Attached files
| file | filename |
|---|---|
| 8-K - NAVIDEA BIOPHARMACEUTICALS, INC. | v202105_8k.htm |
| EX-5.1 - NAVIDEA BIOPHARMACEUTICALS, INC. | v202105_ex5-1.htm |
| EX-1.1 - NAVIDEA BIOPHARMACEUTICALS, INC. | v202105_ex1-1.htm |
| EX-99.2 - NAVIDEA BIOPHARMACEUTICALS, INC. | v202105_ex99-2.htm |
| EX-10.4 - NAVIDEA BIOPHARMACEUTICALS, INC. | v202105_ex10-4.htm |
| EX-10.1 - NAVIDEA BIOPHARMACEUTICALS, INC. | v202105_ex10-1.htm |
| EX-10.3 - NAVIDEA BIOPHARMACEUTICALS, INC. | v202105_ex10-3.htm |
| EX-10.2 - NAVIDEA BIOPHARMACEUTICALS, INC. | v202105_ex10-2.htm |
Exhibit
99.1
 |
IMMEDIATE
RELEASE
CONTACTS:
Brent
Larson,
Sr.
Vice President & CFO
(614)
822-2330
|
November
10, 2010
Gene
Marbach
Makovsky
+ Company
(212)
508-9645
|
|
|
|
|
NEOPROBE
ANNOUNCES THIRD QUARTER 2010 RESULTS
Revenues
Up 6% and Gross Profit Increases 10% Year-to-date
—
Business Update / Quarterly Conference Call Set for Today at 4:30 PM ET
—
DUBLIN,
OHIO – November 10, 2010 — Neoprobe Corporation (OTCBB: NEOP - News), a
diversified developer of innovative oncology surgical and diagnostic products,
today announced consolidated results for the third quarter of 2010 and for the
nine-month period ended September 30, 2010.
Neoprobe’s
revenues for the third quarter of 2010 were $2.3 million compared to $2.6
million for the third quarter of 2009, an 11% decrease as revenues in the third
quarter of 2009 were unseasonably high and included initial stocking orders for
new products. Gross profit remained steady at $1.7 million for the third
quarter of 2010 compared to the third quarter of 2009 despite the decline in
revenues. Third quarter 2010 operating expenses were $3.9 million compared
to $2.0 million for the third quarter of 2009, primarily as a result of the
Company’s continued investment in its Lymphoseek® drug
initiative. Loss from operations for the third quarter of 2010 was $2.2
million compared to $324,000 for the third quarter of 2009.
For the
third quarter of 2010, Neoprobe reported a net loss attributable to common
stockholders of $2.4 million, or $0.03 per share, compared to a net loss
attributable to common stockholders of $25.1 million, or $0.34 per share, for
the third quarter of 2009. As discussed more fully below, the net losses
attributable to common stockholders for the third quarter of 2009 include
significant non-cash losses aggregating $22.6 million. These non-cash
losses were due to the extinguishment accounting treatment related to the
modification of certain terms of the Company’s convertible debt, preferred stock
and related warrants in July 2009 as well as mark-to-market adjustments related
to derivative accounting treatment required for certain financial instruments on
the Company’s balance sheet, most of which were modified in the July 2009
transaction.
Year-to-date
revenues for the nine-month period ended September 30, 2010 were $7.5 million
compared to $7.1 million for the same period in 2009, a 6% increase. Gross
profit was $5.2 million for the nine-month period ended September 30, 2010
compared to $4.7 million for the same period in 2009, a 10% increase.
Operating expenses for the nine-month period ended September 30, 2010 were $10.1
million compared to $6.1 million for the same period of 2009. Neoprobe’s
loss from operations for the nine-month period ended September 30, 2010 was $4.9
million compared to $1.4 million for the same period in 2009.
For the
nine-month period ended September 30, 2010, Neoprobe reported a net loss
attributable to common stockholders of $56.1 million, or $0.70 per share,
compared to a net loss attributable to common stockholders of $39.5 million, or
$0.56 per share, for the same period in 2009. As discussed more fully
below, the net loss attributable to common stockholders for the first nine
months of 2010 and 2009 included significant non-cash losses and deemed
dividends aggregating $50.4 million and $34.8 million, respectively. In
2010, these non-cash charges were primarily due to the extinguishment accounting
related to the June 2010 exchange of the Company’s previous convertible debt and
preferred stock for a new series of preferred stock and to mark-to-market
adjustments related to derivative accounting treatment required for certain
financial instruments on the Company’s balance sheet. In 2009, these
non-cash charges included 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 on the Company’s
balance sheet at that time.
- more
-
NEOPROBE
CORPORATION
ADD
- 2
Brent
Larson, Neoprobe’s Senior Vice President and CFO, said, “Revenue increased on a
year-to-date basis despite being lower for the quarter than in the prior
year. Third quarter 2009 revenues were unseasonably high and included some
initial stock orders on new products. More importantly perhaps than the
year-to-date revenue increase, our gross margins have continued to
improve. For the third quarter of 2010, gross margin rose to 73% of
revenue compared to 64% for the third quarter of 2009 due to the receipt of
grant funds, favorable pricing and lower material costs. This positive
margin movement in the third quarter contributed to an overall increase in our
year-to-date gross margin of 69% for the nine months ended September 30, 2010
compared to 67% for the same period in the prior year. We are pleased with
our ongoing efforts to effectively manage our device business coupled with the
non-dilutive contributions that our grant application efforts are starting to
provide.”
David
Bupp, Neoprobe’s President and CEO, said, “Our operating expenses during the
first nine months of 2010 increased as a direct result of our progress in
clinical, manufacturing and regulatory activities related to our Lymphoseek drug
initiative. We put in a great deal of effort in 2010 to be in a position
to file our new drug application (NDA) for Lymphoseek. That effort has
served us well as we now expect to file the NDA shortly following the completion
of patient enrollment in our ongoing NEO3-09 Phase 3 clinical trial in patients
with breast cancer or melanoma.”
“We are
pleased with the progress we’ve made with the clinical and regulatory pathway
for Lymphoseek,” Bupp continued. “We are also continuing our efforts to
move our biologic development activities ahead to support a second
advanced-stage clinical program with RIGScan™ CR. We
have successfully completed the re-characterization of the RIGScan CR biologic
agent and are now preparing an investigational new drug (IND) amendment and a
Phase 3 clinical protocol to support the ongoing clinical development
program.”
The
following are some of the milestones achieved by Neoprobe so far in
2010:
|
|
·
|
Completion
of 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;
|
|
|
·
|
Completion
of successful pre-NDA dialogue with FDA on Lymphoseek pre-clinical
data;
|
|
|
·
|
Completion
of successful pre-NDA dialogue with FDA on Lymphoseek chemistry,
manufacturing and control data;
|
|
|
·
|
Election
of two new directors to Neoprobe’s Board, bringing significant drug
industry and corporate development expertise to the Company’s
leadership;
|
|
|
·
|
Completion
of exchange transactions that converted all of the Company’s outstanding
debt to equity;
|
|
|
·
|
Initiation
of a third 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 margin increases of 6% and 10%, respectively, for the
first nine months of 2010 over
2009;
|
|
|
·
|
Completion
of 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;
|
- more
-
NEOPROBE
CORPORATION
ADD
- 3
|
|
·
|
Completion
of 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;
|
|
|
·
|
Filing
of 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; and
|
|
|
·
|
Completion
of a $6 million equity financing for working capital purposes and to
support ongoing development
efforts.
|
“In
summary, our gamma detection device business continues to demonstrate positive
performance,” Bupp continued. “We had completed preparation of the
Lymphoseek NDA last month without the clinical data from NEO3-09. Since
FDA would like the data filed with the primary NDA, we may have the opportunity
to launch the product with the enhanced labeling. We are encouraged with
the biologic characterization information for the RIGS technology obtained to
date. Lastly, we believe our recently completed financing should buoy
investor confidence regarding our ability to both reach our near-term milestones
such as the commercialization of Lymphoseek and to take critical steps toward
our longer term product development goals regarding RIGScan.”
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 these instruments contained language
that provided for the resetting of the instruments’ exercise/conversion prices
in the event that the Company issued common stock at prices below the
exercise/conversion prices of the respective instruments. 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 over a given period, 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.
On July
24, 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. During the third
quarter of 2009, the Company recorded $6.3 million in mark-to-market adjustments
related to movement in the price of the Company’s common stock. This
contributed to a net total mark-to-market adjustment of $18.5 million being
recorded for the first three quarters of 2009. As a result of the
extinguishment treatment associated with the elimination of the price reset
features, the Company recorded $16.2 million in non-cash loss on the
extinguishment during the third quarter of 2009 and reclassified approximately
$27 million in derivative liabilities to additional paid-in
capital.
- more
-
NEOPROBE
CORPORATION
ADD
- 4
During
June 2010, Neoprobe’s primary investor, 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, convertible into a total of 32.7 million shares). 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 on the conversion of the new Series B Preferred. 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. 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 related to debt instruments 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 nine-month period ended September 30, 2010,
respectively. Excluding these non-cash losses, we would have reported
losses attributable to common stockholders $0.08 per share for the nine-month
period ended September 30, 2010.
Neoprobe’s
President and CEO, David Bupp, Senior Vice President, Pharmaceutical Research
and Clinical Development, Dr. Frederick Cope, and Senior Vice President and CFO,
Brent Larson, will provide a business update and discuss the third quarter of
2010 during a conference call with the investment community scheduled for later
this afternoon at 4:30 PM ET. The conference call can be accessed as
follows:
|
Conference
Call Information
|
|||
|
TO
PARTICIPATE LIVE:
|
TO
LISTEN TO A REPLAY:
|
||
|
Date:
|
November
10, 2010
|
Available
until:
|
November
24, 2010
|
|
Time:
|
4:30
PM ET
|
Toll-free
(U.S.) Dial in # :
|
877-660-6853
|
|
International
Dial in # :
|
201-612-7415
|
||
|
Toll-free
(U.S.) Dial in # :
|
877-407-8033
|
Replay
Passcodes:
|
|
|
International
Dial in # :
|
201-689-8033
|
Account
#:
|
286
|
|
Conference
ID #:
|
360421
|
||
About
Neoprobe
Neoprobe
is a biomedical company focused on enhancing patient care and improving patient
outcome by meeting the critical intraoperative diagnostic information needs of
physicians and therapeutic treatment needs of patients. 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
RIGScan®
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.
- more -
NEOPROBE
CORPORATION
ADD
- 5
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NEOPROBE
CORPORATION
|
||||||||
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CONDENSED
CONSOLIDATED BALANCE SHEETS
|
||||||||
|
September
30,
|
December
31,
|
|||||||
|
2010
|
2009
|
|||||||
|
(unaudited)
|
||||||||
|
Assets:
|
||||||||
|
Cash
|
$ | 2,611,210 | $ | 5,639,842 | ||||
|
Other
current assets
|
3,732,746 | 2,977,323 | ||||||
|
Non-current
assets
|
643,586 | 400,594 | ||||||
|
Total
assets
|
$ | 6,987,542 | $ | 9,017,759 | ||||
|
Liabilities
and stockholders' equity (deficit):
|
||||||||
|
Current
liabilities, including current portion of notes payable
|
$ | 3,871,948 | $ | 2,402,647 | ||||
|
Notes
payable, long term (net of discounts)
|
- | 10,945,907 | ||||||
|
Derivative
liabilities
|
1,377,406 | 1,951,664 | ||||||
|
Other
liabilities
|
622,370 | 587,393 | ||||||
|
Preferred
stock
|
- | 3,000,000 | ||||||
|
Stockholders'
equity (deficit)
|
1,115,818 | (9,869,852 | ) | |||||
|
Total
liabilities and stockholders' equity (deficit)
|
$ | 6,987,542 | $ | 9,017,759 | ||||
- more -
NEOPROBE
CORPORATION
ADD
- 6
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
||||||||||||||||
|
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
|
September
30,
2010
|
September
30,
2009
|
September
30,
2010
|
September
30,
2009
|
|||||||||||||
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
|||||||||||||
|
Total
revenues
|
$ | 2,303,530 | $ | 2,587,079 | $ | 7,525,278 | $ | 7,073,299 | ||||||||
|
Cost
of goods sold
|
626,630 | 927,587 | 2,327,251 | 2,330,032 | ||||||||||||
|
Gross
profit
|
1,676,900 | 1,659,492 | 5,198,027 | 4,743,267 | ||||||||||||
|
Operating
expenses:
|
||||||||||||||||
|
Research
and development
|
2,569,975 | 1,204,811 | 6,709,148 | 3,730,361 | ||||||||||||
|
Selling,
general and administrative
|
1,355,235 | 778,658 | 3,401,779 | 2,417,622 | ||||||||||||
|
Total
operating expenses
|
3,925,210 | 1,983,469 | 10,110,927 | 6,147,983 | ||||||||||||
|
Loss
from operations
|
(2,248,310 | ) | (323,977 | ) | (4,912,900 | ) | (1,404,716 | ) | ||||||||
|
Interest
expense
|
(832 | ) | (330,806 | ) | (553,821 | ) | (1,249,525 | ) | ||||||||
|
Change
in derivative liabilities
|
(87,753 | ) | (6,334,479 | ) | (671,360 | ) | (18,539,318 | ) | ||||||||
|
Loss
on extinguishment of debt
|
- | (16,240,592 | ) | (41,717,380 | ) | (16,240,592 | ) | |||||||||
|
Other
income, net
|
2,308 | 1,775 | 3,491 | 13,852 | ||||||||||||
|
Loss
from continuing operations
|
(2,334,587 | ) | (23,228,079 | ) | (47,851,970 | ) | (37,420,299 | ) | ||||||||
|
Discontinued
operations
|
(47,072 | ) | (1,781,190 | ) | (59,662 | ) | (1,891,783 | ) | ||||||||
|
Net
loss
|
(2,381,659 | ) | (25,009,269 | ) | (47,911,632 | ) | (39,312,082 | ) | ||||||||
|
Preferred
stock dividends
|
(25,000 | ) | (60,000 | ) | (8,181,745 | ) | (180,000 | ) | ||||||||
|
Loss
attributable to common stockholders
|
$ | (2,406,659 | ) | $ | (25,069,269 | ) | $ | (56,093,377 | ) | $ | (39,492,082 | ) | ||||
|
Loss
per common share (basic and diluted):
|
||||||||||||||||
|
Continuing
operations
|
$ | (0.03 | ) | $ | (0.31 | ) | $ | (0.70 | ) | $ | (0.53 | ) | ||||
|
Discontinued
operations
|
$ | (0.00 | ) | $ | (0.02 | ) | $ | (0.00 | ) | $ | (0.03 | ) | ||||
|
Loss
attributable to common stockholders
|
$ | (0.03 | ) | $ | (0.34 | ) | $ | (0.70 | ) | $ | (0.56 | ) | ||||
|
Weighted
average shares outstanding:
|
||||||||||||||||
|
Basic
and Diluted
|
80,605,072 | 74,380,714 | 80,149,302 | 70,915,204 | ||||||||||||
-
end -