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Intercell AG

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Intercell announces preliminary 2005 full year results: Good progress in product development - significant increase in revenues - strong cash position

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  The issuer is responsible for the content of this announcement.
06.03.2006
Intercell announces preliminary 2005 full year results:  Good
progress in product development - significant increase in revenues -
strong cash position
Financials: » Preliminary 2005 full year results reflect progress in
product development   and commercialization of technologies: revenues
EUR 8.5 million, up 84.9 %,    net loss EUR 25.1 million, up 19.1 %,
R&D expenses EUR 28.5 million, up 68.8 % » Strong cash position with
EUR 50.2 million in liquid funds at year end
Product development progress
» Japanese Encephalitis:  Recruitment for pivotal Phase III study
completed - Orphan Drug Status granted by the European Commission -
Positive initial safety data in Phase III trials
» Hepatitis C Vaccine: Route and frequency of administration
optimized - success criteria for further development met
Commercialization of technologies » EUR 1 million milestone payment
from partner sanofi pasteur for bacterial    vaccine candidate »
Merck & Co., Inc. commences Phase I clinical trial for S. aureus
vaccine    based on antigen identified by Intercell - additional US$
1 million    milestone payment  » Partnered Tuberculosis vaccine
enters Phase I clinical trial
Vienna (Austria), March 6, 2006 - Vaccine company Intercell AG (VSE:
ICLL) today announced its preliminary 2005 full year results.
Intercell’s aggregate annual revenues increased from EUR 4.6 million
in 2004 to EUR 8.5 million in 2005, or by 84.9 percent. Revenues from
collaborations and licensing were up EUR 2.9 million and grant income
was up EUR 1.0 million.
The company’s loss for the year ended December 31, 2005 was up 19.1
percent to EUR 25.1 million from EUR 21.0 million in the year 2004.
This is according to plan and primarily due to higher research and
development costs, which increased by 68.8 percent from EUR 16.9
million in 2004 to EUR 28.5 million in 2005, reflecting the progress
in manufacturing and advancing the company’s JEV vaccine into Phase
III clinical trials. Intercell’s general, selling and administrative
expenses increased from EUR 7.9 million in 2004 to EUR 9.0 million in
2005, or by 12.8 percent. In 2005, net other operating income was EUR
3.1 million, primarily due to R&D tax credits, which compares to net
other operating expenses of EUR 0.9 million in 2004, resulting
primarily from fees relating to the company’s corporate structure and
unrealized foreign exchange losses.
As of December 31, 2005 Intercell had liquid funds of EUR 50.2
million of which EUR 5.3 million was cash and cash equivalents and
EUR 44.9 million was available-for-sale securities.
Financial Highlights
EUR in
thousand      3 months ended    Year ended    Year ended
               Dec 31, 2005    Dec 31, 2005  Dec 31, 2004
Revenues          3,672            8,469         4,581
Net Loss         (7,169)         (25,060)      (21,042)
Net Operating
Cash Flow        (7,857)         (24,023)      (11,962)
Cash and market-
able securities
end of period    50,178           50,178        31,350
Recent Achievement
Recruitment for the pivotal immunogenicity Phase III trial of
Intercell’s Japanese Encephalitis vaccine has successfully been
completed earlier than initially planned.
Operational and Business Strategy Review Fourth Quarter 2005
Japanese Encephalitis (JEV) Recruitment in the global Phase III
program, which consists of a series of immunogenicity and safety
trials with enrolment totalling more than 5,000 subjects, is
progressing faster than initially planned.  In addition, an
independent Data and Safety Monitoring Board (DSMB), which reviewed
and evaluated the safety data from the first proportion of subjects
vaccinated in the Phase III trial, unanimously concluded that it had
observed no safety concerns.  With the designation Orphan Drug Status
by the European Commission, Intercell will receive 10-year sole
exclusive market rights for its product within the EU25 countries
including Norway and Iceland upon licensure of the vaccine as well as
considerable fee reductions during the pre- and post-approval phases.
The fast progress made within the entire Phase III program, supports
the planned development strategy for the Company’s leading product
candidate, which is fully on track towards an expected market
introduction in 2007. BLA (Biologics License Application) filing is
expected at the end of 2006 and product registration in the United
States in 2007.
Hepatitis C (IC41) In previous months, Intercell has made significant
progress in the extended development program of its therapeutic
vaccine against Hepatitis C. A follow-up study has been designed to
further increase the T-cell response pivotal to fight the infection
by optimizing the route and the frequency of vaccinations.  Results
of this study, which was completed in Q1 2006, indicate that IC41,
when given in optimized route and schedule, is considerably more
immunogenic than it has been previously shown. 50 healthy adults were
vaccinated with IC41 in alternative regimes. The optimization study
showed that the T-cell responses were stronger and significantly more
frequent than has been seen up to now. Compared to the previous
regime, the improvements were positive and meet the success criteria
for further development.  Based on these results, Intercell is now
planning to test IC41 with this optimized schedule in a further Phase
II trial in patients with chronic Hepatitis C. This study aims to
show sustained reductions of HCV-RNA through IC41 stand-alone therapy
in a substantial subset of patients. Intercell plans to start the
trial in Q3 2006, with first results expected in mid-2007.  In
addition, results from an ongoing Phase II study in combination with
Interferon/Ribavirin standard therapy are expected in mid-2006.
Strategic Alliances & Licensing
All existing strategic alliances which have resulted from our highly
successful antigen identification and adjuvant (IC31TM) technologies
are moving forward according to the intended timelines:
» In Q4 2005, Merck & Co., Inc. started a Phase I clinical trial for
a vaccine    against S. aureus infections. To date, Intercell has
received a total of US$    5 million in revenues from this
collaboration and is eligible to receive    additional milestone
payments based on the project’s progress and royalties    based on
future net sales. » In July 2005, sanofi pasteur exercised its option
on exclusive worldwide    commercial rights on certain bacterial
vaccine antigens that have been    identified by Intercell’s Antigen
Identification Program. Over the entire    term of its agreement with
sanofi pasteur, Intercell is entitled to further    license and
milestone payments totaling approximately EUR 20 million and
royalties on future net sales. In 2005, Intercell received license
and    milestone payments of EUR 4 million from this collaboration. »
In collaboration with Intercell AG and supported by the European
Union, SSI    has initiated its first clinical trials of a novel TB
which combines two    important TB antigens developed by SSI combined
with Intercell’s synthetic    adjuvant IC31TM.
Intercell currently expects to enter into new technology
collaborations and to achieve further milestones under its existing
partnerships in 2006.
The full quarterly report including un-audited financial statements
can be downloaded at www.intercell.com.
end of announcement                               euro adhoc 06.03.2006 06:42:49

Further inquiry note:

Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market

Plus de actualités: Intercell AG
Plus de actualités: Intercell AG