NAVIDEA BIOPHARMACEUTICALS, INC. - Quarter Report: 2009 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
quarterly period ended September 30,
2009
¨
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
transition period from to _____________________________ to
_____________________________
Commission
File Number: 0-26520
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)
|
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes x No
¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit
and post such files). Yes ¨ No
¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12-b-2 of the Act.) Yes ¨ No
x
Indicate
the number of shares outstanding of each of the issuer’s classes of common
stock, as of the latest practicable date: 79,650,270 shares of common
stock, par value $.001 per share (as of the close of business on November 6,
2009).
NEOPROBE CORPORATION and
SUBSIDIARIES
INDEX
PART
I – Financial Information
|
||
Item
1.
|
Financial
Statements
|
3
|
Consolidated
Balance Sheets as of September 30, 2009 (unaudited) and December 31,
2008
|
3
|
|
Consolidated
Statements of Operations for the Three-Month and Nine-Month Periods Ended
September 30, 2009 and September 30, 2008 (unaudited)
|
5
|
|
Consolidated
Statement of Stockholders’ Deficit for the Nine-Month Period Ended
September 30, 2009 (unaudited)
|
6
|
|
Consolidated
Statements of Cash Flows for the Nine-Month Periods Ended September 30,
2009 and September 30, 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
|
26
|
Forward-Looking
Statements
|
26
|
|
The
Company
|
26
|
|
Product
Line Overview
|
26
|
|
Results
of Operations
|
29
|
|
Liquidity
and Capital Resources
|
31
|
|
Recent
Accounting Developments
|
35
|
|
Critical
Accounting Policies
|
37
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
38
|
Item
4T.
|
Controls
and Procedures
|
38
|
PART
II – Other Information
|
||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
40
|
Item
6.
|
Exhibits
|
40
|
2
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements
Neoprobe
Corporation and Subsidiaries
Consolidated
Balance Sheets
|
September 30,
2009
(unaudited)
|
December 31,
2008
|
||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 6,031,298 | $ | 3,565,837 | ||||
Available-for-sale
securities
|
— | 495,383 | ||||||
Accounts
receivable, net
|
1,393,420 | 1,626,065 | ||||||
Inventory
|
1,038,407 | 544,126 | ||||||
Prepaid
expenses and other
|
319,647 | 573,573 | ||||||
Assets
associated with discontinued operations
|
31,389 | 435,740 | ||||||
Total
current assets
|
8,814,161 | 7,240,724 | ||||||
Property
and equipment
|
1,949,461 | 1,940,748 | ||||||
Less
accumulated depreciation and amortization
|
1,654,969 | 1,593,501 | ||||||
294,492 | 347,247 | |||||||
Patents
and trademarks
|
519,896 | 459,431 | ||||||
Less
accumulated amortization
|
440,018 | 433,358 | ||||||
79,878 | 26,073 | |||||||
Other
assets
|
26,266 | 594,449 | ||||||
Other
assets associated with discontinued operations
|
— | 1,410,957 | ||||||
Total
assets
|
$ | 9,214,797 | $ | 9,619,450 |
Continued
3
Neoprobe
Corporation and Subsidiaries
Consolidated
Balance Sheets, continued
|
September 30,
2009
(unaudited)
|
December 31,
2008
|
||||||
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 772,483 | $ | 725,820 | ||||
Accrued
liabilities and other
|
1,155,398 | 900,796 | ||||||
Capital
lease obligations, current portion
|
7,092 | 9,084 | ||||||
Deferred
revenue, current portion
|
526,898 | 526,619 | ||||||
Notes
payable to finance companies
|
— | 137,857 | ||||||
Liabilities
associated with discontinued operations
|
20,686 | 22,280 | ||||||
Total
current liabilities
|
2,482,557 | 2,322,456 | ||||||
Capital
lease obligations, net of current portion
|
5,721 | 11,095 | ||||||
Deferred
revenue, net of current portion
|
440,873 | 490,165 | ||||||
Notes
payable to CEO, net of discounts of $59,917 and
$76,294, respectively
|
940,083 | 923,706 | ||||||
Notes
payable to investors, net of discounts of $0 and $5,001,149,
respectively
|
10,000,000 | 4,998,851 | ||||||
Derivative
liabilities
|
2,697,487 | 853,831 | ||||||
Other
liabilities
|
36,348 | 45,071 | ||||||
Total
liabilities
|
16,603,069 | 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 September 30, 2009 and
December 31, 2008
|
3,000,000 | 3,000,000 | ||||||
Stockholders’
deficit:
|
||||||||
Common
stock; $.001 par value; 150,000,000 shares authorized; 79,363,787 and
70,862,641 shares outstanding at September 30, 2009 and December 31, 2008,
respectively
|
79,364 | 70,863 | ||||||
Additional
paid-in capital
|
181,877,412 | 145,742,044 | ||||||
Accumulated
deficit
|
(192,345,048 | ) | (148,840,015 | ) | ||||
Unrealized
gain on available-for-sale securities
|
— | 1,383 | ||||||
Total
stockholders’ deficit
|
(10,388,272 | ) | (3,025,725 | ) | ||||
Total
liabilities and stockholders’ deficit
|
$ | 9,214,797 | $ | 9,619,450 |
See
accompanying notes to consolidated financial statements
4
Neoprobe
Corporation and Subsidiaries
Consolidated
Statements of Operations
(unaudited)
Three
Months Ended
September
30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Revenues:
|
||||||||||||||||
Net
sales
|
$ | 2,562,079 | $ | 1,715,324 | $ | 6,998,299 | $ | 5,629,573 | ||||||||
License
and other revenue
|
25,000 | — | 75,000 | — | ||||||||||||
Total
revenues
|
2,587,079 | 1,715,324 | 7,073,299 | 5,629,573 | ||||||||||||
Cost
of goods sold
|
927,587 | 641,106 | 2,330,032 | 2,123,728 | ||||||||||||
Gross
profit
|
1,659,492 | 1,074,218 | 4,743,267 | 3,505,845 | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
1,204,811 | 1,741,484 | 3,730,361 | 3,084,432 | ||||||||||||
Selling,
general and administrative
|
778,658 | 707,794 | 2,417,622 | 2,248,466 | ||||||||||||
Total
operating expenses
|
1,983,469 | 2,449,278 | 6,147,983 | 5,332,898 | ||||||||||||
Loss
from operations
|
(323,977 | ) | (1,375,060 | ) | (1,404,716 | ) | (1,827,053 | ) | ||||||||
Other
income (expense):
|
||||||||||||||||
Interest
income
|
2,360 | 18,824 | 16,068 | 47,891 | ||||||||||||
Interest
expense
|
(330,806 | ) | (456,941 | ) | (1,249,525 | ) | (1,258,500 | ) | ||||||||
Change
in derivative liabilities
|
(6,334,479 | ) | 59,415 | (18,539,318 | ) | (440,773 | ) | |||||||||
Loss
on extinguishment of debt
|
(16,240,592 | ) | — | (16,240,592 | ) | — | ||||||||||
Other
|
(585 | ) | 4,242 | (2,216 | ) | 2,501 | ||||||||||
Total
other expense, net
|
(22,904,102 | ) | (374,460 | ) | (36,015,583 | ) | (1,648,881 | ) | ||||||||
Loss
from continuing operations
|
(23,228,079 | ) | (1,749,520 | ) | (37,420,299 | ) | (3,475,934 | ) | ||||||||
Discontinued
operations:
|
||||||||||||||||
Impairment
loss
|
(1,728,887 | ) | — | (1,728,887 | ) | — | ||||||||||
Loss
from operations
|
(52,303 | ) | (141,070 | ) | (162,896 | ) | (459,506 | ) | ||||||||
Net
loss
|
(25,009,269 | ) | (1,890,590 | ) | (39,312,082 | ) | (3,935,440 | ) | ||||||||
Preferred
stock dividends
|
(60,000 | ) | — | (180,000 | ) | — | ||||||||||
Loss
attributable to common
stockholders
|
$ | (25,069,269 | ) | $ | (1,890,590 | ) | $ | (39,492,082 | ) | $ | (3,935,440 | ) | ||||
Loss
per common share (basic):
|
||||||||||||||||
Continuing
operations
|
$ | (0.31 | ) | $ | (0.03 | ) | $ | (0.53 | ) | $ | (0.05 | ) | ||||
Discontinued
operations
|
$ | (0.03 | ) | $ | (0.00 | ) | $ | (0.03 | ) | $ | (0.01 | ) | ||||
Loss
to common stockholders
|
$ | (0.34 | ) | $ | (0.03 | ) | $ | (0.56 | ) | $ | (0.06 | ) | ||||
Loss
per common share (diluted):
|
||||||||||||||||
Continuing
operations
|
$ | (0.31 | ) | $ | (0.03 | ) | $ | (0.53 | ) | $ | (0.05 | ) | ||||
Discontinued
operations
|
$ | (0.03 | ) | $ | (0.00 | ) | $ | (0.03 | ) | $ | (0.01 | ) | ||||
Loss
to common stockholders
|
$ | (0.34 | ) | $ | (0.03 | ) | $ | (0.56 | ) | $ | (0.06 | ) | ||||
Weighted
average shares outstanding:
|
||||||||||||||||
Basic
|
74,380,714 | 68,758,281 | 70,915,204 | 68,191,889 | ||||||||||||
Diluted
|
74,380,714 | 68,758,281 | 70,915,204 | 68,191,889 |
See
accompanying notes to consolidated financial statements.
5
Neoprobe
Corporation and Subsidiaries
Consolidated
Statement of Stockholders’ Deficit
(unaudited)
Common
Stock
|
Additional
Paid-in
|
Accumulated
|
Accumulated
Other
Comprehensive
|
|||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
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
|
6,641,555 | 6,641 | 6,196,513 | — | — | 6,203,154 | ||||||||||||||||||
Issued
stock upon exercise of
options
|
330,000 | 330 | 133,420 | — | — | 133,750 | ||||||||||||||||||
Issued
stock as payment of interest
on convertible debt and dividends
on preferred stock
|
957,708 | 958 | 553,709 | — | — | 554,667 | ||||||||||||||||||
Effect
of change in terms of notes
payable, warrants and preferred
stock
|
— | — | 37,999,312 | — | — | 37,999,312 | ||||||||||||||||||
Issued
stock to 401(k) plan at
$0.41
|
80,883 | 81 | 33,392 | — | — | 33,473 | ||||||||||||||||||
Stock
compensation expense
|
— | — | 271,554 | — | — | 271,554 | ||||||||||||||||||
Paid
common stock issuance
costs
|
— | — | (98,129 | ) | — | — | (98,129 | ) | ||||||||||||||||
Paid
preferred stock issuance
costs
|
— | — | (6,323 | ) | — | — | (6,323 | ) | ||||||||||||||||
Preferred
stock dividends
|
— | — | — | (180,000 | ) | — | (180,000 | ) | ||||||||||||||||
Comprehensive
loss:
|
||||||||||||||||||||||||
Net
loss
|
— | — | — | (39,312,082 | ) | — | (39,312,082 | ) | ||||||||||||||||
Unrealized
loss on available-for-sale
securities
|
— | — | — | — | (1,383 | ) | (1,383 | ) | ||||||||||||||||
Total
comprehensive loss
|
(39,313,465 | ) | ||||||||||||||||||||||
Balance,
September 30, 2009
|
79,363,787 | $ | 79,364 | $ | 181,877,412 | $ | (192,345,048 | ) | $ | — | $ | (10,388,272 | ) |
See
accompanying notes to consolidated financial statements.
6
Neoprobe
Corporation and Subsidiaries
Consolidated
Statements of Cash Flows
(unaudited)
Nine Months Ended
September 30,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (39,312,082 | ) | $ | (3,935,440 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
284,219 | 302,904 | ||||||
Amortization
of debt discount and debt offering costs
|
420,063 | 515,056 | ||||||
Provision
for bad debts
|
458 | 699 | ||||||
Issuance
of common stock in payment of interest and dividends
|
554,667 | — | ||||||
Stock
compensation expense
|
271,554 | 156,897 | ||||||
Change
in derivative liabilities
|
18,539,318 | 440,773 | ||||||
Loss
on extinguishment of debt
|
16,240,592 | — | ||||||
Impairment
loss on discontinued operations
|
1,728,887 | — | ||||||
Other
|
48,697 | 111,295 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
226,052 | 305,274 | ||||||
Inventory
|
(550,816 | ) | 323,957 | |||||
Prepaid
expenses and other assets
|
260,470 | 111,229 | ||||||
Accounts
payable
|
47,063 | (79,470 | ) | |||||
Accrued
liabilities and other liabilities
|
53,104 | 105,775 | ||||||
Deferred
revenue
|
(49,013 | ) | (81,638 | ) | ||||
Net
cash used in operating activities
|
(1,236,767 | ) | (1,722,689 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Purchases
of available-for-sale securities
|
— | (196,000 | ) | |||||
Maturities
of available-for-sale securities
|
494,000 | 196,000 | ||||||
Purchases
of property and equipment
|
(74,554 | ) | (97,673 | ) | ||||
Proceeds
from sales of property and equipment
|
251 | 120 | ||||||
Patent
and trademark costs
|
(66,317 | ) | (13,616 | ) | ||||
Net
cash provided by (used in) investing activities
|
353,380 | (111,169 | ) | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from issuance of common stock
|
3,625,250 | 232,156 | ||||||
Payment
of common stock offering costs
|
(104,673 | ) | (900 | ) | ||||
Payment
of preferred stock offering costs
|
(6,323 | ) | — | |||||
Proceeds
from notes payable
|
— | 3,000,000 | ||||||
Payment
of debt issuance costs
|
(20,183 | ) | (200,154 | ) | ||||
Payment
of notes payable
|
(137,857 | ) | (124,770 | ) | ||||
Payments
under capital leases
|
(7,366 | ) | (12,878 | ) | ||||
Net
cash provided by financing activities
|
3,348,848 | 2,893,454 | ||||||
Net
increase in cash
|
2,465,461 | 1,059,596 | ||||||
Cash,
beginning of period
|
3,565,837 | 1,540,220 | ||||||
Cash,
end of period
|
$ | 6,031,298 | $ | 2,599,816 |
See
accompanying notes to consolidated financial statements.
7
Notes
to Consolidated Financial Statements
(unaudited)
1.
|
Summary
of Significant Accounting Policies
|
|
a.
|
Basis of
Presentation: The information presented as of September
30, 2009 and for the three-month and nine-month periods ended September
30, 2009 and September 30, 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
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. We have evaluated
subsequent events through November 16, 2009, the date our consolidated
financial statements were issued. The balances as of September
30, 2009 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, 2008, which were included as part of our Annual Report on
Form 10-K.
|
Our
consolidated financial statements include the accounts of Neoprobe, our
wholly-owned subsidiary, Cardiosonix Ltd. (Cardiosonix), and our 90%-owned
subsidiary, Cira Biosciences, Inc. (Cira Bio). All significant
inter-company accounts were eliminated in consolidation.
In August
2009, the Company’s Board of Directors decided to discontinue operations of
Cardiosonix and to attempt to divest our Cardiosonix subsidiary. This
decision was based on the determination that the blood flow measurement device
segment was no longer considered a strategic initiative to the Company, due in
large part to positive events in our other development
initiatives. Our consolidated balance sheets and statements of
operations have been restated for all prior periods presented to reflect
Cardiosonix as a discontinued operation. Cash flows associated with
the operation of Cardiosonix have been combined within operating, investing and
financing cash flows, as appropriate, in our consolidated statements of cash
flows. See Note 2.
|
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:
|
Level 1 – Unadjusted quoted
prices in active markets that are accessible at the measurement date for
identical, unrestricted assets or liabilities;
Level 2 – Quoted prices in
markets that are not active or financial instruments for which all significant
inputs are observable, either directly or indirectly; and
Level 3 – Prices or
valuations that require inputs that are both significant to the fair value
measurement and unobservable.
A
financial instrument’s level within the fair value hierarchy is based on the
lowest level of any input that is significant to the fair value
measurement. In determining the appropriate levels, we perform a
detailed analysis of the assets and liabilities whose fair value is measured on
a recurring basis. At each reporting period, all assets and
liabilities for which the fair value measurement is based on significant
unobservable inputs or instruments which trade infrequently and therefore have
little or no price transparency are classified as Level 3. In
estimating the fair value of our derivative liabilities, we used the
Black-Scholes option pricing model and, where necessary, other macroeconomic,
industry and Company-specific conditions. See Note
3.
8
The
following methods and assumptions were used to estimate the fair value of each
class of financial instruments:
|
(1)
|
Cash,
accounts receivable, accounts payable, and accrued
liabilities: The carrying amounts approximate fair value
because of the short maturity of these
instruments.
|
|
(2)
|
Available-for-sale
securities: Available-for-sale securities are recorded at fair
value. Fair value of available-for-sale securities is
determined based on a discounted cash flow analysis using current market
rates. Unrealized holding gains and losses on
available-for-sale securities are excluded from earnings and are reported
as a separate component of other comprehensive income (loss) until
realized. Realized gains and losses from the sale of
available-for-sale securities are determined on a specific identification
basis.
|
A decline
in the market value of any available-for-sale security below cost that is deemed
to be other than temporary results in a reduction in carrying amount to fair
value. The impairment is charged to earnings or other comprehensive
income (loss) and a new cost basis for the security is
established. Premiums and discounts are amortized or accreted over
the life of the related available-for-sale security as an adjustment to yield
using the effective interest method. Dividend and interest income are
recognized when earned.
Available-for-sale
securities are accounted for on a specific identification basis. As
of December 31, 2008, we held available-for-sale securities with an aggregate
fair value of $495,383, including $1,383 of net unrealized gains recorded in
accumulated other comprehensive income. As of December 31, 2008, all
of our available-for-sale securities were invested in short-term certificates of
deposit with maturity dates within 1 year. Available-for-sale
securities were classified as current based on their maturity dates as well as
our intent to use them to fund short-term working capital needs. We
held no available-for-sale securities at September 30, 2009.
|
(3)
|
Notes
payable to finance companies: The fair value of our debt is
estimated by discounting the future cash flows at rates currently offered
to us for similar debt instruments of comparable maturities by banks or
finance companies. At December 31, 2008, the carrying values of
these instruments approximate fair value. We had no notes
payable to finance companies at September 30,
2009.
|
|
(4)
|
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 September 30, 2009, the
note payable to our CEO had an estimated fair value of $4.5
million. At December 31, 2008, the note payable to our CEO had
an estimated fair value of $1.8
million.
|
|
(5)
|
Notes
payable to outside investors: The carrying value of our debt is
presented as the face amount of the notes less the unamortized discounts
related to the fair value of the beneficial conversion features, the
initial estimated fair value of the put options embedded in the notes and
the initial estimated fair value of the warrants to purchase common stock
issued in connection with the notes. At September 30, 2009, the
notes payable to outside investors had an estimated fair value of $35.6
million. At December 31, 2008, the notes payable to outside
investors had an estimated fair value of $15.9
million.
|
|
(6)
|
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.
|
9
2.
|
Discontinued
Operations
|
In August
2009, the Company’s Board of Directors decided to discontinue operations of
Cardiosonix and to attempt to divest our Cardiosonix subsidiary. This
decision was based on the determination that the blood flow measurement device
segment was no longer considered a strategic initiative of the Company, due in
large part to positive events in our other product and drug development
initiatives.
As a
result of our decision to hold Cardiosonix for sale, we reclassified certain
assets and liabilities as assets and liabilities associated with discontinued
operations. The following assets and liabilities have been segregated
and included in assets associated with discontinued operations or liabilities
associated with discontinued operations, as appropriate, in the consolidated
balance sheets:
September 30,
2009
|
December 31,
2008
|
|||||||
Accounts
receivable, net
|
$ | 5,727 | $ | 18,005 | ||||
Inventory
|
25,662 | 417,735 | ||||||
Property
and equipment, net of accumulated depreciation
|
— | 43,545 | ||||||
Patents
and trademarks, net of accumulated amortization
|
— | 1,367,412 | ||||||
Assets
associated with discontinued operations
|
$ | 31,389 | $ | 1,846,697 | ||||
Accounts
payable
|
$ | 5,800 | $ | 5,400 | ||||
Accrued
expenses
|
14,886 | 16,880 | ||||||
Liabilities
associated with discontinued operations
|
$ | 20,686 | $ | 22,280 |
In
addition, we recorded an impairment loss of $1.7 million and reclassified
certain revenues and expenses to discontinued operations during the third
quarter of 2009. Until a sale is completed, we expect to continue to
generate revenues and incur expenses related to our blood flow measurement
device business. The following amounts have been segregated from
continuing operations and included in discontinued operations in the
consolidated statements of operations:
Three
Months Ended
September
30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Net
sales
|
$ | 9,345 | $ | 84,942 | $ | 81,904 | $ | 208,510 | ||||||||
Cost
of goods sold
|
2,432 | 51,711 | 36,156 | 135,766 | ||||||||||||
Gross
profit
|
6,913 | 33,231 | 45,748 | 72,744 | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
2,642 | 69,445 | 23,128 | 188,912 | ||||||||||||
Selling,
general and administrative
|
56,659 | 104,958 | 185,506 | 343,578 | ||||||||||||
Total
operating expenses
|
59,301 | 174,403 | 208,634 | 532,490 | ||||||||||||
Other
income (expense)
|
85 | 102 | (10 | ) | 240 | |||||||||||
Loss
from discontinued operations
|
$ | (52,303 | ) | $ | (141,070 | ) | $ | (162,896 | ) | $ | (459,506 | ) |
Cash
flows associated with the operation of Cardiosonix were not significant and have
been combined within operating, investing and financing cash flows, as
appropriate, in our consolidated statements of cash flows.
10
3.
|
Fair
Value Hierarchy
|
The
following tables set forth, by level, assets and liabilities measured at fair
value on a recurring basis as of September 30, 2009 and December 31,
2008:
Liabilities Measured at Fair Value on a Recurring
Basis as of September 30, 2009
|
||||||||||||||||
Quoted
Prices
in
Active
Markets
for
Identical
Assets
and
Liabilities
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs
|
Balance
as of
September
30,
|
|||||||||||||
Description
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
2009
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related
to warrants
|
$ | — | $ | 1,731,487 | $ | — | $ | 1,731,487 | ||||||||
Derivative
liabilities related
to put options
|
— | — | 966,000 | 966,000 | ||||||||||||
Total
derivative liabilities
|
$ | — | $ | 1,731,487 | $ | 966,000 | $ | 2,697,487 |
Assets and Liabilities Measured at Fair Value on a
Recurring Basis as of December 31, 2008
|
||||||||||||||||
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 |
11
The
following tables set forth a summary of changes in the fair value of our Level 3
liabilities for the three-month periods ended September 30, 2009 and
2008:
Three Months Ended September 30,
2009
|
||||||||||||||||||||
Description
|
Balance at
June 30,
2009
|
Unrealized
Losses
|
Purchases,
Issuances
and
Settlements
|
Transfers In
and/or (Out)
|
Balance at
September
30,
2009
|
|||||||||||||||
Liabilities:
|
||||||||||||||||||||
Derivative
liabilities related
to conversion and
put options
|
$ | 11,289,422 | $ | 2,465,225 | $ | — | $ | (12,788,647 | ) | $ | 966,000 |
Three Months Ended September 30,
2008
|
||||||||||||||||||||
Description
|
Balance at
June 30,
2008
|
Unrealized
Gains
|
Purchases,
Issuances
and
Settlements
|
Transfers In
and/or (Out)
|
Balance at
September
30,
2008
|
|||||||||||||||
Liabilities:
|
||||||||||||||||||||
Derivative
liabilities related
to conversion and
put options
|
$ | 686,638 | $ | (59,415 | ) | $ | — | $ | — | $ | 627,223 |
The
following tables set forth a summary of changes in the fair value of our Level 3
liabilities for the nine–month periods ended September 30, 2009 and
2008:
Nine Months Ended September 30,
2009
|
||||||||||||||||||||
Description
|
Balance at
December
31,
2008
|
Adoption of
EITF 07-5
(See
Note 10)
|
Unrealized
Losses
|
Transfers In
and/or (Out)
|
Balance at
September
30,
2009
|
|||||||||||||||
Liabilities:
|
||||||||||||||||||||
Derivative
liabilities related
to conversion and
put options
|
$ | 853,831 | $ | 5,304,487 | $ | 7,596,329 | $ | (12,788,647 | ) | $ | 966,000 |
Nine Months Ended September 30,
2008
|
||||||||||||||||||||
Description
|
Balance at
December
31,
2007
|
Purchases,
Issuances
and
Settlements
|
Unrealized
Losses
|
Transfers In
and/or (Out)
|
Balance at
September
30,
2008
|
|||||||||||||||
Liabilities:
|
||||||||||||||||||||
Derivative
liabilities related
to conversion and
put options
|
$ | 1,599,072 | $ | 257,968 | $ | 170,119 | $ | (1,399,936 | ) | $ | 627,223 |
12
4.
|
Stock-Based
Compensation
|
Stock-based
payments to employees, including grants of employee stock options, are
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. 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. Expected volatilities are based on the Company’s historical
volatility, which management believes represents the most accurate basis for
estimating expected volatility under the current
circumstances. Neoprobe uses historical data to estimate forfeiture
rates. The expected term of options granted is based on the vesting
period and the contractual life of the options. The risk-free rate is
based on the U.S. Treasury yield in effect at the time of the
grant.
At
September 30, 2009, we have three stock-based compensation
plans. Under the Amended and Restated Stock Option and Restricted
Stock Purchase Plan (the Amended Plan), the 1996 Stock Incentive Plan (the 1996
Plan), and the Second Amended and Restated 2002 Stock Incentive Plan (the 2002
Plan), we may grant incentive stock options, nonqualified stock options, and
restricted stock awards to full-time employees, and nonqualified stock options
and restricted stock awards may be granted to our consultants and
agents. Total shares authorized under each plan are 2 million shares,
1.5 million shares and 7 million shares, respectively. Although
options are still outstanding under the Amended Plan and the 1996 Plan, these
plans are considered expired and no new grants may be made from
them. Under all three plans, the exercise price of each option is
greater than or equal to the closing market price of our common stock on the day
prior to the date of the grant.
Options
granted under the Amended Plan, the 1996 Plan and the 2002 Plan generally vest
on an annual basis over one to three years. Outstanding options under
the plans, if not exercised, generally expire ten years from their date of grant
or 90 days from the date of an optionee’s separation from employment with the
Company. We issue new shares of our common stock upon exercise of
stock options.
Compensation
cost arising from stock-based awards is recognized as expense using the
straight-line method over the vesting period. As of September 30,
2009, there was approximately $302,000 of total unrecognized compensation cost
related to unvested stock-based awards, which we expect to recognize over
remaining weighted average vesting terms of 0.7 years. For the
three-month periods ended September 30, 2009 and 2008, our total stock-based
compensation expense was approximately $126,000 and $63,000,
respectively. For the nine-month periods ended September 30, 2009 and
2008, our total stock-based compensation expense was approximately $272,000 and
$157,000, respectively. We have not recorded any income tax benefit
related to stock-based compensation in any of the three-month and nine-month
periods ended September 30, 2009 and 2008.
13
A summary
of stock option activity under our stock option plans as of September 30, 2009,
and changes during the nine-month period then ended is presented
below:
Nine Months Ended September 30,
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
|
(330,000 | ) | 0.41 | ||||||||||
Forfeited
|
(10,000 | ) | 0.61 | ||||||||||
Expired
|
(111,000 | ) | 1.10 | ||||||||||
Outstanding
at end of period
|
5,451,500 | $ | 0.39 |
5.1 years
|
$ | 5,492,084 | |||||||
Exercisable
at end of period
|
4,682,833 | $ | 0.38 |
4.5 years
|
$ | 4,763,057 |
A summary
of the status of our unvested restricted stock as of September 30, 2009, and
changes during the nine-month period then ended is presented below:
Nine Months Ended
September 30, 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 |
Restricted
shares generally vest upon occurrence of a specific event or achievement of
goals as defined in the grant agreements. As a result, we have
recorded compensation expense related to grants of restricted stock based on
management’s estimates of the probable dates of the vesting
events. See Note 16.
14
5.
|
Comprehensive
Loss
|
Due to
our net operating loss position, there are no income tax effects on
comprehensive loss components for the three-month and nine-month periods ended
September 30, 2009 and 2008.
Three Months
Ended
September 30,
2009
|
Three Months
Ended
September 30,
2008
|
|||||||
Net
loss
|
$ | (25,009,269 | ) | $ | (1,890,590 | ) | ||
Unrealized
losses on securities
|
— | — | ||||||
Other
comprehensive loss
|
$ | (25,009,269 | ) | $ | (1,890,590 | ) |
Nine Months
Ended
September 30,
2009
|
Nine Months
Ended
September 30,
2008
|
|||||||
Net
loss
|
$ | (39,312,082 | ) | $ | (3,935,440 | ) | ||
Unrealized
losses on securities
|
(1,383 | ) | — | |||||
Other
comprehensive loss
|
$ | (39,313,465 | ) | $ | (3,935,440 | ) |
6.
|
Earnings
(Loss) Per Share
|
Basic
earnings (loss) per share is calculated by dividing net income (loss) by the
weighted-average number of common shares and participating securities
outstanding during the period. Diluted earnings (loss) per share
reflects additional common shares that would have been outstanding if dilutive
potential common shares had been issued. Potential common shares that
may be issued by the Company include convertible securities, options and
warrants, if dilutive.
The
following table sets forth the reconciliation of the weighted average number of
common shares outstanding to those used to compute basic and diluted earnings
(loss) per share for the three-month and nine-month periods ended September 30,
2009 and 2008:
Three Months Ended
September 30, 2009
|
Three Months Ended
September 30, 2008
|
|||||||||||||||
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
|||||||||||||
Outstanding
shares
|
79,363,787 | 79,363,787 | 69,787,540 | 69,787,540 | ||||||||||||
Effect
of weighting changes in
outstanding shares
|
(4,019,073 | ) | (4,019,073 | ) | (579,259 | ) | (579,259 | ) | ||||||||
Unvested
restricted stock
|
(964,000 | ) | (964,000 | ) | (450,000 | ) | (450,000 | ) | ||||||||
Adjusted
shares
|
74,380,714 | 74,380,714 | 68,758,281 | 68,758,281 |
Nine Months Ended
September, 2009
|
Nine Months Ended
September 30, 2008
|
|||||||||||||||
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
|||||||||||||
Outstanding
shares
|
79,363,787 | 79,363,787 | 69,787,540 | 69,787,540 | ||||||||||||
Effect
of weighting changes in
outstanding shares
|
(7,484,583 | ) | (7,484,583 | ) | (1,145,651 | ) | (1,145,651 | ) | ||||||||
Unvested
restricted stock
|
(964,000 | ) | (964,000 | ) | (450,000 | ) | (450,000 | ) | ||||||||
Adjusted
shares
|
70,915,204 | 70,915,204 | 68,191,889 | 68,191,889 |
15
Earnings
(loss) per common share for the three-month and nine-month periods ended
September 30, 2009 and 2008 excludes the effects of 58,660,844 and 49,799,546
common share equivalents, respectively, since such inclusion would be
anti-dilutive. The excluded shares consist of common shares issuable
upon exercise of outstanding stock options and warrants, or upon the conversion
of convertible debt and convertible preferred stock.
Effective
January 1, 2009, as required by current accounting standards, we began including
unvested stock awards which contain nonforfeitable rights to dividends or
dividend equivalents, whether paid or unpaid (referred to as “participating
securities”), in the number of shares outstanding for both basic and diluted
earnings per share calculations. Under the accounting standards, the
Company’s unvested restricted stock is considered a participating
security. All prior period earnings per share data presented were
required to be adjusted retrospectively to conform to these
provisions. In the event of a net loss, the participating securities
are excluded from the calculation of both basic and diluted earnings per
share. Due to our net loss, 964,000 and 450,000 shares of unvested
restricted stock were excluded in determining basic and diluted loss per share
for the three-month and nine-month periods ended September 30, 2009 and 2008,
respectively.
7.
|
Inventory
|
From time
to time, we capitalize certain inventory costs associated with our
Lymphoseek® product
prior to regulatory approval and product launch based on management’s judgment
of probable future commercial use and net realizable value of the
inventory. We could be required to permanently write down previously
capitalized costs related to pre-approval or pre-launch inventory upon a change
in such judgment, due to a denial or delay of approval by regulatory bodies, a
delay in commercialization, or other potential factors. Conversely,
our gross margins may be favorably impacted if some or all of the inventory
previously written down becomes available and is used for commercial
sale. During the third quarter of 2009, we capitalized $525,000 of
inventory costs associated with our Lymphoseek product. During the
three-month and nine-month periods ended September 30, 2008, we did not
capitalize any inventory costs associated with our Lymphoseek
product.
The
components of net inventory are as follows:
September 30,
2009
(unaudited)
|
December 31,
2008
|
|||||||
Materials
and component parts
|
$ | 691,276 | $ | 112,637 | ||||
Finished
goods
|
347,131 | 431,489 | ||||||
Total
|
$ | 1,038,407 | $ | 544,126 |
8.
|
Intangible
Assets
|
Our
intangible assets consist primarily of patents and
trademarks. Details about our intangible assets are as
follows:
September
30, 2009
|
December 31, 2008
|
||||||||||||||||
Wtd
Avg
Life
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
|||||||||||||
Patents
and trademarks
|
0.2
yrs
|
$ | 519,896 | $ | 440,018 | $ | 459,431 | $ | 433,358 |
16
The
estimated amortization expense for the next five fiscal years is as
follows:
Estimated
Amortization
Expense
|
||||
For
the year ended 12/31/20091
|
$ | 126,228 | ||
For
the year ended 12/31/2010
|
2,393 | |||
For
the year ended 12/31/2011
|
1,088 | |||
For
the year ended 12/31/2012
|
885 | |||
For
the year ended 12/31/2013
|
126 |
|
1
|
Amortization
expense for the year ended 12/31/2009 includes approximately $113,000 of
intangible asset amortization related to Cardiosonix, which is included in
loss from discontinued operations. Intangible asset
amortization related to Cardiosonix stopped during the third quarter of
2009 as a result of the decision to discontinue the operations of
Cardiosonix and hold the associated assets for
sale.
|
9.
|
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,
except in cases where the product has a limited use as designed. Our
accrual for warranty expenses is adjusted periodically to reflect actual
experience and is included in accrued liabilities on the consolidated balance
sheets. Our primary marketing partner, Ethicon Endo-Surgery, Inc.
(EES), a Johnson & Johnson company, also reimburses us for a portion of
warranty expense incurred based on end customer sales they make during a given
fiscal year. Payments charged against the reserve are disclosed net
of EES’ estimated reimbursement.
The
activity in the warranty reserve account for the three-month and nine-month
periods ended September 30, 2009 and 2008 is as follows:
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Warranty
reserve at beginning
of period
|
$ | 71,412 | $ | 87,679 | $ | 72,643 | $ | 115,395 | ||||||||
Provision
for warranty claims and changes
in reserve for warranties
|
10,021 | 3,932 | 65,172 | 13,894 | ||||||||||||
Payments
charged against the reserve
|
(21,369 | ) | (18,816 | ) | (77,751 | ) | (56,494 | ) | ||||||||
Warranty
reserve at end of period
|
$ | 60,064 | $ | 72,795 | $ | 60,064 | $ | 72,795 |
10.
|
Convertible
Securities
|
In July
2007, David C. Bupp, our President and CEO, and certain members of his family
(the Bupp Investors) purchased a $1.0 million convertible note (the Bupp Note)
and warrants. The Bupp Note bears interest at 10% per annum, had an
original term of one year and is repayable in whole or in part with no
penalty. The note is convertible, at the option of the Bupp
Investors, into shares of our common stock at a price of $0.31 per share, a 25%
premium to the average closing market price of our common stock for the 5 days
preceding the closing of the transaction. As part of this
transaction, we issued the Bupp Investors Series V Warrants to purchase 500,000
shares of our common stock at an exercise price of $0.31 per share, expiring in
July 2012. The value of the beneficial conversion feature of the note
was estimated at $86,000 based on the effective conversion price at the date of
issuance. The fair value of the warrants issued to the investors was
approximately $80,000 on the date of issuance and was determined using the
Black-Scholes option pricing model with the following assumptions: an
average risk-free interest rate of 4.95%, volatility of 105% and no expected
dividend rate. The value of the beneficial conversion feature and the
fair value of the warrants issued to the investors were recorded as discounts on
the note. We incurred $43,000 of costs related to completing the Bupp
financing, which were recorded in other assets. The discounts and the
deferred debt issuance costs were being amortized over the term of the note
using the effective interest method.
17
In
December 2007, we executed a Securities Purchase Agreement (SPA) with
Platinum Montaur Life Sciences, LLC (Montaur), pursuant to which we issued
Montaur: (1) a 10% Series A Convertible Senior Secured Promissory Note
in the principal amount of $7,000,000, due December 26, 2011 (the
Series A Note); and (2) a Series W Warrant to purchase 6,000,000
shares of our common stock at an exercise price of $0.32 per share, expiring in
December 2012 (the Series W Warrant). Additionally, pursuant to the
terms of the SPA: (1) upon commencement of the Phase 3 clinical studies of
Lymphoseek, in April 2008, we issued Montaur a 10% Series B Convertible
Senior Secured Promissory Note, due December 26, 2011 (the Series B
Note, and hereinafter referred to collectively with the Series A Note as
the Montaur Notes), and a five-year warrant to purchase an amount of common
stock equal to the number of shares into which Montaur may convert the
Series B Note, at an exercise price of 115% of the conversion price of the
Series B Note (the Series X Warrant), for an aggregate purchase price
of $3,000,000; and (2) upon obtaining 135 vital blue dye lymph nodes from
patients with breast cancer or melanoma who completed surgery with the injection
of the drug in a Phase 3 clinical trial of Lymphoseek in December 2008, we
issued Montaur 3,000 shares of our 8% Series A Cumulative Convertible
Preferred Stock (the Preferred Stock) and a five-year warrant to purchase an
amount of common stock equal to the number of shares into which Montaur may
convert the Preferred Stock, at an exercise price of 115% of the conversion
price of the Preferred Stock (the Series Y Warrant, and hereinafter
referred to collectively with the Series W Warrant and Series X
Warrant as the Montaur Warrants), also for an aggregate purchase price of
$3,000,000.
The
conversion option and two put options associated with the Series A Note were
considered derivative instruments at origination and were required to be
bifurcated from the Series A Note and accounted for separately. In
addition, the Series W Warrant was accounted for as a liability at origination
due to the existence of certain provisions in the instrument. As a
result, we recorded a total aggregate derivative liability of $2.6 million on
the date of issuance of the Series A Note and Series W Warrant. The
fair value of the bifurcated conversion option and put options was approximately
$1.45 million on the date of issuance. The fair value of the Series W
Warrant was approximately $1.15 million on the date of issuance and was
determined using the Black-Scholes option pricing model with the following
assumptions: an average risk-free interest rate of 3.7%, volatility
of 94% and no expected dividend rate.
On March
14, 2008, Neoprobe and Montaur executed amendments to the Series A Note and the
Series W Warrant. The amendments eliminated certain minor cash-based
penalty provisions in the Series A Note and Series W Warrant which entitled the
holders to different compensation than our common shareholders under certain
circumstances and qualifying Triggering Events. The provisions that
were eliminated and/or modified were the provisions that led to the derivative
accounting treatment for the embedded conversion option in the Series A Note and
the Series W Warrant. The effect of marking the conversion option and
warrant liabilities to market at March 14, 2008 resulted in an increase in the
estimated fair value of the conversion option and warrant liabilities of
$381,000 which was recorded as non-cash expense during the first quarter of
2008. The estimated fair value of the conversion option and warrant
liabilities of $2.9 million was reclassified to additional paid-in capital
during the first quarter of 2008 as a result of the amendments. The
estimated fair value of the put option liabilities related to the Series A Note
of $360,000 remained classified as derivative liabilities. The
initial aggregate fair value of the conversion option and the put options
related to the Series A Note and the fair value of the Series W Warrant of $2.6
million were recorded as a discount on the note and are being amortized over the
term of the note using the effective interest method.
18
In April
2008, we completed the second closing under the December 2007 Montaur SPA, as
amended, pursuant to which we issued Montaur a 10% Series B
Convertible Senior Secured Promissory Note in the principal amount of
$3,000,000, due December 26, 2011; and a Series X Warrant to purchase
8,333,333 shares of our common stock at an exercise price of $0.46 per share,
expiring in April 2013. The two put options related to the Series B
Note were considered derivative instruments at origination and were required to
be bifurcated from the Series B Note and accounted for
separately. The fair value of the bifurcated put options was
approximately $258,000 on the date of issuance. The value of the
beneficial conversion feature of the Series B Note was estimated at $1.44
million based on the effective conversion price at the date of
issuance. The fair value of the Series X Warrant was approximately
$1.28 million on the date of issuance and was determined using the Black-Scholes
option pricing model with the following assumptions: an average
risk-free interest rate of 2.6%, volatility of 95% and no expected dividend
rate. The initial aggregate fair value of the beneficial conversion
feature and put options related to the Series B Note, and the fair value of the
Series X Warrant of $2.98 million were recorded as discounts on the note and are
being amortized over the term of the note using the effective interest
method. We incurred $188,000 of costs related to completing the
second Montaur financing, which were recorded in other assets on the
consolidated balance sheet. The deferred financing costs are being
amortized using the effective interest method over the term of the
note.
In
December 2008, after we obtained 135 vital blue dye lymph nodes from patients
who had completed surgery and the injection of Lymphoseek in a Phase 3 clinical
trial in patients with breast cancer or melanoma, we issued Montaur 3,000 shares
of our 8% Preferred Stock and a five-year Series Y warrant to purchase 6,000,000
shares of our common stock, at an exercise price of $0.575 per share, for an
aggregate purchase price of $3,000,000. The “Liquidation Preference
Amount” for the Preferred Stock is $1,000 and the “Conversion Price” of the
Preferred Stock was set at $0.50 on the date of issuance, thereby making the
shares of Preferred Stock convertible into an aggregate 6,000,000 shares of our
common stock, subject to adjustment as described in the Certificate of
Designations. The value of the beneficial conversion feature of the
Preferred Stock was estimated at $1.55 million based on the effective conversion
price at the date of issuance. The put option was considered a
derivative instrument at origination and was required to be bifurcated from the
Preferred Stock and accounted for separately. The fair value of the
bifurcated put option was approximately $216,000 on the date of
issuance. The fair value of the Series Y warrant was approximately
$2.07 million on the date of issuance and was determined using the Black-Scholes
option pricing model with the following assumptions: an average
risk-free interest rate of 1.7%, volatility of 74% and no expected dividend
rate. The relative fair value of the warrant of $1.13 million was
recorded to equity.
The
Preferred Stock was classified as temporary equity as the shares are subject to
redemption under the contingent put option. The initial intrinsic
value of the beneficial conversion feature and put option related to the
Preferred Stock and the initial relative fair value of the Series Y warrant of
$1.13 million were recorded as deemed distributions and added to the accumulated
deficit. We incurred $180,000 of costs related to completing the
third Montaur financing, which were recorded as a reduction of additional
paid-in capital on the consolidated balance sheet.
In
connection with the SPA, Montaur requested that the term of the $1.0 million
Bupp Note be extended approximately 42 months or until at least one day
following the maturity date of the Montaur Notes. In consideration
for the Bupp Investors’ agreement to extend the term of the Bupp Note pursuant
to an Amendment to the Bupp Purchase Agreement, dated December 26, 2007, we
agreed to provide security for the obligations evidenced by the Amended 10%
Convertible Note in the principal amount of $1,000,000, due December 31,
2011, executed by Neoprobe in favor of the Bupp Investors (the Amended Bupp
Note), under the terms of a Security Agreement, dated December 26, 2007, by
and between Neoprobe and the Bupp Investors (the Bupp Security
Agreement). As further consideration for extending the term of the
Bupp Note, we issued the Bupp Investors Series V Warrants to purchase 500,000
shares of our common stock at an exercise price of $0.32 per share, expiring in
December 2012. The fair value of the warrants issued to the Bupp
Investors was approximately $96,000 on the date of issuance and was determined
using the Black-Scholes option pricing model with the following
assumptions: an average risk-free interest rate of 3.72%, volatility
of 94% and no expected dividend rate. The fair value of the warrants
was recorded as a discount on the note and is being amortized over the term of
the note using the effective interest method. We treated the
amendment to the Bupp Note as an extinguishment of debt for accounting
purposes. As such, the remaining discount resulting from the value of
the beneficial conversion feature and the fair value of the warrants and the
remaining unamortized deferred financing costs associated with the original note
were written off as a loss on extinguishment of debt in December
2007.
19
On July
24, 2009, we entered into a Securities Amendment and Exchange Agreement with
Montaur, pursuant to which Montaur agreed to the amendment and restatement of
the terms of the Montaur Notes, the Preferred Stock, and the Montaur
Warrants. The Series A Note was amended to grant Montaur conversion
rights with respect to the $3.5 million portion of the Series A Note that was
previously not convertible. The newly convertible portion of the
Series A Note is convertible at $0.9722 per share. The amendments
also eliminated certain price reset features of the Montaur Notes, the Preferred
Stock and the Montaur Warrants that had created significant non-cash derivative
liabilities on the Company’s balance sheet. In conjunction with this
transaction, we issued Montaur a Series AA Warrant to purchase 2.4 million
shares of our common stock at an exercise price of $0.97 per share, expiring in
July 2014.
The
changes in terms of the Montaur Notes, the Preferred Stock and the Montaur
Warrants were treated as an extinguishment of debt for accounting
purposes. The Company recorded an additional $5.6 million in
mark-to-market adjustments related to the increase in the Company’s common stock
from June 30 to July 24, 2009. As a result of the extinguishment
treatment associated with the elimination of the price reset features, the
Company also recorded $16.2 million in non-cash loss on the extinguishment and
reclassified $27.0 million in derivative liabilities to additional paid-in
capital. Following the extinguishment, the Company’s balance sheet
reflects the face value of the $10 million due to Montaur pursuant to the
Montaur Notes.
During
the three-month periods ended September 30, 2009 and 2008, we recorded interest
expense of $47,000 and $154,000, respectively, related to amortization of the
debt discount related to our convertible notes. During the nine-month
periods ended September 30, 2009 and 2008, we recorded interest expense of
$353,000 and $433,000, respectively, related to amortization of the debt
discount related to our convertible notes. During the three-month
periods ended September 30, 2009 and 2008, we recorded interest expense of
$9,000 and $28,000, respectively, related to amortization of the deferred
financing costs related to our convertible notes. During the
nine-month periods ended September 30, 2009 and 2008, we recorded interest
expense of $67,000 and $80,000, respectively, related to amortization of the
deferred financing costs related to our convertible notes.
11.
|
Derivative
Instruments
|
Effective
January 1, 2009, we adopted a new accounting standard which 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. As a result of adopting the new standard, certain embedded
features of our convertible securities, as well as warrants to purchase our
common stock, that were previously treated as equity have been considered
derivative liabilities since the beginning of 2009. We do not use
derivative instruments for hedging of market risks or for trading or speculative
purposes.
20
The
impact of the January 1, 2009 adoption of the new accounting standard is
summarized in the following table:
December 31,
2008
|
Impact of
New
Accounting
Standard
Adoption
|
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 | ) |
Convertible Notes – other
assets increased $2,104, notes payable to investors, net of discount, increased
$518,229, derivative liabilities increased $4,146,392, additional paid-in
capital decreased $2,843,781, and accumulated deficit increased
$1,818,736.
Convertible Preferred Stock –
derivative liabilities increased $1,158,095, additional paid-in capital
decreased $1,550,629, and accumulated deficit decreased $392,534.
Warrants – notes payable to
investors, net of discount, decreased $572,625, derivative liabilities increased
$7,713,053, additional paid-in capital decreased $4,553,679, and accumulated
deficit increased $2,586,749.
The
estimated fair values of the derivative liabilities are recorded as non-current
liabilities on the consolidated balance sheet. Changes in the
estimated fair values of the derivative liabilities are recorded in the
consolidated statement of operations. The effect of marking
the derivative liabilities to market at March 31, 2009 resulted in a net
decrease in the estimated fair values of the derivative liabilities of $1.5
million which was recorded as non-cash income during the first quarter of
2009. The effect of marking the derivative liabilities to market at
June 30, 2009 resulted in a net increase in the estimated fair values of the
derivative liabilities of $13.2 million which was recorded as non-cash expense
during the second quarter of 2009. On July 24, 2009, we entered into
a Securities Amendment and Exchange Agreement with Montaur, pursuant to which
Montaur agreed to the amendment and restatement of the terms of the Montaur
Notes, the Preferred Stock, and the Montaur Warrants. As a result,
the Company recorded an additional $5.6 million in mark-to-market adjustments
related to the increase in the Company’s common stock from June 30 to July 24,
2009, and reclassified $27.0 million in derivative liabilities related to the
Montaur Notes, the Preferred Stock, and the Montaur Warrants to additional
paid-in capital. Also on July 24, 2009, Montaur exercised 2,844,319
of their Series Y Warrants, which resulted in a decrease in the related
derivative liability of $2.2 million. The effect of marking the
Company’s remaining derivative liabilities to market at September 30, 2009
resulted in a net increase in the estimated fair values of the derivative
liabilities of $705,000 which was recorded as non-cash expense during the third
quarter of 2009. The total estimated fair value of the derivative
liabilities was $2.7 million as of September 30, 2009. See Note
10.
12.
|
Stock
Warrants
|
During
the first nine months of 2009, David C. Bupp, our President and CEO, exercised
50,000 Series Q Warrants in exchange for issuance of 50,000 shares of our common
stock, resulting in gross proceeds of $25,000. The remaining 325,000
Series Q Warrants held by Mr. Bupp expired during the period. During
the same period, another Bupp Investor exercised 50,000 Series V Warrants in
exchange for issuance of 50,000 shares of our common stock, resulting in gross
proceeds of $16,000. Also during the first nine months of 2009,
certain outside investors exercised a total of 1,010,000 Series U Warrants on a
cashless basis in exchange for issuance of 541,555 shares of our common
stock.
21
On July
24, 2009, in conjunction with entering into a Securities Amendment and Exchange
Agreement, Montaur exercised 2,844,319 Series Y Warrants in exchange for
issuance of 2,844,319 shares of our common stock, resulting in gross proceeds of
$1.6 million. In September 2009, Montaur exercised their remaining
3,155,681 Series Y Warrants in exchange for issuance of 3,155,681 shares of our
common stock, resulting in additional gross proceeds of $1.8
million. See Note 10.
At
September 30, 2009, there are 18.4 million warrants outstanding to purchase our
common stock. The warrants are exercisable at prices ranging from
$0.31 to $0.97 per share with a weighted average exercise price of $0.48 per
share.
13.
|
Income
Taxes
|
We
account for income taxes in accordance with current accounting standards, which
include guidance on the accounting for uncertainty in income taxes recognized in
the financial statements. Such standards also prescribe a recognition
threshold and measurement model for the financial statement recognition of a tax
position taken, or expected to be taken, and provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition. No adjustment was made to the beginning
retained earnings balance as the ultimate deductibility of all tax positions is
highly certain, although there is uncertainty about the timing of such
deductibility. As a result, no liability for uncertain tax positions
was recorded as of September 30, 2009. Should we need to accrue
interest or penalties on uncertain tax positions, we would recognize the
interest as interest expense and the penalties as a selling, general and
administrative expense.
14.
|
Segment
Information
|
We report
information about our operating segments using the “management approach” in
accordance with current accounting standards. This information
is based on the way management organizes and reports the segments within the
enterprise for making operating decisions and assessing
performance. Our reportable segments are identified based on
differences in products, services and markets served. There were no
inter-segment sales. We own or have rights to intellectual property
involving two primary types of medical device products, including oncology
instruments currently used primarily in the application of sentinel lymph node
biopsy, and blood flow measurement devices. We also own or have
rights to intellectual property related to several drug and therapy
products.
22
The
information in the following table is derived directly from each reportable
segment’s financial reporting.
($ amounts in thousands)
Three Months Ended
September 30, 2009
|
Oncology
Devices
|
Blood
Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales:
|
||||||||||||||||||||
United
States1
|
$ | 2,477 | $ | — | $ | — | $ | — | $ | 2,477 | ||||||||||
International
|
85 | — | — | — | 85 | |||||||||||||||
License
and other revenue
|
25 | — | — | — | 25 | |||||||||||||||
Research
and development expenses
|
220 | — | 985 | — | 1,205 | |||||||||||||||
Selling,
general and administrative expenses,
excluding depreciation and
amortization2
|
26 | — | — | 705 | 731 | |||||||||||||||
Depreciation
and amortization
|
32 | — | 1 | 15 | 48 | |||||||||||||||
Income
(loss) from operations
|
1,382 | — | (986 | ) | (720 | ) | (324 | ) | ||||||||||||
Other
income (expenses)4
|
— | — | — | (22,904 | ) | (22,904 | ) | |||||||||||||
Loss
from discontinued operations
|
— | (1,781 | ) | — | — | (1,781 | ) | |||||||||||||
Total
assets, net of depreciation and
amortization:
|
||||||||||||||||||||
United
States operations
|
2,148 | — | 555 | 6,481 | 9,184 | |||||||||||||||
Discontinued
operations
|
— | 31 | — | — | 31 | |||||||||||||||
Capital
expenditures
|
12 | — | — | 4 | 16 | |||||||||||||||
($ amounts in thousands)
Three Months Ended
September 30, 2008
|
Oncology
Devices
|
Blood
Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales:
|
||||||||||||||||||||
United
States1
|
$ | 1,630 | $ | — | $ | — | $ | — | $ | 1,630 | ||||||||||
International
|
85 | — | — | — | 85 | |||||||||||||||
Research
and development expenses
|
267 | — | 1,474 | — | 1,741 | |||||||||||||||
Selling,
general and administrative expenses,
excluding depreciation and
amortization2
|
7 | — | — | 656 | 663 | |||||||||||||||
Depreciation
and amortization
|
32 | — | 1 | 12 | 45 | |||||||||||||||
Income
(loss) from operations3
|
768 | — | (1,475 | ) | (668 | ) | (1,375 | ) | ||||||||||||
Other
income (expenses)4
|
— | — | — | (374 | ) | (374 | ) | |||||||||||||
Loss
from discontinued operations
|
— | (141 | ) | — | (141 | ) | ||||||||||||||
Total
assets, net of depreciation and
amortization:
|
||||||||||||||||||||
United
States operations
|
1,796 | — | 26 | 3,537 | 5,359 | |||||||||||||||
Discontinued
operations
|
— | 1,990 | — | — | 1,990 | |||||||||||||||
Capital
expenditures
|
2 | — | — | 51 | 53 |
23
($ amounts in thousands)
Nine Months Ended September 30, 2009
|
Oncology
Devices
|
Blood
Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales:
|
||||||||||||||||||||
United
States1
|
$ | 6,745 | $ | — | $ | — | $ | — | $ | 6,745 | ||||||||||
International
|
253 | — | — | — | 253 | |||||||||||||||
License
and other revenue
|
75 | — | — | — | 75 | |||||||||||||||
Research
and development expenses
|
857 | — | 2,873 | — | 3,730 | |||||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
95 | — | — | 2,167 | 2,262 | |||||||||||||||
Depreciation
and amortization
|
108 | — | 3 | 45 | 156 | |||||||||||||||
Income
(loss) from operations
|
3,683 | — | (2,876 | ) | (2,212 | ) | (1,405 | ) | ||||||||||||
Other
income (expenses)4
|
— | — | — | (36,016 | ) | (36,016 | ) | |||||||||||||
Loss
from discontinued operations
|
— | (1,892 | ) | — | — | (1,892 | ) | |||||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||||||
United
States operations
|
2,148 | — | 555 | 6,481 | 9,184 | |||||||||||||||
Discontinued
operations
|
— | 31 | — | — | 31 | |||||||||||||||
Capital
expenditures
|
13 | — | — | 62 | 75 |
($ amounts in thousands)
Nine Months Ended September 30, 2008
|
Oncology
Devices
|
Blood Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales:
|
||||||||||||||||||||
United
States1
|
$ | 5,513 | $ | — | $ | — | $ | — | $ | 5,513 | ||||||||||
International
|
117 | — | — | — | 117 | |||||||||||||||
Research
and development expenses
|
718 | — | 2,366 | — | 3,084 | |||||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
7 | — | — | 2,122 | 2,129 | |||||||||||||||
Depreciation
and amortization
|
86 | — | 1 | 32 | 119 | |||||||||||||||
Income
(loss) from operations3
|
2,694 | — | (2,367 | ) | (2,154 | ) | (1,827 | ) | ||||||||||||
Other
income (expenses)4
|
— | — | — | (1,649 | ) | (1,649 | ) | |||||||||||||
Loss
from discontinued operations
|
— | (460 | ) | — | — | (460 | ) | |||||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||||||
United
States operations
|
1,796 | — | 26 | 3,537 | 5,359 | |||||||||||||||
Discontinued
operations
|
— | 1,990 | — | — | 1,990 | |||||||||||||||
Capital
expenditures
|
4 | — | 18 | 76 | 98 |
1
|
All
sales to EES are made in the United States. EES distributes the
product globally through its international affiliates.
|
2
|
General
and administrative expenses, 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.
|
3
|
Income
(loss) from operations does not reflect the allocation of 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.
|
15.
|
Supplemental
Disclosure for Statements of Cash
Flows
|
During
the nine-month periods ended September 30, 2009 and 2008, we paid interest
aggregating $163,000 and $753,000, respectively. During the
nine-month periods ended September 30, 2009 and 2008, we transferred $33,000 and
$127,000, respectively, of inventory to fixed assets related to the creation and
maintenance of a pool of service loaner equipment. During the
nine-month period ended September 30, 2008, we purchased equipment under a
capital lease totaling $20,000. During the nine-month period ended
September 30, 2009, we issued 957,708 shares of our common stock as payment of
interest on our convertible debt and dividends on our convertible preferred
stock. During the nine-month periods ended September 30, 2009 and
2008, we issued 80,883 and 114,921 shares of common stock, respectively, as
matching contributions to our 401(k) Plan.
24
16.
|
Subsequent
Event
|
On
October 30, 2009, the Compensation, Nominating and Governance (CNG) Committee of
the Board of Directors granted 373,000 stock options to Neoprobe’s officers and
employees with an exercise price of $1.10. Also on October 30, 2009,
the CNG Committee granted 760,000 shares of restricted stock to Neoprobe’s
officers and directors that will vest based on certain defined performance
objectives. See Note 4.
25
Item
2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations
Forward-Looking
Statements
From
time to time, our representatives and we may make written or verbal
forward-looking statements, including statements contained in this report and
other Company filings with the SEC and in our reports to
stockholders. Statements that relate to other than strictly
historical facts, such as statements about our plans and strategies,
expectations for future financial performance, new and existing products and
technologies, anticipated clinical and regulatory pathways, and markets for our
products are forward-looking statements. Generally, the words
“believe,” “expect,” “intend,”
“estimate,” “anticipate,” “will” and other similar expressions
identify forward-looking statements. The forward-looking statements
are and will be based on our then-current views and assumptions regarding future
events and operating performance, and speak only as of their
dates. Investors are cautioned that such statements involve risks and
uncertainties that could cause actual results to differ materially from
historical or anticipated results due to many factors including, but not limited
to, our continuing operating losses, uncertainty of market acceptance of our
products, reliance on third party manufacturers, accumulated deficit, future
capital needs, uncertainty of capital funding, dependence on limited product
line and distribution channels, competition, limited marketing and manufacturing
experience, risks of development of new products, regulatory risks, and other
risks detailed in our most recent Annual Report on Form 10-K and other SEC
filings. We undertake no obligation to publicly update or revise any
forward-looking statements.
The
Company
Neoprobe
Corporation is a biomedical technology company that provides innovative surgical
and diagnostic products that enhance patient care. We currently
market two lines of medical devices; our neo2000®
and neoprobe®
GDS gamma detection systems and the Quantix®
line of blood flow measurement devices of our wholly-owned subsidiary,
Cardiosonix Ltd. (Cardiosonix). In addition to our medical device
products, we have two radiopharmaceutical products, Lymphoseek®
and RIGScan®
CR, in the advanced phases of clinical development. We are also
exploring the development of our activated cellular therapy (ACT) technology for
patient-specific disease treatment through our majority-owned subsidiary, Cira
Biosciences, Inc. (Cira Bio).
Product
Line Overview
This
Overview section contains a number of forward-looking statements, all of which
are based on current expectations. Actual results may differ
materially. Our financial performance is highly dependent on our
ability to continue to generate income and cash flow from our medical device
product lines. We cannot assure you that we will achieve the volume
of sales anticipated, or if achieved, that the margin on such sales will be
adequate to produce positive operating cash flow.
We
believe that the future prospects for Neoprobe continue to improve as we make
progress in all of our key growth areas, especially related to our Lymphoseek
initiative. Despite the current global economic conditions, our gamma
device line continues to provide a strong revenue base. Due in part
to the increased revenue share we receive from EES starting in January 2009, we
expect overall revenue for our gamma device line for 2009 to be higher than
2008. Our primary development efforts over the last few years have
been focused on our oncology drug development initiatives: Lymphoseek and
RIGScan CR. We continue to make progress with both initiatives;
however, neither Lymphoseek nor RIGScan CR is anticipated to generate any
significant revenue for us during 2009 or 2010.
In August
2009, our Board of Directors decided to discontinue operations of Cardiosonix
and to attempt to divest our Cardiosonix subsidiary. This decision
was based on the determination that the blood flow measurement device segment
was no longer considered a strategic initiative to the Company, due in large
part to positive events in our other development initiatives. Until a
sale is completed, we expect to continue to generate modest revenues and incur
minimal expenses related to our blood flow measurement device
business.
26
Our
operating expenses during the first nine months of 2009 were focused primarily
on support of Lymphoseek product development. In addition, we
continued to modestly invest in our gamma detection device line related to
product line expansion and innovation. We expect our drug-related
development expenses to increase significantly over the remainder of 2009 as we
continue the second multi-center Phase 3 clinical evaluation of Lymphoseek and
support the other drug stability and production validation activities related to
supporting the potential marketing registration of Lymphoseek. We
expect to continue to incur modest development expenses to support our device
product lines as well as we work with our marketing partners to expand our
product offerings in the gamma device arena.
Our
efforts thus far in 2009 have resulted in the following milestone
achievements:
|
·
|
Completed
the first Phase 3 clinical trial of Lymphoseek (NEO3-05) in patients with
breast cancer or melanoma and announced that the primary efficacy endpoint
was exceeded with no drug-related safety events
reported.
|
|
·
|
Initiated
patient enrollment in a second Phase 3 clinical trial of Lymphoseek
(NEO3-06 or the “Sentinel” trial) in patients with head and neck squamous
cell carcinoma.
|
|
·
|
Initiated
drug development activities for RIGScan CR to support a Phase 3
study.
|
|
·
|
Began
a new five-year term of our EES gamma detection device distribution
agreement.
|
|
·
|
Added
a high energy (F-18) probe to our gamma detection device product
portfolio.
|
|
·
|
Completed
a debt restructuring agreement allowing reclassification of a majority of
the Company’s derivative liabilities and resulting in the exercise of the
Series Y Warrants, producing $3.45 million in cash flow to the
Company.
|
In June
2008, we initiated the NEO3-05 study, which was a Phase 3 study to support the
filing of a new drug application for Lymphoseek. This trial was
conducted in patients with either breast cancer or melanoma and was designed to
determine the concordance of Lymphoseek uptake in lymph nodes with the uptake of
vital blue dye in the same lymph nodes. In March 2009, we announced
that we had reached the original patient accrual target and, based on a review
of preliminary data, the efficacy endpoint for the trial had been
achieved. We have completed a full audit of the clinical data and
have confirmed that the primary clinical endpoint was statistically
achieved. Final audited data from the trial is expected to be
presented at medical meetings and published in peer-reviewed publications later
this year and early in 2010.
In June
2009, we initiated a second Phase 3 clinical trial to be conducted in patients
with head and neck squamous cell carcinoma (NEO3-06 or the “Sentinel”
trial). The Sentinel study is designed to validate Lymphoseek as a
sentinel lymph node targeting agent. Our discussions with FDA and
EMEA have also suggested that the Sentinel trial will further support the use of
Lymphoseek in sentinel lymph node biopsy procedures. We believe the
outcome of the trial will be beneficial to the marketing and commercial adoption
of Lymphoseek in the U.S. and European Union (EU). We plan to have
approximately 25 – 35 participating institutions in the Sentinel
trial. We hope a larger number of participating sites than we have
had in previous trials will ultimately enable us to enroll patients at a more
rapid rate. The trial protocol is currently under review at a number
of these institutions and patient recruitment and enrollment is actively
underway. The accrual rate for trials of this nature is highly
dependent on the timing of institutional review board (IRB) approvals of the
NEO3-06 protocol. Our experience in the NEO3-05 trial has shown that
this process may be lengthening due to risk management concerns on the part of
hospitals participating in clinical trials and other factors.
We plan
to use the safety and efficacy results from the Phase 3 clinical evaluations of
Lymphoseek, which will include sites in the EU, to support the drug registration
application process in the EU as well as in the U.S. During the
fourth quarter of 2009, we plan to request an end of Phase 3 meeting with FDA to
review the results of the NEO3-05 trial and to clarify our clinical development
and regulatory submission plan. Our goal remains to file the new drug
application with FDA for Lymphoseek in mid-2010. Depending on the
timing of patient accrual, and the timing and outcome of the FDA regulatory
review cycle, we believe that Lymphoseek can be commercialized in
mid-2011. We cannot assure you, however, that this product will
achieve regulatory approval, or if approved, that it will achieve market
acceptance.
27
Over the
past few years, we have made progress in advancing our RIGScan CR development
program while incurring minimal research expenses. Our RIGS®
technology, which had been essentially inactive since failing to gain approval
following our original license application in 1997, has been the subject of
renewed interest due primarily to the analysis of survival data related to
patients who participated in the original Phase 3 clinical studies that were
completed in 1996. After a successful pre-submission meeting with
EMEA in July 2008, we submitted a plan during the third quarter on how we would
propose to complete clinical development for RIGScan CR. The clinical
protocol we submitted to EMEA involves approximately 400 patients in a
randomized trial of patients with colorectal cancer. The participants
in the trial would be randomized to either a control or RIGS treatment
arm. Patients randomized to the RIGS arm would have their disease
status evaluated at the end of their cancer surgery to determine the presence or
absence of RIGS-positive tissue. Patients in both randomized arms
would be followed to determine if patients with RIGS-positive status have a
lower overall survival rate and/or a higher occurrence of disease
recurrence. The hypothesis for the trial is based upon the data from
the earlier NEO2-13 and NEO2-14 trial results. EMEA cleared the
protocol in December 2008. We had planned to submit the protocol to
FDA in December 2008 but were delayed awaiting confirmation that FDA has
transferred responsibility for our IND from the Center for Biologics Evaluation
and Review (CBER) division to the Center for Diagnostics Evaluation and Review
(CDER) division. We are currently planning to submit a pre-Phase 3
meeting request to FDA during the fourth quarter of 2009 in connection with a
request for a Special Protocol Assessment. As we endeavor to clarify
the regulatory pathway for RIGScan CR, we have commenced the initial development
activities for the production of RIGScan CR consistent with the scientific
advice received from EMEA.
We
continue to believe it will be necessary for us to identify a development
partner or an alternative funding source in order to prepare for and fund the
pivotal clinical testing that will be necessary to gain marketing clearance for
RIGScan CR. In the past, we have engaged in discussions with various
parties regarding such a partnership. We believe the recently
clarified regulatory pathway approved by EMEA will assist us in those
efforts. However, we believe it remains important to gain FDA
concurrence with the EMEA decision in order to secure a partnership that is
optimally beneficial to the Company. Even if we are able to make such
arrangements on satisfactory terms, we believe that the time required for
continued development, regulatory approval and commercialization of a RIGS
product would likely be a minimum of five years before we receive any
significant product-related royalties or revenues. We cannot assure
you that we will be able to complete definitive agreements with a development
partner or obtain financing to fund development of the RIGS technology and do
not know if such arrangements could be obtained on a timely basis on terms
acceptable to us, or at all. We also cannot assure you that FDA or
EMEA will clear our RIGS products for marketing or that any such products will
be successfully introduced or achieve market acceptance.
In 2005,
we formed a new subsidiary, Cira Bio, to explore the development of
ACT. Neoprobe owns approximately 90% of the outstanding shares of
Cira Bio with the remaining shares being held by the principals of a private
holding company, Cira LLC. In conjunction with the formation of Cira
Bio, an amended technology license agreement also was executed with The Ohio
State University, from whom both Neoprobe and Cira LLC had originally licensed
or optioned the various cellular therapy technologies. As a result of
the cross-license agreements, Cira Bio has the exclusive development and
commercialization rights to three issued U.S. patents that cover the oncology
and autoimmune applications of its technology. In addition, Cira Bio
has exclusive licenses to several pending patent applications. We
hope to identify a funding source to continue Cira Bio’s development
efforts. If we are successful in identifying a funding source, we
expect that any funding would likely be accomplished by an investment directly
into Cira Bio, so that the funds raised would not dilute current Neoprobe
shareholders. Obtaining this funding would likely dilute Neoprobe’s
ownership interest in Cira Bio; however, we believe that moving forward such a
promising technology will only yield positive results for the Neoprobe
stockholders and the patients who could benefit from these
treatments. We have been encouraged by recent media speculation
regarding the potential connection of a retrovirus with chronic fatigue syndrome
and the potential use of ACT to develop a treatment, which may stimulate some
interest in our ACT platform. However, we do not know if we
will be successful in obtaining funding on terms acceptable to us, or at
all. In the event we fail to obtain financing for Cira Bio, the
technology rights for the oncology applications of ACT may revert back to
Neoprobe and the technology rights for the viral and autoimmune applications may
revert back to Cira LLC upon notice by either party.
28
We expect
that revenues from our gamma detection devices will result in a net profit in
2009 for that line of business, excluding general and administrative costs,
interest and other financing-related charges. Our overall operating
results for 2009 will also be greatly affected by the amount of development of
our radiopharmaceutical products. Primarily as a result of the
significant development costs we expect to incur related to the continued
clinical development of Lymphoseek, we do not expect to achieve operating profit
during 2009. In addition, our net loss and loss per share will likely
be significantly impacted by the non-cash expense we have recorded year-to-date
due to the accounting treatment for the derivative liabilities related to the
convertible debt we issued in December 2007 and April 2008 and the convertible
preferred stock we issued in December 2008. We cannot assure you that
our current or potential new products will be successfully commercialized, that
we will achieve significant product revenues, or that we will achieve or be able
to sustain profitability in the future.
Results
of Operations
Revenue
for the first nine months of 2009 increased to $7.1 million from $5.6 million
for the same period in 2008. Research and development expenses, as a
percentage of net sales, decreased slightly to 53% during the first nine months
of 2009 from 55% during the same period in 2008. Selling, general and
administrative expenses, as a percentage of net sales, decreased to 35% during
the first nine months of 2009 from 40% during the same period in
2008. Due to the ongoing development activities of the Company,
research and development expenses as a percentage of sales are expected to be
somewhat higher in 2009 than they were in 2008.
Three
Months Ended September 30, 2009 and 2008
Net Sales and
Margins. Net sales of our gamma detection systems increased
$847,000, or 49%, to $2.6 million during the third quarter of 2009 from $1.7
million during the same period in 2008. Gross margins on net sales
increased slightly to 64% of net sales for the third quarter of 2009 compared to
63% of net sales for the same period in 2008.
The
increase in net sales was the result of increased gamma detection device sales
of $803,000, increased gamma detection device extended service contract revenue
of $22,000 and increased gamma detection device non-warranty service revenue of
$22,000. The increase in gamma detection device sales was primarily
due to increased unit sales partially offset by decreased unit prices of our
control units and probes. The increase in unit sales compared to the
prior year can be partially attributed to sales of our new high energy probes
and wireless laparoscopic probes, both of which were launched during the last 12
months. The price at which we sell our gamma detection products to
our primary marketing partner, Ethicon Endo-Surgery, Inc. (EES), a Johnson &
Johnson company, is based on a percentage of the global average selling price
(ASP) received by EES on sales of Neoprobe products to end customers, subject to
a minimum floor price. The ASP received by EES on sales outside the
U.S. decreased during the third quarter of 2009. This decrease was
partially offset by an increased percentage of ASP for certain products under
the terms of our amended distribution agreement with EES, which Neoprobe began
receiving in January 2009. The increase in gross margins on net
product sales was due to a combination of factors including the increased
percentage of ASP received by Neoprobe from EES, offset by the decreased ASP on
ex-U.S. sales.
29
Research and Development
Expenses. Research and development expenses decreased
$537,000, or 31%, to $1.2 million during the third quarter of 2009 from $1.7
million during the same period in 2008. Research and development
expenses in the third quarter of 2009 included approximately $985,000 in drug
and therapy product development costs and $220,000 in gamma detection device
development costs. This compares to expenses of $1.5 million and
$268,000 in these segment categories during the same period in
2008. The changes in each category were primarily due to (i)
decreased non-clinical testing, validation and process development activities
related to Lymphoseek and decreased costs related to the Phase 3 clinical trials
of Lymphoseek, and (ii) increased development costs of our new high energy
detection probe offset by decreased development costs of our wireless
laparoscopic and other products in the third quarter of 2009,
respectively.
Selling, General and Administrative
Expenses. Selling, general and administrative expenses
increased $71,000, or 10%, to $779,000 during the third quarter of 2009 from
$708,000 during the same period in 2008. The net difference was due
primarily to increases in compensation costs offset by decreases in investor
relations fees.
Other Income
(Expense). Other expense, net increased $22.5 million to $22.9
million during the third quarter of 2009 from $374,000 during the same period in
2008. During the third quarter of 2009, we recorded a $16.2 million
non-cash loss on extinguishment of debt related to changes in the terms of our
convertible debt, convertible preferred stock and the related warrants to
purchase our common stock. Also during the third quarter of 2009, we
recorded a $6.3 million increase in derivative liabilities resulting from the
accounting treatment for the convertible debt agreements we executed in December
2007 and April 2008, the convertible preferred stock we issued in December 2008,
and the related warrants to purchase our common stock, which contained certain
provisions that resulted in their being treated as derivative liabilities under
new accounting guidance effective January 1, 2009. During the third
quarter of 2008, we recorded a $59,000 decrease in derivative
liabilities. Interest expense, primarily related to the convertible
debt agreements we completed in December 2007 and April 2008, decreased $126,000
to $331,000 during the third quarter of 2009 from $457,000 for the same period
in 2008. Of this interest expense, $55,000 and $181,000 in the third
quarters of 2009 and 2008, respectively, was non-cash in nature related to the
amortization of debt issuance costs and discounts resulting from the warrants
and conversion features of the convertible debt. An additional
$250,000 of interest expense in the third quarter of 2009 was non-cash in nature
due to the payment or accrued payment of interest on our convertible debt with
shares of our common stock.
Discontinued
Operations. During the third quarter of 2009, we made the
decision to discontinue operations of the blood flow measurement device segment
of our business as the segment was no longer considered a strategic initiative
to the Company. This determination was based in large part on
positive events in our other development initiatives. As a result, we
recorded an impairment loss related to discontinued operations of $1.7 million
during the third quarter of 2009. Total revenues from discontinued
operations were $9,000 and $85,000 in the first nine months of 2009 and 2008,
respectively. The net loss from discontinued operations was $52,000
and $141,000 for the third quarter of 2009 and 2008, respectively.
Nine
Months Ended September 30, 2009 and 2008
Net Sales and
Margins. Net sales of our gamma detection systems increased
$1.4 million, or 24%, to $7.0 million during the first nine months of 2009 from
$5.6 million during the same period in 2008. Gross margins on net
sales increased to 67% of net sales for the first nine months of 2009 compared
to 62% of net sales for the same period in 2008.
The
increase in net sales was the result of increased gamma detection device sales
of $1.3 million, increased gamma detection device extended service contract
revenue of $69,000 and increased gamma detection device non-warranty service
revenue of $45,000. The increase in gamma detection device sales was
primarily due to increased unit prices of our control units and detector
probes. The increase in net sales compared to the prior year can also
be partially attributed to sales of our new high energy probes and wireless
laparoscopic probes, both of which were launched during the last 12
months. The price at which we sell our gamma detection products to
EES is based on a percentage of the global ASP received by EES on sales of
Neoprobe products to end customers, subject to a minimum floor
price. In January 2009, Neoprobe began receiving an increased
percentage of ASP for certain products under the terms of our amended
distribution agreement with EES. The increase in gross margins on net
product sales was due to a combination of factors including the increased
percentage of ASP received by Neoprobe from EES.
30
Research and Development
Expenses. Research and development expenses increased
$646,000, or 21%, to $3.7 million during the first nine months of 2009 from $3.1
million during the same period in 2008. Research and development
expenses in the first nine months of 2009 included approximately $2.9 million in
drug and therapy product development costs and $857,000 in gamma detection
device development costs. This compares to expenses of $2.4 million
and $718,000 in these segment categories during the same period in
2008. The changes in each category were primarily due to (i)
increased costs related to the Phase 3 clinical trials of Lymphoseek offset by
decreased non-clinical testing, validation and process development activities
related to Lymphoseek, and (ii) decreased development costs of our neoprobe GDS
control unit and wireless laparoscopic probe, offset by increased development
costs of our new high energy detection probe and other products in the first
nine months of 2009, respectively.
Selling, General and Administrative
Expenses. Selling, general and administrative expenses
increased $169,000, or 8%, to $2.4 million during the first nine months of 2009
from $2.2 million during the same period in 2008. The net difference
was due primarily to increases in compensation and utilities costs offset by
decreases in investor relations fees.
Other Income
(Expense). Other expense, net increased $34.4 million to $36.0
million during the first nine months of 2009 from $1.6 million during the same
period in 2008. During the first nine months of 2009, we recorded a
$16.2 million non-cash loss on extinguishment of debt related to changes in the
terms of our convertible debt, convertible preferred stock and the related
warrants to purchase our common stock. Also during the first nine
months of 2009, we recorded a $18.5 million increase in derivative liabilities
resulting from the accounting treatment for the convertible debt agreements we
executed in December 2007 and April 2008, the convertible preferred stock we
issued in December 2008, and the related warrants to purchase our common stock,
which contained certain provisions that resulted in their being treated as
derivative liabilities under new accounting guidance effective January 1,
2009. During the first nine months of 2008, we recorded a $441,000
increase in derivative liabilities. Interest expense, primarily
related to the convertible debt agreements we completed in December 2007 and
April 2008, decreased $9,000 to $1.25 million during the first nine months of
2009 from $1.26 million for the same period in 2008. Of this interest
expense, $420,000 and $515,000 in the first nine months of 2009 and 2008,
respectively, was non-cash in nature related to the amortization of debt
issuance costs and discounts resulting from the warrants and conversion features
of the convertible debt. An additional $667,000 of interest expense
in the first nine months of 2009 was non-cash in nature due to the payment or
accrued payment of interest on our convertible debt with shares of our common
stock.
Discontinued
Operations. During the third quarter of 2009, we made the
decision to discontinue operations of the blood flow measurement device segment
of our business as the segment was no longer considered a strategic initiative
to the Company. This determination was based in large part on
positive events in our other development initiatives. As a result, we
recorded an impairment loss related to discontinued operations of $1.7 million
during the third quarter of 2009. Total revenues from discontinued
operations were $82,000 and $209,000 in the first nine months of 2009 and 2008,
respectively. The net loss from discontinued operations was $163,000
and $460,000 for the first nine months of 2009 and 2008,
respectively.
Liquidity
and Capital Resources
Cash
balances including short term available-for-sale securities increased to $6.0
million at September 30, 2009 from $4.1 million at December 31,
2008. The net increase was primarily due to cash received for the
issuance of common stock related to the exercise of warrants, partially offset
by cash used to fund our operations, mainly for research and development
activities. The current ratio increased to 3.6:1 at September 30,
2009 from 3.1:1 at December 31, 2008.
31
Operating
Activities. Cash used in operations decreased $486,000 to $1.2
million during the first nine months of 2009 compared to $1.7 million during the
same period in 2008.
Accounts
receivable decreased to $1.4 million at September 30, 2009 from $1.6 million at
December 31, 2008. The decrease was primarily a result of normal
fluctuations in timing of purchases and payments by EES. We expect
overall receivable levels will continue to fluctuate during the remainder of
2009 depending on the timing of purchases and payments by EES.
Inventory
levels increased to $1.0 million at September 30, 2009 compared to $544,000 at
December 31, 2008. The first commercial-grade lot of the active
pharmaceutical ingredient of Lymphoseek was produced during the third quarter of
2009. Gamma detection finished device inventory decreased as sales of
detector probes increased. Gamma detection device materials inventory
increased in preparation for detector probe production. We expect
inventory levels to fluctuate during the remainder of 2009 depending on the
timing of production and sales to EES.
Investing Activities.
Investing activities provided $353,000 during the first nine months of
2009 compared to $111,000 used during the same period in
2008. Available-for-sale securities of $494,000 matured during the
first nine months of 2009. Capital expenditures of $75,000 and
$98,000 during the first nine months of 2009 and 2008, respectively, were
primarily for computers, software, and production and laboratory
equipment. We expect our overall capital expenditures for 2009 will
be comparable to 2008 as we prepare for the commercial production of
Lymphoseek. Payments for patent and trademark costs were $66,000 and
$14,000 during the first nine months of 2009 and 2008,
respectively.
Financing
Activities. Financing activities provided $3.3 million during
the first nine months of 2009 compared to $2.9 million provided during the same
period in 2008. Proceeds from the issuance of common stock were $3.6
million and $232,000 during the first nine months of 2009 and 2008,
respectively. Payments of stock offering costs were $111,000 and
$1,000 during the first nine months of 2009 and 2008,
respectively. Proceeds from notes payable were $3.0 million during
the first nine months of 2008. Payments of debt issuance costs were
$20,000 and $200,000 during the first nine months of 2009 and 2008,
respectively. Payments of notes payable were $138,000 and $125,000
during the first nine months of 2009 and 2008, respectively.
In
December 2006, we entered into a common stock purchase agreement with Fusion
Capital, an Illinois limited liability company, to sell $6.0 million of our
common stock to Fusion Capital over a 24-month period which ended on November
21, 2008. Through November 21, 2008, we sold to Fusion Capital under
the agreement 7,568,671 shares for proceeds of $1.9 million. In
December 2008, we entered into an amendment to the agreement which gave us a
right to sell an additional $6.0 million of our common stock to Fusion Capital
before March 1, 2011, along with the $4.1 million of the unsold balance of the
$6.0 million we originally had the right to sell to Fusion Capital under the
original agreement. After giving effect to this amendment, the
remaining aggregate amount of our common stock we can sell to Fusion Capital is
$10.1 million. We have reserved a total of 10,654,000 shares of our
common stock in respect to potential sales of common stock we may make to Fusion
Capital in the future under the amended agreement.
In
December 2006, we issued to Fusion Capital 720,000 shares of our common stock as
a commitment fee upon execution of the original agreement. As sales
of our common stock were made under the original agreement, we issued an
additional 234,000 shares of our common stock to Fusion Capital as an additional
commitment fee. In connection with entering into the amendment, we
issued an additional 360,000 shares in consideration for Fusion Capital’s
entering into the amendment. Also, as an additional commitment fee,
we have agreed to issue to Fusion Capital an additional 486,000 shares of our
common stock pro rata as we sell the first $4.1 million of our common stock to
Fusion Capital under the amended agreement.
32
In July
2007, David C. Bupp, our President and CEO, and certain members of his family
(the Bupp Investors) purchased a $1.0 million convertible note (the Bupp Note)
and warrants. The note bears interest at 10% per annum, had an
original term of one year and is repayable in whole or in part with no
penalty. The note is convertible into shares of our common stock at a
price of $0.31 per share, a 25% premium to the average closing market price of
our common stock for the 5 days preceding the closing of the
transaction. As part of this transaction, we issued the Bupp
Investors Series V Warrants to purchase 500,000 shares of our common stock at an
exercise price of $0.31 per share, expiring in July 2012.
In
December 2007, we entered into a Securities Purchase Agreement (SPA) with
Platinum Montaur Life Sciences, LLC (Montaur), pursuant to which we issued
Montaur a 10% Series A Convertible Senior Secured Promissory Note in the
principal amount of $7,000,000, due December 26, 2011 (the Series A Note) and a
five-year Series W Warrant to purchase 6,000,000 shares of our common stock,
$.001 par value per share, at an exercise price of $0.32 per
share. Montaur may convert $3.5 million of the Series A Note into
shares of our common stock at the conversion price of $0.26 per
share. The SPA also provided for two further tranches of financing, a
second tranche of $3 million in exchange for a 10% Series B Convertible Senior
Secured Promissory Note along with a five-year Series X Warrant to purchase
shares of our common stock, and a third tranche of $3 million in exchange for
3,000 shares of our 8% Series A Cumulative Convertible Preferred Stock and a
five-year Series Y Warrant to purchase shares of our common
stock. Closings of the second and third tranches were subject to the
satisfaction by the Company of certain milestones related to the progress of the
Phase 3 clinical trials of our Lymphoseek radiopharmaceutical
product.
In April
2008, following receipt by the Company of clearance from FDA to commence a Phase
3 clinical trial for Lymphoseek in patients with breast cancer or melanoma, we
amended the SPA related to the second tranche and issued Montaur a 10% Series B
Convertible Senior Secured Promissory Note in the principal amount of
$3,000,000, also due December 26, 2011 (the Series B Note, and hereinafter
referred to collectively with the Series A Note as the Montaur Notes), and a
five-year Series X Warrant to purchase 8,333,333 shares of our common stock at
an exercise price of $0.46 per share. Montaur may convert the Series
B Note into shares of our common stock at the conversion price of $0.36 per
share. Provided we have satisfied certain conditions stated therein,
we may elect to make payments of interest due under the Montaur Notes in
registered shares of our common stock. If we choose to make interest
payments in shares of common stock, the number of shares of common stock to be
applied against any such interest payment will be determined by reference to the
quotient of (a) the applicable interest payment divided by (b) 90% of the
average daily volume weighted average price of our common stock on the OTCBB (or
national securities exchange, if applicable) as reported by Bloomberg Financial
L.P. for the five days upon which our common stock is traded on the OTCBB
immediately preceding the date of the interest payment.
In
December 2008, after we obtained 135 vital blue dye lymph nodes from patients
who had completed surgery and the injection of the drug in a Phase 3 clinical
trial of Lymphoseek in patients with breast cancer or melanoma, we issued
Montaur 3,000 shares of our 8% Series A Cumulative Convertible Preferred Stock
(the Preferred Stock) and a five-year Series Y Warrant (hereinafter referred to
collectively with the Series W Warrant and Series X Warrant as the Montaur
Warrants) to purchase 6,000,000 shares of our common stock, at an exercise price
of $0.575 per share, also for an aggregate purchase price of
$3,000,000. Montaur may convert each share of the Preferred Stock
into a number of shares of our common stock equal to the quotient of (a) the
Liquidation Preference Amount of the shares of Preferred Stock by (b) the
Conversion Price. The “Liquidation Preference Amount” for the Preferred Stock is
$1,000 and the “Conversion Price” of the Preferred Stock was set at $0.50 on the
date of issuance, thereby making the shares of Preferred Stock convertible into
an aggregate 6,000,000 shares of our common stock, subject to adjustment as
described in the Certificate of Designations, Voting Powers, Preferences,
Limitations, Restrictions, and Relative Rights of Series A 8% Cumulative
Convertible Preferred Stock. We may elect to pay dividends due
to Montaur on the shares of Preferred Stock in registered shares of our common
stock. The number of shares of common stock to be applied against any
such dividend payment will be determined by reference to the quotient of (a) the
applicable dividend payment by (b) 90% of the average daily volume weighted
average price of our common stock on the OTCBB (or national securities exchange,
if applicable) as reported by Bloomberg Financial L.P. for the five days upon
which our common stock is traded on the OTCBB immediately preceding the date of
the dividend payment.
33
On July
24, 2009, we entered into a Securities Amendment and Exchange Agreement with
Montaur, pursuant to which Montaur agreed to the amendment and restatement of
the terms of the Montaur Notes, the Preferred Stock, and the Montaur
Warrants. The Series A Note was amended to grant Montaur conversion
rights with respect to the $3.5 million portion of the Series A Note that was
previously not convertible. The newly convertible portion of the
Series A Note is convertible at $0.9722 per share. The amendments
also eliminated certain price reset features of the Montaur Notes, the Preferred
Stock and the Montaur Warrants that had created significant non-cash derivative
liabilities on the Company’s balance sheet. In conjunction with this
transaction, we issued Montaur a Series AA Warrant to purchase 2.4 million
shares of our common stock at an exercise price of $0.97 per share, expiring in
July 2014. The changes in terms of the Montaur Notes, the Preferred
Stock and the Montaur Warrants was treated as an extinguishment of debt for
accounting purposes. The Company recorded an additional $5.6 million
in mark-to-market adjustments related to the increase in the Company’s common
stock from June 30 to July 24, 2009. As a result of the
extinguishment treatment associated with the elimination of the price reset
features, the Company also recorded $16.2 million in non-cash loss on the
extinguishment and reclassified $27.0 million in derivative liabilities to
additional paid-in capital. Following the extinguishment, the
Company’s balance sheet reflects the face value of the $10 million due to
Montaur pursuant to the Montaur Notes. In connection with this
transaction, Montaur exercised 2,844,319 Series Y Warrants in exchange for
issuance of 2,844,319 shares of our common stock, resulting in gross proceeds of
$1,635,483 received in July 2009. Montaur also exercised their
remaining 3,155,681 Series Y Warrants in exchange for issuance of 3,155,681
shares of our common stock, resulting in additional gross proceeds of $1,814,517
received in September 2009.
In
connection with the Montaur SPA, the term of the $1.0 million Bupp Note was
extended to December 27, 2011, one day following the maturity date of the
Montaur Notes. In consideration for the Bupp Investors’ agreement to
extend the term of the Bupp Note pursuant to an Amendment to the Bupp Purchase
Agreement, dated December 26, 2007, we agreed to provide security for the
obligations evidenced by the Amended 10% Convertible Note in the principal
amount of $1,000,000, due December 31, 2011, executed by Neoprobe in favor of
the Bupp Investors (the Amended Bupp Note), under the terms of a Security
Agreement, dated December 26, 2007, by and between Neoprobe and the Bupp
Investors (the Bupp Security Agreement). This security interest is
subordinate to the security interest of Montaur. As further
consideration for extending the term of the Bupp Note, we issued the Bupp
Investors Series V Warrants to purchase 500,000 shares of our common stock at an
exercise price of $0.32 per share, expiring in December 2012. The
Amended Bupp Note had an outstanding principal amount of $1.0 million on
September 30, 2009, and an outstanding principal amount of $1.0 million as of
November 6, 2009. During the first nine months of 2009, we paid none
of the outstanding principal and paid $75,000 in interest due under the Amended
Bupp Note.
Our
future liquidity and capital requirements will depend on a number of factors,
including our ability to expand market acceptance of our current products, our
ability to complete the commercialization of new products, our ability to
monetize our investment in non-core technologies, our ability to obtain
milestone or development funds from potential development and distribution
partners, regulatory actions by FDA and international regulatory bodies, and
intellectual property protection. Our most significant near-term
development priority is to complete the second Phase 3 clinical trial of
Lymphoseek. We believe our current funds and available capital
resources will be adequate to complete our Lymphoseek development efforts and
sustain our operations at planned levels for the foreseeable
future. We are in the process of determining the total development
cost necessary to commercialize RIGScan CR but believe that it will require
total additional commitments of between $3 million to $5 million to restart
manufacturing and other activities necessary to prepare for the Phase 3 clinical
trial contemplated in the recent EMEA scientific advice response. We
plan to use part of the proceeds from Montaur’s recent warrant exercises to
initiate the first steps of restarting manufacturing of RIGScan CR; however, we
still intend to involve a partner in the longer-term development of RIGScan
CR. We may also be able to raise additional funds through a stock
purchase agreement with Fusion Capital to supplement our capital
needs. However, the extent to which we rely on Fusion Capital as a
source of funding will depend on a number of factors, including the prevailing
market price of our common stock and the extent to which we are able to secure
working capital from other sources. Specifically, Fusion Capital does
not have the right or the obligation to purchase any shares of our common stock
on any business day that the market price of our common stock is less than $0.20
per share. We cannot assure you that we will be successful in raising
additional capital through Fusion Capital or any other sources at terms
acceptable to the Company, or at all. We also cannot assure you that
we will be able to successfully obtain regulatory approval for and commercialize
new products, that we will achieve significant product revenues from our current
or potential new products or that we will achieve or sustain profitability in
the future.
34
Recent
Accounting Developments
In
September 2006, the Financial Accounting Standards Board (FASB) issued Statement
of Financial Accounting Standards (SFAS) No. 157, Fair Value Measurements,
which was primarily codified in FASB Accounting Standards CodificationTM (ASC)
Topic 820, Fair Value
Measurements and Disclosures. FASB ASC 820 defines fair value,
establishes a framework for measuring fair value in generally accepted
accounting principles, and expands disclosures about fair value
measurements. FASB ASC 820 did not require any new fair value
measurements. FASB ASC 820 was initially effective for Neoprobe
beginning January 1, 2008 for nonfinancial assets and nonfinancial liabilities
recognized or disclosed at fair value on at least an annual basis. In
February 2008, the FASB decided to allow entities to electively defer the
effective date of FASB ASC 820 until January 1, 2009 for nonfinancial assets and
nonfinancial liabilities that are not recognized or disclosed at fair value on
at least an annual basis. We began applying the fair value
measurement and disclosure provisions of FASB ASC 820 to nonfinancial assets and
liabilities effective January 1, 2009. The application of such was
not material to our consolidated results of operations or financial
condition. See Note 1(b) and Note 3.
In
December 2007, the FASB issued SFAS No. 141(R) (revised 2007), Business Combinations, which
was primarily codified in FASB ASC Topic 805, Business
Combinations. FASB ASC 805 requires that the acquisition
method (formerly called the purchase method) of accounting be used for all
business combinations and for an acquirer to be identified for each business
combination. FASB ASC 805 defines the acquirer as the entity that
obtains control of one or more businesses in the business combination,
establishes the acquisition date as the date that the acquirer achieves control
and requires the acquirer to recognize the assets and liabilities assumed and
any noncontrolling interest at their fair values as of the acquisition
date. FASB ASC 805 also requires, among other things, that the
acquisition-related costs be recognized separately from the
acquisition. FASB ASC 805 applies prospectively to business
combinations for which the acquisition date is on or after the beginning of the
first annual reporting period beginning on or after December 15, 2008, and was
adopted by Neoprobe beginning January 1, 2009. The effect the
adoption of FASB ASC 805 will have on us will depend on the nature and size of
acquisitions we complete in the future, if any.
Also in
December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in
Consolidated Financial Statements – an Amendment of ARB No. 51, which was
primarily codified in FASB ASC Topic 810, Consolidation. FASB
ASC 810 establishes accounting and reporting standards for the noncontrolling
interest in a subsidiary and for the deconsolidation of a
subsidiary. FASB ASC 810 is effective for fiscal years and interim
periods within those fiscal years beginning on or after December 15, 2008, and
was adopted by Neoprobe beginning January 1, 2009. FASB ASC 810 is
being applied prospectively as of the beginning of the fiscal year in which it
was adopted, except for the presentation and disclosure
requirements. The presentation and disclosure requirements are being
applied retrospectively for all periods presented. The adoption of
the new provisions of FASB ASC 810 did not have a material effect on our
consolidated results of operations or financial condition.
In
December 2007, the FASB ratified the consensus reached by the Emerging Issues
Task Force (EITF) on EITF Issue No. 07-1, Accounting for Collaborative
Arrangements, which was primarily codified in FASB ASC Topic 808, Collaborative
Arrangements. FASB ASC 808 defines a collaborative arrangement
as well as the accounting for transactions between participants in a
collaborative arrangement and between the participants in the arrangement and
third parties. FASB ASC 808 requires that both types of transactions
be reported in each participant’s respective income statement. We
adopted the new provisions of FASB ASC 808 beginning January 1,
2009. The adoption did not have a material effect on our consolidated
results of operations or financial condition.
35
In March
2008, the FASB issued SFAS No. 161, Disclosures about Derivative
Instruments and Hedging Activities – an Amendment of FASB Statement No.
133, which was primarily codified in FASB ASC Topic 815, Derivatives and
Hedging. FASB ASC 815 provides an understanding of how and why
an entity uses derivative instruments, how derivative instruments and related
hedged items are accounted for, and their effect on an entity’s financial
position, financial performance, and cash flows. We adopted the new
provisions of FASB ASC 815 beginning January 1, 2009. The adoption
did not have a material impact on our derivative disclosures. See
Note 11.
In June
2008, the FASB ratified the consensus reached by the EITF on EITF Issue No.
07-5, Determining Whether an
Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock,
which was primarily codified in FASB ASC Topic 815, Derivatives and
Hedging. The new provisions of FASB ASC 815 clarify the
determination of whether equity-linked instruments (or embedded features), such
as our convertible notes or warrants to purchase our common stock, are
considered indexed to our own stock, which would qualify as a scope
exception. We adopted the new provisions of FASB ASC 815 beginning
January 1, 2009. The adoption had a material impact on our
consolidated financial statements. See Note 11.
Also in
June 2008, the FASB issued FSP EITF 03-6-1, Determining Whether Instruments
Granted in Share-Based Payment Transactions are Participating Securities,
which was primarily codified in FASB ASC Topic 260, Earnings Per
Share. FASB ASC 260 provides that unvested share-based payment
awards that contain nonforfeitable rights to dividends or dividend equivalents,
whether paid or unpaid, are participating securities and are required to be
included in the computation of earnings per share pursuant to the two-class
method. The two-class method of computing earnings per share includes
an earnings allocation formula that determines earnings per share for common
stock and any participating securities according to dividends declared, whether
paid or unpaid, and participation rights in undistributed
earnings. All prior period earnings per share data presented are
required to be adjusted retrospectively to conform to the new provisions of FASB
ASC 260. We adopted the new provisions of FASB ASC 260 beginning
January 1, 2009. The adoption had no material impact on our earnings
(loss) per share for the three-month and nine-month periods ended September 30,
2009 and 2008.
In April
2009, the FASB issued FSP FAS 107-1 and APB 28-1, Interim Disclosures About Fair Value
of Financial Instruments, which amends SFAS No. 107, Disclosures About Fair Value of
Financial Instruments, and APB Opinion 28, Interim Financial Reporting,
respectively. FSP FAS 107-1 and APB 28-1 were primarily codified in
FASB ASC Topic 825, Financial
Instruments. FASB ASC 825 requires disclosure about fair value
of financial instruments for interim reporting periods of publicly traded
companies in addition to annual financial statements. We adopted the
new provisions of FASB ASC 825 beginning April 1, 2009. As the new
provisions of FASB ASC 825 provide only disclosure requirements, the adoption of
this standard did not have an impact on our consolidated financial position,
results of operations or cash flows, but did result in increased disclosures in
the second and third quarters of 2009. See Note 1(b).
In May
2009, the FASB issued SFAS No. 165, Subsequent Events, which was
primarily codified in FASB ASC Topic 855, Subsequent
Events. FASB ASC 855 establishes general standards of
accounting for and disclosure of events that occur after the balance sheet date
but before the financial statements are issued or are available to be
issued. It requires the disclosure of the date through which an
entity has evaluated subsequent events and the basis for that
date. We adopted FASB ASC 855 beginning April 1, 2009. The
adoption of FASB ASC 855 did not have a material impact on our consolidated
financial position, results of operations or cash flows. We have
evaluated subsequent events through November 16, 2009, the date our consolidated
financial statements were issued. See Note 1(a) and Note
16.
36
In June
2009, the FASB issued SFAS No. 168, The FASB Accounting Standards
Codification and the Hierarchy of Generally Accepted Accounting Principles — a
replacement of FASB Statement No. 162, which was primarily codified in
FASB ASC Topic 105, Generally
Accepted Accounting Principles. FASB ASC 105 established the
FASB Accounting Standards Codification as the source of authoritative accounting
principles recognized by the FASB to be applied by nongovernmental entities in
the preparation of financial statements in conformity with generally accepted
accounting principles in the United States (U.S. GAAP). All guidance
contained in FASB ASC 105 carries an equal level of authority. FASB
ASC 105 did not change current U.S. GAAP, but is intended to simplify user
access to all authoritative U.S. GAAP by providing all the authoritative
literature related to a particular topic in one place. FASB ASC 105
superseded all then-existing non-SEC accounting and reporting
standards. All other non-grandfathered non-SEC accounting literature
not included in FASB ASC 105 became non-authoritative. FASB ASC 105
is effective for financial statements issued for interim and annual periods
ending after September 15, 2009. The implementation of FASB ASC 105
did not impact our consolidated financial statements.
Critical
Accounting Policies
The
following accounting policies are considered by us to be critical to our results
of operations and financial condition.
Revenue Recognition Related to Net
Sales. We currently generate revenue primarily from sales of
our gamma detection products. Our standard shipping terms are FOB
shipping point, and title and risk of loss passes to the customer upon delivery
to a common carrier. We generally recognize sales revenue related to
sales of our products when the products are shipped and the earnings process has
been completed. However, in cases where product is shipped but the
earnings process is not yet completed, revenue is deferred until it has been
determined that the earnings process has been completed. Our
customers have no right to return products purchased in the ordinary course of
business.
The
prices we charge our primary customer, EES, related to sales of products are
subject to retroactive annual adjustment based on a fixed percentage of the
actual sales prices achieved by EES on sales to end customers made during each
fiscal year. To the extent that we can reasonably estimate the
end-customer prices received by EES, we record sales to EES based upon these
estimates. If we are unable to reasonably estimate end customer sales
prices related to certain products sold to EES, we record revenue related to
these product sales at the minimum (i.e., floor) price provided for under our
distribution agreement with EES.
We also
generate revenue from the service and repair of out-of-warranty
products. Fees charged for service and repair on products not covered
by an extended service agreement are recognized on completion of the service
process when the serviced or repaired product has been returned to the
customer. Fees charged for service or repair of products covered by
an extended warranty agreement are deferred and recognized as revenue ratably
over the life of the extended service agreement.
Use of
Estimates. The preparation of financial statements in
conformity with accounting principles generally accepted in the United States of
America requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosures of contingent assets
and liabilities at the date of the financial statements and the reported amounts
of revenues and expenses during the reporting period. We base these
estimates and assumptions upon historical experience and existing, known
circumstances. Actual results could differ from those
estimates. Specifically, management may make significant estimates in
the following areas:
|
·
|
Stock-Based
Compensation. We
account for stock-based compensation in accordance with FASB ASC Topic
718, Compensation –
Stock Compensation. FASB ASC 718 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.
|
37
|
·
|
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 FASB ASC Topic 360, Property, Plant and
Equipment. FASB ASC 360 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.
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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 Derivative
Instruments. We account for derivative
instruments in accordance with FASB ASC Topic 815, Derivatives and
Hedging. FASB ASC 815 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 new provisions of FASB ASC 815 which 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. As a result of adopting the new provisions of
FASB ASC 815, 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.
|
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
Not
applicable.
Item
4T. Controls and Procedures
Disclosure
Controls and Procedures
We
maintain disclosure controls and procedures designed to ensure that information
required to be disclosed in reports filed under the Exchange Act is recorded,
processed, summarized, and reported within the specified time
periods. As a part of these controls, our management is responsible
for establishing and maintaining adequate internal control over financial
reporting, as such term is defined in Rule 13a-15(f) under the Exchange
Act.
38
Our
internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles, and includes those policies and
procedures that:
|
·
|
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.
|
Under the
supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, we evaluated the effectiveness of
the design and operation of our disclosure controls and procedures (as defined
in Rule 13a-15(e) under the Exchange Act) as of September 30,
2009. Disclosure controls and procedures include, without limitation,
controls and procedures designed to ensure that information required to be
disclosed by us in the reports that we file or submit under the Exchange Act is
accumulated and communicated to our management, including our principal
executive and principal financial officers, as appropriate to allow timely
decisions regarding required disclosure. Based on our evaluation, our
Chief Executive Officer and Chief Financial Officer have concluded that, as of
the end of the period covered by this report, our disclosure controls and
procedures are adequately designed and effective.
Our
management, including our Chief Executive Officer and Chief Financial Officer,
does not expect that our disclosure controls and procedures will prevent all
errors and all improper conduct. A control system, no matter how well
conceived and operated, can provide only reasonable, not absolute assurance that
the objectives of the control systems are met. Further, a design of a
control system must reflect the fact that there are resource constraints, and
the benefit of controls must be considered relative to their
costs. Because of the inherent limitations in all control systems, no
evaluation of controls can provide absolute assurance that all control issues
and instances of improper conduct, if any, have been detected. These
inherent limitations include the realities that judgments and decision-making
can be faulty, and that breakdowns can occur because of a simple error or
mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more persons, or by management
override of the control. Further, the design of any system of
controls is also based in part upon assumptions about the likelihood of future
events, and there can be no assurance that any design will succeed in achieving
its stated goals under all potential future conditions. Over time,
controls may become inadequate because of changes in conditions, or the degree
of compliance with the policies or procedures may
deteriorate. Because of the inherent limitations of a cost-effective
control system, misstatements due to error or fraud may occur and may not be
detected.
Changes
in Control Over Financial Reporting
|
During
the quarter ended September 30, 2009, there were no changes in our internal
control over financial reporting that materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
39
PART
II - OTHER INFORMATION
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
(a)
|
During
the three-month period ended September 30, 2009, we issued 99,884 shares
of our common stock in payment of June 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 (Montaur). During the same
period, we issued 71,917 shares of our common stock in payment of
April-June 2009 dividends of $60,000 on the 8% Series A Cumulative
Convertible Preferred Stock held by Montaur. Also during the
three-month period ended September 30, 2009, Montaur exercised 6,000,000
Series Y Warrants in exchange for issuance of 6,000,000 shares of our
common stock, resulting in gross proceeds of $3,450,000, and we issued
Montaur a Series AA Warrant to purchase 2,400,000 shares of our common
stock at an exercise price of $0.97 per share, expiring in July
2014. The issuances of the shares and warrants to Montaur were
exempt from registration under Sections 4(2) and 4(6) of the Securities
Act and Regulation D promulgated
thereunder.
|
Item
6. Exhibits
|
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.
|
Items
1, 3, 4 and 5 are not applicable and have been omitted. There are no
material changes in Item 1A from the corresponding item reported in the
Company’s Form 10-K for the year ended December 31, 2008, and this item has
therefore been omitted.
40
SIGNATURES
In accordance with the requirements of
the Exchange Act, the registrant caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
NEOPROBE
CORPORATION
|
|
(the
Company)
|
|
Dated:
November 16, 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)
|
41