EANS-News: AGENNIX AG / Agennix AG Reports Financial Results For Fiscal Year 2010
Geschrieben am 16-03-2011 |
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annual result
Heidelberg (euro adhoc) - Planegg/Munich (Germany), Princeton, NJ and
Houston, TX, March 16, 2011 - Agennix AG (Frankfurt Stock Exchange:
AGX) today announced financial results for the fourth quarter and
fiscal year ended December 31, 2010.
Fiscal year 2010 compared to fiscal year 2009 In 2010, net revenues
decreased to E 0.2 million from E 7.7 million in 2009. The
significant difference in revenues is primarily due to the
recognition in the fourth quarter of 2009 of E 7.4 million of
previously deferred revenue from the agreement with Yakult Honsha Co.
Ltd. for the development of satraplatin in Japan. Revenue for 2010
was attributable to an out-license agreement for certain intellectual
property from the Company's discontinued discovery program unrelated
to talactoferrin. Research and development (R&D) expenses increased
to E 29.4million for the year ended December 31, 2010, compared to E
6.7million for the same period in 2009. The increase in R&D expenses
was primarily due to increased clinical trial costs related to the
Company's Phase III trials with talactoferrin in non-small cell lung
cancer (NSCLC) as a result of the inclusion of Agennix Incorporated
operations for the entire year ended December 31, 2010.
Administrative expenses decreased to E 10.0 million for 2010 compared
to E 13.1 million for 2009. Included in administrative expenses for
the year ended December 31, 2009, were approximately E 8.6 million
in one-time merger-related costs (banking fees, legal services, audit
and other related services) and a credit to compensation cost of E
(1.5) million as a result of the forfeiture of convertible bonds and
stock options. There were no such one-time charges for the year ended
December 31, 2010.
Net loss in 2010 increased to E 27.0 million from E 11.9 million in
the preceding year. Net loss before income tax benefit increased to E
36.5 million in 2010 from E 13.1 million in 2009. Basic and diluted
loss per share was E 1.07 for 2010 compared to E 1.31 for 2009.
Cash position At December 31, 2010 the Company had cash, cash
equivalents, other current financial assets and restricted cash of E
79.3 million (December 31, 2009: E 11.5 million). Net cash burn for
2010 was E 34.5 million with E 7.6 million in the first quarter, E
9.9 million for the second quarter, E 7.8 million for the third
quarter and E 9.2 million for the fourth quarter. Net cash burn is
derived by adding net cash used in operating activities and purchases
of property, equipment and intangibles. The figures used to calculate
net cash burn are contained in the Company's respective consolidated
statements of cash flows.
Comparison to previous year: fourth quarter 2010 compared to fourth
quarter 2009 Revenues for the three months ended December 31, 2010
were E 0 compared to E 7.5 million for the same period in 2009. R&D
expenses for the fourth quarter of 2010 increased to E 9.5 million
compared to E 2.9 million for the fourth quarter of 2009.
Administrative expenses decreased for the fourth quarter of 2010 to E
3.6 million compared to E 5.2 million for the same quarter in 2009.
Net loss for the fourth quarter of 2010 was E 7.6 million compared to
E 1.3 million for the fourth quarter of 2009. Net loss before income
tax benefit was E 10.2 million for the fourth quarter of 2010
compared to E 2.5 million for the fourth quarter of 2009. Basic and
diluted loss per share was E 0.19 for the fourth quarter of 2010
compared to E 0.15 for the same period in 2009.
Quarter over quarter results: fourth quarter 2010 compared to third
quarter 2010 Revenues for the fourth quarter of 2010 were E 0
compared to E 0.2 million for the previous quarter. R&D expenses
increased to E 9.5 million for the fourth quarter of 2010 compared to
E8.3 million for third quarter of 2010. Administrative expenses for
the fourth quarter of 2010 increased to E 3.6 million compared to E
2.0 million for the previous quarter. The Company had a net loss of
E 7.6 million in the fourth quarter of 2010 compared to E 11.2
million for the previous quarter. Net loss before income tax benefit
was E 10.2 million in the fourth quarter of 2010 compared to E 14.2
million for the third quarter of 2010. Basic and diluted loss per
share was E 0.19 for the fourth quarter of 2010 compared to E 0.54
for the previous quarter.
Torsten Hombeck, Ph.D., Chief Financial Officer, said: "During 2010,
we made steady progress in advancing our development plans with our
lead program, oral talactoferrin. That progress is continuing with
the recent completion of enrollment in the FORTIS-M Phase III trial
in non-small cell lung cancer." Dr. Hombeck continued, "In 2010 we
also successfully refinanced the Company, including a major offering
in which we raised approximately E 76 million in net proceeds. We
believe we now have sufficient funding to achieve our key near- and
mid-term development goals with talactoferrin, including,
importantly, obtaining topline data from our first Phase III trial in
non-small cell lung cancer as well as from the Phase II portion of
our planned Phase II/III trial in severe sepsis."
Talactoferrin achievements and update The Company earlier today
announced the completion of enrollment in the FORTIS-M Phase III
registration trial. The FORTIS-M trial is a global randomized,
double-blind trial evaluating talactoferrin plus best supportive care
compared to placebo plus best supportive care in patients with NSCLC
whose disease has progressed following two or more prior treatment
regimens. The study enrolled 742 patients at over 160 sites
globally. As also announced, Agennix currently expects topline data
from the FORTIS-M trial in the first half of 2012.
The Company also provided an update on the planned Phase II/III trial
evaluating talactoferrin in patients with severe sepsis. This trial
will enroll approximately 350 patients at sites mainly in the U.S.
and Europe and is currently expected to initiate in the second
quarter of 2011.
Financial guidance
The Company provided the following updated financial guidance:
Cash Position: Based on the current financial position of the
Company, 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 topline data in the FORTIS-M
trial 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 E 15 million loan made to the
Company by dievini Hopp BioTech holding GmbH & Co. KG will not need
to be re-paid prior to the release of topline results from both the
FORTIS-M trial and the Phase II portion of the Phase II/III trial in
severe sepsis.
Revenues: Management expects no substantial cash generating revenues
for 2011. This guidance does not consider cash revenue from 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. The talactoferrin Phase III FORTIS-M
trial in NSCLC has recently completed enrollment. In addition, the
Company plans to initiate further clinical testing with talactoferrin
in severe sepsis.
Administrative Expenses: Administrative expenses in 2011 are expected
to increase moderately compared to 2010 as the Company plans to
initiate certain critical pre-commercialization efforts.
2011 corporate calendar The Company reported the dates for its 2011
corporate calendar as follows:
First quarter financial results: May 4
Annual Shareholders Meeting: May 10
Second quarter financial results: August 4
Third quarter financial results: November 3
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 16th at 15:00 CET/10:00 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 meeting.
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(TM) is a trademark of the Agennix group.
For the full management report and condensed consolidated financial
statements and accompanying notes for the fiscal year ended December
31, 2010, please see the Investor Relations section of the Agennix
website at http://www.agennix.com/index.php?option=com_content&view=a
rticle&id=122&Itemid=77&lang=en
end of announcement euro adhoc
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ots Originaltext: AGENNIX AG
Im Internet recherchierbar: http://www.presseportal.de
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, Vice President
Phone: +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
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