Corporate | 13 October 2010 07:15
WILEX AG / Key word(s): Quarter Results 13.10.2010 07:15 --------------------------------------------------------------------------- WILEX publishes 9-month financial report 2010 - Mandatory offer from dievini Hopp BioTech closed - Rights issue successfully executed - GMP certification renewed - Financials in line with expectations Munich, Germany, 13 October 2010 - WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) today published financial figures for the first nine months 2010 (1 December 2009 - 31 August 2010) and the status of the R&D projects. Peter Llewellyn-Davies, CFO of WILEX AG, summarised the events of the third quarter: 'Following the successful and eventful clinical activities in the first half of the year the third quarter was marked mainly by a mandatory takeover offer and a capital increase. We were very pleased about the high over-subscription of the rights issue. This is an indication of our investors' confidence in our strategy and development and also of their commitment'. Projects and milestones in the third quarter 2010 dievini Hopp BioTech holding & Co. KG submitted a mandatory takeover offer for the Company's shares in July 2010 after passing the 30% share-holding threshold. The Executive Management Board and Supervisory Board recommended that shareholders reject the offer based on management's assessment that the offer price of EUR 4.10 per WILEX share failed to reflect the Company's true potential. A total of 22,953 shares (0.12% of the share capital) were transferred to dievini Hopp Biotech before the mandatory offer closed in August. The Company carried out a rights issue in August and offered 2,455,070 new shares at the subscription price of EUR 4.10 per share. The capital increase was successfully executed with a subscription ratio of approximately 72%, an allocation quota for over-subscription of about 21% and net proceeds of approx. EUR 10 million. Following an inspection by the German authorities (Central Drug Monitoring Office, Government of Upper Bavaria) WILEX was re-certified in September 2010 as being in compliance with the principles and guidelines of Good Manufacturing Practice (GMP). At the same time, the manufacturing and import authorisation pursuant to section 13 and section 72 Arzneimittelgesetz (German Drug Act - AMG) for the production, testing and release of investigational medicinal products for clinical trials and drugs was updated. The GMP certificate is an important prerequisite for marketing all of WILEX's product candidates. Based on the Phase III data for the product candidate REDECTANE(R) for the diagnosis of kidney tumours WILEX is currently preparing an application for approval (Biological License Application, BLA) in the United States. In the RENCAREX(R) Phase III ARISER trial in clear cell renal cell carcinoma the next milestone, the occurrence of the 343rd relapse, which constitutes the basis for the interim analysis for efficacy, is moving closer. As of the end of September 2010, a total of 335 relapses were reported to WILEX by the local trial centres. Patient recruitment in the Phase II trial with the uPA inhibitor MESUPRON(R) in patients with metastatic HER2 receptor negative breast cancer has made good progress. Of the planned 114 patients a total of 103 patients had been recruited in 21 trial centres in Europe, the USA and Brazil by the end of September 2010. Results of the first nine months 2010 WILEX posted earnings before taxes of EUR -17.22 million (previous year: EUR -11.05 million) in the first nine months of the 2010 financial year (1 December 2009 to 31 August 2010). At EUR 17.22 million, the net loss for the period was 55.7% above the previous year's figure (EUR 11.06 million). Earnings per share decreased to EUR -1.06 (previous year: EUR -0.84). WILEX did not recognise any sales revenue in the first nine months of 2010 (previous year: EUR 5.00 million). At EUR 1.24 million, other income fell 35.4% compared to the previous year (EUR 1.92 million) and consists of income realised from the US Department of Defense grants as well from the licence agreements with Esteve and IBA. Operating expenses including depreciation, amortisation and impairment losses amounted to EUR 18.48 million, up almost 2.0% from the previous year (EUR 18.12 million). Research and development costs were EUR 15.09 million (previous year: EUR 15.16 million), corresponding to 81.7% of operating expenses. Administrative costs were EUR 3.38 million, up 14.5% from the previous year (EUR 2.96 million). The increase is due to the revaluation of the stock options in the first quarter and higher consultancy costs. At the end of the third quarter of 2010, the Company had cash and cash equivalents of EUR 7.76 million (30 November 2009: EUR 3.41 million; 31 August 2009: EUR 8.93 million). Equity as of the end of the reporting period was EUR 4.53 million (30 November 2009: EUR 3.04 million). The equity ratio was 41.2% as of 31 August 2010 (30 November 2009: 25.3%; 31 August 2009: 38.0%). Outlook We are currently in talks with the FDA with respect to our diagnostic candidate REDECTANE(R), and the BLA is being prepared. At the same time, we are carrying out pre-marketing activities in the United States jointly with our marketing partner, IBA. WILEX expects the 343rd relapse in the RENCAREX(R) Phase III ARISER trial - i.e. the next milestone according to the study protocol - to occur by the end of the year. Once the 343rd relapse has occurred, all available data from the 864 patients will be collected and the independent centralised evaluations of all patients' radiological scans performed. Subsequently, an independent interim analysis of efficacy of RENCAREX(R) will be initiated and conducted by the Independent Data Monitoring Committee (IDMC). This analysis will provide critical information regarding the trial endpoint - disease-free survival - which could form the basis for the European application for marketing approval. Patient recruitment in the MESUPRON(R) Phase II trial in the breast cancer indication is likely to be completed by the first quarter of 2011. WILEX expects the data from this study to be available in 2012, given the trial endpoint - progression-free survival. The activities related to the commercialisation of our product candidates, as well as the Company's funding in the medium and long term, will be at the forefront of the management's activities in the coming months.Key figures 9M 20101) 9M 20091) Change Earnings in EUR'000 in EUR'000 in % Sales revenue 0 5,000 n/a Other income 1,244 1,925 (35.4) Other expenses (18,479) (18,118) 2.0 of which research and development (15,095) (15,162) (0.4) Operating result (17,235) (11,193) 54.0 Earnings before tax (17,217) (11,049) 55.8 Net loss of the period (17,222) (11,059) 55.7 Earnings per share in EUR (1.06) (0.84) 27.1 Balance sheet as of end of period Total assets 10,994 12,328 (10.8) Cash and cash equivalents 7,762 8,931 (13.1) Equity 4,530 4,690 (3.4) Equity ratio 2) in % 41.2% 38.0% 8.3 Cash flow from operating activities (13,952) (13,178) 5.9 from investing activities (11) (61) (82.6) from financing activities 18,296 9,844 85.8 Employees Employees as of the end of period 3) 72 67 7.5 Employees - annual average 3) 72 68 5.91) The reporting period begins on 1 December and ends on 31 August. 2) Equity / total assets 3) Including members of the Executive Management Board The 9-months Financial Report including the single-entity financial statements prepared in accordance with IFRS has been published on the Company's website: www.wilex.com. Invitation to the conference call WILEX will hold a conference call for media representatives, analysts and investors in English on 13 October 2010 at 3:00 p.m. CET. Please dial in ten minutes before the conference call using the following dial-in numbers: 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 at the website from 2:00 p.m. CET. A replay of the conference will be available on 14 October on the website http://www.wilex.de/IR/Presentations.php. 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: For REDECTANE(R) WILEX is currently preparing an application for approval in the United States. 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 Katja Arnold (CIRO) Corporate Communications WILEX AG Grillparzerstr. 10 81675 München, Germany Phone: +49 (0)89-41 31 38-126 Fax: +49 (0)89-41 31 38-99 Email: 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. 13.10.2010 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. 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 München, Berlin, Düsseldorf, Stuttgart End of Announcement DGAP News-Service ---------------------------------------------------------------------------