Earnings Release • Apr 8, 2009
Earnings Release
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Corporate | 8 April 2009 07:35
WILEX AG:WILEX reports first quarter 2009
WILEX AG / Interim Report
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.
WILEX reports first quarter 2009
Munich, 8 April 2009. The Munich-based biopharmaceutical company WILEX AG
(ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today
published its results for the first quarter of 2009 (1 December 2008 - 28
February 2009) and reported on the status of its projects.
'The first quarter of 2009 was significant in respect of the execution of
our corporate strategy. We continued to pursue the clinical development of
our product candidates RENCAREX(R), REDECTANE(R) and MESUPRON(R), expanded
our product portfolio and also improved our financial position', said Peter
Llewellyn-Davies, Chief Financial Officer of WILEX AG.
Projects and milestones in the first quarter 2009
WILEX and UCB Pharma S.A. (UCB) entered into a strategic alliance on 8
January, which enabled WILEX both to expand its product portfolio and
improve its financial position through a capital increase. In UCB, WILEX
has gained an important development partner and an strategic investor for
its future development. Under the terms of the partnership, WILEX acquired
the worldwide rights to UCB's entire preclinical oncology portfolio and
also agreed different buyback options and payments. As a result of this
transaction, UCB gained a 13.1 9% interest in WILEX AG by way of a capital
increase in kind and invested EUR 10 million. Furthermore, two milestone
payments of EUR 5 million each were agreed for the development of the
portfolio.
The Phase III ARISER trial with RENCAREX(R) reports a lower rate of relapse
than expected. To date a total of 259 relapses have been reported to WILEX
by the trial centres. The next relevant milestone for WILEX is the
occurrence of the 343rd relapse. Once this milestone has been reached, the
data of all patients from the more than 140 study centres in the Phase III
ARISER trial with RENCAREX(R) will be combined and processed by an external
service provider (CRO). Independent radiologists will analyse the patients'
CTs in order to determine disease-free survival. This process will take at
least six months from the time at which the 343rd relapse is reported.
Finally, the Independent Data Monitoring Committee (IDMC) will perform a
centralised analysis of disease-free survival data from all patients, which
can form the basis for filing for approval in the European Union.
In the Phase III registration with REDECTANE(R) a total of 156 patients
were recruited up to the end of March 2009. The study protocol is based on
the assumption that 40% of the patients included in the study will have non
clear cell renal cell carcinoma and 60% will have clear cell renal cell
carcinoma. This distribution resulted in the targeted number of 166
patients. WILEX has determined in the meantime that only 36% of these
patients have non clear cell renal cell carcinoma. For the results to have
the statistical power defined in both the study protocol and the SPA, we
proposed to the FDA that we raise the number of patients in order to
achieve 40% non cell renal cell carcinoma. The FDA approved the proposal in
March. At this point in time, and taking the current level of 36% into
account, WILEX expects the number of patients to increase to approximately
200 and anticipates that patient recruitment will be completed within the
next two months. Analysis of the data will then take another three to six
months. We expect the trial's results to become available in the second
half of 2009.
The application for approval of a Phase I trial for the MEK inhibitor
WX-554 (one of the small molecules from the UCB preclinical portfolio) and
the administration of the first dose in man, are planned for this year.
Results of the first quarter of 2009
WILEX posted earnings before taxes of EUR -5.72 million (previous year: EUR
-4.88 million) in the first quarter of the 2009 financial year (1 December
2008 to 28 February 2009). The net loss for the period increased by 17.0%
to EUR 5.72 million (previous year: EUR 4.89 million). This corresponds to
earnings per share of EUR -0.48 (previous year: EUR -0.41). WILEX did not
generate any sales revenue in the first quarter because all of its products
are still in clinical development and UCB's payments are not expected to be
made until later in the financial year once the stipulated milestones have
been achieved.
At EUR 470 thousand, other income fell by 16.0% compared to the previous
year's EUR 560 thousand, which is essentially due to the lower reversal of
provisions. Other expenses including depreciation, amortisation and
impairment losses rose by approximately 9.2% to EUR 6.28 million (previous
year: EUR 5.75 million). This was primarily a result of the year-on-year
increase of 13.2% in research and development costs, which totalled EUR
5.36 million (previous year: EUR 4.73 million). Costs were within budget.
The Company had cash and cash equivalents of EUR 16.49 million (30 November
2008: EUR 12.14 million) at the close of the first quarter. Due to the
capital increase the subscribed capital rose from EUR 11.96 million as of
30 November 2008 by EUR 1.82 million to EUR 13.78 million as of 28 February
2009. Equity increased to EUR 9.95 million by the end of the first quarter
(30 November 2008: EUR 5.79 million). The equity ratio was 50.4% as of 28
February 2009 (30 November 2008: 37.8%).
The 3-month Financial Report in accordance with IFRS has been published on
the Company's website: www.wilex.com.
Key figures
Q1 2009 Q1 2008 Change
Earnings EUR'000 EUR'000 in%
Other income 470 560 (16.0)
Other expenses (6,281) (5,751) 9.2
of which research and development (5,357) (4,732) 13.2
Operating result (5,811) (5,191) 12.0
Earnings before tax (5,720) (4,884) 17.1
Net loss of the period (5,725) (4,891) 17.0
Earnings per share in EUR (0.48) (0.41) 16.4
Balance sheet as of end of period
Total assets 19,730 31,577 (37.5)
Cash and cash equivalents 16,489 28,0391) (41.2)
Equity 9,948 21,168 (53.0)
Equity ratio2) in % 50.4 67.0 (24.8)
Cash flow
from operating activities (5,718) (6,393) (10.5)
from investing activities (22) (25) (11.7)
from financing activities 10,006 (22) (n/a)
Employees
Employees as of end of period3) 64 60 6.7
Employees - annual average3) 65 59 9.6
1) Including financial assets
2) Equity / total assets
3) Including Members of the Executive Management
Board
Invitation to the conference call:
On 8 April 2009, WILEX will hold a public conference call for media
representatives analysts and investors in English at 3:00 p.m. CEDT.
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 1:00 p.m.
CEDT.
About WILEX AG
WILEX AG 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 in two
indications. The five oncological programmes acquired under the terms of
the strategic partnership with UCB are currently still in the preclinical
phase. 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 (CIRO)
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: [email protected]
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.
08.04.2009 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: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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