euro adhoc: Intercell AG
Financial Figures/Balance Sheet
Approvals for
Japanese Encephalitis vaccine in U.S., Europe and Australia on track for 2008 -
All development programs progressing according to plan - Profitability expected
for full year ...
Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement.
9-month report
11.11.2008
Intercell successfully advanced parallel regulatory processes in all key markets for travelers and military personnel - Vaccine against Japanese Encephalitis expected to obtain market approval in the U.S., Europe and Australia in 2008 - U.S. Defense Logistics Agency Request for Proposal (RFP) for purchase of Japanese Encephalitis (JE) vaccine for U.S. military in negotiation
» United States: On October 20, the U.S. Food and Drug Administration (FDA) gave positive feedback on Intercell's application to market its vaccine against Japanese Encephalitis; Intercell and the agency are working towards the earliest possible approval - ACIP meeting discussion on future recommendation of JE vaccine held on October 22/23 with formal decision expected at the February 2009 meeting
» Europe: Approval process advancing according to plan - Intercell expects a positive opinion from EMEA in December 2008
» Australia: Positive approval decision is expected in December 2008
» Intercell has geared up manufacturing efforts to ensure timely product delivery to the U.S. military by the end of 2008 and for commercial product launch in the United States, Europe and Australia in early 2009
Integration of recent acquisition of IOMAI successfully implemented - Focus now on aggressively progressing Travelers' Diarrhea patch vaccine and leveraging patch-based products and technologies
» Strategic focus on late-stage development and industrialization of the Travelers' Diarrhea patch vaccine and Pandemic Influenza patch vaccine. In addition, investigation of the use of the patch technology in new vaccine applications has been effectively initiated
» Start of pivotal Phase III for Travelers' Diarrhea patch vaccine expected in H1 2009
» Start of Phase II Pandemic flu vaccine expected in H1 2009
Nosocomial infections - S. aureus vaccine and Pseudomonas vaccine progressing in clinical programs - All other development programs and partnerships on track
» Pseudomonas: Start of clinical Phase II/III trials in ventilated Intensive Care Unit patients expected in December 2008
» S. aureus: Phase II study by Intercell's partner Merck & Co. Inc. in cardiothoracic surgery progressing well with efficacy data expected by mid 2009 - further Phase II study initiated in hemodialysis patients with late- stage kidney disease, expanding the field of application of the vaccine
» Pneumococcus: After full preparation of clinical strategy, start of clinical Phase I trials planned for early 2009
Results from 6-month follow-up of Intercell's therapeutic Hepatitis C vaccine showed statistically significant and long-term antiviral effect in Phase II patients
» Intercell is currently examining options for future development including the formulation of the vaccine with IC31® and combination with other antiviral therapies
Therapeutic Monoclonal Antibodies
» Strategic partnering process initiated to extract maximum value out of this franchise and to keep internal focus on vaccines
Financial Statements
» Intercell's aggregate revenues doubled from EUR 12.6 m in the 9 months ended September 30, 2007 to EUR 25.3 m in the same period of 2008
» Intercell's net loss decreased by EUR 8.3 m, or 37.6 percent, to EUR 13.8 m in the first 9 months of 2008 from EUR 22.1 m in the same period of 2007
» As of September 30, 2008 Intercell had liquid funds of EUR 209.0 m, of which EUR 49.1 m was cash and EUR 159.9 m was available-for-sale financial assets
» Cash preservation is the principal goal of Intercell's short-term cash management strategy. The impact of the current conditions in the capital markets on the cash portfolio is therefore minimal
KEY FIGURES - FINANCIAL HIGHLIGHTS
EUR in thousands 3 months ended 9 months ended Year ended
Sept 30, Sept 30 Sept 30 Sept 30, Dec 31,
2008 2007 2008 2007 2007Revenues 7,641 7,375 25,283 12,559 53,349 Net profit/loss (5,140) (6,514) (13,789) (22,085) 5,009 Net operating profit/loss 24,956 (12,978) (430) (27,480) 41,686
Cash and market- able securities, end of period 208,952 218,580 208,952 218,580 284,571
end of announcement euro adhoc
Further inquiry note:
Intercell AG
Lucia Malfent
Head of Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com
Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wiener Börse AG / official market