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Heidelberg Pharma AG

Earnings Release Oct 11, 2007

201_rns_2007-10-11_7c5db365-36e5-4fd9-86a0-cf7f0f9dc69d.html

Earnings Release

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News Details

Corporate | 11 October 2007 10:50

WILEX Q3 report 2007: progress with development projects – 2007 financial outlook confirmed

WILEX AG / Quarter Results

Release of a Corporate News, transmitted by DGAP - a company of EquityStory
AG.
The issuer / publisher is solely responsible for the content of this announcement.


WILEX Q3 report 2007: progress with development projects – 2007 financial
outlook confirmed

Munich, 11 October 2007. The Munich-based biopharmaceutical company WILEX
AG (ISIN DE0006614720/Frankfurt Stock Exchange/Prime Standard) today
published its results and report for Q1 – Q3 / 2007 (1 December 2006 – 31
August 2007).

WILEX AG continued to be successful with the development of its drug and
medical product candidates and the financial result is in line with
expectations. Below is a summary of the highlights:

  • Phase III ARISER trial with RENCAREX® : - The Independent Data Monitoring
    Committee (IDMC) convened on 1 October 2007. The Committee reviews the
    safety of the ongoing ARISER trial at regular intervals. The IDMC members
    were unanimous in their recommendations for continuation of the trial
    according to protocol. - The number of relapses in the trial reached 100 in
    October, triggering the preparations for the interim analysis for futility.
    The results of the comprehensive analysis are expected as planned within
    this year. In addition, patient recruitment has again advanced
    significantly. To date WILEX has enrolled over 670 of the total number of
    856 patients required.

  • Patient recruitment has started in the Phase II combination trial with
    WX-671 in pancreatic cancer.

  • A Phase Ib trial with WX-671 was successfully completed in patients with
    head & neck cancer and demonstrated a good safety and tolerance profile.
    Another important result is that the active principle is found in the
    tumour tissue.

  • WILEX has also made considerable progress with the preparation of the
    registration trial for CA9-SCAN.

  • Income and expenses are within the guidance, thus confirming the
    positively revised targets for 2007 published with the Q2 interim report.

The financial result breaks down as follows:

  • Operating expenses in the first nine months of 2007 totalled EUR 19.49
    million (Q1 – Q3 / 2006: EUR 13.15 million; an increase of 48.2%). This
    increase was again mainly attributable to an increase in research and
    development costs, which was in line with expectations. These costs were up
    from EUR 10.53 million in the previous year to EUR 16.61 million in the
    first nine months of 2007 (an increase of 57.8%), representing 85% of total
    expenses (9M 2006: 80%). Approximately 64% of research and development
    costs were invested in the clinical development of monoclonal antibodies
    (RENCAREX® and CA9-SCAN). The optimisation of cost structures, mainly in
    the production of RENCAREX®, has already made an impact in the third
    quarter. Costs for research and development were reduced by 2% compared to
    the second quarter of 2007.

  • Other operating income rose in the third quarter of 2007 to EUR 0.94
    million (Q2 2007: EUR 0.71 million). The increase is attributable to the
    realisation of milestone payments. In the first nine months of financial
    year 2007, WILEX achieved other operating income totalling EUR 2.16
    million, which is more than double the amount generated in the same period
    in 2006 (EUR 0.97 million).

  • As in the first two quarters of the current year, the net financial
    result reported by WILEX was also clearly positive in the third quarter.
    This is mainly accounted for by the investment of liquid funds not yet
    drawn on for clinical development. For the first nine months of 2007, the
    Company reported a net financial result of EUR 1.32 million in total
    (previous year: EUR -1.36 million).

  • According to plan, WILEX reported a result before tax of EUR
    -16.01 million for the first nine months of the 2007 financial year
    (previous year: EUR -13.54 million; an increase of 18.2%). Of this, EUR
    -5.30 million was attributable to Q3 2007 (Q2 2007: EUR -5.78 million).

'We have made significant progress with our projects and can confirm our
financial guidance,' commented Peter Llewellyn-Davies, CFO of WILEX AG.
Llewellyn-Davies continued: 'Together with our new colleague Dr. Thomas
Borcholte, who was appointed as Chief Business Officer at the beginning of
this month, we will focus our attention on the commercialisation of our
products.'

The 9M report was published on the Company's website: www.wilex.com.

About WILEX
WILEX is a biopharmaceutical Company based in Munich founded in 1997 by a
team of physicians and oncologists from the Technical University of Munich.
WILEX is focused on the development of new cancer therapies based on
antibodies and small molecules. The therapeutic approach of WILEX targets
the prevention of growth, spread and the metastasis of malignant tumours
and the destruction of malignant tumours in the body. The late stage
multi-product portfolio includes both drug and medicinal product candidates
as well as research candidates. Currently the following compounds are in
clinical development: WX-G250 (development name: RENCAREX®), WX-671, WX-UK1
and CA9-SCAN. The company’s strategy is to develop WILEX into a
commercially successful biopharmaceutical company with a broad portfolio of
new drugs and medical products for the treatment of cancer. WILEX AG has
been listed in the Official Market Segment (Amtlicher Markt) / Prime
Standard of the Frankfurt Stock Exchange. ISIN DE0006614720 / WKN 661472 /
Symbol WL6

This communication contains certain forward-looking statements, relating to
the Company's business, which can be identified by the use of
forward-looking terminology such as 'estimates', 'believes', 'expects',
'may', 'will' 'should' 'future', 'potential' or similar expressions or by
general discussion of strategy, plans or intentions of the Company. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial condition, performance, or achievements, or industry results, to
be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements. Given
these uncertainties, prospective investors and partners are cautioned not
to place undue reliance on such forward-looking statements. We disclaim any
obligation to update any such forward-looking statements to reflect future
events or developments. Given these uncertainties, prospective investors
and partners are cautioned not to place undue reliance on such
forward-looking statements. We disclaim any obligation to update any such
forward-looking statements to reflect future events or developments.
11.10.2007 Financial News transmitted by DGAP


Language: English
Issuer: WILEX AG
Grillparzerstr. 10
81675 München
Deutschland
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: [email protected]
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Amtlicher Markt in Frankfurt (Prime Standard); Freiverkehr in
Berlin, Düsseldorf, München, Stuttgart

End of News DGAP News-Service


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