SOURCE: Agennix AG

Agennix AG

November 03, 2011 02:30 ET

Agennix Reports Financial Results for Third Quarter and First Nine Months of 2011

Provides Update on Expected Timing for Top-Line Data From Ongoing Talactoferrin Trials

PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - Nov 3, 2011) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX), a biopharmaceutical company focused on developing 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, today announced financial results for the third quarter and nine months ended September 30, 2011.

Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of the Management Board, said: "We are pleased with our continued good progress in the development of our oral immunotherapy, talactoferrin. Our achievements for the year to date include the completion of patient enrollment in the FORTIS-M Phase III registration trial in non-small cell lung cancer, as well as the initiation of the OASIS Phase II/III trial in severe sepsis at the end of June. Enrollment in the OASIS trial is progressing faster than anticipated, with 45% of the 350 patients already enrolled. We now expect top-line data from both the FORTIS-M trial and the Phase II portion of the OASIS trial in the second quarter of 2012."

Dr. Hombeck continued: "Additionally this year, talactoferrin data from Phase II trials were published in peer-reviewed medical journals and presented at major medical meetings. We have also been very fortunate to have hired several highly experienced executives in key areas as we prepare for a possible regulatory filing for talactoferrin and a potential commercial launch."

First nine months of 2011 compared to first nine months of 2010
The Company did not recognize any revenue during the nine months ended September 30, 2011, compared to EUR 0.2 million during the nine months ended September 30, 2010. The latter was attributable to an out-license agreement for certain intellectual property from a discontinued discovery program.

Research and development (R&D) expenses for the nine months ended September 30, 2011 were EUR 24.6 million compared to EUR 19.9 million for the same period in 2010. The increase in R&D expenses was primarily due to increased patient enrollment in the Company's Phase III FORTIS-M trial with talactoferrin in non-small cell lung cancer (NSCLC) and the Phase II/III OASIS trial with talactoferrin in severe sepsis, which was initiated at the end of the second quarter of 2011.

Administrative expenses for the nine months ended September 30, 2011 and 2010, were EUR 6.6 million and EUR 6.4 million, respectively.

Net loss before tax for the nine months ended September 30, 2011, was EUR 32.4 million compared to EUR 26.3 million for the same period in 2010. Income tax benefit for the nine months ended September 30, 2011, amounted to EUR 7.2 million (EUR 6.9 million for the same period in 2010) and related to the recognition of deferred tax asset on net operating losses incurred by the Company's subsidiary, Agennix Incorporated, during the period. Net loss for the nine months ended September 30, 2011, was EUR 25.2 million compared to EUR 19.4 million for the same period in 2010. Basic and diluted loss per share was EUR (0.60) for the nine months ended September 30, 2011, compared to EUR (0.97) for the same period in 2010.

Third quarter of 2011 compared to third quarter of 2010
The Company did not recognize any revenue during the three months ended September 30, 2011 and recognized EUR 0.2 million for the same period in 2010. R&D expenses were EUR 8.1 million for the third quarter of 2011 compared to EUR 8.3 million for the same period in 2010. The decrease in R&D expenses was primarily due to decreases in drug development activities in the third quarter of 2011 as the enrollment in the Phase III FORTIS-M trial was completed in March 2011. Administrative expenses for the third quarter of 2011 were EUR 2.1 million compared to EUR 2.0 million for the same quarter in 2010. Net loss for the third quarter of 2011 was EUR 8.2 million compared to EUR 11.2 million for the third quarter of 2010 primarily due to foreign exchange gain of approximately EUR 0.7 million in the third quarter of 2011 compared to foreign exchange loss of approximately EUR 4.1 million for the same period in 2010. Basic and diluted loss per share was EUR (0.20) and EUR (0.54) in the third quarter of 2011 and 2010, respectively.

Quarter over quarter results: third quarter 2011 compared to second quarter 2011
The Company did not recognize any revenue during the third or second quarter of 2011. R&D expenses for the third quarter of 2011 were EUR 8.1 million compared to EUR 8.3 million for the second quarter of 2011. Administrative expenses for the third quarter of 2011 were EUR 2.1 million compared to EUR 2.2 million for the second quarter of 2011. Net loss for the third quarter of 2011 was EUR 8.2 million compared to EUR 8.3 million for the second quarter of 2011. Basic and diluted loss per share was EUR (0.20) for the third quarter of 2011 as well as for the second quarter of 2011.

Cash position
As of September 30, 2011, cash, cash equivalents, other current financial assets and restricted cash totaled EUR 43.3 million (December 31, 2010: EUR 79.3 million). Net cash burn for the nine months ended September 30, 2011, was EUR 34.9 million (September 30, 2010: EUR 25.3 million) with net cash burn of EUR 11.5 million in the first quarter, EUR 11.6 million in the second quarter and EUR 11.8 million in the third quarter of 2011. The increase in net cash burn was mainly due to clinical trial costs related to increased patient enrollment in the Phase III FORTIS-M trial and the Phase II portion of the OASIS trial. Net cash burn is derived by adding net cash used in operating activities and purchases of property, equipment and intangible assets. The figures used to calculate net cash burn are contained in the Company's interim consolidated cash flow statement for the respective periods

Financial guidance
The Company provided the following financial guidance for the remainder of 2011 and for 2012:

Revenues
Management expects no substantial cash generating revenues for the remainder of 2011 or for 2012. This guidance does not consider cash revenue from the potential partnering of the Company's product candidates due to the uncertainty of the timing of such events.

R&D expenses
The Company expects R&D expenses for fiscal year 2011 to be higher than in 2010 due to increased talactoferrin clinical trial-related costs. During 2011, patients continue to be treated in the Phase III FORTIS-M trial, and the OASIS Phase II/III trial was initiated in June 2011. Agennix expects R&D expenses in 2012 to increase compared to 2011. The OASIS trial is expected to continue to enroll patients, and Agennix expects to incur additional production and other costs in preparation for a potential regulatory filing and commercial launch of talactoferrin.

Administrative expenses
Administrative expenses for fiscal year 2011 are expected to be slightly higher than for 2010 as the Company engages in certain critical pre-commercialization activities. Administrative expenses are expected to increase in 2012 compared to 2011 because pre-commercialization activities are planned to increase as the Company gets closer to a potential regulatory filing and commercial launch.

Cash position
Management believes that Agennix will have sufficient cash to fund its operations well into the second half of 2012. This should enable the Company to obtain top-line data from the FORTIS-M trial as well as the Phase II portion of the OASIS trial, both expected in the second quarter of 2012, assuming no significant changes to current 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 in 2010 will not need to be re-paid prior to the release of top-line results from both the FORTIS-M trial and the Phase II part of the OASIS trial. Management plans to raise additional funds through licensing agreements and/or through equity or debt investments to fund the Company's operations beyond the second half of 2012.

Talactoferrin update
The Company provided an update on its lead program, the oral immunotherapy, talactoferrin.

Top-line data from Phase III FORTIS-M registration trial expected in the second quarter of 2012. The Company tightened its guidance, indicating that it now anticipates top-line data from the FORTIS-M trial in the second quarter of 2012. The FORTIS-M trial is a randomized, double-blind, placebo-controlled study evaluating talactoferrin plus best supportive care compared to placebo plus best supportive care in non-small cell lung cancer patients whose disease has progressed following two or more prior lines of therapy.

Forty-five percent of patients enrolled in Phase II part of OASIS Phase II/III trial. Agennix provided an update on enrollment in its ongoing Phase II/III OASIS trial in severe sepsis. As of October 31, 2011, 157 patients -- or 45% of the planned 350 patients -- had been enrolled in the Phase II part of the OASIS trial. The study was initiated at the end of June 2011. Top-line results are now expected in the second quarter of 2012.

Enrollment expected to complete in NIH-sponsored Phase I/II study for nosocomial infections in pre-term infants by year-end 2011. Agennix also reported that enrollment in an NIH-sponsored Phase I/II trial evaluating talactoferrin's potential to reduce the incidence of late-onset infections in infants born prematurely is expected to complete by the end of 2011. Data are expected in mid-2012. Agennix does not currently plan to pursue this indication further. The Company's therapeutic focus on oncology and severe sepsis remains unchanged.

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 on the Web site following the live event. The call, which will be conducted in English, will be held today, November 3rd at 9 AM ET/2 PM CET. The dial-in numbers for the call are as follows:

Participants from Europe:
0049 (0)69 710445598
0044 (0)20 3003 2666

Participants from the U.S.:
1 212 999 6659

Please dial in 10 minutes before the beginning of the call.

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 immunotherapy that has demonstrated activity in randomized, double-blind, placebo-controlled Phase II studies in non-small cell lung cancer and in severe sepsis. Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer and in a Phase II/III trial in severe sepsis. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I testing for cancer, 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 our control, 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 we caution investors not to place undue reliance on the forward-looking statements contained in this press release. There can be no guarantee that the Company will have sufficient cash to fund operations into the second half of 2012. The achievement of positive results in early stage clinical studies does not ensure that later stage or large scale clinical studies will be successful. Even if the results from our later stage trials with talactoferrin, including the ongoing FORTIS-M trial in non-small cell lung cancer, are considered positive, there can be no guarantee that they will be sufficient to gain marketing approval in the United States or any other country, and regulatory authorities may require additional information, data and/or further pre-clinical or clinical studies to support approval. In such event, there can be no guarantee that the Company will have or be able to obtain the financial resources to conduct any such additional studies or that such studies will yield results sufficient for approval. 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.

- Financials follow -

For the full interim management report and unaudited interim condensed consolidated financial statements and accompanying notes for the third quarter and nine months ended September 30, 2011, please see the Investor Relations section of the Agennix website at
http://www.agennix.com/index.php?option=com_content&view=article&id=161&Itemid=88&lang=en

Agennix AG
Interim consolidated statement of operations
Three months ended
September 30,
Nine months ended
September 30,
2011
(unaudited)
2010
(unaudited)
2011
(unaudited)
2010
(unaudited)
EUR 000 EUR 000 EUR 000 EUR 000
Revenue - 153 - 153
Research and development expenses (8,078 ) (8,267 ) (24,636 ) (19,879 )
Administrative expenses (2,147 ) (1,962 ) (6,617 ) (6,357 )
Amortization of intangible assets (1 ) (1 ) (5 ) (51 )
Other income 703 173 17 435
Other expenses - (4,141 ) (625 ) (434 )
Finance income 52 3 195 8
Finance costs (230 ) (167 ) (680 ) (171 )
Net loss before tax (9,701 ) (14,209 ) (32,351 ) (26,296 )
Income tax benefit 1,464 3,009 7,187 6,914
Net loss for the period (8,237 ) (11,200 ) (25,164 ) (19,382 )
Basic and diluted loss per share, euro (EUR 0.20 ) (EUR 0.54 ) (EUR 0.60 ) (EUR 0.97 )
Average number of shares used in computing basic and diluted loss per share 41,915,639 20,825,141 41,906,475 20,016,821
Agennix AG
Interim consolidated statement of financial position
September 30, 2011
(unaudited)
December 31, 2010
EUR 000 EUR 000
ASSETS
Non-current assets
Property and equipment 3,297 3,462
Intangible assets 97,100 99,466
Other non-current assets 2,007 2,153
Total non-current assets 102,404 105,081
Current assets
Trade receivables - 4
Prepayments 283 316
Other current assets 1,538 1,443
Other current financial assets 28,445 30,197
Cash and cash equivalents 14,754 49,016
Total current assets 45,020 80,976
TOTAL ASSETS 147,424 186,057
EQUITY AND LIABILITIES
Equity attributable to the Company's equity holders
Issued capital 41,932 41,884
Share premium 151,286 150,931
Other reserves 1,151 3,476
Retained loss (68,663 ) (43,499 )
Total equity 125,706 152,792
Non-current liabilities
Convertible bonds 210 210
Other non-current liabilities 4 18
Deferred tax liability - 7,631
Total non-current liabilities 214 7,859
Current liabilities
Trade payables 1,269 5,020
Accruals and other liabilities 4,170 4,994
Note payable 16,065 15,392
Total current liabilities 21,504 25,406
Total liabilities 21,718 33,265
TOTAL EQUITY AND LIABILITIES 147,424 186,057
Agennix AG
Interim consolidated statement of cash flows
Nine months ended September 30,
2011
(unaudited)
2010
(unaudited)
EUR 000 EUR 000
Net cash used in operating activities (34,377 ) (25,075 )
Net cash used in investing activities (23 ) (7,615 )
Net cash provided by financing activities 73 24,952
Effect of exchange rate changes on cash and cash equivalents 66 (40 )
Net decrease in cash and cash equivalents (34,262 ) (7,776 )
Cash and cash equivalents at beginning of period 49,016 11,413
Cash and cash equivalents at end of period 14,754 3,637

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