PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - March 16, 2011) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today announced financial results for the fourth quarter and fiscal year ended December 31, 2010.
Fiscal year 2010 compared to fiscal year 2009
In 2010, net revenues decreased to EUR 0.2 million from EUR 7.7 million in 2009. The significant difference in revenues is primarily due to the recognition in the fourth quarter of 2009 of EUR 7.4 million of previously deferred revenue from the agreement with Yakult Honsha Co. Ltd. for the development of satraplatin in Japan. Revenue for 2010 was attributable to an out-license agreement for certain intellectual property from the Company's discontinued discovery program unrelated to talactoferrin. Research and development (R&D) expenses increased to EUR 29.4 million for the year ended December 31, 2010, compared to EUR 6.7 million for the same period in 2009. The increase in R&D expenses was primarily due to increased clinical trial costs related to the Company's Phase III trials with talactoferrin in non-small cell lung cancer (NSCLC) as a result of the inclusion of Agennix Incorporated operations for the entire year ended December 31, 2010. Administrative expenses decreased to EUR 10.0 million for 2010 compared to EUR 13.1 million for 2009. Included in administrative expenses for the year ended December 31, 2009, were approximately EUR 8.6 million in one-time merger-related(1) costs (banking fees, legal services, audit and other related services) and a credit to compensation cost of EUR (1.5) million as a result of the forfeiture of convertible bonds and stock options. There were no such one-time charges for the year ended December 31, 2010.
Net loss in 2010 increased to EUR 27.0 million from EUR 11.9 million in the preceding year. Net loss before income tax benefit increased to EUR 36.5 million in 2010 from EUR 13.1 million in 2009. Basic and diluted loss per share was EUR 1.07 for 2010 compared to EUR 1.31 for 2009.
Cash position
At December 31, 2010 the Company had cash, cash equivalents, other current financial assets and restricted cash of EUR 79.3 million (December 31, 2009: EUR 11.5 million). Net cash burn for 2010 was EUR 34.5 million with EUR 7.6 million in the first quarter, EUR 9.9 million for the second quarter, EUR 7.8 million for the third quarter and EUR 9.2 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 respective consolidated statements of cash flows.
Comparison to previous year: fourth quarter 2010 compared to fourth quarter 2009
Revenues for the three months ended December 31, 2010 were EUR 0 compared to EUR 7.5 million for the same period in 2009. R&D expenses for the fourth quarter of 2010 increased to EUR 9.5 million compared to EUR 2.9 million for the fourth quarter of 2009. Administrative expenses decreased for the fourth quarter of 2010 to EUR 3.6 million compared to EUR 5.2 million for the same quarter in 2009. Net loss for the fourth quarter of 2010 was EUR 7.6 million compared to EUR 1.3 million for the fourth quarter of 2009. Net loss before income tax benefit was EUR 10.2 million for the fourth quarter of 2010 compared to EUR 2.5 million for the fourth quarter of 2009. Basic and diluted loss per share was EUR 0.19 for the fourth quarter of 2010 compared to EUR 0.15 for the same period in 2009.
Quarter over quarter results: fourth quarter 2010 compared to third quarter 2010
Revenues for the fourth quarter of 2010 were EUR 0 compared to EUR 0.2 million for the previous quarter. R&D expenses increased to EUR 9.5 million for the fourth quarter of 2010 compared to EUR 8.3 million for third quarter of 2010. Administrative expenses for the fourth quarter of 2010 increased to EUR 3.6 million compared to EUR 2.0 million for the previous quarter. The Company had a net loss of EUR 7.6 million in the fourth quarter of 2010 compared to EUR 11.2 million for the previous quarter. Net loss before income tax benefit was EUR 10.2 million in the fourth quarter of 2010 compared to EUR 14.2 million for the third quarter of 2010. Basic and diluted loss per share was EUR 0.19 for the fourth quarter of 2010 compared to EUR 0.54 for the previous quarter.
Torsten Hombeck, Ph.D., Chief Financial Officer, said: "During 2010, we made steady progress in advancing our development plans with our lead program, oral talactoferrin. That progress is continuing with the recent completion of enrollment in the FORTIS-M Phase III trial in non-small cell lung cancer."
Dr. Hombeck continued, "In 2010 we also successfully refinanced the Company, including a major offering in which we raised approximately EUR 76 million in net proceeds. We believe we now have sufficient funding to achieve our key near- and mid-term development goals with talactoferrin, including, importantly, obtaining topline data from our first Phase III trial in non-small cell lung cancer as well as from the Phase II portion of our planned Phase II/III trial in severe sepsis."
Talactoferrin achievements and update
The Company earlier today announced the completion of enrollment in the FORTIS-M Phase III registration trial. The FORTIS-M trial is a global randomized, double-blind trial evaluating talactoferrin plus best supportive care compared to placebo plus best supportive care in patients with NSCLC whose disease has progressed following two or more prior treatment regimens. The study enrolled 742 patients at over 160 sites globally. As also announced, Agennix currently expects topline data from the FORTIS-M trial in the first half of 2012.
The Company also provided an update on the planned Phase II/III trial evaluating talactoferrin in patients with severe sepsis. This trial will enroll approximately 350 patients at sites mainly in the U.S. and Europe and is currently expected to initiate in the second quarter of 2011.
Financial guidance
The Company provided the following updated financial guidance:
Cash Position: Based on the current financial position of the Company, management believes that the Company will have sufficient cash to fund its operations well into the second half of 2012. This should enable the Company to obtain topline data in the FORTIS-M trial and to complete the Phase II portion of the planned Phase II/III trial with talactoferrin in severe sepsis, assuming no significant changes to currently projected timelines. This projected cash reach also assumes that the EUR 15 million loan made to the Company by dievini Hopp BioTech holding GmbH & Co. KG will not need to be re-paid prior to the release of topline results from both the FORTIS-M trial and the Phase II portion of the Phase II/III trial in severe sepsis.
Revenues: Management expects no substantial cash generating revenues for 2011. This guidance does not consider cash revenue from potential partnering of the Company's product candidates due to the uncertainty of the timing of such events.
R&D Expenses: For 2011, the Company expects R&D expenses to increase compared to 2010 due to an expected increase in talactoferrin clinical trial-related costs. The talactoferrin Phase III FORTIS-M trial in NSCLC has recently completed enrollment. In addition, the Company plans to initiate further clinical testing with talactoferrin in severe sepsis.
Administrative Expenses: Administrative expenses in 2011 are expected to increase moderately compared to 2010 as the Company plans to initiate certain critical pre-commercialization efforts.
2011 corporate calendar
The Company reported the dates for its 2011 corporate calendar as follows:
First quarter financial results: May 4
Annual Shareholders Meeting: May 10
Second quarter financial results: August 4
Third quarter financial results: November 3
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 today, March 16th at 15:00 CET/10:00 AM ET. The dial-in numbers for the call are as follows:
Participants from Europe: 0049 (0)69 71044 5598
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 listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially improve the length and quality of life of critically ill patients in areas of major unmet medical need. The Company's most advanced program is talactoferrin, an oral therapy that has demonstrated activity in randomized, double-blind, placebo-controlled Phase II studies in non-small cell lung cancer, as well as in severe sepsis. Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer, and Agennix plans to develop this program further for the treatment of severe sepsis. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I testing, 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: Planegg/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. There can be no guarantee that the results of the FORTIS-M trial or other ongoing studies with talactoferrin will be obtained when expected, will be positive or will be adequate to support a marketing approval. Additionally, there can be no guarantee that talactoferrin will be approved for marketing in any country or at all. There also can be no guarantee that the Company will have sufficient monies to fund operations well into the second half of 2012. 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.
Agennix™ is a trademark of the Agennix group.
(1) Agennix AG was formed by the business combination of Agennix, Incorporated and GPC Biotech AG and a EUR 15 million cash contribution by dievini Hopp BioTech holding GmbH & Co. KG. The business combination, which concluded with the merger of GPC Biotech into Agennix, became effective on November 5, 2009.
- Financials follow -
For the full management report and condensed consolidated financial statements and accompanying notes for the fiscal year ended December 31, 2010, please see the Investor Relations section of the Agennix website at http://www.agennix.com/index.php?option=com_content&view=article&id=122&Itemid=77&lang=en.
Agennix AG
Consolidated statement of operations
Three months ended Twelve months ended
December 31, December 31,
2010 2009 2010 2009
EUR 000 EUR 000 EUR 000 EUR 000
Revenue - 7,472 153 7,746
Research and development
expenses (9,481) (2,857) (29,360) (6,719)
Administrative expenses (3,625) (5,158) (9,982) (13,141)
Amortization of
intangible assets (1) (40) (52) (169)
Impairment of intangible
assets - (2,965) - (3,372)
Other income, net 2,945 823 2,946 1,318
Finance income 194 257 202 1,446
Finance costs (229) (3) (400) (188)
---------- ---------- ---------- ----------
Net loss before tax (10,197) (2,471) (36,493) (13,079)
Income tax benefit 2,577 1,141 9,491 1,141
---------- ---------- ---------- ----------
Net loss for the period (7,620) (1,330) (27,002) (11,938)
========== ========== ========== ==========
Basic and diluted loss
per share, euro (EUR 0.19) (EUR 0.15) (EUR 1.07) (EUR 1.31)
Average number of shares
used in computing basic
and diluted loss per
share 40,926,000 9,137,687 25,246,336 9,137,687
See accompanying Notes to the consolidated financial statements
Agennix AG
Consolidated statement of financial position
December 31, December 31,
2010 2009
EUR 000 EUR 000
Assets
Non-current assets
Property and equipment 3,462 3,416
Intangible assets 99,466 91,881
Other non-current assets 2,153 2,040
------------- -------------
Total non-current assets 105,081 97,337
Current assets
Trade receivables 4 35
Prepayments 316 596
Other current assets 1,443 259
Other current financial assets 30,197 -
Cash and cash equivalents 49,016 11,413
------------- -------------
Total current assets 80,976 12,303
Total Assets 186,057 109,640
============= =============
Equity and Liabilities
Equity attributable to the Company's
equity holders
Issued capital 41,884 18,705
Share premium 150,931 86,237
Other reserves 3,476 (1,863)
Retained loss (43,499) (16,497)
------------- -------------
Total equity 152,792 86,582
Non-current liabilities
Convertible bonds 210 210
Other non-current liabilities 18 33
Deferred tax liability 7,631 15,850
------------- -------------
Total non-current liabilities 7,859 16,093
Current liabilities
Trade payables 5,020 1,592
Accruals and other current liabilities 4,994 5,330
Short term note payable 15,392 -
Deferred revenue, current portion - 43
------------- -------------
Total current liabilities 25,406 6,965
------------- -------------
Total liabilities 33,265 23,058
Total equity and liabilities 186,057 109,640
============= =============
See accompanying Notes to the consolidated financial statements
Agennix AG
Selected financial data
Consolidated cash flow statement Twelve months ended
December 31,
2010 2009
EUR 000 EUR 000
Net cash used in operating activities (33,786) (21,355)
Net cash used in investing activities (30,876) (12,722)
Net cash provided by financing activities 101,969 13,248
Effect of exchange rate changes on cash
and cash equivalents 294 458
------------- -------------
Net increase (decrease) in cash and cash
equivalents 37,603 (20,273)
Cash and cash equivalents at beginning of
period 11,413 31,686
------------- -------------
Cash and cash equivalents at end of period 49,016 11,413
============= =============
See accompanying Notes to the consolidated financial statements
For further information, please contact:
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693
ir@agennix.com
In the U.S.:
Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
laurie.doyle@agennix.com
Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Phone: +49 (0) 89 210 228 0
raimund.gabriel@mc-services.eu
Additional investor contact for Europe:
Trout International LLC
Lauren Williams
Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.com
