EANS-Adhoc: Intercell AG announces Q3 2010 results and updates on R&D progress and management

--------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------

09.11.2010

Positive sales trend of IXIARO®/JESPECT® vaccine against Japanese Encephalitis -
Focused R&D spending on late-stage programs and negative currency effects lead
to EUR 27.8m loss for Q3 2010 - Good progress in vaccine development programs

Vienna (Austria), November 9, 2010 - Today, Intercell AG (VSE: ICLL) announced
its financial results for the third quarter of 2010 and presented an update on
the Company's key R&D programs as well as changes to the Management Board.

Financial Results

>> IXIARO and JESPECT sales revenues continue showing significant year-on-year
   growth - sales revenues totaled EUR 9.4m in the 9 months ended September 30, 
   2010, compared to EUR 5.6m in the same period of the previous year.

>> Intercell's aggregate revenues decreased by 28.4% from EUR 29.5m in the 
   9 months ended September 30, 2009 to EUR 21.1m in the same period of 2010.

>> Net loss for the first nine months of 2010 increased to EUR 50.9m mainly
   driven by increased R&D expenses for late stage development programs and 
   non-cash currency effects.

>> Solid cash position with EUR 107.1m.

>> Outlook full year 2010: Net loss for the full year 2010 expected to reach
approximately EUR 40.0m, at the high end of previously communicated range,
and this assumes positive outcome of upcoming milestone events.

Key Financial Figures

TEUR                   3 months ended         9 months ended    Year ended
                        September 30           September 30         Dec 31,
                       2010      2009        2010       2009          2009

Revenues 6,704 9,159 21,118 29,480 61,681

Net profit/loss     (27,844)  (14,671)     (50,892)   (25,925)     (18,375)

Net operating 
cash flow           (22,724)  (14,753)     (49,218)   (43,322)     (25,995)

Cash and available-
for-sale financial assets,
end of period 107,141 139,746 107,141 139,746 180,019

IXIARO®/JESPECT®

Intercell reports that the positive trend of increasing sales of IXIARO/JESPECT
seen in Q2 2010 continued in Q3. Intercell's product is the only vaccine against
Japanese Encephalitis licensed in Europe. It is manufactured for, and supplied
into, the U.S., EU and Canada and the only vaccine being produced for the U.S.
military. U.S. military sales in 2010 depend on further use of residual product
stock of JE-Vax®. A significant increase in sales is possible for 2011, when
leftover inventory of JE-Vax is expected to be exhausted or abandoned.

The Department of Health, Government of the Hong Kong Special Administrative
Regions has approved Intercell's vaccine to prevent Japanese Encephalitis. The
licensure process has been initiated for additional territories, and further
recommendations are expected also for other key countries in Europe. These
recommendations are essential to continue advancing product awareness and market
growth.

The pediatric Phase III studies for IXIARO/JESPECT for use in children
travelling to endemic areas are progressing according to plan, with data
expected in 2012. These studies are the basis for a label extension to make the
existing vaccine available for travelling children.

Based on Intercell's technology a novel JE vaccine candidate is also being
developed for the endemic markets, where the WHO recommends that Japanese
Encephalitis vaccination be integrated into national immunization programs.
Clinical development in endemic areas is progressing, with a pivotal Phase III
trial in children scheduled to start by the end of 2010 / early 2011 sponsored
and managed by Intercell's partner, Biological E., in India.

Leading R&D portfolio in hospital infections

A Phase II clinical trial involving IC43, the vaccine candidate against
infections with the bacterium Pseudomonas aeruginosa, met primary immunogenicity
and safety endpoints; a statistically significant reduction in mortality
compared to placebo was observed for the non-adjuvanted vaccine group. If
confirmed by pivotal clinical trials, this could make IC43 an important vaccine
for ICU patients who are subject to a particularly high mortality risk
associated with hospital-acquired infections. The vaccine generated a good
immune response and was well tolerated. Vaccine-related serious side-effects
which would raise any safety concern were not observed.
The results provide a strong basis for evaluation of further development
options. Intercell and its partner Novartis will determine next steps.

Clostridium difficile program planned to enter clinic: After successful
pre-clinical trials, Intercell is progressing its vaccine candidate to prevent
infections with Clostridium difficile (C. diff). C. diff is the leading cause
for nosocomial Diarrhea in Europe and the U.S. A Phase I clinical study is
expected to start in 2010.

Staphylococcus aureus vaccine (V710) on track: The Phase II/III study conducted
and funded by Merck & Co., Inc. in cardiothoracic surgery patients for the
investigational S. aureus vaccine is progressing to plan. The first critical
interim analysis (surpassing futility) is expected in 2011.

Good progress in development pipeline - programs progressing according to plan

>> Recruitment for the pivotal Phase III study of approximately 2,000 travelers
   for Intercell's investigational Travelers' Diarrhea (TD) Vaccine Patch is
   completed. The first data from that trial, conducted in travelers to Mexico 
   and Guatemala, is expected for end 2010/early 2011. The enrollment of a
   complementary 800-traveler Phase II study in those travelling to India has
   also been completed; first data is expected in Q4 2010. The trial in India
   is the first study outside South America and has the potential to
   demonstrate proof of concept for the vaccine in Asia. 

>> Intercell will pursue activities with GSK to prepare markets as soon as data
   on Phase II and Phase III trials becomes available. Diarrhea is the most
   common health problem among travelers from developed countries who visit
   developing areas and most of the diarrheal cases in travelers are caused by
   bacteria, primarily by ETEC strains (Escherichia coli). 

>> Intercell and GSK will continue development of the investigational Vaccine
   Enhancement Patch (VEP) system for Avian H5N1 Influenza vaccination as part
   of a collaborative agreement signed in December 2009. The initiation of a
   respective clinical trial is expected for end 2010/early 2011.

>> Intercell and Romark joined forces in combining therapies against Hepatitis
C. The companies are designing a treatment that combines Intercell's
investigational Hepatitis C vaccine, IC41, with Romark's antiviral drug,
nitazoxanide - a combination Phase II trial is expected to start in H1 2011.

Management

Effective October 1, 2010, Staph Leavenworth Bakali joined Intercell's
Management Board as Chief Business Officer, with key responsibilities for the
commercial aspects of the Company, directly leading Marketing & Sales, Corporate
& Business Development, and Alliance Management.

The full report can be downloaded at
http://www.intercell.com/main/forinvestors/downloads/quarterly-reports/

Further inquiry note:
Intercell AG
Lucia Malfent
Vice President, Global Head Corporate Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com
end of announcement euro adhoc
--------------------------------------------------------------------------------

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, ATX

stockmarkets: official market: Wien
language: English

OTS-ORIGINALTEXT PRESSEAUSSENDUNG UNTER AUSSCHLIESSLICHER INHALTLICHER VERANTWORTUNG DES AUSSENDERS - WWW.OTS.AT | OTB

print