Delaware
|
31-1080091
|
|
(State
or other jurisdiction of
incorporation or organization)
|
(I.R.S.
employer identification no.)
|
ASSETS
|
September
30,
2005
(unaudited)
|
December
31,
2004
|
|||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
3,560,771
|
$
|
9,842,658
|
|||
Available-for-sale
securities
|
3,470,758
|
—
|
|||||
Accounts
receivable, net
|
874,613
|
411,856
|
|||||
Inventory
|
817,723
|
855,022
|
|||||
Prepaid
expenses and other
|
164,286
|
327,408
|
|||||
Total
current assets
|
8,888,151
|
11,436,944
|
|||||
Property
and equipment
|
2,395,652
|
2,341,785
|
|||||
Less
accumulated depreciation and amortization
|
2,101,935
|
2,003,942
|
|||||
293,717
|
337,843
|
||||||
Patents
and trademarks
|
3,170,210
|
3,155,334
|
|||||
Non-compete
agreements
|
584,516
|
584,516
|
|||||
Acquired
technology
|
237,271
|
237,271
|
|||||
3,991,997
|
3,977,121
|
||||||
Less
accumulated amortization
|
1,779,802
|
1,458,012
|
|||||
2,212,195
|
2,519,109
|
||||||
Other
assets
|
885,030
|
1,071,999
|
|||||
Total
assets
|
$
|
12,279,093
|
$
|
15,365,895
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
September
30,
2005
(unaudited)
|
December
31,
2004
|
|||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
307,194
|
$
|
198,912
|
|||
Accrued
liabilities and other
|
383,430
|
378,247
|
|||||
Capital
lease obligations, current
|
18,076
|
13,863
|
|||||
Deferred
revenue, current
|
294,547
|
176,192
|
|||||
Notes
payable to finance companies
|
17,710
|
242,722
|
|||||
Total
current liabilities
|
1,020,957
|
1,009,936
|
|||||
Capital
lease obligations
|
34,564
|
30,297
|
|||||
Deferred
revenue
|
50,171
|
57,591
|
|||||
Notes
payable to CEO, net of discounts of $27,849
|
|||||||
and
$32,204, respectively
|
72,151
|
67,796
|
|||||
Notes
payable to investor, net of discounts of $2,227,915
|
|||||||
and
$2,576,302, respectively
|
5,772,085
|
5,423,698
|
|||||
Liability
related to warrants to purchase common stock
|
—
|
2,560,307
|
|||||
Other
liabilities
|
19,876
|
52,440
|
|||||
Total
liabilities
|
6,969,804
|
9,202,065
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Preferred
stock; $.001 par value; 5,000,000 shares
|
|||||||
authorized
at September 30, 2005 and December 31, 2004;
|
|||||||
none
issued and outstanding (500,000 shares designated
|
|||||||
as
Series A, $.001 par value, at September 30, 2005 and
|
|||||||
and
December 31, 2004; none outstanding)
|
—
|
—
|
|||||
Common
stock; $.001 par value; 150,000,000 shares
|
|||||||
authorized,
58,622,059 shares issued and outstanding
|
|||||||
at
September 30, 2005; 100,000,000 shares authorized,
|
|||||||
58,378,143
shares issued and outstanding at
|
|||||||
December
31, 2004
|
58,622
|
58,378
|
|||||
Additional
paid-in capital
|
134,903,259
|
132,123,605
|
|||||
Accumulated
deficit
|
(129,649,802
|
)
|
(126,018,153
|
)
|
|||
Accumulated
other comprehensive loss
|
(2,790
|
)
|
—
|
||||
Total
stockholders’ equity
|
5,309,289
|
6,163,830
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
12,279,093
|
$
|
15,365,895
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues:
|
|||||||||||||
Net
sales
|
$
|
1,333,536
|
$
|
1,525,134
|
$
|
4,500,301
|
$
|
4,098,679
|
|||||
License
and other revenue
|
—
|
200,000
|
—
|
600,000
|
|||||||||
Total
revenues
|
1,333,536
|
1,725,134
|
4,500,301
|
4,698,679
|
|||||||||
Cost
of goods sold
|
532,601
|
643,303
|
1,738,157
|
1,692,084
|
|||||||||
Gross
profit
|
800,935
|
1,081,831
|
2,762,144
|
3,006,595
|
|||||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
1,106,242
|
588,435
|
3,048,056
|
1,766,265
|
|||||||||
Selling,
general and administrative
|
689,030
|
695,399
|
2,352,977
|
2,361,941
|
|||||||||
Total
operating expenses
|
1,795,272
|
1,283,834
|
5,401,033
|
4,128,206
|
|||||||||
Loss
from operations
|
(994,337
|
)
|
(202,003
|
)
|
(2,638,889
|
)
|
(1,121,611
|
)
|
|||||
Other
income (expenses):
|
|||||||||||||
Interest
income
|
57,596
|
8,367
|
166,475
|
13,724
|
|||||||||
Interest
expense
|
(340,366
|
)
|
(42,494
|
)
|
(1,001,844
|
)
|
(158,647
|
)
|
|||||
Increase
in warrant liability
|
—
|
—
|
(142,427
|
)
|
—
|
||||||||
Other
|
(7,360
|
)
|
(2,628
|
)
|
(14,964
|
)
|
9,326
|
||||||
Total
other expenses
|
(290,130
|
)
|
(36,755
|
)
|
(992,760
|
)
|
(135,597
|
)
|
|||||
Net
loss
|
$
|
(1,284,467
|
)
|
$
|
(238,758
|
)
|
$
|
(3,631,649
|
)
|
$
|
(1,257,208
|
)
|
|
Net
loss per common share:
|
|||||||||||||
Basic
|
$
|
(0.02
|
)
|
$
|
0.00
|
$
|
(0.06
|
)
|
$
|
(0.02
|
)
|
||
Diluted
|
$
|
(0.02
|
)
|
$
|
0.00
|
$
|
(0.06
|
)
|
$
|
(0.02
|
)
|
||
Weighted
average shares outstanding:
|
|||||||||||||
Basic
|
58,469,103
|
58,076,622
|
58,414,293
|
56,290,885
|
|||||||||
Diluted
|
58,469,103
|
58,076,622
|
58,414,293
|
56,290,885
|
Nine
Months Ended
September
30,
|
|||||||
2005
|
2004
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(3,631,649
|
)
|
$
|
(1,257,208
|
)
|
|
Adjustments
to reconcile net loss to
|
|||||||
net
cash used in operating activities:
|
|||||||
Depreciation
and amortization
|
457,986
|
444,021
|
|||||
Amortization
of debt discount and offering costs
|
504,819
|
130,539
|
|||||
Increase
in warrant liability
|
142,427
|
—
|
|||||
Other
|
386
|
130,831
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable
|
(462,757
|
)
|
361,376
|
||||
Inventory
|
22,236
|
51,497
|
|||||
Prepaid
expenses and other assets
|
258,636
|
125,857
|
|||||
Accounts
payable
|
108,282
|
5,647
|
|||||
Accrued
liabilities and other liabilities
|
(27,402
|
)
|
89,120
|
||||
Deferred
revenue
|
110,935
|
(706,297
|
)
|
||||
Net
cash used in operating activities
|
(2,516,101
|
)
|
(624,617
|
)
|
|||
Cash
flows from investing activities:
|
|||||||
Purchases
of available-for-sale securities
|
(5,480,787
|
)
|
—
|
||||
Proceeds
from maturities of available-for-sale securities
|
2,000,000
|
—
|
|||||
Purchases
of property and equipment
|
(71,011
|
)
|
(67,310
|
)
|
|||
Proceeds
from sales of property and equipment
|
11,049
|
375
|
|||||
Patent
and trademark costs
|
(17,208
|
)
|
(17,506
|
)
|
|||
Net
cash used in investing activities
|
(3,557,957
|
)
|
(84,441
|
)
|
|||
Cash
flows from financing activities:
|
|||||||
Proceeds
from issuance of common stock
|
57,922
|
2,349,073
|
|||||
Payment
of offering costs
|
—
|
(15,642
|
)
|
||||
Payment
of debt issuance costs
|
(29,635
|
)
|
—
|
||||
Payment
of notes payable
|
(225,012
|
)
|
(192,272
|
)
|
|||
Payments
under capital leases
|
(11,124
|
)
|
(12,660
|
)
|
|||
Other
|
20
|
—
|
|||||
Net
cash (used in) provided by financing activities
|
(207,829
|
)
|
2,128,499
|
||||
Net
(decrease) increase in cash and cash equivalents
|
(6,281,887
|
)
|
1,419,441
|
||||
Cash
and cash equivalents, beginning of period
|
9,842,658
|
1,588,760
|
|||||
Cash
and cash equivalents, end of period
|
$
|
3,560,771
|
$
|
3,008,201
|
1. |
Basis
of Presentation
|
2. |
Stock
Options
|
Three
Months Ended
September
30,
|
|||||||
2005
|
2004
|
||||||
Net
loss, as reported
|
$
|
(1,284,467
|
)
|
$
|
(238,758
|
)
|
|
Deduct:
Total stock-based employee
compensation
expense determined under
fair
value based method for all awards
|
(95,196
|
)
|
(78,228
|
)
|
|||
Pro
forma net loss
|
$
|
(1,379,663
|
)
|
$
|
(316,986
|
)
|
|
Loss
per common share:
|
|||||||
As
reported (basic and diluted)
|
$
|
(0.02
|
)
|
$
|
(0.00
|
)
|
|
Pro
forma (basic and diluted)
|
$
|
(0.02
|
)
|
$
|
(0.01
|
)
|
Nine
Months Ended
September
30,
|
|||||||
2005
|
2004
|
||||||
Net
loss, as reported
|
$
|
(3,631,649
|
)
|
$
|
(1,257,208
|
)
|
|
Deduct:
Total stock-based employee
compensation
expense determined under
fair
value based method for all awards
|
(400,966
|
)
|
(186,363
|
)
|
|||
Pro
forma net loss
|
$
|
(4,032,615
|
)
|
$
|
(1,443,571
|
)
|
|
Loss
per common share:
|
|||||||
As
reported (basic and diluted)
|
$
|
(0.06
|
)
|
$
|
(0.02
|
)
|
|
Pro
forma (basic and diluted)
|
$
|
(0.07
|
)
|
$
|
(0.03
|
)
|
3. |
Comprehensive
Income (Loss)
|
Three
Months Ended
September
30, 2005
|
Nine
Months
Ended
September
30, 2005
|
||||||
Net
loss
|
$
|
(1,284,467
|
)
|
$
|
(3,631,649
|
)
|
|
Unrealized
gains (losses) on securities
|
3,370
|
(2,790
|
)
|
||||
Other
comprehensive loss
|
$
|
(1,281,097
|
)
|
$
|
(3,634,439
|
)
|
4. |
Earnings
Per Share
|
Three
Months Ended
September
30, 2005
|
Three
Months Ended
September
30, 2004
|
||||||||||||
Basic
Earnings
Per
Share
|
Diluted
Earnings
Per
Share
|
Basic
Earnings
Per
Share
|
Diluted
Earnings
Per
Share
|
||||||||||
Outstanding
shares
|
58,622,059
|
58,622,059
|
58,287,057
|
58,287,057
|
|||||||||
Effect
of weighting changes
in
outstanding shares
|
(22,956
|
)
|
(22,956
|
)
|
(80,435
|
)
|
(80,435
|
)
|
|||||
Contingently
issuable shares
|
(130,000
|
)
|
(130,000
|
)
|
(130,000
|
)
|
(130,000
|
)
|
|||||
Adjusted
shares
|
58,469,103
|
58,469,103
|
58,076,622
|
58,076,622
|
Nine
Months Ended
September
30, 2005
|
Nine
Months Ended
September
30, 2004
|
||||||||||||
Basic
Earnings
Per
Share
|
Diluted
Earnings
Per
Share
|
Basic
Earnings
Per
Share
|
Diluted
Earnings
Per
Share
|
||||||||||
Outstanding
shares
|
58,622,059
|
58,622,059
|
58,287,057
|
58,287,057
|
|||||||||
Effect
of weighting changes
in
outstanding shares
|
(77,766
|
)
|
(77,766
|
)
|
(1,866,172
|
)
|
(1,866,172
|
)
|
|||||
Contingently
issuable shares
|
(130,000
|
)
|
(130,000
|
)
|
(130,000
|
)
|
(130,000
|
)
|
|||||
Adjusted
shares
|
58,414,293
|
58,414,293
|
56,290,885
|
56,290,885
|
5. |
Available-for-Sale
Securities
|
6. |
Inventory
|
September
30,
2005
(unaudited)
|
December
31,
2004
|
||||||
Materials
and component parts
|
$
|
415,303
|
$
|
486,323
|
|||
Finished
goods
|
402,420
|
368,699
|
|||||
$
|
817,723
|
$
|
855,022
|
7. |
Intangible
Assets
|
September
30, 2005
(unaudited)
|
December
31, 2004
|
||||||||||||
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
||||||||||
Patents
and trademarks
|
$
|
3,170,210
|
$
|
1,103,692
|
$
|
3,155,334
|
$
|
915,571
|
|||||
Non-compete
agreements
|
584,516
|
548,393
|
584,516
|
440,005
|
|||||||||
Acquired
technology
|
237,271
|
127,717
|
237,271
|
102,436
|
|||||||||
$
|
3,991,997
|
$
|
1,779,802
|
$
|
3,977,121
|
$
|
1,458,012
|
Estimated
Amortization
Expense
|
||||
For
the year ended 12/31/2005
|
$
|
423,524
|
||
For
the year ended 12/31/2006
|
267,576
|
|||
For
the year ended 12/31/2007
|
235,237
|
|||
For
the year ended 12/31/2008
|
205,170
|
|||
For
the year ended 12/31/2009
|
170,940
|
8. |
Product
Warranty
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Warranty
reserve at
beginning
of period
|
$
|
48,595
|
$
|
46,000
|
$
|
66,000
|
$
|
53,000
|
|||||
Provision
for warranty claims and
changes
in reserve for warranties
|
12,117
|
(1,000
|
)
|
42,730
|
(8,000
|
)
|
|||||||
Payments
charged against the
reserve
|
(12,117
|
)
|
—
|
(60,135
|
)
|
—
|
|||||||
Warranty
reserve at end of period
|
$
|
48,595
|
$
|
45,000
|
$
|
48,595
|
$
|
45,000
|
9. |
Notes
Payable
|
10. |
Stock
Warrants
|
11. |
Segment
and Subsidiary Information
|
($
amounts in thousands)
Three
Months Ended
September
30, 2005
|
Gamma
Detection
Devices
|
Blood
Flow
Devices
|
Drug
and
Therapy
Products
|
Unallocated
|
Total
|
|||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$
|
1,237
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
1,237
|
||||||
International
|
38
|
58
|
—
|
—
|
96
|
|||||||||||
Research
and development expenses
|
79
|
302
|
725
|
—
|
1,106
|
|||||||||||
Selling,
general and administrative
expenses
|
—
|
—
|
—
|
689
|
689
|
|||||||||||
Income
(loss) from operations2
|
693
|
(273
|
)
|
(725
|
)
|
(689
|
)
|
(994
|
)
|
|||||||
Other
expenses
|
—
|
—
|
—
|
(290
|
)
|
(290
|
)
|
|||||||||
Three
Months Ended
September
30, 2004
|
||||||||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$
|
1,474
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
1,474
|
||||||
International
|
24
|
27
|
—
|
—
|
51
|
|||||||||||
License
and other revenue
|
200
|
—
|
—
|
—
|
200
|
|||||||||||
Research
and development expenses
|
54
|
451
|
83
|
—
|
588
|
|||||||||||
Selling,
general and administrative
expenses
|
—
|
—
|
—
|
695
|
695
|
|||||||||||
Income
(loss) from operations2
|
1,039
|
(463
|
)
|
(83
|
)
|
(695
|
)
|
(202
|
)
|
|||||||
Other
expenses
|
—
|
—
|
—
|
(37
|
)
|
(37
|
)
|
($
amounts in thousands)
Nine
Months Ended
September
30, 2005
|
Gamma
Detection
Devices
|
Blood
Flow
Devices
|
Drug
and
Therapy
Products
|
Unallocated
|
Total
|
|||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$
|
4,186
|
$
|
56
|
$
|
—
|
$
|
—
|
$
|
4,242
|
||||||
International
|
97
|
161
|
—
|
—
|
258
|
|||||||||||
Research
and development expenses
|
201
|
1,042
|
1,805
|
—
|
3,048
|
|||||||||||
Selling,
general and administrative
expenses
|
—
|
—
|
—
|
2,353
|
2,353
|
|||||||||||
Income
(loss) from operations2
|
2,438
|
(919
|
)
|
(1,805
|
)
|
(2,353
|
)
|
(2,639
|
)
|
|||||||
Other
expenses
|
—
|
—
|
—
|
(993
|
)
|
(993
|
)
|
|||||||||
Nine
Months Ended
September
30, 2004
|
||||||||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$
|
3,970
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
3,970
|
||||||
International
|
64
|
65
|
—
|
—
|
129
|
|||||||||||
License
and other revenue
|
600
|
—
|
—
|
—
|
600
|
|||||||||||
Research
and development expenses
|
335
|
1,121
|
310
|
—
|
1,766
|
|||||||||||
Selling,
general and administrative
expenses
|
—
|
—
|
—
|
2,362
|
2,362
|
|||||||||||
Income
(loss) from operations2
|
2,713
|
(1,163
|
)
|
(310
|
)
|
(2,362
|
)
|
(1,122
|
)
|
|||||||
Other
expenses
|
—
|
—
|
—
|
(136
|
)
|
(136
|
)
|
12. |
Supplemental
Disclosure for Statements of Cash
Flows
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
· |
Received
501(k) and CE Mark clearances to market the redesigned Quantix/OR
system;
|
· |
Established
a corporate Investigational New Drug (IND) application for Lymphoseek
and
submitted multi-center clinical protocol and related materials
to FDA
under the IND;
|
· |
Received
initial feedback to the Lymphoseek IND from the
FDA;
|
· |
Licensed
methodology patents strengthening RIGS intellectual property
estate;
|
· |
Expanded
Lymphoseek license to cover photodynamic and ultrasound applications;
|
· |
Initiated
and received draft reports to non-clinical studies for Lymphoseek
requested by regulatory agencies;
|
· |
Completed
initial commercial manufacturing of Lymphoseek with Good Manufacturing
Practices (cGMP) manufacturers;
|
· |
Received
positive independent technology assessment of CIRA Bio’s ACT platform;
and,
|
· |
Established
a corporate Investigational New Drug (IND) application for humanized
version of RIGScan CR.
|
· |
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.
|
· |
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.
|
· |
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
September 30, 2005, 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 intraoperative
lymphatic mapping. 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.
|
· |
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.
|
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
|