Advanced Magnetics, Inc. Reports Results for the Second Fiscal Quarter and Six Months Ended March 31, 2005
April 19 2005 - 9:00AM
PR Newswire (US)
Advanced Magnetics, Inc. Reports Results for the Second Fiscal
Quarter and Six Months Ended March 31, 2005 CAMBRIDGE, Mass., April
19 /PRNewswire-FirstCall/ -- Advanced Magnetics, Inc. (AMEX:AVM)
today announced operating results and revenues for the second
fiscal quarter and six-month period ended March 31, 2005. Revenues
for the quarter were $612,491 as compared to revenues of $766,530
for the same period in fiscal 2004. The company recorded a net loss
of ($3,335,835) or ($0.42) per share compared to a net loss of
($566,001) or ($0.07) per share for the same period in fiscal 2004.
Revenues for the six-month period ended March 31, 2005 were
$1,634,755 as compared to revenues of $1,398,494 for the same
period in fiscal 2004. The company recorded a net loss of
($5,884,947) or ($0.73) per share in the six-month period ended
March 31, 2005 compared to a net loss of ($1,506,701) or ($0.19)
per share for the same period in fiscal 2004. The increase in the
loss in both the quarter and the six-month period ended March 31,
2005, as compared to the same respective periods in fiscal 2004,
resulted primarily from an increase in research and development
expenses. Cash, cash equivalents, and short-term investments, the
latter consisting entirely of U.S. Treasury Notes, totaled
approximately $13.3 million at March 31, 2005. "We continue to work
toward our corporate goals," stated Jerome Goldstein, Chairman,
President and CEO of Advanced Magnetics. "We have formally
requested a meeting with the U.S. Food and Drug Administration
(FDA) to discuss next steps in the regulatory process for
Combidex(R) and we continue to move forward our clinical
development program for ferumoxytol in iron replacement therapy."
In March, Advanced Magnetics received an approvable letter from the
FDA regarding Combidex, its investigational functional molecular
imaging agent. Combidex (ferumoxtran-10) consists of iron oxide
nanoparticles for use in conjunction with magnetic resonance
imaging (MRI) to aid in the differentiation of cancerous from
normal lymph nodes. Phase III clinical trials for ferumoxytol in
iron replacement therapy for chronic kidney disease patients
whether or not on dialysis are currently ongoing and the company
expects to submit a New Drug Application to the FDA in mid-2006.
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
cardiovascular disease and cancer. 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 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, one
of our two products currently under development, or may not be able
to complete the development in a timely 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 studies, or any other factor causing a delay in or negatively
affecting the results of the clinical studies for ferumoxytol;(2)
the possibility that we may not be able to raise additional needed
capital on terms and on a timeframe acceptable to us, if at all;(3)
the possibility that the results of past ferumoxytol studies may
not be replicated in future studies; (4) uncertainties surrounding
the timing and results of FDA interactions regarding the clinical
development of ferumoxytol; (5) 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; (6) uncertainties surrounding our ability to resolve
final labeling for Combidex with the FDA; (7) uncertainties
regarding market acceptance of Combidex; (8) uncertainties relating
to third-party reimbursements to us or our partners for Combidex
when patients are prescribed Combidex; (9) our reliance on a
limited number of customers and our dependence on our collaborative
relationships; (10) the timing of recognition of deferred revenue
which is affected by the performance of our obligations under our
license agreements;(11) uncertainties relating to the cyclical
nature of our product sales cycles;(12) uneven demand for our
products by end users;(13) uncertainties relating to our ability to
continue to operate at commercial scale in compliance with FDA
regulations and other applicable manufacturing requirements when
producing Combidex or ferumoxytol; (14) uncertainties relating to
patents and proprietary rights and 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 AND SIX-MONTH PERIODS ENDED
MARCH 31, 2005 (unaudited) Three Months Six Months Ended March 31,
Ended March 31, 2005 2004 2005 2004 Revenues $612,491 $766,530
$1,634,755 $1,398,494 Costs and expenses (4,017,268) (1,382,375)
(7,651,462) (2,965,124) Other income* 68,942 49,844 131,760 59,929
Net income (loss) $(3,335,835) $(566,001) $(5,884,947) $(1,506,701)
Earnings (loss) per share, Basic and diluted $(0.42) $(0.07)
$(0.73) $(0.19) Weighted average shares outstanding, basic and
diluted 8,028,954 7,793,161 8,006,929 7,780,707 * Other income
consists of interest income. Balance Sheet Data 3/31/05 9/30/04
Cash, cash equivalents and short-term investments* $13,283,815
$14,334,278 Long-term investment** $ --- $ 4,768,159 Working
capital $11,243,335 $12,313,754 Total assets $18,117,169
$23,810,611 Shareholders' equity $12,027,771 $17,546,455 *
Short-term investment at 9/30/04 consists of a U.S. Treasury Bond
with a maturity date of January 31, 2005. Short-term investments at
3/31/05 consist of a U.S. Treasury Bill with a maturity date of May
5, 2005 and a U.S. Treasury Bond with a maturity date of February
15, 2006. ** Long-term investment consists of a U.S. Treasury Bond
with a maturity date of February 15, 2006. Contact: Mike Avallone,
CFO (617) 497-2070 (x3013) or Lisa Gordon, VP of Business
Development Advanced Magnetics, Inc. (617) 497-2070 (x3024)
DATASOURCE: Advanced Magnetics, Inc. CONTACT: Mike Avallone, CFO,
+1-617-497-2070 ext. 3013, or Lisa Gordon, VP of Business
Development, +1-617-497-2070 ext. 3024, both of Advanced Magnetics,
Inc. Web site: http://www.advancedmagnetics.com/
Copyright
Advance Magnetic (AMEX:AVM)
Historical Stock Chart
From Sep 2024 to Oct 2024
Advance Magnetic (AMEX:AVM)
Historical Stock Chart
From Oct 2023 to Oct 2024