euro adhoc: Intercell AG
Financial Figures/Balance Sheet
preliminary 2005 full year results:
Good progress in product development - significant increase in revenues - strong
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Intercell announces preliminary 2005 full year results: Good progress in product development - significant increase in revenues - strong cash position
Financials: » Preliminary 2005 full year results reflect progress in
product development and commercialization of technologies: revenues
EUR 8.5 million, up 84.9 %, net loss EUR 25.1 million, up 19.1 %,
R&D expenses EUR 28.5 million, up 68.8 % » Strong cash position with
EUR 50.2 million in liquid funds at year end
Product development progress
» Japanese Encephalitis: Recruitment for pivotal Phase III study completed - Orphan Drug Status granted by the European Commission - Positive initial safety data in Phase III trials
» Hepatitis C Vaccine: Route and frequency of administration optimized - success criteria for further development met
Commercialization of technologies » EUR 1 million milestone payment
from partner sanofi pasteur for bacterial vaccine candidate »
Merck & Co., Inc. commences Phase I clinical trial for S. aureus
vaccine based on antigen identified by Intercell - additional US$
1 million milestone payment » Partnered Tuberculosis vaccine
enters Phase I clinical trial
Vienna (Austria), March 6, 2006 - Vaccine company Intercell AG (VSE: ICLL) today announced its preliminary 2005 full year results. Intercells aggregate annual revenues increased from EUR 4.6 million in 2004 to EUR 8.5 million in 2005, or by 84.9 percent. Revenues from collaborations and licensing were up EUR 2.9 million and grant income was up EUR 1.0 million.
The companys loss for the year ended December 31, 2005 was up 19.1 percent to EUR 25.1 million from EUR 21.0 million in the year 2004. This is according to plan and primarily due to higher research and development costs, which increased by 68.8 percent from EUR 16.9 million in 2004 to EUR 28.5 million in 2005, reflecting the progress in manufacturing and advancing the companys JEV vaccine into Phase III clinical trials. Intercells general, selling and administrative expenses increased from EUR 7.9 million in 2004 to EUR 9.0 million in 2005, or by 12.8 percent. In 2005, net other operating income was EUR 3.1 million, primarily due to R&D tax credits, which compares to net other operating expenses of EUR 0.9 million in 2004, resulting primarily from fees relating to the companys corporate structure and unrealized foreign exchange losses.
As of December 31, 2005 Intercell had liquid funds of EUR 50.2 million of which EUR 5.3 million was cash and cash equivalents and EUR 44.9 million was available-for-sale securities.
thousand 3 months ended Year ended Year ended
Dec 31, 2005 Dec 31, 2005 Dec 31, 2004
Revenues 3,672 8,469 4,581
Net Loss (7,169) (25,060) (21,042)
Cash Flow (7,857) (24,023) (11,962)
Cash and market-
end of period 50,178 50,178 31,350
Recruitment for the pivotal immunogenicity Phase III trial of Intercells Japanese Encephalitis vaccine has successfully been completed earlier than initially planned.
Operational and Business Strategy Review Fourth Quarter 2005
Japanese Encephalitis (JEV) Recruitment in the global Phase III program, which consists of a series of immunogenicity and safety trials with enrolment totalling more than 5,000 subjects, is progressing faster than initially planned. In addition, an independent Data and Safety Monitoring Board (DSMB), which reviewed and evaluated the safety data from the first proportion of subjects vaccinated in the Phase III trial, unanimously concluded that it had observed no safety concerns. With the designation Orphan Drug Status by the European Commission, Intercell will receive 10-year sole exclusive market rights for its product within the EU25 countries including Norway and Iceland upon licensure of the vaccine as well as considerable fee reductions during the pre- and post-approval phases. The fast progress made within the entire Phase III program, supports the planned development strategy for the Companys leading product candidate, which is fully on track towards an expected market introduction in 2007. BLA (Biologics License Application) filing is expected at the end of 2006 and product registration in the United States in 2007.
Hepatitis C (IC41) In previous months, Intercell has made significant progress in the extended development program of its therapeutic vaccine against Hepatitis C. A follow-up study has been designed to further increase the T-cell response pivotal to fight the infection by optimizing the route and the frequency of vaccinations. Results of this study, which was completed in Q1 2006, indicate that IC41, when given in optimized route and schedule, is considerably more immunogenic than it has been previously shown. 50 healthy adults were vaccinated with IC41 in alternative regimes. The optimization study showed that the T-cell responses were stronger and significantly more frequent than has been seen up to now. Compared to the previous regime, the improvements were positive and meet the success criteria for further development. Based on these results, Intercell is now planning to test IC41 with this optimized schedule in a further Phase II 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 trial in Q3 2006, with first results expected in mid-2007. In addition, results from an ongoing Phase II study in combination with Interferon/Ribavirin standard therapy are expected in mid-2006.
Strategic Alliances & Licensing
All existing strategic alliances which have resulted from our highly successful antigen identification and adjuvant (IC31TM) technologies are moving forward according to the intended timelines:
» In Q4 2005, Merck & Co., Inc. started a Phase I clinical trial for
a vaccine against S. aureus infections. To date, Intercell has
received a total of US$ 5 million in revenues from this
collaboration and is eligible to receive additional milestone
payments based on the projects progress and royalties based on
future net sales. » In July 2005, sanofi pasteur exercised its option
on exclusive worldwide commercial rights on certain bacterial
vaccine antigens that have been identified by Intercells Antigen
Identification Program. Over the entire term of its agreement with
sanofi pasteur, Intercell is entitled to further license and
milestone payments totaling approximately EUR 20 million and
royalties on future net sales. In 2005, Intercell received license
and milestone payments of EUR 4 million from this collaboration. »
In collaboration with Intercell AG and supported by the European
Union, SSI has initiated its first clinical trials of a novel TB
which combines two important TB antigens developed by SSI combined
with Intercells synthetic adjuvant IC31TM.
Intercell currently expects to enter into new technology collaborations and to achieve further milestones under its existing partnerships in 2006.
The full quarterly report including un-audited financial statements can be downloaded at www.intercell.com.
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de
Further inquiry note:
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
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