Corporate | 19 February 2009 08:58
WILEX AG / Final 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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* Significant milestones achieved
* Reduced expenses and increased income in 2008
* Revenue and other income expected to increase to more than EUR 13 million
Munich, 19 February 2009. The Munich-based biopharmaceutical company WILEX
AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today
published its results and annual report for the financial year 2008 (1
December 2007 - 30 November 2008).
Milestones
WILEX reached important milestones in the development of its product
candidates during the last twelve months:
Patient recruitment for the Phase III ARISER trial with RENCAREX(R) in the
indication clear cell renal cell carcinoma was completed in July 2008. A
total of 864 patients are participating in the trial. The Independent Data
Monitoring Committee had conducted an interim analysis for futility in
December 2007 during the Phase III ARISER trial and determined that the
study will probably deliver a significant result.
Patient recruitment for the Phase III trial with REDECTANE(R) in patients
with renal masses commenced in May 2008, after the US Food and Drug
Administration (FDA) granted WILEX a Special Protocol Assessment (SPA) (in
February 2008). The study is being conducted in accordance with the design
stipulated in the SPA.
Furthermore, in June 2008 WILEX entered into an exclusive worldwide
marketing and sales agreement for REDECTANE(R) with the Belgian company Ion
Beam Applications S.A. (IBA).
Patient recruitment in the Phase II trial with MESUPRON(R) in combination
with Gemcitabine in patients with pancreatic cancer was completed In July
2008. More than 90 patients have been enrolled in this trial. The first
patient in a second Phase II trial with MESUPRON(R) was enrolled in August
2008. In this trial, the drug will be administered in combination with
Capecitabine, a chemotherapeutic agent, as a first-line treatment of 114
patients with HER2 receptor negative breast cancer.
WILEX announced at the beginning of 2009, after the close of the reporting
year, that it will enter into a strategic alliance with UCB Pharma S.A.
(UCB). WILEX has found in UCB an important development partner and a
significant strategic investor to support its further development. Under
the terms of this partnership, WILEX will acquire the worldwide rights to
continue developing UCB's entire preclinical oncology portfolio, which
comprises two small-molecule programmes and three antibody programmes. As a
result of this transaction and a planned capital increase in kind from
authorised capital, UCB will acquire an interest of 13.19% in WILEX AG. UCB
will also invest EUR 10 million and make two milestone payments of EUR 5
million each.
Peter Llewellyn-Davies, Chief Financial Officer of WILEX AG, commented: 'We
are very pleased with the development in 2008. We succeeded in
substantially reducing our funding requirements for 2008 as a result of the
commercialisation agreement with IBA as well as cost-sensitive management
policies. Implementing these measures enabled us to increase income and
reduce costs. The partnership with UCB provides WILEX AG with sufficient
liquidity until the first quarter of 2010. Based on this, our strategic
focus in 2009 will be on the further development of our product candidates
as well as on the commercialisation of our portfolio.'
Results of the 2008 financial year
Other income increased by 24.2% from EUR 2.6 million in 2007 to EUR 3.2
million. As in previous years, WILEX did not generate sales revenue in the
financial year 2008 since all its products are still in clinical
development.
Other expenses were reduced by approximately 7.2% compared to the previous
year, from EUR 26.5 million to EUR 24.6 million. This was primarily a
result of the year-on-year decline in research and development costs, which
totalled EUR 20.2 million in 2008 (previous year: EUR 23.0 million).
The net loss in the financial year 2008 decreased by 8.1% to EUR 20.4
million (previous year: EUR 22.3 million).
As announced, WILEX further improved its cost structure, resulting in
funding requirements of approximately EUR 21.7 million. This figure is in
the lower range of the Company's guidance, which had anticipated funding
requirements of between EUR 21 million and EUR 25 million.
As at the close of the financial year 2008, before the effects of the UCB
transaction, WILEX had cash and cash equivalents of EUR 12.1 million
(previous year: EUR 34.2 million including
financial assets, a decrease of 64.5%).
Taking into account the strategic partnership with UCB, the Executive
Management Board of WILEX AG expects the Company's earnings to improve
substantially in 2009 compared to 2008. Due to the milestone payments to be
expected from UCB, the Executive Management Board anticipates that the
Company will post sales revenue in the amount of EUR 10 million for the
very first time in the financial year 2009. This is based on the
assumption that these payments, as far as the Company knows at the present
time, need not be accrued and thus need not be recognised as other income.
Provided that the Company's projects proceed as planned, the Executive
Management Board expects other income of between EUR 3.0 million and EUR
3.5 million, which would be on a par with the previous year. Other expenses
should range from EUR 25 million and EUR 29 million, which would be above
the figure posted in the 2008 financial year. This increase will result
mainly from the two registration trials with RENCAREX(R) and REDECTANE(R),
as well as the expected expenses for the development of the preclinical
programmes acquired from UCB.
The annual report including the annual financial statements in accordance
with IFRS and the annual financial statements pursuant to HGB (German
Commercial Code) have been published on the Company's website:
www.wilex.com.
Key figures
2008 2007 Change
Earnings in EUR'000 in
%
Other operating income 3,208 2,583 24.2
Other expenses (24,601) (26,510) (7.2)
of which research and development (20,157) (22,999) (12.4)
Operating result (21,394) (23,927) (10.6)
Earnings before tax (20,433) (22,234) (8.1)
Net loss of the period (20,448) (22,258) (8.1)
Earnings per share in EUR (1.71) (1.86) (8.1)
Balance sheet as at 30.11. in EUR'000
Total assets 15,327 37,627 (59.3)
Liquid funds 12,137 34,170 1) (64.5)
Equity 5,790 25,951 (77.7)
Equity ratio2) in % 37.8 69.0 (45.2)
Cash flow in EUR'000
from operating activities (22,830) (22,659) 0.8
from investing activities 14,932 (15,599) (195.7)
from financing activities (89) (960) (90.7)
Employees
Employees as at 30.11.3) 66 57 15.8
Employees - annual average3) 62 51 22.0
1) Including financial assets
2) Equity / total assets
3) Including Members of the Board
Invitation to the conference calls:
On 19 February, WILEX will hold a public conference call for media
representatives in German at 10:30 a.m. CET, and for analysts and investors
in English at 3:00 p.m. CET.
Press conference (in German)
Time: 10:30 a.m.
1. Dial-in number: +49 (0)69 22 22 32 50
2. When asked, please enter the PIN code 400404#.
Analyst conference (in English)
Time: 3:00 p.m.
1. Dial-in number Germany: +49 (0)69 22 22 32 50
2. Dial-in number UK: +44 (0)207 09 80 693
3. When asked, please enter the PIN code 500505#.
Please dial in ten minutes before the conference and state your name and
company when asked to do so. The presentation for the conference (in
English) will be available for download at www.wilex.com from 9:00 a.m.
About WILEX AG:
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 with a low side effect profile and targeted
treatment of different types of cancer as well as diagnostic agents for
specific 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(R) and REDECTANE(R) are currently undergoing a Phase III
registration trial. MESUPRON(R) is in a Phase II programme. WILEX aims
within a few years to be able to finance its research and development
programmes from its operating cash flow. In order to achieve this goal, the
Executive Management Board pursues a commercialisation strategy for all
products.
Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6
Contact:
Katja Arnold
WILEX AG
Grillparzerstr. 10
81675 Munich
Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
E-Mail: investors@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.
19.02.2009 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
End of News DGAP News-Service
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