EANS-Adhoc: Intercell AG Announces Q3 2009 Results and Updates on R&D Progress and Management:
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9-month report
09.11.2009
» Progress on Japanese Encephalitis vaccine (IXIARO®/JESPECT®) business and global reach - approval in Canada obtained - Phase III study start in India for JE-vaccine for endemic countries imminent » Start of the Phase III study for Travelers' Diarrhea Vaccine Patch in October » Phase II data for single-dose Pandemic Influenza vaccine with Vaccine Enhancement Patch expected before end 2009 » First interim data from Phase II for Pseudomonas vaccine expected before end of 2009 » Net loss for the first nine months increased to EUR 25.9m - Revenues increased by 16.6% in the same period - Lower than anticipated sales increase for IXIARO® with Q3 sales revenues of EUR 2.7m » Strong Q4 revenues anticipated from expected partnering of future commercialization of Travelers' Diarrhea Vaccine and of certain aspects of Patch Technology » Lower than anticipated IXIARO® sales revenues and significant investments in strongly progressing late-stage development programs likely to result in full year net loss » Management Board appointed for the next three years; Alexander von Gabain to transition from Management Board (Chief Scientific Officer) into a new strategic role within the Company
Vienna (Austria), November 9, 2009 - Today, Intercell AG (VSE: ICLL) announced its financial results for the third quarter of 2009 and presented an update on the Company's key R&D programs as well as changes to the Management Board.
Japanese Encephalitis vaccine: Progress on IXIARO®/JESPECT® business and global reach
The market preparation and launch activities in the 30 countries where IXIARO®/JESPECT® is approved have been slower than anticipated, with more than 50% of the countries still awaiting product launch. Significant efforts are needed to create national recommendations for JE-vaccination, to build awareness and hence optimize product uptake in the markets. Some countries have successfully reached vaccination rates that are already now in reach of the anticipated business opportunity and hence we are optimistic that others can achieve similarly over time. First deliveries of IXIARO® to the U.S. military were concluded in September under the exclusive Supply Agreement signed earlier this year. As sole supplier for the U.S. military, Intercell is working closely with the Army's health representatives on recommendations towards an increased use of the novel, cell-culture vaccine to prevent Japanese Encephalitis (JE). Recently Intercell reported that Health Canada granted product approval for IXIARO®. This decision of the Canadian authorities represents another important milestone for the product's global reach. Intercell's vaccine has already been successfully approved and launched in the USA, Europe, and Australia. The vaccine will be available for the Canadian market by the end of the year and will be distributed and marketed to travelers by Novartis Pharmaceuticals Canada Inc. and to the military personnel by Intercell.
Additionally Intercell has initiated regulatory licensure processes in other, small territories where there is an attractive market segment for a product already approved in highly regulated environments. Intercell AG and its partner Biological E. Ltd. are expecting an imminent start of a pivotal Phase III study for the investigational vaccine to protect children and adults from JE. The investigational vaccine is manufactured in India by Biological E. and is based on Intercell's technology, which was successfully used to gain product licensure of the adult vaccine in Europe, the United States, and Canada (IXIARO®) as well as in Australia (JESPECT®). The randomized and controlled study will be the key pivotal Phase III trial in an endemic region towards licensure of the JE vaccine. The planned Phase III trial will investigate safety and immunogenicity compared to JenceVacTM, the locally licensed, Korean-made, inactivated, mouse brain-derived JE vaccine. The approval of the vaccine in India is expected by the end of 2010 with WHO pre-qualification planned to follow in 2011.
Strong performance on late-stage patch-based vaccine pipeline
In October, Intercell's investigational Travelers' Diarrhea (TD) Vaccine Patch entered clinical Phase III development. This pivotal efficacy field study started with the first subjects vaccinated in the United Kingdom. The randomized and placebo-controlled study with 1,800 travelers from Europe to Mexico and Guatemala will evaluate the efficacy of the TD Vaccine Patch to actively immunize against moderate to severe enterotoxigenic E. coli (ETEC) disease in a field setting. The investigational TD vaccine system consists of a self-adhesive patch containing the vaccine antigen, the heat-labile toxin (LT) from E. coli, and a single-use device used to prepare the skin at the site of patch administration, the Skin Preparation System (SPS). Intercell combines the classical toxin approach to vaccination with its innovative patch-based, needle-free delivery system. The SPS partially disrupts the stratum corneum of the skin. The dry patch contains the antigen in a stabilizing excipient formulation and delivers the antigen through the skin.
Phase II data for an investigational Vaccine Enhancement Patch to potentially enable single application for Pandemic Influenza prevention is expected before the end of 2009.
The clinical trial is investigating Intercell's Vaccine Enhancement (VE) Patch in combination with an injectable H5N1 Pandemic Influenza vaccine (manufactured by Solvay Biologicals, B.V., The Netherlands) and enrolled 500 subjects in the USA with serological analysis under way. The study, as part of Intercell`s overall PanFlu program, is fully funded by the U.S. Department of Health and Human Services (HHS). In 2008, Intercell announced the results of a Phase I clinical trial in a similar setting with the VE Patch combined with an injectable H5N1 Influenza vaccine. The data revealed that a single 45-microgram dose of the H5N1 Influenza vaccine, when administered with the Intercell VE Patch containing 50-microgram LT adjuvant, was sufficient to provide an immune response seen to be protective in 73% of the vaccinees. This was the first time that a single dose of H5N1 Pandemic Influenza vaccine met the level of protection suggested in the U.S. Food and Drug Administration guidance. The U.S. Food and Drug Administration considers a pandemic vaccine to be protective if it achieves immune response levels in at least 70% of the vaccine recipients.
Excellent progress for all other clinical programs
Staphylococcus aureus vaccine (V710) clinical program: First critical interim analysis (surpassing futility) from the ongoing Phase II/III trial in cardiothoracic surgery patients is expected in 2010. The Phase II/III trial is designed to evaluate investigational vaccine efficacy/safety in patients undergoing cardiothoracic surgery. To date, the trial has experienced slower than anticipated enrollment and accrual of individuals with S. aureus infections. The double-blind, randomized, placebo-controlled trial utilizes an adaptive (group-sequential) design incorporating several interim analyses to evaluate accrued data and allow for objective assessment of study progress. The study involves more than 90 centers in 18 countries, including the USA, Europe, South America, and Japan. Collaborator Merck & Co., Inc. is responsible for clinical development, manufacturing, and marketing.
Pseudomonas aeruginosa vaccine: First interim data on the Phase II study are expected by the end of 2009. Intercell's investigational prophylactic Pseudomonas aeruginosa vaccine aims to protect Intensive Care Unit (ICU) patients against Ventilator-Associated Pneumonia (VAP) and Bacteremia. For the current Phase II clinical trial, about 400 patients are enrolled in more than 50 ICUs in 11 countries in Europe and Latin America.
Streptococcus pneumoniae vaccine: Initial results of the clinical Phase I trial with the Company's protein-based vaccine are expected at the beginning of 2010. The program is financially supported by PATH.
Therapeutic Hepatitis C vaccine: the strategic partnering process is progressing well and it is expected that a partnership will be closed in the first half of 2010. The strategic aim is to combine Intercell´s vaccine approach, which in a previous Phase II trial showed a significant virus decline in chronic Hepatitis C patients, with a small molecule treatment scheme of the potential partner.
Tuberculosis vaccine: Phase I/II clinical programs are proceeding according to plan. These programs are based on a partnership between Intercell, Statens Serum Institut, Sanofi Pasteur, and the AERAS Global Tuberculosis Foundation. Further clinical data is expected for 2010.
Management Board
Intercell's Supervisory Board confirmed the existing Management Board members Gerd Zettlmeissl as Chief Executive Officer and Thomas Lingelbach as Chief Operating Officer for the next three years.
Reinhard Kandera, Chief Financial Officer since March 2009, has been appointed for a term of three years as a new member of Intercell's Management Board. Kandera, who joined Intercell in 2001, has served the Company in different areas of responsibility - most recently as Global Head of Investor Relations and Chief Financial Officer of Intercell USA, Inc. He played a pivotal role in the Company's multiple financing events, including the IPO in 2005, and contributed significantly to the successful integration of Intercell's subsidiaries in Scotland and the USA. Before joining Intercell, Reinhard Kandera held various positions at the Deutsche Bank.
Alexander von Gabain, Intercell's Chief Scientific Officer, co-founder and former Chief Executive Officer, has decided to transition from his current Management Board role into a less operational one. He commits himself for a three-year period and will support the Company as Strategic Advisor to both the Management Board and the Supervisory Board. In this role, he will continue to be fully employed by Intercell. Alexander von Gabain will be strongly involved in key research and development topics and will substantially contribute to the Company by leveraging his excellent network in the arena of academia, biotech and the pharmaceutical industry.
Eszter Nagy, Ph.D., M.D, who has been with Intercell since 1999, will continue to be in charge of Intercell's pre-clinical research activities and to lead Intercell's Research function as Senior Vice President & Head Pre-clinical Research.
Corporate / Other
In September, Intercell was awarded the prestigious Triple-A Award for outstanding annual reports and was named "Newcomer of the Year" by the Austrian business magazine "Trend".
Key Financial Figures
EUR in thousands 3 months ended 9 months ended Year ended
Sept 30, Sept 30, Sept 30, Sept 30, Dec 31,
2009 2008 2009 2008 2008Revenues 9,159 7,641 29,480 25,283 55,763
Net profit/(loss) (14,671) (5,140) (25,925) (13,789) 17,175
Net operating cash flow (14,753) 24,956 (43,322) (430) (10,186)
Cash and available-
for-sale financial assets, end of period 139,746 208,952 139,746 208,952 190,865
The report can be downloaded at http://www.intercell.com/main/forinve stors/downloads/quarterly-reports/
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