WILEX publishes financial report for the first quarter of 2012
• Rights issue successfully concluded
• Process for final analysis of RENCAREX® started
• Revenue and earnings improved
Munich, Germany, 12 April 2012. WILEX AG (ISIN DE0006614720 / WL6 / FWB) today published its 3-month financial report for 2012 (1 December 2011 – 29 February 2012) and reported on the status of the Group’s projects.
Peter Llewellyn-Davies, Chief Financial Officer of WILEX AG, commented: “We are pleased with our performance in the first quarter of 2012. The successful rights issue generated gross proceeds of € 9.9 million for the further funding of our studies, and we reported on several milestones and activities. Our earnings improved significantly year on year.”
Activities and outlook of the operating segments
RENCAREX® (INN: Girentuximab): In the Phase III ARISER registration trial for the adjuvant therapy of non-metastatic clear cell renal cell carcinoma, the process for the final analysis was started. This decision was made following the recommendation of the Independent Data Monitoring Committee (IDMC) to dispense with the interim analysis and, instead, move directly to conducting the final analysis for the endpoint disease-free survival (DFS). The US Food and Drug Administration (FDA) and European regulatory authorities approved the necessary modification of the study protocol in the first quarter.
The DFS results are expected in the fourth quarter of 2012, although the trial will be continued until the analysis of the overall survival rate. The approval application could be submitted in Europe and the US during the first half of 2013.
Under the terms of the licence agreement with Prometheus Laboratories Inc., WILEX has the option either to be paid USD 15 million six months or USD 20 million twelve months after contract signing, or to be granted the commercial rights to an undisclosed product from Prometheus in Europe.
MESUPRON® (INN: Upamostat): The oral uPA inhibitor is currently being tested in a Phase II trial in patients with metastatic HER2 receptor negative breast cancer. A total of 132 patients were included in this randomised double-blind trial that is designed to examine the efficacy of MESUPRON® in combination with the chemotherapeutic agent Capecitabine compared to Capecitabine alone.
WILEX anticipates that data from this trial on its primary endpoint progression-free survival will be available in 2012. Data on overall survival are expected to be available in 2013.
WX-554: WILEX received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in the first quarter of 2012 to conduct a Phase Ib/II dose escalation trial of the MEK inhibitor MK-554 with cancer patients. The first dose in man was administered in April 2012. This open-label trial will investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of WX-554 in patients with solid tumours.
REDECTANE® (INN: 124I-Girentuximab): A Phase III trial for the imaging diagnostic candidate REDECTANE® was completed and the final data were published in 2010. In the trial, 226 patients were examined with REDECTANE® PET/CT (positron emission tomography / computer tomography) as well as with state-of-the-art CT prior to kidney surgery. The trial showed that REDECTANE® with PET/CT is clearly superior to CT alone in diagnosing clear cell renal cell carcinomas. WILEX expects the FDA’s decision on convening an Advisory Committee, which is to deliberate on the next steps in regulatory development and strategy.
In vitro diagnostic tests: The CA IX IHC assay for the identification of the CA IX antigen in tissue or cell samples was registered in December 2011 as a “Class I 510(k)-exempt medical device”. WILEX Inc. reports an increase in sales revenue for the first quarter of 2012.
Customer Specific Research (Cx)
Heidelberg Pharma GmbH has entered into several research agreements for its customer specific ADC technology and reported increasing sales revenue in the reporting period, particularly for its preclinical service business.
Further events during the reporting period
WILEX AG carried out a rights issue in the first quarter of 2012. The shareholders exercised their subscription and oversubscription rights for all 3,201,928 new no par value bearer shares at a price of € 3.10 per share by the end of the subscription period on 30 January 2012. Following the entry of the capital measure in the Commercial Register on 3 February 2012, the total number of WILEX shares issued increased to 24,814,963.
Key financial figures for the first three months of 2012
Heidelberg Pharma AG has been consolidated since 17 March 2011 (after the Q1 2011 reporting period) and was not included in the previous year’s report. Comparability of the Group’s figures with prior-year figures is therefore limited.
In the first three months of 2012, the WILEX Group generated sales revenue of EUR 3.7 million, compared with EUR 71k in the previous year. This significant increase is mainly due to sales revenue of EUR 2.9 million in the Rx segment from the ongoing pro rata accrual of payments for RENCAREX®. At EUR 0.2 million, other income was lower year on year (EUR 0.3 million), mainly due to gains from exchange rate differences.
Operating expenses (including depreciation and amortisation) were EUR 6.3 million and despite the expanded consolidated group slightly higher than the previous year (EUR 6.2 million), when Heidelberg Pharma was not yet part of the WILEX Group. At EUR 1.5 million, cost of sales were higher than the previous year (EUR 0.3 million), when only the expenses of WILEX Inc. were included. Research and development costs fell to EUR 3.3 million in the reporting period (previous year: EUR 4.6 million) and accounted for 53 % of total costs (previous year: 75 %). The decline stems from both the partial reclassification to cost of sales and the progress of the trials, especially RENCAREX® and MESUPRON®.
WILEX reported a net loss for the period of EUR 2.6 million, which corresponds to an improvement in earnings by 57 % on the previous year (loss of EUR 6.0 million). Earnings per share improved by 66 % to -EUR 0.11 (previous year: -EUR 0.32).
The Therapeutics segment generated sales revenue of EUR 2.9 million and reported a net loss of EUR 1.3 million in the first three months. The Diagnostics segment posted sales revenue of EUR 0.1 million and a net loss of EUR 0.8 million. Customer Specific Research reported sales revenue of EUR 0.7 million and a net loss of EUR 0.5 million.
Total assets as of the end of the reporting period amounted to EUR 26.3 million (30 November 2011: EUR 20.8 million). This increase resulted mainly from the rights issue.
Non-current assets of EUR 12.7 million were at the level reported at the end of the financial year (EUR 12.8 million). Current assets rose to EUR 13.6 million (30 November 2011: EUR 8.0 million). They comprise EUR 7.9 million in cash and cash equivalents (30 November 2011: EUR 3.4 million) and EUR 5.7 million in other current assets (30 November 2011: EUR 4.6 million).
Equity at the end of the reporting period was EUR 2.9 million (30 November 2011: – EUR 4.5 million). Non-current liabilities as of 29 February 2012 decreased to EUR 3.8 million (30 November 2011: EUR 5.1 million). Current liabilities were EUR 19.7 million (30 November 2011: EUR 20.2 million).
|Earnings before tax||
|Net loss for the period||
|Earnings per share in EUR
|Balance sheet as of the end of the period|
|Cash and cash equivalents||7,883||4,624|
|Equity ratio in %||10.9||(87.2)|
|Cash flow statement|
|Cash flow from operating activities||(5,180)||(7,291)|
|Cash flow from investing activities||(37)||(10)|
|Cash flow from financing activities||9,684||9,986|
|Employees as of the end of the period3)||126||74|
|Employees as of the end of the period (full-time equivalents)3)||116,76||70,23|
1 The reporting period begins on 1 December and ends on 29/28 February.
2 Heidelberg Pharma is not included in the comparative figures for Q1/2011.
3 Including members of the Executive Management Board.
Rounding of exact figures may result in differences.
The 3-month financial report 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:
On 12 April 2012, WILEX will hold a public conference call for media, 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:
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 taking your name and company. The presentation for the conference will be available for download from www.wilex.com at 2:00 p.m. CET.
Katja Arnold (CIRO)
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
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® in Phase II, WX-554 in Phase Ib/II and WX-037 in preclinical development). In the field of diagnostics, REDECTANE® is an antibody-based, imaging in vivo 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, which are used as companion diagnostics for clinical trials and therapy monitoring. The wholly owned 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.