x
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
o
|
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 o
|
Accelerated
filer o
|
|
Non-accelerated
filer o
|
Smaller
reporting company x
|
PART
I – Financial Information
|
||
Item
1.
|
Financial
Statements
|
3
|
Consolidated
Balance Sheets as of
March 31, 2010 (unaudited) and December 31, 2009 |
3
|
|
Consolidated
Statements of Operations for the Three-Month Periods Ended
March 31, 2010 and March 31, 2009 (unaudited) |
5
|
|
Consolidated
Statement of Stockholders’ Deficit for the Three-Month Period Ended
March 31, 2010 (unaudited) |
6
|
|
Consolidated
Statements of Cash Flows for the Three-Month Periods Ended
March 31, 2010 and March 31, 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
|
22
|
Forward-Looking
Statements
|
22
|
|
The
Company
|
22
|
|
Product
Line Overview
|
22
|
|
Results
of Operations
|
26
|
|
Liquidity
and Capital Resources
|
27
|
|
Recent
Accounting Developments
|
30
|
|
Critical
Accounting Policies
|
31
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
32
|
Item
4T.
|
Controls
and Procedures
|
32
|
PART
II – Other Information
|
||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
34
|
Item
6.
|
Exhibits
|
34
|
ASSETS
|
March 31,
2010
(unaudited)
|
December 31,
2009
|
||||||
Current
assets:
|
||||||||
Cash
|
$ | 5,956,271 | $ | 5,639,842 | ||||
Accounts
receivable, net
|
1,136,073 | 1,331,908 | ||||||
Inventory
|
1,361,412 | 1,143,697 | ||||||
Prepaid
expenses and other
|
212,723 | 474,243 | ||||||
Assets
associated with discontinued operations
|
16,572 | 27,475 | ||||||
Total
current assets
|
8,683,051 | 8,617,165 | ||||||
Property
and equipment
|
2,219,250 | 1,990,603 | ||||||
Less
accumulated depreciation and amortization
|
1,749,164 | 1,693,290 | ||||||
470,086 | 297,313 | |||||||
Patents
and trademarks
|
533,261 | 524,224 | ||||||
Less
accumulated amortization
|
444,378 | 445,650 | ||||||
88,883 | 78,574 | |||||||
Other
assets
|
22,534 | 24,707 | ||||||
Total
assets
|
$ | 9,264,554 | $ | 9,017,759 |
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
March 31,
2010
(unaudited)
|
December 31,
2009
|
||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 1,091,743 | $ | 763,966 | ||||
Accrued
liabilities and other
|
1,777,795 | 1,048,304 | ||||||
Capital
lease obligations, current portion
|
11,633 | 11,265 | ||||||
Deferred
revenue, current portion
|
522,320 | 560,369 | ||||||
Liabilities
associated with discontinued operations
|
19,029 | 18,743 | ||||||
Total
current liabilities
|
3,422,520 | 2,402,647 | ||||||
Capital
lease obligations
|
16,519 | 19,912 | ||||||
Deferred
revenue
|
502,875 | 534,119 | ||||||
Note
payable to CEO, net of discounts of $48,076 and $54,093,
respectively
|
951,924 | 945,907 | ||||||
Notes
payable to investors
|
10,000,000 | 10,000,000 | ||||||
Derivative
liabilities
|
2,380,956 | 1,951,664 | ||||||
Other
liabilities
|
29,906 | 33,362 | ||||||
Total
liabilities
|
17,304,700 | 15,887,611 | ||||||
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 March 31, 2010 and
December 31, 2009
|
3,000,000 | 3,000,000 | ||||||
Stockholders’
deficit:
|
||||||||
Common
stock; $.001 par value; 150,000,000 shares authorized; 81,891,716 and
80,936,711 shares issued and outstanding at March 31, 2010 and December
31, 2009, respectively
|
81,892 | 80,937 | ||||||
Additional
paid-in capital
|
184,096,762 | 182,747,897 | ||||||
Accumulated
deficit
|
(195,218,800 | ) | (192,698,686 | ) | ||||
Total
stockholders’ deficit
|
(11,040,146 | ) | (9,869,852 | ) | ||||
Total
liabilities and stockholders’ deficit
|
$ | 9,264,554 | $ | 9,017,759 |
Three
Months Ended
March
31,
|
||||||||
2010
|
2009
|
|||||||
Revenues:
|
||||||||
Net
sales
|
$ | 2,657,872 | $ | 2,657,221 | ||||
License
revenue
|
25,000 | 25,000 | ||||||
Total
revenues
|
2,682,872 | 2,682,221 | ||||||
Cost
of goods sold
|
888,867 | 826,363 | ||||||
Gross
profit
|
1,794,005 | 1,855,858 | ||||||
Operating
expenses:
|
||||||||
Research
and development
|
2,401,672 | 1,221,969 | ||||||
Selling,
general and administrative
|
1,128,202 | 837,323 | ||||||
Total
operating expenses
|
3,529,874 | 2,059,292 | ||||||
Loss
from operations
|
(1,735,869 | ) | (203,434 | ) | ||||
Other
income (expense):
|
||||||||
Interest
income
|
1,814 | 9,947 | ||||||
Interest
expense
|
(284,438 | ) | (457,134 | ) | ||||
Change
in derivative liabilities
|
(429,292 | ) | 1,525,365 | |||||
Other
|
(456 | ) | (274 | ) | ||||
Total
other (expense) income, net
|
(712,372 | ) | 1,077,904 | |||||
(Loss)
income from continuing operations
|
(2,448,241 | ) | 874,470 | |||||
Discontinued
operations – loss from operations
|
(11,873 | ) | (60,349 | ) | ||||
Net
(loss) income
|
(2,460,114 | ) | 814,121 | |||||
Preferred
stock dividends
|
(60,000 | ) | (60,000 | ) | ||||
(Loss)
income attributable to common stockholders
|
$ | (2,520,114 | ) | $ | 754,121 | |||
(Loss)
income per common share (basic and diluted):
|
||||||||
Continuing
operations
|
$ | (0.03 | ) | $ | 0.01 | |||
Discontinued
operations
|
$ | 0.00 | $ | 0.00 | ||||
Attributable
to common stockholders
|
$ | (0.03 | ) | $ | 0.01 | |||
Weighted
average shares outstanding:
|
||||||||
Basic
|
79,571,399 | 71,387,438 | ||||||
Diluted
|
79,571,399 | 96,346,846 |
Common Stock
|
Additional
Paid-in
|
Accumulated
|
||||||||||||||||||
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
|
239,757 | 240 | 309,760 | — | 310,000 | |||||||||||||||
Issued
stock upon net-share exercise of options
|
1,208 | 1 | (1 | ) | — | — | ||||||||||||||
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 | |||||||||||||||
Paid
common stock issuance costs
|
— | — | (1,366 | ) | — | (1,366 | ) | |||||||||||||
Stock
compensation expense
|
— | — | 223,105 | — | 223,105 | |||||||||||||||
Preferred
stock dividends
|
— | — | — | (60,000 | ) | (60,000 | ) | |||||||||||||
Comprehensive
loss:
|
||||||||||||||||||||
Net
loss
|
— | — | — | (2,460,114 | ) | (2,460,114 | ) | |||||||||||||
Balance,
March 31, 2010
|
81,891,716 | $ | 81,892 | $ | 184,096,762 | $ | (195,218,800 | ) | $ | (11,040,146 | ) |
Three
Months Ended
March
31,
|
||||||||
2010
|
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
(loss) income
|
$ | (2,460,114 | ) | $ | 814,121 | |||
Adjustments
to reconcile net (loss) income to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
61,981 | 100,896 | ||||||
Amortization
of debt discount and debt offering costs
|
8,190 | 179,730 | ||||||
Issuance
of common stock in payment of interest and dividends
|
250,000 | 83,333 | ||||||
Stock
compensation expense
|
223,105 | 70,536 | ||||||
Change
in derivative liabilities
|
429,292 | (1,525,365 | ) | |||||
Other
|
40,977 | 4,581 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
200,735 | (41,139 | ) | |||||
Inventory
|
(226,003 | ) | (28,794 | ) | ||||
Prepaid
expenses and other assets
|
38,976 | 33,955 | ||||||
Accounts
payable
|
328,977 | (38,918 | ) | |||||
Accrued
liabilities and other liabilities
|
597,321 | (38,217 | ) | |||||
Deferred
revenue
|
(69,293 | ) | (30,815 | ) | ||||
Net
cash used in operating activities
|
(575,856 | ) | (416,096 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Maturities
of available-for-sale securities
|
— | 494,000 | ||||||
Purchases
of equipment
|
(90,422 | ) | (40,491 | ) | ||||
Proceeds
from sales of equipment
|
— | 251 | ||||||
Patent
and trademark costs
|
(12,902 | ) | (12,665 | ) | ||||
Net
cash (used in) provided by investing activities
|
(103,324 | ) | 441,095 | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from issuance of common stock
|
1,000,000 | 25,500 | ||||||
Payment
of stock offering costs
|
(1,366 | ) | (12,866 | ) | ||||
Payment
of notes payable
|
— | (50,992 | ) | |||||
Payments
under capital leases
|
(3,025 | ) | (3,421 | ) | ||||
Net
cash provided by (used in) financing activities
|
995,609 | (41,779 | ) | |||||
Net
increase (decrease) in cash
|
316,429 | (16,780 | ) | |||||
Cash,
beginning of period
|
5,639,842 | 3,565,837 | ||||||
Cash,
end of period
|
$ | 5,956,271 | $ | 3,549,057 |
1.
|
Summary
of Significant Accounting Policies
|
|
a.
|
Basis of
Presentation: The information presented as of March 31,
2010 and for the three-month periods ended March 31, 2010 and March 31,
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 March 31, 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.
|
|
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)
|
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 March 31, 2010 and
December 31, 2009, the note payable to our CEO had an estimated fair value
of $5.3 million and $3.9 million, respectively, based on the closing
market price of our common stock.
|
|
(3)
|
Notes
payable to investors: The carrying value of our debt is
presented as the face amount of the notes. At March 31, 2010
and December 31, 2009, the notes payable to investors had an estimated
fair value of $41.6 million and $31.0 million, respectively, based on the
closing market price of our common
stock.
|
(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 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
|
March 31,
2010
|
December 31,
2009
|
|||||||
Accounts
receivable, net
|
$ | 10,450 | $ | 15,349 | ||||
Inventory
|
6,122 | 12,126 | ||||||
Current
assets associated with discontinued operations
|
$ | 16,572 | $ | 27,475 | ||||
Accounts
payable
|
$ | 6,600 | $ | 5,400 | ||||
Accrued
expenses
|
12,429 | 13,343 | ||||||
Current
liabilities associated with discontinued operations
|
$ | 19,029 | $ | 18,743 |
Three Months Ended
March 31,
|
||||||||
2010
|
2009
|
|||||||
Net
sales
|
$ | 14,445 | $ | 42,815 | ||||
Cost
of goods sold
|
6,389 | 22,171 | ||||||
Gross
profit
|
8,056 | 20,644 | ||||||
Operating
expenses:
|
||||||||
Research
and development
|
251 | 16,089 | ||||||
Selling,
general and administrative
|
19,862 | 64,725 | ||||||
Total
operating expenses
|
20,113 | 80,814 | ||||||
Other
income (expense)
|
184 | (179 | ) | |||||
Loss
from discontinued operations
|
$ | (11,873 | ) | $ | (60,349 | ) |
3.
|
Fair
Value Hierarchy
|
Liabilities Measured at Fair Value on a Recurring Basis as of March 31, 2010
|
||||||||||||||||
Quoted Prices
in Active
Markets for
Identical
Liabilities
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs
|
Balance as of
March 31,
|
|||||||||||||
Description
|
(Level
1)
|
(Level
2)
|
(Level
3)
|
2010
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to warrants
|
$ | — | $ | 1,414,956 | $ | — | $ | 1,414,956 | ||||||||
Derivative
liabilities related to conversion and put options
|
— | — | 966,000 | 966,000 | ||||||||||||
Total
derivative liabilities
|
$ | — | $ | 1,414,956 | $ | 966,000 | $ | 2,380,956 |
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 |
Three Months Ended March 31, 2010
|
||||||||||||||||
Description
|
Balance at
December 31,
2009
|
Unrealized
(Gains)
Losses
|
Transfers In
and/or (Out)
|
Balance at
March 31,
2010
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to conversion and put options
|
$ | 966,000 | $ | — | $ | — | $ | 966,000 |
Three Months Ended March 31, 2009
|
||||||||||||||||
Description
|
Balance at
December 31,
2008
|
Unrealized
(Gains)
Losses
|
Transfers In
and/or (Out)
(See Note 10)
|
Balance at
March 31,
2009
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to conversion and put options
|
$ | 853,831 | $ | (556,637 | ) | $ | 5,304,487 | $ | 5,601,681 |
4.
|
Stock-Based
Compensation
|
Three Months Ended March 31, 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
|
(5,000 | ) | 1.03 | ||||||||||
Forfeited
|
— | — | |||||||||||
Expired
|
— | — | |||||||||||
Outstanding
at end of period
|
5,704,500 | $ | 0.44 |
5.1
years
|
$ | 6,843,420 | |||||||
Exercisable
at end of period
|
4,965,500 | $ | 0.38 |
4.5
years
|
$ | 6,252,044 |
Three Months Ended
March 31, 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 |
Three Months
Ended
March 31, 2009
|
||||
Net
income
|
$ | 814,121 | ||
Unrealized
losses on available-for-sale securities
|
(1,383 | ) | ||
Other
comprehensive income
|
$ | 812,738 |
Three Months Ended
March 31, 2010
|
Three Months Ended
March 31, 2009
|
|||||||||||||||
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
|||||||||||||
Outstanding
shares
|
81,891,716 | 81,891,716 | 71,555,707 | 71,555,707 | ||||||||||||
Effect
of weighting changes in
outstanding shares
|
(601,317 | ) | (601,317 | ) | (168,269 | ) | (168,269 | ) | ||||||||
Unvested
restricted stock
|
(1,719,000 | ) | (1,719,000 | ) | — | — | ||||||||||
Stock
options
|
— | — | — | 1,803,941 | ||||||||||||
Warrants
|
— | — | — | 5,596,328 | ||||||||||||
Convertible
debt
|
— | — | — | 11,559,139 | ||||||||||||
Convertible
preferred stock
|
— | — | — | 6,000,000 | ||||||||||||
Adjusted
shares
|
79,571,399 | 79,571,399 | 71,387,438 | 96,346,846 |
Three Months Ended
March 31, 2009
|
||||||||||||
Earnings
(Numerator)
|
Weighted
Average
Shares
(Denominator)
|
Per
Share
Amount
|
||||||||||
Net
income
|
$ | 814,121 | ||||||||||
Preferred
stock dividends
|
(60,000 | ) | ||||||||||
Basic
EPS:
|
||||||||||||
Income
available to common stockholders
|
754,121 | 71,387,438 | $ | 0.01 | ||||||||
Effect
of Dilutive Securities:
|
||||||||||||
Stock
options
|
- | 1,803,941 | ||||||||||
Warrants
|
- | 5,596,328 | ||||||||||
Convertible
debt
|
105,315 | 11,559,139 | ||||||||||
Convertible
preferred stock
|
60,000 | 6,000,000 | ||||||||||
Diluted
EPS:
|
||||||||||||
Income
available to common stockholders, including
assumed conversions
|
$ | 919,436 | 96,346,846 | $ | 0.01 |
March
31,
2010
(unaudited)
|
December
31,
2009
|
|||||||
Pharmaceutical
materials
|
$ | 352,500 | $ | 525,000 | ||||
Gamma
detection device materials
|
211,818 | 137,695 | ||||||
Pharmaceutical
work-in-process
|
172,500 | — | ||||||
Gamma
detection device finished goods
|
624,594 | 481,002 | ||||||
Total
|
$ | 1,361,412 | $ | 1,143,697 |
8.
|
Intangible
Assets
|
March 31, 2010
|
December 31, 2009
|
||||||||||||||||
Weighted
Average
Remaining
Life1
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
|||||||||||||
Patents
and trademarks
|
2.7
yrs
|
$ | 533,261 | $ | 444,378 | $ | 524,224 | $ | 445,650 |
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 |
Three Months Ended
March 31,
|
||||||||
2010
|
2009
|
|||||||
Warranty
reserve at beginning of period
|
$ | 61,400 | $ | 62,261 | ||||
Provision
for warranty claims and changes in reserve for warranties
|
38,097 | 37,623 | ||||||
Payments
charged against the reserve
|
(21,873 | ) | (30,291 | ) | ||||
Warranty
reserve at end of period
|
$ | 77,624 | $ | 69,593 |
13.
|
Common
Stock Purchase Agreement
|
14.
|
Income
Taxes
|
($ amounts in thousands)
Three Months Ended March 31, 2010
|
Oncology
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
||||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$ | 2,637 | $ | — | $ | — | $ | 2,637 | ||||||||
International
|
21 | — | — | 21 | ||||||||||||
License
revenue
|
25 | — | — | 25 | ||||||||||||
Research
and development expenses
|
172 | 2,230 | — | 2,402 | ||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
60 | — | 1,006 | 1,066 | ||||||||||||
Depreciation
and amortization
|
33 | 13 | 16 | 62 | ||||||||||||
Income
(loss) from operations3
|
1,529 | (2,243 | ) | (1,022 | ) | (1,736 | ) | |||||||||
Other
income (expense)4
|
— | — | (712 | ) | (712 | ) | ||||||||||
Income
(loss) from continuing operations
|
1,529 | (2,243 | ) | (1,734 | ) | (2,448 | ) | |||||||||
Loss
from discontinued operations
|
— | — | (12 | ) | (12 | ) | ||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||
United
States operations
|
2,204 | 754 | 6,290 | 9,248 | ||||||||||||
Discontinued
operations
|
— | — | 17 | 17 | ||||||||||||
Capital
expenditures
|
— | 78 | 12 | 90 |
($ amounts in thousands)
Three Months Ended March 31, 2009
|
Oncology
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
||||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$ | 2,553 | $ | — | $ | — | $ | 2,553 | ||||||||
International
|
104 | — | — | 104 | ||||||||||||
License
revenue
|
25 | — | — | 25 | ||||||||||||
Research
and development expenses
|
294 | 928 | — | 1,222 | ||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
34 | — | 750 | 784 | ||||||||||||
Depreciation
and amortization
|
37 | 1 | 15 | 53 | ||||||||||||
Income
(loss) from operations3
|
1,491 | (929 | ) | (765 | ) | (203 | ) | |||||||||
Other
income (expense)4
|
— | — | 1,078 | 1,078 | ||||||||||||
Income
(loss) from continuing operations
|
1,491 | (929 | ) | 313 | 874 | |||||||||||
Loss
from discontinued operations
|
— | — | (60 | ) | (60 | ) | ||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||
United
States operations
|
2,526 | 24 | 4,793 | 7,343 | ||||||||||||
Discontinued
operations
|
— | — | 1,728 | 1,728 | ||||||||||||
Capital
expenditures
|
— | — | 40 | 40 |
|
·
|
Completion
of a successful meeting with the United States Food and Drug
Administration (FDA) for the NEO3-05 clinical study to review Phase 3
clinical study results and discuss development plans to support a New Drug
Application (NDA) submission later this summer for Lymphoseek as a
lymphatic tissue tracing agent;
|
|
·
|
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.
|
|
·
|
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.
|
|
·
|
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.
|
|
·
|
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 March 31, 2010, we issued 180,233 shares of
our common stock in payment of December 2009, January 2010 and February
2010 interest of $250,000 on the 10% Series A and Series B Convertible
Senior Secured Promissory Notes held by Platinum Montaur Life Sciences,
LLC (Montaur). Also during the three-month period ended March
31, 2010, we issued 59,524 shares of our common stock in payment of fourth
quarter 2009 dividends of $60,000 on the 8% Series A Cumulative
Convertible Preferred Stock held by 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.
|
(b)
|
During
the three-month period ended March 31, 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. The issuance of the commitment shares to Fusion
Capital was exempt from registration under Sections 4(2) and 4(6) of the
Securities Act and Regulation D.
|
|
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:
May 14, 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) |