Quarterly Report • Oct 11, 2012
Quarterly Report
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| 9M 20121 € '000 |
9M 20111 € '000 |
|
|---|---|---|
| Earnings | ||
| Sales revenue | 11,359 | 4,738 |
| Other income | 1,472 | 814 |
| Operating expenses | (19,799) | (18,416) |
| of which research and development costs | (9,735) | (13,595) |
| Operating result | (6,968) | (12,864) |
| Earnings before tax | (7,418) | (13,228) |
| Net loss for the period | (7,420) | (13,230) |
| Earnings per share in € | (0.31) | (0.65) |
| Balance sheet as of the end of the period | ||
| Total assets | 43,174 | 32,398 |
| Cash and cash equivalents | 28,677 | 8,073 |
| Equity | 21,449 | 4,638 |
| Equity ratio 2 in% |
49.7 | 14.3 |
| Cash flow statement | ||
| Cash flow from operating activities | 111 | (3,370) |
| Cash flow from investing activities | (268) | (399) |
| Cash flow from financing activities | 25,440 | 9,907 |
| Employees (number) | ||
| Employees as of the end of the period | 127 | 119 |
| Employees as of the end of the period (full-time equivalents) 3 | 118 | 111 |
1 The reporting period begins on 1 December and ends on 31 August.
Equity/total assets
3 Including Heidelberg Pharma (from March 2011) and members of the Executive Management Board
In August, WILEX AG announced plans to appoint a new CFO. After six years as Chief Financial Officer of WILEX AG, Peter Llewellyn-Davies left the Executive Management Board at the end of his contract. Dr Jan Schmidt-Brand succeeded him as CFO on 1 September 2012. A trained lawyer, Dr Schmidt-Brand is the Managing Director of WILEX's subsidiary Heidelberg Pharma GmbH. Up to 2011 he was a member of the Management Board of Heidelberg Pharma AG until it was taken over by WILEX and the legal form was changed. His experience in the industry stems from positions such as Managing Director of Austrian BASF Pharma subsidiary, EBEWE Arzneimittel GmbH, and from various positions within the BASF Group, most recently as an executive in the central tax department with a general commercial power of attorney ("Prokurist"). Dr Schmidt-Brand is also a member of the Board of BIO Deutschland and Head of the Finance and Tax working group. We look forward to working together and to continuing the successful development of WILEX AG.
Thanks to the capital increase against cash and contributions in kind we successfully implemented in the third quarter, we are in a very good position to carry out the important tasks we face. This capitalisation measure enabled us to significantly reduce the financial liabilities of WILEX AG without adversely affecting the Company's liquidity. Moreover, the cash portion of the rights issue generated gross proceeds of around €16.1 million for the Company which together with Prometheus's payment of USD 17.5 million in July 2012 will allow us to finance the ongoing and planned clinical trials and further growth into 2014. We would like to thank you as a shareholder in WILEX AG for the trust you have placed in us.
A meeting of the Oncologic Drugs Advisory Committee (ODAC) was held in July 2012 which will influence the development of the diagnostic candidate REDECTANE®. The Advisory Committee addressed the question of whether the identification of a clear cell renal cell carcinoma through imaging provides clinically relevant information in patients with indeterminate renal masses. ODAC answered with a clear vote in favour of the clinical use of the diagnostic agent. The FDA has accepted the vote of this independent committee of experts in writing and confirmed that the outcomes-based study it required in the past to be no longer necessary. However, the FDA requires a further study to provide additional proof of the diagnostic performance and safety of REDECTANE®. We assume that this trial must be successfully completed prior to approval. WILEX is currently developing the protocol for this Phase III trial (REDECT 2) for submission to the FDA on the basis of a special protocol assessment.
We will witness an important event for our drug candidate RENCAREX®. This quarter we are expecting the results of the Phase III ARISER trial in the clear cell renal cell carcinoma indication. The data on disease-free survival (DFS data) will be analysed statistically and evaluated by our Independent Data Monitoring Committee (IDMC). The recommendation of the IDMC will be released to the public as soon as we have them. If the results are positive, the marketing authorisation application could be submitted by WILEX in Europe in the first half of 2013 followed by our partner Prometheus in the United States.
We anticipate an eventful fourth quarter and look forward to your continuing support.
Munich, 11 October 2012
Professor Olaf G. Wilhelm Dr Jan Schmidt-Brand Chief Executive Officer Chief Financial Officer
WILEX is a biopharmaceutical company focused on oncology with an attractive portfolio of diagnostic and therapeutic products for the detection and the targeted treatment of various types of cancer. Our therapeutic product candidates are based on antibodies and small molecules. They are designed to have a low side-effect profile, inhibit tumour growth and prevent metastases.
Our business model includes the marketing of oncological biomarker tests through our US subsidiary WILEX Inc. Our second subsidiary, Heidelberg Pharma GmbH, offers an innovative platform technology for therapeutic antibody drug conjugates (ADCs) and operates a preclinical service business within the scope of Customer Specific Research.
The WILEX Group's business activities are subdivided into three segments: Therapeutics (Rx), Diagnostics (Dx) and Customer Specific Research (Cx).
RENCAREX® (INN: Girentuximab) is currently in a Phase III registration trial for the adjuvant therapy of non-metastatic clear cell renal cell carcinoma. The ARISER trial conducted at more than 140 trial centres in 14 countries enrolled 864 patients who had undergone either total or partial nephrectomy and who had no detectable metastases after surgery.
In November 2011, the Independent Data Monitoring Committee (IDMC) recommended cancelling the planned interim analysis and, instead, moving directly to the final analysis for the endpoint disease-free survival (DFS). Given the continued decline in the relapse rate in the past year and although the data remained blinded, the IDMC also stated that the trial was sufficiently advanced for the final DFS analysis to be conducted based on 360 relapses and not, as originally planned, following 512 relapses.
The FDA and European regulatory authorities approved the amendment of the study protocol in February 2012. Over the past few months, all existing clinical data and radiological findings for the patients included in the trial were collected at the trial centres, checked and then imported into a database for independent evaluation. The DFS data will be analysed statistically and the trial results evaluated by the IDMC in the fourth quarter of 2012.
Under the licence agreement with Prometheus Laboratories Inc. (Prometheus), San Diego, CA, USA, concerning the US commercial rights to RENCAREX®, WILEX AG resolved in July 2012 to call a further cash payment from the licence agreement with Prometheus. WILEX had the option to receive a payment or to be granted the commercial rights in Europe to an undisclosed product. The payment of USD 17.5 million was made in July. Additionally, the milestone payment due upon regulatory submission of RENCAREX® increases by USD 2.5 million and substitutes a later milestone for the same amount. The parties mutually terminated the negotiations for the commercial rights to an undisclosed product in Europe. Prometheus will co-fund the development of RENCAREX® and WILEX is entitled to milestone payments and royalty payments on net sales of RENCAREX® in the USA.
MESUPRON® (INN: Upamostat) is a small molecule drug candidate developed by WILEX AG to inhibit the Urokinase Plasminogen Activator (uPA) system. The uPA system seems to play a key role in tumour cell invasion and metastasis, as well as in the growth of solid primary tumours.
In June 2012, WILEX AG published data from its Phase II trial with its oral drug candidate MESUPRON® in first line treatment of patients with HER2-receptor negative metastatic breast cancer. A total of 132 patients in 20 centres in five countries were recruited for the study. The double blind randomised study evaluated the efficacy and safety of MESUPRON® 200 mg oral once daily in combination with Capecitabine compared to Capecitabine alone (control group).
The primary objective of the study was to evaluate the efficacy of the combination of MESUPRON® and Capecitabine compared to monotherapy with Capecitabine by assessment of progression-free survival (PFS). In the total study population (intent to treat; ITT), MESUPRON® led to a modest increase of median progression-free survival from 7.5 months in the control group to 8.3 months with the combination therapy. The tumour response rate in the control group was 9%. Co-administration of MESUPRON® 200 mg almost doubled the response rate to 17%. The combination therapy of MESUPRON® and Capecitabine was safe and well tolerated.
Metastatic breast cancer is a heterogeneous disease. To test whether MESUPRON® shows efficacy in more homogeneous patient sub-populations, two subgroups were identified which had sufficient numbers of patients to allow separate analysis. In the subgroup of patients who were Caucasian (n =109), median PFS improved from 7.5 months in the control group to 9.1 months in patients treated with MESUPRON®. In the subgroup of patients (n = 95) who had received adjuvant chemotherapy following the primary diagnosis of breast cancer, PFS improved from 4.3 months in the Capecitabine group to 8.3 months in the MESUPRON® combination group.
By meeting its primary objective (improving progression-free survival) and its secondary objectives (objective response rate, safety and tolerability as well as pharmacokinetics) in this proof-of-concept study, WILEX AG has successfully confirmed an important potential role for MESUPRON® in cancer therapy. The trial has therefore been terminated.
It is planned to sign a licence agreement with a partner for MESUPRON® and decide the further development strategy together with the future partner.
Mitogen-activated protein kinase (MEK) has been shown to play a central role in signal transduction. The MEK signalling pathway is overexpressed in more than 30% of cancers, resulting in uncontrolled tumour cell growth.
In April 2012, WILEX announced the start of a Phase Ib/II dose escalation trial with cancer patients. This open-label trial will investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of WX-554 in patients with solid tumours. After a dose escalation part to confirm the biologically effective dose, a dose expansion part will follow that focuses on patients with MEK pathway relevant mutations to investigate clinical activity. The study is being conducted within the Experimental Cancer Medicine Centre (ECMC) network in the UK.
The small molecule agent WX-037 binds to the phosphatidylinositol-3-kinase-B pathway (PI3K). The PI3K pathway sends a "growth" signal to the nucleus of a tumour cell. It has been shown that mutations of the PI3K signalling pathway are present in most types of cancer. Identifying an inhibitor for the PI3K signalling pathway is thus of therapeutic interest.
With the WX-037 project, which is still in a preclinical stage, WILEX AG is participating in the m4 Personalised Medicine and Targeted Therapies initiative of the Munich-based m4 Biotech Cluster and received a funding commitment of up to €2.6 million from the Federal Ministry of Education and Research (BMBF). Within the project, WX-037 will be tested in preclinical models as a monotherapy and in combination with the MEK inhibitor WX-554 before being transferred to clinical development in cancer patients. In recent months, several preclinical trials concerning toxicology, pharmacology and pharmacokinetics were conducted and the process for producing WX-037 in capsule form was developed.
Two of the three antibody-based projects acquired from UCB Pharma are in the research phase. The third project is not being pursued. The aim is to identify a specific antibody that binds to each new target structure. The unpublished molecular targets of the antibody-based projects play different roles in spreading cancer or are overexpressed on tumour cells of various carcinomas.
A Phase III trial for the imaging diagnostic candidate REDECTANE® (INN: 124I-Girentuximab) was completed and the final data were announced in 2010. In the trial, 226 patients were examined with REDECTANE® PET/CT (positron emission tomography/computer tomography) as well as with state-of-the-art CT prior to kidney surgery. The trial showed that REDECTANE® with PET/CT is clearly superior to CT alone in diagnosing clear cell renal cell carcinomas.
The FDA suggested in the second quarter of 2011 that WILEX AG and IBA Pharma SPRL, Louvain-la-Neuve, Belgium (IBA, formerly IBA Pharma S.A.) consider conducting an outcomes-based study to obtain additional evidence of the product's clinical usefulness. However, WILEX, IBA and external medical advisors were of the opinion that such a trial could only be conducted as a Phase IV trial after market approval. Thus, in the fourth quarter of 2011, a Type C meeting took place at the FDA, in which the further development of REDECTANE® was outlined, including the scheduling of a second trial and the options to conduct an "outcomes-based study" or a "confirmatory" study similar to the REDECT trial to confirm the candidate's diagnostic performance. The FDA suggested resolving the question of clinical usefulness and the resulting regulatory pathway with an FDA Advisory Committee.
The following question was discussed in the Oncologic Drugs Advisory Committee (ODAC) meeting on 25 July 2012: "Would an imaging test provide useful clinical information if it identified only clear cell renal cell carcinoma (ccRCC) within the kidney of patients with an indeterminate renal mass?" The Advisory Committee voted by 16 to 0 (1 abstention) in support of the imaging information being clinically useful. As the ODAC provides the FDA with independent expert advice and recommendations, the final decision is made by FDA.
In September 2012, the FDA and WILEX discussed the recommendations of the ODAC and the development strategy for WILEX's diagnostic candidate REDECTANE® at a further Type C meeting. Since then, the FDA has confirmed in writing that it will follow the positive recommendation of the ODAC. WILEX and the FDA agreed also that WILEX will conduct a "confirmatory" study of the candidate's diagnostic performance instead of an outcomes-based study originally required by the FDA. The FDA requires a second study to provide additional proof of the diagnostic performance and safety of REDECTANE®. WILEX assumes that this trial must be successfully completed prior to approval. The concept and design of a further trial have been discussed with the FDA.
WILEX is currently developing the protocol for this Phase III trial (REDECT 2) for submission to the FDA on the basis of a special protocol assessment (SPA). The details of the design of this trial will be released once the protocol has been approved.
The subsidiary WILEX Inc. markets biomarker tests in oncology under the brand name Oncogene Science with the aim of supporting treatment regimens for cancer patients. These include "Enzyme-Linked ImmunoSorbent Assay" (ELISA) tests for a variety of biomarkers (HER2/neu, EGFr, uPA, PAI-1, TIMP-1 and CA IX) and immunohistochemical (IHC) tests (CA IX). ELISA assays are used to detect antigens or proteins in the blood for instance. Measuring proteins in the blood and using the respective bioanalytical methods could make it possible to predict whether a patient will respond to a particular therapy. At the same time, the progression of the disease could be monitored.
WILEX Inc.'s HER2/neu ELISA assay is the only FDA-cleared ELISA assay for quantifying the blood serum HER2/neu level deployable as part of treatment management and therapy monitoring for women with metastatic breast cancer.
The CA IX IHC assay for the identification of the CA IX antigen in tissue or cell samples was registered in December 2011 as a "Class I 510(k)-exempt medical device". The protein CA IX is overexpressed in many types of cancer and its expression is strongly induced by hypoxia. In a variety of human cancers, tumour hypoxia is associated with an increased incidence of metastases.
The Customer Specific Research segment comprises the services offered by the subsidiary Heidelberg Pharma GmbH.
The service business of Heidelberg Pharma includes customer specific preclinical contract research related to cancers and inflammatory and autoimmune diseases. This infrastructure and expertise are offered as a service to third parties and are also utilised within the Group. Heidelberg Pharma uses syngeneic and human tumour implant models based on human tumour cells to conduct in-depth studies of potential oncological compounds. In the field of inflammatory and autoimmune diseases, the company offers a broad range of in vivo models and methods for examining the mechanisms of new compounds. In the field of bioanalytics, the company analyses substance levels from in vivo experiments, particularly within the scope of pharmacokinetic investigations. In vitro analyses test substances in terms of protein binding and metabolic stability for example. Heidelberg Pharma's molecular biology unit specialises in in vitro profiling of substances. This work involves target protein expression analysis in cell lines and in tissue, as well as standard assays and other specialised techniques.
Heidelberg Pharma also possesses an innovative platform for therapeutic antibodies (antibody drug conjugates, ADCs). This ADC technology has the potential to enhance and improve the efficacy of many antibody-based therapies, including those on the market. Heidelberg Pharma aims to enter into customer specific collaborative partnerships with research institutes as well as pharmaceutical and biotech companies and performs contract work for customers related to designing, optimising, profiling and manufacturing new ADCs. These collaborations will take place under technology cooperation agreements and product licences and are intended to tap into short-term and long-term potential for generating sales revenue and creating added value. Current research is examining whether ADCs are capable of killing both dividing tumour cells and quiescent tumour cells.
Heidelberg Pharma recruited Professor Andreas Pahl to fill the vacant position of Chief Scientific Officer as of September 2012. Professor Pahl has 20 years' experience in research and teaching – most recently in industry at Nycomed and Takeda – and excellent expertise in pharmacology, toxicology and pharmacokinetics. Professor Pahl will continue to teach pharmacology and toxicology at the University of Erlangen-Nuremberg.
WILEX AG carried out a rights issue in the first quarter of 2012. The shareholders subscribed all 3,201,928 new no par value bearer shares at a price of €3.10 per share by the end of the subscription period on 30 January 2012. Following the entry of the capital measure in the Commercial Register on 3 February 2012, the total number of WILEX shares issued increased to 24,814,963. WILEX AG received gross proceeds of approximately €9.9 million from the rights issue.
A combined capital increase against cash and contributions in kind was implemented in the third quarter of 2012 and a total of 6,460,544 new shares were issued. The subscription or purchase price was €3.70 per share. In the form of a contribution in kind, the Company's shareholder dievini Hopp BioTech holding GmbH & Co. KG, Walldorf, Germany (dievini) converted its existing claim to repayment from a loan extended to WILEX AG amounting to approximately €7.8 million, including interest, into 2,100,337 new shares. As a result, the greater part of the shareholder loan was repaid, considerably reducing the financial liabilities of the WILEX Group without adversely affecting its liquidity. In the cash portion of the rights issue, 4,360,207 new shares were subscribed through the exercise of subscription rights and by oversubscription as well as through private placements. This generated gross proceeds of around €16.1 million for the Company. Following the entry of the capital measure in the Commercial Register on 27 August 2012, the total number of WILEX shares issued increased to 31,275,507.
In August, WILEX announced a change in the composition of its Executive Management Board effective 1 September 2012. Peter Llewellyn-Davies left the Executive Management Board upon expiration of his contract. He was succeeded as Chief Financial Officer of WILEX AG by Dr Jan Schmidt-Brand.
See pages 24 to 27 of the 2011 annual report for further information on the market environment for WILEX's products and product candidates. In the Company's view there have been no significant changes since then.
The WILEX Group, comprising WILEX AG and the subsidiaries WILEX Inc. and Heidelberg Pharma GmbH, reports consolidated figures for the first nine months of the 2012 financial year (1 December 2011 to 31 August 2012). The previous year's figures including the segment reporting are not directly comparable with the consolidated figures for the current reporting period because Heidelberg Pharma was not consolidated until the capital increase against contribution in kind was recorded in the German Commercial Register on 17 March 2011.
The WILEX Group reports on three operating segments: The Therapeutics (Rx) segment comprises RENCAREX®, MESUPRON®, WX-554, WX-037 as well as all preclinical research activities of WILEX AG. The Diagnostics (Dx) segment includes WILEX AG's imaging diagnostic candidate REDECTANE® and the in vitro diagnostics of WILEX Inc. The Customer Specific Research (Cx) segment comprises the ADC platform technology and the preclinical service business of Heidelberg Pharma.
In the first nine months of the 2012 financial year, the WILEX Group generated sales revenue of €11.3 million (previous year: €4.7 million), excluding intersegment sales revenue. This significant increase is mainly due to sales revenue of €9.7 million (previous year: €3.6 million) in the Rx segment from the ongoing pro rata reversals of accrued payments for RENCAREX® under the Prometheus licence agreement. The Dx segment maintained the previous year's level with sales revenue of €0.2 million (previous year: €0.2 million), generated primarily by the Company's subsidiary WILEX Inc. Sales revenue in the Cx segment rose to €1.4 million (previous year: €0.9 million).
At €1.5 million, other income was significantly higher year on year (€0.8 million), mainly due to gains from exchange rate differences. Both the Rx segment and the Cx segment recognised grants from the Federal Ministry of Education and Research (BMBF) for research projects. In the previous year, the Rx segment had reported deferred income from the licence agreement with Esteve as well as income from US Department of Defense grants for the uPA programme.
Operating expenses including depreciation and amortisation amounted to €19.8 million in the reporting period, up on the previous year (€18.4 million), mainly because Heidelberg Pharma was not part of the Group during the entire comparative period.
The operating expenses are distributed as follows across the three segments: Rx (€13.5 million), Dx (€2.8 million) and Cx (€3.5 million).
The WILEX Group has been reporting costs of sales since the consolidated financial statements as of 30 November 2011 and other expenses since the first quarter of 2012. Costs of sales concern costs directly related to revenues in the respective segments. Other expenses include costs of preparing for commercial supply as well as business development costs.
The Group's cost of sales amounted to €4.9 million in the reporting period, up substantially on the previous year's figure of €0.9 million owing to the reclassification of costs and the consolidation of Heidelberg Pharma in the entire financial year. Since the financial statements as of 30 November 2011, the Rx segment has reported the development costs for RENCAREX® – for which it receives refunds from Prometheus that are reported under sales revenue – under cost of sales. The recognition of these expenses under cost of sales therefore reduces research and development costs.
The Cx segment generates cost of sales for the provision of services and the Dx segment generates this cost type through the production of biomarker tests as tradable products.
While research and development costs of €9.7 million were down 28% year on year (previous year: €13.6 million), accounting for just 49% of total expenditure (previous year: 74%), the decline is mainly due to both the aforementioned reclassification of development costs as cost of sales in the Rx segment and the progress of the trials, especially RENCAREX® and MESUPRON®, with the associated decrease in costs.
Administrative costs were €3.4 million in the first nine months (previous year: €3.9 million). The following should be noted when comparing this to the previous year's figure: A total of €0.5 million in expenses for business development was included in administrative costs in the same period the previous year. Without this reclassification, administrative costs would have been at the previous year's level for the entire reporting period – despite the consolidation of Heidelberg Pharma.
Given the increased marketability of RENCAREX®, the costs of activities related to business development (€0.6 million), marketing and commercial supply (€1.2 million) have been reported as "other expenses" (€1.8 million in total) since the beginning of the current financial year. In the same period the previous year, all marketing activities together with cost of sales were combined under the item "manufacturing, service and distribution costs" (€0.9 million in total).
The WILEX Group posted a loss of €7.4 million for the first nine months of the 2012 financial year. This corresponds to an improvement by 44% on the same period of the previous year (–€13.2 million) and is particularly due to the year increase in sales revenue. Earnings per share improved to –€0.31 (previous year: –€0.65), mainly as a result of the lower loss for the period.
Finance costs rose to €0.5 million in the reporting period (previous year: €0.4 million). These primarily comprise the interest accrued on the shareholder loans from dievini and UCB Pharma S.A. (UCB), but also the interest payments related to leases of WILEX AG and Heidelberg Pharma. Due to the fact that the dievini shareholder loan (€7.8 million including interest) was converted into shares in the third quarter, future interest payments will be limited to the UCB loan and will increase up to year-end at a much slower pace than in recent quarters.
Finance income remained insignificant.
The financial result of the WILEX Group as of 31 August 2012 was therefore –€0.5 million (previous year: –€0.4 million).
WILEX AG carried out a cash rights issue in the first quarter of 2012 and a combined capital increase against cash and contributions in kind in the third quarter. These capitalisation measures generated cash of around €26 million (gross) for WILEX AG in the first nine months of the year. Prometheus also made a further payment of USD 17.5 million in the third quarter of 2012.
The WILEX Group had cash and cash equivalents of €28.7 million as of 31 August 2012 (30 November 2011: €3.4 million).
The net cash inflow from operating activities during the reporting period was €0.1 million compared with a net cash outflow of €3.4 million in the same period the previous year. This significant increase stems in part from the improved result for the period, but also from the cash inflows from the Prometheus transaction and their effects on the financial figures.
The outflow of funds for investing activities was €0.2 million (previous year: €0.4 million) and is mainly attributable to the acquisition of equipment at WILEX AG in connection with the laboratory re-fit.
The inflow of funds from financing activities of €25.4 million is primarily the result of the two capital increases implemented in the first and third quarters of 2012. In particular, the combined capital increase against cash and contributions in kind that was implemented in August 2012 generated gross proceeds of around €16.1 million and led to the repayment of a shareholder loan including interest of €7.8 million. The previous year's figure of €9.9 million principally comprised the shareholder loans by the two main shareholders.
The net change in cash and cash equivalents was €25.3 million (previous year: €6.1 million); exchange rate effects accounted for –€27k of the change in cash and cash equivalents (previous year: €8k).
Total assets as of 31 August 2012 amounted to €43.2 million (30 November 2011: €20.8 million). The increase compared to the close of the 2011 financial year is mainly attributable to the significantly higher cash and cash equivalents, which results in turn from the capital increase implemented in the third quarter and, in particular, from the payment of USD 17.5 million made by Prometheus in July 2012.
Non-current assets at the end of the reporting period amounted to €12.7 million (30 November 2011: €12.8 million). Of that amount, property, plant and equipment (mainly laboratory and office equipment) were €2.2 million and thus at the level recorded at the end of the 2011 financial year (€2.1 million).
Intangible assets were €4.1 million (30 November 2011: €4.4 million). The customer base acquired from Heidelberg Pharma was impaired in the amount of €46k (approximately 20% of the net carrying amount). The customer base was valued at €0.3 million as of the acquisition date and is attributable to the Cx segment. The impairment does not affect the useful life of originally nine years. Despite rising revenues and a steadily growing customer portfolio at Heidelberg Pharma, this impairment was necessitated by the exit from the portfolio of one key account at the acquisition date (March 2011). At the reporting date, non-current assets continue to include the goodwill of Heidelberg Pharma amounting to €6.1 million as well as rent security of €0.3 million (30 November 2011: €0.3 million).
At €30.5 million, current assets at the close of the reporting period were substantially higher than at the end of the 2011 financial year (€8.0 million). This sharp rise is again attributable to the cash inflows from the recent capital increase as well as to the Prometheus payment in July 2012. The significant decrease in other current assets from €4.6 million to €1.8 million is due to the fact that the receivable from Prometheus accrued on a pro-rata basis was extinguished by this company's payment of USD 17.5 million.
Equity at the end of the reporting period was €21.4 million (30 November 2011: –€4.5 million). The equity ratio was 49.7% (30 November 2011: –21.7%). This significant improvement and the strengthened equity base are due to the capital increases implemented in the first and, in particular, the third quarter of 2012. Further information regarding the equity measures can be found in the notes.
Non-current liabilities at the end of the reporting period amounted to €3.0 million (30 November 2011: €5.1 million). The decline is due mainly to the pro rata reversal of the accrued payments received in connection with the Prometheus transaction and the reclassification of lease liabilities from non-current to current.
Current liabilities decreased to €18.8 million as of the end of the period (30 November 2011: €20.2 million). While the composition of this balance sheet item has changed considerably, the change in its amount is negligible. Financial liabilities now solely comprise the UCB shareholder loan including interest of €2.6 million (30 November 2011: €10.5 million). Liabilities were nevertheless increased by the deferred income from the Prometheus payment of USD 17.5 million, which is principally reported under other current liabilities.
Page 18
Including the members of its Executive Management Board, WILEX had 127 employees at the close of the reporting period (117.8 full-time equivalents – FTEs). This compares to 124 employees (115.9 FTEs) in the WILEX Group as of 30 November 2011 and 119 employees (110.7 FTEs) as of 31 August 2011, the end of the previous year's reporting period. The increase compared to 2011 is mainly due to members of staff returning from parental leave.
The Company has developed a performance-related compensation system for its employees comprising a fixed annual salary and a variable salary component. In addition, the 2005 and 2011 stock option programmes give employees a stake in the Company's performance. No further options may be issued under the 2005 stock option programme. The Company's Annual General Meeting in May 2011 authorised the Executive Management Board to issue, with the approval of the Supervisory Board, up to 1,156,412 new options ("stock options") under the new WILEX Stock Option Plan 2011 valid up to and including 1 July 2016. The corresponding amount of new Contingent Capital was created and recorded in the Commercial Register.
A total of 270,500 stock options were issued under the 2011 Stock Option Plan in the second quarter of 2012, of which 52,000 were issued to members of the Executive Management Board and 218,500 to employees. Of the stock options issued to members of the Executive Management Board, 8,000 were returned effective 31 August 2012. Employees of WILEX Inc. and Heidelberg Pharma were also taken into consideration for the first time. No stock options were issued in the third quarter of the 2012 financial year.
As a result, WILEX issued a total of 1,431,931 subscription rights to employees and members of the Executive Management Board under the 2005 and 2011 plans, of which 971,285 options had vested as of the end of the reporting period. No stock options have been exercised to date.
Risks and opportunities in connection with WILEX's business are described in detail on pages 63 to 71 of the 2011 annual report and in the prospectus dated 6 August 2012. They remain unchanged unless noted otherwise. We refer particularly to the financing 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 the commencement of drug development and marketing approval usually spans many years. Even though our portfolio has matured, there is a continued risk that none of the drug and diagnostic candidates in our current portfolio will receive marketing approval or additional trials become necessary.
The following events occurred after the close of the reporting period:
Pages 2 to 6
Details of the events after the reporting period are outlined directly in the "Business performance" chapter in the sections relating to the product candidates.
The results of the DFS analysis in the Phase III trial with RENCAREX® are expected in the fourth quarter of 2012. If the results are positive, the marketing authorisation application could be submitted by WILEX in Europe in the first half of 2013 followed by our partner Prometheus in the United States.
The further development strategy for the orally administered drug candidate MESUPRON® will be decided in the coming months and with any future partners.
The Phase Ib/II dose escalation trial with WX-554 in cancer patients will be continued.
The development strategy for the diagnostic candidate REDECTANE® was decided with the FDA and the concept for a further trial was discussed. WILEX is currently developing the protocol for this Phase III trial (REDECT 2) for submission to the FDA on the basis of a special protocol assessment (SPA). The details of the design of this trial will be released once the protocol has been approved.
WILEX Inc. plans to intensify the marketing of the biomarker tests and increase its sales revenue. Additional development and marketing alliances are planned.
Heidelberg Pharma plans to increase sales revenue from the services business and acquire new customers for the Cx segment. Additional partnerships planned for the ADC technology shall provide the basis for successfully commercialising this platform. Expenses are likely to be higher than income because the business activities related to the ADC technology are still in an early stage.
Reporting period from 1 December 2011 to 31 August 2012
| 9M 2012 € |
9M 2011 € |
|
|---|---|---|
| Revenue | 11,358,733 | 4,738,121 |
| Other income | 1,472,001 | 813,590 |
| Income | 12,830,734 | 5,551,710 |
| Cost of sales | (4,931,382) | (862,310) |
| Research and development costs | (9,735,287) | (13,594,685) |
| Administrative costs | (3,377,947) | (3,958,794) |
| Other expenses | (1,753,996) | 0 |
| Operating expenses | (19,798,612) | (18,415,789) |
| Operating result | (6,967,878) | (12,864,079) |
| Finance income | 18,709 | 6,401 |
| Finance costs | (469,215) | (370,383) |
| Financial result | (450,506) | (363,981) |
| Earnings before tax | (7,418,384) | (13,228,060) |
| Income tax | (1,282) | (1,598) |
| Net loss for the period | (7,419,667) | (13,229,658) |
| Net currency gain from consolidation | (97,999) | 2,127 |
| Comprehensive income | (7,517,666) | (13,227,531) |
| Earnings per share | ||
| Basic and diluted earnings per share | (0.31) | (0.65) |
| Average number of shares issued | 24,163,759 | 20,375,079 |
Rounding of exact figures may result in differences.
| Quarterly comparison | Q3 2012 € '000 |
Q2 2012 € '000 |
Q1 2012 € '000 |
Q4 2011 € '000 |
Q3 2011 € '000 |
|---|---|---|---|---|---|
| Revenue | 4,145 | 3,503 | 3,711 | 5,139 | 3,371 |
| Other income | 433 | 809 | 230 | 1,022 | 175 |
| Operating expenses | (6,257) | (7,224) | (6,317) | (6,680) | (6,008) |
| Operating result | (1,679) | (2,912) | (2,376) | (519) | (2,462) |
| Earnings before tax | (1,810) | (3,054) | (2,554) | (696) | (2,608) |
| Net loss for the period | (1,810) | (3,054) | (2,555) | (696) | (2,608) |
| Net currency gain/loss from consolidation |
4 | (119) | 17 | 7 | (19) |
| Comprehensive Income | (1,806) | (3,174) | (2,538) | (689) | (2,627) |
| Basic and diluted earnings per share in € |
(0.07) | (0.13) | (0.11) | (0.03) | (0.11) |
| Average number of shares issued | 25,095,856 | 24,814,963 | 22,563,058 | 21,613,035 | 21,613,035 |
as of 31 August 2012 and as of 30 November 2011
| Assets | 31.08.2012 € |
30.11.2011 € |
|---|---|---|
| Property, plant and equipment | 2,153,649 | 2,074,278 |
| Intangible assets | 4,144,215 | 4,355,771 |
| Goodwill | 6,111,166 | 6,111,166 |
| Other non-current assets | 261,940 | 276,563 |
| Non-current assets | 12,670,970 | 12,817,778 |
| Inventories | 292,455 | 514,627 |
| Prepayments | 885,617 | 952,400 |
| Trade receivables | 111,977 | 159,254 |
| Other receivables | 535,528 | 2,949,762 |
| Cash and cash equivalents | 28,677,226 | 3,420,640 |
| Current assets | 30,502,802 | 7,996,682 |
| Total assets | 43,173,772 | 20,814,460 |
| Equity and liabilities | 31.08.2012 € |
30.11.2011 € |
|---|---|---|
| Subscribed capital | 31,275,507 | 21,613,035 |
| Capital reserve | 158,857,579 | 135,030,430 |
| Accumulated losses | (168,547,738) | (161,128,070) |
| Net currency gain/loss from consolidation | (135,925) | (37,926) |
| Equity | 21,449,423 | (4,522,532) |
| Pension provisions | 0 | 25,319 |
| Lease liabilities | 95,201 | 218,421 |
| Other non-current liabilities | 2,878,138 | 4,887,989 |
| Non-current liabilities | 2,973,339 | 5,131,729 |
| Trade payables | 1,630,916 | 1,412,070 |
| Liabilities arising from leases | 278,354 | 251,625 |
| Financial liabilities | 2,616,250 | 10,548,169 |
| Other current liabilities | 14,225,490 | 7,993,400 |
| Current liabilities | 18,751,010 | 20,205,263 |
| Total equity and liabilities | 43,173,772 | 20,814,460 |
Reporting period from 1 December 2011 to 31 August 2012
| 9M 2012 € |
9M 2011 € |
|
|---|---|---|
| Net loss for the period | (7,419,667) | (13,231,752) |
| Adjustment for income statement items | ||
| Stock options | 202,549 | 87,841 |
| Depreciation/amortisation | 489,019 | 347,987 |
| Increase in pension obligations | 0 | 720 |
| Finance costs | 753,233 | 372,900 |
| Finance income | (302,728) | (6,401) |
| Tax expense | 1,282 | 1,598 |
| 1,143,355 | 804,645 | |
| Changes in net working capital | ||
| Inventories | 232,194 | 54,953 |
| Trade receivables | 129,716 | (13,486) |
| Other receivables | 2,122,896 | (1,491,243) |
| Prepayments | 69,884 | 73,240 |
| Other non-current assets | (11,229) | (387,596) |
| Trade payables | 146,789 | 499,844 |
| Other liabilities | 4,205,983 | 10,320,633 |
| 6,896,231 | 9,056,345 | |
| Cash flow from operating activities | 619,919 | (3,370,762) |
| Finance costs paid | (527,409) | (5,400) |
| Finance income received | 18,710 | 6,401 |
| Net cash flow from operating activities | 111,220 | (3,369,761) |
| Cash flow from investing activities | ||
| Purchase of property, plant and equipment | (212,167) | (389,330) |
| Purchase of intangible assets | (55,914) | (9,579) |
| Net cash flow from investing activities | (268,081) | (398,909) |
| Cash flow from financing activities | ||
| Proceeds from capital increases | 33,829,993 | 0 |
| Capital increase costs | (409,628) | (50,000) |
| Changes in shareholder loans | (7,771,250) | 10,000,000 |
| Other financing activities | (39,835) | 0 |
| Repayment finance leases | (168,914) | (42,980) |
| Net cash flow from financing activities | 25,440,366 | 9,907,020 |
| Influence of foreign exchange effects on cash and cash equivalents | (26,919) | (8,436) |
| Net change in cash and cash equivalents | 25,256,586 | 6,129,914 |
| Cash and cash equivalents | ||
| at beginning of period | 3,420,640 | 1,943,151 |
Reporting period from 1 December 2011 to 31 August 2012
| Capital reserve | |||||||
|---|---|---|---|---|---|---|---|
| Shares | Subscribed capital € |
Capital measures/ premium € |
Measure ment of stock options € |
Currency translation differences € |
Accumulated losses € |
Total € |
|
| As of | 124,819,448 | 2,665,370 | |||||
| 1 December 2010 | 18,413,035 | 18,413,035 | 127,484,818 | 9,398 | (147,202,343) | (1,295,093) | |
| Measurement of stock options |
87,841 | 87,841 | |||||
| Net currency gain/loss from consolidation |
2,127 | 2,127 | |||||
| Net loss for the period |
(13,229,658) | (13,229,658) | |||||
| Capital increase after accounting for capital pro curement costs |
3,200,000 | 3,200,000 | 15,873,101 | 19,073,101 | |||
| Net change in equity |
5,933,411 | ||||||
| 140,692,549 | 2,753,211 | ||||||
| As of 31 August 2011 |
21,613,035 | 21,613,035 | 143,445,760 | 11,525 | (160,432,001) | 4,638,319 |
| Capital reserve | |||||||
|---|---|---|---|---|---|---|---|
| Shares | Subscribed capital € |
Capital measures/ premium € |
Measure ment of stock options € |
Currency translation differences € |
Accumulated losses € |
Total € |
|
| As of | 132,267,971 | 2,762,459 | |||||
| 1 December 2011 | 21,613,035 | 21,613,035 | 135,030,430 | (37,926) | (161,128,070) | (4,522,532) | |
| Measurement of stock options |
202,549 | 202,549 | |||||
| Net currency gain/loss from consolidation |
(97,999) | (97,999) | |||||
| Net loss for the period |
(7,419,667) | (7,419,667) | |||||
| Capital increase after accounting for capital pro curement costs |
9,662,472 | 9,662,472 | 23,624,600 | 33,287,072 | |||
| Net change in equity |
25,971,955 | ||||||
| 155,892,571 | 2,965,008 | ||||||
| As of 31 August 2012 |
31,275,507 | 31,275,507 | 158,857,579 | (135,925) | (168,547,737) | 21,449,423 |
These interim consolidated financial statements as of 31 August 2012 were prepared in accordance with the same accounting policies as the consolidated financial statements as of 30 November 2011. The interim consolidated financial statements as of 31 August 2012 include the Group's parent, WILEX AG, Munich, Germany, as well as its subsidiaries WILEX Inc., Cambridge, MA, USA, and Heidelberg Pharma GmbH, Ladenburg, Germany – jointly the "Group".
Heidelberg Pharma completed the change in its legal form from an AG (German stock corporation) to a GmbH (German limited liability company) as of 1 December 2011.
Comparability with the previous year's figures is neither given nor available due to the previous year's change in the Group structure. Heidelberg Pharma was included in consolidation during the second quarter of 2011.
The Company's earnings, financial position and net assets as well as essential items of these interim financial statements are explained in detail in the interim management report. The Company's business activities are not subject to seasonal or macroeconomic influences.
The interim consolidated financial statements reproduced in this report were generally prepared in accordance with the International Financial Reporting Standards (IFRS) endorsed by the European Union, specifically in accordance with 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). These interim financial statements must be read in the context of the IFRS consolidated financial statements as of 30 November 2011 published by WILEX AG for the 2011 financial year.
The interim consolidated financial statements were not subjected to a review by an auditor. Pursuant to our Declaration of Compliance from 10 February 2012 with Section 7.1.2 of the German Corporate Governance Code, both the interim consolidated financial statements and the interim management report for the Group were discussed with the Supervisory Board's Audit Committee before being published. This interim report was approved for publication by the Executive Management Board on 11 October 2012.
The WILEX Group comprises three operating segments, each of which is explained below, along with its separate core business and core projects. There has been no change in the segmentation of WILEX compared to the financial statements as of 30 November 2011 and compared to 31 August 2011, the closing date of the previous year's comparative period.
The Therapeutics segment posted sales revenue of €9.7 million and a net loss of €3.6 million in the first nine months of the financial year. WILEX AG develops drug candidates in its Rx segment for the targeted treatment of various types of cancer. The compounds are based on antibodies and small molecules aimed at inhibiting tumour growth and preventing metastases while displaying a low side-effect profile. The Therapeutics segment comprises the following programmes: RENCAREX®, MESUPRON®, WX-554, WX-037 as well as all preclinical and research activities of WILEX AG.
The Diagnostics segment generated sales revenue of €0.3 million and a net loss for the period of €2.6 million. WILEX AG develops the imaging diagnostic candidate REDECTANE®, which is allocated to the Diagnostics segment. WILEX Inc. produces and markets a multitude of biomarker tests related to oncology under the Oncogene Science brand. It is the objective of WILEX to offer approved in vitro diagnostics for the clinical, oncological and immunodiagnostic market in order to improve treatment for cancer patients worldwide.
Customer Specific Research generated sales revenue of €1.5 million and a net loss for the period of €1.9 million. For one, Heidelberg Pharma provides customer specific services in connection with a novel platform technology for therapeutic antibody drug conjugates (ADCs), which is still being developed. These services are being provided in collaboration with research institutes as well as pharmaceutical and biotech companies. For another, Heidelberg Pharma performs work on drug metabolism, pharmacology and pharmacokinetics especially in oncology in its preclinical service business. At this time Heidelberg Pharma's business is based mainly on fee for service.
Intersegment sales revenue as of 31 August 2012 amounted to €99k. The Dx segment generated sales revenue of €11k with the Rx segment, and the Cx segment generated sales revenue of €88k with the Rx segment.
The segment results were as follows:
| Segment results 9M 20121 | Rx € '000 |
Dx € '000 |
Cx € '000 |
Not allocated € '000 |
Consoli dation Group € '000 |
Group € '000 |
|---|---|---|---|---|---|---|
| Sales revenue | 9,677 | 253 | 1,528 | 0 | (99) | 11,359 |
| External sales revenue | 9,677 | 242 | 1,440 | 0 | 0 | 11,359 |
| Intersegment sales revenue | 0 | 11 | 88 | 0 | (99) | 0 |
| Other income | 258 | 11 | 213 | 997 | (7) | 1,472 |
| Operating expenses | (13,542) | (2,782) | (3,580) | 0 | 106 | (19,799) |
| Operating result at segment level |
(3,607) | (2,518) | (1,840) | 997 | (0) | (6,968) |
| Financial result | 0 | (98) | (72) | (280) | 0 | (451) |
| Income tax | 0 | (1) | 0 | 0 | 0 | (1) |
| Net loss for the period at segment level |
(3,607) | (2,617) | (1,912) | 717 | 0 | (7,420) |
| Total assets | 1,358 | 4,260 | 14,872 | 30,403 | (7,720) | 43,174 |
1 rounded
As before, the breakdown of segment assets for purposes of interim reporting pursuant to IAS 34 concerns the intangible assets of Heidelberg Pharma that were identified and taken over as well as its goodwill. The non-allocated portion of total assets largely represents the cash and cash equivalents not attributable to a specific segment.
With the approval of the Supervisory Board, on 1 February 2012 the Executive Management Board fixed the scope of the rights issue at 3,201,928 new no par value bearer shares. WILEX received gross proceeds of approximately €9.9 million, which it used to finance its ongoing clinical studies and to enhance its equity. The capital increase was completed once recorded in the Commercial Register on 3 February 2012.
On 24 August 2012, the Executive Management Board resolved with the approval of the Supervisory Board to set the final number of shares from the mixed capital increase against cash and contributions in kind at 6,460,544 new no par value bearer shares. WILEX AG received gross proceeds of around €16.1 million from the cash portion of the rights issue, which the company will use for financing ongoing and planned clinical studies as well as future growth. Following the entry of the capital measure in the Commercial Register on 27 August 2012, the total number of WILEX shares issued (subscribed capital) increased to 31,275,507.
The equity of the WILEX Group at the end of the reporting period was €21.4 million (30 November 2011: –€4.5 million). The subscribed capital increased from €21.6 million at the end of previous year's reporting period by €9.7 million to €31.3 million as a result of the capital increases. The capital reserve was €158.9 million (30 November 2011: €135.0 million) and the losses accumulated since WILEX's foundation totalled €168.5 million (30 November 2011: €161.1 million). The Company recognised a currency loss of €0.1 million in equity in connection with the consolidation of its US subsidiary. The equity ratio of the WILEX Group as of 31 August 2012 was 49.7% (30 November 2011: –21.7%).
On 18 May 2011 the Company's Annual General Meeting resolved the WILEX Stock Option Plan 2011. This resolution authorises the Company to issue a total of up to 1,156,412 stock options, of which up to 346,924 stock options (approx. 30%) may be issued to members of the Company's Executive Management Board, up to 173,462 stock options (approx. 15%) to executives of affiliated companies, up to 346,923 stock options (approx. 30%) to employees of the Company and up to 289,103 stock options (approx. 25%) to employees of the Company's affiliates. A total of 270,500 stock options were issued under the 2011 Stock Option Plan in the first six months of 2012; of these, 52,000 were issued to members of the Executive Management Board and the remaining 218,500 options were issued to employees of the three Group companies.
Similar to the approach described in the annual report as of 30 November 2011, WILEX's liabilities to employees resulting from the issue of stock options were reported pursuant to IFRS 2 in the reporting period just ended. These liabilities are calculated using a binomial model at the time the options are granted. The fair value of the work provided by the employees in return for the options granted to them is charged against the capital reserve, i. e. recognised in equity. The total expense to be recognised until the time at which the options become vested is determined by the fair value of the options granted, excluding effects of exercise thresholds that are not based on capital market parameters (e. g. profit and sales growth targets). Such non-capital-market exercise thresholds are considered in the assumptions regarding the number of options that are expected to become exercisable. Settlement is carried out in equity securities. The estimate of the number of options expected to become exercisable is reviewed on every reporting date. The effects of any adjustments that have to be considered with regard to initial estimates are recognised in the statement of comprehensive income as well as by adjusting equity accordingly.
The fair value of the tranche issued is shown below. The grant date was 30 March 2012 and the term of the tranche issued is a standard 48 months, which is why there is only one option value for the entire tranche.
| Stock options issued | Issue date | Expected vesting period | Option value1 € |
|---|---|---|---|
| 270,500 | 30 March 2012 | 48 months | 1.14 |
rounded
The measurement of the stock options in the first nine months of the 2012 financial year entailed staff costs of €203k, of which €31k was attributable to the measurement of the newly issued stock options under the 2011 Stock Option Plan. A total of €129k relates to the reduction of the exercise price of the stock options under the 2005 Stock Option Plan. The exercise price for all stock options issued until 3 February 2012 was reduced to €3.10 (the subscription price fixed for the capital increase) across the board in accordance with Article 7 (1i) of the 2005 Stock Option Plan once the capital increase subject to shareholders' subscription rights had been recorded in the Commercial Register on that date.
In the reporting period, the Company's executives reported the following transactions subject to disclosure in accordance with Section 15a German Securities Trading Act (Wertpapierhandelsgesetz) (Directors' dealings):
| Name | Date | Trans action |
Market place |
Price € |
Number | Volume € |
|---|---|---|---|---|---|---|
| dievini1 | 29.08.2012 | Subscription/ Purchase |
OTC | 3.70 | 8,477 | 31,364.90 |
| dievini1 | 21.08.2012 | Subscription obligation |
OTC | 3.70 | 2,100,337 | 7,771,246.90 |
| dievini1 | 21.06.2012 | Sale | OTC | 3.51 | 112,454 | 3,947,713.54 |
| dievini1 | 21.06.2012 | Sale | OTC | 3.51 | 260,018 | 912,663.18 |
| dievini1 | 21.06.2012 | Sale | OTC | 3.51 | 140,390 | 492,768.90 |
| dievini1 | 21.06.2012 | Sale | OTC | 3.51 | 28,077 | 98,550.27 |
| dievini1 | 21.06.2012 | Sale | OTC | 3.51 | 2,954 | 10,368.54 |
| dievini1 | 21.06.2012 | Sale | OTC | 3.51 | 260,018 | 912,663.18 |
| dievini1 | 21.06.2012 | Sale | OTC | 3.51 | 608,358 | 2,135,336.58 |
| dievini1 | 21.06.2012 | Securities loan |
OTC | 0.00 | 1,152,251 | 0.00 |
| Professor Olaf G. Wilhelm (Executive Management Board)2 |
06.02.2012 | Subscription/ Purchase |
OTC | 3.10 | 2,000 | 6,200.00 |
| Dr Georg Baur (Supervisory Board) |
06.02.2012 | Subscription/ Purchase |
OTC | 3.10 | 26,840 | 83,204.00 |
| Andreas R. Krebs (Supervisory Board) |
03.02.2012 | Subscription/ Purchase |
OTC | 3.10 | 10,000 | 31,000.00 |
| dievini1 | 03.02.2012 | Subscription/ Purchase |
OTC | 3.10 | 1,144,334 | 3,547,435.40 |
1 The Supervisory Board members Professor Christof Hettich and Professor Friedrich von Bohlen und Halbach have management responsibilities at dievini Hopp BioTech holding GmbH & Co. KG, which is a shareholder of WILEX AG.
2 The wife of Professor Olaf G. Wilhelm, Dr Sabine Wilhelm, subscribed further 2,000 shares.
A total of 52,000 stock options were issued to members of the Executive Management Board in the first six months of the 2012 financial year under the 2011 Stock Option Plan. Of these, 8,000 options were returned by Mr Peter Llewellyn-Davies effective 31 August 2012. No stock options have been exercised to date. Furthermore, no stock options under this Plan have expired or were forfeited.
A total of 5,500 options of the Executive Management Board and 27,313 options of employees have vested as of the reporting date.
| Price | |||
|---|---|---|---|
| Name | Date | € | Number |
| Professor Olaf G. Wilhelm | 30.03.2012 | 3.53 | 28,000 |
| Dr Thomas Borcholte | 30.03.2012 | 3.53 | 8,000 |
| Dr Paul Bevan | 30.03.2012 | 3.53 | 8,000 |
| Peter Llewellyn-Davies1 | 30.03.2012 | 3.53 | 8,000 |
1 Returned effective 31 August 2012.
WILEX made payments of €12k to Rittershaus law firm for legal consulting services in the first quarter of 2012. Furthermore consulting services related to capital increase in the amount of €16k were provided in the third quarter. Rittershaus is a related party because the chairman of the Supervisory Board, Professor Christof Hettich, is a partner in this law firm.
In the course of a contribution in kind, the Company's shareholder dievini converted its existing claim to repayment from a loan extended to WILEX AG amounting to approximately €7.8 million, including interest, into 2,100,337 new shares.
No other relationships to related parties exist.
The following events occurred after the close of the reporting period:
Apart from this, no key events occurred after the interim reporting period.
"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 the WILEX Group, and the interim management report includes a fair review of the development and performance of the business and the position of the WILEX Group, together with a description of the material opportunities and risks associated with the expected development of the WILEX Group."
Munich, 11 October 2012
The Executive Management Board
Professor Olaf G. Wilhelm Dr Jan Schmidt-Brand Dr Paul Bevan Dr Thomas Borcholte
WILEX's shares started the trading year at €3.43 and closed on 28 September 2012 at €3.66, posting a gain of approximately 7%. The DAXsubsector Biotechnology Index gained around 39% versus the beginning of the year, and the NASDAQ Biotechnology Index continued its positive trend with plus 37%.
The average daily trading volume of the ordinary shares was 21,855 shares in the nine months of the current financial year, which is a decrease of 18% compared with the same period the previous year (26,739 shares). Market capitalisation as of 31 August 2012 was €117.4 million (31 August 2011: €84.9 million).
| Key share figures | |||
|---|---|---|---|
| as of the end of the reporting period | 9M 2012 | 9M 2011 | |
| Shares issued | Number | 31,275,507 | 21,613,035 |
| Market capitalisation | € million | 117.4 | 84.94 |
| Closing price (XETRA) | € | 3.755 | 3.930 |
| High1 | € | 4.665 (07.12.11) |
5.320 (20.05.11) |
| Low1 | € | 2.866 (10.01.12) |
3.023 (16.03.11) |
| Volatility (260 days, XETRA) | % | 42.854 | 63.570 |
| Average daily trading volume1 | Shares | 21,855 | 26,739 |
| Average daily trading volume1 | € | 80,524 | 116,517 |
| Earnings per share | € | (0.31)3 | (0.65)2 |
All stock exchanges
Based on an average of 20,375,079 shares outstanding
Based on an average of 24,163,759 shares outstanding
Source: Bloomberg
WILEX AG implemented a combined capital increase against cash and contributions in kind in August 2012. The Company's main shareholders participated in this capitalisation measure and Curacyte AG was secured as a new shareholder with a major shareholding of 7.25%. Curacyte AG is a Munich-based company and an equity interest of dievini Hopp BioTech holding GmbH & Co. KG.
1 Comprises dievini Hopp BioTech holding GmbH & Co. KG, Curacyte AG and Verwaltungsgesellschaft Golf Club St. Leon-Rot mbH. All figures are assumptions by WILEX AG based on the most recent notifications in accordance with the German Securities Trading Act (Wertpapierhandelsgesetz – WpHG) and/or the voting rights reported at the most recent Annual General Meeting.
| Date | |
|---|---|
| 27 February 2013 | Annual Report 2012, Financial press conference and analysts' meeting |
| 11 April 2013 | 3-month Financial Report 2013 |
| 14 June 2013 | Annual General Meeting 2013 |
| 11 July 2013 | Half-yearly Financial Report 2013 |
| 10 October 2013 | 9-month Financial Report 2013 |
Grillparzerstr. 10 81675 Munich, Germany Tel. +49(0)89–413138–0 Fax +49(0)89–413138–99 www.wilex.com [email protected]
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]
Chief Financial Officer Senior Manager Corporate Communications
Responsible for the project: Katja Arnold, WILEX AG
Published by: WILEX AG, Grillparzerstr. 10, 81675 Munich, Germany
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: 11 October 2012
WILEX AG Grillparzerstr. 10 · 81675 Munich · Germany · www.wilex.com
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