PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - July 31, 2012) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX), a biopharmaceutical company focused on developing novel therapies that have the potential to substantially lengthen and improve the lives 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, 2012.
Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of the Management Board, said: "These are exciting times for Agennix as we approach the top-line data readout from our Phase III FORTIS-M trial with talactoferrin alfa in non-small cell lung cancer, expected in August. We are preparing for the success of the Phase III trial, and much of our effort during the first half of the year involved activities to support future potential regulatory submissions and the commercial launch of talactoferrin alfa. We believe we are well positioned for the future and look forward to reporting the results from this study in the coming month."
First six months of 2012 compared to first six months of 2011
The Company did not recognize any revenue during the six months ended June 30, 2012 and 2011.
Research and development (R&D) expenses for the six months ended June 30, 2012 were EUR 17.7 million compared to EUR 16.6 million for the same period in 2011. The increase in R&D expenses was primarily due to increased costs associated with the compiling of data from the FORTIS-M Phase III trial of talactoferrin alfa (talactoferrin) for analysis. The increase was partially offset by decreases in patient costs as the FORTIS-M trial nears completion.
Administrative expenses for the six months ended June 30, 2012 were EUR 5.8 million compared to EUR 4.5 million for the same period in 2011. Administrative expenses were higher as the Company engaged in certain critical pre-commercialization activities related to a potential regulatory filing and commercial launch of talactoferrin.
Net loss before tax for the six months ended June 30, 2012 was EUR 23.3 million compared to EUR 22.7 million for the same period in 2011. Income tax benefit for the six months ended June 30, 2012, was EUR 0 compared to EUR 5.7 million for the same period in 2011. Income tax benefit recorded in 2011 related to the recognition of deferred tax asset on net operating losses incurred by the Company's subsidiary, Agennix Incorporated, during the period. In the first six months of 2012, the Company did not recognize any income tax benefit, because, as of June 30, 2012, it was not probable that future taxable profits or sufficient taxable temporary differences would be available against which the accumulated tax losses could be utilized before they expire.
Net loss for the six months ended June 30, 2012 was EUR 23.3 million compared to EUR 16.9 million for the same period in 2011. This increase was primarily due to the recognition of the deferred tax asset during the first six months of 2011 which did not occur in the current period. Basic and diluted loss per share was EUR (0.45) for the six months ended June 30, 2012, compared to EUR (0.40) for the same period in 2011.
Second quarter of 2012 compared to second quarter of 2011
The Company did not recognize any revenue during the three months ended June 30, 2012 and 2011.
R&D expenses of EUR 8.2 million were virtually unchanged for the second quarter of 2012 compared to the same period in 2011. This was a result of the increased costs associated with the compiling of data from the FORTIS-M trial for analysis in the second quarter of 2012, which was offset by decreases in patient costs as the FORTIS-M trial nears completion. Administrative expenses for the second quarter of 2012 were EUR 2.8 million compared to EUR 2.2 million for the same quarter in 2011.
Net loss for the second quarter of 2012 was EUR 10.5 million compared to EUR 8.3 million for the second quarter of 2011. Basic and diluted loss per share was EUR (0.21) and EUR (0.20) for the second quarter of 2012 and 2011, respectively.
As of June 30, 2012, cash, cash equivalents, other current financial assets and restricted cash totaled EUR 22.7 million (December 31, 2011: EUR 44.0 million). Net cash burn for the six months ended June 30, 2012, was EUR 21.5 million, with net cash burn of EUR 10.8 million in the first quarter and EUR 10.7 million for the second quarter. 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.
Quarter over quarter results: second quarter of 2012 compared to first quarter of 2012
The Company did not recognize any revenue in the first or second quarter of 2012. R&D expenses were EUR 8.2 million for the second quarter of 2012 compared EUR 9.5 million for the first quarter of 2012. This decrease was due to a decrease in patient costs related to the FORTIS-M trial. Administrative expenses for the second quarter of 2012 were EUR 2.8 million compared to EUR 2.9 million for the first quarter of 2012. The Company had a net loss of EUR 10.5 million for the second quarter of 2012 compared to EUR 12.7 million for the previous quarter. Basic and diluted loss per share was EUR (0.21) for the second quarter of 2012 compared to EUR (0.25) for the first quarter of 2012.
The Company's financial outlook for the remainder of 2012 and 2013 is highly dependent on the outcome of the FORTIS-M Phase III trial, which is expected to read out in August 2012. The Company provided the following financial guidance:
Revenues: Management expects no substantial cash generating revenues for 2012 or 2013. 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. However, if the FORTIS-M trial is positive, Agennix expects to generate revenue from one or more collaboration and license agreements for talactoferrin during this time period.
R&D expenses: For the second half of 2012 and for 2013, the amount of R&D expenses is dependent on the outcome of the FORTIS-M trial. Should the FORTIS-M trial be positive, the Company expects to incur additional costs related to regulatory filings and increased manufacturing costs in preparation for a potential market launch. In addition, in such a positive scenario, Agennix is likely to expand its clinical development activities in 2013.
Administrative expenses: Administrative expenses in 2012 and 2013 are expected to increase compared to 2011 as the Company expects to continue to moderately ramp up certain critical pre-commercialization activities for a potential market launch of talactoferrin. Should the FORTIS-M trial be positive, these activities and related expenses would increase significantly, potentially including costs related to beginning to build a commercial infrastructure in the U.S.
Cash position: Management believes that Agennix will have sufficient cash to fund its current level of operations into the first quarter of 2013. However, if the top-line data from the FORTIS-M trial, currently expected in August 2012, are positive, the Company anticipates significantly increasing its spending related to talactoferrin production, as well as regulatory and pre-commercialization activities, in anticipation of a Biologics License Application (BLA) submission with the U.S. Food and Drug Administration (FDA) and potential commercial launch. In this positive scenario, Agennix believes that it will have sufficient cash to fund operations into the middle of the fourth quarter of 2012. In such a positive data scenario, the Company anticipates raising additional funds through the issuance of equity or debt in the near term to fund increased spending into 2013 and continue as a going concern and would then expect to raise additional funds through licensing agreements and/or the issuance of equity during 2013.
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, July 31st at 15:00 CET/9 AM EDT. The dial-in numbers for the call are as follows:
Participants from Europe:
+49 (0)69 710 445 598
+44 (0)20 3003 2666
Participants from the U.S.:
+1 212 999 6659
Please dial in 10 minutes before the beginning of the call.
Agennix AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially lengthen and improve the lives of critically ill patients in areas of major unmet medical need. The Company's most advanced investigational agent is talactoferrin alfa, a first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI). Talactoferrin alfa is currently in Phase III clinical trials in non-small cell lung cancer. 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 and the timing of clinical trial results. 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 those 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. 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. Even if the results from the FORTIS-M trial are considered positive, there can be no guarantee that the Company will be able to partner talactoferrin or obtain additional financial resources within the projected timeframe. 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 Agennix AG.
- Financials follow -
For the full management report and condensed consolidated financial statements and accompanying notes for the second quarter and three months ended June 30, 2012, please see the Investor Relations section of the Agennix website at http://www.agennix.com/index.php?option=com_content&view=article&id=207&Itemid=104&lang=en
Interim consolidated statement of operations
Three months ended Six months ended
June 30, June 30,
2012 2011 2012 2011
(unaudited) (unaudited) (unaudited) (unaudited)
EUR 000 EUR 000 EUR 000 EUR 000
Revenue - - - -
Research and development
expenses (8,191) (8,320) (17,671) (16,558)
Administrative expenses (2,837) (2,177) (5,781) (4,470)
intangible assets (2) (3) (4) (4)
Other income 495 9 155 9
Other expenses - (500) - (1,320)
Finance income 12 65 49 143
Finance costs (3) (226) (5) (450)
----------- ----------- ----------- -----------
Net loss before tax (10,526) (11,152) (23,257) (22,650)
Income tax benefit - 2,818 - 5,723
----------- ----------- ----------- -----------
Net loss for the period (10,526) (8,334) (23,257) (16,927)
=========== =========== =========== ===========
Basic and diluted loss
per share, euro (EUR 0.21) (EUR 0.20) (EUR 0.45) (EUR 0.40)
Average number of shares
used in computing basic
and diluted loss per
share 51,270,258 41,913,591 51,270,258 41,906,171
Interim consolidated statement of financial position
2012 December 31,
EUR 000 EUR 000
Property and equipment 3,604 3,678
Intangible assets 105,004 101,962
Other non-current assets 452 545
Total non-current assets 109,060 106,185
Prepayments 326 430
Other current assets 2,527 5,376
Other current financial assets 6,883 20,024
Cash and cash equivalents 15,773 23,912
Total current assets 25,509 49,742
TOTAL ASSETS 134,569 155,927
EQUITY AND LIABILITIES
Equity attributable to the Company's equity
Issued capital 51,270 51,270
Share premium 169,468 169,199
Other reserves 7,800 4,860
Retained loss (107,906) (84,649)
Total equity 120,632 140,680
Convertible bonds 110 178
Other non-current liabilities 83 -
Deferred tax liability 7,156 6,950
Total non-current liabilities 7,349 7,128
Trade payables 2,707 3,013
Accruals and other liabilities 3,881 5,106
Total current liabilities 6,588 8,119
Total liabilities 13,937 15,247
TOTAL EQUITY AND LIABILITIES 134,569 155,927
Interim consolidated statement of cash flows Six months ended June 30,
EUR 000 EUR 000
Net cash used in operating activities (21,333) (22,664)
Net cash provided by/(used in) investing
activities 12,947 (9,936)
Net cash provided by financing activities - 34
Effect of exchange rate changes on cash and cash
equivalents 247 (154)
Net decrease in cash and cash equivalents (8,139) (32,721)
Cash and cash equivalents at beginning of period 23,912 49,016
Cash and cash equivalents at end of period 15,773 16,295