November 08, 2011
Intercell AG announces Q3 2011 results and provides an update
on ongoing operations
IXIARO®/JESPECT® net product sales of EUR 15.5m in the
first nine months of 2011 - an increase of 65% compared to
Re-structuring measures successfully implemented -
operating loss for the first nine months of 2011 reduced by
63% compared to 2010
Development programs progressing according to plan
Significant progress in net loss-reduction (minus 72% in
Q3) and cash-conservation (EUR 68.8m liquid funds at
Vienna (Austria), November 8, 2011 - Today, Intercell AG
(VSE: ICLL) announced its financial results for the third
quarter of 2011 and provided an update on its operations.
The IXIARO®/JESPECT® sales revenues exceeded EUR 15m in the
first nine months 2011 and showed a year-on-year revenue
growth of 65% compared to the prior year. Hence, the product
sales development is progressing towards the company´s
expectations for a full year-on-year growth of 60-70%
compared to 2010.
Intercell and its distribution partner, Novartis, will
continue to employ its resources to increase penetration in
key markets, the military sector, and expand into new
territories. The approval for the Japanese Encephalitis
vaccine was obtained for Hong Kong, and approval for
Singapore is expected in the next few months. Furthermore,
the first submission in Latin America has been filed, and
other submissions are planned.
In September Intercell and its partner, Biological E. Ltd.,
announced the successful completion of a pediatric pivotal
Phase II/III study for its vaccine to protect children from
Japanese Encephalitis (JE). Analysis of the pivotal Phase III
safety and immunogenicity data showed positive results, and
the study met its primary endpoint. Because of a rolling
submission process initiated during the course of 2010 as
well as Biological E´s recent completion of submissions for
licensure to the Indian authorities (DCGI), licensure is
expected in the very near future. The launch preparations for
the product are on track and launch is expected in H1 2012.
Manufacturing of commercial launch batches at Biological E.'s
facility in Hyderabad has already commenced.
The pediatric development program for IXIARO®/JESPECT® label
extension for children traveling to endemic areas is
progressing towards Phase III results and submission in early
2012. The pediatric approval is expected by the end of 2012
or beginning of 2013.
Following a batch-specific, voluntary recall of IXIARO® in
May, Intercell is completing a comprehensive investigation
and root cause analysis in order to reduce the risk for
future potential recalls, regulatory actions or
batch-specific measures. These activities as well as other
relevant measures and clinical implications are overseen and
governed by the EMA (European Medicines Agency) under a
procedure in accordance with Article 20 of the Commission
Regulation (EC) 726/2004. Intercell is working closely with
the authorities to execute against the regulatory
In order to further improve operational and
cost-effectiveness Intercell plans to fully license its
Quality Control Operations at the Vienna site for assays used
to test and release IXIARO®/JESPECT®. .As an important step
to achieve this goal, Intercell successfully passed a
pre-approval inspection by the U.S. Food and Drug
Following Intercell´s presentation of its renewal strategy
the Company successfully implemented its key consolidation
and cost reduction measures while maintaining focused R&D
activities, key talents and capabilities.
The commercial operations at Intercell's U.S. site in
Gaithersburg (MD) have been consolidated. The patch R&D
activities have been successfully transferred to Vienna.
Intercell is transitioning the residual R&D facility leases
and selling the unused equipment, and hence, expects to
deliver its objective to eliminate any remaining R&D costs
from its U.S. operations as of 2012.
The Company's operating expenses have been reduced by 50.1%
year-to date compared to 2010 - the majority gained through
cost reduction implemented by R&D prioritization,
consolidation and general rationalization.
Pseudomonas aeruginosa infections - high unmet medical need
In September Intercell received positive scientific advice
from the European Medicines Agency (EMA) for an
investigational Pseudomonas vaccine Phase II/III study.
Intercell is preparing for the pivotal clinical efficacy
trial of the Pseudomonas aeruginosa vaccine candidate in
ventilated ICU (Intensive Care Unit) patients. The planned
double-blind study is powered to show a clinically meaningful
and statistically significant reduction in overall mortality
between the vaccine and control group and expects to enroll
approximately 800 subjects. Intercell obtained clearance from
the EMA for the proposed key elements of the study design,
i.e. size, population, and primary endpoint.
Based on the positive feedback, Intercell intends to initiate
the confirmatory efficacy study in Q1/2012. First interim
data are expected in mid 2013. The program is one of the
development programs under the strategic alliance between
Novartis and Intercell. The trial will be executed by
Clostridium difficile vaccine candidate - leading cause of
Intercell received positive first data from a Phase I
clinical trial with the Company's vaccine candidate,
IC84, to prevent disease caused by the bacterium Clostridium
difficile (C. difficile). The pathogen is one of the main
causes of nosocomial diarrhea. Data showed good safety and
immunogenicity of the vaccine candidate and indicates
functionality of the induced antibodies.
The investigational vaccine induced antibodies which reacted
with both native toxins, A and B, of C. difficile. A dose
response to the vaccine candidate could be observed, and the
non-adjuvanted candidates were at least as immunogenic as the
adjuvanted candidates for both toxins. Functionality of
vaccine-induced antibodies could be shown in
This Phase I trial is a first-in-man study to obtain safety
and immunogenicity data. The first part of the study was
conducted in a population of healthy adults up to 65 years.
The second part will enroll healthy elderly subjects above 65
years of age, as this age group is considered to represent
the main target population for a C. difficile vaccine.
Tuberculosis: The start of a Phase II study is expected by
the end of 2011. The Phase I clinical programs are proceeding
according to schedule, and promising clinical data have been
obtained in multiple other Phase I studies.
Pandemic Influenza Vaccine Enhancement Patch (VEP): The
enrollment for the confirmatory Phase I trial is nearing
completion, and a first safety analysis has been completed.
The study will involve 300 healthy adults and will
investigate various combinations of antigen and patch doses
in one- and two-injection regimes to confirm the mode of
action and the value of "external" adjuvantation.
GSK's adjuvanted and licensed H5N1 vaccine will be used
to provide a positive control for the patch. Final data are
expected by mid 2012.
IC31® adjuvant: The Phase I clinical trial (undisclosed
indication) with Intercell's adjuvant IC31®, initiated by
Novartis, is ongoing. In 2007, Novartis acquired a
non-exclusive license for the use of IC31® in selected new
Hepatitis C: Romark is still awaiting regulatory clearance
for study initiation of a combination Phase II trial which is
expected to start in H2 2011. In the absence of receipt of
regulatory clearance in the near future, the trial will not
proceed as expected. Intercell and Romark joined forces in
2010 in combining therapies against Hepatitis C for a trial
fully funded by Romark.
In September Intercell announced that it is part of the
collaborative research program - Advanced Immunization
Technologies (ADITEC). The program started in order to
accelerate the development of novel and powerful immunization
technologies for the next generation of human vaccines.
ADITEC is co-funded with EUR 30m by the European Commission
to establish a robust platform for innovation in this key
strategic area with a high socio-economic impact. Scientists
from 42 research partners in 13 countries will collaborate in
this new program.
EUR in thousands
3 months ended
Sept 30, 2011
3 months ended
Sept 30, 2010
9 months ended
Sept 30, 2011
9 months ended
Sept 30, 2010
Net operating cash flow
Cash and marketable securities, end of
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