Corporate | 13 October 2009 07:21
WILEX AG / Quarter Results
13.10.2009
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WILEX releases 9-month Financial Report 2009: Significant progress in
development projects
- REDECTANE(R): Patient recruitment completed
- MESUPRON(R): Impressive, preliminary Phase II data
- WX-554: Approval for Phase I trial granted
- Sales revenue of EUR 5 million; earnings considerably improved
Munich, 13 October 2009. The Munich-based biopharmaceutical company WILEX
AG (ISIN DE0006614720/Frankfurt Stock Exchange/Prime Standard) today
published its results and the 9-month Financial Report 2009 (1 December
2008 - 31 August 2009).
'The third quarter, and the past weeks in particular, have been very
successful for WILEX. We completed patient recruitment in the Phase III
registration trial with REDECTANE(R), and our application for a Phase I
trial with the MEK inhibitor WX-554 was approved. The milestone payment
from UCB had a positive impact on our earnings. We are especially pleased
about the preliminary, positive data from the Phase II pancreatic cancer
trial with MESUPRON(R)', said Peter Llewellyn-Davies, Chief Financial
Officer of WILEX AG.
Projects and milestones in the third quarter of 2009
In August, WILEX filed an application with the German Federal Institute for
Drugs and Medical Devices (BfArM) for the approval of a Phase I trial with
the MEK inhibitor WX-554, one of the preclinical projects that it acquired
from UCB. As per WILEX's agreement with UCB, achievement of this milestone
triggered a payment of EUR 5 million to WILEX in the third quarter. In the
meantime, approval for the Phase I trial has been granted. Administration
of the first dose to healthy volunteers is planned for the fourth quarter.
Achieving this second milestone will trigger another payment from UCB in
the amount of EUR 5 million.
Patient recruitment for the Phase III registration trial with the
diagnostic agent REDECTANE(R) was completed in late August. A total of 226
patients with suspected renal cell cancer have been enrolled in the trial.
WILEX expects preliminary results from the trial to be available by year
end.
In the Phase III ARISER trial with RENCAREX(R) in patients with clear cell
renal cell cancer, the local trial centres as of the end of September
reported 293 relapses among the 864 patients enrolled in the trial. The
next relevant milestone for WILEX is the occurrence of the 343rd relapse.
WILEX announced after the close of the third quarter preliminary data from
the clinical Phase II trial with the oral drug candidate MESUPRON(R) in
combination with the chemotherapeutic agent Gemcitabine (Gemzar(R)) in
pancreatic cancer patients. The aim of this proof-of-concept study is to
show for the first time the activity of MESUPRON(R) in tumour patients as
well as to demonstrate that the inhibition of the uPA system may represent
an innovative and promising approach for the treatment of cancer patients.
The 95 patients are administered either the chemotherapeutic agent
Gemzar(R) alone or in combination with a daily oral dose of 200 mg or 400
mg MESUPRON(R) respectively until progression. Preliminary results of
MESUPRON(R) in combination with Gemzar(R) showed clear improvement in
tumour response as well as median survival and one year survival. The data,
which were reviewed and endorsed by the Medical Advisory Board, are
preliminary as only 59 of the patients enrolled in the trial have died; 72
deaths are required for the final analysis.
Results of the first nine months of 2009
WILEX posted earnings before taxes of EUR -11.05 million (previous year:
EUR -16.52 million) in the first nine months of the 2009 financial year. At
EUR 11.06 million, the net loss for the period was 33.1% below the previous
year's figure (EUR 16.54 million). This corresponds to earnings per share
of EUR -0.84 (previous year: EUR -1.38).
Sales revenue was EUR 5 million (previous year: EUR 0). At EUR 1.92
million, other income fell by 21.8% below the previous year's EUR 2.46
million. The income realised from licence agreements with Esteve and IBA
amounted to EUR 1.50 million (previous year: EUR 1.87 million). The other
income also contained EUR 0.27 million in development funds from the US
Department of Defense for the uPA programme (previous year: EUR 0.29
million). Prepayments received for research projects are accrued and
recognised as other income in line with project costs. The amount of income
accrued was lower year on year due to the greater number of patients in the
REDECT trial and the lower rate of relapse in the ARISER trial.
Other expenses, including depreciation, amortisation and impairment losses,
amounted to EUR 18.12 million, down approximately 8.4% from the previous
year (EUR 19.77 million). Other expenses included EUR 2.96 million in
administrative costs, which was 8.3% less than in the previous year (EUR
3.22 million). Research and development costs were EUR 15.16 million
(previous year: EUR 16.55 million). While the costs for the ARISER trial
with RENCAREX(R) declined as expected, the expenses for the REDECT trial
with REDECTANE(R) rose as a result of the increase in the number of
patients. The costs for the uPA programme involving MESUPRON(R) declined
because the preclinical trials were completed and because the Phase II
pancreatic cancer trial has progressed to a substantial degree. Costs
related to WX-554 and WX-037 as well as the antibody projects were incurred
for the first time in 2009.
WILEX had cash and cash equivalents of EUR 8.93 million at the close of the
third quarter (30 November 2008: EUR 12.14 million). The change was
effected for one by both the capital increase that was executed in February
and UCB's milestone payment and for another by the use of funds in the
first nine months of the year.
Equity as of the end of the reporting period was EUR 4.69 million (30
November 2008: EUR 5.79 million). This corresponds to an equity ratio of
38.0% as of 31 August 2009 (30 November 2008: 37.9%; 31 August 2008:
44.9%).
The 9-month 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
9M 2009 9M 2008 Change
Earnings EUR '000 EUR '000 in %
Sales revenue 5,000 0 n/a
Other income 1,925 2,460 (21.8)
Other expenses (18,118) (19,773) (8.4)
of which research and development (15,162) (16,549) (8.4)
Operating result (11,193) (17,313) (35.3)
Earnings before tax (11,049) (16,522) (33.1)
Net loss for the period (11,059) (16,536) (33.1)
Earnings per share in euros (0.84) (1.38) (39.4)
Balance sheet as of end of period
Total assets 12,328 21,520 (42.7)
Cash and cash equivalents 8,931 18,2331) (51.0)
Equity 4,690 9,658 (51.4)
Equity ratio2) in % 38.0 44.9 (15.2)
Cash flow
from operating activities (13,178) (16,558) (20.4)
from investing activities (61) 14,951 (100.4)
from financing activities 9,844 (63) n/a
Employees
Employees as of end of period3) 67 64 4.7
Employees-average for reporting period3)
68 61 10.9
The reporting period begins on 1 December and ends on 31 August
1) Including financial assets
2) Equity / total assets
3) Including members of the Executive Management Board
Invitation to the conference call:
On 13 October 2009, WILEX will hold a conference call for media
representatives, analysts and investors in English at 3:00 p.m. CET. Please
dial in ten minutes before the conference call using the following dial-in
numbers:
1. Germany: +49 (0)89 2040 3812
2. UK: +44 (0)207 0980 693
3. USA: +1 703 621 9129
When asked, please enter the PIN code 400404# and clearly state your name
and company. The presentation for the conference (in English) will be
available for download at www.wilex.com from 1:00 p.m. CET.
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. WILEX acquired the MEK inhibitor WX-554 and the PI3K inhibitor
WX-037 as well as three antibody programmes under the terms of the
strategic partnership with UCB. The application for approval of a Phase I
trial with WX-554 was granted. The other four oncology programmes are
currently still in preclinical development. WILEX aims within a few years
to be able to finance its research and development programmes from its
operating cash flow.
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.
13.10.2009 financial News transmitted by DGAP
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Language: English
Company: 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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