PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - August 04, 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 second quarter and six months ended June 30, 2011.
Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of the Management Board, said: "We had a very productive first half of 2011, highlighted by solid progress with our clinical programs for our oral immunotherapy, talactoferrin. During the first half of the year, enrollment completed in the FORTIS-M Phase III trial in non-small cell lung cancer, and the OASIS Phase II/III trial in severe sepsis was initiated. These trials both are on track for data readouts in 2012 using our existing financial resources. Additionally, data on talactoferrin were presented at a variety of major medical meetings in the U.S. and Europe. We were also very pleased to hire several highly experienced executives in key areas as we prepare for a possible regulatory filing for talactoferrin and a potential commercial launch."
First six months of 2011 compared to first six months of 2010
The Company did not recognize any revenue during the six months ended June 30, 2011 and 2010.
Research and development (R&D) expenses for the six months ended June 30, 2011, were EUR 16.6 million compared to EUR 11.6 million for the same period in 2010. The increase in R&D expenses is primarily due to increased patient enrollment in the Phase III FORTIS-M trial with talactoferrin in non-small cell lung cancer (NSCLC) and preparation for 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 six months ended June 30, 2011, were EUR 4.5 million compared to EUR 4.4 million for the same period in 2010.
Net loss before tax for the six months ended June 30, 2011, was EUR 22.7 million compared to EUR 12.1 million for the same period in 2010. Income tax benefit for the six months ended June 30, 2011, amounted to EUR 5.7 million (EUR 3.9 million for the same period in 2010) and related to the deferred tax asset on net operating losses incurred by the Company's subsidiary, Agennix Incorporated, during the period. Net loss for the six months ended June 30, 2011, was EUR 16.9 million compared to EUR 8.2 million for the same period in 2010. Basic and diluted loss per share was EUR (0.40) for the six months ended June 30, 2011, compared to EUR (0.42) for the same period in 2010.
Second quarter of 2011 compared to second quarter of 2010
The Company did not recognize any revenue during the three months ended June 30, 2011 and 2010. R&D expenses for the second quarter of 2011 were EUR 8.3 million compared to EUR 6.6 million for the same period in 2010. The increase in R&D expenses is primarily due to increased patient enrollment in the Phase III FORTIS-M trial and preparation for the Phase II/III OASIS trial, which was initiated at the end of the second quarter of 2011. Administrative expenses for the second quarter of 2011 were EUR 2.2 million compared to EUR 2.3 million for the same quarter in 2010. Net loss for the second quarter of 2011 was EUR 8.3 million compared to EUR 3.9 million for the second quarter of 2010. Basic and diluted loss per share was EUR (0.20) and EUR (0.19) for the second quarter of 2011 and 2010, respectively.
Quarter over quarter results: second quarter 2011 compared to first quarter 2011
The Company did not recognize any revenue during the three months ended June 30, 2011 and the first quarter of 2011. R&D expenses for the second quarter of 2011 were EUR 8.3 million compared to EUR 8.2 million in the first quarter 2011. Administrative expenses for the second quarter of 2011 were EUR 2.2 million compared to EUR 2.3 million for the first quarter of 2011. Net loss for the second quarter of 2011 was EUR 8.3 million compared to EUR 8.6 million for the first quarter of 2011. Basic and diluted loss per share was EUR (0.20) for the second quarter of 2011 compared to EUR (0.21) for the first quarter of 2011.
Cash position
As of June 30, 2011, cash, cash equivalents, other current financial assets and restricted cash totaled EUR 54.2 million (December 31, 2010: EUR 79.3 million). Net cash burn for the six months ended June 30, 2011, was EUR 23.1 million (June 30, 2010: EUR 17.5 million) with net cash burn of EUR 11.5 million in the first quarter and EUR 11.6 million in the second quarter of 2011. The increase in net cash burn compared to the 2010 period was mainly due to clinical trial costs related to increased patient enrollment in the FORTIS-M trial and preparations for 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 confirmed its financial guidance that was provided in May 2011:
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: For 2011 and 2012, the Company expects R&D expenses to increase compared to 2010 due to an expected increase in talactoferrin clinical trial-related costs. Enrollment in the Phase III FORTIS-M trial was completed in March 2011. Agennix initiated the OASIS Phase II/III trial in June 2011.
Administrative expenses: Administrative expenses for the remainder of 2011 and 2012 are expected to increase slightly compared to 2010 as the Company engages in certain critical pre-commercialization activities.
Cash position: 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 top-line data in the FORTIS-M trial, expected in the first half of 2012, and to complete the Phase II portion of the Phase II/III OASIS trial, 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 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 portion of the OASIS trial. The Company will need to raise additional funds through licensing agreements and/or through strategic and/or public equity or debt investments to fund the Company's operations beyond this point.
Talactoferrin update
The Company confirmed that management continues to expect top-line data from the FORTIS-M trial evaluating talactoferrin in third-line+ NSCLC in the first half of 2012. Accrual for this study was completed in March 2011. The Company also reported that patients in both the United States and Europe have already been enrolled in the Phase II/III OASIS trial in severe sepsis. The OASIS trial was initiated at the end of the second quarter of 2011. The Phase II part of the trial is planned to enroll approximately 350 patients, and data are expected in mid-2012.
Agennix also reported data from an exploratory single center study, which was initiated prior to the establishment of Agennix AG and funded in part by a grant from the U.S. National Institutes of Health. The study evaluated the effect of talactoferrin versus placebo in 47 patients with acute myelogenous leukemia (AML) in preventing neutropenic fever and oral mucositis, which are common side effects of chemotherapies used to treat AML. There was no difference between the arms regarding neutropenic fever. More cases of clinically relevant mucositis were reported in the talactoferrin arm, but the difference was not statistically significant. No increase in mucositis has been reported in other clinical studies with talactoferrin. Talactoferrin was well tolerated with a safety profile similar to placebo. Management does not 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, August 4th at 15:00 CET/9:00 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 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 a Phase II/III trial with talactoferrin in severe sepsis is underway. 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 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. 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 second quarter and six months ended June 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 Six months ended
June 30, June 30,
2011 2010 2011 2010
(unaudited) (unaudited) (unaudited) (unaudited)
EUR 000 EUR 000 EUR 000 EUR 000
Revenue - - - -
Research and development
expenses (8,320) (6,635) (16,558) (11,612)
Administrative expenses (2,177) (2,306) (4,470) (4,395)
Amortization of
intangible assets (3) (11) (4) (50)
Other income 9 2,850 9 3,970
Other expenses (500) (1) (1,320) (1)
Finance income 65 4 143 5
Finance costs (226) (2) (450) (4)
----------- ----------- ----------- -----------
Net loss before tax (11,152) (6,101) (22,650) (12,087)
Income tax benefit 2,818 2,248 5,723 3,905
----------- ----------- ----------- -----------
Net loss for the period (8,334) (3,853) (16,927) (8,182)
=========== =========== =========== ===========
Basic and diluted loss
per share, euro (EUR 0.20) (EUR 0.19) (EUR 0.40) (EUR 0.42)
Average number of shares
used in computing basic
and diluted loss per
share 41,913,591 20,589,577 41,906,171 19,658,314
Agennix AG
Interim consolidated statement of financial position
June 30,
2011 December 31,
(unaudited) 2010
EUR 000 EUR 000
ASSETS
Non-current assets
Property and equipment 3,226 3,462
Intangible assets 91,751 99,466
Other non-current assets 1,969 2,153
------------ ------------
Total non-current assets 96,946 105,081
Current assets
Trade receivables - 4
Prepayments 293 316
Other current assets 1,398 1,443
Other current financial assets 37,806 30,197
Cash and cash equivalents 16,295 49,016
------------ ------------
Total current assets 55,792 80,976
TOTAL ASSETS 152,738 186,057
============ ============
EQUITY AND LIABILITIES
Equity attributable to the Company's equity
holders
Issued capital 41,906 41,884
Share premium 151,153 150,931
Other reserves (4,701) 3,476
Retained loss (60,426) (43,499)
------------ ------------
Total equity 127,932 152,792
Non-current liabilities
Convertible bonds 210 210
Other non-current liabilities 8 18
Deferred tax liability 1,449 7,631
------------ ------------
Total non-current liabilities 1,667 7,859
Current liabilities
Trade payables 2,294 5,020
Accruals and other liabilities 5,007 4,994
Note payable 15,838 15,392
------------ ------------
Total current liabilities 23,139 25,406
Total liabilities 24,806 33,265
TOTAL EQUITY AND LIABILITIES 152,738 186,057
============ ============
Agennix AG
Interim consolidated statement of cash flows
Six months ended June 30,
2011 2010
(unaudited) (unaudited)
EUR 000 EUR 000
Net cash used in operating activities (22,664) (17,292)
Net cash used in investing activities (9,936) (1,292)
Net cash provided by financing activities 34 9,705
Effect of exchange rate changes on cash and
cash equivalents (154) 266
Net decrease in cash and cash equivalents (32,721) (8,611)
Cash and cash equivalents at beginning of
period 49,016 11,413
------------ ------------
Cash and cash equivalents at end of period 16,295 2,802
============ ============
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
