SAN DIEGO, March 10, 2011 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) today reported financial
results for the fourth quarter and year ended December 31, 2010.
"Our activities over the past 18 months have positioned ADVENTRX
for success in 2011 and beyond. Near-term, we continue to prepare
for the commercial launch of Exelbine and our September 1 PDUFA date. Over the next 12
months, we expect to reach agreement with FDA on phase 3 clinical
trials for both ANX-514 and purified poloxamer 188, providing a
robust, late-stage pipeline to complement Exelbine as it moves
toward marketing approval," said Brian M.
Culley, chief executive officer at ADVENTRX.
"FDA's request for additional safety data for ANX-514 provides
an opportunity to investigate the clinical benefits of our
polysorbate 80-free docetaxel formulation. These benefits, if
demonstrated, will differentiate ANX-514 from Taxotere and other
detergent-containing formulations in the sizeable docetaxel
market," Mr. Culley continued.
"We're very excited about the near- and long-term news flow from
purified poloxamer 188, ANX-514 and Exelbine. In addition, we
continue to evaluate strategic acquisitions that would further
enhance our product pipeline and create value for our stockholders,
while maintaining appropriate controls on our expenditures" Mr.
Culley concluded.
Fourth Quarter 2010 Operating Results
ADVENTRX's net loss applicable to common stock for the fourth
quarter of 2010 was $2.3 million, or
$0.15 per share, compared to a net
loss applicable to common stock of $6.5
million, or $1.00 per share,
for the same period in 2009. Included in the net loss applicable to
common stock for the fourth quarter of 2009 was a non-cash, deemed
dividend expense of $3.3 million
incurred in connection with the Company's October 2009 equity financing.
Research and development (R&D) expenses for the fourth
quarter of 2010 were $0.9 million, a
decrease of $1.1 million, or 55%,
compared to $2.0 million for the same
period in 2009. The decrease was due primarily to a $1.4 million decrease in external nonclinical
study fees and expenses partially offset by a $0.1 million increase in personnel costs and a
$0.2 million increase in external
bioequivalence clinical consulting fees for ANX-514. The
decrease in external nonclinical study fees and expenses resulted
largely from a $0.5 million decrease
in research-related manufacturing expenses for Exelbine, a
$0.5 million decrease in
regulatory-related consulting fees for Exelbine and a $0.5 million decrease in research-related
manufacturing expenses for ANX-514, partially offset by a
$0.1 million increase in toxicology
study expenses related to Exelbine.
Selling, general and administrative (SG&A) expenses for the
fourth quarter of 2010 were $1.9
million, an increase of $0.6
million, or 46%, compared to $1.3
million for the same period in 2009. The increase was due
primarily to a $0.3 million increase
in fees for professional legal, audit and tax services, a
$0.2 million increase in consulting
fees, a $0.2 million increase in
Delaware corporate franchise tax
and a $0.1 million increase in
share-based compensation expense, partially offset by a
$0.2 million decrease in personnel
costs.
Full-Year 2010 Operating Results
ADVENTRX's net loss applicable to common stock for 2010 was
$14.1 million, or $1.07 per share, compared to a net loss
applicable to common stock of $16.2
million, or $3.47 per share,
for 2009. Included in the net loss applicable to common stock
for 2010 and 2009 were non-cash deemed dividend expenses of
$5.6 million and $4.9 million, respectively, incurred in
connection with the Company's 2010 and 2009 registered direct
equity financings. Also included in the net loss and net loss
applicable to common stock for 2009 were charges associated with
the Company's 2009 and 2008 workforce reductions.
R&D expenses for 2010 were $3.7
million, a decrease of $2.8
million, or 43%, compared to $6.5
million for 2009. The decrease was due primarily to a
$1.9 million decrease in external
nonclinical study fees and expenses, resulting largely from to a
$2.6 million decrease in
research-related manufacturing expenses for Exelbine and a
$0.1 million decrease in
regulatory-related consulting fees for Exelbine, partially offset
by a $0.5 million increase in fees
for regulatory-related consulting fees for ANX-514 and a
$0.3 million increase in toxicology
study expenses related to Exelbine.
SG&A expenses for 2010 were $5.3
million, an increase of $0.3
million, or 6%, compared to $5.0
million for 2009. The increase was due primarily to a
$0.5 million increase in consulting
fees, a $0.2 million increase in
Delaware corporate franchise tax
and a $0.2 million increase in
share-based compensation expense, partially offset by a
$0.5 million decrease in personnel
costs attributable to lower headcount and the absence of severance
costs in 2010 and a $0.1 million
decrease in fees for professional legal, audit and tax
services.
Balance Sheet Highlights
As of December 31, 2010, the
Company had cash totaling $28.0 million. Stockholders' equity amounted
to $26.7 million as of December 31, 2010. Taking into account net
proceeds of $21.0 million from the
equity financing completed in January
2011, pro forma cash at December 31,
2010 was $49.0 million.
Note Regarding Use of Non-GAAP Financial Measures
"Pro forma" is not a term defined by U.S. generally accepted
accounting principles (GAAP). The non-GAAP pro forma cash
information presented herein should be considered in addition to,
not as a substitute for, or superior to, financial measures
calculated in accordance with GAAP. The Company believes the pro
forma cash information presented herein may be useful to investors
in evaluating the Company's actual and effective cash positions
following its January 2011 equity
financing. The Company's management uses the pro forma
information presented herein to assess the Company's cash position
going into 2011 and to budget for 2011 operations.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company
focused on acquiring, developing and commercializing proprietary
product candidates. The Company's current lead product
candidates include novel emulsion formulations of currently
marketed chemotherapy drugs. More information can be found on
the Company's web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press
release that are not a description of historical facts are
forward-looking statements that are based on ADVENTRX's current
expectations and assumptions. Such forward-looking statements
include, but are not limited to, statements regarding the Company's
expectations for success in 2011 and beyond, the timing and receipt
of FDA approval of Exelbine, ADVENTRX's expectation of closing its
acquisition of SynthRx, Inc., development plans for ANX-514 and
purified poloxamer 188, differentiation of ANX-514 from Taxotere
and other detergent-containing formulations of docetaxel, the
potential size of the market for ANX-514, and additional strategic
transactions that would enhance ADVENTRX's product pipeline and
create value for stockholders. Actual events or results may differ
materially from those expressed or implied by the forward-looking
statements in this press release due to a number of risks and
uncertainties, including, without limitation: the risk that
ADVENTRX does not receive FDA approval of Exelbine on a timely
basis, or at all; the potential for the FDA to impose other
requirements to be completed before or after approval of the
Exelbine NDA, including that the FDA may require ADVENTRX to
perform additional nonclinical, bioequivalence or clinical studies;
the risk that ADVENTRX does not consummate its acquisition of
SynthRx on a timely basis, or at all; the potential for the FDA to
require significant additional nonclinical studies and/or clinical
testing of ANX-514 and/or purified poloxamer 188 for the treatment
of sickle cell crisis in children, including more than one clinical
trial; the risk that additional nonclinical and/or clinical study
results that may be required by the FDA do not support the safety
or efficacy or the commercial viability of Exelbine, ANX-514 or
purified poloxamer 188 and that ADVENTRX consequently determines to
discontinue one or more of those development programs; difficulties
or delays in obtaining regulatory approval for its product
candidates, even if ADVENTRX conducts additional nonclinical and/or
clinical activities required by the FDA; difficulties or delays in
manufacturing material for clinical or bioequivalence studies of
its product candidates; ADVENTRX's current dependence on the
success of Exelbine and ANX-514 and the possibility that ADVENTRX
does not receive regulatory approval of Exelbine or ANX-514 on a
timely basis, or at all; difficulties or delays in manufacturing
Exelbine and any other product candidate on a commercial scale,
should they receive regulatory approval, including validating
commercial manufacturing processes and manufacturers, as well as
suppliers; difficulties or delays in marketing Exelbine and any
other product candidate, should they receive regulatory approval,
including developing or acquiring marketing, sales and distribution
capabilities; the risk that ADVENTRX may not be able to
successfully commercialize its product candidates, even if it
receives regulatory approval for one or more of them; ADVENTRX's
past and continued reliance on the performance of third parties to
assist in the conduct of its nonclinical, clinical and
bioequivalence studies, regulatory submissions, CMC activities,
commercial launch activities and other important aspects of the
Exelbine and ANX-514 development programs, and that such third
parties have failed or may fail to perform as expected; the risk
that ADVENTRX will pursue development activities at levels or on
timelines, or will incur unexpected expenses, that shorten the
period through which its operating funds will sustain it; the
potential for ADVENTRX to raise additional capital to fund the
development and/or commercialization activities for current and/or
future product candidates; the potential that one or more of
ADVENTRX's product candidates will be subject to a future
collaboration or other strategic transaction and that such
partnership or transaction may not succeed in developing or
commercializing its product candidates; the potential for ADVENTRX
to enter into a merger or other business combination in connection
with a new product candidate acquisition resulting in a successor
entity that focuses its resources on developing products and
product candidates other than ADVENTRX's existing product
candidates, including Exelbine and ANX-514; and other risks and
uncertainties more fully described in ADVENTRX's press releases and
periodic filings with the Securities and Exchange Commission.
ADVENTRX's public filings with the Securities and Exchange
Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date when made. ADVENTRX
does not intend to revise or update any forward-looking statement
set forth in this press release to reflect events or circumstances
arising after the date hereof, except as may be required by
law.
[Tables to Follow]
ADVENTRX
Pharmaceuticals, Inc.
|
|
(A
Development Stage Enterprise)
|
|
Summary
Consolidated Financial Information
|
|
(In 000s
except for per share data)
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statement of
Operations Data* +:
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Year
ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing revenue
|
$
-
|
|
$
-
|
|
$
-
|
|
$
300
|
|
Grant revenue
|
$
489
|
|
$
-
|
|
$
489
|
|
$
-
|
|
Total net revenue
|
$
489
|
|
$
-
|
|
$
489
|
|
$
300
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
898
|
|
1,962
|
|
3,689
|
|
6,508
|
|
Selling,
general and administrative
|
1,897
|
|
1,253
|
|
5,320
|
|
4,998
|
|
Depreciation
and amortization
|
3
|
|
10
|
|
20
|
|
80
|
|
Total operating expenses
|
2,798
|
|
3,225
|
|
9,029
|
|
11,586
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
(2,309)
|
|
(3,225)
|
|
(8,540)
|
|
(11,286)
|
|
Interest
income (expense) / Other income
(expense)
|
24
|
|
5
|
|
89
|
|
(39)
|
|
Loss before income
taxes
|
(2,285)
|
|
(3,220)
|
|
(8,451)
|
|
(11,325)
|
|
Provision for
income taxes
|
-
|
|
-
|
|
-
|
|
-
|
|
Net loss
|
(2,285)
|
|
(3,220)
|
|
(8,451)
|
|
(11,325)
|
|
Deemed dividends on preferred
stock
|
-
|
|
(3,258)
|
|
(5,640)
|
|
(4,867)
|
|
Net loss applicable to common
stock
|
$ (2,285)
|
|
$ (6,478)
|
|
$(14,091)
|
|
$ (16,192)
|
|
Net loss per share – basic and
diluted
|
$ (0.15)
|
|
$ (1.00)
|
|
$ (1.07)
|
|
$
(3.47)
|
|
Weighted average shares – basic
and diluted
|
14,921
|
|
6,509
|
|
13,181
|
|
4,667
|
|
* Sums may
not equal totals due to rounding.
|
|
|
|
+ Share and
per share information reflect the 1-for-25 reverse split of
outstanding common stock that took place on April 23, 2010 at 4:01
p.m. Eastern time. Share and per share information related to dates
or periods prior to April 23, 2010 have been restated to reflect
retrospective application of the reverse stock
split.
|
|
|
|
|
|
|
|
|
|
Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
2010
|
|
2009
|
|
|
|
|
|
Total cash
|
$ 27,979
|
|
$ 8,667
|
|
|
|
|
|
Working capital
|
26,608
|
|
6,619
|
|
|
|
|
|
Total assets
|
28,487
|
|
9,027
|
|
|
|
|
|
Total liabilities
|
1,801
|
|
2,354
|
|
|
|
|
|
Stockholders' equity
|
26,685
|
|
6,674
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SOURCE ADVENTRX Pharmaceuticals, Inc.