MARTINSRIED/MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - March 24, 2010) -
Agennix AG (FRANKFURT: AGX) today announced financial results for the fourth quarter and fiscal year ended December 31, 2009.
Agennix AG was formed by the combination of Agennix Incorporated and GPC Biotech AG. The accounting for the business combination was based on the acquisition method specified in IFRS 3 (Revised 2008), Business Combinations. Based on that accounting treatment, GPC Biotech AG was identified as the acquirer and Agennix Incorporated as the acquiree in this transaction. Therefore, the historical financial information of Agennix AG is that of GPC Biotech AG. The net results of Agennix Incorporated's operations from the acquisition date of November 5, 2009 to December 31, 2009, as well as its financial position as of December 31, 2009, are included in the 2009 fiscal year results.
Fiscal year 2009 compared to fiscal year 2008
Revenues decreased 38% to EUR 7.7 million for the fiscal year ended December 31, 2009 compared to EUR 12.4 million in 2008. The decrease in revenues is primarily due to a decline in payments received under the co-development and license agreement for satraplatin with Celgene Corporation, which was terminated in 2008. The decrease in revenue was offset by the recognition of EUR 7.4 million previously deferred revenue from the agreement with Yakult Honsha Co. Ltd. for the development of satraplatin in Japan.
Research and development (R&D) expenses decreased 60% to EUR 6.7 million for 2009 compared to EUR 16.8 million for 2008. The decrease in 2009 was primarily due to staff reductions as a result of the restructuring plan implemented in the first quarter of 2008, as well as a decrease in clinical trial costs due to reduced clinical trial volumes related to satraplatin.
In 2009, administrative expenses decreased 14% to EUR 13.1 million compared to EUR 15.2 million for 2008. The decrease in administrative expenses was mainly due to staff reductions and other associated activities as a result of the restructuring plans implemented in 2008. This reduction, primarily in personnel costs, was largely offset by one-time costs associated with the business combination of Agennix Incorporated and GPC Biotech. Of the EUR 13.1 million in administrative expenses, approximately EUR 8.6 million are one-time costs relating to the business combination, which includes legal and advisory fees for banks, legal counsel and auditors, and severance.
Net loss for 2009 decreased 44% to EUR 11.9 million compared to EUR 21.3 million for 2008. Net loss before tax was EUR 13.1 million in 2009 (2008: EUR 21.3 million). In 2009, a non-cash income tax benefit of EUR 1.1 million was recognized in connection with the accounting for the business combination of Agennix Incorporated and GPC Biotech; no such tax benefit was recognized by the Company for 2008. Basic and diluted loss per share was EUR 1.31 for 2009 compared to EUR 2.89 for 2008. Loss per share amounts for 2008 have been retrospectively adjusted to reflect the effect of the 5-to-1 exchange ratio related to the merger.
Cash position
As of December 31, 2009, cash, cash equivalents and available-for-sale investments totaled EUR 11.5 million (December 31, 2008: EUR 32.0 million), including EUR 0.1 million in restricted cash. Net cash burn for fiscal year 2009 was EUR 21.4 million (December 31, 2008: EUR 33.1 million), with net cash burn of EUR 4.9 million in the first quarter, EUR 6.5 million for the second quarter, EUR 4.1 million for the third quarter and EUR 5.9 million for the fourth quarter. Net cash burn is derived by adding net cash used in operating activities and purchases of property, equipment and intangibles. The figures used to calculate net cash burn are contained in the Company's consolidated cash flow statement for the fiscal year ended December 31, 2009.
Comparison to previous year: fourth quarter 2009 compared to fourth quarter 2008
Revenues for the three months ended December 31, 2009 increased 241% to EUR 7.5 million compared to EUR 31,000 for the same period in 2008. The increase in revenues is due to the recognition of EUR 7.4 million previously deferred revenue from the agreement with Yakult for the development of satraplatin in Japan. R&D expenses for the fourth quarter of 2009 decreased 15% to EUR 2.9 million compared to EUR 3.4 million for the fourth quarter of 2008. Administrative expenses increased 6% for the fourth quarter of 2009 to EUR 5.2 million compared to EUR 4.9 million for the same quarter in 2008. Net loss for the fourth quarter of 2009 was EUR 1.3 million compared to EUR 9.0 million for the fourth quarter of 2008. Net loss before tax was EUR 2.5 million for the fourth quarter of 2009 compared to EUR 9.0 million for the fourth quarter of 2008. Basic and diluted loss per share was EUR 0.15 for the fourth quarter of 2009 compared to EUR 1.23 for the same period in 2008.
Quarter over quarter results: fourth quarter 2009 compared to third quarter 2009
Revenues for the fourth quarter of 2009 were EUR 7.5 million compared to EUR 0.2 million for the previous quarter. R&D expenses were EUR 2.9 million for the fourth quarter of 2009 compared to EUR 1.3 million for third quarter of 2009. Administrative expenses for the fourth quarter of 2009 were EUR 5.2 million compared to EUR 1.6 million for the previous quarter. The Company had a net loss of EUR 1.3 million in the fourth quarter of 2009 compared to EUR 2.1 million for the previous quarter. Net loss before tax was EUR 2.5 million for the fourth quarter of 2009 compared to EUR 2.1 million for the previous quarter. Basic and diluted loss per share was EUR 0.15 for the fourth quarter of 2009 compared to EUR 0.29 for the previous quarter.
Torsten Hombeck, Ph.D., Chief Financial Officer, said: "We are excited about what we have already achieved since the close of the merger, including positive results from a Phase 2 trial in severe sepsis, expansion of the FORTIS-M trial beyond the U.S. into Europe and other parts of the world, and the completion of a private placement raising EUR 9.8 million."
Dr. Hombeck continued: "Ensuring that Agennix has sufficient funding to get to the next major milestone with talactoferrin, which we expect to be Phase 3 data in non-small cell lung cancer at the end of 2011, is a high priority. We also look forward to advancing talactoferrin in the development of severe sepsis and are pleased that more details from the Phase 2 trial in that indication will be presented at the American Thoracic Society International Conference in May."
Financial guidance
With the recently completed financing, the Company expects to have sufficient cash to fund operations into the third quarter of 2010. The Company plans to raise additional funds during 2010 to have sufficient capital to complete the FORTIS-M trial and continue other key development and corporate activities beyond the third quarter of 2010. The Company is also actively seeking a partnership for oral talactoferrin, which would provide a non-dilutive source of funding.
2010 financial calendar
The Company announced dates for its 2010 quarterly results as follows: First quarter: May 6, 2010 Second quarter: August 5, 2010 Third quarter: November 4, 2010
Conference call scheduled
As previously announced, the Company has scheduled a conference call to which participants may listen via live webcast, accessible through the Agennix Web site at www.agennix.com or via telephone. A replay will be available via the Web site following the live event. The call, which will be conducted in English, will be held on March 24th at 14:00 CET/9:00 AM EDT. The dial-in numbers for the call are as follows:
Participants from Europe: 0049 (0)69 667775756
0044 (0)20 3003 2666
Participants from the U.S.: 1-646-843-4608
Please dial in 10 minutes before the beginning of the meeting.
About Agennix
Agennix AG is a publicly traded biopharmaceutical company that is developing novel therapies in areas of major unmet medical need to improve the length and quality of life of seriously ill patients. The Company's most advanced program is talactoferrin, an oral targeted therapy that has demonstrated activity in randomized, double-blind, placebo-controlled Phase 2 studies in non-small cell lung cancer as well as in severe sepsis. Talactoferrin is currently in Phase 3 clinical trials in non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase 1 testing; the oral platinum-based compound satraplatin; and a topical gel form of talactoferrin for diabetic foot ulcers. Agennix's registered seat is in Heidelberg, Germany. The Company has three sites of operation: Martinsried/Munich, Germany; Princeton, New Jersey and Houston, Texas. For additional information, please visit the Agennix Web site at www.agennix.com.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix AG, including statements about the Company's future cash position. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond the control of the Company, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and management cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
- Financials follow -
For the full management report and condensed consolidated financial statements and accompanying notes for the fiscal year ended December 31, 2009, please see the Investor Relations section of the Agennix website at http://www.agennix.com/index.php?option=com_content&view=article&id=14&Itemid=33&lang=en.
Agennix AG
Consolidated Statement of Operations
Three months ended Year ended
December 31, December 31,
2009 2008 2009 2008
EUR 000 EUR 000 EUR 000 EUR 000
Revenue 7,472 31 7,746 12,372
Research and development
expenses (2,857) (3,405) (6,719) (16,815)
Administrative expenses (5,158) (4,859) (13,141) (15,160)
Amortization of intangible
assets (40) (49) (169) (213)
Impairment of intangible
assets (2,965) - (3,372) (2,306)
Other income 980 1,467 3,328 3,312
Other expenses (157) (2,512) (2,010) (3,994)
Finance income 257 338 1,446 1,824
Finance costs (3) (53) (188) (304)
---------- ---------- ---------- ----------
Net loss before tax (2,471) (9,042) (13,079) (21,284)
Income tax benefit 1,141 - 1,141 -
---------- ---------- ---------- ----------
Net loss for the period (1,330) (9,042) (11,938) (21,284)
========== ========== ========== ==========
Basic and diluted loss per
share (EUR 0.15) (EUR 1.23) (EUR 1.31) (EUR 2.89)
Weighted average number of
shares used in computing
basic and diluted loss per
share (1) 9,137,687 7,367,370 9,137,687 7,367,370
(1) Per share amount for 2008 has been retrospectively adjusted to reflect
the effect of the 5 to 1 merger exchange ratio related
to the merger of GPC Biotech AG into Agennix AG.
See accompanying notes to the consolidated financial statements
Agennix AG
Consolidated Statement of Financial Position
at December 31, 2009
2009 2008
EUR 000 EUR 000
ASSETS
Non-current assets
Property and equipment 3,416 524
Intangible assets 91,881 3,584
Other non-current assets 2,040 146
-------- --------
Total non-current assets 97,337 4,254
Current assets
Trade receivables 35 6
Prepayments 596 432
Other current assets 259 2,209
Available-for-sale investments - 136
Cash and cash equivalents 11,413 31,686
-------- --------
Total current assets 12,303 34,469
TOTAL ASSETS 109,640 38,723
======== ========
EQUITY AND LIABILITIES
Equity attributable to the Company's equity holders
Issued capital (1) 18,705 7,367
Share premium (1) 86,237 399,124
Other reserves (1,863) (3,918)
Retained loss (16,497) (378,949)
-------- --------
Total equity 86,582 23,624
Non-current liabilities
Convertible bonds 210 1,705
Deferred revenue, net of current portion - 7,380
Other non-current liabilities 33 -
Deferred tax liability 15,850 -
-------- --------
Total non-current liabilities 16,093 9,085
Current liabilities
Trade payables 1,592 1,221
Accruals and other liabilities 5,330 4,750
Deferred revenue, current portion 43 43
-------- --------
Total current liabilities 6,965 6,014
-------- --------
Total liabilities 23,058 15,099
TOTAL EQUITY AND LIABILITIES 109,640 38,723
======== ========
(1) Shares, issued capital and share premium have been retrospectively
adjusted to reflect the effect of the 5 to 1 merger exchange ratio
related to the merger of GPC Biotech AG into Agennix AG.
See accompanying notes to the consolidated financial statements
Agennix AG
Selected Financial Data
Consolidated Statement of Cash Flows
Year ended December 31,
2009 2008
EUR 000 EUR 000
Net cash used in operating activities (21,355) (33,130)
Net cash (used in) provided by investing
activities (12,722) 15,104
Net cash provided by (used in) financing
activities 13,248 (1,460)
Effect of exchange rate changes on cash and cash
equivalents 458 221
Changes in restricted cash 98 1,270
Net decrease in cash and cash equivalents (20,273) (17,995)
Cash and cash equivalents at beginning of period 31,686 49,681
Cash and cash equivalents at end of period 11,413 31,686
See accompanying notes to the consolidated financial statements
For further information, please contact:
Agennix AG
Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693
ir@agennix.com
In the U.S.:
Laurie Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
laurie.doyle@agennix.com
Additional media contacts for Europe:
MC Services AG
Phone: +49 (0)89 210 228 0
Raimund Gabriel
raimund.gabriel@mc-services.eu
Hilda Juhasz
hilda.juhasz@mc-services.eu
Additional investor contact for Europe:
Trout International LLC
Lauren Williams
Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.com
