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Heidelberg Pharma AG

Earnings Release Oct 13, 2008

201_10-q_2008-10-13_be6c8b84-8e17-420d-a1bb-964ecb2e139c.pdf

Earnings Release

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  • Patient recruitment completed for Phase II trial with MESUPRON® (pancreatic cancer)
  • Patient recruitment started for Phase II trial with MESUPRON® (breast cancer)
  • Financial results for the period as projected

9-month Financial Report 2008

At a glance

Key figures 9M 20081)
EUR
'000
9M 20071)
EUR
'000
Change
in%
Earnings
Other operating income 2,460 2,158 14.0
Operating expenses (19,773) (19,486) 1.5
of which research and development costs (16,549) (16,948) (2.4)
Operating result (17,313) (17,328) (0.1)
Earnings before tax (16,522) (16,005) 3.2
Net loss for the period (16,536) (16,024) 3.2
Earnings per share in EUR (1.38) (1.34) 2.8
Balance sheet as at end of period
Total assets 21,520 44,118 (51.2)
Cash and cash equivalents 2) 18,233 40,108 (54.5)
Equity 9,658 32,089 (69.9)
Equity ratio 3) in% 44.9 72.7 (38.3)
Cash flow statement
Cash flow from operating activities (16,558) (16,437) 0.7
Cash flow from investing activities 14,951 (30,525) (149.0)
Cash flow from financing activities (63) (988) (93.7)
Employees (number)
Employees as at end of period 4) 64 53 20.8
Employees – average for reporting period 4) 61 52 17.5

1) The reporting period begins on 1 December and ends on 31 August.

2) including financial assets

3) equity/total assets

4) including members of the Executive Management Board

Significant events in the third quarter of 2008

Dear Shareholders,

Our clinical projects continued to make progress in the past few months. In July 2008, we completed patient recruitment of our Phase II trial with MESUPRON® for patients with non-metastatic pancreatic cancer. An independent radiological analysis will probably be carried out in December 2008. Provided that a sufficient number of patients have relapsed, initial preliminary data could be available after that. In August 2008, we started patient recruitment for the Phase II trial with MESUPRON® for patients with metastatic breast cancer. To the best of our knowledge, MESUPRON® is the first uPA inhibitor worldwide to have entered a clinical Phase II trial.

Our Phase III registration trials for RENCAREX® and REDECTANE® also made significant progress in the third quarter. The chapter "Research and development" contains details on all our projects.

We signed a licence agreement for REDECTANE® with the Belgian company, Ion Beam Application S.A. (IBA), at the start of the third quarter. IBA was given the exclusive worldwide rights and licences required for marketing, distributing and selling the product. The agreement is an important step towards the commercialisation of our portfolio. It ensures that WILEX will receive up to 45% of future net sales revenues in addition to a variety of payments and contributions in kind. Detailed disclosures regarding both this agreement and IBA are contained in the 2008 half-yearly financial report.

At EUR 16.54 million, the net loss for the period reflects the planned progress of our projects and is in line with the Company's expectations (previous year: net loss of EUR 16.02 million). Earnings before taxes (EBT) decreased by 3.2% to EUR –16.52 million compared to the same period in 2007 (EUR –16.00 million). Higher other operating income was offset by both higher operating expenses and a lower net financial result than in the previous year. Operating income of EUR 2.46 million surpassed the previous year's level (EUR 2.16 million) by 14%. In particular the income realisation from IBA as well as from both Laboratorios del Dr. Esteve S.A. (Esteve) and the US Department of Defense had an effect on the third quarter of 2008. At EUR 19.77 million, operating expenses for the first nine months of 2008 were 1.5% higher year on year while the net financial result fell by 40.3% year on year because the decline in cash and cash equivalents led to lower interest income.

We will continue to pursue our research and development projects. Furthermore, we are in intensive discussions regarding the commercialisation of our other product candidates. We hope that you, our shareholders, will continue to accompany us on our path, and we thank you for your support.

Sincerely,

Peter Llewellyn-Davies, CFO

INTERIM MANAGEMENT REPORT

for the period from 1 December 2007 to 31 August 2008

Market environment

WILEX continues to be convinced that the medical need in the target indications of our drug and diagnostic candidates remains very high.

Neither the US Food and Drug Administration (FDA) nor the European Medicines Evaluation Agency (EMEA) have approved a drug for treating non-metastatic clear cell renal cell carcinoma to date. We are developing our antibody RENCAREX® – which is currently in its Phase III registration trial – for the adjuvant treatment of this disease. The peak sales potential worldwide for this indication alone is expected to exceed USD 500 million.

A further Phase III registration trial is being carried out to determine whether our diagnostic candidate REDECTANE® is significantly more specific than the methods used to date (CT) for diagnosing clear cell renal cell carcinoma. In this case, REDECTANE® could improve treatment planning for patients with renal masses. This results in a peak sales potential of more than USD 100 million worldwide for this indication alone.

The potential use of our product candidates RENCAREX® and REDECTANE® may not be limited to a single type of cancer because the target of the antibody is also expressed on tumours such as bladder, head and neck, breast and colon cancer.

Our uPA inhibitor MESUPRON® is being developed as a drug that inhibits the biological functions of a tumour which would otherwise enable the tumour to invade the surrounding tissue and trigger metastatic growth. This drug candidate, which has entered the Phase II clinical development stage, may also not be restricted to a single indication. The inhibition of the uPA system could play a role in the long-term control of various types of cancer. We expect the worldwide peak sales potential for MESUPRON® to exceed USD one billion.

Research and development

The most important event in the third quarter of 2008 with regard to our Phase III registration trial involving our drug candidate RENCAREX® was the completion in July 2008 of patient recruitment, announced in the section "Events after the balance sheet date" of the half-yearly financial report. At the time of publication of that report, additional patients were still undergoing the trial's pre-enrolment screening process. If they qualified for inclusion, they were also able to take part in the trial. The screening process was concluded in the third quarter. The final number of patients included in the trial increased from 856 to 864, of which 584 were recruited in Europe and 280 in North and South America. A total of 343 relapses are required in order to reach the next clinical milestone. As of 31 August 2008, WILEX is aware of a total of 199 relapses, which have been recorded locally in the trial centres. A central, independent assessment will be carried out once the 343th relapse has occurred. The relapse rate continues to be lower than anticipated. We currently expect to reach 343 relapses in the second quarter of 2009 at the earliest.

In May 2008, we began patient recruitment for REDECTANE®, our second product undergoing a Phase III registration trial. The product is intended for the improved diagnosis of renal masses. The trial investigates whether REDECTANE® can improve diagnosis with PET-CT compared to the standard procedure (CT). It will be conducted at more than 15 centres in the USA.

In our Phase II trial with the drug candidate MESUPRON®, which began in 2007 and involves patients with locally advanced inoperable, non-metastatic pancreatic cancer, we were able to complete patient recruitment in July 2008. The randomised, open, three-armed Phase II trial with 95 patients investigates the anti-metastatic effect of MESUPRON® in combination with the chemotherapeutic agent Gemcitabine (Gemzar®, Eli Lilly and Company, USA).

We began patient recruitment in August 2008 in the second clinical Phase II trial with MESUPRON® in patients with metastatic breast cancer. The double blind, two-arm randomised trial examines the efficacy of the combination therapy of MESUPRON® with the chemotherapeutic agent Capecitabine (Xeloda®, Hoffmann La Roche AG, Switzerland) in 114 patients with metastatic, HER2 receptor negative breast cancer in comparison with monotherapy using Capecitabine. The patients receive the substances in first-line treatment, i.e. the first treatment following a relapse.

Earnings

WILEX posted earnings before taxes of EUR –16.52 million for the first nine months of the 2008 financial year (previous year: EUR –16.00 million). At EUR –5.23 million, earnings before taxes in the third quarter were almost on par with the previous year (EUR –5.30 million). Earnings per share in the first nine months totalled EUR –1.38, which was below the figure reported for the previous year (9M 2007: EUR –1.34). Earnings per share in the third quarter of 2008 were EUR –0.44, the same as in the previous year.

Income

As in previous years, WILEX did not generate sales revenues in the first nine months of 2008 since all its products are in clinical development phases. Prepayments received for research projects are accrued and recognised as other operating income in line with project costs. Other operating income totalled EUR 2.46 million (previous year: EUR 2.16 million) in the reporting period and EUR 1.68 million in the third quarter (previous year: EUR 0.94 million). The increase is essentially due to the accrued income from the payment of our cooperation partner IBA. Income was also affected positively by the reversal of other provisions.

Operating expenses

Operating expenses of EUR 19.77 million were up 1.5% on the previous year's figure (9M 2007: EUR 19.49 million). While research and development costs at EUR 16.55 million were lower compared to the previous year (EUR 16.95 million) as a result of anticipated costs for the ARISER trial with RENCAREX®, administrative costs increased year on year, as planned, totalling EUR 3.22 million in the first nine months of 2008 (previous year: EUR 2.54 million). The increased costs of EUR 0.68 million compared to the previous year are primarily related to the expenses for business development and the higher number of employees. Besides the usual general and administrative costs, these expenses also include the pro rata measurement of the stock option plan.

A total of 83.7% (previous year: 87.0%) of operating expenses were attributable to research and development. Approximately 68% of this amount was invested in the clinical development of the product candidates RENCAREX® and REDECTANE®, based on the monoclonal antibody cG250, and 31% in the development of small molecule drugs (uPA programme/MESUPRON®). The remaining 1% of research and development costs were invested in other projects.

Net financial result

At EUR 0.79 million (9M 2007: EUR 1.32 million), the net financial result of the first nine months of 2008 was positive, continuing the trend of previous quarters. This is mainly due to the investment of funds not yet drawn on for clinical development in fixed-term deposits and other types of short-term investments. The outflow of funds and the resulting decrease in interest income led to a net financial result of EUR 0.24 million in the third quarter (Q3 2007: EUR 0.42 million).

Net assets and financial position

Total assets declined to EUR 21.52 million as at the 31 August 2008 reporting date, down EUR 16.11 million from the close of the 2007 financial year (30 November 2007: EUR 37.63 million). Compared to the end of the second quarter (31 May 2008), total assets decreased by EUR 2.58 million. As in the previous quarters, the decrease in assets is attributable to the use of funds for clinical development, with the corresponding reduction in equity.

The financial investments included in cash and cash equivalents as at the close of the financial year had already been eliminated as at the 31 May 2008 reporting date. Some of these funds have been used for clinical trials. Other current and non-current assets remained almost unchanged compared to the close of the financial year.

Equity as at 31 August 2008 totalled EUR 9.66 million, down EUR 16.29 million from the close of the 2007 financial year (EUR 25.95 million). As expected, the equity ratio thus fell from 69.0% as at 30 November 2007 to 44.9%. The Company's liquidity ratio (cash plus bank credit balances divided by current liabilities) was 158.1% at the end of the third quarter (30 November 2007: 307.2%).

Non-current liabilities decreased to EUR 0.33 million as at the end of the third quarter (30 November 2007: EUR 0.55 million). Current liabilities of EUR 11.53 million were 3.69% above the level reported at the end of the financial year (EUR 11.12 million). While trade payables rose 26.32% compared with 30 November 2007, other current liabilities were almost level compared with the close of the 2007 financial year. Current liabilities under leases in the first nine months of 2008 decreased by 53.12% to EUR 0.04 million.

Other current liabilities were comprised as follows:

31.8.2008
EUR
'000
30.11.2007
EUR
'000
Accruals for holidays not taken 281 262
Accruals US Department of Defense 1,019 962
Accruals licence agreements 1) 3,270 1,387
Other deferred income 0 4
Social security and other taxes 109 93
Payment obligations under licence acquisitions 1) 0 356
Accrued liabilities 4,609 6,232
Total 9,287 9,296

1) of which current portion

Net cash used in operating activities in the first nine months totalled EUR 15.45 million (previous year: EUR 15.51 million). Net cash provided by investing activities in the reporting period amounted to EUR 14.95 million. Adjusted for the payment received from an expired financial investment in the amount of EUR 15 million, net cash used for investing activities totalled EUR 0.05 million, which was below the previous year's figure of EUR 0.52 million. Net cash used in financing activities amounted to EUR 0.06 million. In the previous year's period, net cash used in financing activities had totalled EUR 0.99 million, mainly due to payments made subsequent to the IPO. Total net cash used excluding the repayment of the financial investment amounted to EUR 15.56 million in the first nine months of 2008, which corresponds to an average use of liquidity of EUR 1.73 million per month.

Employees and compensation

In the third quarter and compared to 31 May 2008, the number of employees rose as planned from 61 to 64.

In the past nine months, no subscription rights were issued to employees or members of the Executive Management Board as part of the Stock Option Plan. In addition, no options were exercised. A total of 1,750 stock options were returned in connection with an employee's resignation. Consequently, the total number of options issued to employees and members of the Executive Management Board stood at 905,834. A total of 383,323 options are therefore still available for issuance.

Related party transactions

There were no related party transactions in the period under review.

Events after the balance sheet date

No significant events occurred after the balance sheet date.

Report on risks and opportunities

We provided a detailed description of the risks and opportunities that arise in connection with the business activities of WILEX on pages 48 to 53 of our 2007 Annual Report. Please see these disclosures. WILEX uses an IT-based risk management system that complies with the requirements of the German Control and Transparency in Business Act (Gesetz zur Kontrolle und Transparenz im Unternehmensbereich) to monitor 16 different risk areas.

WILEX is exposed to the 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 licensing usually spans many years. Even though our portfolio has matured further, there is a continued risk that none of our current drug and diagnostic candidates will receive marketing approval.

As at 31 August 2008 the equity of WILEX under the German Commercial Code was EUR 10.7 million. There are currently no discernible risks that could jeopardise WILEX as a going concern in the 2008 financial year. According to current plans, the existing liquidity will suffice until the second calendar quarter of 2009. Additional losses from the Company's business activities until that time could reduce its equity (as determined under the German Commercial Code) to such an extent that we might have to file a notice of loss pursuant to Section 92 para. 1 German Stock Corporation Act. This would be the case if the loss totalled half of the Company's share capital. WILEX is currently working on different projects in order to improve its equity base and secure its continued existence as a going concern in the medium and long term. The Executive Management Board of WILEX is confident that, due to appropriate measures, it will not be required to file a notice of loss.

Outlook

Patient recruitment in the Phase III registration trial of REDECTANE® is carried out in accordance with the Special Protocol Assessment (SPA), and we anticipate completing recruitment within the next three to six months.

In the pancreatic Phase II study with MESUPRON®, an independent radiological analysis will probably be carried out in December 2008. Provided that a sufficient number of patients have relapsed, initial preliminary data could be available after that.

INCOME STATEMENT

of WILEX AG in accordance with IFRS for the period from 1 December 2007 to 31 August 2008

9M 2008
EUR
9M 2007
EUR
Q3 2008
EUR
Q3 2007
EUR
Revenue 0 0 0 0
Other operating income 2,459,999 2,157,991 1,676,498 940,398
Income 2,459,999 2,157,991 1,676,498 940,398
Research and development costs (16,548,588) (16,947,579) (5,953,107) (5,910,893)
Administrative costs (3,224,031) (2,538,888) (1,184,636) (757,061)
Operating expenses
(incl. depreciation/amortisation)
(19,772,619) (19,486,467) (7,137,742) (6,667,954)
OPER
ATING
RESULT
(17,312,620) (17,328,476) (5,461,245) (5,727,556)
Finance income 801,527 1,361,469 239,559 436,314
Finance costs (11,085) (37,663) (4,408) (12,938)
Net financial result 790,442 1,323,807 235,151 423,375
EARNINGS
BEFORE TAX
(16,522,178) (16,004,669) (5,226,094) (5,304,180)
Income tax (13,968) (18,902) (5,611) (12,439)
NET
LOSS FOR THE
PERI
OD
(16,536,147) (16,023,571) (5,231,706) (5,316,619)
Earnings per share
Basic and diluted earnings per share (1.38) (1.34) (0.44) (0.44)
Average number of shares issued 11,962,754 11,962,754 11,962,754 11,962,754

Rounding of exact figures may result in differences.

Quarterly comparison

of WILEX AG in accordance with IFRS

Q3 2008
EUR
'000
Q2 2008
EUR
'000
Q1 2008
EUR
'000
Q4 2007
EUR
'000
Q3 2007
EUR
'000
Revenue 0 0 0 0 0
Other operating income 1,676 223 560 425 940
Operating expenses (7,138) (6,884) (5,751) (7,024) (6,668)
of which research and development costs (5,953) (5,864) (4,732) (6,052) (5,911)
Operating result (5,461) (6,661) (5,191) (6,598) (5,728)
Earnings before tax (5,226) (6,412) (4,884) (6,229) (5,304)
NET
LOSS FOR THE
PERI
OD
(5,232) (6,413) (4,891) (6,234) (5,317)
Earnings per share in EUR* (0.44) (0.54) (0.41) (0.52) (0.44)

* basic = diluted; average number of shares issued: 11,962,754

BALANCE SHEET

of WILEX AG in accordance with IFRS as at 31 August 2008 and as at 30 November 2007

ASSETS 31.8.2008
EUR
30.11.2007
EUR
Property, plant and equipment 480,147 523,843
Intangible assets 1,460,885 1,557,092
Non-current assets 1,941,031 2,080,935
Inventories 22,200 22,200
Other assets and prepayments 1,139,652 1,242,720
Other receivables 184,186 111,011
Financial investments 0 15,374,513
Cash and cash equivalents 18,233,199 18,795,851
Current assets 19,579,237 35,546,295
TOTAL ASSETS 21,520,269 37,627,230
EQUITY
AND LIABILITIES
31.8.2008
EUR
30.11.2007
EUR
Subscribed capital 11,962,754 11,962,754
Capital reserve 105,157,881 104,914,715
Accumulated losses (107,462,936) (90,926,789)
Equity 9,657,699 25,950,680
Pension provisions 22,462 21,877
Liabilities arising from leasing agreements 0 22,977
Other non-current liabilities 306,526 506,974
Non-current liabilities 328,988 551,828
Trade accounts payable 2,208,001 1,747,900
Liabilities arising from leasing agreements 38,098 81,275
Other current liabilities 9,287,482 9,295,547
Current liabilities 11,533,582 11,124,722
TOTAL EQUITY
AND LIABILITIES
21,520,269 37,627,230

CASH FLOW STATEMENT

of WILEX AG in accordance with IFRS for the period from 1 December 2007 to 31 August 2008

9M 2008
EUR
9M 2007
EUR
Net loss for the period (16,536,147) (16,023,571)
Adjustment for income statement items:
Measurement of stock options 243,166 378,288
Depreciation/amortisation 193,613 169,985
Increase in pension obligations 585 585
Accrued rent, IFRS 35,603 0
Finance costs 11,085 37,663
Finance income (801,527) (1,361,469)
Tax expense 13,968 18,902
(303,507) (756,047)
Changes in net working capital:
Other receivables (73,175) (483,768)
Prepayments 103,067 (211,665)
Trade accounts payable 460,101 1,216,793
Other liabilities (208,513) (178,334)
281,481 343,028
Cash flow from operating activities (16,558,173) (16,436,591)
Interest paid (6,936) (10,829)
Interest received 1,114,153 940,018
NET
CASH FLOW FROM OPER
ATING
ACTIVITIES
(15,450,957) (15,507,401)
Cash flow from investing activities
Purchase of property, plant and equipment (42,101) (89,988)
Purchase of intangible assets (6,931) (434,780)
Purchase/sale of financial investments 15,000,000 (30,000,000)
NET
CASH FLOW FROM INVESTING
ACTIVITIES
14,950,968 (30,524,768)
Cash flow from financing activities
Capital increase costs 0 (882,981)
Redemption of silent partnership loans (total investments/interest) 0 (42,964)
Repayment finance leasing (62,664) (62,190)
NET
CASH FLOW FROM FINANCING ACTIVITIES
(62,664) (988,134)
NET
CHANGE
IN CASH AND CASH EQUI
VALENTS
(562,652) (47,020,304)
Cash and cash equivalents
at beginning of period 18,795,851 56,708,532
at end of period 18,233,199 9,688,228

STATEMENT OF CHANGES IN EQUITY

of WILEX AG in accordance with IFRS for the period from 1 December 2007 to 31 August 2008

Shares Subscribed
capital
EUR
Capital
reserve
EUR
Accumulated
losses
EUR
Total
EUR
As at 1 December 2006 11,962,754 11,962,754 104,426,653 (68,669,279) 47,720,128
Capital procurement costs IPO 14,282 14,282
Measurement of stock options 378,288 378,288
Net loss for the period (16,023,571) (16,023,571)
Net change in equity (15,631,001)
As at 31 AUGUST
2007
11,962,754 11,962,754 104,819,223 (84,692,850) 32,089,127
As at 1 December 2007 11,962,754 11,962,754 104,914,715 (90,926,789) 25,950,680
Measurement of stock options 243,166 243,166
Net loss for the period (16,536,147) (16,536,147)
Net change in equity (16,292,981)
As at 31 AUGUST
2008
11,962,754 11,962,754 105,157,881 (107,462,936) 9,657,699

SELECTED NOTES

General

The interim financial statements reproduced in this report were prepared in accordance with the International Financial Reporting Standards (IFRS), 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) as well as in accordance with the IFRS recognised by the European Union. These interim financial statements must be read in the context of the annual financial statements as at 30 November 2007 published by the Company for the 2007 financial year. The interim financial statements as at 31 August 2008 were prepared in accordance with the same accounting policies as the annual financial statements.

The Company's assets, liabilities and financial position as well as individual items of the financial statements for the first nine months are explained in detail in the interim management report.

WILEX has no subsidiaries. All business activities are carried out by WILEX AG. WILEX therefore prepares singleentity financial statements in accordance with IFRS.

As the business activities do not differ significantly in their risk/reward profiles, WILEX operates in one segment only and therefore does not prepare segment reporting. The Company's business activities are not subject to seasonal influences.

The interim financial statements were not subject to a review and have not been audited. They were approved for publication by the Executive Management Board on 13 October 2008.

Directors' dealings

During the period from 1 December 2007 to 31 August 2008, the officers and directors of the Company did not report any securities dealings that require disclosure under Section 15a of the German Securities Trading Act (WpHG).

Change in equity

The Company's subscribed capital remained unchanged at EUR 11.96 million, compared to the 30 November 2007 balance sheet date and the previous year's comparative reporting date, 31 August 2007. At 11.96 million, the number of issued bearer shares of common stock also remained the same.

The measurement of stock options resulted in an increase in the capital reserve of EUR 243 thousand to EUR 105.16 million in the first nine months of the current financial year. In accordance with IFRS 2, the expenses for stock options are recognised in income at fair value over the estimated vesting period. In addition to these expenses (EUR 378 thousand), costs incurred directly in connection with raising equity by way of an IPO totalling EUR 14.3 thousand were charged to the capital reserve in the comparative period of the previous financial year.

The net loss for the first nine months of EUR 16.54 million brings the deficit accumulated by WILEX since the beginning of its operations to EUR 107.46 million.

Overall, the Company's equity decreased by EUR 16.29 million to EUR 9.66 million in the first nine months. In the first nine months of the previous year, this decrease was EUR 15.63 million.

Responsibility statement of the Executive Management Board

"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 WILEX AG, and the interim management report includes a fair review of the development and performance of the business and the position of WILEX AG, together with a description of the principal opportunities and risks associated with the expected development of WILEX AG."

Munich, Germany, 13 October 2008

The Executive Management Board

Peter Llewellyn-Davies Prof. Dr. Olaf G. Wilhelm Dr. Paul Bevan Dr. Thomas Borcholte

Investor Relations

Share price performance

The biotech industry succeeded relatively well in holding its position despite the turbulences gripping the capital markets since the beginning of 2008. The Prime Biotechnology Index closed at minus 6% at the end of September while the leading German indices (DAX and TecDAX) fell massively, losing up to 28% since the beginning of January 2008. WILEX's share started the financial year on 1 December 2007 at a share price of EUR 5.11 and posted strong gains in mid-December 2007 following the positive outcome of the interim analysis for futility for the Phase III ARISER trial. However, the share declined in the first three months of 2008, reaching a low of EUR 5.25 at the end of March 2008. It started to recover steadily in May and reached the year's high of EUR 8.53 in early July 2008. Following a correction at the end of July, the share settled on a relatively stable level of EUR 7.35, closing the reporting period at EUR 7.30 on 30 September 2008. Its gain of more than 32% means that it has outperformed both the Prime Biotechnology Index (–6%) and comparable companies in the German biotech industry (–1%) since the beginning of the financial year.

The first nine months of the 2008 financial year saw a marked year-on-year increase in the share's trading volume. A total of 8,567 WILEX shares were traded per day on average (9M 2007: 2,207 shares).

Key share figures
160
(XETR
A)
9M 2008
EUR
9M 2007
EUR
150
140
Opening price (beginning of period)
5.11 13.75
130
Closing price (end of period)
120
7.49 10.00
110
High
8.53 16.00
100
Low
4.45 10.00
90
80
Closing price, change vs. 13.11.2006 (IPO)
–45.84% –27.69%
Average daily trading volume, shares (all stock exchanges) 8,567 2,207
Average daily trading volume (all stock exchanges) 55,621.23 29,660.52
Market capitalisation (at end of period) in EUR million 89.61 119.63

Investor relations

In the third quarter, WILEX actively participated in investor conferences in both London and Frankfurt/Main and used these events to present its business strategy and the progress of its clinical research in one-on-one discussions with investors and analysts.

Financial calendar

Date
13 October 2008 9-month Financial Report 2008
19 February 2009 Annual Report 2008
19 February 2009 Financial press conference and analysts' meeting
8 April 2009 3-month Financial Report 2009
26 May 2009 Annual General Meeting
14 July 2009 Half-yearly Financial Report 2009
13 October 2009 9-month Financial Report 2009

Conference calendar

Date Location Conference
11–15 October Munich Annual Congress of the European Association of Nuclear Medicine
29–31 October San
Francisco
Seventh Annual Bio Investor Forum
10–12 November New York Rodman & Renshaw 10th Annual Healthcare Conference
17–19 November Mannheim/
Heidelberg
BIO-Europe 2008
30 November –
2 December
Bethesda SUO 7th Annual Meeting
2–3 December New York Piper Jaffray 20th Annual Health Care Conference
11–14 December San Antonio CTRC – AACR San Antonio Breast Cancer Symposium

More information can be found on our website under Investor Relations/Dates and Events.

Listing of new shares from contingent capital

Upon application by WILEX AG, on 11 June 2008 the Frankfurt/Main Stock Exchange admitted up to 1,289,157 ordinary bearer shares in the form of no-par bearer shares with a pro-rata interest in capital of EUR 1.00 each for trading on the Regulated Market as well as in the Prime Standard. The shares from this Contingent Capital II, which was approved at the Annual General Meeting on 8 September 2005, serve to secure options under the 2005 Stock Option Plan that participate in profits from the start of the financial year in which they are issued to legal effect. The Company's share capital is modified only upon exercise of the options and registration of the new shares in the Commercial Register.

Contact

WILEX AG

Grillparzerstr. 10 81675 Munich, Germany Tel. +49(0)89–413138–0 Fax +49(0)89–413138–99 www.wilex.com [email protected]

Peter Llewellyn-Davies Katja Arnold (CIRO) Juliane Giese

Chief Financial Officer Investor Relations Public Relations E-mail: [email protected] E-mail: [email protected] E-mail: [email protected]

Tel. +49(0)89–413138–20 Tel. +49(0)89–413138–126 Tel. +49(0)89–413138–29 Fax +49(0)89–413138–98 Fax +49(0)89–413138–99 Fax +49(0)89–413138–99

Publishing information

Published by: WILEX AG, Grillparzerstr. 10, 81675 Munich, Germany Responsible for the project: Katja Arnold and Juliane Giese, WILEX AG Design by: Annika Müller, Artdirection und Design, Hamburg

This 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 at: 13 October 2008

WILEX AG

Grillparzerstr. 10 81675 Munich Germany www.wilex.com

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