Earnings Release • Feb 28, 2012
Earnings Release
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Corporate | 28 February 2012 07:01
WILEX AG reports on a successful financial year 2011
WILEX AG / Key word(s): Final Results
28.02.2012 / 07:01
PRESS RELEASE
WILEX reports on a successful financial year 2011
– Outperformed financial guidance
– Sales revenue and other income increased significantly
– Operating result improved and funding requirements reduced
– Development and marketing of product candidates further advanced
Munich, 28 February 2012. WILEX AG (ISIN DE0006614720 / WL6 / FSE) today published its financial results and annual report for the 2011 financial year (1 December 2010 – 30 November 2011). Due to the acquisition of two subsidiaries – Heidelberg Pharma GmbH and WILEX Inc. – WILEX now reports on three operating segments: Therapeutics, Diagnostics und Customer Specific Research.
Peter Llewellyn-Davies, Chief Financial Officer of WILEX AG, commented: 'We integrated two acquisitions into the WILEX Group in 2011, creating a broader structure for our company. For RENCAREX (R) , we signed an important out-licensing agreement with Prometheus and will conduct the final analysis of the Phase III ARISER trial following the recommendation of the IDMC earlier than originally planned. We expect decisive data for MESUPRON (R) and RENCAREX (R) in 2012. Our guidance 2011 was bettered and our current financial forecast reflects the positive outlook.'
Activities in the operating segments in 2011 and outlook for 2012
Therapeutics (Rx)
RENCAREX (R) : In the Phase III ARISER registration trial in the adjuvant therapy of clear cell renal cell carcinoma the IDMC recommended cancelling the interim analysis and performing the final analysis for the endpoint 'disease-free survival' (DFS) instead. The study protocol was amended accordingly and submitted to the relevant authorities for approval.
The US Food and Drug Administration (FDA) has approved the amended study protocol. Final DFS analysis and results are expected in Q4 2012; the study will continue as planned in order to assess overall survival. If the data are positive, WILEX could file for approval in Europe and in the United States in the first half of 2013.
WILEX was granted Fast Track designation for RENCAREX (R) by the FDA in October 2011.
In late April 2011, WILEX signed a licence agreement with Prometheus for the US commercial rights for RENCAREX (R) . Under the terms of the agreement WILEX received USD 19.0 million upon signing and furthermore has the option either to be paid an additional USD 15.0 million six months or USD 20.0 million twelve months after contract signing, or to be granted the commercial rights to a product in Europe. In addition, WILEX is entitled to receive milestone payments, cost reimbursements for the ongoing development and royalties on net sales of RENCAREX (R) in the USA.
WILEX will make a decision regarding its options under the licence agreement with Prometheus in the second quarter of 2012.
MESUPRON (R) : 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 recruited for this randomised double-blind trial that is designed to examine the efficacy of MESUPRON (R) in combination with the chemotherapeutic agent Capecitabine compared to Capecitabine alone. Patient recruitment was completed in May 2011.
WILEX expects data from this trial on its endpoint 'progression-free survival' in 2012. Data on overall survival are expected in 2013.
WX-554: In September 2011, WILEX started a Phase I trial with the orally administered agent WX-554 in healthy volunteers. This trial was completed in January 2012.
A Phase Ib/II trial with cancer patients is scheduled to start in the first quarter of 2012.
Diagnostics (Dx)
REDECTANE (R) : In the fourth quarter of 2011, a Type C meeting took place at the FDA, in which the further development of REDECTANE (R) , the radiolabelled antibody for diagnosing clear cell renal cell carcinomas, was outlined. This includes the scheduling of a second trial and the options to conduct an 'outcomes-based study' or a 'confirmatory' study of the candidate's diagnostic performance similar to the Phase-III REDECT trial that was completed in 2010. The FDA suggested discussing the regulatory pathway with an FDA Advisory Committee.
In vitro diagnostic tests: In August 2011, the WILEX Inc. production facility in Cambridge, MA, USA, obtained ISO certification. WILEX Inc. entered into an exclusive co-marketing and distribution agreement with ALPCO Diagnostics for the commercialisation of the Serum HER2/neu ELISA test in North America (USA and Canada) in October 2011. The CA IX IHC assay for the identification of the CA IX antigen in tissue or cell samples was registered in the fourth quarter of 2011 as a 'Class I 510(k)-exempt medical device'.
Customer Specific Research (Cx)
WILEX successfully completed the integration of the wholly-owned subsidiary Heidelberg Pharma into the Group during the financial year. The preclinical service business reported significantly increased sales revenue. Several material transfer agreements have been concluded for the ADC technology.
Key financial figures for financial year 2011
Income of the WILEX Group increased significantly to EUR 11.7 million in the 2011 financial year compared to EUR 1.3 million in 2010. WILEX posted sales revenue of EUR 9.9 million (previous year: EUR 0), mainly due to the licence agreement with Prometheus for the US marketing rights to RENCAREX (R) . At EUR 1.8 million, other income rose 38.5 % compared to the previous year (EUR 1.3 million). Heidelberg Pharma was not included in the previous year's accounts and has been consolidated since 17 March 2011.
Operating expenses including depreciation and amortisation rose to EUR 25.1 million in 2011 (previous year: EUR 24.4 million). Manufacturing costs are being shown for the first time owing to the consolidation of the two subsidiaries and the cost reimbursements for development services. Manufacturing costs were EUR 4.2 million, i. e. 16.7 % of total costs. Administrative costs including business development costs were EUR 5.3 million.
In the 2011 financial year, WILEX substantially reduced its net loss to EUR 13.9 million (previous year: EUR 23.1 million). Earnings per share improved from EUR -1.38 in the previous year to EUR -0.67.
The key items in the income statement for the three operating segments are as follows:
| Segment results in EUR million | Therapeutics (Rx) | Diagnostics (Dx) | Customer specific research (Cx) |
| Sales revenue | 8.4 | 0.3 | 1.6 |
| Other income | 0.8 | 0 | 0.5 |
| Operating expenses | (16.5) | (5.9) | (2.9) |
| Net loss for the year | (7.4) | (5.8) | (0.8) |
Total assets as of the close of the financial year were EUR 20.8 million and thus higher than the previous year's level of EUR 5.6 million. This is mainly due to the substantial year-on-year changes in all relevant balance sheet items arising from the acquisition of Heidelberg Pharma and the shareholder loans. Non-current assets rose to EUR12.8 million as of 30 November 2011 (previous year: EUR 2.2 million). Current assets rose to EUR 8.0 million (previous year: EUR 3.4 million). WILEX had cash and cash equivalents of EUR 3.4 million (30 November 2010: EUR 1.9 million) at the close of the financial year just ended.
Equity as of 30 November 2011 was EUR -4.5 million (previous year: EUR
-1.3 million). The subscribed capital rose to EUR 21.6 million as of 30 November 2011 as a result of the non-cash capital increase in connection with the acquisition of Heidelberg Pharma (30 November 2010: EUR 18.4 million).
A rights issue generating gross proceeds of approx. EUR 9.9 million was completed in February 2012 to fund the business activities and strengthen the equity base of WILEX.
Financial outlook of the WILEX Group for 2012
WILEX expects increasing revenue in the 2012 financial year. Sales revenue and other income are projected to be between EUR 14.0 million and EUR 16.0 million (2011: EUR 11.7 million). Operating expenses will be in the range of EUR 25.0 million to EUR 29.0 million (2011: EUR 25.1 million). Research and development costs, which are part of operating expenses, are projected to be between EUR 15.0 million and EUR 17.0 million (2011: EUR 15.6 million). EBIT in the 2012 financial year is expected to be between EUR -10.0 million and EUR -14.0 million (2011: EUR -13.4 million). WILEX anticipates in 2012 a monthly cash usage of between EUR 1.7 million and EUR 2.0 million (2011: EUR 2.0 million).
Key figures for the WILEX Group
| In EUR million | 2011 1;2 | 2010 1;2 |
| Earnings | ||
| Sales revenue | 9.9 | 0.0 |
| Other income | 1.8 | 1.3 |
| Operating expenses | (25.1) | (24.4) |
| Operating result (EBIT) | (13.4) | (23.1) |
| Earnings before tax | (13.9) | (23.1) |
| Comprehensive income | (13.9) | (23.1) |
| Earnings per share in EUR | (0.67) | (1.38) |
| Balance sheet as of 30.11 | ||
| Total assets | 20.8 | 5.6 |
| Cash and cash equivalents | 3.4 | 1.9 |
| Equity | (4.5) | (1.3) |
| Equity ratio in % | (21.7) | (23.2) |
| Cash flow statement | ||
| Cash flow from operating activities | (9.0) | (19.3) |
| Cash flow from investing activities | 0.6 | (0.5) |
| Cash flow from financing activities | 9.8 | 18.2 |
| Employees (number) | ||
| Employees as of 30.11. 3 | 124 | 80 |
1 The reporting period begins on 1 December and ends on 30 November.
2 Including WILEX Inc. (25.10.2010) and Heidelberg Pharma (17.3.2011)
3 Including WILEX Inc. (2010) and Heidelberg Pharma (2011) and members of the Executive Management Board
Rounding of exact figures may result in differences.
The annual report including the consolidated financial statements in accordance with International Financial Reporting Standards (IFRS) was published at www.wilex.com .
Invitation to the conference call:
On 28 February 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 from 2:00 p.m. CET.
Contact
WILEX AG
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 [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 near-to-market therapeutic and diagnostic products for the targeted treatment and specific detection of various types of cancer. The company's therapeutic product candidates are based on antibodies and small molecules. Through its US subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of research use only and in vitro diagnostic tests under the brand Oncogene Science. These diagnostic tests could be developed as companion diagnostics in clinical trials and for therapy monitoring. The wholly owned subsidiary Heidelberg Pharma GmbH gives WILEX access to an attractive and highly promising antibody drug conjugate technology platform and a pre-clinical service business. The business model of WILEX covers the entire value chain in the oncology market and comprises research, technology, development collaboration as well as sales and marketing. 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.
End of Corporate News
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| Language: | English |
| Company: | WILEX AG |
| Grillparzerstr. 10 | |
| 81675 München | |
| Germany | |
| Phone: | +49 (0)89 41 31 38 – 0 |
| Fax: | +49 (0)89 41 31 38 – 99 |
| E-mail: | [email protected] |
| 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 |
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| 158287 28.02.2012 |
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