EANS-Adhoc: Intercell announces Q2 and H1 2011 financial results and provides an
update on execution of strategic plan
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6-month report
16.08.2011
» IXIARO®/JESPECT® sales growth up by 85% in H1 2011
» Net loss reduced by 80% in Q2 and by 44% in H1 2011
» USD 6.0m milestone payment received from Merck & Co., Inc. for S. aureus
interim data
Vienna (Austria), August 16, 2011 - Today, the biotech-vaccine company Intercell
AG (VSE: ICLL) announced its financial results for Q2 and H1 2011 and provided
an update on execution of strategic plan.
Financial Results
» Year-on-year revenue growth of 31.3% in Q2 2011 driven by strong
IXIARO®/JESPECT® sales revenues
» Restructuring progressing successfully - cost reduction by 57.7% in R&D
and 21.9% in S,G&A in H1 2011
» Net loss reduction by 80.7% to EUR 1.6m in Q2 2011 and by 44.2% to
EUR 12.9m in H1 2011
» Cash position of EUR 79.6m at quarter-end - significant reduction of
cash-outflow
» Unchanged net loss expectation of EUR 30-40m for full year 2011
Key Financial Figures
EUR in thousands 3 months ended 6 months ended Year ended
June 30, June 30, June 30, June 30, Dec 31,
2011 2010 2011 2010 2010
Revenues 12,686 9,659 18,377 14,414 34,215
Net profit/(loss) (1,608) (8,346) (12,866) (23,048) (255,182)
Net operating
cash flow (5,452) (11,026) (28,905) (26,494) (65,120)
Cash and marketable
securities,
end of period 79,649 127,802 79,649 127,802 86,182
IXIARO®/JESPECT®
In H1 2011, the IXIARO®/JESPECT® sales were up 85% compared to H1 2010 resulting
in the best quarterly sales since launch of the product. This was made possible
through a strong uptake in the military sector and strong growth in key travel
markets such as the U.S. and the UK. Hence Intercell is on track to meet its
expectation of full-year 2011 growth rate of at least 60-70%.
Together with its distribution partner Novartis, Intercell will continue to
focus resources to further increase penetration in the key markets, the military
sector, and expand into new territories. The approval for Singapore is expected
in the next months, and the first application for approval in South America has
also been submitted.
Enrollment for the Phase III clinical study for the IXIARO® pediatric label
extension is completed. The pediatric approval is expected by the end of 2012 or
beginning of 2013.
The pivotal Phase II/III trial in children living in India has been fully
enrolled and partner Biological E. Ltd. is moving towards submission for
licensure in India, with a planned launch in 2012.
Following an "Out of Specification" result in a follow-up test for potency of
IXIARO® lot JEV09L37 after a period of 11 months, Novartis and Intercell
initiated a batch-specific, voluntary recall in Canada (March), Europe (May) and
Australia (May), in close coordination with the relevant authorities. Vaccinee
safety is of primary importance to Intercell, and re-vaccination was initiated
for individuals who had received vaccine from the respective lot.
In addition, Intercell is performing a comprehensive investigation and root
cause analysis in order to reduce the risk for further potential recalls,
regulatory actions or batch-specific measures in the future. These activities as
well as other relevant measures and clinical implications are overseen and
governed by the EMA (European Medicines Agency) under a procedure according to
Article 20 of the Commission Regulation (EC) 726/2004. Novartis and Intercell
are working closely with the authorities to execute against the regulatory
requirements.
Update on Staphylococcus aureus (V710): Intercell receives milestone payment
from Merck & Co., Inc.
Following a detailed analysis of the data from the Phase II/III clinical trial
evaluating V710, an investigational vaccine for the prevention of Staphylococcus
aureus (S. aureus) infections, the external Data Monitoring Committee (DMC)
unanimously recommended the termination of the study. On June 8, 2011, Merck &
Co., Inc. (Merck) and Intercell announced the termination of the trial.
However, as the trial did meet the pre-specified criteria for non-futility,
Intercell received the related USD 6.0m milestone payment from Merck.
Furthermore, Intercell and Merck are currently evaluating potential future
approaches in the field of S. aureus under the existing licensing agreement.
Focus on core R&D programs
» Pandemic Influenza Vaccine Enhancement Patch (VEP) - Pursuing
confirmatory mode of action trial with GSK antigen: The enrollment for
the confirmatory Phase I trial is ongoing and a first safety analysis has
been completed. Final data are expected by mid-2012.
» Pneumococcus vaccine: As part of Intercell's pipeline prioritization, the
development of a Pneumococcus vaccine candidate has been put on hold.
» Hepatitis C: Intercell and Romark joined forces in combining therapies
against Hepatitis C. Romark is still awaiting regulatory clearance for
study initiation of a combination Phase II trial which is expected to
start in H2 2011. The trial is fully funded by Romark.
Corporate
» French Prix Galien 2011 awarded to IXIARO® in the category "Medicines
available solely in international vaccination centers"
The full report can be downloaded at
http://www.intercell.com/main/forinvestors/downloads/quarterly-reports
Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com
end of announcement euro adhoc
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issuer: Intercell AG
Campus Vienna Biocenter 3
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: investors@intercell.com
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes: ATX Prime, ATX
stockmarkets: official market: Wien
language: English