Earnings Release • Oct 13, 2010
Earnings Release
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| 9M 2010 1 € '000 |
9M 2009 1 € '000 |
Change in % |
|
|---|---|---|---|
| Earnings | |||
| Sales revenue | 0 | 5,000 | n/a |
| Other income | 1,244 | 1,925 | (35.4) |
| Operating expenses | (18,479) | (18,118) | 2.0 |
| of which research and development costs | (15,095) | (15,162) | (0.4) |
| Operating result | (17,235) | (11,193) | 54.0 |
| Earnings before tax | (17,217) | (11,049) | 55.8 |
| Net loss for the period | (17,222) | (11,059) | 55.7 |
| Earnings per share in € | (1.06) | (0.84) | 27.1 |
| Balance sheet as of end of period | |||
| Total assets | 10,994 | 12,328 | (10.8) |
| Cash and cash equivalents | 7,762 | 8,931 | (13.1) |
| Equity | 4,530 | 4,690 | (3.4) |
| Equity ratio 2 in % |
41.2 | 38.0 | 8.3 |
| Cash fl ow statement | |||
| Cash fl ow from operating activities | (13,952) | (13,178) | 5.9 |
| Cash fl ow from investing activities | (11) | (61) | (82.6) |
| Cash fl ow from fi nancing activities | 18,296 | 9,844 | 85.8 |
| Employees (number) | |||
| Employees as of end of period 3 | 72 | 67 | 7.5 |
| Employees – average for the reporting period 3 | 72 | 68 | 5.9 |
1 The reporting period begins on 1 December and ends on 31 August.
equity/total assets
3 including members of the Executive Management Board
As we reported to you in July, the fi rst half of the year was both successful and eventful in terms of our clinical activities whilst the third quarter was marked mainly by a takeover offer and a capital increase.
In July, we announced that our main shareholder, dievini Hopp BioTech, had become obliged to submit a takeover offer for the Company's shares after passing the 30 % share-holding threshold. Following publication of the offer document in July, the Executive Management Board and Supervisory Board issued a joint statement recommending shareholders to reject the offer. This recommendation to WILEX AG's shareholders was based on management's assessment that, although the offer price of € 4.10 per WILEX share was slightly above the minimum offer prescribed by law, it failed to refl ect the Company's true potential. A total of 22,953 shares (0.12 % of the share capital) were transferred to dievini Hopp Biotech before the mandatory offer closed in August.
We thank you for the trust that you placed in us in connection with the rights issue in August. It was not just the subscription ratio of 72 % that was very positive but also the large demand for additional subscriptions to shares. Due to this high level of over-subscription, each over-subscription right placed resulted in an allocation ratio of approximately 21 %. The net proceeds of the issue, amounting to approx. € 10 million, will be used to fund our ongoing clinical trials.
The clinical development of our product candidates continues on track and as planned. We are approaching the next milestone in the RENCAREX® ARISER trial and have made good progress in patient recruitment for the MESUPRON® breast cancer trial. We are currently preparing all documents, reports and analyses necessary for fi ling the US drug approval application related to our diagnostic candidate REDECTANE® in the kidney tumour indication based on the positive data from the candidate's Phase III registration trial. This is being done in close collaboration with the US Food and Drug Administration (FDA).
We are pleased that, following a comprehensive inspection by the responsible German authorities (Government of Upper Bavaria), our manufacturing site has been re-certifi ed as being in compliance with the standards and guidelines of Good Manufacturing Practice (GMP). This means that we have met another key requirement for marketing WILEX's product candidates.
Management focus in the coming months will be on activities related to the commercialisation of our product candidates, as well as securing the Company's fi nances in the medium and long term.
The next few months promise to be very interesting. We hope that you will continue to accompany us on our path.
Munich, 13 October 2010
Peter Llewellyn-Davies Chief Financial Offi cer
WILEX is a biopharmaceutical company that is focused on oncology and develops drugs with a low side-effect profi le for the targeted treatment of different types of cancer as well as diagnostic agents for the specifi c detection of these diseases. The Company's product candidates are based on antibodies and small molecules aimed at inhibiting tumour growth and preventing metastases. For a detailed description of the Company's business activities, please see the most recent annual report.
WILEX announced the fi nal data of the Phase III registration trial of its diagnostic candidate REDECTANE® (INN: Iodine (124I) Girentuximab) in the second quarter of 2010. The REDECT trial has shown that combining REDECTANE® with positron emission tomography (PET) and computer tomography (CT) is clearly superior to the use of CT alone in diagnosing clear cell renal cell carcinomas. In the trial, 226 patients were examined with PET/CT and REDECTANE® as well as with a diagnostic CT prior to kidney surgery. Subsequently, histological examinations of the surgically removed tissue samples were performed in order to verify the analyses by the radiologists and the nuclear medicine specialists. WILEX is currently preparing an application for approval (Biological License Application, BLA) with the FDA whilst working at the same time with our marketing partner, Ion Beam Applications S.A., Brussels, Belgium (IBA), on pre-marketing activities in the United States.
The Phase III ARISER trial of RENCAREX® (INN: Girentuximab) included 864 patients who had either the whole kidney or the diseased part of the kidney removed and who had no detectable metastases after surgery. These patients were randomly divided into two groups and administered either RENCAREX® or a placebo. This double-blind trial will have achieved its endpoint when disease-free survival of patients in the group treated with RENCAREX® shows a statistically signifi cant improvement compared to the placebo group. The next milestone pursuant to the study protocol is the occurrence of the 343rd relapse, which constitutes the basis for the interim analysis for effi cacy. As of the end of September 2010, a total of 335 relapses were reported to WILEX by the local trial centres.
The small-molecule product candidate MESUPRON® was examined in 95 patients with locally advanced, inoperable, non-metastatic pancreatic cancer. The fi nal data from this Phase II trial of the uPA inhibitor were published in June 2010 and met with a very positive response. This randomised, open, three-arm proof-of-concept trial studied the activity of MESUPRON® given orally once a day in combination with the chemotherapeutic agent Gemcitabine compared with Gemcitabine alone. The therapy proved to be safe and well tolerated. The tumour response rate, one-year survival and median survival of patients treated with MESUPRON® all showed an impressive improvement. The data were presented in October 2010 at the 35th ESMO Conference of the European Society of Medical Oncology in Milan, Italy.
MESUPRON® is currently also being tested in a Phase II trial in patients with metastatic HER2 receptor negative breast cancer. MESUPRON® inhibits the urokinase-specifi c plasminogen activator (uPA) system, which is believed to play an important role in cancer cell metastasis. This randomised double-blind trial is designed to examine the effi cacy of MESUPRON® in combination with the chemotherapeutic agent Capecitabine compared to Capecitabine alone. Patients receive the study medication as fi rst-line treatment after diagnosis of metastases. Of the planned 114 patients a total of 103 patients had been recruited in 21 trial centres in Europe, the USA and Brazil by the end of September 2010. The primary endpoint of the trial is progression-free survival.
WILEX acquired the mitogen-activated protein kinase (MEK) inhibitor WX-554 as a preclinical project from UCB Pharma S.A., Brussels, Belgium (UCB). MEK has been shown to play a central role in signal transduction and is linked to a multitude of biological processes such as cell division, cell differentiation and cell death. The MEK signalling pathway is over expressed in more than 30 % of cancers, resulting in uncontrolled cell growth and proliferation. The fi rst Phase I trial commenced in late 2009 and the trial data were announced in June 2010. This dose escalation trial aimed to determine safety, tolerability and the optimal biological dose for inhibition of the MEK system by WX-554. The study, which was conducted in Germany, tested fi ve increasing dose levels, each administered once by a 15-minute infusion of WX-554 in fi ve healthy male volunteers. In addition to safety and tolerance, the pharmacokinetic and pharmacodynamic properties of the MEK inhibitor were also investigated. The substance was safe and well tolerated in the 25 healthy volunteers. The MEK signal transduction pathway was inhibited in a dose-dependent manner reaching complete inhibition at 1 mg / kg WX-554.
Preclinical trials are being carried out in connection with the orally administered PI3K inhibitor WX-037, which WILEX also took over from UCB. The phosphatidylinositol-3-kinase/protein kinase (PI3K) signalling pathway sends a "growth" signal to the nucleus of a tumour cell and is mutated in many types of cancer. The antibody-based projects acquired from UCB are currently in the research and validation phase.
WILEX believes that the market environment for antibodies and small molecules has not changed signifi cantly compared to the disclosures made in the 2009 annual fi nancial statements. For more detailed information, please see pages 34 and 35 of the Annual Report 2009.
WILEX posted earnings before taxes of € –17.22 million (previous year: € –11.05 million) in the fi rst nine months of the 2010 fi nancial year (1 December 2009 to 31 August 2010). At € 17.22 million, the net loss for the period was 55.7 % above the previous year's fi gure (€ 11.06 million). Earnings per share decreased to € –1.06 (previous year: € –0.84).
WILEX did not recognise any sales revenue in the fi rst nine months of 2010 (previous year: € 5.00 million).
At € 1.24 million, other income fell 35.4 % compared to the previous year (€ 1.92 million). Income from the US Department of Defense grants for the uPA programme in the amount of € 0.40 million (previous year: € 0.27 million) increased year on year due to the project's degree of completion. Income realised from the licence agreements with Esteve and IBA was € 0.84 million (previous year: € 1.50 million), mainly impacted by the REDECT trial. Income from the reversal of other provisions declined to € 0.01 million year on year (previous year: € 0.15 million). Prepayments received for research projects are accrued and recognised as other income in line with project costs (percentage-of-completion method).
Operating expenses including depreciation, amortisation and impairment losses amounted to € 18.48 million, up almost 2.0 % from the previous year (€ 18.12 million).
Research and development costs were € 15.09 million, corresponding to 81.7 % of operating expenses. They were 0.4 % lower year on year (previous year: € 15.16 million). The ongoing clinical development of the monoclonal antibody Girentuximab for RENCAREX® and REDECTANE® accounted for 47.6 % of the research and development costs but was lower year on year (previous year: 69.2 %) due to the project's degree of completion. The uPA programme involving the small-molecule drug candidate MESUPRON® accounted for approximately 35.1 % (previous year: 19.5 %). The planned increase is due to the expenditures for the breast cancer trial given the progress made in patient recruitment. The other projects, which mainly comprise the programmes acquired from UCB, account for 17.3 % of our research and development costs. The costs of the WX-554 Phase I trial, preclinical work on WX-037 and research on antibodies were higher year on year (11.3 %).
Administrative costs were € 3.38 million, up 14.5 % from the previous year (€ 2.96 million). The increase is due to the fi rstquarter rise in staff costs which was triggered by the revaluation of the stock options and to consultancy costs incurred as part of the takeover offer, amongst others.
Finance income fell to € 21 k in the reporting period (previous year: € 150 k) due to the use of cash as planned and lower interest rates. The Company exclusively used short-term deposits for investing its liquid funds (e. g. overnight money). Finance costs comprising interest expense and the interest element of liabilities were approximately € 3 k (previous year: € 6 k). The fi nancial result thus fell from € 144 k the previous year to € 18 k this year.
The Company carried out a rights issue in the third quarter during which all 2,455,070 new no par value bearer shares were subscribed at the subscription price of € 4.10 per share in accordance with subscription and oversubscription rights. Following the entry of the capital measure in the Commercial Register on 5 August 2010, the total number of WILEX shares issued increased to 18,413,035. Shareholders exercised subscription rights for a total of 1,766,498 new shares, which corresponds to a subscription ratio of approximately 72 %. A total of 688,572 shares were available under shareholders' oversubscription rights. The shareholders had registered their demand for an additional 3,275,479 shares at the subscription price. The capital increase was therefore substantially oversubscribed and fulfi lled based on an allocation quota of about 21 %. WILEX AG plans to use the net proceeds of approximately € 10 million from the rights issue to fi nance its ongoing clinical studies and continued growth as well as to enhance its equity.
At the end of the third quarter of 2010, the Company had cash and cash equivalents of € 7.76 million (30 November 2009: € 3.41 million; 31 August 2009: € 8.93 million).
The net cash fl ow from operating activities during the reporting period was € –13.93 million (previous year: € –12.99 million). At € 10.65 k, the net cash used in investing activities was insignifi cant (previous year: € 61.33 k). The net cash fl ow from fi nancing activities in the fi rst nine months was € 18.30 million (previous year: € 9.84 million) and was generated by the cash capital increases executed in the fi rst and third quarter. Total net infl ow of cash and cash equivalents was € 4.35 million (previous year: outfl ow of € 3.21 million). Adjusted for the effects of both the cash capital increase and the milestone payment in the fi rst quarter, WILEX's average use of cash per month in the reporting period was € 2.11 million (previous year: € 2.01 million).
Total assets as of 31 August 2010 amounted to € 10.99 million (30 November 2009: € 12.01 million).
At € 9.08 million, current assets at the end of the reporting period were lower than at the close of the 2009 fi nancial year (€ 10.13 million).
Non-current assets as of 31 August 2010 amounted to € 1.91 million (30 November 2009: € 1.88 million). Intangible assets essentially comprise licence fees and royalties from various cooperation agreements. At € 1.20 million, these were slightly lower than on 30 November 2009 (€ 1.29 million). Property, plant and equipment amounting to € 0.55 million (30 November 2009: € 0.42 million) primarily concerns laboratory and offi ce equipment. The increase stems from a new leasing contract related to the purchase of one item of laboratory equipment.
Equity as of the end of the reporting period was € 4.53 million (30 November 2009: € 3.04 million). The two capital measures carried out in the 2010 fi nancial year had a substantial impact on the development of equity compared to the close of the 2009 fi nancial year. New no par value bearer shares were issued in connection with the cash capital increase from authorised capital that was carried out in the third quarter of the fi nancial year to raise the Company's share capital by € 2,455,070.00 to € 18,413,035.00. The changes in equity are explained in more detail in the notes on page 13.
Non-current liabilities fell by 38.0 % to € 0.38 million, down from € 0.62 million as of 30 November 2009. Lease liabilities in the amount of € 0.10 million, which did not exist in the previous year, have been recognised since the second quarter of 2010. Other non-current liabilities of € 0.26 million as of 31 August 2010 (30 November 2009: € 0.59 million) comprised the accrual related to payments from the US Department of Defense over a period of more than one year, the accrual for rented offi ces as well as the liability for employment anniversaries.
Non-current liabilities decreased to € 6.08 million as of the end of the period (30 November 2009: € 8.35 million). Other current liabilities fell to € 4.09 million (30 November 2009: € 6.25 million) due to the progress of the Phase III trials and the fact that the accruals related to the payments from Esteve and IBA were recognised as income. Trade payables amounted to € 1.93 million (30 November 2009: € 2.10 million).
At the end of the reporting period, 72 employees (30 November 2009: 71; 31 August 2009: 67), including Executive Management Board members, were employed by WILEX. The Company 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 fi rst nine months of the fi nancial year, no subscription rights were issued to employees and members of the Executive Management Board. WILEX has issued a total of 1,076,424 subscription rights to employees and members of the Executive Management Board, of which 901,734 options were outstanding at the end of the reporting period. A total of 387,423 subscription rights were available for issuance to employees and to members of the Executive Management Board on 31 August 2010. No stock options were exercised to date.
The risks and opportunities that arise in connection with WILEX's business are described in detail on pages 42 to 47 of the Annual Report 2009. We refer particularly to the fi nancing risks and going concern risks described therein. 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 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.
Following an inspection by the Central Drug Monitoring Offi ce of the government of Upper Bavaria, WILEX was re-certifi ed in September 2010 as being in compliance with the principles and guidelines of Good Manufacturing Practice (GMP). At the same time, the manufacturing and import authorisation pursuant to section 13 and section 72 Arzneimittelgesetz (German Drug Act – AMG) for the production, testing and release of investigational medicinal products for clinical trials and drugs was updated. The comprehensive GMP inspection at WILEX had been conducted in July 2010. The GMP certifi cate is an important prerequisite for marketing all of WILEX's product candidates.
We are currently in talks with the FDA with respect to our diagnostic candidate REDECTANE®, and the BLA is being prepared. At the same time, we are carrying out pre-marketing activities in the United States jointly with our marketing partner, IBA.
WILEX expects the 343rd relapse in the RENCAREX® Phase III ARISER trial – i. e. the next milestone according to the study protocol – to occur by the end of the year. Once the 343rd relapse has occurred, all available data from the 864 patients will be collected and the independent centralised evaluations of all patients' radiological scans performed. Subsequently, an independent interim analysis of effi cacy of RENCAREX® will be initiated and conducted by the Independent Data Monitoring Committee (IDMC). This analysis will provide critical information regarding the trial endpoint – disease-free survival – which could form the basis for the European application for marketing approval.
Patient recruitment in the MESUPRON® Phase II trial in the breast cancer indication is likely to be completed by the fi rst quarter of 2011. WILEX expects the data from this study to be available in 2012, given the trial endpoint – progression-free survival.
The activities related to the commercialisation of our product candidates, as well as the Company's funding in the medium and long term, will be at the forefront of the management's activities in the coming months.
of WILEX AG in accordance with IFRS for the period from 1 December 2009 to 31 August 2010
| 9M 2010 € |
9M 2009 € |
Q3 2010 € |
Q3 2009 € |
|
|---|---|---|---|---|
| Sales revenue | 0 | 5,000,000 | 0 | 5,000,000 |
| Other income | 1,243,624 | 1,924,790 | 331,145 | 786,550 |
| Income | 1,243,624 | 6,924,790 | 331,145 | 5,786,550 |
| Research and development costs | (15,094,694) | (15,161,521) | (4,900,057) | (5,483,408) |
| Administrative costs | (3,384,139) | (2,956,387) | (1,101,347) | (933,364) |
| Operating expenses | (18,478,833) | (18,117,908) | (6,001,404) | (6,416,772) |
| Operating result | (17,235,209) | (11,193,118) | (5,670,259) | (630,222) |
| Finance income | 21,184 | 150,499 | 4,263 | 9,599 |
| Finance costs | (3,034) | (6,230) | 530 | 1,746 |
| Financial result | 18,150 | 144,270 | 4,792 | 11,346 |
| Earnings before tax | (17,217,059) | (11,048,848) | (5,665,467) | (618,876) |
| Income tax | (5,311) | (10,559) | (944) | (3,381) |
| Net loss for the period | (17,222,370) | (11,059,407) | (5,666,411) | (622,257) |
| Earnings per share | ||||
| Basic and diluted earnings per share | (1.06) | (0.84) | (0.34) | (0.05) |
| Average number of shares issued | 16,176,052 | 13,203,629 | 16,678,475 | 13,780,935 |
Rounding of exact fi gures may result in differences.
of WILEX AG in accordance with IFRS
| Q3 2010 € '000 |
Q2 2010 € '000 |
Q1 2010 € '000 |
Q4 2009 € '000 |
Q3 2009 € '000 |
|
|---|---|---|---|---|---|
| Sales revenue | 0 | 0 | 0 | 5,000 | 5,000 |
| Other income | 331 | 349 | 564 | 1,089 | 787 |
| Operating expenses | (6,001) | (6,508) | (5,969) | (7,760) | (6,417) |
| of which research and development costs |
(4,900) | (5,418) | (4,777) | (6,661) | (5,483) |
| Operating result | (5,670) | (6,160) | (5,405) | (1,671) | (630) |
| Earnings before tax | (5,665) | (6,157) | (5,394) | (1,665) | (619) |
| Net loss for the period | (5,666) | (6,156) | (5,400) | (1,670) | (622) |
| Basic and diluted earnings per share in € |
(0.34) | (0.39) | (0.34) | (0.12) | (0.05) |
| Average number of shares issued in million |
16.68 | 15.96 | 15.89 | 13.78 | 13.78 |
of WILEX AG in accordance with IFRS as of 31 August 2010 and as of 30 November 2009
| 31.08.2010 | 30.11.2009 | |
|---|---|---|
| Assets | € | € |
| Property, plant and equipment | 551,622 | 424,080 |
| Intangible assets | 1,197,398 | 1,293,821 |
| Other non-current assets | 161,612 | 160,715 |
| Non-current assets | 1,910,633 | 1,878,617 |
| Inventories | 34,100 | 34,100 |
| Other assets and prepayments | 1,198,480 | 1,348,781 |
| Trade receivables | 0 | 5,017,864 |
| Other receivables | 88,835 | 322,260 |
| Cash and cash equivalents | 7,762,207 | 3,411,063 |
| Current assets | 9,083,622 | 10,134,069 |
| Total assets | 10,994,254 | 12,012,686 |
| Equity and liabilities | 31.08.2010 € |
30.11.2009 € |
|---|---|---|
| Subscribed capital | 18,413,035 | 13,780,935 |
| Capital reserve | 127,443,362 | 113,367,618 |
| Accumulated losses | (141,326,086) | (124,103,716) |
| Equity | 4,530,311 | 3,044,837 |
| Pension provisions | 24,163 | 23,533 |
| Liabilities arising from leases | 96,288 | 0 |
| Other non-current liabilities | 261,528 | 592,997 |
| Non-current liabilities | 381,979 | 616,530 |
| Trade payables | 1,929,795 | 2,099,138 |
| Liabilities arising from leases | 57,773 | 0 |
| Other current liabilities | 4,094,397 | 6,252,181 |
| Current liabilities | 6,081,964 | 8,351,318 |
| Total equity and liabilities | 10,994,254 | 12,012,686 |
of WILEX AG in accordance with IFRS for the period from 1 December 2009 to 31 August 2010
| 9M 2010 € |
9M 2009 € |
|
|---|---|---|
| Net loss for the period | (17,222,370) | (11,059,407) |
| Adjustment for income statement items | ||
| Measurement of stock options | 428,969 | 100,276 |
| Depreciation/amortisation | 157,194 | 172,969 |
| Increase in pension obligations | 630 | 585 |
| Finance costs | 3,034 | 6,230 |
| Finance income | (21,184) | (150,499) |
| Tax expense | 5,311 | 10,559 |
| 573,954 | 140,120 | |
| Changes in net working capital | ||
| Trade receivables | 5,017,864 | 41,912 |
| Other receivables | 233,425 | 26,134 |
| Prepayments | 150,302 | (389,632) |
| Other non-current assets | (897) | (585) |
| Trade payables | (169,343) | 124,365 |
| Other liabilities | (2,534,753) | (2,061,112) |
| 2,696,598 | (2,258,919) | |
| Cash fl ow from operating activities | (13,951,818) | (13,178,206) |
| Finance costs paid | (3,255) | (119) |
| Finance income received | 21,184 | 189,029 |
| Net cash fl ow from operating activities | (13,933,889) | (12,989,296) |
| Cash fl ow from investing activities | ||
| Purchase of property, plant and equipment | (6,646) | (56,793) |
| Purchase of intangible assets | (4,002) | (4,534) |
| Net cash fl ow from investing activities | (10,648) | (61,327) |
| Cash fl ow from fi nancing activities | ||
| Proceeds from capital increase | 18,991,610 | 10,000,000 |
| Capital increase costs | (672,325) | (140,198) |
| Repayment fi nance leases | (23,605) | (15,357) |
| Net cash fl ow from fi nancing activities | 18,295,680 | 9,844,445 |
| Net change in cash and cash equivalents | 4,351,143 | (3,206,178) |
| Cash and cash equivalents | ||
| at beginning of period | 3,411,063 | 12,136,987 |
| at end of period | 7,762,207 | 8,930,809 |
of WILEX AG in accordance with IFRS for the period from 1 December 2009 to 31 August 2010
| Capital reserve | ||||||
|---|---|---|---|---|---|---|
| Shares | Subscribed capital € |
Capital measures/ premium € |
Measurement of stock options € |
Accumulated losses € |
Total € |
|
| 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 | |
| 111,172,673 | 2,194,945 | |||||
| As of 1 December 2009 | 13,780,935 | 13,780,935 | 113,367,618 | (124,103,716) | 3,044,837 | |
| Measurement of stock options | 428,969 | 428,969 | ||||
| Net loss for the period | (17,222,370) | (17,222,370) | ||||
| Capital increase after accounting for capital procurement costs |
4,632,100 | 4,632,100 | 13,646,775 | 18,278,875 | ||
| Net change in equity | (1,485,474) | |||||
| 124,819,448 | 2,623,914 | |||||
| As of 31 August 2010 | 18,413,035 | 18,413,035 | 127,443,362 | (141,326,086) | 4,530,311 |
Rounding of exact fi gures may result in differences.
"To the best of our knowledge, and in accordance with the applicable reporting principles, the fi nancial statements for the fi rst nine months give a true and fair view of the assets, liabilities, fi nancial position and profi t 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 material opportunities and risks associated with the expected development of WILEX AG."
Munich, 13 October 2010
Executive Management Board
Professor Olaf G. Wilhelm Peter Llewellyn-Davies Dr Paul Bevan Dr Thomas Borcholte
The interim fi nancial 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 fi nancial statements must be read in the context of the annual fi nancial statements as of 30 November 2009 published by the Company for the 2009 fi nancial year.
The Company's assets, liabilities and fi nancial position as well as individual items of the fi nancial statements for the fi rst nine months are explained in detail in the interim management report.
As the business activities do not differ signifi cantly in their risk/reward profi les, WILEX operates in one segment only and therefore does not prepare segment reporting. The Company's business activities are not subject to seasonal infl uences.
The interim fi nancial statements were not subjected to a review. Pursuant to our Declaration of Compliance from 18 February 2010 with Section 7.1.2 of the German Corporate Governance Code, both the interim fi nancial statements and the management report were discussed with the Supervisory Board's Audit Committee before being published. The 9-month fi nancial report was approved for publication by the Executive Management Board on 13 October 2010.
These interim fi nancial statements as of 31 August 2010 were prepared in accordance with the same accounting policies as the annual fi nancial statements as of 30 November 2009.
Equity as of the end of the reporting period was € 4.53 million (30 November 2009: € 3.04 million). The subscribed capital amounted to € 18.41 million compared to € 13.78 million as of 30 November 2009. The capital reserve was € 127.44 million (30 November 2009: € 113.37 million) and the losses accumulated since the Company's foundation totalled € 141.33 million (30 November 2009: € 124.10 million). The equity ratio was 41.2 % as of 31 August 2010 (30 November 2009: 25.3 %; 31 August 2009: 38.0 %).
The capital measure that was carried out in the fi rst quarter of 2010 resulted in higher expenditure from the measurement of stock options, which is also refl ected in the half-yearly fi nancial statements. If the Company increases its share capital by issuing new shares in connection with a capital increase subject to shareholders' subscription right and if the subscription price per share is lower than the exercise price fi xed in the option offer, under Article 7 para. 1 of the option terms the exercise price shall be reduced by the difference. Given that no stock options had been exercised under Tranches 1 through 7 by the time the exercise price was repriced, said repricing affected all stock options under these tranches that have not yet expired. All aspects and model parameters were explained in detail on pages 14 and 15 of the 3-month fi nancial report.
WILEX incurred the following costs under the stock option plan as of the reporting date, taking the repricing of the exercise price into account:
| 9M 2010 € '000 |
9M 2009 € '000 |
|
|---|---|---|
| Expenses from equity-based compensation transactions |
429 | 100 |
The following reportable purchases were made by members of the Supervisory Board during the 2010 reporting period:
| Name | Date | Trans action |
Market place |
Price € |
Number | Volume € |
|---|---|---|---|---|---|---|
| Andreas R. Krebs | 06.08.2010 | Purchase | Frankfurt | 4.60 | 18,338 | 84,354.80 |
| Dr Georg Baur | 05.08.2010 | Purchase | XETRA | 4.59 | 30,000 | 138,983.45 |
| Dr Georg Baur | 05.08.2010 | Purchase | OTC | 4.10 | 25,750 | 105,575.00 |
| Andreas R. Krebs | 05.08.2010 | Purchase | OTC | 4.10 | 10,662 | 43,714.20 |
| Professor Friedrich von Bohlen und Halbach and Professor Christof Hettich 1 |
30.07.2010 | Purchase | OTC | 4.10 | 875,338 | 3,588,885.80 |
| Andreas R. Krebs | 20.07.2010 | Purchase | Frankfurt | 4.92 | 1,000 | 4,920.40 |
| Professor Friedrich von Bohlen und Halbach and Professor Christof Hettich 1 |
28.05.2010 | Purchase | OTC | 3.90 | 704,966 | 2,749,367.40 |
| Professor Friedrich von Bohlen und Halbach and Professor Christof Hettich 1 |
27.05.2010 | Purchase | OTC | 3.90 | 356,923 | 1,391,999.70 |
| Professor Friedrich von Bohlen und Halbach 1 |
07.12.2009 | Purchase | OTC | 4.10 | 362,869 | 1,487,762.90 |
| Professor Friedrich von Bohlen und Halbach 1 |
08.12.2009 | Loan of securities 2 |
OTC | 30,000 | 944,449 | 30,000.00 |
1 Professor Friedrich von Bohlen und Halbach and Professor Christof Hettich did not carry out transactions of their own but acted indirectly in their capacity as Managing Directors of dievini Verwaltungs GmbH, which is the general partner of dievini Biotech holding GmbH und Co. KG.
2 The loan of securities was a technical transaction that must be disclosed in connection with the capital increase but did not change the number of shares overall.
No other relationships to related parties exist.
WILEX's share started the year at € 3.65 and closed the third quarter on 30 September 2010 at € 4.69, posting a gain of 28 %. While the DAXsubsector Biotechnology Index gained just under 5 % compared to the start of the year, the NASDAQ Biotechnology Index lost 12 % of its value during the year's fi rst nine months. The rapid rise in the Company's share price in late May was triggered by the positive data related to the REDECTANE® and MESUPRON® trials, as well as the fact that dievini Hopp BioTech and UCB fully took over APAX's equity interest in WILEX. The announcement of both the offer price of € 4.10 per share for dievini Hopp BioTech's mandatory offer and the subscription price of € 4.10 per share for the capital increase that was carried out simultaneously helped to dispel speculations over a takeover battle.
| Key share fi gures | |||
|---|---|---|---|
| as of the end of the reporting period | 9M 2010 | 9M 2009 | |
| Shares issued | Number | 18,413,035 | 13,780,935 |
| Market capitalisation | € million | 79.91 | 67.53 |
| Closing price (XETRA) | € | 4.34 (31.08.10) | 4.90 (31.08.09) |
| High (all stock exchanges) | € | 7.30 (21.06.10) | 5.38 (14.07.09) |
| Low (all stock exchanges) | € | 3.35 (09.03.10) | 2.10 (22.12.08) |
| Volatility (260 days, XETRA) | % | 68.2 | 73.62 |
| Average daily trading volume (all stock exchanges) | Shares | 48,403 | 13,955 |
| Average daily trading volume (all stock exchanges) | € | 214,377 | 50,201 |
| Earnings per share | € | (1.06) 1 | (0.84) |
1 based on an average of 16,176,052 shares outstanding
Source: Bloomberg
The average daily trading volume of WILEX's shares in the fi rst nine months of the fi nancial year had more than tripled with 48,403 shares compared to 13,955 shares in the previous year. Especially in the third quarter, this development was heavily infl uenced by the capital measure and the mandatory offer. The Company's market capitalisation was about € 85 million at the end of September.
The shareholder structure is as follows, given the capital measure and the mandatory offer by dievini Hopp BioTech:
| Date | |
|---|---|
| 22 February 2011 | Annual Report 2010; Financial press conference and analysts' meeting |
| 13 April 2011 | 3-month Financial Report 2011 |
| 18 May 2011 | Annual General Meeting 2011 |
| 19 July 2011 | Half-yearly Financial Report 2011 |
| 13 October 2011 | 9-month Financial Report 2011 |
Grillparzerstr. 10 81675 Munich, Germany Tel. + 49 (0) 89 – 41 31 38 – 0 Fax + 49 (0) 89 – 41 31 38 – 99 www.wilex.com [email protected]
Fax + 49 (0) 89 – 41 31 38 – 98 Fax + 49 (0) 89 – 41 31 38 – 99 E-mail: [email protected] E-mail: [email protected]
Chief Financial Offi cer Senior Manager Corporate Communications Tel. + 49 (0) 89 – 41 31 38 – 20 Tel. + 49 (0) 89 – 41 31 38 – 126
Responsible for the project: Katja Arnold, WILEX AG
Published by: WILEX AG, Grillparzerstr. 10, 81675 Munich, Germany Design by: Annika Häussler, Artdirektion und Grafi kdesign, 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 defi nitive.
As of: 12 October 2010
WILEX AG Grillparzerstr. 10 · 81675 Munich · Germany · www.wilex.com
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