Corporate | 14 July 2010 07:38
WILEX AG / Half Year Results 14.07.2010 07:38 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer / publisher is solely responsible for the content of this announcement. --------------------------------------------------------------------------- WILEX reports on successful first half of 2010 - All milestones achieved for the first half year - Half-year figures in line with expectations Munich, 14 July 2010. WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) today published financial figures for the first half year 2010 (1 December 2009 - 31 May 2010) and the status of the R&D projects. Peter Llewellyn-Davies, CFO of WILEX AG, commented: 'In the past half year we have achieved all planned milestones and published positive, final data for three important clinical trials. We are very pleased with the progress of our product portfolio and have come closer to our goal of submitting a first product for approval.' Projects and milestones in the second quarter 2010 WILEX published final data of the Phase III trial with REDECTANE(R) for the diagnosis of renal masses in May 2010. The results of the study demonstrate that PET/CT with REDECTANE(R) is able to distinguish clear cell from non-clear cell renal cell carcinoma and is significantly superior to conventional CT alone. In the Phase III ARISER trial of RENCAREX(R) in patients with clear cell renal cell cancer, a total of 324 relapses had been reported to WILEX by the local trial centres as of the end of June. In June 2010, WILEX presented impressive final data of a Phase II study with the uPA-inhibitor MESUPRON(R) in 95 patients with locally advanced, inoperable, non-metastatic pancreatic cancer at ASCO (American Society of Clinical Oncology). In the combination trial with the chemotherapeutic agent Gemcitabine, MESUPRON(R) showed an improvement in the study end points tumour response rate, progression-free survival, one-year survival and median survival. Final results of the Phase I dose escalation study with the MEK-inhibitor WX-554 were also published in June 2010. The trial aimed to determine safety, tolerance and the optimal biological dose for inhibition of the MEK system by WX-554. The substance was found to be a potent inhibitor of MEK and was safe and well tolerated in healthy volunteers. Results of the first half year 2010 WILEX reported a net loss for the 6 month period (1 December 2009 - 31 May 2010) of EUR 11.56 million (previous year: EUR 10.44 million). Earnings per share were EUR -0.73 (previous year: EUR -0.81). No sales revenue were realised (H1 2009: EUR 0) in the first six months. At EUR 0.91 million, other income was 19.8% below the previous year's figure (EUR 1.14 million). Operating expenses, including depreciation, amortisation and impairment losses, amounted to EUR 12.48 million, up approximately 6.6% from the previous year (EUR 11.70 million). This figure includes research and development costs of EUR 10.20 million, which represents 81.7% of the operating expenses and an increase of 5.3% compared to the previous year (EUR 9.68 million). Whilst the costs for the RENCAREX(R) ARISER trial and the REDECT trial with REDECTANE(R) have declined as expected compared to last year, costs for the MESUPRON(R) breast cancer trial have risen as planned as a result of increasing patient recruitment. Further expenses arose from the Phase I trial of WX-554 as well as preclinical trials with WX-037 and the antibody research. Administrative costs were EUR 2.28 million (previous year: EUR 2.02 million). At the end of the first half year the Company had cash and cash equivalents of EUR 3.31 million (30 November 2009: EUR 3.41 million, 31 May 2009: EUR 10.55 million). Equity as of the end of the reporting period was EUR 0.14 million (30 November 2009: EUR 3.04 million). Outlook WILEX will continue to pursue commercialisation of its product candidates and the financing of the Company. The following clinical milestones are expected in the coming months: For REDECTANE(R), application for approval will be prepared for submission. The next milestone in the Phase III ARISER study with RENCAREX(R), the 343rd relapse, is expected in the second half of the year. As anticipated in the study protocol, an interim analysis for efficacy of the antibody will be carried out after that, which could be the basis for filing for approval in the European Union. Recruitment will be continued in the Phase II study with MESUPRON(R) in breast cancer patients. We anticipate receiving study data on the study endpoint (progression-free survival) in 2012. Invitation to the conference call On 14 July 2010, WILEX will hold a conference call for media representatives, 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: Germany +49 (0) 69 6677 75756 UK +44 (0) 2030032666 USA +1 212 999 6659 You will be welcomed by an operator taking your name and company. The presentations for the conference (in English) will be available for download on the website from 2:00 p.m. CET. A replay of the conference will be available on the website on 15 July http://www.wilex.de/IR/Presentations.php.Key figures H1 20101) H1 20091) Change Earnings EUR '000 EUR '000 in % Sales revenue 0 0 n/a Other income 912 1,138 (19.8) Operating expenses (12,477) (11,701) 6.6 of which research and development (10,195) (9,678) 5.3 Operating result (11,565) (10,563) 9.5 Earnings before tax (11,552) (10,430) 10.8 Net loss for the period (11,556) (10,437) 10.7 Earnings per share in euros (0.73) (0.81) (10.2) Balance sheet as of end of period Total assets 6,747 13,956 (51.7) Cash and cash equivalents 3,309 10,553 (68.6) Equity 142 5,284 (97.3) Equity ratio2) in % 2.1 37.9 (94.4) Cash flow from operating activities (8,398) (11,546) (27.3) from investing activities (4) (47) (91.8) from financing activities 8,283 9,844 (15.9) Employees Employees as of end of period3) 72 66 9.1 Employees - average for reporting period3) 72 65 10.31) The reporting period begins on 1 December and ends on 31 May 2) Equity / total assets 3) Including members of the Executive Management Board The Half-yearly Financial Report including the single-entity financial statements prepared in accordance with IFRS has been published on the Company's website: www.wilex.com. 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: A pivotal Phase III study with REDECTANE(R) has been completed and positive data published. RENCAREX(R) is undergoing a Phase III registration trial. Positive MESUPRON(R) Phase II data in the indication pancreatic cancer have been published and another Phase II trial in breast cancer is ongoing. The MEK inhibitor WX-554 has completed a Phase I trial. A further oncology project (PI3K inhibitor WX-037) is in preclinical development and three antibody programmes are in research. 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 WILEX AG Corporate Communications Katja Arnold (CIRO) 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 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. 14.07.2010 Ad hoc announcement, Financial News and Press Release distributed by DGAP. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: WILEX AG Grillparzerstr. 10 81675 München Deutschland Phone: +49 (0)89 41 31 38 - 0 Fax: +49 (0)89 41 31 38 - 99 E-mail: info@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 ---------------------------------------------------------------------------