pilot
study and has requested its sponsor, AP-HP (Assistance Publique -
Hôpitaux de Paris), to provide a timeline for the statistical analysis
of the efficacy and safety data.
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In the first half of 2013, DBV will collaborate with the Consortium
for Food Allergy Research ("CoFAR") for the launch of an important
NIH-sponsored efficacy study, CoFAR6, in peanut allergic patients.
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In June 2013, DBV will be present at the European Allergy And Clinical
Immunology congress (EAACI; http://www.eaaci-wao2013.com).
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Throughout 2013, DBV will continue its partnership with the University
of Geneva in the field of vaccination, and expects to make good
progress in a promising joint development program.
About peanut allergy: a life-threatening risk for millions of people
In the US, about 1.1% of the general population, or over 3 million
people, are allergic to peanuts, which results in about 100 to 150
deaths per year. This allergy affects both adults and children, and in
the United Kingdom, it has been estimated that peanut allergy affects
1.8% of young children. The prevalence of peanut allergy in other
Western countries (e.g., Canada, France and Spain) has been studied by
many researchers, and the prevalence ranges from 0.9% to 1.5%. Peanut
allergy is generally considered to be persistent; many studies indicate
that fewer than 20% of children will outgrow their allergy. Peanut
allergy is more severe than other common food allergies, including milk
and egg allergies.
About DBV Technologies
DBV Technologies is developing Viaskin®, an innovative new approach to
the treatment of allergies - a major public health issue that is
constantly increasing in prevalence. Food allergies represent a true
handicap in everyday life for millions of people, constituting a major
unmet medical need. DBV Technologies, incorporated in France in 2002,
has developed a proprietary, worldwide-patented technology for
administering an allergen to intact skin while avoiding transfer to the
blood. The Viaskin® technology combines efficacy and safety as part of a
treatment that seeks to improve the patient's tolerability of peanuts,
and thus considerably lowers the risk of a systemic, allergic reaction
in the event of accidental exposure The product's clinically proven
safety profile enables the application of effective desensitization
techniques in the most severe forms of the allergy. DBV Technologies is
focusing on food allergies, including milk and peanut, for which there
are currently no effective treatments. DBV Technologies has designed two
products: Viaskin® Peanut and Viaskin® Milk. The clinical development
program for Viaskin® Peanut has received Fast Track designation from the
US Food and Drug Administration and is currently being studies in Phase
II program. The company will subsequently develop a Viaskin® patch for
young children with house dust mite allergy - a true public health issue
because this pathology is a primary risk factors for childhood asthma.
DBV Technologies shares are traded on segment C of Euronext Paris
(Ticker: DBV, ISIN code: FR0010417345).
For more information on DBV Technologies, please visit our website: www.dbv-technologies.com
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein
are based on the Company's management strategy, current views and
assumptions. Such statements involve known and unknown risks and
uncertainties that may cause actual results, performance or events to
differ materially from those anticipated herein. Furthermore, the
Research and Development process involves several stages each of which
involve the substantial risk that the Company may fail to achieve its
objectives and be forced to abandon its efforts with regards to a
product in which it has invested significant sums. Therefore, the
Company cannot be certain that favorable results obtained during
pre-clinical trials will be confirmed subsequently during clinical
trials, or that the results of clinical trials will be sufficient to
demonstrate the safe and effective nature of the product concerned. DBV
technologies' business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
Financiers.

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