Recent Highlights
- Definitive agreement to acquire SynthRx and purified
poloxamer 188
- $47.2 million in cash at March 1, 2011
- Exelbine NDA submitted to and accepted by FDA
- September 1, 2011 PDUFA goal date
- Pipeline expansion activities on-going
SAN DIEGO, March 10, 2011 /PRNewswire via COMTEX/ --
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 $28.0million.
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.