Quarterly Report • Oct 10, 2013
Quarterly Report
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| 9M 20131 € '000 |
9M 20121 € '000 |
|
|---|---|---|
| Earnings | ||
| Sales revenue | 10,090 | 11,359 |
| Other income | 1,295 | 1,472 |
| Operating expenses | (15,278) | (19,799) |
| of which research and development costs | (7,355) | (9,735) |
| Operating result | (3,893) | (6,968) |
| Earnings before tax | (3,956) | (7,418) |
| Net loss for the period | (3,956) | (7,420) |
| Earnings per share in € | (0.13) | (0.31) |
| Balance sheet as of the end of the period | ||
| Total assets | 24,917 | 43,174 |
| Cash and cash equivalents | 9,876 | 28,677 |
| Equity | 16,043 | 21,449 |
| Equity ratio 2 in% |
64.4 | 49.7 |
| Cash flow statement | ||
| Cash flow from operating activities | (13,499) | 111 |
| Cash flow from investing activities | (111) | (268) |
| Cash flow from financing activities | (160) | 25,440 |
| Employees (number) | ||
| Employees as of the end of the period 3 | 110 | 127 |
| Employees as of the end of the period (full-time equivalents) 3 | 101 | 118 |
1 The reporting period begins on 1 December and ends on 31 August.
Equity/total assets
3 Including members of the Executive Management Board
Rounding of exact figures may result in differences.
The third quarter of the year was devoted to the implementation of our corporate strategy with the three elements partnerships, financing and cost management, as described at our Annual General Meeting.
1. Partnerships: WILEX's objective is to find licensing and development partners for each of its projects who will license the projects and pursue their development. One step in this direction was our subsidiary Heidelberg Pharma's signing of a licence agreement with Roche for the joint development of a novel class of antibody drug conjugates (ADCs) based on Heidelberg Pharma's patented technology to couple α-Amanitin to antibodies. The licence agreement covers initial joint research to apply this technology to multiple Roche antibodies towards the identification of development candidates with favourable efficacy and safety profiles. Roche will have the opportunity to exercise options for licences and could then continue the development of these projects. Heidelberg Pharma will receive a down payment reimbursed for the research and development work already done and is eligible for further milestone payments and single-digit royalties.
2. Financing: In parallel to our negotiations with potential licensing partners from the biotechnology and pharmaceutical industries, we are working with financial investors on ensuring financing of individual portfolio projects. Given the low price of our shares at present, we are mainly looking at options for project-oriented financing, though we are also open to financing through a strategic investor. We currently do not exclude any form of financing, though the classic rights issue has the lowest priority.
The Company has engaged investment bank Burrill Securities LLC to advice on the financial strategy.
3. Cost management: One cornerstone of our strategy is leveraging cost savings potential and efficient use of the available cash reserves. We therefore decided in early September to sell our subsidiary WILEX Inc. to Nuclea Biotechnologies Inc. WILEX AG will not incur running costs in the short term or investments necessary for the extensive market development of WILEX Inc.'s biomarker tests in the medium term. The expansion of the cooperation with Nuclea will also enable WILEX AG to develop a companion diagnostic – for the identification of patient tumours with a high density of the tumour-specific antigen CAIX for the planned clinical trial with RENCAREX® – without using its own cash funds.
WILEX AG will continue the strategy of not filling vacant positions, re-assigning the tasks within the team or seeking the assistance of external advisers instead. We continued to achieve cost savings in the third quarter, further reducing our loss for the period.
After making good progress in implementing our business strategy in the third quarter, we have raised our earnings forecast for the year as a whole, thus extending our cash reach into the third quarter of 2014.
Munich, 10 October 2013
Dr Jan Schmidt-Brand Chief Financial Officer
| Segment | Product | Technology | Indication | Research+ preclinical |
Clinical development |
Market | Partners | ||
|---|---|---|---|---|---|---|---|---|---|
| I | II | III | |||||||
| RENCAREX® | Antibody (therapeutic) |
Non-metastatic ccRCC |
Phase III completed1 | Esteve (Southern Europe) Prometheus (USA) |
|||||
| Rx | WX-554 | MEK inhibitor | Cancer | Phase Ib/II ongoing | UCB (worldwide) | ||||
| WX-037 | PI3K inhibitor | Cancer | Phase I started | UCB (worldwide) | |||||
| Dx | REDECTANE® | Antibody (diagnostic) |
Renal mass2 | Phase III completed | IBA (worldwide) | ||||
| Cx | ADC platform | Antibody Targeted Amanitin Conjugates |
Cancer | Various early-stage collaborations |
1 The Phase III ARISER trial in the adjuvant therapy of clear cell renal cell carcinoma (ccRCC) missed the trial endpoint. ccRCC
| Product | Technology | Indication | Research+ preclinical |
Clinical development |
Market | Partners | ||
|---|---|---|---|---|---|---|---|---|
| I | II | III | ||||||
| MESU PRON® |
uPA inhibitor | Pancreatic cancer Breast cancer |
Phase IIa completed Phase IIa completed |
|||||
| Antibody programme | n/a | Non-oncology | UCB (opt-in 2013) | |||||
| CAIX CDx to RENCAREX® | IHC tests | Oncology | In development | Nuclea | ||||
| ADC platform | Antibody Targeted Amanitin Conjugates |
Cancer | Roche |
WILEX AG is a biopharmaceutical company focused on oncology. It has an attractive portfolio of diagnostic and therapeutic products for the detection and 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. The 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. In the reporting period, the US subsidiary WILEX Inc. produced and marketed biomarker tests for oncology, but was sold to Nuclea Biotechnologies Inc. at the beginning of September 2013 (see "Events after the reporting period"). The transactions and partnerships executed in 2013 changed the portfolio such that WILEX now divides its portfolio into an internal and external pipeline.
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The WILEX Group's business activities are subdivided into three segments: Therapeutics (Rx), Diagnostics (Dx) and Customer Specific Research (Cx).
The antibody RENCAREX® (INN: Girentuximab) was tested in the double-blind, placebo-controlled Phase III ARISER trial for adjuvant therapy of clear cell renal cell carcinoma (ccRCC). The final analysis performed in October 2012 showed no improvement in median disease-free survival following treatment with RENCAREX® compared to placebo.
However, intensive biomarker and subgroup analyses were conducted in the first half of the year and in June 2013 all data from the ARISER trial including the data from the positive subgroup analysis was presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. The data confirmed that CAIX expression is a characteristic of ccRCC. A surprising outcome was that the antigen density, as determined by the CAIX score, varies from patient to patient and evidently plays a key role in the efficacy of RENCAREX®. Analysis of all CAIX scores revealed that as the CAIX score increases, the more pronounced the RENCAREX® treatment effect becomes. A CAIX score of ≥2.6 resulted in a clinically and statistically significant treatment effect with median DFS increasing from 51.2 months in the placebo arm to 73.6 months in RENCAREX® patients (N=151; HR=0.54; p=0.02).
The retrospective subgroup analysis indicates that RENCAREX® could deliver a well-tolerated and effective therapy for ccRCC patients with a high CAIX score. WILEX has held initial talks with regulatory authorities (the FDA and European agencies) and reached agreement on plans for a confirmatory prospective Phase III trial with RENCAREX® in the adjuvant therapy of ccRCC in the defined subgroup using the biomarker CAIX for stratification. All work concerning the ARISER trial was duly completed as planned in accordance with "Good Clinical Practice" in the third quarter of 2013.
WILEX is in discussions with Prometheus about the termination of the existing licence agreement for the US commercial rights to RENCAREX®.
MESUPRON® (INN: Upamostat) is a small molecule drug 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. Data from two Phase IIa trials (proof of concept) in locally advanced pancreatic cancer (2010) and metastatic breast cancer (2012) indications show the safety and activity of the drug candidate in combination with chemotherapeutic agents. Data from the breast cancer trial were also presented at this year's ASCO Annual Meeting.
WILEX aims to sign a licensing deal with a partner for further development of MESUPRON®.
WX-554 is an inhibitor of mitogen-activated protein kinase (MEK), which has been shown to play a key role in signal transduction. Mitogens are proteins that are linked to a multitude of biological processes such as cell division, cell differentiation and cell death. The MEK signalling pathway is overexpressed in more than 30% of cancers, resulting in uncontrolled tumour cell growth.
A Phase Ib/II dose escalation study with WX-554 in cancer patients started in the UK in April 2012. This open-label trial investigates the safety, pharmacokinetics, pharmacodynamics and clinical activity of WX-554 in patients with solid tumours. The first part of the study served to determine the biologically effective dose by way of a dose escalation.
The second part, which began in August 2013, is designed to obtain initial data on clinical activity and on pharmacodynamics in tumour tissue. Patient recruitment is expected to be completed by the end of the year.
The small molecule agent WX-037 inhibits the phosphatidylinositol-3-kinase-B pathway (PI3K), an important higher-level enzyme of one of the cell's signal transduction pathways, which sends a "cell division" signal to the nucleus of a tumour cell. Mutations and overactivity of the PI3K signalling pathway are present in many types of cancer. Inhibiting this enzyme is therefore a promising approach in tumour therapy.
Clinical development of the PI3K inhibitor WX-037 began in July 2013. At the beginning of August, WILEX announced that the first patient had been included in the trial. The open-label, dose-escalation study is being conducted in patients with solid tumours in three study centres in the UK. The purpose of the trial is to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of the PI3K inhibitor.
The MEK and PI3K programmes were both acquired from UCB Pharma S.A., Brussels, Belgium, as part of a strategic alliance.
Three antibody projects were also acquired from UCB in 2009. WILEX identified a lead candidate for one of these antibody programmes and generated preclinical data which prompted UCB to acquire the rights for indications outside oncology. In July 2013, UCB acquired this antibody programme from WILEX's preclinical portfolio with the objective of developing the antibody further in indications outside the field of oncology. However, WILEX keeps the rights to the antibody's further development in oncology. WILEX will be reimbursed an undisclosed amount for its development costs to date and is also eligible for development, regulatory and commercial milestone payments as well as royalties.
REDECTANE® (INN: Iodine (124I) Girentuximab) is a radiolabelled form of the antibody Girentuximab, which binds to the antigen CAIX on clear cell renal cell carcinoma. The radiopharmaceutical REDECTANE® is designed to support physicians in diagnosing renal cancers and determine whether or not clear cell renal cell carcinoma is present. This could fundamentally change therapy planning for renal cancer patients and potentially avoid surgery. Furthermore, REDECTANE® may also prove suitable for monitoring response to treatment and for diagnosing other kinds of tumours.
In 2010 the Phase III REDECT trial was completed and data were published which showed that REDECTANE® with PET/CT is clearly superior to CT alone in diagnosing clear cell renal cell carcinomas. Following extensive talks with the FDA, agreement was reached to conduct a confirmatory diagnostic performance study.
In the third quarter, WILEX received written notification from the FDA confirming agreement on the development strategy and study design for the confirmatory Phase III diagnostic performance clinical trial with REDECTANE® (REDECT 2). In parallel to the finalisation of the study protocol, financing options are being investigated to enable the implementation of the trial.
After the reporting period had ended, the subsidiary WILEX Inc. was acquired by the US company Nuclea Biotechnologies Inc., Pittsfield, MA, USA, at the beginning of September (see "Events after the reporting period").
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WILEX Inc. produces and markets biomarker tests in oncology under the brand name Oncogene Science with the aim of supporting treatment regimens for cancer patients. ELISA assays are used to detect antigens or proteins for example in the blood. Measuring proteins in the blood and using the appropriate bioanalytical method could predict whether a patient is likely to respond to a particular therapy. At the same time, the progression of the disease could be monitored. IHC assays are used for histological examinations of tissue.
The 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 CAIX IHC assay for the identification of the CAIX antigen in tissue or cell samples is registered as a "Class I 510(k)-exempt medical device" and may be used to measure the CAIX level in tumour tissue from patients. In the "Research Use Only" (RUO) field, ELISA assays are available for the CAIX, uPA, PAI-1, EGFR and TIMP-1 biomarkers.
Nuclea will develop Oncogene Science's CAIX IHC diagnostic test for use as a potential future companion diagnostic to RENCAREX® (see "Events after the reporting period").
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The partnerships WILEX Inc. concluded in the 2013 financial year with established distribution companies (Immundiagnostik AG for the German-speaking region, GeneDiagnostics for China and IBL-America Inc. for the United States) were transferred to Nuclea as part of the sale of WILEX Inc.
The Customer Specific Research segment comprises the services offered by the subsidiary Heidelberg Pharma GmbH.
The service business includes customer specific preclinical contract research related to cancers and inflammatory and autoimmune diseases. Heidelberg Pharma also possesses a platform for therapeutic antibody drug conjugates (ADC). This ADC technology has the potential to enhance and improve the efficacy of many antibody-based therapies, including those on the market. This technology is unique in that it links the antibody's specificity with the efficiency of the toxin Amanitin, which is found in the green Death Cap mushroom.
In experimental testing, these ATACs (Antibody Targeted Amanitin Conjugates) – the second generation of ADCs – show clear advantages over established ADC technologies due to their mode of action. They are highly effective and are able to break through common resistance mechanisms. ATACs target slow-growing tumours regardless of whether the tumour cell is dividing or not and can also destroy "dormant" tumour cells. As a result, they have the potential to prevent tumour recurrence.
Heidelberg Pharma has entered into several collaborations with research institutions as well as pharmaceutical and biotechnology companies to examine the applicability of this ADC technology to its partners' proprietary antibodies. A first partnership has been closed with Roche in September 2013 (see "Events after the reporting period").
Furthermore, work on the CapStem® project continues with the aim of refining this innovative ADC technology as an independent business model. This opens the opportunity not only to license the patented α-Amanitin linker technology but also to develop complete ADC molecules with in-licensed antibodies. This will enable the Company to exploit the attractive market potential and to use project finance to support development.
In July, WILEX engaged the investment bank Burrill Securities LLC as an advisor to assist WILEX in selecting partners for the financing of its projects. Burrill Securities provides life sciences companies with access to financial resources through global capital and a complementary blend of financial advisory services on public and private financings and cross-border transactions, including M&A, strategic partnerships, spin-outs, and public and private capital raising. The aim is to ensure financing for the planned Phase III trials by exploring all possible alternatives.
See pages 16 to 20 of the 2012 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 – as of the reporting date comprising WILEX AG and the subsidiaries WILEX Inc. and Heidelberg Pharma GmbH – reports consolidated figures. The reporting period referred to below concerns the period from 1 December 2012 to 31 August 2013 (9M 2013). Due to rounding, it is possible that individual figures in this report may not add up exactly to the totals and that percentages given may not precisely reflect the absolute figures to which they relate.
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 service business based on the ADC platform technology and the preclinical service business of Heidelberg Pharma.
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In the first nine months of the 2013 financial year, the WILEX Group generated sales revenue of €10.1 million (previous year: €11.3 million), excluding intersegment sales revenue. Most of this (€8.8 million; previous year: €9.7 million) is attributable to sales revenue from the Rx segment generated from the individual components of the licence agreement concluded with Prometheus for RENCAREX®; payments received were recognised as deferred income and will be reversed through profit or loss on a pro rata basis. The Dx segment generated sales revenue of €0.2 million and, contrary to our expectations, was unable to improve on the prior-year figure (€0.2 million). Sales revenue of €1.1 million in the Cx segment showed a clear recovery compared to previous quarters, but continued to fall short of expectations and the prior-year level (€1.4 million). The figure for the previous year had included the final work on a major contract completed in the first quarter of 2012.
At €1.3 million, other income came in slightly below the prior-year figure (€1.5 million) and mainly stems from the reversal through profit or loss of provisions for bonuses and restructuring measures that were not required in the amounts planned. Both the Rx segment and the Cx segment recognised grants from the Federal Ministry of Education and Research (BMBF) for research projects.
Operating expenses including depreciation and amortisation amounted to €15.3 million in the reporting period, down from the previous year (€19.8 million). They are distributed as follows across the three segments: Rx €8.9 million (previous year: €13.5 million), Dx €3.2 million (previous year: €2.8 million) and Cx €3.2 million (previous year: €3.5 million).
The cost of sales concerns costs directly related to sale revenue of the Group's segments. Cost of sales fell to €3.7 million in the reporting period (previous year: €4.9 million). This is due to lower expenses for RENCAREX® in the Rx segment, for which it receives cost reimbursements from Prometheus that are reported in sales revenue. The Dx segment generates this cost type through the production of biomarker tests as tradable products.
Research and development costs, which were €9.7 million the previous year, fell to €7.4 million. This reduction is due mainly to the Rx segment. The previous year had included costs for the breast cancer trial with MESUPRON® concluded in the second quarter of 2012; these costs were no longer incurred in the current reporting period. Furthermore, the expenses for RENCAREX® in the first three quarters were down significantly year on year. R&D expenses in the Dx segment were higher than in the previous year, reflecting the preparations for the next Phase III trial with REDECTANE®. The Cx segment recorded lower expenses than in the previous year.
Administrative costs were trimmed to €2.8 million in the first nine months of 2013 due to the cost cutting following the restructuring programme (previous year: €3.4 million).
Other expenses comprise the costs for activities in the areas of business development, marketing and commercial market supply. These amounted to €1.4 million in the reporting period (previous year: €1.8 million).
The WILEX Group reported an improved financial result of –€62k (previous year: –€451k). While finance income rose to €65k (previous year: €19k), finance costs were substantially reduced to €127k (previous year: €469k). The prior-year figure had still included the dievini shareholder loan including interest that was converted into shares in the third quarter of 2012. This item now primarily comprises the interest expense on the UCB loan.
The WILEX Group posted a loss of €4.0 million for the first nine months of the current financial year. This represents an improvement of 47% on the loss in the same period of the previous year (€7.4 million) and is solely attributable to lower costs. Earnings per share improved by 59% to –€0.13 (previous year: –€0.31), which is also due to the higher number of shares in circulation compared with the first nine months of 2012.
Further information regarding segment reporting can be found in the notes. Page 18
Total assets as of 31 August 2013 amounted to €24.9 million, down from the figure of €37.7 million shown as of the 30 November 2012 reporting date.
Non-current assets at the end of the reporting period amounted to €12.0 million (30 November 2012: €12.5 million). Of that amount, property, plant and equipment (mainly laboratory and office equipment) were €1.7 million and thus below the level recorded at the end of the 2012 financial year (€2.1 million). Intangible assets also fell to €3.9 million (30 November 2012: €4.1 million). Non-current assets continue to include the goodwill of Heidelberg Pharma amounting, as previously, to €6.1 million as well as rent security of €0.2 million (30 November 2012: €0.2 million).
Current assets totalled €12.4 million (30 November 2012: €25.2 million). The decline is due to the use of cash and cash equivalents for the Company's operations, amounting to €9.9 million as of 31 August (30 November 2012: €23.4 million). Final invoicing with a service provider in the ARISER trial reduced the prepayments made. In contrast, trade receivables rose to €1.7 million (30 November 2012: €0.3 million), with the lion's share (€1.5 million) relating to a receivable from Prometheus arising from the obligation to assume a portion of the costs for the ARISER trial. In this context, an audit was conducted by an independent audit firm in the third quarter. This audit, which reviewed the type and amount of the ARISER costs, is the prerequisite for terminating the agreement with Prometheus.
In accordance with IFRS 5, the assets and liabilities of WILEX Inc., which was sold after the reporting date in early September 2013 and is classified as a disposal group, are shown as a separate balance sheet item. These assets, which belong to a disposal group classified as held for sale, amounted to €0.5 million and included current assets, non-current assets and cash. There were no such assets the previous year.
Equity as of the end of the reporting period was €16.0 million (30 November 2012: €19.9 million). The equity ratio was 64.4% (30 November 2012: 52.8%; 31 August 2012: 49.7%). Further information regarding the development of equity can be found in the notes.
Non-current liabilities include deferrals from a staggered lease for rented offices, liabilities for service anniversaries and leasing liabilities. This item was reduced to €0.1 million (30 November 2012: €1.1 million). This is mainly attributable to expired leases and the exclusive accrual of payments received in the context of the Prometheus transaction reported under current liabilities.
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Current liabilities decreased to €8.6 million as of the end of the period (30 November 2012: €16.7 million). While liabilities arising from lease agreements (€0.1 million; 30 November 2012: €0.2 million) and financial liabilities (€2.6 million; 30 November 2012: €2.6 million) remained almost constant, trade payables (€0.5 million; 30 November 2012: €0.9 million) and other current liabilities (€5.4 million; 30 November 2012: €13.0 million) saw a further, substantial reduction.
As with the assets, the liabilities of the disposal group must also be shown separately. These total €0.2 million and comprise both current and non-current liabilities. There were no such liabilities the previous year.
At €13.5 million, in spite of the lower net loss for the period, the net cash outflow from operating activities during the first nine months of 2013 was substantially higher than in the same period of 2012 (cash inflow of €0.1 million), which had been dominated by the second payment (USD17.5 million) under the Prometheus partnership.
The outflow of funds for investing activities was €111k (previous year: €268k).
A cash outflow from financing activities of €160k that was used to repay finance leases was recorded in the reporting period. This contrasts with the same period of the previous year, which had been impacted by a significant inflow of funds of €25.4 million from the capital increases implemented in the first and third quarter of 2012.
In spite of a positive influence from exchange rate effects of €311k on cash (previous year: negative effect of –€27k), the net change in cash and cash equivalents therefore amounted to –€13.5 million (previous year: €25.3 million).
Including the members of its Executive Management Board, WILEX had 110 employees (101 FTEs) at the close of the reporting period (30 November 2012: 128 employees/120 FTEs; 31 August 2012: 127 employees/118 FTEs). The reduction of the workforce is to a large extent a result of the restructuring programme at the Munich site.
The Company has 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. For more information, see section "E. Issue and measurement of stock options" of the notes.
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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 the portfolio has matured, further studies have to be carried out and funded. It is important to note that financing of the company must be secured from the third quarter of 2014. There is a continued risk that not all or none of the drug and diagnostic candidates in our current portfolio will receive marketing approval. Risks and opportunities in connection with the WILEX Group's business are described in detail on pages 56 to 69 of the 2012 annual report. They remain unchanged unless noted otherwise.
Heidelberg Pharma GmbH signed a licence agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) at the beginning of September. One component of this agreement is the joint development of a novel class of antibody drug conjugates on the basis of Heidelberg Pharma's patented technology to couple α-Amanitin to antibodies (Antibody Targeted Amanitin Conjugates, ATACs). Roche plans to apply the ATAC technology to its own antibodies for the identification of suitable development candidates with favourable efficacy and safety profiles. Heidelberg Pharma will receive regular payments for granting access to its technology and providing research services. Roche will subsequently have the opportunity to exercise options for licences to develop and market selected antibody amanitin conjugates. Heidelberg Pharma will receive customary upfront payments, milestone payments and royalties as a percentage of net sales for each development candidate selected by Roche.
Another event after the end of the reporting period was the sale of the wholly owned subsidiary WILEX Inc. (Oncogene Science) to Nuclea Biotechnologies Inc. Nuclea acquired all shares of WILEX Inc. for a price of one US dollar. Under the terms of the deal, Nuclea will also assume responsibility for repayment of USD2.5 million which is a part of an intercompany loan from WILEX AG to WILEX Inc. In addition, WILEX AG is eligible for single-digit royalties on net sales of the HER2/ neu and CAIX assays.
Concurrently, and as an essential part of the overall deal, WILEX AG and Nuclea entered into a development agreement under which Nuclea will develop an automated CAIX IVD IHC assay ("CAIX Dx") to be submitted for FDA approval under the investigational device exemption ("IDE"). This CAIX Dx is intended to be used for patient stratification in a planned pivotal study with RENCAREX® and as a potential future companion diagnostic in the adjuvant treatment of clear cell renal cell carcinoma. Nuclea will bear the costs for the development of this CAIX Dx as a contribution in kind which will lead to savings of at least USD2.5 million for WILEX AG.
After the end of the reporting period, no other significant events occurred which have a direct influence on the business activities of the WILEX Group.
As a result of the recently concluded deals, the guidance for the WILEX Group for the current financial year issued in February 2013 is revised as follows:
| Guidance 10/2013 € million |
Guidance 02/2013 € million |
Actual 2012 € million |
|
|---|---|---|---|
| Sales revenue and other income | 14.0–17.0 | 15.0–19.0 | 17.8 |
| Operating expenses | 18.0–22.0 | 22.0–27.0 | 26.8 |
| Operating result | (2.0)–(6.0) | (5.0)–(9.0) | (8.9) |
| Total funding requirement | 14.0–17.0 | 16.0–20.0 | 20.0 |
| Funds required per month | 1.2–1.4 | 1.3–1.7 | 1.7 |
Sales revenue and other income in 2013 will be below or at the lower end of the original projections, resulting in a slight adjustment of targets. As forecast, the Rx segment will account for €12.5 million to €15.0 million of sales revenue and other income, principally resulting from the revenue generated from the Prometheus payments. The DX segment will generate sales revenue of approximately €0.3 million; no further revenue from the marketing of the biomarker tests at WILEX Inc. and its distribution partners is anticipated in the fourth quarter. In the Cx segment, due to the weaker first half, income will fall short of the original projections at €1.5 million to €2.0 million. The earnings target for 2013 does not include potential sales revenue from further licence agreements in the individual segments.
Research and development costs, which are part of operating expenses, are projected to be substantially lower at between €9.0 million and €12.0 million. Other expenses concern manufacturing costs, administrative costs and other operating expenses, which are also expected to be lower than in the reporting year.
The Company expects earnings before interest and taxes (EBIT) in the 2013 financial year to improve significantly to between –€2.0 million and –€6.0 million.
Due to a reduction in costs, the projected net change in cash and cash equivalents in the 2013 financial year will be between –€14 million and –€17 million. This corresponds to an average monthly use of cash of €1.2 million to €1.4 million.
Based on the promising subgroup data for the product candidate RENCAREX® and the talks with the regulatory authorities, the planning for a confirmatory prospective Phase III trial in the CAIX subgroup will be continued and a study protocol prepared.
WILEX is in discussion with Prometheus about the termination of the existing licence agreement for the US commercial rights to RENCAREX®. Following termination, WILEX could regain the global rights except Southern Europe and offer these to a new partner. Talks are being held in parallel with several parties for out-licensing the rights for the rest of the world Europe (except Southern Europe and the USA). WILEX's goal is to find a partner that will participate in the financing, development and commercialisation.
The partnering process for the drug candidate MESUPRON® is under way with the goal of signing a licensing agreement with a partner that will advance the further development of MESUPRON®. The talks initiated with several parties are well advanced. We currently assume that we will be able to adhere to our plan of signing a licence agreement by the end of 2013.
The dose escalation part in the ongoing Phase Ib/II trial with the MEK inhibitor WX-554 will be completed in the coming weeks. In parallel, initial data on safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics in tumour tissue will be collected. Patient recruitment is expected to be completed by the end of the year, with data becoming available in the second half of 2014.
In the recently initiated Phase I trial with the PI3K inhibitor WX-037, patient recruitment continues and various dosages are currently being tested.
WILEX AG will prepare full documentation for REDECT 2 and submit it to the FDA for formal approval under the Special Protocol Assessment (SPA) procedure. The start of the trial is not planned until WILEX has secured financing for the entire study.
With the support of cooperation partner Nuclea Biotechnologies Inc., WILEX Inc.'s CAIX in-vitro diagnostic test will be developed further as a companion diagnostic, which may be helpful in identifying and stratifying patients who might benefit from RENCAREX® therapy.
Following the sale of WILEX Inc., the Diagnostics segment will report exclusively on WILEX AG's imaging diagnostic candidate REDECTANE®.
WILEX plans to further increase sales revenue from the services business and acquire new customers for this service by expanding its offering for inflammatory diseases, oncology and bioanalytics.
Additional partnerships planned for the ADC technology shall provide the basis for successfully commercialising this platform. Furthermore, the activities necessary for establishing and funding the CapStem® project shall be advanced. Going forward, all ADC activities are intended to tap into short-term and long-term future potential for generating sales revenue and creating added value through licence agreements.
The partnership deal signed with Roche in September is an important building block for reaching the annual targets for 2013 and offers options for a dynamic development of the net assets, financial position and earnings of the Cx segment in 2014. Despite the good opportunities, expenses are likely to remain higher than income because the business activities related to the ADC technology are still in an early stage.
Reporting period from 1 December 2012 to 31 August 2013
| 9M 2013 € |
9M 2012 € |
|
|---|---|---|
| Revenue | 10,089,625 | 11,358,733 |
| Other income | 1,295,369 | 1,472,001 |
| Income | 11,384,995 | 12,830,734 |
| Cost of sales | (3,691,445) | (4,931,382) |
| Research and development costs | (7,355,455) | (9,735,287) |
| Administrative costs | (2,799,704) | (3,377,947) |
| Other expenses | (1,431,861) | (1,753,996) |
| Operating expenses | (15,278,467) | (19,798,612) |
| Operating result | (3,893,472) | (6,967,878) |
| Finance income | 64,547 | 18,709 |
| Finance costs | (127,031) | (469,215) |
| Financial result | (62,485) | (450,506) |
| Earnings before tax | (3,955,957) | (7,418,384) |
| Income tax | (121) | (1,282) |
| Net loss for the period | (3,956,078) | (7,419,667) |
| Net currency gain/loss from consolidation | (9,832) | (97,999) |
| Comprehensive income | (3,965,910) | (7,517,666) |
| Earnings per share | ||
| Basic and diluted earnings per share | (0.13) | (0.31) |
| Average number of shares issued | 31,275,507 | 24,163,759 |
Rounding of exact figures may result in differences.
| Quarterly comparison | Q3 2013 € '000 |
Q2 2013 € '000 |
Q1 2013 € '000 |
Q4 2012 € '000 |
Q3 2012 € '000 |
|---|---|---|---|---|---|
| Revenue | 3,495 | 3,272 | 3,323 | 4,783 | 4,145 |
| Other income | 257 | 473 | 565 | 228 | 433 |
| Operating expenses | (4,156) | (5,288) | (5,834) | (6,953) | (6,257) |
| Operating result | (403) | (1,543) | (1,947) | (1,942) | (1,679) |
| Earnings before tax | (416) | (1,562) | (1,978) | (1,970) | (1,810) |
| Net loss for the period | (416) | (1,562) | (1,978) | (1,971) | (1,810) |
| Net currency gain/loss from consolidation |
(9) | 4 | (5) | 88 | 4 |
| Comprehensive income | (425) | (1,558) | (1,983) | (1,883) | (1,806) |
| Basic and diluted earnings per share in € |
(0.01) | (0.05) | (0.06) | (0.05) | (0.07) |
| Average number of shares issued | 31,276 | 31,276 | 31,276 | 31,276 | 25,096 |
Rounding of exact figures may result in differences.
as of 31 August 2013 and as of 30 November 2012
| Assets | 31.08.2013 € |
30.11.2012 € |
|---|---|---|
| Property, plant and equipment | 1,677,043 | 2,086,534 |
| Intangible assets | 3,932,898 | 4,106,758 |
| Goodwill | 6,111,166 | 6,111,166 |
| Other non-current assets | 237,116 | 227,674 |
| Non-current assets | 11,958,223 | 12,532,132 |
| Inventories | 127,996 | 258,210 |
| Prepayments | 250,733 | 734,759 |
| Trade receivables | 1,685,029 | 269,550 |
| Other receivables | 484,481 | 562,894 |
| Cash and cash equivalents | 9,875,825 | 23,363,335 |
| Current assets | 12,424,064 | 25,188,748 |
| Assets of disposal group classified as held for sale | 534,817 | 0 |
| Total assets | 24,917,105 | 37,720,880 |
| Equity and liabilities | 31.08.2013 € |
30.11.2012 € |
|---|---|---|
| Subscribed capital | 31,275,507 | 31,275,507 |
| Capital reserve | 159,299,442 | 159,211,811 |
| Accumulated losses | (174,474,944) | (170,518,867) |
| Net currency gain/loss from consolidation | (57,469) | (47,637) |
| Equity | 16,042,535 | 19,920,815 |
| Lease liabilities | 39,455 | 129,746 |
| Other non-current liabilities | 81,088 | 930,901 |
| Non-current liabilities | 120,544 | 1,060,646 |
| Trade payables | 492,659 | 904,365 |
| Liabilities arising from leases | 141,071 | 210,501 |
| Financial liabilities | 2,600,133 | 2,637,500 |
| Other current liabilities | 5,350,614 | 12,987,053 |
| Current liabilities | 8,584,478 | 16,739,419 |
| Liabilities of disposal group classified as held for sale | 169,549 | 0 |
| Total equity and liabilities | 24,917,105 | 37,720,880 |
Rounding of exact figures may result in differences.
Reporting period from 1 December 2012 to 31 August 2013
| 9M 2013 € |
9M 2012 € |
|
|---|---|---|
| Net loss for the period | (3,956,078) | (7,419,667) |
| Adjustment for items in the statement of comprehensive income | ||
| Measurement of stock options | 87,630 | 202,549 |
| Depreciation/amortisation | 440,452 | 489,019 |
| Finance costs | 127,031 | 753,233 |
| Finance income | (64,497) | (302,728) |
| Tax expense | 0 | 1,282 |
| 590,616 | 1,143,355 | |
| Changes in net working capital | ||
| Inventories | (13,905) | 232,194 |
| Trade receivables | (1,448,577) | 129,716 |
| Other receivables | (707,480) | 2,122,896 |
| Prepayments | 419,081 | 69,884 |
| Other non-current assets | (10,153) | (11,229) |
| Trade payables | (424,345) | 146,789 |
| Other liabilities | (7,848,066) | 4,205,983 |
| (10,033,446) | 6,896,231 | |
| Cash flow from operating activities | (13,398,907) | 619,919 |
| Finance costs paid | (164,652) | (527,409) |
| Finance income received | 64,695 | 18,710 |
| Net cash flow from operating activities | (13,498,864) | 111,220 |
| Cash flow from investing activities | ||
| Purchase of property, plant and equipment | (87,794) | (212,167) |
| Purchase of intangible assets | (23,316) | (55,914) |
| Net cash flow from investing activities | (111,110) | (268,081) |
| Cash flow from financing activities | ||
| Proceeds from capital increase | 0 | 33,829,993 |
| Capital increase costs | 0 | (409,628) |
| Changes in shareholder loans | 0 | (7,771,250) |
| Other financing activities | 0 | (39,835) |
| Repayment of finance leases | (159,721) | (168,914) |
| Net cash flow from financing activities | (159,721) | 25,440,366 |
| Influence of foreign exchange effects on cash and cash equivalents | 311,090 | (26,919) |
| Net change in cash and cash equivalents | (13,458,605) | 25,256,586 |
| Cash and cash equivalents | ||
| at beginning of period | 23,363,335 | 3,420,640 |
| at end of period | 9,904,7301 | 28,677,226 |
1 Figure differs by €28,905 from the amount shown in the balance sheet because it includes the cash of WILEX Inc. Rounding of exact figures may result in differences.
Reporting period from 1 December 2012 to 31 August 2013
| Capital measures/ premium |
Measure ment of stock options |
Currency | |||||
|---|---|---|---|---|---|---|---|
| Subscribed capital |
Capital reserve | translation differences |
Accumulated losses |
Total | |||
| Shares | € | € | € | € | € | € | |
| 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 | |
| 155,892,571 | 3,319,240 | ||||||
| As of 1 December 2012 |
31,275,507 | 31,275,507 | 159,211,811 | (47,637) | (170,518,867) | 21,449,423 | |
| Measurement of stock options |
87,630 | 87,630 | |||||
| Net currency gain/loss from consolidation |
(9,832) | (9,832) | |||||
| Net loss for the period |
(3,956,078) | (3,956,078) | |||||
| Capital increase after accounting for capital pro curement costs |
0 | ||||||
| Net change in equity |
(3,878,280) | ||||||
| 155,892,571 | 3,406,871 | ||||||
| As of 31 August 2013 |
31,275,507 | 31,275,507 | 159,299,442 | (57,469) | (174,474,944) | 16,042,535 |
Rounding of exact figures may result in differences.
This 9-month financial report as of 31 August 2013 was prepared in accordance with the same accounting policies as the consolidated financial statements as of 30 November 2012. The interim consolidated financial statements as of 31 August 2013 include the Group's parent, WILEX AG, Munich, Germany, as well as its subsidiaries WILEX Inc., Cambridge, MA, USA (which was sold after the reporting date) and Heidelberg Pharma GmbH, Ladenburg, Germany – jointly the "Group".
The Company's earnings, financial position and net assets as well as essential items of these 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 2012 published for the 2012 financial year.
The interim consolidated financial statements were not subjected to a review by an auditor. Pursuant to our Declaration of Conformity issued in February 2013 concerning Section 7.1.2 of the German Corporate Governance Code, both the interim 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 10 October 2013.
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 2012 and compared to 31 August 2012, the closing date of the previous year's comparative period.
The Therapeutics segment posted sales revenue of €8.8 million and a profit of €0.5 million in the first nine months. 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 €0.2 million and a net loss for the period of €3.1 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.
Customer Specific Research generated sales revenue of €1.1 million and a net loss for the period of €2.2 million. For one, Heidelberg Pharma provides customer specific services in connection with a novel technology platform for therapeutic antibody drug conjugates, which is still being developed. These services are provided in collaboration with pharmaceutical and biotech companies. For another, Heidelberg Pharma performs work for businesses and research institutes 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 in the first nine months of 2013 totalled €9k, all of which was generated by the Cx segment in transactions with the Rx segment.
The segment results were as follows:
| Segment results 9M 20131 | Rx € '000 |
Dx € '000 |
Cx € '000 |
Not allocated € '000 |
Consoli dation € '000 |
Group € '000 |
|---|---|---|---|---|---|---|
| Sales revenue | 8,820 | 176 | 1,103 | 0 | (9) | 10,090 |
| External sales revenue | 8,820 | 176 | 1,094 | 0 | 0 | 10,090 |
| Intersegment sales revenue | 0 | 0 | 9 | 0 | 0 | 9 |
| Other income | 564 | 106 | 124 | 509 | (8) | 1,295 |
| Operating expenses | (8,868) | (3,205) | (3,223) | 0 | 17 | (15,278) |
| Operating result | 516 | (2,923) | (1,996) | 509 | 0 | (3,893) |
| Financial result | 0 | (168) | (161) | 267 | 0 | (62) |
| Profit/loss for the period | 516 | (3,091) | (2,157) | 776 | 0 | (3,956) |
| Total assets | 2,202 | 3,974 | 16,948 | 11,978 | (10,185) | 24,917 |
rounded
The breakdown of segment assets for purposes of interim reporting pursuant to IAS 34 has not changed; it continues to concern 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.
As of the reporting date, the total number of WILEX shares issued (subscribed capital) remained at 31,275,507.
The equity of the WILEX Group at the end of the reporting period was €16.0 million (30 November 2012: €19.9 million). The capital reserve was €159.3 million (30 November 2012: €159.2 million) and the losses accumulated since WILEX's foundation totalled €174.5 million (30 November 2012: €170.5 million). The Company recognised a currency loss of €57k in equity in connection with the consolidation of its US subsidiary (30 November 2012: currency loss of €48k). The equity ratio of the WILEX Group was 64.4% (30 November 2012: 52.8%).
Following resolutions of the Executive Management Board and the Supervisory Board in early September, WILEX AG signed the agreement on the sale of WILEX Inc. to Nuclea Biotechnologies Inc., Pittsfield, MA, USA (Nuclea) on 6 September 2013.
Nuclea will acquire all shares of WILEX Inc. from WILEX AG for a price of one US dollar. Under the terms of the deal, Nuclea will also assume responsibility for repayment of USD2.5 million which is a part of an intercompany loan from WILEX AG to WILEX Inc. In addition, WILEX AG is eligible for royalties on net sales of the HER2/neu and CAIX assays.
On account of REDECTANE® and in the interests of continuous reporting, the Dx segment, to which WILEX Inc. was allocated during the reporting period, will be maintained. Please see "Business performance and research and development activities" for a detailed description of what is presented as a disposal group as defined in IFRS 5 (in vitro diagnostic tests (WILEX Inc./Oncogene Science).
In the first nine months of the year, WILEX Inc. generated a net loss for the period of €1.6 million (previous year: €1.6 million) and is part of the consolidated statement of comprehensive income in each case.
The net change in the cash and cash equivalents of WILEX Inc. in the reporting period was –€147k (previous year: €89k). After adjusting these figures for the loan financing by WILEX AG in these periods, net cash flows amounted to –€1.5 million (previous year: –€1.4 million).
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. In the first nine months of the 2013 financial year, no stock options were issued under the 2011 Stock Option Plan.
Similar to the approach described in the annual report as of 30 November 2012, 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.
Page 5
The measurement of the stock options in the first nine months of the 2013 financial year entailed staff costs of €88k, of which €73k was attributable to the measurement of the stock options issued in 2012 under the 2011 Stock Option Plan. The remaining €15k relates to the 2005 Stock Option Plan, under which no more new options can be issued; not all of the issued options have vested, however.
No stock options were issued or exercised in the first nine months of the 2013 financial year. A total of 6,000 stock options were returned because employees left the Company. Furthermore, no options held by employees or members of the Executive Management Board under the relevant plans have expired or were forfeited for other reasons. This means that 1,215,487 options – 833,335 for current or former members of the Executive management Board and 382,152 for current or former employees – had been issued as of the end of the period.
A total of 6,500 options of the Executive Management Board and 12,142 options of employees have vested as of the reporting 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 € |
|---|---|---|---|---|---|---|
| Dr Georg Baur1 | 01.03.2013 | Sale | XETRA | 1.6962 | 50,000 | 84,808.45 |
| Dr Georg Baur | 28.02.2013 | Sale | XETRA | 1.7046 | 50,000 | 85,229.42 |
1 Dr Georg Baur is Deputy Chairman of the Supervisory Board of WILEX AG.
In addition the Rittershaus law firm provided legal consulting services for WILEX AG and Heidelberg Pharma of approximately €15k in the reporting period. Rittershaus is a related party because the chairman of the Supervisory Board, Professor Christof Hettich, is a partner in this law firm.
All significant events that occurred after the end of the reporting period are explained in the report on events after the reporting period that is part of the interim management report. Page 11
"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, 10 October 2013
Executive Management Board
Professor Olaf G. Wilhelm Dr Jan Schmidt-Brand Dr Paul Bevan Dr Thomas Borcholte
WILEX's shares started the 2013 trading year at €0.976 and closed at €1.190 on 30 September 2013, posting a gain of around 22%. The DAXsubsector Biotechnology Index and the NASDAQ Biotechnology Index both continued the positive trend witnessed in the previous year, gaining 28% and 53%, respectively.
| Key share figures as of the end of the reporting period |
9M 2013 | 9M 2012 | |
|---|---|---|---|
| Shares issued | Number | 31,275,507 | 31,275,507 |
| Market capitalisation | € million | 35.97 | 117.44 |
| Closing price (XETRA) | € | 1.150 | 3.755 |
| High1 | € | 2.299 (27.02.13) |
4.665 (07.12.11) |
| Low1 | € | 0.830 (11.12.12) |
2.866 (10.01.12) |
| Volatility (260 days, XETRA) | % | 118.243 | 42.854 |
| Average daily trading volume1 | Shares | 111,643 | 21,855 |
| Average daily trading volume1 | € | 165,434 | 80,524 |
| Earnings per share | € | (0.13) | (0.31) |
All stock exchanges
Source: Bloomberg
The average daily trading volume of the ordinary shares was 111,643 shares in the first nine months of the current financial year, which is a five-fold increase compared with the same period the previous year (21,855 shares). As a result of the substantially lower share price, market capitalisation as of 31 August 2013 was just €35.97 million (31 August 2012: €117.4 million).
| Shareholder structure of WILEX AG | |
|---|---|
| dievini Hopp BioTech holding GmbH & Co. KG, Curacyte AG and DH-Holding Verwaltungs GmbH (formerly: Verwaltungsgesellschaft Golf Club St. Leon-Rot mbH) |
≈47% |
| UCB | ≈14% |
| Corporate bodies | ≈2% |
| Free float less than 3% | ≈37% |
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 2014 | Annual Report 2013, Financial press conference and analysts' meeting |
| 15 April 2014 | 3-month Financial Report 2014 |
| 23 May 2014 | Annual General Meeting 2014 |
| 15 July 2014 | Half-yearly Financial Report 2014 |
| 15 October 2014 | 9-month Financial Report 2014 |
Dr. Jan Schmidt-Brand Sylvia Wimmer Katja Arnold (CIRO)
Chief Financial Officer Associate Manager Corporate Communications Executive Director Tel. +49(0)89–41 31 38–23 Tel. +49(0)89–41 31 38–29 Tel. +49(0)89–21 02 28–40 E-mail: [email protected] E-mail: [email protected] E-mail: [email protected]
Published by: WILEX AG, Grillparzerstr. 10, 81675 München, Germany, www.wilex.com Responsible for the project: Sylvia Wimmer, WILEX AG, and Katja Arnold, MC Services AG
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: 10 October 2013
WILEX AG Grillparzerstr. 10 · 81675 Munich · Germany · www.wilex.com
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