Advanced Magnetics, Inc. Reports Results for the First Fiscal Quarter of 2006 Ended December 31, 2005
January 19 2006 - 8:30AM
PR Newswire (US)
CAMBRIDGE, Mass., Jan. 19 /PRNewswire-FirstCall/ -- Advanced
Magnetics, Inc. (AMEX:AVM) today announced operating results and
revenues for the first fiscal quarter of 2006 ended December 31,
2005. Revenues for the quarter were $664,355 as compared to
revenues of $1,022,264 for the same period in fiscal 2005. The
company reported a net loss of $(4,214,732) or $(0.43) per share
compared to a net loss of $(2,549,112) or $(0.32) per share for the
same period in fiscal 2005. The decrease in revenues for the first
fiscal quarter of 2006 as compared to the equivalent fiscal quarter
last year is attributable to a decrease in the recognition of
deferred license fee revenue from a license and marketing agreement
covering Combidex(R) and a decrease in product sales of Feridex
I.V.(R) by our marketing partners. The increase in the loss for the
quarter ended December 31, 2005 as compared to the quarter ended
December 31, 2004 was primarily due to a non-cash charge of
$1,108,891 associated with the company's adoption of SFAS 123R
relative to accounting for employee stock-based compensation. Costs
and expenses associated with the same period last year do not
include, and have not been restated to reflect, a non-cash
accounting charge of $245,320 associated with employee stock-based
compensation. In addition, research and development expenses
related to the Phase III clinical trials for ferumoxytol in iron
replacement therapy increased in the first fiscal quarter of 2006
compared to the same period in fiscal 2005. Cash, cash equivalents
and short-term investments (consisting entirely of U.S. Treasury
Notes and Bills), totaled approximately $20 million at December 31,
2005. "We believe that during the first fiscal quarter of 2006 we
continued to make significant progress in our development program
for ferumoxytol as an iron replacement therapeutic. A key element
in our continuing progress was the recruitment of Dr. Brian J.G.
Pereira, a renowned nephrologist and physician executive, as our
new President," stated Jerome Goldstein, Chairman and CEO of
Advanced Magnetics. "We remain confident in the potential that both
ferumoxytol and Combidex have in their respective markets." "We
believe there is an unmet clinical need for an intravenous iron
that can be safely delivered in large doses as a single injection,"
stated Dr. Brian J. G. Pereira, President of Advanced Magnetics.
"We are strengthening our clinical and regulatory teams to ensure
that we bring ferumoxytol as quickly as possible to dialysis
dependent chronic kidney disease patients and those not yet on
dialysis." Ferumoxytol, our key product candidate, is in Phase III
multi-center clinical trials for use as an iron replacement
therapeutic in chronic kidney disease patients, whether or not on
dialysis. Combidex, our other product under development, is an
investigational functional molecular imaging agent consisting of
iron oxide nanoparticles for use in conjunction with magnetic
resonance imaging, or MRI, to aid in the differentiation of
cancerous from normal lymph nodes. In March 2005, we received an
approvable letter from the FDA with respect to Combidex, subject to
certain conditions. About Advanced Magnetics Advanced Magnetics,
Inc. is a developer of superparamagnetic iron oxide nanoparticles
used in pharmaceutical products. As a leader in our field, we are
dedicated to the development and commercialization of our
proprietary nanoparticle technology for use in therapeutic iron
compounds to treat anemia, as well as novel imaging agents to aid
in the diagnosis of cancer and cardiovascular disease. For more
information about us, please visit our website at
http://www.advancedmagnetics.com/, the content of which is not part
of this press release. This document contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 and federal securities laws. Any statements
contained in this press release that do not describe historical
facts, including but not limited to, statements regarding the
development programs and regulatory process for ferumoxytol or
Combidex, and our belief in the role these products will play in
the marketplace, are forward-looking statements that involve risks
and uncertainties that could cause actual results to differ
materially from those discussed in such forward-looking statements.
Such risks and uncertainties include the following: (1) the
possibility that we may not be able to successfully complete the
clinical development of ferumoxytol, or may not be able to complete
the development in a timely or cost-effective manner, due to the
timing of enrollment of patients in the Phase III studies,
unexpected results from our clinical sites, inadequate performance
by third-party service providers involved in the conduct of the
clinical trials, deficiencies in the design or oversight by us of
these trials, or any other factor causing an increase in expenses,
a delay and/or a negative effect on the results of the clinical
studies for ferumoxytol; (2) uncertainties surrounding the timing
and results of FDA interactions regarding the clinical development
of ferumoxytol and our ability to obtain regulatory approval for
ferumoxytol from the FDA; (3) the possibility that the results of
past ferumoxytol studies may not be replicated in future studies;
(4) the possibility that we may not be able to timely or
cost-effectively resolve the questions raised by the FDA and
satisfy the conditions specified for approval of Combidex,
including the provision of additional data or the conduct of
additional clinical trials to demonstrate the efficacy of Combidex;
(5) the possibility that we may not be able to raise additional
capital on terms and on a timeframe acceptable to us, if at all;
and (6) other risks identified in our Securities and Exchange
Commission filings. We caution readers not to place undue reliance
on any forward- looking statements which speak only as of the date
they are made. We disclaim any obligation to publicly update or
revise any such statements to reflect any change in expectations or
in events, conditions or circumstances on which any such statements
may be based, or that may affect the likelihood that actual results
will differ from those set forth in the forward-looking statements.
Advanced Magnetics, Inc. CONDENSED INCOME STATEMENT FOR THE
THREE-MONTH PERIOD ENDED DECEMBER 31, 2005 (unaudited) Three Months
Ended December 31, 2005 2004 Revenues $664,355 $1,022,264 Costs and
expenses* (5,054,022) (3,634,194) Interest income 174,935 62,818
Net loss $(4,214,732) $(2,549,112) Loss per share, basic and
diluted: $(0.43) $(0.32) Weighted average shares outstanding, basic
and diluted 9,886,262 7,985,382 * Costs and expenses in the first
quarter of fiscal year 2006 include a non-cash charge of $1,108,891
associated with the Company's adoption of SFAS 123R relative to
accounting for employee stock-based compensation. Costs and
expenses associated with the same period last year do not include,
and have not been restated to reflect, a non-cash accounting charge
of $245,320 associated with employee stock-based compensation.
Balance Sheet Data 12/31/05 9/30/05 Cash, cash equivalents and
short-term investments* $20,107,889 $23,727,298 Working capital
$18,262,134 $21,211,412 Total assets $25,097,510 $28,291,982
Shareholders' equity $19,585,822 $22,379,159 * Short-term
investments at 12/31/05 consist of a U.S. Treasury Note with a
maturity date of February 15, 2006, and two U.S. Treasury Bills
having maturity dates of January 5, 2006 and January 26, 2006.
Short-term investments at 9/30/05 consist of a U.S. Treasury Note
with a maturity date of February 15, 2006, combined with three U.S.
Treasury bills having maturity dates of October 27, 2005, November
3, 2005 and January 26, 2006. Contact: Lisa Gordon, Vice President
of Business Development Advanced Magnetics, Inc. (617) 497-2070
(x3024) First Call Analyst: FCMN Contact: DATASOURCE: Advanced
Magnetics, Inc. CONTACT: Lisa Gordon, Vice President of Business
Development of Advanced Magnetics, Inc., +1-617-497-2070 ext. 3024,
Web site: http://www.advancedmagnetics.com/
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