Quarterly Report • Oct 13, 2009
Quarterly Report
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| 9M 20091 € '000 |
9M 20081 € '000 |
Change in% |
|
|---|---|---|---|
| Earnings | |||
| Sales revenue | 5,000 | 0 | n/a |
| Other income | 1,925 | 2,460 | (21.8) |
| Other expenses | (18,118) | (19,773) | (8.4) |
| of which research and development costs | (15,162) | (16,549) | (8.4) |
| Operating result | (11,193) | (17,313) | (35.3) |
| Earnings before tax | (11,049) | (16,522) | (33.1) |
| Net loss for the period | (11,059) | (16,536) | (33.1) |
| Earnings per share in € | (0.84) | (1.38) | (39.4) |
| Balance sheet as of end of period | |||
| Total assets | 12,328 | 21,520 | (42.7) |
| Cash and cash equivalents | 8,931 | 18,2332 | (51.0) |
| Equity | 4,690 | 9,658 | (51.4) |
| Equity ratio 3 in % |
38.0 | 44.9 | (15.2) |
| Cash flow statement | |||
| Cash flow from operating activities | (13,178) | (16,558) | (20.4) |
| Cash flow from investing activities | (61) | 14,951 | (100.4) |
| Cash flow from financing activities | 9,844 | (63) | n/a |
| Employees (number) | |||
| Employees as of end of period 4 | 67 | 64 | 4.7 |
| Employees – average for the reporting period 4 | 68 | 61 | 10.9 |
1 The reporting period begins on 1 December and ends on 31 August.
including financial assets
3 equity/total assets
4 including members of the Executive Management Board
We are pleased to report on a very successful quarter.
In August, we filed an application with the German Federal Institute for Drugs and Medical Devices (BfArM) for the approval of a Phase I trial with the MEK inhibitor WX-554, one of the preclinical projects that we acquired from UCB. As per our agreement with UCB, achievement of this milestone triggered a payment of € 5 million to WILEX in the third quarter. As a result of this we posted sales revenue for the first time and improved our earnings substantially. In the meantime, approval for the Phase I trial has been granted. We expect the first dose to be administered to healthy volunteers in the fourth quarter and thus reach the second milestone, which will trigger another payment from UCB in the amount of € 5 million.
Patient recruitment in our Phase III registration trial with the diagnostic candidate REDECTANE® was completed at the end of August. This constitutes a significant milestone. We expect the trial's preliminary results to be available by year end.
We announced after the close of the third quarter preliminary data from the clinical Phase II trial with the oral drug candidate MESUPRON® in combination with the chemotherapeutic agent Gemcitabine (Gemzar®, Eli Lilly and Company, USA) in pancreatic cancer patients. The aim of this proof-of-concept study is to show for the first time the activity of MESUPRON® in tumour patients as well as to demonstrate that the inhibition of the uPA system may represent an innovative and promising therapeutic approach for the treatment of cancer patients. Preliminary results of MESUPRON® in combination with Gemzar® showed clear improvement in tumour response as well as median survival and one year survival.
Dear shareholders, we thank you for your support and hope that you will continue to join us on our way.
Munich, 13 October 2009
Peter Llewellyn-Davies Chief Financial Officer
WILEX is a biopharmaceutical company, focused on oncology, and developing product candidates based on antibodies and small molecules aimed at preventing tumour growth and metastases.
The Phase III ARISER trial with RENCAREX® (INN: girentuximab) comprises 864 patients in more than 140 centres in 14 countries. Relapses continue to take longer than originally anticipated. The trial will have achieved its objective when diseasefree survival for patients in the group treated with RENCAREX® shows a statistically significant improvement compared to the placebo group. The next relevant milestone for WILEX is the occurrence of the 343rd relapse. As of the end of September, a total of 293 relapses had been reported to WILEX by the local trial centres.
Patient recruitment for the Phase III registration trial with the diagnostic candidate REDECTANE® (INN: 124I-girentuximab), which began last year, was completed at the end of August 2009. A total of 226 patients with suspected renal cell cancer have been enrolled in the trial. All patients were examined by PET/CT (positron emission tomography (PET)/computer tomography (CT)) scan using the imaging agent REDECTANE® prior to complete or partial removal of the kidney. The trial aims to determine whether the PET/CT procedure using REDECTANE® improves the diagnosis of clear cell renal cell cancer compared to CT, the current diagnostic standard.
The urokinase-specific plasminogen activator (uPA) system, which is inhibited by MESUPRON®, is believed to play an important role in tumour growth and cancer cell metastasis, and so may represent a key target in cancer therapy. With MESUPRON®, WILEX has developed an oral serine protease inhibitor that is designed to block the activity of tumour-relevant serine proteases such as uPA.
In the randomised, open, three-arm Phase II trial with MESUPRON®, the last of the 95 patients with locally advanced, inoperable, non-metastatic pancreatic cancer, was enrolled in July 2008. The trial studies the activity of 200 mg and 400 mg of MESUPRON® given orally once daily in combination with the chemotherapeutic agent Gemzar® compared with Gemzar® alone. This proof-of-concept study examines whether there is any improvement in the response rate, progression-free survival, time to metastases and overall survival. On 29 September 2009, preliminary, positive data for the pancreatic cancer trial were announced. For more information, please see the report on events after the balance sheet date on page 8.
Patient recruitment for the second Phase II trial with MESUPRON® in patients with metastatic, HER2 receptor negative breast cancer commenced in August 2008. This randomised double-blind trial involves 114 patients. It is designed to examine the efficacy of MESUPRON® in combination with the chemotherapeutic agent Capecitabine (Xeloda®, Hoffmann-La Roche AG, Switzerland) compared to Xeloda® alone. The trial's primary endpoint is progression-free survival, i.e. time during which the 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. Fifty-two patients were recruited up to the end of September 2009.
WX-554 is a mitogen-activated protein kinase (MEK) inhibitor, which 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 oral small-molecule MEK inhibitor WX-554, part of the preclinical portfolio acquired from UCB, is about to start clinical development. In August 2009, WILEX filed an application with the German Federal Institute for Drugs and Medical Devices (BfArM) for the approval of a Phase I trial. Approval has been granted in the meantime.
Another project acquired from UCB concerns an oral small-molecule PI3K inhibitor, for which the drug candidate WX-037 was selected as the lead compound. The phosphatidylinositol-3-kinase/protein-kinase (PI3K) signalling pathway sends a "growth" signal to the nucleus of a tumour cell. It has also been shown that abnormal mutations of the PI3K signalling pathway are present in many types of cancer. Identifying an inhibitor for the PI3K signalling pathway is thus of therapeutic interest. WX-037 is in preclinical development.
The three antibody-based projects acquired from UCB 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 believes that the market environment for antibodies and small molecules has not changed significantly compared to the disclosures made in the half-yearly financial report. For more details, please see page 3 of that report and page 29 of our 2008 Annual Report.
WILEX posted earnings before taxes of € –11.05 million (previous year: € –16.52 million) in the first nine months of the 2009 financial year (1 December 2008 to 31 August 2009). At € 11.06 million, the net loss for the period was 33.1% below the previous year's figure (€ 16.54 million). This corresponds to earnings per share of € –0.84 (previous year: € –1.38). Expenditures were on target and, as expected, exceeded sales revenue and other income.
Sales revenue was € 5 million (previous year: € 0). At € 1.92 million, other income was 21.8% below the previous year's figure (€ 2.46 million). The income realised from licence agreements with Esteve and IBA amounted to € 1.50 million (previous year: € 1.87 million). The other income also contained € 0.27 million in development funds from the US Department of Defense for the uPA programme (previous year: € 0.29 million). Prepayments received for research projects are accrued and recognised as other income in line with project costs. The amount of income accrued was lower year on year due to
the greater number of patients in the REDECT trial and the lower rate of relapse in the ARISER trial. The reversal of provisions and other income related to other periods resulted in income of € 0.15 million (previous year: € 0.30 million).
Other expenses including depreciation, amortisation and impairment losses amounted to € 18.12 million, down approximately 8.4% from the previous year (€ 19.77 million). Research and development costs were € 15.16 million (previous year: € 16.55 million).
The ongoing clinical development of the monoclonal antibody cG250 for RENCAREX® and REDECTANE® accounted for 69.2% (previous year: 67.8%) of our research and development costs in the reporting period. Approximately 19.5% (previous year: 30.7%) were attributable to the uPA programme, the small-molecule drug candidate MESUPRON®, and 11.3% (previous year: 1.5%) to the other projects (including preclinical projects). While the costs for the ARISER trial with RENCAREX® declined as expected, the expenses for the REDECT trial with REDECTANE® rose as a result of the increase in the number of patients. The costs for the uPA programme involving MESUPRON® declined because the preclinical trials were completed and because the Phase II pancreatic cancer trial has progressed to a substantial degree. Costs related to WX-554 and WX-037 as well as the antibody projects were incurred for the first time in 2009.
Administrative costs were € 2.96 million, down 8.3% from the previous year (€ 3.22 million).
The net financial result fell from € 0.79 million in the previous year to € 0.14 million due to the use of cash as planned and a decrease in interest income. Compared to the same period the previous year, the decrease in 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 € 8.93 million (30 November 2008: € 12.14 million) at the close of the third quarter. The change was effected for one by both the capital increase that was executed in February and UCB's milestone payment and for another by the use of funds in the first nine months of the year.
Net cash flow from operating activities during the reporting period was € –12.99 million (previous year: € –15.45 million) due to the improvement in the net loss for the period and a year-on-year reduction in the reversal of provisions. Net cash used for investing activities amounted to € 61 thousand, compared to a net cash flow of € 14.95 million from the repayment of a financial investment (€ 15.00 million) in the same period the previous year. Excluding this effect, the change in the same period of 2008 was € –49 thousand. The net cash flow from financing activities in the first nine months was € 9.84 million (previous year: € –63 thousand) and was generated by the capital increase executed in the first quarter in connection with the UCB transaction. Total net outflow of cash and cash equivalents was € 3.21 million (previous year: outflow € 0.56 million). Excluding the effect of the capital increase, WILEX's average use of cash per month in the first nine months was € 1.45 million (previous year: € 1.73 million per month).
Total assets as of 31 August 2009 amounted to € 12.33 million (30 November 2008: € 15.33 million).
At € 10.53 million, current assets were lower than at the close of the 2008 financial year (€ 13.42 million). At € 8.93 million, total cash and cash equivalents as of 31 August 2009 were lower than on 30 November 2008 (€ 12.14 million) due to the planned use of cash. Prepayments made rose to € 1.46 million (30 November 2008: € 1.07 million) and essentially comprise payments to service providers for clinical trials.
Non-current assets at the end of the first half-year were € 1.80 million (30 November 2008: € 1.91 million). Intangible assets comprise licence fees and royalties from various cooperation agreements. At € 1.33 million, they were lower than on 30 November 2008 (€ 1.43 million) because amortisation and impairment losses exceeded additions.
Property, plant and equipment amounting to € 0.45 million (30 November 2008: € 0.46 million) primarily concerns laboratory and office equipment. The asset value of reinsurance amounting to € 0.23 million was recognised under non-current assets, just as of the close of the previous financial year.
Equity as of the end of the reporting period was € 4.69 million (30 November 2008: € 5.79 million). The subscribed capital amounted to € 13.78 million compared to € 11.96 million as of 30 November 2008. The capital reserve increased to € 113.34 million (30 November 2008: € 105.20 million), essentially as a result of the capital increase executed in the first quarter. The accumulated losses amounted to € 122.43 million (30 November 2008: € 111.37 million). The equity ratio was 38.0% as of 31 August 2009 (30 November 2008: 37.9%; 31 August 2008: 44.9%).
Non-current liabilities as of 31 August 2009 amounted to € 0.17 million (30 November 2008: € 0.27 million). Liabilities to third parties are recognised based on their contractually stipulated terms and reclassified to current liabilities if their residual terms are shorter.
At € 7.47 million, current liabilities at the close of the reporting period also were below the level on 30 November 2008 (€ 9.26 million). Trade payables were € 1.91 million (30 November 2008: € 1.79 million); at € 5.56 million, other current liabilities were lower than on 30 November 2008 (€ 7.46 million) due the planned decline in accruals related to payments under licence agreements.
At the end of the reporting period, 67 employees (31 August 2008: 64, 31 May 2009: 66), 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 nine months of the year, 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 on 31 August 2009. No stock options could be exercised to date.
There were no related party transactions in the period under review.
On 1 September 2009, WILEX announced the successful completion of patient recruitment for the Phase III registration trial with the diagnostic agent REDECTANE®. A total of 226 patients with suspected renal cell cancer have been enrolled in the trial.
On 29 September 2009, preliminary data for the Phase II trial with MESUPRON® in pancreatic cancer patients were published. The 95 patients are administered either Gemzar® alone or in combination with a daily oral dose of 200 mg or 400 mg MESUPRON® respectively until progression. Gemzar® alone demonstrated a tumour response rate of 9.7%. Co-administration of 200 mg MESUPRON® led to an increase to 22.6% and to 33.3% with 400 mg MESUPRON®. One year survival with Gemzar® alone was 37%. This increased to 45% with 200 mg MESUPRON® and to 53% with 400 mg MESUPRON®. The median survival of the patients improved by 30% from 10.2 months with Gemzar® to 13.5 months in combination with 400 mg MESUPRON®. The data, which were reviewed and endorsed by the Medical Advisory Board, are preliminary as only 59 of the patients enrolled in the trial have died; 72 deaths are required for the final analysis.
In September 2009, the BfArM approved the planned Phase I trial with the MEK inhibitor WX-554.
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.
We expect the following milestones to be achieved in the coming months:
We expect preliminary data for the Phase III registration trial with REDECTANE® to be available by the end of the year.
The final analysis of the pancreatic cancer trial with MESUPRON® will be performed when the 72 deaths defined in the study protocol have occurred.
The trial with the MEK inhibitor WX-554 is planned to commence in the fourth quarter with the administration of the first dose to healthy volunteers. WILEX would receive the second milestone payment of € 5 million from UCB upon achievement of this milestone.
of WILEX AG in accordance with IFRS for the period from 1 December 2008 to 31 August 2009
| 9M 2009 € |
9M 2008 € |
Q3 2009 € |
Q3 2008 € |
|
|---|---|---|---|---|
| Sales revenue | 5,000,000 | 0 | 5,000,000 | 0 |
| Other income | 1,924,790 | 2,459,999 | 786,550 | 1,676,498 |
| Income | 6,924,790 | 2,459,999 | 5,786,550 | 1,676,498 |
| Research and development costs | (15,161,521) | (16,548,588) | (5,483,408) | (5,953,107) |
| Administrative costs | (2,956,387) | (3,224,031) | (933,364) | (1,184,636) |
| Other expenses (incl. depreciation/amortisation) | (18,117,908) | (19,772,619) | (6,416,772) | (7,137,742) |
| Operating result | (11,193,118) | (17,312,620) | (630,222) | (5,461,245) |
| Finance income | 150,499 | 801,527 | 9,599 | 239,559 |
| Finance costs | (6,230) | (11,085) | 1,746 | (4,408) |
| Net financial result | 144,270 | 790,442 | 11,346 | 235,151 |
| Earnings before tax | (11,048,848) | (16,522,178) | (618,876) | (5,226,094) |
| Income tax | (10,559) | (13,968) | (3,381) | (5,611) |
| Net loss for the period | (11,059,407) | (16,536,147) | (622,257) | (5,231,706) |
| Earnings per share | ||||
| Basic and diluted earnings per share | (0.84) | (1.38) | (0.05) | (0.44) |
| Average number of shares issued | 13,203,629 | 11,962,754 | 13,780,935 | 11,962,754 |
Rounding of exact figures may result in differences.
of WILEX AG in accordance with IFRS
| Q3 2009 € '000 |
Q2 2009 € '000 |
Q1 2009 € '000 |
Q4 2008 € '000 |
Q3 2008 € '000 |
|
|---|---|---|---|---|---|
| Sales revenue | 5,000 | 0 | 0 | 0 | 0 |
| Other income | 787 | 668 | 470 | 748 | 1,676 |
| Other expenses | (6,417) | (5,420) | (6,281) | (4,829) | (7,138) |
| of which research and development costs |
(5,483) | (4,321) | (5,357) | (3,608) | (5,953) |
| Operating result | (630) | (4,752) | (5,811) | (4,081) | (5,461) |
| Earnings before tax | (619) | (4,710) | (5,720) | (3,911) | (5,226) |
| Net loss for the period | (622) | (4,712) | (5,725) | (3,912) | (5,232) |
| Basic and diluted earnings per share in € |
(0.05) | (0.34) | (0.48) | (0.33) | (0.44) |
| Average number of shares issued in million |
13,780,935 | 13,780,935 | 12,023,360 | 11,962,754 | 11,962,754 |
of WILEX AG in accordance with IFRS as of 31 August 2009 and as of 30 November 2008
| Assets | 31.08.2009 € |
30.11.2008 € |
|---|---|---|
| Property, plant and equipment | 445,078 | 461,713 |
| Intangible assets | 1,328,129 | 1,426,564 |
| Other non-current assets | 23,274 | 22,689 |
| Non-current assets | 1,796,482 | 1,910,966 |
| Inventories | 22,200 | 22,200 |
| Other assets and prepayments | 1,461,880 | 1,072,248 |
| Other receivables | 116,841 | 184,888 |
| Cash and cash equivalents | 8,930,809 | 12,136,987 |
| Current assets | 10,531,731 | 13,416,323 |
| Total assets | 12,328,213 | 15,327,289 |
| Equity and liabilities | 31.08.2009 € |
30.11.2008 € |
|---|---|---|
| Subscribed capital | 13,780,935 | 11,962,754 |
| Capital reserve | 113,343,149 | 105,201,252 |
| Accumulated losses | (122,433,861) | (111,374,454) |
| Equity | 4,690,224 | 5,789,552 |
| Pension provisions | 23,274 | 22,689 |
| Liabilities arising from leases | 0 | 0 |
| Other non-current liabilities | 141,994 | 251,755 |
| Non-current liabilities | 165,268 | 274,444 |
| Trade payables | 1,912,356 | 1,787,991 |
| Liabilities arising from leases | 0 | 15,357 |
| Other current liabilities | 5,560,365 | 7,459,944 |
| Current liabilities | 7,472,721 | 9,263,293 |
| Total equity and liabilities | 12,328,213 | 15,327,289 |
of WILEX AG in accordance with IFRS for the period from 1 December 2008 to 31 August 2009
| Net loss for the period (11,059,407) (16,536,147) Adjustment for income statement items Measurement of stock options 100,276 243,166 Depreciation/amortisation 172,969 193,613 Increase in pension obligations 585 585 Finance costs 6,230 11,085 Finance income (150,499) (801,527) Tax expense 10,559 13,968 140,120 (303,507) Changes in net working capital Other receivables 68,046 (73,175) Prepayments (389,632) 103,067 Other non-current assets (585) 0 Trade payables 124,365 460,101 Other liabilities (2,061,112) (208,513) (2,258,919) 281,481 Cash flow from operating activities (13,178,206) (16,558,173) Finance costs paid (119) (6,936) Finance income received 189,029 1,114,153 Net cash flow from operating activities (12,989,296) (15,450,957) Cash flow from investing activities Purchase of property, plant and equipment (56,793) (42,101) Purchase of intangible assets (4,534) (6,931) Sale/purchase of financial investments 0 15,000,000 Net cash flow from investing activities (61,327) 14,950,968 Cash flow from financing activities Capital increase 10,000,000 0 Capital increase costs (140,198) 0 Repayment finance leases (15,357) (62,664) Net cash flow from financing activities 9,844,445 (62,664) Net change in cash and cash equivalents (3,206,178) (562,652) Cash and cash equivalents at beginning of period 12,136,987 18,795,851 |
9M 2009 € |
9M 2008 € |
|
|---|---|---|---|
| at end of period | 8,930,809 | 18,233,199 |
of WILEX AG in accordance with IFRS for the period from 1 December 2008 to 31 August 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 | 243,166 | 243,166 | ||||
| Net loss for the period | (16,536,147) | (16,536,147) | ||||
| Net change in equity | (16,292,981) | |||||
| 103,131,052 | 2,026,829 | |||||
| As of 31 August 2008 | 11,962,754 | 11,962,754 | 105,157,881 | (107,462,936) | 9,657,699 | |
| 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 | 100,276 | 100,276 | ||||
| Net loss for the period | (11,059,407) | (11,059,407) | ||||
| Capital increase after accounting for capital procurement costs |
1,818,181 | 1,818,181 | 8,041,621 | 9,859,802 | ||
| Net change in equity | (1,099,328) | |||||
| 111,172,673 | 2,170,476 | |||||
| As of 31 August 2009 | 13,780,935 | 13,780,935 | 113,343,149 | (122,433,861) | 4,690,224 |
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 nine 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 13 October 2009.
These interim financial statements as of 31 August 2009 were prepared in accordance with the same accounting policies as the annual financial statements.
Single-entity financial statements according to IFRS were prepared after WILEX Research GmbH was merged into WILEX AG during the second quarter.
After signing the strategic alliance with UCB, WILEX AG acquired WILEX Research GmbH as a wholly-owned subsidiary 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. WILEX Research GmbH was merged into WILEX AG in the second quarter.
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. In accordance with IFRS 3.62 and 3.69, this allocation will remain provisional and will be adjusted to reflect a final purchase price allocation if such allocation becomes necessary. Any adjustments of the provisional figures must be made within 12 months of the acquisition date.
The Company's subscribed capital rose to € 13.78 million as a result of the capital increase compared to 30 November 2008 and the 31 August 2008 comparative date. The number of ordinary bearer shares also rose to 13.78 million.
The capital reserve increased to € 113.34 million in the first nine months of the current financial year as a result of the capital increase less capital procurement costs (€ 8.04 million) and the measurement of stock options (€ 100.28 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 € 243.17 thousand was charged against the capital reserve in the same period the previous year for the same purpose.
The net loss of € 11.06 million for the first nine months of the financial year raised the deficit accumulated since the beginning of the Company's operations to € 122.43 million.
In conclusion, the Company's equity in the first nine months decreased by € 1.10 million to € 4.69 million, compared to a decline of € 16.29 million in the same period the previous year.
During the period from 1 December 2008 to 31 August 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 |
"To the best of our knowledge, and in accordance with the applicable reporting principles, the financial statements for the first nine 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, 13 October 2009
The Executive Management Board
Professor Olaf G. Wilhelm Peter Llewellyn-Davies Dr Paul Bevan Dr Thomas Borcholte
WILEX's share showed a highly positive development during the current financial year. Starting in March 2009, it successfully regained the ground it had lost at the start of the financial year. Since then, WILEX's share has been following an upward trend, surpassing its level at the start of the financial year by more than 40% by the end of September 2009. In contrast, the Prime Biotechnology Performance Index and shares of the German peer group rose by 18% and 28%, respectively. Deutsche Börse AG reorganised the Prime Biotechnology Index in September and adjusted all share price performance data retroactively. The shares of Jerini AG and Curasan AG (which are no longer listed in the Prime Standard) were eliminated. Mologen AG was newly added such that this subgroup of the DAX now comprises 15 biotechnology companies.
| 160 Key share figures 150 as of the end of the reporting period |
9M 2009 | 9M 2008 | |
|---|---|---|---|
| 140 | |||
| 130 120 Shares issued as of end of period |
Number | 13,780,935 | 11,962,754 |
| 110 Market capitalisation as of end of period 100 |
€ million | 66.15 | 87.30 |
| 90 Closing price (XETRA) as of end of period 80 |
€ | 4.80 | 7.30 |
| 70 High (all stock exchanges)* 60 50 |
€ | 5.38 (on 14.07.09) |
8.44 (on 09.07.08) |
| Low (all stock exchanges)* | € | 2.19 (on 19.12.08) |
4.76 (on 06.12.07) |
| Volatility (260 days; XETRA) | % | 73.62 | 62.96 |
| Average daily trading volume (all stock exchanges) | Shares | 13,881 | 8,524 |
| Average daily trading volume (all stock exchanges) | € | 49,934 | 55,335 |
| Earnings per share | € | (0.84) | (1.38) |
* Closing prices. Source: Bloomberg
The average daily trading volume of the WILEX's share also showed a positive trend. In the first nine months of the financial year, the average daily trading volume rose to 13,881 shares, up more than 60% compared to the same period the previous year (8,524 shares). Market capitalisation, which had been € 44.10 million at the end of the year's first half, increased to € 66.15 million by the end of the third quarter.
Between June and September, WILEX participated in and held presentations at a number of investor conferences, among them Sal. Oppenheim's European Healthcare Investors Conference in Frankfurt/Main, the Rodman & Renshaw 11th Annual Healthcare Conference in New York, the 9th Annual Biotech in Europe Investor Forum in Zurich and the NewsMakers in the Biotech Industry Conference in New York. The Company's presentations were very well received by analysts and investors alike.
| Date | Location | Type of report/event |
|---|---|---|
| 24 February 2010 | Munich | Annual Report 2009 |
| 24 February 2010 | Munich | Financial press conference and analysts' meeting |
| 14 April 2010 | Munich | 3-month Financial Report 2010 |
| 21 May 2010 | Munich | Annual General Meeting 2010 |
| 14 July 2010 | Munich | Half-yearly Financial Report 2010 |
| 13 October 2010 | Munich | 9-month Financial Report 2010 |
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 Tel. +49(0)89–413138–20 Tel. +49(0)89–413138–126 Fax +49(0)89–413138–98 Fax +49(0)89–413138–99 E-mail: [email protected] E-mail: [email protected]
Published by: WILEX AG, Grillparzerstr. 10, 81675 Munich, Germany Responsible for the project: Katja Arnold, WILEX AG Design by: Annika Müller, Artdirection und Design, Hamburg
The 9-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 9-month Financial Report is provided for convenience only. The German original is definitive.
As of: 13 October 2009
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