WILEX AG: Interim Management Statement on the First Nine Months of 2016

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Munich, 13 October 2016 – WILEX AG (ISIN DE000A11QVV0 / WL6 / FSE) today reported on the first nine months of the 2016 financial year (1 December 2015 – 31 August 2016) and the Group’s financial figures. WILEX and its subsidiary Heidelberg Pharma are developing a proprietary platform technology for Antibody Targeted Amanitin Conjugates (ATAC technology) to make the highly effective compound Amanitin usable in various cancer treatments.

“We are very pleased with the scientific and operational progress made in recent months. The work on our ATAC technology is proceeding well, and we have generated promising data as a result. We therefore signed an option agreement for the in-licensing of various antibodies with the Max Delbrück Center in Berlin in early September and from these have selected our first development candidate, HDP-101”, commented Dr Jan Schmidt-Brand, Spokesman of the Executive Management Board and CFO of WILEX AG. “Some of these activities were financed with corporate actions during the reporting period. Just recently we also secured a loan from our main shareholder, dievini. These funds are enabling the company to advance HDP-101. Our goal is to begin clinical development in 2018.”

Preparations for the clinical development of HDP-101 will be ongoing in the coming months. Activities will include establishing the manufacturing process for the relevant antibodies, the Amanitin drug and various ATAC candidates at subcontractors in accordance with Good Manufacturing Practice (GMP) standards, as well as conducting additional preclinical studies under Good Laboratory Practice (GLP) conditions.

Partnerships remain a key component of the business model so that Amanitin can be linked with various antibodies by other companies and undergo preclinical testing.

Key events in the first nine months

Events after the reporting period

Results of operations, financial position and net assets

The WILEX Group – as of the reporting date comprising WILEX AG and the subsidiary Heidelberg Pharma GmbH – reports consolidated figures. The reporting period referred to below concerns the period from 1 December 2015 to 31 August 2016 (9M 2016).

In the first nine months of the 2016 financial year, the WILEX Group generated sales revenue and income totaling EUR 2.3 million, down 21% compared to the previous year (EUR 2.9 million), in which income from the license agreement with Roche still had an impact.

The 2016 figure includes sales revenue of EUR 1.1 million (previous year: EUR 1.7 million), which is largely made up of the business of Heidelberg Pharma (EUR 1.0 million). A total of EUR 0.1 million was generated from the license agreement with Link Health.

At EUR 1.2 million, other income was at the same level as the previous year (EUR 1.2 million), due in particular to income from the government grants provided by the Federal Ministry of Education and Research (BMBF) in the amount of EUR 0.6 million. There was also income of EUR 0.4 million from the reversal of provisions that were not needed. Furthermore, income of EUR 0.2 million was recognized related to the 2013 sale of former subsidiary WILEX Inc. to Nuclea Biotechnologies Inc.

Operating expenses including depreciation and amortization amounted to EUR 6.4 million in the reporting period, the same as in the previous year. Cost of sales includes costs that are directly related to sales revenue and were incurred by the Group for customer-specific research; they amounted to EUR 0.5 million (previous year: EUR 0.9 million). Research and development (R&D) costs of EUR 4.3 million were up EUR 1.2 million compared to the prior-year period (EUR 3.1 million), due to the expansion of preclinical studies at Heidelberg Pharma. R&D costs accounted for by far the largest share of all operating expenses, at 67%. Administrative costs decreased in the first nine months of 2016 to EUR 1.4 million from EUR 2.1 million for the previous year. Among others, this figure includes the costs of the holding company activities and the stock market listing. Other expenses for activities related to business development, marketing and commercial market supply amounted to EUR 0.2 million in the current reporting period, down from EUR 0.3 million in the previous year.

At EUR 4.1 million, the WILEX Group’s net loss for the first nine months of the financial year increased year-on-year from EUR 3.5 million as a result of lower sales revenue. In spite of the higher net loss for the period, earnings per share improved by 15% to EUR -0.35 (previous year: EUR -0.41), due exclusively to the higher average number of shares resulting from the completed capital increases.

Total assets as of 31 August 2016 amounted to EUR 13.9 million, up from EUR 12.1 million at the end of the 2015 financial year. Equity was EUR 12.0 million, up compared with 30 November 2015 (EUR 9.5 million). This corresponds to an equity ratio of 86.0% (30 November 2015: 78.3%).

Cash inflow from financing activities of EUR 6.6 million was recorded in the reporting period as a result of the successfully completed capital increases. Cash and cash equivalents as of the end of the third quarter amounted to EUR 3.3 million (30 November 2015: EUR 1.3 million). WILEX’s average monthly cash inflow was EUR 0.22 million (previous year: EUR 0.10 million). Excluding the capital increases in both periods, this is equivalent to an average monthly reduction in cash and cash equivalents of EUR 0.51 million in 2016 resulting from operating and investing activities (previous year: EUR 0.36 million).

There is no change to the guidance for the WILEX Group for the current financial year issued at the end of March 2016. Based on current planning the Company’s financing has been secured into the second quarter of 2017.

The complete figures for the interim financial statements can be downloaded here.

Key figures for the WILEX Group

  9M 20161
EUR ‘000
9M 20151
EUR ‘000
Earnings    
Sales revenue 1,104 1,714
Other income 1,169 1,161
Operating expenses (6,385) (6,388)
of which research and development costs (4,282) (3,092)
Operating result (4,112) (3,513)
Earnings before tax (4,113) (3,511)
Net loss for the period (4,122) (3,548)
Earnings per share in EUR (0.35) (0.41)
     
Balance sheet as of the end of the period
   
Total assets 13,937 15,427
Cash and cash equivalents 3,269 3,068
Equity 11,991 12,489
Equity ration2 in % 86.0 81.0
     
Cash flow statement    
Cash flow from operating activities (4,162) (3,212)
Cash flow from investing activities (450) (56)
Cash flow from financing activities 6,587 4,103
     
Employees (Number)    
Employees as of the end of the period 3 53 51
Full-time equivalents as of the end of the period3 49 46

1 The reporting period begins on 1 December and ends on 31 August.
2 Equity / total assets.
3 Including members of the Executive Management Board.
Rounding of exact figures may result in differences.

Contact
WILEX AG
Sylvia Wimmer
Corporate Communications
Tel.: +49 (0)89-41 31 38-29
Email: investors[at]wilex.com
Grillparzerstr. 18, 81675 Munich

IR/PR support
MC Services AG

Katja Arnold (CIRO)
Managing Director & Partner
Tel.: +49 (0)89-210 228-40
Email: katja.arnold[at]mc-services.eu 

About WILEX and Heidelberg Pharma
WILEX AG is a biopharmaceutical company based in Munich, Germany, that serves as a parent and holding company. The Company’s research and development work is conducted by its subsidiary Heidelberg Pharma GmbH in Ladenburg. Heidelberg Pharma is focused on developing an innovative ADC technology platform based on the compound Amanitin (ATAC technology) and also provides preclinical drug research and development services. WILEX has diagnostic and therapeutic Phase III drug candidates, which are available for out-licensing. WILEX AG is listed at the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6. More information is available at http://www.wilex.com/.

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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