(Registrieren)

EANS-Adhoc: Intercell announces Q2 and H1 2010 financial results and updates on program progress

Geschrieben am 17-08-2010


--------------------------------------------------------------------------------
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

17.08.2010

• Significant increase in product sales totaling EUR 5.2m in Q2 2010
- strongest quarter since IXIARO®/JESPECT® launch • R&D pipeline
progress according to plan • Focused R&D spending in late-stage
programs lead to EUR 23.0m loss for H1 2010 • Outlook full year 2010:
Growing revenues from product sales, expected net loss between EUR
20.0m and EUR 40.0m.

Vienna (Austria), August 17, 2010 - Today, Intercell AG (VSE: ICLL)
announced its financial results for Q2 and H1 2010.

IXIARO®/JESPECT® sales increased significantly from EUR 2.4m in Q2
2009 to EUR 5.2m in Q2 2010 - Continued focus on growing marketing
and sales of product in traveler and military markets

Revenues from IXIARO/JESPECT product sales in Q2 2010 represent the
best quarterly sales since the product launch in Q1 2009. The Company
expects continued growth of net product sales during H2 2010.
Following the recent approval of IXIARO® by Swissmedic and the
successful product launch in Switzerland, Intercell expects enhanced
vaccination recommendations and increasing global marketing and sales
efforts by its partners Novartis and CSL Ltd., fostering disease and
product awareness. Besides the traveler´s market the focus remains on
the U.S. military. The growth rate of 2010 military sales will depend
on the use of the stockpile for JE-Vax® and rapid adaption of the
broadened recommendations for deployed military personal.

At the end of 2009, Intercell initiated a pediatric Phase III study
for IXIARO®/JESPECT® in children above 6 months of age travelling
from the U.S., Europe, and Australia to JE-endemic areas. The
multinational study, which includes 100 children, will be the first
of two Phase III trials in support of the IXIARO®/JESPECT® label
extension for pediatric licensure for children above 2 months of age.
The study investigates the safety and immunogenicity of the vaccine
and is progressing according to plan - final data is expected for
2012.

Intercell is also working with its partner Biological E. of
Hyderabad, India, for the investigational vaccine to protect children
and adults from JE - the project is progressing according to plan and
the start of a Phase III trial for the investigational Japanese
Encephalitis vaccine produced by Biological E. in India is expected
to commence by the end of 2010.

Pandemic Influenza Vaccine Enhancement Patch (VEP) - Next clinical
evaluation using GSK´s pandemic H5N1 vaccine to test single
application protection

At the beginning of July, Intercell reported the results of a Phase
II clinical trial of its investigational Vaccine Enhancement Patch
(VEP) system for Avian H5N1 Influenza. Following encouraging
pre-clinical and clinical Phase I proof-of-concept trials conducted
under a Health and Human Services (HHS) contract, the clinical Phase
II study was designed to determine the safety and the optimal
combination/dose of an injectable H5N1 Influenza vaccine and
Intercell´s VEP applied at the injection site. The study did not
identify the optimal combination of antigen and adjuvant and the
results did not show a statistically significant difference in
seroprotection rates as measured by Haemagglutinin Inhibition (HI)
assay when comparing groups with and without VEP. However, the VEP
does appear to be effective in delivering adjuvants and did
demonstrate a good safety profile.

Intercell intends to conduct further clinical evaluation using its
VEP in combination with an injectable H5N1 vaccine to be supplied by
GlaxoSmithKline (GSK) as part of a collaborative agreement signed in
December 2009. Timelines for initiation of the next clinical trial
are currently being evaluated between GSK, HHS and Intercell.

All clinical programs progressing well - Key data to be announced
later this year

Recruitment for the pivotal Phase III study (approximately 2,000
travelers) for Intercell's investigational Travelers´ Diarrhea (TD)
Vaccine Patch is completed. The randomized and placebo-controlled
study will evaluate the efficacy of the TD Vaccine Patch to actively
immunize against moderate to severe enterotoxigenic Escherichia coli
(ETEC) disease and Diarrhea in a field setting. First data is
expected late 2010 or at the beginning of 2011. The enrollment of a
complementary Phase II study in travelers to India (approximately 800
travelers) was also completed and first data is expected by Q4 2010.

Phase II results for the vaccine candidate to prevent Pseudomonas
infections in hospitals are expected at the end of Q3 / early Q4
2010, depending on data analysis timelines. Intercell´s
investigational prophylactic vaccine is a recombinant subunit vaccine
consisting of two outer membrane proteins of Pseudomonas aeruginosa.
In the initial clinical setting, it aims to evaluate protection of
intensive care unit (ICU) patients against Ventilator-Associated
Pneumonia (VAP) and Bacteremia. The current Phase II clinical trial
includes about 400 patients in more than 50 ICUs in 11 countries in
Europe and Latin America.

The recruitment for the Phase II/III clinical study testing the
Staphylococcus aureus vaccine candidate (V710) in cardiothoracic
surgery patients conducted by Merck & Co., Inc. is progressing well.
First critical interim analysis (surpassing futility) is now expected
in 2011, as disclosed at Merck's R&D day on May 11, 2010.

Pneumococcus vaccine: based on the satisfactory Phase I safety and
immunogenicity data in healthy adults, Intercell and its partner PATH
are evaluating the timeline for the start of clinical trials in
children.

Tuberculosis vaccine: Phase I clinical programs are proceeding
according to plan.

Intercell reports good progress towards a collaboration in 2010 for
its therapeutic vaccine candidate against Hepatitis C. The potential
collaboration aims at conducting combination studies of the vaccine
with a small molecule approach.

Additional transactions securing long-term growth and technology
leadership

In June 2010, Intercell announced the closing of the acquisition of
Cytos' platform technology for monoclonal antibody discovery to treat
infectious diseases. Intercell acquired this technology, which is
based on expression cloning of monoclonal antibodies from human
B-cells, for EUR 15m to complement its technology platform and to
open novel medically and commercially relevant applications for the
Company's Antigen Identification Program (AIP®), which has already in
the past provided promising targets for antibodies such as the S.
aureus antibody.

In May 2010, Intercell entered into a worldwide Option and Exclusive
License Agreement under which Boehringer Ingelheim Vetmedica has the
right to use certain antigens derived from Intercell´s Antigen
Identification Program (AIP®) to develop animal vaccines. Under the
agreement, Intercell will receive upfront, option and milestone
payments as well as royalties on product net sales.

Corporate/Other

In July 2010, Bill Gates, Co-chair of the Bill & Melinda Gates
Foundation, visited Intercell's headquarters in Vienna for a close
look at the Company's product pipeline and innovative technologies to
fight infectious diseases. Bill Gates and Intercell's Management team
discussed potential ways of future cooperation to develop novel and
innovative vaccines for the developing world.

Financial Highlights

Revenues from product sales increased significantly from EUR 2.4m in
Q2 2009 to EUR 5.2m in Q2 2010. Aggregate revenues decreased from EUR
14.9m in Q2 2009 to EUR 9.7m in Q2 2010, or by 35.2%. Research and
development (R&D) expenses increased from EUR 13.6m in Q2 2009 to EUR
16.9m in Q2 2010, or by 24.0%. This increase was primarily due to
increased expenses for our clinical TD Vaccine patch program in Phase
III. Intercell's net loss increased from EUR 3.1m in Q2 2009 to EUR
8.3m in Q2 2010. This increase was primarily due to a decrease in
revenues and an increase in research and development expenses. As of
June 30, 2010, Intercell had liquid funds of EUR 127.8m, of which EUR
51.3m was cash and short-term deposits and EUR 76.5m were
available-for-sale financial assets.

Key Financial Figures


EUR in thousands 3 months ended 6 months ended Year ended
June 30, June 30, June 30, June 30, Dec 31,
2010 2009 2010 2009 2009
Revenues 9,659 14,897 14,414 20,321 61,681
Net profit/(loss) (8,346) (3,078) (23,048) (11,254) (18,375)
Net operating
cash flow (11,026) (14,364) (26,494) (28,570) (25,995)
Cash, short-term
deposits and
available-for-sale
financial assets,
end of period 127,802 154,390 127,802 154,390 180,019


The full report can be downloaded at
http://www.intercell.com/main/forinvestors/downloads/quarterly-reports/



end of announcement euro adhoc
--------------------------------------------------------------------------------


ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Intercell AG

Lucia Malfent

Vice President, Global Head Corporate Communications

Tel. +43 1 20620-1303

lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wien / official market


Kontaktinformationen:

Leider liegen uns zu diesem Artikel keine separaten Kontaktinformationen gespeichert vor.
Am Ende der Pressemitteilung finden Sie meist die Kontaktdaten des Verfassers.

Neu! Bewerten Sie unsere Artikel in der rechten Navigationsleiste und finden
Sie außerdem den meist aufgerufenen Artikel in dieser Rubrik.

Sie suche nach weiteren Pressenachrichten?
Mehr zu diesem Thema finden Sie auf folgender Übersichtsseite. Desweiteren finden Sie dort auch Nachrichten aus anderen Genres.

http://www.bankkaufmann.com/topics.html

Weitere Informationen erhalten Sie per E-Mail unter der Adresse: info@bankkaufmann.com.

@-symbol Internet Media UG (haftungsbeschränkt)
Schulstr. 18
D-91245 Simmelsdorf

E-Mail: media(at)at-symbol.de

284252

weitere Artikel:
  • EANS-Adhoc: Intercell veröffentlicht die Finanzergebnisse des 2. Quartals und des 1. Halbjahres 2010 und informiert über Entwicklungsfortschritte -------------------------------------------------------------------------------- Ad-hoc-Mitteilung übermittelt durch euro adhoc mit dem Ziel einer europaweiten Verbreitung. Für den Inhalt ist der Emittent verantwortlich. -------------------------------------------------------------------------------- 6-Monatsbericht 17.08.2010 • Signifikante Steigerung des Produktumsatzes auf insgesamt EUR 5,2 Mio. im 2. Quartal 2010 - stärkstes Quartal seit der Markteinführung von IXIARO®/JESPECT®. • F&E Pipeline entwickelt mehr...

  • EANS-News: Didier-Werke AG / Halbjahresergebnis 2010 -------------------------------------------------------------------------------- Corporate News übermittelt durch euro adhoc. Für den Inhalt ist der Emittent/Meldungsgeber verantwortlich. -------------------------------------------------------------------------------- 6-Monatsbericht Wiesbaden (euro adhoc) - Der Geschäftsverlauf der Didier-Werke AG war im 1. Halbjahr 2010 von der globalen wirtschaftlichen Erholung gekennzeichnet und zeigte in den zentralen Kundenindustrien - Stahl, Zement/Kalk, Glas und Nichteisenmetalle - mehr...

  • EANS-Hinweisbekanntmachung: Didier-Werke AG / Bekanntmachung gemäß § 37v, 37w, 37x ff. WpHG mit dem Ziel der europaweiten Verbreitung -------------------------------------------------------------------------------- Hinweisbekanntmachung für Finanzberichte übermittelt durch euro adhoc mit dem Ziel einer europaweiten Verbreitung. Für den Inhalt ist der Emittent verantwortlich. -------------------------------------------------------------------------------- Hiermit gibt die Didier-Werke AG bekannt, dass folgende Finanzberichte veröffentlicht werden: Bericht: Halbjahresfinanzbericht Deutsch: Veröffentlichungsdatum: 17.08.2010 Veröffentlichungsort : mehr...

  • EANS-Tip Announcement: Binder+Co Aktiengesellschaft / Interim Announcement (with document) -------------------------------------------------------------------------------- Tip announcement for financial statements transmitted by euro adhoc. The issuer is responsible for the content of this announcement. -------------------------------------------------------------------------------- The company Binder+Co Aktiengesellschaft is declaring its financial reporting publication plan below: Report Type: Interim Announcement German: Publication Date : 17.08.2010 Publication Location: http://www.binder-co.com English: mehr...

  • EANS-Hinweisbekanntmachung: Binder+Co Aktiengesellschaft / Zwischenmitteilung (mit Dokument) -------------------------------------------------------------------------------- Hinweisbekanntmachung für Finanzberichte übermittelt durch euro adhoc mit dem Ziel einer europaweiten Verbreitung. Für den Inhalt ist der Emittent verantwortlich. -------------------------------------------------------------------------------- Hiermit gibt die Binder+Co Aktiengesellschaft bekannt, dass folgende Finanzberichte veröffentlicht werden: Bericht: Zwischenmitteilung Deutsch: Veröffentlichungsdatum: 17.08.2010 Veröffentlichungsort mehr...

Mehr zu dem Thema Finanzen

Der meistgelesene Artikel zu dem Thema:

Century Casinos wurde in Russell 2000 Index aufgenommen

durchschnittliche Punktzahl: 0
Stimmen: 0

Bitte nehmen Sie sich einen Augenblick Zeit, diesen Artikel zu bewerten:

Exzellent
Sehr gut
gut
normal
schlecht