EANS-News: Agennix AG Reports Financial Results for First Quarter of 2011
Quarter highlighted by completion of enrollment in talactoferrin Phase III FORTIS-M trial and issuance of key U.S. patent for talactoferrin in oncology
-------------------------------------------------------------------------------- Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible for the content of this announcement. --------------------------------------------------------------------------------
quarterly report
Subtitle: Quarter highlighted by completion of enrollment in talactoferrin Phase III FORTIS-M trial and issuance of key U.S. patent for talactoferrin in oncology
Planegg/Munich (Germany), Princeton, NJ and Houston, TX (euro adhoc) - Agennix AG (Frankfurt Stock Exchange: 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 first quarter ended March 31, 2011.
Torsten Hombeck, Ph.D., Chief Financial Officer, said: "The first quarter of 2011 was highlighted by the completion of patient enrollment in the talactoferrin Phase III FORTIS-M trial, as well as the issuance of an important U.S. patent covering the use of talactoferrin to treat our lead indication, non-small cell lung cancer. We expect to continue making solid progress in the months ahead with the planned initiation of the Phase II portion of a Phase II/III trial in severe sepsis during the second quarter. We also expect data on talactoferrin to be presented at several upcoming major medical meetings. In addition, we are adding to our internal expertise with the selected hiring of highly experienced individuals in critical areas as we prepare for topline data from the FORTIS-M trial, expected in the first half of next year."
First quarter of 2011 compared to first quarter of 2010 The Company did not recognize any revenue for the three months ended March 31, 2011 and 2010.
Research and development (R&D) expenses for the three months ended March 31, 2011 were EUR 8.2 million compared to EUR 5.0 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 and preparation for the planned Phase II/III trial with talactoferrin in severe sepsis. Administrative expenses for the three months ended March 31, 2011 were EUR 2.3 million compared to EUR 2.1 million for the same period in 2010 due mainly to the Company engaging in certain critical pre-commercialization activities.
Net loss before income tax benefit for the three months ended March 31, 2011 was EUR 11.5 million compared to EUR 6.0 million for the same period in 2010. Income tax benefit for the three months ended March 31, 2011 amounted to EUR 2.9 million (EUR 1.7 million for the same period in 2010) and related to the net operating losses incurred by the Company´s subsidiary, Agennix Incorporated, during the period. Net loss for the three months ended March 31, 2011 was EUR 8.6 million compared to EUR 4.3 million for the same period in 2010. Basic and diluted loss per share was EUR (0.21) for the three months ended March 31, 2011, compared to EUR (0.23) for the same period in 2010.
Cash position As of March 31, 2011, cash, cash equivalents, other current financial assets and restricted cash totaled EUR 66.2 million (December 31, 2010: EUR 79.3 million). Net cash burn for the three months ended March 31, 2011 was EUR 11.5 million. 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: first quarter of 2011 compared to fourth quarter of 2010 The Company did not recognize any revenue in the first quarter of 2011 or in the fourth quarter 2010. R&D expenses were EUR 8.2 million for the first quarter of 2011 compared to EUR 9.5 million for the fourth quarter of 2010. Administrative expenses for the first quarter of 2011 were EUR 2.3 million compared to EUR 3.6 million for the fourth quarter of 2010. The Company had a net loss of EUR 8.6 million compared to EUR 7.6 million for the previous quarter. Net loss before income tax benefit was EUR 11.5 million for the first quarter of 2011 compared to net loss before income tax benefit of EUR 10.2 million for the fourth quarter of 2010. Basic and diluted loss per share was EUR (0.21) for the first quarter of 2011 compared to EUR (0.19) for the fourth quarter of 2010.
Financial guidance The Company provided the following financial guidance, which is consistent with the guidance provided in March 2011 at the time Agennix reported its fiscal year 2010 results:
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 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 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 Phase II/III trial in severe sepsis. 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 that point.
Revenues: Management expects no substantial cash-generating revenues during 2011. 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, 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, and Agennix is planning to initiate a Phase II/III trial with talactoferrin in severe sepsis in the second quarter of this year.
Administrative expenses: Administrative expenses in 2011 are expected to increase compared to 2010 as the Company plans to initiate certain critical pre-commercialization efforts.
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, May 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 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.
For the full management report and condensed consolidated financial statements and accompanying notes for the first three months ended March 31, 2011, please see the Investor Relations section of the Agennix website at http://www.agennix.com/index.php?option=com_conten t&view=article&id=161&Itemid=88&lang=en
end of announcement euro adhoc --------------------------------------------------------------------------------
Contact:
Agennix AG
Barbara Mueller
Manager, Investor Relations & Corporate Communications
Tel.: +49 89 8565-2693
ir@agennix.com
In the USA: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Tel.: 609-524-5884
laurie.doyle@agennix.com
Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Tel.: +49 89 210 228 0
raimund.gabriel@mc-services.eu
Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Vice President
Tel.: +44 207 936 9325
lwilliams@troutgroup.com
Branche: Pharmaceuticals
ISIN: DE000A1A6XX4
WKN: A1A6XX
Index: CDAX, Prime All Share, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Düsseldorf / free trade
Hannover / free trade
München / free trade