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

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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/forinvestors/downloads/quarterly-reports/

Further inquiry note:
Intercell AG
Lucia Malfent
Head of Corporate Communications
Tel. +43 1 20620-1303
[email protected]
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:     [email protected] 
WWW:      www.intercell.com
sector:   Biotechnology
ISIN:     AT0000612601
indexes:  ATX Prime, ATX

stockmarkets: official market: Wien
language: English

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