WILEX reports on the successful financial year 2009
• Significant progress of all clinical
projects
•
Income quadrupled to EUR 13.0 million
•
Result improved by 38%
Munich, 24 February,
2010. The biopharmaceutical company WILEX AG (ISIN DE0006614720/
Frankfurt Stock Exchange / Prime Standard) announced today its
financial results and annual report for the financial year 2009
(1 December 2008 - 30 November 2009).
Peter Llewellyn-Davies, Chief Financial Officer of WILEX AG commented: "Our
Company took a decisive step forward in 2009. Our product candidates
delivered positive clinical data and REDECTANE® is getting
closer to market. At the same time, we fully met our forecasts
for the 2009 financial year. Income quadrupled compared to last
year and we were able to improve our result significantly."
Developments in financial year 2009
WILEX was successful in making significant progress in all its
operations: its clinical trials, the expansion of its product
portfolio and the development of its income.
REDECTANE®: Patient recruitment in the Phase III trial of
the diagnostic antibody REDECTANE® was successfully completed
in September 2009. Preliminary data from this trial, which were
announced at the end of November 2009, showed that PET/CT with
REDECTANE® provides a better diagnosis of clear cell renal
cell carcinoma than CT alone.
RENCAREX®: The last patient in the Phase III ARISER trial
with the therapeutic antibody RENCAREX® in the indication
of clear cell renal cell cancer, completed the 24-week treatment
in February 2009. The independent interim analysis for efficacy
of RENCAREX® requires 343 relapses. A total of 303 patients
had relapsed by the end of January 2010.
MESUPRON®: The small molecule drug candidate MESUPRON® generated
encouraging, preliminary data when administered in combination
with the chemotherapeutic agent gemcitabine in a Phase II trial
with pancreatic cancer patients. The trial endpoints tumour response
rate, one-year survival rate and median survival time improved
following combination therapy with MESUPRON®.
Strategic alliance: WILEX and UCB Pharma S.A. (UCB)
signed a strategic alliance at the start of the 2009
financial
year, which saw WILEX
taking over UCB's preclinical oncology portfolio.
WX-554, the
first product candidate from this partnership, was
successfully transitioned to a Phase I trial in 2009. Consequently,
milestone payments from UCB totalling EUR 10 million
became payable.
Capital measures: A capital increase was executed
in February 2009 as part of the UCB deal using authorised
capital
in return for contributions in-kind. A rights issue
using authorised
capital was completed after the end of the reporting
period in December
2009. The Company received total proceeds of EUR
18.5 million.
Key financial figures for financial year 2009
In the 2009 financial year, WILEX posted a pre-tax loss of EUR 12.7
million (previous year: loss of EUR 20.4 million). The net loss
for the year fell by 37.7% to EUR 12.7 million (from EUR 20.4 million
the previous year) thanks to the revenue generated. This corresponds
to earnings per share of EUR -0.95 (previous year: EUR -1.71).
The Company posted sales
revenue for the very first time in
2009, resulting from the UCB milestone payments totalling
EUR 10 million.
Other income fell by 6.1% from EUR 3.2 million the previous year
to EUR 3.0 million. This income comprises advance prepayments
from our cooperation partners deferred and recognised at
the time the
relevant services are rendered.
The operating expenses rose from EUR 24.6 million by approximately
5.2% to EUR 25.9 million. Research and development costs rose
by 8.3% to EUR 21.8 million (2008: EUR 20.2 million) compared
to last
year as a result of the increase in the number of project. Administrative
costs fell from EUR 4.4 million by 8.8% to EUR 4.1 million compared
to last year.
The equity at the end of the reporting period was EUR 3.0 million
(30 November 2008: EUR 5.8 million), which corresponds to
an equity ratio of 25.3% as of 30 November 2009 (30 November
2008:
37.8%).
WILEX’s cash
and cash equivalents totalled EUR 3.4 million
(previous year: EUR 12.1 million) as at the close of the
2009 financial year. WILEX’s liquidity and equity situation
has improved since the reporting date thanks to both the milestone
payment of
EUR 5.0 million and the net proceeds of about EUR 8.5 million
from the cash capital increase completed in December 2009. Based
on current
planning, WILEX is financed into the third quarter of 2010.
Outlook for the 2010 financial year
WILEX expects its operational successes to continue in 2010
and anticipates a succession of key operating and commercial
milestones.
The Phase III trial of REDECTANE® is expected to be reported
in the second quarter and could serve as the basis for submitting
a marketing application to the FDA in Q4 2010. Final data on the
Phase II trial of MESUPRON® in pancreatic cancer are expected
in first half of the year. At the same time, the Company expects
to conclude a commercial deal with MESUPRON®.
The annual report including the annual financial
statements in accordance with International Financial Reporting
Standards
(IFRS)
and the
annual financial statements pursuant to the German Commercial
Code (HGB) were published at www.wilex.com.
Key figures
| Earnings in €’000 |
2009 1)
|
2008 1)
|
Change
in %
|
| Sales revenues |
10.000
|
0 |
N/A
|
| Other operating income |
3,013
|
3,208
|
(6.1)
|
| Other expenses |
(25,878)
|
(24,601)
|
5.2
|
| of which research and development |
(21,823)
|
(20,157)
|
8.3
|
| Operating result |
(12,864)
|
(21,394)
|
(39.9)
|
| Earnings before tax |
(12,714)
|
(20,433)
|
(37.8)
|
| Net loss of the period |
(12,729)
|
(20,448)
|
(37.7)
|
| Earnings per share in EUR |
(0.95)
|
(1.71)
|
(44.2)
|
|
|
|
|
| Balance sheet as at 30.11. in €’000 |
|
|
|
| Total assets |
12,013
|
15,327
|
(21.6)
|
| Liquid funds |
3,411
|
12,137
|
(71.9)
|
| Equity |
3,045
|
5,790
|
(47.4)
|
| Equity ratio 2) in % |
25.3
|
37.8
|
(32.9)
|
|
|
|
|
| Cash flow in €’000 |
|
|
|
| from operating activities |
(18,638)
|
(22,830)
|
(18.4)
|
| from investing activities |
(71)
|
14,932
|
(100.5)
|
| from financing activities |
9,794
|
(89)
|
N/A
|
| |
|
|
|
| Employees |
|
|
|
| Employees as at 30.11. 3) |
71 |
66
|
7.6
|
| Employees – annual average 3) |
66 |
62
|
6.6
|
| |
|
|
|
1) The reporting period begins on 1 December
and ends on 30 November.
2) Equity / total assets
3) Including Members of the Board
Invitation to the conference calls:
On 24 February 2010, WILEX will hold a public conference call for
media at 10:30 a.m. CET, and for analysts and investors at 3:00
p.m. CET.
Press conference (in English)
Time: 10.30 a.m. CET
1. Dial-in number: +49 69 20 17 44 210
2. When asked, please enter the PIN code 400404#.
Analyst conference (in English)
Time: 3:00 p.m. CET
1. Dial-in number:
Germany: +49 69 20 17 44 210
UK: +44 207 153 9154
USA: +1 877 423 0830
2. When asked, please enter the PIN code 265704#.
Please dial in ten minutes before the conference
and state your name and company when asked to do so. The presentations
for the
conference (in English) will be available for download at wilex.com from
9:00 a.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 candidates REDECTANE® and RENCAREX® are
undergoing Phase III registration trials. MESUPRON® is in Phase II trials
in two indications. The MEK inhibitor WX-554 is in a Phase I trial, and the
other four oncology projects (PI3K inhibitor WX-037 and three antibody programmes)
are 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
Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Tel.: +49 (0)89-210 228 0
E-mail: raimund.gabriel@mc-services.eu
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.
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