Heidelberg Pharma AG

Earnings Release • Feb 20, 2008

News Details

Corporate | 20 February 2008 08:28

WILEX AG reports a successful financial year 2007– positive outlook for 2008

WILEX AG / Final Results

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PRESS INFORMATION

WILEX reports a successful financial year 2007– positive outlook for 2008

• All operational and financial targets for 2007 successfully achieved.

Munich, 20 February 2008. The Munich-based biopharmaceutical company WILEX
AG (ISIN DE0006614720 / Frankfurt Stock exchange / Prime Standard) today
published its results and annual report for the 2007 financial year (1
December 2006 – 30 November 2007).
WILEX achieved important milestones in the development of its product
candidates in 2007, amongst them are the following:

• RENCAREX®: In December 2007 the interim analysis for futility in the
  Phase III registration ARISER trial with RENCAREX® showed that the trial
  will probably deliver a significant result. Recruitment in Europe was
  completed in January 2008. Recruitment in the Americas is being continued
  for several months. At present more than 800 patients of the target of 856
  patients have been included in the trial.

• CA9-SCAN: In October 2007 the U.S. Food and Drug Administration (FDA)
  approved an Investigational New Drug application (IND) for a pivotal Phase
  III trial with the diagnostic candidate CA9-SCAN. At the beginning of
  February 2008 the FDA issued a special protocol assessment (SPA) for a
  Phase III registration trial with CA9-SCAN. With this SPA the FDA confirms
  that the design and planned analysis of the clinical trial adequately
  address the requirements for a regulatory submission.

• WX-671 / WX-UK1: WILEX successfully completed two Phase I trials with its
  uPA inhibitors and started its Phase II programme with WX-671: First
  patient in the clinical Phase II pancreatic cancer trial was randomised in
  June 2007; in January 2008 WILEX received an IND from the FDA for a
  clinical Phase II trial with its drug candidate WX-671 in patients with
  metastatic breast cancer.

WILEX is now in a position to proceed with the commercialisation of the
more mature portfolio with the aim of translating opportunities into
revenues. This is underlined by the appointment of the new CBO, Dr Thomas
Borcholte, who joined Wilex’ Executive Management Board in October 2007.
WILEX aims to enter into alliances and partnerships in order to maximise
value for both the Company and its shareholders.
The results of the financial year 2007 in detail:

• Other operating income increased as planned by 55.4% from EUR 1.7 million
  in 2006 to EUR 2.6 million.

• Operating expenses amounted to EUR 26.5 million. They increased as a
  result of intensified research and development, in particular with
  RENCAREX®, by 33.1% compared to the previous year (EUR 19.9 million). Of
  the operating expenses, EUR 23.0 million (previous year: EUR 16.2 million)
  or 86.8% (previous year: 81.1%) was attributable to research and
  development.

• WILEX recorded a budgeted net loss of EUR 22.3 million in financial year
  2007 (previous year: EUR 18.7 million; increase of 19.3%).

• As announced, WILEX improved its cost structure; with EUR 22.9 million
  the use of cash was lower then planned. The use of cash was expected to
  range between EUR 24.0 million and EUR 28.0 million.

• At the end of the financial year 2007 WILEX had liquid funds including
  financial assets of EUR 34.2 million (previous year: EUR 56.7 million; a
  decrease of 39.7%).

'We are very pleased with the development of our programmes in 2007.' said
Peter Llewellyn-Davies, CFO and member of the Executive Management Board of
WILEX AG. 'On the basis of our current plans we anticipate that our
liquidity could reach until the first quarter of 2009', Llewellyn-Davies
continued.

'With our focus on commercialisation we will increase our operating
expenses for research and development in 2008 thereby investing in
long-term creation of value', said Mr. Llewellyn-Davies, and announces the
financial guidance for 2008. 'WILEX plans to invest between EUR 29 and 33
million in research and development. Basically these costs are attributable
to the two Phase III registration trials with RENCAREX® and CA9-SCAN but
also for the Phase II trials with the uPA inhibitor WX-671. Operating
expenses 2008 should total between EUR 33 and 38 million. WILEX expects
other operating income from existing project partners between EUR 1.9 and
2.4 million, based on project progress. If income and expenses occur as
planned the use of cash should amount to between EUR 26 and 30 million'.

The annual report including the annual financial statements in accordance
with IFRS and the annual financial statements pursuant to HGB (German
Commercial Code) were published on the Company's website: www.wilex.com.

Invitation to a conference call:

WILEX will hold a public conference call on 20 February 2008 at 10:30 CET.
Conference language is German; the presentation for the conference in
English is available on the Company’s website from 9.00 CET on.

Dial-in number for the Conference Call (listen-only):
Germany: +49 (0) 69 – 25 499 300
UK: +44 (0) 207 – 108 6206
Please dial in 10 minutes before the beginning of the conference.

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’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. WILEX’s product candidates are based on
antibodies and small molecules. WILEX possesses an attractive pipeline
which includes both drug and diagnostic product candidates: The substances
RENCAREX® and CA9-SCAN are currently undergoing a Phase III registration
trial. The substance 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 commercialisation of its products and in the long term to
finance its research and development programmes from its operating
business. WILEX AG is listed at the Frankfurt Stock Exchange at the
Regulated Market / Prime Standard (ISIN DE0006614720 / WKN 661472 / Symbole
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.
20.02.2008 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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