DGAP-News: WILEX AG announces successful half year results
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Half Year Results/Change in
Forecast
WILEX AG announces successful half year results
14.07.2011 / 07:03
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PRESS RELEASE
WILEX announces successful half year results
- Income more than doubled, liquidity and equity strengthened
- Commercialisation strategy on track
- Financial guidance improved
Munich, Germany, 14 July 2011. WILEX AG (ISIN DE0006614720 / WL6 /
Frankfurt Stock Exchange) today published its financial report for the
first six months of the 2011 financial year (1 December 2010 - 31 May 2011)
and reported on the status of the Company's projects.
Peter Llewellyn-Davies, Chief Financial Officer of WILEX AG, commented:
'Strategic acquisitions have expanded our business model over the past
half-year and we are on track with our commercialisation strategy. We have
doubled income and strengthened liquidity and equity, therefore
significantly improving our financial position and our guidance for the
current financial year.'
Business performance, research and development activities in 2011
WILEX granted the exclusive US commercial rights for RENCAREX(R) to
Prometheus Laboratories Inc., a US pharmaceutical company, in April 2011
and received payments totalling USD 19 million during the reporting period.
Under this agreement, WILEX has the option of receiving either the European
commercial rights to an already marketed Prometheus product or a
compensation payment of USD 20 million 12 months after signing. Overall the
alliance has a potential value of more than USD 145 million plus royalties
on US sales.
The recruitment of breast cancer patients for the MESUPRON(R) Phase II
trial was successfully completed in May 2011.
The Pre-BLA Meeting for the diagnostic candidate REDECTANE(R) took place in
the second quarter. The FDA confirmed during the discussions at this
meeting that the Phase III REDECT trial delivers reasonable evidence of the
diagnostic efficacy and safety of REDECTANE(R). Two issues remain to be
resolved by WILEX and its partner Ion Beam Applications S.A.,
Louvain-la-Neuve, Belgium (IBA). The FDA suggested that WILEX and IBA might
consider an outcomes based study to provide additional evidence of clinical
benefit before BLA filing. WILEX and IBA agree with the FDA that a trial
with a clinical benefit outcome could represent the next logical step in
REDECTANE's development. WILEX, IBA and external medical advisors however
are of the opinion that such a trial should be conducted as a Phase IV
trial after market approval. WILEX and IBA will first discuss the trial
design and strategy with the Medical Advisory Board and subsequently with
the FDA. The second set of issues discussed with the FDA concerns matters
related to the manufacturing of REDECTANE(R). WILEX and IBA will make the
required data available to the FDA in the next months.
In connection with marketing Oncogene Science's in vitro diagnostic tests,
WILEX Inc. successfully acquired important customers and expanded its
client base. ISO certification, a prerequisite for manufacturing and
selling the diagnostic tests, as well as the changeover of the product
range to WILEX Inc. is ongoing and are expected to be completed in the next
weeks. Initial sales revenue has been generated.
The acquisition of Heidelberg Pharma AG was successfully completed in March
and is now being integrated into the WILEX Group. Heidelberg Pharma has
successfully expanded its preclinical service business and reports
increasing sales revenue.
Financial results of the first half of 2011
In the first six months of the 2011 financial year, the WILEX Group
generated higher income of EUR 2.0 million (previous year: EUR 912 k - plus
120%). In the first half of 2011, the WILEX Group posted sales revenue of
EUR 1.4 million (previous year: EUR 0 k), of which EUR 898 k are
attributable to the sales revenue from deferred income relating to the
Prometheus transaction. Additional revenue will be generated from the
marketing of WILEX Inc.'s diagnostic tests and Heidelberg Pharma's customer
specific preclinical contract research. Other income amounted to EUR 639 k
(previous year: EUR 912 k) primarily based on income realisation from
grants and milestone payments.
Operating expenses including depreciation and amortisation amounted to EUR
12.41 million at the level of the previous year (EUR 12.48 million).
Research and development costs at just under 71% account for the majority
of operating expenses. They were EUR 8.75 million in the first half of 2011
and thus 14.1% lower than 2010 (EUR 10.19 million). The ongoing clinical
development of the monoclonal antibody Girentuximab (for RENCAREX(R) and
REDECTANE(R)) accounted for 52.3% of research and development costs. As
expected and reflecting the progress of the two Phase III trials, this
figure was lower than 2010 in absolute terms but slightly higher in
relative terms than the previous year's 47.9%. The uPA programme involving
the small-molecule drug candidate MESUPRON(R) - specifically, the Phase II
breast cancer trial - accounted for 29.4% of the research and development
costs (previous year 32.7%). Costs fell compared to the previous year as
the Phase II trial involving patients with pancreatic cancer, which
incurred expenditures the previous year, has been completed. The other
projects, which mainly comprise the programmes acquired from UCB, account
for 18.3% of research and development costs. Administrative costs rose by
17.1% to EUR 2.67 million (previous year: EUR 2.28 million) due mainly to
the consolidation of our subsidiaries' expenses as well as transaction
costs in connection with the acquisition.
The consolidated net loss for the period was EUR 10.62 million. This
represents an improvement of 8.1% compared with the previous year (EUR
11.56 million) as a result of higher income and lower costs. Earnings per
share improved to EUR -0.54 (previous year: EUR -0.73).
The WILEX Group had cash and cash equivalents of EUR 13.52 million (30
November 2010: EUR 1.94 million, 31 May 2010: EUR 3.31 million) at the
close of the first half of 2011. Equity at the end of the reporting period
was EUR 7.37 million (30 November 2010: EUR -1.30 million). The equity
ratio improved to 20.2%.
Outlook
The WILEX Group has adjusted its financial guidance for the current
financial year and now expects sales revenue and other income to increase
considerably to between EUR 9 million and EUR 11 million.
Operating expenses in 2011 will be lower than previously forecast at
between EUR 26 million and EUR 30 million if business goes as planned.
Accordingly, the operating loss for the year will decrease to between EUR
16 million and EUR 20 million, compared to a loss of EUR 23.1 million in
2010. As previously forecast, the result includes the business activities
of both WILEX Inc. and Heidelberg Pharma at between EUR -2 million and EUR
-3 million based on both entities' revenue and cost planning. Both
companies are anticipated to achieve positive results by the end of 2012.
WILEX expects the following clinical milestones to be achieved in the
coming months: The Company continues to prepare the approval application
for REDECTANE(R) jointly with its partner IBA. WILEX and IBA will address
the issues raised at the pre-BLA Meeting and prepare proposals ready for
discussion with the FDA. The recommendation of the Independent Data
Monitoring Committee in the Phase III ARISER trial of RENCAREX(R) is
expected in the second half of 2011.
Under the agreement with Prometheus, WILEX will make a decision by May 2012
on whether to take over an approved and marketed product for Europe or
receive the agreed payment of USD 20 million.
The Phase I programme for the MEK inhibitor WX-554 will be continued in the
second half of 2011 with the orally administered version in healthy
volunteers and patients studies. The final data of progression-free
survival from the Phase II trial of MESUPRON(R) in HER2 receptor negative
breast cancer are expected in 2012.
WILEX Inc. will continue expanding its customer base for marketing the in
vitro diagnostic tests. The integration of Heidelberg Pharma AG and the
expansion of contract-based business activities will be continued. The
conclusion of licence agreements for the ADC platform technology is a key
task for the next months.
Invitation to the conference call
On 14 July 2011, WILEX will hold a public conference call for media,
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 69 6677 75758
2. UK: +44 2030032666
3. USA: +1 212 999 6659
You will be welcomed by an operator taking your name and company. The
presentation for the conference will be available for download from
http://www.wilex.com/ at 2:00 p.m. CET. A replay of the conference will be
available from 15 July on the website
http://www.wilex.de/IR/Presentations.php.
Key figures H1 2011 1) H1 2010 1) Change1) The reporting period begins on 1 December and ends on 31 May
Earnings EUR '000 EUR '000 in %
Income 2,006 912 120.0
of which sales revenue 1,367 0 n/a
of which other income 639 912 (30.0)
Other expenses (12,407) (12,477) (0.6)
of which research and development costs (8,755) (10,195) (14.1)
Operating result (10,402) (11,565) (10.1)
Earnings before tax (10,620) (11,552) (8.1)
Comprehensive income (10,621) (11,556) (8.1)
Earnings per share in EUR (0.54) (0.73) (25.9)
Balance sheet as of end of period
Total assets 36,477 6,747 440.7
Liquid funds 13,516 3,309 308.5
Equity 7,372 142 n/a
Equity ratio2) in % 20.2 2.1 n/a
Cash flow
from operating activities 1,668 (8,382) n/a
from investing activities (98) (4) n/a
from financing activities 9,972 8,283 20.4
Employees
Employees as of the end of the period3) 118 72 63.9
Employees - average for the reporting
period3) 93 72 29.2
2) Equity / total assets
3) Including WILEX Inc. and Heidelberg Pharma AG (2011) and the members of
the Executive Management Board
The 2011 half-yearly financial report including the consolidated 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, Germany. Focused
on oncology, the company has a broad portfolio of near-to-market
therapeutic and diagnostic products for the targeted treatment and specific
detection of various types of cancer. The company's therapeutic product
candidates are based on antibodies and small molecules. Through its US
subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of
oncological diagnostic tests under the brand Oncogene Science. These
diagnostic tests could be used as companion diagnostics in clinical trials
and for therapy monitoring. Furthermore, the acquisition of HeidelbergPharma AG is set to give WILEX access to an attractive and highly promising
antibody drug conjugate technology platform and a pre-clinical service
business. The business model of WILEX covers the entire value chain in the
oncology market and comprises research, technology, development
collaboration as well as sales and marketing. WILEX's customers and
partners include leading international pharmaceutical companies.
Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6
Contact
Katja Arnold (CIRO)
Corporate Communications
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: mailto: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.
End of Corporate News
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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 Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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Datum: 14.07.2011 - 07:03 Uhr
Sprache: Deutsch
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