Delaware
|
31-1080091
|
(State
or other jurisdiction of
|
(I.R.S.
employer identification no.)
|
incorporation
or organization)
|
3
|
||
3
|
||
5
|
||
6
|
||
7
|
||
14
|
||
14
|
||
14
|
||
16
|
||
17
|
||
18
|
||
19
|
||
21
|
||
22
|
||
23
|
ASSETS
|
March
31,
2006
(unaudited)
|
December
31,
2005
|
|||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
5,658,771
|
$
|
4,940,946
|
|||
Available-for-sale
securities
|
54,853
|
1,529,259
|
|||||
Accounts
receivable, net
|
710,820
|
673,008
|
|||||
Inventory
|
800,910
|
803,703
|
|||||
Prepaid
expenses and other
|
307,340
|
501,557
|
|||||
Total
current assets
|
7,532,694
|
8,448,473
|
|||||
Property
and equipment
|
2,065,528
|
2,051,793
|
|||||
Less
accumulated depreciation and amortization
|
1,785,645
|
1,768,558
|
|||||
279,883
|
283,235
|
||||||
Patents
and trademarks
|
3,170,333
|
3,162,547
|
|||||
Acquired
technology
|
237,271
|
237,271
|
|||||
3,407,604
|
3,399,818
|
||||||
Less
accumulated amortization
|
1,365,875
|
1,300,908
|
|||||
2,041,729
|
2,098,910
|
||||||
Other
assets
|
685,703
|
739,823
|
|||||
Total
assets
|
$
|
10,540,009
|
$
|
11,570,441
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
March
31,
2006
(unaudited)
|
December
31,
2005
|
|||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
423,037
|
$
|
207,824
|
|||
Accrued
liabilities and other
|
348,737
|
821,781
|
|||||
Capital
lease obligations, current
|
19,401
|
19,530
|
|||||
Deferred
revenue, current
|
249,898
|
252,494
|
|||||
Notes
payable to finance companies
|
132,299
|
200,054
|
|||||
Total
current liabilities
|
1,173,372
|
1,501,683
|
|||||
Capital
lease obligations
|
27,302
|
31,855
|
|||||
Deferred
revenue
|
31,944
|
41,132
|
|||||
Notes
payable to CEO, net of discounts of $24,568 and
$26,249, respectively
|
75,432
|
73,751
|
|||||
Notes
payable to investors, net of discounts of $1,965,435 and
$2,099,898, respectively
|
6,034,565
|
5,900,102
|
|||||
Other
liabilities
|
4,510
|
5,122
|
|||||
Total
liabilities
|
7,347,125
|
7,553,645
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Preferred
stock; $.001 par value; 5,000,000 shares
|
|||||||
authorized
at March 31, 2006 and December 31, 2005;
|
|||||||
none
issued and outstanding
|
—
|
—
|
|||||
Common
stock; $.001 par value; 150,000,000 shares
|
|||||||
authorized;
58,690,046 shares issued and outstanding
|
|||||||
at
March 31, 2006; 58,622,059 shares issued and
|
|||||||
outstanding
at December 31, 2005
|
58,690
|
58,622
|
|||||
Additional
paid-in capital
|
135,008,954
|
134,903,259
|
|||||
Accumulated
deficit
|
(131,874,705
|
)
|
(130,947,103
|
)
|
|||
Accumulated
other comprehensive (loss) income
|
(55
|
)
|
2,018
|
||||
Total
stockholders’ equity
|
3,192,884
|
4,016,796
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
10,540,009
|
$
|
11,570,441
|
Three
Months Ended
March
31,
|
|||||||
2006
|
2005
|
||||||
Net
sales
|
$
|
1,787,918
|
$
|
1,465,887
|
|||
Cost
of goods sold
|
737,220
|
563,323
|
|||||
Gross
profit
|
1,050,698
|
902,564
|
|||||
Operating
expenses:
|
|||||||
Research
and development
|
834,183
|
638,445
|
|||||
Selling,
general and administrative
|
852,483
|
836,115
|
|||||
Total
operating expenses
|
1,686,666
|
1,474,560
|
|||||
Loss
from operations
|
(635,968
|
)
|
(571,996
|
)
|
|||
Other
income (expenses):
|
|||||||
Interest
income
|
66,203
|
40,963
|
|||||
Interest
expense
|
(356,534
|
)
|
(327,573
|
)
|
|||
Increase
in warrant liability
|
—
|
(142,427
|
)
|
||||
Other
|
(1,303
|
)
|
(1,738
|
)
|
|||
Total
other expenses
|
(291,634
|
)
|
(430,775
|
)
|
|||
Net
loss
|
$
|
(927,602
|
)
|
$
|
(1,002,771
|
)
|
|
Net
loss per common share:
|
|||||||
Basic
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
|
Diluted
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
|
Weighted
average shares outstanding:
|
|||||||
Basic
|
58,510,944
|
58,317,098
|
|||||
Diluted
|
58,510,944
|
58,317,098
|
Three
Months Ended
March
31,
|
|||||||
2006
|
2005
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(927,602
|
)
|
$
|
(1,002,771
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
|||||||
used
in operating activities:
|
|||||||
Depreciation
and amortization
|
100,700
|
149,812
|
|||||
Amortization
of debt discount and offering costs
|
190,264
|
161,391
|
|||||
Increase
in warrant liability
|
—
|
142,427
|
|||||
Stock
option expense
|
79,150
|
—
|
|||||
Other
|
26,521
|
(111
|
)
|
||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable
|
(37,812
|
)
|
(500,245
|
)
|
|||
Inventory
|
(16,658
|
)
|
(8,259
|
)
|
|||
Prepaid
expenses and other assets
|
196,217
|
87,532
|
|||||
Accounts
payable
|
215,213
|
9,465
|
|||||
Accrued
liabilities and other liabilities
|
(473,657
|
)
|
(74,761
|
)
|
|||
Deferred
revenue
|
(11,784
|
)
|
172,978
|
||||
Net
cash used in operating activities
|
(659,448
|
)
|
(862,542
|
)
|
|||
Cash
flows from investing activities:
|
|||||||
Purchases
of available-for-sale securities
|
—
|
(3,494,029
|
)
|
||||
Maturities
of available-for-sale securities
|
1,476,000
|
—
|
|||||
Purchases
of property and equipment
|
(16,504
|
)
|
(24,748
|
)
|
|||
Proceeds
from sales of property and equipment
|
—
|
154
|
|||||
Patent
and trademark costs
|
(7,786
|
)
|
(8,470
|
)
|
|||
|
|||||||
Net
cash provided by (used in) investing activities
|
1,451,710
|
(3,527,093
|
)
|
||||
Cash
flows from financing activities:
|
|||||||
Proceeds
from issuance of common stock
|
—
|
57,922
|
|||||
Payment
of debt issuance costs
|
(5,000
|
)
|
(9,635
|
)
|
|||
Payment
of notes payable
|
(64,755
|
)
|
(76,977
|
)
|
|||
Payments
under capital leases
|
(4,682
|
)
|
(3,181
|
)
|
|||
Other
|
—
|
20
|
|||||
Net
cash used in financing activities
|
(74,437
|
)
|
(31,851
|
)
|
|||
Net
increase (decrease) in cash and cash equivalents
|
717,825
|
(4,421,486
|
)
|
||||
Cash
and cash equivalents, beginning of period
|
4,940,946
|
9,842,658
|
|||||
Cash
and cash equivalents, end of period
|
$
|
5,658,771
|
$
|
5,421,172
|
1. |
Basis
of Presentation
|
2.
|
Stock-Based
Compensation
|
Three
Months Ended
March
31, 2005
|
||||
Net
loss, as reported
|
$
|
(1,002,771
|
)
|
|
Deduct:
Total stock-based employee compensation expense determined
under fair value based method for all awards
|
(214,301
|
)
|
||
Pro
forma net loss
|
$
|
(1,217,072
|
)
|
|
Loss
per common share:
|
||||
As
reported (basic and diluted)
|
$
|
(0.02
|
)
|
|
Pro
forma (basic and diluted)
|
$
|
(0.02
|
)
|
3. |
Comprehensive
Income (Loss)
|
Three
Months Ended
March
31,
|
|||||||
2006
|
2005
|
||||||
Net
loss
|
$
|
(927,602
|
)
|
$
|
(1,002,771
|
)
|
|
Unrealized
losses on securities
|
(2,073
|
)
|
(2,198
|
)
|
|||
Other
comprehensive loss
|
$
|
(929,675
|
)
|
$
|
(1,004,969
|
)
|
4. |
Earnings
Per Share
|
Three
Months Ended
March
31, 2006
|
Three
Months Ended
March
31, 2005
|
||||||||||||
Basic
Earnings
Per
Share
|
Diluted
Earnings
Per
Share
|
Basic
Earnings
Per
Share
|
Diluted
Earnings
Per
Share
|
||||||||||
Outstanding
shares
|
58,690,046
|
58,690,046
|
58,585,008
|
58,585,008
|
|||||||||
Effect
of weighting changes in
outstanding shares
|
(49,102
|
)
|
(49,102
|
)
|
(137,910
|
)
|
(137,910
|
)
|
|||||
Contingently
issuable shares
|
(130,000
|
)
|
(130,000
|
)
|
(130,000
|
)
|
(130,000
|
)
|
|||||
Adjusted
shares
|
58,510,944
|
58,510,944
|
58,317,098
|
58,317,098
|
5. |
Available-for-Sale
Securities
|
6. |
Inventory
|
March
31,
2006
(unaudited)
|
December
31,
2005
|
||||||
Materials
and component parts
|
$
|
380,956
|
$
|
461,218
|
|||
Finished
goods
|
419,954
|
342,485
|
|||||
Total
|
$
|
800,910
|
$
|
803,703
|
7. |
Intangible
Assets
|
March
31, 2006
|
December
31, 2005
|
|||||||||||||||
Wtd
Avg Life
|
Gross
Carrying Amount
|
Accumulated
Amortization
|
Gross
Carrying Amount
|
Accumulated
Amortization
|
||||||||||||
Patents
and trademarks
|
10
yrs
|
$
|
3,170,333
|
$
|
1,221,303
|
$
|
3,162,547
|
$
|
1,164,763
|
|||||||
Acquired
technology
|
3
yrs
|
237,271
|
144,572
|
237,271
|
136,145
|
|||||||||||
Total
|
$
|
3,407,604
|
$
|
1,365,875
|
$
|
3,399,818
|
$
|
1,300,908
|
Estimated
Amortization Expense
|
||||
For
the year ended 12/31/2006
|
$
|
262,992
|
||
For
the year ended 12/31/2007
|
226,830
|
|||
For
the year ended 12/31/2008
|
201,976
|
|||
For
the year ended 12/31/2009
|
168,267
|
|||
For
the year ended 12/31/2010
|
168,267
|
8. |
Product
Warranty
|
Three
Months Ended
March
31,
|
|||||||
2006
|
2005
|
||||||
Warranty
reserve at beginning of period
|
$
|
41,185
|
$
|
66,000
|
|||
Provision
for warranty claims and changes
in reserve for warranties
|
13,451
|
23,573
|
|||||
Payments
charged against the reserve
|
(10,911
|
)
|
(23,073
|
)
|
|||
Warranty
reserve at end of period
|
$
|
43,725
|
$
|
66,500
|
9. |
Notes
Payable
|
10. |
Stock
Warrants
|
11. |
Segment
and Subsidiary Information
|
($
amounts in thousands)
Three
Months Ended March 31, 2006
|
Gamma
Detection 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
|
|||||||||||
($
amounts in thousands)
Three
Months Ended March 31, 2005
|
Gamma
Detection Devices
|
Blood
Flow Devices
|
Drug
and Therapy Products
|
Corporate
|
Total
|
|||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$
|
1,354
|
$
|
56
|
$
|
—
|
$
|
—
|
$
|
1,410
|
||||||
International
|
42
|
14
|
—
|
—
|
56
|
|||||||||||
Research
and development expenses
|
38
|
350
|
250
|
—
|
638
|
|||||||||||
Selling,
general and administrative expenses,
excluding depreciation and
amortization2
|
—
|
—
|
—
|
686
|
686
|
|||||||||||
Depreciation
and amortization
|
34
|
101
|
—
|
15
|
150
|
|||||||||||
Income
(loss) from operations3
|
793
|
(414
|
)
|
(250
|
)
|
(701
|
)
|
(572
|
)
|
|||||||
Other
income (expenses)4
|
—
|
—
|
—
|
(431
|
)
|
(431
|
)
|
|||||||||
Total
assets, net of depreciation and
amortization:
|
||||||||||||||||
United
States operations
|
1,590
|
171
|
7
|
10,186
|
11,954
|
|||||||||||
Israeli
operations (Cardiosonix Ltd.)
|
—
|
2,766
|
—
|
—
|
2,766
|
|||||||||||
Capital
expenditures
|
—
|
16
|
1
|
8
|
25
|
|||||||||||
1 |
All
sales to EES are made in the United States. EES distributes the product
globally through its international
affiliates.
|
2 |
Selling,
general and administrative expenses, excluding depreciation and
amortization, represent expenses 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 selling,
general
and administrative expenses to the operating
segments.
|
4 |
Amounts
consist primarily of interest income and interest expense which are
not
currently allocated to our individual reportable
segments.
|
12. |
Supplemental
Disclosure for Statements of Cash
Flows:
|
· |
Received
notification of the renewal of our Marketing and Distribution agreement
with our primary gamma detection device marketing partner, Ethicon
Endo-Surgery, Inc. (EES), a Johnson & Johnson company, through
December 2008;
|
· |
Completed
a submission to the U.S. Food and Drug Administration (FDA) to respond
to
information requested by FDA regarding both preclinical toxicity
studies
and the chemistry, manufacturing and control (CMC) issues surrounding
the
commercial production of
Lymphoseek;
|
· |
Authorized
by FDA to commence patient enrollment in a Phase II clinical study of
Lymphoseek;
|
· |
Reviewed
Phase II Lymphoseek protocol and clinical program with clinical
investigators at the Society of Surgical Oncology
meeting;
|
· |
Completed
Investigational New Drug amendment submission for RIGScan CR;
and
|
· |
Received
first commercial production of Quantix devices from U.S.-based contract
manufacturer.
|
· |
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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Allowance
for Doubtful Accounts.
We maintain an allowance for doubtful accounts receivable to cover
estimated losses resulting from the inability of our customers to
make
required payments. We determine the adequacy of this allowance by
regularly reviewing our accounts receivable aging and evaluating
individual customer receivables, considering customers’ credit and
financial condition, payment history and relevant economic conditions.
If
the financial condition of our customers were to deteriorate, resulting
in
an impairment of their ability to make payments, additional allowances
for
doubtful accounts may be required.
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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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Impairment
or Disposal of Long-Lived Assets.
We
account for long-lived assets in accordance with the provisions of
SFAS
No. 144.
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, 2006, 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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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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Fair
Value of Warrant Liability.
U.S. generally accepted accounting principles required us to classify
the
warrants issued in connection with our December 2004 placement of
convertible promissory notes as a liability due to penalty provisions
contained in the underlying securities purchase agreement. The penalty
provisions could have required us to pay a penalty of 0.0667% per
day of
the total debt amount if we failed to meet certain registration deadlines,
or if our stock was suspended from trading for more than 30 days.
As a
liability, the warrants were considered derivative instruments that
were
required to be periodically “marked to market” on our balance sheet. We
estimated the fair value of the warrants at December 31, 2004 using
the
Black-Scholes option pricing model. On February 16, 2005, Neoprobe
and the
investors confirmed in writing their intention that the penalty provisions
which led to this accounting treatment were intended to apply only
to the
$8.1 million principal balance of the promissory notes and underlying
conversion shares and not to the warrant shares. Because the value
of our
stock increased $0.19 per share from $0.40 per share at the closing
date
of the financing on December 14, 2004 to $0.59 per share at December
31,
2004, our year end, the effect of marking the warrant liability to
“market” at December 31, 2004 resulted in an increase in the estimated
fair value of the warrant liability of $1.2 million which was recorded
as
non-cash expense during the fourth quarter of 2004. Subsequently,
the
value of our stock increased $0.02 per share from $0.59 at December
31,
2004 to $0.61 per share at February 16, 2005, such that marking the
warrant liability to “market” at February 16, 2005 resulted in an increase
in the estimated fair value of the warrant liability of $142,427
which was
recorded as non-cash expense during the first quarter of 2005. The
estimated fair value of the warrant liability was then reclassified
to
additional paid-in capital during the first quarter of
2005.
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Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.*
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Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.*
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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.*
|
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.*
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* |
Filed
herewith.
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