euro adhoc: Intercell AG
quarterly or semiannual financial statement /
Intercell AG announces Q1 2008 results and update on development programs:
Vaccine against Japanese Encephalitis moving towards global market approvals: US
FDA inspection ...
Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement.
3-month report
13.05.2008
Intercell's investigational Japanese Encephalitis vaccine expected to obtain market approval in global traveler markets in 2008 - commercial production started
» Intercell´s manufacturing facility in Livingston receives Manufacturer's License from MHRA for future commercial manufacturing of the vaccine against Japanese Encephalitis » Day-80 review from EMEA (European Medicines Agency) received » FDA waives VRPAC (Vaccines and Related Biological Products Advisory Committee) - Pre-approval inspection of the facilities started on time and is currently ongoing » Licensure application submitted to Australian Therapeutic Goods Administration (TGA) - TGA grants priority review for Intercell's vaccine candidate » Licensure application for approval in Switzerland to Swissmedic submitted via Novartis » EU, US and Australian market approvals expected in 2008 » Vaccine shows excellent safety and immunogenicity in Phase II trials in children at "half dose"
Significant progress in vaccines against hospital-acquired infections
» S. aureus: Phase II results for vaccine designed by Intercell expected for end 2008 / early 2009 (conducted by Merck & Co., Inc.) » Pseudomonas : Start of clinical Phase II/III trials expected for 2008 » Pneumococcus: Outstanding pre-clinical results on novel protein-based universal vaccine published in the Journal of Experimental Medicine; initiation of Phase I trials is planned for later in 2008 » Acceleration of pre-clinical candidates for further nosocomial vaccine and antibody product targets including Klebsiella and Enterococcus
Unique clinical data for therapeutic Hepatitis C vaccine
» Therapeutic Hepatitis C vaccine candidate meets primary endpoints in Phase II trials - data from 46 vaccinated chronic patients reveal statistically significant viral load reduction and favorable safety profile » Intercell and Novartis initiated co-development; further clinical trials will include IC31® » Intercell was awarded "The Vaccine Industry Excellence Award" in the category of "Best New Therapeutic Vaccine" for its therapeutic Hepatitis C vaccine candidate at the "World Vaccine Congress" in Washington D.C.
Adjuvant IC31® - Phase I Influenza trials with IC31® successfully completed - Collaboration on Malaria - Tuberculosis cooperation expanded
» Influenza: Intercell's adjuvant IC31® demonstrates a very good safety and tolerability profile in first Phase I Influenza vaccine clinical trial » Malaria: ICLL and PATH Malaria Vaccine Initiative (MVI) initiated a new collaboration to evaluate adjuvant IC31® in combination with malaria antigens from the US National Institutes of Health (NIH) » Tuberculosis: TB vaccine formulated with adjuvant IC31® and developed in a partnership between Statens Serum Institut (SSI) and Sanofi Pasteur enters a series of further clinical trials
Strong financial and strategic position - Costs under control, fully on track for strong increase in revenues and sustained profitability for the full year 2008
» EUR 4.6 m net loss for Q1 2008 compared to EUR 7.1 m in Q1 2007, a reduction of 35.2 percent » Increase in aggregate revenues - EUR 8.6 m in Q1 2008 compared to EUR 1.5 m in Q1 2007, an increase of 473.3 percent » EUR 10.4 m R&D expenses in Q1 2008 - up 41.0 percent compared to EUR 7.4 m in Q1 2007 following progress of development programs as planned » Strong strategic cash position: EUR 272.2 m in liquid funds at March 31, 2008. Further EUR 40 m already unconditionally committed for 2008. » Intercell will finance the cash component of the acquisition of Iomai Corporation, which was announced today, comfortably from existing reserves. Despite higher costs through the acquisition, Intercell also expects to maintain its target of profitability in 2008.
Key Financial Figures
TEUR 3 months ended Year ended
March 31, March 31, Dec 31,
2008 2007 2007Revenues 8,625 1,502 53,349
Net profit/(loss) (4,617) (7,050) 5,009
Net operating cash flow (12,808) (9,635) (41,686)
Cash and available-for- sale financial assets 272,223 86,262 287,571
end of announcement euro adhoc
Further inquiry note:
Intercell AG
Lucia Malfent
Head of Communications
Tel. +43 1 20620-303
lmalfent@intercell.com
Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wiener Börse AG / official market