Corporate | 14 July 2009 07:24
WILEX AG / Half Year Results
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- Successful integration and start of preclinical programmes
acquired from UCB
- Income and expenses on target; earnings improved
- Clinical projects continue to progress; significant milestones ahead
Munich, 14 July 2009. The Munich-based biopharmaceutical company WILEX AG
(ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today
published its half-year figures (1 December 2008 - 31 May 2009) and
reported on the status of its projects.
'In the past few months, we have successfully integrated the preclinical
projects that we acquired from UCB Pharma S.A., Brussels, Belgium, (UCB)
into our operating business and began developing them further. We continued
to pursue the development of our clinical product candidates, which are
approaching important milestones. Higher income and reduced expenses have
resulted in improved earnings in the first half of the year', said Peter
Llewellyn-Davies, Chief Financial Officer of WILEX AG.
Projects and milestones in the second quarter of 2009
The next milestone in the Phase III ARISER trial with RENCAREX(R) is the
occurrence of the 343rd relapse. Relapses for the 864 patients in the trial
continue to take longer than originally anticipated. As of the end of June,
a total of 276 relapses had been reported to WILEX by the local trial
centres.
The Phase III registration trial with the diagnostic candidate REDECTANE(R)
began last year and is nearing the end of patient recruitment. The trial
aims to determine whether the PET/CT procedure using REDECTANE(R) improves
the diagnosis of clear cell renal cell cancer compared to CT, the current
diagnostic standard. As reported in the previous quarter, WILEX has
determined that the percentage of patients recruited with non clear cell
renal cell carcinoma is lower than expected and that the number of patients
must therefore be increased. As predicted in the last quarterly report, a
total of 201 patients had been recruited by the end of June 2009. According
to current estimates, WILEX expects the total number of patients to rise to
about 220 before 63 patients with non clear cell renal cell cancer will
have been included in the trial. WILEX expects patient recruitment to be
completed within the next few weeks. The data analysis will take three to
six months, which means that the trial's findings are likely to be
available before the end of this year.
In the Phase II trial with MESUPRON(R), the last of the 95 patients with
locally advanced, inoperable, non-metastatic pancreatic cancer was enrolled
in July 2008. Some patients are continuing on treatment for longer than
anticipated and this is coupled to a lower mortality. We expect preliminary
data to be available in the second half of this year.
Patient recruitment for the second Phase II trial with MESUPRON(R) in 114
patients with metastatic, HER2 receptor negative breast cancer commenced in
August 2008. Forty-five patients were recruited in Europe up to the end of
June 2009. Trial centres in the US and Brazil are due to come on-line as
planned and commence patient recruitment soon.
The small-molecule MEK inhibitor WX-554, part of the preclinical portfolio
acquired from UCB, is progressing towards clinical development. The
preclinical research has been concluded and the data are now being
analysed. We expect to file an application for approval for a Phase I trial
in Q3 and the trial itself to commence in Q4 (administration of the first
dose in man). WILEX will receive payments of EUR 5 million from UCB upon
achievement of each of these two milestones.
Results of the first half of 2009
WILEX posted earnings before taxes of EUR -10.43 million (previous year:
EUR -11.30 million) in the first half of the 2009 financial year. At EUR
10.44 million, the net loss for the period was 7.7% below the previous
year's figure (EUR 11.30 million). This corresponds to earnings per share
of EUR -0.81 (previous year: EUR -0.94). WILEX did not generate any sales
revenue in the first half year because all of its products are still in
development. The UCB payments are not expected to be made until later in
the financial year once the stipulated milestones have been reached.
At EUR 1.14 million, other income rose by 45.3% over the previous year's
EUR 0.78 million. This was essentially due to the income realised from
licence agreements with Laboratorios del Dr. Esteve S.A., Barcelona, Spain,
(Esteve) and, in particular, Ion Beam Applications S.A., Brussels, Belgium,
(IBA) for the amount of EUR 812 thousand (previous year: EUR 418 thousand).
The other income also contained EUR 216 thousand in development funds from
the US Department of Defense for the uPA programme (previous year: EUR 237
thousand). The reversal of provisions and other income related to other
periods resulted in income of EUR 111 thousand, which was almost at the
previous year's level (EUR 128 thousand).
Other expenses, including depreciation, amortisation and impairment losses,
amounted to EUR 11.70 million, down approximately 7.4% from the previous
year (EUR 12.63 million). Research and development costs were EUR 9.68
million (previous year: EUR 10.60 million) as the costs for the ARISER
trial with RENCAREX(R) declined as expected. The costs for the uPA
programme involving MESUPRON(R) in the first half of the year were lower
than planned due to slight delays in the approvals required for the
establishment of the trial centres for the breast cancer trial in both the
US and Brazil. The expenses for the trial with REDECTANE(R) rose as a
result of the increase in the number of patients, and initial costs have
been incurred in connection with the preclinical projects obtained from
UCB. Costs were as planned.
WILEX had cash and cash equivalents of EUR 10.55 million (30 November 2008:
EUR 12.14 million) at the close of the first half of 2009. The change is
due to the capital increase executed in February and the funds used in the
first six months of the year. Equity as of the end of the reporting period
was EUR 5.28 million (30 November 2008: EUR 5.79 million). This corresponds
to an equity ratio of 37.9% as of 31 May 2009 (30 November 2008: 37.8%; 31
May 2008: 61.5%).
The half-yearly financial report including the single-entity financial
statements prepared in accordance with IFRS has been published on the
Company's website: www.wilex.com.
Key figures
H1 2009 H1 2008 Change
Earnings EUR '000 EUR '000 in
%
Other income 1,139 784 45.3
Other expenses (11,701) (12,635) (7.4)
of which research and development (9,678) (10,595) (8.7)
Operating result (10,563) (11,851) (10.9)
Earnings before tax (10,430) (11,296) (7.7)
Net loss for the period (10,437) (11,304) (7.7)
Earnings per share in euros (0.81) (0.94) (14.5)
Balance sheet as of end of period
Total assets 13,956 24,096 (42.1)
Cash and cash equivalents 10,553 20.8051) (49.3)
Equity 5,284 14,830 (64.4)
Equity ratio2) in % 37.9 61.5 (38.5)
Cash flow
from operating activities (11,546) (13,833) (16.5)
from investing activities (47) 14,969 (100.3)
from financing activities 9,844 (22) N/A
Employees
Employees as of end of period3) 66 61 8.2
Employees - average for reporting period 3) 65 60 7.8
1) Including financial assets
2) Equity / total assets
3) Including members of the Executive
Management Board
Invitation to the conference call:
On 14 July 2009, WILEX will hold a public conference call for media
representatives, analysts and investors in English at 3:00 p.m. CEST.
1. Dial-in number Germany: +49 (0)89 2040 3812
2. Dial-in number UK: +44 (0)207 0980 693
3. When asked, please enter the PIN code400404#.
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.
CEST.
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 Phase II trials in two
indications. The five oncological programmes acquired under the terms of a
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: 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.
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: investors@wilex.com
14.07.2009 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
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