Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
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 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 EUR10.7 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
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.
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
Further inquiry note:
Manager, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693
In the U.S.: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
Additional media contact for Europe:
MC Services AG
Phone: +49 (0) 89 210 228 0
Additional investor contact for Europe:
Trout International LLC
Lauren Williams, Senior Vice President
Phone: +44 207 936 9325
end of announcement euro adhoc
company: AGENNIX AG
Im Neuenheimer Feld 515
phone: +49 89 8565 2693
FAX: +49 89 8565 2610
indexes: CDAX, Prime All Share, Technology All Share
stockmarkets: free trade: Hannover, Berlin, München, Hamburg, Düsseldorf,
regulated dealing/prime standard: Frankfurt