Heidelberg Pharma AG

Earnings Release • Jul 14, 2008

News Details

Corporate | 14 July 2008 08:55

WILEX reports successful first half year 2008

WILEX AG / Half Year 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.

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PRESS INFORMATION

WILEX reports successful first half year 2008
- Worldwide licence agreement for REDECTANE® signed with IBA
- Patient recruitment completed for Phase III ARISER trial with RENCAREX®
- Patient recruitment started for pivotal Phase III trial with REDECTANE®
- Financial outlook improved

Munich, 14 July 2008 Munich-based biopharmaceutical company WILEX AG (ISIN
DE0006614720/Frankfurt Stock Exchange/Prime Standard) today published its
half-yearly financial report 2008 (1 December 2007 – 31 May 2008) and the
financial result for the second quarter of 2008. The results for the period
reflect the progress of the projects, which is according to plan and in
line with Company expectations.

Noteworthy events in the last three months in the development of the
clinical projects and the company were:

• Commercialisation: In June 2008 WILEX signed an agreement with Ion Beam
  Applications S.A. (IBA) for the worldwide marketing, distribution and sale
  as well as the manufacture (radio-labelling) of the diagnostic candidate
  REDECTANE® (CA9-SCAN). The agreement guarantees WILEX a share of future net
  sales revenues of up to 45% as well as various payments and
  contributions-in-kind.

• RENCAREX®: Patient recruitment in the Phase III ARISER was successfully
  completed at the beginning of July 2008. A total of 856 patients are taking
  part in the trial, of which 583 were recruited in Europe and 273 in North
  and South America. The number of relapses recorded currently stands at more
  than 180. WILEX assumes that the number of 343 relapses necessary for the
  interim analysis for efficacy could be reached early in 2009.

• REDECTANE® Patient recruitment for the diagnostic candidate REDECTANE®
  began in May 2008. The product is indicated for differential diagnosis of
  renal masses. Patient recruitment in the trial should be completed this
  year.

• MESUPRON®: The Phase II trial with our drug candidate MESUPRON® (WX-671),
  which began in 2007, for patients with pancreatic cancer continues to
  progress well. By the end of the quarter, 75 of the planned total of 90
  patients had been enrolled in the trial.

A summary of the financial data:
- Operating expenses in the first six months of 2008 were lower compared to
the same period last year. However, earnings before taxes were down by 5.6
% to EUR -11.30 million due to the year-on-year decline in other operating
income, lower operating expenses and a lower net financial result.
- Other operating income amounts to EUR 0.78 million in the first half year
of 2008 (previous year: EUR 1.22 million). In the second quarter it was EUR
0.22 million (previous year: EUR 0.71 million) due to the year-on-year
decline in revenue realisation from our cooperation partner Esteve's
milestone payments and the US Department of Defense grant for our uPA
programme.
- Operating expenses of EUR 12.63 million in the first half of 2008 were
down 1.4% on the previous year's figure (EUR 12.82 million). The research
and development costs of EUR 10.60 million contained in this figure
represent a 4.0% year-on-year decrease as the costs for treating patients
in the ARISER study are lower than a year ago.
- Earnings per share amounted to EUR -0.94 in the first half year compared
to EUR -0.90 last year.

'With the REDECTANE® agreement, we have made significant progress in
commercialising our portfolio whilst at the same time securing additional
liquidity,' commented Peter Llewellyn-Davies, CFO of WILEX AG. 'This also
improves our financial outlook.'

Due to the upfront payment and contributions-in-kind received from IBA in
the current financial year and the revised scheduling for the Phase III
registration trial after the Special Protocol Assessment (SPA) obtained in
February 2008, the financial outlook for 2008 has improved. Assuming that
all projects continue to be implemented as planned, we now anticipate
operating expenses of between EUR 27 million and EUR 32 million (previous
guidance: between EUR 33 and 38 million). The research and development
costs included in this item are expected to range between EUR 23 and EUR 27
million (previous guidance: between EUR 29 and 33 million). We forecast an
increase in other operating income to between EUR 3.7 million and EUR 4.2
million (previous guidance: between EUR 1.9 and 2.4 million). Other
operating income does not usually give an indication of payments made, as
according to IFRS payments are accrued and subsequently released in line
with the progress of the respective projects. Overall, we will require
funds of between EUR 21 million and EUR 25 million in 2008, approximately
17.6% less than previously announced (previous guidance: between EUR 26 and
30 million)
WILEX now assumes, as already announced, that if its projects progress
according to plan and no additional inflows of capital are generated, its
current liquidity will suffice until the second calendar quarter of 2009
rather than until the first calendar quarter of 2009 previously announced.
The half-yearly financial report 2008 is published on 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® (WX-671) 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

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.
14.07.2008 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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