DGAP-News: WILEX AG publishes 9-months financial report 2012
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Quarter Results
WILEX AG publishes 9-months financial report 2012
11.10.2012 / 06:55
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PRESS RELEASE
WILEX publishes 9-months financial report 2012
- Sales revenue and earnings significantly improved
- Oncologic Drugs Advisory Committee vote in favour of diagnostic
performance
- Combined capital increase against cash and contributions in kind
successfully completed
- Dr Jan Schmidt-Brand appointed as new CFO
Munich, Germany, 11 October 2012. WILEX AG (ISIN DE0006614720 / WL6 / FWB)
published its financial report for the first nine months of the 2012
financial year (1 December 2011 - 31 August 2012) and reported on the
status of the Group's projects.
Dr. Jan Schmidt-Brand, Chief Financial Officer of WILEX AG, commented: 'The
previous nine months of the 2012 financial year were very successful for
us: Due to higher sales revenue we managed to boost our earnings by 44%
compared to the same period of the previous year. Regarding our development
projects and our economic progress the third quarter was eventful and
successful. The implemented capital increase and the payment from our
partner Prometheus allow us to finance ongoing and planned clinical studies
until 2014. We are on track with our preparations for the final analysis in
the phase III trial with RENCAREX(R) to be expected in Q4 this year.'
Activities and outlook of the operating segments
Therapeutics (Rx)
RENCAREX(R) (INN: Girentuximab): Over the past few months, all existing
clinical data of all patients included in the Phase III registration trial
ARISER were collected at the trial centres, checked and then imported into
a database for independent evaluation. The DFS (disease-free survival) data
will be analysed statistically and the trial results evaluated by the
ARISER Independent Data Monitoring Committee (IDMC) in the fourth quarter
of 2012. If the results are positive, the marketing authorisation
application could be submitted by WILEX in Europe in the first half of 2013
followed by our partner Prometheus in the United States.
MESUPRON(R) (INN: Upamostat): WILEX published positive data from its Phase
II trial with the oral uPA inhibitor MESUPRON(R) in breast cancer in June
2012. These results showed that MESUPRON(R) improves median progression
free survival, particularly in subgroups, as well as the objective response
rate and that the therapy is safe and well tolerated. The data confirm the
results of the pancreatic cancer trial reported in 2010. It is planned to
sign a license agreement with a partner for MESUPRON(R) and decide the
further development strategy together with the future partner.
WX-554: A Phase Ib/II trial with the small molecule MEK inhibitor WX-554
was started in April 2012 to analyse the safety, pharmacokinetics,
pharmacodynamics and efficacy of WX-554 in patients with solid tumours. The
study will be continued over the next few months.
Diagnostics (Dx)
REDECTANE(R) (INN: 124I-Girentuximab): In July 2012, a meeting of the
Oncologic Drugs Advisory Committee (ODAC) took place. The FDA Advisory
Committee delivered a clear vote in favour of the clinical use of the
diagnostic agent. ODAC addressed the following question: Would an imaging
test provide useful clinical information if it identified only clear cell
renal cell carcinoma (ccRCC) within the kidney of patients with an
indeterminate renal mass?'
In September 2012, the FDA and WILEX discussed the recommendations of the
ODAC and the development strategy for the imaging diagnostic at a further
Type C meeting. The agency confirmed that the outcomes-based study it
required in the past to be no longer necessary, but requires a further
study to provide additional proof of the diagnostic performance and safety
of REDECTANE(R). WILEX assumes that this trial must be successfully
completed prior to approval. Currently, WILEX is developing the protocol
for this Phase III trial (REDECT 2) for submission to the FDA on the basis
of a special protocol assessment. The details of the design of this trial
will be released once the protocol has been approved.
In vitro diagnostic tests: WILEX Inc. generated sales revenue in the first
nine months of the financial year at the previous year's level. The US
subsidiary markets under the brand name Oncogene Science Enzyme-Linked
ImmunoSorbent Assay (ELISA) tests for a variety of biomarkers (HER2/neu,
EGFr, uPA, PAI-1, TIMP-1 and CA IX) and immunohistochemical (IHC) tests (CA
IX) and intensifies the marketing activities to increase its sales revenue.
Customer Specific Research (Cx)
Due to the services offered in the field ADC technology and preclinical
service business Heidelberg Pharma GmbH's sales revenues rose year on year.
Furthermore, the company recruited Professor Andreas Pahl in September 2012
and has filled the vacant position of Chief Scientific Officer. Additional
partnerships planned for the ADC technology shall provide the basis for
successfully commercialising this platform.
Financing and business development
WILEX AG carried out a combined capital increase against cash and
contributions in kind in the third quarter of 2012. In the form of a
contribution in kind, the Company's shareholder dievini Hopp BioTech
holding GmbH&Co. KG, Walldorf, Germany (dievini) converted its existing
claim to repayment from a loan extended to WILEX AG amounting to
approximately EUR 7.8 million (including interest) into 2,100,337 new
shares. As a result, the greater part of the shareholder loan was repaid,
considerably reducing the financial liabilities of the WILEX Group. In the
cash portion of the rights issue, 4,360,207 new shares were subscribed.
This generated gross proceeds of around EUR 16.1 million for the Company.
The total number of WILEX shares issued increased to 31,275,507.
Prometheus's payment of USD 17.5 million in July 2012 secures in addition
to that the financing and further growth into 2014.
On 1 September 2012, Dr. Jan Schmidt-Brand assumed the position of Chief
Financial Officer and succeeded Peter Llewellyn-Davies, who left the
Executive Management Board at the end of his contract.
Key financial figures for the first nine months of 2012
The previous year's figures are not directly comparable with the
consolidated figures for the current reporting period because Heidelberg
Pharma was not consolidated until the capital increase against contribution
in kind was recorded in the German Commercial Register on 17 March 2011.
In the first nine months of the 2012 financial year, the WILEX Group
generated sales revenue of EUR 11.3 million (previous year: EUR 4.7
million). This significant increase is mainly due to sales revenue of EUR
9.7 million in the Rx segment from the ongoing pro rata reversals of
accrued payments for RENCAREX(R) and additional receivables under the
Prometheus licence agreement. At EUR 1.5 million, other income was
significantly higher year on year (EUR 0.8 million), mainly due to gains
from exchange rate differences.
Operating expenses including depreciation and amortisation amounted to EUR
19.8 million in the reporting period, up on the previous year (EUR 18.4
million). Research and development costs of EUR 9.7 million were down 28%
year on year (previous year: EUR 13.6 million). A part of the R&D costs has
been reclassified in cost of sales since the 2011 annual financial
statements. Cost of sales were EUR 4.9 million in the reporting period, up
substantially owing to the reclassification of costs and the consolidation
of Heidelberg Pharma in the entire financial year. Administrative costs
were EUR 3.4 million in the first nine months (previous year: EUR 3.9
million). A total of EUR 0.5 million in expenses for business development
was included in administrative costs in the same period the previous year.
Given the increased marketability of RENCAREX(R), the costs of activities
related to business development (EUR 0.6 million), marketing and commercial
supply (EUR 1.2 million) have been reported as 'other expenses' (EUR 1.8
million in total) since the beginning of the current financial year. In the
same period the previous year, all marketing activities together with cost
of sales were combined under the item 'manufacturing, service and
distribution costs' (EUR 0.9 million in total).
The WILEX Group posted a loss of EUR 7.4 million for the first nine months
of the 2012 financial year. This corresponds to an improvement by 44% on
the same period of the previous year
(-EUR 13.2 million) and is particularly due to the increase in sales
revenue. Earnings per share improved to -EUR 0.31 (previous year: -EUR
0.65), mainly as a result of the lower loss for the period.
The Therapeutics segment posted sales revenue of EUR 9.7 million and a net
loss of EUR 3.6 million in the first nine months of the financial year. The
Diagnostics segment generated sales revenue of EUR 0.2 million and a net
loss for the period of EUR 2.6 million. Customer Specific Research posted
sales revenue of EUR 1.4 million and a net loss for the period of EUR 1.9
million.
Total assets as of 31 August 2012 amounted to EUR 43.2 million (30 November
2011: EUR 20.8 million). Non-current assets at the end of the reporting
period amounted to EUR?12.7 million (30 November 2011: EUR 12.8 million).
At EUR 30.5 million, current assets at the close of the reporting period
were substantially higher than at the end of the 2011 financial year (EUR
8.0 million). This sharp rise is again attributable to the cash inflows
from the recent capital increase as well as to the Prometheus payment in
July 2012. The WILEX Group had cash and cash equivalents of EUR 28.7
million as of 31 August 2012 (30 November 2011: EUR 3.4 million).
Equity at the end of the reporting period improved significantly to EUR
21.4 million (30 November 2011: -EUR 4.5 million). Non-current liabilities
at the end of the reporting period reduced to EUR?3.0 million compared to
EUR?5.1 million at the end of 2011 financial year. The decline is mainly
due to the pro rata reversal of the accrued payments received in connection
with the Prometheus transaction and the reclassification of lease
liabilities from non-current to current. Current liabilities decreased to
EUR 18.8 million as of the end of the period (30 November 2011: EUR 20.2
million). Financial liabilities now solely comprise the UCB shareholder
loan including interest of EUR 2.6 million (30 November 2011: EUR 10.5
million).
Key figures for the WILEX Group
Key figures 9M 20121) 9M 20111)1 The reporting period begins on 1 December and ends on 31 August.
Earnings EUR '000 EUR '000
Sales revenue 11,359 4,738
Other income 1,472 814
Operating expenses (19,799) (18,416)
of which research and development costs (9,735) (13,595)
Operating result (6,968) (12,864)
Earnings before tax (7,418) (13,228)
Net loss for the period (7,420) (13,230)
Earnings per share in EUR (0.31) (0.65)
Balance sheet as of end of period
Total assets 43,174 32,398
Cash and cash equivalents 28,677 8,073
Equity 21,449 4,638
Equity ratio2) in %49.7 14.3
Cash flow
from operating activities 111 (3.370)
from investing activities (268) (399)
from financing activities 25,440 9,907
Employees (number)
Employees as of the end of the period3) 127 119
Employees as of the end of the period (full-time
equivalents)3) 118 111
2 Equity/total assets
3 Including Heidelberg Pharma (from March 2011) and members of the
Executive Management Board
Rounding of exact figures may result in differences.
The 9-Month Financial Report 2012 including the consolidated financial
statements prepared in accordance with International Financial Reporting
Standards (IFRS) was published at www.wilex.com.
Invitation to the conference call:
On 11 October 2012, 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 71044 5598
2. UK: +44 20 3003 2666
3. USA: +1 212 999 6659
4. USA Freephone: +1 866 966 5335
You will be welcomed by an operator taking your name and company. The
presentation for the conference will be available for download from
www.wilex.com at 2:30 p.m. CET.
Contact
WILEX AG
Katja Arnold (CIRO)
Grillparzerstrasse 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
About WILEX
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the Company has a broad portfolio of diagnostic and
therapeutic products for the specific detection and targeted treatment of
various types of cancer. WILEX's therapeutic product candidates are based
on antibodies (RENCAREX(R) in Phase III) and small molecules (MESUPRON(R)
two Phase IIa trials completed, WX-554 in Phase Ib/II and WX-037 in
preclinical development). In the field of diagnostics, REDECTANE(R) is an
antibody-based, imaging diagnostic agent that is currently in a Phase III
programme. WILEX's US subsidiary WILEX Inc. in Cambridge, MA, markets a
portfolio of research use only tests and in vitro diagnostic agents under
the brand Oncogene Science. The subsidiary Heidelberg Pharma GmbH offers an
attractive and highly promising antibody drug conjugate technology platform
and preclinical contract research services. The business model of WILEX
comprises research, technology, product development and commercialisation.
WILEX's customers and partners include leading international pharmaceutical
companies.
Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6
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
Germany
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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