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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.
>> 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
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
Net profit/loss (27,844) (14,671) (50,892) (25,925) (18,375)
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
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
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.
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
The full report can be downloaded at http://www.intercell.com/main/fo
end of announcement euro adhoc
ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.ch
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