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EANS-News: AGENNIX AG Reports Financial Results for Third Quarter and First Nine Months of 2012

Geschrieben am 30-11-2012

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Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
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9-month report

Planegg/Munich (Germany) and Princeton, NJ (USA) (euro adhoc) -
Agennix AG (Frankfurt Stock Exchange: AGX) today announced financial
results for the third quarter and nine months ended September 30,
2012.

Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of
the Management Board, said: "We are in discussions with existing
investors and potential partners regarding strategic options for
Agennix, including possible business combinations with other
companies and/or acquiring assets with near-term revenue potential.
While this has been a very challenging time for Agennix, we are
working diligently to find a viable strategic path forward that will
be in the best interests of the Company and our shareholders. We
will further update the market as soon as we are in a position to do
so."

First nine months of 2012 compared to first nine months of 2011

The Company did not recognize any revenue during the nine months
ended September 30, 2012 and 2011.

Research and development ("R&D") expenses for the nine months ended
September 30, 2012 were EUR 27.5 million compared to EUR 24.6 million
for the same period in 2011. The increase in R&D expenses is
primarily due to increased costs associated with the talactoferrin
FORTIS-M Phase III trial in non-small cell lung cancer (NSCLC) and
the OASIS Phase II/III trial in severe sepsis, the majority of which
were incurred in the first half of 2012, and costs associated with
the overall evaluation of the talactoferrin program to determine a
potential future development path in the third quarter of 2012.

Administrative expenses for the nine months ended September 30, 2012
were EUR 7.7 million compared to EUR 6.6 million for the same period
in 2011. Administrative expenses were higher as the Company had
engaged in certain critical pre-commercialization activities related
to talactoferrin ahead of the FORTIS-M trial results. Any ongoing
activities were terminated once the FORTIS-M trial results were
known.

In August 2012, the Company announced a restructuring plan that
involved staff reductions of approximately 55 percent (or 37
employees) of the Company's workforce. The staff reductions occurred
at all three of the Company's sites of operation, and the Houston,
Texas location was closed. The Company recorded restructuring charges
of approximately EUR 3.0 million in the third quarter of 2012,
related to employee terminations, lease losses and other contract
termination costs. In addition, Agennix recorded approximately EUR
3.3 million and EUR 75.8 million of impairment charges for property
and equipment and for intangible assets, respectively, in the third
quarter of 2012. The property and equipment charge was mainly
related to equipment held by the Company's subsidiary, Agennix Inc.,
and the intangible assets charge was mainly related to talactoferrin.
The Company did not incur such charges in the first nine months of
2011.

Net loss before tax for the nine months ended September 30, 2012 was EUR 117.1
million compared to EUR 32.4 million for the same period in 2011, mainly as a
result of the restructuring and impairment charges discussed above. Income tax
benefit for the nine months ended September 30, 2012, was EUR 7.0 million
compared to EUR 7.2 million for the same period in 2011. Income tax benefit
recorded in 2011 related to the recognition of a deferred tax asset on net
operating losses incurred by the Company's subsidiary, Agennix Inc. No
additional deferred tax asset on net operating losses was recognized during the
first nine months of 2012. However, in the third quarter of 2012, in
conjunction with the impairment of the intangible asset related to
talactoferrin, the recognized deferred tax liability together with the deferred
tax asset were adjusted, resulting in a EUR 7.0 million net tax benefit for the
period. Net loss for the nine months ended September 30, 2012, was EUR 110.0
million compared to EUR 25.2 million for the same period in 2011. Basic and
diluted loss per share was EUR 2.15 for the nine months ended September 30,
2012, compared to EUR 0.60 for the same period in 2011.

Third quarter of 2012 compared to third quarter of 2011

The Company did not recognize any revenue during the three months ended
September 30, 2012 and 2011.

R&D expenses for the third quarter of 2012 were EUR 9.9 million compared to EUR
8.1 million for the same period in 2011. The increase in R&D expenses was
primarily due to increased costs associated with the FORTIS-M Phase III trial
before its termination and costs associated with the overall evaluation of the
talactoferrin program to determine a potential future development path.

Administrative expenses for the third quarter of 2012 decreased to
EUR 2.0 million compared to EUR 2.1 million for the same quarter in
2011. Administrative expenses were lower as any ongoing activities
relating to talactoferrin pre-commercialization were terminated once
the FORTIS-M trial results were known.

In the third quarter of 2012, the Company recorded a restructuring
charge of approximately EUR 3.0 million related to employee
terminations, lease losses and other contract termination costs.
Approximately EUR 3.3 million and EUR 75.8 million of impairment
charges for property and equipment and for intangible assets,
respectively, were also recorded.

Net loss before tax for the third quarter of 2012 was EUR 93.8
million compared to EUR 9.7 million for the third quarter of 2011.
Basic and diluted loss per share was EUR 1.69 and EUR 0.20 for the
third quarter of 2012 and 2011, respectively.

Quarter over quarter results: third quarter of 2012 compared to
second quarter of 2012

The Company did not recognize any revenue during the third or second
quarter of 2012. R&D expenses for the third quarter of 2012 were EUR
9.9 million compared to EUR 8.2 million for the second quarter of
2012. Administrative expenses for the third quarter of 2012 were EUR
2.0 million compared to EUR 2.8 million for the second quarter of
2012. Net loss before tax for the third quarter of 2012 was EUR 93.8
million compared to EUR 10.5 million for the second quarter of
2012. Basic and diluted loss per share was EUR (1.69) for the third
quarter of 2012 compared to EUR (0.21) for the second quarter of
2012.

Cash position

As of September 30, 2012, cash, cash equivalents, other current
financial assets and restricted cash totaled EUR 11.2 million
(December 31, 2011: EUR 44.0 million). Net cash burn for the nine
months ended September 30, 2012, was EUR 33.0 million, with net cash
burn of EUR 10.8 million in the first quarter, EUR 10.7 million for
the second quarter and EUR 11.5 million for the third 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.

Going concern

Based on the Company's current financial position and updated
estimates of future cash burn, management believes that Agennix will
have sufficient cash to fund its operations into the first quarter of
2013. Due to major setbacks with talactoferrin during 2012, the
Company's ability to raise additional cash on a stand-alone basis
through equity financing, debt issues or drug development partnering
agreements is very limited. As a result, the Company's ability to
continue as a going concern is at immediate risk and its liquidation
or insolvency may be imminent if additional funding is not obtained
early in the first quarter of 2013.

Management is currently in discussions with existing investors and
potential partners regarding strategic options for Agennix, including
possible business combinations with other companies and/or acquiring
assets with near-term revenue potential. Management believes that it
is possible that a transaction will move forward and expects to
undertake a bridge financing to extend its cash reach beyond the
first quarter of 2013 to complete any potential strategic
transaction.

There can be no guarantee that a strategic transaction will be
successfully completed or that the Company will be able to obtain
additional funding.

Outlook

The Company has performed extensive analyses of the data from the
FORTIS-M and FORTIS-C trials, as well as earlier studies, to
determine if there is a potential explanation for the negative
outcomes of those trials as compared to earlier successful clinical
studies with talactoferrin. If the hypotheses generated from these
analyses can be confirmed by additional research, a new development
path forward for talactoferrin may be considered.

In the Company's current situation, no revenues are expected to be
generated during the remainder of 2012 or in 2013. The Company has
taken significant steps to reduce expenses, including staff
reductions, site closures and ceasing various activities, such as
commercial manufacturing preparations and pre-commercialization
activities related to talactoferrin. In addition to the restructuring
during the third quarter of 2012, Agennix made the decision in the
fourth quarter of 2012 to close its Planegg/Munich, Germany site,
which will involve an additional staff reduction of six employees.
The closure is expected to occur in the first half of 2013. The
one-time cost of the restructurings and expenses related to
terminating various activities and operations will in the near term
offset anticipated longer-term savings from these cuts. In the
Company's current situation, expenses in 2013 would be expected to be
significantly lower than in 2012.

As discussed above, management is currently in discussions regarding
strategic options for Agennix and believes that it is possible that a
transaction will move forward.

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, November 30th
at 15:00 CET/9 AM EST. 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 lengthen and improve the lives of critically ill
patients in areas of major unmet medical need. The Company's clinical
development programs include oral talactoferrin alfa; a topical gel
form of talactoferrin and RGB-286638, a multi-targeted kinase
inhibitor. Agennix's registered seat is in Heidelberg, Germany. The
Company has two sites of operation: Planegg/Munich, Germany and
Princeton, New Jersey. 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 cash reach, financing and potential
strategic transactions. 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 clinical studies will be successful.
There can be no guarantee that the Company will have or be able to
obtain the financial resources to conduct additional studies with its
product candidates or that it will be successful in pursuing a
strategic transaction. 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 third quarter and three
months ended September 30, 2012, please see the Investor Relations
section of the Agennix website at: http://www.agennix.com/index.php?o
ption=com_content&view=article&id=207&Itemid=104&lang=en

Further inquiry note:
Agennix AG
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

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, München, Hamburg, Düsseldorf,
regulated dealing/prime standard: Frankfurt
language: English


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