EANS-Adhoc: Intercell AG announces Q1 2012 results and operational update
08.05.2012 – 07:38
-------------------------------------------------------------------------------- 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. -------------------------------------------------------------------------------- quarterly report 08.05.2012 » Solid IXIARO®/JESPECT® sales revenues up by 36.4% to EUR 4.6m in Q1 2012 compared to Q1 2011 » Net loss reduced by 28.2 % to EUR 8.1m; cash position of EUR 38.5m at quarter end Q1 2012 financial results » Total revenues of EUR 6.0m in Q1 2012 compared to EUR 5.7m in Q1 2011 - lower revenues from collaboration and licensing were offset by higher JEV sales » Reduction of R&D expenses by 28.3% to EUR 5.7m in Q1 2012 (Q1 2011: EUR 7.9m) and reduction of SG&A expenses by 3.3% to EUR 4.1m (Q1 2011: EUR 4.2m) » Net loss of EUR 8.1m in Q1 2012 compared to EUR 11.3m in Q1 2011 » Cash position of EUR 38.5m at the end of Q1 2012 compared to EUR 50.9m at the end of December 2011 Key Financial Information TEUR 3 months ended March 31, Year ended 2012 2011 Dec 31, 2011 Revenues 5,994 5,692 32,884 Net loss (8,077) (11,257) (29,265) Net operating cash flow (8,949) (23,453) (42,858) Cash,short-term deposits and marketable securities, end of period 38,451 87,697 50,859 Solid product sales growth performance - Launch preparations in India IXIARO®/JESPECT® product sales revenues increased by 36.4 % to EUR 4.6m in Q1 2012 compared to EUR 3.3m in Q1 2011. Intercell is on track for the sales revenue - growth expectations for the full year 2012 of EUR 8-10m. Intercell's partner Biological E. Ltd. is preparing to launch the Japanese Encephalitis vaccine to protect small children and adults in India in H1 2012. The product will be marketed under the brand name JEEV®. Intercell began the submission process to major regulatory agencies for approval of IXIARO®/JESPECT® pediatric label extension. The pediatric approval is expected by the end of 2012 or beginning of 2013. Intercell received a positive CHMP opinion on the close out of the EMA Article 20 procedure (Commission Regulation (EC) No 726/2004) initiated in June 2011 in connection with a voluntary, batch specific recall in May 2011. Currently the European Commission (EC) adoption procedure towards final EC decision is progressing and the formal close out by the European Commission is expected for Q2 2012. R&D programs and activities on track Pseudomonas aeruginosa vaccine candidate - On March 13, Intercell announced the start of a pivotal Phase II/III efficacy trial of its investigational Pseudomonas aeruginosa vaccine. The trial follows an exploratory Phase II study in which lower all-cause mortality rates were observed in the vaccine groups as compared to the control group. First interim data of the futility analysis are expected by mid 2013. Clostridium difficile vaccine candidate -Intercell initiated the second part of the Phase I clinical trial (Phase Ib) with the Company's vaccine candidate IC84 to prevent C. difficile infection. This follows positive first data from a Phase I study (Phase Ia) in a population of healthy adults aged 18-65 years. Results are expected by mid 2013. Tuberculosis: In addition to the Phase II study announced in January 2012, Intercell and Statens Serum Institut (SSI) will initiate a second clinical Phase II study to assess the safety and immunogenicity of the vaccine candidate in healthy adolescents by mid 2012. Pandemic Influenza Vaccine Enhancement Patch (VEP): The currently ongoing Phase I study investigates Intercell's adjuvant patch (Vaccine Enhancement Patch - VEP) containing LT (a heat-labile toxin from E.coli) in combination with GSK's H5N1-pandemic antigen. Final data are expected in mid or late 2012. Pre-clinical activities: Intercell's pre-clinical lead vaccine candidate against Borrelia (Lyme Borreliosis) is heading towards pre-clinical proof of concept. The report can be downloaded at http://www.intercell.com/main/forinvestors/downloads/quarterly-reports/ Further inquiry note: Intercell AG Nina Waibel Corporate Communications Tel. +43 1 20620-1222 communications@intercell.com end of announcement euro adhoc -------------------------------------------------------------------------------- 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