DGAP-News: WILEX AG reports on successful first half of 2010
(firmenpresse) - WILEX AG / Half Year Results
14.07.2010 07:38
Dissemination of a Corporate News, transmitted by
DGAP - a company of EquityStory AG.
The issuer / publisher is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
WILEX reports on successful first half of 2010
- All milestones achieved for the first half year
- Half-year figures in line with expectations
Munich, 14 July 2010. WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock
Exchange) today published financial figures for the first half year 2010 (1
December 2009 - 31 May 2010) and the status of the R&D projects.
Peter Llewellyn-Davies, CFO of WILEX AG, commented: 'In the past half year
we have achieved all planned milestones and published positive, final data
for three important clinical trials. We are very pleased with the progress
of our product portfolio and have come closer to our goal of submitting a
first product for approval.'
Projects and milestones in the second quarter 2010
WILEX published final data of the Phase III trial with REDECTANE(R) for the
diagnosis of renal masses in May 2010. The results of the study demonstrate
that PET/CT with REDECTANE(R) is able to distinguish clear cell from
non-clear cell renal cell carcinoma and is significantly superior to
conventional CT alone.
In the Phase III ARISER trial of RENCAREX(R) in patients with clear cell
renal cell cancer, a total of 324 relapses had been reported to WILEX by
the local trial centres as of the end of June.
In June 2010, WILEX presented impressive final data of a Phase II study
with the uPA-inhibitor MESUPRON(R) in 95 patients with locally advanced,
inoperable, non-metastatic pancreatic cancer at ASCO (American Society of
Clinical Oncology). In the combination trial with the chemotherapeutic
agent Gemcitabine, MESUPRON(R) showed an improvement in the study end
points tumour response rate, progression-free survival, one-year survival
and median survival.
Final results of the Phase I dose escalation study with the MEK-inhibitor
WX-554 were also published in June 2010. The trial aimed to determine
safety, tolerance and the optimal biological dose for inhibition of the MEK
system by WX-554. The substance was found to be a potent inhibitor of MEK
and was safe and well tolerated in healthy volunteers.
Results of the first half year 2010
WILEX reported a net loss for the 6 month period (1 December 2009 - 31 May
2010) of EUR 11.56 million (previous year: EUR 10.44 million). Earnings per
share were EUR -0.73 (previous year: EUR -0.81). No sales revenue were
realised (H1 2009: EUR 0) in the first six months. At EUR 0.91 million,
other income was 19.8% below the previous year's figure (EUR 1.14 million).
Operating expenses, including depreciation, amortisation and impairment
losses, amounted to EUR 12.48 million, up approximately 6.6% from the
previous year (EUR 11.70 million). This figure includes research and
development costs of EUR 10.20 million, which represents 81.7% of the
operating expenses and an increase of 5.3% compared to the previous year
(EUR 9.68 million). Whilst the costs for the RENCAREX(R) ARISER trial and
the REDECT trial with REDECTANE(R) have declined as expected compared to
last year, costs for the MESUPRON(R) breast cancer trial have risen as
planned as a result of increasing patient recruitment. Further expenses
arose from the Phase I trial of WX-554 as well as preclinical trials with
WX-037 and the antibody research. Administrative costs were EUR 2.28
million (previous year: EUR 2.02 million).
At the end of the first half year the Company had cash and cash equivalents
of EUR 3.31 million (30 November 2009: EUR 3.41 million, 31 May 2009: EUR
10.55 million). Equity as of the end of the reporting period was EUR 0.14
million (30 November 2009: EUR 3.04 million).
Outlook
WILEX will continue to pursue commercialisation of its product candidates
and the financing of the Company. The following clinical milestones are
expected in the coming months:
For REDECTANE(R), application for approval will be prepared for submission.
The next milestone in the Phase III ARISER study with RENCAREX(R), the
343rd relapse, is expected in the second half of the year. As anticipated
in the study protocol, an interim analysis for efficacy of the antibody
will be carried out after that, which could be the basis for filing for
approval in the European Union. Recruitment will be continued in the Phase
II study with MESUPRON(R) in breast cancer patients. We anticipate
receiving study data on the study endpoint (progression-free survival) in
2012.
Invitation to the conference call
On 14 July 2010, 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:
Germany +49 (0) 69 6677 75756
UK +44 (0) 2030032666
USA +1 212 999 6659
You will be welcomed by an operator taking your name and company. The
presentations for the conference (in English) will be available for
download on the website from 2:00 p.m. CET. A replay of the conference will
be available on the website on 15 July
http://www.wilex.de/IR/Presentations.php.
Key figures H1 20101) H1 20091) Change1) The reporting period begins on 1 December and ends on 31 May
Earnings EUR '000 EUR '000 in %
Sales revenue 0 0 n/a
Other income 912 1,138 (19.8)
Operating expenses (12,477) (11,701) 6.6
of which research and development (10,195) (9,678) 5.3
Operating result (11,565) (10,563) 9.5
Earnings before tax (11,552) (10,430) 10.8
Net loss for the period (11,556) (10,437) 10.7
Earnings per share in euros (0.73) (0.81) (10.2)
Balance sheet as of end of period
Total assets 6,747 13,956 (51.7)
Cash and cash equivalents 3,309 10,553 (68.6)
Equity 142 5,284 (97.3)
Equity ratio2) in % 2.1 37.9 (94.4)
Cash flow
from operating activities (8,398) (11,546) (27.3)
from investing activities (4) (47) (91.8)
from financing activities 8,283 9,844 (15.9)
Employees
Employees as of end of period3) 72 66 9.1
Employees - average for reporting
period3) 72 65 10.3
2) Equity / total assets
3) Including members of the Executive Management Board
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.
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: A
pivotal Phase III study with REDECTANE(R) has been completed and positive
data published. RENCAREX(R) is undergoing a Phase III registration trial.
Positive MESUPRON(R) Phase II data in the indication pancreatic cancer have
been published and another Phase II trial in breast cancer is ongoing. The
MEK inhibitor WX-554 has completed a Phase I trial. A further oncology
project (PI3K inhibitor WX-037) is in preclinical development and three
antibody programmes are in research. 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
WILEX AG
Corporate Communications
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
E-Mail: investors(at)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.
14.07.2010 07:38 Ad hoc announcement, Financial News and Press Release distributed by DGAP. Medienarchiv atwww.dgap-medientreff.deandwww.dgap.de---------------------------------------------------------------------------
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(at)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
---------------------------------------------------------------------------Unternehmensinformation / Kurzprofil:
Bereitgestellt von Benutzer: EquityStory
" alt="London Hong Kong Exchange Plc acquires a 51% shareholding in CMX Capital Markets Exchange AG that has been renamed to LHKX Capital AGDatum: 14.07.2010 - 07:38 Uhr
Sprache: Deutsch
News-ID 23855
Anzahl Zeichen: 0
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 223 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: WILEX AG reports on successful first half of 2010"
steht unter der journalistisch-redaktionellen Verantwortung von
WILEX AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
