EANS-Adhoc: Intercell AG
Intercell AG announces Q1 2009 results and business
update:
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.
3-month report
11.05.2009
» First product sales of Japanese Encephalitis vaccine in Australia
» Solid revenue growth and profitability expected for full year 2009
» Excellent progress in vaccine development: Start of Phase II with investigational Vaccine Enhancement Patch against Pandemic Influenza expected soon
Vienna (Austria), May 11, 2009 - Today, Intercell AG (VSE: ICLL) announced its financial results for the first quarter of 2009 and presented an update on the Company's development programs.
Following the approval of its Japanese Encephalitis vaccine, Intercell posted its first revenues from product sales of EUR 0.4 m in Q1 2009. The company´s aggregate revenues decreased from EUR 8.6 m in Q1 2008 to EUR 5.4 m in Q1 2009. Research and development expenses increased from EUR 10.4 m in Q1 2008 to EUR 15.1 m in Q1 2009. Intercell´s net loss increased from EUR 4.6 m in Q1 2008 to EUR 8.2 m in Q1 2009. The increased loss was primarily due to a decrease in revenues and an increase in research and development expenses. For the full year 2009, management expects solid revenue growth and profitability, based on product sales and collaboration revenues. With liquid funds of EUR 172.2 m as of March 31, 2009 Intercell has a strong financial and strategic position.
Intercell's vaccine to prevent Japanese Encephalitis (JE) approved in the USA, Europe and Australia
Europe
Intercell's new vaccine to prevent JE, IXIARO® has been approved by the European Commission. Novartis will introduce the product in Europe within May 2009.
USA
On March 31, 2009, Intercell announced the FDA approval of IXIARO. Last week, an exclusive multi-year contract was signed by Intercell and the U.S. Department of Defense for purchase of IXIARO® - first sales of IXIARO under this military contract and on the US traveler market are expected soon.
Australia
In Australia, where Intercell's vaccine was approved in January 2009, delivery to travel clinics has started and first product sales have been recognized.
Next expected steps are to expand approvals in other markets (i.e., Canada, Switzerland) and to start Phase III studies in children.
Start of a Phase II trial of Intercell´s investigational Vaccine Enhancement Patch to prevent Pandemic Influenza expected soon
All preparations are on track for the start of a clinical Phase II trial investigating the effectiveness of the Vaccine Enhancement Patch in combination with an injected Pandemic Influenza vaccine to improve prevention of Pandemic Influenza. The investigational Vaccine Enhancement Patch to improve Pandemic Influenza prevention is developed in collaboration with the U.S. Department of Health and Human Services (HHS) - the Intercell and HHS contract allows for potential funding of up to USD 128 m for the clinical development of the Vaccine Enhancement Patch. First data from this trial are expected at the end of 2009.
Start of a Phase III clinical study for Travelers´ Diarrhea Vaccine Patch expected for Q2 2009, providing the H1N1 Flu situation in Mexico and surrounding areas is resolved
The Phase III TREK study will follow travelers from the USA and Europe to Mexico and Guatemala and will evaluate the prevention of diarrhea. The randomized, placebo-controlled study will include some 1,800 individuals from the USA and Europe. The start of the study is still planned for Q2.
Pipeline Vaccines - development according to plan
S. aureus vaccine Phase II/III clinical trials - study progress according to plan (Merck & Co. Inc) - Phase II interim data expected later in 2009.
Pseudomonas aeruginosa vaccine Phase II study (started at the end of 2008) is progressing well - initial results expected later in 2009.
Streptococcus pneumoniae vaccine On April 7, 2009, Intercell announced the start of a clinical Phase I trial with the company's vaccine candidate - initial results expected by the end of 2009.
Therapeutic Hepatitis C vaccine strategic partnering process ongoing.
Tuberculosis vaccine Phase I/II clinical development proceeding according to plan (Intercell, Statens Serum Institut, Sanofi Pasteur, AERAS Global Tuberculosis Foundation).
Other
In March, Reinhard Kandera was appointed as Intercell's new Chief Financial Officer (CFO). In his new role, he is responsible for global Finance and Investor Relations.
In order to provide a more convenient way for US investors to invest in Intercell, the company announced in May that it had launched a sponsored Level 1 American Depositary Receipt (ADR) facility in the United States.
Key Financial Figures
TEUR 3 months ended
March 31, Year ended Dec. 31,
2009 2008 2008Revenues 5,424 8,625 55,763 Net profit / (loss) (8,176) (4,617) 17,175 Net operating cash flow (14,251) (12,808) (10,186) Cash and available- for-sale financial assets 172,200 272,223 190,865
end of announcement euro adhoc
Further inquiry note:
Intercell AG
Lucia Malfent
Head of Corporate Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com
Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wien / official market