NAVIDEA BIOPHARMACEUTICALS, INC. - Quarter Report: 2010 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
quarterly period ended June
30,
2010
¨
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
transition period from to
to
Commission
File Number: 0-26520
NEOPROBE
CORPORATION
|
(Exact
name of registrant as specified in its
charter)
|
Delaware
|
31-1080091
|
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
425
Metro Place North, Suite 300, Dublin, Ohio
|
43017-1367
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(614)
793-7500
|
(Registrant’s
telephone number, including area code)
|
(Former
name, former address and former fiscal year, if changed since last
report)
|
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes x No
o
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit
and post such files).
Yes ¨ No
¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,” “accelerated
filer” and “smaller reporting company” in Rule 12b-2 of the Exchange
Act.
Large accelerated filer
¨
|
Accelerated filer ¨
|
Non-accelerated filer
¨
|
Smaller reporting company
x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12-b-2 of the Act.)
Yes ¨ No
x
Indicate
the number of shares outstanding of each of the issuer’s classes of common
stock, as of the latest practicable date: 82,280,216 shares of common
stock, par value $.001 per share (as of the close of business on August 6,
2010).
NEOPROBE CORPORATION and
SUBSIDIARIES
INDEX
PART
I – Financial Information
|
||
Item
1.
|
Financial
Statements
|
3
|
Consolidated
Balance Sheets as of June 30, 2010 (unaudited) and December 31,
2009
|
3
|
|
Consolidated
Statements of Operations for the Three-Month and Six-Month Periods Ended
June 30, 2010 and June 30, 2009 (unaudited)
|
5
|
|
Consolidated
Statement of Stockholders’ Deficit for the Six-Month Period Ended June 30,
2010 (unaudited)
|
6
|
|
Consolidated
Statements of Cash Flows for the Six-Month Periods Ended June 30, 2010 and
June 30, 2009 (unaudited)
|
7
|
|
Notes
to the Consolidated Financial Statements (unaudited)
|
8
|
|
|
||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
23
|
Forward-Looking
Statements
|
23
|
|
The
Company
|
23
|
|
Product
Line Overview
|
23
|
|
Results
of Operations
|
27
|
|
Liquidity
and Capital Resources
|
29
|
|
Recent
Accounting Developments
|
32
|
|
Critical
Accounting Policies
|
32
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
33
|
Item
4T.
|
Controls
and Procedures
|
33
|
PART
II – Other Information
|
||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
35
|
Item
6.
|
Exhibits
|
35
|
2
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements
Neoprobe
Corporation and Subsidiaries
Consolidated
Balance Sheets
June 30,
2010
(unaudited)
|
December 31,
2009
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 3,944,782 | $ | 5,639,842 | ||||
Accounts
receivable, net
|
1,896,956 | 1,331,908 | ||||||
Inventory
|
1,326,780 | 1,143,697 | ||||||
Prepaid
expenses and other
|
138,243 | 474,243 | ||||||
Assets
associated with discontinued operations
|
5,531 | 27,475 | ||||||
Total
current assets
|
7,312,292 | 8,617,165 | ||||||
Property
and equipment
|
2,265,914 | 1,990,603 | ||||||
Less
accumulated depreciation and amortization
|
1,779,731 | 1,693,290 | ||||||
486,183 | 297,313 | |||||||
Patents
and trademarks
|
532,561 | 524,224 | ||||||
Less
accumulated amortization
|
446,769 | 445,650 | ||||||
85,792 | 78,574 | |||||||
Other
assets
|
7,421 | 24,707 | ||||||
Total
assets
|
$ | 7,891,688 | $ | 9,017,759 |
Continued
3
Neoprobe
Corporation and Subsidiaries,
Consolidated
Balance Sheets, continued
June 30,
2010
(unaudited)
|
December 31,
2009
|
|||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 1,372,286 | $ | 763,966 | ||||
Accrued
liabilities and other
|
1,041,438 | 1,048,304 | ||||||
Capital
lease obligations, current portion
|
11,958 | 11,265 | ||||||
Deferred
revenue, current portion
|
587,786 | 560,369 | ||||||
Liabilities
associated with discontinued operations
|
15,894 | 18,743 | ||||||
Total
current liabilities
|
3,029,362 | 2,402,647 | ||||||
Capital
lease obligations
|
13,404 | 19,912 | ||||||
Deferred
revenue
|
545,245 | 534,119 | ||||||
Note
payable to Bupp Investors, net of discount of $54,093
|
— | 945,907 | ||||||
Notes
payable to investor
|
— | 10,000,000 | ||||||
Derivative
liabilities
|
1,569,271 | 1,951,664 | ||||||
Other
liabilities
|
30,057 | 33,362 | ||||||
Total
liabilities
|
5,187,339 | 15,887,611 | ||||||
Commitments
and contingencies
|
||||||||
Preferred
stock; $.001 par value; 5,000,000 shares authorized;
|
||||||||
3,000
Series A shares, $1,000 face value, issued and
|
||||||||
outstanding
at December 31, 2009
|
— | 3,000,000 | ||||||
Stockholders’
equity (deficit):
|
||||||||
Preferred
stock; $.001 par value; 5,000,000 shares authorized;
|
||||||||
10,000
Series B shares and 1,000 Series C shares issued
|
||||||||
and
outstanding at June 30, 2010
|
11 | — | ||||||
Common
stock; $.001 par value; 150,000,000 shares authorized;
|
||||||||
82,151,043
and 80,936,711 shares outstanding at
|
||||||||
June
30, 2010 and December 31, 2009, respectively
|
82,151 | 80,937 | ||||||
Additional
paid-in capital
|
249,007,591 | 182,747,897 | ||||||
Accumulated
deficit
|
(246,385,404 | ) | (192,698,686 | ) | ||||
Total
stockholders’ equity (deficit)
|
2,704,349 | (9,869,852 | ) | |||||
Total
liabilities and stockholders’ equity (deficit)
|
$ | 7,891,688 | $ | 9,017,759 |
See
accompanying notes to consolidated financial statements
4
Neoprobe
Corporation and Subsidiaries
Consolidated
Statements of Operations
(unaudited)
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Revenues:
|
||||||||||||||||
Net
sales
|
2,513,876 | $ | 1,778,999 | $ | 5,171,748 | $ | 4,436,220 | |||||||||
License
revenue
|
25,000 | 25,000 | 50,000 | 50,000 | ||||||||||||
Total
revenues
|
2,538,876 | 1,803,999 | 5,221,748 | 4,486,220 | ||||||||||||
Cost
of goods sold
|
811,754 | 576,082 | 1,700,621 | 1,402,445 | ||||||||||||
Gross
profit
|
1,727,122 | 1,227,917 | 3,521,127 | 3,083,775 | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
1,737,501 | 1,303,581 | 4,139,173 | 2,525,550 | ||||||||||||
Selling,
general and administrative
|
918,342 | 801,641 | 2,046,544 | 1,638,964 | ||||||||||||
Total
operating expenses
|
2,655,843 | 2,105,222 | 6,185,717 | 4,164,514 | ||||||||||||
Loss
from operations
|
(928,721 | ) | (877,305 | ) | (2,664,590 | ) | (1,080,739 | ) | ||||||||
Other
income (expense):
|
||||||||||||||||
Interest
income
|
1,947 | 3,761 | 3,761 | 13,708 | ||||||||||||
Interest
expense
|
(268,551 | ) | (461,585 | ) | (552,989 | ) | (918,719 | ) | ||||||||
Change
in derivative liabilities
|
(154,315 | ) | (13,730,204 | ) | (583,607 | ) | (12,204,839 | ) | ||||||||
Loss
on extinguishment of debt
|
(41,717,380 | ) | — | (41,717,380 | ) | — | ||||||||||
Other
|
(2,122 | ) | (1,357 | ) | (2,578 | ) | (1,631 | ) | ||||||||
Total
other expense, net
|
(42,140,421 | ) | (14,189,385 | ) | (42,852,793 | ) | (13,111,481 | ) | ||||||||
Loss
from continuing operations
|
(43,069,142 | ) | (15,066,690 | ) | (45,517,383 | ) | (14,192,220 | ) | ||||||||
Discontinued
operations – loss from operations
|
(717 | ) | (50,244 | ) | (12,590 | ) | (110,593 | ) | ||||||||
Net
loss
|
(43,069,859 | ) | (15,116,934 | ) | (45,529,973 | ) | (14,302,813 | ) | ||||||||
Preferred
stock dividends
|
(8,096,745 | ) | (60,000 | ) | (8,156,745 | ) | (120,000 | ) | ||||||||
Loss
attributable to common stockholders
|
$ | (51,166,604 | ) | $ | (15,176,934 | ) | $ | (53,686,718 | ) | $ | (14,422,813 | ) | ||||
Loss
per common share (basic and diluted):
|
||||||||||||||||
Continuing
operations
|
$ | (0.64 | ) | $ | (0.21 | ) | $ | (0.67 | ) | $ | (0.20 | ) | ||||
Discontinued
operations
|
$ | — | $ | — | $ | — | $ | — | ||||||||
Attributable
to common stockholders
|
$ | (0.64 | ) | $ | (0.21 | ) | $ | (0.67 | ) | $ | (0.20 | ) | ||||
Weighted
average shares outstanding:
|
||||||||||||||||
Basic
and diluted
|
80,260,077 | 71,316,657 | 79,917,641 | 70,908,835 |
See
accompanying notes to consolidated financial statements.
5
Neoprobe
Corporation and Subsidiaries
Consolidated
Statement of Stockholders’ Deficit
(unaudited)
Preferred Stock
|
Common Stock
|
Additional
Paid-In
|
Accumulated
|
|||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||||||||
Balance,
December 31, 2009
|
— | $ | — | 80,936,711 | $ | 80,937 | $ | 182,747,897 | $ | (192,698,686 | ) | $ | (9,869,852 | ) | ||||||||||||||
Issued
stock in payment of interest on convertible debt and dividends on
convertible preferred stock
|
— | — | 347,832 | 348 | 476,319 | — | 476,667 | |||||||||||||||||||||
Issued
stock upon exercise of options, net of issuance costs
|
— | — | 152,460 | 152 | 1,036 | — | 1,188 | |||||||||||||||||||||
Issued
stock in connection with stock purchase agreement, net of
costs
|
— | — | 660,541 | 661 | 776,797 | — | 777,458 | |||||||||||||||||||||
Issued
stock to 401(k) plan at $0.76
|
— | — | 53,499 | 53 | 40,570 | — | 40,623 | |||||||||||||||||||||
Issued
Series B and Series C convertible preferred stock, net of issuance
costs
|
11,000 | 11 | — | — | 64,661,789 | — | 64,661,800 | |||||||||||||||||||||
Stock
compensation expense
|
— | — | — | — | 303,183 | — | 303,183 | |||||||||||||||||||||
Preferred
stock dividends, including deemed dividends
|
— | — | — | — | — | (8,156,745 | ) | (8,156,745 | ) | |||||||||||||||||||
Comprehensive
loss:
|
||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | (45,529,973 | ) | (45,529,973 | ) | |||||||||||||||||||
Balance,
June 30, 2010
|
11,000 | $ | 11 | 82,151,043 | $ | 82,151 | $ | 249,007,591 | $ | (246,385,404 | ) | $ | 2,704,349 |
See
accompanying notes to consolidated financial statements.
6
Neoprobe
Corporation and Subsidiaries
Consolidated
Statements of Cash Flows
(unaudited)
Six Months Ended
June 30,
|
||||||||
2010
|
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (45,529,973 | ) | $ | (14,302,813 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
112,217 | 204,014 | ||||||
Amortization
of debt discount and debt offering costs
|
16,109 | 364,838 | ||||||
Issuance
of common stock in payment of interest and dividends
|
476,667 | 411,333 | ||||||
Stock
compensation expense
|
303,183 | 145,314 | ||||||
Non-cash
inventory adjustment
|
324,000 | — | ||||||
Change
in derivative liabilities
|
583,607 | 12,204,839 | ||||||
Loss
on extinguishment of debt
|
41,717,380 | — | ||||||
Other
|
42,487 | 38,902 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
(552,843 | ) | 497,529 | |||||
Inventory
|
(541,511 | ) | (172,788 | ) | ||||
Prepaid
expenses and other assets
|
113,456 | 101,700 | ||||||
Accounts
payable
|
608,320 | (195,413 | ) | |||||
Accrued
liabilities and other liabilities
|
(131,075 | ) | (66,763 | ) | ||||
Deferred
revenue
|
38,543 | (11,993 | ) | |||||
Net
cash used in operating activities
|
(2,419,433 | ) | (781,301 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Maturities
of available-for-sale securities
|
— | 494,000 | ||||||
Purchases
of equipment
|
(253,797 | ) | (58,652 | ) | ||||
Proceeds
from sales of equipment
|
— | 251 | ||||||
Patent
and trademark costs
|
(12,202 | ) | (60,967 | ) | ||||
Net
cash (used in) provided by investing activities
|
(265,999 | ) | 374,632 | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from issuance of common stock
|
1,044,400 | 95,250 | ||||||
Payment
of stock offering costs
|
(48,212 | ) | (12,867 | ) | ||||
Payment
of notes payable
|
— | (102,826 | ) | |||||
Payments
under capital leases
|
(5,816 | ) | (5,684 | ) | ||||
Net
cash provided by (used in) financing activities
|
990,372 | (26,127 | ) | |||||
Net
decrease in cash
|
(1,695,060 | ) | (432,796 | ) | ||||
Cash,
beginning of period
|
5,639,842 | 3,565,837 | ||||||
Cash,
end of period
|
$ | 3,944,782 | $ | 3,133,041 |
See
accompanying notes to consolidated financial statements.
7
Notes
to Consolidated Financial Statements
(unaudited)
1.
|
Summary
of Significant Accounting Policies
|
|
a.
|
Basis of
Presentation: The information presented as of June 30,
2010 and for the three-month and six-month periods ended June 30, 2010 and
June 30, 2009 is unaudited, but includes all adjustments (which consist
only of normal recurring adjustments) that the management of Neoprobe
Corporation (Neoprobe, the Company, or we) believes to be necessary for
the fair presentation of results for the periods presented. Certain
information and footnote disclosures normally included in financial
statements prepared in accordance with accounting principles generally
accepted in the United States of America have been condensed or omitted
pursuant to the rules and regulations of the U.S. Securities and Exchange
Commission. The balances as of June 30, 2010 and the results for the
interim periods are not necessarily indicative of results to be expected
for the year. The consolidated financial statements should be read
in conjunction with Neoprobe’s audited consolidated financial statements
for the year ended December 31, 2009, which were included as part of our
Annual Report on Form 10-K.
|
Our
consolidated financial statements include the accounts of Neoprobe, our
wholly-owned subsidiary, Cardiosonix Ltd. (Cardiosonix), and our 90%-owned
subsidiary, Cira Biosciences, Inc. (Cira Bio). All significant
inter-company accounts were eliminated in consolidation.
In August
2009, the Company’s Board of Directors decided to discontinue the operations of
Cardiosonix and to attempt to divest our Cardiosonix subsidiary. This
decision was based on the determination that the blood flow measurement device
segment was no longer considered a strategic initiative of the Company, due in
large part to positive events in our other development initiatives. Our
consolidated statements of operations have been reclassified, as required, for
all prior periods presented to reflect Cardiosonix as a discontinued
operation. Cash flows associated with the operation of Cardiosonix have
been combined within operating, investing and financing cash flows, as
appropriate, in our consolidated statements of cash flows. See Note
2.
|
b.
|
Financial Instruments and Fair
Value: The fair value hierarchy prioritizes the inputs
to valuation techniques used to measure fair value, giving the highest
priority to unadjusted quoted prices in active markets for identical
assets or liabilities (Level 1 measurements) and the lowest priority to
unobservable inputs (Level 3 measurements). The three levels of the
fair value hierarchy are described
below:
|
Level 1 – Unadjusted quoted
prices in active markets that are accessible at the measurement date for
identical, unrestricted assets or liabilities;
Level 2 – Quoted prices in
markets that are not active or financial instruments for which all significant
inputs are observable, either directly or indirectly; and
Level 3 – Prices or
valuations that require inputs that are both significant to the fair value
measurement and unobservable.
A
financial instrument’s level within the fair value hierarchy is based on the
lowest level of any input that is significant to the fair value
measurement. In determining the appropriate levels, we perform a detailed
analysis of the assets and liabilities whose fair value is measured on a
recurring basis. At each reporting period, all assets and liabilities for
which the fair value measurement is based on significant unobservable inputs or
instruments which trade infrequently and therefore have little or no price
transparency are classified as Level 3. In estimating the fair value of
our derivative liabilities, we used the Black-Scholes option pricing model and,
where necessary, other macroeconomic, industry and Company-specific
conditions. See Note 3.
8
The
following methods and assumptions were used to estimate the fair value of each
class of financial instruments:
|
(1)
|
Cash,
accounts receivable, accounts payable, and accrued
liabilities: The carrying amounts approximate fair value
because of the short maturity of these
instruments.
|
|
(2)
|
Note
payable to Bupp Investors: The carrying value of our debt is
presented as the face amount of the note less the unamortized discount
related to the initial estimated fair value of the warrants to purchase
common stock issued in connection with the note. At December 31,
2009, the note payable to the Bupp Investors had an estimated fair value
of $3.9 million, based on the closing market price of our common
stock. During June 2010, the Bupp Investors exchanged their note for
preferred stock, resulting in extinguishment of the debt. See Note
10.
|
|
(3)
|
Notes
payable to investor: The carrying value of our debt is
presented as the face amount of the notes. At December 31, 2009, the
notes payable to investors had an estimated fair value of $31.0 million,
based on the closing market price of our common stock. During June
2010, the investor exchanged their notes for preferred stock, resulting in
extinguishment of the debt. See Note
10.
|
|
(4)
|
Derivative
liabilities: Derivative liabilities are recorded at fair
value. Fair value of warrant liabilities is determined based on a
Black-Scholes option pricing model calculation. Fair value of put
option liabilities is determined based on a probability-weighted
Black-Scholes option pricing model calculation. Unrealized gains and
losses on the derivatives are classified in other expenses as a change in
derivative liabilities in the statements of operations. During June
2010, certain investors exchanged their notes for preferred stock,
resulting in extinguishment of our remaining put option liabilities.
See Note 10.
|
|
c.
|
Recent Accounting
Developments: In January 2010, the Financial Accounting
Standards Board (FASB) issued Accounting Standards Update (ASU) 2010-6,
Improving Disclosures
about Fair Value Measurements. ASU 2010-6 amends FASB ASC
Topic 820, Fair Value
Measurements and Disclosures. ASU 2010-6 requires new
disclosures as follows: (1) Transfers in and out of Levels 1 and 2 and (2)
Activity in Level 3 fair value measurements. An entity should
disclose separately the amounts of significant transfers in and out of
Level 1 and Level 2 fair value measurements and describe the reasons for
the transfers. In the reconciliation of fair value measurements
using significant unobservable inputs (Level 3), an entity should present
separately information about purchases, sales, issuances, and settlements
(that is, on a gross basis rather than as one net number). ASU
2010-6 also clarifies existing disclosures as follows: (1)
Level of disaggregation and (2) Disclosures about inputs and valuation
techniques. An entity should provide fair value measurement
disclosures for each class of assets and liabilities. A class is
often a subset of assets or liabilities within a line item in the
statement of financial position. An entity needs to use judgment in
determining the appropriate classes of assets and liabilities. An
entity should provide disclosures about the valuation techniques and
inputs used to measure fair value for both recurring and nonrecurring fair
value measurements. Those disclosures are required for fair value
measurements that fall in either Level 2 or Level 3. ASU 2010-6 is
effective for interim and annual reporting periods beginning after
December 15, 2009, except for the separate disclosures about purchases,
sales, issuances, and settlements in the roll forward of activity in Level
3 fair value measurements. Those disclosures are effective for
fiscal years beginning after December 15, 2010, and for interim periods
within those fiscal years. We adopted the initial provisions of ASU
2010-6 beginning January 1, 2010. As the new provisions of ASU
2010-6 provide only disclosure requirements, the adoption of this standard
did not impact our consolidated financial position, results of operations
or cash flows, but did result in increased
disclosures.
|
9
2.
|
Discontinued
Operations
|
In August
2009, the Company’s Board of Directors decided to discontinue the operations of
Cardiosonix and to attempt to sell our Cardiosonix subsidiary. This
decision was based on the determination that the blood flow measurement device
segment was no longer considered a strategic initiative of the Company, due in
large part to positive events in our other device product and drug development
initiatives. We are in the process of identifying potential buyers, but
our efforts thus far have not resulted in any definitive offers.
As a
result of our decision to hold Cardiosonix for sale, we reclassified certain
assets and liabilities as assets and liabilities associated with discontinued
operations and reduced them to their estimated fair value at that time.
The following assets and liabilities have been segregated and included in assets
associated with discontinued operations or liabilities associated with
discontinued operations, as appropriate, in the consolidated balance
sheets:
June 30,
2010
|
December 31,
2009
|
|||||||
Accounts
receivable, net
|
$ | 3,144 | $ | 15,349 | ||||
Inventory
|
2,387 | 12,126 | ||||||
Current
assets associated with discontinued operations
|
$ | 5,531 | $ | 27,475 | ||||
Accounts
payable
|
$ | 5,400 | $ | 5,400 | ||||
Accrued
expenses
|
10,494 | 13,343 | ||||||
Current
liabilities associated with discontinued operations
|
$ | 15,894 | $ | 18,743 |
We
recorded an impairment loss of $1.7 million related to the assets of Cardiosonix
during the third quarter of 2009 and have reclassified all related revenues and
expenses to discontinued operations for all periods presented. Until a
sale is completed, we expect to continue to generate minimal revenues and incur
minimal expenses related to our blood flow measurement device business.
The following amounts have been segregated from continuing operations and
included in discontinued operations in the consolidated statements of
operations:
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Net
sales
|
$ | 21,790 | $ | 29,744 | $ | 36,235 | $ | 72,559 | ||||||||
Cost
of goods sold
|
5,227 | 11,553 | 11,616 | 33,724 | ||||||||||||
Gross
profit
|
16,563 | 18,191 | 24,619 | 38,835 | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
10,557 | 4,397 | 10,808 | 20,486 | ||||||||||||
Selling,
general and administrative
|
6,660 | 64,122 | 26,522 | 128,847 | ||||||||||||
Total
operating expenses
|
17,217 | 68,519 | 37,330 | 149,333 | ||||||||||||
Other
income (expense)
|
(63 | ) | 84 | 121 | (95 | ) | ||||||||||
Loss
from discontinued operations
|
$ | (717 | ) | $ | (50,244 | ) | $ | (12,590 | ) | $ | (110,593 | ) |
10
3.
|
Fair
Value Hierarchy
|
The
following tables set forth, by level, financial liabilities measured at fair
value on a recurring basis:
Liabilities Measured at Fair Value on a Recurring Basis as of June 30, 2010
|
||||||||||||||||
Quoted Prices
in Active
Markets for
Identical
Liabilities
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs
|
Balance as of
June 30,
|
|||||||||||||
Description
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
2010
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to warrants
|
$ | — | $ | 1,569,271 | $ | — | $ | 1,569,271 |
Liabilities Measured at Fair Value on a Recurring Basis as of December 31, 2009
|
||||||||||||||||
Quoted Prices
in Active
Markets for
Identical
Assets and
Liabilities
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs
|
Balance as of
December 31,
|
|||||||||||||
Description
|
(Level
1)
|
(Level
2)
|
(Level
3)
|
2009
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to warrants
|
$ | — | $ | 985,664 | $ | — | $ | 985,664 | ||||||||
Derivative
liabilities related to put options
|
— | — | 966,000 | 966,000 | ||||||||||||
Total
derivative liabilities
|
$ | — | $ | 985,664 | $ | 966,000 | $ | 1,951,664 |
The
following tables set forth a summary of changes in the fair value of our Level 3
liabilities for the three-month periods ended June 30, 2010 and
2009:
Three Months Ended June 30, 2010
|
||||||||||||||||
Description
|
Balance as of
March 31,
2010
|
Unrealized
(Gains)
Losses
|
Purchases,
Issuances
and
Settlements
|
Balance as of
June 30,
2010
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to conversion and put options
|
$ | 966,000 | $ | — | $ | (966,000 | ) | $ | — |
Three Months Ended June 30, 2009
|
||||||||||||||||
Description
|
Balance as of
March 31,
2009
|
Unrealized
(Gains)
Losses
|
Purchases,
Issuances
and
Settlements
|
Balance as of
June 30,
2009
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to conversion and put options
|
$ | 5,601,681 | $ | 5,687,741 | $ | — | $ | 11,289,422 |
11
The
following tables set forth a summary of changes in the fair value of our Level 3
liabilities for the six-month periods ended June 30, 2010 and 2009:
Six Months Ended June 30, 2010
|
||||||||||||||||
Description
|
Balance as of
December 31,
2009
|
Unrealized
(Gains)
Losses
|
Purchases,
Issuances
and
Settlements
|
Balance as of
June 30,
2010
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to conversion and put options
|
$ | 966,000 | $ | — | $ | (966,000 | ) | $ | — |
Six Months Ended June 30, 2009
|
||||||||||||||||
Description
|
Balance as of
December 31,
2008
|
Unrealized
(Gains)
Losses
|
Adoption of
New
Accounting
Standard
(See Note 10)
|
Balance as of
June 30,
2009
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to conversion and put options
|
$ | 853,831 | $ | 5,131,104 | $ | 5,304,487 | $ | 11,289,422 |
There
were no transfers in or out of our Level 1 and Level 2 fair value measurements
during the six-month period ended June 30, 2010. During the six-month
period ended June 30, 2009, we transferred $7.7 million into our Level 2
liabilities. The transfer was a result of the required January 1, 2009
adoption of a new accounting standard which clarified the determination of
whether equity-linked instruments, such as warrants to purchase our common
stock, are considered indexed to our own stock. As a result of adopting
the new standard, certain warrants to purchase our common stock that were
previously treated as equity were reclassified as derivative
liabilities.
4.
|
Stock-Based
Compensation
|
At June
30, 2010, we have instruments outstanding under three stock-based compensation
plans; the Amended and Restated Stock Option and Restricted Stock
Purchase Plan (the Amended Plan), the 1996 Stock Incentive Plan (the 1996 Plan),
and the Second Amended and Restated 2002 Stock Incentive Plan (the 2002
Plan). Currently, under the 2002 Plan, we may grant incentive stock
options, nonqualified stock options, and restricted stock awards to full-time
employees and directors, and nonqualified stock options and restricted stock
awards may be granted to our consultants and agents. Total shares
authorized under each plan are 2 million shares, 1.5 million shares and 7
million shares, respectively. Although instruments are still outstanding
under the Amended Plan and the 1996 Plan, these plans are considered expired and
no new grants may be made from them. Under all three plans, the exercise
price of each stock option is greater than or equal to the closing market price
of our common stock on the day prior to the date of the grant.
Stock
options granted under the Amended Plan, the 1996 Plan and the 2002 Plan
generally vest on an annual basis over one to three years. Outstanding
stock options under the plans, if not exercised, generally expire ten years from
their date of grant or 90 days from the date of an optionee’s separation from
employment with the Company. We issue new shares of our common stock upon
exercise of stock options.
Stock-based
payments to employees and directors, including grants of stock options, are
recognized in the statement of operations based on their estimated fair
values. The fair value of each stock option award is estimated on the date
of grant using the Black-Scholes option pricing model to value share-based
payments. Expected volatilities are based on the Company’s historical
volatility, which management believes represents the most accurate basis for
estimating expected volatility under the current circumstances. Neoprobe
uses historical data to estimate forfeiture rates. The expected term of
stock options granted is based on the vesting period and the contractual life of
the options. The risk-free rate is based on the U.S. Treasury yield in
effect at the time of the grant.
12
Compensation
cost arising from stock-based awards is recognized as expense using the
straight-line method over the vesting period. For the three-month periods
ended June 30, 2010 and 2009, our total stock-based compensation expense was
approximately $80,000 and $75,000, respectively. For the six-month periods
ended June 30, 2010 and 2009, our total stock-based compensation expense was
approximately $303,000 and $145,000, respectively. We have not recorded
any income tax benefit related to stock-based compensation in either of the
three-month or six-month periods ended June 30, 2010 and 2009.
A summary
of the status of our stock options as of June 30, 2010, and changes during the
six-month period then ended, is presented below:
Six Months Ended June 30, 2010
|
|||||||||||||
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Life
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at beginning of period
|
5,689,500 | $ | 0.44 | ||||||||||
Granted
|
20,000 | 1.72 | |||||||||||
Exercised
|
(200,000 | ) | 0.43 | ||||||||||
Forfeited
|
(18,333 | ) | 0.74 | ||||||||||
Expired
|
— | — | |||||||||||
Outstanding
at end of period
|
5,491,167 | $ | 0.44 |
4.9 years
|
$ | 7,468,223 | |||||||
Exercisable
at end of period
|
4,794,167 | $ | 0.38 |
4.4 years
|
$ | 6,804,093 |
A summary
of the status of our unvested restricted stock as of June 30, 2010, and changes
during the six-month period then ended, is presented below:
Six Months Ended
June 30, 2010
|
||||||||
Number of
Shares
|
Weighted
Average
Grant-Date
Fair Value
|
|||||||
Unvested
at beginning of period
|
1,719,000 | $ | 0.76 | |||||
Granted
|
— | — | ||||||
Vested
|
— | — | ||||||
Forfeited
|
— | — | ||||||
Unvested
at end of period
|
1,719,000 | $ | 0.76 |
Restricted
shares vest upon occurrence of a specific event or achievement of goals as
defined in the grant agreements. As a result, we have recorded
compensation expense related to grants of restricted stock based on management’s
estimates of the probable dates of the vesting events.
As of
June 30, 2010, there was approximately $844,000 of total unrecognized
compensation cost related to unvested stock-based awards, which we expect to
recognize over remaining weighted average vesting terms of 1.1
years.
13
5.
|
Comprehensive
Income (Loss)
|
We had no
accumulated other comprehensive income (loss) activity during the three-month
and six-month periods ended June 30, 2010, or for the three-month period ended
June 30, 2009; therefore, our total comprehensive loss was equal to our net loss
for those periods. Due to our net operating loss carryforwards, there are
no income tax effects on comprehensive income (loss) components for the
six-month period ended June 30, 2009.
Six Months
Ended
June 30, 2009
|
||||
Net
loss
|
$ | (14,302,813 | ) | |
Unrealized
losses on available-for-sale securities
|
(1,383 | ) | ||
Other
comprehensive income
|
$ | (14,304,196 | ) |
6.
|
Earnings
(Loss) Per Share
|
Basic
earnings (loss) per share is calculated by dividing net income (loss) by the
weighted-average number of common shares and, except for periods with a loss
from operations, participating securities outstanding during the period.
Diluted earnings (loss) per share reflects additional common shares that would
have been outstanding if dilutive potential common shares had been issued.
Potential common shares that may be issued by the Company include convertible
securities, options and warrants.
The
following table sets forth the reconciliation of the weighted average number of
common shares outstanding to those used to compute basic and diluted earnings
(loss) per share for the three-month and six-month periods ended June 30, 2010
and 2009:
Three Months Ended
June 30, 2010
|
Three Months Ended
June 30, 2009
|
|||||||||||||||
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
|||||||||||||
Outstanding
shares
|
82,151,043 | 82,151,043 | 73,031,986 | 73,031,986 | ||||||||||||
Effect
of weighting changes in outstanding shares
|
(171,966 | ) | (171,966 | ) | (751,329 | ) | (751,329 | ) | ||||||||
Unvested
restricted stock
|
(1,719,000 | ) | (1,719,000 | ) | (964,000 | ) | (964,000 | ) | ||||||||
Adjusted
shares
|
80,260,077 | 80,260,077 | 71,316,657 | 71,316,657 |
Six Months Ended
June 30, 2010
|
Six Months Ended
June 30, 2009
|
|||||||||||||||
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
|||||||||||||
Outstanding
shares
|
82,151,043 | 82,151,043 | 73,031,986 | 73,031,986 | ||||||||||||
Effect
of weighting changes in outstanding shares
|
(514,402 | ) | (514,402 | ) | (1,159,151 | ) | (1,159,151 | ) | ||||||||
Unvested
restricted stock
|
(1,719,000 | ) | (1,719,000 | ) | (964,000 | ) | (964,000 | ) | ||||||||
Adjusted
shares
|
79,917,641 | 79,917,641 | 70,908,835 | 70,908,835 |
Earnings
(loss) per common share for the three-month and six-month periods ended June 30,
2010 and 2009 excludes the effects of 60,242,500 and 58,796,178 common share
equivalents, respectively, since such inclusion would be anti-dilutive.
The excluded shares consist of common shares issuable upon exercise of
outstanding stock options and warrants, or upon the conversion of convertible
debt and convertible preferred stock.
14
The
Company’s unvested stock awards contain nonforfeitable rights to dividends or
dividend equivalents, whether paid or unpaid (referred to as “participating
securities”). Therefore, the unvested stock awards are included in the
number of shares outstanding for both basic and diluted earnings per share
calculations, except in the event of a net loss from operations. Due to
our net loss, 1,719,000 and 964,000 shares of unvested restricted stock were
excluded in determining basic and diluted loss per share for the three-month and
six-month periods ended June 30, 2010 and 2009, respectively.
7.
|
Inventory
|
From time
to time, we capitalize certain inventory costs associated with our
Lymphoseek® product
prior to regulatory approval and product launch based on management’s judgment
of probable future commercial use and net realizable value of the
inventory. We could be required to permanently write down previously
capitalized costs related to pre-approval or pre-launch inventory upon a change
in such judgment, due to a denial or delay of approval by regulatory bodies, a
delay in commercialization, or other potential factors. Conversely, our
gross margins may be favorably impacted if some or all of the inventory
previously written down becomes available and is used for commercial sale.
During the three-month and six-month periods ended June 30, 2010 and 2009, we
did not capitalize any inventory costs associated with our Lymphoseek drug
product. During the three-month period ended June 30, 2010, we expensed
$324,000 of previously capitalized pharmaceutical materials to research and
development as they were no longer considered to be usable in the production of
future saleable final drug product inventory.
The
components of net inventory are as follows:
June 30,
2010
(unaudited)
|
December 31,
2009
|
|||||||
Pharmaceutical
materials
|
$ | 201,000 | $ | 525,000 | ||||
Gamma
detection device materials
|
263,270 | 137,695 | ||||||
Gamma
detection device finished goods
|
862,510 | 481,002 | ||||||
Total
|
$ | 1,326,780 | $ | 1,143,697 |
8.
|
Intangible
Assets
|
The major
classes of intangible assets are as follows:
June 30, 2010
|
December 31, 2009
|
||||||||||||||||
Weighted
Average
Remaining
Life1
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
|||||||||||||
Patents
and trademarks
|
3.2
yrs
|
$ | 532,261 | $ | 446,769 | $ | 524,224 | $ | 445,650 |
1 The
weighted average remaining life is calculated for issued patents and does not
include pending patent applications or trademarks which are not currently being
amortized.
15
The
estimated amortization expenses, related to those patents and trademarks
currently being amortized, for the next five fiscal years are as
follows:
Estimated
Amortization
Expense
|
||||
For
the year ended 12/31/2010
|
$ | 2,755 | ||
For
the year ended 12/31/2011
|
1,256 | |||
For
the year ended 12/31/2012
|
980 | |||
For
the year ended 12/31/2013
|
263 | |||
For
the year ended 12/31/2014
|
244 |
9.
|
Product
Warranty
|
We
warrant our products against defects in design, materials, and workmanship
generally for a period of one year from the date of sale to the end customer,
except in cases where the product has a limited use as designed. Our
accrual for warranty expenses is adjusted periodically to reflect actual
experience and is included in accrued liabilities and other on the consolidated
balance sheets. Our primary marketing partner, Ethicon Endo-Surgery, Inc.
(EES), a Johnson & Johnson company, has reimbursed us for a portion of
warranty expense incurred based on end customer sales they make during a given
fiscal year. Payments charged against the reserve are disclosed net of
EES’ estimated reimbursement.
The
activity in the warranty reserve account for the three-month and six-month
periods ended June 30, 2010 and 2009 is as follows:
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Warranty
reserve at beginning of period
|
$ | 77,624 | $ | 69,593 | $ | 61,400 | $ | 62,261 | ||||||||
Provision
for warranty claims and changes in reserve for warranties
|
12,473 | 20,273 | 50,571 | 57,356 | ||||||||||||
Payments
charged against the reserve
|
(16,280 | ) | (26,425 | ) | (38,154 | ) | (56,176 | ) | ||||||||
Warranty
reserve at end of period
|
$ | 73,817 | $ | 63,441 | $ | 73,817 | $ | 63,441 |
10.
|
Convertible
Securities
|
In July
2007, David C. Bupp, our President and CEO, and certain members of his family
(the Bupp Investors) purchased a $1.0 million convertible note (the Bupp Note)
and warrants. The Bupp Note bore interest at 10% per annum, had an
original term of one year and was repayable in whole or in part with no
penalty. The note was convertible, at the option of the Bupp Investors,
into shares of our common stock at a price of $0.31 per share. As part of
this transaction, we issued the Bupp Investors Series V Warrants to purchase
500,000 shares of our common stock at an exercise price of $0.31 per share,
expiring in July 2012. See Note 17(a).
In
December 2007, we entered into a Securities Purchase Agreement (SPA) with
Platinum Montaur Life Sciences, LLC (Montaur), pursuant to which we issued
Montaur a 10% Series A Convertible Senior Secured Promissory Note in the
principal amount of $7,000,000, $3.5 million of which was convertible into
shares of our common stock at the conversion price of $0.26 per share, due
December 26, 2011 (the Series A Note); and a five-year Series W Warrant to
purchase 6,000,000 shares of our common stock at an exercise price of $0.32 per
share. The SPA also provided for two further tranches of financing, a
second tranche of $3 million in exchange for a 10% Series B Convertible Senior
Secured Promissory Note along with a five-year Series X Warrant to purchase
shares of our common stock, and a third tranche of $3 million in exchange for
3,000 shares of our 8% Series A Cumulative Convertible Preferred Stock and a
five-year Series Y Warrant to purchase shares of our common stock.
Closings of the second and third tranches were subject to the satisfaction by
the Company of certain milestones related to the progress of the Phase 3
clinical trials of our Lymphoseek radiopharmaceutical product.
16
In
connection with the SPA, Montaur requested that the term of the $1.0 million
Bupp Note be extended approximately 42 months or until at least one day
following the maturity date of the Series A Note. In consideration for the
Bupp Investors’ agreement to extend the term of the Bupp Note pursuant to an
Amendment to the Bupp Purchase Agreement, dated December 26, 2007, we
agreed to provide security for the obligations evidenced by the Amended 10%
Convertible Note in the principal amount of $1,000,000, due December 31,
2011, executed by Neoprobe in favor of the Bupp Investors (the Amended Bupp
Note), under the terms of a Security Agreement, dated December 26, 2007, by
and between Neoprobe and the Bupp Investors (the Bupp Security Agreement).
As further consideration for extending the term of the Bupp Note, we issued the
Bupp Investors additional Series V Warrants to purchase 500,000 shares of our
common stock at an exercise price of $0.32 per share, expiring in December
2012.
In April
2008, following receipt by the Company of clearance from the United States Food
and Drug Administration to commence a Phase 3 clinical trial for Lymphoseek in
patients with breast cancer or melanoma, we amended the SPA related to the
second tranche and issued Montaur a 10% Series B Convertible Senior Secured
Promissory Note in the principal amount of $3,000,000, which was convertible
into shares of our common stock at the conversion price of $0.36 per share, also
due December 26, 2011 (the Series B Note, and hereinafter referred to
collectively with the Series A Note as the Montaur Notes); and a five-year
Series X Warrant to purchase 8,333,333 shares of our common stock at an exercise
price of $0.46 per share.
In
December 2008, after we obtained 135 vital blue dye lymph nodes from patients
who had completed the injection of the drug and surgery in a Phase 3 clinical
trial of Lymphoseek in patients with breast cancer or melanoma, we issued
Montaur 3,000 shares of our 8% Series A Cumulative Convertible Preferred Stock
(the Series A Preferred Stock) and a five-year Series Y Warrant to purchase
6,000,000 shares of our common stock at an exercise price of $0.575 per share
(hereinafter referred to collectively with the Series W Warrant and Series X
Warrant as the Montaur Warrants), for an aggregate purchase price of
$3,000,000. The “Liquidation Preference Amount” for the Series A Preferred
Stock was $1,000 and the “Conversion Price” of the Series A Preferred Stock was
set at $0.50 on the date of issuance, thereby making the shares of Series A
Preferred Stock convertible into an aggregate 6,000,000 shares of our common
stock, subject to adjustment as described in the Certificate of
Designations.
In July
2009, we entered into a Securities Amendment and Exchange Agreement with
Montaur, pursuant to which Montaur agreed to the amendment and restatement of
the terms of the Montaur Notes, the Series A Preferred Stock, and the Montaur
Warrants. The Series A Note was amended to grant Montaur conversion rights
with respect to the $3.5 million portion of the Series A Note that was
previously not convertible. The newly convertible portion of the Series A
Note was convertible into 3,600,000 shares of our common stock at $0.9722 per
share. The amendments also eliminated certain price reset features of the
Montaur Notes, the Series A Preferred Stock and the Montaur Warrants that had
created significant non-cash derivative liabilities on the Company’s balance
sheet. See Note 11. In conjunction with this transaction, we issued
Montaur a Series AA Warrant to purchase 2.4 million shares of our common stock
at an exercise price of $0.97 per share, expiring in July 2014. The change
in terms of the Montaur Notes, the Series A Preferred Stock and the Montaur
Warrants were treated as an extinguishment of debt for accounting
purposes. Following the extinguishment, the Company’s balance sheet
reflected the face value of the $10 million due to Montaur pursuant to the
Montaur Notes, which approximated fair value at the date of the
extinguishment.
17
On June
25, 2010, we entered into a Securities Exchange Agreement with Montaur, pursuant
to which Montaur exchanged the Montaur Notes and the Series A Preferred Stock
for 10,000 shares of Series B Convertible Preferred Stock (the Series B
Preferred Stock), convertible into 32,700,000 shares of common stock. The
Series B Preferred Stock is convertible at the option of Montaur, carries no
dividend requirements and participates equally with our common stock in
liquidation proceeds based upon the number of common shares into which the
Series B Preferred Stock is then convertible. As consideration for the
exchange, Neoprobe issued additional Series B Preferred Stock which is
convertible into 1.3 million shares of common stock. Also on June 25,
2010, we entered into a Securities Exchange Agreement with the Bupp Investors,
pursuant to which the Bupp Investors exchanged the Amended Bupp Note for 1,000
shares of Series C Convertible Preferred Stock (the Series C Preferred Stock),
convertible into 3,226,000 shares of common stock. The Series C Preferred
Stock has a 10% dividend rate, payable quarterly until December 31, 2011, and
participates equally with our common stock in liquidation proceeds based upon
the number of common shares into which the Series C Preferred Stock is then
convertible. The exchange of the Montaur Notes, the Series A Preferred
Stock and the Amended Bupp Note were treated as extinguishments for accounting
purposes. As a result, the Company recognized a loss on extinguishment of
debt of $47.1 million, recorded a deemed dividend of $8.0 million, and wrote off
$966,000 in put option derivative liabilities during the second quarter of
2010. As a result of these exchange transactions, all security interests
in the Company’s assets held by Montaur and the Bupp Investors were
extinguished.
During
the three-month periods ended June 30, 2010 and 2009, we recorded interest
expense of $6,000 and $156,000, respectively, related to amortization of the
debt discount related to our convertible notes. During the six-month
periods ended June 30, 2010 and 2009, we recorded interest expense of $12,000
and $307,000, respectively, related to amortization of the debt discount related
to our convertible notes. During the three-month periods ended June 30,
2010 and 2009, we recorded interest expense of $2,000 and $29,000, respectively,
related to amortization of the deferred financing costs related to our
convertible notes. During the six-month periods ended June 30, 2010 and
2009, we recorded interest expense of $4,000 and $58,000, respectively, related
to amortization of the deferred financing costs related to our convertible
notes.
11.
|
Derivative
Instruments
|
Effective
January 1, 2009, we adopted a new accounting standard which clarified the
determination of whether equity-linked instruments (or embedded features), such
as our convertible securities and warrants to purchase our common stock, are
considered indexed to our own stock. As a result of adopting the new
standard, certain embedded features of our convertible securities which were
extinguished in the quarter ended June 30, 2010, as well as warrants to purchase
our common stock, that were previously treated as equity are now considered
derivative liabilities. We do not use derivative instruments for hedging
of market risks or for trading or speculative purposes.
The
estimated fair values of the derivative liabilities are recorded as non-current
liabilities on the consolidated balance sheet. Changes in the estimated
fair values of the derivative liabilities are recorded in the consolidated
statement of operations. The net effect of
marking the derivative liabilities to market during the first half of 2009
resulted in a net increase in the estimated fair values of the derivative
liabilities of $12.2 million which was recorded as non-cash expense during that
period. On July 24, 2009, we entered into a Securities Amendment and
Exchange Agreement with Montaur, pursuant to which Montaur agreed to the
amendment and restatement of the terms of the Montaur Notes, the Series A
Preferred Stock, and the Montaur Warrants. As a result, the Company
recorded an additional $5.6 million in mark-to-market adjustments related to the
increase in the Company’s common stock from June 30 to July 24, 2009, and
reclassified $27.0 million in derivative liabilities related to the Montaur
Notes, the Series A Preferred Stock, and the Montaur Warrants to additional
paid-in capital. Also on July 24, 2009, Montaur exercised 2,844,319 of
their Series Y Warrants, which resulted in a decrease in the related derivative
liability of $2.2 million. The net effect of marking the Company’s
remaining derivative liabilities to market from July 25 through December 31,
2009 resulted in a net increase in the estimated fair values of the derivative
liabilities of $298,000 which was recorded as non-cash expense during the second
half of 2009. The effect of marking the Company’s remaining derivative
liabilities to market at March 31, 2010 resulted in a net increase in the
estimated fair values of the derivative liabilities of $429,000 which was
recorded as non-cash expense during the first quarter of 2010. On June 25,
2010, we entered into a Securities Exchange Agreement with Montaur, pursuant to
which Montaur exchanged the Montaur Notes and the Series A Preferred Stock for
10,000 shares of Series B Convertible Preferred Stock. Also on June 25,
2010, we entered into a Securities Exchange Agreement with the Bupp Investors,
pursuant to which the Bupp Investors exchanged the Amended Bupp Note for 1,000
shares of Series C Convertible Preferred Stock. As a result of these
exchange transactions, the Company wrote off $966,000 in put option derivative
liabilities during the second quarter of 2010. The effect of marking the
Company’s remaining derivative liabilities to market at June 30, 2010 resulted
in a net increase in the estimated fair values of the derivative liabilities of
$154,000 which was recorded as non-cash expense during the second quarter of
2010. The total estimated fair value of the remaining derivative
liabilities was $1.6 million as of June 30, 2010. See Note
10.
18
12.
|
Stock
Warrants
|
During
the first six months of 2009, David C. Bupp, our President and CEO, exercised
50,000 Series Q Warrants in exchange for issuance of 50,000 shares of our common
stock, resulting in gross proceeds of $25,000. The remaining 325,000
Series Q Warrants held by Mr. Bupp expired during the period. During the
same period, another Bupp Investor exercised 50,000 Series V Warrants in
exchange for issuance of 50,000 shares of our common stock, resulting in gross
proceeds of $16,000. Also during the first six months of 2009, certain
outside investors exercised a total of 1,010,000 Series U Warrants on a cashless
basis in exchange for issuance of 541,555 shares of our common
stock.
At June
30, 2010, there are 17.8 million warrants outstanding to purchase our common
stock. The warrants are exercisable at prices ranging from $0.31 to $0.97
per share with a weighted average exercise price of $0.48 per share. See
Note 17(a).
13.
|
Common
Stock Purchase Agreement
|
Under a
previously existing agreement, in March 2010, we sold to Fusion Capital Fund II,
LLC (Fusion Capital), an Illinois limited liability company, 540,541 shares for
proceeds of $1.0 million under a common stock purchase agreement, as
amended. In connection with this sale, we issued 120,000 shares of our
common stock to Fusion Capital as an additional commitment fee.
Subsequent to this sale, the remaining aggregate amount of our common
stock we can sell to Fusion Capital under the amended agreement is $9.1
million.
14.
|
Income
Taxes
|
We
account for income taxes in accordance with current accounting standards, which
include guidance on the accounting for uncertainty in income taxes recognized in
the financial statements. Such standards also prescribe a recognition
threshold and measurement model for the financial statement recognition of a tax
position taken, or expected to be taken, and provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition. As a result, no liability for uncertain tax
positions was recorded as of June 30, 2010. Should we need to accrue
interest or penalties on uncertain tax positions, we would recognize the
interest as interest expense and the penalties as a selling, general and
administrative expense.
15.
|
Segment
and Subsidiary Information
|
We report
information about our operating segments using the “management approach” in
accordance with current accounting standards. This information is based on
the way management organizes and reports the segments within the enterprise for
making operating decisions and assessing performance. Our reportable
segments are identified based on differences in products, services and markets
served. There were no inter-segment sales. We own or have rights to
intellectual property involving two primary types of medical device products,
including oncology instruments currently used primarily in the application of
sentinel lymph node biopsy, and blood flow measurement devices. We also
own or have rights to intellectual property related to several drug and therapy
products.
19
The
information in the following table is derived directly from each reportable
segment’s financial reporting.
($ amounts in thousands)
Three Months Ended June 30,
2010
|
Oncology
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
||||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$ | 2,479 | $ | — | $ | — | $ | 2,479 | ||||||||
International
|
35 | — | — | 35 | ||||||||||||
License
revenue
|
25 | — | — | 25 | ||||||||||||
Research
and development expenses
|
83 | 1,655 | — | 1,738 | ||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
54 | — | 814 | 868 | ||||||||||||
Depreciation
and amortization
|
31 | 2 | 17 | 50 | ||||||||||||
Income
(loss) from operations3
|
1,559 | (1,657 | ) | (831 | ) | (929 | ) | |||||||||
Other
income (expense)4
|
— | — | (42,140 | ) | (42,140 | ) | ||||||||||
Income
(loss) from continuing operations
|
1,559 | (1,657 | ) | (42,971 | ) | (43,069 | ) | |||||||||
Loss
from discontinued operations
|
— | — | (1 | ) | (1 | ) | ||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||
United
States operations
|
3,251 | 441 | 4,194 | 7,886 | ||||||||||||
Discontinued
operations
|
— | — | 6 | 6 | ||||||||||||
Capital
expenditures
|
— | 142 | 21 | 163 | ||||||||||||
($ amounts in thousands)
Three Months Ended June 30,
2009
|
Oncology
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
||||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$ | 1,715 | $ | — | $ | — | $ | 1,715 | ||||||||
International
|
64 | — | — | 64 | ||||||||||||
License
revenue
|
25 | — | — | 25 | ||||||||||||
Research
and development expenses
|
344 | 960 | — | 1,304 | ||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
35 | — | 713 | 748 | ||||||||||||
Depreciation
and amortization
|
39 | 1 | 14 | 54 | ||||||||||||
Income
(loss) from operations3
|
810 | (961 | ) | (727 | ) | (877 | ) | |||||||||
Other
income (expense)4
|
— | — | (14,189 | ) | (14,189 | ) | ||||||||||
Income
(loss) from continuing operations
|
810 | (961 | ) | (14,916 | ) | (15,067 | ) | |||||||||
Loss
from discontinued operations
|
— | — | (50 | ) | (50 | ) | ||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||
United
States operations
|
2,036 | 23 | 4,282 | 6,341 | ||||||||||||
Discontinued
operations
|
— | — | 1,784 | 1,784 | ||||||||||||
Capital
expenditures
|
1 | — | 17 | 18 |
20
($ amounts in thousands)
Six Months Ended June 30, 2010
|
Oncology
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
||||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$ | 5,116 | $ | — | $ | — | $ | 5,116 | ||||||||
International
|
56 | — | — | 56 | ||||||||||||
License
revenue
|
50 | — | — | 50 | ||||||||||||
Research
and development expenses
|
254 | 3,885 | — | 4,139 | ||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
115 | — | 1,820 | 1,935 | ||||||||||||
Depreciation
and amortization
|
64 | 15 | 33 | 112 | ||||||||||||
Income
(loss) from operations3
|
3,089 | (3,900 | ) | (1,853 | ) | (2,664 | ) | |||||||||
Other
income (expense)4
|
— | — | (42,853 | ) | (42,853 | ) | ||||||||||
Income
(loss) from continuing operations
|
3,089 | (3,900 | ) | (44,706 | ) | (45,517 | ) | |||||||||
Loss
from discontinued operations
|
— | — | (13 | ) | (13 | ) | ||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||
United
States operations
|
3,251 | 441 | 4,194 | 7,886 | ||||||||||||
Discontinued
operations
|
— | — | 6 | 6 | ||||||||||||
Capital
expenditures
|
— | 220 | 34 | 254 | ||||||||||||
($ amounts in thousands)
Six Months Ended June 30,
2009
|
Oncology
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
||||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$ | 4,268 | $ | — | $ | — | $ | 4,268 | ||||||||
International
|
168 | — | — | 168 | ||||||||||||
License
revenue
|
50 | — | — | 50 | ||||||||||||
Research
and development expenses
|
637 | 1,888 | — | 2,525 | ||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
69 | — | 1,462 | 1,531 | ||||||||||||
Depreciation
and amortization
|
76 | 2 | 30 | 108 | ||||||||||||
Income
(loss) from operations3
|
2,301 | (1,890 | ) | (1,492 | ) | (1,081 | ) | |||||||||
Other
income (expense)4
|
— | — | (13,111 | ) | (13,111 | ) | ||||||||||
Income
(loss) from continuing operations
|
2,301 | (1,890 | ) | (14,603 | ) | (14,192 | ) | |||||||||
Loss
from discontinued operations
|
— | — | (111 | ) | (111 | ) | ||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||
United
States operations
|
2,036 | 23 | 4,282 | 6,341 | ||||||||||||
Discontinued
operations
|
— | — | 1,784 | 1,784 | ||||||||||||
Capital
expenditures
|
1 | — | 58 | 59 |
1
|
All
sales to EES are made in the United States. EES distributes the
product globally through its international
affiliates.
|
2
|
General
and administrative expenses, excluding depreciation and amortization,
represent costs that relate to the general administration of the Company
and as such are not currently allocated to our individual reportable
segments. Marketing and selling expenses are allocated to our
individual reportable segments.
|
3
|
Income
(loss) from operations does not reflect the allocation of selling, general
and administrative expenses, excluding depreciation and amortization, to
our individual reportable segments.
|
4
|
Amounts
consist primarily of interest income, interest expense and changes in
derivative liabilities which are not currently allocated to our individual
reportable segments.
|
16.
Supplemental Disclosure for Statements of Cash Flows
During
the six-month periods ended June 30, 2010 and 2009, we paid interest aggregating
$134,000 and $137,000, respectively. During the six-month periods ended
June 30, 2010 and 2009, we transferred $44,000 and $23,000, respectively, of
inventory to fixed assets related to the creation and maintenance of a pool of
service loaner equipment. During the six-month periods ended June 30, 2010
and 2009, we issued 347,832 and 785,907, respectively, shares of our common
stock as payment of interest on our convertible debt and dividends on our
convertible preferred stock. During the six-month periods ended June 30,
2010, we issued 53,499 and 80,883 shares of our common stock, respectively, as a
matching contribution to our 401(k) plan. During the six-month period
ended June 30, 2010, we reclassified $223,000 of deferred stock offering costs
to additional paid-in capital related to the issuance of our common stock to
Fusion Capital. See Note 13. Also during the six-month period ended
June 30, 2010, we recorded a deemed dividend of $8.0 million related to the
exchange of the Series A Preferred Stock for Series B Preferred Stock. See
Note 10.
21
17.
|
Subsequent
Events
|
|
a.
|
Warrant
Exercises: In July 2010, a Bupp Investor exercised
120,000 Series V Warrants in exchange for issuance of 120,000 shares of
our common stock, resulting in gross proceeds of $37,200. See Notes
10 and 12.
|
22
Item
2. Management’s Discussion and Analysis of Financial Condition
and Results of Operations
Forward-Looking
Statements
From
time to time, our representatives and we may make written or verbal
forward-looking statements, including statements contained in this report and
other Company filings with the SEC and in our reports to stockholders.
Statements that relate to other than strictly historical facts, such as
statements about our plans and strategies, expectations for future financial
performance, new and existing products and technologies, anticipated clinical
and regulatory pathways, and markets for our products are forward-looking
statements. Generally, the words
“believe,” “expect,” “intend,”
“estimate,” “anticipate,” “will” and other similar expressions
identify forward-looking statements. The forward-looking statements are
and will be based on our then-current views and assumptions regarding future
events and operating performance, and speak only as of their dates.
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, our
continuing operating losses, uncertainty of market acceptance of our 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 our most recent Annual Report on Form 10-K and other SEC
filings. We undertake no obligation to publicly update or revise any
forward-looking statements.
The
Company
Neoprobe
Corporation is a biomedical technology company that provides innovative surgical
and diagnostic oncology products that enhance patient care and improve patient
outcome. We currently market a line of medical devices, our neoprobe® GDS
gamma detection systems that are used in a cancer staging procedure called
intraoperative lymphatic mapping. In addition to our medical device
products, we have two radiopharmaceutical products, Lymphoseek® and
RIGScanTM CR, in
advanced phases of clinical development. We are also exploring the
development of our activated cellular therapy (ACT) technology for
patient-specific disease treatment through our majority-owned subsidiary, Cira
Biosciences, Inc. (Cira Bio).
Product
Line Overview
We
believe that the future prospects for Neoprobe continue to improve as we make
progress in all of our key growth areas, especially related to our Lymphoseek
initiative. Despite the uncertain current global economic conditions, our
gamma detection device line continues to provide a strong revenue base.
Revenue from our gamma detection device product line for the first half of 2010
has exceeded our expectations, and while we expect overall revenue from our
gamma detection device products to continue to be strong for 2010 as a whole, we
expect revenue from this line to be lower in the second half of 2010 than it was
for the second half of 2009. We expect to continue to incur modest
development expenses to support our gamma detection device product line as well
as we work with our marketing partners to expand our product offerings in the
gamma detection device arena. Our primary development efforts over the
last few years have been focused on our oncology drug development
initiatives: Lymphoseek and RIGScan CR. We continue to make
progress with both initiatives; however, neither Lymphoseek nor RIGScan CR is
anticipated to generate any significant revenue for us during 2010.
In August
2009, our Board of Directors decided to discontinue operations of Cardiosonix
and to attempt to divest our Cardiosonix subsidiary. This decision was
based on the determination that the blood flow measurement device segment was no
longer considered a strategic initiative of the Company, due in large part to
positive events in our other development initiatives. Until a sale is
completed, we expect to continue to generate modest revenues and incur minimal
expenses related to our blood flow measurement device business.
23
Our
efforts thus far in 2010 have resulted in the following milestone
achievements:
|
·
|
Completion
of a successful meeting with the United States Food and Drug
Administration (FDA) to review the Phase 3 (NEO3-05) clinical study
results and discuss development plans to support a New Drug Application
(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;
|
|
·
|
Initiation
of a third Lymphoseek Phase 3 clinical study in subjects with breast
cancer or melanoma (NEO3-09) to support expanded post-marketing product
labeling;
|
|
·
|
Validation
of the first lot of commercial drug product of Lymphoseek that will be
used for the commercial launch of the product in the United States upon
NDA clearance;
|
|
·
|
Election
of two new directors to Neoprobe’s Board, bringing significant drug
development and medical product industry
expertise;
|
|
·
|
Completion
of exchange transactions that effectively converted all of the Company’s
outstanding debt to equity; and
|
|
·
|
Filed
a shelf registration on Form S-3 to allow the Company to raise capital as
necessary to provide us with additional financial planning flexibility and
to support the diversification of our share ownership to new
institutions.
|
Our
operating expenses during the first half of 2010 were focused primarily on
support of Lymphoseek product development and on efforts to re-qualify the
manufacturing process for our RIGScan CR product initiative. We expect our
drug-related development expenses for 2010 to be considerably higher than 2009
as we complete preparations for the filing of a NDA for Lymphoseek and as we
continue the other clinical evaluations of Lymphoseek to support post-marketing
amendments to the NDA.
Lymphoseek
During
2008, we initiated patient enrollment in a Phase 3 clinical study in subjects
with either breast cancer or melanoma (NEO3-05). In March 2009, we
announced that this study had reached the accrual of 203 lymph nodes, the
study’s primary accrual objective. The NEO3-05 Phase 3 clinical study was
an open label trial of node-negative subjects with either breast cancer or
melanoma. It was designed to evaluate the safety and the accuracy of
Lymphoseek while identifying the lymph nodes draining from the subject’s tumor
site. To demonstrate the accuracy of Lymphoseek, each subject consenting
to participate in the study was injected in proximity to the tumor with
Lymphoseek and one of the vital blue dyes that are commonly used in lymphatic
mapping procedures. The primary efficacy objective of the study was to
identify lymph nodes that contained the vital blue dye and to demonstrate a
statistically acceptable concordance rate between the identification of lymph
nodes with the vital blue dye and Lymphoseek. To be successful, the study
needed to achieve a statistical p-value of at least 0.05. In addition, the
secondary endpoint of the study was to pathologically examine lymph nodes
identified by either the vital blue dyes or Lymphoseek to determine if cancer
was present in the lymph nodes.
24
In March
2010, Neoprobe met with FDA to review the clinical outcomes of NEO3-05.
The FDA meeting included a review of the efficacy and safety results of the
NEO3-05 clinical study and Neoprobe’s plans for the submission of a NDA for
Lymphoseek based on the results of NEO3-05 and other previously completed
clinical studies. During the meeting, Neoprobe provided FDA with the
clinical results of the protocol-compliant clinical sites that participated in
the NEO3-05 clinical study that contributed 136 intent-to-treat subjects who
provided 215 lymph nodes containing the vital blue dye. 210 of the vital
blue dye positive lymph nodes contained Lymphoseek for an overall concordance
rate of 98%, achieving a very high level of statistical correlation (p-value =
0.0001) for the primary endpoint of the clinical study. Prior to the
meeting, FDA requested that Neoprobe conduct a “reserve concordance” assessment
of the clinical study where Lymphoseek might identify lymph nodes missed by the
vital blue dyes. This assessment showed that Lymphoseek was able to
identify 85 additional lymph nodes that did not contain the vital blue dye, and
18% of these nodes were found by pathology to contain cancer. There were
no significant safety events related to Lymphoseek. FDA indicated that the
clinical data from the NEO3-05 clinical study and other completed clinical
evaluations of Lymphoseek would be supportive of a NDA submission for
Lymphoseek.
The
Lymphoseek NDA submission will be based on the clinical results of NEO3-05 and
other already completed clinical evaluations of Lymphoseek. However,
Neoprobe initiated enrollment in another Phase 3 clinical evaluation of
Lymphoseek in subjects with either breast cancer or melanoma (NEO3-09) for the
purpose of providing supplemental safety data and to support post-marketing
product claim NDA amendments for Lymphoseek. FDA agreed that this trial
does not need to be completed prior to NDA submission. The Company
believes the trial will be complete prior to potential marketing clearance for
Lymphoseek. FDA also encouraged Neoprobe to request a series of pre-NDA
meetings to review the non-clinical and chemistry, manufacturing and control
(CMC) components of the NDA prior to its formal submission. Neoprobe
completed successful non-clinical and CMC pre-NDA reviews with FDA during the
second quarter of 2010. We intend to request a final pre-NDA meeting with
FDA late in the third quarter prior to submission of the NDA in the fourth
quarter of 2010.
In June
2009, we initiated a Phase 3 clinical trial to be conducted in subjects with
head and neck squamous cell carcinoma (NEO3-06). The NEO3-06 clinical
study was designed to expand the potential labeling for Lymphoseek as a sentinel
lymph node targeting agent after the initial marketing clearance for the
product. Our discussions with FDA and the European Medicinal Evaluation
Agency (EMEA) have also suggested that the NEO3-06 clinical trial will further
support the use of Lymphoseek in sentinel lymph node biopsy procedures. We
believe the outcome of the trial will be beneficial to the marketing and
commercial adoption of Lymphoseek in the U.S. and European Union (EU).
Based on the discussion with FDA regarding NEO3-05 and the plan to submit a NDA
based upon the results of that study, we expanded the scope of NEO3-06 and we
now plan to have approximately 20 participating institutions in the NEO3-06
clinical trial. Subject recruitment and enrollment is actively underway at
a number of institutions and the trial protocol is currently under review at
several other institutions. The accrual rate for trials of this nature is
highly dependent on the timing of institutional review board approvals of the
NEO3-06 protocol. Our experience in the NEO3-05 trial has shown that this
process may be lengthening due to risk management concerns on the part of
hospitals participating in clinical trials, as well as other
factors.
We plan
to use the safety and efficacy results from the Phase 3 clinical evaluations of
Lymphoseek, which will include sites in the EU, to support the drug registration
application process in the EU as well as to amend the filing in the U.S. for
expanded product labeling. Based on the positive outcome of the March 2010
meeting with FDA regarding NEO3-05, Neoprobe expects to submit the NDA for
Lymphoseek during the fourth quarter of 2010. Depending on the timing of
the final pre-NDA meeting with FDA and the outcome of the FDA regulatory review
cycle, we believe that Lymphoseek could be commercialized in mid-2011. We
cannot assure you, however, that this product will achieve regulatory approval,
or if approved, that it will achieve market acceptance.
RIGScan
CR
Over the
past few years, we have also made progress in advancing our RIGScan CR
development program while incurring minimal research expenses. Our
RIGS®
technology, which had been essentially inactive since failing to gain approval
following our original license application in 1997, has been the subject of
renewed interest due primarily to the analysis of survival data related to
patients who participated in the original Phase 3 clinical studies that were
completed in 1996. After a successful pre-submission meeting with EMEA in
July 2008, we submitted a plan during the third quarter of 2008 on how we would
propose to complete clinical development for RIGScan CR. The clinical
protocol we submitted to EMEA involves approximately 400 patients in a
randomized trial of patients with colorectal cancer. The participants in
the trial would be randomized to either a control or RIGS treatment arm.
Patients randomized to the RIGS arm would have their disease status evaluated at
the end of their cancer surgery to determine the presence or absence of
RIGS-positive tissue. Patients in both randomized arms would be followed
to determine if patients with RIGS-positive status have a lower overall survival
rate and/or a higher occurrence of disease recurrence. The hypothesis for
the trial is based upon the data from the earlier NEO2-13 and NEO2-14 trial
results.
25
Our
desire has been, and continues to be, to develop a clinical development plan
which is harmonized between the U.S. and the EU. To that end, during
December 2009 we submitted an investigational new drug (IND) amendment to FDA
which includes the design of a proposed Phase 3 clinical trial of RIGScan CR.
The IND amendment included a Special Protocol Assessment (SPA) in
accordance with the Prescription Drug User Fee Act of 1992 and current
regulatory guidelines, and will be registered on the clinicaltrials.gov website
following discussions with FDA regarding the SPA. Since filing the IND
amendment and SPA request, we have determined that due to differences in the
current manufacturing process from the process used in the 1990’s, a further
amendment to the IND should be filed addressing the differences. We expect
to file the IND amendment in the near future and subsequently re-file the IND
request and a revised Phase 3 clinical study protocol. As a result, we do
not expect to receive feedback from FDA on a RIGS SPA request until sometime in
the fourth quarter of 2010 or first quarter of 2011.
The Phase
3 clinical study as currently envisioned would be a randomized clinical study
that would evaluate the ability of RIGScan CR to identify tumor-associated
tissue in a group of patients as compared to a group of patients provided with
traditional surgical care. Based on our current statistical analysis, we now
believe the sample size for the proposed Phase 3 clinical study would be
approximately 350 patients including both the RIGScan CR and traditional
treatment groups. The primary endpoint of the trial as proposed is the
assessment of the diagnostic ability of RIGScan CR to identify tumor-associated
tissue, with a secondary endpoint of the survival rate of the RIGScan CR treated
patients compared to patients treated with conventional treatment
modalities.
It should
also be noted that the RIGScan CR biologic drug has not been produced for
several years. We would have to perform some additional work related to
ensuring the drug cell line is still viable and submit this data to EMEA and
possibly FDA for their evaluation in connection with preparations to restart
pivotal clinical trials. During the third quarter of 2009, we announced
that we had executed a Biopharmaceutical Development and Supply Agreement with
Laureate Pharma, Inc. This agreement will support the initial evaluation
of the viability of the CC49 master working cell bank as well as the initial
steps in re-validating the commercial production process for the biologic agent
used in RIGScan CR. Laureate has made progress in the re-validation of the
manufacturing process and has completed preliminary biologic characterization
activities. They are expected to provide Neoprobe with GMP-produced
material to support non-clinical and clinical evaluation within the next few
months. In addition, we will need to re-establish radiolabeling
capabilities for the CC49 antibody in order to meet the regulatory needs for the
RIGScan CR product. We have also begun discussions with parties capable of
supporting such activities.
We
continue to believe it will be necessary for us to identify a development
partner or an alternative funding source in order to prepare for and fund the
pivotal clinical testing that will be necessary to gain marketing clearance for
RIGScan CR. In the past, we have engaged in discussions with various
parties regarding such a partnership. We believe the recently clarified
regulatory pathway approved by EMEA is very valuable, but we believe clarifying
the regulatory pathway in the U.S. is important for us and our potential
partners in assessing the full potential for RIGScan CR. However, even if
we are able to make such arrangements on satisfactory terms, we believe that the
time required for continued development, regulatory approval and
commercialization of a RIGS product would likely be a minimum of five years
before we receive any significant product-related royalties or revenues.
We cannot assure you that we will be able to complete definitive agreements with
a development partner or obtain financing to fund development of the RIGS
technology and do not know if such arrangements could be obtained on a timely
basis on terms acceptable to us, or at all. We also cannot assure you that
FDA or EMEA will clear our RIGS products for marketing or that any such products
will be successfully introduced or achieve market acceptance.
26
Activated
Cellular Therapy
In 2005,
we formed a new subsidiary, Cira Bio, to explore the development of ACT.
Neoprobe owns approximately 90% of the outstanding shares of Cira Bio with the
remaining shares being held by the principals of a private holding company, Cira
LLC. In conjunction with the formation of Cira Bio, an amended technology
license agreement also was executed with The Ohio State University, from whom
both Neoprobe and Cira LLC had originally licensed or optioned the various
cellular therapy technologies. As a result of the cross-license
agreements, Cira Bio has the exclusive development and commercialization rights
to three issued U.S. patents that cover the oncology and autoimmune applications
of its technology. In addition, Cira Bio has exclusive licenses to several
pending patent applications. We hope to identify a funding source to
continue Cira Bio’s development efforts. If we are successful in
identifying a funding source, we expect that any funding would likely be
accomplished by an investment directly into Cira Bio, so that the funds raised
would not dilute current Neoprobe shareholders. Obtaining this funding
would likely dilute Neoprobe’s ownership interest in Cira Bio; however, we
believe that moving forward such a promising technology will only yield positive
results for the Neoprobe stockholders and the patients who could benefit from
these treatments. We have been encouraged by recent media speculation
regarding the potential connection of a retrovirus with chronic fatigue syndrome
and the potential use of ACT to develop a treatment, which may stimulate some
interest in our ACT platform. However, we do not know if we will be
successful in obtaining funding on terms acceptable to us, or at all. In
the event we fail to obtain financing for Cira Bio, the technology rights for
the oncology applications of ACT may revert back to Neoprobe and the technology
rights for the viral and autoimmune applications may revert back to Cira LLC
upon notice by either party.
We expect
our gamma detection device products to contribute a net profit in 2010 for that
line of business, excluding general and administrative costs, interest and other
financing-related charges. Our overall operating results for 2010 will
also be greatly affected by the amount of development of our radiopharmaceutical
products. Primarily as a result of the significant development costs we
expect to incur related to the continued clinical development of Lymphoseek, we
do not expect to achieve overall operating profitability during 2010. We
cannot assure you that our current or potential new products will be
successfully commercialized, that we will achieve significant product revenues,
or that we will achieve or be able to sustain profitability in the
future.
Results
of Operations
Revenue
for the first six months of 2010 increased to $5.2 million from $4.5 million for
the same period in 2009. Research and development expenses, as a
percentage of net sales, increased to 80% during the first six months of 2010
from 57% during the same period in 2009. Due to the ongoing Lymphoseek and
RIGScan CR development activities of the Company, research and development
expenses as a percentage of sales are expected to be higher in 2010 than they
were in 2009. Selling, general and administrative expenses, as a
percentage of net sales, decreased slightly to 40% during the first six months
of 2010 compared to 37% during the same period in 2009.
Three
Months Ended June 30, 2010 and 2009
Net Sales and Margins.
Net sales, comprised primarily of sales of our gamma detection systems,
increased $735,000, or 41%, to $2.5 million during the second quarter of 2010
from $1.8 million during the same period in 2009. Gross margins on net
sales increased slightly to 67% of net sales for the second quarter of 2010
compared to 66% of net sales for the same period in 2009.
Gamma
detection device sales increased by $687,000 along with increases of $37,000 and
$11,000 in service and extended warranty revenue, respectively. Of the
$687,000 increase in gamma detection device sales, approximately $718,000 was
attributable to increased sales prices, offset by $31,000 attributable to
decreased sales volumes. The price at which we sold our gamma detection
products to our primary marketing partner, Ethicon Endo-Surgery, Inc. (EES), a
Johnson & Johnson company, is based on a percentage of the global average
selling price (ASP) received by EES on sales of Neoprobe products to end
customers, subject to a minimum floor price. Increased sales prices and
unit sales volumes of our wireless probes, coupled with increased unit sales
volumes of our control units, were offset by decreased sales prices of our
control units and corded probes. The increase in gross margins on net
product sales was due to net changes in the product mix coupled with the impact
of the increase in wireless probe sales prices.
27
License Revenue.
License revenue for the second quarter of both 2010 and 2009 included
$25,000 from the pro-rata recognition of license fees related to the 2009
renewal of our distribution agreement with EES.
Research and Development
Expenses. Research and development expenses increased $434,000, or
33%, to $1.7 million during the second quarter of 2010 from $1.3 million during
the same period in 2009. Research and development expenses in the second
quarter of 2010 included approximately (i) $1.7 million in drug and therapy
product development costs and (ii) $83,000 in gamma detection device development
costs. This compares to expenses of $960,000 and $344,000 in these segment
categories during the same period in 2009. The changes in each category
were primarily due to (i) increased compensation costs of $115,000 related to
increased headcount, increased process development costs of $267,000, clinical
activity costs of $70,000 and regulatory consulting costs of $69,000 related to
Lymphoseek, and increased process development costs of $101,000 offset by
decreased license fees of $51,000 related to RIGScan CR; and (ii) lower
compensation costs of $21,000 related to decreased headcount and less time spent
on device development projects, lower development costs related to our new high
energy detection probe which was launched in 2009 of $31,000, and lower
development costs related to various other product improvements of $27,000,
respectively.
Selling, General and Administrative
Expenses. Selling, general and administrative expenses increased
$117,000, or 15%, to $918,000 during the second quarter of 2010 from $802,000
during the same period in 2009. The net increase was primarily due to
increased investor relations fees and compensation costs.
Other Income (Expense).
Other expense, net, was $42.1 million during the second quarter of 2010
compared to $14.2 million during the same period in 2009. During the
second quarter of 2010, we recorded a loss on the extinguishment of debt of
$41.7 million related to the exchange of our outstanding convertible debt for
convertible preferred stock. During the second quarters of 2010 and 2009,
we recorded charges of $154,000 and $13.7 million, respectively, related to the
increase in the fair value of our derivative liabilities resulting from the
requirement to mark our derivative liabilities to market. Interest
expense, primarily related to the convertible debt agreements we completed in
December 2007 and April 2008, decreased $193,000 to $269,000 during the second
quarter of 2010 from $462,000 for the same period in 2009. Of this
interest expense, $8,000 and $185,000 in the second quarters of 2010 and 2009,
respectively, were non-cash in nature related to the amortization of debt
issuance costs and discounts resulting from the warrants and conversion features
of the convertible debt. An additional $236,000 and $250,000 of interest
expense in the second quarters of 2010 and 2009, respectively, was non-cash in
nature due to the payment or accrued payment of interest on our convertible debt
with shares of our common stock.
Six
Months Ended June 30, 2010 and 2009
Net Sales and Margins.
Net sales, comprised primarily of sales of our gamma detection systems,
increased $736,000, or 17%, to $5.2 million during the first six months of 2010
from $4.4 million during the same period in 2009. Gross margins on net
sales decreased slightly to 66% of net sales for the first six months of 2010
compared to 68% of net sales for the same period in 2009.
Gamma
detection device sales increased by $651,000 along with increases of $59,000 and
$26,000 in service and extended warranty revenue, respectively. Of the
$651,000 increase in gamma detection device sales, approximately $710,000 was
attributable to increased sales prices, offset by $59,000 attributable to
decreased sales volumes. The price at which we sell our gamma detection
products to EES is based on a percentage of the global ASP received by EES on
sales of Neoprobe products to end customers, subject to a minimum floor
price. Increased sales prices and unit sales volumes of our wireless
probes, coupled with increased unit sales volumes of our control units, were
offset by decreased sales prices of our control units and corded probes.
The decrease in gross margins on net product sales was due to net changes in the
product mix coupled with the impact of the decrease in control unit sales
prices.
28
License Revenue.
License revenue for the first six months of both 2010 and 2009 included
$50,000 from the pro-rata recognition of license fees related to the renewed
distribution agreement with EES.
Research and Development
Expenses. Research and development expenses increased $1.6 million,
or 64%, to $4.1 million during the first six months of 2010 from $2.5 million
during the same period in 2009. Research and development expenses in the
first six months of 2010 included approximately (i) $3.9 million in drug and
therapy product development costs and (ii) $254,000 in gamma detection device
development costs. This compares to expenses of $1.9 million and $637,000
in these segment categories during the same period in 2009. The changes in
each category were primarily due to (i) increased compensation costs of $319,000
related to increased headcount and incentive-based compensation, increased
process development costs of $502,000, pricing study costs of $217,000, clinical
activity costs of $126,000 and regulatory consulting costs of $82,000 related to
Lymphoseek, and increased process development costs of $425,000 and pricing
study costs of $108,000 offset by decreased license fees of $17,000 related to
RIGScan CR; and (ii) higher compensation costs of $68,000 related to increased
incentive-based compensation offset by lower development costs related to our
new high energy detection probe which was launched in 2009 of $67,000 and lower
development costs related to various other product improvements of $29,000,
respectively.
Selling, General and Administrative
Expenses. Selling, general and administrative expenses increased
$408,000, or 25%, to $2.0 million during the first six months of 2010 from $1.6
million during the same period in 2009. The net increase was primarily due
to increased compensation costs and investor relations fees.
Other Income (Expense).
Other expense, net, was $42.9 million during the first six months of 2010
compared to $13.1 million during the same period in 2009. During the first
six months of 2010, we recorded a loss on the extinguishment of debt of $41.7
million related to the exchange of our outstanding convertible debt for
convertible preferred stock. During the first six months of 2010 and 2009,
we recorded charges of $584,000 and $12.2 million, respectively, related to the
increase in the fair value of our derivative liabilities resulting from the
requirement to mark our derivative liabilities to market. Interest
expense, primarily related to the convertible debt agreements we completed in
December 2007 and April 2008, decreased $366,000 to $553,000 during the first
six months of 2010 from $919,000 for the same period in 2009. Of this
interest expense, $16,000 and $365,000 in the first six months of 2010 and 2009,
respectively, were non-cash in nature related to the amortization of debt
issuance costs and discounts resulting from the warrants and conversion features
of the convertible debt. An additional $403,000 and $417,000 of interest
expense in the first six months of 2010 and 2009, respectively, was non-cash in
nature due to the payment or accrued payment of interest on our convertible debt
with shares of our common stock.
Liquidity
and Capital Resources
Cash
balances decreased to $3.9 million at June 30, 2010 from $5.6 million at
December 31, 2009. The net decrease was primarily due to cash used to fund
our operations, mainly for research and development activities, partially offset
by cash received for the issuance of common stock related to a stock purchase
agreement. The current ratio decreased to 2.4:1 at June 30, 2010 from
3.6:1 at December 31, 2009.
Operating Activities.
Cash used in operations increased $1.6 million to $2.4 million during the
first six months of 2010 compared to $781,000 during the same period in
2009.
Accounts
receivable increased to $1.9 million at June 30, 2010 from $1.3 million at
December 31, 2009. The increase was primarily a result of normal
fluctuations in timing of purchases and payments by EES and Century Medical,
Inc. We expect overall receivable levels will continue to fluctuate during
2010 depending on the timing of purchases and payments by our
customers.
29
Inventory
levels increased to $1.3 million at June 30, 2010 from $1.1 million at December
31, 2009. Gamma detection device materials and finished goods inventory
levels increased as we have increased our product safety stock levels to ensure
efficient and uninterrupted supply of our products to our distribution
partners. During
the first six months of 2010, we expensed $324,000 of previously capitalized
pharmaceutical materials to research and development as they were no longer
considered to be usable in the production of future saleable drug product
inventory. We expect
inventory levels to increase over the remainder of 2010 as expected decreases in
the level of our gamma detection device inventory are more than offset by
increased levels of drug product materials.
Accounts
payable increased to $1.4 million at June 30, 2010 from $764,000 at December 31,
2009. The increase was primarily due to increased activities related to
advancing our Lymphoseek and RIGScan initiatives.
Investing Activities.
Investing activities used $266,000 during the first six months of 2010
compared to providing $375,000 during the same period in 2009.
Available-for-sale securities of $494,000 matured during the first six months of
2009. Capital expenditures of $254,000 during the first six months of 2010
were primarily for equipment to be used in the production of Lymphoseek,
software, and computers. Capital expenditures of $59,000 during the first
six months of 2009 were primarily for computers, software, laboratory equipment,
and office furniture. We expect our overall capital expenditures for 2010
will be higher than 2009 as we continue the commercial production of
Lymphoseek. Payments for patent and trademark costs decreased to $12,000
during the first six months of 2010 compared to $61,000 during the same period
in 2009.
Financing Activities.
Financing activities provided $990,000 during the first six months of
2010 compared to $26,000 used during the same period in 2009. The $990,000
provided by financing activities in the first six months of 2010 consisted
primarily of proceeds from the issuance of common stock of $1.0 million, offset
slightly by payments of stock offering costs of $48,000 and payments of capital
leases of $6,000. The $26,000 used in financing activities in the first
six months of 2009 consisted primarily of payments of notes payable of $103,000,
payments of stock offering costs of $13,000, and payments of capital leases of
$6,000, offset by proceeds from the issuance of common stock of
$95,000.
In
December 2006, we entered into a common stock purchase agreement with Fusion
Capital Fund II, LLC (Fusion Capital), an Illinois limited liability company, to
sell $6.0 million of our common stock to Fusion Capital over a 24-month period
which ended on November 21, 2008. Upon execution of the agreement, we
issued to Fusion Capital 720,000 shares of our common stock as a commitment
fee. Through November 2008, we sold to Fusion Capital under the agreement
7,568,671 shares for proceeds of $1.9 million. As sales of our common
stock were made under the original agreement, we issued an additional 234,000
shares of our common stock to Fusion Capital as an additional commitment
fee. In December 2008, we entered into an amendment to the agreement which
gave us a right to sell an additional $6.0 million of our common stock to Fusion
Capital before March 1, 2011, along with the $4.1 million of the unsold balance
of the $6.0 million we originally had the right to sell to Fusion Capital under
the original agreement. In connection with entering into the amendment, we
issued an additional 360,000 shares in consideration for Fusion Capital’s
entering into the amendment. Also, as an additional commitment fee, we
agreed to issue to Fusion Capital an additional 486,000 shares of our common
stock pro rata as we sell the first $4.1 million of our common stock to Fusion
Capital under the amended agreement. In March 2010, we sold to Fusion
Capital under the amended agreement 540,541 shares for proceeds of $1.0 million
and issued an additional 120,000 shares of our common stock to Fusion Capital as
an additional commitment fee related to the sale. Subsequent to this sale,
the remaining aggregate amount of our common stock we can sell to Fusion Capital
is $9.1 million, and we have reserved a total of 10,113,459 shares of our common
stock in respect to potential sales of common stock we may make to Fusion
Capital in the future under the amended agreement.
30
On June
25, 2010, we entered into a Securities Exchange Agreement with Montaur, pursuant
to which Montaur exchanged the Montaur Notes and the Series A Preferred Stock
for 10,000 shares of Series B Convertible Preferred Stock (the Series B
Preferred Stock), convertible into 32,700,000 shares of common stock. The
Series B Preferred Stock is convertible at the option of Montaur, carries no
dividend requirements and participates equally with our common stock in
liquidation proceeds based upon the number of common shares into which the
Series B Preferred Stock is then convertible. As consideration for the
exchange, Neoprobe issued additional Series B Preferred Stock which is
convertible into 1.3 million shares of common stock. Also on June 25,
2010, we entered into a Securities Exchange Agreement with the Bupp Investors,
pursuant to which the Bupp Investors exchanged the Amended Bupp Note for 1,000
shares of Series C Convertible Preferred Stock (the Series C Preferred Stock),
convertible into 3,226,000 shares of common stock. The Series C Preferred
Stock has a 10% dividend rate, payable quarterly until December 31, 2011, and
participates equally with our common stock in liquidation proceeds based upon
the number of common shares into which the Series C Preferred Stock is then
convertible. The exchange of the Montaur Notes, the Series A Preferred
Stock and the Amended Bupp Note were treated as extinguishments for accounting
purposes. As a result of these exchange transactions, all security
interests in the Company’s assets held by Montaur and the Bupp Investors were
extinguished.
Our
future liquidity and capital requirements will depend on a number of factors,
including our ability to expand market acceptance of our current products, our
ability to complete the commercialization of new products, our ability to
monetize our investment in non-core technologies, our ability to obtain
milestone or development funds from potential development and distribution
partners, regulatory actions by FDA and international regulatory bodies, and
intellectual property protection. Our most significant near-term
development priority is to prepare for the NDA submission for Lymphoseek and to
complete additional clinical testing for Lymphoseek to support potential safety
and post-marketing amendments. We believe our current funds and available
capital resources will be adequate to complete our Lymphoseek development
efforts and sustain our operations at planned levels for the foreseeable
future. We are in the process of determining the total development cost
necessary to commercialize RIGScan CR but believe that it will require total
additional commitments of between $3 million to $5 million to restart
manufacturing and other activities necessary to prepare for the Phase 3 clinical
trial contemplated in the recent EMEA scientific advice response. We have
used currently available funds to initiate the first steps of restarting
manufacturing of RIGScan CR; however, we still intend to involve a partner in
the longer-term development of RIGScan CR. We recently filed a shelf
registration on Form S-3 registering the potential sale of up to $20 million in
a primary offering of common stock and/or warrants of the Company. We may
also be able to raise additional funds through a stock purchase agreement with
Fusion Capital to supplement our capital needs. However, the extent to
which we sell securities under the shelf registration or rely on Fusion Capital
as a source of funding will depend on a number of factors, including the
prevailing market price of our common stock and the extent to which we are able
to secure working capital from other sources. Specifically, Fusion Capital
does not have the right or the obligation to purchase any shares of our common
stock on any business day that the market price of our common stock is less than
$0.20 per share. We cannot assure you that we will be successful in
raising additional capital through Fusion Capital or any other sources at terms
acceptable to the Company, or at all. We also cannot assure you that we
will be able to successfully obtain regulatory approval for and commercialize
new products, that we will achieve significant product revenues from our current
or potential new products or that we will achieve or sustain profitability in
the future.
31
Recent
Accounting Developments
In
January 2010, the Financial Accounting Standards Board (FASB) issued Accounting
Standards Update (ASU) 2010-6, Improving Disclosures about Fair
Value Measurements. ASU 2010-6 amends FASB ASC Topic 820, Fair Value Measurements and
Disclosures. ASU 2010-6 requires new disclosures as follows: (1)
Transfers in and out of Levels 1 and 2 and (2) Activity in Level 3 fair value
measurements. An entity should disclose separately the amounts of
significant transfers in and out of Level 1 and Level 2 fair value measurements
and describe the reasons for the transfers. In the reconciliation of fair
value measurements using significant unobservable inputs (Level 3), an entity
should present separately information about purchases, sales, issuances, and
settlements (that is, on a gross basis rather than as one net number). ASU
2010-6 also clarifies existing disclosures as follows: (1) Level of
disaggregation and (2) Disclosures about inputs and valuation techniques.
An entity should provide fair value measurement disclosures for each class of
assets and liabilities. A class is often a subset of assets or liabilities
within a line item in the statement of financial position. An entity needs
to use judgment in determining the appropriate classes of assets and
liabilities. An entity should provide disclosures about the valuation
techniques and inputs used to measure fair value for both recurring and
nonrecurring fair value measurements. Those disclosures are required for
fair value measurements that fall in either Level 2 or Level 3. ASU 2010-6
is effective for interim and annual reporting periods beginning after December
15, 2009, except for the separate disclosures about purchases, sales, issuances,
and settlements in the roll forward of activity in Level 3 fair value
measurements. Those disclosures are effective for fiscal years beginning
after December 15, 2010, and for interim periods within those fiscal
years. We adopted the initial provisions of ASU 2010-6 beginning January
1, 2010. As the new provisions of ASU 2010-6 provide only disclosure
requirements, the adoption of this standard did not impact our consolidated
financial position, results of operations or cash flows, but did result in
increased disclosures.
Critical
Accounting Policies
The
following accounting policies are considered by us to be critical to our results
of operations and financial condition.
Revenue Recognition Related to Net
Sales. We currently generate revenue primarily from sales of our
gamma detection products. Our standard shipping terms are FOB shipping
point, and title and risk of loss passes to the customer upon delivery to a
common carrier. We generally recognize sales revenue related to sales of
our products when the products are shipped. Our customers have no right to
return products purchased in the ordinary course of business.
The
prices we charge our primary customer, EES, related to sales of products are
subject to retroactive annual adjustment based on a fixed percentage of the
actual sales prices achieved by EES on sales to end customers made during each
fiscal year. To the extent that we can reasonably estimate the
end-customer prices received by EES, we record sales to EES based upon these
estimates. If we are unable to reasonably estimate end customer sales
prices related to certain products sold to EES, we record revenue related to
these product sales at the minimum (i.e., floor) price provided for under our
distribution agreement with EES.
We also
generate revenue from the service and repair of out-of-warranty products.
Fees charged for service and repair on products not covered by an extended
service agreement are recognized on completion of the service process when the
serviced or repaired product has been returned to the customer. Fees
charged for service or repair of products covered by an extended warranty
agreement are deferred and recognized as revenue ratably over the life of the
extended service agreement.
Use of Estimates. The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosures of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues and expenses
during the reporting period. We base these estimates and assumptions upon
historical experience and existing, known circumstances. Actual results
could differ from those estimates. Specifically, management may make
significant estimates in the following areas:
|
·
|
Stock-Based
Compensation. Stock-based payments to employees and
directors, including grants of stock options, are recognized in the
statement of operations based on their estimated fair values. The
fair value of each option award is estimated on the date of grant using
the Black-Scholes option pricing model to value share-based
payments. Compensation cost arising from stock-based awards is
recognized as expense using the straight-line method over the vesting
period.
|
32
|
·
|
Inventory Valuation.
We value our inventory at the lower of cost (first-in, first-out
method) or market. Our valuation reflects our estimates of excess,
slow moving and obsolete inventory as well as inventory with a carrying
value in excess of its net realizable value. Write-offs are recorded
when product is removed from saleable inventory. We review inventory
on hand at least quarterly and record provisions for excess and obsolete
inventory based on several factors, including current assessment of future
product demand, anticipated release of new products into the market,
historical experience and product expiration. Our industry is
characterized by rapid product development and frequent new product
introductions. Uncertain timing of product approvals, variability in
product launch strategies, regulations regarding use and shelf life,
product recalls and variation in product utilization all impact the
estimates related to excess and obsolete
inventory.
|
|
·
|
Impairment or Disposal of
Long-Lived Assets. Long-lived assets and certain identifiable
intangibles are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be
recoverable. The recoverability of assets to be held and used is
measured by a comparison of the carrying amount of an asset to future net
undiscounted cash flows expected to be generated by the asset. If
such assets are considered to be impaired, the impairment to be recognized
is measured by the amount by which the carrying amount of the assets
exceeds the fair value of the assets. Assets to be disposed of are
reported at the lower of the carrying amount or fair value less costs to
sell.
|
|
·
|
Product Warranty.
We warrant our products against defects in design, materials, and
workmanship generally for a period of one year from the date of sale to
the end customer. Our accrual for warranty expenses is adjusted
periodically to reflect actual experience. EES also reimburses us
for a portion of warranty expense incurred based on end customer sales
they make during a given fiscal
year.
|
|
·
|
Fair Value of Derivative
Instruments. Derivative instruments embedded in contracts, to
the extent not already a free-standing contract, are bifurcated from the
debt instrument and accounted for separately. All derivatives are
recorded on the consolidated balance sheet at fair value in accordance
with current accounting guidelines for such complex financial
instruments. Fair value of warrant liabilities is determined based
on a Black-Scholes option pricing model calculation. Fair value of
conversion and put option liabilities is determined based on a
probability-weighted Black-Scholes option pricing model calculation.
Unrealized gains and losses on the derivatives are classified in other
expenses as a change in derivative liabilities in the statements of
operations. We do not use derivative instruments for hedging of
market risks or for trading or speculative
purposes.
|
Item
3. Quantitative and Qualitative Disclosures About Market Risk
Not
applicable.
Item
4T. Controls and Procedures
Disclosure
Controls and Procedures
We
maintain disclosure controls and procedures designed to ensure that information
required to be disclosed in reports filed under the Exchange Act is recorded,
processed, summarized, and reported within the specified time periods. As
a part of these controls, our management is responsible for establishing and
maintaining adequate internal control over financial reporting, as such term is
defined in Rule 13a-15(f) under the Exchange Act.
33
Our
internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles, and includes those policies and
procedures that:
|
·
|
pertain
to the maintenance of records that, in reasonable detail, accurately and
fairly reflect the transactions and dispositions of the assets of the
Company;
|
|
·
|
provide
reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted
accounting principles and that receipts and expenditures of the Company
are being made only in accordance with authorization of management and
directors of the Company; and
|
|
·
|
provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the Company's assets that
could have a material effect on the financial
statements.
|
Under the
supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, we evaluated the effectiveness of
the design and operation of our disclosure controls and procedures (as defined
in Rule 13a-15(e) under the Exchange Act) as of June 30, 2010. Disclosure
controls and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed by us in the
reports that we file or submit under the Exchange Act is accumulated and
communicated to our management, including our principal executive and principal
financial officers, as appropriate to allow timely decisions regarding required
disclosure. Based on our evaluation, our Chief Executive Officer and Chief
Financial Officer have concluded that, as of the end of the period covered by
this report, our disclosure controls and procedures are adequately designed and
effective.
Our
management, including our Chief Executive Officer and Chief Financial Officer,
does not expect that our disclosure controls and procedures will prevent all
errors and all improper conduct. A control system, no matter how well
conceived and operated, can provide only reasonable, not absolute assurance that
the objectives of the control systems are met. Further, a design of a
control system must reflect the fact that there are resource constraints, and
the benefit of controls must be considered relative to their costs.
Because of the inherent limitations in all control systems, no evaluation of
controls can provide absolute assurance that all control issues and instances of
improper conduct, if any, have been detected. These inherent limitations
include the realities that judgments and decision-making can be faulty, and that
breakdowns can occur because of a simple error or mistake. Additionally,
controls can be circumvented by the individual acts of some persons, by
collusion of two or more persons, or by management override of the
control. Further, the design of any system of controls is also based in
part upon assumptions about the likelihood of future events, and there can be no
assurance that any design will succeed in achieving its stated goals under all
potential future conditions. Over time, controls may become inadequate
because of changes in conditions, or the degree of compliance with the policies
or procedures may deteriorate. Because of the inherent limitations of a
cost-effective control system, misstatements due to error or fraud may occur and
may not be detected.
Changes
in Control Over Financial Reporting
During
the quarter ended June 30, 2010, there were no changes in our internal control
over financial reporting that materially affected, or are reasonably likely to
materially affect, our internal control over financial
reporting.
34
PART
II - OTHER INFORMATION
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
(a)
|
During
the three-month period ended June 30, 2010, we issued 108,075 shares of
our common stock in payment of April and May 2010 interest of $166,667 on
the 10% Series A and Series B Convertible Senior Secured Promissory Notes
held by Platinum Montaur Life Sciences, LLC (Montaur). The issuances
of the shares to Montaur were exempt from registration under Sections 4(2)
and 4(6) of the Securities Act and Regulation
D.
|
Item
6. Exhibits
10.1
|
Manufacture
and Supply agreement, dated November 30, 2009, between the Company and
Reliable Biopharmaceutical Corporation (portions of this Exhibit have been
omitted pursuant to a request for confidential treatment and have been
filed separately with the
Commission).*
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.*
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.*
|
|
32.1
|
Certification
of Chief Executive Officer of Periodic Financial Reports pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section
1350.*
|
|
32.2
|
Certification
of Chief Financial Officer of Periodic Financial Reports pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section
1350.*
|
|
*
|
Filed
herewith.
|
Items
1, 3, 4 and 5 are not applicable and have been omitted. There are no
material changes in Item 1A from the corresponding item reported in the
Company’s Form 10-K for the year ended December 31, 2009, and this item has
therefore been omitted.
35
SIGNATURES
In accordance with the requirements of
the Exchange Act, the registrant caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
NEOPROBE
CORPORATION
|
|
(the
Company)
|
|
Dated:
August 10, 2010
|
|
By:
|
/s/ David C.
Bupp
|
David
C. Bupp
|
|
President
and Chief Executive Officer
|
|
(duly
authorized officer; principal executive officer)
|
|
By:
|
/s/ Brent L.
Larson
|
Brent
L. Larson
|
|
Vice
President, Finance and Chief Financial Officer
|
|
(principal
financial and accounting
officer)
|
36