DGAP-News: WILEX AG publishes 9-month Financial Report 2013
DGAP-News: WILEX AG / Key word(s): Quarter Results
WILEX AG publishes 9-month Financial Report 2013
10.10.2013 / 07:06
WILEX publishes 9-month Financial Report 2013
- UCB acquires rights to an antibody programme for non-oncology
- Cooperation and licence agreement for ADC signed with Roche
- Nuclea acquires WILEX Inc. and will develop CAIX companion diagnostic
- Improved financial guidance for 2013
Munich, Germany, 10 October 2013. WILEX AG (ISIN DE0006614720 / WL6 / FSE)
today published its financial figures for the first nine months of the 2013
financial year and reported on the progress of its projects.
Dr Jan Schmidt-Brand, Chief Financial Officer of WILEX AG, commented:
'Having made good progress in the third quarter in implementing our
business strategy comprising the three elements partnerships, financing and
cost management, we have raised our earnings forecast for the year as a
whole, thus extending our cash reach into the third quarter of 2014.'
Activities and outlook of the operating segments
RENCAREX(R) (INN: Girentuximab): All work concerning the Phase III ARISER
trial was duly completed as planned in accordance with 'Good Clinical
Practice' in the third quarter of 2013. The antibody was tested in the
double-blind, placebo-controlled Phase III ARISER trial for adjuvant
therapy of clear cell renal cell carcinoma (ccRCC). While the final
analysis performed in October 2012 showed no improvement in median
disease-free survival following treatment with RENCAREX(R) compared to
placebo, positive subgroup data were presented at the Annual Meeting of the
American Society of Clinical Oncology (ASCO) in Chicago in June 2013.
The retrospective subgroup analysis showed that RENCAREX(R) could deliver a
well-tolerated and effective therapy for ccRCC patients with a high CAIX
antigen score. WILEX has held initial talks with regulatory authorities
(the FDA and European agencies) and reached agreement on plans for a
confirmatory prospective Phase III trial with RENCAREX(R) in the defined
subgroup using the biomarker CAIX for stratification.
WILEX is in discussions with Prometheus about the termination of the
existing licence agreement for the US commercial rights to RENCAREX(R).
MESUPRON(R) (INN: Upamostat): Based on the positive Phase II data
(proof-of-concept) in the pancreatic cancer (2010) and breast cancer (2012)
indications, the partnering process for this uPA inhibitor was advanced
WILEX aims to sign a licensing deal with a partner for the further
development of MESUPRON(R).
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 serves to confirm the biologically effective dose
by way of a dose escalation. The second part, which began in August 2013,
is designed to obtain initial data on clinical activity and on
pharmacodynamics in tumour tissue.
The plan is to complete patient recruitment by the end of 2013 and to
present data in the second half of 2014.
WX-037: Clinical development of the PI3K inhibitor WX-037 began in the
third quarter, and the first patient has been included in the study. The
open-label, dose-escalation study is being conducted in patients with solid
tumours in three study centres in the UK. The purpose of the trial is to
investigate the safety, pharmacokinetics, pharmacodynamics and clinical
activity of the PI3K inhibitor.
The MEK and PI3K programmes, as well as three antibody programmes, were
acquired from UCB for further development as part of a strategic alliance.
WILEX identified a lead candidate for one of the antibody programmes and
generated preclinical data, which prompted UCB in July 2013 to acquire the
rights outside oncology to develop the antibody further in non-oncology
indications. However, WILEX keeps the rights to the antibody's further
development in oncology and will be reimbursed for the development costs
incurred to date. WILEX is also eligible for development, regulatory and
commercial milestone payments as well as royalties.
REDECTANE(R) (INN: Iodine (124I) Girentuximab): The radiolabelled form of
the antibody Girentuximab is being developed as an imaging diagnostic agent
for the detection clear cell renal cell carcinomas. A Phase III trial
already showed that REDECTANE(R) with PET/CT is clearly superior to CT
alone in diagnosing clear cell renal cell carcinomas.
In the third quarter, WILEX received written notification from the FDA
confirming agreement on the development strategy and study design for the
confirmatory Phase III diagnostic performance clinical trial with
REDECTANE(R) (REDECT 2).
In parallel to the finalisation of the study protocol as part of a Special
Protocol Assessment (SPA), financing options are being investigated to
enable the implementation of the trial.
In vitro diagnostic tests: The subsidiary WILEX Inc. was acquired by the US
company Nuclea Biotechnologies Inc., at the beginning of September. Under
the terms of the deal, Nuclea will also assume responsibility for repayment
of USD 2.5 million which is a part of an intercompany loan from WILEX AG to
WILEX Inc. In addition, WILEX AG is eligible for single-digit royalties on
net sales of the HER2/neu and CAIX assays.
Concurrently, and as an essential part of the overall deal, WILEX AG and
Nuclea entered into a development agreement under which Nuclea will develop
an automated CAIX IVD IHC assay ('CAIX Dx') to be submitted for FDA
approval under the investigational device exemption ('IDE'). This CAIX Dx
is intended to be used for patient stratification in a planned pivotal
study with RENCAREX(R) and as a potential future companion diagnostic in
the adjuvant treatment of clear cell renal cell carcinoma. Nuclea will bear
the costs for the development of this CAIX Dx as a contribution in kind
which will lead to savings of at least USD 2.5 million for WILEX AG.
Customer Specific Research (Cx)
The subsidiary Heidelberg Pharma GmbH offers customer specific preclinical
contract research related to cancers and inflammatory and autoimmune
diseases and possesses a technology platform for therapeutic antibody drug
conjugates (ADCs). This ADC technology has the potential to enhance and
improve the efficacy of many antibody-based therapies, including those on
Heidelberg Pharma GmbH signed a licence agreement with Roche at the
beginning of September. One component of this agreement is the joint
development of a novel class of antibody drug conjugates on the basis of
Heidelberg Pharma's patented technology to couple α-Amanitin to antibodies
(Antibody Targeted Amanitin Conjugates, ATACs). Heidelberg Pharma will
receive regular payments for granting access to its technology and
providing research services and at a later time will be eligible for
customary upfront payments, milestone payments and royalties as a
percentage of net sales for each development candidate selected by Roche.
A project (CapStem(R)) has also been developed in recent months to refine
this innovative ADC technology as an independent business model. This opens
the opportunity not only to license the toxin linker technology but also to
develop complete ADC molecules with in-licensed antibodies. This will
enable the Company to exploit the attractive market potential and to use
project finance to support development.
Financial results for the first nine months of 2013
In the first nine months of the 2013 financial year, the WILEX Group
generated income of EUR 11.4 million (previous year: EUR 12.8 million).
This figure includes sales revenue of EUR 10.1 million (previous year: EUR
11.3 million) and other income of EUR 1.3 million (previous year: EUR 1.5
million). Most of the sales revenue is attributable to the license
agreement concluded with Prometheus for RENCAREX(R), whereby 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
15.3 million in the reporting period, down substantially from the previous
year (EUR 19.8 million). Cost of sales fell to EUR 3.7 million (previous
year: EUR 4.9 million) due to lower expenses for RENCAREX(R) in the Rx
segment. Research and development costs, which were EUR 9.7 million the
previous year, fell to EUR 7.4 million and administrative costs were
trimmed from EUR 3.4 million to EUR 2.8 million due to the cost-cutting
following the restructuring programme. Other expenses, comprising the costs
for activities in the areas of business development, marketing and
commercial market supply, were EUR 1.4 million (previous year: EUR 1.8
The WILEX Group reported an improved financial result of EUR -62 k
EUR -451 k). The net loss for the period was EUR 4.0 million, which
represents an improvement of 47% on the loss in the same period of the
previous year (EUR 7.4 million) and is solely attributable to lower costs.
Earnings per share improved by 59% to EUR -0.13 (previous year: EUR -0.31),
which is also due to the higher number of shares in circulation compared
with the first nine months of 2012.
The three segments of the WILEX Group achieved the following results in the
reporting period: Therapeutics (Rx) posted sales revenue of EUR 8.8 million
and a profit for the period of EUR 0.5 million. The Diagnostics (Dx)
segment recorded sales revenue of EUR 0.2 million and a net loss of EUR 3.1
million. Customer Specific Research generated sales revenue of EUR 1.1
million and a net loss for the period of EUR 2.2 million.
In the interests of continuous reporting, the Dx segment, to which WILEX
Inc. was allocated during the reporting period, will be maintained as this
segment also reports activities relating to REDECTANE(R). In accordance
with IFRS 5, the assets and liabilities of WILEX Inc., which was sold after
the reporting date in early September 2013, are classified as a disposal
group and shown as a separate balance sheet item as of the reporting date.
These assets amounted to EUR 0.5 million and included current assets,
non-current assets and cash.
Total assets as of 31 August 2013 amounted to EUR 24.9 million (30 November
2012: EUR 37.7 million). The WILEX Group had cash and cash equivalents of
EUR 9.9 million (30 November 2012: EUR 23.4 million). Equity at the end of
the reporting period was EUR 16.0 million (30 November 2012: EUR 19.9
million) and the equity ratio was 64.4%.
As a result of the implementation of our strategy, the guidance for the
WILEX Group for the current financial year issued in February 2013 is
revised as follows:
Guidance 10/2013 Guidance 02/2013 Actual 2012
EUR million EUR million EUR million
Sales revenue and other income 14.0 - 17.0 15.0 - 19.0 17.8
Operating expenses 18.0 - 22.0 22.0 - 27.0 26.8
Operating result (2.0) - (6.0) (5.0) - (9.0) (8.9)
Total funding requirement 14.0 - 17.0 16.0 - 20.0 20.0
Funds required per month 1.2 - 1.4 1.3 - 1.7 1.7
Key figures for the WILEX Group
Key figures 9M 20131 9M 20121
Earnings EUR '000 EUR '000
Sales revenue 10,090 11,359
Other income 1,295 1,472
Operating expenses (15,278) (19,799)
of which research and development costs (7,355) (9,735)
Operating result (3,893) (6,968)
Earnings before tax (3,956) (7,418)
Net loss for the period (3,956) (7,420)
Earnings per share in EUR (0.13) (0.31)
Balance sheet as of end of period
Total assets 24,917 43,174
Cash and cash equivalents 9,876 28,677
Equity 16,043 21,449
Equity ratio2 in % 64.4 49.7
from operating activities (13,499) 111
from investing activities (111) (268)
from financing activities (160) 25,440
Employees as of the end of the period3 110 127
Employees as of the end of the period (full-time
equivalents)3 101 118
1 The reporting period begins on 1 December and ends on 31 August.
2 Equity/total assets
3 Including members of the Executive Management Board
Rounding of exact figures may result in differences.
The entire 9-month 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 10 October 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.
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the Company develops diagnostic and therapeutic product
candidates for the specific detection and targeted treatment of various
types of cancer based on antibodies and small molecules. The subsidiary
Heidelberg Pharma GmbH offers preclinical contract research services and an
antibody drug conjugate (ADC) technology platform. The business model
comprises research and product development as well as the commercialisation
of its activities. Our customers and partners include leading international
pharmaceutical companies. WILEX AG is listed at the Frankfurt Stock
Exchange. ISIN DE0006614720 / WKN 661472 / Symbol WL6. More information is
available at www.wilex.com.
WILEX AG MC Services AG
Corporate Communications Katja Arnold (CIRO)
Sylvia Wimmer Tel.: +49 (0)89-210 228-40
Tel.: +49 (0)89-41 31 38-29 Mobil: +49 (0)160-9360 3022
E-Mail: investors[at]wilex.com E-Mail: katja.arnold[at]mc-
Grillparzerstr. 10, 81675 Munich, 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.
End of Corporate News
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Company: WILEX AG
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
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