EANS-Adhoc: Intercell announces Q2 and H1 2011 financial results and provides an update on execution of strategic plan
16.08.2011 – 07:22
-------------------------------------------------------------------------------- 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. -------------------------------------------------------------------------------- 6-month report 16.08.2011 » IXIARO®/JESPECT® sales growth up by 85% in H1 2011 » Net loss reduced by 80% in Q2 and by 44% in H1 2011 » USD 6.0m milestone payment received from Merck & Co., Inc. for S. aureus interim data Vienna (Austria), August 16, 2011 - Today, the biotech-vaccine company Intercell AG (VSE: ICLL) announced its financial results for Q2 and H1 2011 and provided an update on execution of strategic plan. Financial Results » Year-on-year revenue growth of 31.3% in Q2 2011 driven by strong IXIARO®/JESPECT® sales revenues » Restructuring progressing successfully - cost reduction by 57.7% in R&D and 21.9% in S,G&A in H1 2011 » Net loss reduction by 80.7% to EUR 1.6m in Q2 2011 and by 44.2% to EUR 12.9m in H1 2011 » Cash position of EUR 79.6m at quarter-end - significant reduction of cash-outflow » Unchanged net loss expectation of EUR 30-40m for full year 2011 Key Financial Figures EUR in thousands 3 months ended 6 months ended Year ended June 30, June 30, June 30, June 30, Dec 31, 2011 2010 2011 2010 2010 Revenues 12,686 9,659 18,377 14,414 34,215 Net profit/(loss) (1,608) (8,346) (12,866) (23,048) (255,182) Net operating cash flow (5,452) (11,026) (28,905) (26,494) (65,120) Cash and marketable securities, end of period 79,649 127,802 79,649 127,802 86,182 IXIARO®/JESPECT® In H1 2011, the IXIARO®/JESPECT® sales were up 85% compared to H1 2010 resulting in the best quarterly sales since launch of the product. This was made possible through a strong uptake in the military sector and strong growth in key travel markets such as the U.S. and the UK. Hence Intercell is on track to meet its expectation of full-year 2011 growth rate of at least 60-70%. Together with its distribution partner Novartis, Intercell will continue to focus resources to further increase penetration in the key markets, the military sector, and expand into new territories. The approval for Singapore is expected in the next months, and the first application for approval in South America has also been submitted. Enrollment for the Phase III clinical study for the IXIARO® pediatric label extension is completed. The pediatric approval is expected by the end of 2012 or beginning of 2013. The pivotal Phase II/III trial in children living in India has been fully enrolled and partner Biological E. Ltd. is moving towards submission for licensure in India, with a planned launch in 2012. Following an "Out of Specification" result in a follow-up test for potency of IXIARO® lot JEV09L37 after a period of 11 months, Novartis and Intercell initiated a batch-specific, voluntary recall in Canada (March), Europe (May) and Australia (May), in close coordination with the relevant authorities. Vaccinee safety is of primary importance to Intercell, and re-vaccination was initiated for individuals who had received vaccine from the respective lot. In addition, Intercell is performing a comprehensive investigation and root cause analysis in order to reduce the risk for further potential recalls, regulatory actions or batch-specific measures in the future. These activities as well as other relevant measures and clinical implications are overseen and governed by the EMA (European Medicines Agency) under a procedure according to Article 20 of the Commission Regulation (EC) 726/2004. Novartis and Intercell are working closely with the authorities to execute against the regulatory requirements. Update on Staphylococcus aureus (V710): Intercell receives milestone payment from Merck & Co., Inc. Following a detailed analysis of the data from the Phase II/III clinical trial evaluating V710, an investigational vaccine for the prevention of Staphylococcus aureus (S. aureus) infections, the external Data Monitoring Committee (DMC) unanimously recommended the termination of the study. On June 8, 2011, Merck & Co., Inc. (Merck) and Intercell announced the termination of the trial. However, as the trial did meet the pre-specified criteria for non-futility, Intercell received the related USD 6.0m milestone payment from Merck. Furthermore, Intercell and Merck are currently evaluating potential future approaches in the field of S. aureus under the existing licensing agreement. Focus on core R&D programs » Pandemic Influenza Vaccine Enhancement Patch (VEP) - Pursuing confirmatory mode of action trial with GSK antigen: The enrollment for the confirmatory Phase I trial is ongoing and a first safety analysis has been completed. Final data are expected by mid-2012. » Pneumococcus vaccine: As part of Intercell's pipeline prioritization, the development of a Pneumococcus vaccine candidate has been put on hold. » Hepatitis C: Intercell and Romark joined forces in combining therapies against 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. The trial is fully funded by Romark. Corporate » French Prix Galien 2011 awarded to IXIARO® in the category "Medicines available solely in international vaccination centers" The full 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, ATX stockmarkets: official market: Wien language: English