DGAP-News: WILEX AG publishes half-yearly financial report 2013
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Half Year Results
WILEX AG publishes half-yearly financial report 2013
11.07.2013 / 06:57
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PRESS RELEASE
WILEX publishes half-yearly financial report 2013
- Positive subgroup data for RENCAREX(R) presented at the ASCO Annual
Meeting
- Agreement reached with the FDA on the trial design for REDECTANE(R)
- Financial figures in line with guidance
- Invitation to the conference call
Munich, Germany, 11 July 2013. WILEX AG (ISIN DE0006614720 / WL6 / FSE)
published today its financial report for the first six months of the 2013
financial year (1 December 2012 - 31 May 2013). The WILEX Group, comprising
WILEX AG and the subsidiaries WILEX Inc. and Heidelberg Pharma GmbH,
reports consolidated figures and on three operating segments.
Dr Jan Schmidt-Brand, Chief Financial Officer of WILEX AG, commented: 'The
second quarter of the year saw extensive preparations for the ASCO Annual
Meeting to present data on MESUPRON(R) and from the ARISER study with the
new, encouraging findings from the retrospective subgroup analysis. We are
working hard to bring all of our projects to the next stage of development
and to secure financing for them.'
WILEX presented its financing plans at the Annual General Meeting on 14
June 2013 on the basis of a three-pillar strategy: the search for licensing
and development partners for MESUPRON(R), RENCAREX(R) and for the ADC
technology remains the main economic objective. Parallel to the endeavours
with potential licensing partners from industry, WILEX will work together
with financial investors on ensuring financing of projects or of the entire
portfolio, whereby the classic rights issue has the lowest priority in this
context. The investment bank Burrill Securities LLC has been engaged as an
advisor to assist in finding project financing. In addition to possible
financing options, WILEX will continue with cost saving measures introduced
at the beginning of the financial year. Vacant positions have not been
filled with tasks re-assigned within the team instead. Management functions
within the Executive Management Board and the executive management of the
subsidiaries were consolidated. The Executive Management Board was
effectively reduced from 4 to 3 full-time equivalents.
Activities and outlook of the operating segments
Therapeutics (Rx)
RENCAREX(R) (INN: Girentuximab): Over the last few months the data of the
ARISER trial in the adjuvant therapy of clear cell renal cell carcinoma
were analysed intensively with respect to biomarkers and subgroups.
Retrospective analysis revealed that as the score of the antigen CAIX
increases, the more pronounced the RENCAREX(R) treatment effect becomes.
A CAIX score of>= 2.6 resulted in a clinically and statistically
significant treatment effect with median DFS increasing from 51.2 months in
the placebo arm to 73.6 months in RENCAREX(R) patients (N=151; HR=0.54;
p=0.02). Further analyses of the subgroup population underpinned this
effect. In patients under the age of 65 years RENCAREX(R) showed a
clinically and statistically significant DFS with a CAIX score as low as>=
2.0 (N=286; HR=0.60; p=0.01).
This indicates that RENCAREX(R) could deliver a well-tolerated and
effective therapy for ccRCC patients with a high CAIX score. The relevance
of CAIX as a prognostic biomarker was introduced to leading urologists at
the AUA Annual Meeting in May 2013 in San Diego, and the detailed data from
the ARISER trial were presented at the ASCO Annual Meeting in Chicago at
the beginning of June 2013.
Based on the promising subgroup data, initial talks with the regulatory
authorities (the FDA and European agencies) on a confirmatory prospective
Phase III trial with RENCAREX(R) in the stratified subgroup using the
biomarker CAIX are planned for the second half of 2013. The Company plans
to further develop the CAIX in vitro diagnostic test as a companion
diagnostic, which may be helpful in identifying and stratifying patients
who might benefit from RENCAREX(R) therapy.
WILEX is currently in discussion with Prometheus about the termination of
the existing licence agreement for the US commercial rights to RENCAREX(R).
Following termination, WILEX will regain the global rights with the
exception of Southern Europe and could offer these to a new partner. Talks
are being held in parallel with several parties for out-licensing the
rights for Europe and the rest of the world with a possible option for the
United States. WILEX's goal is to find a partner that will participate in
financing, development and commercialisation. If RENCAREX(R) receives
regulatory approval, the definition of the subgroup for a further Phase III
trial could mean adjusted peak sale potential of over USD 300 million in
adjuvant therapy of ccRCC.
MESUPRON(R) (INN: Upamostat): The partnering process for the uPA inhibitor
is progressing based on the positive Phase II data (proof-of-concept) in
the pancreatic cancer (2010) and breast cancer (2012) indications. WILEX
aims to sign a licence agreement for MESUPRON(R) and decide together with
the partner the further development strategy for a Phase IIb/III programme.
WILEX is currently holding in-depth direct discussions with several parties
with oncology expertise.
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
first part of the study (a dose escalation) serves to confirm the
biologically effective dose. This is followed by a second part in which
this dose is administered to patients with MEK pathway relevant mutations
to obtain initial data on clinical activity and on pharmacodynamics within
the tumour tissue.
The plan is to complete patient recruitment for the second part by the end
of 2013 and to present data in the second half of 2014.
WX-037: The small molecule PI3K inhibitor is under development supported by
the 'm4 Personalised Medicine and Targeted Therapies' initiative of the
Munich-based m4 Biotech Cluster and will receive grants of up to EUR 2.6
million from the Federal Ministry of Education and Research (BMBF) for
preclinical and clinical development. Preclinical work has been completed
and clinical development began in July 2013. A Phase I trial will examine
the safety and tolerability of WX-037 in patients first as monotherapy and
then in combination with the MEK inhibitor WX-554.
The MEK and PI3K programmes together with several antibody programmes were
acquired from the biopharmaceutical company UCB in 2009. WILEX identified a
lead candidate for one of these antibody programmes and generated
preclinical data, which prompted UCB to acquire the rights for indications
outside oncology in July 2013. WILEX will be reimbursed an undisclosed
amount for its development to date and is eligible for future, undisclosed
development, regulatory and commercial milestone payments and royalties
whilst keeping all rights in oncology. UCB will work on these antibodies in
immunology/inflammatory diseases and, as part of the strategic partnership
between the two companies, will make available data to WILEX relevant for
oncology.
Diagnostics (Dx)
REDECTANE(R) (INN: 124I-Girentuximab): The radiolabelled form of the
antibody Girentuximab is being developed as an imaging agent for the
diagnosis of clear cell renal cell carcinoma. Data of a Phase III trial
showed thatREDECTANE(R) with PET/CT is clearly superior to CT alone in
diagnosing clear cell renal cell carcinomas. WILEX AG is currently
developing the protocol for a confirmatory Phase III trial (REDECT 2)
together with the FDA under a Special Protocol Assessment (SPA). At the
beginning of July, WILEX received written notification from the FDA
confirming agreement on the development strategy and study design for a
confirmatory Phase III diagnostic performance clinical trial with
REDECTANE(R). WILEX AG will now prepare and submit full documentation for
REDECT 2 to the FDA under the SPA procedure for formal approval. Details
will be disclosed at the start of the study, which is planned when WILEX
has secured financing for the entire study.
In vitro diagnostic tests: The US subsidiary WILEX Inc. produces and
markets ELISA and immunohistochemical tests under the brand name Oncogene
Science for various biomarkers (e.g. HER2/neu and CAIX). In addition to
manufacturing the biomarker tests, WILEX Inc. offers a range of contract
manufacturing services for third parties.
Since WILEX Inc. does not have a distribution structure of its own, several
partnerships have been concluded in recent months with established
distribution companies (Immundiagnostik AG for the German-speaking region,
GeneDiagnostics for China plus IBL-America Inc. and Nuclea Inc. for the
United States) to step up the marketing of the tests and extend their scope
of application.
Customer Specific Research (Cx)
The subsidiary Heidelberg Pharma GmbH offers customer specific preclinical
contract research related to cancers and inflammatory and autoimmune
diseases and also possesses a technology platform for therapeutic
antibodies (antibody drug conjugates, ADCs). This ADC technology has the
potential to enhance and improve the efficacy of many antibody-based
therapies, including those on the market.
Heidelberg Pharma has entered into several partnerships with research
institutions as well as pharmaceutical and biotechnology companies to
examine the applicability of this ADC technology to its partners' specific,
proprietary antibodies and performs contract work for customers related to
designing, optimising, profiling and manufacturing new ADCs. Important
scientific findings and data have been recorded that could form the basis
for continuing the collaboration.
A project (CapStem(R)) has also been developed in recent months to refine
this innovative ADC technology as an independent business model. This
presents the opportunity to market not only the toxin linker technology but
also to create complete ADC molecules with licensed antibodies. With this
model Heidelberg Pharma is able to harness the attractive market potential
better and finance development on a project basis.
Key financial figures for the first half year of 2013
In the first six months of the 2013 financial year, the WILEX Group
generated income of EUR 7.6 million (previous year: EUR 8.3 million). This
includes sales revenue of EUR 6.6 million (previous year: EUR 7.2 million)
and other income of EUR 1.0 million (previous year: EUR 1.1 million). Most
of this is attributable to sales revenue from the license agreement
concluded with Prometheus for RENCAREX(R); payments received were
recognised as deferred income and will be reversed through profit or loss
on a pro rata basis.
Operating expenses including depreciation and amortisation amounted to EUR
11.1 million in the reporting period, down from the previous year (EUR 13.5
million). The cost of sales amounted to EUR 2.7 million, down on the
prior-year figure of EUR 3.3 million as a result of lower expenses in the
Cx segment for the provision of services in the services business. Research
and development costs, which were EUR 6.9 million the previous year, fell
to EUR 5.4 million and also administrative costs were trimmed to EUR 1.9
million in the first half of the year due to the cost cutting following the
restructuring programme (previous year: EUR 2.2 million). Other expenses
for activities in the areas of business development, marketing and
commercial market supply amounted to EUR 1.1 million in the reporting
period (previous year: EUR 1.2 million).
The Therapeutics segment (Rx) posted sales revenue of EUR 5.8 million and a
net loss of EUR 0.5 million in the first six months of the financial year.
The Diagnostics segment (Dx) generated sales revenue of EUR 0.1 million and
a net loss for the period of EUR 2.1 million. Customer Specific Research
(Cx) generated sales revenue of EUR 0.6 million and a net loss for the
period of EUR 1.6 million.
The WILEX Group reported an improved financial result of EUR -50 k (H1
2012: EUR -320 k). The net loss for the period amounted to EUR 3.5 million.
This represents an improvement of 37% on the loss in the same period of the
previous year (EUR 5.6 million) and is solely attributable to lower costs.
Earnings per share improved by 53% to EUR -0.11 (H1 2012: EUR -0.24), also
due to the higher number of shares in circulation compared with H1 2012.
Total assets as of 31 May 2013 amounted to EUR 28.0 million (30 November
2012: EUR 37.7 million). The WILEX Group had cash and cash equivalents of
EUR 12.9 million (30 November 2012: EUR 23.4 million). Equity as of the end
of the reporting period was EUR 16.4 million (30 November 2012: EUR 19.9
million) with an equity ratio of 58.7% (30 November 2012: 52.8%).
WILEX confirms its guidance for the current financial year issued in
February 2013.
Key figures for the WILEX Group
Key figures H1 2013 1) H1 2012 1)1 The reporting period begins on 1 December and ends on 31 May.
Earnings EUR'000 EUR'000
Sales revenue 6,595 7,214
Other income 1,038 1,039
Operating expenses (11,123) (13,541)
of which research and development costs (5,415) (6,906)
Operating result (3,490) (5,289)
Earnings before tax (3,540) (5,608)
Net loss for the period (3,540) (5,609)
Earnings per share in EUR (0.11) (0.24)
Balance sheet as of end of period
Total assets 27,983 22,414
Cash and cash equivalents 12,894 2,920
Equity 16,439 (281)
Equity ratio in % 58.7 (1.3)
Cash flow
from operating activities (10,504) (9,906)
from investing activities (43) (140)
from financing activities (115) 9,639
Employees (number)
Employees as of the end of the period2) 111 126
Full-time equivalents as of the end of the period 2) 104 116
2 Including members of the Executive Management Board
Rounding of exact figures may result in differences.
The entire half-yearly Financial Report 2013 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
WILEX will hold a public conference call for media, analysts and investors
in English at 03:00 p.m. CEST on 11 July 2013. 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 who will ask for the password (WILEX)
and take your name and company. The presentation for the conference will be
available for download from www.wilex.com from 02:30 p.m. CEST.
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
WILEXAG 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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