o |
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
|
NEOPROBE
CORPORATION
|
(Exact
name of small business issuer 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, OH 43017-1367
|
(Address
of principal executive offices)
|
(614)
793-7500
|
(Issuer’s
telephone number)
|
_____________________________________________________
|
(Former
name, former address and former fiscal year, if changed since last
report)
|
PART
I - Financial Information
|
||
Item
1. Financial Statements
|
3
|
|
Consolidated
Balance Sheets as of March 31, 2007 (unaudited) and December 31,
2006
|
3
|
|
Consolidated
Statements of Operations for the Three-Month Periods Ended March
31, 2007
and March 31, 2006 (unaudited)
|
5
|
|
Consolidated
Statements of Cash Flows for the Three-Month Periods Ended March
31, 2006
and March 31, 2005 (unaudited)
|
6
|
|
Notes
to the Consolidated Financial Statements (unaudited)
|
7
|
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
14
|
|
The
Company
|
14
|
|
Overview
|
14
|
|
Results
of Operations
|
17
|
|
Liquidity
and Capital Resources
|
18
|
|
Recent
Accounting Developments
|
20
|
|
|
||
Critical
Accounting Policies
|
20
|
|
Forward-Looking
Statements
|
22
|
|
|
||
Item
3. Controls and Procedures
|
23
|
|
PART
II - Other Information
|
||
Item
6. Exhibits
|
24
|
March
31,
2007
(unaudited)
|
December
31,
2006
|
||||||
ASSETS | |||||||
Current
assets:
|
|||||||
Cash
|
$
|
1,977,505
|
$
|
2,502,655
|
|||
Accounts
receivable, net
|
977,930
|
1,246,089
|
|||||
Inventory
|
1,047,321
|
1,154,376
|
|||||
Prepaid
expenses and other
|
268,953
|
430,623
|
|||||
Total
current assets
|
4,271,709
|
5,333,743
|
|||||
Property
and equipment
|
2,278,519
|
2,238,050
|
|||||
Less
accumulated depreciation and amortization
|
1,925,433
|
1,882,371
|
|||||
353,086
|
355,679
|
||||||
Patents
and trademarks
|
3,131,508
|
3,131,391
|
|||||
Acquired
technology
|
237,271
|
237,271
|
|||||
3,368,779
|
3,368,662
|
||||||
Less
accumulated amortization
|
1,601,152
|
1,540,145
|
|||||
1,767,627
|
1,828,517
|
||||||
Other
assets
|
458,161
|
515,593
|
|||||
Total
assets
|
$
|
6,850,583
|
$
|
8,033,532
|
March
31,
2007
(unaudited)
|
December
31,
2006
|
||||||
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
922,891
|
$
|
668,288
|
|||
Accrued
liabilities and other
|
632,742
|
544,215
|
|||||
Capital
lease obligations
|
13,944
|
14,841
|
|||||
Deferred
revenue
|
305,211
|
348,568
|
|||||
Notes
payable to finance companies
|
78,812
|
136,925
|
|||||
Notes
payable to investors, current portion, net of discounts of
$161,500 and $53,585, respectively
|
2,813,500
|
1,696,415
|
|||||
Total
current liabilities
|
4,767,100
|
3,409,252
|
|||||
Capital
lease obligations
|
13,358
|
17,014
|
|||||
Deferred
revenue
|
39,782
|
40,495
|
|||||
Notes
payable to CEO, net of discounts of $17,156 and
$19,030, respectively
|
82,844
|
80,970
|
|||||
Notes
payable to investors, net of discounts of $1,209,873 and
$1,468,845, respectively
|
3,290,127
|
4,781,155
|
|||||
Other
liabilities
|
2,061
|
2,673
|
|||||
Total
liabilities
|
8,195,272
|
8,331,559
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders’
deficit:
|
|||||||
Preferred
stock; $.001 par value; 5,000,000 shares
|
|||||||
authorized
at March 31, 2007 and December 31, 2006;
|
|||||||
none
issued and outstanding
|
-
|
-
|
|||||
Common
stock; $.001 par value; 150,000,000 shares
|
|||||||
authorized;
60,088,384 and 59,624,379 shares issued and
|
|||||||
outstanding
at March 31, 2007 and December 31, 2006,
|
|||||||
respectively
|
60,088
|
59,624
|
|||||
Additional
paid-in capital
|
135,394,439
|
135,330,668
|
|||||
Accumulated
deficit
|
(136,799,216
|
)
|
(135,688,319
|
)
|
|||
Total
stockholders’ deficit
|
(1,344,689
|
)
|
(298,027
|
)
|
|||
Total
liabilities and stockholders’ deficit
|
$
|
6,850,583
|
$
|
8,033,532
|
Three
Months Ended
March
31,
|
|||||||
2007
|
2006
|
||||||
Net
sales
|
$
|
1,743,320
|
$
|
1,787,918
|
|||
Cost
of goods sold
|
789,492
|
737,220
|
|||||
Gross
profit
|
953,828
|
1,050,698
|
|||||
Operating
expenses:
|
|||||||
Research
and development
|
863,841
|
834,183
|
|||||
Selling,
general and administrative
|
782,576
|
852,483
|
|||||
Total
operating expenses
|
1,646,417
|
1,686,666
|
|||||
Loss
from operations
|
(692,589
|
)
|
(635,968
|
)
|
|||
Other
income (expenses):
|
|||||||
Interest
income
|
25,058
|
66,203
|
|||||
Interest
expense
|
(442,145
|
)
|
(356,534
|
)
|
|||
Other
|
(1,221
|
)
|
(1,303
|
)
|
|||
Total
other expenses
|
(418,308
|
)
|
(291,634
|
)
|
|||
Net
loss
|
$
|
(1,110,897
|
)
|
$
|
(927,602
|
)
|
|
Net
loss per common share:
|
|||||||
Basic
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
|
Diluted
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
|
Weighted
average shares outstanding:
|
|||||||
Basic
|
59,651,298
|
58,510,944
|
|||||
Diluted
|
59,651,298
|
58,510,944
|
Three
Months Ended
March
31,
|
|||||||
2007
|
2006
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(1,110,897
|
)
|
$
|
(927,602
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
|||||||
used
in operating activities:
|
|||||||
Depreciation
and amortization
|
106,142
|
100,700
|
|||||
Amortization
of debt discount and debt offering costs
|
210,364
|
190,264
|
|||||
Stock
compensation expense
|
34,348
|
79,150
|
|||||
Other
|
31,493
|
26,521
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable
|
268,159
|
(37,812
|
)
|
||||
Inventory
|
91,947
|
(16,658
|
)
|
||||
Prepaid
expenses and other assets
|
82,197
|
196,217
|
|||||
Accounts
payable
|
254,603
|
215,213
|
|||||
Accrued
liabilities and other liabilities
|
37,914
|
(473,657
|
)
|
||||
Deferred
revenue
|
(44,070
|
)
|
(11,784
|
)
|
|||
Net
cash used in operating activities
|
(37,800
|
)
|
(659,448
|
)
|
|||
Cash
flows from investing activities:
|
|||||||
Maturities
of available-for-sale securities
|
-
|
1,476,000
|
|||||
Purchases
of property and equipment
|
(29,259
|
)
|
(16,504
|
)
|
|||
Patent
and trademark costs
|
(385
|
)
|
(7,786
|
)
|
|||
Net
cash (used in) provided by investing activities
|
(29,644
|
)
|
1,451,710
|
||||
Cash
flows from financing activities:
|
|||||||
Proceeds
from issuance of common stock
|
150,000
|
-
|
|||||
Payment
of stock offering costs
|
(20,040
|
)
|
(5,000
|
)
|
|||
Payment
of notes payable
|
(583,113
|
)
|
(64,755
|
)
|
|||
Payments
under capital leases
|
(4,553
|
)
|
(4,682
|
)
|
|||
Net
cash used in financing activities
|
(457,706
|
)
|
(74,437
|
)
|
|||
Net
(decrease) increase in cash
|
(525,150
|
)
|
717,825
|
||||
Cash,
beginning of period
|
2,502,655
|
4,940,946
|
|||||
Cash,
end of period
|
$
|
1,977,505
|
$
|
5,658,771
|
1.
|
Basis
of Presentation
|
2.
|
Stock-Based
Compensation
|
Three
Months Ended March 31, 2007
|
|||||||||||||
Number
of Options
|
Weighted
Average Exercise Price
|
Weighted
Average Remaining Contractual Life
|
Aggregate
Intrinsic Value
|
||||||||||
Outstanding,
January 1, 2007
|
5,975,473
|
$
|
0.42
|
||||||||||
Granted
|
-
|
-
|
|||||||||||
Exercised
|
-
|
-
|
|||||||||||
Forfeited
|
-
|
-
|
|||||||||||
Expired
|
-
|
-
|
|||||||||||
Outstanding,
March 31, 2007
|
5,975,473
|
$
|
0.42
|
5.8
years
|
-
|
||||||||
Exercisable,
March 31, 2007
|
4,887,806
|
$
|
0.44
|
5.4
years
|
-
|
3.
|
Comprehensive
Income (Loss)
|
Three
Months Ended
March
31, 2006
|
||||
Net
loss
|
$
|
(927,602
|
)
|
|
Unrealized
losses on securities
|
(2,073
|
)
|
||
Other
comprehensive loss
|
$
|
(929,675
|
)
|
4.
|
Earnings
Per Share
|
Three
Months Ended
March
31, 2007
|
Three
Months Ended
March
31, 2006
|
||||||||||||
Basic
Earnings
Per
Share
|
Diluted
Earnings
Per
Share
|
Basic
Earnings
Per
Share
|
Diluted
Earnings
Per
Share
|
||||||||||
Outstanding
shares
|
60,088,384
|
60,088,384
|
58,690,046
|
58,690,046
|
|||||||||
Effect
of weighting changes in
outstanding shares
|
(437,086
|
)
|
(437,086
|
)
|
(49,102
|
)
|
(49,102
|
)
|
|||||
Contingently issuable shares |
-
|
-
|
(130,000
|
)
|
(130,000
|
)
|
|||||||
Adjusted
shares
|
59,651,298
|
59,651,298
|
58,510,944
|
58,510,944
|
5.
|
Inventory
|
March
31,
2007
(unaudited)
|
December
31,
2006
|
||||||
Materials
and component parts
|
$
|
579,666
|
$
|
522,225
|
|||
Work-in-process
|
-
|
167,188
|
|||||
Finished
goods
|
467,655
|
464,963
|
|||||
Total
|
$
|
1,047,321
|
$
|
1,154,376
|
6. |
Intangible
Assets
|
March
31, 2007
|
December
31, 2006
|
|||||||||||||||
Wtd
Avg Life
|
Gross
Carrying Amount
|
Accumulated
Amortization
|
Gross
Carrying Amount
|
Accumulated
Amortization
|
||||||||||||
Patents
and trademarks
|
9.4
yrs
|
$
|
3,131,508
|
$
|
1,422,871
|
$
|
3,131,391
|
$
|
1,370,291
|
|||||||
Acquired
technology
|
1.8
yrs
|
237,271
|
178,281
|
237,271
|
169,854
|
|||||||||||
Total
|
$
|
3,368,779
|
$
|
1,601,152
|
$
|
3,368,662
|
$
|
1,540,145
|
Estimated
Amortization Expense
|
||||
For
the year ended 12/31/2007
|
$
|
222,709
|
||
For
the year ended 12/31/2008
|
216,116
|
|||
For
the year ended 12/31/2009
|
170,852
|
|||
For
the year ended 12/31/2010
|
170,033
|
|||
For
the year ended 12/31/2011
|
168,581
|
7. |
Product
Warranty
|
Three
Months Ended
March
31,
|
|||||||
2007
|
2006
|
||||||
Warranty
reserve at beginning of period
|
$
|
44,858
|
$
|
41,185
|
|||
Provision
for warranty claims and changes
in reserve for warranties
|
32,752
|
13,451
|
|||||
Payments
charged against the reserve
|
(10,209
|
)
|
(10,911
|
)
|
|||
Warranty
reserve at end of period
|
$
|
67,401
|
$
|
43,725
|
8. |
Notes
Payable
|
9. |
Stock
Warrants
|
10. |
Income
Taxes
|
11. |
Segment
and Subsidiary Information
|
($
amounts in thousands)
Three
Months Ended March 31, 2007
|
Oncology
Devices
|
Blood
Flow Devices
|
Drug
and Therapy Products
|
Corporate
|
Total
|
|||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$
|
1,552
|
$
|
45
|
$
|
-
|
$
|
-
|
$
|
1,597
|
||||||
International
|
84
|
62
|
-
|
-
|
146
|
|||||||||||
Research
and development expenses
|
213
|
108
|
543
|
-
|
864
|
|||||||||||
Selling,
general and administrative expenses,
excluding depreciation and
amortization2
|
-
|
-
|
-
|
677
|
677
|
|||||||||||
Depreciation
and amortization
|
26
|
66
|
-
|
14
|
106
|
|||||||||||
Income
(loss) from operations3
|
675
|
(134
|
)
|
(543
|
)
|
(691
|
)
|
(693
|
)
|
|||||||
Other
income (expenses)4
|
-
|
-
|
-
|
(418
|
)
|
(418
|
)
|
|||||||||
Total
assets, net of depreciation and
amortization:
|
||||||||||||||||
United
States operations
|
1,602
|
708
|
57
|
2,766
|
5,133
|
|||||||||||
Israeli
operations (Cardiosonix Ltd.)
|
-
|
1,718
|
-
|
-
|
1,718
|
|||||||||||
Capital
expenditures
|
10
|
9
|
-
|
10
|
29
|
($
amounts in thousands)
Three
Months Ended March 31, 2006
|
Oncology
Devices
|
Blood
Flow Devices
|
Drug
and Therapy Products
|
Corporate
|
Total
|
|||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$
|
1,479
|
$
|
35
|
$
|
-
|
$
|
-
|
$
|
1,514
|
||||||
International
|
95
|
179
|
-
|
-
|
274
|
|||||||||||
Research
and development expenses
|
112
|
257
|
465
|
-
|
834
|
|||||||||||
Selling,
general and administrative expenses,
excluding depreciation and
amortization2
|
-
|
-
|
-
|
751
|
751
|
|||||||||||
Depreciation
and amortization
|
28
|
59
|
-
|
14
|
101
|
|||||||||||
Income
(loss) from operations3
|
793
|
(199
|
)
|
(465
|
)
|
(765
|
)
|
(636
|
)
|
|||||||
Other
income (expenses)4
|
-
|
-
|
-
|
(292
|
)
|
(292
|
)
|
|||||||||
Total
assets, net of depreciation and
amortization:
|
||||||||||||||||
United
States operations
|
986
|
565
|
36
|
6,778
|
8,365
|
|||||||||||
Israeli
operations (Cardiosonix Ltd.)
|
-
|
2,175
|
-
|
-
|
2,175
|
|||||||||||
Capital
expenditures
|
-
|
1
|
-
|
16
|
17
|
12. |
Supplemental
Disclosure for Statements of Cash
Flows:
|
·
|
Granted
authorization by the U.S. Food and Drug Administration (FDA) to commence
patient enrollment in two Phase 1 clinical studies to evaluate the
safety
and efficacy of Lymphoseek in prostate and colon
cancers.
|
·
|
Achieved
and reported positive interim results from the first 40-patient stage
of
the Phase 2 Lymphoseek trial in breast cancer and melanoma. Lymphoseek
identified lymphatic tissue in over 97% of treated
patients.
|
·
|
Commenced
patient enrollment in the second and final 40-patient stage of the
Phase 2
Lymphoseek breast cancer and melanoma
trial.
|
·
|
Reviewed
proposed Phase 3 Lymphoseek protocols and clinical development program
with prospective clinical investigators at the March 2007 Society
of
Surgical Oncology meeting.
|
·
|
Extended
the Company’s option agreement with the University of California, San
Diego covering the potential use of Lymphoseek as an optical or ultrasound
agent.
|
·
|
Filed
an updated chemistry, manufacturing and control (CMC) amendment on
Lymphoseek and an expanded non-clinical study package with FDA in
preparation for the next phase of Lymphoseek clinical development
program.
|
·
|
Stock-Based
Compensation. Effective
January 1, 2006, we adopted SFAS No. 123(R), Share-Based
Payment,
which is a revision of SFAS No. 123, Accounting
for Stock-Based Compensation.
SFAS No. 123(R) supersedes APB Opinion No. 25, Accounting
for Stock Issued to Employees,
and amends SFAS No. 95, Statement
of Cash Flows.
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 used the modified prospective application
method in adopting SFAS No. 123 (R). 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. Prior to
the
adoption of SFAS No. 123(R), we followed the guidance in APB No.
25 which
resulted in disclosure only of the financial impact of stock options.
Financial statements of the Company for periods prior to January
1, 2006
do not reflect any recorded stock-based compensation expense. In
adopting
SFAS No. 123(R), we made no modifications to outstanding stock options,
nor do we have any other outstanding share-based payment instruments
subject to SFAS No. 123(R). Based in part on the anticipated adoption
of
SFAS No. 123(R), the Company generally reduced number of stock options
issued by individual in 2005 and shortened the vesting periods, with
a
portion of the options vesting immediately and the remainder vesting
over
a two-year period as compared to our previous practice of issuing
stock
options that vested over a three-year period. We will continue to
evaluate
compensation trends and may further revise our option granting practices
in future years.
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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, product
recalls and variation in product utilization all impact the estimates
related to excess and obsolete
inventory.
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·
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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, 2007, the most significant long-lived assets on our balance sheet
relate to assets recorded in connection with the acquisition of
Cardiosonix and gamma detection device patents related to ILM. The
recoverability of these assets is based on the financial projections
and
models related to the future sales success of Cardiosonix’ products and
the continuing success of our gamma detection product line. 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.
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·
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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.
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31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.*
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31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.*
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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.*
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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.*
|
NEOPROBE CORPORATION
(the
Company)
Dated:
May 15, 2007
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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)
|