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Intercell AG

EANS-Adhoc: Intercell announces Q4 and preliminary full year 2009 financial results

  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.
quarterly report
02.03.2010
Vienna (Austria), March 2, 2010 - Today, the biotech-vaccine company 
Intercell AG (VSE: ICLL) announced its financial results for Q4 and 
the preliminary results for the full financial year 2009, and 
presented an update on the Company's development programs.
Intercell's revenues in Q4 2009 increased to EUR 32.2m including 
product sales from IXIARO®/JESPECT® of EUR 2.2m. The net profit for 
Q4 was EUR 7.5m. For the full year 2009, Intercell's revenues 
increased by 10.6% to EUR 61.7m, including product sales revenues of 
EUR 7.7m. Costs of goods sold of EUR 12.5m, exceeding revenues from 
product sales in the launch year, and increased research and 
development expenses of EUR 62.5m, reflecting Intercell's commitment 
to value creation through innovation, resulted in a net loss of EUR 
18.4m for the full year 2009, compared to a net profit of EUR 17.2m 
in 2008. With EUR 180.0m in cash and marketable securities at 
year-end, Intercell has a strong financial position to enable the 
progression of late-stage product candidates and its advanced 
clinical pipeline. For 2010, the Company's management expects growing
revenues from product sales, further increases in R&D spending and a 
resulting net loss comparable to 2009.
IXIARO®/JESPECT® - Foundation for further growth
In 2009, Intercell gained approvals for IXIARO®/JESPECT®, a vaccine 
protecting travelers against Japanese Encephalitis, in Australia, the
U.S., Europe, and Canada, totaling 32 countries. Novartis, 
Intercell's marketing partner in the majority of these territories, 
is building awareness and optimizing product uptake in all relevant 
countries. Intercell entered into an exclusive long-term supply 
contract with the U.S. military, with first sales of IXIARO® to the 
U.S. military in September 2009.
Global marketing and sales efforts for IXIARO®/JESPECT® by 
Intercell's partners to increase awareness and vaccination 
recommendations are the basis for growing product uptake in 2010. 
According to current plans, product sales are expected to increase as
of Q2 2010. Product supplies to marketing and distribution partners 
for the main travel season are expected to partially shift from Q1 to
Q2 2010 due to lot release timing for European markets.
To increase the product's global reach, Intercell has initiated a 
Phase III study for pediatric label extension of IXIARO®/JESPECT®. In
addition, the Company is pursuing further regulatory approvals and 
continues the product development for endemic countries through its 
partner, Biological E. Following discussion with regulatory 
authorities in India, the start of Phase III pediatric trials by 
Biological E. is now planned by the end of 2010.
TD Vaccine Patch - First-ever patch vaccine in Phase III and basis 
for patch collaboration with GSK
In December 2009, Intercell signed a key collaboration agreement with
GlaxoSmithKline Biologicals SA (GSK) for the development and 
commercialization of needle-free, patch-based vaccines. Under the 
terms of the agreement, GSK made an up-front cash contribution of EUR
33.6m (USD 49.4m), in addition to an equity investment of up to EUR 
84.0m (USD 123.5m) through staggered share purchases of up to 5% of 
Intercell, of which 900,000 shares, or 1.9%, have been purchased in 
December 2009 at a price of EUR 31.21 per share.
With GSK as its future marketing partner, Intercell is pushing its 
development efforts for the investigational Travelers' Diarrhea (TD) 
Vaccine Patch towards licensure. The vaccine candidate targets an 
indication that affects approximately 20 million international 
travelers annually and for which no vaccine is currently available. 
The TD Vaccine Patch is presently being investigated in a randomized,
placebo-controlled Phase III pivotal efficacy study of 1,800 
travelers from Europe to Mexico and Guatemala. In addition, a Phase 
II placebo-controlled pilot-efficacy trial was launched in 800 
subjects from the UK and Germany traveling to India as well as a 
recently initiated Phase II supportive safety study in healthy U.S. 
volunteers.
Vaccine Enhancement (VE) Patch - Pandemic Influenza partnership with 
GSK validates technology
Intercell and GSK will continue developing the single application 
Pandemic Influenza Vaccine Patch system that consists of the VE Patch
administered in conjunction with GSK's injected Pandemic Influenza 
vaccine. Intercell's VE Patch contains the heat-labile enterotoxin 
(LT) from E. coli, a potent stimulator of the immune system. Because 
LT is able to boost the effectiveness of an injectable vaccine, 
Intercell believes that the VE Patch may improve the efficacy of 
numerous vaccines for which increased immunogenicity, decreased 
antigen doses or fewer immunizations are desired.
The VE Patch is currently being studied in a Phase II trial in 
combination with an injectable H5N1 (commonly called Avian Flu) 
Pandemic Influenza vaccine (manufactured by Solvay Biologicals, B.V.)
in 500 subjects in the USA. The trial is fully funded by the U.S. 
Department of Health and Human Services.
Enrollment in this study has concluded and the serological analysis 
is under way. The availability of data has shifted to Q2 2010 due to 
broader than expected validation activities related to this analysis.
A leading position in vaccines against hospital-acquired infections
Intercell expects important data from two ongoing late-stage vaccine 
candidates against hospital-acquired infections during 2010. If 
successful, we expect the Staphylococcus aureus vaccine candidate 
(partnered with Merck & Co., Inc.) and our Pseudomonas aeruginosa 
vaccine candidate to significantly contribute to the prevention of 
these conditions if adults and children are vaccinated on, or before,
admittance to hospital.
Staphylococcus aureus vaccine (V710): Merck & Co., Inc. is developing
a vaccine against S. aureus based on Intercell's antigen. Two 
clinical trials are ongoing in high-risk patient populations: one 
evaluating vaccine efficacy in patients undergoing elective 
cardiothoracic surgery (adaptive Phase II/III trial), and one testing
immunogenicity in patients with end-stage kidney disease and 
receiving hemodialysis (Phase II). Intercell anticipates that interim
data from the Phase II/III trial in cardiothoracic surgery patients 
will be available in 2010.
Pseudomonas aeruginosa vaccine: Intercell's vaccine candidate against
the nosocomial infection, Pseudomonas aeruginosa, is currently being 
investigated in a 400-patient Phase II clinical trial. Immunogenicity
and safety are being examined and first indications for the vaccine's
efficacy are expected. In December 2009, the interim analysis from 
225 patients has shown good safety, tolerability and immunogenicity 
of the vaccine, with final data expected in Q3 2010.
Additional candidate vaccines with high medical need progressing in 
development
Streptococcus pneumoniae vaccine: Results were reported in February 
2010 from a first Phase I clinical trial of the Company's 
investigational prophylactic Streptococcus pneumoniae vaccine 
candidate. Intercell's Streptococcus pneumoniae vaccine candidate 
demonstrated a good safety and tolerability profile in all study 
groups. In addition, the vaccine was shown to be immunogenic, and 
antigen dose-dependent induction of antibodies was confirmed for all 
three proteins of the vaccine. The development of Intercell's 
Streptococcus pneumoniae vaccine is supported by PATH (Program for 
Appropriate Technology in Health), a U.S.-based non-profit 
organization dedicated to finding solutions for global health.
Therapeutic Hepatitis C Virus (HCV) vaccine: Results from a Phase II 
study of Intercell's HCV vaccine candidate were reported in 2008, and
demonstrated a statistically significant viral load reduction at 2 
weeks (0.2 log) and 6 months (0.46 log) after the last vaccination. 
Currently, no vaccine against HCV is available and the present 
standard therapy of Interferon and Ribavirin has limited efficacy and
severe side effects, leading to high dropout rates. Intercell 
anticipates that a partnership to conduct combination studies with 
its vaccine will be identified in 2010. Consequently, Intercell and 
Novartis terminated their partnership in this field in February 2010.
Intercell received a non-exclusive, worldwide license from Novartis 
to further develop and commercialize its therapeutic HCV vaccine 
under Novartis' strong genomic patent portfolio in HCV.
Tuberculosis vaccine: Phase I clinical programs are proceeding 
according to plan. These programs are based on a partnership between 
Intercell, Statens Serum Institut, sanofi-aventis, and the AERAS 
Global Tuberculosis Foundation. Further clinical data is expected 
during 2010.
Key Financial Figures (EUR in thousands)
Year ended December 31,    2009         2008          2007
Revenues                  61,681       55,763        53,349
Net profit/(loss)        (18,375)      17,175         5,009
Net operating
cash flow               (25,995)     (10,186)       41,686
Cash and marketable
 Securities, end of
 the year                180,019      190,865       287,571
The report can be downloaded at http://www.intercell.com/main/forinve
stors/downloads/quarterly-reports/
end of announcement                               euro adhoc

Further inquiry note:

Intercell AG
Lucia Malfent
Head of Corporate Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wien / official market

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