Earnings Release • Apr 8, 2009
Earnings Release
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| Q1 20091 € '000 |
Q1 20081 € '000 |
Change in % |
|
|---|---|---|---|
| Earnings | |||
| Other income | 470 | 560 | (16.0) |
| Other expenses | (6,281) | (5,751) | 9.2 |
| of which research and development costs | (5,357) | (4,732) | 13.2 |
| Operating result | (5,811) | (5,191) | 12.0 |
| Earnings before tax | (5,720) | (4,884) | 17.1 |
| Net loss for the period | (5,725) | (4,891) | 17.0 |
| Earnings per share in € | (0.48) | (0.41) | 16.4 |
| Balance sheet as of end of period | |||
| Total assets | 19,730 | 31,577 | (37.5) |
| Cash and cash equivalents | 16,489 | 28,0392 | (41.2) |
| Equity | 9,948 | 21,168 | (53.0) |
| Equity ratio 3 in% |
50.4 | 67.0 | (24.8) |
| Cash flow statement | |||
| Cash flow from operating activities | (5,718) | (6,393) | (10.5) |
| Cash flow from investing activities | (22) | (25) | (11.7) |
| Cash flow from financing activities | 10,006 | (22) | n/a |
| Employees (number) | |||
| Employees as of end of period 4 | 64 | 60 | 6.7 |
| Employees – average for the reporting period 4 | 65 | 59 | 9.6 |
1 The first quarter begins on 1 December and ends on 28 February, previous year adjusted accordingly
including financial assets
3 equity/total assets
4 including members of the Executive Management Board
The first quarter of 2009 was significant in respect of the execution of our corporate strategy.
We continued to pursue the clinical development of our product candidates RENCAREX®, REDECTANE® and MESUPRON®, expanded our product portfolio and also improved our financial position through a capital increase.
WILEX and UCB Pharma entered into a comprehensive strategic alliance on 8 January 2009. WILEX acquired the worldwide rights to develop UCB's entire preclinical oncological portfolio and gained UCB as a strategic investor.
UCB's preclinical oncology portfolio, which comprises two small-molecule programmes and three antibody programmes, ideally supplements and expands our advanced clinical pipeline and provides access to UCB's broad antibody technology.
UCB will also make two milestone payments of € 5.00 million each to WILEX under the terms of the strategic alliance. The milestones defined are the submission of an application to conduct a clinical Phase I trial and the first dose in man. WILEX expects to reach these milestones in 2009.
This strategic alliance represents an innovative way for pharmaceutical and biopharmaceutical companies to cooperate. Our financial situation has improved due to the agreement. The planned milestone payments secure the Company's financing until the first quarter of 2010.
Munich, 8 April 2009
Peter Llewellyn-Davies Chief Financial Officer
The global financial crisis is now affecting the real economy, making it increasingly difficult for small and medium-sized companies to raise capital.
WILEX discussed the market environment for antibodies and small molecules in detail on page 29 of its 2008 Annual Report. Drugs such as Torisel® from Wyeth, Sutent® from Pfizer, Nexavar® from Bayer/Onyx and Afinitor® from Novartis have been approved for the treatment of advanced metastatic renal cell carcinoma. However, no drug has been approved to date by the FDA or EMEA for the adjuvant therapy of non-metastatic clear cell renal carcinoma. As a result, RENCAREX® continues to address a high unmet medical need.
WILEX acquired the worldwide rights to develop UCB's entire preclinical oncological portfolio and gained UCB as a strategic investor. UCB granted the rights to the five preclinical programmes to a company wholly-owned by UCB and also funded this company with € 10.00 million in cash. WILEX acquired this company for 1,818,181 newly issued shares from authorised capital, subject to the exclusion of shareholders' subscription rights, by means of a capital increase in kind. As part of this transaction, UCB fully subscribed the new shares, which can participate in profits from 1 December 2008, and now has an equity interest of 13.19% in WILEX.
The Commercial Registry recorded the capital increase on 26 February 2009. The share capital of WILEX AG is now € 13,780,935.00. Fifty percent of the new shares (909,091 shares) were admitted to trading at the stock exchange on 6 March 2009. Under the terms of the strategic agreement, the other half of the shares (909,090 shares) will be subject to a lock-up period until 9 January 2011.
WILEX and UCB also agreed that UCB will retain the exclusive right to buy back each one of the five programmes following the completion of initial clinical proof of concept studies and to develop and market them itself. WILEX will retain the right to continue developing and to commercialise the programmes on its own if UCB does not exercise its buyback right for any programme. Milestone and licence payments have already been agreed for both scenarios. Furthermore, the partners may jointly develop the programmes after the successful completion of the proof of concept studies.
The Phase III ARISER trial with RENCAREX® comprises 864 patients, who were enrolled in more than 140 centres in 14 countries. The trial is multicentre, randomised and double-blind. The trial will have achieved its objective when diseasefree survival for patients in the group treated with RENCAREX® show a statistically significant improvement compared to the placebo group. The next relevant milestone for WILEX is the occurrence of the 343rd relapse. As previously announced, the rate of relapse is lower than expected. To date a total of 259 relapses have been reported by the local trial centres to WILEX.
WILEX started a Phase III registration trial last year with the diagnostic candidate REDECTANE®. Patients with suspected renal cancer will be included in this trial. They are to be examined by positron emission tomography (PET)/computer tomography (CT) scan prior to surgery, using the imaging agent REDECTANE®, in order to establish whether this procedure facilitates better diagnosis of clear cell renal cell carcinoma than CT, the standard of care. The trial is being conducted in accordance with the design specified in the Special Protocol Assessment (SPA), which WILEX received from the Food and Drug Administration (FDA) prior to the trial's start. An SPA documents, that the FDA has evaluated the protocol and the planned analysis and considers the clinical trial suitable and appropriate to obtain marketing approval.
The study protocol is based on the assumption that 40% of the patients included in the study will have non clear cell renal cell carcinoma and 60% will have clear cell renal cell carcinoma. This distribution resulted in the targeted number of 166 patients. A total of 156 patients were recruited by the end of March 2009. WILEX has determined in the meantime that 36% of these patients have non clear cell renal cell carcinoma. For the results to have the statistical power defined in both the study protocol and the SPA, we suggested to the FDA that we raise the number of patients in order to achieve 40% non cell renal cell carcinoma. The FDA approved the proposal in March. At this point in time, and taking the current level of 36% into account, WILEX expects the number of patients to increase to approximately 200. Pursuant to current estimates WILEX anticipates that patient recruitment will be completed within the next two months.
We completed recruitment of more than 90 patients with locally advanced, inoperable, non-metastatic pancreatic cancer for the Phase II trial with MESUPRON® in July 2008. The randomised, open, three-arm Phase II trial investigates the antimetastatic effect of MESUPRON® in combination with the chemotherapeutic agent Gemcitabine (Eli Lilly and Company, USA). An independent radiological analysis of the patients with pancreatic cancer was performed in December 2008. This radiological analysis is used to determine the time to metastases. An interim analysis regarding the patients' progressionfree survival was also carried out. Statistically, the data available were insignificant because the disease had not yet progressed radiologically in a sufficient number of patients. The trial will therefore take longer even though patient recruitment went as planned.
Patient recruitment for the second Phase II trial with MESUPRON® for patients with metastatic, HER2 receptor negative breast cancer commenced in August 2008. This randomised double-blind Phase II trial involves 114 patients. It is designed to examine the efficacy of MESUPRON® in combination with the chemotherapeutic agent Capecitabine (Hoffmann-La Roche AG, Switzerland). The trial's primary endpoint is progression-free survival, i. e. time during which patients do not show progression of the disease. The patients receive the drugs as first-line treatment, i. e. the first treatment following a relapse.
The orally available, small-molecule MEK inhibitor (WX-554) is in preclinical development. Mitogen-activated protein kinase (MEK) has been shown to play a central role in signal transduction. MEK has been linked to a multitude of biological processes such as cell division, cell differentiation and cell death. The MEK signalling pathway is overexpressed in more than 30% of cancers, resulting in uncontrolled cell growth and proliferation.
The second small-molecule project, a PI3K inhibitor, was in the final phase of lead optimisation when it was acquired from UCB. In this phase, a lead compound is defined and prepared for preclinical development. The phosphatidylinositol-3 kinase/proteine-kinase-B signalling pathway – PI3K in short – sends a "growth" signal to the nucleus of a tumour cell. It has also been shown that abnormal mutations of the PI3K-B signalling pathway are present in most types of cancer. Identifying an inhibitor for the PI3K-B signalling pathway is thus of therapeutic interest. WILEX has now identified a lead compound (WX-037), for which a development plan is being prepared.
The three antibody-based projects are currently in the research phase. The aim is to identify a specific antibody that binds to each new target structure. The molecular targets of the antibody-based projects play different roles in spreading cancer or are overexpressed on tumour cells of various carcinomas.
WILEX posted earnings before taxes of € –5.72 million (previous year: € –4.88 million) in the first quarter of the 2009 financial year (1 December 2008 to 28 February 2009). The net loss for the period increased by 17.0% to € 5.72 million (previous year: € 4.89 million). This corresponds to earnings per share of € –0.48 (previous year: € –0.41). WILEX again did not generate any sales revenue in the first quarter because all of its products are still in clinical development and UCB's payments are not expected to be made until later in the financial year once the stipulated milestones have been achieved. Expenditures were on target and, as expected, exceeded other income.
The successful capital increase by 1,818,181 shares in connection with the UCB transaction largely influenced the Company's financial position and net assets in the first quarter. This is the first time WILEX has prepared consolidated financial statements pursuant to IAS 27. WILEX Research GmbH, which UCB contributed in connection with the transaction, is a wholly-owned subsidiary of WILEX AG.
At € 470 thousand, other income fell by 16.0% compared to the previous year's € 560 thousand, which is essentially due to the lower reversal of provisions. The income realised from licence agreements with Esteve and IBA amounted to € 350 thousand (previous year: € 372 thousand). The other income also contained € 52 thousand in development funds from the US Department of Defense for the uPA programme (previous year: € 79 thousand). Prepayments received for research projects are accrued and recognised as other income in line with project costs. The reversal of provisions and other income related to other periods resulted in income of € 68 thousand, which is below the previous year's figure of € 110 thousand.
Other expenses including depreciation, amortisation and impairment losses rose by approximately 9.2% to € 6.28 million (previous year: € 5.75 million). This was primarily a result of the year-on-year increase of 13.2% in research and development costs, which totalled € 5.36 million (previous year: € 4.73 million). Costs were within budget.
The ongoing clinical development of the monoclonal antibody cG250 for RENCAREX® and REDECTANE® in the first quarter of 2009 accounted for 72.8% (previous year: 77.3%) of our research and development costs. Approximately 24.5% (previous year: 20.3%) were attributable to the uPA programme, which includes the small-molecule drug candidate MESUPRON®, and 2.7% (previous year: 2.4%) to the other projects.
Administrative costs accounted for 14.7% of other expenses (previous year: 17.7%). At € 0.92 million, these stayed below the previous year's level (€ 1.02 million), despite the increase in the number of employees, thanks to cost-sensitive management.
The net financial result fell from € 0.31 million to € 0.09 million due to the use of cash as planned and a decrease in interest income. Compared to the same period the previous year, the lower income was caused not just by the decline in the amount of funds invested but also by the substantial drop in interest rates. The Company had cash and cash equivalents of € 16.49 million (30 November 2008: € 12.14 million) at the close of the first quarter. The increase results from the capital increase executed in February, less the funds used in the first quarter.
The net cash flow from operating activities during the reporting period was € –5.63 million (previous year: € –6.25 million). Net cash used in investing activities amounted to € 22 thousand (previous year: € 25 thousand). The net cash flow from financing activities in the first quarter was € 10.01 million (previous year: € –22 thousand) and was generated largely by the UCB transaction. Total net inflow of cash and cash equivalents was € 4.35 million (previous year: net cash outflow of € 6.29 million). Excluding the effect of the capital increase, WILEX's average use of cash per month in the first quarter was € 1.89 million (previous year: € 2.10 million per month).
Compared to 30 November 2008, total assets rose from € 15.33 million to € 19.73 million due to the capital increase from the issuance of 1,818,181 new shares and the proceeds of € 10.0 million. The planned use of cash and financial investments for the Company's clinical development programmes were offset by an increase in cash and cash equivalents.
At € 17.86 million, current assets were higher than at the close of the 2008 financial year (€ 13.42 million). Total cash and cash equivalents increased from € 12.14 million as of 30 November 2008 to € 16.49 million as of 28 February 2009. Prepayments made in the amount of € 1.11 million (previous year: € 1.07 million) essentially comprise payments to service providers for clinical trials.
Non-current assets at the end of the first quarter were € 1.87 million (30 November 2008: € 1.91 million). Intangible assets comprise licence fees and royalties from various cooperation agreements. At € 1.39 million, they fell below the level at 30 November 2008 (€ 1.43 million) because amortisation and impairment losses exceeded additions.
Property, plant and equipment amounting to € 0.46 million (30 November 2008: € 0.46 million) primarily concerns laboratory and office equipment. The asset value of reinsurance amounting to € 0.23 was recognised under non-current assets million, just as of the close of the previous financial year.
Equity increased to € 9.95 million by the end of the first quarter (30 November 2008: € 5.79 million). The subscribed capital rose from € 11.96 million as of 30 November 2008 by € 1.82 million to € 13.78 million as of 28 February 2009. An additional € 8.03 million from the capital increase were allocated to the capital reserve after accounting for the capital procurement costs. The accumulated losses rose from € 111.37 million as of 30 November 2008 to € 117.10 million as of 28 February 2009. The equity ratio was 50.4% as of 28 February 2009 (30 November 2008: 37.8%; 29 February 2008: 67.0%).
Non-current liabilities fell to € 0.13 million as of 28 February 2009, down from € 0.27 million at the end of the 2008 financial year. Liabilities to third parties, primarily in connection with external research and development orders, are recognised based on their contractually stipulated terms and reclassified to current liabilities if their residual terms fall below 12 months.
Current liabilities at the end of the quarter were € 9.65 million (30 November 2008: € 9.26 million), primarily due to higher trade payables amounting to € 2.54 million (30 November 2008: €1.79 million). At € 7.11 million, other current liabilities fell below the level at 30 November 2008 (€ 7.46 million) due to the planned decline in accruals related to licence agreements.
At the end of the first quarter, 64 employees (29 February 2008: 60), including Executive Management Board members, were employed by WILEX.
WILEX has a performance-related compensation system for its employees. In addition, a stock option plan enables employees and Executive Management Board members to participate in the Company's success. In the first quarter, no subscription rights were issued to employees and members of the Executive Management Board. A total of 383,323 subscription rights were available for issuance to employees and to members of the Executive Management Board at the end of the first quarter. No stock options could be exercised to date.
There were no related party transactions in the period under review.
In March, the FDA agreed to an increase in the number of patients in the Phase III trial with REDECTANE®. According to current plans, WILEX will include about 200 patients in the trial instead of 166. For further details please see the chapter on Research and Development.
We provided a detailed description of the risks and opportunities that arise in connection with our business on pages 38 to 42 of our 2008 Annual Report. Please refer to these disclosures. WILEX uses an IT-based risk management system that complies with the requirements of the German Control and Transparency in Business Act (Gesetz zur Kontrolle und Transparenz im Unternehmensbereich) to monitor 16 different risk areas.
WILEX is exposed to risks typical for the industry, namely those arising from the development and production of drug candidates used in cancer therapies. The time between the commencement of drug development and approval usually spans many years. Even though our portfolio has matured further, there is a continuing risk that none of our current drug and diagnostic candidates will receive marketing approval.
The data of all patients from the more than 140 study centres in the Phase III ARISER trial with RENCAREX® will be combined and processed by an external service provider (CRO) once the 343rd relapse has occurred. Independent radiologists will analyse the patients' CTs in order to determine disease-free survival. This process will take at least six months from the time at which the 343rd relapse is reported. Finally, the Independent Data Monitoring Committee (IDMC) will perform a centralised analysis of disease-free survival data from all patients, which can form the basis for filing for approval in the European Union. Whilst the data remain blinded for WILEX, they will nonetheless provide critical information with regard to the trial's endpoint – disease-free survival - and the efficacy of RENCAREX®.
Patient recruitment in the Phase III registration trial of REDECTANE® is continuing in accordance with the Special Protocol Assessment (SPA), and we anticipate completing recruitment within the next two months. Analysis of the data will then take another three to six months. We expect the trial's results to become available in the second half of 2009.
Medication is still being administered to patients with pancreatic cancer in the Phase II trial with MESUPRON®. Patient recruitment in the second Phase II trial in breast cancer patients with the uPA inhibitor is also ongoing.
The application for approval of a Phase I trial for the MEK inhibitor WX-554 and the administration of the first dose in man are planned for this year.
"To the best of our knowledge, and in accordance with the applicable reporting principles, financial statements for the first three months give a true and fair view of the assets, liabilities, financial position and profit or loss of WILEX AG, and the interim management report includes a fair review of the development and performance of the business and the position of WILEX AG, together with a description of the principal opportunities and risks associated with the expected development of WILEX AG."
Munich, 8 April 2009
The Executive Management Board
Professor Olaf G. Wilhelm Peter Llewellyn-Davies Dr Paul Bevan Dr Thomas Borcholte
of WILEX AG in accordance with IFRS for the period from 1 December 2008 to 28 February 2009
| Q1 2009 € |
Q1 2008 € |
|
|---|---|---|
| Revenue | 0 | 0 |
| Other income | 470,446 | 560,125 |
| Income | 470,446 | 560,125 |
| Research and development costs | (5,357,483) | (4,731,949) |
| Administrative costs | (923,975) | (1,018,701) |
| Other expenses (incl. depreciation/amortisation) | (6,281,458) | (5,750,651) |
| Operating result | (5,811,011) | (5,190,526) |
| Finance income | 91,399 | 311,202 |
| Finance costs | (119) | (4,720) |
| Net financial result | 91,280 | 306,482 |
| Earnings before tax | (5,719,732) | (4,884,044) |
| Income tax | (4,948) | (7,431) |
| Net loss for the period | (5,724,680) | (4,891,475) |
| Earnings per share | ||
| Basic and diluted earnings per share | (0.48) | (0.41) |
| Average number of shares issued | 12,023,360 | 11,962,754 |
Rounding of exact figures may result in differences.
of WILEX AG in accordance with IFRS
| Q1 2009 € '000 |
Q4 2008 € '000 |
Q3 2008 € '000 |
Q2 2008 € '000 |
Q1 2008 € '000 |
|
|---|---|---|---|---|---|
| Revenue | 0 | 0 | 0 | 0 | 0 |
| Other income | 470 | 748 | 1,676 | 223 | 560 |
| Other expenses | (6,281) | (4,829) | (7,138) | (6,884) | (5,751) |
| of which research and development costs |
(5,357) | (3,608) | (5,953) | (5,864) | (4,732) |
| Operating result | (5,811) | (4,081) | (5,461) | (6,661) | (5,191) |
| Earnings before tax | (5,720) | (3,911) | (5,226) | (6,412) | (4,884) |
| Net loss for the period | (5,725) | (3,912) | (5,232) | (6,413) | (4,891) |
| Basic and diluted earnings per share |
(0.48) | (0.33) | (0.44) | (0.54) | (0.41) |
| Average number of shares issued | 12,023,360 | 11,962,754 | 11,962,754 | 11,962,754 | 11,962,754 |
of WILEX AG in accordance with IFRS as of 28 February 2009 and as of 30 November 2008
| Assets | 28.02.2009 € |
30.11.2008 € |
|---|---|---|
| Property, plant and equipment | 459,252 | 461,713 |
| Intangible assets | 1,392,243 | 1,426,564 |
| Other non-current assets | 22,884 | 22,689 |
| Non-current assets | 1,874,379 | 1,910,966 |
| Inventories | 22,200 | 22,200 |
| Other assets and prepayments | 1,110,473 | 1,072,248 |
| Other receivables | 233,760 | 184,888 |
| Cash and cash equivalents | 16,489,204 | 12,136,987 |
| Current assets | 17,855,637 | 13,416,323 |
| Total assets | 19,730,016 | 15,327,289 |
| Equity and liabilities | 28.02.2009 € |
30.11.2008 € |
|---|---|---|
| Subscribed capital | 13,780,935 | 11,962,754 |
| Capital reserve | 113,265,964 | 105,201,252 |
| Accumulated losses | (117,099,134) | (111,374,454) |
| Equity | 9,947,765 | 5,789,552 |
| Pension provisions | 22,884 | 22,689 |
| Liabilities arising from leases | 0 | 0 |
| Other non-current liabilities | 105,648 | 251,755 |
| Non-current liabilities | 128,532 | 274,444 |
| Trade payables | 2,544,416 | 1,787,991 |
| Liabilities arising from leases | 0 | 15,357 |
| Other current liabilities | 7,109,303 | 7,459,944 |
| Current liabilities | 9,653,719 | 9,263,293 |
| Total equity and liabilities | 19,730,016 | 15,327,289 |
of WILEX AG in accordance with IFRS for the period from 1 December 2008 to 28 February 2009
| Q1 2009 € |
Q1 2008 € |
|
|---|---|---|
| Net loss for the period | (5,724,680) | (4,891,475) |
| Adjustment for income statement items | ||
| Measurement of stock options | 38,662 | 108,934 |
| Depreciation/amortisation | 58,654 | 67,073 |
| Increase in pension obligations | 195 | 195 |
| Finance costs | 119 | 4,720 |
| Finance income | (91,399) | (311,202) |
| Tax expense | 4,948 | 7,431 |
| 11,179 | (122,849) | |
| Changes in net working capital | ||
| Other receivables | (48,873) | (136,684) |
| Prepayments | (38,225) | 4,674 |
| Other non-current assets | (195) | 0 |
| Trade payables | 756,425 | 745,345 |
| Other liabilities | (673,923) | (1,991,714) |
| 4,790 | (1,378,380) | |
| Cash flow from operating activities | (5,718,291) | (6,392,703) |
| Finance costs paid | (119) | (3,003) |
| Finance income received | 86,450 | 150,696 |
| Net cash flow from operating activities | (5,631,960) | (6,245,011) |
| Cash flow from investing activities | ||
| Purchase of property, plant and equipment | (21,872) | (24,184) |
| Purchase of intangible assets | 0 | (597) |
| Sale/purchase of financial investments | 0 | 0 |
| Net cash flow from investing activities | (21,872) | (24,781) |
| Cash flow from financing activities | ||
| Capital increase | 10,025,000 | 0 |
| Capital increase costs | (3,595) | 0 |
| Repayment finance leases | (15,357) | (21,711) |
| Net cash flow from financing activities | 10,006,048 | (21,711) |
| Net change in cash and cash equivalents | 4,352,216 | (6,291,503) |
| Cash and cash equivalents | ||
| at beginning of period | 12,136,987 | 18,795,851 |
| at end of period | 16,489,204 | 12,504,348 |
of WILEX AG in accordance with IFRS for the period from 1 December 2008 to 28 February 2009
| Capital reserve | ||||||
|---|---|---|---|---|---|---|
| Shares | Subscribed capital € |
Capital measures/ premium € |
Measurement of stock options € |
Accumulated losses € |
Total € |
|
| 103,131,052 | 1,783,664 | |||||
| As of 1 December 2007 | 11,962,754 | 11,962,754 | 104,914,715 | (90,926,789) | 25,950,680 | |
| Measurement of stock options | 108,934 | 108,934 | ||||
| Net loss for the period | (4,891,475) | (4,891,475) | ||||
| Net change in equity | (4,782,540) | |||||
| 103,131,052 | 1,892,598 | |||||
| As of 29 February 2008 | 11,962,754 | 11,962,754 | 105,023,650 | (95,818,264) | 21,168,140 | |
| 103,131,052 | 2,070,200 | |||||
| As of 1 December 2008 | 11,962,754 | 11,962,754 | 105,201,252 | (111,374,454) | 5,789,552 | |
| Measurement of stock options | 38,662 | 38,662 | ||||
| Net loss for the period | (5,724,680) | (5,724,680) | ||||
| Capital increase after accounting for capital procurement costs |
1,818,181 | 1,818,181 | 8,026,050 | 9,844,231 | ||
| Net change in equity | 4,158,213 | |||||
| 111,157,102 | 1,931,260 | |||||
| As of 28 February 2009 | 13,780,935 | 13,780,935 | 113,265,964 | 117,099,134 | 9,947,765 |
The interim financial statements reproduced in this report were prepared in accordance with the International Financial Reporting Standards (IFRS), IAS 34 "Interim Financial Reporting" issued by the International Accounting Standards Board (IASB) and in compliance with the Interpretations of the Standing Interpretations Committee (SIC) and the International Financial Reporting Interpretations Committee (IFRIC) as well as in accordance with the IFRS recognised by the European Union. These interim financial statements must be read in the context of the annual financial statements as of 30 November 2008 published by the Company for the 2008 financial year.
The Company's assets, liabilities and financial position as well as individual items of the financial statements for the first three months are explained in detail in the interim management report.
As the business activities do not differ significantly in their risk/reward profiles, WILEX operates in one segment only and therefore does not prepare segment reporting. The Company's business activities are not subject to seasonal influences.
The interim financial statements were not reviewed or certified by an auditor. Pursuant to our Declaration of Compliance from 18 February 2009 with Section 7.1.2 of the German Corporate Governance Code, both the interim financial statements and the management report were discussed with the Supervisory Board's Audit Committee before being published. They were approved for publication by the Executive Management Board on 8 April 2009.
The interim financial statements as of 28 February 2009 were prepared in accordance with the same accounting policies as the annual financial statements, with the following exception: these are the first consolidated financial statements according to IFRS that include both WILEX AG as the parent and WILEX Research GmbH as the subsidiary.
Under IFRS 3 (Business Combinations), the purchase method shall be used to recognise and measure all identifiable assets acquired and liabilities assumed in connection with a business combination at their fair value.
The Company has provisionally prepared the accounting of the business activities that were added in the first quarter of 2009 and will carry out a purchase price allocation because the transaction with UCB was not completed until immediately before the balance sheet date. Under IFRS 3.62, the outcome of this purchase price allocation could lead to an adjustment of goodwill; all provisional figures must be adjusted within 12 months of the acquisition date.
By signing its strategic alliance with UCB, WILEX AG acquired WILEX Research GmbH, a wholly-owned subsidiary of WILEX AG. WILEX acquired this company for 1,818,181 newly issued shares from authorised capital subject to the exclusion of shareholders' subscription rights by means of a capital increase in kind.
The Group provisionally allocated goodwill in accordance with IFRS 3.62 and 3.69. This allocation will remain provisional until the final purchase price allocation is made at the time the financial statements for the financial year 2009 are prepared.
The Company's subscribed capital rose to € 13.78 million as a result of the capital increase compared to 30 November 2008 and the 29 February 2008 comparative date. The number of ordinary bearer shares also rose to 13.78 million.
The capital reserve rose to € 113.27 million in the first three months of the current financial year as a result of the capital increase less capital procurement costs (€ 8.03 million) and the measurement of stock options (€ 38.66 thousand). In accordance with IFRS 2, expenses for stock options are recognised in income at the reporting date at fair value over the estimated vesting period. A total of € 108.93 thousand was charged against the capital reserve in the same period the previous year for the same purpose.
The net loss of € 5.72 million for the first three months of the financial year raised the deficit accumulated by WILEX AG since the beginning of its operations to € 117.10 million.
In conclusion, the Company's equity in the first quarter rose by € 4.16 million to € 9.95 million, compared to a decline of € 4.78 million in the same period the previous year.
During the period from 1 December 2008 to 28 February 2009, the officers and directors of the Company reported the following securities dealings that require disclosure under Section 15a of the German Securities Trading Act (WpHG).
| Name | Date | Trans action |
Market place |
Price € |
Number | Volume € |
|---|---|---|---|---|---|---|
| Dr David Ebsworth, Chairman of the Supervisory Board |
09.01.2009 | Purchase | XETRA, Frankfurt/M. |
3.99 | 10,000 | 39,900.00 |
| Dr Georg F. Baur, Deputy Chairman of the Supervisory Board |
09.01.2009 | Purchase | XETRA | 4.00 | 30,000 | 120,000.00 |
| Dr Rüdiger Hauffe, Member of the Supervisory Board |
09.01.2009 | Purchase | XETRA | 4.00 | 4,000 | 16,000.00 |
WILEX's share lost more than 33% of its value between the start of the financial year and the end of March and fell to its all-time low of € 2.10 in December 2008. At the start of the year however, it made substantial gains following the announcement of WILEX's strategic alliance with UCB but then dropped again by the end of the first quarter. The share recovered in March.
| 100 Key share figures as of the end of the reporting period |
Q1 2009 | Q1 2008 | |
|---|---|---|---|
| 80 Shares issued as of end of period |
Number | 13,780,935 | 11,962,754 |
| 60 Market capitalisation as of end of period |
€ million | 31.15 | 70.46 |
| Closing price (XETRA) as of end of period 40 |
€ | 2.26 (on 27.02.09) |
5.89 (on 29.02.08) |
| High (all stock exchanges) | € | 3.98 (on 08.12.08) |
7.22 (on 02.01.08) |
| Low (all stock exchanges) | € | 2.19 (on 19.12.08) |
4.76 (on 06.12.07) |
| Volatility (260 days; XETRA) | % | 62.00 (on 27.02.09) |
61,39 (on 29.02.08) |
| Average daily trading volume (all stock exchanges) | Shares | 13,393 | 12,990 |
| Average daily trading volume (all stock exchanges) | € | 38,850 | 81,940 |
| Earnings per share | € | (0.48) | (0.41) |
Source: Bloomberg
WILEX participated in and made presentations at a number of investor conferences in the first quarter, for example the JP Morgan 27th Annual Healthcare Conference in San Francisco, the BIO CEO & Investor Conference in New York, the 2nd Annual European Life Science CEO Forum in Zurich, the Bio-Europe Spring in Milan and the Cowen 29th Annual Health Care Conference in Boston. We held numerous meetings with analysts and investors.
The analysts of Sal. Oppenheim Research and WestLB regularly publish research on WILEX. In February, we succeeded in gaining a third analyst, EDISON Investment Research, which has analysed WILEX's business model. All assessments are published on our website.
| Date | |
|---|---|
| 8 April 2009 | 3-month Financial Report 2009 |
| 26 May 2009 | Annual General Meeting |
| 14 July 2009 | Half-yearly Financial Report 2009 |
| 13 October 2009 | 9-month Financial Report 2009 |
Grillparzerstr. 10 81675 Munich, Germany Tel. +49(0)89–413138–0 Fax +49(0)89–413138–99 www.wilex.com [email protected]
Chief Financial Officer Investor & Public Relations Fax +49(0)89–413138–98 Fax +49(0)89–413138–99 E-mail: [email protected] E-mail: [email protected]
Tel. +49(0)89–413138–20 Tel. +49(0)89–413138–126
Responsible for the project: Katja Arnold, WILEX AG
The 3-month Financial Report is also published in German and is available for download from our website at www.wilex.com.
The English translation of the 3-month Financial Report 2009 is provided for convenience only. The German original is definitive.
As of: 8 April 2009
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