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Financial Figures/Balance Sheet
Subtitle: PROVIDES UPDATE ON LEAD PRODUCT CANDIDATE, ORAL TALACTOFERRIN
Planegg/Munich (Germany), Princeton, NJ and Houston, TX, March 15, 2012 (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 fourth
quarter and fiscal year ended December 31, 2011.
Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of the
Management Board, said: "Our efforts in 2011 focused on advancing the
development of our lead product candidate, the first-in-class oral Dendritic
Cell Mediated Immunotherapy, talactoferrin. We are preparing for success and
have been putting in place key elements to achieve our goals while keeping a
watchful eye on what we spend. Prior to Phase III data from our ongoing FORTIS-M
trial, which we now expect in the July/August 2012 timeframe, we are investing
only in those activities that we believe are on the critical path for a timely
and successful regulatory submission and potential product launch."
Fiscal year 2011 compared to fiscal year 2010
The Company did not recognize any revenues in 2011 compared to EUR 0.2 million
recognized in 2010. Research and development expenses were EUR 36.6 million for
the year ended December 31, 2011, compared with EUR 29.4 million for the same
period in 2010. The increase in R&D expenses was primarily due to increased
patient enrollment in the Phase III FORTIS-M trial with talactoferrin in
non-small cell lung cancer (NSCLC) and the Phase II portion of the OASIS trial
with talactoferrin in severe sepsis, which was initiated at the end of the
second quarter of 2011 and stopped in the first quarter of 2012. Administrative
expenses were EUR 8.8 million for the year ended December 31, 2011, compared to
EUR 10.0 million for the same period in 2010. The decrease was primarily due to
decreases in legal expenses related to shareholder litigation and variable
employee compensation expense, neither of which were incurred in 2011. Net loss
in 2011 was EUR 41.8 million compared to EUR 27.0 million for the preceding
year. Net loss before income tax benefit was EUR 42.6 million in 2011 compared
to EUR 36.5 million in 2010. Income tax benefit for the year ended December 31,
2011 was EUR 0.8 million (EUR 9.5 million for the same period in 2010) and
related to the net operating losses incurred by the Companys subsidiary,
Agennix Incorporated, during the period. Basic and diluted loss per share was
EUR (0.98) for 2011 compared to EUR (1.07) for 2010.
Cash position
At December 31, 2011, the Company had cash, cash equivalents, other current
financial assets and restricted cash of EUR 44.0 million (2010: EUR 79.3
million). Net cash burn for 2011 was EUR 45.8 million (2010: EUR 34.5
million), with net cash burn of EUR 11.5 million in the first quarter, EUR 11.6
million in the second quarter, EUR 11.8 million in the third quarter and EUR
10.9 million in the fourth quarter of 2011. 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 Companys respective consolidated statements of cash flows.
Comparison to previous year: fourth quarter 2011 compared to fourth quarter 2010
The Company did not recognize any revenues for the three months ended December
31, 2011 or 2010. R&D expenses for the fourth quarter of 2011 were EUR 12.0
million compared to EUR 9.5 million for the fourth quarter of 2010.
Administrative expenses for the fourth quarter of 2011 were EUR 2.2 million
compared to EUR 3.6 million for the same quarter in 2010. Net loss for the
fourth quarter of 2011 was EUR 16.7 million compared to EUR 7.6 million for the
fourth quarter of 2010. Net loss before income tax expense/benefit was EUR 10.3
million for the fourth quarter of 2011 compared to EUR 10.2 million for the
fourth quarter of 2010. Basic and diluted loss per share was EUR (0.37) for the
fourth quarter of 2011 compared to
EUR (0.19) for the same period in 2010.
Quarter over quarter results: fourth quarter 2011 compared to third quarter 2011
The Company did not recognize any revenues for the fourth quarter or third
quarter of 2011. R&D expenses were EUR 12.0 million for the fourth quarter of
2011 compared to EUR 8.1 million for the third quarter of 2011. Administrative
expenses for the fourth quarter of 2011 were EUR 2.2 million compared to EUR 2.1
million for the previous quarter. The Company had a net loss of EUR 16.7
million in the fourth quarter of 2011 compared to EUR 8.2 million for the
previous quarter. Net loss before income tax expense/benefit was EUR 10.3
million in the fourth quarter of 2011 compared to EUR 9.7 million for the third
quarter of 2011. Basic and diluted loss per share was EUR (0.37) for the fourth
quarter of 2011 compared to EUR (0.20) for the previous quarter.
Talactoferrin update
Agennix also provided an update on its lead product candidate, the oral
Dendritic Cell Mediated Immunotherapy (DCMI), talactoferrin.
The Company reported that top-line results from the ongoing FORTIS-M trial in
NSCLC patients whose disease has progressed following two or more prior
therapies are now expected in the July/August 2012 timeframe, rather than in the
second quarter of 2012 as previously anticipated. The change is due to the fact
that the analysis of the FORTIS-M data is event driven and the rate at which
events have occurred to date is slower than previously projected. The number of
events needed to perform the analysis has not yet been reached.
Agennix reported that its review of the available results from the OASIS Phase
II/III trial with talactoferrin in severe sepsis confirmed the finding of the
trials Data Safety Monitoring Board (DSMB), which had recommended that the
study be stopped. The Company reported that the latest data from the trial,
which incorporates additional patients data that were not available to the DSMB
at the time of its analysis, indicate that 28-day all-cause mortality, the
primary endpoint of the study, in the talactoferrin arm was 25% compared to 18%
in the placebo group. This difference was not statistically significant. These
results were based on 305 patients treated in the study, with 153 in the
talactoferrin group and 152 in the placebo group. No other safety issues have
been identified to date.
Further evaluation of apparent differences in some baseline characteristics
between the two arms in the OASIS trial is ongoing. Women in the talactoferrin
arm, particularly those with cardiovascular dysfunction (septic shock), had an
apparent higher 28-day mortality compared to women in the placebo arm. Male
patients without cardiovascular dysfunction who received talactoferrin had an
apparent lower 28-day mortality than those who received placebo. Further
analyses are ongoing to more fully understand the findings.
The above results are still preliminary and subject to change. The final results
from the OASIS trial are expected to be presented at a medical meeting later in
the year.
Once the ongoing data review is completed and Agennix has held further
discussions with the critical care community and consultants, the Company will
make a decision on whether further development of talactoferrin in severe sepsis
is warranted. Until that time, Agennix does not intend to invest further in the
development of talactoferrin in severe sepsis.
The Company has discussed the results of the OASIS trial with the DSMB of the
FORTIS trials. The FORTIS DSMB has agreed with Agennixs assessment that, based
on the available data from the OASIS trial, no changes to the conduct of the
ongoing FORTIS-M trial are necessary and the trial can continue as planned.
Financial guidance
Agennix provided the following updated financial guidance. The Companys
financial outlook for 2012 and 2013 is highly dependent on the outcome of the
FORTIS-M Phase III trial in NSCLC.
Revenues: Management expects no substantial cash-generating revenues for 2012
and 2013. This guidance does not consider any potential cash revenue from future
partnering of talactoferrin due to the uncertainty of the timing of such events.
If the FORTIS-M trial is positive, Agennix plans to submit a Biologics License
Application (BLA) to the U.S. Food & Drug Administration (FDA), and a Marketing
Authorization Application (MAA) to the European Medicines Agency (EMA),
requesting marketing approval of talactoferrin.
R&D expenses: The Company expects R&D expenses for the first half of 2012 to be
in line with the first half of 2011. For the second half of 2012 and for 2013,
R&D expenses are dependent on the outcome of the FORTIS-M trial. Should the
FORTIS-M trial be positive, the Company would expect 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.
Administrative expenses: Administrative expenses in 2012 and 2013 are expected
to increase compared to 2011 as the Company expects to 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 operations into the first quarter of 2013. This should enable the
Company to obtain top-line data from the FORTIS-M trial, now expected in
July/August 2012, assuming no significant changes to currently projected
timelines, and to significantly advance potential partnering discussions. 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 Companys
operations beyond that point.
2012 corporate calendar
The Company reported the dates for its 2012 corporate calendar as follows:
First quarter financial results: May 9
Annual Shareholders Meeting: June 15 (previously August 7)
Second quarter financial results: July 31
Third quarter financial results: November 8
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, March 15th at 14:00 CET/9:00 AM EDT. The dial-in numbers for
the call are as follows:
Participants from Europe: 0049 (0)69 710 445 598
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 Companys most advanced program is talactoferrin, a
first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI). Talactoferrin
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. Agennixs 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 Companys 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
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. 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.
For the full management report, condensed consolidated financial statements and
accompanying notes for the fiscal year ended December 31, 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
Further inquiry note:
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, Senior Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.com
end of announcement euro adhoc
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company: AGENNIX AG
Im Neuenheimer Feld 515
D-69120 Heidelberg
phone: +49 89 8565 2693
FAX: +49 89 8565 2610
mail: ir@agennix.com
WWW: http://www.agennix.com
sector: Pharmaceuticals
ISIN: DE000A1A6XX4
indexes: CDAX, Prime All Share, Technology All Share
stockmarkets: free trade: Hannover, Berlin, Mnchen, Hamburg, Dsseldorf,
regulated dealing/prime standard: Frankfurt
language: English
