EANS-Adhoc: Intercell AG announces Q3 2012 financial results and provides
operational update
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9-month report
07.11.2012
» IXIARO®/JESPECT® - product sales growth trend continues despite lower than
expected product sales of EUR 3.5m in Q3 2012
» U.S. military places largest IXIARO® order to date in Q4 2012
» Net loss for Q3 2012 slightly decreased by 2.8% to EUR 7.5m
Q3 2012 Financial results
» Total revenues decreased by 41.3% to EUR 4.4m in Q3 2012 compared to EUR 7.5m
in Q3 2011, mainly resulting from lower IXIARO®/JESPECT® product sales
» Net loss of EUR 7.5m in Q3 2012, compared to a net loss of EUR 7.8m in Q3 2011
» Full year 2012 net loss between EUR 20m and EUR 24m expected
» Cash position of EUR 59.3m at the end of Q3 2012 reflects progress in
reduction of operating cash outflow on the way towards financial
self-sustainability
Key Financial Information
EUR in thousands 3 months ended 9 months ended Year ended
Sept 30, Sept 30, Sept 30, Sept 30, Dec 31,
2012 2011 2012 2011 2011
Revenues 4,416 7,527 25,592 25,904 32,884
Net profit/(loss) (7,536) (7,754) (14,600) (20,620) (29,265)
Net operating
cash flow (943) (3,035) (10,372) (31,940) (42,858)
Cash and marketable
securities,
end of period 59,328 68,791 59,328 68,791 50,859
IXIARO®/JESPECT® product sales for the nine months ended September 30, 2012 of
EUR 18.2m still represent a considerable 17.4% increase compared to the same
period in 2011 (EUR 15.5m). Delay in orders and higher than anticipated
post-travel season stock-levels in-market in Q3 2012 led to decreased product
sales of EUR 3.5m compared to 2011(EUR 5.1m).
Intercell recently received its largest order ever of IXIARO® vaccine from the
U.S. military. Subject to timely product release to secure supply of the vaccine
and based on current orders and demand, Intercell expects strong Q4 2012 sales
of EUR 8.5m to 10.5m (Q4 2011: EUR 6.1m) underscoring the unlocked potential of
this vaccine.
In September 2012, Intercell's partner Biological E. Ltd. launched the product
JEEV® - a vaccine to protect small children and adults from Japanese
Encephalitis (JE) - in India. First deliveries of the product are expected to
take place in Q4 2012. This is the first time this next-generation Japanese
Encephalitis vaccine is available in an endemic country.
Biological E. Ltd. plans to focus its sales efforts of JEEV® primarily on
private market customers including pediatricians and general practitioners. To
ensure a successful product launch, Biological E. Ltd. has recruited and trained
its own sales force, which will initially be fully dedicated to the product.
Intercell received "Medsafe Consent to Distribute a New Medicine" and the
corresponding Gazette notice for JESPECT®, equivalent to the registration
approval letter and the marketing authorization. This means JESPECT® is now
registered in New Zealand and can be marketed there.
The Company's Japanese Encephalitis vaccine IXIARO® was granted Orphan Drug
status by the FDA following its recent submission of the pediatric licensure
indications for ages from 1 year to less than 17 years. The Orphan Drug
designation includes a substantial reduction of fees payable and waivers during
the pre- and post-approval phases for this pediatric indication.
Intercell obtained favorable data from a Phase III trial in 300 children
conducted in the Philippines. Interim results of the trial showed that a booster
dose of the vaccine was well tolerated and highly immunogenic in children aged 1
to <18 years. Intercell plans to present the data at the International Society
of Travel Medicine meeting in May 2013.
R&D programs and activities are proceeding to next stages of development
Pandemic Influenza Vaccine Enhancement Patch (VEP) - In September 2012,
Intercell announced the results from a Phase I study investigating Intercell's
adjuvant patch (Vaccine Enhancement Patch - VEP) containing LT (a heat-labile
toxin from E. coli) in combination with an intramuscular (IM) administration of
an A/H5N1 antigen supplied by GSK. The study was performed to confirm the mode
of action of transcutaneous applied adjuvants when co-administered with an
Influenza A/H5N1 antigen, following different and inconsistent results from the
previous Phase I and Phase II clinical studies.
The study involved 300 healthy adults and investigated two combinations of
A/H5N1 antigen doses with or without patch in one and two injection regimes.
GSK's adjuvanted and licensed H5N1 vaccine was used to provide a positive
control arm.
The combination of A/H5N1 with VEP met two of three CHMP criteria for Pandemic
Influenza Vaccines (GMT fold rise from day 0 and seroconversion). However, the
study endpoint of a 2 or more fold rise in HI titers was not achieved since the
immunogenicity was only moderately increased by VEP. However, VEP enhanced
significantly the immune response in subjects with existing HI titers,
indicating the potential use of VEP in booster vaccination.
Based on this study outcome and other pre-clinical results achieved with
different antigens, Intercell will focus its future patch strategy on partnering
and out-licensing - with a strong emphasis on antigen delivery as well as
booster vaccination target product profiles.
IC31® adjuvant - Intercell maintains research collaborations with different
partners to evaluate IC31® in new vaccine formulations, additional
collaborations have been initiated in the field of cancer.
Pre-clinical proof of concept for vaccine candidate against Lyme borreliosis
The Company's pre-clinical lead vaccine candidate against Lyme borreliosis is
completing pre-clinical proof of concept studies according to plan. The
proprietary vaccine candidate, based on a novel technology has passed all
pre-clinical research steps and is moving towards pre-clinical development in
preparation for clinical testing. These studies will include toxicology testing,
GMP production of proteins and assay development.
Update of Intercell's technology partnering options
Positive pre-clinical data for a Tetanus toxoid booster vaccine patch support
partnering and out-licensing of the Vaccine Delivery Patch (VDP) for use as
possible needle-free booster vaccine technology. Besides Tetanus, Intercell is
also testing the applicability of the VDP in additional indications to support
licensing discussions
The report can be downloaded at
http://www.intercell.com/main/investors/financial-reports-presentations/quarterly-reports/
Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com
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: investors@intercell.com
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes: ATX Prime
stockmarkets: official market: Wien
language: English