EANS-Adhoc: Intercell announces Q2 and H1 2010 financial results and updates on program progress

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17.08.2010

• Significant increase in product sales totaling EUR 5.2m in Q2 2010 -
strongest quarter since IXIARO®/JESPECT® launch
• R&D pipeline progress according to plan
• Focused R&D spending in late-stage programs lead to EUR 23.0m loss for H1 2010
• Outlook full year 2010: Growing revenues from product sales, expected net
loss between EUR 20.0m and EUR 40.0m.

Vienna (Austria), August 17, 2010 - Today, Intercell AG (VSE: ICLL) announced
its financial results for Q2 and H1 2010.

IXIARO®/JESPECT® sales increased significantly from EUR 2.4m in Q2 2009 to EUR
5.2m in Q2 2010 - Continued focus on growing marketing and sales of product in
traveler and military markets

Revenues from IXIARO/JESPECT product sales in Q2 2010 represent the best
quarterly sales since the product launch in Q1 2009. The Company expects
continued growth of net product sales during H2 2010. Following the recent
approval of IXIARO® by Swissmedic and the successful product launch in
Switzerland, Intercell expects enhanced vaccination recommendations and
increasing global marketing and sales efforts by its partners Novartis and CSL
Ltd., fostering disease and product awareness. Besides the traveler´s market the
focus remains on the U.S. military. The growth rate of 2010 military sales will
depend on the use of the stockpile for JE-Vax® and rapid adaption of the
broadened recommendations for deployed military personal.

At the end of 2009, Intercell initiated a pediatric Phase III study for
IXIARO®/JESPECT® in children above 6 months of age travelling from the U.S.,
Europe, and Australia to JE-endemic areas. The multinational study, which
includes 100 children, will be the first of two Phase III trials in support of
the IXIARO®/JESPECT® label extension for pediatric licensure for children above
2 months of age. The study investigates the safety and immunogenicity of the
vaccine and is progressing according to plan - final data is expected for 2012.

Intercell is also working with its partner Biological E. of Hyderabad, India,
for the investigational vaccine to protect children and adults from JE - the
project is progressing according to plan and the start of a Phase III trial for
the investigational Japanese Encephalitis vaccine produced by Biological E. in
India is expected to commence by the end of 2010.

Pandemic Influenza Vaccine Enhancement Patch (VEP) - Next clinical evaluation
using GSK´s pandemic H5N1 vaccine to test single application protection

At the beginning of July, Intercell reported the results of a Phase II clinical
trial of its investigational Vaccine Enhancement Patch (VEP) system for Avian
H5N1 Influenza. Following encouraging pre-clinical and clinical Phase I
proof-of-concept trials conducted under a Health and Human Services (HHS)
contract, the clinical Phase II study was designed to determine the safety and
the optimal combination/dose of an injectable H5N1 Influenza vaccine and
Intercell´s VEP applied at the injection site. The study did not identify the
optimal combination of antigen and adjuvant and the results did not show a
statistically significant difference in seroprotection rates as measured by
Haemagglutinin Inhibition (HI) assay when comparing groups with and without VEP.
However, the VEP does appear to be effective in delivering adjuvants and did
demonstrate a good safety profile.

Intercell intends to conduct further clinical evaluation using its VEP in
combination with an injectable H5N1 vaccine to be supplied by GlaxoSmithKline
(GSK) as part of a collaborative agreement signed in December 2009. Timelines
for initiation of the next clinical trial are currently being evaluated between
GSK, HHS and Intercell.

All clinical programs progressing well - Key data to be announced later this
year

Recruitment for the pivotal Phase III study (approximately 2,000 travelers) for
Intercell's investigational Travelers´ Diarrhea (TD) Vaccine Patch is completed.
The randomized and placebo-controlled study will evaluate the efficacy of the TD
Vaccine Patch to actively immunize against moderate to severe enterotoxigenic
Escherichia coli (ETEC) disease and Diarrhea in a field setting. First data is
expected late 2010 or at the beginning of 2011. The enrollment of a
complementary Phase II study in travelers to India (approximately 800 travelers)
was also completed and first data is expected by Q4 2010.

Phase II results for the vaccine candidate to prevent Pseudomonas infections in
hospitals are expected at the end of Q3 / early Q4 2010, depending on data
analysis timelines. Intercell´s investigational prophylactic vaccine is a
recombinant subunit vaccine consisting of two outer membrane proteins of
Pseudomonas aeruginosa. In the initial clinical setting, it aims to evaluate
protection of intensive care unit (ICU) patients against Ventilator-Associated
Pneumonia (VAP) and Bacteremia. The current Phase II clinical trial includes
about 400 patients in more than 50 ICUs in 11 countries in Europe and Latin
America.

The recruitment for the Phase II/III clinical study testing the Staphylococcus
aureus vaccine candidate (V710) in cardiothoracic surgery patients conducted by
Merck & Co., Inc. is progressing well. First critical interim analysis
(surpassing futility) is now expected in 2011, as disclosed at Merck's R&D day
on May 11, 2010.

Pneumococcus vaccine: based on the satisfactory Phase I safety and
immunogenicity data in healthy adults, Intercell and its partner PATH are
evaluating the timeline for the start of clinical trials in children.

Tuberculosis vaccine: Phase I clinical programs are proceeding according to
plan.

Intercell reports good progress towards a collaboration in 2010 for its
therapeutic vaccine candidate against Hepatitis C. The potential collaboration
aims at conducting combination studies of the vaccine with a small molecule
approach.

Additional transactions securing long-term growth and technology leadership

In June 2010, Intercell announced the closing of the acquisition of Cytos'
platform technology for monoclonal antibody discovery to treat infectious
diseases. Intercell acquired this technology, which is based on expression
cloning of monoclonal antibodies from human B-cells, for EUR 15m to complement
its technology platform and to open novel medically and commercially relevant
applications for the Company's Antigen Identification Program (AIP®), which has
already in the past provided promising targets for antibodies such as the S.
aureus antibody.

In May 2010, Intercell entered into a worldwide Option and Exclusive License
Agreement under which Boehringer Ingelheim Vetmedica has the right to use
certain antigens derived from Intercell´s Antigen Identification Program (AIP®)
to develop animal vaccines. Under the agreement, Intercell will receive upfront,
option and milestone payments as well as royalties on product net sales.

Corporate/Other

In July 2010, Bill Gates, Co-chair of the Bill & Melinda Gates Foundation,
visited Intercell's headquarters in Vienna for a close look at the Company's
product pipeline and innovative technologies to fight infectious diseases. Bill
Gates and Intercell's Management team discussed potential ways of future
cooperation to develop novel and innovative vaccines for the developing world.

Financial Highlights

Revenues from product sales increased significantly from EUR 2.4m in Q2 2009 to
EUR 5.2m in Q2 2010. Aggregate revenues decreased from EUR 14.9m in Q2 2009 to
EUR 9.7m in Q2 2010, or by 35.2%. Research and development (R&D) expenses
increased from EUR 13.6m in Q2 2009 to EUR 16.9m in Q2 2010, or by 24.0%. This
increase was primarily due to increased expenses for our clinical TD Vaccine
patch program in Phase III. Intercell's net loss increased from EUR 3.1m in Q2
2009 to EUR 8.3m in Q2 2010. This increase was primarily due to a decrease in
revenues and an increase in research and development expenses. As of June 30,
2010, Intercell had liquid funds of EUR 127.8m, of which EUR 51.3m was cash and
short-term deposits and EUR 76.5m were available-for-sale financial assets.

Key Financial Figures

EUR in thousands     3 months ended          6 months ended     Year ended
                   June 30,   June 30,    June 30,   June 30,      Dec 31,
                       2010       2009        2010       2009         2009
Revenues              9,659     14,897      14,414     20,321       61,681
Net profit/(loss)    (8,346)    (3,078)    (23,048)   (11,254)     (18,375)
Net operating 
cash flow           (11,026)   (14,364)    (26,494)   (28,570)     (25,995)
Cash, short-term 
deposits and

available-for-sale
financial assets,
end of period 127,802 154,390 127,802 154,390 180,019

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
[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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