SOURCE: Agennix AG

Agennix AG

March 16, 2011 02:43 ET

Agennix AG Reports Financial Results for Fiscal Year 2010

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-related1 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, 2010     December 31, 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
 

Contact Information

  • 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