NAVIDEA BIOPHARMACEUTICALS, INC. - Quarter Report: 2010 March (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
March 31,
2010
o
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
transition period from
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
o
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 o No
o
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 o
|
Accelerated
filer o
|
|
Non-accelerated
filer o
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act.)
Yes o No x
Indicate
the number of shares outstanding of each of the issuer’s classes of common
stock, as of the latest practicable date: 81,957,277 shares of common
stock, par value $.001 per share (as of the close of business on May 7,
2010).
NEOPROBE CORPORATION and
SUBSIDIARIES
INDEX
PART
I – Financial Information
|
||
Item
1.
|
Financial
Statements
|
3
|
Consolidated
Balance Sheets as of
March 31, 2010 (unaudited) and December 31, 2009 |
3
|
|
Consolidated
Statements of Operations for the Three-Month Periods Ended
March 31, 2010 and March 31, 2009 (unaudited) |
5
|
|
Consolidated
Statement of Stockholders’ Deficit for the Three-Month Period Ended
March 31, 2010 (unaudited) |
6
|
|
Consolidated
Statements of Cash Flows for the Three-Month Periods Ended
March 31, 2010 and March 31, 2009 (unaudited) |
7
|
|
Notes
to the Consolidated Financial Statements (unaudited)
|
8
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
22
|
Forward-Looking
Statements
|
22
|
|
The
Company
|
22
|
|
Product
Line Overview
|
22
|
|
Results
of Operations
|
26
|
|
Liquidity
and Capital Resources
|
27
|
|
Recent
Accounting Developments
|
30
|
|
Critical
Accounting Policies
|
31
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
32
|
Item
4T.
|
Controls
and Procedures
|
32
|
PART
II – Other Information
|
||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
34
|
Item
6.
|
Exhibits
|
34
|
2
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements
Neoprobe
Corporation and Subsidiaries
Consolidated
Balance Sheets
ASSETS
|
March 31,
2010
(unaudited)
|
December 31,
2009
|
||||||
Current
assets:
|
||||||||
Cash
|
$ | 5,956,271 | $ | 5,639,842 | ||||
Accounts
receivable, net
|
1,136,073 | 1,331,908 | ||||||
Inventory
|
1,361,412 | 1,143,697 | ||||||
Prepaid
expenses and other
|
212,723 | 474,243 | ||||||
Assets
associated with discontinued operations
|
16,572 | 27,475 | ||||||
Total
current assets
|
8,683,051 | 8,617,165 | ||||||
Property
and equipment
|
2,219,250 | 1,990,603 | ||||||
Less
accumulated depreciation and amortization
|
1,749,164 | 1,693,290 | ||||||
470,086 | 297,313 | |||||||
Patents
and trademarks
|
533,261 | 524,224 | ||||||
Less
accumulated amortization
|
444,378 | 445,650 | ||||||
88,883 | 78,574 | |||||||
Other
assets
|
22,534 | 24,707 | ||||||
Total
assets
|
$ | 9,264,554 | $ | 9,017,759 |
Continued
3
Neoprobe
Corporation and Subsidiaries
Consolidated
Balance Sheets, continued
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
March 31,
2010
(unaudited)
|
December 31,
2009
|
||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 1,091,743 | $ | 763,966 | ||||
Accrued
liabilities and other
|
1,777,795 | 1,048,304 | ||||||
Capital
lease obligations, current portion
|
11,633 | 11,265 | ||||||
Deferred
revenue, current portion
|
522,320 | 560,369 | ||||||
Liabilities
associated with discontinued operations
|
19,029 | 18,743 | ||||||
Total
current liabilities
|
3,422,520 | 2,402,647 | ||||||
Capital
lease obligations
|
16,519 | 19,912 | ||||||
Deferred
revenue
|
502,875 | 534,119 | ||||||
Note
payable to CEO, net of discounts of $48,076 and $54,093,
respectively
|
951,924 | 945,907 | ||||||
Notes
payable to investors
|
10,000,000 | 10,000,000 | ||||||
Derivative
liabilities
|
2,380,956 | 1,951,664 | ||||||
Other
liabilities
|
29,906 | 33,362 | ||||||
Total
liabilities
|
17,304,700 | 15,887,611 | ||||||
Commitments
and contingencies
|
||||||||
Preferred
stock; $.001 par value; 5,000,000 shares authorized; 3,000 Series A
shares, par value $1,000, issued and outstanding at March 31, 2010 and
December 31, 2009
|
3,000,000 | 3,000,000 | ||||||
Stockholders’
deficit:
|
||||||||
Common
stock; $.001 par value; 150,000,000 shares authorized; 81,891,716 and
80,936,711 shares issued and outstanding at March 31, 2010 and December
31, 2009, respectively
|
81,892 | 80,937 | ||||||
Additional
paid-in capital
|
184,096,762 | 182,747,897 | ||||||
Accumulated
deficit
|
(195,218,800 | ) | (192,698,686 | ) | ||||
Total
stockholders’ deficit
|
(11,040,146 | ) | (9,869,852 | ) | ||||
Total
liabilities and stockholders’ deficit
|
$ | 9,264,554 | $ | 9,017,759 |
See
accompanying notes to consolidated financial statements
4
Neoprobe
Corporation and Subsidiaries
Consolidated
Statements of Operations
(unaudited)
Three
Months Ended
March
31,
|
||||||||
2010
|
2009
|
|||||||
Revenues:
|
||||||||
Net
sales
|
$ | 2,657,872 | $ | 2,657,221 | ||||
License
revenue
|
25,000 | 25,000 | ||||||
Total
revenues
|
2,682,872 | 2,682,221 | ||||||
Cost
of goods sold
|
888,867 | 826,363 | ||||||
Gross
profit
|
1,794,005 | 1,855,858 | ||||||
Operating
expenses:
|
||||||||
Research
and development
|
2,401,672 | 1,221,969 | ||||||
Selling,
general and administrative
|
1,128,202 | 837,323 | ||||||
Total
operating expenses
|
3,529,874 | 2,059,292 | ||||||
Loss
from operations
|
(1,735,869 | ) | (203,434 | ) | ||||
Other
income (expense):
|
||||||||
Interest
income
|
1,814 | 9,947 | ||||||
Interest
expense
|
(284,438 | ) | (457,134 | ) | ||||
Change
in derivative liabilities
|
(429,292 | ) | 1,525,365 | |||||
Other
|
(456 | ) | (274 | ) | ||||
Total
other (expense) income, net
|
(712,372 | ) | 1,077,904 | |||||
(Loss)
income from continuing operations
|
(2,448,241 | ) | 874,470 | |||||
Discontinued
operations – loss from operations
|
(11,873 | ) | (60,349 | ) | ||||
Net
(loss) income
|
(2,460,114 | ) | 814,121 | |||||
Preferred
stock dividends
|
(60,000 | ) | (60,000 | ) | ||||
(Loss)
income attributable to common stockholders
|
$ | (2,520,114 | ) | $ | 754,121 | |||
(Loss)
income per common share (basic and diluted):
|
||||||||
Continuing
operations
|
$ | (0.03 | ) | $ | 0.01 | |||
Discontinued
operations
|
$ | 0.00 | $ | 0.00 | ||||
Attributable
to common stockholders
|
$ | (0.03 | ) | $ | 0.01 | |||
Weighted
average shares outstanding:
|
||||||||
Basic
|
79,571,399 | 71,387,438 | ||||||
Diluted
|
79,571,399 | 96,346,846 |
See
accompanying notes to consolidated financial statements.
5
Neoprobe
Corporation and Subsidiaries
Consolidated
Statement of Stockholders’ Deficit
(unaudited)
Common Stock
|
Additional
Paid-in
|
Accumulated
|
||||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||
Balance,
December 31, 2009
|
80,936,711 | $ | 80,937 | $ | 182,747,897 | $ | (192,698,686 | ) | $ | (9,869,852 | ) | |||||||||
Issued
stock in payment of interest on convertible debt and dividends on
convertible preferred stock
|
239,757 | 240 | 309,760 | — | 310,000 | |||||||||||||||
Issued
stock upon net-share exercise of options
|
1,208 | 1 | (1 | ) | — | — | ||||||||||||||
Issued
stock in connection with stock purchase agreement, net of
costs
|
660,541 | 661 | 776,797 | — | 777,458 | |||||||||||||||
Issued
stock to 401(k) plan at $0.76
|
53,499 | 53 | 40,570 | — | 40,623 | |||||||||||||||
Paid
common stock issuance costs
|
— | — | (1,366 | ) | — | (1,366 | ) | |||||||||||||
Stock
compensation expense
|
— | — | 223,105 | — | 223,105 | |||||||||||||||
Preferred
stock dividends
|
— | — | — | (60,000 | ) | (60,000 | ) | |||||||||||||
Comprehensive
loss:
|
||||||||||||||||||||
Net
loss
|
— | — | — | (2,460,114 | ) | (2,460,114 | ) | |||||||||||||
Balance,
March 31, 2010
|
81,891,716 | $ | 81,892 | $ | 184,096,762 | $ | (195,218,800 | ) | $ | (11,040,146 | ) |
See
accompanying notes to consolidated financial statements.
6
Neoprobe
Corporation and Subsidiaries
Consolidated
Statements of Cash Flows
(unaudited)
Three
Months Ended
March
31,
|
||||||||
2010
|
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
(loss) income
|
$ | (2,460,114 | ) | $ | 814,121 | |||
Adjustments
to reconcile net (loss) income to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
61,981 | 100,896 | ||||||
Amortization
of debt discount and debt offering costs
|
8,190 | 179,730 | ||||||
Issuance
of common stock in payment of interest and dividends
|
250,000 | 83,333 | ||||||
Stock
compensation expense
|
223,105 | 70,536 | ||||||
Change
in derivative liabilities
|
429,292 | (1,525,365 | ) | |||||
Other
|
40,977 | 4,581 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
200,735 | (41,139 | ) | |||||
Inventory
|
(226,003 | ) | (28,794 | ) | ||||
Prepaid
expenses and other assets
|
38,976 | 33,955 | ||||||
Accounts
payable
|
328,977 | (38,918 | ) | |||||
Accrued
liabilities and other liabilities
|
597,321 | (38,217 | ) | |||||
Deferred
revenue
|
(69,293 | ) | (30,815 | ) | ||||
Net
cash used in operating activities
|
(575,856 | ) | (416,096 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Maturities
of available-for-sale securities
|
— | 494,000 | ||||||
Purchases
of equipment
|
(90,422 | ) | (40,491 | ) | ||||
Proceeds
from sales of equipment
|
— | 251 | ||||||
Patent
and trademark costs
|
(12,902 | ) | (12,665 | ) | ||||
Net
cash (used in) provided by investing activities
|
(103,324 | ) | 441,095 | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from issuance of common stock
|
1,000,000 | 25,500 | ||||||
Payment
of stock offering costs
|
(1,366 | ) | (12,866 | ) | ||||
Payment
of notes payable
|
— | (50,992 | ) | |||||
Payments
under capital leases
|
(3,025 | ) | (3,421 | ) | ||||
Net
cash provided by (used in) financing activities
|
995,609 | (41,779 | ) | |||||
Net
increase (decrease) in cash
|
316,429 | (16,780 | ) | |||||
Cash,
beginning of period
|
5,639,842 | 3,565,837 | ||||||
Cash,
end of period
|
$ | 5,956,271 | $ | 3,549,057 |
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 March 31,
2010 and for the three-month periods ended March 31, 2010 and March 31,
2009 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. The balances as of March 31, 2010 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, 2009, 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 the 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 development
initiatives. Our consolidated 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)
|
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 March 31, 2010 and
December 31, 2009, the note payable to our CEO had an estimated fair value
of $5.3 million and $3.9 million, respectively, based on the closing
market price of our common stock.
|
|
(3)
|
Notes
payable to investors: The carrying value of our debt is
presented as the face amount of the notes. At March 31, 2010
and December 31, 2009, the notes payable to investors had an estimated
fair value of $41.6 million and $31.0 million, respectively, based on the
closing market price of our common
stock.
|
(4)
|
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.
|
2.
|
Discontinued
Operations
|
In August
2009, the Company’s Board of Directors decided to discontinue the operations of
Cardiosonix and to attempt to sell 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. We are in the process of identifying potential buyers;
however, no agreement has yet been reached.
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 and reduced them to their estimated fair value at that
time. 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:
March 31,
2010
|
December 31,
2009
|
|||||||
Accounts
receivable, net
|
$ | 10,450 | $ | 15,349 | ||||
Inventory
|
6,122 | 12,126 | ||||||
Current
assets associated with discontinued operations
|
$ | 16,572 | $ | 27,475 | ||||
Accounts
payable
|
$ | 6,600 | $ | 5,400 | ||||
Accrued
expenses
|
12,429 | 13,343 | ||||||
Current
liabilities associated with discontinued operations
|
$ | 19,029 | $ | 18,743 |
9
We
recorded an impairment loss of $1.7 million during the third quarter of 2009 and
have reclassified all related revenues and expenses to discontinued operations
for all periods presented. 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
March 31,
|
||||||||
2010
|
2009
|
|||||||
Net
sales
|
$ | 14,445 | $ | 42,815 | ||||
Cost
of goods sold
|
6,389 | 22,171 | ||||||
Gross
profit
|
8,056 | 20,644 | ||||||
Operating
expenses:
|
||||||||
Research
and development
|
251 | 16,089 | ||||||
Selling,
general and administrative
|
19,862 | 64,725 | ||||||
Total
operating expenses
|
20,113 | 80,814 | ||||||
Other
income (expense)
|
184 | (179 | ) | |||||
Loss
from discontinued operations
|
$ | (11,873 | ) | $ | (60,349 | ) |
10
3.
|
Fair
Value Hierarchy
|
The
following tables set forth, by level, financial liabilities measured at fair
value on a recurring basis:
Liabilities Measured at Fair Value on a Recurring Basis as of March 31, 2010
|
||||||||||||||||
Quoted Prices
in Active
Markets for
Identical
Liabilities
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs
|
Balance as of
March 31,
|
|||||||||||||
Description
|
(Level
1)
|
(Level
2)
|
(Level
3)
|
2010
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to warrants
|
$ | — | $ | 1,414,956 | $ | — | $ | 1,414,956 | ||||||||
Derivative
liabilities related to conversion and put options
|
— | — | 966,000 | 966,000 | ||||||||||||
Total
derivative liabilities
|
$ | — | $ | 1,414,956 | $ | 966,000 | $ | 2,380,956 |
Liabilities Measured at Fair Value on a Recurring Basis as of December 31, 2009
|
||||||||||||||||
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)
|
2009
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to warrants
|
$ | — | $ | 985,664 | $ | — | $ | 985,664 | ||||||||
Derivative
liabilities related to put options
|
— | — | 966,000 | 966,000 | ||||||||||||
Total
derivative liabilities
|
$ | — | $ | 985,664 | $ | 966,000 | $ | 1,951,664 |
The
following tables set forth a summary of changes in the fair value of our Level 3
liabilities for the three-month periods ended March 31, 2010 and
2009:
Three Months Ended March 31, 2010
|
||||||||||||||||
Description
|
Balance at
December 31,
2009
|
Unrealized
(Gains)
Losses
|
Transfers In
and/or (Out)
|
Balance at
March 31,
2010
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to conversion and put options
|
$ | 966,000 | $ | — | $ | — | $ | 966,000 |
Three Months Ended March 31, 2009
|
||||||||||||||||
Description
|
Balance at
December 31,
2008
|
Unrealized
(Gains)
Losses
|
Transfers In
and/or (Out)
(See Note 10)
|
Balance at
March 31,
2009
|
||||||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to conversion and put options
|
$ | 853,831 | $ | (556,637 | ) | $ | 5,304,487 | $ | 5,601,681 |
11
There
were no transfers in or out of our Level 1 and Level 2 fair value measurements
during the three-month period ended March 31, 2010. During the
three-month period ended March 31, 2009, we transferred $7.7 million into our
Level 2 liabilities. The transfer was a result of the required
January 1, 2009 adoption of a new accounting standard which clarified the
determination of whether equity-linked instruments, such as warrants to purchase
our common stock, are considered indexed to our own stock. As a
result of adopting the new standard, certain warrants to purchase our common
stock that were previously treated as equity were reclassified as derivative
liabilities.
4.
|
Stock-Based
Compensation
|
At March
31, 2010, we have instruments outstanding under three stock-based compensation
plans; 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). Currently, under the 2002 Plan, we may grant incentive stock
options, nonqualified stock options, and restricted stock awards to full-time
employees and directors, 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.
Stock-based
payments to employees and directors, including grants of stock options, are
recognized in the statement of operations based on their estimated fair
values. 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.
Compensation
cost arising from stock-based awards is recognized as expense using the
straight-line method over the vesting period. For the three-month
periods ended March 31, 2010 and 2009, our total stock-based compensation
expense was approximately $223,000 and $71,000, respectively. We have
not recorded any income tax benefit related to stock-based compensation in
either of the three-month periods ended March 31, 2010 and
2009.
12
A summary
of stock option activity under our stock option plans as of March 31, 2010, and
changes during the three-month period then ended, is presented
below:
Three Months Ended March 31, 2010
|
|||||||||||||
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Life
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at beginning of period
|
5,689,500 | $ | 0.44 | ||||||||||
Granted
|
20,000 | 1.72 | |||||||||||
Exercised
|
(5,000 | ) | 1.03 | ||||||||||
Forfeited
|
— | — | |||||||||||
Expired
|
— | — | |||||||||||
Outstanding
at end of period
|
5,704,500 | $ | 0.44 |
5.1
years
|
$ | 6,843,420 | |||||||
Exercisable
at end of period
|
4,965,500 | $ | 0.38 |
4.5
years
|
$ | 6,252,044 |
A summary
of the status of our unvested restricted stock as of March 31, 2010, and changes
during the three-month period then ended, is presented below:
Three Months Ended
March 31, 2010
|
||||||||
Number of
Shares
|
Weighted
Average
Grant-Date
Fair Value
|
|||||||
Unvested
at beginning of period
|
1,719,000 | $ | 0.76 | |||||
Granted
|
— | — | ||||||
Vested
|
— | — | ||||||
Forfeited
|
— | — | ||||||
Unvested
at end of period
|
1,719,000 | $ | 0.76 |
Restricted
shares 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.
As of
March 31, 2010, there was approximately $1.0 million 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.
5. Comprehensive
Income (Loss)
We had no
accumulated other comprehensive income (loss) activity during the three-month
period ended March 31, 2010; therefore, our total comprehensive loss was equal
to our net loss for that period. Due to our net operating loss
carryforwards, there are no income tax effects on comprehensive income (loss)
components for the three-month period ended March 31, 2009.
Three Months
Ended
March 31, 2009
|
||||
Net
income
|
$ | 814,121 | ||
Unrealized
losses on available-for-sale securities
|
(1,383 | ) | ||
Other
comprehensive income
|
$ | 812,738 |
13
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, except for periods of loss,
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.
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 periods ended March 31, 2010 and
2009:
Three Months Ended
March 31, 2010
|
Three Months Ended
March 31, 2009
|
|||||||||||||||
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
|||||||||||||
Outstanding
shares
|
81,891,716 | 81,891,716 | 71,555,707 | 71,555,707 | ||||||||||||
Effect
of weighting changes in
outstanding shares
|
(601,317 | ) | (601,317 | ) | (168,269 | ) | (168,269 | ) | ||||||||
Unvested
restricted stock
|
(1,719,000 | ) | (1,719,000 | ) | — | — | ||||||||||
Stock
options
|
— | — | — | 1,803,941 | ||||||||||||
Warrants
|
— | — | — | 5,596,328 | ||||||||||||
Convertible
debt
|
— | — | — | 11,559,139 | ||||||||||||
Convertible
preferred stock
|
— | — | — | 6,000,000 | ||||||||||||
Adjusted
shares
|
79,571,399 | 79,571,399 | 71,387,438 | 96,346,846 |
Earnings
(loss) per common share for the periods ended March 31, 2010 and 2009 excludes
the effects of 59,108,511 and 14,163,538 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.
The
Company’s unvested stock awards contain nonforfeitable rights to dividends or
dividend equivalents, whether paid or unpaid (referred to as “participating
securities”). Therefore, the unvested stock awards are included in
the number of shares outstanding for both basic and diluted earnings per share
calculations. 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, 1,719,000 shares of unvested
restricted stock were excluded in determining basic and diluted loss per share
for the three-month period ended March 31, 2010.
14
The
following table presents the key factors considered in the calculation of basic
and diluted net earnings per common share for the three-month period ended March
31, 2009. There was no difference in basic and diluted loss per share
for the three-month period ended March 31, 2010.
Three Months Ended
March 31, 2009
|
||||||||||||
Earnings
(Numerator)
|
Weighted
Average
Shares
(Denominator)
|
Per
Share
Amount
|
||||||||||
Net
income
|
$ | 814,121 | ||||||||||
Preferred
stock dividends
|
(60,000 | ) | ||||||||||
Basic
EPS:
|
||||||||||||
Income
available to common stockholders
|
754,121 | 71,387,438 | $ | 0.01 | ||||||||
Effect
of Dilutive Securities:
|
||||||||||||
Stock
options
|
- | 1,803,941 | ||||||||||
Warrants
|
- | 5,596,328 | ||||||||||
Convertible
debt
|
105,315 | 11,559,139 | ||||||||||
Convertible
preferred stock
|
60,000 | 6,000,000 | ||||||||||
Diluted
EPS:
|
||||||||||||
Income
available to common stockholders, including
assumed conversions
|
$ | 919,436 | 96,346,846 | $ | 0.01 |
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 three-month periods ended March 31, 2010 and 2009,
we did not capitalize any inventory costs associated with our Lymphoseek
product.
The
components of net inventory are as follows:
March
31,
2010
(unaudited)
|
December
31,
2009
|
|||||||
Pharmaceutical
materials
|
$ | 352,500 | $ | 525,000 | ||||
Gamma
detection device materials
|
211,818 | 137,695 | ||||||
Pharmaceutical
work-in-process
|
172,500 | — | ||||||
Gamma
detection device finished goods
|
624,594 | 481,002 | ||||||
Total
|
$ | 1,361,412 | $ | 1,143,697 |
15
8.
|
Intangible
Assets
|
The major
classes of intangible assets are as follows:
March 31, 2010
|
December 31, 2009
|
||||||||||||||||
Weighted
Average
Remaining
Life1
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
|||||||||||||
Patents
and trademarks
|
2.7
yrs
|
$ | 533,261 | $ | 444,378 | $ | 524,224 | $ | 445,650 |
1 The
weighted average remaining life is calculated for issued patents and does not
include pending patent applications or trademarks which are not currently being
amortized.
The
estimated amortization expenses, related to those patents and trademarks
currently being amortized, for the next five fiscal years are as
follows:
Estimated
Amortization
Expense
|
||||
For
the year ended 12/31/2010
|
$ | 2,755 | ||
For
the year ended 12/31/2011
|
1,256 | |||
For
the year ended 12/31/2012
|
980 | |||
For
the year ended 12/31/2013
|
263 | |||
For
the year ended 12/31/2014
|
244 |
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 and other 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 for the three-month periods ended March 31,
2010 and 2009 is as follows:
Three Months Ended
March 31,
|
||||||||
2010
|
2009
|
|||||||
Warranty
reserve at beginning of period
|
$ | 61,400 | $ | 62,261 | ||||
Provision
for warranty claims and changes in reserve for warranties
|
38,097 | 37,623 | ||||||
Payments
charged against the reserve
|
(21,873 | ) | (30,291 | ) | ||||
Warranty
reserve at end of period
|
$ | 77,624 | $ | 69,593 |
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. 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.
16
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, $3.5 million of which is convertible into shares
of our common stock at the conversion price of $0.26 per share, 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 at an exercise price of $0.32 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
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 Series A Note. 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 additional 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.
In April
2008, following receipt by the Company of clearance from the United States Food
and Drug Administration 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, which is convertible into
shares of our common stock at the conversion price of $0.36 per share, 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
In
December 2008, after we obtained 135 vital blue dye lymph nodes from patients
who had completed the injection of the drug and surgery 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 to purchase 6,000,000
shares of our common stock at an exercise price of $0.575 per share (hereinafter
referred to collectively with the Series W Warrant and Series X Warrant as the
Montaur Warrants), 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.
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 into 3,600,000 shares of our common stock 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 change
in terms of the Montaur Notes, the Preferred Stock and the Montaur Warrants were
treated as an extinguishment of debt for accounting
purposes. Following the extinguishment, the Company’s balance sheet
reflects the face value of the $10 million due to Montaur pursuant to the
Montaur Notes. See Note 11.
17
During
the three-month periods ended March 31, 2010 and 2009, we recorded interest
expense of $6,000 and $151,000, respectively, related to amortization of the
debt discount related our convertible notes. During the three-month
periods ended March 31, 2010 and 2009, we recorded interest expense of $2,000
and $29,000, 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. 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
are now considered derivative liabilities. We do not use derivative
instruments for hedging of market risks or for trading or speculative
purposes.
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 net effect of
marking the derivative liabilities to market at March 31 and June 30, 2009
resulted in a net increase in the estimated fair values of the derivative
liabilities of $12.2 million which was recorded as non-cash expense during the
first half 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 net effect of marking the Company’s
remaining derivative liabilities to market at September 30 and December 31, 2009
resulted in a net increase in the estimated fair values of the derivative
liabilities of $298,000 which was recorded as non-cash expense during the second
half of 2009. The effect of marking the Company’s remaining
derivative liabilities to market at March 31, 2010 resulted in a net increase in
the estimated fair values of the derivative liabilities of $429,000 which was
recorded as non-cash expense during the first quarter of 2010. The
total estimated fair value of the derivative liabilities was $2.4 million as of
March 31, 2010. See Note 10.
12.
Stock Warrants
During
the first quarter 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 expired during the quarter.
At March
31, 2010, there are 17.8 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.
18
13.
|
Common
Stock Purchase Agreement
|
In March
2010, we sold to Fusion Capital Fund II, LLC (Fusion Capital), an Illinois
limited liability company, 540,541 shares for proceeds of $1.0 million under a
common stock purchase agreement, as amended. In connection with this
sale, we issued 120,000 shares of our common stock to Fusion Capital as an
additional commitment fee. Subsequent to this sale, the
remaining aggregate amount of our common stock we can sell to Fusion Capital
under the amended agreement is $9.1 million.
14.
|
Income
Taxes
|
We
account for income taxes in accordance with current accounting standards, which
include guidance on the accounting for uncertainty in income taxes recognized in
the financial statements. Such standards also prescribe a recognition
threshold and measurement model for the financial statement recognition of a tax
position taken, or expected to be taken, and provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition. As a result, no liability for uncertain
tax positions was recorded as of March 31, 2010. Should we need to
accrue interest or penalties on uncertain tax positions, we would recognize the
interest as interest expense and the penalties as a selling, general and
administrative expense.
15.
Segment and Subsidiary Information
We report
information about our operating segments using the “management approach” in
accordance with current accounting standards. This information is
based on the way management organizes and reports the segments within the
enterprise for making operating decisions and assessing
performance. Our reportable segments are identified based on
differences in products, services and markets served. There were no
inter-segment sales. We own or have rights to intellectual property
involving two primary types of medical device products, including oncology
instruments currently used primarily in the application of sentinel lymph node
biopsy, and blood flow measurement devices. We also own or have
rights to intellectual property related to several drug and therapy
products.
19
The
information in the following table is derived directly from each reportable
segment’s financial reporting.
($ amounts in thousands)
Three Months Ended March 31, 2010
|
Oncology
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
||||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$ | 2,637 | $ | — | $ | — | $ | 2,637 | ||||||||
International
|
21 | — | — | 21 | ||||||||||||
License
revenue
|
25 | — | — | 25 | ||||||||||||
Research
and development expenses
|
172 | 2,230 | — | 2,402 | ||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
60 | — | 1,006 | 1,066 | ||||||||||||
Depreciation
and amortization
|
33 | 13 | 16 | 62 | ||||||||||||
Income
(loss) from operations3
|
1,529 | (2,243 | ) | (1,022 | ) | (1,736 | ) | |||||||||
Other
income (expense)4
|
— | — | (712 | ) | (712 | ) | ||||||||||
Income
(loss) from continuing operations
|
1,529 | (2,243 | ) | (1,734 | ) | (2,448 | ) | |||||||||
Loss
from discontinued operations
|
— | — | (12 | ) | (12 | ) | ||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||
United
States operations
|
2,204 | 754 | 6,290 | 9,248 | ||||||||||||
Discontinued
operations
|
— | — | 17 | 17 | ||||||||||||
Capital
expenditures
|
— | 78 | 12 | 90 |
($ amounts in thousands)
Three Months Ended March 31, 2009
|
Oncology
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
||||||||||||
Net
sales:
|
||||||||||||||||
United
States1
|
$ | 2,553 | $ | — | $ | — | $ | 2,553 | ||||||||
International
|
104 | — | — | 104 | ||||||||||||
License
revenue
|
25 | — | — | 25 | ||||||||||||
Research
and development expenses
|
294 | 928 | — | 1,222 | ||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
34 | — | 750 | 784 | ||||||||||||
Depreciation
and amortization
|
37 | 1 | 15 | 53 | ||||||||||||
Income
(loss) from operations3
|
1,491 | (929 | ) | (765 | ) | (203 | ) | |||||||||
Other
income (expense)4
|
— | — | 1,078 | 1,078 | ||||||||||||
Income
(loss) from continuing operations
|
1,491 | (929 | ) | 313 | 874 | |||||||||||
Loss
from discontinued operations
|
— | — | (60 | ) | (60 | ) | ||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||
United
States operations
|
2,526 | 24 | 4,793 | 7,343 | ||||||||||||
Discontinued
operations
|
— | — | 1,728 | 1,728 | ||||||||||||
Capital
expenditures
|
— | — | 40 | 40 |
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. Marketing and selling expenses are allocated to our
individual reportable segments.
3 Income
(loss) from operations does not reflect the allocation of selling, general and
administrative expenses, excluding depreciation and amortization, to our
individual reportable 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.
20
16.
Supplemental Disclosure for Statements of Cash Flows
During
the three-month periods ended March 31, 2010 and 2009, we paid interest
aggregating $26,000 and $111,000, respectively. During the
three-month periods ended March 31, 2010 and 2009, we transferred $14,000 and
$15,000, respectively, of inventory to fixed assets related to the creation and
maintenance of a pool of service loaner equipment. During the
three-month periods ended March 31, 2010 and 2009, we issued 239,757 and
152,066, respectively, shares of our common stock as payment of interest on our
convertible debt and dividends on our convertible preferred
stock. During the three-month period ended March 31, 2010, we issued
53,499 shares of our common stock as a matching contribution to our 401(k)
plan.
21
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 oncology products that enhance patient care and improve patient
outcome. We currently market a line of medical devices, our
neoprobe® GDS
gamma detection systems that are used in a cancer staging procedure called
intraoperative lymphatic mapping. In addition to our medical device
products, we have two radiopharmaceutical products, Lymphoseek® and
RIGScanTM CR, in
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
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
detection device line continues to provide a strong revenue base. Due
primarily to stocking orders related to products introduced in 2009 that we do
not expect to recur in 2010, we expect overall revenue for our gamma detection
device line for 2010 to be lower than 2009. We expect to continue to
incur modest development expenses to support our gamma detection device product
line as well as we work with our marketing partners to expand our product
offerings in the gamma detection device arena. 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 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 of 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.
22
Our
efforts thus far in 2010 have resulted in the following milestone
achievements:
|
·
|
Completion
of a successful meeting with the United States Food and Drug
Administration (FDA) for the NEO3-05 clinical study to review Phase 3
clinical study results and discuss development plans to support a New Drug
Application (NDA) submission later this summer for Lymphoseek as a
lymphatic tissue tracing agent;
|
|
·
|
Validation
of the first lot of commercial drug product of Lymphoseek that will be
used for the commercial launch of the product in the United States upon
NDA clearance.
|
Our
operating expenses during the first quarter of 2010 were focused primarily on
support of Lymphoseek product development and on efforts to re-qualify the
manufacturing process for our RIGScan CR product initiative. We
expect our drug-related development expenses for 2010 to be considerably higher
than 2009 as we complete preparations for the filing of a NDA for Lymphoseek and
as we continue the other clinical evaluations of Lymphoseek to support
post-marketing amendments to the NDA.
During
2008, we initiated patient enrollment in a Phase 3 clinical study in subjects
with either breast cancer or melanoma (NEO3-05). In March 2009, we
announced that this study had reached the accrual of 203 lymph nodes, the
study’s primary accrual objective. The NEO3-05 Phase 3 clinical study
was an open label trial of node-negative subjects with either breast cancer or
melanoma. It was designed to evaluate the safety and the accuracy of
Lymphoseek while identifying the lymph nodes draining from the subject’s tumor
site. To demonstrate the accuracy of Lymphoseek, each subject
consenting to participate in the study was injected in proximity to the tumor
with Lymphoseek and one of the vital blue dyes that are commonly used in
lymphatic mapping procedures. The primary efficacy objective of the
study was to identify lymph nodes that contained the vital blue dye and to
demonstrate a statistically acceptable concordance rate between the
identification of lymph nodes with the vital blue dye and
Lymphoseek. To be successful, the study needed to achieve a
statistical p-value of at least 0.05. In addition, the secondary
endpoint of the study was to pathologically examine lymph nodes identified by
either the vital blue dyes or Lymphoseek to determine if cancer was present in
the lymph nodes.
In March
2010, Neoprobe met with FDA regarding the clinical outcomes of
NEO3-05. The FDA meeting included a review of the efficacy and safety
results of the NEO3-05 clinical study and Neoprobe’s plans for the submission of
a NDA for Lymphoseek. During the meeting, Neoprobe provided FDA with
the clinical results of the protocol-compliant clinical sites that participated
in the NEO3-05 clinical study that contributed 136 intent-to-treat subjects who
provided 215 lymph nodes containing the vital blue dye. 210 of the
vital blue dye positive lymph nodes contained Lymphoseek for an overall
concordance rate of 98%, achieving a very high level of statistical correlation
(p-value = 0.0001) for the primary endpoint of the clinical
study. Prior to the meeting, FDA requested that Neoprobe conduct a
“reserve concordance” assessment of the clinical study where Lymphoseek might
identify lymph nodes missed by the vital blue dyes. This assessment
showed that Lymphoseek was able to identify 85 additional lymph nodes that did
not contain the vital blue dye, and 18% of these nodes were found by pathology
to contain cancer. There were no significant safety events related to
Lymphoseek. FDA indicated that the clinical data from the NEO3-05
clinical study and other completed clinical evaluations of Lymphoseek would be
supportive of a NDA submission for Lymphoseek.
The
Lymphoseek NDA submission will be based on the clinical results of NEO3-05 and
other already completed clinical evaluations of Lymphoseek. However,
Neoprobe intends to complete another Phase 3 clinical evaluation of Lymphoseek
in subjects with either breast cancer or melanoma (NEO3-09) for the purpose of
supplementing already submitted safety data and to support post-marketing
product claim amendments for Lymphoseek. FDA agreed that this trial
does not need to be completed prior to NDA submission. The Company
believes the trial will be complete prior to potential marketing clearance for
Lymphoseek. FDA also encouraged Neoprobe to request a series of
pre-NDA meetings in the coming months to review the components of the NDA prior
to its formal submission. Neoprobe indicated to FDA that the Company
plans to submit the NDA following satisfactory completion of these
meetings. In future pre-NDA meetings, Neoprobe will continue
discussions with the FDA reviewers regarding the pre-clinical and chemistry,
manufacturing and control quality data modules that will be part of the NDA
submission. Neoprobe will be discussing elements of the statistical
analysis plan that would support the NDA, including the design of any
prospective clinical evaluations to support the primary indication, and to
potentially expand the future indications for Lymphoseek.
23
In June
2009, we initiated a Phase 3 clinical trial to be conducted in subjects with
head and neck squamous cell carcinoma (NEO3-06). The NEO3-06 clinical
study is designed to expand the potential labeling for Lymphoseek as a sentinel
lymph node targeting agent after the initial marketing clearance for the
product. Our discussions with FDA and the European Medicinal
Evaluation Agency (EMEA) have also suggested that the NEO3-06 clinical 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 now plan to have approximately 20 participating
institutions in the NEO3-06 clinical trial. Subject recruitment and
enrollment is actively underway at a number of institutions and the trial
protocol is currently under review at several other institutions. The
accrual rate for trials of this nature is highly dependent on the timing of
institutional review board 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, as well as 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 to amend the filing in the U.S. for
expanded product labeling. Based on the positive outcome of the
recent meeting with FDA regarding NEO3-05, Neoprobe expects to submit the NDA
for Lymphoseek later in the summer of 2010. Depending on the timing
of the planned pre-NDA meetings with FDA and the outcome of FDA regulatory
review cycle, we believe that Lymphoseek could 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. See Risk Factors.
Over the
past few years, we have also 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 of 2008 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.
Our
desire has been, and continues to be, to develop a clinical development plan
which is harmonized between the U.S. and the EU. To that end, during
December 2009 we submitted an investigational new drug (IND) amendment to FDA
which includes the design of a proposed Phase 3 clinical trial of RIGScan CR.
The IND amendment included a Special Protocol Assessment (SPA) in
accordance with the Prescription Drug User Fee Act of 1992 and current
regulatory guidelines, and will be registered on the clinicaltrials.gov website
following discussions with FDA regarding the SPA. Since filing the
IND amendment and SPA request, we have determined that due to differences in the
current manufacturing process from the process used in the 1990’s, a further
amendment to the IND should be filed addressing the differences. We
expect to file the IND amendment in the near future and subsequently re-file the
IND request. As a result, we do not expect to receive feedback from
FDA on a RIGS SPA request until sometime in the third quarter of
2010.
24
The Phase
3 clinical study as currently designed would be a randomized clinical study that
would evaluate the ability of RIGScan CR to identify tumor-associated tissue in
a group of patients as compared to a group of patients provided with traditional
surgical care. Based on our current statistical analysis, we now believe the
sample size for the proposed Phase 3 clinical study would be
approximately 350 patients including both the RIGScan CR and traditional
treatment groups. The primary endpoint of the trial as proposed is the
assessment of the diagnostic ability of RIGScan CR to identify tumor-associated
tissue, with a secondary endpoint of the survival rate of the RIGScan CR treated
patients compared to patients treated with conventional treatment
modalities.
It should
also be noted that the RIGScan CR biologic drug has not been produced for
several years. We would have to perform some additional work related
to ensuring the drug cell line is still viable and submit this data to EMEA and
possibly FDA for their evaluation in connection with preparations to restart
pivotal clinical trials. During the third quarter of 2009, we
announced that we had executed a Biopharmaceutical Development and Supply
Agreement with Laureate Pharma, Inc. This agreement will support the
initial evaluation of the viability of the CC49 master working cell bank as well
as the initial steps in re-validating the commercial production process for the
biologic agent used in RIGScan CR. Laureate has made progress in the
re-validation of the manufacturing process and we expect to have GMP-produced
material for evaluation within the next few months. In addition, we
will need to re-establish radiolabeling capabilities for the CC49 antibody in
order to meet the regulatory needs for the RIGScan CR product. We
have also begun discussions with parties capable of supporting such
activities.
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 is very valuable, but we believe
clarifying the regulatory pathway in the U.S. is important for us and our
potential partners in assessing the full potential for RIGScan
CR. However, 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.
25
We expect
that revenues from our gamma detection devices may decline from 2009 levels due
to the previously discussed non-recurring stocking revenues, but should still
result in a net profit in 2010 for that line of business, excluding general and
administrative costs, interest and other financing-related
charges. Our overall operating results for 2010 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 overall operating profitability during
2010. 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 quarter of 2010 was consistent with revenue for the first quarter
of 2009 at $2.7 million. Research and development expenses, as a
percentage of net sales, increased to 90% during the first quarter of 2010 from
46% during the same period in 2009. Due to the ongoing development
activities of the Company, research and development expenses as a percentage of
sales are expected to be higher in 2010 than they were in
2009. Selling, general and administrative expenses, as a percentage
of net sales, increased to 42% during the first quarter of 2010 from 32% during
the same period in 2009.
Three
Months Ended March 31, 2010 and 2009
Net Sales and
Margins. Net sales, comprised primarily of sales of our gamma
detection systems, remained steady at $2.7 million during the first quarter of
both 2010 and 2009. Gross margins on net sales decreased to 67% of
net sales for the first quarter of 2010 compared to 69% of net sales for the
same period in 2009.
A
decrease in gamma detection device sales of $36,000 was offset by increases of
$22,000 and $15,000 in service and extended warranty revenue,
respectively. 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 received by EES on sales of Neoprobe products to end customers, subject to
a minimum floor price. A slight decline in sales prices and control
unit sales volumes were offset by increased sales of wireless
probes. The decrease in gross margins on net product sales was due to
net changes in the product mix coupled with the impact of the decline in sales
prices.
License
Revenue. License revenue for the first quarter of both 2010
and 2009 included $25,000 from the pro-rata recognition of license fees related
to the renewed distribution agreement with EES.
Research and Development
Expenses. Research and development expenses increased $1.2
million, or 97%, to $2.4 million during the first quarter of 2010 from $1.2
million during the same period in 2009. Research and development
expenses in the first quarter of 2010 included approximately $2.2 million in
drug and therapy product development costs and $172,000 in gamma detection
device development costs. This compares to expenses of $928,000 and
$294,000 in these segment categories during the same period in
2009. The changes in each category were primarily due to (i)
increased compensation of $337,000, process development costs of $254,000,
pricing study costs of $217,000, and clinical activity costs of $61,000 related
to Lymphoseek, coupled with increased process development costs of $317,000,
pricing study costs of $108,000, and license fees of $50,000 related to RIGScan
CR, and (ii) lower compensation of $42,000 and lower development costs related
to our new high energy detection probe which was launched in 2009 of $35,000,
respectively.
Selling, General and Administrative
Expenses. Selling, general and administrative expenses
increased $291,000, or 35%, to $1.1 million during the first quarter of 2010
from $837,000 during the same period in 2009. The net increase was
primarily due to increased stock and other incentive-based compensation
costs.
26
Other Income
(Expenses). Other expense, net, was $712,000 during the first
quarter of 2010 as compared to other income, net, of $1.1 million during the
same period in 2009. During the first quarter of 2010, we recorded a
$429,000 charge related to the increase in derivative liabilities resulting from
the requirement to mark our derivative liabilities to market. During
the first quarter of 2009, we recorded a $1.5 million credit related to the
decrease in derivative liabilities. Interest expense, primarily
related to the convertible debt agreements we completed in December 2007 and
April 2008, decreased $173,000 to $284,000 during the first quarter of 2010 from
$457,000 for the same period in 2009. Of this interest expense,
$8,000 and $180,000 in the first quarters of 2010 and 2009, respectively, were
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 $167,000 of interest expense in the first
quarters of 2010 and 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.
Liquidity
and Capital Resources
Cash
balances increased to $6.0 million at March 31, 2010 from $5.6 million at
December 31, 2009. The net increase was primarily due to cash
received for the issuance of common stock related to a stock purchase agreement,
partially offset by cash used to fund our operations, mainly for research and
development activities. The current ratio decreased to 2.5:1 at March
31, 2010 from 3.6:1 at December 31, 2009.
Operating
Activities. Cash used in operations increased $160,000 to
$576,000 during the first quarter of 2010 compared to $416,000 during the same
period in 2009.
Accounts
receivable decreased to $1.1 million at March 31, 2010 from $1.3 million at
December 31, 2009. The decrease was primarily a result of normal
fluctuations in timing of purchases and payments by EES and Century Medical,
Inc. We expect overall receivable levels will continue to fluctuate
during 2010 depending on the timing of purchases and payments by our
customers.
Inventory
levels increased to $1.4 million at March 31, 2010 from $1.1 million at December
31, 2009. Gamma detection device materials and finished goods
inventory levels increased as we have increased our product safety stock levels
to ensure efficient and uninterrupted supply of our products to our distribution
partners. We expect inventory levels to increase during 2010 as a
result of the production of commercial-grade Lymphoseek.
Accounts
payable increased to $1.1 million at March 31, 2010 from $764,000 at December
31, 2009. Accrued liabilities and other increased to $1.8 million at
March 31, 2010 from $1.0 million at December 31, 2009. Accounts
payable and accrued liabilities, primarily for consulting services and
production equipment, related to our Lymphoseek and RIGScan initiatives
increased as activities related to advancing those product lines
increased.
Investing Activities.
Investing activities used $103,000 during the first quarter of 2010
compared to providing $441,000 during the same period in
2009. Available-for-sale securities of $494,000 matured during the
first quarter of 2009. Capital expenditures of $90,000 during the
first quarter of 2010 were primarily for equipment to be used in the production
of Lymphoseek and software. Capital expenditures of $40,000 during
the first quarter of 2009 were primarily for software, computers, and office
furniture. We expect our overall capital expenditures for 2010 will
be higher than 2009 as we begin the commercial production of
Lymphoseek. Payments for patent and trademark costs remained steady
at $13,000 during the first quarters of 2010 and 2009.
Financing
Activities. Financing activities provided $996,000 during the
first quarter of 2010 compared to $42,000 used during the same period in
2009. The $996,000 provided by financing activities in the first
quarter of 2010 consisted primarily of proceeds from the issuance of common
stock of $1.0 million, offset slightly by payments of capital leases of $3,000
and payments of stock offering costs of $1,000. The $42,000 used in
financing activities in the first quarter of 2009 consisted primarily of
payments of notes payable of $51,000, payments of stock offering costs of
$13,000, and payments of capital leases of $3,000, offset by proceeds from the
issuance of common stock of $26,000.
27
In
December 2006, we entered into a common stock purchase agreement with Fusion
Capital Fund II, LLC (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 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. In March 2010, we sold to
Fusion Capital under the amended agreement 540,541 shares for proceeds of $1.0
million. Subsequent to this sale, the remaining aggregate amount of
our common stock we can sell to Fusion Capital is $9.1 million, and we have
reserved a total of 10,113,459 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 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. In March 2010, we issued an
additional 120,000 shares of our common stock to Fusion Capital as an additional
commitment fee related to the 540,541 shares of stock that we sold to Fusion
Capital for $1.0 million.
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. 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, $3.5 million of which is convertible into shares
of our common stock at the conversion price of $0.26 per share, 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 at an exercise price of $0.32 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
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 Series
A Note. 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 additional 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 March 31, 2010, and an outstanding principal amount of $1.0
million as of May 7, 2010. During the first quarter of 2010, we paid
none of the outstanding principal and paid or accrued $25,000 in interest due
under the Amended Bupp Note.
28
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, which is convertible into shares of our common stock at the
conversion price of $0.36 per share, 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. 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 the injection of the drug and surgery 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 to purchase 6,000,000
shares of our common stock, at an exercise price of $0.575 per share
(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 “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.
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 into 3,600,000 shares of our common stock 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 change
in terms of the Montaur Notes, the Preferred Stock and the Montaur Warrants was
treated as an extinguishment of debt for accounting
purposes. 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.
29
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 prepare for the NDA submission for Lymphoseek and to
complete additional clinical testing for Lymphoseek to support potential safety
and post-marketing amendments. 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 have used currently available funds 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.
Recent
Accounting Developments
In
January 2010, the Financial Accounting Standards Board (FASB) issued Accounting
Standards Update (ASU) 2010-6, Improving Disclosures about Fair
Value Measurements. ASU 2010-6 amends FASB ASC Topic 820,
Fair Value Measurements and
Disclosures. ASU 2010-6 requires new disclosures as follows:
(1) Transfers in and out of Levels 1 and 2 and (2) Activity in Level 3 fair
value measurements. An entity should disclose separately the amounts
of significant transfers in and out of Level 1 and Level 2 fair value
measurements and describe the reasons for the transfers. In the
reconciliation of fair value measurements using significant unobservable inputs
(Level 3), an entity should present separately information about purchases,
sales, issuances, and settlements (that is, on a gross basis rather than as one
net number). ASU 2010-6 also clarifies existing disclosures as
follows: (1) Level of disaggregation and (2) Disclosures about inputs
and valuation techniques. An entity should provide fair value
measurement disclosures for each class of assets and liabilities. A
class is often a subset of assets or liabilities within a line item in the
statement of financial position. An entity needs to use judgment in
determining the appropriate classes of assets and liabilities. An
entity should provide disclosures about the valuation techniques and inputs used
to measure fair value for both recurring and nonrecurring fair value
measurements. Those disclosures are required for fair value
measurements that fall in either Level 2 or Level 3. ASU 2010-6 is
effective for interim and annual reporting periods beginning after December 15,
2009, except for the separate disclosures about purchases, sales, issuances, and
settlements in the roll forward of activity in Level 3 fair value
measurements. Those disclosures are effective for fiscal years
beginning after December 15, 2010, and for interim periods within those fiscal
years. We adopted the initial provisions of ASU 2010-6 beginning
January 1, 2010. As the new provisions of ASU 2010-6 provide only
disclosure requirements, the adoption of this standard did not impact our
consolidated financial position, results of operations or cash flows, but did
result in increased disclosures.
30
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. 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:
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·
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Stock-Based
Compensation. Stock-based payments to employees and
directors, including grants of stock options, are recognized in the
statement of operations based on their estimated fair
values. 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. Compensation cost arising from
stock-based awards is recognized as expense using the straight-line method
over the vesting period.
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|
·
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Inventory
Valuation. We value our inventory at the lower of cost
(first-in, first-out method) or market. Our valuation reflects
our estimates of excess, slow moving and obsolete inventory as well as
inventory with a carrying value in excess of its net realizable
value. Write-offs are recorded when product is removed from
saleable inventory. We review inventory on hand at least
quarterly and record provisions for excess and obsolete inventory based on
several factors, including current assessment of future product demand,
anticipated release of new products into the market, historical experience
and product expiration. Our industry is characterized by rapid
product development and frequent new product
introductions. Uncertain timing of product approvals,
variability in product launch strategies, regulations regarding use and
shelf life, product recalls and variation in product utilization all
impact the estimates related to excess and obsolete
inventory.
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31
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·
|
Impairment or Disposal of
Long-Lived Assets. Long-lived assets and certain
identifiable intangibles are 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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|
·
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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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|
·
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Fair Value of Derivative
Instruments. Derivative instruments embedded in
contracts, to the extent not already a free-standing contract, are
bifurcated from the debt instrument and accounted for
separately. All derivatives are recorded on the consolidated
balance sheet at fair value in accordance with current accounting
guidelines for such complex financial instruments. 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. We do not use derivative instruments for hedging of
market risks or for trading or speculative
purposes.
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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.
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:
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·
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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
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32
|
·
|
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 March 31,
2010. 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 March 31, 2010, 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.
33
PART
II - OTHER INFORMATION
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
(a)
|
During
the three-month period ended March 31, 2010, we issued 180,233 shares of
our common stock in payment of December 2009, January 2010 and February
2010 interest of $250,000 on the 10% Series A and Series B Convertible
Senior Secured Promissory Notes held by Platinum Montaur Life Sciences,
LLC (Montaur). Also during the three-month period ended March
31, 2010, we issued 59,524 shares of our common stock in payment of fourth
quarter 2009 dividends of $60,000 on the 8% Series A Cumulative
Convertible Preferred Stock held by Montaur. The issuances of
the shares to Montaur were exempt from registration under Sections 4(2)
and 4(6) of the Securities Act and Regulation
D.
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(b)
|
During
the three-month period ended March 31, 2010, we sold to Fusion Capital
Fund II, LLC (Fusion Capital), an Illinois limited liability company,
540,541 shares for proceeds of $1.0 million under a common stock purchase
agreement, as amended. In connection with this sale, we issued
120,000 shares of our common stock to Fusion Capital as an additional
commitment fee. The issuance of the commitment shares to Fusion
Capital was exempt from registration under Sections 4(2) and 4(6) of the
Securities Act and Regulation D.
|
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, 2009, and this item has
therefore been omitted.
34
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:
May 14, 2010
|
|||
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) |
35