euro adhoc: Intercell AG
quarterly or semiannual financial statement /
Intercell announces Q2 results:
Positive JEV Phase III Results - Strategic Marketing and Distribution
partnership with Novartis - Strong financial position for the next stage of
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Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement.
11.08.2006
Significant clinical progress: » Positive results for Intercells Japanese Encephalitis Virus vaccine in pivotal clinical Phase III immunogenicity trial - primary endpoint met » Preparations for the filing process with the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) started
Important new partnerships: » Additional Strategic Alliance with Merck & Co., Inc. (US) for the development of monoclonal antibodies against severe Staphylococcus Aureus infections » Novartis was selected as Marketing and Distribution partner of Intercells Japanese Encephalitis Virus Vaccine in the United States, Europe and certain other markets in Asia and Latin America
Financial strength for further growth: » Revenues of EUR 5.8 m in the first six months of 2005 - Up 40.6 % compared to first half year 2005. Net loss of EUR 12.3 m in first half of 2006 - Up 51% compared to 2005 - primaryily driven by advancement of JEV vaccine development » Successful offering of existing and new shares with a total offering volume of EUR 110.6 m and approx. EUR 55.4 m net proceeds for Intercell » Strong cash position with approx. EUR 90 m in liquid funds at July 4, 2006
Future Milestones 2006 » Results from pivotal JEV vaccine safety study expected within the next weeks » Start of further Phase II clinical trial in chronic HCV patients and results of the ongoing combination trial with Interferon/Ribavirin » Additional license deals expected for AIP and VIP technology platforms
Vienna (Austria), August 14, 2006 - Vaccine company Intercell AG (VSE: ICLL) today announced its financial results for the second quarter of 2006.
Intercells aggregate revenues increased from EUR 4.1 million in the first six month of 2005 to EUR 5.8 million in the same period of 2006, or by 40.6 percent. Revenues from collaborations and licensing increased by 51.5 percent, from EUR 3.6 million in the first half year 2005 to EUR 5.4 million in the first half year 2006. Grant income decreased by 29.5 percent, from EUR 0.6 million in the first six months of 2005 to EUR 0.4 million in the first six months of 2006.
Intercells net loss in the second quarter 2006 was EUR 3.5 million compared to EUR 3.1 million in the second quarter of 2005. This increase was primarily due to higher research and development expenses, which were partly offset by an increase in revenues.
As of June 30, 2006 Intercell had liquid funds of EUR 39.6 million of which EUR 10.7 million was cash and EUR 28.9 million was available for sale financial assets.
Liquid funds, as adjusted for the net proceeds of the public offering completed on July 4, 2006, were approximately EUR 90.4 million.
Financial Highlights
EUR thousands 3 months ended 6 months ended Year ended
March 31, March 31, June 30, June 30, Dec 31,
2006 2005 2006 2005 2005
Revenues 5,445 3,752 5,771 4,105 8,469
Net loss (3,477) (3,095) (12,291) (8,139) (25,060)
Net operating
cash flow (3,096) (4,045) (11,578) (11,025) (24,023)
Cash & marketable
securities,
end of period 39,646 65,966 39,646 65,966 50,178Operational and Business Strategy Review Q2 2006
Japanese Encephalitis (JEV)
Over the last few months, Intercells priority has been its ongoing global Phase III clinical trial program for its Japanese Encephalitis virus (JEV) vaccine. First analysis of the pivotal immunogenicity Phase III clinical data of Intercell´s investigational JEV vaccine showed positive results and met its primary endpoint. With these results, the filing process with the United States Food and Drug Administration (FDA) will start shortly to prepare for the market launch in the United States expected in 2007. The results of the ongoing pivotal safety study are expected within the next weeks. In June 2006, Intercell has made significant progress in putting its global marketing distribution process for this product in place. Novartis was selected as Intercells marketing and distribution partner for the JEV vaccine in the United States, Europe and certain other markets in Asia and Latin America
Hepatitis C (IC41)
In previous months, Intercell has made significant progress in its clinical trial program for its therapeutic Hepatitis C vaccine. Results of the optimization trial clinical trial, which was completed in Q1 2006, indicate that IC41, when given in optimized route and schedule, is considerably more immunogenic than has been previously shown. Based on these results, Intercell is now finalizing all preparations to test IC41 with this optimized schedule in a further Phase II clinical trial in patients with chronic Hepatitis C. This study aims to show sustained reductions of HCV-RNA through IC41 stand-alone therapy in a substantial subset of patients. Intercell plans to start the clinical trial in Q3 2006, with initial results expected in mid-2007. Results of the ongoing clinical trial where IC41 is tested in a combination treatment with Interferon/ Ribavirin are expected for Q4 2006.
Strategic Alliances & Licensing
All existing strategic partnerships and collaborations are moving forward according to schedule. In the previous months, Intercell entered further strategic alliancies important for the companies strategic growth: » Strategic partnership with Merck & Co., Inc. to develop human monoclonal antibodies against severe infections caused by Staphylococcus aureus, a bacterium, that causes severe hospital-acquired infections and has become increasingly resistant to a variety of antibiotics. » Strategic alliance with Novartis for the marketing and distribution of its Japanese Encephalitis Vaccine in the United States, Europe and certain other markets in Asia and Latin America. Intercell will be entitled to milestone payments of up to EUR 37 million from Novartis. Novartis made an equity investment of EUR 30 million in shares of Intercell in the recently completed secondary public offering.
Financials: In July 2006, Intercell successfully completed its combined primary and secondary public offering: » The total offer proceeds amount to EUR 110.6 million with approx. EUR 55.4 million net proceeds for Intercell. The offer price per share was set at EUR 12.36.
Intercell intends to use the net proceeds of this offering for further organic growth of its promising vaccine pipeline, expansion of its manufacturing capacities and general corporate purposes.
The full quarterly report including un-audited financial statements can be downloaded at www.intercell.com.
end of announcement euro adhoc 14.08.2006 06:59:30
Further inquiry note:
Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com
Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market