DGAP-News: WILEX AG publishes 9-month financial report 2010
(firmenpresse) - WILEX AG / Key word(s): Quarter Results
13.10.2010 07:16
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WILEX publishes 9-month financial report 2010
- Mandatory offer from dievini Hopp BioTech closed
- Rights issue successfully executed
- GMP certification renewed
- Financials in line with expectations
Munich, Germany, 13 October 2010 - WILEX AG (ISIN DE0006614720 / WL6 /
Frankfurt Stock Exchange) today published financial figures for the first
nine months 2010 (1 December 2009 - 31 August 2010) and the status of the
R&D projects.
Peter Llewellyn-Davies, CFO of WILEX AG, summarised the events of the third
quarter: 'Following the successful and eventful clinical activities in the
first half of the year the third quarter was marked mainly by a mandatory
takeover offer and a capital increase. We were very pleased about the high
over-subscription of the rights issue. This is an indication of our
investors' confidence in our strategy and development and also of their
commitment'.
Projects and milestones in the third quarter 2010
dievini Hopp BioTech holding&Co. KG submitted a mandatory takeover offer
for the Company's shares in July 2010 after passing the 30% share-holding
threshold. The Executive Management Board and Supervisory Board recommended
that shareholders reject the offer based on management's assessment that
the offer price of EUR 4.10 per WILEX share failed to reflect the Company's
true potential. A total of 22,953 shares (0.12% of the share capital) were
transferred to dievini Hopp Biotech before the mandatory offer closed in
August.
The Company carried out a rights issue in August and offered 2,455,070 new
shares at the subscription price of EUR 4.10 per share. The capital
increase was successfully executed with a subscription ratio of
approximately 72%, an allocation quota for over-subscription of about 21%
and net proceeds of approx. EUR 10 million.
Following an inspection by the German authorities (Central Drug Monitoring
Office, Government of Upper Bavaria) WILEX was re-certified in September
2010 as being in compliance with the principles and guidelines of Good
Manufacturing Practice (GMP). At the same time, the manufacturing and
import authorisation pursuant to section 13 and section 72
Arzneimittelgesetz (German Drug Act - AMG) for the production, testing and
release of investigational medicinal products for clinical trials and drugs
was updated. The GMP certificate is an important prerequisite for marketing
all of WILEX's product candidates.
Based on the Phase III data for the product candidate REDECTANE(R) for the
diagnosis of kidney tumours WILEX is currently preparing an application for
approval (Biological License Application, BLA) in the United States.
In the RENCAREX(R) Phase III ARISER trial in clear cell renal cell
carcinoma the next milestone, the occurrence of the 343rd relapse, which
constitutes the basis for the interim analysis for efficacy, is moving
closer. As of the end of September 2010, a total of 335 relapses were
reported to WILEX by the local trial centres.
Patient recruitment in the Phase II trial with the uPA inhibitor
MESUPRON(R) in patients with metastatic HER2 receptor negative breast
cancer has made good progress. Of the planned 114 patients a total of 103
patients had been recruited in 21 trial centres in Europe, the USA and
Brazil by the end of September 2010.
Results of the first nine months 2010
WILEX posted earnings before taxes of EUR -17.22 million (previous year:
EUR -11.05 million) in the first nine months of the 2010 financial year (1
December 2009 to 31 August 2010). At EUR 17.22 million, the net loss for
the period was 55.7% above the previous year's figure (EUR 11.06 million).
Earnings per share decreased to EUR -1.06 (previous year: EUR -0.84).
WILEX did not recognise any sales revenue in the first nine months of 2010
(previous year: EUR 5.00 million). At EUR 1.24 million, other income fell
35.4% compared to the previous year (EUR 1.92 million) and consists of
income realised from the US Department of Defense grants as well from the
licence agreements with Esteve and IBA.
Operating expenses including depreciation, amortisation and impairment
losses amounted to EUR 18.48 million, up almost 2.0% from the previous year
(EUR 18.12 million). Research and development costs were EUR 15.09 million
(previous year: EUR 15.16 million), corresponding to 81.7% of operating
expenses. Administrative costs were EUR 3.38 million, up 14.5% from the
previous year (EUR 2.96 million). The increase is due to the revaluation of
the stock options in the first quarter and higher consultancy costs.
At the end of the third quarter of 2010, the Company had cash and cash
equivalents of EUR 7.76 million (30 November 2009: EUR 3.41 million; 31
August 2009: EUR 8.93 million).
Equity as of the end of the reporting period was EUR 4.53 million (30
November 2009: EUR 3.04 million). The equity ratio was 41.2% as of 31
August 2010 (30 November 2009: 25.3%; 31 August 2009: 38.0%).
Outlook
We are currently in talks with the FDA with respect to our diagnostic
candidate REDECTANE(R), and the BLA is being prepared. At the same time, we
are carrying out pre-marketing activities in the United States jointly with
our marketing partner, IBA.
WILEX expects the 343rd relapse in the RENCAREX(R) Phase III ARISER trial -
i.e. the next milestone according to the study protocol - to occur by the
end of the year. Once the 343rd relapse has occurred, all available data
from the 864 patients will be collected and the independent centralised
evaluations of all patients' radiological scans performed. Subsequently, an
independent interim analysis of efficacy of RENCAREX(R) will be initiated
and conducted by the Independent Data Monitoring Committee (IDMC). This
analysis will provide critical information regarding the trial endpoint -
disease-free survival - which could form the basis for the European
application for marketing approval.
Patient recruitment in the MESUPRON(R) Phase II trial in the breast cancer
indication is likely to be completed by the first quarter of 2011. WILEX
expects the data from this study to be available in 2012, given the trial
endpoint - progression-free survival.
The activities related to the commercialisation of our product candidates,
as well as the Company's funding in the medium and long term, will be at
the forefront of the management's activities in the coming months.
Key figures 9M 20101) 9M 20091) Change1) The reporting period begins on 1 December and ends on 31 August.
Earnings in EUR'000 in EUR'000 in %
Sales revenue 0 5,000 n/a
Other income 1,244 1,925 (35.4)
Other expenses (18,479) (18,118) 2.0
of which research and development (15,095) (15,162) (0.4)
Operating result (17,235) (11,193) 54.0
Earnings before tax (17,217) (11,049) 55.8
Net loss of the period (17,222) (11,059) 55.7
Earnings per share in EUR (1.06) (0.84) 27.1
Balance sheet as of end of period
Total assets 10,994 12,328 (10.8)
Cash and cash equivalents 7,762 8,931 (13.1)
Equity 4,530 4,690 (3.4)
Equity ratio 2) in % 41.2% 38.0% 8.3
Cash flow
from operating activities (13,952) (13,178) 5.9
from investing activities (11) (61) (82.6)
from financing activities 18,296 9,844 85.8
Employees
Employees as of the end of period 3) 72 67 7.5
Employees - annual average 3) 72 68 5.9
2) Equity / total assets
3) Including members of the Executive Management Board
The 9-months Financial Report including the single-entity financial
statements prepared in accordance with IFRS has been published on the
Company's website: www.wilex.com.
Invitation to the conference call
WILEX will hold a conference call for media representatives, analysts and
investors in English on 13 October 2010 at 3:00 p.m. CET. Please dial in
ten minutes before the conference call using the following dial-in numbers:
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 at the website from 2:00 p.m. CET. A replay of the conference will
be available on 14 October on the website
http://www.wilex.de/IR/Presentations.php.
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: For
REDECTANE(R) WILEX is currently preparing an application for approval in
the United States. 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
Katja Arnold (CIRO)
Corporate Communications
WILEX AG
Grillparzerstr. 10
81675 München, Germany
Phone: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: 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.
13.10.2010 07:16 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
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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(at)wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in München, Berlin, Düsseldorf, Stuttgart
End of Announcement DGAP News-Service
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Datum: 13.10.2010 - 07:16 Uhr
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