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
|
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)
|
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 March 31, 2009 (unaudited) and December 31,
2008
|
3 | ||||
Consolidated
Statements of Operations for the Three-Month Periods Ended March 31, 2009
and March 31, 2008 (unaudited)
|
5 | ||||
Consolidated
Statement of Stockholders’ Deficit for the Three-Month Period Ended March
31, 2009 (unaudited)
|
6 | ||||
Consolidated
Statements of Cash Flows for the Three-Month Periods Ended March 31, 2009
and March 31, 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
|
21 | |||
Forward-Looking
Statements
|
21 | ||||
The
Company
|
21 | ||||
Product
Line Overview
|
21 | ||||
Results
of Operations
|
23 | ||||
Liquidity
and Capital Resources
|
25 | ||||
Recent
Accounting Developments
|
27 | ||||
Critical
Accounting Policies
|
29 | ||||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
31 | |||
Item
4T.
|
Controls
and Procedures
|
31 | |||
PART
II – Other Information
|
|||||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
33 | |||
Item
6.
|
Exhibits
|
33 |
ASSETS
|
March 31,
2009
(unaudited)
|
December 31,
2008
|
||||||
Current
assets:
|
||||||||
Cash
|
$ | 3,549,057 | $ | 3,565,837 | ||||
Available-for-sale
securities
|
- | 495,383 | ||||||
Accounts
receivable, net
|
1,685,209 | 1,644,070 | ||||||
Inventory
|
976,138 | 961,861 | ||||||
Prepaid
expenses and other
|
546,162 | 573,573 | ||||||
Total
current assets
|
6,756,566 | 7,240,724 | ||||||
Property
and equipment
|
2,082,459 | 2,060,588 | ||||||
Less
accumulated depreciation and amortization
|
1,696,304 | 1,669,796 | ||||||
386,155 | 390,792 | |||||||
Patents
and trademarks
|
3,032,667 | 3,020,001 | ||||||
Acquired
technology
|
237,271 | 237,271 | ||||||
3,269,938 | 3,257,272 | |||||||
Less
accumulated amortization
|
1,909,871 | 1,863,787 | ||||||
1,360,067 | 1,393,485 | |||||||
Other
assets
|
568,019 | 594,449 | ||||||
Total
assets
|
$ | 9,070,807 | $ | 9,619,450 |
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
March 31,
2009
(unaudited)
|
December 31,
2008
|
||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 692,302 | $ | 731,220 | ||||
Accrued
liabilities and other
|
942,210 | 917,676 | ||||||
Capital
lease obligations, current portion
|
7,417 | 9,084 | ||||||
Deferred
revenue, current portion
|
511,776 | 526,619 | ||||||
Notes
payable to finance companies
|
86,865 | 137,857 | ||||||
Total
current liabilities
|
2,240,570 | 2,322,456 | ||||||
Capital
lease obligations, net of current portion
|
9,341 | 11,095 | ||||||
Deferred
revenue, net of current portion
|
474,193 | 490,165 | ||||||
Notes
payable to CEO, net of discounts of $71,012 and
$76,294, respectively
|
928,988 | 923,706 | ||||||
Notes
payable to investors, net of discounts of $4,909,630 and
$5,001,149, respectively
|
5,090,370 | 4,998,851 | ||||||
Derivative
liabilities
|
12,345,006 | 853,831 | ||||||
Other
liabilities
|
42,320 | 45,071 | ||||||
Total
liabilities
|
21,130,788 | 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
March 31, 2009 and December 31, 2008
|
3,000,000 | 3,000,000 | ||||||
Stockholders’
deficit:
|
||||||||
Common
stock; $.001 par value; 150,000,000 shares authorized;
|
||||||||
71,555,707
and 70,862,641 shares issued and outstanding at
|
||||||||
March
31, 2009 and December 31, 2008, respectively
|
71,556 | 70,863 | ||||||
Additional
paid-in capital
|
136,967,308 | 145,742,044 | ||||||
Accumulated
deficit
|
(152,098,845 | ) | (148,840,015 | ) | ||||
Unrealized
gain on available-for-sale securities
|
- | 1,383 | ||||||
Total
stockholders’ deficit
|
(15,059,981 | ) | (3,025,725 | ) | ||||
Total
liabilities and stockholders’ deficit
|
$ | 9,070,807 | $ | 9,619,450 |
Three Months Ended
March 31,
|
||||||||
2009
|
2008
|
|||||||
Revenues:
|
||||||||
Net
sales
|
$ | 2,700,036 | $ | 1,782,792 | ||||
License
and other revenue
|
25,000 | - | ||||||
Total
revenues
|
2,725,036 | 1,782,792 | ||||||
Cost
of goods sold
|
848,534 | 660,007 | ||||||
Gross
profit
|
1,876,502 | 1,122,785 | ||||||
Operating
expenses:
|
||||||||
Research
and development
|
1,238,058 | 563,703 | ||||||
Selling,
general and administrative
|
902,048 | 875,408 | ||||||
Total
operating expenses
|
2,140,106 | 1,439,111 | ||||||
Loss
from operations
|
(263,604 | ) | (316,326 | ) | ||||
Other
income (expense):
|
||||||||
Interest
income
|
9,949 | 10,608 | ||||||
Interest
expense
|
(457,134 | ) | (331,779 | ) | ||||
Change
in derivative liabilities
|
1,525,365 | (386,746 | ) | |||||
Other
|
(455 | ) | (1,748 | ) | ||||
Total
other income (expense), net
|
1,077,725 | (709,665 | ) | |||||
Net
income (loss)
|
814,121 | (1,025,991 | ) | |||||
Preferred
stock dividends
|
(60,000 | ) | - | |||||
Income
(loss) attributable to common stockholders
|
$ | 754,121 | $ | (1,025,991 | ) | |||
Income
(loss) per common share:
|
||||||||
Basic
|
$ | 0.01 | $ | (0.02 | ) | |||
Diluted
|
$ | 0.01 | $ | (0.02 | ) | |||
Weighted
average shares outstanding:
|
||||||||
Basic
|
71,387,438 | 67,284,589 | ||||||
Diluted
|
96,346,846 | 67,284,589 |
Common Stock
|
Additional
Paid-in
|
Accumulated
|
Accumulated
Other
Comprehensive
|
|||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Income (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
|
50,000 | 50 | 25,950 | - | - | 26,000 | ||||||||||||||||||
Issued
stock as payment of interest
on convertible debt
|
152,066 | 152 | 83,181 | - | - | 83,333 | ||||||||||||||||||
Stock
compensation expense
|
- | - | 70,536 | - | - | 70,536 | ||||||||||||||||||
Paid
preferred stock issuance costs
|
- | - | (6,323 | ) | - | - | (6,323 | ) | ||||||||||||||||
Preferred
stock dividends
|
- | - | - | (60,000 | ) | - | (60,000 | ) | ||||||||||||||||
Comprehensive
income (loss):
|
||||||||||||||||||||||||
Net
income
|
- | - | - | 814,121 | - | 814,121 | ||||||||||||||||||
Unrealized
loss on available-for-sale
securities
|
- | - | - | - | (1,383 | ) | (1,383 | ) | ||||||||||||||||
Total
comprehensive income
|
812,738 | |||||||||||||||||||||||
Balance,
March 31, 2009
|
71,555,707 | $ | 71,556 | $ | 136,967,308 | $ | (152,098,845 | ) | $ | - | $ | (15,059,981 | ) |
Three Months Ended
March 31,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
income (loss)
|
$ | 814,121 | $ | (1,025,991 | ) | |||
Adjustments
to reconcile net income (loss) to net cash
|
||||||||
used
in operating activities:
|
||||||||
Depreciation
and amortization
|
100,896 | 95,815 | ||||||
Amortization
of debt discount and debt offering costs
|
179,730 | 129,373 | ||||||
Provision
for bad debts
|
- | 4,558 | ||||||
Issuance
of common stock in payment of interest
|
83,333 | - | ||||||
Stock
compensation expense
|
70,536 | 48,211 | ||||||
Change
in derivative liabilities
|
(1,525,365 | ) | 386,746 | |||||
Other
|
4,581 | 32,795 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
(41,139 | ) | 404,655 | |||||
Inventory
|
(28,794 | ) | 123,057 | |||||
Prepaid
expenses and other assets
|
33,955 | 64,041 | ||||||
Accounts
payable
|
(38,918 | ) | 36,996 | |||||
Accrued
liabilities and other liabilities
|
(38,217 | ) | (312,631 | ) | ||||
Deferred
revenue
|
(30,815 | ) | (29,976 | ) | ||||
Net
cash used in operating activities
|
(416,096 | ) | (42,351 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Maturities
of available-for-sale securities
|
494,000 | - | ||||||
Purchases
of property and equipment
|
(40,491 | ) | (15,572 | ) | ||||
Proceeds
from sales of property and equipment
|
251 | 120 | ||||||
Patent
and trademark costs
|
(12,665 | ) | (487 | ) | ||||
Net
cash provided by (used in) investing activities
|
441,095 | (15,939 | ) | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from issuance of common stock
|
25,500 | 114,200 | ||||||
Payment
of common stock offering costs
|
(6,544 | ) | - | |||||
Payment
of preferred stock offering costs
|
(6,322 | ) | - | |||||
Payment
of debt issuance costs
|
- | (11,406 | ) | |||||
Payment
of notes payable
|
(50,992 | ) | (52,887 | ) | ||||
Payments
under capital leases
|
(3,421 | ) | (3,656 | ) | ||||
Net
cash (used in) provided by financing activities
|
(41,779 | ) | 46,251 | |||||
Net
decrease in cash
|
(16,780 | ) | (12,039 | ) | ||||
Cash,
beginning of period
|
3,565,837 | 1,540,220 | ||||||
Cash,
end of period
|
$ | 3,549,057 | $ | 1,528,181 |
1.
|
Summary
of Significant Accounting Policies
|
|
a.
|
Basis of
Presentation: The information presented as of March 31,
2009 and for the three-month periods ended March 31, 2009 and March 31,
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 U.S. generally accepted accounting
principles have been condensed or omitted pursuant to the rules and
regulations of the U.S. Securities and Exchange Commission. 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: We adopted Statement of Financial Accounting
Standards (SFAS) No. 157, Fair Value
Measurements, for financial assets and liabilities as of January 1,
2008. SFAS No. 157 establishes a fair value hierarchy that
prioritizes the inputs to valuation techniques used to measure fair
value. The hierarchy gives 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
under SFAS No. 157 are described
below:
|
2.
|
Fair
Value Hierarchy
|
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)
|
2009
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related
to warrants
|
$ | - | $ | 6,743,325 | $ | - | $ | 6,743,325 | ||||||||
Derivative
liabilities
related to conversion and
put options
|
- | - | 5,601,681 | 5,601,681 | ||||||||||||
Total
derivative liabilities
|
$ | - | $ | 6,743,325 | $ | 5,601,681 | $ | 12,345,006 |
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 |
Description
|
Balance at
December 31,
2008
|
Unrealized
Gains
|
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 |
3.
|
Stock-Based
Compensation
|
Three Months Ended March 31, 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
|
(80,000 | ) | 0.30 | ||||||||||
Forfeited
|
- | - | |||||||||||
Expired
|
(79,000 | ) | 1.25 | ||||||||||
Outstanding
at end of period
|
5,743,500 | $ | 0.40 |
5.4 years
|
$ | 938,200 | |||||||
Exercisable
at end of period
|
4,914,500 | $ | 0.39 |
4.8 years
|
$ | 847,700 |
Three Months Ended
March 31, 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 |
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, 2009
|
Three Months Ended
March 31, 2008
|
|||||||||||||||
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
|||||||||||||
Outstanding
shares
|
71,555,707 | 71,555,707 | 68,950,821 | 68,950,821 | ||||||||||||
Effect
of weighting changes in
outstanding shares
|
(168,269 | ) | (168,269 | ) | (1,216,232 | ) | (1,216,232 | ) | ||||||||
Unvested
restricted stock
|
- | - | (450,000 | ) | (450,000 | ) | ||||||||||
Stock
options
|
- | 1,803,941 | - | - | ||||||||||||
Warrants
|
- | 5,596,328 | - | - | ||||||||||||
Convertible
debt
|
- | 11,559,139 | - | - | ||||||||||||
Convertible
preferred stock
|
- | 6,000,000 | - | - | ||||||||||||
Adjusted
shares
|
71,387,438 | 96,346,846 | 67,284,589 | 67,284,589 |
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,
2009
(unaudited)
|
December 31,
2008
|
|||||||
Materials
and component parts
|
$ | 301,667 | $ | 380,912 | ||||
Finished
goods
|
674,471 | 580,949 | ||||||
Total
|
$ | 976,138 | $ | 961,861 |
7.
|
Intangible
Assets
|
March 31, 2009
|
December 31, 2008
|
|||||||||||||||||
Wtd
Avg
Life
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
||||||||||||||
Patents
and trademarks
|
7.5
yrs
|
$ | 3,032,667 | $ | 1,672,600 | $ | 3,020,001 | $ | 1,626,516 | |||||||||
Acquired
technology
|
0
yrs
|
237,271 | 237,271 | 237,271 | 237,271 | |||||||||||||
Total
|
$ | 3,269,938 | $ | 1,909,871 | $ | 3,257,272 | $ | 1,863,787 |
Estimated
Amortization
Expense
|
||||
For
the year ended 12/31/2009
|
$ | 170,957 | ||
For
the year ended 12/31/2010
|
170,341 | |||
For
the year ended 12/31/2011
|
169,224 | |||
For
the year ended 12/31/2012
|
168,885 | |||
For
the year ended 12/31/2013
|
168,675 |
Three Months Ended
March 31,
|
||||||||
2009
|
2008
|
|||||||
Warranty
reserve at beginning of period
|
$ | 72,643 | $ | 115,395 | ||||
Provision
for warranty claims and changes
in reserve for warranties
|
37,109 | (14,036 | ) | |||||
Payments
charged against the reserve
|
(30,380 | ) | (19,846 | ) | ||||
Warranty
reserve at end of period
|
$ | 79,372 | $ | 81,513 |
December 31,
2008
|
Impact of
Adopting
EITF Issue
No. 07-5
|
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.
|
Income
Taxes
|
($ amounts in thousands)
Three Months Ended March 31, 2009
|
Oncology
Devices
|
Blood
Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales:
|
||||||||||||||||||||
United
States1
|
$ | 2,553 | $ | 29 | $ | - | $ | - | $ | 2,582 | ||||||||||
International
|
104 | 14 | - | - | 118 | |||||||||||||||
Research
and development expenses
|
294 | 16 | 928 | - | 1,238 | |||||||||||||||
Selling,
general and administrative expenses,
excluding depreciation and
amortization2
|
34 | 15 | - | 752 | 801 | |||||||||||||||
Depreciation
and amortization
|
37 | 48 | 1 | 15 | 101 | |||||||||||||||
Income
(loss) from operations
|
1,491 | (58 | ) | (929 | ) | (768 | ) | (264 | ) | |||||||||||
Other
income (expenses)4
|
- | - | - | 1,078 | 1,078 | |||||||||||||||
Total
assets, net of depreciation and
amortization:
|
||||||||||||||||||||
United
States operations
|
2,526 | 411 | 24 | 4,793 | 7,754 | |||||||||||||||
Israeli
operations (Cardiosonix Ltd.)
|
- | 1,317 | - | - | 1,317 | |||||||||||||||
Capital
expenditures
|
- | - | - | 40 | 40 |
($ amounts in thousands)
Three Months Ended March 31, 2008
|
Oncology
Devices
|
Blood
Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales:
|
||||||||||||||||||||
United
States1
|
$ | 1,732 | $ | 3 | $ | - | $ | - | $ | 1,735 | ||||||||||
International
|
11 | 37 | - | - | 48 | |||||||||||||||
Research
and development expenses
|
164 | 69 | 331 | - | 564 | |||||||||||||||
Selling,
general and administrative expenses,
excluding depreciation and
amortization2
|
- | - | - | 779 | 779 | |||||||||||||||
Depreciation
and amortization
|
23 | 64 | - | 9 | 96 | |||||||||||||||
Income
(loss) from operations3
|
932 | (128 | ) | (331 | ) | (789 | ) | (316 | ) | |||||||||||
Other
income (expenses)4
|
- | - | - | (710 | ) | (710 | ) | |||||||||||||
Total
assets, net of depreciation and
amortization:
|
||||||||||||||||||||
United
States operations
|
1,751 | 664 | 186 | 2,247 | 4,848 | |||||||||||||||
Israeli
operations (Cardiosonix Ltd.)
|
- | 1,510 | - | - | 1,510 | |||||||||||||||
Capital
expenditures
|
2 | - | - | 14 | 16 |
|
1
All sales to EES are made in the United States. EES
distributes the product globally through its international
affiliates.
|
|
2
General and administrative costs, 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. Beginning in the third quarter of 2008,
marketing and selling costs 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 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.
|
|
·
|
Achievement
of target enrollment in a Phase 3 (NEO3-05) clinical evaluation of
Lymphoseek in patients with breast cancer or
melanoma
|
|
·
|
Assessment
of preliminary data that the NEO3-05 clinical study achieved its primary
efficacy end-point
|
|
·
|
Stock-Based
Compensation. We
account for stock-based compensation in accordance with SFAS No. 123(R),
Share-Based
Payment, which is a revision of SFAS No. 123, Accounting for Stock-Based
Compensation. SFAS No. 123(R) 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. The valuation assumptions used have not
changed from those used under SFAS No.
123.
|
|
·
|
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 SFAS No. 144, Accounting for the Impairment
or Disposal of Long-Lived Assets. This Statement
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. As of
March 31, 2009, the most significant long-lived assets on our balance
sheet relate to assets recorded in connection with the acquisition of
Cardiosonix. The recoverability of these assets is based on the
financial projections and models related to the future sales success of
Cardiosonix’ products. As such, these assets could be subject
to significant adjustment should the Cardiosonix technology not be
successfully commercialized or the sales amounts in our current
projections not be realized.
|
|
·
|
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 SFAS No. 133, Accounting for Derivative
Instruments and Hedging Activities, which 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 EITF Issue No. 07-5, Determining Whether an
Instrument (or Embedded Feature) is Indexed to an Entity’s Own
Stock. EITF Issue No. 07-5 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 under SFAS No. 133. As a result of adopting EITF
Issue No. 07-5, 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 March 31, 2009, we issued 152,066 shares of
our common stock in payment of January 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. Also during the
three-month period ended March 31, 2009, our President and CEO, David C.
Bupp, exercised a portion of his Series Q Warrant and we issued 50,000
shares of our common stock in exchange for gross proceeds of
$25,000. The issuances of the shares to the noteholder and Mr.
Bupp were 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 15, 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)
|