x
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
¨
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
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)
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company x
|
PART
I – Financial Information
|
||
Item
1.
|
Financial
Statements
|
3
|
Consolidated
Balance Sheets as of September 30, 2009 (unaudited) and December 31,
2008
|
3
|
|
Consolidated
Statements of Operations for the Three-Month and Nine-Month Periods Ended
September 30, 2009 and September 30, 2008 (unaudited)
|
5
|
|
Consolidated
Statement of Stockholders’ Deficit for the Nine-Month Period Ended
September 30, 2009 (unaudited)
|
6
|
|
Consolidated
Statements of Cash Flows for the Nine-Month Periods Ended September 30,
2009 and September 30, 2008 (unaudited)
|
7
|
|
Notes
to the Consolidated Financial Statements (unaudited)
|
8
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial
Condition and Results of Operations
|
26
|
Forward-Looking
Statements
|
26
|
|
The
Company
|
26
|
|
Product
Line Overview
|
26
|
|
Results
of Operations
|
29
|
|
Liquidity
and Capital Resources
|
31
|
|
Recent
Accounting Developments
|
35
|
|
Critical
Accounting Policies
|
37
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
38
|
Item
4T.
|
Controls
and Procedures
|
38
|
PART
II – Other Information
|
||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
40
|
Item
6.
|
Exhibits
|
40
|
|
September 30,
2009
(unaudited)
|
December 31,
2008
|
||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 6,031,298 | $ | 3,565,837 | ||||
Available-for-sale
securities
|
— | 495,383 | ||||||
Accounts
receivable, net
|
1,393,420 | 1,626,065 | ||||||
Inventory
|
1,038,407 | 544,126 | ||||||
Prepaid
expenses and other
|
319,647 | 573,573 | ||||||
Assets
associated with discontinued operations
|
31,389 | 435,740 | ||||||
Total
current assets
|
8,814,161 | 7,240,724 | ||||||
Property
and equipment
|
1,949,461 | 1,940,748 | ||||||
Less
accumulated depreciation and amortization
|
1,654,969 | 1,593,501 | ||||||
294,492 | 347,247 | |||||||
Patents
and trademarks
|
519,896 | 459,431 | ||||||
Less
accumulated amortization
|
440,018 | 433,358 | ||||||
79,878 | 26,073 | |||||||
Other
assets
|
26,266 | 594,449 | ||||||
Other
assets associated with discontinued operations
|
— | 1,410,957 | ||||||
Total
assets
|
$ | 9,214,797 | $ | 9,619,450 |
|
September 30,
2009
(unaudited)
|
December 31,
2008
|
||||||
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 772,483 | $ | 725,820 | ||||
Accrued
liabilities and other
|
1,155,398 | 900,796 | ||||||
Capital
lease obligations, current portion
|
7,092 | 9,084 | ||||||
Deferred
revenue, current portion
|
526,898 | 526,619 | ||||||
Notes
payable to finance companies
|
— | 137,857 | ||||||
Liabilities
associated with discontinued operations
|
20,686 | 22,280 | ||||||
Total
current liabilities
|
2,482,557 | 2,322,456 | ||||||
Capital
lease obligations, net of current portion
|
5,721 | 11,095 | ||||||
Deferred
revenue, net of current portion
|
440,873 | 490,165 | ||||||
Notes
payable to CEO, net of discounts of $59,917 and
$76,294, respectively
|
940,083 | 923,706 | ||||||
Notes
payable to investors, net of discounts of $0 and $5,001,149,
respectively
|
10,000,000 | 4,998,851 | ||||||
Derivative
liabilities
|
2,697,487 | 853,831 | ||||||
Other
liabilities
|
36,348 | 45,071 | ||||||
Total
liabilities
|
16,603,069 | 9,645,175 | ||||||
Commitments
and contingencies
|
||||||||
Preferred
stock; $.001 par value; 5,000,000 shares authorized; 3,000 Series A
shares, par value $1,000, issued and outstanding at September 30, 2009 and
December 31, 2008
|
3,000,000 | 3,000,000 | ||||||
Stockholders’
deficit:
|
||||||||
Common
stock; $.001 par value; 150,000,000 shares authorized; 79,363,787 and
70,862,641 shares outstanding at September 30, 2009 and December 31, 2008,
respectively
|
79,364 | 70,863 | ||||||
Additional
paid-in capital
|
181,877,412 | 145,742,044 | ||||||
Accumulated
deficit
|
(192,345,048 | ) | (148,840,015 | ) | ||||
Unrealized
gain on available-for-sale securities
|
— | 1,383 | ||||||
Total
stockholders’ deficit
|
(10,388,272 | ) | (3,025,725 | ) | ||||
Total
liabilities and stockholders’ deficit
|
$ | 9,214,797 | $ | 9,619,450 |
Three
Months Ended
September
30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Revenues:
|
||||||||||||||||
Net
sales
|
$ | 2,562,079 | $ | 1,715,324 | $ | 6,998,299 | $ | 5,629,573 | ||||||||
License
and other revenue
|
25,000 | — | 75,000 | — | ||||||||||||
Total
revenues
|
2,587,079 | 1,715,324 | 7,073,299 | 5,629,573 | ||||||||||||
Cost
of goods sold
|
927,587 | 641,106 | 2,330,032 | 2,123,728 | ||||||||||||
Gross
profit
|
1,659,492 | 1,074,218 | 4,743,267 | 3,505,845 | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
1,204,811 | 1,741,484 | 3,730,361 | 3,084,432 | ||||||||||||
Selling,
general and administrative
|
778,658 | 707,794 | 2,417,622 | 2,248,466 | ||||||||||||
Total
operating expenses
|
1,983,469 | 2,449,278 | 6,147,983 | 5,332,898 | ||||||||||||
Loss
from operations
|
(323,977 | ) | (1,375,060 | ) | (1,404,716 | ) | (1,827,053 | ) | ||||||||
Other
income (expense):
|
||||||||||||||||
Interest
income
|
2,360 | 18,824 | 16,068 | 47,891 | ||||||||||||
Interest
expense
|
(330,806 | ) | (456,941 | ) | (1,249,525 | ) | (1,258,500 | ) | ||||||||
Change
in derivative liabilities
|
(6,334,479 | ) | 59,415 | (18,539,318 | ) | (440,773 | ) | |||||||||
Loss
on extinguishment of debt
|
(16,240,592 | ) | — | (16,240,592 | ) | — | ||||||||||
Other
|
(585 | ) | 4,242 | (2,216 | ) | 2,501 | ||||||||||
Total
other expense, net
|
(22,904,102 | ) | (374,460 | ) | (36,015,583 | ) | (1,648,881 | ) | ||||||||
Loss
from continuing operations
|
(23,228,079 | ) | (1,749,520 | ) | (37,420,299 | ) | (3,475,934 | ) | ||||||||
Discontinued
operations:
|
||||||||||||||||
Impairment
loss
|
(1,728,887 | ) | — | (1,728,887 | ) | — | ||||||||||
Loss
from operations
|
(52,303 | ) | (141,070 | ) | (162,896 | ) | (459,506 | ) | ||||||||
Net
loss
|
(25,009,269 | ) | (1,890,590 | ) | (39,312,082 | ) | (3,935,440 | ) | ||||||||
Preferred
stock dividends
|
(60,000 | ) | — | (180,000 | ) | — | ||||||||||
Loss
attributable to common
stockholders
|
$ | (25,069,269 | ) | $ | (1,890,590 | ) | $ | (39,492,082 | ) | $ | (3,935,440 | ) | ||||
Loss
per common share (basic):
|
||||||||||||||||
Continuing
operations
|
$ | (0.31 | ) | $ | (0.03 | ) | $ | (0.53 | ) | $ | (0.05 | ) | ||||
Discontinued
operations
|
$ | (0.03 | ) | $ | (0.00 | ) | $ | (0.03 | ) | $ | (0.01 | ) | ||||
Loss
to common stockholders
|
$ | (0.34 | ) | $ | (0.03 | ) | $ | (0.56 | ) | $ | (0.06 | ) | ||||
Loss
per common share (diluted):
|
||||||||||||||||
Continuing
operations
|
$ | (0.31 | ) | $ | (0.03 | ) | $ | (0.53 | ) | $ | (0.05 | ) | ||||
Discontinued
operations
|
$ | (0.03 | ) | $ | (0.00 | ) | $ | (0.03 | ) | $ | (0.01 | ) | ||||
Loss
to common stockholders
|
$ | (0.34 | ) | $ | (0.03 | ) | $ | (0.56 | ) | $ | (0.06 | ) | ||||
Weighted
average shares outstanding:
|
||||||||||||||||
Basic
|
74,380,714 | 68,758,281 | 70,915,204 | 68,191,889 | ||||||||||||
Diluted
|
74,380,714 | 68,758,281 | 70,915,204 | 68,191,889 |
Common
Stock
|
Additional
Paid-in
|
Accumulated
|
Accumulated
Other
Comprehensive
|
|||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Loss
|
Total
|
|||||||||||||||||||
Balance,
December 31, 2008
|
70,862,641 | $ | 70,863 | $ | 145,742,044 | $ | (148,840,015 | ) | $ | 1,383 | $ | (3,025,725 | ) | |||||||||||
Effect
of adopting EITF 07-5
|
— | — | (8,948,089 | ) | (4,012,951 | ) | — | (12,961,040 | ) | |||||||||||||||
Issued
restricted stock
|
500,000 | 500 | — | — | — | 500 | ||||||||||||||||||
Cancelled
restricted stock
|
(9,000 | ) | (9 | ) | 9 | — | — | — | ||||||||||||||||
Issued
stock upon exercise of
warrants and other
|
6,641,555 | 6,641 | 6,196,513 | — | — | 6,203,154 | ||||||||||||||||||
Issued
stock upon exercise of
options
|
330,000 | 330 | 133,420 | — | — | 133,750 | ||||||||||||||||||
Issued
stock as payment of interest
on convertible debt and dividends
on preferred stock
|
957,708 | 958 | 553,709 | — | — | 554,667 | ||||||||||||||||||
Effect
of change in terms of notes
payable, warrants and preferred
stock
|
— | — | 37,999,312 | — | — | 37,999,312 | ||||||||||||||||||
Issued
stock to 401(k) plan at
$0.41
|
80,883 | 81 | 33,392 | — | — | 33,473 | ||||||||||||||||||
Stock
compensation expense
|
— | — | 271,554 | — | — | 271,554 | ||||||||||||||||||
Paid
common stock issuance
costs
|
— | — | (98,129 | ) | — | — | (98,129 | ) | ||||||||||||||||
Paid
preferred stock issuance
costs
|
— | — | (6,323 | ) | — | — | (6,323 | ) | ||||||||||||||||
Preferred
stock dividends
|
— | — | — | (180,000 | ) | — | (180,000 | ) | ||||||||||||||||
Comprehensive
loss:
|
||||||||||||||||||||||||
Net
loss
|
— | — | — | (39,312,082 | ) | — | (39,312,082 | ) | ||||||||||||||||
Unrealized
loss on available-for-sale
securities
|
— | — | — | — | (1,383 | ) | (1,383 | ) | ||||||||||||||||
Total
comprehensive loss
|
(39,313,465 | ) | ||||||||||||||||||||||
Balance,
September 30, 2009
|
79,363,787 | $ | 79,364 | $ | 181,877,412 | $ | (192,345,048 | ) | $ | — | $ | (10,388,272 | ) |
Nine Months Ended
September 30,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (39,312,082 | ) | $ | (3,935,440 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
284,219 | 302,904 | ||||||
Amortization
of debt discount and debt offering costs
|
420,063 | 515,056 | ||||||
Provision
for bad debts
|
458 | 699 | ||||||
Issuance
of common stock in payment of interest and dividends
|
554,667 | — | ||||||
Stock
compensation expense
|
271,554 | 156,897 | ||||||
Change
in derivative liabilities
|
18,539,318 | 440,773 | ||||||
Loss
on extinguishment of debt
|
16,240,592 | — | ||||||
Impairment
loss on discontinued operations
|
1,728,887 | — | ||||||
Other
|
48,697 | 111,295 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
226,052 | 305,274 | ||||||
Inventory
|
(550,816 | ) | 323,957 | |||||
Prepaid
expenses and other assets
|
260,470 | 111,229 | ||||||
Accounts
payable
|
47,063 | (79,470 | ) | |||||
Accrued
liabilities and other liabilities
|
53,104 | 105,775 | ||||||
Deferred
revenue
|
(49,013 | ) | (81,638 | ) | ||||
Net
cash used in operating activities
|
(1,236,767 | ) | (1,722,689 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Purchases
of available-for-sale securities
|
— | (196,000 | ) | |||||
Maturities
of available-for-sale securities
|
494,000 | 196,000 | ||||||
Purchases
of property and equipment
|
(74,554 | ) | (97,673 | ) | ||||
Proceeds
from sales of property and equipment
|
251 | 120 | ||||||
Patent
and trademark costs
|
(66,317 | ) | (13,616 | ) | ||||
Net
cash provided by (used in) investing activities
|
353,380 | (111,169 | ) | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from issuance of common stock
|
3,625,250 | 232,156 | ||||||
Payment
of common stock offering costs
|
(104,673 | ) | (900 | ) | ||||
Payment
of preferred stock offering costs
|
(6,323 | ) | — | |||||
Proceeds
from notes payable
|
— | 3,000,000 | ||||||
Payment
of debt issuance costs
|
(20,183 | ) | (200,154 | ) | ||||
Payment
of notes payable
|
(137,857 | ) | (124,770 | ) | ||||
Payments
under capital leases
|
(7,366 | ) | (12,878 | ) | ||||
Net
cash provided by financing activities
|
3,348,848 | 2,893,454 | ||||||
Net
increase in cash
|
2,465,461 | 1,059,596 | ||||||
Cash,
beginning of period
|
3,565,837 | 1,540,220 | ||||||
Cash,
end of period
|
$ | 6,031,298 | $ | 2,599,816 |
1.
|
Summary
of Significant Accounting Policies
|
|
a.
|
Basis of
Presentation: The information presented as of September
30, 2009 and for the three-month and nine-month periods ended September
30, 2009 and September 30, 2008 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. We have evaluated
subsequent events through November 16, 2009, the date our consolidated
financial statements were issued. The balances as of September
30, 2009 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, 2008, which were included as part of our Annual Report on
Form 10-K.
|
|
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:
|
|
(1)
|
Cash,
accounts receivable, accounts payable, and accrued
liabilities: The carrying amounts approximate fair value
because of the short maturity of these
instruments.
|
|
(2)
|
Available-for-sale
securities: Available-for-sale securities are recorded at fair
value. Fair value of available-for-sale securities is
determined based on a discounted cash flow analysis using current market
rates. Unrealized holding gains and losses on
available-for-sale securities are excluded from earnings and are reported
as a separate component of other comprehensive income (loss) until
realized. Realized gains and losses from the sale of
available-for-sale securities are determined on a specific identification
basis.
|
|
(3)
|
Notes
payable to finance companies: The fair value of our debt is
estimated by discounting the future cash flows at rates currently offered
to us for similar debt instruments of comparable maturities by banks or
finance companies. At December 31, 2008, the carrying values of
these instruments approximate fair value. We had no notes
payable to finance companies at September 30,
2009.
|
|
(4)
|
Note
payable to CEO: 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 September 30, 2009, the
note payable to our CEO had an estimated fair value of $4.5
million. At December 31, 2008, the note payable to our CEO had
an estimated fair value of $1.8
million.
|
|
(5)
|
Notes
payable to outside investors: The carrying value of our debt is
presented as the face amount of the notes less the unamortized discounts
related to the fair value of the beneficial conversion features, the
initial estimated fair value of the put options embedded in the notes and
the initial estimated fair value of the warrants to purchase common stock
issued in connection with the notes. At September 30, 2009, the
notes payable to outside investors had an estimated fair value of $35.6
million. At December 31, 2008, the notes payable to outside
investors had an estimated fair value of $15.9
million.
|
|
(6)
|
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
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.
|
2.
|
Discontinued
Operations
|
September 30,
2009
|
December 31,
2008
|
|||||||
Accounts
receivable, net
|
$ | 5,727 | $ | 18,005 | ||||
Inventory
|
25,662 | 417,735 | ||||||
Property
and equipment, net of accumulated depreciation
|
— | 43,545 | ||||||
Patents
and trademarks, net of accumulated amortization
|
— | 1,367,412 | ||||||
Assets
associated with discontinued operations
|
$ | 31,389 | $ | 1,846,697 | ||||
Accounts
payable
|
$ | 5,800 | $ | 5,400 | ||||
Accrued
expenses
|
14,886 | 16,880 | ||||||
Liabilities
associated with discontinued operations
|
$ | 20,686 | $ | 22,280 |
Three
Months Ended
September
30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Net
sales
|
$ | 9,345 | $ | 84,942 | $ | 81,904 | $ | 208,510 | ||||||||
Cost
of goods sold
|
2,432 | 51,711 | 36,156 | 135,766 | ||||||||||||
Gross
profit
|
6,913 | 33,231 | 45,748 | 72,744 | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
2,642 | 69,445 | 23,128 | 188,912 | ||||||||||||
Selling,
general and administrative
|
56,659 | 104,958 | 185,506 | 343,578 | ||||||||||||
Total
operating expenses
|
59,301 | 174,403 | 208,634 | 532,490 | ||||||||||||
Other
income (expense)
|
85 | 102 | (10 | ) | 240 | |||||||||||
Loss
from discontinued operations
|
$ | (52,303 | ) | $ | (141,070 | ) | $ | (162,896 | ) | $ | (459,506 | ) |
3.
|
Fair
Value Hierarchy
|
Liabilities Measured at Fair Value on a Recurring
Basis as of September 30, 2009
|
||||||||||||||||
Quoted
Prices
in
Active
Markets
for
Identical
Assets
and
Liabilities
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs
|
Balance
as of
September
30,
|
|||||||||||||
Description
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
2009
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related
to warrants
|
$ | — | $ | 1,731,487 | $ | — | $ | 1,731,487 | ||||||||
Derivative
liabilities related
to put options
|
— | — | 966,000 | 966,000 | ||||||||||||
Total
derivative liabilities
|
$ | — | $ | 1,731,487 | $ | 966,000 | $ | 2,697,487 |
Assets and Liabilities Measured at Fair Value on a
Recurring Basis as of December 31, 2008
|
||||||||||||||||
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)
|
2008
|
||||||||||||
Assets:
|
||||||||||||||||
Available-for-sale
securities
|
$ | 495,383 | $ | — | $ | — | $ | 495,383 | ||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related
to conversion and
put options
|
$ | — | $ | — | $ | 853,831 | $ | 853,831 |
Three Months Ended September 30,
2009
|
||||||||||||||||||||
Description
|
Balance at
June 30,
2009
|
Unrealized
Losses
|
Purchases,
Issuances
and
Settlements
|
Transfers In
and/or (Out)
|
Balance at
September
30,
2009
|
|||||||||||||||
Liabilities:
|
||||||||||||||||||||
Derivative
liabilities related
to conversion and
put options
|
$ | 11,289,422 | $ | 2,465,225 | $ | — | $ | (12,788,647 | ) | $ | 966,000 |
Three Months Ended September 30,
2008
|
||||||||||||||||||||
Description
|
Balance at
June 30,
2008
|
Unrealized
Gains
|
Purchases,
Issuances
and
Settlements
|
Transfers In
and/or (Out)
|
Balance at
September
30,
2008
|
|||||||||||||||
Liabilities:
|
||||||||||||||||||||
Derivative
liabilities related
to conversion and
put options
|
$ | 686,638 | $ | (59,415 | ) | $ | — | $ | — | $ | 627,223 |
Nine Months Ended September 30,
2009
|
||||||||||||||||||||
Description
|
Balance at
December
31,
2008
|
Adoption of
EITF 07-5
(See
Note 10)
|
Unrealized
Losses
|
Transfers In
and/or (Out)
|
Balance at
September
30,
2009
|
|||||||||||||||
Liabilities:
|
||||||||||||||||||||
Derivative
liabilities related
to conversion and
put options
|
$ | 853,831 | $ | 5,304,487 | $ | 7,596,329 | $ | (12,788,647 | ) | $ | 966,000 |
Nine Months Ended September 30,
2008
|
||||||||||||||||||||
Description
|
Balance at
December
31,
2007
|
Purchases,
Issuances
and
Settlements
|
Unrealized
Losses
|
Transfers In
and/or (Out)
|
Balance at
September
30,
2008
|
|||||||||||||||
Liabilities:
|
||||||||||||||||||||
Derivative
liabilities related
to conversion and
put options
|
$ | 1,599,072 | $ | 257,968 | $ | 170,119 | $ | (1,399,936 | ) | $ | 627,223 |
4.
|
Stock-Based
Compensation
|
Nine Months Ended September 30,
2009
|
|||||||||||||
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Life
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at beginning of
period
|
5,619,500 | $ | 0.40 | ||||||||||
Granted
|
283,000 | 0.59 | |||||||||||
Exercised
|
(330,000 | ) | 0.41 | ||||||||||
Forfeited
|
(10,000 | ) | 0.61 | ||||||||||
Expired
|
(111,000 | ) | 1.10 | ||||||||||
Outstanding
at end of period
|
5,451,500 | $ | 0.39 |
5.1 years
|
$ | 5,492,084 | |||||||
Exercisable
at end of period
|
4,682,833 | $ | 0.38 |
4.5 years
|
$ | 4,763,057 |
Nine Months Ended
September 30, 2009
|
||||||||
Number of
Shares
|
Weighted
Average
Grant-Date
Fair Value
|
|||||||
Unvested
at beginning of period
|
473,000 | $ | 0.37 | |||||
Granted
|
500,000 | 0.60 | ||||||
Vested
|
— | — | ||||||
Forfeited
|
(9,000 | ) | 0.68 | |||||
Unvested
at end of period
|
964,000 | $ | 0.49 |
5.
|
Comprehensive
Loss
|
Three Months
Ended
September 30,
2009
|
Three Months
Ended
September 30,
2008
|
|||||||
Net
loss
|
$ | (25,009,269 | ) | $ | (1,890,590 | ) | ||
Unrealized
losses on securities
|
— | — | ||||||
Other
comprehensive loss
|
$ | (25,009,269 | ) | $ | (1,890,590 | ) |
Nine Months
Ended
September 30,
2009
|
Nine Months
Ended
September 30,
2008
|
|||||||
Net
loss
|
$ | (39,312,082 | ) | $ | (3,935,440 | ) | ||
Unrealized
losses on securities
|
(1,383 | ) | — | |||||
Other
comprehensive loss
|
$ | (39,313,465 | ) | $ | (3,935,440 | ) |
6.
|
Earnings
(Loss) Per Share
|
Three Months Ended
September 30, 2009
|
Three Months Ended
September 30, 2008
|
|||||||||||||||
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
|||||||||||||
Outstanding
shares
|
79,363,787 | 79,363,787 | 69,787,540 | 69,787,540 | ||||||||||||
Effect
of weighting changes in
outstanding shares
|
(4,019,073 | ) | (4,019,073 | ) | (579,259 | ) | (579,259 | ) | ||||||||
Unvested
restricted stock
|
(964,000 | ) | (964,000 | ) | (450,000 | ) | (450,000 | ) | ||||||||
Adjusted
shares
|
74,380,714 | 74,380,714 | 68,758,281 | 68,758,281 |
Nine Months Ended
September, 2009
|
Nine Months Ended
September 30, 2008
|
|||||||||||||||
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
|||||||||||||
Outstanding
shares
|
79,363,787 | 79,363,787 | 69,787,540 | 69,787,540 | ||||||||||||
Effect
of weighting changes in
outstanding shares
|
(7,484,583 | ) | (7,484,583 | ) | (1,145,651 | ) | (1,145,651 | ) | ||||||||
Unvested
restricted stock
|
(964,000 | ) | (964,000 | ) | (450,000 | ) | (450,000 | ) | ||||||||
Adjusted
shares
|
70,915,204 | 70,915,204 | 68,191,889 | 68,191,889 |
7.
|
Inventory
|
September 30,
2009
(unaudited)
|
December 31,
2008
|
|||||||
Materials
and component parts
|
$ | 691,276 | $ | 112,637 | ||||
Finished
goods
|
347,131 | 431,489 | ||||||
Total
|
$ | 1,038,407 | $ | 544,126 |
8.
|
Intangible
Assets
|
September
30, 2009
|
December 31, 2008
|
||||||||||||||||
Wtd
Avg
Life
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
|||||||||||||
Patents
and trademarks
|
0.2
yrs
|
$ | 519,896 | $ | 440,018 | $ | 459,431 | $ | 433,358 |
Estimated
Amortization
Expense
|
||||
For
the year ended 12/31/20091
|
$ | 126,228 | ||
For
the year ended 12/31/2010
|
2,393 | |||
For
the year ended 12/31/2011
|
1,088 | |||
For
the year ended 12/31/2012
|
885 | |||
For
the year ended 12/31/2013
|
126 |
|
1
|
Amortization
expense for the year ended 12/31/2009 includes approximately $113,000 of
intangible asset amortization related to Cardiosonix, which is included in
loss from discontinued operations. Intangible asset
amortization related to Cardiosonix stopped during the third quarter of
2009 as a result of the decision to discontinue the operations of
Cardiosonix and hold the associated assets for
sale.
|
9.
|
Product
Warranty
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Warranty
reserve at beginning
of period
|
$ | 71,412 | $ | 87,679 | $ | 72,643 | $ | 115,395 | ||||||||
Provision
for warranty claims and changes
in reserve for warranties
|
10,021 | 3,932 | 65,172 | 13,894 | ||||||||||||
Payments
charged against the reserve
|
(21,369 | ) | (18,816 | ) | (77,751 | ) | (56,494 | ) | ||||||||
Warranty
reserve at end of period
|
$ | 60,064 | $ | 72,795 | $ | 60,064 | $ | 72,795 |
10.
|
Convertible
Securities
|
11.
|
Derivative
Instruments
|
December 31,
2008
|
Impact of
New
Accounting
Standard
Adoption
|
January 1,
2009
|
||||||||||
Other
assets
|
$ | 594,449 | $ | 2,104 | $ | 596,553 | ||||||
Total
assets
|
$ | 9,619,450 | $ | 9,621,554 | ||||||||
Notes
payable to investors, net
of discounts
|
$ | 4,998,851 | (54,396 | ) | $ | 4,944,455 | ||||||
Derivative
liabilities
|
853,831 | 13,017,540 | 13,871,371 | |||||||||
Total
liabilities
|
$ | 9,645,175 | $ | 22,608,319 | ||||||||
Additional
paid-in capital
|
$ | 145,742,044 | (8,948,089 | ) | $ | 136,793,955 | ||||||
Accumulated
deficit
|
(148,840,015 | ) | (4,012,951 | ) | (152,852,966 | ) | ||||||
Total
stockholders’ deficit
|
$ | (3,025,725 | ) | $ | (15,986,765 | ) |
12.
|
Stock
Warrants
|
13.
|
Income
Taxes
|
14.
|
Segment
Information
|
($ amounts in thousands)
Three Months Ended
September 30, 2009
|
Oncology
Devices
|
Blood
Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales:
|
||||||||||||||||||||
United
States1
|
$ | 2,477 | $ | — | $ | — | $ | — | $ | 2,477 | ||||||||||
International
|
85 | — | — | — | 85 | |||||||||||||||
License
and other revenue
|
25 | — | — | — | 25 | |||||||||||||||
Research
and development expenses
|
220 | — | 985 | — | 1,205 | |||||||||||||||
Selling,
general and administrative expenses,
excluding depreciation and
amortization2
|
26 | — | — | 705 | 731 | |||||||||||||||
Depreciation
and amortization
|
32 | — | 1 | 15 | 48 | |||||||||||||||
Income
(loss) from operations
|
1,382 | — | (986 | ) | (720 | ) | (324 | ) | ||||||||||||
Other
income (expenses)4
|
— | — | — | (22,904 | ) | (22,904 | ) | |||||||||||||
Loss
from discontinued operations
|
— | (1,781 | ) | — | — | (1,781 | ) | |||||||||||||
Total
assets, net of depreciation and
amortization:
|
||||||||||||||||||||
United
States operations
|
2,148 | — | 555 | 6,481 | 9,184 | |||||||||||||||
Discontinued
operations
|
— | 31 | — | — | 31 | |||||||||||||||
Capital
expenditures
|
12 | — | — | 4 | 16 | |||||||||||||||
($ amounts in thousands)
Three Months Ended
September 30, 2008
|
Oncology
Devices
|
Blood
Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales:
|
||||||||||||||||||||
United
States1
|
$ | 1,630 | $ | — | $ | — | $ | — | $ | 1,630 | ||||||||||
International
|
85 | — | — | — | 85 | |||||||||||||||
Research
and development expenses
|
267 | — | 1,474 | — | 1,741 | |||||||||||||||
Selling,
general and administrative expenses,
excluding depreciation and
amortization2
|
7 | — | — | 656 | 663 | |||||||||||||||
Depreciation
and amortization
|
32 | — | 1 | 12 | 45 | |||||||||||||||
Income
(loss) from operations3
|
768 | — | (1,475 | ) | (668 | ) | (1,375 | ) | ||||||||||||
Other
income (expenses)4
|
— | — | — | (374 | ) | (374 | ) | |||||||||||||
Loss
from discontinued operations
|
— | (141 | ) | — | (141 | ) | ||||||||||||||
Total
assets, net of depreciation and
amortization:
|
||||||||||||||||||||
United
States operations
|
1,796 | — | 26 | 3,537 | 5,359 | |||||||||||||||
Discontinued
operations
|
— | 1,990 | — | — | 1,990 | |||||||||||||||
Capital
expenditures
|
2 | — | — | 51 | 53 |
($ amounts in thousands)
Nine Months Ended September 30, 2009
|
Oncology
Devices
|
Blood
Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales:
|
||||||||||||||||||||
United
States1
|
$ | 6,745 | $ | — | $ | — | $ | — | $ | 6,745 | ||||||||||
International
|
253 | — | — | — | 253 | |||||||||||||||
License
and other revenue
|
75 | — | — | — | 75 | |||||||||||||||
Research
and development expenses
|
857 | — | 2,873 | — | 3,730 | |||||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
95 | — | — | 2,167 | 2,262 | |||||||||||||||
Depreciation
and amortization
|
108 | — | 3 | 45 | 156 | |||||||||||||||
Income
(loss) from operations
|
3,683 | — | (2,876 | ) | (2,212 | ) | (1,405 | ) | ||||||||||||
Other
income (expenses)4
|
— | — | — | (36,016 | ) | (36,016 | ) | |||||||||||||
Loss
from discontinued operations
|
— | (1,892 | ) | — | — | (1,892 | ) | |||||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||||||
United
States operations
|
2,148 | — | 555 | 6,481 | 9,184 | |||||||||||||||
Discontinued
operations
|
— | 31 | — | — | 31 | |||||||||||||||
Capital
expenditures
|
13 | — | — | 62 | 75 |
($ amounts in thousands)
Nine Months Ended September 30, 2008
|
Oncology
Devices
|
Blood Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales:
|
||||||||||||||||||||
United
States1
|
$ | 5,513 | $ | — | $ | — | $ | — | $ | 5,513 | ||||||||||
International
|
117 | — | — | — | 117 | |||||||||||||||
Research
and development expenses
|
718 | — | 2,366 | — | 3,084 | |||||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
7 | — | — | 2,122 | 2,129 | |||||||||||||||
Depreciation
and amortization
|
86 | — | 1 | 32 | 119 | |||||||||||||||
Income
(loss) from operations3
|
2,694 | — | (2,367 | ) | (2,154 | ) | (1,827 | ) | ||||||||||||
Other
income (expenses)4
|
— | — | — | (1,649 | ) | (1,649 | ) | |||||||||||||
Loss
from discontinued operations
|
— | (460 | ) | — | — | (460 | ) | |||||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||||||
United
States operations
|
1,796 | — | 26 | 3,537 | 5,359 | |||||||||||||||
Discontinued
operations
|
— | 1,990 | — | — | 1,990 | |||||||||||||||
Capital
expenditures
|
4 | — | 18 | 76 | 98 |
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.
|
3
|
Income
(loss) from operations does not reflect the allocation of general and
administrative expenses, excluding depreciation and amortization, to the
operating 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.
|
15.
|
Supplemental
Disclosure for Statements of Cash
Flows
|
16.
|
Subsequent
Event
|
|
·
|
Completed
the first Phase 3 clinical trial of Lymphoseek (NEO3-05) in patients with
breast cancer or melanoma and announced that the primary efficacy endpoint
was exceeded with no drug-related safety events
reported.
|
|
·
|
Initiated
patient enrollment in a second Phase 3 clinical trial of Lymphoseek
(NEO3-06 or the “Sentinel” trial) in patients with head and neck squamous
cell carcinoma.
|
|
·
|
Initiated
drug development activities for RIGScan CR to support a Phase 3
study.
|
|
·
|
Began
a new five-year term of our EES gamma detection device distribution
agreement.
|
|
·
|
Added
a high energy (F-18) probe to our gamma detection device product
portfolio.
|
|
·
|
Completed
a debt restructuring agreement allowing reclassification of a majority of
the Company’s derivative liabilities and resulting in the exercise of the
Series Y Warrants, producing $3.45 million in cash flow to the
Company.
|
|
·
|
Stock-Based
Compensation. We
account for stock-based compensation in accordance with FASB ASC Topic
718, Compensation –
Stock Compensation. FASB ASC 718 requires all
share-based payments to employees, including grants of employee stock
options, to be recognized in the income statement based on their estimated
fair values. Compensation cost arising from stock-based awards
is recognized as expense using the straight-line method over the vesting
period. We use the Black-Scholes option pricing model to value
share-based payments.
|
|
·
|
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. We account for long-lived assets in
accordance with the provisions of FASB ASC Topic 360, Property, Plant and
Equipment. FASB ASC 360 requires that long-lived assets
and certain identifiable intangibles be 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. We account for derivative
instruments in accordance with FASB ASC Topic 815, Derivatives and
Hedging. FASB ASC 815 provides accounting and reporting
standards for derivative instruments, including certain derivative
instruments embedded in other contracts. We do not use
derivative instruments for hedging of market risks or for trading or
speculative purposes. Effective January 1, 2009, we were
required to adopt new provisions of FASB ASC 815 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, which would qualify as a
scope exception. As a result of adopting the new provisions of
FASB ASC 815, certain embedded features of our convertible securities, as
well as warrants to purchase our common stock, that were previously
treated as equity are now considered derivative
liabilities.
|
|
·
|
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.
|
|
(a)
|
During
the three-month period ended September 30, 2009, we issued 99,884 shares
of our common stock in payment of June 2009 interest of $83,333 on the 10%
Series A and Series B Convertible Senior Secured Promissory Notes held by
Platinum Montaur Life Sciences, LLC (Montaur). During the same
period, we issued 71,917 shares of our common stock in payment of
April-June 2009 dividends of $60,000 on the 8% Series A Cumulative
Convertible Preferred Stock held by Montaur. Also during the
three-month period ended September 30, 2009, Montaur exercised 6,000,000
Series Y Warrants in exchange for issuance of 6,000,000 shares of our
common stock, resulting in gross proceeds of $3,450,000, and we issued
Montaur a Series AA Warrant to purchase 2,400,000 shares of our common
stock at an exercise price of $0.97 per share, expiring in July
2014. The issuances of the shares and warrants to Montaur were
exempt from registration under Sections 4(2) and 4(6) of the Securities
Act and Regulation D promulgated
thereunder.
|
|
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.
|
NEOPROBE
CORPORATION
|
|
(the
Company)
|
|
Dated:
November 16, 2009
|
|
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)
|