x
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
|
NEOPROBE
CORPORATION
|
(Exact
name of registrant as specified in its
charter)
|
Delaware
|
31-1080091
|
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification No.)
|
|
425
Metro Place North, Suite 300, Dublin, Ohio
|
43017-1367
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Common
Stock, par value $.001 per share
|
(Title
of Class)
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
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Smaller
reporting company x
|
|
·
|
general
economic and business conditions, both nationally and in our
markets,
|
|
·
|
our
history of losses, negative net worth and uncertainty of future
profitability;
|
|
·
|
our
expectations and estimates concerning future financial performance,
financing plans and the impact of
competition;
|
|
·
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our
ability to implement our growth
strategy;
|
|
·
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anticipated
trends in our business;
|
|
·
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advances
in technologies; and
|
|
·
|
other
risk factors set forth under “Risk Factors” in this
report.
|
Indication
|
|
Phase
|
|
Number of
Patients
|
|
Status
|
Breast
(peritumoral injection)
|
1
|
24
|
Completed
|
|||
Melanoma
|
1
|
24
|
Completed
|
|||
Breast
(intradermal injection, next day surgery)
|
1
|
31
|
Ongoing
|
|||
Prostate
|
1
|
20
|
Ongoing
|
|||
Colon
|
1
|
20
|
Ongoing
|
|||
Breast
or Melanoma
|
2
|
80
|
Completed
|
|||
Breast
or Melanoma
|
3
|
179
|
Completed
|
|||
Head
and Neck Squamous Cell Carcinoma (“Sentinel”)
|
|
3
|
|
196*
|
|
Ongoing
|
|
·
|
ineffectiveness
of the product candidate;
|
|
·
|
discovery
of unacceptable toxicities or side
effects;
|
|
·
|
development
of disease resistance or other physiological
factors;
|
|
·
|
delays
in patient enrollment; or
|
|
·
|
other
reasons that are internal to the businesses of our potential collaborative
partners, which reasons they may not share with
us.
|
|
·
|
generate
cash flow and revenue;
|
|
·
|
offset
some of the costs associated with our internal research and development,
preclinical testing, clinical trials and
manufacturing;
|
|
·
|
seek
and obtain regulatory approvals faster than we could on our own;
and,
|
|
·
|
successfully
commercialize existing and future product
candidates.
|
|
·
|
delay
marketing of potential products for a considerable period of
time;
|
|
·
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limit
the indicated uses for which potential products may be
marketed;
|
|
·
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impose
costly requirements on our activities;
and
|
|
·
|
provide
competitive advantage to other pharmaceutical and biotechnology
companies.
|
|
·
|
restrictions
on the products, manufacturers or manufacturing
processes;
|
|
·
|
warning
letters;
|
|
·
|
civil
or criminal penalties;
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|
·
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fines;
|
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·
|
injunctions;
|
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·
|
product
seizures or detentions;
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|
·
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import
bans;
|
|
·
|
voluntary
or mandatory product recalls and publicity
requirements;
|
|
·
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suspension
or withdrawal of regulatory
approvals;
|
|
·
|
total
or partial suspension of production;
and
|
|
·
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refusal
to approve pending applications for marketing approval of new drugs or
supplements to approved
applications.
|
|
·
|
we
pay all principal by December 26,
2011;
|
|
·
|
we
use the proceeds from the sale of the Notes only for permitted purposes,
such as Lymphoseek development and general corporate
purposes;
|
|
·
|
we
keep reserved out of our authorized shares of common stock sufficient
shares to satisfy our obligation to issue shares on conversion of the
Notes and the exercise of the warrants issued in connection with the sale
of the Notes; and
|
|
·
|
we
indemnify the purchasers of the Notes against certain
liabilities.
|
|
·
|
amending
our organizational or governing agreements and documents, entering into
any merger or consolidation, dissolving the company or liquidating its
assets, or acquiring all or any substantial part of the business or assets
of any other person;
|
|
·
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engaging
in transactions with any affiliate;
|
|
·
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entering
into any agreement inconsistent with our obligations under the Notes and
related agreements;
|
|
·
|
incurring
any indebtedness, capital leases, or contingent obligations outside the
ordinary course of business;
|
|
·
|
granting
or permitting liens against or security interests in our
assets;
|
|
·
|
making
any material dispositions of our assets outside the ordinary course of
business;
|
|
·
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declaring
or paying any dividends or making any other restricted payments;
or
|
|
·
|
making
any loans to or investments in other persons outside of the ordinary
course of business.
|
|
·
|
price
and volume fluctuations in the stock market at large which do not relate
to our operating performance;
|
|
·
|
financing
arrangements we may enter that require the issuance of a significant
number of shares in relation to the number of shares currently
outstanding;
|
|
·
|
public
concern as to the safety of products that we or others develop;
and
|
|
·
|
fluctuations
in market demand for and supply of our
products.
|
High
|
Low
|
Close
|
||||||||||
Fiscal
Year 2009:
|
||||||||||||
First
Quarter
|
$ | 0.80 | $ | 0.42 | $ | 0.54 | ||||||
Second
Quarter
|
1.20 | 0.35 | 0.95 | |||||||||
Third
Quarter
|
1.48 | 0.91 | 1.40 | |||||||||
Fourth
Quarter
|
1.40 | 0.95 | 1.22 | |||||||||
Fiscal
Year 2008:
|
||||||||||||
First
Quarter
|
$ | 0.42 | $ | 0.29 | $ | 0.35 | ||||||
Second
Quarter
|
0.87 | 0.34 | 0.68 | |||||||||
Third
Quarter
|
0.75 | 0.42 | 0.57 | |||||||||
Fourth
Quarter
|
0.68 | 0.45 | 0.57 |
|
·
|
Completed
a Phase 3 clinical trial of Lymphoseek (NEO3-05) in patients with breast
cancer or melanoma and announced that the primary efficacy endpoint was
exceeded with no drug-related safety events
reported.
|
|
·
|
Initiated
patient enrollment in a second Phase 3 clinical trial of Lymphoseek
(NEO3-06 or the “Sentinel” trial) in patients with head and neck squamous
cell carcinoma.
|
|
·
|
Initiated
drug development activities for RIGScan CR to support a Phase 3
study.
|
|
·
|
Began
a new five-year term of our EES gamma detection device distribution
agreement.
|
|
·
|
Added
a high energy (F-18) probe to our gamma detection device product
portfolio.
|
|
·
|
Completed
a debt restructuring agreement allowing reclassification of a majority of
the Company’s derivative liabilities and resulting in the exercise of the
Series Y Warrants, producing $3.5 million in gross cash flow to the
Company.
|
·
|
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.
|
|
·
|
Inventory
Valuation. We value our inventory at the lower of cost
(first-in, first-out method) or market. Our valuation reflects
our estimates of excess, slow moving and obsolete inventory as well as
inventory with a carrying value in excess of its net realizable
value. Write-offs are recorded when product is removed from
saleable inventory. We review inventory on hand at least
quarterly and record provisions for excess and obsolete inventory based on
several factors, including current assessment of future product demand,
anticipated release of new products into the market, historical experience
and product expiration. Our industry is characterized by rapid
product development and frequent new product
introductions. Uncertain timing of product approvals,
variability in product launch strategies, regulations regarding use and
shelf life, product recalls and variation in product utilization all
impact the estimates related to excess and obsolete
inventory.
|
|
·
|
Impairment or Disposal of
Long-Lived Assets. 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.
|
|
·
|
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.
|
·
|
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.
|
|
·
|
pertain
to the maintenance of records that, in reasonable detail, accurately and
fairly reflect the transactions and dispositions of the assets of the
company;
|
|
·
|
provide
reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted
accounting principles and that receipts and expenditures of the company
are being made only in accordance with authorization of management and
directors of the company; and
|
|
·
|
provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the company's assets that
could have a material effect on the financial
statements.
|
Name
|
Age
|
Position
|
||
Anthony
K. Blair
|
49
|
Vice
President, Manufacturing Operations
|
||
Rodger
A. Brown
|
59
|
Vice
President, Regulatory Affairs
and
Quality Assurance
|
||
Frederick
O. Cope, Ph.D.
|
63
|
Vice
President, Pharmaceutical Research
and
Clinical Development
|
||
Brent
L. Larson
|
46
|
Vice
President, Finance; Chief Financial
Officer;
Treasurer and Secretary
|
||
Douglas
L. Rash
|
66
|
Vice
President,
Marketing
|
(c)
|
||||||||||||||||||||||||||
(b)
|
Restricted
|
(d)
|
||||||||||||||||||||||||
(a)
|
Option
|
Stock
|
All
Other
|
Total
|
||||||||||||||||||||||
Name and Principal Position
|
Year
|
Salary
|
Bonus
|
Awards
|
Awards
|
Compensation
|
Compensation
|
|||||||||||||||||||
David
C. Bupp
|
2009
|
$ | 335,000 | $ | 45,000 | $ | — | $ | 565,308 | $ | 8,621 | $ | 953,929 | |||||||||||||
President
and
|
2008
|
325,000 | 40,000 | 57,953 | 107,717 | 9,439 | 540,109 | |||||||||||||||||||
Chief
Executive Officer
|
||||||||||||||||||||||||||
Frederick
O. Cope, Ph.D.
|
2009
|
$ | 175,000 | $ | 25,000 | $ | 78,520 | $ | 147,328 | $ | 4,360 | $ | 430,208 | |||||||||||||
Vice
President,
|
2008
|
— | — | — | — | — | — | |||||||||||||||||||
Pharmaceutical
Research
|
||||||||||||||||||||||||||
and
Clinical Development
|
||||||||||||||||||||||||||
Brent
L. Larson
|
2009
|
$ | 184,000 | $ | 15,313 | $ | 65,247 | $ | 82,426 | $ | 4,934 | $ | 351,920 | |||||||||||||
Vice
President, Finance and
|
2008
|
177,000 | 15,000 | 14,488 | 17,953 | 5,442 | 229,883 | |||||||||||||||||||
Chief
Financial Officer
|
(a)
|
Bonuses,
if any, have been disclosed for the year in which they were earned (i.e.,
the year to which the service
relates).
|
(b)
|
Amount
represents the aggregate grant date fair value in accordance with FASB ASC
Topic 718. Assumptions made in the valuation of stock option
awards are disclosed in Note 1(o) of the Notes to the Consolidated
Financial Statements in this Form
10-K.
|
(c)
|
Amount
represents the aggregate grant date fair value in accordance with FASB ASC
Topic 718. Assumptions made in the valuation of restricted
stock awards are disclosed in Note 1(o) of the Notes to the Consolidated
Financial Statements in this Form
10-K.
|
(d)
|
Amount
represents life insurance premiums and club dues paid during the fiscal
year for the benefit of the Named Executives and matching contributions
under the Neoprobe Corporation 401(k) Plan (the Plan). Eligible
employees may make voluntary contributions and we may, but are not
obligated to, make matching contributions based on 40 percent of the
employee’s contribution, up to 5 percent of the employee’s
salary. Employee contributions are invested in mutual funds
administered by an independent plan administrator. Company
contributions, if any, are made in the form of shares of common
stock. The Plan qualifies under section 401 of the Internal
Revenue Code, which provides that employee and company contributions and
income earned on contributions are not taxable to the employee until
withdrawn from the Plan, and that we may deduct our contributions when
made.
|
|
·
|
by
the Company without cause (cause is defined as any willful breach of a
material duty by Mr. Bupp in the course of his employment or willful and
continued neglect of his duty as an
employee);
|
|
·
|
by
the expiration of the term of Mr. Bupp’s employment agreement;
or
|
|
·
|
by
the resignation of Mr. Bupp because his title, authority,
responsibilities, salary, bonus opportunities or benefits have materially
diminished, a material adverse change in his working conditions has
occurred, his services are no longer required in light of the Company’s
business plan, or we breach the
agreement;
|
|
·
|
the
acquisition, directly or indirectly, by a person (other than our Company,
an employee benefit plan established by the Board of Directors, or a
participant in a transaction approved by the Board of Directors for the
principal purpose of raising additional capital) of beneficial ownership
of 30% or more of our securities with voting power in the next meeting of
holders of voting securities to elect the
directors;
|
|
·
|
a
majority of the Directors elected at any meeting of the holders of our
voting securities are persons who were not nominated by our then current
Board of Directors or an authorized committee
thereof;
|
|
·
|
our
stockholders approve a merger or consolidation of our Company with another
person, other than a merger or consolidation in which the holders of our
voting securities outstanding immediately before such merger or
consolidation continue to hold voting securities in the surviving or
resulting corporation (in the same relative proportions to each other as
existed before such event) comprising 80% or more of the voting power for
all purposes of the surviving or resulting corporation;
or
|
|
·
|
our
stockholders approve a transfer of substantially all of our assets to
another person other than a transfer to a transferee, 80% or more of the
voting power of which is owned or controlled by us or by the holders of
our voting securities outstanding immediately before such transfer in the
same relative proportions to each other as existed before such
event.
|
|
·
|
by
the Company without cause (cause is defined as any willful breach of a
material duty by Dr. Cope in the course of his employment or willful and
continued neglect of his duty as an
employee);
|
|
·
|
by
the expiration of the term of Dr. Cope’s employment agreement;
or
|
|
·
|
by
the resignation of Dr. Cope because his title, authority,
responsibilities, salary, bonus opportunities or benefits have materially
diminished, a material adverse change in his working conditions has
occurred, his services are no longer required in light of the Company’s
business plan, or we breach the
agreement;
|
|
·
|
the
acquisition, directly or indirectly, by a person (other than our Company,
an employee benefit plan established by the Board of Directors, or a
participant in a transaction approved by the Board of Directors for the
principal purpose of raising additional capital) of beneficial ownership
of 30% or more of our securities with voting power in the next meeting of
holders of voting securities to elect the
directors;
|
|
·
|
a
majority of the directors elected at any meeting of the holders of our
voting securities are persons who were not nominated by our then current
Board of Directors or an authorized committee
thereof;
|
|
·
|
our
stockholders approve a merger or consolidation of our Company with another
person, other than a merger or consolidation in which the holders of our
voting securities outstanding immediately before such merger or
consolidation continue to hold voting securities in the surviving or
resulting corporation (in the same relative proportions to each other as
existed before such event) comprising 80% or more of the voting power for
all purposes of the surviving or resulting corporation;
or
|
|
·
|
our
stockholders approve a transfer of substantially all of the assets of our
Company to another person other than a transfer to a transferee, 80% or
more of the voting power of which is owned or controlled by us or by the
holders of our voting securities outstanding immediately before such
transfer in the same relative proportions to each other as existed before
such event.
|
|
·
|
If
a change in control occurs with respect to our Company and the employment
of Mr. Larson is concurrently or subsequently terminated, then Mr. Larson
will be paid a severance payment of $360,000;
and
|
|
·
|
Mr.
Larson will be paid a severance amount of $184,000 if his employment is
terminated at the end of his employment agreement or without
cause.
|
Option Awards
|
Stock Awards
|
|||||||||||||||||||||||
Number of Securities
Underlying Unexercised
Options (#)
|
Option
Exercise
|
Option
Expiration
|
Number of
Unearned
|
Market
Value of
Unearned
|
||||||||||||||||||||
Name
|
Exercisable
|
Unexercisable
|
Price
|
Date
|
Note
|
Shares
|
Shares (s)
|
Note
|
||||||||||||||||
David
C. Bupp
|
180,000 | — | $ | 0.41 |
1/3/2011
|
(a)
|
300,000 | $ | 366,000 |
(n)
|
||||||||||||||
180,000 | — | $ | 0.42 |
1/7/2012
|
(b)
|
400,000 | $ | 488,000 |
(o)
|
|||||||||||||||
100,000 | — | $ | 0.14 |
1/15/2013
|
(c)
|
300,000 | $ | 366,000 |
(q)
|
|||||||||||||||
70,000 | — | $ | 0.13 |
2/15/2013
|
(d)
|
|||||||||||||||||||
125,000 | — | $ | 0.30 |
1/7/2014
|
(e)
|
|||||||||||||||||||
150,000 | — | $ | 0.49 |
7/28/2014
|
(f)
|
|||||||||||||||||||
200,000 | — | $ | 0.39 |
12/10/2014
|
(g)
|
|||||||||||||||||||
200,000 | — | $ | 0.26 |
12/27/2015
|
(h)
|
|||||||||||||||||||
300,000 | — | $ | 0.27 |
12/15/2016
|
(i)
|
|||||||||||||||||||
66,667 | 133,333 | $ | 0.362 |
1/3/2018
|
(j)
|
|||||||||||||||||||
Frederick
O. Cope, Ph.D.
|
— | 50,000 | $ | 0.65 |
2/16/2019
|
(l)
|
100,000 | $ | 122,000 |
(p)
|
||||||||||||||
— | 75,000 | $ | 1.10 |
10/30/2019
|
(m)
|
75,000 | $ | 91,500 |
(r)
|
|||||||||||||||
Brent
L. Larson
|
60,000 | — | $ | 0.41 |
1/3/2011
|
(a)
|
50,000 | $ | 61,000 |
(n)
|
||||||||||||||
50,000 | — | $ | 0.42 |
1/7/2012
|
(b)
|
75,000 | $ | 91,500 |
(r)
|
|||||||||||||||
40,000 | — | $ | 0.14 |
1/15/2013
|
(c)
|
|||||||||||||||||||
30,000 | — | $ | 0.13 |
2/15/2013
|
(d)
|
|||||||||||||||||||
70,000 | — | $ | 0.30 |
1/7/2014
|
(e)
|
|||||||||||||||||||
50,000 | — | $ | 0.49 |
7/28/2014
|
(f)
|
|||||||||||||||||||
50,000 | — | $ | 0.39 |
12/10/2014
|
(g)
|
|||||||||||||||||||
40,000 | — | $ | 0.26 |
12/27/2015
|
(h)
|
|||||||||||||||||||
50,000 | — | $ | 0.27 |
12/15/2016
|
(i)
|
|||||||||||||||||||
16,667 | 33,333 | $ | 0.362 |
1/3/2018
|
(j)
|
|||||||||||||||||||
— | 25,000 | $ | 0 59 |
1/5/2009
|
(k)
|
|||||||||||||||||||
— | 75,000 | $ | 1.10 |
10/30/2009
|
(m)
|
(a)
|
Options
were granted 1/3/2001 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(b)
|
Options
were granted 1/7/2002 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(c)
|
Options
were granted 1/15/2003 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(d)
|
Options
were granted 2/15/2003 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(e)
|
Options
were granted 1/7/2004 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(f)
|
Options
were granted 7/28/2004 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(g)
|
Options
were granted 12/10/2004 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(h)
|
Options
were granted 12/27/2005 and vested as to one-third immediately and on each
of the first two anniversaries of the date of
grant.
|
(i)
|
Options
were granted 12/15/2006 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(j)
|
Options
were granted 1/3/2008 and vest as to one-third on each of the first three
anniversaries of the date of grant.
|
(k)
|
Options
were granted 1/5/2009 and vest as to one-third on each of the first three
anniversaries of the date of grant.
|
(l)
|
Options
were granted 2/16/2009 and vest as to one-third on each of the first three
anniversaries of the date of grant.
|
(m)
|
Options
were granted 10/30/2009 and vest as to one-third on each of the first
three anniversaries of the date of
grant.
|
(n)
|
Restricted
shares granted January 3, 2008. Pursuant to the terms of
Restricted Stock Agreements between the Company and each grantee, the
restricted shares will vest upon the approval of a New Drug Application
(NDA) for Lymphoseek by the United States Food and Drug Administration
(FDA). If the employment of a grantee with the Company is
terminated before all of the restricted shares have vested, then pursuant
to the terms of the Restricted Stock Agreements all restricted shares that
have not vested at the effective date of such grantee’s termination shall
immediately be forfeited by the grantee. Pursuant to its
authority under Section 3.2 of the Restricted Stock Agreements the
Company’s Compensation, Nominating and Governance Committee eliminated the
forfeiture provision in Section 3.2(b) of the Restricted Stock Agreements
effective January 1, 2009, which provision effected the forfeiture of the
shares if the vesting event did not occur before June 30,
2010.
|
(o)
|
Restricted
shares granted January 1, 2009. Pursuant to the terms of the
Restricted Stock Agreement between the Company and Mr. Bupp, the
restricted shares will vest upon the approval of a NDA for Lymphoseek by
the FDA or the approval of marketing authorization for Lymphoseek by the
European Medicines Agency (EMEA). All of the restricted shares
vest upon the occurrence of a Termination Without Cause or in the event of
an End of Term Termination or in the event of a Change of Control as
defined in Mr. Bupp’s employment agreement. If the employment
of Mr. Bupp with the Company is terminated for reasons other than a
Termination Without Cause, an End of Term Termination, or a Change of
Control before all of the restricted shares have vested, then pursuant to
the terms of the Restricted Stock Agreement all restricted shares that
have not vested at the effective date of Mr. Bupp’s termination shall
immediately be forfeited by Mr.
Bupp.
|
(p)
|
Restricted
shares granted February 16, 2009. Pursuant to the terms of the
Restricted Stock Agreement between the Company and Dr. Cope, 50% of the
restricted shares will vest upon the approval of a NDA for Lymphoseek by
FDA or the approval of marketing authorization for Lymphoseek by the EMEA
and 50% of the restricted shares will vest upon the commencement of
patient enrollment in a Phase 3 clinical trial in humans of RIGScan
CR. All of the restricted shares vest upon the occurrence of a
Change of Control as defined in Dr. Cope’s employment
agreement. If the employment of Dr. Cope with the Company is
terminated for reasons other than a Change of Control before all of the
restricted shares have vested, then pursuant to the terms of the
Restricted Stock Agreement all restricted shares that have not vested at
the effective date of Dr. Cope’s termination shall immediately be
forfeited by Dr. Cope.
|
(q)
|
Restricted
shares granted December 1, 2009. Pursuant to the terms of the
Restricted Stock Agreement between the Company and Mr. Bupp, the
restricted shares will vest upon the approval of a NDA for Lymphoseek by
the FDA or the approval of marketing authorization for Lymphoseek by the
EMEA. All of the restricted shares vest upon the occurrence of
a Termination Without Cause or in the event of an End of Term Termination
or in the event of a Change of Control as defined in the Restricted Stock
Agreement. If the employment of Mr. Bupp with the Company is
terminated for reasons other than a Termination Without Cause, an End of
Term Termination, or a Change of Control before all of the restricted
shares have vested, then pursuant to the terms of the Restricted Stock
Agreement all restricted shares that have not vested at the effective date
of Mr. Bupp’s termination shall immediately be forfeited by Mr.
Bupp.
|
(r)
|
Restricted
shares granted December 1, 2009. Pursuant to the terms of
Restricted Stock Agreements between the Company and each grantee, the
restricted shares will vest upon the approval of a NDA for Lymphoseek by
the FDA or the approval of marketing authorization for Lymphoseek by the
EMEA. All of the restricted shares vest upon the occurrence of
a Change of Control as defined in the Restricted Stock
Agreement. If the employment of a grantee with the Company is
terminated for reasons other than a Change of Control before all of the
restricted shares have vested, then pursuant to the terms of the
Restricted Stock Agreements all restricted shares that have not vested at
the effective date of such grantee’s termination shall immediately be
forfeited by the grantee.
|
(s)
|
Estimated
by reference to the closing market price of the Company’s common stock on
December 31, 2009, pursuant to Instruction 3 to Item 402(p)(2) of
Regulation S-K. The closing price of the Company’s common stock
on December 31, 2009, was $1.22.
|
Name
|
(a)
Fees Earned
or Paid in
Cash
|
(b),(c)
Option
Awards
|
(d),(e)
Restricted
Stock Awards
|
Total
Compensation
|
||||||||||||
Carl
J. Aschinger, Jr.
|
$ | 42,000 | $ | 4,294 | $ | 32,970 | $ | 79,264 | ||||||||
Reuven
Avital
|
28,500 | 4,294 | 32,970 | 65,764 | ||||||||||||
Kirby
I. Bland, M.D.
|
27,500 | 4,294 | 32,970 | 64,764 | ||||||||||||
Owen
E. Johnson, M.D.
|
28,000 | 4,294 | 32,970 | 65,264 | ||||||||||||
Fred
B. Miller
|
43,500 | 4,294 | 32,970 | 80,764 | ||||||||||||
Gordon
A. Troup
|
33,500 | 4,294 | 32,970 | 70,764 | ||||||||||||
J.
Frank Whitley, Jr.
|
29,000 | 4,294 | 32,970 | 66,264 |
(a)
|
Amount
represents fees earned during the fiscal year ended December 31, 2009
(i.e., the year to which the service relates). Quarterly
retainers and meeting attendance fees are paid during the quarter
following the quarter in which they are
earned.
|
(b)
|
Amount
represents the aggregate grant date fair value in accordance with FASB ASC
Topic 718. Assumptions made in the valuation of stock option
awards are disclosed in Note 1(o) of the Notes to the Consolidated
Financial Statements in this Form
10-K.
|
(c)
|
At
December 31, 2009, the non-employee directors held an aggregate of
1,065,000 options to purchase shares of common stock of the
Company.
|
(d)
|
Amount
represents the aggregate grant date fair value in accordance with FASB ASC
Topic 718. Assumptions made in the valuation of restricted
stock awards are disclosed in Note 1(o) of the Notes to the Consolidated
Financial Statements in this Form
10-K.
|
(e)
|
At
December 31, 2009, the non-employee directors held an aggregate of 210,000
shares of unvested restricted
stock.
|
(a)
Number of
Securities to be
Issued Upon
Exercise of
Outstanding
Options, Warrants
and Rights
|
(b)
Weighted-Average
Exercise Price of
Outstanding
Options, Warrants
and Rights
|
(c)
Number of
Securities
Remaining Available
for Issuance Under
Equity
Compensation Plans
(Excluding
Securities Reflected
in Column (a))
|
||||||||||
Equity
compensation plans approved
by security holders
|
5,689,500 | $ | 0.44 | 464,500 | ||||||||
Equity
compensation plans not approved
by security holders
|
- | - | - | |||||||||
Total
|
5,689,500 | $ | 0.44 | 464,500 |
Beneficial Owner
|
Number of Shares
Beneficially Owned (*)
|
Percent
of Class (**)
|
|||||||
Carl
J. Aschinger, Jr.
|
367,300 |
(a)
|
(m)
|
||||||
Reuven
Avital
|
455,556 |
(b)
|
(m)
|
||||||
Kirby
I. Bland, M.D.
|
205,000 |
(c)
|
(m)
|
||||||
David
C. Bupp
|
7,015,706 |
(d)
|
8.0 | % | |||||
Frederick
O. Cope, Ph.D.
|
19,173 |
(e)
|
(m)
|
||||||
Owen
E. Johnson, M.D.
|
75,000 |
(f)
|
(m)
|
||||||
Brent
L. Larson
|
697,987 |
(g)
|
(m)
|
||||||
Fred
B. Miller
|
386,000 |
(h)
|
(m)
|
||||||
Gordon
A. Troup
|
50,000 |
(i)
|
(m)
|
||||||
J.
Frank Whitley, Jr.
|
286,500 |
(j)
|
(m)
|
||||||
All directors and
officers as a group
(13
persons)
|
10,407,379 |
(k)(n)
|
11.5 | % | |||||
Platinum
Montaur Life Sciences, LLC
|
7,563,546 |
(l)
|
9.2 | % |
(*)
|
Beneficial
ownership is determined in accordance with the rules of the Securities and
Exchange Commission which generally attribute beneficial ownership of
securities to persons who possess sole or shared voting power and/or
investment power with respect to those securities. Unless
otherwise indicated, voting and investment power are exercised solely by
the person named above or shared with members of such person’s
household.
|
(**)
|
Percent
of class is calculated on the basis of the number of shares outstanding on
March 15, 2010, plus the number of shares the person has the right to
acquire within 60 days of March 15,
2010.
|
(a)
|
This
amount includes 150,000 shares issuable upon exercise of options which are
exercisable within 60 days and 200 shares held in a trust account for
which Mr. Aschinger is the custodian, but does not include 30,000 shares
of unvested restricted stock.
|
(b)
|
This
amount consists of 139,256 shares of our common stock owned by Mittai
Investments Ltd. (Mittai), an investment fund under the management and
control of Mr. Avital, and 195,000 shares issuable upon exercise of
options which are exercisable within 60 days but does not include 13,000
shares of unvested restricted stock. The shares held by Mittai
were obtained through a distribution of 2,785,123 shares previously held
by Ma’Aragim Enterprise Ltd. (Ma’Aragim), another investment fund under
the management and control of Mr. Avital. On February 28, 2005,
Ma’Aragim distributed its shares to the partners in the
fund. Mr. Avital is not an affiliate of the other fund to which
the remaining 2,645,867 shares were distributed. Of the
2,785,123 shares previously held by Ma’Aragim, 2,286,712 were acquired in
exchange for surrendering its shares in Cardiosonix Ltd. on December 31,
2001, in connection with our acquisition of Cardiosonix, and 498,411 were
acquired by Ma’Aragim based on the satisfaction of certain developmental
milestones on December 30, 2002, associated with our acquisition of
Cardiosonix.
|
(c)
|
This
amount includes 180,000 shares issuable upon exercise of options which are
exercisable within 60 days but does not include 30,000 shares of unvested
restricted stock.
|
(d)
|
This
amount includes 1,638,333 shares issuable upon exercise of options which
are exercisable within 60 days, 770,000 warrants which are exercisable
within 60 days, a promissory note convertible into 3,225,806 shares of our
common stock,
213,746 shares that are held by Mr. Bupp’s wife for which he disclaims
beneficial ownership and 125,792 shares in Mr. Bupp’s account in the
401(k) Plan, but it does not include 1,000,000 shares of unvested
restricted stock and 66,667 shares issuable upon exercise of options which
are not exercisable within 60 days.
|
(e)
|
This
amount includes 16,667 shares issuable upon exercise of options which are
exercisable within 60 days and 2,506 shares in Dr. Cope’s account in the
401(k) Plan, but it does not include 175,000 shares of unvested restricted
stock and 108,333 shares issuable upon exercise of options which are not
exercisable within 60 days.
|
(f)
|
This
amount includes 40,000 shares issuable upon exercise of options which are
exercisable within 60 days but does not include 30,000 shares issuable
upon exercise of options which are not exercisable within 60
days.
|
(g)
|
This
amount includes 481,667 shares issuable upon exercise of options which are
exercisable within 60 days and 92,928 shares in Mr. Larson’s account in
the 401(k) Plan, but it does not include 125,000 shares of unvested
restricted stock and 108,333 shares issuable upon exercise of options
which are not exercisable within 60
days.
|
(h)
|
This
amount includes 255,000 shares issuable upon exercise of options which are
exercisable within 60 days and 81,000 shares held by Mr. Miller’s wife for
which he disclaims beneficial ownership, but does not include 30,000
shares of unvested restricted
stock.
|
(i)
|
This
amount includes 20,000 shares issuable upon exercise of options which are
exercisable within 60 days, but does not include 30,000 shares of unvested
restricted stock.
|
(j)
|
This
amount includes 225,000 shares issuable upon exercise of options which are
exercisable within 60 days, but does not include 30,000 shares of unvested
restricted stock.
|
(k)
|
This
amount includes 3,943,334 shares issuable upon exercise of options which
are exercisable within 60 days, 770,000 warrants which are exercisable
within 60 days, a promissory note convertible into 3,225,806 shares of our
common stock,
294,946 shares that are held by spouses of our Directors and Officers or
in trusts for which they are custodian but for which they disclaim
beneficial ownership, and 273,896 shares held in the 401(k) Plan on behalf
of certain officers, but it does not include 1,680,000 shares of unvested
restricted stock and 526,666 shares issuable upon the exercise of options
which are not exercisable within 60 days. The Company itself is
the trustee of the Neoprobe 401(k) Plan and may, as such, share investment
power over common stock held in such plan. The trustee
disclaims any beneficial ownership of shares held by the 401(k)
Plan. The 401(k) Plan holds an aggregate total of 624,627
shares of common stock.
|
(l)
|
Based
on information filed on Schedule 13G with the Securities and Exchange
Commission on August 18, 2009 and information supplied subsequently by
holder. The number of shares beneficially owned by
Platinum-Montaur Life Sciences, LLC (Montaur), 152 W. 57th Street, 54th
Floor, New York, NY 10019, does not include 17,061,538 shares of common
stock issuable upon conversion of a 10% Series A Convertible Senior
Secured Promissory Note issued to Montaur on December 26, 2007, as amended
(the Series A Note), 8,333,333 shares of common stock issuable upon
conversion of a 10% Series B Convertible Senior Secured Promissory Note
issued to Montaur on April 16, 2008 (the Series B Note), 6,000,000 shares
of common stock issuable upon conversion of 3,000 shares Series A 8%
Cumulative Convertible Preferred Stock issued to Montaur on December 5,
2008 (the Preferred Stock), 6,000,000 shares of common stock issuable upon
exercise of a Series W Warrant issued to Montaur on December 26, 2007, as
amended (the Series W Warrant), 8,333,333 shares of common stock issuable
upon exercise of a Series X Warrant issued to Montaur on April 16, 2008
(the Series X Warrant), and 2,400,000 shares of common stock issuable upon
exercise of a Series AA Warrant issued to Montaur on July 24, 2009 (the
Series AA Warrant). The Certificates of Designation of the Preferred
Stock, the Series A Note, the Series B Note, the Series W Warrant, the
Series X Warrant and the Series AA Warrant each provide that the holder of
shares of the Preferred Stock, the Series A Note, the Series B Note, the
Series W Warrant, the Series X Warrant and the Series AA Warrant,
respectively, may not convert any of the preferred stock or notes or
exercise any of the warrants to the extent that such conversion or
exercise would result in the holder and its affiliates together
beneficially owning more than 4.99% or 9.99% of the outstanding shares of
Common Stock, except on 61 days’ prior written notice to Neoprobe that the
holder waives such limitation. Effective September 23, 2009,
the 4.99% limitation, however, does not apply to shares of Common Stock
issued as a dividend on the Preferred Stock or shares of Common Stock
issued as interest on the Series A Note or the Series B
Note.
|
(m)
|
Less
than one percent.
|
(n)
|
The
address of all directors and executive officers is c/o Neoprobe
Corporation, 425 Metro Place North, Suite 300, Dublin, Ohio
43017-1367.
|
Exhibit
|
||
Number
|
Exhibit
Description
|
|
3.1
|
Amended
and Restated Certificate of Incorporation of Neoprobe Corporation as
corrected February 18, 1994 and amended June 27, 1994, June 3, 1996, March
17, 1999, May 9, 2000, June 13, 2003, July 27, 2004, June 22, 2005 and
November 20, 2006 (incorporated by reference to Exhibit 3.1 to the
Company’s Registration Statement on Form SB-2 filed December 7,
2006).
|
|
3.2
|
Amended
and Restated By-Laws dated July 21, 1993, as amended July 18, 1995, May
30, 1996 and July 26, 2007 (filed as Exhibit 3.2 to the Company’s Current
Report on Form 8-K dated August 3, 2007, and incorporated herein by
reference).
|
|
4.1
|
Neoprobe
Corporation Certificate of Designations, Voting Powers, Preferences,
Limitations, Restrictions, and Relative Rights of Series A 8% Cumulative
Convertible Preferred Stock (incorporated by reference to Exhibit 4.1 to
the Company’s Current Report on Form 8-K filed January 2,
2008).
|
|
4.2
|
Neoprobe
Corporation First Amended and Restated Certificate of Designations, Voting
Powers, Preferences, Limitations, Restrictions, and Relative Rights of
Series A 8% Cumulative Convertible Preferred Stock (incorporated by
reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed
May 6, 2009).
|
|
4.3
|
Neoprobe
Corporation Second Amended and Restated Certificate of Designations,
Voting Powers, Preferences, Limitations, Restrictions, and Relative Rights
of Series A 8% Cumulative Convertible Preferred Stock (incorporated by
reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed
July 29, 2009).
|
|
10.1
|
Amended
and Restated Stock Option and Restricted Stock Purchase Plan dated March
3, 1994 (incorporated by reference to Exhibit 10.2.26 to the Company’s
December 31, 1993 Form 10–K).
|
|
10.2
|
1996
Stock Incentive Plan dated January 18, 1996 as amended March 13, 1997
(incorporated by reference to Exhibit 10.2.37 to the Company’s December
31, 1997 Form 10–K).
|
|
10.3
|
Neoprobe
Corporation Second Amended and Restated 2002 Stock Incentive Plan
(incorporated by reference to Exhibit 10.1 to the Company’s Current Report
on Form 8-K filed June 27, 2008).
|
|
10.4
|
Form
of Stock Option Agreement under the Neoprobe Corporation Amended and
Restated 2002 Stock Incentive Plan (incorporated by reference to Exhibit
10.1 to the Company’s Current Report on Form 8-K filed December 21,
2006).
|
|
10.5
|
Form
of Restricted Stock Award and Agreement under the Neoprobe Corporation
Amended and Restated 2002 Stock Incentive Plan (incorporated by reference
to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed January
9, 2008).
|
|
10.6
|
Form
of Employment Agreement between the Company and certain named executive
officers (incorporated by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed December 23, 2008). This
Agreement is one of three substantially identical employment agreements
and is accompanied by a schedule which identifies material details in
which each agreement differs from the form filed
herewith.
|
10.7
|
Schedule
identifying material differences between the employment agreements
incorporated by reference as Exhibit 10.6 to this Registration Statement
on Form S-1 (incorporated by reference to Exhibit 10.2 to the Company’s
Current Report on Form 8-K filed December 23, 2008).
|
|
10.8
|
Employment
Agreement, commencing February 15, 2009, by and between the Company and
Frederick O. Cope, Ph.D. (incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed February 17,
2009).
|
|
10.9
|
Employment
Agreement dated January 1, 2010, by and between the Company and David C.
Bupp (incorporated by reference to Exhibit 10.1 to the Company’s Current
Report on Form 8-K filed January 6, 2010).
|
|
10.10
|
Employment
Agreement, commencing February 15, 2010, by and between the Company and
Frederick O. Cope, Ph.D. (incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed February 26,
2010).
|
|
10.11
|
Technology
Transfer Agreement dated July 29, 1992 between the Company and The Dow
Chemical Corporation (portions of this Exhibit have been omitted pursuant
to a request for confidential treatment and have been filed separately
with the Commission) (incorporated by reference to Exhibit 10.10 to the
Company’s Form S-1 filed October 15, 1992).
|
|
10.12
|
Cooperative
Research and Development Agreement between the Company and the National
Cancer Institute (incorporated by reference to Exhibit 10.3.31 to the
Company’s September 30, 1995 Form 10–QSB).
|
|
10.13
|
License
dated May 1, 1996 between the Company and The Dow Chemical Company
(incorporated by reference to Exhibit 10.3.45 to the Company’s June 30,
1996 Form 10–QSB).
|
|
10.14
|
License
Agreement dated May 1, 1996 between the Company and The Dow Chemical
Company (portions of this Exhibit have been omitted pursuant to a request
for confidential treatment and have been filed separately with the
Commission) (incorporated by reference to Exhibit 10.3.46 to the Company’s
June 30, 1996 Form 10–QSB).
|
|
10.15
|
License
Agreement dated January 30, 2002 between the Company and the Regents of
the University of California, San Diego, as amended on May 27, 2003 and
February 1, 2006 (portions of this Exhibit have been omitted pursuant to a
request for confidential treatment and have been filed separately with the
Commission) (incorporated by reference to Exhibit 10.11 to the Company’s
Annual Report on Form 10-KSB filed March 31, 2006).
|
|
10.16
|
Evaluation
License Agreement dated March 31, 2005 between the Company and the Regents
of the University of California, San Diego (portions of this Exhibit have
been omitted pursuant to a request for confidential treatment and have
been filed separately with the Commission) (incorporated by reference to
Exhibit 10.12 to the Company’s Annual Report on Form 10-KSB filed March
31, 2006).
|
|
10.17
|
Distribution
Agreement between the Company and Ethicon Endo-Surgery, Inc. dated October
1, 1999 (portions of this Exhibit have been omitted pursuant to a request
for confidential treatment and have been filed separately with the
Commission) (incorporated by reference to Exhibit 10.13 to the Company’s
Annual Report on Form 10-KSB filed March 16,
2007).
|
10.18
|
First
Amendment to Distribution Agreement, dated December 14, 2007, by and
between the Company and Ethicon Endo-Surgery, Inc. (portions of this
Exhibit have been omitted pursuant to a request for confidential treatment
and have been filed separately with the Commission) (incorporated by
reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed December 20, 2007).
|
|
10.19
|
Product
Supply Agreement between the Company and TriVirix International, Inc.,
dated February 5, 2004 (portions of this Exhibit have been omitted
pursuant to a request for confidential treatment and have been filed
separately with the Commission) (incorporated by reference to Exhibit
10.17 to the Company’s December 31, 2004 Form 10-KSB).
|
|
10.20
|
Supply
and Distribution Agreement, dated November 15, 2007, by and between the
Company and Cardinal Health 414, LLC (portions of this Exhibit have been
omitted pursuant to a request for confidential treatment and have been
filed separately with the Commission) (incorporated by reference to
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed November
21, 2007).
|
|
10.21
|
Warrant
to Purchase Common Stock of Neoprobe Corporation dated March 8, 2004
between the Company and David C. Bupp (incorporated by reference to
Exhibit 10.28 to the Company’s December 31, 2003 Form
10-KSB).
|
|
10.22
|
Registration
Rights Agreement dated April 2, 2003 between the Company, David C. Bupp
and Donald E. Garlikov (incorporated by reference to Exhibit 99(i) to the
Company’s Current Report on Form 8-K filed April 2,
2003).
|
|
10.23
|
Common
Stock Purchase Agreement between the Company and Fusion Capital Fund II,
LLC dated December 1, 2006 (incorporated by reference to Exhibit 10.5 to
the Company’s Current Report on Form 8-K filed December 4,
2006).
|
|
10.24
|
First
Amendment to Common Stock Purchase Agreement between the Company and
Fusion Capital Fund II, LLC, dated December 24, 2008 (incorporated by
reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed December 31, 2008).
|
|
10.25
|
Registration
Rights Agreement dated December 1, 2006, between the Company and Fusion
Capital Fund II, LLC (incorporated by reference to Exhibit 10.6 to the
Company’s Current Report on Form 8-K filed December 4,
2006).
|
|
10.26
|
10%
Convertible Note Purchase Agreement, dated July 3, 2007, between the
Company and David C. Bupp, Cynthia B. Gochoco and Walter H. Bupp, as joint
tenants with right of survivorship (incorporated by reference to Exhibit
10.1 to the Company’s Current Report on Form 8-K filed July 9,
2007).
|
|
10.27
|
Amendment
to Convertible Note Purchase Agreement, dated December 26, 2007, between
the Company and David C. Bupp, Cynthia B. Gochoco and Walter H. Bupp, as
joint tenants with right of survivorship (incorporated by reference to
Exhibit 10.10 to the Company’s Current Report on Form 8-K filed January 2,
2008).
|
|
10.28
|
Neoprobe
Corporation 10% Convertible Promissory Note Due July 8, 2007, executed in
favor of David C. Bupp, Cynthia B. Gochoco and Walter H. Bupp, as joint
tenants with right of survivorship (incorporated by reference to Exhibit
10.2 to the Company’s Current Report on Form 8-K filed July 9,
2007).
|
|
10.29
|
Amended
Neoprobe Corporation 10% Convertible Promissory Note Due December 31,
2011, executed in favor of David C. Bupp, Cynthia B. Gochoco and Walter H.
Bupp, as joint tenants with right of survivorship (incorporated by
reference to Exhibit 10.11 to the Company’s Current Report on Form 8-K
filed January 2,
2008).
|
10.30
|
Security
Agreement, dated December 26, 2007, by and between the Company and David
C. Bupp, Cynthia B. Gochoco and Walter H. Bupp, as joint tenants with
right of survivorship (incorporated by reference to Exhibit 10.12 to the
Company’s Current Report on Form 8-K filed January 2,
2008).
|
|
10.31
|
Series
V Warrant to Purchase Common Stock of Neoprobe Corporation issued to David
C. Bupp, Cynthia B. Gochoco and Walter H. Bupp, as joint tenants with
right of survivorship (incorporated by reference to Exhibit 10.3 to the
Company’s Current Report on Form 8-K filed July 9,
2007).
|
|
10.32
|
Additional
Series V Warrant to Purchase Common Stock of Neoprobe Corporation issued
to David C. Bupp, Cynthia B. Gochoco and Walter H. Bupp, as joint tenants
with right of survivorship (incorporated by reference to Exhibit 10.13 to
the Company’s Current Report on Form 8-K filed January 2,
2008).
|
|
10.33
|
Registration
Rights Agreement, dated July 3, 2007, by and among Neoprobe Corporation
and David C. Bupp, Cynthia B. Gochoco and Walter H. Bupp, as joint tenants
with right of survivorship (incorporated by reference to Exhibit 10.4 to
the Company’s Current Report on Form 8-K filed July 9,
2007).
|
|
10.34
|
Securities
Purchase Agreement, dated as of December 26, 2007, by and between the
Company and Platinum-Montaur Life Sciences, LLC (incorporated by reference
to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed January
2, 2008).
|
|
10.35
|
Amendment
and Waiver for Securities Purchase Agreement, dated April 16, 2008,
between Neoprobe Corporation and Platinum-Montaur Life Sciences, LLC
(incorporated by reference to Exhibit 10.1 to the Company’s Current Report
on Form 8-K filed April 18, 2008).
|
|
10.36
|
Agreement
Modifying the Interest and Dividend Payment Dates of the Neoprobe
Corporation Series A and B Promissory Notes and Series A Preferred Stock,
and Exercise and Conversion Price Adjustment Provisions of the Neoprobe
Corporation Series X and Y Warrants and Series A Preferred Stock, dated
March 31, 2009, by and between Neoprobe Corporation and Platinum-Montaur
Life Sciences, LLC (incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed April 6,
2009).
|
|
10.37
|
Securities
Amendment and Exchange Agreement, dated July 24, 2009, by and between the
Company and Platinum-Montaur Life Sciences, LLC (incorporated by reference
to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed July 29,
2009).
|
|
10.38
|
Neoprobe
Corporation 10% Series A Convertible Senior Secured Promissory Note in the
principal amount of $7,000,000, due December 26, 2011 (incorporated by
reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K
filed January 2, 2008).
|
|
10.39
|
Second
Amendment to 10% Series A Senior Secured Convertible Promissory Note,
dated April 16, 2008, between Neoprobe Corporation and Platinum-Montaur
Life Sciences, LLC (incorporated by reference to Exhibit 10.5 to the
Company’s Current Report on Form 8-K filed April 18,
2008).
|
|
10.40
|
Amended
and Restated Neoprobe Corporation 10% Series A Convertible Senior Secured
Promissory Note in the principal amount of $7,000,000, due December 26,
2011 (incorporated by reference to Exhibit 10.2 to the Company’s Current
Report on Form 8-K filed July 29,
2009).
|
10.41
|
Neoprobe
Corporation 10% Series B Convertible Senior Secured Promissory Note in the
principal amount of $3,000,000, due December 26, 2011 (incorporated by
reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K
filed April 18, 2008).
|
|
10.42
|
Amended
and Restated Neoprobe Corporation 10% Series B Convertible Senior Secured
Promissory Note in the principal amount of $3,000,000, due December 26,
2011 (incorporated by reference to Exhibit 10.3 to the Company’s Current
Report on Form 8-K filed July 29, 2009).
|
|
10.43
|
Series
W Warrant to Purchase Shares of Common Stock of Neoprobe Corporation
issued to Platinum-Montaur Life Sciences, LLC (incorporated by reference
to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed January
2, 2008).
|
|
10.44
|
Amended
and Restated Series W Warrant to Purchase Shares of Common Stock of
Neoprobe Corporation issued to Platinum-Montaur Life Sciences, LLC
(incorporated by reference to Exhibit 10.4 to the Company’s Current Report
on Form 8-K filed July 29, 2009).
|
|
10.45
|
Series
X Warrant to Purchase Shares of Common Stock of Neoprobe Corporation
issued to Platinum-Montaur Life Sciences, LLC (incorporated by reference
to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed April
18, 2008).
|
|
10.46
|
Amended
and Restated Series X Warrant to Purchase Shares of Common Stock of
Neoprobe Corporation issued to Platinum-Montaur Life Sciences, LLC
(incorporated by reference to Exhibit 10.5 to the Company’s Current Report
on Form 8-K filed July 29, 2009).
|
|
10.47
|
Series
Y Warrant to Purchase Shares of Common Stock of Neoprobe Corporation
issued to Platinum-Montaur Life Sciences, LLC (incorporated by reference
to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed December
9, 2008).
|
|
10.48
|
Amended
and Restated Series Y Warrant to Purchase Shares of Common Stock of
Neoprobe Corporation issued to Platinum-Montaur Life Sciences, LLC
(incorporated by reference to Exhibit 10.6 to the Company’s Current Report
on Form 8-K filed July 29, 2009).
|
|
10.49
|
Series
AA Warrant to Purchase Shares of Common Stock of Neoprobe Corporation
issued to Platinum-Montaur Life Sciences, LLC (incorporated by reference
to Exhibit 10.7 to the Company’s Current Report on Form 8-K filed July 29,
2009).
|
|
10.50
|
Registration
Rights Agreement, dated December 26, 2007, between the Company and
Platinum-Montaur Life Sciences, LLC (incorporated by reference to Exhibit
10.7 to the Company’s Current Report on Form 8-K filed January 2,
2008).
|
|
10.51
|
Second
Amendment to Registration Rights Agreement, dated April 16, 2008, between
Neoprobe Corporation and Platinum-Montaur Life Sciences, LLC (incorporated
by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K
filed April 18, 2008).
|
|
10.52
|
Third
Amendment to Registration Rights Agreement, dated July 10, 2008, between
Neoprobe Corporation and Platinum-Montaur Life Sciences, LLC (incorporated
by reference to Exhibit 10.55 to pre-effective amendment No. 2 to the
Company’s Registration Statement on Form S-1, filed July 24, 2008,
Registration file No. 333-150650).
|
|
10.53
|
Fourth
Amendment to Registration Rights Agreement, dated December 5, 2008,
between Neoprobe Corporation and Platinum-Montaur Life Sciences, LLC
(incorporated by reference to Exhibit 10.1 to the Company’s Current Report
on Form 8-K filed December 9,
2008).
|
10.54
|
Fifth
Amendment to Registration Rights Agreement, dated December 21, 2009,
between Neoprobe Corporation and Platinum-Montaur Life Sciences, LLC
(incorporated by reference to Exhibit 10.1 to the Company’s Current Report
on Form 8-K filed December 22, 2009).
|
|
10.55
|
Security
Agreement, dated December 26, 2007, between the Company and
Platinum-Montaur Life Sciences, LLC (incorporated by reference to Exhibit
10.8 to the Company’s Current Report on Form 8-K filed January 2,
2008).
|
|
10.56
|
Patent,
Trademark, and Copyright Security Agreement, dated December 25, 2007, by
and among Neoprobe Corporation, Cardiosonix Ltd., Cira Biosciences, Inc.
and Platinum-Montaur Life Sciences, LLC (incorporated by reference to
Exhibit 10.9 to the Company’s Current Report on Form 8-K filed January 2,
2008).
|
|
21.1
|
Subsidiaries
of the registrant.*
|
|
23.1
|
Consent
of BDO Seidman, LLP.*
|
|
24.1
|
Power
of Attorney.*
|
|
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.*
|
NEOPROBE
CORPORATION
|
|
(the
Company)
|
|
By:
|
/s/
David C. Bupp
|
David
C. Bupp, President and
|
|
Chief
Executive Officer
|
Signature
|
Title
|
Date
|
||
/s/David
C. Bupp
|
Director,
President and
|
March
31, 2010
|
||
David
C. Bupp
|
Chief
Executive Officer
(principal
executive officer)
|
|||
/s/
Brent L. Larson*
|
Vice
President, Finance and
|
March
31, 2010
|
||
Brent
L. Larson
|
Chief
Financial Officer
(principal
financial officer)
|
|||
/s/
Carl J. Aschinger, Jr.*
|
Chairman,
Director
|
March
31, 2010
|
||
Carl
J. Aschinger, Jr.
|
||||
/s/
Reuven Avital*
|
Director
|
March
31, 2010
|
||
Reuven
Avital
|
||||
/s/
Kirby I. Bland*
|
Director
|
March
31, 2010
|
||
Kirby
I. Bland
|
||||
/s/
Owen E. Johnson*
|
Director
|
March
31, 2010
|
||
Owen
E. Johnson
|
||||
/s/
Fred B. Miller*
|
Director
|
March
31, 2010
|
||
Fred
B. Miller
|
||||
/s/
Gordon A. Troup*
|
Director
|
March
31, 2010
|
||
Gordon
A. Troup
|
||||
/s/
J. Frank Whitley, Jr.*
|
Director
|
March
31, 2010
|
||
J.
Frank Whitley, Jr.
|
/s/
David C. Bupp
|
|
David
C. Bupp,
Attorney-in-fact
|
Consolidated
Financial Statements of Neoprobe Corporation
|
||
Report
of Independent Registered Public Accounting Firm BDO Seidman,
LLP
|
F-2
|
|
Consolidated
Balance Sheets as of December 31, 2009 and December 31,
2008
|
F-3
|
|
Consolidated
Statements of Operations for the years ended December 31, 2009 and
December 31, 2008
|
F-5
|
|
Consolidated
Statements of Stockholders’ Deficit for the years ended December 31, 2009
and December 31, 2008
|
F-6
|
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2009 and
December 31, 2008
|
F-7
|
|
Notes
to the Consolidated Financial Statements
|
F-8
|
ASSETS
|
2009
|
2008
|
||||||
Current
assets:
|
||||||||
Cash
|
$ | 5,639,842 | $ | 3,565,837 | ||||
Available-for-sale
securities
|
— | 495,383 | ||||||
Accounts
receivable, net
|
1,331,908 | 1,626,065 | ||||||
Inventory
|
1,143,697 | 544,126 | ||||||
Prepaid
expenses and other
|
474,243 | 573,573 | ||||||
Assets
associated with discontinued operations
|
27,475 | 435,740 | ||||||
Total
current assets
|
8,617,165 | 7,240,724 | ||||||
Property
and equipment
|
1,990,603 | 1,940,748 | ||||||
Less
accumulated depreciation and amortization
|
1,693,290 | 1,593,501 | ||||||
297,313 | 347,247 | |||||||
Patents
and trademarks
|
524,224 | 459,431 | ||||||
Less
accumulated amortization
|
445,650 | 433,358 | ||||||
78,574 | 26,073 | |||||||
Other
assets
|
24,707 | 594,449 | ||||||
Other
assets associated with discontinued operations
|
— | 1,410,957 | ||||||
Total
assets
|
$ | 9,017,759 | $ | 9,619,450 |
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
2009
|
2008
|
||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 763,966 | $ | 725,820 | ||||
Accrued
liabilities and other
|
1,048,304 | 900,796 | ||||||
Capital
lease obligations, current portion
|
11,265 | 9,084 | ||||||
Deferred
revenue, current portion
|
560,369 | 526,619 | ||||||
Notes
payable to finance companies
|
— | 137,857 | ||||||
Liabilities
associated with discontinued operations
|
18,743 | 22,280 | ||||||
Total
current liabilities
|
2,402,647 | 2,322,456 | ||||||
Capital
lease obligations
|
19,912 | 11,095 | ||||||
Deferred
revenue
|
534,119 | 490,165 | ||||||
Note
payable to CEO, net of discounts of $54,093 and $76,294,
respectively
|
945,907 | 923,706 | ||||||
Notes
payable to investors, net of discounts of $0 and $5,001,149,
respectively
|
10,000,000 | 4,998,851 | ||||||
Derivative
liabilities
|
1,951,664 | 853,831 | ||||||
Other
liabilities
|
33,362 | 45,071 | ||||||
Total
liabilities
|
15,887,611 | 9,645,175 | ||||||
Commitments
and contingencies
|
||||||||
Preferred
stock; $.001 par value; 5,000,000 shares authorized; 3,000 Series A
shares, par value $1,000, issued and outstanding at December 31, 2009 and
2008
|
3,000,000 | 3,000,000 | ||||||
Stockholders’
deficit:
|
||||||||
Common
stock; $.001 par value; 150,000,000 shares authorized; 80,936,711 and
70,862,641 shares issued and outstanding at December 31, 2009 and 2008,
respectively
|
80,937 | 70,863 | ||||||
Additional
paid-in capital
|
182,747,897 | 145,742,044 | ||||||
Accumulated
deficit
|
(192,698,686 | ) | (148,840,015 | ) | ||||
Unrealized
gain on available-for-sale securities
|
— | 1,383 | ||||||
Total
stockholders’ deficit
|
(9,869,852 | ) | (3,025,725 | ) | ||||
Total
liabilities and stockholders’ deficit
|
$ | 9,017,759 | $ | 9,619,450 |
Years Ended December 31,
|
||||||||
2009
|
2008
|
|||||||
Revenues:
|
||||||||
Net
sales
|
$ | 9,418,032 | $ | 7,417,751 | ||||
License
and other revenue
|
100,000 | 171,750 | ||||||
Total
revenues
|
9,518,032 | 7,589,501 | ||||||
Cost
of goods sold
|
3,134,740 | 2,845,498 | ||||||
Gross
profit
|
6,383,292 | 4,744,003 | ||||||
Operating
expenses:
|
||||||||
Research
and development
|
4,967,861 | 4,286,474 | ||||||
Selling,
general and administrative
|
3,240,337 | 2,965,342 | ||||||
Total
operating expenses
|
8,208,198 | 7,251,816 | ||||||
Loss
from operations
|
(1,824,906 | ) | (2,507,813 | ) | ||||
Other
income (expense):
|
||||||||
Interest
income
|
18,749 | 60,808 | ||||||
Interest
expense
|
(1,533,047 | ) | (1,744,825 | ) | ||||
Change
in derivative liabilities
|
(18,132,274 | ) | (451,381 | ) | ||||
Loss
on extinguishment of debt
|
(16,240,592 | ) | — | |||||
Other
|
(3,422 | ) | 11,308 | |||||
Total
other expense, net
|
(35,890,586 | ) | (2,124,090 | ) | ||||
Loss
from continuing operations
|
(37,715,492 | ) | (4,631,903 | ) | ||||
Discontinued
operations:
|
||||||||
Impairment
loss
|
(1,713,822 | ) | — | |||||
Loss
from operations
|
(176,406 | ) | (534,323 | ) | ||||
Net
loss
|
(39,605,720 | ) | (5,166,226 | ) | ||||
Preferred
stock dividends
|
(240,000 | ) | — | |||||
Loss
attributable to common stockholders
|
$ | (39,845,720 | ) | $ | (5,166,226 | ) | ||
Loss
per common share (basic and diluted):
|
||||||||
Continuing
operations
|
$ | (0.51 | ) | $ | (0.07 | ) | ||
Discontinued
operations
|
$ | (0.03 | ) | $ | (0.01 | ) | ||
Loss
attributable to common stockholders
|
$ | (0.54 | ) | $ | (0.08 | ) | ||
Weighted
average shares outstanding:
|
||||||||
Basic
|
73,771,871 | 68,594,172 | ||||||
Diluted
|
73,771,871 | 68,594,172 |
Common
Stock
|
Additional
Paid-in
|
Accumulated
|
Accumulated
Other
Comprehensive
|
|||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Income
|
Total
|
|||||||||||||||||||
Balance,
December 31, 2007
|
67,240,030 | $ | 67,240 | $ | 136,765,697 | $ | (140,776,531 | ) | $ | — | $ | (3,943,594 | ) | |||||||||||
Issued
restricted stock to employees
|
480,000 | 480 | (30 | ) | — | — | 450 | |||||||||||||||||
Issued
stock to investor advisory service firms
|
117,500 | 118 | 78,433 | — | — | 78,551 | ||||||||||||||||||
Issued
stock to 401(k) plan at $0.26
|
114,921 | 115 | 29,916 | — | — | 30,031 | ||||||||||||||||||
Issued
stock upon exercise of warrants
|
2,365,190 | 2,365 | 167,441 | — | — | 169,806 | ||||||||||||||||||
Issued
stock upon exercise of options
|
185,000 | 185 | 61,715 | — | — | 61,900 | ||||||||||||||||||
Issued
stock as a commitment fee in connection with a stock purchase
agreement
|
360,000 | 360 | 215,640 | — | — | 216,000 | ||||||||||||||||||
Paid
preferred stock issuance costs
|
— | — | (180,000 | ) | — | — | (180,000 | ) | ||||||||||||||||
Paid
common stock issuance costs
|
— | — | (900 | ) | — | — | (900 | ) | ||||||||||||||||
Issued
warrants to purchase common stock
|
— | — | 2,473,087 | (1,130,629 | ) | — | 1,342,458 | |||||||||||||||||
Effect
of beneficial conversion feature of convertible promissory
note
|
— | — | 1,443,845 | — | — | 1,443,845 | ||||||||||||||||||
Effect
of beneficial conversion feature of convertible preferred
stock
|
— | — | 1,550,629 | (1,550,629 | ) | — | — | |||||||||||||||||
Effect
of put option feature of convertible preferred stock
|
— | — | — | (216,000 | ) | — | (216,000 | ) | ||||||||||||||||
Reclassified
derivative liabilities
|
— | — | 2,924,994 | — | — | 2,924,994 | ||||||||||||||||||
Stock
compensation expense
|
— | — | 211,577 | — | — | 211,577 | ||||||||||||||||||
Comprehensive
loss:
|
||||||||||||||||||||||||
Net
loss
|
— | — | — | (5,166,226 | ) | — | (5,166,226 | ) | ||||||||||||||||
Unrealized
gain on available-for- sale securities
|
— | — | — | — | 1,383 | 1,383 | ||||||||||||||||||
Total
comprehensive loss
|
— | — | — | — | — | (5,164,843 | ) | |||||||||||||||||
Balance,
December 31, 2008
|
70,862,641 | 70,863 | 145,742,044 | (148,840,015 | ) | 1,383 | (3,025,725 | ) | ||||||||||||||||
Effect
of adopting new provisions of FASB ASC Topic 815
|
— | — | (8,948,089 | ) | (4,012,951 | ) | — | (12,961,040 | ) | |||||||||||||||
Issued
restricted stock to employees and directors
|
1,260,000 | 1,260 | — | — | — | 1,260 | ||||||||||||||||||
Cancelled
restricted stock
|
(9,000 | ) | (9 | ) | 9 | — | — | — | ||||||||||||||||
Issued
stock to 401(k) plan at $0.41
|
80,883 | 81 | 33,392 | — | — | 33,473 | ||||||||||||||||||
Issued
stock upon exercise of warrants
|
6,948,507 | 6,949 | 6,534,985 | — | — | 6,541,934 | ||||||||||||||||||
Issued
stock upon exercise of options
|
400,441 | 400 | 124,216 | — | — | 124,616 | ||||||||||||||||||
Issued
stock in payment of interest on convertible debt and dividends on
convertible preferred stock
|
1,393,239 | 1,393 | 1,029,940 | — | — | 1,031,333 | ||||||||||||||||||
Paid
preferred stock issuance costs
|
— | — | (6,323 | ) | — | — | (6,323 | ) | ||||||||||||||||
Paid
common stock issuance costs
|
— | — | (207,000 | ) | — | — | (207,000 | ) | ||||||||||||||||
Effect
of change in terms of notes payable, preferred stock and
warrants
|
— | — | 37,999,312 | — | — | 37,999,312 | ||||||||||||||||||
Stock
compensation expense
|
— | — | 445,411 | — | — | 445,411 | ||||||||||||||||||
Preferred
stock dividends
|
— | — | — | (240,000 | ) | — | (240,000 | ) | ||||||||||||||||
Comprehensive
loss:
|
||||||||||||||||||||||||
Net
loss
|
— | — | — | (39,605,720 | ) | — | (39,605,720 | ) | ||||||||||||||||
Unrealized
loss on available-for-sale securities
|
— | — | — | — | (1,383 | ) | (1,383 | ) | ||||||||||||||||
Total
comprehensive loss
|
— | — | — | — | — | (39,607,103 | ) | |||||||||||||||||
Balance,
December 31, 2009
|
80,936,711 | $ | 80,937 | $ | 182,747,897 | $ | (192,698,686 | ) | $ | — | $ | (9,869,852 | ) |
Years Ended December 31,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (39,605,720 | ) | $ | (5,166,226 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization of property and equipment
|
202,703 | 183,209 | ||||||
Amortization
of intangible assets
|
131,046 | 225,143 | ||||||
Loss
on disposal and abandonment of assets
|
18,794 | 30,850 | ||||||
Amortization
of debt discount and debt offering costs
|
428,060 | 706,064 | ||||||
Issuance
of common stock in payment of interest and dividends
|
791,333 | — | ||||||
Stock
compensation expense
|
445,411 | 211,577 | ||||||
Change
in derivative liabilities
|
18,132,274 | 451,381 | ||||||
Loss
on extinguishment of debt
|
16,240,592 | — | ||||||
Impairment
loss on discontinued operations
|
1,713,822 | — | ||||||
Other
|
33,473 | 130,341 | ||||||
Change
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
296,813 | (22,160 | ) | |||||
Inventory
|
(653,043 | ) | 93,372 | |||||
Prepaid
expenses and other assets
|
105,262 | 131,039 | ||||||
Accounts
payable
|
38,146 | (46,865 | ) | |||||
Accrued
liabilities and other liabilities
|
121,277 | 108,525 | ||||||
Deferred
revenue
|
77,704 | (58,368 | ) | |||||
Net
cash used for operating activities
|
(1,482,053 | ) | (3,022,118 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Purchases
of available-for-sale securities
|
— | (690,000 | ) | |||||
Maturities
of available-for-sale securities
|
494,000 | 196,000 | ||||||
Purchases
of equipment
|
(96,331 | ) | (116,352 | ) | ||||
Proceeds
from sales of property and equipment
|
251 | 495 | ||||||
Patent
and trademark costs
|
(71,344 | ) | (17,486 | ) | ||||
Net
cash provided from (used for) investing activities
|
326,576 | (627,343 | ) | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from issuance of preferred stock
|
— | 3,000,000 | ||||||
Payment
of preferred stock offering costs
|
(6,323 | ) | (180,000 | ) | ||||
Proceeds
from issuance of common stock
|
3,641,010 | 232,156 | ||||||
Payment
of common stock offering costs
|
(237,678 | ) | (900 | ) | ||||
Proceeds
from notes payable
|
— | 3,000,000 | ||||||
Payment
of debt issuance costs
|
(20,183 | ) | (200,154 | ) | ||||
Payment
of notes payable
|
(137,857 | ) | (158,304 | ) | ||||
Payments
under capital leases
|
(9,487 | ) | (17,720 | ) | ||||
Net
cash provided from financing activities
|
3,229,482 | 5,675,078 | ||||||
Net
increase in cash
|
2,074,005 | 2,025,617 | ||||||
Cash,
beginning of year
|
3,565,837 | 1,540,220 | ||||||
Cash,
end of year
|
$ | 5,639,842 | $ | 3,565,837 |
1.
|
Organization
and Summary of Significant Accounting
Policies
|
|
a.
|
Organization and Nature of
Operations: Neoprobe Corporation (Neoprobe, the Company,
or we), a Delaware corporation, is engaged in the development and
commercialization of innovative surgical and diagnostic products that
enhance patient care by meeting the critical decision making needs of
physicians. We currently manufacture a line of gamma radiation
detection equipment used in the application of sentinel lymph node biopsy
(SLNB).
|
|
b.
|
Principles of
Consolidation: Our consolidated financial statements
include the accounts of Neoprobe, our wholly-owned subsidiary,
Cardiosonix, and our majority-owned subsidiary, Cira Bio. All
significant inter-company accounts were eliminated in
consolidation.
|
|
c.
|
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 disclosure
of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those
estimates.
|
|
d.
|
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:
|
|
(1)
|
Cash,
accounts receivable, accounts payable, and accrued
liabilities: The carrying amounts approximate fair value
because of the short maturity of these
instruments.
|
|
(2)
|
Available-for-sale
securities: Available-for-sale securities are recorded at fair
value. Fair value of available-for-sale securities is
determined based on quoted market prices. Unrealized holding
gains and losses on available-for-sale securities are excluded from
earnings and are reported as a separate component of other comprehensive
income (loss) until realized. Realized gains and losses from
the sale of available-for-sale securities are determined on a specific
identification basis.
|
|
(3)
|
Notes
payable to finance companies: The fair value of our debt is
estimated by discounting the future cash flows at rates currently offered
to us for similar debt instruments of comparable maturities by banks or
finance companies. At December 31, 2008, the carrying values of
these instruments approximated fair value. We had no notes
payable to finance companies at December 31,
2009.
|
|
(4)
|
Note
payable to CEO: The carrying value of our debt is presented as
the face amount of the note less the unamortized discount related to the
initial estimated fair value of the warrants to purchase common stock
issued in connection with the note. At December 31, 2009 and
2008, the note payable to our CEO had an estimated fair value of $3.9
million and $1.8 million, respectively, based on the closing market price
of our common stock.
|
|
(5)
|
Notes
payable to investors: The carrying value of our debt at
December 31, 2009 is presented as the face amount of the
notes. The carrying value of our debt at December 31, 2008 is
presented as the face amount of the notes less the unamortized discounts
related to the beneficial conversion features, the initial estimated fair
value of the put options embedded in the notes and the initial estimated
fair value of the warrants to purchase common stock issued in connection
with the notes. At December 31, 2009 and 2008, the notes
payable to investors had an estimated fair value of $31.0 million and
$15.9 million, respectively, based on the closing market price of our
common stock.
|
|
(6)
|
Derivative
liabilities: Derivative liabilities are recorded at fair
value. Fair value of warrant liabilities is determined based on
a Black-Scholes option pricing model calculation. Fair value of
conversion and put option liabilities is determined based on a
probability-weighted Black-Scholes option pricing model
calculation. Unrealized gains and losses on the derivatives are
classified in other expenses as a change in derivative liabilities in the
statements of operations.
|
|
e.
|
Cash and Cash
Equivalents: Cash equivalents are highly liquid
instruments such as U.S. Treasury bills, bank certificates of
deposit, corporate commercial paper and money market funds which have
maturities of less than 3 months from the date of purchase. The
Company held no cash equivalents at December 31, 2009 or
2008.
|
|
f.
|
Inventory: All
components of inventory are valued at the lower of cost (first-in,
first-out) or market. We adjust inventory to market value when
the net realizable value is lower than the carrying cost of the
inventory. Market value is determined based on recent sales
activity and margins achieved. During 2009 and 2008, we wrote
off $2,000 and $4,000, respectively, of excess and obsolete
materials. During 2009, we also wrote off $416,000 of
Cardiosonix inventory as part of the impairment of the discontinued
operation. See Note 2.
|
2009
|
2008
|
|||||||
Pharmaceutical
materials
|
$ | 525,000 | $ | — | ||||
Gamma
detection device materials
|
137,695 | 112,637 | ||||||
Gamma
detection device finished goods
|
481,002 | 431,489 | ||||||
$ | 1,143,697 | $ | 544,126 |
|
g.
|
Property and
Equipment: Property and equipment are stated at cost,
less accumulated depreciation and amortization. Property and
equipment under capital leases are stated at the present value of minimum
lease payments. Depreciation is computed using the
straight-line method over the estimated useful lives of the depreciable
assets ranging from 2 to 7 years, and includes amortization related to
equipment under capital leases, which is amortized over the shorter of the
estimated useful life of the leased asset or the term of the
lease. Maintenance and repairs are charged to expense as
incurred, while renewals and improvements are
capitalized. Property and equipment includes $40,000 and
$44,000 of equipment under capital leases with accumulated amortization of
$10,000 and $25,000 at December 31, 2009 and 2008,
respectively. During 2009 and 2008, we recorded losses of
$18,000 and $31,000, respectively, on the disposal of property and
equipment. During 2009, we also wrote off $30,000 of
Cardiosonix equipment as part of the impairment of the discontinued
operation. See Note
2.
|
Useful Life
|
2009
|
2008
|
||||||||
Production
machinery and equipment
|
5
years
|
$ | 613,659 | $ | 605,532 | |||||
Other
machinery and equipment, primarily research equipment, loaners and
computers
|
2 –
5 years
|
765,340 | 745,058 | |||||||
Furniture
and fixtures
|
7
years
|
353,863 | 349,369 | |||||||
Software
|
3
years
|
183,059 | 166,107 | |||||||
Leasehold
improvements
|
Life
of Lease1
|
74,682 | 74,682 | |||||||
$ | 1,990,603 | $ | 1,940,748 |
|
h.
|
Intangible
Assets: Intangible assets consist primarily of patents
and trademarks. Intangible assets are stated at cost, less
accumulated amortization. Patent costs are amortized using the
straight-line method over the estimated useful lives of the patents of
approximately 5 to 15 years. Patent application costs are
deferred pending the outcome of patent applications. Costs
associated with unsuccessful patent applications and abandoned
intellectual property are expensed when determined to have no recoverable
value. We evaluate the potential alternative uses of all
intangible assets, as well as the recoverability of the carrying values of
intangible assets, on a recurring
basis.
|
December 31, 2009
|
December 31, 2008
|
||||||||||||||||
Weighted
Average Remaining Life1 |
Gross
Carrying Amount |
Accumulated
Amortization |
Gross
Carrying Amount |
Accumulated
Amortization |
|||||||||||||
Patents
and trademarks
|
3.1
yrs
|
$ | 524,224 | $ | 445,650 | $ | 459,431 | $ | 433,358 |
|
The
estimated future amortization expenses 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 |
|
i.
|
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. 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 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. During
2009, we wrote off $30,000 of Cardiosonix equipment as part of the
impairment of the discontinued operation. We recorded no
impairment charges during 2008. See Note
2.
|
|
j.
|
Other
Assets: Other assets consist primarily of deferred debt
issuance costs. We defer costs associated with the issuance of
notes payable and amortize those costs over the period of the notes using
the effective interest method. In 2009 and 2008, we incurred
$20,000 and $200,000, respectively, of debt issuance costs related to
notes payable. During 2009, we expensed $524,000 of deferred
debt issuance costs as a result of debt modification
activities. Other assets include deferred debt issuance costs
of $17,000 and $588,000 at December 31, 2009 and 2008,
respectively. See Note
8.
|
|
k.
|
Deferred Revenue:
Deferred revenue as of December 31, 2009 and 2008 consists
primarily of $400,000 and $500,000, respectively, in non-refundable
license fees and reimbursement of past research and development expenses
which EES paid us as consideration for extending our distribution
agreement with them. We recognized $100,000 of this payment as
license revenue during 2009, and we intend to recognize the remaining
$400,000 as license revenue on a straight-line basis over the remaining
term of the agreement, from January 2010 through December
2013. In addition, deferred revenue as of December 31, 2009 and
2008 includes revenues from the sale of extended warranties covering our
medical devices over periods of one to five years. We recognize
revenue from extended warranty sales on a pro-rata basis over the period
covered by the extended warranty.
|
|
l.
|
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. We do not
use derivative instruments for hedging of market risks or for trading or
speculative purposes. See Note
9.
|
m.
|
Revenue
Recognition:
|
(1)
|
Product Sales: We derive
revenues primarily from sales of our medical devices. 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 when the products are shipped and the earnings process has
been completed. However, in cases where product is shipped but the
earnings process is not yet completed, revenue is deferred until it has
been determined that the earnings process has been completed. Our
customers generally have no right to return products purchased in the
ordinary course of business.
|
|
(2)
|
Extended Warranty
Revenue: We derive revenues from the sale of extended
warranties covering our medical devices over periods of one to five
years. We recognize revenue from extended warranty sales on a
pro-rata basis over the period covered by the extended
warranty. Expenses related to the extended warranty are
recorded when incurred.
|
|
(3)
|
Service
Revenue: We derive revenues from the repair and service
of our medical devices that are in use beyond the term of the original
warranty and that are not covered by an extended warranty. We
recognize revenue from repair and service activities once the activities
are complete and the repaired or serviced device has been shipped back to
the customer.
|
|
n.
|
Research and Development
Costs: All costs related to research and development are
expensed as incurred.
|
|
o.
|
Stock-Based
Compensation: At December 31, 2009, 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.
|
2009
|
2008
|
|||||||
Expected
volatility
|
73%-91%
|
93%-104%
|
||||||
Weighted-average
volatility
|
81%
|
101%
|
||||||
Expected
dividends
|
—
|
—
|
||||||
Expected
term (in years)
|
5.5-6.0
|
5.5-6.0
|
||||||
Risk-free
rate
|
1.8%-2.7%
|
3.3%-3.6%
|
Year Ended December 31,
2009
|
|||||||||||||
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Life
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at beginning of year
|
5,619,500 | $ | 0.40 | ||||||||||
Granted
|
656,000 | 0.88 | |||||||||||
Exercised
|
(465,000 | ) | 0.43 | ||||||||||
Forfeited
|
(10,000 | ) | 0.61 | ||||||||||
Expired
|
(111,000 | ) | 1.10 | ||||||||||
Outstanding
at end of year
|
5,689,500 | $ | 0.44 |
5.3 years
|
$ | 4,458,374 | |||||||
Exercisable
at end of year
|
4,697,833 | $ | 0.38 |
4.5 years
|
$ | 3,965,447 |
Year Ended
December 31, 2009
|
||||||||
Number of
Shares
|
Weighted
Average
Grant-Date
Fair Value
|
|||||||
Unvested
at beginning of year
|
473,000 | $ | 0.37 | |||||
Granted
|
1,260,000 | 0.90 | ||||||
Vested
|
(5,000 | ) | 0.65 | |||||
Forfeited
|
(9,000 | ) | 0.68 | |||||
Unvested
at end of year
|
1,719,000 | $ | 0.76 |
|
p.
|
Income
Taxes: Income taxes are accounted for under the asset
and liability method. Deferred tax assets and liabilities are
recognized for the future tax consequences attributable to differences
between the financial statement carrying amounts of existing assets and
liabilities and their respective tax bases, and operating loss and tax
credit carryforwards. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in
the years in which those temporary differences are expected to be
recovered or settled. The effect on deferred tax assets and
liabilities of a change in tax rates is recognized in income in the period
that includes the enactment date. Due to the uncertainty
surrounding the realization of the deferred tax assets in future tax
returns, all of the deferred tax assets have been fully offset by a
valuation allowance at December 31, 2009 and 2008. See Note
10.
|
|
q.
|
Recent Accounting
Developments: In September 2006, the Financial
Accounting Standards Board (FASB) issued Statement of Financial Accounting
Standards (SFAS) No. 157, Fair Value
Measurements, which was primarily codified in FASB Accounting
Standards CodificationTM
(ASC) Topic 820, Fair
Value Measurements and Disclosures. This statement
defines fair value, establishes a framework for measuring fair value in
generally accepted accounting principles, and expands disclosures about
fair value measurements. This statement did not require any new
fair value measurements. This statement was initially effective
for Neoprobe beginning January 1, 2008 for nonfinancial assets and
nonfinancial liabilities recognized or disclosed at fair value on at least
an annual basis. In February 2008, the FASB decided to allow
entities to electively defer the effective date of this statement until
January 1, 2009 for nonfinancial assets and nonfinancial liabilities that
are not recognized or disclosed at fair value on at least an annual
basis. We began applying the fair value measurement and
disclosure provisions of this statement to nonfinancial assets and
liabilities effective January 1, 2009. The application of such
was not material to our consolidated results of operations or financial
condition. See Note 1(d) and Note
3.
|
2.
|
Discontinued
Operations
|
December 31,
2009
|
December 31,
2008 |
|||||||
Accounts
receivable, net
|
$ | 15,349 | $ | 18,005 | ||||
Inventory
|
12,126 | 417,735 | ||||||
Current
assets associated with discontinued operations
|
27,475 | 435,740 | ||||||
Property
and equipment, net of accumulated depreciation
|
— | 43,545 | ||||||
Patents
and trademarks, net of accumulated amortization
|
— | 1,367,412 | ||||||
Other
assets associated with discontinued operations
|
— | 1,410,957 | ||||||
Assets
associated with discontinued operations
|
$ | 27,475 | $ | 1,846,697 | ||||
Accounts
payable
|
$ | 5,400 | $ | 5,400 | ||||
Accrued
expenses
|
13,343 | 16,880 | ||||||
Liabilities
associated with discontinued operations
|
$ | 18,743 | $ | 22,280 |
Balance at
December
31,
2009
|
Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
|
Significant
Other
Observable
Inputs
(Level 2)
|
Significant
Unobservable
Inputs
(Level 3)
|
Total Gains
(Losses)
|
||||||||||||||||
Property
and equipment, net
|
$ | — | $ | — | $ | — | $ | — | $ | (29,507 | ) | |||||||||
Patents
and trademarks, net
|
— | — | — | — | (1,254,509 | ) | ||||||||||||||
Total
non-financial assets related to discontinued operations
|
$ | — | $ | — | $ | — | $ | — | $ | (1,284,016 | ) |
Years Ended
December 31,
|
||||||||
2009
|
2008
|
|||||||
Net
sales
|
$ | 129,128 | $ | 296,769 | ||||
Cost
of goods sold
|
50,844 | 164,734 | ||||||
Gross
profit
|
78,284 | 132,035 | ||||||
Operating
expenses:
|
||||||||
Research
and development
|
38,374 | 219,148 | ||||||
Selling,
general and administrative
|
216,318 | 447,192 | ||||||
Total
operating expenses
|
254,692 | 666,340 | ||||||
Other
income (expense)
|
2 | (18 | ) | |||||
Loss
from discontinued operations
|
$ | (176,406 | ) | $ | (534,323 | ) |
3.
|
Fair
Value Hierarchy
|
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 |
Assets and Liabilities Measured at Fair Value on a Recurring Basis as of December 31, 2008
|
||||||||||||||||
Quoted Prices
in Active
Markets for
Identical
Assets and
Liabilities
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs
|
Balance as of
December 31,
|
|||||||||||||
Description
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
2008
|
||||||||||||
Assets:
|
||||||||||||||||
Available-for-sale
securities
|
$ | 495,383 | $ | — | $ | — | $ | 495,383 | ||||||||
Liabilities:
|
||||||||||||||||
Derivative
liabilities related to conversion and put options
|
$ | — | $ | — | $ | 853,831 | $ | 853,831 |
Year Ended December 31, 2009
|
||||||||||||||||||||
Description
|
Balance at
December
31,
2008
|
Adoption of
New
Accounting
Standard
(See
Note 9)
|
Unrealized
Losses
|
Transfers In
and/or (Out)
|
Balance at
December
31,
2009
|
|||||||||||||||
Liabilities:
|
||||||||||||||||||||
Derivative
liabilities related to conversion and put options
|
$ | 853,831 | $ | 5,304,487 | $ | 7,596,329 | $ | (12,788,647 | ) | $ | 966,000 |
Year Ended December 31, 2008
|
||||||||||||||||||||
Description
|
Balance at
December
31,
2007
|
Issuance of
Put Options
Related to
the Montaur
Notes and
Preferred
Stock
|
Unrealized
Losses
|
Transfers In
and/or (Out)
|
Balance at
December
31,
2008
|
|||||||||||||||
Liabilities:
|
||||||||||||||||||||
Derivative
liabilities related to conversion and put options
|
$ | 1,599,072 | $ | 473,968 | $ | 180,727 | $ | (1,399,936 | ) | $ | 853,831 |
4.
|
Earnings
Per Share
|
Year Ended
December 31, 2009
|
Year Ended
December 31, 2008
|
|||||||||||||||
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
Basic
Earnings
Per Share
|
Diluted
Earnings
Per Share
|
|||||||||||||
Outstanding
shares
|
80,936,711 | 80,936,711 | 70,862,641 | 70,862,641 | ||||||||||||
Effect
of weighting changes in outstanding shares
|
(5,445,840 | ) | (1,795,469 | ) | (1,795,469 | ) | (1,795,469 | ) | ||||||||
Unvested
restricted stock
|
(1,719,000 | ) | (1,719,000 | ) | (473,000 | ) | (473,000 | ) | ||||||||
Adjusted
shares
|
73,771,871 | 73,771,871 | 68,594,172 | 68,594,172 |
5.
|
Accounts
Receivable and Concentrations of Credit
Risk
|
2009
|
2008
|
|||||||
Trade
|
$ | 1,321,687 | $ | 1,585,709 | ||||
Other
|
10,221 | 40,356 | ||||||
$ | 1,331,908 | $ | 1,626,065 |
6.
|
Accrued
Liabilities and Other
|
2009
|
2008
|
|||||||
Contracted
services and other
|
$ | 549,840 | $ | 584,004 | ||||
Compensation
|
259,859 | 220,487 | ||||||
Warranty
reserve
|
61,400 | 62,261 | ||||||
Interest
and dividends
|
168,333 | 18,000 | ||||||
Inventory
purchases
|
8,872 | 16,044 | ||||||
$ | 1,048,304 | $ | 900,796 |
7.
|
Product
Warranty
|
2009
|
2008
|
|||||||
Warranty
reserve at beginning of year
|
$ | 62,261 | $ | 104,365 | ||||
Provision
for warranty claims and changes in reserve for warranties
|
98,894 | 32,194 | ||||||
Payments
charged against the reserve
|
(99,755 | ) | (74,298 | ) | ||||
Warranty
reserve at end of year
|
$ | 61,400 | $ | 62,261 |
8.
|
Convertible
Securities
|
9.
|
Derivative
Instruments
|
December 31,
2008
|
Impact of
New
Accounting
Standard
Adoption
|
January 1,
2009
|
||||||||||
Other
assets
|
$ | 594,449 | $ | 2,104 | $ | 596,553 | ||||||
Total
assets
|
$ | 9,619,450 | $ | 9,621,554 | ||||||||
Notes
payable to investors, net of discounts
|
$ | 4,998,851 | (54,396 | ) | $ | 4,944,455 | ||||||
Derivative
liabilities
|
853,831 | 13,017,540 | 13,871,371 | |||||||||
Total
liabilities
|
$ | 9,645,175 | $ | 22,608,319 | ||||||||
Additional
paid-in capital
|
$ | 145,742,044 | (8,948,089 | ) | $ | 136,793,955 | ||||||
Accumulated
deficit
|
(148,840,015 | ) | (4,012,951 | ) | (152,852,966 | ) | ||||||
Total
stockholders’ deficit
|
$ | (3,025,725 | ) | $ | (15,986,765 | ) |
10.
|
Income
Taxes
|
As
of December 31,
|
||||||||
2009
|
2008
|
|||||||
Deferred
tax assets:
|
||||||||
Federal
net operating loss carryforwards
|
$ | 27,513,699 | $ | 30,071,041 | ||||
State
net operating loss carryforwards
|
— | 1,945,601 | ||||||
R&D
credit carryforwards
|
5,067,722 | 4,781,584 | ||||||
Temporary
differences
|
1,617,390 | 979,828 | ||||||
Deferred
tax assets before valuation allowance
|
34,198,811 | 37,778,054 | ||||||
Valuation
allowance
|
(34,198,811 | ) | (37,778,054 | ) | ||||
Net
deferred tax assets
|
$ | — | $ | — |
Years
Ended December 31,
|
||||||||||||||||
2009
|
2008
|
|||||||||||||||
Amount
|
%
|
Amount
|
%
|
|||||||||||||
Benefit
at statutory rate
|
$ | (13,465,945 | ) | (34.0 | %) | $ | (1,756,517 | ) | (34.0 | %) | ||||||
Adjustments
to valuation allowance
|
7,816,084 | 19.7 | % | 1,582,238 | 30.6 | % | ||||||||||
Loss
on extinguishment of debt
|
5,343,694 | 13.5 | % | -- | -- | |||||||||||
Other
|
306,167 | 0.8 | % | 174,279 | 3.4 | % | ||||||||||
Benefit
per financial statements
|
$ | -- | $ | -- |
11.
|
Equity
|
|
a.
|
Stock
Warrants: At December 31, 2009, 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 per share of
$0.48.
|
Exercise
Price
|
Number of
Warrants
|
Expiration Date
|
|||||||
Series
V
|
$ | 0.31 | 500,000 |
July
2012
|
|||||
Series
V
|
0.32 | 450,000 |
December
2012
|
||||||
Series
W
|
0.32 | 6,000,000 |
December
2012
|
||||||
Series
X
|
0.46 | 8,333,333 |
April
2013
|
||||||
Series
Z
|
0.70 | 60,000 |
August
2013
|
||||||
Series
Z
|
0.85 | 60,000 |
August
2013
|
||||||
Series
AA
|
0.97 | 2,400,000 |
July
2014
|
||||||
$ | 0.48 | 17,803,333 |
b.
|
Common Stock Purchase
Agreement: In December 2006, we entered into a Common Stock
Purchase Agreement with Fusion Capital, an Illinois limited liability
company, to sell $6.0 million of our common stock to Fusion Capital over a
24-month period which ended on November 21, 2008. Through November 21,
2008, we sold to Fusion Capital under the agreement 7,568,671 shares for
proceeds of $1.9 million. In December 2008, we entered into the First
Amendment to the Common Stock Purchase Agreement (the First Amendment)
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. As of December 31,
2009, the remaining aggregate amount of our common stock we can sell to
Fusion Capital is $10.1 million.
|
|
c.
|
Common Stock
Reserved: As of December 31, 2009, we have reserved
58,840,844 shares of authorized common stock for the exercise of all
outstanding options, warrants, convertible debt, and convertible preferred
stock.
|
12.
|
Segments
and Subsidiary Information
|
|
a.
|
Segments: We
report information about our operating segments using the “management
approach” in accordance with current accounting standards. This
information is based on the way management organizes and reports the
segments within the enterprise for making operating decisions and
assessing performance. Our reportable segments are identified
based on differences in products, services and markets
served. There were no inter-segment sales. We own or
have rights to intellectual property involving two primary types of
medical device products, including oncology instruments currently used
primarily in the application of sentinel lymph node biopsy, and blood flow
measurement devices. We also own or have rights to intellectual
property related to several drug and therapy
products.
|
($ amounts in thousands)
2009
|
Gamma
Detection
Devices
|
Blood
Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales:
|
||||||||||||||||||||
United
States1
|
$ | 8,946 | $ | — | $ | — | $ | — | $ | 8,946 | ||||||||||
International
|
472 | — | — | — | 472 | |||||||||||||||
License
and other revenue
|
100 | — | — | — | 100 | |||||||||||||||
Research
and development expenses
|
1,074 | — | 3,894 | — | 4,968 | |||||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
134 | — | — | 2,900 | 3,034 | |||||||||||||||
Depreciation
and amortization
|
142 | — | 4 | 60 | 206 | |||||||||||||||
Income
(loss) from operations3
|
5,033 | — | (3,898 | ) | (2,960 | ) | (1,825 | ) | ||||||||||||
Other
income (expense)4
|
— | — | — | (35,891 | ) | (35,891 | ) | |||||||||||||
Income
(loss) from continuing operations
|
5,033 | — | (3,898 | ) | (38,851 | ) | (37,716 | ) | ||||||||||||
Loss
from discontinued operations
|
— | (1,890 | ) | — | — | (1,890 | ) | |||||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||||||
United
States operations
|
2,199 | — | 554 | 6,238 | 8,991 | |||||||||||||||
Discontinued
operations
|
— | 27 | — | — | 27 | |||||||||||||||
Capital
expenditures
|
16 | — | — | 80 | 96 |
($ amounts in thousands)
2008
|
Gamma
Detection
Devices
|
Blood
Flow
Devices
|
Drug and
Therapy
Products
|
Corporate
|
Total
|
|||||||||||||||
Net
sales
|
||||||||||||||||||||
United
States1
|
$ | 7,423 | $ | — | $ | — | $ | — | $ | 7,423 | ||||||||||
International
|
167 | — | — | — | 167 | |||||||||||||||
Research
and development expenses
|
948 | — | 3,338 | — | 4,286 | |||||||||||||||
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
17 | — | — | 2,780 | 2,797 | |||||||||||||||
Depreciation
and amortization
|
120 | — | 2 | 46 | 168 | |||||||||||||||
Income
(loss) from operations3
|
3,658 | — | (3,340 | ) | (2,826 | ) | (2,508 | ) | ||||||||||||
Other
income (expense)
4
|
— | — | — | (2,124 | ) | (2,124 | ) | |||||||||||||
Income
(loss) from continuing operations
|
3,658 | — | (3,340 | ) | (4,950 | ) | (4,632 | ) | ||||||||||||
Loss
from discontinued operations
|
— | (534 | ) | — | — | (534 | ) | |||||||||||||
Total
assets, net of depreciation and amortization:
|
||||||||||||||||||||
United
States operations
|
2,410 | — | 25 | 5,337 | 7,772 | |||||||||||||||
Discontinued
operations
|
— | 1,847 | — | — | 1,847 | |||||||||||||||
Capital
expenditures
|
9 | — | 18 | 89 | 116 |
b.
|
Subsidiary: In December
2001, we acquired 100 percent of the outstanding common shares of
Cardiosonix, an Israeli company. In August 2009, the Company’s Board of
Directors decided to discontinue operations of Cardiosonix and to attempt
to divest our Cardiosonix subsidiary. This decision was based on the
determination that the blood flow measurement device segment was no longer
considered a strategic initiative to the Company, due in large part to
positive events in our other development initiatives. Our consolidated
balance sheets and statements of operations have been restated for all
prior periods presented to reflect Cardiosonix as a discontinued
operation. Cash flows associated with the operation of Cardiosonix have
been combined within operating, investing and financing cash flows, as
appropriate, in our consolidated statements of cash flows. See Note
2.
|
13.
|
Agreements
|
a.
|
Supply Agreements: In February
2004, we entered into a product supply agreement with TriVirix
International (TriVirix) for the manufacture of certain of our medical
device products. The term of this agreement expired in February 2009, but
was automatically extended through February 2010, and may continue to be
automatically extended for successive one-year periods. Either party has
the right to terminate the agreement at any time upon 180 days prior
written notice, or may terminate the agreement upon a material breach or
repeated non-material breaches by the other. Total purchases under the
product supply agreement were $1.5 million for the years ended December
31, 2009 and 2008. As of December 31, 2009, we have issued purchase orders
under the agreement with TriVirix for $1.3 million of our products for
delivery through December 2010.
|
b.
|
Marketing and Distribution
Agreement: During 1999, we entered into a distribution agreement
with EES covering our gamma detection devices used in surgical radiation
detection. The initial five-year term expired December 31, 2004, with
options to extend for two successive two-year terms. In March 2006, EES
exercised its option for a second two-year term extension of the
distribution agreement covering our gamma detection devices, thus
extending the distribution agreement through the end of 2008. In December
2007, Neoprobe and EES executed an amendment to the distribution agreement
which extended the agreement through the end of 2013. Under the agreement,
we manufacture and sell our current line of gamma detection device
products exclusively to EES, who distributes the products globally, except
in Japan. EES agreed to purchase minimum quantities of our products over
the first three years of the term of the agreement and to reimburse us for
certain research and development costs and a portion of our warranty
costs. We are obligated to continue certain product maintenance activities
and to provide ongoing regulatory support for the
products.
|
c.
|
Research and Development
Agreements: Cardiosonix’s research and development efforts have
been partially financed through grants from the Office of the Chief
Scientist of the Israeli Ministry of Industry and Trade (the OCS). Through
the end of 2004, Cardiosonix received a total of $775,000 in grants from
the OCS. In return for the OCS’s participation, Cardiosonix is committed
to pay royalties to the Israeli Government at a rate of 3% to 5% of the
sales if its products, if any, up to 300% of the total grants received,
depending on the portion of manufacturing activity that takes place in
Israel. There are no future performance obligations related to the grants
received from the OCS. We do not believe we will be obligated to pay the
OCS any amounts greater than any royalties due on future sales in the
event that future sales are not sufficient to generate adequate revenue to
completely cover the full amount of the grant. However, under certain
limited circumstances, the OCS may withdraw its approval of a research
program or amend the terms of its approval. Upon withdrawal of approval,
Cardiosonix may be required to refund the grant, in whole or in part, with
or without interest, as the OCS determines. In January 2006, the OCS
consented to the transfer of manufacturing as long as we comply with the
terms of the OCS statutes under Israeli law. As long as we maintain at
least 10% Israeli content in our blood flow devices, we will pay a royalty
rate of 4% on sales of applicable blood flow devices and must repay the
OCS a total of $1.2 million in royalties. However, should the amount of
Israeli content of our blood flow device products decrease below 10%, the
royalty rate could increase to 5% and the total royalty payments due could
increase to $2.3 million. As such, the total amount we will have to repay
the OCS will likely be 150% to 300% of the amounts of the original grants.
Through December 2009, we have paid the OCS a total of $76,000 in
royalties related to sales of products developed under this program. As of
December 31, 2009, we have accrued obligations for royalties totaling
$2,000.
|
d.
|
Employment Agreements:
We maintain employment agreements with six of our officers. The
employment agreements contain change in control provisions that would
entitle each of the officers to 1 to 2.5 times their current annual
salaries, vest outstanding restricted stock and options to purchase common
stock, and continue certain benefits if there is a change in control of
the Company (as defined) and their employment terminates. As of December
31, 2009, our maximum contingent liability under these agreements in such
an event is approximately $2.4 million. The employment agreements also
provide for severance, disability and death benefits. See Note
18(b).
|
14.
|
Leases
|
Capital
Leases
|
Operating
Leases
|
|||||||
2010
|
$ | 14,797 | $ | 101,285 | ||||
2011
|
10,848 | 104,105 | ||||||
2012
|
6,900 | 106,925 | ||||||
2013
|
6,325 | 8,930 | ||||||
38,870 | $ | 321,245 | ||||||
Less
amount representing interest
|
7,693 | |||||||
Present
value of net minimum lease payments
|
31,177 | |||||||
Less
current portion
|
11,265 | |||||||
Capital
lease obligations, excluding current portion
|
$ | 19,912 |
15.
|
Employee
Benefit Plan
|
16.
|
Supplemental
Disclosure for Statements of Cash
Flows
|
17.
|
Contingencies
|
18.
|
Subsequent
Events
|
a.
|
Common Stock Purchase
Agreement: In March 2010, we sold to Fusion Capital 540,541 shares
for proceeds of $1.0 million under the amended Common Stock Purchase
Agreement. We also issued an additional 120,000 shares of our common stock
to Fusion Capital as an additional commitment fee related to this
transaction. Subsequent to this sale, the remaining aggregate amount of
our common stock we can sell to Fusion Capital is $9.1 million. See Note
11(b).
|
b.
|
Employment Agreements:
During January 2010, we entered into a new 3-year employment agreement
with David C. Bupp, our President and CEO. The new agreement has
substantially similar terms to Mr. Bupp’s previous agreement. During
February 2010, we entered into a new 10.5-month employment agreement with
one of our officers. The new agreement has substantially similar terms to
the officer’s previous agreement. See Note
13(d).
|
19.
|
Supplemental
Information (Unaudited)
|
(Amounts
in thousands, except per share data)
|
Years
Ended December 31,
|
|||||||||||||||||||
2009
|
2008
|
2007
|
2006
|
2005
|
||||||||||||||||
Statement
of Operations Data:
|
||||||||||||||||||||
Net
sales
|
$ | 9,418 | $ | 7,418 | $ | 6,773 | $ | 5,445 | $ | 5,579 | ||||||||||
License
and other revenue
|
100 | 172 | — | — | — | |||||||||||||||
Gross
profit
|
6,383 | 4,744 | 3,872 | 3,291 | 3,356 | |||||||||||||||
Research
and development expenses
|
4,968 | 4,286 | 2,506 | 3,095 | 2,618 | |||||||||||||||
Selling,
general and administrative expenses
|
3,240 | 2,965 | 2,380 | 2,467 | 2,442 | |||||||||||||||
Loss
from operations
|
(1,825 | ) | (2,508 | ) | (1,015 | ) | (2,270 | ) | (1,704 | ) | ||||||||||
Other
expenses, net
|
(35,891 | ) | (2,124 | ) | (3,325 | ) | (1,283 | ) | (1,278 | ) | ||||||||||
Loss
from continuing operations
|
(37,715 | ) | (4,632 | ) | (4,340 | ) | (3,553 | ) | (2,982 | ) | ||||||||||
Discontinued
operations
|
(1,890 | ) | (534 | ) | (748 | ) | (1,188 | ) | (1,947 | ) | ||||||||||
Net
loss
|
(39,606 | ) | (5,166 | ) | (5,088 | ) | (4,741 | ) | (4,929 | ) | ||||||||||
Preferred
stock dividends
|
(240 | ) | — | — | — | — | ||||||||||||||
Loss
attributable to common stockholders
|
$ | (39,606 | ) | $ | (5,166 | ) | $ | (5,088 | ) | $ | (4,741 | ) | $ | (4,929 | ) | |||||
Loss
per common share (basic and diluted):
|
||||||||||||||||||||
Continuing
operations
|
$ | (0.51 | ) | $ | (0.07 | ) | $ | (0.07 | ) | $ | (0.06 | ) | $ | (0.05 | ) | |||||
Discontinued
operations
|
$ | (0.03 | ) | $ | (0.01 | ) | $ | (0.01 | ) | $ | (0.02 | ) | $ | (0.03 | ) | |||||
Loss
attributable to common stockholders
|
$ | (0.54 | ) | $ | (0.08 | ) | $ | (0.08 | ) | $ | (0.08 | ) | $ | (0.08 | ) | |||||
Shares used in
computing loss per common share: (1)
|
||||||||||||||||||||
Basic
|
73,772 | 68,594 | 62,921 | 58,587 | 58,434 | |||||||||||||||
Diluted
|
73,772 | 68,594 | 62,921 | 58,587 | 58,434 |
As of December 31,
|
||||||||||||||||||||
2009
|
2008
|
2007
|
2006
|
2005
|
||||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||||||
Total
assets
|
$ | 9,018 | $ | 9,619 | $ | 7,063 | $ | 8,034 | $ | 11,570 | ||||||||||
Long-term
obligations
|
13,485 | 7,323 | 8,836 | 4,922 | 6,052 | |||||||||||||||
Accumulated
deficit
|
(192,699 | ) | (148,840 | ) | (140,777 | ) | (135,688 | ) | (130,947 | ) |
|
(1)
|
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. See Note
4.
|