WILEX announces results of successful first half year 2012
• Positive Phase II data for MESUPRON® in breast cancer
• Decision to opt for further payment under the licence agreement with Prometheus
• Half-year figures in line with expectations; earnings up 46%
• 2012 guidance improved
Munich, Germany, 12 July 2012. WILEX AG (ISIN DE0006614720 / WL6 / FWB) published its financial report for the first six months of the 2012 financial year (1 December 2011 – 31 May 2012) and reported on the status of the Group’s projects.
Peter Llewellyn-Davies, Chief Financial Officer of WILEX AG, commented: “The first half year of 2012 was a very successful one for us: We managed to boost our earnings by 46% due to higher sales revenue. To reflect this positive business performance, we have adjusted our financial guidance for the current financial year. Under the licence agreement with Prometheus we opted for a further payment. Our financing is now secured until Q2 2013.”
Activities and outlook of the operating segments
RENCAREX® (INN: Girentuximab): The study amendment was approved by the FDA and European regulatory authorities in February 2012 for the Phase III ARISER registration trial to start the final analysis. All existing clinical data and radiological findings for the patients included in the trial are currently being collected from the trial centres, checked, and then imported into a database for independent evaluation. The trial results on disease-free survival are expected in the fourth quarter of 2012.
After the end of the reporting period, WILEX opted for a further payment under the licence agreement with Prometheus. The parties agreed on an immediate payment of USD 17.5 million. 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.
MESUPRON® (INN: Upamostat): In June 2012 WILEX published positive data from its Phase II trial with the oral uPA inhibitor MESUPRON® in breast cancer. These showed that MESUPRON® improves median progression free survival, particularly in subgroups, as well as the objective response rate and that the therapy is safe and well tolerated. The data confirm the results of the pancreatic cancer trial reported in 2010. The further development strategy for MESUPRON® will be decided in the coming months with the medical advisory board and with any potential future partners.
WX-554: A Phase Ib/II trial with the small molecule MEK inhibitor WX-554 was started in April 2012 to analyse the safety, pharmacokinetics, pharmacodynamics and efficacy of WX-554 in patients with solid tumours. First data could be available by the end of the year.
REDECTANE® (INN: 124I-Girentuximab): For the imaging diagnostic candidate REDECTANE® a FDA Advisory Committee (Oncologic Drugs Advisory Committee, ODAC) is asked to discuss and issue a recommendation on the extent to which the identification of a clear cell renal carcinoma through imaging provides clinically relevant information in indeterminate renal masses. Following the ODAC meeting, WILEX will meet with the FDA several weeks later to discuss the results of the meeting and the way forward.
In vitro diagnostic tests: WILEX Inc. reported an increase in sales revenue for the first six months of 2012. The US subsidiary markets under the brand name Oncogene Science 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).
Customer Specific Research (Cx)
Heidelberg Pharma GmbH has entered into several research agreements for its customer specific ADC technology and reported increasing sales revenue in the reporting period, particularly for its preclinical service business.
Key financial figures for the first half of 2012
The previous year’s figures are not directly comparable with the consolidated figures for the current reporting period because Heidelberg Pharma was not consolidated until the non-cash capital increase was recorded in the German Commercial Register on 17 March 2011 (i.e. during the H1 2011 reporting period).
In the first six months of the 2012 financial year, the WILEX Group generated sales revenue of EUR 7.2 million (previous year: EUR 1.4 million). This significant increase is mainly due to sales revenue of EUR 5.9 million (previous year: EUR 0.9 million) in the Rx segment from the ongoing pro rata reversals of accrued payments for RENCAREX® and additional receivables under the Prometheus licence agreement. Other income amounted to EUR 1.0 million and was higher year on year (EUR 0.6 million), mainly due to gains from exchange rate differences.
Operating expenses including depreciation and amortisation amounted to EUR 13.5 million in the reporting period, up on the previous year (EUR 12.4 million). The Group’s cost of sales was EUR 3.3 million in the first half of the year, a substantial increase on the figure for the previous year (EUR 1.0 million). Research and development costs, which were EUR 8.8 million the previous year, fell by 21% to EUR 6.9 million during the first half of 2012 and accounted for 51.0% of all costs (previous year: 71%). The decline is mainly due to both the reclassification of development costs for the cost reimbursements from Prometheus to cost of sales and the stage of the trials, especially RENCAREX® and MESUPRON®, and the resulting decline in costs.
The WILEX Group posted a loss of EUR 5.6 million for the first six months of the 2012 financial year. This corresponds to an improvement in earnings by 46% on the same period of the previous year (EUR -10.6 million), particularly due to the year-on-year increase in sales revenue. Earnings per share improved to EUR – 0.24 (previous year: EUR -0.54) as a result of the lower loss for the period and the increase in the number of shares.
The therapeutics segment posted sales revenue of EUR 5.9 million and a net loss of EUR 3.2 million in the first six months of the financial year. The Diagnostics segment generated sales revenue of EUR 0.2 million and a net loss for the period of EUR 1.7 million. Customer Specific Research generated sales revenue of EUR 1.2 million and a net loss of EUR 1.3 million in the first six months just ended.
Total assets as of 31 May 2012 amounted to EUR 22.4 million (30 November 2011: EUR 20.8 million). Non-current assets at the end of the reporting period amounted to EUR 12.7 million and were at the level reported at the end of the financial year (EUR 12.8 million). At EUR 9.7 million, current assets at the close of the reporting period were higher than at the close of the 2011 financial year (EUR 8.0 million). They comprise EUR 2.9 million in cash and cash equivalents (30 November 2011: EUR 3.4 million) and EUR 6.8 million in other current assets (30 November 2011: EUR 4.6 million).
Equity at the end of the reporting period was EUR -0.3 million (30 November 2011: EUR -4.5 million). Non-current liabilities at the end of the reporting period amounted to EUR 2.6 million (30 November 2011: EUR 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 EUR 20.1 million as of the end of the period (30 November 2011: EUR 20.2 million). This includes EUR 10.3 million in financial liabilities from the dievini Hopp BioTech holding GmbH & Co. KG and UCB Pharma S.A., shareholder loans which were lower than the level as of 30 November 2011 (EUR 10.5 million) due to an interest payment.
Improved Guidance 2012
The WILEX Group has adjusted its financial guidance for the current financial year and now expects sales revenue and other income to increase to between EUR 16 and 18 million (previously: EUR 14 to 16 million; 2011: EUR 11.7 million). Operating expenses will continue to be between EUR 25.0 and 29.0 million in 2012. The operating loss for the year will reduce to between EUR 8 and 12 million (previously: EUR 10 to 14 million; 2011: EUR 13.4 million). WILEX anticipates an unchanged monthly cash usage of between EUR 1.7 and 2.0 million (2011: EUR 2.0 million).
Key figures for the WILEX Group
|Earnings before tax||
|Net loss for the period||
|Earnings per share in EUR
|Balance sheet as of the end of the period|
|Cash and cash equivalents||2,920||13,516|
|Equity ratio2) in %||(1.3)||(3.5)|
|Cash flow statement|
|Cash flow from operating activities||(9,906)||1,668|
|Cash flow from investing activities||(140)||(98)|
|Cash flow from financing activities||9,639||9,972|
|Employees as of the end of the period3)||126||118|
|Employees as of the end of the period (full-time equivalents)3)||116.2||109.5|
1) The reporting period begins on 1 December and ends on 31 May.
2) Equity/total assets
3) Including Wilex Inc. (from Nov. 2010), Heidelberg Pharma (from March 2011) and members of the Executive Management Board
Rounding of exact figures may result in differences.
The 2012 half-yearly financial report including the consolidated financial statements prepared in accordance with International Financial Reporting Standards (IFRS) was published at www.wilex.com.
Invitation to the conference call:
On 12 July 2012, WILEX will hold a public conference call for media, analysts and investors in English at 3:00 p.m. CET. Please dial in ten minutes before the conference call using the following dial-in numbers:
1. Germany: +49 69 71044 5598
2. UK: +44 20 3003 2666
3. USA: +1 212 999 6659
4. USA Freephone: +1 866 966 5335
You will be welcomed by an operator taking your name and company. The presentation for the conference will be available for download from www.wilex.com at 2:30 p.m. CET.
Katja Arnold (CIRO)
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
E-mail: investors [at] wilex.com
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the Company has a broad portfolio of diagnostic and therapeutic products for the specific detection and targeted treatment of various types of cancer. WILEX’s therapeutic product candidates are based on antibodies (RENCAREX® in Phase III) and small molecules (MESUPRON® in Phase II, WX-554 in Phase Ib/II and WX-037 in preclinical development). In the field of diagnostics, REDECTANE® is an antibody-based, imaging in vivo diagnostic agent that is currently in a Phase III programme. WILEX’s US subsidiary WILEX Inc. in Cambridge, MA, markets a portfolio of research use only tests and in vitro diagnostic agents under the brand Oncogene Science, which are used as companion diagnostics for clinical trials and therapy monitoring. The wholly owned subsidiary Heidelberg Pharma GmbH offers an attractive and highly promising antibody drug conjugate technology platform and preclinical contract research services. The business model of WILEX comprises research, technology, product development and commercialisation. WILEX’s customers and partners include leading international pharmaceutical companies.
Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6
This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”, “should”, “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial position, earnings, achievements, or industry results, to be materially different from any future results, earnings or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.