Published: March 07, 2011
Neoprobe Announces 2010 Results with Record Medical Device Sales
DUBLIN, Ohio - (BUSINESS WIRE) - Neoprobe Corporation (NYSE Amex: NEOP) today announced its consolidated
results for the fourth quarter of 2010 and for the year ended December
31, 2010.
Neoprobe's revenues for the fourth quarter of 2010 were $3.2 million
compared to $2.4 million for the fourth quarter of 2009, a 30% increase.
Gross profit for the fourth quarter of 2010 was $2.3 million compared to
$1.6 million for the fourth quarter of 2009. Fourth quarter 2010
operating expenses were $3.7 million compared to $2.1 million for the
fourth quarter of 2009. Loss from operations for the fourth quarter of
2010 was $1.4 million compared to $420,000 for the fourth quarter of
2009. For the fourth quarter of 2010, Neoprobe reported a net loss
attributable to common stockholders of $2.1 million, or $0.03 per share,
compared to a net loss attributable to common stockholders of $354,000,
or $0.00 per share, for the fourth quarter of 2009.
Year-to-date revenues for the year ended December 31, 2010 were $10.7
million compared to $9.5 million for 2009, a 12% increase. Gross profit
was $7.5 million for the year ended December 31, 2010 compared to $6.4
million for 2009. Operating expenses for the year ended December 31,
2010 were $13.8 million compared to $8.2 million for 2009. Neoprobe's
loss from operations for the year ended December 31, 2010 was $6.3
million compared to $1.8 million for 2009. For the year ended December
31, 2010, Neoprobe reported a net loss attributable to common
stockholders of $58.2 million, or $0.72 per share, compared to a net
loss attributable to common stockholders of $39.8 million, or $0.54 per
share, for 2009. As discussed more fully below, the net loss
attributable to common stockholders for the years ended December 31,
2010 and 2009 included significant non-cash losses and deemed dividends.
Increases in the Company's stock price over the respective periods
resulted in significant non-cash charges being reflected in the
Company's financial statements. In 2010, non-cash charges totaling
approximately $51 million were the result of the extinguishment
accounting related to the Company's June 2010 exchange of convertible
debt and preferred stock for a new series of preferred stock as well as
mark-to-market adjustments related to derivative accounting treatment
required for certain financial instruments on the Company's balance
sheet. In 2009, non-cash charges aggregating $34.4 million resulted from
the extinguishment accounting related to the modification of certain
terms of the Company's convertible debt, preferred stock and related
warrants and the mark-to-market adjustments related to derivative
accounting treatment required for certain financial instruments.
Brent Larson, Neoprobe's Senior Vice President and CFO, said, "Our
revenue increased on both a quarterly and year-to-date basis due to the
combined impact of increased sales of our gamma detection devices and
revenue related to government grants received from both the federal and
state levels. In addition, and perhaps more importantly, our gross
profit has also continued to improve. For the fourth quarter of 2010,
gross profit rose to 72% of revenue compared to 67% for the same period
in 2009 due to the receipt of the grants, favorable pricing and lower
material costs. These positive movements in the second half of 2010
contributed to an overall increase in our year-to-date gross profit to
70% of revenue for the year ended December 31, 2010 compared to 67% for
2009. We are pleased with our ongoing efforts to effectively manage our
device business coupled with the non-dilutive contributions that our
grant application efforts have been able to provide."
David Bupp, Neoprobe's President and CEO, said, "Our operating expenses
during 2010 increased as a direct result of our progress in clinical,
manufacturing and regulatory activities related to our Lymphoseek drug
initiative. Due in large part to our efforts in 2010, we are nearing the
culmination of our efforts and continue to expect to be in a position to
file our new drug application (NDA) for Lymphoseek during the second
quarter of 2011. As we announced earlier today, we have also made
progress in clarifying the regulatory pathway to support further efforts
to move our ahead with our RIGScan biologic development activities."
"We ended 2010 with $6.4 million in cash," Larson continued, and since
that time we have received over $4 million in funds from the exercise of
issued warrants. Our cash position is stronger than it has been in
recent years, which we believe provides the ability to fund our current
drug development initiatives."
Following are some of the key milestones achieved by Neoprobe in 2010
and to date in 2011:
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Completed a successful meeting with FDA to review the Phase 3
(NEO3-05) clinical study results and development plan discussion to
support a NDA submission for Lymphoseek as a lymphatic-tissue tracing
agent;
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Completed a successful pre-NDA dialogue with FDA on Lymphoseek
pre-clinical data;
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Completed a successful pre-NDA dialogue with FDA on Lymphoseek
chemistry, manufacturing and control data;
-
Elected two new directors to Neoprobe's Board, bringing significant
drug industry and corporate development expertise to the Company's
leadership;
-
Completed exchange transactions that converted all of the Company's
outstanding debt to equity;
-
Initiated a third (NEO3-09) Phase 3 Lymphoseek clinical study in
patients with breast cancer or melanoma to support the filing of the
NDA with the potential to expand Lymphoseek's product labeling;
-
Achieved revenue and gross profit increases of 12% and 17%,
respectively, for 2010 over 2009;
-
Completed preliminary RIGS development activities
including transfer of biologic license application to CDER and
preparation of an IND for the biologic product;
-
Received notice of grant awards totaling over $1.2 million to support
Lymphoseek development through non-dilutive funding;
-
Completed a pre-NDA meeting for Lymphoseek clarifying the regulatory
pathway for Lymphoseek approval;
-
Filed a complete response to the open biologic license application
(BLA) for RIGScan CR;
-
Filed a shelf registration on Form S-3 to allow the Company to raise
capital as necessary through the sale of up to $20 million in a
primary offering of securities to provide us with additional financial
planning flexibility and to support the diversification of our share
ownership to new institutions;
-
Completed a $6 million equity financing for working capital purposes
and to support ongoing development efforts;
-
Achieved the lymph node accrual goal for the NEO3-09 Phase 3 clinical
study conducted in subjects with either breast cancer or melanoma;
-
Completed a successful pre-IND meeting with FDA to reinitiate
development activities for the RIGS technology; and
-
Published the clinical results of a multicenter clinical study in
surgical peer review journals, presented the development history of
Lymphoseek at the March 2011 Society of Surgical Oncology meeting, and
announced that the Company expects to present Phase 3 study results
from NEO3-09 at the June 2011 American Society of Clinical Oncology
meeting.
"In summary, our gamma detection device business continues to
demonstrate positive performance, we are moving ever closer to our goal
of commercializing Lymphoseek, and we are making positive strides in
moving our other initiatives forward to support an expanded pipeline,"
Bupp continued. "We look forward to an even more exciting 2011."
Under the applicable accounting rules for complex financial instruments,
embedded features in certain of the Company's notes and preferred stock
and the warrants to purchase common stock that have been issued from
time to time have been considered derivative liabilities because of
specific terms contained in the instrument documents. Treatment of these
instruments as derivative liabilities resulted in them being required to
be reflected on the Company's balance sheet at their fair values (i.e.,
marked to market) based on certain assumptions, including the trading
price of the Company's common stock. As the share price of the Company's
common stock increased during 2009 and 2010, significant mark-to-market
adjustments were recorded as non-cash expenses in the Company's
statements of operations. Neoprobe's management believes that the
inclusion of such mark-to-market adjustments in the Company's financial
results does not appropriately communicate the results of the Company's
operating performance and development activities to our investors. As a
result, Neoprobe's management believes the ability of investors to
analyze Neoprobe's business trends and to understand Neoprobe's
performance may be better served from reviewing certain operational
measures such as revenues, development expenses and income (loss) from
operations.
In July 2009, Neoprobe agreed with the holder of a majority of the
instruments with derivative characteristics, Platinum-Montaur Life
Sciences, LLC (Montaur), to eliminate the price reset features that had
substantially caused the derivative treatment of the instruments thereby
permitting the Company to effectively extinguish the majority of its
derivative liabilities. The increase in the price of the Company's
common stock during 2009 resulted in total mark-to-market adjustments of
$18.1 million being recorded for the year. As a result of the
extinguishment treatment associated with the elimination of the price
reset features that had caused the original derivative treatment of the
instruments, the Company recorded an additional $16.2 million in
non-cash loss on the extinguishment during 2009 and ultimately
reclassified approximately $27.0 million in derivative liabilities to
additional paid-in capital in connection with the extinguishment.
During June 2010, Montaur agreed to exchange all $10 million of its
outstanding 10% senior secured convertible notes and all $3 million of
its perpetual convertible preferred stock for a single new series of
preferred stock convertible into 32.7 million common shares. Under the
terms of the transaction, Montaur's $7 million Series A Convertible
Secured Note (originally convertible into 17.1 million common shares),
$3 million Series B Convertible Note (originally convertible into 8.3
million common shares) and Series A Convertible Preferred Stock
(originally convertible into 6.0 million common shares) were exchanged
for Series B Convertible Preferred Stock (the Series B Preferred). As
part of the consideration for the conversion, Neoprobe "prepaid"
interest and dividends due through the original note maturity in
December 2011 by agreeing to issue Series B Preferred which is
convertible into 1.3 million shares of common stock. The Series B
Preferred is convertible at the option of Montaur but carries no
dividend and has no liquidation preference over the common stock. The
Series A Convertible Preferred Stock was convertible at the option of
Montaur and paid an 8% dividend until converted. Concurrent with the
Montaur exchange, the Company exchanged $1 million in convertible notes
due to our President and CEO for Series C Convertible Preferred Stock.
Under the applicable accounting rules for financial instruments, the
exchange transactions were accounted for as extinguishments of the old
instruments which resulted in the Company recording non-cash losses on
extinguishment of all of the Company's secured debt of $41.7 million and
a deemed dividend of $8.0 million related to the retirement of the
Series A Preferred Stock. These charges accounted for the vast majority
of the losses attributable to common stockholders for the year ended
December 31, 2010. Excluding these non-cash losses, we would have
reported losses attributable to common stockholders of $0.10 per share
for the year ended December 31, 2010.
Neoprobe's President and CEO, David Bupp, Executive Vice President and
CDO, Dr. Mark Pykett, Senior Vice President, Pharmaceutical Research and
Clinical Development, Dr. Fred Cope, and Senior Vice President and CFO,
Brent Larson, will provide a development and business update and will
discuss the Company's financial results for the fourth quarter and full
year of 2010 during the conference call. The conference call can be
accessed as follows:
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Conference Call Information
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TO PARTICIPATE LIVE:
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TO LISTEN TO A REPLAY:
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Date:
Time:
Toll-free (U.S.) Dial in # :
International Dial in # :
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Mar. 7, 2011
4:30 PM ET
(877) 407-8033
(201) 689-8033
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Available until:
Toll-free (U.S.) Dial in # :
International Dial in # :
Replay passcode:
Account #:
Conference ID #:
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Mar. 21, 2011
(877) 660-6853
(201) 612-7415
286
368667
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About Neoprobe
Neoprobe is a biomedical company focused on enhancing oncology patient
care and improving patient benefit. Neoprobe currently markets the
neoprobe GDS line of gamma detection systems that are widely
used by cancer surgeons. In addition, Neoprobe holds significant
interests in the development of related biomedical systems and
radiopharmaceutical agents including Lymphoseek and RIGScanTM
CR. Neoprobe's subsidiary, Cira Biosciences, Inc., is also
advancing a patient-specific cellular therapy technology platform called
ACT. Neoprobe's strategy is to deliver superior growth and shareholder
return by maximizing its strong position in gamma detection technologies
and diversifying into new, synergistic biomedical markets through
continued investment and selective acquisitions. www.neoprobe.com
Statements in this news release, which relate to other than strictly
historical facts, such as statements about the Company's plans and
strategies, expectations for future financial performance, new and
existing products and technologies, anticipated clinical and regulatory
pathways, and markets for the Company's products are forward-looking
statements The words "believe," "expect," "anticipate,"
"estimate," "project," and similar expressions identify forward-looking
statements that speak only as of the date hereof. Investors are
cautioned that such statements involve risks and uncertainties that
could cause actual results to differ materially from historical or
anticipated results due to many factors including, but not limited to,
the Company's continuing operating losses, uncertainty of market
acceptance of its products, reliance on third party manufacturers,
accumulated deficit, future capital needs, uncertainty of capital
funding, dependence on limited product line and distribution channels,
competition, limited marketing and manufacturing experience, risks of
development of new products, regulatory risks and other risks detailed
in the Company's most recent Annual Report on Form 10-K and other
Securities and Exchange Commission filings. The Company
undertakes no obligation to publicly update or revise any
forward-looking statements.
NEOPROBE CORPORATION
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CONDENSED CONSOLIDATED BALANCE SHEETS
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December 31,
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December 31,
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2010
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2009
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(unaudited)
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Assets:
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Cash
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$
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6,420,506
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$
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5,639,842
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Other current assets
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3,812,497
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2,977,323
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Non-current assets
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629,735
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400,594
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Total assets
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$
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10,862,738
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$
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9,017,759
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Liabilities and stockholders' equity (deficit):
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Current liabilities, including current portions of notes payable and
derivative liabilities
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$
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3,944,439
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$
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2,402,647
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Notes payable, long-term (net of discounts)
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-
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10,945,907
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Derivative liabilities, long-term
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2,077,799
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1,951,664
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Other liabilities
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708,755
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587,393
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Preferred stock
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-
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3,000,000
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Stockholders' equity (deficit)
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4,131,745
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(9,869,852
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)
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Total liabilities and stockholders' equity (deficit)
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$
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10,862,738
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$
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9,017,759
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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Three Months Ended
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Twelve Months Ended
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December 31,
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December 31,
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December 31,
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December 31,
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2010
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2009
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2010
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2009
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(unaudited)
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(unaudited)
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(unaudited)
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Total revenues
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$
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3,175,288
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$
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2,444,733
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$
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10,700,566
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$
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9,518,032
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Cost of goods sold
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879,458
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804,708
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3,206,709
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3,134,740
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Gross profit
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2,295,830
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1,640,025
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7,493,857
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6,383,292
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Operating expenses:
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Research and development
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2,512,273
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1,237,500
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9,221,421
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4,967,861
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Selling, general and administrative
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1,181,724
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822,715
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4,583,503
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3,240,337
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Total operating expenses
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3,693,997
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2,060,215
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13,804,924
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8,208,198
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Loss from operations
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(1,398,167
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(420,190
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(6,311,067
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(1,824,906
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Interest expense
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(1,167
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(283,522
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)
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(554,988
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(1,533,047
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Change in derivative liabilities
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(664,874
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407,044
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(1,336,234
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(18,132,274
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Loss on extinguishment of debt
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-
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-
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(41,717,380
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(16,240,592
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Other income, net
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37,907
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1,475
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41,398
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15,327
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Loss from continuing operations
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(2,026,301
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(295,193
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(49,878,271
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(37,715,492
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Discontinued operations
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(26,935
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1,555
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(86,597
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(1,890,228
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Net loss
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(2,053,236
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(293,638
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(49,964,868
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(39,605,720
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Preferred stock dividends
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(25,000
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(60,000
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(8,206,745
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(240,000
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Loss attributable to common stockholders
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$
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(2,078,236
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$
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(353,638
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$
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(58,171,613
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$
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(39,845,720
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Loss per common share (basic and diluted):
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Continuing operations
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$
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(0.03
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$
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(0.00
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$
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(0.72
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$
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(0.51
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Discontinued operations
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$
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(0.00
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$
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0.00
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$
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(0.00
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$
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(0.03
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Loss attributable to common stockholders
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$
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(0.03
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$
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(0.00
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$
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(0.72
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$
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(0.54
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)
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Weighted average shares outstanding:
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Basic and diluted
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82,439,262
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78,795,739
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80,726,498
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73,771,871
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Neoprobe Corporation Brent Larson, 614-822-2330 Sr.
VP & CFO or Investor Relations LifeSci
Advisors Michael Rice, 201-408-4923 or Public
Relations/Media Relations Makovsky & Co. Mark
Marmur, 212-508-9670
Copyright © 2012, Business Wire, Inc., All rights reserved. Copyright © 2012, NewsBlaze, Daily News
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