Heidelberg Pharma AG

Earnings Release • Oct 13, 2008

News Details

Corporate | 13 October 2008 08:25

WILEX releases 9-month Financial Report 2008: Significant progress in development projects

WILEX AG / Quarter Results

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

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PRESS RELEASE

WILEX releases 9-month Financial Report 2008: Significant progress in
development projects

Munich, 13 October 2008. The Munich-based biopharmaceutical company WILEX
AG (ISIN DE0006614720/Frankfurt Stock Exchange/Prime Standard) today
published its results and the 9-month Financial Report (1 December 2007 –
31 August 2008).

The results for the period are in line with Company expectations.
Noteworthy events in the last three months in the development of the
clinical projects were:

• Phase III ARISER trial with RENCAREX®
  The most important event in the third quarter of 2008 was the completion of
  patient recruitment in July 2008 for the Phase III registration trial with
  our drug candidate RENCAREX A total of 343 relapses are required in order
  to reach the next clinical milestone. As of 31 August 2008, WILEX is aware
  of a total of 199 relapses, which have been recorded locally in the trial
  centres. The relapse rate continues to be lower than anticipated. We
  currently expect to reach 343 relapses in the second quarter of 2009 at the
  earliest.

• Phase III trial with REDECTANE®
  In May 2008, we began patient recruitment for REDECTANE®, our second
  product undergoing a Phase III registration trial. The product is intended
  for the improved diagnosis of renal masses. We anticipate completing
  recruitment within the next three to six months.

• Phase II trial with MESUPRON® in patients with pancreatic cancer
  In our Phase II trial with the drug candidate MESUPRON in 95 patients with
  locally advanced inoperable, non-metastatic pancreatic cancer, we were able
  to conclude patient recruitment in July 2008. An independent radiological
  analysis will probably be carried out in December 2008. Provided that a
  sufficient number of patients have relapsed, initial preliminary data could
  be available after that.

• Phase II trial with MESUPRON® in patients with breast cancer
  We began patient recruitment in August 2008 in our second clinical Phase II
  trial with MESUPRON® in 114 patients with metastatic breast cancer.

The financial result breaks down as follows:

• At EUR 16.54 million, the net loss for the nine month period reflects the
  planned progress of our projects and is in line with the Company's
  expectations (previous year: net loss of EUR 16.02 million). Earnings
  before taxes (EBT) decreased by 3.2% to EUR -16.52 million compared to the
  same period in 2007 (EUR -16.00 million). Higher other operating income was
  offset by both higher operating expenses and a lower net financial result
  than in the previous year.

• Operating income of EUR 2.46 million surpassed the previous year's level
  (EUR 2.16 million) by 14%. The operating income documents the progress of
  clinical projects as prepayments received by our cooperation partners IBA,
  Esteve and grants from the US Department of Defense for the research
  projects are accrued and recognised as other operating income in line with
  project costs.

• Earnings per share in the first nine months totalled EUR -1.38, which was
  slightly below the figure reported for the previous year (EUR -1.34).

• Operating expenses of EUR 19.77 million were up 1.5% on the previous
  year's figure (EUR 19.49 million).

• At EUR 16.55 million, research and development costs were below the
  previous year's level (EUR 16.95 million, -2.4%) because the costs for
  conducting the ARISER trial with RENCAREX® so far were lower.

• A total of 83.7% (previous year: 87.0%) of operating expenses were
  attributable to research and development. Approximately 68% of this amount
  was invested in the clinical development of the product candidates
  RENCAREX® and REDECTANE®, based on the monoclonal antibody cG250, and 31%
  in the development of small molecule drugs (uPA programme/MESUPRON®). 1% of
  the research and development costs were attributable for other projects.

• Administrative costs increased year on year, as planned, totalling EUR
  3.22 million in the first nine months of 2008 (previous year: EUR 2.54
  million). The increase of 20.8% compared to the previous year is primarily
  related to the expenses for business development and the higher number of
  employees.

• At EUR 0.79 million (9M 2007: EUR 1.32 million), the net financial result
  of the first nine months of 2008 was positive, continuing the trend of
  previous quarters. This is mainly due to the investment of funds not yet
  drawn on for clinical development in fixed-term deposits and other types of
  short-term investments.

The 9-month Financial Report 2008 was published on the Company's website:
www.wilex.com.

About WILEX
WILEX is a biopharmaceutical company based in Munich and is listed at the
Frankfurt Stock Exchange at the Regulated Market / Prime Standard. WILEX’s
mission is to develop drugs and diagnostic agents with a low side effect
profile and targeted treatment of different types of cancer as well as for
early detection of tumours. The Company's product candidates are based on
antibodies and small molecules. WILEX has an attractive product pipeline
which includes both drug and diagnostic candidates: The substances
RENCAREX® and REDECTANE® are currently undergoing a Phase III registration
trial. The substance MESUPRON® is currently in a Phase II programme. Based
on this pipeline, WILEX's aim is to achieve profitability within a few
years through the consistent commercialisation of its products and in the
long term to finance its research and development programmes from its
operating business.
Website: http://www.wilex.com

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 a
general discussion of the Company's strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial position, earnings, achievements, or industry results, to be
materially different from any future results, earnings 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.
13.10.2008 Financial News transmitted by DGAP

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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: info@wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart

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