EANS-Adhoc: Intercell Announces Q4 and Preliminary Full Year 2010 Financial
Results
Geschrieben am 01-03-2011 |
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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.
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quarterly report
01.03.2011
Vienna (Austria), March 1, 2011 - Today Intercell AG (VSE: ICLL)
announced its financial results for Q4 and the preliminary results
for the full financial year 2010 and presented an update on the
Company's development programs.
» Increase in IXIARO®/JESPECT® sales by approximately 66% to EUR
12.8m for the full year 2010, due to increased sales in key travel
markets and to U.S. military. » EUR 255.2m net loss for the full
year 2010 resulting mainly from one-time, non-cash impairment cost
due to the discontinuation of the Travelers' Diarrhea vaccine
program. » Restructuring charges fully reflected in 2010 result -
reorganization and reduction of headcount by approximately 100
employees largely completed. » R&D expenses for the full year 2010 of
EUR 74.7m driven by Phase III studies for Travelers' Diarrhea
vaccine program and progression of other clinical stage product
candidates and technologies - 40% R&D cost reduction expected for
2011 with increased focus on hospital-acquired infections. » Cash
position of EUR 86.2m at year-end 2010 - recently further
strengthened through placement of EUR 33.0 m senior unsecured
convertible notes. » Outlook 2011: Growing revenues from product
sales and significantly lower expected net loss of EUR 30-40m.
IXIARO®/JESPECT® - Significant year-on-year growth achieved
In 2010, Intercell achieved a strong increase of IXIARO®/JESPECT®
sales with a growth of approximately 66% as compared to 2009.
Following a very good year-on-year performance in Q4 2010, Intercell
also expects strong sales results in Q1 2011 and a continuous,
significant increase in sales, with a planned full-year 2011 growth
rate of at least 60-70%. Intercell's vaccine is currently marketed to
travelers in the U.S., EU, Australia, Canada and Switzerland and it
is supplied to the U.S. military under an exclusive five-year
contract. Remaining military stock of mouse brain-derived JE-Vax®,
which is no longer produced, are expected to be depleted soon,
allowing the full transition to the IXIARO®.
Phase III clinical trials for IXIARO® as JE vaccine candidate for
children traveling to endemic areas is currently ongoing and the
pediatric vaccine launch is expected for end 2012 / beginning of
2013.
Furthermore, the WHO recommends that Japanese Encephalitis
vaccination be integrated into national immunization programs in
endemic areas. Towards this end, a pivotal Phase II/III trial in
children started in February 2011. This randomized and controlled
study will be the first pivotal Phase II/III study for the Intercell
vaccine in an endemic region and is designed to lead to Asian
licensure of the product. The first product launch for the new
vaccine in Asia is expected in H1 2012.
Focus on leading position in vaccines against nosocomial infections
Vaccine candidate to prevent infections with Pseudomonas aeruginosa
(Phase II): Intercell previously announced results from a Phase II
clinical trial involving the Company's investigational nosocomial
vaccine candidate against infections with the bacterium Pseudomonas
aeruginosa, one of the leading causes of nosocomial infections. The
primary endpoints of the study were met in that all vaccine groups
showed good seroconversion rates and a favorable safety profile.
Secondary immunogenicity endpoints were also met in this study.
Although this trial was not powered for efficacy, the Clinical
Endpoint Committee (CEC) confirmed infection rates and mortality were
recorded within the secondary endpoints analysis. A lower mortality
rate was observed in all vaccine groups as compared to the control
group. Novartis and Intercell are currently analyzing all data
obtained so far for the vaccine candidate in detail and plan to
decide on next development steps, taking into consideration the
Novartis opt-in rights, by the end of Q1, 2011.
Staphylococcus aureus vaccine candidate (Phase II/III, Phase II): In
November 2010, Intercell announced top-line results from the Phase II
clinical trial of the investigational vaccine for the prevention of
S. aureus infections. The study, conducted by Intercell's
collaborator, Merck & Co., Inc., was designed to evaluate the safety
and immunogenicity of the vaccine in patients with end-stage renal
disease (ESRD) undergoing hemodialysis treatment. The study met
primary immunogenicity and safety objectives. Study results show that
all formulations of the vaccine were immunogenic following a one- or
two-dose application. The Phase II/III study also conducted and
funded by Merck & Co., Inc. in cardiothoracic surgery patients is
progressing according to plan. An interim analysis is still expected
in 2011.
Clostridium difficile vaccine candidate (Phase I) - main cause of
nosocomial diarrhea: In December 2010, Intercell announced the start
of a Phase I clinical trial with the Company's vaccine candidate to
prevent disease caused by C. difficile. This Phase I trial is a
first-in-man study to obtain safety and immunogenicity data in
healthy adults aged 18-65 years in the first part of the study as
well as from healthy elderly subjects above 65 years of age in a
second part of the study, the latter age group representing the main
target population for a C. difficile vaccine. The pathogen is one of
the main causes of nosocomial diarrhea. First study results are
expected for 2011.
Intercell remains committed to the development of patch technology as
potential innovation for existing or novel vaccines
In December 2010, Intercell announced clinical results on its
investigational Travelers' Diarrhea (TD) Vaccine Patch program and
the decision not to pursue further the development of this vaccine
candidate. The decision was made following the top-line analysis of
results of a randomized and placebo-controlled Phase III study with
travelers from Europe to Mexico and Guatemala as well as the pilot
efficacy Phase II trial with travelers from Europe to India.
However, the studies clearly support the continued investigation of
the patch technology as a suitable route of immunization for future
potential vaccine candidates in other diseases. The patch is an
innovative and needle-free delivery technology, which can be used to
develop new vaccines that are appropriate for transcutaneous
administration without a needle (Vaccine Patch) and to enhance the
effect of injected vaccines: Vaccine Enhancement Patch (VE Patch).
Activities to adapt the strategic collaboration on patches with GSK
based on the findings from the TD studies have been initiated.
Additional candidate vaccines with high medical need progressing in
development
Hepatitis C vaccine: 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.
Pneumococcus vaccine: Following the successfully completed Phase I
study in healthy adults. Intercell and its partner PATH are currently
evaluating the next development steps.
Tuberculosis vaccine: Phase I clinical programs are proceeding
according to schedule and promising clinical data have been obtained
in multiple Phase I studies. The start of a Phase II study is
expected in 2011.
Corporate/Other
Implementation steps for headcount reduction of approximately 20%
(corresponding to about 100 people) have been largely completed and
the reduction of R&D costs by approximately 40% for full year 2011 as
announced in December 2010 is on track.
Last week Intercell announced the successful placement of EUR 33.0m
of Senior Unsecured Convertible Notes in a private placement
transaction to international institutional investors. The Notes have
a conversion price of EUR 11.43 and a fixed rate coupon of 6% per
annum.
Key Financial Information (EUR in thousands)
Year ended December 31, 2010 2009
2008
Revenues 34,215 61,681 55,763
Net profit/(loss) (255,182) (18,375) 17,175
Net operating cash flow (65,120) (25,995) (10,186)
Cash, short-term deposits, and
marketable securities, end of the year 86,182 180,019 190,865
The report can be downloaded at
http://www.intercell.com/main/forinvestors/downloads/quarterly-report
s/
end of announcement euro adhoc
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de
Further inquiry note:
Intercell AG
Lucia Malfent
Vice President, Global Head 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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