WILEX publishes 3-months financial report 2013

ENGLISH DEUTSCH

• Subgroup analysis of the ARISER trial shows significant improvement in disease-free survival with RENCAREX®
• WILEX Inc. enters into several partnerships
• First quarter in line with guidance

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Munich, Germany, 11 April 2013. WILEX AG (ISIN DE0006614720 / WL6 / FWB) published its financial report for the first three months of the 2013 financial year (1 December 2012 – 28 February 2013) and reported on the status of the Group’s projects. 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: “We worked intensively on the scientific follow-up of the results of the ARISER trial and the partnership activities in the first quarter. Furthermore, WILEX AG hosted a joint Good Manufacturing Practice (GMP) inspection by the US Food and Drug Administration (FDA) and by the national authority (Government of Upper Bavaria) in Munich. The first quarter financials for 2013 were in line with our guidance.”

Activities and outlook of the operating segments
Therapeutics (Rx)

RENCAREX® (INN: Girentuximab): Over the last few months we analysed intensively and meticulously the biomarker and subgroup data of the ARISER trial in the adjuvant therapy of clear cell renal cell carcinoma. In February 2013, WILEX announced that the results of the retrospective subgroup analysis showed that RENCAREX® has a therapeutic effect in the subgroup of patients with a high CAIX score. Disease-free survival in this group showed a clinically and statistically significant improvement compared to both placebo and patients with a low CAIX score.

The detailed results will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO), which will take place from 31 May to 4 June 2013 in Chicago, USA. All work concerning the ARISER trial is scheduled to be duly completed in accordance with “Good Clinical Practice” in the third quarter of 2013. Besides, the further steps to be taken regarding RENCAREX® will be evaluated.

MESUPRON® (INN: Upamostat): The partnering process for the uPA inhibitor was initiated in the fourth quarter of 2012 based on the positive Phase II data (proof-of-concept) in the pancreatic cancer (2010) and breast cancer (2012) indications. The goal is to sign a licence agreement with a partner for MESUPRON® and decide the further development strategy together with the future partner. The Company’s aim is to finalise a partnership agreement in the 2013 financial year.

WX-554: A Phase Ib/II trial with the small molecule MEK inhibitor 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 agent WX-037 is under development supported by the “m4 Personalised Medicine and Targeted Therapies initiative” of the Munich-based m4 Biotech Cluster and receives grants of up to EUR 2.6 million from the Federal Ministry of Education and Research (BMBF). WX-037 has been tested in preclinical models and is scheduled to commence clinical development in the second quarter of 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.

Diagnostics (Dx)

REDECTANE® (INN: 124I-Girentuximab): The radiolabelled form of the antibody Girentuximab has been developed as an imaging agent for the diagnosis of clear cell renal cell carcinoma. Data of a Phase III trial showed that REDECTANE® 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). The trial design will determine the scope, duration and hence the costs of the trial. WILEX AG will not start the trial until it has secured the financing for the entire study.

In vitro diagnostic tests: The US subsidiary WILEX Inc. produces and markets ELISA and imunohistochemical 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. has developed a range of contract manufacturing services for third parties.

In the first quarter of the 2013 financial year, WILEX Inc. focused on forging partnerships to step up its marketing of the tests and extend their scope of application. An exclusive distributor agreement was entered into with Immundiagnostik AG, Bensheim, for the commercialisation of the serum HER2/neu and CAIX ELISA tests in Germany, Austria and Switzerland. Another exclusive partnership was arranged with GeneDiagnostics Inc., Hangzhou, China, for the approval and marketing of the serum HER2/neu ELISA test in China. A non-exclusive marketing and distribution agreement was signed with Immuno-Biological Laboratories Inc., Minneapolis, MN, USA, (IBL-America) for the commercialisation of the complete diagnostics portfolio in the USA. After the end of the reporting period a collaboration with Nuclea Biotechnologies Inc., Pittsfield, MA, USA, (Nuclea) was announced, which will use the HER2/neu ELISA assay in conjunction with other clinical tests at its state-of-the-art CLIA laboratory to quantify the blood serum HER2/neu level.

WILEX Inc. plans to significantly step up its marketing of the biomarker tests in the coming months. In addition to the partnership agreements that have already been signed, the US subsidiary aims to enter into new ones and expand the range of applications for the ELISA tests. The goal is to become profitable in the medium term.

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 aims to enter into customer specific collaborative partnerships with research institutes as well as pharmaceutical and biotech companies and performs contract work for customers related to designing, optimising, profiling and manufacturing new ADCs.

In 2012 several contracts were signed with pharmaceutical and biotechnology companies concerning the testing of the applicability of ADC technology for specific and proprietary antibodies of these contract partners. These collaborations are intended to tap into short-term and long-term future potential for generating sales revenue and creating added value through licence agreements. Thanks to the rising number of orders, Heidelberg Pharma expects increasing sales revenue in the financial year. However, expenses are likely to be higher than income because the business activities related to the ADC technology are still in an early stage.

Key financial figures for the first three months of 2013

In the first three months of the 2013 financial year, the WILEX Group generated income of EUR 3.9 million (previous year: EUR 3.9 million). This includes sales revenue of EUR 3.3 million (previous year: EUR 3.7 million) and other income of EUR 0.6 million EUR (previous year: EUR 0.2 million). Most of this is attributable to sales revenue from the license agreement concluded with Prometheus for RENCAREX®; 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 5.8 million in the reporting period, down from the previous year (EUR 6.3 million). The cost of sales concerns costs directly related to sale revenue and amounted to EUR 1.3 million in the reporting period, down on the prior-year figure of EUR 1.5 million. Research and development costs, which were EUR 3.3 million the previous year, fell to EUR 2.8 million. In the previous year, this included costs for the breast cancer trial with MESUPRON® concluded in the second quarter of 2012. Administrative costs were EUR 1.0 million in the first three months (previous year: EUR 1.0 million). Other expenses comprise the costs for activities in the areas of business development, marketing and commercial market supply. These amounted to EUR 0.7 million in the reporting period (previous year: EUR 0.5 million).

The WILEX Group reported a financial result of – EUR 31 k (previous year: – EUR 178 k) and a loss for the period of EUR 2.0 million. This represents an improvement of 23% on the loss in the same period of the previous year (- EUR 2.6 million) and is mainly attributable to lower costs. Earnings per share improved to – EUR 0.06 (previous year: – EUR 0.11), an increase of 43% also due to the higher number of shares in circulation compared with the same period of the previous year.

The Therapeutics segment (Rx) posted sales revenue of EUR 3.0 million and a net loss of EUR 0.6 million in the first three months of the financial year. The Diagnostics segment (Dx) generated sales revenue of EUR 43 k and a net loss for the period of EUR 1.1 million. Development costs for the imaging diagnostic candidate REDECTANE® are allocated to the Diagnostics segment. Customer Specific Research (Cx) generated sales revenue of EUR 0.3 million and a net loss for the period of EUR 0.7 million.

Total assets as of 28 February 2013 amounted to EUR 32.5 million (30 November 2012: EUR 37.7 million). The WILEX Group had cash and cash equivalents of EUR 17.7 million as of 28 February 2013 (30 November 2012: EUR 23.4 million). Equity as of the end of the reporting period was EUR 18.0 million (30 November 2012: EUR 19.9 million). The equity ratio was 55.2% (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

3M 2013 1)
EUR‘000

3M 2012 1)
EUR‘000

Earnings
Sales revenue

3,323

3,711

Other income

565

230

Operating expenses

(5,834)

(6,317)

of which research and development costs

(2,796)

(3,346)

Operating result

(1,947)

(2,376)

Earnings before tax

(1,978)

(2,554)

Net loss for the period

(1,978)

(2,555)

Earnings per share in EUR

(0.06)

(0.11)

 

 

 

Balance sheet as of end of period

 

 

Total assets

32,532

26,326

Cash and cash equivalents

17,675

7,883

Equity

17,968

2,867

Equity ratio in %

55.2

10.9

 

 

 

Cash flow

 

 

from operating activities

(5,692)

(5,180)

from investing activities

(10)

(37)

from financing activities

(70)

9,684

 

 

 

Employees (number)

 

 

Employees as of the end of the period2)

125

126

Full-time equivalents as of the end of the period 2)

116

117

 

1 The reporting period begins on 1 December and ends on 28/29 February.
2 Including members of the Executive Management Board
Rounding of exact figures may result in differences.

The entire 3-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 10:00 a.m. CEST  on 11 April 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 09:30 a.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
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® in Phase III) and small molecules (MESUPRON® two Phase IIa trials completed, WX-554 in Phase Ib/II and WX-037 in preclinical development). In the field of diagnostics, REDECTANE® 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. 

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