WILEX publishes 9-months financial report 2012

ENGLISH DEUTSCH

•Sales revenue and earnings significantly improved
•Oncologic Drugs Advisory Committee vote in favour of diagnostic performance
•Combined capital increase against cash and contributions in kind successfully completed
•Dr Jan Schmidt-Brand appointed as new CFO

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Munich, Germany, 11 October 2012. WILEX AG (ISIN DE0006614720 / WL6 / FWB) published its financial report for the first nine months of the 2012 financial year (1 December 2011 – 31 August 2012) and reported on the status of the Group’s projects.

Dr. Jan Schmidt-Brand, Chief Financial Officer of WILEX AG, commented: “The previous nine months of the 2012 financial year were very successful for us: Due to higher sales revenue we managed to boost our earnings by 44% compared to the same period of the previous year. Regarding our development projects and our economic progress the third quarter was eventful and successful. The implemented capital increase and the payment from our partner Prometheus allow us to finance ongoing and planned clinical studies until 2014. We are on track with our preparations for the final analysis in the phase III trial with RENCAREX® to be expected in Q4 this year.”

Activities and outlook of the operating segments
Therapeutics (Rx)
RENCAREX® (INN: Girentuximab): Over the past few months, all existing clinical data of all patients included in the Phase III registration trial ARISER were collected at the trial centres, checked and then imported into a database for independent evaluation. The DFS (disease-free survival) data will be analysed statistically and the trial results evaluated by the ARISER Independent Data Monitoring Committee (IDMC) 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.

MESUPRON® (INN: Upamostat): WILEX published positive data from its Phase II trial with the oral uPA inhibitor MESUPRON® in breast cancer in June 2012. These results 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. It is planned to sign a license agreement with a partner for MESUPRON® and decide the further development strategy together with the future partner.

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. The study will be continued over the next few months.

Diagnostics (Dx)
REDECTANE® (INN: 124I-Girentuximab): In July 2012, a meeting of the Oncologic Drugs Advisory Committee (ODAC) took place. The FDA Advisory Committee delivered a clear vote in favour of the clinical use of the diagnostic agent. ODAC addressed the following question: 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?”

In September 2012, the FDA and WILEX discussed the recommendations of the ODAC and the development strategy for the imaging diagnostic at a further Type C meeting. The agency confirmed that the outcomes-based study it required in the past to be no longer necessary, but requires a further 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. Currently, WILEX is developing the protocol for this Phase III trial (REDECT 2) for submission to the FDA on the basis of a special protocol assessment. The details of the design of this trial will be released once the protocol has been approved.

In vitro diagnostic tests: WILEX Inc. generated sales revenue in the first nine months of the financial year at the previous year’s level. 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) and intensifies the marketing activities to increase its sales revenue.

Customer Specific Research (Cx)
Due to the services offered in the field ADC technology and preclinical service business Heidelberg Pharma GmbH’s sales revenues rose year on year. Furthermore, the company recruited Professor Andreas Pahl in September 2012 and has filled the vacant position of Chief Scientific Officer. Additional partnerships planned for the ADC technology shall provide the basis for successfully commercialising this platform.

Financing and business development
WILEX AG carried out a combined capital increase against cash and contributions in kind in the third quarter of 2012. 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 EUR 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. In the cash portion of the rights issue, 4,360,207 new shares were subscribed. This generated gross proceeds of around EUR 16.1 million for the Company. The total number of WILEX shares issued increased to 31,275,507. Prometheus’s payment of USD 17.5 million in July 2012 secures in addition to that the financing and further growth into 2014.

On 1 September 2012, Dr. Jan Schmidt-Brand assumed the position of Chief Financial Officer and succeeded Peter Llewellyn-Davies, who left the Executive Management Board at the end of his contract.

Key financial figures for the first nine months 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 capital increase against contribution in kind was recorded in the German Commercial Register on 17 March 2011.

In the first nine months of the 2012 financial year, the WILEX Group generated sales revenue of EUR 11.3 million (previous year: EUR 4.7 million). This significant increase is mainly due to sales revenue of EUR 9.7 million in the Rx segment from the ongoing pro rata reversals of accrued payments for RENCAREX® and additional receivables under the Prometheus licence agreement. At EUR 1.5 million, other income was significantly higher year on year (EUR 0.8 million), mainly due to gains from exchange rate differences.

Operating expenses including depreciation and amortisation amounted to EUR 19.8 million in the reporting period, up on the previous year (EUR 18.4 million). Research and development costs of EUR 9.7 million were down 28% year on year (previous year: EUR 13.6 million). A part of the R&D costs has been reclassified in cost of sales since the 2011 annual financial statements. Cost of sales were EUR 4.9 million in the reporting period, up substantially owing to the reclassification of costs and the consolidation of Heidelberg Pharma in the entire financial year. Administrative costs were EUR 3.4 million in the first nine months (previous year: EUR 3.9 million). A total of EUR 0.5 million in expenses for business development was included in administrative costs in the same period the previous year. Given the increased marketability of RENCAREX®, the costs of activities related to business development (EUR 0.6 million), marketing and commercial supply (EUR 1.2 million) have been reported as “other expenses” (EUR 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” (EUR 0.9 million in total).

The WILEX Group posted a loss of EUR 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 (-EUR 13.2 million) and is particularly due to the increase in sales revenue. Earnings per share improved to -EUR 0.31 (previous year: -EUR 0.65), mainly as a result of the lower loss for the period.

The Therapeutics segment posted sales revenue of EUR 9.7 million and a net loss of EUR 3.6 million in the first nine 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 2.6 million. Customer Specific Research posted sales revenue of EUR 1.4 million and a net loss for the period of EUR 1.9 million.

Total assets as of 31 August 2012 amounted to EUR 43.2 million (30 November 2011: EUR 20.8 million). Non-current assets at the end of the reporting period amounted to EUR 12.7 million (30 November 2011: EUR 12.8 million). At EUR 30.5 million, current assets at the close of the reporting period were substantially higher than at the end of the 2011 financial year (EUR 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 WILEX Group had cash and cash equivalents of EUR 28.7 million as of 31 August 2012 (30 November 2011: EUR 3.4 million).

Equity at the end of the reporting period improved significantly to EUR 21.4 million (30 November 2011: -EUR 4.5 million). Non-current liabilities at the end of the reporting period reduced to EUR 3.0 million compared to EUR 5.1 million at the end of 2011 financial year. The decline is mainly due 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 18.8 million as of the end of the period (30 November 2011: EUR 20.2 million). Financial liabilities now solely comprise the UCB shareholder loan including interest of EUR 2.6 million (30 November 2011: EUR 10.5 million).

Key figures for the WILEX Group

Key Figures

9M 20121)
EUR ’000

9M 20111)
EUR ’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 EUR

(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 ratio2) 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 period3) 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.

2 Equity/total assets

3 Including Heidelberg Pharma (from March 2011) and members of the Executive Management Board

Rounding of exact figures may result in differences.

The 9-Month Financial Report 2012 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 11 October 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.

Contact
WILEX AG
Katja Arnold (CIRO)
Grillparzerstrasse 10
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

About WILEX
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.

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