EANS-Adhoc: Intercell AG announces Q3 2012 financial results and provides operational update

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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/

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(END) Dow Jones Newswires

   November 07, 2012 01:32 ET (06:32 GMT)- - 01 32 AM EST 11-07-12