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EANS-Adhoc: Intercell AG announces Q3 2012 financial results and provides operational update

Geschrieben am 07-11-2012

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ad-hoc disclosure transmitted by euro adhoc with the aim of a Europe-wide
distribution. The issuer is solely responsible for the content of this
announcement.
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9-month report

07.11.2012

» IXIARO®/JESPECT® - product sales growth trend continues despite
lower than expected product sales of EUR 3.5m in Q3 2012 » U.S.
military places largest IXIARO® order to date in Q4 2012 » Net loss
for Q3 2012 slightly decreased by 2.8% to EUR 7.5m

Q3 2012 Financial results

» Total revenues decreased by 41.3% to EUR 4.4m in Q3 2012 compared
to EUR 7.5m in Q3 2011, mainly resulting from lower IXIARO®/JESPECT®
product sales » Net loss of EUR 7.5m in Q3 2012, compared to a net
loss of EUR 7.8m in Q3 2011 » Full year 2012 net loss between EUR 20m
and EUR 24m expected » Cash position of EUR 59.3m at the end of Q3
2012 reflects progress in reduction of operating cash outflow on the
way towards financial self-sustainability

Key Financial Information

EUR in thousands 3 months ended 9 months ended Year ended
Sept 30, Sept 30, Sept 30, Sept 30, Dec 31,
2012 2011 2012 2011 2011
Revenues 4,416 7,527 25,592 25,904 32,884
Net profit/(loss) (7,536) (7,754) (14,600) (20,620) (29,265)
Net operating
cash flow (943) (3,035) (10,372) (31,940) (42,858)
Cash and marketable
securities,
end of period 59,328 68,791 59,328 68,791 50,859


IXIARO®/JESPECT® product sales for the nine months ended September 30, 2012 of
EUR 18.2m still represent a considerable 17.4% increase compared to the same
period in 2011 (EUR 15.5m). Delay in orders and higher than anticipated
post-travel season stock-levels in-market in Q3 2012 led to decreased product
sales of EUR 3.5m compared to 2011(EUR 5.1m).
Intercell recently received its largest order ever of IXIARO® vaccine from the
U.S. military. Subject to timely product release to secure supply of the vaccine
and based on current orders and demand, Intercell expects strong Q4 2012 sales
of EUR 8.5m to 10.5m (Q4 2011: EUR 6.1m) underscoring the unlocked potential of
this vaccine.


In September 2012, Intercell's partner Biological E. Ltd. launched the product
JEEV® - a vaccine to protect small children and adults from Japanese
Encephalitis (JE) - in India. First deliveries of the product are expected to
take place in Q4 2012. This is the first time this next-generation Japanese
Encephalitis vaccine is available in an endemic country.
Biological E. Ltd. plans to focus its sales efforts of JEEV® primarily on
private market customers including pediatricians and general practitioners. To
ensure a successful product launch, Biological E. Ltd. has recruited and trained
its own sales force, which will initially be fully dedicated to the product.


Intercell received "Medsafe Consent to Distribute a New Medicine" and the
corresponding Gazette notice for JESPECT®, equivalent to the registration
approval letter and the marketing authorization. This means JESPECT® is now
registered in New Zealand and can be marketed there.

The Company's Japanese Encephalitis vaccine IXIARO® was granted
Orphan Drug status by the FDA following its recent submission of the
pediatric licensure indications for ages from 1 year to less than 17
years. The Orphan Drug designation includes a substantial reduction
of fees payable and waivers during the pre- and post-approval phases
for this pediatric indication.

Intercell obtained favorable data from a Phase III trial in 300
children conducted in the Philippines. Interim results of the trial
showed that a booster dose of the vaccine was well tolerated and
highly immunogenic in children aged 1 to <18 years. Intercell plans
to present the data at the International Society of Travel Medicine
meeting in May 2013.

R&D programs and activities are proceeding to next stages of
development

Pandemic Influenza Vaccine Enhancement Patch (VEP) - In September
2012, Intercell announced the results from a Phase I study
investigating Intercell's adjuvant patch (Vaccine Enhancement Patch -
VEP) containing LT (a heat-labile toxin from E. coli) in combination
with an intramuscular (IM) administration of an A/H5N1 antigen
supplied by GSK. The study was performed to confirm the mode of
action of transcutaneous applied adjuvants when co-administered with
an Influenza A/H5N1 antigen, following different and inconsistent
results from the previous Phase I and Phase II clinical studies. The
study involved 300 healthy adults and investigated two combinations
of A/H5N1 antigen doses with or without patch in one and two
injection regimes. GSK's adjuvanted and licensed H5N1 vaccine was
used to provide a positive control arm. The combination of A/H5N1
with VEP met two of three CHMP criteria for Pandemic Influenza
Vaccines (GMT fold rise from day 0 and seroconversion). However, the
study endpoint of a 2 or more fold rise in HI titers was not achieved
since the immunogenicity was only moderately increased by VEP.
However, VEP enhanced significantly the immune response in subjects
with existing HI titers, indicating the potential use of VEP in
booster vaccination. Based on this study outcome and other
pre-clinical results achieved with different antigens, Intercell will
focus its future patch strategy on partnering and out-licensing -
with a strong emphasis on antigen delivery as well as booster
vaccination target product profiles.

IC31® adjuvant - Intercell maintains research collaborations with
different partners to evaluate IC31® in new vaccine formulations,
additional collaborations have been initiated in the field of cancer.

Pre-clinical proof of concept for vaccine candidate against Lyme
borreliosis

The Company's pre-clinical lead vaccine candidate against Lyme
borreliosis is completing pre-clinical proof of concept studies
according to plan. The proprietary vaccine candidate, based on a
novel technology has passed all pre-clinical research steps and is
moving towards pre-clinical development in preparation for clinical
testing. These studies will include toxicology testing, GMP
production of proteins and assay development.

Update of Intercell's technology partnering options

Positive pre-clinical data for a Tetanus toxoid booster vaccine patch
support partnering and out-licensing of the Vaccine Delivery Patch
(VDP) for use as possible needle-free booster vaccine technology.
Besides Tetanus, Intercell is also testing the applicability of the
VDP in additional indications to support licensing discussions

The report can be downloaded at http://www.intercell.com/main/investo
rs/financial-reports-presentations/quarterly-reports/

Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com

end of announcement euro adhoc
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issuer: Intercell AG
Campus Vienna Biocenter 3
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: investors@intercell.com
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes: ATX Prime
stockmarkets: official market: Wien
language: English


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