Unassociated Document
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
x
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ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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For the
fiscal year ended December 31,
2008
¨
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
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For the
transition period from to to
Commission
file number 0-26520
NEOPROBE
CORPORATION
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(Exact
name of registrant as specified in its
charter)
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Delaware
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31-1080091
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(State
or other jurisdiction of incorporation or organization)
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(I.R.S.
Employer Identification No.)
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425
Metro Place North, Suite 300, Dublin, Ohio
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43017-1367
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant's
telephone number, including area code (614)
793-7500
Securities
registered pursuant to Section 12(b) of the Act: None
Securities
registered pursuant to Section 12(g) of the Act:
Common
Stock, par value $.001 per share
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(Title
of Class)
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Indicate
by check mark whether the registrant is a well-known seasoned issuer, as defined
in Rule 405 of the Securities Act. Yes ¨
No x
Indicate
by check mark whether the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. Yes ¨
No x
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes x
No ¨
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not
be contained, to the best of registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K. Yes x
No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the
definitions of “large accelerated filer” and “smaller reporting company” in Rule
12b-2 of the Exchange Act.
|
Large
accelerated filer ¨
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Accelerated
filer ¨
|
|
Non-accelerated
filer ¨
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Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12-b-2 of the Act.) Yes ¨
No x
The
aggregate market value of shares of common stock held by non-affiliates of the
registrant on June 30, 2008 was $46,998,239.
The
number of shares of common stock outstanding on March 16, 2009 was
71,636,707.
DOCUMENTS
INCORPORATED BY REFERENCE
None.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
report contains forward-looking statements within the meaning of Section 27A of
the Securities Act and Section 21E of the Exchange Act. We have based
these forward-looking statements largely on our current expectations and
projections about future events and financial trends affecting the financial
condition of our business. These forward-looking statements are
subject to a number of risks, uncertainties and assumptions, including, among
other things:
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general
economic and business conditions, both nationally and in our
markets,
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our
history of losses, negative net worth and uncertainty of future
profitability;
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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
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other
risk factors set forth under “Risk Factors” in this
report.
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In
addition, in this report, we use words such as “anticipate,” “believe,” “plan,”
“expect,” “future,” “intend,” and similar expressions to identify
forward-looking statements.
We
undertake no obligation to update publicly or revise any forward-looking
statements, whether as a result of new information, future events or otherwise
after the date of this report. In light of these risks and
uncertainties, the forward-looking events and circumstances discussed in this
report may not occur and actual results could differ materially from those
anticipated or implied in the forward-looking statements.
PART
I
Item
1. Business
Development
of the Business
Neoprobe
Corporation (Neoprobe, the company or we) is a biomedical company that develops
and commercializes innovative products that enhance patient care and improve
patient outcome by meeting the critical intraoperative diagnostic information
needs of physicians and therapeutic treatment needs of patients. We
were originally incorporated in Ohio in 1983 and reincorporated in Delaware in
1988. Our executive offices are located at 425 Metro Place North,
Suite 300, Dublin, Ohio 43017. Our telephone number is (614)
793-7500.
From our
inception through 1998, we devoted substantially all of our efforts and
resources to the research and clinical development of radiopharmaceutical and
medical device technologies related to the intraoperative diagnosis and
treatment of cancers, including our proprietary radioimmunoguided surgery (RIGS®)
technology. In 1998, U.S. and European regulatory agencies completed
an evaluation of the status of the regulatory pathway for our RIGS products, which coupled
with our limited financial resources at the time, caused us to suspend our
radiopharmaceutical development activities and refocus our operating strategy on
our medical device business. After achieving profitability in the
fourth quarter of 1999 following this retrenchment, we expanded our medical
device offerings in 2002 following the acquisition of an Israeli company that
was developing a line of blood flow measurement devices.
Although
we had expanded our strategic focus with the addition of medical devices outside
the oncology field, we continued to look for other avenues to reinvigorate our
radiopharmaceutical development portfolio. During 2004, our efforts
resulted in a number of positive events that caused us to take steps to
re-activate our radiopharmaceutical and therapeutic initiatives. As a
result of our efforts over the past few years, we now have one
radiopharmaceutical product, Lymphoseek®, in the
final stages of completion of one pivotal Phase 3 clinical trial and on the
verge of commencing another pivotal Phase 3 clinical trial. Our
activity related to our second radiopharmaceutical product, RIGScan® CR,
increased significantly during 2008 as we sought and received formal scientific
advice on our regulatory and clinical pathways from the European Medicinal
Evaluation Agency (EMEA) and are taking steps to obtain similar feedback from
the U.S. Food and Drug Administration (FDA). Our subsidiary, Cira
Biosciences, Inc. (Cira Bio), also took steps in early 2008 to identify funding
sources to assist it in evaluating the market opportunities for yet another
technology platform, activated cellular therapy (ACT); however, such steps have
been unsuccessful to date.
We
believe that our virtual business model is unique within our industry as we
combine revenue generation from medical devices covering our public company
overhead while we devote capital raised through financing efforts to the
development of products such as Lymphoseek which possess even
greater potential for shareholder return. In addition, we have sought
to maintain a development pipeline with additional longer-term return potential
such as RIGScan CR and
ACT that provide the opportunity for incremental return on the achievement of
key development and funding milestones.
Our
Technology
Gamma
Detection Devices
Through
2008, our line of gamma radiation detection devices has generated substantially
all of our revenue. Our gamma detection systems are used by surgeons
in the diagnosis and treatment of cancer and related diseases. Our
currently-marketed line of gamma detection devices has been cleared by FDA and
other international regulatory agencies for marketing and commercial
distribution throughout most major global markets.
Our
patented gamma detection device systems consist of hand-held detector probes and
a control unit. The critical detection component is a highly
radiosensitive crystal contained in the tip of the probe that relays a signal
through a preamplifier to the control unit to produce both a digital readout and
an audible signal. The detector element fits into a housing
approximately the size of a pen flashlight. The neoprobe® GDS gamma detection system,
originally released in 1998 under the name neo2000®,
is the fourth generation of our gamma detection products. The neoprobe GDS is designed as a
platform for future growth of our instrument business. The neoprobe GDS is software
upgradeable and is designed to support future surgical targeting probes without
the necessity of costly remanufacture. Since 1998, we have developed
and released four major software upgrades for customer units designed to improve
the utility of the system and/or offer the users additional features, including
our most recent release that enables our entire installed base of neoprobe GDS users to use our
wireless gamma detection probes based on Bluetooth® wireless
technology that have been commercially launched over the last few
years. Generally, these software upgrades have been included in new
units offered for sale but have also been offered for sale
separately.
Surgeons
are using our gamma detection devices in a surgical application referred to as
sentinel lymph node biopsy (SLNB) or intraoperative lymphatic mapping (ILM or
lymphatic mapping). SLNB helps trace the lymphatic drainage patterns
in a cancer patient to evaluate potential tumor drainage and cancer spread in
lymphatic tissue. The technique does not detect cancer; rather it
helps surgeons identify the lymph node(s) to which a tumor is likely to drain
and spread. The lymph node(s), sometimes referred to as the
"sentinel" node(s), may provide critical information about the stage of a
patient’s disease. SLNB begins when a patient is injected at the site
of the main tumor with a commercially available radioactive tracing
agent. The agent is intended to follow the same lymphatic flow as the
cancer would have if it had metastasized. The surgeon may then track
the agent's path with a hand-held gamma radiation detection probe, thus
following the potential avenues of metastases and identifying lymph nodes to be
biopsied for evaluation and determination of cancer spread.
The
application of SLNB to solid tumor cancer treatment has been most widely
developed in the breast cancer and melanoma indications. Numerous
clinical studies, involving a total of nearly 2,000 patients and published in
peer-reviewed medical journals as far back as Oncology (January 1999) and
The Journal of The American
College of Surgeons (December 2000), have indicated SLNB is approximately
97% accurate in predicting the presence or absence of disease spread in melanoma
and breast cancers. Consequently, it is estimated that more than 80%
of breast cancer patients who would otherwise have undergone full axillary lymph
node dissections (ALND), involving the removal of as many as 20 - 30 lymph
nodes, might be spared this radical surgical procedure if the sentinel node was
found to be free of cancer. Surgeons practicing SLNB have found that
our gamma detection probes are well-suited to the procedure.
Hundreds
of articles have been published in recent years in peer-reviewed journals on the
topic of SLNB. Furthermore, a number of thought leaders and cancer
treatment institutions have recognized and embraced the technology as standard
of care for melanoma and for breast cancer. Our marketing partner
continues to see strong sales, especially for use in breast cancer
treatment. SLNB in breast cancer has been the subject of national and
international clinical trials, including one major study sponsored by the U.S.
Department of Defense and the National Cancer Institute (NCI) and one sponsored
by the American College of Surgeons. The first of these trials
completed accrual approximately three years ago. While we are not
aware of the exact timing of publication or presentation of results from these
trials, it is possible that such data may be available later this
year. Accrual on the second trial was halted early (in 2007), due, we
believe, to the overwhelming desire of patients to be treated with SLNB rather
than be randomized in a trial whereby they might receive a full axillary
dissection. We believe that once data from these trials are widely
published, there may be an additional demand for our devices from those surgeons
who have not yet adopted the SLNB procedure. We also believe, based
on an estimate of the total number of operating rooms in medical centers that
are capable of performing the types of procedures in which our gamma detection
devices are used, that while we are potentially reaching saturation at the major
cancer centers and teaching institutions, a significant portion of the global
market for gamma detection devices such as ours remains untapped. We
also believe we are beginning to see the development of a replacement device
market in the gamma detection device sector, aided in part by new offerings such
as our wireless probes, as devices purchased over ten years ago during the early
years of lymphatic mapping begin to be retired. However, the impact
of current economic conditions on our business is uncertain at this
time.
Although
lymphatic mapping has found its greatest acceptance thus far in breast cancer
and melanoma, we believe that Lymphoseek may be instrumental
in extending SLNB into other solid tumor cancers in which surgeons are currently
investigating such as prostate, gastric, colon, head and neck, and non-small
cell lung cancers. Investigations in these other cancer types have
thus far met with mixed levels of success; however, we believe our development
of Lymphoseek may
positively impact the effectiveness of SLNB in such
indications. Surgeons have also been using our devices for other
gamma-guided surgery applications, such as evaluating the thyroid function and
conducting parathyroid surgery, and in determining the state of disease in
patients with vulvar and penile cancers. Expanding the application of
SLNB beyond the current primary uses in the treatment of breast cancer and
melanoma is a primary focus of our strategy regarding our gamma-guided surgery
products and is consistent with our Phase 3 Lymphoseek clinical trial
strategy. To support that expansion, we continue to work with our
marketing and distribution partners to develop additional software-based
enhancements to the neoprobe
GDS platform as well as the wireless probes that were introduced over the
last few years and the new high energy probe we launched at the recent Society
of Surgical Oncology (SSO) 62nd Annual
Cancer Symposium.
Blood
Flow Measurement Devices
Accurate
blood flow measurement is essential for a variety of clinical needs,
including:
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intra-operative
quantification;
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non-invasive
diagnostics; and
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evaluation
of cardiac function.
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Blood
flow velocity measurements are often confused with volume blood
flow. These two variables, however, are normally different parameters
that respond differently to pathological conditions and provide different
data. Blood flow velocity is used primarily for determining the
existence of a stenosis (narrowing or obstruction) in the vascular surgery
setting, while the applications of blood flow volume have potential impact
across a much broader range of medical disciplines.
Our
wholly-owned subsidiary, Cardiosonix Ltd. (Cardiosonix) has developed and is
commercializing the Quantix product line that
employs a unique and proprietary technology for measurement of blood flow
volume, velocity and several other hemodynamic parameters, permitting the
real-time assessment of conduit hemodynamic status.
The Quantix technology utilizes a
special application of the Doppler method through simultaneous projection of a
combination of narrow beams with a known angle between them. Thus,
based on trigonometric and Doppler considerations, the angle of insonation can
be obtained, resulting in accurate, angle-independent blood flow velocity
measurements that do not require the use of complicated, expensive imaging
systems. In order to obtain high-resolution velocity profiles, the
Quantix device uses a
multi-gated pulse wave Doppler beam. With this method, specific
sample volumes along the ultrasound beam can be separately evaluated, and the
application of a flow/no flow criterion can be made. The Cardiosonix
technology applies a special use of digital Doppler technology, which with the
digital signal processing power of the system allows hundreds of sample volumes
to be sampled and processed simultaneously, thus providing high resolution
velocity profiles for both angle and vascular diameter calculations, and
subsequently volume blood flow measurements. Through 2008, we have
focused our blood flow measurement efforts primarily on measuring blood flow in
cardiac bypass grafts and have performed some preliminary investigations of
application of the technology for use in vascular assessment, particularly
associated with dialysis applications. Thus far, our efforts have met
with limited success.
Quantix/ORTM is
designed to permit cardiovascular surgeons to obtain intraoperative volume blood
flow readings in various targeted blood vessels within seconds. The
system consists of an insonation angle-independent ultrasound probe and digital
numerical displays of blood flow rate. Thus, the surgeon obtains
immediate, real-time and quantitative readings while focused on the target
vessel. Quantifying blood flow can be very beneficial during
anastomostic or other bypass graft procedures to determine adequate blood
flow. While measurement is advisable whenever a blood vessel is
exposed and manipulated intra-operatively, generally this is not the current
practice.
Ultimately,
in practice, the surgeon typically resorts to using his or her eyes and fingers
in a process called finger palpation to qualitatively assess vessel
flow. The Quantix/OR offers the surgeon
immediate and simple quantitative assessment of blood flow in multiple blood
vessels and grafts. The primary advantage of finger palpation is that
it is fast, simple and low cost; the disadvantages are that it requires a good
deal of experience, it is difficult to perform in vessels embedded in tissue, it
can become difficult to interpret in large vessels, and it permits only a very
qualitative and subjective assessment. A significant partial
occlusion (or even a total occlusion) will result in significant vessel
“distention” and strong pulse that may mislead the surgeon. Rather
than rely on such a subjective clinical practice, which is highly
experience-dependent, the Quantix/OR is designed to
allow the surgeon to rely on more quantifiable and objective
information. We believe that Quantix/OR represents a
measurable improvement over existing technologies to directly measure blood flow
intraoperatively. Other technologies that attempt to measure
intraoperative blood flow directly are generally more invasive and are
impractical when non-skeletonized vessel measurements are
required. As a result, a majority of surgeons generally resort to
finger palpation to qualitatively, rather than quantitatively, measure vessel
perfusion.
During
2009, we intend to continue the modest support activities we have underway to
support greater penetration of the Quantix/OR in cardiovascular
and vascular applications. However, given our limited success in
achieving market penetration to-date and the minimal support activities we are
currently devoting to the product line, we cannot assure you that any of
Cardiosonix’s products will achieve market acceptance. As a result,
we may be forced to consider other strategic alternatives. See Risk
Factors.
Lymphoseek
Our gamma
detection devices are primarily capital in nature; as such, they generate
revenue only on the initial sale. To complement the one-time revenue
stream related to capital products, we are working on developing recurring
revenue or "procedural" products that would generate revenue based on each
procedure in which they are used. The product we are developing with
the greatest near-term potential in this area is Lymphoseek, a proprietary drug
compound under exclusive worldwide license from the University of California,
San Diego (UCSD). The UCSD license grants Neoprobe the
commercialization rights to Lymphoseek for diagnostic
imaging and intraoperative detection applications. If proven
effective and cleared for commercial sale, Lymphoseek would be the first
radiopharmaceutical product specifically designed and labeled for the targeting
of sentinel lymph nodes.
Neoprobe
and UCSD completed the initial pre-clinical evaluations of Lymphoseek in
2001. Since that time, UCSD has completed or initiated five Phase 1
clinical trials involving Lymphoseek. The
status of these trials is listed below:
Indication
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Phase
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Number
of
Patients
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Status
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Breast
(peritumoral injection)
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1
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24
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Completed
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Melanoma
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1
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24
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Completed
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Breast
(intradermal injection, next day surgery)
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1
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60
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Ongoing
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Prostate
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1
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20
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Ongoing
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Colon
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1
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20
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Ongoing
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Breast
and Melanoma
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2
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80
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Completed
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Breast
and Melanoma
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3
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150*
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Completing
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Head
and Neck Squamous Cell Carcinoma (“Sentinel”)
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3
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180
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Pending
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* Patient number is approximate and is
based on an estimated average number of lymph nodes expected to be removed from
each patient. The trial size is based on extracting a total of 203
lymph nodes from the patients enrolled.
The Phase
1 studies were or are being supported, including being substantially funded
through research grants, by a number of organizations such as the Susan G. Komen
Breast Cancer Research Foundation, the American Cancer Society (ACS) and the
NCI. Research data from some of these clinical evaluations of Lymphoseek have been presented
at recent meetings of the Society of Nuclear Medicine, the SSO and the World
Sentinel Node Congress. The ongoing breast, prostate and colon
studies are being conducted under Neoprobe’s investigational new drug (IND)
application that has been cleared with FDA using drug product supplied by
Neoprobe.
In
November 2003, we met with the Interagency Council on Biomedical Imaging in
Oncology, an organization representing FDA, the NCI and the Centers for Medicare
and Medicaid Services, to discuss the regulatory approval process and to
determine the objectives for the next clinical trial involving Lymphoseek. During
2004, we prepared and submitted an IND application to FDA to support the
marketing clearance of Lymphoseek.
In early
2005, we announced that FDA had accepted our application to establish a
corporate IND for Lymphoseek. With
the transfer of the UCSD physician IND to Neoprobe, we assumed full clinical and
commercial responsibility for the development of Lymphoseek. Following
the establishment of the corporate IND, Neoprobe’s clinical and regulatory
personnel began discussions with FDA regarding the clinical development program
for Lymphoseek.
As a
“first in class” drug, Neoprobe was advised that additional non-clinical studies
needed to be completed before additional clinical testing of the drug could
occur in humans. The non-clinical testing was successfully completed
in late 2005 and the reports were filed with FDA in December
2005. The seven studies included repeat administrations of Lymphoseek at dosages
significantly in excess of the anticipated clinical dosage. None of
the non-clinical studies revealed any toxicity issues associated with the
drug.
Upon the
submission of the IND and draft Phase 2 protocol, FDA advised Neoprobe that
commercially produced Lymphoseek would need to be
used in the Phase 2 clinical study, as opposed to using drug previously
manufactured in laboratories at UCSD. Also, the regulatory agencies
raised a number of Chemistry, Manufacturing and Control (CMC) questions
regarding the drug compound and its complete
characterization. Neoprobe began the transfer of bulk drug
manufacturing to Reliable Biopharmaceutical Corporation (Reliable) early in 2005
and engaged OSO BioPharmaceuticals Manufacturing LLC (OSO Bio, formerly Cardinal
Health PTS) to develop and validate procedures and assays to establish
commercial standards for the formulation, filling and lyophilization of the drug
compound. We submitted an initial CMC response to FDA in
2006.
We
received clearance from FDA in May 2006 to move forward with patient enrollment
for a multi-center Phase 2 clinical study of Lymphoseek. The
first of our Phase 2 clinical sites received clearance from its internal
clinical review committee, or Institutional Review Board (IRB), in July
2006. The IRB clearance permitted us to finalize arrangements to
begin patient screening and enrollment activities for the Phase 2 trial, and we
began patient enrollment in September 2006 and completed enrollment of the 80
patients in June 2007. We announced positive preliminary efficacy
results from our Phase 2 Lymphoseek trial in June 2007
and final results in December 2007. Localization of Lymphoseek to lymphoid tissue
was confirmed by pathology in over 99% of the lymph node tissue samples removed
during the Phase 2 trial. We held an end of Phase 2 meeting with FDA
during late October 2007 during which the final results were
reviewed. The Phase 2 study was conducted at five of the leading
cancer centers in the U.S.: John Wayne Cancer Center; University of
California, San Francisco; MD Anderson Cancer Center; University Hospital
Cleveland (Case Western Reserve); and the University of Louisville.
Based on
discussions and correspondence with FDA, we proposed to FDA that we conduct two
separate Phase 3 studies to support an application for marketing
clearance. During 2008, we initiated patient enrollment in the first
of the two phase 3 clinical studies to be conducted in patients with either
breast cancer or melanoma. In March 2009, we announced that this
first study had reached the accrual of 203 lymph nodes, the study’s primary
accrual objective. In the previous Phase 2 multi-center study of
Lymphoseek, which was
also conducted in patients with breast cancer or melanoma, an overall
localization rate of 94% in lymph nodes was achieved in those patients where
both a vital blue dye and Lymphoseek were
used. A similar concordance rate of 94% was established by Neoprobe
and FDA as the primary efficacy objective for the Phase 3 trial,
NEO3-05. Based upon the intraoperative worksheets and preliminary
pathology reports, we believe that the primary efficacy end-point of NEO3-05 has
been achieved and no incidents related to drug safety have been reported in the
Lymphoseek
studies. Upon completion of a full analysis of the Phase 3 data, we
will provide a complete update on the study results after all clinical data has
been reviewed by our internal clinical team and external
consultants. We expect full data will be available in the 2nd quarter
of 2009.
We have
provided FDA and EMEA with the full protocol and associated materials for a
second Phase 3 study to be conducted in patients with head and neck squamous
cell carcinoma. This second Phase 3 study is designed to validate
Lymphoseek as a sentinel
lymph node targeting agent. Our discussions with FDA and EMEA have
also suggested that the Phase 3 trials will support an intended labeling for use
of Lymphoseek in
sentinel lymph node biopsy procedures. We believe such an indication
would be beneficial to the marketing and commercial adoption of Lymphoseek in the U.S. and
European Union (EU). We plan to have approximately 25 – 35
institutions, located primarily in the U.S. and EU, participate in the
trial. The trial protocol is currently under review at a number of
these institutions. We expect to receive our first IRB clearance at a
participating institution shortly and expect patient accrual to commence during
the second quarter of 2009.
Our goal
remains to file the new drug application for Lymphoseek in early 2010;
however, this will be dependent upon our ability to commence and successfully
conclude the Phase 3 clinical studies in a timely fashion. We expect
to incur approximately $4 million in out-of-pocket development costs in 2009
related to the clinical and regulatory development of Lymphoseek. Depending
on the timing and outcome of the FDA regulatory review cycle, we believe that
Lymphoseek can be
commercialized by early 2011. We cannot assure you, however, that
this product will achieve regulatory approval, or if approved, that it will
achieve market acceptance. See Risk Factors.
RIGS
From
inception until 1998, Neoprobe devoted significant efforts and resources to the
development of its proprietary RIGS
technology. The RIGS system combines a
patented hand-held gamma radiation detection probe, proprietary radiolabeled
cancer-specific targeting agents, and patented surgical methods to provide
surgeons with real-time information to locate tumor deposits not detectable by
conventional methods. The RIGS system is designed to
assist the surgeon in the more thorough removal of the cancer, thereby leading
to improved surgical treatment of the patient. The targeting agents
used in the RIGS process
are monoclonal antibodies, labeled with a radioactive isotope that emits low
energy gamma rays. The device used is a very sensitive radiation
detection instrument that is capable of detecting small amounts of radiation
bound to the targeting agent. Before surgery, a cancer patient is
injected with one of the targeting agents which circulates throughout the
patient’s body and binds specifically to cancer cell antigens or
receptors. Concentrations of the targeting agent are then located
during surgery by Neoprobe's gamma detection device, which emits an audible tone
to direct the surgeon to targeted tissue.
RIGScan CR is an
intraoperative targeting agent consisting of a radiolabeled murine monoclonal
antibody (CC49 MAb). The radiolabel used is 125I, a 27
- 35 KeV emitting isotope. The CC49 MAb was developed by the NCI and
is licensed to Neoprobe by the National Institutes of Health
(NIH). The CC49 MAb is produced from a murine cell line generated by
the fusion of splenic lymphocytes from mice immunized with tumor-associated
glycoprotein-72 (TAG-72) with non-immunoglobulin secreting P3-NS-1-Ag4 myeloma
cells. The CC49 MAb localizes or binds to TAG-72 antigen and shows a
strong reactivity with both LS-174T colon cancer extract and to a breast cancer
extract.
RIGScan CR is the biologic
component for the RIGS
system to be used in patients with colon or rectal cancer. The RIGS system was conceived to
be a diagnostic aid in the intraoperative detection of clinically occult
disease. RIGScan CR is intended to be
used in conjunction with other diagnostic methods, for the detection of the
extent and location of tumor in patients with colorectal cancer. The
detection of clinically occult tumor provides the surgeon with a more accurate
assessment of the extent of disease, and therefore may impact the surgical and
therapeutic management of the patient. Clinical trials suggest that
RIGScan CR provides
additional information outside that provided by standard diagnostic modalities
(including surgical exploration) that may aid in patient
management. Specifically, RIGScan CR, used as a
component of the RIGS
system, confirms the location of surgically suspicious metastases, evaluates the
margins of surgical resection, and detects occult tumor in perihepatic (portal
and celiac axis) lymph nodes.
Neoprobe
conducted two Phase 3 studies, NEO2-13 and NEO2-14, of RIGScan CR in the mid-1990s in
patients with primary and metastatic colorectal cancer,
respectively. Both studies were multi-institutional involving cancer
treatment institutions in the U.S., Israel, and the EU. The primary
endpoint of both studies was to demonstrate that RIGScan CR detected
pathology-confirmed disease that had not been detected by traditional
preoperative (i.e., CT Scans) or
intraoperative (i.e., surgeon’s visual observations and palpation)
means. That is, the trials were intended to show that the use of
RIGScan CR assisted the
surgeon in the detection of occult tumor. In 1996, Neoprobe submitted
applications to EMEA and FDA for marketing approval of RIGScan CR for the detection
of metastatic colorectal cancer.
Clinical
study NEO2-14, which was submitted to FDA in the RIGScan CR Biologic License
Application (BLA), enrolled 151 colorectal cancer patients with either suspected
metastatic primary colorectal disease or recurrent colorectal
disease. During FDA’s review of the BLA, 109 of the enrolled patients
were determined to be evaluable patients. Clinical study NEO2-13 was
conducted in 287 enrolled patients with primary colorectal
disease. The primary end-point for clinical study NEO2-13 was the
identification of occult tumor.
NEO2-14
was the pivotal study submitted with Neoprobe’s referenced BLA. Two
additional studies evaluating patients with either primary or metastatic
colorectal disease, NEO2-11 (a multi-center study) and NEO2-18 (a single
institution study), were included in the BLA and provided supportive proof of
concept (i.e., localization and occult tumor detection) and safety
data. A study summary report for NEO2-13 was submitted under the BLA;
however, FDA undertook no formal review of the study.
Following
review of our applications, we received requests for further information from
FDA and from the European Committee for Proprietary Medicinal Products on behalf
of EMEA. Both FDA and EMEA acknowledged that our studies met the
diagnostic endpoint of the Phase 3 clinical study, which was to provide
incremental information to the surgeon regarding the location of hidden
tumor. However, both agencies wanted to know how the finding of
additional tumor provided clinical benefit that altered patient management or
outcome for patients with metastatic colorectal cancer. In a series
of conversations with FDA, the product claims were narrowed to the
intraoperative detection of hepatic and perihepatic disease in patients with
advanced colorectal cancer and patients with recurrent colorectal
cancer.
FDA
determined during its review of the BLA that the clinical studies of RIGScan CR needed to
demonstrate clinical utility in addition to identifying additional
pathology-confirmed disease. In discussions between Neoprobe and the
agency, an FDA-driven post hoc analysis plan was developed to limit the
evaluation of RIGScan CR
to patients with hepatic and perihepatic disease with known metastasis to the
liver. Findings of occult disease and subsequent changes in patient
management (i.e., abandoning otherwise risky hepatic resections) in this limited
population would serve as a measure of patient benefit. FDA's analysis of the
patients enrolled in NEO2-14 matching the limited criteria was evaluated with a
determination to confirm the surgical resection abandonment
outcome. The number of evaluable patients in this redefined patient
population was deemed too small by the agency and the lack of pre-stated
protocol guidance precluded consistent sets of management changes given similar
occult findings. The number of evaluable patients for any measure of
clinical utility, therefore, was too small to meet relevant licensing
requirements and FDA ultimately issued a not approvable letter for the BLA on
December 22, 1997, describing certain clinical and manufacturing
deficiencies. Neoprobe withdrew its application to EMEA in November
1997.
We
developed a clinical response plan for both agencies during the first half of
1998. However, following our analysis of the regulatory pathways for
approval that existed at that time, we determined that we did not have
sufficient financial resources to conduct the additional studies requested and
sought to identify others with an interest in continuing the development
process.
In recent
years, we have obtained access to survival analyses of patients treated with
RIGScan CR which have
been prepared by third parties, indicating that RIGScan CR may be predictive
of, or actually contribute to, a positive outcome when measuring survival of the
patients that participated in our original BLA studies. The data or
its possible significance was unknown at the time of the BLA review given the
limited maturity of the follow-up experience. The data includes
publication by some of the primary investigators involved in the Phase 3 RIGS trials who have
independently conducted survival follow-up analyses to their own institution’s
RIGS trial patients with
apparently favorable results relating to the long-term survival prognosis of
patients who were treated with RIGS. In addition,
we learned that FDA has held open the BLA originally filed with FDA in
1996. Based primarily on this information, we requested a meeting
with FDA in 2004 to discuss the possible next steps for evaluating the survival
related to our previous Phase 3 clinical trials as well as the possible
submission of this data, if acceptable, as a prospective analysis in response to
questions originally asked by FDA in response to our original
BLA.
The April
2004 meeting with FDA was an important event in the re-activation of the RIGS program. The
meeting was very helpful from a number of aspects: we confirmed that the RIGS BLA remains active and
open. We believe this will improve both the cost effectiveness and
timeliness of future regulatory submissions for RIGScan
CR. Additionally, FDA preliminarily confirmed that the BLA may be
applicable to the general colorectal population; and not just the recurrent
colorectal market as applied for in 1996. Applicability to a general
colorectal population could result in a greater market potential for the product
than if applicable to just the recurrent population. During the
meeting, FDA also indicated that it would consider possible prognostic
indications for RIGScan
CR and that survival data from one of our earlier Phase 3 studies could be
supportive of a prognostic indication.
It should
be noted, however, that the RIGScan CR biologic drug has
not been produced for several years and based on the feedback we recently
received from EMEA, we would have to perform some additional work related to
ensuring the drug cell line is still viable and submit this data to EMEA and
possibly FDA for their evaluation in connection with preparations to restart
pivotal clinical trials. We have initiated discussions with
established biologic manufacturing organizations to determine the costs and
timelines associated with the production of commercial quantities of the CC49
antibody. In addition, we will need to re-establish radiolabeling
capabilities for the CC49 antibody in order to meet the regulatory needs for the
RIGScan CR
product.
In
parallel with our ongoing discussions with the regulatory authorities, we have
discussed the clinical and regulatory strategy for RIGScan CR with reimbursement
consultants who provided us with valuable input regarding the potential target
pricing for a RIGScan
product.
In
November 2005, Neoprobe submitted a corporate IND application for the modified
humanized version of RIGScan CR. With
the establishment of the corporate IND, responsibility for the clinical and
commercial development of the humanized version of RIGScan CR was officially
transferred from a physician sponsored IND to Neoprobe. Prior to the
evaluation of the modified antibody in a Phase 1 clinical trial, all clinical
development of RIGScan
CR had been conducted with a murine (i.e., mouse DNA-based) version of a
monoclonal antibody. The Phase 1 trial was the first test in human
patients using a modified version of the antibody from which the prominent parts
of the mouse DNA chain had been removed. In early 2006, we filed an
IND amendment that included a final report to FDA of the Phase 1
study.
Over the
past few years, the progress we have made in advancing our RIGScan CR development program
while incurring little in the way of research expenses. Our RIGS technology, which had
been essentially inactive since failing to gain approval following our original
license application in 1997, has been the subject of renewed interest due
primarily to the analysis of survival data related to patients who participated
in the original Phase 3 clinical studies that were completed in
1996. After a successful pre-submission meeting with EMEA in July
2008, we submitted a plan during the third quarter on how we would propose to
complete clinical development plan for RIGScan CR. The
clinical protocol we submitted to EMEA involves approximately 400 patients in a
randomized trial of patients with colorectal cancer. The participants
in the trial would be randomized to either a control or RIGS treatment
arm. Patients randomized to the RIGS arm would have their
disease status evaluated at the end of their cancer surgery to determine the
presence or absence of RIGS-positive
tissue. Patients in both randomized arms would be followed to
determine if patients with RIGS-positive status have a
lower overall survival rate and/or a higher occurrence of disease
recurrence. The hypothesis for the trial is based upon the data from
the earlier NEO2-13 and NEO2-14 trial results.
We
continue to believe it will be necessary for us to identify a development
partner or an alternative funding source in order to prepare for and fund the
pivotal clinical testing that will be necessary to gain marketing clearance for
RIGScan
CR. In the past, we have engaged in discussions with various parties
regarding such a partnership. We believe the recently clarified
regulatory pathway approved by EMEA will assist us in those
efforts. However, even if we are able to make such arrangements on
satisfactory terms, we believe that the time required for continued development,
regulatory approval and commercialization of a RIGS product would likely be a
minimum of five years before we receive any significant product-related
royalties or revenues. We cannot assure you that we will be able to
complete definitive agreements with a development partner or obtain financing to
fund development of the RIGS technology and do not
know if such arrangements could be obtained on a timely basis on terms
acceptable to us, or at all. We also cannot assure you that FDA or
EMEA will clear our RIGS
products for marketing or that any such products will be successfully introduced
or achieve market acceptance.
Activated
Cellular Therapy
Through
various research collaborations, we performed early-stage research on another
technology platform, ACT, based on work originally done in conjunction with the
RIGS
technology. ACT is intended to boost the patient’s own immune system
by removing lymph nodes identified during surgery and then, in a cell processing
technique, activating and expanding “helper” T-cells found in the
nodes. Within 10 to 14 days, the patient’s own immune cells,
activated and numbering more than 20 billion, are infused into the patient in an
attempt to trigger a more effective immune response to the cancer.
In the
course of our research into ACT performed with RIGS, we learned that these
lymph node lymphocytes containing helper T-cells could be activated and expanded
to treat patients afflicted with viral and autoimmune disease as well as
oncology patients. We have seen promising efficacy of this technology
demonstrated from six Phase 1 clinical trials covering the oncology, viral and
autoimmune applications.
In 2005,
we formed a new subsidiary, Cira Bio, to explore the development of
ACT. Neoprobe owns approximately 90% of the outstanding shares of
Cira Bio with the remaining shares being held by the principals of a private
holding company, Cira LLC. In conjunction with the
formation of Cira Bio, an amended technology license agreement also was executed
with The Ohio State University, from whom both Neoprobe and Cira LLC had
originally licensed or optioned the various cellular therapy
technologies. As a result of the cross-license agreements, Cira Bio
has the exclusive development and commercialization rights to three issued U.S.
patents that cover the oncology and autoimmune applications of its
technology. In addition, Cira Bio has exclusive licenses to several
pending patent applications.
In 2006,
Cira Bio engaged the Battelle Memorial Institute to complete a technology and
manufacturing process assessment of the cellular therapy approach. In
addition, a scientific advisory group is being formed to develop a clinical and
regulatory approach for the Cira Bio technology. Following the
completion of these assessments and the formation of a commercialization
strategy, Cira Bio intends to raise the necessary capital to move this
technology platform forward. In August 2007 we entered into a Stock
and Technology Option Agreement whereby Neoprobe gained the option to purchase
the remaining 10% of Cira Bio from Cira LLC for $250,000 in connection with the
successful completion of a financing transaction by Cira Bio. In the
first quarter of 2008, we also entered into discussions with an investment
banking firm to help us gauge the interest of potential investment in the ACT
technology. We still hope to raise funds through Cira Bio to support
the continued development of ACT; however, our fundraising efforts have thus far
not been successful and our option to purchase the remaining 10% interest in
Cira Bio expired on June 30, 2008. If we are successful in
identifying a funding source, we expect that any funding would likely be
accomplished by an investment directly into Cira Bio, so that the funds raised
would not dilute current Neoprobe shareholders. Obtaining this
funding would likely dilute Neoprobe’s ownership interest in Cira Bio; however,
we believe that moving forward such a promising technology will only yield
positive results for the Neoprobe stockholders and the patients who could
benefit from these treatments. However, we do not know if we will be
successful in obtaining funding on terms acceptable to us, or at
all. In the event we fail to obtain financing for Cira Bio, the
technology rights for the oncology applications of ACT may revert back to
Neoprobe and the technology rights for the viral and autoimmune applications may
revert back to Cira LLC upon notice by either party. See Risk
Factors.
Market
Overviews
The
medical device marketplace is a fast growing market. Medical Device & Diagnostic
Industry magazine has reported an annual medical device and diagnostic
market of as much as $75 billion in the U.S. and $169 billion
internationally.
Cancer
Market Overview
Cancer is
the second leading cause of death in the U.S. and Western Europe and has been
estimated to be responsible for over 565,000 deaths annually in 2008 in the U.S.
alone. The NIH has estimated the overall annual costs for cancer (the
primary focus of our gamma detection and pharmaceutical products) for the U.S.
for 2007 at $219.2 billion: $89.0 billion for direct medical costs, $18.2
billion for indirect morbidity, and $112.0 billion for indirect
mortality. Our line of gamma detection systems is currently used
primarily in the application of SLNB in breast cancer and melanoma which,
according to the ACS, have been estimated to account for 13% and 4%,
respectively, of new cancer cases which occurred in the U.S. in
2008.
The NIH
has estimated that breast cancer will annually affect half a million women in
North America, Western Europe, and other major economic
markets. Breast cancer is the second leading cause of death from
cancer among all women in the U.S. The incidence of breast cancer,
while starting to show minor declines in the past year or so, generally
increases with age, rising from about 100 cases per 100,000 women at age 40 to
about 400 cases per 100,000 women at age 65. While the incidence rate
for breast cancer appears to be decreasing, the overall number of new cases of
breast cancer is still increasing. According to the ACS, over 182,000
new cases of invasive breast cancer are expected to be diagnosed and
approximately 41,000 women are estimated to have died from the disease during
2008 in the U.S. alone. Thus, we believe that the significant aging
of the population, combined with improved education and awareness of breast
cancer and diagnostic methods, will continue to lead to an increased number of
breast cancer surgical diagnostic procedures.
Approximately
80% of the patients diagnosed with breast cancer undergo a lymph node dissection
(either ALND or SLNB) to determine if the disease has spread. While
many breast cancer patients are treated in large cancer centers or university
hospitals, regional and/or community hospitals continue to treat the majority of
breast cancer patients. Over 10,000 hospitals are located in the
markets targeted for our gamma detection SLNB products. We believe a
significant portion of the potential market for gamma detection devices remains
unpenetrated and that a replacement market is beginning to develop as units
placed in the early years of SLNB begin to exceed over ten years of
use. In addition, if the potential of Lymphoseek as a radioactive
tracing agent is ultimately realized, it has the potential to address not only
the current breast and melanoma markets on a procedural basis, but also to
assist in the clinical evaluation and staging of solid tumor cancers and
expanding SLNB to additional indications, such as gastric, non-small cell lung
and other solid tumor cancers.
We
estimate the total market potential for Lymphoseek, if ultimately
approved for all of these indications, could exceed $250
million. However, we cannot assure you that Lymphoseek will be cleared to
market, or if cleared to market, that it will achieve the prices or sales we
have estimated.
The ACS
has also estimated that nearly 148,000 new incidences of colon and rectal
cancers were expected to occur in the U.S. in 2008. Based on an
assumed recurrence rate of 40%, this would translate into total potential
surgical procedures of over 200,000 annually in the U.S. alone. We
believe the number of procedures in other markets of the world to be
approximately two times the estimated U.S. market. As a result, we
believe the total potential global market for RIGScan CR could be in excess
of $2 billion annually, depending on the level of reimbursement
allowed. However, we cannot assure you that RIGScan CR will be cleared to
market, or if cleared to market, that it will receive the reimbursement or
achieve the level of sales we have currently estimated.
Blood
Flow Measurement Market Overview
Cardiovascular
disease is the number one killer of men and women in the U.S. and in a majority
of countries in the rest of the world that track such statistics. The
National Center for Healthcare Services (NCHS) registered nearly 7 million
inpatient cardiovascular procedures in the U.S. during 2005 with a primary
diagnosis of cardiovascular disease. In the U.S. in 2005, the NCHS
estimates that there were 469,000 coronary artery bypass surgeries performed on
261,000 patients. We, as well as our competitors and other industry
analysts, generally estimate the rest of the world’s incidence of such
modalities at approximately equal to as much as two times U.S.
estimates.
The
American Heart Association (AHA) last year estimated the total cost of
cardiovascular diseases and stroke in the United States would exceed $448
billion in 2008. A substantial portion of these expenditures is
expected to be for non-invasive image and intravascular
examination.
Based on
data obtained from the AHA, the Society of Thoracic Surgeons and the American
Hospital Association, it is estimated that there are approximately 500,000
vascular and cardiovascular procedures performed in the U.S. that could benefit
from qualitative blood flow measurement. Based on these estimates,
information obtained from industry sources and data published by our competitors
and other medical device companies, we estimate the worldwide total of target
procedures to be approximately equal to as much as two times the U.S.
totals.
At
present, we would estimate that less than 25% of by-pass procedures involve
blood flow measurement. Industry analysts have estimated the
potential market for blood flow measurement devices will exceed $240 million
annually by 2010. However, at the present state of market development
and acceptance of blood flow measurement within the medical community, the
penetrable market is likely significantly less. Our success to date
has been limited and we cannot assure you that Cardiosonix’s products will
achieve greater market acceptance and generate the level of sales or prices
anticipated.
Marketing
and Distribution
Gamma
Detection Devices
We began
marketing the neo2000
gamma detection system in October 1998. Since October of 1999, our
gamma detection systems have been marketed and distributed throughout most of
the world through Ethicon Endo-Surgery, Inc. (EES), a Johnson & Johnson
company. In Japan, however, we market our products through a
pre-existing relationship with Century Medical, Inc.
The heart
of our gamma detection product line, the neoprobe GDS, is a control
unit that is software-upgradeable, permitting product enhancements without
costly remanufacturing. Since the original launch of the GDS’
predecessor platform, the neo2000 (in 1998), we have
also introduced a number of enhanced radiation detection probes optimized for
lymphatic mapping procedures, including three wireless probes, as
well as a new probe optimized for the detection of high energy
radioisotopes. We have also developed four major software upgrades
for the system that have been made available for sale to
customers. We intend to continue developing additional SLNB-related
probes and instrument products in cooperation with EES to maintain our
leadership position in the gamma detection field.
Physician
training is critical to the use and adoption of SLNB products by surgeons and
other medical professionals. Our company and our marketing partners
have established relationships with leaders in the SLNB surgical community and
have established and supported training courses internationally for lymphatic
mapping. We intend to continue to work with our partners to expand
the number of SLNB training courses available to surgeons.
We
entered into a distribution agreement with EES effective October 1, 1999 for an
initial five-year term with options to extend for two successive two-year
terms. In March 2004, EES exercised its first two-year extension
option, and in March 2006 EES exercised its option for the second and final
two-year term extension, thus extending the term of our the 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 this agreement, we manufacture and sell our SLNB
products almost exclusively to EES, who distributes the products globally
(except for Japan). EES has no ongoing purchase or reimbursement
commitments to us other than the rolling four-month binding purchase commitment
for gamma detection devices and certain annual minimum sales levels in order to
maintain their exclusivity in distribution in most global markets. In
addition, the economic terms of the revenue sharing from the end customer sale
of our gamma detection devices increased commencing in January
2009. Our agreement with EES also contains certain termination
provisions and licenses to our intellectual property that take effect only in
the event we fail to supply product, or for other reasons such as a change of
control. See Risk Factors.
Gamma
Detection Radiopharmaceuticals
During
the fourth quarter of 2007, we executed an agreement with Cardinal Health,
Inc.’s radiopharmaceutical distribution division (Cardinal Health) for the
exclusive distribution of Lymphoseek in the United
States. The agreement is for a term of five years from the date of
marketing clearance of a NDA from FDA. Under the terms of our
agreement with Cardinal Health, Neoprobe will receive a share of each patient
dose sold. In addition, Neoprobe will receive up to $3 million in
payments upon the achievement of certain sales milestones by Cardinal Health. We
do not currently have collaborative agreements covering Lymphoseek in other areas of
the world or for RIGScan
CR or ACT. We cannot assure you that we will be successful in
securing collaborative partners for other global markets or radiopharmaceutical
products, or that we will be able to negotiate acceptable terms for such
arrangements. We believe the most preferable and likely distribution
partners for Lymphoseek
would be entities with established radiopharmaceutical distribution channels,
although it is possible that other entities with more traditional oncology
pharmaceutical portfolios may also have interest.
With
respect to RIGScan CR,
we believe there are development milestones that can be achieved prior to the
need for significant capital investment in RIGScan CR, such as
harmonizing the regulatory requirements in the US and EU for the planned Phase 3
trial. We continue to believe it will be necessary for us to identify
a development partner or an alternative funding source in order to prepare for
and to fund the pivotal clinical testing that will be necessary to gain
marketing clearance for RIGScan CR. At the
present time, while we have parties who have indicated an interest in entering
into a development relationship, we do not believe these efforts will result in
a definitive partnership at least until a regulatory and development pathway is
obtained. We anticipate continuing discussions for RIGScan CR as we move forward
with the clinical development of the product; however, we cannot assure you that
we will be able to secure marketing and distribution partners for the product,
or if secured, that such arrangements will result in significant sales of RIGScan CR.
Blood
Flow Measurement Devices
Our
initial blood flow measurement device, the Quantix/OR has received
marketing clearance in the U.S. and the EU and certain other foreign
markets. Our goal is to ensure sales and distribution coverage
through third parties of substantially all of the U.S., the EU, the Pacific Rim
of Asia and selective markets in the rest of the world. Our marketing
partnership efforts in the U.S. and EU to date have been largely ineffective in
penetrating our target market and as a result we are re-evaluating our marketing
representation in those markets and investigating other distribution
alternatives. In addition, we have distribution arrangements in place
covering major portions of Central and South America.
Our time
and effort in the marketing and sales of blood flow devices through 2008 has
been to improve market penetration for the Quantix/OR through working
with third party distributors. We continue to critically evaluate our
outlook for our blood flow measurement business and investigate other strategic
alternatives.
Manufacturing
Medical
Devices
We rely
on independent contract manufacturers, some of which are single-source
suppliers, for the manufacture of the principal components of our current line
of gamma detection system products. See Risk Factors. We
have devoted significant resources to develop production capability of our gamma
detection systems at qualified contract manufacturers. Production of
the neoprobe GDS control
unit, the 14mm probe, the 11mm laparoscopic probe, and the wireless probes
involve the manufacture of components by a combination of subcontractors,
including but not limited to, eV Products, a division of II-VI Incorporated
(eV), and TriVirix International, Inc. (TriVirix). We also purchase
certain accessories for our line of gamma detection systems from other qualified
manufacturers.
We have
purchased certain solid-state crystals and associated electronics used in the
manufacture of our proprietary line of hand-held gamma detection probes from
eV. We do not currently have a supply agreement with eV, however we
currently purchase from them under extended blanket purchase
orders. The number of potential suppliers of such solid-state
crystals is limited. In the event we are unable to secure a viable
alternative source of supply should we become unable to obtain crystals from eV,
any prolonged interruption of this source could restrict the availability of our
probe products, which would adversely affect our operating results.
In
February 2004, we executed a Product Supply Agreement with TriVirix for the
manufacture and/or final assembly of our gamma detection products, including
probes and control units, and our blood flow measurement control
units. The original term of this agreement expired in February 2007
but has been extended under the automatic renewal terms of the agreement through
February 2010. The Agreement will continue to be automatically
extended for successive one-year periods unless six months notice is provided by
either party.
The Quantix blood flow measurement
devices distributed through early 2006 were manufactured by Cardiosonix in
Israel. In early 2006, we received approval from the Office of the
Chief Scientist (OCS) of Israel to transfer manufacturing rights for the Quantix devices to
Neoprobe. See Risk Factors. Future assembly of Quantix blood flow control
units will therefore be done under the terms of the Product Supply Agreement we
have in place with TriVirix for the assembly of our gamma detection
products. Assembly of the Quantix/OR control units
started at TriVirix in March 2006. We currently purchase ultrasound
transducer modules and probe subassemblies from Vermon S.A. of France under
purchase orders. The ultrasound probe assemblies are then completed
by Technical Services for Electronics, Inc., also under purchase
orders.
We cannot
assure you that we will be able to maintain agreements or other purchasing
arrangements with our subcontractors on terms acceptable to us, or that our
subcontractors will be able to meet our production requirements on a timely
basis, at the required levels of performance and quality. In the
event that any of our subcontractors is unable or unwilling to meet our
production requirements, we cannot assure you that an alternate source of supply
could be established without significant interruption in product supply or
without significant adverse impact to product availability or
cost. Any significant supply interruption or yield problems that we
or our subcontractors experience would have a material adverse effect on our
ability to manufacture our products and, therefore, a material adverse effect on
our business, financial condition, and results of operations until a new source
of supply is qualified. See Risk Factors.
Gamma
Detection Radiopharmaceuticals
In
preparation for the commencement of a multi-center clinical evaluation of Lymphoseek, Neoprobe engaged
drug manufacturing organizations to produce the drug that was used in the Phase
2 trial and is expected to be used in the pivotal (i.e., Phase 3) clinical
trials. Reliable has produced the active chemical compound and OSO
Bio has performed final product manufacturing including final drug formulation,
lyophilization (i.e., freeze-drying) and packaging processes. Once
packaged, the vialed drug can then be shipped to a hospital or regional
commercial radiopharmacy where it can be made radioactive (i.e., radiolabeled)
with Tc99m to become Lymphoseek. The
commercial manufacturing processes at Reliable and OSO Bio are being validated
and both organizations have assisted Neoprobe in the preparation of the
chemistry, manufacturing and control sections of our submissions to FDA and
EMEA. Both Reliable and OSO Bio are registered manufacturers with FDA
and/or EMEA. At this point, drug product produced by Reliable and OSO
Bio has been produced under clinical development
agreements. Commercial supply and distribution agreements are being
negotiated with both Reliable and OSO Bio. We cannot assure you that
we will be successful in reaching such agreements with Reliable or OSO Bio on
terms satisfactory to us or at all.
In
preparation for the initiation of the next phase of clinical evaluation of RIGScan CR, we have also
initiated discussions with potential biologic manufacturers and radiolabeling
organizations. We have held discussions with parties who may assist
in the manufacturing validation and radiolabeling of the RIGScan CR product; however,
we have not yet finalized agreements with these entities. We
anticipate finalizing these discussions following securing a development partner
in order to support the commencement of future RIGScan CR clinical
trials. We cannot assure you that we will be successful in securing
and/or maintaining the necessary biologic, product and/or radiolabeling
capabilities. See Risk Factors.
Competition
We face
competition from medical product and biotechnology companies, as well as from
universities and other non-profit research organizations in the field of cancer
diagnostics and treatment. Many emerging medical product companies
have corporate partnership arrangements with large, established companies to
support the research, development, and commercialization of products that may be
competitive with our products. In addition, a number of large
established companies are developing proprietary technologies or have enhanced
their capabilities by entering into arrangements with or acquiring companies
with technologies applicable to the detection or treatment of cancer and the
measurement of blood flow. Many of our existing or potential
competitors have substantially greater financial, research and development,
regulatory, marketing, and production resources than we have. Other
companies may develop and introduce products and processes competitive with or
superior to those of ours. See Risk Factors.
For our
products, an important factor in competition is the timing of market
introduction of our products or those of our competitors’
products. Accordingly, the relative speed with which we can develop
products, complete the regulatory clearance processes and supply commercial
quantities of the products to the market is an important competitive
factor. We expect that competition among products cleared for
marketing will be based on, among other things, product efficacy, safety,
reliability, availability, price, and patent position.
Gamma
Detection Devices
With the
continued emergence of SLNB, a number of companies have begun to market gamma
radiation detection instruments. Most of the competitive products
have been designed from an industrial or nuclear medicine perspective rather
than being developed initially for surgical use. We compete with
products produced and/or marketed by Care Wise Medical Products Corporation,
Intra-Medical Imaging LLC, RMD Instruments LLC (a subsidiary of Dynasil
Corporation), SenoRx, Eurorad S.A and other companies.
It is
often difficult to glean accurate competitive information within the lymphatic
mapping field, primarily because most of our competitors are either subsidiaries
or divisions of larger corporations or privately held corporations, whose sales
revenue or volume data is not readily available or determinable. In
addition, lymphatic mapping does not currently have a separate reimbursement
code in most healthcare systems. As such, determining trends in the
actual number of procedures being performed using lymphatic mapping is
difficult. We believe, based on our understanding of EES’ success
rate in competitive bid situations, that our market share has remained
relatively constant or increased slightly in light of changes in the competitive
landscape over the past few years. As we have discussed, we believe
that current sales levels indicate that some prospective customers may be
waiting on the results of important international clinical trials prior to
adoption of the SLNB procedure and purchasing a gamma detection
device. We expect the results from these trials, when announced, will
likely have a positive impact on sales volumes. We believe our
intellectual property portfolio will be a barrier to competitive products;
however, we cannot assure you that competitive products will not be developed,
be successful in eroding our market share or affect the prices we receive for
our gamma detection devices. See Risk Factors.
Gamma
Detection Radiopharmaceuticals
We do not
believe there are any directly competitive intraoperative diagnostic
radiopharmaceuticals with RIGScan CR that would be used
intraoperatively in the colorectal cancer application that RIGScan CR is initially
targeted for. There are other radiopharmaceuticals that are used as
preoperative imaging agents; however, we are unaware of any that could be used
as a real-time diagnostic aid during surgery such as RIGScan CR.
Surgeons
who practice the lymphatic mapping procedure for which Lymphoseek is intended
currently use other radiopharmaceuticals such as a sulphur-colloid compound in
the U.S. and other colloidal compounds in other markets. However,
these drugs are being used “off-label” in most major global markets (i.e., they
are not specifically indicated for use as a sentinel node targeting
agent). As such, we believe that Lymphoseek, if ultimately
approved, would be the first drug specifically labeled for use as a sentinel
lymph node targeting agent.
Blood
Flow Measurement Devices
There are
several technologies on the market that measure or claim to measure indices of
blood flow. These products can be categorized as devices that measure
blood flow directly and devices that only obtain an estimation of flow
conditions. We believe our device is most directly competitive in the
cardiac bypass graft (CABG) marketplace with Transit Time Ultrasound (TT)
Flowmetry. TT is the leading modality for blood flow measurement in
the operating room today. TT systems monitor blood flow invasively
and are restricted to isolated vessels. They require probe adaptation
to the vessel size, and do not provide additional vascular
parameters. The technology requires the operator to encircle the
blood vessel with a probe that includes two ultrasound transmitters/receivers on
one side, and a mirror reflector on the opposite side of the
vessel. By measuring the transit time of the ultrasound beam in the
upstream and downstream directions, volume blood flow estimates can be
evaluated. In addition, there are other competitive technologies in
CABG applications that utilize Doppler ultrasound. Doppler technology
has been around for several decades, and is being widely used in non-invasive
vascular diagnostics. Duplex ultrasound systems have the potential to
measure blood flow non-invasively. Duplex systems are designed for
imaging the anatomical severity of pathology. This method is also
technician-dependent, often cumbersome and does not offer monitoring
capabilities. Plain Doppler systems provide only blood flow velocity
rather than volume flow.
Cardiosonix
products are designed to address blood flow measurement across a variety of
clinical and surgical settings, and there are a number of companies already in
the marketplace that offer products related to blood flow
measurement. However, most of these products do not directly compete
with Cardiosonix products. The companies that do offer potentially
competitive products are, for the most part, smaller, privately held companies,
with which we believe we can effectively compete. Indeed, due to our
belief in the technical superiority of our products, we believe the existence of
competitors will help to educate the marketplace regarding the importance of
blood flow measurement. As we have discussed, adoption of blood flow
monitoring devices for the measurement of hemodynamic status will likely take an
involved education process as it often involves a change in clinical or surgical
management. While there is not a clear leader in blood flow
measurement in the broader vascular assessment market, the following companies
compete most directly with the Quantix products in the CABG
market: Transonic Systems, Inc., Medi-Stim AS, and Carolina Medical,
Inc.
Patents
and Proprietary Rights
We regard
the establishment of a strong intellectual property position in our technology
as an integral part of the development process. We attempt to protect
our proprietary technologies through patents and intellectual property positions
in the United States as well as major foreign
markets. Approximately 20 instrument patents issued in the
United Sates as well as major foreign markets protect our gamma detection
technology.
Cardiosonix
has also applied for patent coverage for the key elements of its Doppler blood
flow technology in the U.S. The first of the two patents covering
Cardiosonix technology was issued in the U.S. in January 2003 and claims for the
second patent have been allowed.
Lymphoseek is also the subject
of patents and patent applications in the United States and certain major
foreign markets. The patents and patent applications are held by The
Regents of the University of California and have been licensed exclusively to
Neoprobe for lymphatic tissue imaging and intraoperative detection
worldwide. The first composition of matter patent covering Lymphoseek was issued in the
United States in June 2002. The claims of the composition of matter
patent covering Lymphoseek have been allowed
in the EU and issued in the majority of EU countries in 2005. The
composition of matter patent is being prosecuted in Japan and we have received
notice of the allowance of the underlying claims.
We
continue to support proprietary protection for the products related to RIGS and ACT in major global
markets such as the U.S. and the EU, which although not currently integral to
our near-term business plans, may be important to a potential RIGS or ACT development
partner. Composition of matter patents have been issued in the U.S.
and EU that cover the antibodies used in clinical studies. The most
recent of these patents was issued in 2004 and additional patent applications
are pending. We have a license to these patents through the NIH;
however, our license is subject to ongoing diligence requirements.
The
activated cellular therapy technology of Cira Bio is the subject of issued
patents in the United States to which Neoprobe has exclusive license
rights. European patent statutes do not permit patent coverage for
treatment technologies such as Cira Bio’s. The oncology applications
of Cira Bio’s treatment approach are covered by issued patents with expiration
dates of 2018 and 2020, unless extended. The autoimmune applications
are covered by an issued patent with an expiration date of 2018, unless
extended. The viral applications are the subject of patent
applications and other aspects of the Cira Bio technology that are in the
process of being reviewed by the United States Patent and Trademark
Office. Cira Bio has received favorable office action correspondence
on both applications.
The
patent position of biotechnology and medical device firms, including our
company, generally is highly uncertain and may involve complex legal and factual
questions. Potential competitors may have filed applications, or may
have been issued patents, or may obtain additional patents and proprietary
rights relating to products or processes in the same area of technology as that
used by our company. The scope and validity of these patents and
applications, the extent to which we may be required to obtain licenses
thereunder or under other proprietary rights, and the cost and availability of
licenses are uncertain. We cannot assure you that our patent
applications will result in additional patents being issued or that any of our
patents will afford protection against competitors with similar technology; nor
can we assure you that any of our patents will not be designed around by others
or that others will not obtain patents that we would need to license or design
around.
We also
rely upon unpatented trade secrets. We cannot assure you that others
will not independently develop substantially equivalent proprietary information
and techniques, or otherwise gain access to our trade secrets, or disclose such
technology, or that we can meaningfully protect our rights to our unpatented
trade secrets.
We
require our employees, consultants, advisers, and suppliers to execute a
confidentiality agreement upon the commencement of an employment, consulting or
manufacturing relationship with us. The agreement provides that all
confidential information developed by or made known to the individual during the
course of the relationship will be kept confidential and not disclosed to third
parties except in specified circumstances. In the case of employees,
the agreements provide that all inventions conceived by the individual will be
the exclusive property of our company. We cannot assure you, however,
that these agreements will provide meaningful protection for our trade secrets
in the event of an unauthorized use or disclosure of such
information. See Risk Factors.
Government
Regulation
Most
aspects of our business are subject to some degree of government regulation in
the countries in which we conduct our operations. As a developer,
manufacturer and marketer of medical products, we are subject to extensive
regulation by, among other governmental entities, FDA and the corresponding
state, local and foreign regulatory bodies in jurisdictions in which our
products are sold. These regulations govern the introduction of new
products, the observance of certain standards with respect to the manufacture,
safety, efficacy and labeling of such products, the maintenance of certain
records, the tracking of such products and other matters.
Failure
to comply with applicable federal, state, local or foreign laws or regulations
could subject us to enforcement action, including product seizures, recalls,
withdrawal of marketing clearances, and civil and criminal penalties, any one or
more of which could have a material adverse effect on our
business. We believe that we are in substantial compliance with such
governmental regulations. However, federal, state, local and foreign
laws and regulations regarding the manufacture and sale of medical devices are
subject to future changes. We cannot assure you that such changes
will not have a material adverse effect on our company.
For some
products, and in some countries, government regulation is significant and, in
general, there is a trend toward more stringent regulation. In recent
years, FDA and certain foreign regulatory bodies have pursued a more rigorous
enforcement program to ensure that regulated businesses like ours comply with
applicable laws and regulations. We devote significant time, effort
and expense addressing the extensive governmental regulatory requirements
applicable to our business. To date, we have not received any
notifications or warning letters from FDA or any other regulatory bodies of
alleged deficiencies in our compliance with the relevant requirements, nor have
we recalled or issued safety alerts on any of our products. However,
we cannot assure you that a warning letter, recall or safety alert, if it
occurred, would not have a material adverse effect on our company.
In the
early- to mid-1990s, the review time by FDA to clear medical products for
commercial release lengthened and the number of marketing clearances
decreased. In response to public and congressional concern, FDA
Modernization Act of 1997 (the 1997 Act) was adopted with the intent of bringing
better definition to the clearance process for new medical
products. While FDA review times have improved since passage of the
1997 Act, we cannot assure you that FDA review process will not continue to
delay our company's introduction of new products in the U.S. in the
future. In addition, many foreign countries have adopted more
stringent regulatory requirements that also have added to the delays and
uncertainties associated with the release of new products, as well as the
clinical and regulatory costs of supporting such releases. It is
possible that delays in receipt of, or failure to receive, any necessary
clearance for our new product offerings could have a material adverse effect on
our business, financial condition or results of operations.
While we
are unable to predict the extent to which our business may be affected by future
regulatory developments, we believe that our substantial experience dealing with
governmental regulatory requirements and restrictions on our operations
throughout the world, and our development of new and improved products, should
enable us to compete effectively within this environment.
Gamma
Detection and Blood Flow Measurement Devices
As a
manufacturer of medical devices sold in various global markets, we are required
by regulatory agency regulations to manufacture the devices under recognized
quality standards and controls. Our medical devices are regulated in
the United States by FDA in accordance with 21CFR requirements, in the EU
according to the Medical Device Directive (93/42/EEC), and in Canada and Japan
according to the Medical Devices Regulation. These regulatory
requirements for quality systems are prescribed in the international standard
ISO 13485 Medical devices –
Quality management systems – Requirements for regulatory
purposes. To ensure continued compliance in our daily
processes, we have established and maintain the Neoprobe Corporate Quality
Management System, which is based on the ISO 13485 standard. These
requirements can also be extended to drug and biologic products regarding our
future product portfolio.
Our first
generation gamma detection instrument received 510(k) marketing clearance from
FDA in December 1986 with modified versions receiving similar clearances in 1992
through 1997. In March 1998, FDA reclassified "nuclear uptake
detectors" as Class 1 and conditionally exempt from 510(k) with full quality
controls. We obtained the European CE mark, by “self-declaration,”
for the neo2000 device
in January 1999, with full quality controls. The gamma detection
products are Class IIa in the EU. We maintain a “manufacturer’s
license” in order to import our gamma detection products into Canada, with full
quality controls. The gamma detection products are Class II in
Canada.
Similar
to the gamma detection products, and under our Quality Management System
controls, the Cardiosonix products have received 510(k) and CE mark clearance to
market the Quantix/OR
device in the U.S. and EU, respectively. Our distribution partners in
certain foreign markets other than the EU are seeking marketing clearances, as
required, for the Quantix/OR. The
Quantix/OR product is
Class II in the U.S. and Class IIa in the EU.
Gamma
Detection Radiopharmaceuticals (Lymphoseek and RIGScan)
Our
radiolabeled targeting agents and biologic products, if developed, would require
a regulatory license to market by FDA and by comparable agencies in foreign
countries. The process of obtaining regulatory licenses and approvals
is costly and time consuming, and we have encountered significant impediments
and delays related to our previously proposed biologic products.
The
process of completing pre-clinical and clinical testing, manufacturing
validation and submission of a marketing application to the appropriate
regulatory bodies usually takes a number of years and requires the expenditure
of substantial resources, and we cannot assure you that any approval will be
granted on a timely basis, if at all. Additionally, the length of
time it takes for the various regulatory bodies to evaluate an application for
marketing approval varies considerably, as does the amount of preclinical and
clinical data required to demonstrate the safety and efficacy of a specific
product. The regulatory bodies may require additional clinical
studies that may take several years to perform. The length of the
review period may vary widely depending upon the nature and indications of the
proposed product and whether the regulatory body has any further questions or
requests any additional data. Also, the regulatory bodies will likely
require post-marketing reporting and surveillance programs to monitor the side
effects of the products. We cannot assure you that any of our
potential drug or biologic products will be approved by the regulatory bodies or
approved on a timely or accelerated basis, or that any approvals received will
not subsequently be revoked or modified.
In
addition to regulations enforced by FDA, the manufacture, distribution, and use
of radioactive targeting agents, if developed, are also subject to regulation by
the Nuclear Regulatory Commission (NRC), the Department of Transportation and
other federal, state, and local government authorities. We, or our
manufacturer of the radiolabeled antibodies, must obtain a specific license from
the NRC to manufacture and distribute radiolabeled antibodies, as well as comply
with all applicable regulations. We must also comply with Department
of Transportation regulations on the labeling and packaging requirements for
shipment of radiolabeled antibodies to licensed clinics, and must comply with
federal, state, and local governmental laws regarding the disposal of
radioactive waste. We cannot assure you that we will be able to
obtain all necessary licenses and permits and be able to comply with all
applicable laws. The failure to obtain such licenses and permits or
to comply with applicable laws would have a materially adverse effect on our
business, financial condition, and results of operations.
Research
and Development
We spent
approximately $4.5 million and $2.9 million on research and development
activities in the fiscal years ended December 31, 2008, and December 31, 2007,
respectively.
As of
March 16, 2009, we had 25 full-time employees. We consider our
relations with our employees to generally be good.
Item
1A. Risk Factors
An
investment in our common stock is highly speculative, involves a high degree of
risk, and should be made only by investors who can afford a complete
loss. You should carefully consider the following risk factors,
together with the other information in this report, including our financial
statements and the related notes, before you decide to buy our common
stock. Our most significant risks and uncertainties are described
below; however, they are not the only risks we face. If any of the
following risks actually occur, our business, financial condition, or results of
operations could be materially adversely affected, the trading of our common
stock could decline, and you may lose all or part of your investment
therein.
We
have suffered significant operating losses for several years in our history and
we may not be able to again achieve profitability.
We had an
accumulated deficit of approximately $148.8 million and had an overall deficit
in stockholders’ equity as of December 31, 2008. Although we were
profitable in 2000 and in 2001, we incurred substantial losses in the years
prior to that, and again in 2002 and subsequent years. The deficit
resulted because we expended more money in the course of researching, developing
and enhancing our technology and products and establishing our marketing and
administrative organizations than we generated in revenues. We expect
to continue to incur significant expenses in the foreseeable future, primarily
related to the completion of development and commercialization of Lymphoseek, but also
potentially related to RIGS and our device product
lines. As a result, we are sustaining substantial operating and net
losses, and it is possible that we will never be able to sustain or develop the
revenue levels necessary to again attain profitability.
Our
products and product candidates may not achieve the broad market acceptance they
need in order to be a commercial success.
Widespread
use of our handheld gamma detection devices is currently limited to one surgical
procedure, SLNB, used in the diagnosis and treatment of two primary types of
cancer: melanoma and breast cancer. While the adoption of SLNB within
the breast and melanoma indications appears to be widespread, expansion of SLNB
to other indications such as head and neck, colorectal and prostate cancers is
likely dependent on a better lymphatic tissue targeting agent than is currently
available. Without expanded indications in which to apply SLNB, it is
likely that gamma detection devices will eventually reach market
saturation. Our efforts and those of our marketing and distribution
partners may not result in significant demand for our products, and the current
demand for our products may decline.
To date,
our efforts to place Cardiosonix’s Quantix products have met with
limited success. The long-term commercial success of the Quantix product line will
require much more widespread acceptance of our blood flow measurement products
than we have experienced to date. Widespread acceptance of blood flow
measurement would represent a significant change in current medical practice
patterns. Other cardiac monitoring procedures, such as pulmonary
artery catheterization, are generally accepted in the medical community and have
a long standard of use. It is possible that the Quantix product line will
never achieve the broad market acceptance necessary to become a commercial
success.
Our
radiopharmaceutical product candidates, Lymphoseek and RIGScan CR, are still in the
process of development, and even if we are successful in commercializing them,
we cannot assure you that they will obtain significant market
acceptance.
We
may have difficulty raising additional capital, which could deprive us of
necessary resources.
We expect
to continue to devote significant capital resources to fund research and
development and to maintain existing and secure new manufacturing
capacity. In order to support the initiatives envisioned in our
business plan, we may need to raise additional funds through the sale of assets,
public or private debt or equity financing, collaborative relationships or other
arrangements. Our ability to raise additional financing depends on
many factors beyond our control, including the state of capital markets, the
market price of our common stock and the development or prospects for
development of competitive technology by others. Because our common
stock is not listed on a major stock market, many investors may not be willing
or allowed to purchase it or may demand steep discounts. Sufficient
additional financing may not be available to us or may be available only on
terms that would result in further dilution to the current owners of our common
stock.
We
believe that we have access to sufficient financial resources with which to fund
our operations or those of our subsidiaries for the foreseeable
future. We expect to raise additional capital during 2009 through
existing financing facilities already available to us in order to continue
executing on our current business plan. The continuation of the
current worldwide financial crisis and depressed stock market valuations may
adversely affect our ability to raise additional capital, either under
facilities in place or from new sources of capital. If we are
unsuccessful in raising additional capital, closing on financing under already
agreed to terms, or the terms of raising such capital are unacceptable, we may
have to modify our business plan and/or significantly curtail our planned
development activities and other operations.
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 over a 24-month period which ended on November 21,
2008. Through November 21, 2008, we sold Fusion Capital under the
agreement 7,568,671 shares for proceeds of $1.9 million. In December
2008, we entered into an amendment to the agreement which gave us a right to
sell an additional $6.0 million of our common stock to Fusion Capital before
March 1, 2011, along with the $4.1 million of the unsold balance of the $6.0
million we originally had the right to sell to Fusion Capital under the original
agreement. After giving effect to this amendment, the remaining
aggregate amount of our common stock we can sell to Fusion Capital is $10.1
million, and we have reserved a total of 10,654,000 shares of our common stock
for sale under the amended agreement. Our right to make sales under
the agreement is limited to $50,000 every two business days, unless our stock
price equals or exceeds $0.30 per share, in which case we can sell greater
amounts to Fusion Capital as the price of our common stock
increases. Fusion Capital does not have the right or any obligation
to purchase any shares on any business day that the market price of our common
stock is less than $0.20 per share. Assuming all 10,654,000 shares
are sold, the selling price per share would have to average approximately $0.94
for us to receive the full $10.1 million remaining proceeds under the agreement
as amended. Assuming we sell to Fusion Capital all 10,654,000 shares
at a sale price of $0.51 per share (the closing sale price of the common stock
on March 16, 2009), we would only receive $5.4 million under the
agreement. Under the agreement, we have the right but not the
obligation to sell more than the 10,654,000 shares to Fusion
Capital. As of the date hereof, we do not currently have any plans or
intent to sell to Fusion Capital any shares beyond the 10,654,000
shares. However, if we elect to sell more than the 10,654,000 shares,
we must first register any additional shares we may elect to sell to Fusion
Capital under the Securities Act before we can sell such additional
shares.
The
extent to which we rely on Fusion Capital as a source of funding will depend on
a number of factors, including the prevailing market price of our common stock
and the extent to which we are able to secure working capital from other
sources, such as through the sale of our products. To the extent that
we are unable to make sales to Fusion Capital to meet our capital needs, or to
the extent that we decide not to make such sales because of excessive dilution
or other reasons, and if we are unable to generate sufficient revenues from
sales of our products, we will need to secure another source of funding in order
to satisfy our working capital needs. Even if we are able to access
the full $10.1 million potentially remaining under the agreement with Fusion
Capital, we may still need additional capital to fully implement our business,
operating and development plans. Should the financing we require to
sustain our working capital needs be unavailable or prohibitively expensive when
we require it, the consequences could be a material adverse effect on our
business, operating results, financial condition and prospects.
Clinical
trials for our radiopharmaceutical product candidates will be lengthy and
expensive and their outcome is uncertain.
Before
obtaining regulatory approval for the commercial sale of any product candidates,
we must demonstrate through preclinical testing and clinical trials that our
product candidates are safe and effective for use in
humans. Conducting clinical trials is a time consuming, expensive and
uncertain process and may take years to complete. During 2008, we
successfully completed a Phase 2 clinical trial for our most advanced
radiopharmaceutical product candidate, Lymphoseek. We are
in the process of completing first of two pivotal Phase 3 trials for this
product in breast cancer or melanoma and have a second trial pending in head and
neck squamous cell carcinoma. We have recently obtained approval from
EMEA of a Phase 3 clinical protocol for our next radiopharmaceutical candidate,
RIGScan CR and are
preparing to approach FDA to obtain similar clearance. Historically,
the results from preclinical testing and early clinical trials have often not
been predictive of results obtained in later clinical
trials. Frequently, drugs that have shown promising results in
preclinical or early clinical trials subsequently fail to establish sufficient
safety and efficacy data necessary to obtain regulatory approval. At
any time during the clinical trials, we, the participating institutions, FDA or
EMEA might delay or halt any clinical trials for our product candidates for
various reasons, including:
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ineffectiveness
of the product candidate;
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discovery
of unacceptable toxicities or side
effects;
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development
of disease resistance or other physiological
factors;
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delays
in patient enrollment; or
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other
reasons that are internal to the businesses of our potential collaborative
partners, which reasons they may not share with
us.
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While we
have achieved some level of success in our recent Phase 2 and Phase 3 clinical
trials for Lymphoseek,
the results of these clinical trials, as well as pending and future trials, are
subject to review and interpretation by various regulatory bodies during the
regulatory review process and may ultimately fail to demonstrate the safety or
effectiveness of our product candidates to the extent necessary to obtain
regulatory approval or such that commercialization of our product candidates is
worthwhile. Any failure or substantial delay in successfully
completing clinical trials and obtaining regulatory approval for our product
candidates could severely harm our business.
If
we fail to obtain collaborative partners, or those we obtain fail to perform
their obligations or discontinue clinical trials for particular product
candidates, our ability to develop and market potential products could be
severely limited.
Our
strategy for the development and commercialization of our product candidates
depends, in large part, upon the formation of collaborative
arrangements. Collaborations may allow us to:
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generate
cash flow and revenue;
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offset
some of the costs associated with our internal research and development,
preclinical testing, clinical trials and
manufacturing;
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seek
and obtain regulatory approvals faster than we could on our own;
and,
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successfully
commercialize existing and future product
candidates.
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We
recently executed an agreement with Cardinal Health for the distribution of
Lymphoseek in the United
States. We do not currently have collaborative agreements covering
Lymphoseek in other
areas of the world or for RIGScan CR or
ACT. We cannot assure you that we will be successful in securing
collaborative partners for other markets or radiopharmaceutical products, or
that we will be able to negotiate acceptable terms for such
arrangements. The development, regulatory approval and
commercialization of our product candidates will depend substantially on the
efforts of collaborative partners, and if we fail to secure or maintain
successful collaborative arrangements, or if our partners fail to perform their
obligations, our development, regulatory, manufacturing and marketing activities
may be delayed, scaled back or suspended.
We
rely on third parties for the worldwide marketing and distribution of our gamma
detection and blood flow measurement devices, who may not be successful in
selling our products.
We
currently distribute our gamma detection devices in most global markets through
two partners who are solely responsible for marketing and distributing these
products. The partners assume direct responsibility for business
risks related to credit, currency exchange, foreign tax laws or tariff and trade
regulation. Our blood flow products are marketed and sold in the U.S.
and a number of foreign markets through other distribution partners specific to
those markets. Further, we have had only limited success to date in
marketing or selling our Quantix line of blood flow
products. While we believe that our distribution partners intend to
continue to aggressively market our products, we cannot assure you that the
distribution partners will succeed in marketing our products on a global
basis. We may not be able to maintain satisfactory arrangements with
our marketing and distribution partners, who may not devote adequate resources
to selling our products. If this happens, we may not be able to
successfully market our products, which would decrease our
revenues.
Our
radiopharmaceutical product candidates are subject to extensive government
regulations and we may not be able to obtain necessary regulatory
approvals.
We may
not receive the regulatory approvals necessary to commercialize our Lymphoseek and RIGScan product candidates,
which could cause our business to be severely harmed. Our product
candidates are subject to extensive and rigorous government
regulation. FDA regulates, among other things, the development,
testing, manufacture, safety, record-keeping, labeling, storage, approval,
advertising, promotion, sale and distribution of pharmaceutical
products. If our potential products are marketed abroad, they will
also be subject to extensive regulation by foreign governments. None
of our product candidates has been approved for sale in the United States or in
any foreign market. The regulatory review and approval process, which
includes preclinical studies and clinical trials of each product candidate, is
lengthy, complex, expensive and uncertain. Securing FDA clearance to
market requires the submission of extensive preclinical and clinical data and
supporting information to FDA for each indication to establish the product
candidate's safety and efficacy. Data obtained from preclinical and
clinical trials are susceptible to varying interpretation, which may delay,
limit or prevent regulatory approval. The approval process may take
many years to complete and may involve ongoing requirements for post-marketing
studies. In light of the limited regulatory history of monoclonal
antibody-based therapeutics, regulatory approvals for our products may not be
obtained without lengthy delays, if at all. Any FDA or other
regulatory approvals of our product candidates, once obtained, may be
withdrawn. The effect of government regulation may be
to:
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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
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provide
competitive advantage to other pharmaceutical and biotechnology
companies.
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We may
encounter delays or rejections in the regulatory approval process because of
additional government regulation from future legislation or administrative
action or changes in FDA policy during the period of product development,
clinical trials and FDA regulatory review. Failure to comply with
applicable FDA or other regulatory requirements may result in criminal
prosecution, civil penalties, recall or seizure of products, total or partial
suspension of production or injunction, as well as other regulatory action
against our product candidates or us. Outside the United States, our
ability to market a product is contingent upon receiving clearances from the
appropriate regulatory authorities. This foreign regulatory approval
process includes risks similar to those associated with FDA approval
process.
Our
radiopharmaceutical product candidates will remain subject to ongoing regulatory
review even if they receive marketing approval. If we fail to comply
with continuing regulations, we could lose these approvals and the sale of our
products could be suspended.
Even if
we receive regulatory clearance to market a particular product candidate, the
approval could be conditioned on us conducting additional costly post-approval
studies or could limit the indicated uses included in our
labeling. Moreover, the product may later cause adverse effects that
limit or prevent its widespread use, force us to withdraw it from the market or
impede or delay our ability to obtain regulatory approvals in additional
countries. In addition, the manufacturer of the product and its
facilities will continue to be subject to FDA review and periodic inspections to
ensure adherence to applicable regulations. After receiving marketing
clearance, the manufacturing, labeling, packaging, adverse event reporting,
storage, advertising, promotion and record-keeping related to the product will
remain subject to extensive regulatory requirements. We may be slow
to adapt, or we may never adapt, to changes in existing regulatory requirements
or adoption of new regulatory requirements.
If we
fail to comply with the regulatory requirements of FDA and other applicable U.S.
and foreign regulatory authorities or previously unknown problems with our
products, manufacturers or manufacturing processes are discovered, we could be
subject to administrative or judicially imposed sanctions,
including:
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restrictions
on the products, manufacturers or manufacturing
processes;
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civil
or criminal penalties;
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product
seizures or detentions;
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voluntary
or mandatory product recalls and publicity
requirements;
|
|
·
|
suspension
or withdrawal of regulatory
approvals;
|
|
·
|
total
or partial suspension of production;
and
|
|
·
|
refusal
to approve pending applications for marketing approval of new drugs or
supplements to approved
applications.
|
Our
existing products are highly regulated and we could face severe problems if we
do not comply with all regulatory requirements in the global markets in which
these products are sold.
FDA
regulates our gamma detection and blood flow measurement products in the United
States. Foreign countries also subject these products to varying
government regulations. In addition, these regulatory authorities may
impose limitations on the use of our products. FDA enforcement policy
strictly prohibits the marketing of FDA cleared medical devices for unapproved
uses. Within the European Union, our products are required to display
the CE Mark in order to be sold. We have obtained FDA clearance to
market and European certification to display the CE Mark on our current line of
gamma detection systems and on initial blood flow product, the Quantix/OR. We may
not be able to obtain clearance to market any new products in a timely manner,
or at all. Failure to comply with these and other current and
emerging regulatory requirements in the global markets in which our products are
sold could result in, among other things, warning letters, fines, injunctions,
civil penalties, recall or seizure of products, total or partial suspension of
production, refusal of the government to grant pre-market clearance for devices,
withdrawal of clearances, and criminal prosecution.
We
rely on third parties to manufacture our products and our business will suffer
if they do not perform.
We rely
on independent contract manufacturers for the manufacture of our current neoprobe GDS line of gamma
detection systems and for our Quantix line of blood flow
monitoring products. Our business will suffer if our contract
manufacturers have production delays or quality
problems. Furthermore, medical device manufacturers are subject to
the quality system regulations of FDA, international quality standards, and
other regulatory requirements. If our contractors do not operate in
accordance with regulatory requirements and quality standards, our business will
suffer. We use or rely on components and services used in our devices
that are provided by sole source suppliers. The qualification of
additional or replacement vendors is time consuming and costly. If a
sole source supplier has significant problems supplying our products, our sales
and revenues will be hurt until we find a new source of supply. In
addition, our distribution agreement with EES for gamma detection devices
contains failure to supply provisions, which, if triggered, could have a
significant negative impact on our business.
We
may be unable to establish the pharmaceutical manufacturing capabilities
necessary to develop and commercialize our potential products.
We do not
have our own manufacturing facility for the manufacture of the
radiopharmaceutical compounds necessary for clinical testing or commercial
sale. We intend to rely on third-party contract manufacturers to
produce sufficiently large quantities of drug materials that are and will be
needed for clinical trials and commercialization of our potential
products. Third-party manufacturers may not be able to meet our needs
with respect to timing, quantity or quality of materials. If we are
unable to contract for a sufficient supply of needed materials on acceptable
terms, or if we should encounter delays or difficulties in our relationships
with manufacturers, our clinical trials may be delayed, thereby delaying the
submission of product candidates for regulatory approval and the market
introduction and subsequent commercialization of our potential
products. Any such delays may lower our revenues and potential
profitability.
We may
develop our manufacturing capacity in part by expanding our current facilities
or building new facilities. Either of these activities would require
substantial additional funds and we would need to hire and train significant
numbers of employees to staff these facilities. We may not be able to
develop manufacturing facilities that are sufficient to produce drug materials
for clinical trials or commercial use. We and any third-party
manufacturers that we may use must continually adhere to current Good
Manufacturing Practices regulations enforced by FDA through its facilities
inspection program. If our facilities or the facilities of
third-party manufacturers cannot pass a pre-approval plant inspection, FDA will
not grant approval to our product candidates. In complying with these
regulations and foreign regulatory requirements, we and any of our third-party
manufacturers will be obligated to expend time, money and effort on production,
record-keeping and quality control to assure that our potential products meet
applicable specifications and other requirements. If we or any
third-party manufacturer with whom we may contract fail to maintain regulatory
compliance, we or the third party may be subject to fines and/or manufacturing
operations may be suspended.
Unfavorable
pricing regulations, third-party reimbursement practices or healthcare reform
initiatives applicable to our radiopharmaceutical products and product
candidates could limit our potential product revenue.
The
regulations governing drug pricing and reimbursement vary widely from country to
country. Some countries require approval of the sale price of a drug
before it can be marketed and, in many of these countries, the pricing review
period begins only after approval is granted. In some countries,
prescription pharmaceutical pricing remains subject to continuing governmental
control even after initial approval is granted. Although we monitor
these regulations, our product candidates are currently in the development stage
and we will not be able to assess the impact of price regulations for at least
several years. As a result, we may obtain regulatory approval for a
product in a particular country, but then be subject to price regulations that
may delay the commercial launch of the product and may negatively impact the
revenues we are able to derive from sales in that country.
The
healthcare industry is undergoing fundamental changes resulting from political,
economic and regulatory influences. In the United States,
comprehensive programs have been proposed that seek to increase access to
healthcare for the uninsured, to control the escalation of healthcare
expenditures within the economy and to use healthcare reimbursement policies to
balance the federal budget.
We expect
that Congress and state legislatures will continue to review and assess
healthcare proposals, and public debate of these issues will likely
continue. We cannot predict which, if any, of such reform proposals
will be adopted and when they might be adopted. Other countries also
are considering healthcare reform. Significant changes in healthcare
systems could have a substantial impact on the manner in which we conduct our
business and could require us to revise our strategies.
The
resale of our common stock sold to investors in private placements may cause
dilution and cause the price of our common stock to decline.
Over the
past few years, we completed various financings in which we issued common stock,
convertible notes, warrants and other securities convertible into common stock
to certain private investors. The terms of these transactions require
that we file registration statements with the Securities and Exchange Commission
under which the investors may resell to the public common stock acquired in
these transactions, as well as common stock acquired on the exercise of the
warrants and convertible securities held by them. Further, some or
all of the common stock sold in these transactions may become eligible for
resale without registration under the provisions of Rule 144, upon satisfaction
of the holding period and other requirements of the Rule.
As
described earlier in this Item 1A, as required by our financing arrangements
with Fusion Capital, we have filed a registration statement registering for
resale a total of 11,500,000 common shares, consisting of (i) 10,654,000 shares
which we may sell to Fusion Capital pursuant to the amended common stock
purchase agreement, (ii) 360,000 shares issued to Fusion Capital in
consideration for its agreement to the amendment; and (iii) 486,000 commitment
fee shares to be issued pro rata as we sell the first $4.1 million of common
stock under the amended agreement. The number of shares ultimately
sold under the registration statement will be dependent upon the number of
shares purchased by Fusion Capital under the amended agreement. It is
anticipated that these shares will be sold from time to time over a period
ending on March 1, 2011, at prices that will fluctuate based on changes in the
market price of our common stock over that period. We have the right
to control the timing and amount of any sales of our shares to Fusion Capital
and the agreement may be terminated by us at any time at our discretion without
any cost to us.
On
December 26, 2007, we entered into a Securities Purchase Agreement (SPA) with
Platinum-Montaur Life Sciences, LLC (Montaur), pursuant to which we issued
Montaur a 10% Series A Convertible Senior Secured Promissory Note in the
principal amount of $7,000,000, due December 26, 2011 (the Series A Note) and a
five-year Series W warrant to purchase 6,000,000 shares of our common stock at
an exercise price of $0.32 per share. On April 16, 2008, following
receipt by the Company of clearance by FDA to commence a Phase 3 clinical trial
for Lymphoseek in
patients with breast cancer or melanoma, we amended the SPA and issued Montaur a
10% Series B Convertible Senior Secured Promissory Note in the principal amount
of $3,000,000, also due December 26, 2011 (the Series B Note, and hereinafter
referred to collectively with the Series A Note as the Montaur Notes), and a
five-year Series X warrant to purchase 8,333,333 shares of our common stock at
an exercise price of $0.46 per share. Montaur may convert the Series B Note into
shares of common stock at the conversion price of $0.36 per share. On
December 5, 2008, after the Company had obtained 135 vital blue dye lymph nodes
from patients who had completed surgery and the injection of the drug in the
Phase 3 clinical trial of Lymphoseek in patients with
breast cancer or melanoma, we issued Montaur 3,000 shares of our 8% Series A
Cumulative Convertible Preferred Stock (the Preferred Stock) and a five-year
Series Y warrant (hereinafter referred to collectively with the Series W warrant
and Series X warrant as the Montaur Warrants) to purchase 6,000,000 shares of
our common stock, at an exercise price of $0.575 per share, also for an
aggregate purchase price of $3,000,000.
The
Series A Note bears interest at a rate per annum equal to 10%, and is partially
convertible at the option of Montaur into common stock at a price of $0.26 per
share. The Series B Note also bears interest at a rate per annum
equal to 10%, and is convertible into shares of common stock at the conversion
price of $0.36 per share. Pursuant to the provisions of the
Certificate of Designations, Voting Powers, Preferences, Limitations,
Restrictions, and Relative Rights of Series A 8% Cumulative Convertible
Preferred Stock, Montaur may convert all or any portion of the shares of the
Preferred Stock into an aggregate 6,000,000 shares of our common stock, subject
to adjustment as described in the Certificate of Designations.
Pursuant
to registration rights of Montaur under the SPA, we have filed a registration
statement covering the sale by Montaur of up to up to: (i) 6,000,000 shares of
common stock issuable upon the conversion of the Preferred Stock; (ii) 6,000,000
shares of common stock issuable upon the exercise of the Series Y warrant; (iii)
3,500,000 shares of common stock issuable as interest and dividends on the
Montaur Notes and Preferred Stock; and (iv) 4,666,666 shares of common stock
issuable upon the conversion of the Series B Note, for a total of 20,166,666
shares. Additionally, we agreed that within thirty-five days of
receipt from Montaur of written request therefor, we would prepare and file an
additional “resale” registration statement providing for the resale of: (i) the
shares of common stock issuable upon the conversion of the Series A Note; (ii)
the shares of common stock issuable upon the exercise of the Series W warrant;
(iii) any unregistered shares of common stock issuable upon the conversion of
the Series B Note.
The
selling stockholders may sell none, some or all of the shares of common stock
acquired from us, as well as common stock acquired on the exercise of the
warrants and convertible securities held by them. We have no way of
knowing whether or when the selling stockholders will sell these shares.
Depending upon market liquidity at the time, a sale of these shares at any given
time could cause the trading price of our common stock to decline. The
sale of a substantial number of shares of our common stock, or anticipation of
such sales, could make it more difficult for us to sell equity or equity-related
securities in the future at a time and at a price that we might otherwise wish
to effect sales.
We
may lose out to larger and better-established competitors.
The
medical device and biotechnology industries are intensely competitive.
Some of our competitors have significantly greater financial, technical,
manufacturing, marketing and distribution resources as well as greater
experience in the medical device industry than we have. The particular
medical conditions our product lines address can also be addressed by other
medical devices, procedures or drugs. Many of these alternatives are
widely accepted by physicians and have a long history of use. Physicians
may use our competitors’ products and/or our products may not be competitive
with other technologies. If these things happen, our sales and revenues
will decline. In addition, our current and potential competitors may
establish cooperative relationships with large medical equipment companies to
gain access to greater research and development or marketing resources.
Competition may result in price reductions, reduced gross margins and loss of
market share.
Our
products may be displaced by newer technology.
The
medical device and biotechnology industries are undergoing rapid and significant
technological change. Third parties may succeed in developing or marketing
technologies and products that are more effective than those developed or
marketed by us, or that would make our technology and products obsolete or
non-competitive. Additionally, researchers could develop new surgical
procedures and medications that replace or reduce the importance of the
procedures that use our products. Accordingly, our success will depend, in
part, on our ability to respond quickly to medical and technological changes
through the development and introduction of new products. We may not have
the resources to do this. If our products become obsolete and our efforts
to develop new products do not result in any commercially successful products,
our sales and revenues will decline.
We
may not have sufficient legal protection against infringement or loss of our
intellectual property, and we may lose rights to our licensed intellectual
property if diligence requirements are not met.
Our
success depends, in part, on our ability to secure and maintain patent
protection, to preserve our trade secrets, and to operate without infringing on
the patents of third parties. While we seek to protect our proprietary
positions by filing United States and foreign patent applications for our
important inventions and improvements, domestic and foreign patent offices may
not issue these patents. Third parties may challenge, invalidate, or
circumvent our patents or patent applications in the future. Competitors,
many of which have significantly more resources than we have and have made
substantial investments in competing technologies, may apply for and obtain
patents that will prevent, limit, or interfere with our ability to make, use, or
sell our products either in the United States or abroad.
In the
United States, patent applications are secret until patents are issued, and in
foreign countries, patent applications are secret for a time after filing.
Publications of discoveries tend to significantly lag the actual discoveries and
the filing of related patent applications. Third parties may have already
filed applications for patents for products or processes that will make our
products obsolete or will limit our patents or invalidate our patent
applications.
We
typically require our employees, consultants, advisers and suppliers to execute
confidentiality and assignment of invention agreements in connection with their
employment, consulting, advisory, or supply relationships with
us. They may breach these agreements and we may not obtain an
adequate remedy for breach. Further, third parties may gain access to
our trade secrets or independently develop or acquire the same or equivalent
information.
Agencies
of the United States government conducted some of the research activities that
led to the development of antibody technology that some of our proposed
antibody-based surgical cancer detection products use. When the
United States government participates in research activities, it retains rights
that include the right to use the technology for governmental purposes under a
royalty-free license, as well as rights to use and disclose technical data that
could preclude us from asserting trade secret rights in that data and
software.
The
government grants Cardiosonix has received for research and development
expenditures restrict our ability to manufacture blood flow monitoring products
and transfer technologies outside of Israel and require us to satisfy specified
conditions. If we fail to satisfy these conditions, we may be required to refund
grants previously received together with interest and penalties, and may be
subject to criminal charges.
Cardiosonix
received grants from the government of Israel through the OCS of the Ministry of
Industry and Trade for the financing of a portion of its research and
development expenditures associated with our blood flow monitoring
products. From 1998 to 2001, Cardiosonix received grants totaling
$775,000 from the OCS. The terms of the OCS grants may affect our
efforts to transfer manufacturing of products developed using these grants
outside of Israel without special approvals. In January 2006, the OCS
consented to the transfer of manufacturing as long as Neoprobe complies 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. This may impair our ability to effectively
outsource manufacturing or engage in similar arrangements for those products or
technologies. In addition, if we fail to comply with any of the
conditions imposed by the OCS, we may be required to refund any grants
previously received together with interest and penalties, and may be subject to
criminal charges. In recent years, the government of Israel has
accelerated the rate of repayment of OCS grants related to other grantees and
may further accelerate them in the future.
We
may lose the license rights to certain in-licensed products if we do not
exercise adequate diligence.
Our
license agreements for Lymphoseek, RIGS, and ACT contain
provisions that require that we demonstrate ongoing diligence in the continuing
research and development of these potential products. Cira Bio’s
rights to certain applications of the ACT technology may be affected by its
failure to achieve certain capital raising milestones although no such notices
to that effect have been received to date. We have provided
information, as required or requested, to the licensors of our technology
indicating the steps we have taken to demonstrate our diligence and believe we
are adequately doing so to meet the terms and/or intent of our license
agreements. However, it is possible that the licensors may not
consider our actions adequate in demonstrating such diligence. Should
we fail to demonstrate the requisite diligence required by any such agreements
or as interpreted by the respective licensors, we may lose our development and
commercialization rights for the associated product.
We
could be damaged by product liability claims.
Our
products are used or intended to be used in various clinical or surgical
procedures. If one of our products malfunctions or a physician
misuses it and injury results to a patient or operator, the injured party could
assert a product liability claim against our company. We currently
have product liability insurance with a $10 million per occurrence limit, which
we believe is adequate for our current activities. However, we
may not be able to continue to obtain insurance at a reasonable
cost. Furthermore, insurance may not be sufficient to cover all of
the liabilities resulting from a product liability claim, and we might
not have sufficient funds available to pay any claims over the limits of
our insurance. Because personal injury claims based on product
liability in a medical setting may be very large, an underinsured or an
uninsured claim could financially damage our company.
We
may have difficulty attracting and retaining qualified personnel and our
business may suffer if we do not.
Our
business has experienced challenges the past two years that have resulted in
several significant changes in our strategy and business plan, including the
shifting of resources to support our current product initiatives and downsizings
to what we consider to be the minimal support structure necessary to operate a
publicly traded company. Our management will need to remain flexible
to support our business model over the next few years. However,
losing members of the Neoprobe management team could have an adverse effect on
our operations. Our success depends on our ability to attract and
retain technical and management personnel with expertise and experience in the
medical device business. The competition for qualified personnel in
the medical device industry is intense and we may not be successful in hiring or
retaining the requisite personnel. If we are unable to attract and
retain qualified technical and management personnel, we will suffer diminished
chances of future success.
Our
secured indebtedness imposes significant restrictions on us, and a default could
cause us to cease operations.
All of
our material assets have been pledged as collateral for the $10 million in
principal amount of our Series A and Series B Convertible Notes issued to
Montaur, and a $1 million in principal amount Series B Convertible Note issued
to our CEO and members of his family dated July 3, 2007, as amended December 26,
2007 (collectively, the Notes). In addition to the security interest in our
assets, the Notes carry substantial covenants that impose significant
requirements on us, including, among others, requirements that:
|
·
|
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.
|
Additionally,
with certain exceptions, the Notes prohibit us from:
|
·
|
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;
|
|
·
|
engaging
in transactions with any affiliate;
|
|
·
|
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;
|
|
·
|
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.
|
Our
ability to comply with these provisions may be affected by changes in our
business condition or results of our operations, or other events beyond our
control. The breach of any of these covenants would result in a default under
the Notes, permitting the holders of the Notes to accelerate their maturity and
to sell the assets securing them. Such actions by the holders of the Notes could
cause us to cease operations or seek bankruptcy protection.
Our
common stock is traded over the counter, which may deprive stockholders of the
full value of their shares.
Our
common stock is quoted via the OTC Bulletin Board (OTCBB). As such,
our common stock may have fewer market makers, lower trading volumes and larger
spreads between bid and ask prices than securities listed on an exchange such as
the New York Stock Exchange or the NASDAQ Stock Market. These factors
may result in higher price volatility and less market liquidity for the common
stock.
A
low market price may severely limit the potential market for our common
stock.
Our
common stock is currently trading at a price substantially below $5.00 per
share, subjecting trading in the stock to certain SEC rules requiring additional
disclosures by broker-dealers. These rules generally apply to any
non-NASDAQ equity security that has a market price share of less than $5.00 per
share, subject to certain exceptions (a "penny stock"). Such rules
require the delivery, prior to any penny stock transaction, of a disclosure
schedule explaining the penny stock market and the risks associated therewith
and impose various sales practice requirements on broker-dealers who sell penny
stocks to persons other than established customers and institutional or wealthy
investors. For these types of transactions, the broker-dealer must
make a special suitability determination for the purchaser and have received the
purchaser's written consent to the transaction prior to the sale. The
broker-dealer also must disclose the commissions payable to the broker-dealer,
current bid and offer quotations for the penny stock and, if the broker-dealer
is the sole market maker, the broker-dealer must disclose this fact and the
broker-dealer's presumed control over the market. Such information
must be provided to the customer orally or in writing before or with the written
confirmation of trade sent to the customer. Monthly statements must
be sent disclosing recent price information for the penny stock held in the
account and information on the limited market in penny stocks. The
additional burdens imposed upon broker-dealers by such requirements could
discourage broker-dealers from effecting transactions in our common
stock.
The
price of our common stock has been highly volatile due to several factors that
will continue to affect the price of our stock.
Our
common stock traded as low as $0.29 per share and as high as $0.87 per share
during the 12-month period ended December 31, 2008. The market price
of our common stock has been and is expected to continue to be highly
volatile. Factors, including announcements of technological
innovations by us or other companies, regulatory matters, new or existing
products or procedures, concerns about our financial position, operating
results, litigation, government regulation, developments or disputes relating to
agreements, patents or proprietary rights, may have a significant impact on the
market price of our stock. In addition, potential dilutive effects of
future sales of shares of common stock by the company and by stockholders, and
subsequent sale of common stock by the holders of warrants and options could
have an adverse effect on the market price of our shares.
Some
additional factors which could lead to the volatility of our common stock
include:
|
·
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price
and volume fluctuations in the stock market at large which do not relate
to our operating performance;
|
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·
|
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.
|
An
investor’s ability to trade our common stock may be limited by trading
volume.
Generally,
the trading volume for our common stock has been relatively
limited. A consistently active trading market for our common stock
may not occur on the OTCBB. The average daily trading volume for our
common stock on the OTCBB for the 12-month period ended December 31, 2008, was
approximately 118,000 shares.
Some
provisions of our organizational and governing documents may have the effect of
deterring third parties from making takeover bids for control of our company or
may be used to hinder or delay a takeover bid.
Our
certificate of incorporation authorizes the creation and issuance of “blank
check” preferred stock. Our Board of Directors may divide this stock
into one or more series and set their rights. The Board of Directors
may, without prior stockholder approval, issue any of the shares of “blank
check” preferred stock with dividend, liquidation, conversion, voting or other
rights, which could adversely affect the relative voting power or other rights
of the common stock. Preferred stock could be used as a method of
discouraging, delaying, or preventing a take-over of our company. If
we issue “blank check” preferred stock, it could have a dilutive effect upon our
common stock. This would decrease the chance that our stockholders
would realize a premium over market price for their shares of common stock as a
result of a takeover bid.
Because
we will not pay dividends in the foreseeable future, stockholders will only
benefit from owning common stock if it appreciates.
We have
never paid dividends on our common stock and we do not intend to do so in the
foreseeable future. We intend to retain any future earnings to
finance our growth. Accordingly, any potential investor who
anticipates the need for current dividends from his investment should not
purchase our common stock.
Item
1B. Unresolved Staff Comments
None.
Item
2. Properties
We
currently lease approximately 11,300 square feet of office space at 425 Metro
Place North, Dublin, Ohio, as our principal offices. The current lease term is
from June 1, 2007 and ending on January 31, 2013, at a monthly base rent of
approximately $8,200 during 2009. We must also pay a pro-rata portion
of the operating expenses and real estate taxes of the building. We
believe these facilities are in good condition. Although these
facilities are adequate for our current needs, we may need to expand our leased
space related to our radiopharmaceutical activities depending on the level of
activities performed internally versus by third parties.
Item
3. Legal Proceedings
None.
Item
4. Submission of Matters to a Vote of Security Holders
None.
PART
II
Item
5. Market for Registrant’s Common Equity, Related Stockholder Matters
and Issuer Purchases of Equity Securities
Our
common stock trades on the OTC Bulletin Board (OTCBB) under the trading symbol
NEOP. The prices set forth below reflect the quarterly high, low and
closing sales prices for shares of our common stock during the last two fiscal
years as reported by Reuters Limited. These quotations reflect
inter-dealer prices, without retail markup, markdown or commission, and may not
represent actual transactions.
|
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High
|
|
|
Low
|
|
|
Close
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal
Year 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
First
Quarter
|
|
$ |
0.27 |
|
|
$ |
0.20 |
|
|
$ |
0.24 |
|
Second
Quarter
|
|
|
0.32 |
|
|
|
0.19 |
|
|
|
0.31 |
|
Third
Quarter
|
|
|
0.50 |
|
|
|
0.23 |
|
|
|
0.31 |
|
Fourth
Quarter
|
|
|
0.35 |
|
|
|
0.25 |
|
|
|
0.29 |
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As of
March 16, 2009, we had approximately 790 holders of common stock of
record.
We have
not paid any dividends on our common stock and do not anticipate paying cash
dividends on our common stock in the foreseeable future. We intend to
retain any earnings to finance the growth of our business. We cannot
assure you that we will ever pay cash dividends. Whether we pay cash
dividends in the future will be at the discretion of our Board of Directors and
will depend upon our financial condition, results of operations, capital
requirements and any other factors that the Board of Directors decides are
relevant. See Management’s Discussion and Analysis of Financial
Condition and Results of Operations.
Recent
Sales of Unregistered Securities
The
following sets forth certain information regarding the sale of equity securities
of our Company during the period covered by this report that were not registered
under the Securities Act of 1933 (the Securities Act), and have not been
previously reported by us in periodic reports filed under the Securities
Exchange Act of 1934 (the Exchange Act).
During
2008, an outside investor who received warrants to purchase our common stock in
connection with a November 2003 financing exercised a total of 200,200 Series R
warrants in exchange for issuance of 200,200 shares of our common stock,
resulting in gross proceeds of $56,056. In addition, certain outside
investors who also received warrants to purchase our common stock in connection
with the November 2003 financing exercised a total of 2,658,698 Series R
warrants and 644,565 Series S warrants on a cashless basis in exchange for
issuance of 1,289,990 shares of our common stock. The issuances of
the shares to the investors were exempt from registration under Sections 4(2)
and 4(6) of the Securities Act and Regulation D
During
2008, David C. Bupp, our President and CEO, who received warrants in connection
with an April 2003 financing, exercised 375,000 Series Q warrants in exchange
for issuance of 375,000 shares of our common stock, resulting in gross proceeds
of $48,750. In addition, an outside investor, who also received
warrants in connection with an April 2003 financing, exercised 500,000 Series Q
warrants in exchange for issuance of 500,000 shares of our common stock,
resulting in gross proceeds of $65,000. During 2009 to date, Mr. Bupp
exercised a portion of his outstanding Series Q warrants in exchange for
issuance of 50,000 shares of our common stock, resulting in gross proceeds of
$25,000. The issuance of the warrants to Mr. Bupp and the outside
investor were exempt from registration under Sections 4(2) and 4(6) of the
Securities Act and Regulation D.
Item
6. Selected Financial Data
Not
applicable to smaller reporting companies.
Item
7. Management’s Discussion and Analysis of Financial Condition and
Results of Operations
The
following discussion should be read together with our Consolidated Financial
Statements and the Notes related to those statements, as well as the other
financial information included in this Form 10-K. Some of our
discussion is forward-looking and involves risks and uncertainties. For
information regarding risk factors that could have a material adverse effect on
our business, refer to Item 1A of this Form 10-K, Risk Factors.
The
Company
Neoprobe
Corporation is a biomedical technology company that provides innovative surgical
and diagnostic products that enhance patient care. We currently
market two lines of medical devices; our neoprobe® GDS gamma detection systems
and the Quantix® line of blood flow
measurement devices of our subsidiary, Cardiosonix. In addition to
our medical device products, we have two radiopharmaceutical products, Lymphoseek® and
RIGScan® CR, in advanced phases
of clinical development. We are also exploring the development of our
activated cellular therapy (ACT) technology for patient-specific disease
treatment through our majority-owned subsidiary, Cira Biosciences, Inc. (Cira
Bio).
Executive
Summary
This
Executive Summary section contains a number of forward-looking statements, all
of which are based on our current expectations. Actual results may
differ materially. Our financial performance is highly dependent on
our ability to continue to generate income and cash flow from our medical device
product lines. We cannot assure you that we will achieve the volume
of sales anticipated, or if achieved, that the margin on such sales will be
adequate to produce positive operating cash flow. We continue to be
optimistic about the longer-term potential for our proprietary, procedural-based
technologies such as Lymphoseek and RIGS®
(radioimmunoguided surgery); however, these technologies are not anticipated to
generate any significant revenue for us during 2009. In addition, we
cannot assure you that these products will ever obtain marketing clearance from
the appropriate regulatory bodies.
We
believe that the future prospects for Neoprobe continue to improve as we make
progress in all of our key growth areas. Our development efforts during 2008
were focused primarily on support of Lymphoseek product
development. However, we continued to modestly invest in our gamma detection
device line related to product line expansion and innovation and to move our
RIGS initiative forward
with modest expenditures. Our efforts during 2008 resulted in the following
research and investment milestone achievements:
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Initiated
patient enrollment in a Phase 3 clinical study to evaluate the efficacy of
Lymphoseek in
patients with breast cancer or
melanoma.
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Submitted
a protocol design for a second Phase 3 clinical study to evaluate the
efficacy of Lymphoseek as a sentinel
lymph node tracing agent in patients with head and neck squamous cell
carcinoma to the U.S. Food and Drug Administration (FDA) and the European
Medicinal Evaluation Agency (EMEA) and received a positive protocol
assessment from EMEA.
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Received
a positive response on a regulatory pathway and a Phase 3 clinical trial
design for RIGScan
CR with regulatory authorities in the European Union (EU) under the
scientific review process.
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Completed
$6 million in investments from Platinum-Montaur Life Sciences LLC
(Montaur). The closings represented the second and third
tranches of a total $13 million investment received from Montaur since
December of 2007. The third closing of the investment occurred
following notification to Montaur of results from the first 135 lymph
nodes tested in a Phase 3 clinical trial for Lymphoseek in patients
with breast cancer or melanoma.
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Introduced
an enhanced neoprobe
GDS gamma detection system control
unit.
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Introduced
a wireless version of a laparoscopic gamma detection probe based on
Bluetooth®
wireless technology.
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Our
Outlook for our Drug and Therapeutic Initiatives
The
primary focus of our drug and therapeutic development efforts during 2008
centered on completing regulatory submissions of our successful Phase 2 clinical
trial for Lymphoseek for
patients with breast cancer or melanoma and on preparing for and initiating of
Phase 3 clinical trial activities with Lymphoseek in similar patient
populations. Lymphoseek is intended to be
used in surgical procedures for the detection of cancer cells in lymph nodes in
a variety of tumor types including breast, melanoma, prostate, gastric and colon
cancers. If approved, Lymphoseek would be the first
radiopharmaceutical specifically designed to target the sentinel lymph node(s)
that may be predictive of the spread of cancer into the lymphatic
system. We expect our drug-related development expenses to increase
significantly for 2009 over 2008 as we conclude the first of two multi-center
Phase 3 clinical evaluations of Lymphoseek, as we prepare to
initiate the second of such Phase 3 trials and as we continue to support the
drug manufacturing and validation activities related to supporting the potential
marketing registration of Lymphoseek.
During
2008, we initiated patient enrollment in the first of the two phase 3 clinical
studies to be conducted in patients with either breast cancer or
melanoma. In March 2009, we announced that this first study had
reached the accrual of 203 lymph nodes, the study’s primary accrual
objective. In the previous Phase 2 multi-center study of Lymphoseek, which was also
conducted in patients with breast cancer or melanoma, an overall localization
rate of 94% in lymph nodes was achieved in those patients where both a vital
blue dye and Lymphoseek
were used. A similar concordance rate of 94% was established by
Neoprobe and FDA as the primary efficacy objective for the Phase 3 trial,
NEO3-05. Based upon the intraoperative worksheets and preliminary
pathology reports, we believe that the primary efficacy end-point of NEO3-05 has
been achieved and no incidents related to drug safety have been reported in the
Lymphoseek
studies. Upon completion of a full analysis of the Phase 3 data, we
will provide a complete update on the study results after all clinical data has
been reviewed by our internal clinical team and external
consultants. We expect full data will be available in the 2nd quarter
of 2009.
In
addition, we continue to prepare to commence a second Phase 3 study to be
conducted in patients with head and neck squamous cell
carcinoma. This second Phase 3 study is designed to validate Lymphoseek as a sentinel lymph
node targeting agent. Our discussions with FDA and EMEA have also
suggested that the Phase 3 trials will support an intended use of Lymphoseek in sentinel lymph
node biopsy procedures. We believe such an indication, if approved,
would be beneficial to the marketing and commercial adoption of Lymphoseek in the U.S. and
EU. We plan to use the safety and efficacy results from the Phase 3
clinical evaluations of Lymphoseek, which will include
sites in the EU, to support the drug registration application process in the EU
as well as in the U.S. We received EMEA’s consent to an open label
Phase 3 trial in the third quarter of 2008 and began efforts during the fourth
quarter to harmonize the trial approach with FDA. We plan to have
approximately 25 participating institutions in the trial, which we hope will
enable us to enroll patients at a fairly rapid rate. We have provided
a number of the trial sites with the protocol and other supporting documentation
and are awaiting clearances from the institutional review boards at a number of
the participating institutions in order to commence patient
enrollment. Our goal is to file the new drug application for Lymphoseek in early 2010;
however, this will be dependent upon our ability to commence and successfully
conclude the Phase 3 clinical studies in a timely fashion. Depending
on the timing and outcome of the FDA regulatory review cycle, we believe that
Lymphoseek may be
commercialized in late 2010 or early 2011. We cannot assure you,
however, that this product will achieve regulatory approval, or if approved,
that it will achieve market acceptance.
During
2008, we continued to make progress in advancing our RIGScan CR development program
while incurring minimal research expenses. Our RIGS technology, which had
been essentially inactive since failing to gain approval following our original
license application in 1997, has been the subject of renewed interest due
primarily to the analysis of survival data related to patients who participated
in the original Phase 3 clinical studies that were completed in
1996. We believe our RIGScan progress took a
significant step forward during 2008.
In July
2008, we initiated a scientific review of a Phase 3 trial design for RIGScan CR with EMEA and
completed a pre-submission meeting; we received their decision on the scientific
review of the RIGScan
clinical program in October 2008. The scientific advice review
process and EMEA response yielded a number of positive
outcomes. First, we were able to present and to have accepted a
proposal for the reactivation of the manufacturing of the biologic used in RIGScan CR and the
radiolabeling of the product. Second, EMEA indicated all of the
safety data previously generated in the RIGScan clinical trials was
accepted by opinion; further, the opinion indicated that the historical safety
data coupled with any prospective data would be sufficient to establish the
safety parameters for RIGScan
CR. Thirdly, the scientific advice opinion agreed with our assessment
that RIGScan CR could be
assessed in a mixed population of primary and recurrent/metastatic colorectal
patients. This resulted in a proposed trial design involving
approximately 380 patients in total with equal control and RIGS treatment
groups. This number of patients is significantly less than had been
considered previously. The participants in the trial would be
randomized to either a control or RIGS treatment
arm. Patients randomized to the RIGS arm would have their
disease status evaluated at the end of their cancer surgery to determine the
presence or absence of RIGS-positive
tissue. Patients in both randomized arms would be followed to
determine if patients with RIGS-positive status have a
lower overall survival rate and/or a higher occurrence of disease
recurrence. The hypothesis for the trial is based upon the data from
the earlier NEO2-13 and NEO2-14 trial results. Finally, the advice
opinion provided Neoprobe with the opportunity to seek a conditional marketing
authorization (CMA) for RIGScan CR in the EU at
various points in the development process, although there can be no assurance
that if such a request is submitted, it would receive a favorable
response. CMA procedures were established by EMEA in 2007, and
provide a time specific marketing authorization for a product treating a
life-threatening illness while additional development work is being
completed. A CMA is subject to annual review by EMEA’s governing body
which ratified the RIGScan
scientific advice.
We
continue to believe it will be necessary for us to identify a development
partner or an alternative funding source in order to prepare for and fund the
pivotal clinical testing that will be necessary to gain marketing clearance for
RIGScan
CR. We believe the recent positive feedback from EMEA adequately
clarifies the regulatory pathway in a fashion that will allow us to re-approach
parties that we have talked to in the past as well as potential new
parties. The development timeline for RIGScan CR is highly dependent
on securing adequate financial support to move the project forward in a timely
fashion in order to satisfy development diligence
requirements. However, even if we are able to establish a development
partnership or obtain funding arrangements on satisfactory terms, we believe it
would take a minimum of 12 – 15 months following the restart of biologic
production activities before a pivotal clinical trial could
commence. Excluding the potential opportunity to seek a CMA, the time
required for continued development, regulatory approval and commercialization of
a RIGS product would
likely be a minimum of five years before we receive any significant
product-related royalties or revenues. We cannot assure you that we
will be able to complete definitive agreements with a development partner or
obtain financing to fund development of the RIGS technology, and do not
know if such arrangements could be obtained on a timely basis on terms
acceptable to us, or at all. We also cannot assure you that FDA or
EMEA will clear our RIGS
products for marketing or that any such products will be successfully introduced
or achieve market acceptance.
We still
hope to raise funds through our subsidiary, Cira Bio, to support the continued
development of ACT; however, our fundraising efforts have thus far not been
successful. We do not know if we will be successful in obtaining
funding on terms acceptable to us, or at all. In the event we fail to
obtain financing for Cira Bio, the technology rights for the oncology
applications of ACT may revert back to Neoprobe and the technology rights for
the viral and autoimmune applications may revert back to Cira LLC upon notice by
either party.
Medical
Device Business Outlook
We
believe our core gamma detection device business line will continue to achieve
positive results in 2009. Our belief is based on continued interest in the
research community in lymphatic mapping. Although numerous studies have examined
the correlation between the sentinel node and the remaining axillary nodes, two
large randomized multi-center trials ended about three years ago that will
compare the long-term results of sentinel lymph node removal with full axillary
node dissection. While both of these trials are now closed, we expect data from
these studies may be published and/or presented in the near future. We expect
the results from these clinical trials, when widely publicized, will have a
further positive impact on helping us to penetrate the remaining market for
breast cancer and melanoma. We believe that the surgical community will continue
to adopt the sentinel lymph node biopsy (SLNB) application while a standard of
care determination is still pending. We also believe that Lymphoseek, our lymphatic
targeting agent, should it become commercially available, could significantly
improve the adoption of SLNB in future years in areas beyond melanoma and breast
cancer. To that end, we are supporting the clinical evaluation of Lymphoseek in human patients
in a planned Phase 3 trial in head and neck squamous cell carcinoma and in
ongoing Phase 1 trials in patients with either prostate or colon
cancers.
We
believe that most of the leading cancer treatment institutions in the U.S. and
other major global markets have adopted SLNB and purchased gamma detection
systems such as the neoprobe
GDS. As a result, we may be reaching saturation within this
segment of the market, except for a replacement sales market which we also
believe is developing as devices introduced during the early years of lymphatic
mapping begin to age over ten years. A decline in the adoption rate
of SLNB or the development of alternative technologies by competitors may
negatively impact our sales volumes, and therefore, revenues and net income in
future years. In order to address the issue of potential saturation
as well as to continue to provide our customers with the highest quality tools
for performing SLNB, we have introduced several enhancements to our gamma device
product line over the past few years and anticipate the launch of a higher
energy gamma detection probe in mid- 2009.
Our gamma
detection devices are distributed in most global markets by Ethicon
Endo-Surgery, Inc. (EES), a Johnson & Johnson
company. Under the terms of our distribution agreement with
EES, the transfer prices we receive on product sales to EES are based on a fixed
percentage of their end-customer average sales price (ASP), subject to a floor
transfer price. Throughout their sales history, our products have
generally commanded a price premium in most of the markets in which they are
sold, which we believe is due to their superior performance and ease of
use. The end-customer ASP received by EES for our base gamma
detection systems increased approximately 11% in 2008 as compared to 2007, due
in part to the favorable impact of the exchange rate on our sales prices coupled
with improved pricing on our neoprobe GDS
system. While we continue to believe in the technical and
user-friendly superiority of our products, the competitive landscape continues
to evolve and current economic conditions present a number of challenges to the
outlook for medical device sales. We may lose market share or
experience price erosion and/or lower sales volumes as a result, any of which
would have a direct negative impact on net income. If price erosion
occurs to a greater extent in 2009, or if the U.S. Dollar gains significantly
against the Euro, there is a risk associated with future sales prices of our
gamma detection devices to EES that may erode some or all of the premium we
received in prior years in excess of the floor price. However, in
December 2007, Neoprobe and EES executed an amendment to the distribution
agreement which extended the agreement through the end of 2013. The
amendment modified certain terms of the agreement including increasing the
percentage of EES’ sales which Neoprobe receives by 15-20% and setting minimum
performance requirements in order to maintain exclusivity.
We expect
revenue from our medical device lines to continue to provide a strong revenue
base during 2009 and for our device gross margins to improve based on changes in
our underlying distribution agreements; however, it is difficult, given the
potential impact of current economic conditions on medical device purchasing, to
precisely estimate where overall revenues for 2009 may be. We expect
to continue to incur modest development expenses to support our device product
lines as we work with our marketing partners to expand our product offerings in
the gamma detection device arena. During 2008, we significantly
curtailed our financial support for our blood flow measurement
products. We expect to continue to limit such expenditures in
2009. We expect that sales of our medical devices in 2009 will result
in a net profit for these business lines in 2009, excluding the allocation of
any corporate general and administrative costs. If we are
unsuccessful in achieving adequate commercial sales from our medical device
sales, our profitability outlook will be adversely affected and our business
plan may need to be modified.
Primarily
as a result of the significant development costs we expect to incur related to
the continued clinical development of Lymphoseek, we do not expect
to achieve operating profit during 2009. In addition, our net loss
and loss per share will likely be significantly impacted by the non-cash
interest expense we expect to record due to the accounting treatment for the
derivative liabilities related to the convertible debt we issued in December
2007, and the beneficial conversion feature, warrants and derivative liabilities
related to the convertible debt we issued in April 2008. We cannot
assure you that our current or potential new products will be successfully
commercialized, that we will achieve significant product revenues, or that we
will achieve or be able to sustain profitability in the future.
Results
of Operations
Revenue
for 2008 increased to $7.9 million from $7.1 million in the prior
year. The increase was primarily due to sales of our neoprobe GDS control units
(launched during 2008) and wireless probes, offset by decreases in sales of the
legacy versions of our gamma detection systems (i.e., neo2000 control units and
corded probes) and of our blood flow measurement devices. In
addition, we recognized revenue of $172,000 related to research and
development revenue from EES related to the development of a high energy
probe recently introduced at a conference of the Society of Surgical
Oncology.
Gross
margins for 2008 increased to 62% as compared to 55% in 2007. The
increase in gross margins was due to a combination of factors including research
and development revenue from EES in 2008, a lower proportionate level of
demonstration units placed in 2008 compared to 2007, increased unit sales and
prices of gamma detection control units and increased unit sales and prices of
wireless probes offset by a decrease in the percentage of ASP for wireless
probes received by Neoprobe. The price increases we experienced in
2008 were due in part to the current favorable impact on our sales prices to EES
of the Euro to U.S. Dollar exchange rate as well as improvement in prices in
base currencies. Gross margins in 2008 and 2007 were also adversely
affected by inventory impairments of $26,000 and $105,000, respectively, related
to our Quantix
products.
Results
for 2008 also reflect an increase in research and development expenditures of
$1.6 million to $4.5 million from $2.9 million in 2007. The increase
was primarily due to higher Lymphoseek development
expenses related to conducting the Phase 3 clinical trials as well as increased
activities related to RIGScan
CR. Research and development costs were further increased by
additional expenses related to investment in our gamma detection device line
related to product line expansion and innovation, offset by cost savings related
to curtailing our activities associated with the blood flow measurement
line. Consolidated selling, general and administrative expenses
increased to $3.4 million in 2008 from $2.8 million in 2007.
Net Sales and
Margins. Net sales, comprised primarily of sales of our gamma
detection systems, increased $590,000, or 8%, to $7.7 million during 2008 from
$7.1 million in 2007. Gross margins on net sales increased to 62% of
net sales for 2008 compared to 55% of net sales for 2007.
The
wireless innovations we have made to both the probes and control units in our
gamma detection device product line over the last two years have positively
impacted our sales in 2008. Overall, the increase in net sales was
the result of increased gamma detection device sales of $491,000, increased
gamma detection device extended service contract revenue of $145,000 and
increased gamma detection device service-related revenue of $9,000, offset by
decreased blood flow measurement device sales of $55,000. Increased
unit sales of our control units and wireless probes were partially offset by
decreased unit sales of corded probes. Increased unit prices of our
control units and corded probes were partially offset by decreased unit prices
of our wireless probes due to a decrease in the percentage of ASP received by
Neoprobe offsetting an overall increase in ASP for wireless
probes.
The
increase in gross margins on net product sales was due to a combination of
factors including a lower proportionate level of demonstration units placed in
2008 compared to 2007, increased unit sales and prices of gamma detection
control units and increased unit sales and prices of wireless probes offset by a
decrease in the percentage of ASP for wireless probes received by
Neoprobe. The price increases we experienced in 2008 were due in part
to the current favorable impact on our sales prices to EES of the Euro to U.S.
Dollar exchange rate. Gross margins in 2008 and 2007 were also
adversely affected by inventory impairments of $26,000 and $105,000,
respectively, related to our Quantix products.
Research and Development
Expenses. Research and development expenses increased $1.6
million, or 57%, to $4.5 million during 2008 from $2.9 million in
2007. Research and development expenses in 2008 included
approximately $3.3 million in drug and therapy product development costs,
$949,000 in gamma detection device development costs, and $219,000 in product
design and support activities for the Quantix
products. This compares to expenses of $1.8 million, $680,000 and
$359,000 in these segment categories in 2007. The changes in each
category were primarily due to (i) increased clinical activities related to
Lymphoseek due to costs
of conducting the Phase 3 clinical trials in 2008 being higher than costs of
conducting the Phase 2 clinical trials in 2007, as well as increased activities
related to RIGScan CR,
(ii) development of our neoprobe GDS control units and
various probes in 2008, and (iii) decreased product refinement activities
related to our Quantix
devices, respectively.
Selling, General and Administrative
Expenses. Selling, general and administrative expenses
increased $575,000, or 20%, to $3.4 million during 2008 from $2.8 million in
2007. The net difference was due primarily to increases in investor
relations expenses, professional services and personnel-related
expenses.
Other Income
(Expenses). Other expenses, net decreased $1.2 million to $2.1
million during 2008 from $3.3 million in 2007. Interest expense,
primarily related to the convertible debt agreements we completed in December
2004, July 2007, December 2007 and April 2008, decreased $539,000 to $1.7
million during 2008 from $2.3 million in 2007. Of this interest
expense, $706,000 and $1.4 million in 2008 and 2007, respectively, was non-cash
in nature related to the amortization of debt issuance costs and discounts
resulting from the warrants, beneficial conversion features and derivative
liabilities related to the convertible debt. Interest expense in 2007
also included an adjustment to non-cash interest which was recorded in the third
quarter of 2007. During the fourth quarter of 2007, we also recorded
debt extinguishment charges of $860,000 related to modification of the terms of
a convertible debt agreement with our CEO. In addition, during 2008
and 2007, we recorded $451,000 and $248,000, respectively, of increases in
derivative liabilities resulting from the accounting treatment for the
convertible note agreements we executed in December 2007 and April 2008 and the
related warrants to purchase our common stock, which contained certain
provisions that resulted in their being treated as derivative
instruments.
Liquidity
and Capital Resources
Cash and
investment balances increased to $4.1 million at December 31, 2008 from $1.5
million at December 31, 2007. The net increase was primarily derived
from proceeds from new convertible debt and the issuance of preferred stock
during 2008, offset by cash used to service our outstanding debt and to fund our
operations, mainly for research and development activities. The
current ratio increased to 3.1:1 at December 31, 2008 from 2.1:1 at December 31,
2007. The increase in the current ratio was primarily due to the
increase in cash and investment balances.
Operating
Activities. Cash used in operations increased $1.7 million to
$3.0 million during 2008 compared to $1.3 million in 2007.
Accounts
receivable remained steady at $1.6 million at December 31, 2008 and
2007. We expect overall receivable levels will continue to fluctuate
during 2009 depending on the timing of purchases and payments by
EES.
Inventory
levels decreased to $962,000 at December 31, 2008 as compared to $1.2 million at
December 31, 2007. Gamma detection device materials decreased as
materials were converted into finished devices. Blood flow
measurement device materials decreased primarily as a result of inventory
impairments of $26,000. Blood flow measurement finished device
inventories also decreased as a result of sales. During the third
quarter of 2008 we recorded an inventory adjustment charge related to our Lymphoseek product of $153,000
due to changes in our projections of the probability of future commercial use of
the previously capitalized costs. These decreases were offset by
increased gamma detection device finished goods due primarily to the timing of
production runs and sales to EES. We expect inventory levels to
increase during 2009 primarily as a result of production of a commercial lot of
Lymphoseek.
Investing Activities. Cash
used in investing activities increased $579,000 to $627,000 during 2008 compared
to $48,000 during 2007. We purchased $690,000 of available-for-sale securities
during 2008, $196,000 of which also matured during 2008. Capital expenditures
during 2008 were primarily for software, computers, production tools and
equipment and laboratory equipment. Capital expenditures during 2007 were
primarily for production tools and equipment and software. We expect our overall
capital expenditures for 2009 will be higher than in 2008 as we prepare for the
commercial production of Lymphoseek.
Financing
Activities. Cash provided by financing activities increased
$5.3 million to $5.7 million during 2008 compared to $351,000 during
2007. Proceeds from the issuance of preferred stock were $3.0 million
during 2008. Proceeds from the issuance of common stock were $232,000
and $1.9 million during 2008 and 2007, respectively. Payments of
stock issuance costs were $181,000 and $23,000 during the same
periods. Proceeds from the issuance of new notes payable were $3.0
and $8.0 million during 2008 and 2007, respectively. Payments of
notes payable were $158,000 and $8.3 million during 2008 and 2007,
respectively. Payments of debt issuance costs were $200,000 and
$565,000 during the same periods. Payments for the repurchase of
warrants related to debt extinguished in 2007 totaled $675,000.
In
December 2004, we completed a private placement of four-year convertible
promissory notes in an aggregate principal amount of $8.1 million under a
Securities Purchase Agreement with Biomedical Value Fund, L.P., Biomedical
Offshore Value Fund, Ltd. and David C. Bupp, our President and
CEO. Biomedical Value Fund, L.P. and Biomedical Offshore Value Fund,
Ltd. are funds managed by Great Point Partners, LLC (collectively, the Great
Point Funds). The notes originally bore interest at 8% per annum and
were due on December 13, 2008. As part of the original transaction
with the Great Point Funds, we issued the investors Series T warrants to
purchase 10,125,000 shares of our common stock at an exercise price of $0.46 per
share, expiring in December 2009. In connection with this financing,
we also issued Series U warrants to purchase 1,600,000 shares of our common
stock to the placement agents, containing substantially the same terms as the
warrants issued to the investors.
In
November 2006, we amended the Securities Purchase Agreement and modified several
of the key terms in the related notes, including the interest rate which was
increased to 12% per annum, and modified the maturity of the notes to provide
for a series of scheduled payments due on approximately six month intervals
through January 7, 2009. We were also required to make additional
mandatory repayments of principal to the Great Point Funds under certain
circumstances. In exchange for the increased interest rate and
accelerated principal repayment schedule, the note holders eliminated the
financial covenants under the original notes and eliminated certain conversion
price adjustments from the original notes related to sales of equity securities
by Neoprobe. During 2007, we made scheduled principal payments
and mandatory repayments totaling $2.4 million. We made no payments
during 2008 due to the complete repayment of all outstanding obligations under
the Replacement Series A Promissory Notes in December 2007.
In
December 2006, we entered into a common stock purchase agreement with Fusion
Capital, an Illinois limited liability company, to sell $6.0 million of our
common stock to Fusion Capital over a 24-month period which ended on November
21, 2008. Through November 21, 2008, we sold to Fusion Capital under
the agreement 7,568,671 shares for proceeds of $1.9 million. In
December 2008, we entered into an amendment to the agreement which gave us a
right to sell an additional $6.0 million of our common stock to Fusion Capital
before March 1, 2011, along with the $4.1 million of the unsold balance of the
$6.0 million we originally had the right to sell to Fusion Capital under the
original agreement. After giving effect to this amendment, the
remaining aggregate amount of our common stock we can sell to Fusion Capital is
$10.1 million. In respect of sales to Fusion Capital that we may make
in the future under the amended agreement, we have reserved authorized a total
of 10,654,000 shares of our common stock.
In
December 2006, we issued to Fusion Capital 720,000 shares of our common stock as
a commitment fee upon execution of the original agreement. As sales
of our common stock were made under the original agreement, we issued an
additional 234,000 shares of our common stock to Fusion Capital as an additional
commitment fee. In connection with entering into the amendment, we
issued an additional 360,000 shares in consideration for Fusion Capital’s
entering into the amendment. Also, as an additional commitment fee,
we have agreed to issue to Fusion Capital an additional 486,000 shares of our
common stock pro rata as we sell the first $4.1 million of our common stock to
Fusion Capital under the amended agreement.
In July
2007, David C. Bupp, our President and CEO, and certain members of his family
(the Bupp Investors) purchased a $1.0 million convertible note (the Bupp Note)
and warrants. The note bears interest at 10% per annum, had an
original term of one year and is repayable in whole or in part with no
penalty. The note is convertible into shares of our common stock at a
price of $0.31 per share, a 25% premium to the average closing market price of
our common stock for the 5 days preceding the closing of the
transaction. As part of this transaction, we issued the investors
500,000 Series V warrants to purchase our common stock at an exercise price of
$0.31 per share, expiring in July 2012.
In
December 2007, we entered into a Securities Purchase Agreement (SPA) with
Montaur, pursuant to which we issued Montaur a 10% Series A Convertible Senior
Secured Promissory Note in the principal amount of $7,000,000, due December 26,
2011 (the Series A Note) and a five-year Series W warrant to purchase 6,000,000
shares of our common stock, $.001 par value per share, at an exercise price of
$0.32 per share. Montaur may convert $3.5 million of the Series A
Note into shares of our common stock at the conversion price of $0.26 per
share. The SPA also provided for two further tranches of financing, a
second tranche of $3 million in exchange for a 10% Series B Convertible Senior
Secured Promissory Note along with a five-year Series X warrant to purchase
shares of our common stock, and a third tranche of $3 million in exchange for
3,000 shares of our 8% Series A Cumulative Convertible Preferred Stock and a
five-year Series Y warrant to purchase shares of our common
stock. Closings of the second and third tranches were subject to the
satisfaction by the Company of certain milestones related to the progress of the
Phase 3 clinical trials of our Lymphoseek radiopharmaceutical
product.
In April
2008, following receipt by the Company of clearance by FDA to commence a Phase 3
clinical trial for Lymphoseek in patients with
breast cancer or melanoma, we amended the SPA related to the second tranche and
issued Montaur a 10% Series B Convertible Senior Secured Promissory Note in the
principal amount of $3,000,000, also due December 26, 2011 (the Series B Note,
and hereinafter referred to collectively with the Series A Note as the Montaur
Notes), and a five-year Series X warrant to purchase 8,333,333 shares of our
common stock at an exercise price of $0.46 per share. Montaur may
convert the Series B Note into shares of our common stock at the conversion
price of $0.36 per share. Provided we have satisfied certain
conditions stated therein, we may elect to make payments of interest due under
the Montaur Notes in registered shares of our common stock. If we
choose to make interest payments in shares of common stock, the number of shares
of common stock to be applied against any such interest payment will be
determined by reference to the quotient of (a) the applicable interest payment
divided by (b) 90% of the average daily volume weighted average price of our
common stock on the OTCBB (or national securities exchange, if applicable) as
reported by Bloomberg Financial L.P. for the five days upon which our common
stock is traded on the OTCBB immediately preceding the date of the interest
payment.
In
December 2008, after we obtained 135 vital blue dye lymph nodes from patients
who had completed surgery and the injection of the drug in a Phase 3 clinical
trial of Lymphoseek in
patients with breast cancer or melanoma, we issued Montaur 3,000 shares of our
8% Series A Cumulative Convertible Preferred Stock (the Preferred Stock) and a
five-year Series Y warrant (hereinafter referred to collectively with the Series
W warrant and Series X warrant as the Montaur Warrants) to purchase 6,000,000
shares of our common stock, at an exercise price of $0.575 per share, also for
an aggregate purchase price of $3,000,000. Montaur may convert each
share of the Preferred Stock into a number of shares of our common stock equal
to the quotient of (a) the Liquidation Preference Amount of the shares of
Preferred Stock by (b) the Conversion Price. The “Liquidation Preference Amount”
for the Preferred Stock is $1,000 and the “Conversion Price” of the Preferred
Stock was set at $0.50 on the date of issuance, thereby making the shares of
Preferred Stock convertible into an aggregate 6,000,000 shares of our common
stock, subject to
adjustment as described in the Certificate of Designations, Voting Powers,
Preferences, Limitations, Restrictions, and Relative Rights of Series A 8%
Cumulative Convertible Preferred Stock. We may elect to pay
dividends due to Montaur on the shares of Preferred Stock in registered shares
of our common stock. The number of shares of common stock to be
applied against any such dividend payment will be determined by reference to the
quotient of (a) the applicable dividend payment by (b) the average daily volume
weighted average price of our common stock on the OTCBB (or national securities
exchange, if applicable) as reported by Bloomberg Financial L.P. for the five
days upon which our common stock is traded on the OTCBB immediately preceding
the date of the dividend payment.
In
connection with the Montaur SPA, the term of the $1.0 million Bupp Note was
extended to December 27, 2011, one day following the maturity date of the
Montaur Notes. In consideration for the Bupp Investors’ agreement to
extend the term of the Bupp Note pursuant to an Amendment to the Bupp Purchase
Agreement, dated December 26, 2007, we agreed to provide security for the
obligations evidenced by the Amended 10% Convertible Note in the principal
amount of $1,000,000, due December 31, 2011, executed by Neoprobe in favor of
the Bupp Investors (the Amended Bupp Note), under the terms of a Security
Agreement, dated December 26, 2007, by and between Neoprobe and the Bupp
Investors (the Bupp Security Agreement). This security interest is
subordinate to the Security interest of Montaur. As further
consideration for extending the term of the Bupp Note, we issued the Bupp
Investors Series V warrants to purchase 500,000 shares of our common stock at an
exercise price of $0.32 per share, expiring in December 2012. The
Amended Bupp Note had an outstanding principal amount of $1.0 million on
December 31, 2008, and an outstanding principal amount of $1.0 million as of
March 16, 2009. During 2008, we paid no amount of the outstanding
principal, and paid $100,000 in interest due under the Amended Bupp
Note.
We
applied $5,725,000 from the proceeds of our issuance of the Series A Note and
Series W warrant to the complete repayment of our outstanding obligations under
the Replacement Series A Convertible Promissory Notes issued to the Great Point
Funds and David C. Bupp as of November 30, 2006, pursuant to the Securities
Purchase Agreement, dated as of December 13, 2004, by and among Neoprobe, the
Great Point Funds and Mr. Bupp, as amended by the Amendment dated as of November
30, 2006 (the Amended GPP Purchase Agreement). We applied an
additional $675,000 from the proceeds of our issuance of the Series A Note
and Series W warrant to the redemption of Series T warrants to purchase
10,000,000 shares of our common stock at an exercise price of $0.46 per share,
issued to the Great Point Funds pursuant to the Amended GPP Purchase
Agreement. In connection with the consummation of the Montaur SPA and
amendment of the Bupp Purchase Agreement, Mr. Bupp agreed to the cancellation of
Series T warrants to purchase 125,000 shares of our common stock at an exercise
price of $0.46 per share, issued to Mr. Bupp pursuant to the Amended GPP
Purchase Agreement without additional consideration to Mr. Bupp other than
discussed above.
Our
future liquidity and capital requirements will depend on a number of factors,
including our ability to expand market acceptance of our current products, our
ability to complete the commercialization of new products, our ability to
monetize our investment in non-core technologies, our ability to obtain
milestone or development funds from potential development and distribution
partners, regulatory actions by FDA and international regulatory bodies, and
intellectual property protection. Our most significant near-term
development priority is to finalize the results from the first of two Phase 3
clinical trials for Lymphoseek and to initiate the
second Phase 3 trial. We believe our current funds and available
capital resources will be adequate to complete our Lymphoseek development efforts
and sustain our operations at planned levels through 2009. We are
also in the process of determining the total development cost necessary to
commercialize RIGScan CR
but believe that it will require commitments of between $3 million to $5 million
to restart manufacturing and other activities necessary to prepare for the Phase
3 clinical trial contemplated in the recent EMEA scientific advice
response. We may be able to raise additional funds through a stock
purchase agreement with Fusion Capital to supplement our capital
needs. However, the extent to which we rely on Fusion Capital as a
source of funding will depend on a number of factors, including the prevailing
market price of our common stock and the extent to which we are able to secure
working capital from other sources. Specifically, Fusion Capital does
not have the right or the obligation to purchase any shares of our common stock
on any business day that the market price of our common stock is less than $0.20
per share. We cannot assure you that we will be successful in raising
additional capital through Fusion Capital or any other sources at terms
acceptable to the Company, or at all. We also cannot assure you that
we will be able to successfully commercialize products, that we will achieve
significant product revenues from our current or potential new products or that
we will achieve or sustain profitability in the future.
Recent
Accounting Developments
In
September 2006, the Financial Accounting Standards Board (FASB) issued Statement
of Financial Accounting Standards (SFAS) No. 157, Fair Value Measurements (SFAS
No. 157). SFAS No. 157 defines fair value, establishes a framework for measuring
fair value in generally accepted accounting principles, and expands disclosures
about fair value measurements. SFAS No. 157 applies under other accounting
pronouncements that require or permit fair value measurements, the FASB having
previously concluded in those accounting pronouncements that fair value is the
relevant measurement attribute. Accordingly, SFAS No. 157 does not require any
new fair value measurements. SFAS No. 157 was initially effective for Neoprobe
beginning January 1, 2008. In February 2008, the FASB approved the issuance of
FASB Staff Position (FSP) FAS 157-2. FSP FAS 157-2 allows entities to electively
defer the effective date of SFAS No. 157 until January 1, 2009 for nonfinancial
assets and nonfinancial liabilities except those items recognized or disclosed
at fair value on at least an annual basis. We will apply the fair value
measurement and disclosure provisions of SFAS No. 157 to nonfinancial assets and
liabilities effective January 1, 2009. The application of such is not expected
to be material to our consolidated results of operations or financial
condition.
In
February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities – Including an Amendment of FASB Statement No.
115 (SFAS No. 159). SFAS No. 159 permits entities to choose to
measure many financial instruments and certain other items at fair value at
specified election dates. Most of the provisions of SFAS No. 159
apply only to entities that elect the fair value option. However, the
amendment to FASB Statement No. 115, Accounting for Certain Investments
in Debt and Equity Securities, applies to all entities with
available-for-sale and trading securities. The fair value option
established by SFAS No. 159 permits all entities to choose to measure eligible
items at fair value at specified election dates. A business entity
shall report unrealized gains and losses on items for which the fair value
option has been elected in earnings at each subsequent reporting
date. The fair value option may be applied instrument by instrument,
with a few exceptions, such as investments otherwise accounted for by the equity
method, is irrevocable (unless a new election date occurs), and is applied only
to entire instruments and not to portions of instruments. SFAS No.
159 is effective for fiscal years beginning after November 15,
2007. We adopted SFAS No. 159 as required on January 1, 2008;
however, we did not elect to measure any of our currently outstanding financial
instruments using the fair value option outlined in SFAS No. 159. As
such, the adoption of SFAS No. 159 did not have any impact on our consolidated
results of operations or financial condition.
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS
No. 141(R)). SFAS No. 141(R) retains the fundamental requirements of
the original pronouncement requiring that the acquisition method (formerly
called the purchase method) of accounting be used for all business combinations
and for an acquirer to be identified for each business
combination. SFAS No. 141(R) defines the acquirer as the entity that
obtains control of one or more businesses in the business combination,
establishes the acquisition date as the date that the acquirer achieves control
and requires the acquirer to recognize the assets and liabilities assumed and
any noncontrolling interest at their fair values as of the acquisition
date. SFAS No. 141(R) requires, among other things, that the
acquisition-related costs be recognized separately from the
acquisition. SFAS No. 141(R) applies prospectively to business
combinations for which the acquisition date is on or after the beginning of the
first annual reporting period beginning on or after December 15, 2008, and is
required to be adopted by Neoprobe beginning January 1, 2009. The
effect the adoption of SFAS No. 141(R) will have on us will depend on the nature
and size of acquisitions we complete after we adopt SFAS No. 141(R), if
any.
Also in
December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in
Consolidated Financial Statements – an Amendment of ARB No. 51 (SFAS No.
160). SFAS No. 160 amends ARB No. 51 to establish accounting and reporting
standards for the noncontrolling interest in a subsidiary and for the
deconsolidation of a subsidiary. It also amends certain of ARB No. 51’s
consolidation procedures for consistency with the requirements of SFAS No.
141(R), Business
Combinations. SFAS No. 160 is effective for fiscal years and interim
periods within those fiscal years beginning on or after December 15, 2008, and
is required to be adopted by Neoprobe beginning January 1, 2009. Earlier
adoption is prohibited. SFAS No. 160 shall be applied prospectively as of the
beginning of the fiscal year in which it is adopted, except for the presentation
and disclosure requirements. The presentation and disclosure requirements shall
be applied retrospectively for all periods presented. We do not expect the
adoption of SFAS No. 160 to have a material effect on our consolidated results
of operations or financial condition.
In
December 2007, the FASB ratified the consensus reached by the Emerging Issues
Task Force (EITF) on EITF Issue No. 07-1, Accounting for Collaborative
Arrangements. EITF Issue No. 07-1 focuses on defining a
collaborative arrangement as well as the accounting for transactions between
participants in a collaborative arrangement and between the participants in the
arrangement and third parties. The EITF concluded that both types of
transactions should be reported in each participant’s respective income
statement. EITF Issue No. 07-1 is effective for financial statements
issued for fiscal years beginning after December 15, 2008, and interim periods
within those fiscal years and should be applied retrospectively to all prior
periods presented for all collaborative arrangements existing as of the
effective date. We do not expect EITF Issue No. 07-1 to have a
material effect on our consolidated results of operations or financial
condition.
In March
2008, the FASB issued SFAS No. 161, Disclosures about Derivative
Instruments and Hedging Activities – an Amendment of FASB Statement No.
133 (SFAS No. 161). SFAS No. 161 amends and expands the
disclosure requirements of Statement No. 133 to provide a better understanding
of how and why an entity uses derivative instruments, how derivative instruments
and related hedged items are accounted for, and their effect on an entity’s
financial position, financial performance, and cash flows. SFAS No.
161 is effective for fiscal years beginning after November 15,
2008. We are currently evaluating the impact that the adoption of
SFAS No. 161 will have on our derivative disclosures.
In June
2008, the FASB ratified the consensus reached by the EITF on EITF Issue No.
07-5, Determining Whether an
Instrument (or Embedded Feature) is Indexed to an Entity’s Own
Stock. EITF Issue No. 07-5 clarifies the determination of
whether equity-linked instruments (or embedded features), such as our
convertible notes or warrants to purchase our common stock, are considered
indexed to our own stock, which would qualify as a scope exception under SFAS
No. 133, Accounting for
Derivative Instruments and Hedging Activities. EITF Issue No.
07-5 is effective for financial statements issued for fiscal years beginning
after December 15, 2008. Early adoption for an existing instrument is
not permitted. We are currently evaluating the impact that the
adoption of EITF Issue No. 07-5 will have on our consolidated financial
statements. If we determine that the provisions of EITF Issue No.
07-5 are applicable to our financial instruments, we currently estimate that the
adoption of EITF Issue No. 07-5 will result in a cumulative effect adjustment of
approximately $3.9 million that would be recorded as additional accumulated
deficit during the first quarter of 2009 as well as the disclosure of additional
derivative liabilities in our balance sheet in future reports.
Critical
Accounting Policies
The following accounting policies
are considered by us to be critical to our results of operations and financial
condition.
Revenue Recognition Related to Net
Sales. We currently generate revenue primarily from sales of
our gamma detection products; however, sales of blood flow measurement products
constituted approximately 4% of total revenues for 2008. Our standard
shipping terms are FOB shipping point, and title and risk of loss passes to the
customer upon delivery to a common carrier. We generally recognize
sales revenue related to sales of our products when the products are shipped and
the earnings process has been completed. However, in cases where
product is shipped but the earnings process is not yet completed, revenue is
deferred until it has been determined that the earnings process has been
completed. Our customers have no right to return products purchased
in the ordinary course of business.
The
prices we charge our primary customer, EES, related to sales of products are
subject to retroactive annual adjustment based on a fixed percentage of the
actual sales prices achieved by EES on sales to end customers made during each
fiscal year. To the extent that we can reasonably estimate the
end-customer prices received by EES, we record sales to EES based upon these
estimates. If we are unable to reasonably estimate end customer sales
prices related to certain products sold to EES, we record revenue related to
these product sales at the minimum (i.e., floor) price provided for under our
distribution agreement with EES.
We also
generate revenue from the service and repair of out-of-warranty
products. Fees charged for service and repair on products not covered
by an extended service agreement are recognized on completion of the service
process when the serviced or repaired product has been returned to the
customer. Fees charged for service or repair of products covered by
an extended warranty agreement are deferred and recognized as revenue ratably
over the life of the extended service agreement.
Use of
Estimates. The preparation of financial statements in
conformity with U.S. generally accepted accounting principles requires
management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosures of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. We base these estimates and
assumptions upon historical experience and existing, known
circumstances. Actual results could differ from those
estimates. Specifically, management may make significant estimates in
the following areas:
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Stock-Based
Compensation. We
account for stock-based compensation in accordance with SFAS No. 123(R),
Share-Based
Payment, which is a revision of SFAS No. 123, Accounting for Stock-Based
Compensation. SFAS No. 123(R) requires all share-based
payments to employees, including grants of employee stock options, to be
recognized in the income statement based on their estimated fair
values. Compensation cost arising from stock-based awards is
recognized as expense using the straight-line method over the vesting
period. We use the Black-Scholes option pricing model to value
share-based payments. The valuation assumptions used have not
changed from those used under SFAS No.
123.
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Inventory
Valuation. We value our inventory at the lower of cost
(first-in, first-out method) or market. Our valuation reflects
our estimates of excess, slow moving and obsolete inventory as well as
inventory with a carrying value in excess of its net realizable
value. Write-offs are recorded when product is removed from
saleable inventory. We review inventory on hand at least
quarterly and record provisions for excess and obsolete inventory based on
several factors, including current assessment of future product demand,
anticipated release of new products into the market, historical experience
and product expiration. Our industry is characterized by rapid
product development and frequent new product
introductions. Uncertain timing of product approvals,
variability in product launch strategies, regulations regarding use and
shelf-life, product recalls and variation in product utilization all
impact the estimates related to excess and obsolete
inventory.
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Impairment or Disposal of
Long-Lived Assets. We account for long-lived assets in
accordance with the provisions of SFAS No. 144, Accounting for the Impairment
or Disposal of Long-Lived Assets. This Statement
requires that long-lived assets and certain identifiable intangibles be
reviewed for impairment whenever events or changes in circumstances
indicate that the carrying amount of an asset may not be
recoverable. The recoverability of assets to be held and used
is measured by a comparison of the carrying amount of an asset to future
net undiscounted cash flows expected to be generated by the
asset. If such assets are considered to be impaired, the
impairment to be recognized is measured by the amount by which the
carrying amount of the assets exceeds the fair value of the
assets. Assets to be disposed of are reported at the lower of
the carrying amount or fair value less costs to sell. As of
December 31, 2008, the most significant long-lived assets on our balance
sheet relate to assets recorded in connection with the acquisition of
Cardiosonix. The recoverability of these assets is based on the
financial projections and models related to the future sales success of
Cardiosonix’ products. As such, these assets could be subject
to significant adjustment should the Cardiosonix technology not be
successfully commercialized or the sales amounts in our current
projections not be realized.
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Product
Warranty. We warrant our products against defects in
design, materials, and workmanship generally for a period of one year from
the date of sale to the end customer. Our accrual for warranty
expenses is adjusted periodically to reflect actual
experience. EES also reimburses us for a portion of warranty
expense incurred based on end customer sales they make during a given
fiscal year.
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Fair Value of Derivative
Liabilities. We account for derivatives in accordance with SFAS No.
133, Accounting for
Derivative Instruments and Hedging Activities, which provides
accounting and reporting standards for derivative instruments, including
certain derivative instruments embedded in other contracts, and for
hedging activities. Derivative instruments embedded in contracts, to the
extent not already a free-standing contract, are required to be bifurcated
from the debt instrument and accounted for separately. All derivatives are
recorded on the consolidated balance sheet at fair value. In accordance
with SFAS No. 133, the conversion option and two put options embedded in
the Series A Note issued in December 2007 were considered derivative
instruments and were required to be bifurcated from the debt instrument
and accounted for separately. In addition, in accordance with SFAS No.
150, Accounting for
Certain Financial Instruments with Characteristics of both Liabilities and
Equity, the Series W warrant issued in connection with the Series A
Note was accounted for as a liability due to the existence of certain
provisions in the instrument. As a result, we recorded a total aggregate
derivative liability of $2.6 million on the date of issuance of the note.
The fair value of the Series W warrant was determined using the
Black-Scholes option pricing model. Changes in the fair value of the
derivative liabilities are recorded in the consolidated statement of
operations. As of December 31, 2007, the derivative liabilities had a fair
value of $1.60 million and $1.25 million for the conversion and put
options and the warrants,
respectively.
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On March
14, 2008, Neoprobe and Montaur executed amendments to the Series A Note and the
Series W warrant. The amendments eliminated certain minor cash-based
penalty provisions in the Series A Note and Series W warrant which entitled the
holders to different compensation than our common shareholders under certain
circumstances and qualifying Triggering Events. The provisions that
were eliminated and/or modified were the provisions that led to the derivative
accounting treatment for the embedded conversion option in the Series A Note and
the Series W warrant. Because the value of our stock increased
between December 31, 2007, our year end, and March 14, 2008, the effect of
marking the conversion option and warrant liabilities to “market” at March 14,
2008 resulted in an increase in the estimated fair value of the conversion
option and warrant liabilities of $381,000 which was recorded as non-cash
expense during the first quarter of 2008. The estimated fair value of
the conversion option and warrant liabilities of $2.9 million was reclassified
to additional paid-in capital during the first quarter of 2008. The
effect of marking the put option liabilities related to the Series A Note to
“market” at March 31, June 30, September 30, and December 31, 2008 resulted in a
net increase in the estimated fair value of the put option liabilities of
$51,000 which was recorded as non-cash expense during 2008. The
estimated fair value of the put option liabilities related to the Series A Note
of $360,000 remained classified as derivative liabilities as of December 31,
2008.
The two
put options embedded in the Series B Note issued in April 2008 were also
considered derivative instruments and were required to be bifurcated from the
debt instrument and accounted for separately. The fair value of the
bifurcated put options was approximately $258,000 on the date of
issuance. Changes in the fair value of the derivative liabilities are
recorded in the consolidated statement of operations. The effect of
marking the put option liabilities related to the Series B Note to “market” at
June 30, September 30, and December 31, 2008 resulted in a net increase in the
estimated fair value of the put option liabilities of $20,000 which was recorded
as non-cash expense during 2008. The estimated fair value of the put
option liabilities related to the Series B Note of $277,000 remained classified
as derivative liabilities as of December 31, 2008.
The put
option embedded in the Series A Convertible Preferred Stock issued in December
2008 was also considered a derivative instrument and was required to be
bifurcated from the equity instrument and accounted for separately. The fair
value of the bifurcated put option was approximately $216,000 on the date of
issuance. Changes in the fair value of the derivative liability are recorded in
the consolidated statement of operations. The estimated fair value of the put
option liability related to the Preferred Stock of $216,000 remained classified
as a derivative liability as of December 31, 2008.
Our
accounting for the financial instruments discussed above will likely be affected
by the outcome of our determination of whether the provisions of EITF Issue No.
07-5 are applicable to these instruments.
Other
Items Affecting Financial Condition
At
December 31, 2008, we had deferred tax assets in the U.S. related to net
operating tax loss carryforwards and tax credit carryforwards of approximately
$32.0 million and $4.8 million, respectively, available to offset or reduce
future income tax liabilities, if any, through 2028. However, under
Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, use of
prior tax loss and credit carryforwards may be limited after an ownership
change. As a result of ownership changes as defined by Sections 382
and 383, which have occurred at various points in our history, we believe
utilization of our tax loss carryforwards and tax credit carryforwards may be
significantly limited and are therefore fully reserved in our financial
statements.
Item
7A. Quantitative and Qualitative Disclosures About Market
Risk
Not
applicable to smaller reporting companies.
Item
8. Financial Statements and Supplementary Data
Our
consolidated financial statements, and the related notes, together with the
report of BDO Seidman, LLP dated March 27, 2009, are set forth at pages F-1
through F-32 attached hereto.
Item
9. Changes in and Disagreements with Accountants on Accounting and
Financial Disclosure
None.
Item
9A(T). Controls and Procedures
Disclosure
Controls and Procedures
We
maintain disclosure controls and procedures designed to ensure that information
required to be disclosed in reports filed under the Exchange Act is recorded,
processed, summarized, and reported within the specified time
periods. As a part of these controls, our management is responsible
for establishing and maintaining adequate internal control over financial
reporting, as such term is defined in Rule 13a-15(f) under the Exchange
Act.
Our
internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles, and includes those policies and
procedures that:
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pertain
to the maintenance of records that, in reasonable detail, accurately and
fairly reflect the transactions and dispositions of the assets of the
company;
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provide
reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted
accounting principles and that receipts and expenditures of the company
are being made only in accordance with authorization of management and
directors of the company; and
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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.
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Under the
supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, we evaluated the effectiveness of
the design and operation of our disclosure controls and procedures (as defined
in Rule 13a-15(e) under the Exchange Act) as of December 31,
2008. Disclosure controls and procedures include, without limitation,
controls and procedures designed to ensure that information required to be
disclosed by us in the reports that we file or submit under the Exchange Act is
accumulated and communicated to our management, including our principal
executive and principal financial officers, as appropriate to allow timely
decisions regarding required disclosure. Based on our evaluation, our
Chief Executive Officer and Chief Financial Officer have concluded that, as of
the end of the period covered by this report, our disclosure controls and
procedures are adequately designed and effective.
Our
management, including our Chief Executive Officer and Chief Financial Officer,
does not expect that our disclosure controls and procedures will prevent all
errors and all improper conduct. A control system, no matter how well
conceived and operated, can provide only reasonable, not absolute assurance that
the objectives of the control systems are met. Further, a design of a
control system must reflect the fact that there are resource constraints, and
the benefit of controls must be considered relative to their
costs. Because of the inherent limitations in all control systems, no
evaluation of controls can provide absolute assurance that all control issues
and instances of improper conduct, if any, have been detected. These
inherent limitations include the realities that judgments and decision-making
can be faulty, and that breakdowns can occur because of a simple error or
mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more persons, or by management
override of the control. Further, the design of any system of
controls is also based in part upon assumptions about the likelihood of future
events, and there can be no assurance that any design will succeed in achieving
its stated goals under all potential future conditions. Over time,
controls may become inadequate because of changes in conditions, or the degree
of compliance with the policies or procedures may
deteriorate. Because of the inherent limitations of a cost-effective
control system, misstatements due to error or fraud may occur and may not be
detected.
Management’s
Report on Internal Control Over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting. Our internal control system was
designed to provide reasonable assurance to management and the Board of
Directors regarding the preparation and fair presentation of published financial
statements. All internal control systems, no matter how well
designed, have inherent limitations. Therefore, even those systems
determined to be effective can provide only reasonable assurance with respect to
financial statement preparation and presentation.
Our
management assessed the effectiveness of our internal control over financial
reporting as of December 31, 2008. In making this assessment, it used
the criteria set forth by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO) in Internal Control – Integrated
Framework. Based on our assessment we believe that, as of December
31, 2008, our internal control over financial reporting is effective based on
those criteria.
This
Annual Report does not include an attestation report of our independent
registered public accounting firm regarding internal control over financial
reporting. Management’s report was not subject to attestation by
our independent registered public accounting firm pursuant to temporary
rules of the Securities and Exchange Commission that permit us to provide only
management’s report in this Annual Report on Form 10-K.
Changes
in Internal Control Over Financial Reporting
During
the quarter ended December 31, 2008, there were no changes in our internal
control over financial reporting that materially affected, or is reasonably
likely to materially affect, our internal control over financial
reporting.
Item
9B. Other Information.
None.
PART
III
Item
10. Directors, Executive Officers and Corporate
Governance
Directors
Directors
whose terms continue until the 2009 Annual Meeting:
Kirby I. Bland, M.D., age 67,
has served as a director of our Company since May 2004. Dr. Bland
currently serves as Professor and Chairman and Fay Fletcher Kerner Professor and
Chairman, Department of Surgery of the University of Alabama at Birmingham (UAB)
School of Medicine since 1999 and 2002, respectively, Deputy Director of the UAB
Comprehensive Cancer Center since 2000 and Senior Scientist, Division of Human
Gene Therapy, UAB School of Medicine since 2001. Prior to his
appointments at UAB, Dr. Bland was J. Murry Breadsley Professor and Chairman,
Professor of Medical Science, Department of Surgery and Director, Brown
University Integrated Program in Surgery at Brown University School of Medicine
from 1993 to 1999. Prior to his appointments at Brown University, Dr.
Bland was Professor and Associate Chairman, Department of Surgery, University of
Florida College of Medicine from 1983 to 1993 and Associate Director of Clinical
Research at the University of Florida Cancer Center from 1991 to
1993. Dr. Bland held a number of medical staff positions at the
University of Louisville, School of Medicine from 1977 to 1983 and at M. D.
Anderson Hospital and Tumor Institute from 1976 to 1977. Dr. Bland is
a member of the Board of Governors of the American College of Surgeons (ACS), a
member of the ACS’ Advisory Committee, Oncology Group (ACOSOG), a member of the
ACS’ American Joint Committee on Cancer Task Force and serves as Chairman of the
ACS’ Breast Disease Site Committee, COC. Dr. Bland is a past
President of the Society of Surgical Oncology. Dr. Bland received his
B.S. in Chemistry/Biology from Auburn University and a M.D. degree from the
University of Alabama, Medical College of Alabama.
Gordon A. Troup, age 55, has
served as a director of our Company since July 2008, Mr. Troup served
as President of the Nuclear Pharmacy Services business at Cardinal Health, Inc.
(Cardinal Health), a multinational medical products and services company, from
January 2003 until his retirement in December 2007. Mr. Troup joined
Cardinal Health in 1990 and was appointed Group President of Pharmaceutical
Distribution and Specialty Distribution Services in 1999. Prior to
joining Cardinal Health, Mr. Troup was employed for 10 years by American
Hospital Supply Corporation and 3 years by Zellerbach Paper, a Mead
Company. Mr. Troup has a B.S. degree in Business Management from San
Diego State University. Mr. Troup is a member of several national
healthcare trade organizations and is active in a number of not-for-profit
organizations.
J. Frank Whitley, Jr., age 66,
has served as a director of our Company since May
1994. Mr. Whitley was Director of Mergers, Acquisitions and
Licensing at The Dow Chemical Company (Dow), a multinational chemical company,
from June 1993 until his retirement in June 1997. After joining Dow
in 1965, Mr. Whitley served in a variety of marketing, financial, and
business management functions. Mr. Whitley is also involved with
several not-for-profit health care organizations, serving as a member of their
Boards of Trustees and/or Committees of the Board. Mr. Whitley
has a B.S. degree in Mathematics from Lamar State College of
Technology.
Directors
whose terms continue until the 2010 Annual Meeting:
Reuven Avital, age 57, has
served as a director of our Company since January 2002. Mr. Avital is
a partner and general manager of Ma’Aragim Enterprises Ltd., an investment
company in Israel, and he is a board member of a number of privately-held
Israeli companies, two of them in the medical device field. Mr. Avital was
a board member of Cardiosonix, Ltd. from April 2001 through December 31, 2001,
when we acquired the company. Previously, Mr. Avital served in the
Israeli government in a variety of middle and senior management positions.
He is also chairman or a board member of several not-for-profit organizations,
mainly involved in education for the under-privileged and international
peace-building. Mr. Avital has B.A. degrees in The History of the
Middle East and International Relations from the Hebrew University of Jerusalem,
and a M.P.A. from the Kennedy School of Government at Harvard
University.
David C. Bupp, age 59, has
served as President and a director of our Company since August 1992 and as Chief
Executive Officer since February 1998. From August 1992 to May 1993,
Mr. Bupp served as our Treasurer. In addition to the foregoing
positions, from December 1991 to August 1992, he was Acting President, Executive
Vice President, Chief Operating Officer and Treasurer, and from December 1989 to
December 1991, he was Vice President, Finance and Chief Financial
Officer. From 1982 to December 1989, Mr. Bupp was Senior Vice
President, Regional Manager for AmeriTrust Company National Association, a
nationally chartered bank holding company, where he was in charge of commercial
and retail banking operations throughout Central Ohio. Mr. Bupp has a B.A.
degree in Economics from Ohio Wesleyan University. Mr. Bupp also
completed a course of study at Stonier Graduate School of Banking at Rutgers
University.
Directors
whose terms continue until the 2011 Annual Meeting:
Carl J. Aschinger, Jr., age
70, has served as a director of our Company since June 2004 and as Chairman of
the Board since July 2007. Mr. Aschinger is the Chairman of CSC
Worldwide (formerly Columbus Show Case Co.), a privately-held company that
manufactures showcases for the retail industry. Mr. Aschinger also
serves on the Board of Directors and as Chairman of the Audit Committee of
Pinnacle Data Systems, a publicly-traded company that provides software and
hardware solutions to original equipment manufacturers. Mr. Aschinger
is a former director of Liqui-Box Corporation and Huntington National Bank as
well as other privately-held ventures and has served on boards or advisory
committees of several not-for-profit organizations.
Owen E. Johnson, M.D., age 68,
has served as a director of our Company since July 2007. Prior to his
retirement in December 2006, Dr. Johnson served as Vice President and Senior
Medical Director of UnitedHealthcare of Ohio, Inc. (UHC), a subsidiary of
UnitedHealth Group, where he was involved in a number of roles and activities
including new technology assessment and reimbursement
establishment. During 2007, Dr. Johnson rejoined UnitedHealth
Networks, a subsidiary of UnitedHealth Group, as Medical Director for their
cardiac line of service. Dr. Johnson has also served on the Board and
on numerous Committees of UHC as well as other related
organizations. Prior to joining UHC, Dr. Johnson held several
hospital appointments with Riverside Methodist Hospital in Columbus,
Ohio. Dr. Johnson has also been active in numerous professional,
fraternal and community organizations in the Columbus, Ohio area.
Fred B. Miller, age 69, has
served as a director of our Company since January 2002. Mr. Miller
serves as Chairman of the Audit Committee. Mr. Miller is the
President and Chief Operating Officer of Seicon, Limited, a privately held
company that specializes in developing, applying and licensing technology to
reduce seismic and mechanically induced vibration. Mr. Miller also
serves on the board of one other privately-held company. Until his
retirement in 1995, Mr. Miller had been with Price Waterhouse LLP since
1962. Mr. Miller is a Certified Public Accountant, a member of the
American Institute of Certified Public Accountants (AICPA), a past member of the
Council of the AICPA and a member and past president of the Ohio Society of
Certified Public Accountants. He also has served on the boards or
advisory committees of several universities and not-for-profit
organizations. Mr. Miller has a B.S. degree in Accounting from The
Ohio State University.
Executive
Officers
In
addition to Mr. Bupp, the following individuals are executive officers of our
Company and serve in the position(s) indicated below:
Name
|
|
Age
|
|
Position
|
|
|
|
|
|
Anthony
K. Blair
|
|
48
|
|
Vice
President, Manufacturing Operations
|
Rodger
A. Brown
|
|
58
|
|
Vice
President, Regulatory Affairs and
Quality Assurance
|
Frederick
O. Cope, Ph.D.
|
|
62
|
|
Vice
President, Pharmaceutical Research and
Clinical Development
|
Brent
L. Larson
|
|
45
|
|
Vice
President, Finance; Chief Financial Officer;
Treasurer and Secretary
|
Douglas
L. Rash
|
|
65
|
|
Vice
President, Marketing
|
Anthony K. Blair has served as
Vice President, Manufacturing Operations of our Company since July
2004. Prior to joining our Company, he served as Vice President,
Manufacturing Operations of Enpath Medical, Lead Technologies Division, formerly
known as Biomec Cardiovascular, Inc. from 2002 to June 2004. From
1998 through 2001, Mr. Blair led the manufacturing efforts at Astro
Instrumentation, a medical device contract manufacturer. From 1989 to
1998 at Ciba Corning Diagnostics (now Bayer), Mr. Blair held managerial
positions including Operations Manager, Materials Manager, Purchasing Manager
and Production Supervisor. From 1985 to 1989, Mr. Blair was employed
by Bailey Controls and held various positions in purchasing and industrial
engineering. Mr. Blair started his career at Fisher Body, a division
of General Motors, in production supervision. Mr. Blair has a B.B.A.
degree in management and labor relations from Cleveland State
University.
Rodger A. Brown has served as
Vice President, Regulatory Affairs and Quality Assurance of our Company since
November 2000. From July 1998 through November 2000, Mr. Brown served
as our Director, Regulatory Affairs and Quality Assurance. Prior to
joining our Company, Mr. Brown served as Director of Regulatory Affairs/Quality
Assurance for Biocore Medical Technologies, Inc. from April 1997 to April
1998. From 1981 through 1996, Mr. Brown served as Director,
Regulatory Affairs/Quality Assurance for E for M Corporation, a subsidiary of
Marquette Electronics, Inc.
Frederick O. Cope, Ph.D. has
served as Vice President, Pharmaceutical Research and Clinical Development of
our Company since February 2009. Prior to accepting this position
with the Company, Dr. Cope served as the Assistant Director for Research and
Head of Program Research Development for The Ohio State University Comprehensive
Cancer Center, The James Cancer Hospital and The Richard J. Solove Research
Institute, from April 2001 to February 2009. Dr. Cope is also active
in a number of professional and scientific organizations such as serving as an
Ad Hoc Member of the FDA Scientific Advisory Panel and a member of Emory
University’s Scientific Advisory Board. Dr. Cope received his BSc
from the Delaware Valley College of Science and Agriculture, his MS from
Millersville University of Pennsylvania and his Ph.D. from the University of
Connecticut.
Brent L. Larson has served as
Vice President, Finance, Chief Financial Officer and Treasurer of our Company
since February 1999 and as Secretary since 2003. Prior to that, he
served as our Vice President, Finance from July 1998 to January 1999 and as
Controller from July 1996 to June 1998. Before joining our Company,
Mr. Larson was employed by Price Waterhouse LLP. Mr. Larson has a
B.B.A. degree in accounting from Iowa State University of Science and Technology
and is a Certified Public Accountant.
Douglas L. Rash has served as
Vice President, Marketing of our Company since January 2005. Prior to
that, Mr. Rash was Neoprobe’s Director, Marketing and Product Management from
March to December 2004. Before joining our Company, Mr. Rash served
as Vice President and General Manager of MTRE North America, Inc. from 2000 to
2003. From 1994 to 2000, Mr. Rash served as Vice President and
General Manager (Medical Division) of Cincinnati Sub-Zero, Inc. From
1993 to 1994, Mr. Rash was Executive Vice President of Everest & Jennings
International, Ltd. During his nine-year career at Gaymar Industries,
Inc. from 1984 to 1993, Mr. Rash held positions as Vice President and General
Manager (Clinicare Division) and Vice President, Marketing and Sales (Acute Care
Division). From 1976 to 1984, Mr. Rash held management positions at
various divisions of British Oxygen Corp. Mr. Rash has a B.S. degree
in Business Administration with a minor in Chemistry from Wisconsin State
University.
Section
16(a) Beneficial Ownership Reporting Compliance
Section
16(a) of the Securities Exchange Act of 1934 requires our officers and
directors, and greater than 10% stockholders, to file reports of ownership and
changes in ownership of our securities with the Securities and Exchange
Commission. Copies of the reports are required by SEC regulation to be furnished
to us. Based on our review of these reports and written representations
from reporting persons, we believe that all reporting persons complied with all
filing requirements during the fiscal year ended December 31, 2008.
Code
of Business Conduct and Ethics
We have
adopted a code of business conduct and ethics that applies to our directors,
officers and all employees. The code of business conduct and ethics
is posted on our website at www.neoprobe.com. The code of business
conduct and ethics may be also obtained free of charge by writing to Neoprobe
Corporation, Attn: Chief Financial Officer, 425 Metro Place North, Suite 300,
Dublin, Ohio 43017.
Audit
Committee
The Audit
Committee of the Board of Directors selects our independent public accountants
with whom the Audit Committee reviews the scope of audit and non-audit
assignments and related fees, the accounting principles that we use in financial
reporting, and the internal controls
over financial reporting identified by the independent accountants as a
basis for designing their audit procedures. The members of
our Audit Committee are: Fred B. Miller (Chairman), Reuven Avital,
Gordon A. Troup, and J. Frank Whitley, Jr., each of whom is “independent” under
the Nasdaq rules referenced below in Part III, Item 13 of this Form
10-K. The Board of Directors has determined that Fred B. Miller meets
the requirements of an “audit committee financial expert” as set forth in
Section 407(d)(5) of Regulation S-K promulgated by the SEC. The Audit
Committee held five meetings in fiscal 2008.
Item
11. Executive Compensation
Summary
Compensation Table
The
following table sets forth certain information concerning the annual and
long-term compensation of our Chief Executive Officer and our other two highest
paid executive officers during the last fiscal year (the Named Executives) for
the last two fiscal years.
|
|
|
|
|
|
|
|
|
|
|
|
|
(c)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(b)
|
|
|
Restricted
|
|
|
(d)
|
|
|
|
|
|
|
|
|
|
|
|
(a)
|
|
|
Option
|
|
|
Stock
|
|
|
All
Other
|
|
|
Total
|
|
Name and Principal Position
|
|
Year
|
|
Salary
|
|
|
Bonus
|
|
|
Awards
|
|
|
Awards
|
|
|
Compensation
|
|
|
Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anthony
K. Blair
|
|
2008
|
|
$ |
150,000 |
|
|
$ |
15,700 |
|
|
$ |
10,827 |
|
|
$ |
8,975 |
|
|
$ |
4,676 |
|
|
$ |
190,178 |
|
Vice
President,
|
|
2007
|
|
|
134,000 |
|
|
|
19,125 |
|
|
|
8,550 |
|
|
|
- |
|
|
|
3,887 |
|
|
|
165,562 |
|
Manufacturing
Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David
C. Bupp
|
|
2008
|
|
$ |
325,000 |
|
|
$ |
40,000 |
|
|
$ |
43,875 |
|
|
$ |
53,850 |
|
|
$ |
7,208 |
|
|
$ |
469,933 |
|
President
and
|
|
2007
|
|
|
305,000 |
|
|
|
60,000 |
|
|
|
51,808 |
|
|
|
- |
|
|
|
8,398 |
|
|
|
425,206 |
|
Chief
Executive Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brent
L. Larson
|
|
2008
|
|
$ |
177,000 |
|
|
$ |
15,000 |
|
|
$ |
9,677 |
|
|
$ |
8,975 |
|
|
$ |
5,442 |
|
|
$ |
216,094 |
|
Vice
President, Finance and
|
|
2007
|
|
|
170,000 |
|
|
|
19,125 |
|
|
|
10,184 |
|
|
|
- |
|
|
|
4,896 |
|
|
|
204,205 |
|
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 dollar amount recognized for financial statement reporting
purposes in accordance with SFAS No. 123(R). 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 dollar amount recognized for financial statement reporting
purposes in accordance with SFAS No. 123(R). 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 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.
|
Compensation
of Mr. Bupp
Employment
Agreement. David C. Bupp is employed under a 12-month
employment agreement effective January 1, 2009. The employment
agreement provides for an annual base salary of $335,000.
The Board
of Directors and/or the Compensation, Nominating and Governance (CNG) Committee
will, on an annual basis, review the performance of our Company and of Mr. Bupp
and may pay a bonus to Mr. Bupp as it deems appropriate, in its
discretion. Such review and bonus will be consistent with any bonus
plan adopted by the CNG Committee that covers the executive officers of the
Company generally. For the calendar year ending December 31, 2009,
the CNG Committee has determined that the maximum bonus payment to Mr. Bupp will
be $90,000.
If a
change in control occurs with respect to our Company and the employment of Mr.
Bupp is concurrently or subsequently terminated:
|
·
|
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;
|
then, Mr.
Bupp will be paid a severance payment of $762,500 (less amounts paid as Mr.
Bupp’s salary and benefits that continue for the remaining term of the agreement
if his employment is terminated without cause).
For
purposes of Mr. Bupp’s employment agreement, a change in control
includes:
|
·
|
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.
|
Mr. Bupp
will be paid a severance amount of $406,250 if his employment is terminated at
the end of his employment agreement or without cause. If Mr. Bupp is
terminated without cause, his benefits will continue for the longer of 36 months
or the full term of the agreement.
Compensation
of Other Named Executives
Our
Executive Officers are employed under employment agreements of varying terms as
outlined below. In addition, the CNG Committee will, on an annual
basis, review the performance of our Company and may pay bonuses to our
executives as it deems appropriate, in its discretion. Such review
and bonus will be consistent with any bonus plan adopted by the CNG Committee
that covers Mr. Bupp as well as the executive officers of the Company
generally.
Anthony
K. Blair
Employment
Agreement. Anthony Blair is employed under a 24-month
employment agreement effective January 1, 2009. The employment
agreement provides for an annual base salary of $157,000.
The CNG
Committee will, on an annual basis, review the performance of our Company and of
Mr. Blair and may pay a bonus to Mr. Blair as it deems appropriate, in its
discretion. Such review and bonus will be consistent with any bonus
plan adopted by the CNG Committee that covers the executive officers of the
Company generally.
If a
change in control occurs with respect to our Company and the employment of Mr.
Blair is concurrently or subsequently terminated:
|
·
|
by
the Company without cause (cause is defined as any willful breach of a
material duty by Mr. Blair 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. Blair’s employment agreement;
or
|
|
·
|
by
the resignation of Mr. Blair 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;
|
then, Mr.
Blair will be paid a severance payment of $310,000 and will continue his
benefits for the longer of 12 months or the remaining term of his employment
agreement.
For
purposes of Mr. Blair’s employment agreement, a change in control
includes:
|
·
|
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.
|
Mr. Blair
will be paid a severance amount of $157,000 if his employment is terminated at
the end of his employment agreement or without cause. If Mr. Blair is
terminated without cause, his benefits will continue for the longer of 12 months
or the full term of the agreement.
Brent
L. Larson
Employment
Agreement. Brent Larson is employed under a 24-month
employment agreement effective January 1, 2009. The employment
agreement provides for an annual base salary of $184,000.
The terms
of Mr. Larson’s employment agreement are substantially identical to Mr. Blair’s
employment agreement, except that:
|
·
|
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.
|
The CNG
Committee will, on an annual basis, review the performance of our Company and of
Mr. Larson and may pay a bonus to Mr. Larson as it deems appropriate, in its
discretion. Such review and bonus will be consistent with any bonus
plan adopted by the CNG Committee that covers the executive officers of the
Company generally.
Outstanding
Equity Awards at Fiscal Year End
The
following table presents certain information concerning outstanding equity
awards held by the Named Executives as of December 31, 2008.
|
|
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 (o)
|
|
Note
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anthony
K. Blair
|
|
|
50,000 |
|
|
|
- |
|
|
$ |
0.60 |
|
7/1/2014
|
|
(h)
|
|
|
50,000 |
|
|
$ |
28,500 |
|
(p)
|
|
|
|
40,000 |
|
|
|
- |
|
|
$ |
0.39 |
|
12/10/2014
|
|
(j)
|
|
|
|
|
|
|
|
|
|
|
|
|
30,000 |
|
|
|
- |
|
|
$ |
0.26 |
|
12/27/2015
|
|
(k)
|
|
|
|
|
|
|
|
|
|
|
|
|
20,000 |
|
|
|
10,000 |
|
|
$ |
0.27 |
|
12/15/2016
|
|
(l)
|
|
|
|
|
|
|
|
|
|
|
|
|
6,667 |
|
|
|
13,333 |
|
|
$ |
0.35 |
|
7/27/2017
|
|
(m)
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
50,000 |
|
|
$ |
0.362 |
|
1/3/2018
|
|
(n)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David
C. Bupp
|
|
|
180,000 |
|
|
|
- |
|
|
$ |
0.50 |
|
1/4/2010
|
|
(b)
|
|
|
300,000 |
|
|
$ |
171,000 |
|
(p)
|
|
|
|
180,000 |
|
|
|
- |
|
|
$ |
0.41 |
|
1/3/2011
|
|
(c)
|
|
|
|
|
|
|
|
|
|
|
|
|
180,000 |
|
|
|
- |
|
|
$ |
0.42 |
|
1/7/2012
|
|
(d)
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
- |
|
|
$ |
0.14 |
|
1/15/2013
|
|
(e)
|
|
|
|
|
|
|
|
|
|
|
|
|
70,000 |
|
|
|
- |
|
|
$ |
0.13 |
|
2/15/2013
|
|
(f)
|
|
|
|
|
|
|
|
|
|
|
|
|
150,000 |
|
|
|
- |
|
|
$ |
0.30 |
|
1/7/2014
|
|
(g)
|
|
|
|
|
|
|
|
|
|
|
|
|
150,000 |
|
|
|
- |
|
|
$ |
0.49 |
|
7/28/2014
|
|
(i)
|
|
|
|
|
|
|
|
|
|
|
|
|
200,000 |
|
|
|
- |
|
|
$ |
0.39 |
|
12/10/2014
|
|
(j)
|
|
|
|
|
|
|
|
|
|
|
|
|
200,000 |
|
|
|
- |
|
|
$ |
0.26 |
|
12/27/2015
|
|
(k)
|
|
|
|
|
|
|
|
|
|
|
|
|
200,000 |
|
|
|
100,000 |
|
|
$ |
0.27 |
|
12/15/2016
|
|
(l)
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
200,000 |
|
|
$ |
0.362 |
|
1/3/2018
|
|
(n)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brent
L. Larson
|
|
|
25,000 |
|
|
|
- |
|
|
$ |
1.25 |
|
2/11/2009
|
|
(a)
|
|
|
50,000 |
|
|
$ |
28,500 |
|
(p)
|
|
|
|
60,000 |
|
|
|
- |
|
|
$ |
0.50 |
|
1/4/2010
|
|
(b)
|
|
|
|
|
|
|
|
|
|
|
|
|
60,000 |
|
|
|
- |
|
|
$ |
0.41 |
|
1/3/2011
|
|
(c)
|
|
|
|
|
|
|
|
|
|
|
|
|
50,000 |
|
|
|
- |
|
|
$ |
0.42 |
|
1/7/2012
|
|
(d)
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000 |
|
|
|
- |
|
|
$ |
0.14 |
|
1/15/2013
|
|
(e)
|
|
|
|
|
|
|
|
|
|
|
|
|
30,000 |
|
|
|
- |
|
|
$ |
0.13 |
|
2/15/2013
|
|
(f)
|
|
|
|
|
|
|
|
|
|
|
|
|
70,000 |
|
|
|
- |
|
|
$ |
0.30 |
|
1/7/2014
|
|
(g)
|
|
|
|
|
|
|
|
|
|
|
|
|
50,000 |
|
|
|
- |
|
|
$ |
0.49 |
|
7/28/2014
|
|
(i)
|
|
|
|
|
|
|
|
|
|
|
|
|
50,000 |
|
|
|
- |
|
|
$ |
0.39 |
|
12/10/2014
|
|
(j)
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000 |
|
|
|
- |
|
|
$ |
0.26 |
|
12/27/2015
|
|
(k)
|
|
|
|
|
|
|
|
|
|
|
|
|
33,333 |
|
|
|
16,667 |
|
|
$ |
0.27 |
|
12/15/2016
|
|
(l)
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
50,000 |
|
|
$ |
0.362 |
|
1/3/2018
|
|
(n)
|
|
|
|
|
|
|
|
|
|
(a)
|
Options
were granted 2/11/1999 and vested as to one-third immediately and on each
of the first two anniversaries of the date of
grant.
|
(b)
|
Options
were granted 1/4/2000 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(c)
|
Options
were granted 1/3/2001 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(d)
|
Options
were granted 1/7/2002 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(e)
|
Options
were granted 1/15/2003 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(f)
|
Options
were granted 2/15/2003 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(g)
|
Options
were granted 1/7/2004 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(h)
|
Options
were granted 7/1/2004 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(i)
|
Options
were granted 7/28/2004 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(j)
|
Options
were granted 12/10/2004 and vested as to one-third on each of the first
three anniversaries of the date of
grant.
|
(k)
|
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.
|
(l)
|
Options
were granted 12/15/2006 and vest as to one-third on each of the first
three anniversaries of the date of
grant.
|
(m)
|
Options
were granted 7/27/2007 and vest as to one-third on each of the first three
anniversaries of the date of grant.
|
(n)
|
Options
were granted 1/3/2008 and vest as to one-third on each of the first three
anniversaries of the date of grant.
|
(o)
|
Estimated
by reference to the closing market price of the Company’s common stock on
December 31, 2008, 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, 2008, was $0.57.
|
(p)
|
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 by the United States Food
and Drug Administration of the New Drug Application for
Lymphoseek. 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.
|
Compensation
of Non-Employee Directors
Each
non-employee director received an annual cash retainer of $20,000 and earned an
additional $1,500 per board meeting attended in person or $500 per telephonic
board meeting during the fiscal year ended December 31, 2008. The
Chairmen of the Company’s Board of Directors and Audit Committee each received
an additional annual retainer of $10,000 for their services in those capacities
during 2008. Members of committees of the Company’s Board of
Directors earned an additional $500 per committee meeting attended in person or
telephonically. We also reimbursed non-employee directors for travel
expenses for meetings attended during 2008.
Each
non-employee director also received 10,000 options to purchase common stock as a
part of the Company’s annual stock incentive grants, in accordance with the
provisions of the Neoprobe Corporation Second Amended and Restated 2002 Stock
Incentive Plan. The options granted to purchase common stock vested
on the first anniversary of the date of grant and have an exercise price of
$0.362, the closing price of the Company’s common stock as reported on the OTC
Bulletin Board regulated quotation service on January 3, 2008, the date of
grant. The aggregate number of option awards outstanding at March 15,
2009 for each Director is set forth in the footnotes to the beneficial ownership
table provided in Part III, Item 12 of this Form 10-K. Directors who
are also officers or employees of Neoprobe do not receive any compensation for
their services as directors.
The
following table sets forth certain information concerning the compensation of
non-employee Directors for the fiscal year ended December 31, 2008.
Name
|
|
(a)
Fees
Earned
or
Paid in
Cash
|
|
|
(b),(c)
Option
Awards
|
|
|
Total
Compensation
|
|
|
|
|
|
|
|
|
|
|
|
Carl
J. Aschinger, Jr.
|
|
$ |
37,500 |
|
|
$ |
3,046 |
|
|
$ |
40,546 |
|
Reuven
Avital
|
|
|
28,000 |
|
|
|
3,046 |
|
|
|
31,046 |
|
Kirby
I. Bland, M.D.
|
|
|
27,500 |
|
|
|
3,046 |
|
|
|
30,546 |
|
Owen
E. Johnson, M.D.
|
|
|
27,500 |
|
|
|
6,011 |
|
|
|
33,511 |
|
Fred
B. Miller
|
|
|
38,000 |
|
|
|
3,046 |
|
|
|
41,046 |
|
Gordon
A. Troup
|
|
|
13,000 |
|
|
|
2,020 |
|
|
|
15,202 |
|
J.
Frank Whitley, Jr.
|
|
|
28,000 |
|
|
|
3,046 |
|
|
|
31,046 |
|
|
(a)
|
Amount
represents fees earned during the fiscal year ended December 31, 2008
(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 dollar amount recognized for financial statement reporting
purposes in accordance with SFAS No. 123(R). 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, 2008, the non-employee directors held an aggregate of
1,057,500 options to purchase shares of common stock of the
Company.
|
Item
12. Security Ownership of Certain Beneficial Owners and Management
and Related Stockholder Matters
Equity
Compensation Plan Information
The
following table sets forth additional information as of December 31, 2008,
concerning shares of our common stock that may be issued upon the exercise of
options and other rights under our existing equity compensation plans and
arrangements, divided between plans approved by our stockholders and plans or
arrangements not submitted to our stockholders for approval. The
information includes the number of shares covered by, and the weighted average
exercise price of, outstanding options and other rights and the number of shares
remaining available for future grants excluding the shares to be issued upon
exercise of outstanding options, warrants, and other rights.
|
|
(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
|
|
|
5,619,500 |
|
|
$ |
0.40 |
|
|
|
2,370,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
compensation plans not approved by security holders
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
5,619,500 |
|
|
$ |
0.40 |
|
|
|
2,370,500 |
|
Security
Ownership of Principal Stockholders, Directors, Nominees and Executive Officers
and Related Stockholder Matters
The
following table sets forth, as of March 15, 2009, certain information with
respect to the beneficial ownership of shares of our common stock by:
(i) each person known to us to be the beneficial owner of more than 5% of
our outstanding shares of common stock, (ii) each director or nominee for
director of our Company, (iii) each of the Named Executives (see “Executive
Compensation – Summary Compensation Table”), and (iv) our directors and
executive officers as a group.
Beneficial Owner
|
|
Number of Shares
Beneficially Owned (*)
|
|
|
Percent
of Class (**)
|
|
Carl
J. Aschinger, Jr.
|
|
|
292,145 |
(a) |
|
|
(n)
|
Reuven
Avital
|
|
|
404,256 |
(b) |
|
|
(n)
|
Anthony
K. Blair
|
|
|
247,097 |
(c) |
|
|
(n)
|
Kirby
I. Bland, M.D.
|
|
|
195,000 |
(d) |
|
|
(n)
|
David
C. Bupp
|
|
|
6,920,309 |
(e) |
|
|
8.9 |
% |
Frederick
O. Cope, Ph.D.
|
|
|
- |
(f) |
|
|
(n)
|
Owen
E. Johnson, M.D.
|
|
|
50,000 |
(g) |
|
|
(n)
|
Brent
L. Larson
|
|
|
687,414 |
(h) |
|
|
1.0 |
% |
Fred
B. Miller
|
|
|
376,000 |
(i) |
|
|
(n)
|
Gordon
A. Troup
|
|
|
15,000 |
(j) |
|
|
(n) |
J.
Frank Whitley, Jr.
|
|
|
281,500 |
(k) |
|
|
(n)
|
All
directors and officers as a group
|
|
|
10,011,377 |
(l)(o) |
|
|
12.5 |
% |
(13
persons)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Platinum
Montaur Life Sciences, LLC
|
|
|
3,758,650 |
(m) |
|
|
4.99 |
% |
(*)
|
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, 2009, plus the number of shares the person has the right to
acquire within 60 days of March 15,
2009.
|
(a)
|
This
amount includes 140,000 shares issuable upon exercise of options which are
exercisable within 60 days and 1,145 shares held in a trust account for
which Mr. Aschinger is the custodian, but does not include 10,000 shares
issuable upon exercise of options which are not exercisable within 60
days.
|
(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 185,000 shares issuable upon exercise of
options which are exercisable within 60 days but does not include 10,000
shares issuable upon exercise of options which are not exercisable within
60 days. 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 163,334 shares issuable upon exercise of options which are
exercisable within 60 days and 33,763 shares in Mr. Blair’s account in the
401(k) Plan, but it does not include 50,000 shares of unvested restricted
stock and 81,166 shares issuable upon exercise of options which are not
exercisable within 60 days.
|
(d)
|
This
amount includes 170,000 shares issuable upon exercise of options which are
exercisable within 60 days but does not include 10,000 shares issuable
upon exercise of options which are not exercisable within 60
days.
|
(e)
|
This
amount includes 1,676,667 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,
203,746 shares that are held by Mr. Bupp’s wife for which he disclaims
beneficial ownership and 119,390 shares in Mr. Bupp’s account in the
401(k) Plan, but it does not include 700,000 shares of unvested restricted
stock and 233,333 shares issuable upon exercise of options which are not
exercisable within 60 days.
|
(f)
|
This
amount does not include 100,000 shares of unvested restricted stock and
50,000 shares issuable upon exercise of options which are not exercisable
within 60 days.
|
(g)
|
This
amount includes 30,000 shares issuable upon exercise of options which are
exercisable within 60 days but does not include 10,000 shares issuable
upon exercise of options which are not exercisable within 60
days.
|
(h)
|
This
amount includes 500,000 shares issuable upon exercise of options which are
exercisable within 60 days and 87,414 shares in Mr. Larson’s account in
the 401(k) Plan, but it does not include 50,000 shares of unvested
restricted stock and 75,000 shares issuable upon exercise of options which
are not exercisable within 60 days.
|
(i)
|
This
amount includes 245,000 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 10,000
shares issuable upon the exercise of options which are not exercisable
within 60 days.
|
(j)
|
This
amount does not include 20,000 shares issuable upon exercise of options
which are not exercisable within 60
days.
|
(k)
|
This
amount includes 260,000 shares issuable upon exercise of options which are
exercisable within 60 days, but does not include 10,000 shares issuable
upon exercise of options which are not exercisable within 60
days.
|
(l)
|
This
amount includes 3,900,000 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,
285,891 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 253,224 shares held in the 401(k) Plan on behalf
of certain officers, but it does not include 920,000 shares of unvested
restricted stock and 595,000 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 575,350
shares of common stock.
|
(m)
|
Platinum-Montaur
Life Sciences, LLC (Montaur), 152 W. 57th Street, 54th Floor, New York, NY
10019, holds promissory notes in the principal amount of $10,000,000
convertible into 21,794,871 shares of our common stock, warrants to
purchase 20,333,333 shares of our common stock, and 3,000 shares of Series
A 8% Cumulative Convertible Preferred Stock convertible into 6,000,000
shares of our common stock. Each of our convertible promissory
notes held by Montaur, the warrants held by Montaur, and the Certificate
of Designations, Voting Powers, Preferences, Limitations, Restrictions,
and Relative Rights of Series A 8% Cumulative Convertible Preferred Stock
provide that those instruments are not convertible or exercisable if,
after such conversion or exercise, Montaur would beneficially own more
than 4.99% of our outstanding common stock. This provision may
be waived by Montaur giving us at least 61 days prior written
notice. Similarly, each of our convertible promissory notes and
warrants held by Montaur provides that those instruments are not
convertible or exercisable if, after such conversion or exercise, Montaur
would beneficially own more than 9.99% of our outstanding common stock,
subject to Montaur’s right to request a waiver of this restriction in
writing at least 61 days prior to the effective date of that
waiver.
|
(n)
|
Less
than one percent.
|
(o)
|
The
address of all directors and executive offices is c/o Neoprobe
Corporation, 425 Metro Place North, Suite 300, Dublin, Ohio
43017-1367.
|
Item
13. Certain Relationships and Related Transactions, and Director
Independence
Director
Independence
Our Board
of Directors has adopted the definition of “independence” as described under the
Sarbanes-Oxley Act of 2002 (Sarbanes-Oxley) Section 301, Rule 10A-3 under the
Securities Exchange Act of 1934 (the Exchange Act) and Nasdaq Rules 4200 and
4350. Our Board of Directors has determined that Messrs. Aschinger,
Avital, Miller, Troup and Whitley, and Drs. Bland and Johnson meet the
independence requirements.
See
Liquidity and Capital Resources in Part II, Item 7 of this Form 10-K for
information about our related party transactions.
Item
14. Principal Accountant Fees and Services
Audit
Fees. The aggregate fees billed and expected to be billed for
professional services rendered by BDO Seidman, LLP for the audit of the
Company’s annual consolidated financial statements for the 2008 fiscal year, the
reviews of the financial statements included in the Company’s Quarterly Reports
on Form 10-Q for the 2008 fiscal year, and consents related to the Company’s
registration statements filed during the 2008 fiscal year were $177,540
(including direct engagement expenses). The aggregate fees billed for
professional services rendered by BDO Seidman, LLP for the audit of the
Company’s annual consolidated financial statements for the 2007 fiscal year, the
reviews of the financial statements included in the Company’s Quarterly Reports
on Form 10-QSB for the 2007 fiscal year, and consents related to the Company’s
registration statements filed during the 2007 fiscal year were $158,259
(including direct engagement expenses).
Audit-Related
Fees. The aggregate fees billed by BDO Seidman, LLP for
audit-related services for the 2007 fiscal year were $2,385. No fees
were billed by BDO Seidman, LLP for audit-related services for the 2008 fiscal
year.
Tax
Fees. The aggregate fees billed by BDO Seidman, LLP for
tax-related services for the 2007 fiscal year were $500. No fees were
billed by BDO Seidman, LLP for tax-related services for the 2008 fiscal
year.
All Other
Fees. No fees were billed by BDO Seidman, LLP for services
other than the audit, audit-related and tax services for the 2008 or 2007 fiscal
years.
Pre-Approval
Policy. The Audit Committee is required to pre-approve all
auditing services and permitted non-audit services (including the fees and terms
thereof) to be performed for the Company by its independent auditor or other
registered public accounting firm, subject to the de minimis exceptions for
non-audit services described in Section 10A(i)(1)(B) of the Securities Exchange
Act of 1934 that are approved by the Audit Committee prior to completion of the
audit.
PART
IV
Item
15. Exhibits, Financial Statement Schedules
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).
|
|
|
|
5.1
|
|
Opinion
of Porter, Wright, Morris & Arthur LLP.*
|
|
|
|
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
|
|
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).
|
|
|
|
10.10
|
|
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).
|
|
|
|
10.11
|
|
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).
|
|
|
|
10.12
|
|
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).
|
|
|
|
10.13
|
|
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).
|
|
|
|
10.14
|
|
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).
|
|
|
|
10.15
|
|
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).
|
|
|
|
10.16
|
|
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).
|
|
|
|
10.17
|
|
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).
|
|
|
|
10.18
|
|
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).
|
10.19
|
|
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).
|
|
|
|
10.20
|
|
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).
|
|
|
|
10.21
|
|
Stock
Purchase Agreement dated October 22, 2003 between the Company and Bridges
& Pipes, LLC. This agreement is one of 21 substantially
identical agreements and is accompanied by a schedule identifying the
other agreements omitted and setting forth the material details in which
such documents differ from the one that is filed herewith (incorporated by
reference to Exhibit 10.32 to the Company’s registration statement on Form
SB-2 filed December 2, 2003).
|
|
|
|
10.22
|
|
Registration
Rights Agreement dated October 22, 2003 between the Company and Bridges
& Pipes, LLC. This agreement is one of 21 substantially
identical agreements and is accompanied by a schedule identifying the
other agreements omitted and setting forth the material details in which
such documents differ from the one that is filed herewith (incorporated by
reference to Exhibit 10.33 to the Company’s registration statement on Form
SB-2 filed December 2, 2003).
|
|
|
|
10.23
|
|
Series
R Warrant Agreement dated October 22, 2003 between the Company and Bridges
& Pipes, LLC. This agreement is one of 21 substantially
identical agreements and is accompanied by a schedule identifying the
other agreements omitted and setting forth the material details in which
such documents differ from the one that is filed herewith (incorporated by
reference to Exhibit 10.34 to the Company’s registration statement on Form
SB-2 filed December 2, 2003).
|
|
|
|
10.24
|
|
Series
S Warrant Agreement dated November 21, 2003 between the Company and
Alberdale Capital, LLC. This agreement is one of 7
substantially identical agreements and is accompanied by a schedule
identifying the other agreements omitted and setting forth the material
details in which such documents differ from the one that is filed herewith
(incorporated by reference to Exhibit 10.35 to the Company’s registration
statement on Form SB-2 filed December 2, 2003).
|
|
|
|
10.25
|
|
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).
|
|
|
|
10.26
|
|
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).
|
|
|
|
10.27
|
|
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).
|
|
|
|
10.28
|
|
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).
|
|
|
|
10.29
|
|
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).
|
10.30
|
|
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).
|
|
|
|
10.31
|
|
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).
|
|
|
|
10.32
|
|
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).
|
|
|
|
10.33
|
|
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).
|
|
|
|
10.34
|
|
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).
|
|
|
|
10.35
|
|
Form
of Series U Warrant Agreement, dated December 13, 2004, between the
Company and the placement agents for the Series A Convertible Promissory
Notes and Series T Warrants (incorporated by reference to Exhibit 10.35 to
the Company’s December 31, 2004 Form 10-KSB. This is the form
of six substantially identical agreements. A schedule
identifying the warrants and setting forth the material details in which
such agreements differ from the form that is incorporated by reference
herein is filed as Exhibit 10.34 to this Annual Report on Form
10-K).
|
|
|
|
10.36
|
|
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).
|
|
|
|
10.37
|
|
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).
|
|
|
|
10.38
|
|
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).
|
|
|
|
10.39
|
|
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).
|
|
|
|
10.40
|
|
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).
|
10.41
|
|
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
|
|
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).
|
|
|
|
10.43
|
|
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).
|
|
|
|
10.44
|
|
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).
|
|
|
|
10.45
|
|
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).
|
|
|
|
10.46
|
|
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).
|
|
|
|
10.47
|
|
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).
|
|
|
|
10.48
|
|
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).
|
|
|
|
10.49
|
|
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).
|
|
|
|
10.50
|
|
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.*
|
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Company has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Dated:
March 30, 2009
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
30, 2009
|
David
C. Bupp
|
|
Chief
Executive Officer
|
|
|
|
|
(principal
executive officer)
|
|
|
|
|
|
|
|
/s/ Brent L. Larson*
|
|
Vice
President, Finance and
|
|
March
30, 2009
|
Brent
L. Larson
|
|
Chief
Financial Officer
|
|
|
|
|
(principal
financial officer)
|
|
|
|
|
|
|
|
/s/ Carl J. Aschinger, Jr.*
|
|
Chairman,
Director
|
|
March
30, 2009
|
Carl
J. Aschinger, Jr.
|
|
|
|
|
|
|
|
|
|
/s/ Reuven Avital*
|
|
Director
|
|
March
30, 2009
|
Reuven
Avital
|
|
|
|
|
|
|
|
|
|
/s/ Kirby I. Bland*
|
|
Director
|
|
March
30, 2009
|
Kirby
I. Bland
|
|
|
|
|
|
|
|
|
|
/s/ Owen E. Johnson*
|
|
Director
|
|
March
30, 2009
|
Owen
E. Johnson
|
|
|
|
|
|
|
|
|
|
/s/ Fred B. Miller*
|
|
Director
|
|
March
30, 2009
|
Fred
B. Miller
|
|
|
|
|
|
|
|
|
|
/s/ Gordon A. Troup*
|
|
Director
|
|
March
30, 2009
|
Gordon
A. Troup
|
|
|
|
|
|
|
|
|
|
/s/ J. Frank Whitley, Jr.*
|
|
Director
|
|
March
30, 2009
|
J.
Frank Whitley, Jr.
|
|
|
|
|
*By:
|
/s/ David C. Bupp
|
|
David
C. Bupp,
Attorney-in-fact
|
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
NEOPROBE
CORPORATION
FORM
10-K ANNUAL REPORT
FOR THE
FISCAL YEARS ENDED:
DECEMBER
31, 2008 AND 2007
FINANCIAL
STATEMENTS
NEOPROBE
CORPORATION and SUBSIDIARY
Index
to Financial Statements
|
|
|
|
Report
of Independent Registered Public Accounting Firm BDO Seidman,
LLP
|
F-2
|
|
|
Consolidated
Balance Sheets as of December 31, 2008 and December 31,
2007
|
F-3
|
|
|
Consolidated
Statements of Operations for the years ended December 31, 2008 and
December 31, 2007
|
F-5
|
|
|
Consolidated
Statements of Stockholders’ Deficit for the years ended December 31, 2008
and December 31, 2007
|
F-6
|
|
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2008 and
December 31, 2007
|
F-7
|
|
|
Notes
to the Consolidated Financial Statements
|
F-8
|
Report
of Independent Registered Public Accounting Firm
Board of
Directors
Neoprobe
Corporation
Dublin,
Ohio
We have
audited the accompanying consolidated balance sheets of Neoprobe Corporation as
of December 31, 2008 and 2007 and the related consolidated statements of
operations, stockholders’ deficit, and cash flows for the years then
ended. These financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on
these financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. The
Company is not required to have, nor were we engaged to perform, an audit of its
internal control over financial reporting. Our audits included
consideration of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the circumstances, but not
for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no
such opinion. An audit also includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements,
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of Neoprobe Corporation at
December 31, 2008 and 2007 and the results of its operations and its cash flows
for the years then ended in conformity with accounting principles generally
accepted in the United States of America.
/s/ BDO
Seidman,
LLP
Chicago,
Illinois
March 27,
2009
Neoprobe
Corporation and Subsidiaries
Consolidated
Balance Sheets
December
31, 2008 and 2007
ASSETS
|
|
2008
|
|
|
2007
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
|
|
$ |
3,565,837 |
|
|
$ |
1,540,220 |
|
Available-for-sale
securities
|
|
|
495,383 |
|
|
|
- |
|
Accounts
receivable, net
|
|
|
1,644,070 |
|
|
|
1,621,910 |
|
Inventory
|
|
|
961,861 |
|
|
|
1,237,403 |
|
Prepaid
expenses and other
|
|
|
573,573 |
|
|
|
247,035 |
|
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
7,240,724 |
|
|
|
4,646,568 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment
|
|
|
2,060,588 |
|
|
|
1,918,343 |
|
Less
accumulated depreciation and amortization
|
|
|
1,669,796 |
|
|
|
1,630,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
390,792 |
|
|
|
287,603 |
|
|
|
|
|
|
|
|
|
|
Patents
and trademarks
|
|
|
3,020,001 |
|
|
|
3,016,783 |
|
Acquired
technology
|
|
|
237,271 |
|
|
|
237,271 |
|
|
|
|
3,257,272 |
|
|
|
3,254,054 |
|
Less
accumulated amortization
|
|
|
1,863,787 |
|
|
|
1,652,912 |
|
|
|
|
|
|
|
|
|
|
|
|
|
1,393,485 |
|
|
|
1,601,142 |
|
|
|
|
|
|
|
|
|
|
Other
assets
|
|
|
594,449 |
|
|
|
527,634 |
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$ |
9,619,450 |
|
|
$ |
7,062,947 |
|
Continued
Neoprobe
Corporation and Subsidiaries
Consolidated
Balance Sheets, continued
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
|
2008
|
|
|
2007
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
731,220 |
|
|
$ |
778,085 |
|
Accrued
liabilities and other
|
|
|
917,676 |
|
|
|
801,949 |
|
Capital
lease obligations
|
|
|
9,084 |
|
|
|
14,592 |
|
Deferred
revenue
|
|
|
526,619 |
|
|
|
451,512 |
|
Notes
payable to finance companies
|
|
|
137,857 |
|
|
|
124,770 |
|
|
|
|
|
|
|
|
|
|
Total
current liabilities
|
|
|
2,322,456 |
|
|
|
2,170,908 |
|
|
|
|
|
|
|
|
|
|
Capital
lease obligations
|
|
|
11,095 |
|
|
|
2,422 |
|
Deferred
revenue
|
|
|
490,165 |
|
|
|
623,640 |
|
Note
payable to CEO, net of discounts of $76,294 and $95,786,
respectively
|
|
|
923,706 |
|
|
|
904,214 |
|
Notes
payable to investors, net of discounts of $5,001,149 and $2,600,392,
respectively
|
|
|
4,998,851 |
|
|
|
4,399,608 |
|
Derivative
liabilities
|
|
|
853,831 |
|
|
|
2,853,476 |
|
Other
liabilities
|
|
|
45,071 |
|
|
|
52,273 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
9,645,175 |
|
|
|
11,006,541 |
|
|
|
|
|
|
|
|
|
|
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, 2008;
none outstanding at December 31, 2007
|
|
|
3,000,000 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Stockholders’
deficit:
|
|
|
|
|
|
|
|
|
Common
stock; $.001 par value; 150,000,000 shares authorized; 70,862,641 and
67,240,030 shares issued and outstanding at December 31, 2008 and 2007,
respectively
|
|
|
70,863 |
|
|
|
67,240 |
|
Additional
paid-in capital
|
|
|
145,742,044 |
|
|
|
136,765,697 |
|
Accumulated
deficit
|
|
|
(148,840,015 |
) |
|
|
(140,776,531 |
) |
Unrealized
gain on available-for-sale securities
|
|
|
1,383 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total
stockholders’ deficit
|
|
|
(3,025,725 |
) |
|
|
(3,943,594 |
) |
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders’ deficit
|
|
$ |
9,619,450 |
|
|
$ |
7,062,947 |
|
See
accompanying notes to consolidated financial statements.
Neoprobe
Corporation and Subsidiaries
Consolidated
Statements of Operations
|
|
Years Ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
Net
sales
|
|
$ |
7,714,520 |
|
|
$ |
7,124,811 |
|
License
and other revenue
|
|
|
171,750 |
|
|
|
- |
|
Total
revenues
|
|
|
7,886,270 |
|
|
|
7,124,811 |
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
3,010,232 |
|
|
|
3,184,706 |
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
|
|
4,876,038 |
|
|
|
3,940,105 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
4,505,622 |
|
|
|
2,865,539 |
|
Selling,
general and administrative
|
|
|
3,412,534 |
|
|
|
2,837,344 |
|
Total
operating expenses
|
|
|
7,918,156 |
|
|
|
5,702,883 |
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(3,042,118 |
) |
|
|
(1,762,778 |
) |
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
60,860 |
|
|
|
70,976 |
|
Interest
expense
|
|
|
(1,744,825 |
) |
|
|
(2,284,135 |
) |
Loss
on extinguishment of debt
|
|
|
- |
|
|
|
(859,955 |
) |
Change
in derivative liabilities
|
|
|
(451,381 |
) |
|
|
(247,876 |
) |
Other
|
|
|
11,238 |
|
|
|
(4,444 |
) |
Total
other expenses, net
|
|
|
(2,124,108 |
) |
|
|
(3,325,434 |
) |
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(5,166,226 |
) |
|
$ |
(5,088,212 |
) |
|
|
|
|
|
|
|
|
|
Net
loss per common share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
Diluted
|
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
68,594,172 |
|
|
|
62,921,491 |
|
Diluted
|
|
|
68,594,172 |
|
|
|
62,921,491 |
|
See
accompanying notes to consolidated financial statements.
Neoprobe
Corporation and Subsidiaries
Consolidated
Statements of Stockholders’ Deficit
|
|
Common
Stock
|
|
|
Additional
Paid-in
|
|
|
Accumulated
|
|
|
Accumulated
Other
Comprehensive
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Income
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2006
|
|
|
59,624,379 |
|
|
$ |
59,624 |
|
|
$ |
135,330,668 |
|
|
$ |
(135,688,319 |
) |
|
$ |
- |
|
|
$ |
(298,027 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled
restricted stock that did not vest
|
|
|
(130,000 |
) |
|
|
(130 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(130 |
) |
Issued
stock to 401(k) plan at $0.28
|
|
|
107,313 |
|
|
|
108 |
|
|
|
29,423 |
|
|
|
- |
|
|
|
- |
|
|
|
29,531 |
|
Issued
stock in connection with stock purchase agreement, net of
costs
|
|
|
7,588,338 |
|
|
|
7,588 |
|
|
|
1,703,953 |
|
|
|
- |
|
|
|
- |
|
|
|
1,711,541 |
|
Issued
stock as fees to an investment banking firm
|
|
|
50,000 |
|
|
|
50 |
|
|
|
11,950 |
|
|
|
- |
|
|
|
- |
|
|
|
12,000 |
|
Effect
of beneficial conversion feature of convertible promissory
note
|
|
|
- |
|
|
|
- |
|
|
|
86,587 |
|
|
|
- |
|
|
|
- |
|
|
|
86,587 |
|
Issued
warrants to purchase common stock
|
|
|
- |
|
|
|
- |
|
|
|
175,719 |
|
|
|
- |
|
|
|
- |
|
|
|
175,719 |
|
Repurchased
warrants related to extinguishment of debt
|
|
|
- |
|
|
|
- |
|
|
|
(675,000 |
) |
|
|
- |
|
|
|
- |
|
|
|
(675,000 |
) |
Stock
compensation expense
|
|
|
- |
|
|
|
- |
|
|
|
102,397 |
|
|
|
- |
|
|
|
- |
|
|
|
102,397 |
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5,088,212 |
) |
|
|
- |
|
|
|
(5,088,212 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
income (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 |
) |
See
accompanying notes to consolidated financial statements.
Neoprobe
Corporation and Subsidiaries
Consolidated
Statements of Cash Flows
|
|
Years Ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(5,166,226 |
) |
|
$ |
(5,088,212 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
of property and equipment
|
|
|
183,209 |
|
|
|
171,713 |
|
Amortization
of intangible assets
|
|
|
225,143 |
|
|
|
233,006 |
|
Loss
on disposal and abandonment of assets
|
|
|
30,850 |
|
|
|
22,551 |
|
Amortization
of debt discount and debt offering costs
|
|
|
706,064 |
|
|
|
1,406,195 |
|
Provision
for bad debts
|
|
|
849 |
|
|
|
1,000 |
|
Stock
compensation expense
|
|
|
211,577 |
|
|
|
102,397 |
|
Loss
on extinguishment of debt
|
|
|
- |
|
|
|
859,955 |
|
Change
in derivative liabilities
|
|
|
451,381 |
|
|
|
247,876 |
|
Other
|
|
|
130,341 |
|
|
|
29,400 |
|
Change
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(23,009 |
) |
|
|
(376,821 |
) |
Inventory
|
|
|
93,372 |
|
|
|
(166,838 |
) |
Prepaid
expenses and other assets
|
|
|
131,039 |
|
|
|
177,351 |
|
Accounts
payable
|
|
|
(46,865 |
) |
|
|
109,797 |
|
Accrued
liabilities and other liabilities
|
|
|
108,525 |
|
|
|
319,337 |
|
Deferred
revenue
|
|
|
(58,368 |
) |
|
|
686,089 |
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(3,022,118 |
) |
|
|
(1,265,204 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchases
of available-for-sale securities
|
|
|
(690,000 |
) |
|
|
- |
|
Maturities
of available-for-sale securities
|
|
|
196,000 |
|
|
|
- |
|
Purchases
of property and equipment
|
|
|
(116,352 |
) |
|
|
(41,274 |
) |
Proceeds
from sales of property and equipment
|
|
|
495 |
|
|
|
- |
|
Patent
and trademark costs
|
|
|
(17,486 |
) |
|
|
(6,736 |
) |
|
|
|
|
|
|
|
|
|
Net
cash used in investing activities
|
|
|
(627,343 |
) |
|
|
(48,010 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of preferred stock
|
|
|
3,000,000 |
|
|
|
- |
|
Payment
of preferred stock offering costs
|
|
|
(180,000 |
) |
|
|
- |
|
Proceeds
from issuance of common stock
|
|
|
232,156 |
|
|
|
1,900,000 |
|
Payment
of common stock offering costs
|
|
|
(900 |
) |
|
|
(22,674 |
) |
Proceeds
from notes payable
|
|
|
3,000,000 |
|
|
|
8,000,000 |
|
Payment
of debt issuance costs
|
|
|
(200,154 |
) |
|
|
(565,004 |
) |
Payment
of notes payable
|
|
|
(158,304 |
) |
|
|
(8,271,702 |
) |
Payments
under capital leases
|
|
|
(17,720 |
) |
|
|
(14,841 |
) |
Payment
for repurchase of warrants
|
|
|
- |
|
|
|
(675,000 |
) |
|
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
5,675,078 |
|
|
|
350,779 |
|
|
|
|
|
|
|
|
|
|
Net
increase (decrease) in cash
|
|
|
2,025,617 |
|
|
|
(962,435 |
) |
|
|
|
|
|
|
|
|
|
Cash,
beginning of year
|
|
|
1,540,220 |
|
|
|
2,502,655 |
|
|
|
|
|
|
|
|
|
|
Cash,
end of year
|
|
$ |
3,565,837 |
|
|
$ |
1,540,220 |
|
See
accompanying notes to consolidated financial statements.
Notes
to the Consolidated Financial Statements
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 two lines of medical
devices: the first is a line of gamma radiation detection equipment used
in the application of sentinel lymph node biopsy (SLNB), and the second is
a line of blood flow monitoring devices for a variety of diagnostic and
surgical applications.
|
Our gamma
detection device products are marketed throughout most of the world through a
distribution arrangement with Ethicon Endo-Surgery, Inc. (EES), a Johnson &
Johnson company. For the years ended December 31, 2008 and 2007, 93%
and 91% of net sales, respectively, were made to EES. The loss of
this customer would have a significant adverse effect on our operating
results. In addition, we operate a blood flow measurement device
business that was initiated as a result of our acquisition of Cardiosonix Ltd.
(Cardiosonix, formerly Biosonix Ltd.) on December 31, 2001.
We also
have developmental and/or intellectual property rights related to two drugs that
could be used in connection with gamma detection devices in cancer
surgeries. The first, Lymphoseek®, is
intended to be used in determining the spread of certain solid tumor cancers
into the lymphatic system. The second, RIGScan® CR, is
intended to be used to help surgeons locate cancerous or disease involved tissue
during colorectal cancer surgeries. Both of these drug products are
still in development and must be cleared for marketing by the appropriate
regulatory bodies before they can be sold in any markets.
In
addition, in January 2005 we formed a new corporation, Cira Biosciences, Inc.
(Cira Bio), to explore the development of patient-specific cellular therapies
that have shown positive patient responses in a variety of clinical
settings. Cira Bio is combining our activated cellular therapy (ACT)
technology for patient-specific oncology treatment with similar technology
licensed from Cira LLC, a privately held company, for treating viral and
autoimmune diseases. Neoprobe owns approximately 90% of the
outstanding shares of Cira Bio with the remaining shares being held by the
principals of Cira LLC. During the third quarter of 2007, we executed an option
agreement with Cira Ltd., the sole minority shareholder in Cira Bio, whereby
Neoprobe may acquire Cira Ltd.’s 10% interest in Cira Bio for
$250,000. The option to acquire Cira Ltd.’s interest in Cira Bio
expired on June 30, 2008.
|
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: We adopted Statement of Financial Accounting
Standards (SFAS) No. 157, Fair Value
Measurements, for financial assets and liabilities as of January 1,
2008. SFAS No. 157 establishes a fair value hierarchy that
prioritizes the inputs to valuation techniques used to measure fair
value. The hierarchy gives 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
under SFAS No. 157 are described
below:
|
Level 1 – Unadjusted quoted
prices in active markets that are accessible at the measurement date for
identical, unrestricted assets or liabilities;
Level 2 – Quoted prices in
markets that are not active or financial instruments for which all significant
inputs are observable, either directly or indirectly; and
Notes
to the Consolidated Financial Statements
Level 3 – Prices or
valuations that require inputs that are both significant to the fair value
measurement and unobservable.
A
financial instrument’s level within the fair value hierarchy is based on the
lowest level of any input that is significant to the fair value
measurement. In determining the appropriate levels, we perform a
detailed analysis of the assets and liabilities that are subject to SFAS No.
157. At each reporting period, all assets and liabilities for which
the fair value measurement is based on significant unobservable inputs or
instruments which trade infrequently and therefore have little or no price
transparency are classified as Level 3. In estimating the fair value
of our derivative liabilities, we used the Black-Scholes option pricing model
and, where necessary, other macroeconomic, industry and Company-specific
conditions. See Note 2.
The
following methods and assumptions were used to estimate the fair value of each
class of financial instruments:
|
(1)
|
Cash,
accounts receivable, accounts payable, and accrued
liabilities: The carrying amounts approximate fair value
because of the short maturity of these
instruments.
|
|
(2)
|
Available-for-sale
securities: Available-for-sale securities are recorded at fair
value. Unrealized holding gains and losses on
available-for-sale securities are excluded from earnings and are reported
as a separate component of other comprehensive income (loss) until
realized. Realized gains and losses from the sale of
available-for-sale securities are determined on a specific identification
basis.
|
|
A
decline in the market value of any available-for-sale security below cost
that is deemed to be other than temporary results in a reduction in
carrying amount to fair value. The impairment is charged to
earnings and a new cost basis for the security is
established. Premiums and discounts are amortized or accreted
over the life of the related available-for-sale security as an adjustment
to yield using the effective interest method. Dividend and
interest income are recognized when
earned.
|
|
Available-for-sale
securities are accounted for on a specific identification
basis. As of December 31, 2008, we held available-for-sale
securities with an aggregate fair value of $495,383, including $1,383 of
net unrealized gains recorded in accumulated other comprehensive
income. As of December 31, 2008, all of our available-for-sale
securities were invested in short-term certificates of deposit with
maturity dates within 1 year. Available-for-sale securities
were classified as current based on their maturity dates as well as our
intent to use them to fund short-term working capital needs. We
held no available-for-sale securities at December 31,
2007.
|
|
(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 and 2007, the carrying
values of these instruments approximate fair
value.
|
|
(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, 2008, the
note payable to our CEO had an estimated fair value of $1.8
million. At December 31, 2007, the carrying value of the note
payable to our CEO approximated fair
value.
|
|
(5)
|
Notes
payable to outside investors: The carrying value of our debt is
presented as the face amount of the notes less the unamortized discounts
related to the fair value of the beneficial conversion feature, 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, 2008, the
notes payable to outside investors had an estimated fair value of $15.9
million. At December 31, 2007, the carrying value of the notes
payable to outside investors approximated fair
value.
|
Notes
to the Consolidated Financial Statements
|
e.
|
Cash and Cash
Equivalents: There were no cash equivalents at December
31, 2008 or 2007. No cash was restricted as of December 31,
2008 or 2007.
|
|
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 2008 and 2007, we wrote
off $30,000 and $142,000, respectively, of excess and obsolete materials,
primarily due to design changes to our Quantix®
product line.
|
From time
to time, we capitalize certain inventory costs associated with our Lymphoseek
product prior to regulatory approval and product launch based on management’s
judgment of probable future commercial use and net realizable value of the
inventory. We could be required to permanently write down previously
capitalized costs related to pre-approval or pre-launch inventory upon a change
in such judgment, due to a denial or delay of approval by regulatory bodies, a
delay in commercialization, or other potential factors. Conversely,
our gross margins may be favorably impacted if some or all of the inventory
previously written down becomes available and is used for commercial
sale. During 2007, we capitalized $150,000 associated with our
Lymphoseek product. During 2008, we wrote off $153,000 of previously
capitalized Lymphoseek inventory due to changes in our projections of the
probability of future commercial use for the specific units previously
capitalized.
The components of net inventory at
December 31, 2008 and 2007 are as follows:
|
|
2008
|
|
|
2007
|
|
Materials
and component parts
|
|
$ |
380,912 |
|
|
$ |
471,753 |
|
Work-in-process
|
|
|
- |
|
|
|
151,741 |
|
Finished
goods
|
|
|
580,949 |
|
|
|
613,909 |
|
|
|
$ |
961,861 |
|
|
$ |
1,237,403 |
|
|
g.
|
Property and
Equipment: Property and equipment are stated at
cost. 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. Maintenance and repairs are charged to expense as
incurred, while renewals and improvements are
capitalized. Property and equipment includes $44,000 and
$57,000 of equipment under capital leases with accumulated amortization of
$25,000 and $47,000 at December 31, 2008 and 2007,
respectively. During 2008 and 2007, we recorded losses of
$31,000 and $21,000, respectively, on the disposal of property and
equipment.
|
The major
classes of property and equipment are as follows:
|
Useful
Life
|
|
2008
|
|
|
2007
|
|
Production
machinery and equipment
|
5
years
|
|
$ |
736,840 |
|
|
$ |
720,225 |
|
Other
machinery and equipment, primarily research equipment, loaners and
computers
|
2 –
5 years
|
|
|
733,590 |
|
|
|
655,609 |
|
Furniture
and fixtures
|
7
years
|
|
|
349,369 |
|
|
|
340,007 |
|
Software
|
3
years
|
|
|
166,107 |
|
|
|
127,820 |
|
Leasehold
improvements
|
Life
of Lease1
|
|
|
74,682 |
|
|
|
74,682 |
|
|
|
|
$ |
2,060,588 |
|
|
$ |
1,918,343 |
|
1 We
amortize leasehold improvements over the life of the lease, which in all cases
is shorter than the estimated useful life of the asset.
|
h.
|
Intangible
Assets: Intangible assets consist primarily of patents
and other acquired intangible assets. 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 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. Acquired technology costs are amortized using the
straight-line method over the estimated useful life of seven
years. 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.
|
Notes
to the Consolidated Financial Statements
The major
classes of intangible assets are as follows:
|
|
|
December 31, 2008
|
|
|
December 31, 2007
|
|
|
Wtd
Avg
Life
|
|
Gross
Carrying
Amount
|
|
|
Accumulated
Amortization
|
|
|
Gross
Carrying
Amount
|
|
|
Accumulated
Amortization
|
|
Patents
and trademarks
|
7.8
yrs
|
|
$ |
3,020,001 |
|
|
$ |
1,626,516 |
|
|
$ |
3,016,783 |
|
|
$ |
1,449,350 |
|
Acquired
technology
|
0
yrs
|
|
|
237,271 |
|
|
|
237,271 |
|
|
|
237,271 |
|
|
|
203,562 |
|
Total
|
|
|
$ |
3,257,272 |
|
|
$ |
1,863,787 |
|
|
$ |
3,254,054 |
|
|
$ |
1,652,912 |
|
|
During
2008 and 2007, we recorded $225,000 and $233,000, respectively, of
intangible asset amortization in general and administrative
expenses. During 2007, we wrote off $1,000 of intangible assets
related to patents and trademarks that were determined to have no
recoverable value. No intangible assets were written off during
2008.
|
|
The
estimated future amortization expenses for the next five fiscal years are
as follows:
|
|
|
Estimated
Amortization
Expense
|
|
For
the year ended 12/31/2009
|
|
$ |
170,957 |
|
For
the year ended 12/31/2010
|
|
|
170,341 |
|
For
the year ended 12/31/2011
|
|
|
169,224 |
|
For
the year ended 12/31/2012
|
|
|
168,885 |
|
For
the year ended 12/31/2013
|
|
|
168,675 |
|
|
i.
|
Impairment or Disposal of
Long-Lived Assets: We account for the impairment of
long-lived assets in accordance with the provisions of SFAS No. 144, Accounting for the Impairment
or Disposal of Long-Lived Assets. This Statement requires
that long-lived assets and certain identifiable intangibles be reviewed
for impairment whenever events or changes in circumstances indicate that
the carrying amount of an asset may not be recoverable.
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. We recorded
no impairment charges during 2008 or
2007.
|
|
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 2008 and 2007, we incurred
$200,000 and $565,000, respectively, of debt issuance costs related to
notes payable. During 2007, we expensed $209,000 of deferred
debt issuance costs related to debt refinancing
activities. Other assets include deferred debt issuance costs
of $588,000 and $496,000 at December 31, 2008 and 2007,
respectively. See Note
7.
|
|
k.
|
Deferred Revenue:
Deferred revenue as of December 31, 2008 and 2007 consists
primarily of $500,000 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 intend
to recognize the $500,000 payment as license revenue on a straight-line
basis over the extended term of the agreement, or January 2009 through
December 2013. In addition, deferred revenue as of December 31,
2008 and 2007 includes revenues from the sale of extended warranties
covering our medical devices over periods of one to four
years. We recognize revenue from extended warranty sales on a
pro-rata basis over the period covered by the extended
warranty.
|
Notes
to the Consolidated Financial Statements
|
l.
|
Derivatives: We
account for
derivatives in accordance with SFAS No. 133, Accounting for Derivative
Instruments and Hedging Activities, which provides accounting and
reporting standards for derivative instruments, including certain
derivative instruments embedded in other contracts. Derivative
instruments embedded in contracts, to the extent not already a
free-standing contract, are required to be 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. See Note 7.
|
|
(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.
|
Sales
prices on gamma detection products sold to EES are subject to retroactive annual
adjustment based on a fixed percentage of the actual sales prices achieved by
EES on sales to end customers made during each fiscal year, subject to a minimum
(i.e., floor) price. To the extent that we can reasonably estimate
the end customer prices received by EES, we record sales to EES based upon these
estimates. To the extent that we are not able to reasonably estimate
end customer sales prices related to certain products sold to EES, we record
revenue related to these product sales at the floor price provided for under our
distribution agreement with EES.
We
recognize revenue related to the sales of products to be used for demonstration
units when products are shipped and the earnings process has been
completed. Our distribution agreements do not permit return of
purchased demonstration units in the ordinary course of business nor do we have
any performance obligations other than normal product warranty
obligations. To the extent that the earnings process has not been
completed, revenue is deferred. To the extent we enter into
multiple-element arrangements, we allocate revenue based on the relative fair
value of the elements.
|
(2)
|
Extended Warranty
Revenue: We derive revenues from the sale of extended
warranties covering our medical devices over periods of one to four
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, 2008, we have three
stock-based compensation plans. Under the Amended and Restated
Stock Option and Restricted Stock Purchase Plan (the Amended Plan), the
1996 Stock Incentive Plan (the 1996 Plan), and the Second Amended and
Restated 2002 Stock Incentive Plan (the 2002 Plan), we may grant incentive
stock options, nonqualified stock options, and restricted stock awards to
full-time employees, and nonqualified stock options and restricted stock
awards may be granted to our consultants and agents. Total
shares authorized under each plan are 2 million shares, 1.5 million shares
and 7 million shares, respectively. Although options are still
outstanding under the Amended Plan and the 1996 Plan, these plans are
considered expired and no new grants may be made from
them. Under all three plans, the exercise price of each option
is greater than or equal to the closing market price of our common stock
on the date of the grant.
|
Notes
to the Consolidated Financial Statements
Options
granted under the Amended Plan, the 1996 Plan and the 2002 Plan generally vest
on an annual basis over one to three years. Outstanding options under
the plans, if not exercised, generally expire ten years from their date of grant
or 90 days from the date of an optionee’s separation from employment with the
Company. The Company issues new shares of our common stock upon
exercise of stock options.
Compensation
cost arising from stock-based awards is recognized as expense using the
straight-line method over the vesting period. As of December 31,
2008, there was approximately $321,000 of total unrecognized compensation cost
related to unvested stock-based awards, which we expect to recognize over
remaining weighted average vesting terms of 0.8 years. For the years
ended December 31, 2008 and 2007, our total stock-based compensation expense was
approximately $212,000 and $102,000, respectively. We have not
recorded any income tax benefit related to stock-based compensation for the
years ended December 31, 2008 and 2007.
The fair
value of each option award is estimated on the date of grant using the
Black-Scholes option pricing model to value share-based
payments. Expected volatilities are based on the Company’s historical
volatility, which management believes represents the most accurate basis for
estimating expected volatility under the current
circumstances. Neoprobe uses historical data to estimate forfeiture
rates. The expected term of options granted is based on the vesting
period and the contractual life of the options. The risk-free rate is based on
the U.S. Treasury yield in effect at the time of the grant. The
assumptions used for the years ended December 31, 2008 and 2007 are noted in the
following table:
|
2008
|
|
2007
|
Expected
volatility
|
93%-104%
|
|
102%-104%
|
Weighted-average
volatility
|
101%
|
|
103%
|
Expected
dividends
|
-
|
|
-
|
Expected
term
|
5.9
years
|
|
5.8
years
|
Risk-free
rate
|
3.4%
|
|
4.6%
|
A summary
of stock option activity under our stock option plans as of December 31, 2008,
and changes during the year then ended is presented below:
|
|
Year
Ended December 31, 2008
|
|
|
|
Number
of
Options
|
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining
Contractual
Life
|
|
Aggregate
Intrinsic
Value
|
|
Outstanding
at beginning of period
|
|
|
5,495,473 |
|
|
$ |
0.42 |
|
|
|
|
|
Granted
|
|
|
576,000 |
|
|
$ |
0.42 |
|
|
|
|
|
Exercised
|
|
|
(185,000 |
) |
|
$ |
0.33 |
|
|
|
|
|
Forfeited
|
|
|
- |
|
|
|
- |
|
|
|
|
|
Expired
|
|
|
(266,973 |
) |
|
$ |
1.02 |
|
|
|
|
|
Outstanding
at end of period
|
|
|
5,619,500 |
|
|
$ |
0.40 |
|
5.3
years
|
|
$ |
1,102,325 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable
at end of period
|
|
|
4,880,167 |
|
|
$ |
0.40 |
|
4.8
years
|
|
$ |
958,712 |
|
The
weighted average grant-date fair value of options granted in 2008 and 2007 was
$0.33 and $0.28, respectively. During 2008, 185,000 stock options
with an aggregate intrinsic value of $43,550 were exercised in exchange for
issuance of 185,000 shares of our common stock, resulting in proceeds of
$61,900.
Notes
to the Consolidated Financial Statements
A summary
of the status of our unvested restricted stock as of December 31, 2008, and
changes during the year then ended is presented below:
|
|
Year Ended
December 31, 2008
|
|
|
|
Number of
Shares
|
|
|
Weighted
Average
Grant-Date
Fair Value
|
|
Unvested
at beginning of period
|
|
|
- |
|
|
|
- |
|
Granted
|
|
|
480,000 |
|
|
$ |
0.38 |
|
Vested
|
|
|
(7,000 |
) |
|
$ |
0.65 |
|
Forfeited
|
|
|
- |
|
|
|
- |
|
Unvested
at end of period
|
|
|
473,000 |
|
|
$ |
0.37 |
|
During
2008, 7,000 shares of restricted stock vested with an aggregate fair value of
$4,060. During 2007, all of our then-outstanding restricted shares
were effectively cancelled due to failure to vest under the terms of issuance of
these shares. Restricted shares generally vest upon occurrence of a
specific event or achievement of goals as defined in the grant
agreements. As a result, we have recorded compensation expense
related to grants of restricted stock based on management’s estimates of the
probable dates of the vesting events. See Note 17(a).
|
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, 2008 and 2007. See Note
8.
|
In July
2006, the Financial Accounting Standards Board (FASB) issued Interpretation No.
48, Accounting for Uncertainty
in Income Taxes–An Interpretation of FASB Statement No. 109 (FIN
48). We adopted the provisions of FIN 48 on January 1,
2007. FIN 48 clarifies the accounting for uncertainty in income taxes
recognized in the financial statements in accordance with FASB Statement No.
109. FIN 48 also prescribes a recognition threshold and measurement
model for the financial statement recognition of a tax position taken, or
expected to be taken, and provides guidance on derecognition, classification,
interest and penalties, accounting in interim periods, disclosure and
transition. No adjustment was made to the beginning retained earnings
balance as the ultimate deductibility of all tax positions is highly certain,
although there is uncertainty about the timing of such
deductibility. As a result, no liability for uncertain tax positions
was recorded as of December 31, 2008 or 2007. Should the Company need
to accrue interest or penalties on uncertain tax positions, it would recognize
the interest as interest expense and the penalties as a selling, general and
administrative expense. As of
December 31, 2008, federal and state tax returns for tax years 2005-2007
remained subject to examination by tax authorities.
|
q.
|
Recent Accounting
Developments: In September 2006, the FASB issued SFAS
No. 157, Fair Value
Measurements (SFAS No. 157). SFAS No. 157 defines fair
value, establishes a framework for measuring fair value in generally
accepted accounting principles, and expands disclosures about fair value
measurements. SFAS No. 157 applies under other accounting
pronouncements that require or permit fair value measurements, the FASB
having previously concluded in those accounting pronouncements that fair
value is the relevant measurement attribute. Accordingly, SFAS
No. 157 does not require any new fair value measurements. SFAS
No. 157 was initially effective for Neoprobe beginning January 1,
2008. In February 2008, the FASB approved the issuance of FASB
Staff Position (FSP) FAS 157-2. FSP FAS 157-2 allows entities
to electively defer the effective date of SFAS No. 157 until January 1,
2009 for nonfinancial assets and nonfinancial liabilities except those
items recognized or disclosed at fair value on at least an annual
basis. We will apply the fair value measurement and disclosure
provisions of SFAS No. 157 to nonfinancial assets and liabilities
effective January 1, 2009. The application of such is not
expected to be material to our consolidated results of operations or
financial condition. See Note 1(d) and Note 2 for a discussion
regarding the January 1, 2008 implementation of SFAS No. 157 relating to
our financial assets and
liabilities.
|
Notes
to the Consolidated Financial Statements
In
February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities – Including an Amendment of FASB Statement No.
115 (SFAS No. 159). SFAS No. 159 permits entities to choose to
measure many financial instruments and certain other items at fair value at
specified election dates. Most of the provisions of SFAS No. 159
apply only to entities that elect the fair value option. However, the
amendment to FASB Statement No. 115, Accounting for Certain Investments
in Debt and Equity Securities, applies to all entities with
available-for-sale and trading securities. The fair value option
established by SFAS No. 159 permits all entities to choose to measure eligible
items at fair value at specified election dates. A business entity
shall report unrealized gains and losses on items for which the fair value
option has been elected in earnings at each subsequent reporting
date. The fair value option may be applied instrument by instrument,
with a few exceptions, such as investments otherwise accounted for by the equity
method, is irrevocable (unless a new election date occurs), and is applied only
to entire instruments and not to portions of instruments. SFAS No.
159 is effective for fiscal years beginning after November 15,
2007. We adopted SFAS No. 159 as required on January 1, 2008;
however, we did not elect to measure any of our currently outstanding financial
instruments using the fair value option outlined in SFAS No. 159. As
such, the adoption of SFAS No. 159 did not have any impact on our consolidated
results of operations or financial condition.
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS
No. 141(R)). SFAS No. 141(R) retains the fundamental requirements of
the original pronouncement requiring that the acquisition method (formerly
called the purchase method) of accounting be used for all business combinations
and for an acquirer to be identified for each business
combination. SFAS No. 141(R) defines the acquirer as the entity that
obtains control of one or more businesses in the business combination,
establishes the acquisition date as the date that the acquirer achieves control
and requires the acquirer to recognize the assets and liabilities assumed and
any noncontrolling interest at their fair values as of the acquisition
date. SFAS No. 141(R) requires, among other things, that the
acquisition-related costs be recognized separately from the
acquisition. SFAS No. 141(R) applies prospectively to business
combinations for which the acquisition date is on or after the beginning of the
first annual reporting period beginning on or after December 15, 2008, and is
required to be adopted by Neoprobe beginning January 1, 2009. The
effect the adoption of SFAS No. 141(R) will have on us will depend on the nature
and size of acquisitions we complete after we adopt SFAS No. 141(R), if
any.
Also in
December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in
Consolidated Financial Statements – an Amendment of ARB No. 51 (SFAS No.
160). SFAS No. 160 amends ARB No. 51 to establish accounting and
reporting standards for the noncontrolling interest in a subsidiary and for the
deconsolidation of a subsidiary. It also amends certain of ARB No.
51’s consolidation procedures for consistency with the requirements of SFAS No.
141(R), Business
Combinations. SFAS No. 160 is effective for fiscal years and
interim periods within those fiscal years beginning on or after December 15,
2008, and is required to be adopted by Neoprobe beginning January 1,
2009. Earlier adoption is prohibited. SFAS No. 160 shall
be applied prospectively as of the beginning of the fiscal year in which it is
adopted, except for the presentation and disclosure requirements. The
presentation and disclosure requirements shall be applied retrospectively for
all periods presented. We do not expect the adoption of SFAS No. 160
to have a material effect on our consolidated results of operations or financial
condition.
In
December 2007, the FASB ratified the consensus reached by the Emerging Issues
Task Force (EITF) on EITF Issue No. 07-1, Accounting for Collaborative
Arrangements. EITF No. 07-1 focuses on defining a
collaborative arrangement as well as the accounting for transactions between
participants in a collaborative arrangement and between the participants in the
arrangement and third parties. The EITF concluded that both types of
transactions should be reported in each participant’s respective income
statement. EITF No. 07-1 is effective for financial statements issued
for fiscal years beginning after December 15, 2008, and interim periods within
those fiscal years and should be applied retrospectively to all prior periods
presented for all collaborative arrangements existing as of the effective
date. We do not expect EITF No. 07-1 to have a material effect on our
consolidated results of operations or financial condition.
Notes
to the Consolidated Financial Statements
In March
2008, the FASB issued SFAS No. 161, Disclosures about Derivative
Instruments and Hedging Activities – an Amendment of FASB Statement No.
133 (SFAS No. 161). SFAS No. 161 amends and expands the
disclosure requirements of Statement No. 133 to provide a better understanding
of how and why an entity uses derivative instruments, how derivative instruments
and related hedged items are accounted for, and their effect on an entity’s
financial position, financial performance, and cash flows. SFAS No.
161 is effective for fiscal years beginning after November 15,
2008. We are currently evaluating the impact that the adoption of
SFAS No. 161 will have on our derivative disclosures.
In June
2008, the FASB ratified the consensus reached by the EITF on EITF Issue No.
07-5, Determining Whether an
Instrument (or Embedded Feature) is Indexed to an Entity’s Own
Stock. EITF Issue No. 07-5 clarifies the determination of
whether equity-linked instruments (or embedded features), such as our
convertible notes or warrants to purchase our common stock, are considered
indexed to our own stock, which would qualify as a scope exception under SFAS
No. 133, Accounting for
Derivative Instruments and Hedging Activities. EITF Issue No.
07-5 is effective for financial statements issued for fiscal years beginning
after December 15, 2008. Early adoption for an existing instrument is
not permitted. We are currently evaluating the impact that the
adoption of EITF Issue No. 07-5 will have on our consolidated financial
statements. If we determine that the provisions of EITF Issue No.
07-5 are applicable to our financial instruments, we currently estimate that the
adoption of EITF Issue No. 07-5 will result in a cumulative effect adjustment of
approximately $3.9 million that would be recorded as additional accumulated
deficit during the first quarter of 2009 as well as the disclosure of additional
derivative liabilities in our balance sheet in future reports.
The
following tables set forth by level financial assets and liabilities measured at
fair value on a recurring basis.
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 |
|
Notes
to the Consolidated Financial Statements
Liabilities
Measured at Fair Value on a Recurring Basis as of December 31, 2007
|
|
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)
|
|
|
2007
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative
liabilities
related to warrants
|
|
$ |
- |
|
|
$ |
1,254,404 |
|
|
$ |
- |
|
|
$ |
1,254,404 |
|
Derivative
liabilities
related to conversion
and put options
|
|
|
- |
|
|
|
- |
|
|
|
1,599,072 |
|
|
|
1,599,072 |
|
Total
derivative liabilities
|
|
$ |
- |
|
|
$ |
1,254,404 |
|
|
$ |
1,599,072 |
|
|
$ |
2,853,476 |
|
The
following table sets forth a summary of changes in the fair value of our Level 3
liabilities for the year ended December 31, 2008:
Description
|
|
Balance at
December 31,
2007
|
|
|
Unrealized
Losses
|
|
|
Issuance of
Put Options
Related to
the Montaur
Notes and
Preferred
Stock
|
|
|
Transfers In
and/or (Out)
(See Note 7)
|
|
|
Balance at
December 31,
2008
|
|
Derivative
liabilities related
to conversion and
put options
|
|
$ |
1,599,072 |
|
|
$ |
180,727 |
|
|
$ |
473,968 |
|
|
$ |
(1,399,936 |
) |
|
$ |
853,831 |
|
The Level
2 Series W warrant derivative liability and the Level 3 Series A Note conversion
option derivative liability were $1,254,404 and $1,289,215 as of January 1,
2008, respectively. These derivative liabilities incurred unrealized
losses of $270,654 and $110,721, respectively, through March 14, 2008 when the
Series W warrant and Series A Note were amended as discussed in Note
7. As a result of the amendment, the Level 2 warrant derivative
liability and the Level 3 conversion option derivative liability required equity
treatment. The warrant derivative liability and the conversion option
derivative liability were reclassified to equity on March 14, 2008 at their fair
value amounts of $1,525,058 and $1,399,936, respectively, for a total of
$2,924,994.
The
unrealized gains and losses on the derivatives are classified in other expenses
as a change in derivative liabilities in the statement of operations. Fair
value of available-for-sale securities is determined based on a discounted cash
flow analysis using current market rates. Fair value of conversion and put
option liabilities is determined based on a probability-weighted Black-Scholes
option pricing model calculation.
Notes
to the Consolidated Financial Statements
Basic
earnings (loss) per share is calculated using the weighted average number of
common shares outstanding during the periods. Diluted earnings (loss)
per share is calculated using the weighted average number of common shares
outstanding during the periods, adjusted for the effects of unvested restricted
stock, convertible securities, options and warrants, if dilutive.
|
|
Year Ended
December 31, 2008
|
|
|
Year Ended
December 31, 2007
|
|
|
|
Basic
Earnings
Per Share
|
|
|
Diluted
Earnings
Per Share
|
|
|
Basic
Earnings
Per Share
|
|
|
Diluted
Earnings
Per Share
|
|
Outstanding
shares
|
|
|
70,862,641 |
|
|
|
70,862,641 |
|
|
|
67,240,030 |
|
|
|
67,240,030 |
|
Effect
of weighting changes in outstanding shares
|
|
|
(1,795,469 |
) |
|
|
(1,795,469 |
) |
|
|
(4,318,539 |
) |
|
|
(4,318,539 |
) |
Contingently
issuable shares
|
|
|
(473,000 |
) |
|
|
(473,000 |
) |
|
|
- |
|
|
|
- |
|
Adjusted
shares
|
|
|
68,594,172 |
|
|
|
68,594,172 |
|
|
|
62,921,491 |
|
|
|
62,921,491 |
|
There is
no difference in basic and diluted loss per share related to 2008 or
2007. The net loss per common share for these periods excludes the
effects of 59,793,178 and 35,691,194 common share equivalents, respectively,
since such inclusion would be anti-dilutive. The excluded shares
consist of unvested restricted stock and common shares issuable upon exercise of
outstanding stock options and warrants, or upon the conversion of convertible
debt or convertible preferred stock.
4.
|
Accounts
Receivable and Concentrations of Credit
Risk:
|
Accounts
receivable at December 31, 2008 and 2007, net of allowance for doubtful accounts
of $1,000, consist of the following:
|
|
2008
|
|
|
2007
|
|
Trade
|
|
$ |
1,602,919 |
|
|
$ |
1,609,690 |
|
Other
|
|
|
41,151 |
|
|
|
12,220 |
|
|
|
$ |
1,644,070 |
|
|
$ |
1,621,910 |
|
At
December 31, 2008 and 2007, approximately 93% and 94%, respectively, of net
accounts receivable were due from EES. We do not believe we are
exposed to significant credit risk related to EES based on the overall financial
strength and credit worthiness of the customer and its parent
company. We believe that we have adequately addressed other credit
risks in estimating the allowance for doubtful accounts.
We
estimate an allowance for doubtful accounts based on a review and assessment of
specific accounts receivable and write off accounts when deemed
uncollectible.
5.
|
Accrued
Liabilities and Other:
|
Accrued
liabilities at December 31, 2008 and 2007 consist of the following:
|
|
2008
|
|
|
2007
|
|
Contracted
services and other
|
|
$ |
590,502 |
|
|
$ |
446,037 |
|
Compensation
|
|
|
220,487 |
|
|
|
207,904 |
|
Warranty
reserve
|
|
|
72,643 |
|
|
|
115,395 |
|
Interest
|
|
|
18,000 |
|
|
|
9,409 |
|
Inventory
purchases
|
|
|
16,044 |
|
|
|
23,204 |
|
|
|
$ |
917,676 |
|
|
$ |
801,949 |
|
Notes
to the Consolidated Financial Statements
6. Product
Warranty:
We
warrant our products against defects in design, materials, and workmanship
generally for a period of one year from the date of sale to the end customer,
except in cases where the product has a limited use as designed. Our
accrual for warranty expenses is adjusted periodically to reflect actual
experience and is included in accrued liabilities on the consolidated balance
sheets. EES also reimburses us for a portion of warranty expense
incurred based on end customer sales they make during a given fiscal
year. Payments charged against the reserve are disclosed net of EES’
estimated reimbursement.
The
activity in the warranty reserve account for the years ended December 31, 2008
and 2007 is as follows:
|
|
2008
|
|
|
2007
|
|
Warranty
reserve at beginning of year
|
|
$ |
115,395 |
|
|
$ |
44,858 |
|
Provision
for warranty claims and changes
in reserve for warranties
|
|
|
42,436 |
|
|
|
121,996 |
|
Payments
charged against the reserve
|
|
|
(85,188 |
) |
|
|
(51,459 |
) |
Warranty
reserve at end of year
|
|
$ |
72,643 |
|
|
$ |
115,395 |
|
7. Notes
Payable:
In
December 2004, we completed a private placement of four-year convertible
promissory notes in an aggregate principal amount of $8.1 million under a
Securities Purchase Agreement with Biomedical Value Fund, L.P., Biomedical
Offshore Value Fund, Ltd. and David C. Bupp, our President and
CEO. Biomedical Value Fund, L.P. and Biomedical Offshore Value Fund,
Ltd. are funds managed by Great Point Partners, LLC (collectively, the Great
Point Funds). The notes originally bore interest at 8% per annum and
were due on December 13, 2008. As part of the original transaction
with the Great Point Funds, we issued the investors Series T warrants to
purchase 10,125,000 shares of our common stock at an exercise price of $0.46 per
share, expiring in December 2009. In connection with this financing,
we also issued Series U warrants to purchase 1,600,000 shares of our common
stock to the placement agents, containing substantially the same terms as the
warrants issued to the investors. The fair value of the warrants
issued to the investors and the value of the beneficial conversion feature were
recorded as discounts on the note and were being amortized over the term of the
notes using the effective interest method. The fair value of the
warrants issued to the placement agents was recorded as a deferred debt issuance
cost and was also being amortized over the term of the notes using the effective
interest method. In November 2006, we amended the Agreement and
modified several of the key terms in the related notes, including the interest
rate which was increased to 12% per annum, and modified the maturity of the
notes to provide for a series of scheduled payments due on approximately six
month intervals through January 7, 2009. We were also required to
make additional mandatory repayments of principal to the Great Point Funds under
certain circumstances. During 2007, we made scheduled principal
payments and mandatory repayments totaling $2.4 million.
In
exchange for the increased interest rate and accelerated principal repayment
schedule, the note holders eliminated the financial covenants under the original
notes and eliminated certain conversion price adjustments from the original
notes related to sales of equity securities by Neoprobe. We treated
the amendment to the Agreement as a modification for accounting purposes, and
the amortization of debt discount and issuance costs using the effective
interest method was revised accordingly. During the third quarter of
2007, management determined that we had, from the date of the modification of
the notes payable on November 30, 2006, through June 30, 2007, incorrectly
applied the effective interest method in calculating the amortization of the
debt discount and issuance costs related to the notes. As a result of
the error in calculation, we recorded a total adjustment of $286,000 in non-cash
interest expense related to the seven months ended June 30, 2007 in our results
of operations for the third quarter of 2007. We determined that the
net effect of this adjustment was not material, either quantitatively or
qualitatively, to our results of operations and would not have resulted in
changes to net loss per share, as reported, for the year ended December 31, 2006
or for the quarters ended March 31, 2007 and June 30, 2007. Recording
the adjustment did not require amendment of the previously filed reports for the
periods affected.
Notes
to the Consolidated Financial Statements
In July
2007, David C. Bupp, our President and CEO, and certain members of his family
(the Bupp Investors) purchased a $1.0 million convertible note (the Bupp Note)
and warrants. The note bears interest at 10% per annum, had an
original term of one year and is repayable in whole or in part with no
penalty. The note is convertible, at the option of the Bupp
Investors, into shares of our common stock at a price of $0.31 per share, a 25%
premium to the average closing market price of our common stock for the 5 days
preceding the closing of the transaction. As part of this
transaction, we issued the Bupp Investors Series V warrants to purchase 500,000
shares of our common stock at an exercise price of $0.31 per share, expiring in
July 2012. The fair value of the warrants issued to the investors was
approximately $80,000 on the date of issuance and was determined using the
Black-Scholes option pricing model with the following assumptions: an
average risk-free interest rate of 4.95%, volatility of 105% and no expected
dividend rate. The value of the beneficial conversion feature of the
note was estimated at $86,000 based on the effective conversion price at the
date of issuance. The fair value of the warrants issued to the
investors and the value of the beneficial conversion feature were recorded as
discounts on the note. We incurred $43,000 of costs related to
completing the Bupp financing, which were recorded in other
assets. The discounts and the deferred debt issuance costs were being
amortized over the term of the note using the effective interest
method.
In
December 2007, we executed a Securities Purchase Agreement (SPA) with
Platinum Montaur Life Sciences, LLC (Montaur), pursuant to which we issued
Montaur: (1) a 10% Series A Convertible Senior Secured Promissory Note
in the principal amount of $7,000,000, due December 26, 2011 (the
Series A Note); and (2) a Series W warrant to purchase 6,000,000
shares of our common stock at an exercise price of $0.32 per share, expiring in
December 2012 (the Series W warrant). Additionally, pursuant to the
terms of the SPA: (1) upon commencement of the Phase 3 clinical studies of
Lymphoseek, we agreed to issue to Montaur a 10% Series B Convertible Senior
Secured Promissory Note, due December 26, 2011 (the Series B Note, and
hereinafter referred to collectively with the Series A Note as the Montaur
Notes), and a five-year warrant to purchase an amount of common stock equal to
the number of shares into which Montaur may convert the Series B Note, at
an exercise price of 115% of the conversion price of the Series B Note (the
Series X warrant), for an aggregate purchase price of $3,000,000; and
(2) upon completion of enrollment of 200 patients in the Phase 3 clinical
studies of Lymphoseek, we agreed to issue to Montaur 3,000 shares of our 8%
Series A Cumulative Convertible Preferred Stock (the Preferred Stock) and a
five-year warrant to purchase an amount of common stock equal to the number of
shares into which Montaur may convert the Preferred Stock, at an exercise price
of 115% of the conversion price of the Preferred Stock (the Series Y
warrant, and hereinafter referred to collectively with the Series W warrant
and Series X warrant as the Montaur warrants), also for an aggregate
purchase price of $3,000,000. See Note 9.
The
Series A Note bears interest at 10% per annum and is partially convertible
at the option of Montaur into common stock at a price of $0.26 per
share. Interest is payable monthly, in arrears, beginning February
2008 until the earlier of the maturity date or the date of
conversion. At our discretion, we may pay the monthly interest
payments in cash, common stock, or a combination of cash and common stock,
subject to certain limitations set forth in the Series A
Note. According to the provisions of the Certificate of Designations,
Voting Powers, Preferences, Limitations, Restrictions, and Relative Rights of
Series A 8% Cumulative Convertible Preferred Stock (the Certificate of
Designations), Montaur may convert all or any portion of the shares of Preferred
Stock into a number of shares of common stock equal to the quotient of:
(1) the Liquidation Preference Amount of the shares of Preferred Stock by
(2) the Conversion Price then in effect for the Preferred
Stock. Per the Certificate of Designations, the Liquidation
Preference Amount is equal to $1,000 per share of Preferred Stock, and the
Conversion Price is equal to the lesser of $0.50 or the closing price of the
common stock on the issuance date of the Preferred Stock, subject to adjustment
as described in the Certificate of Designations.
Notes
to the Consolidated Financial Statements
Under the
terms of the original Registration Rights Agreement, dated December 26, 2007, we
agreed to file a registration statement with the Commission registering the
shares of common stock underlying the Notes, the Preferred Stock and the
warrants issued to Montaur pursuant to the SPA. On April 16, 2008, we
entered into the Second Amendment to Registration Rights Agreement (the Second
Amendment), pursuant to which Montaur agreed to limit our registration
obligations to (a) the shares of common stock issuable upon conversion of the
Series B Note; (b) the shares of common stock issuable upon exercise
of the Series W and X warrants; and (c) 3,500,000 shares of common
stock issuable as interest on the Montaur Notes. On July 10, 2008, we
entered into a Third Amendment to Registration Rights Agreement (the Third
Amendment), pursuant to which Montaur agreed to further limit our registration
obligations to: (a) the shares of common stock issuable upon conversion of the
Series B Note; (b) the shares of common stock issuable upon exercise of the
Series X warrant; and (c) 3,500,000 shares of common stock issuable as interest
on the Montaur Notes. Additionally, pursuant to the terms of the
Registration Rights Agreement, as amended by the Second Amendment and Third
Amendment, we agreed that: (a) within thirty-five (35) days following the Third
Closing Date (as that term is defined in the SPA) we will prepare and file with
the Commission an additional “resale” registration statement providing for the
resale of (in the following order of priority): (i) the shares of common stock
issuable upon the conversion of the Preferred Shares; (ii) the shares of common
stock issuable upon exercise of the Series Y warrant; and (iii) shares of common
stock issuable as dividends on the Preferred Stock, for an offering to be made
on a continuous basis pursuant to Rule 415, and (b) within thirty-five (35) days
of a receipt by the written request of the Holder therefore, we will prepare and
file with the Commission an additional “resale” Registration Statement providing
for the resale of the shares of common stock issuable upon the conversion of the
Series A Note, and the shares of common stock issuable upon the exercise of the
Series W warrant.
In
accordance with SFAS No. 133, Accounting for Derivative
Instruments and Hedging Activities, the conversion option and two put
options were considered derivative instruments and were required to be
bifurcated from the Series A Note and accounted for separately. In
addition, in accordance with SFAS No. 150, Accounting for Certain Financial
Instruments with Characteristics of both Liabilities and Equity, the
Series W warrant was accounted for as a liability due to the existence of
certain provisions in the instrument. As a result, we recorded a total
aggregate derivative liability of $2.6 million on the date of issuance of the
Series A Note and Series W warrant. The fair value of the bifurcated
conversion option and put options was approximately $1.45 million on the date of
issuance. The fair value of the Series W warrant was approximately $1.15
million on the date of issuance and was determined using the Black-Scholes
option pricing model with the following assumptions: an average
risk-free interest rate of 3.7%, volatility of 94% and no expected dividend
rate. Changes in the fair value of the derivative liabilities are
recorded in the consolidated statement of operations. As of December
31, 2007, the derivative liabilities had estimated fair values of $1.60 million
and $1.25 million for the conversion and put options and the warrants,
respectively.
On March
14, 2008, Neoprobe and Montaur executed amendments to the Series A Note and the
Series W warrant. The amendments eliminated certain minor cash-based
penalty provisions in the Series A Note and Series W warrant which entitled the
holders to different compensation than our common shareholders under certain
circumstances and qualifying Triggering Events. The provisions that
were eliminated and/or modified were the provisions that led to the derivative
accounting treatment for the embedded conversion option in the Series A Note and
the Series W warrant. Because the value of our stock increased
between December 31, 2007, our year end, and March 14, 2008, the effect of
marking the conversion option and warrant liabilities to “market” at March 14,
2008 resulted in an increase in the estimated fair value of the conversion
option and warrant liabilities of $381,000 which was recorded as non-cash
expense during the first quarter of 2008. The estimated fair value of
the conversion option and warrant liabilities of $2.9 million was reclassified
to additional paid-in capital during the first quarter of 2008 as a result of
the amendments. The effect of marking the put option liabilities
related to the Series A Note to “market” at March 31, June 30, September 30 and
December 31, 2008 resulted in a net increase in the estimated fair value of the
put option liabilities of $51,000 which was recorded as non-cash expense during
2008. The estimated fair value of the put option liabilities related
to the Series A Note of $360,000 remained classified as derivative liabilities
as of December 31, 2008.
The
initial aggregate fair value of the conversion option and the put options
related to the Series A Note and the fair value of the Series W warrant of $2.6
million were recorded as a discount on the note and are being amortized over the
term of the note using the effective interest method. During 2008, we
recorded interest expense of $543,000 related to the amortization of the debt
discount. We incurred $510,000 of costs related to completing the
initial Montaur financing, which were recorded in other assets on the
consolidated balance sheet. The deferred financing costs are being
amortized using the effective interest method over the term of the
note. During 2008, we recorded interest expense of $106,000 related
to the amortization of the deferred financing costs.
Notes
to the Consolidated Financial Statements
In April
2008, we completed the second closing under the December 2007 Montaur Purchase
Agreement, as amended, pursuant to which we issued Montaur a 10%
Series B Convertible Senior Secured Promissory Note in the principal amount
of $3,000,000, due December 26, 2011; and a Series X warrant to purchase
8,333,333 shares of our common stock at an exercise price of $0.46 per share,
expiring in April 2013. The Series B Note bears interest at 10%
per annum and is fully convertible at the option of Montaur into common stock at
a price of $0.36 per share. Interest is payable monthly, in arrears,
beginning in April 2008 until the earlier of the maturity date or the date of
conversion. At our discretion, we may pay the monthly interest
payments in cash, common stock, or a combination of cash and common stock,
subject to certain limitations set forth in the Series B Note.
The fair
value of the Series X warrant was approximately $1.28 million on the date of
issuance and was determined using the Black-Scholes option pricing model with
the following assumptions: an average risk-free interest rate of
2.6%, volatility of 95% and no expected dividend rate. The value of
the beneficial conversion feature of the Series B Note was estimated at $1.44
million based on the effective conversion price at the date of
issuance. The fair value of the warrant issued to the investors and
the value of the beneficial conversion feature were recorded as discounts on the
note and are being amortized over the term of the note using the effective
interest method. The two put options were considered derivative
instruments and were required to be bifurcated from the Series B Note and
accounted for separately. The fair value of the bifurcated put
options was approximately $258,000 on the date of issuance. Changes
in the fair value of the derivative liabilities are recorded in the consolidated
statement of operations. The effect of marking the put option
liabilities related to the Series B Note to “market” at June 30, September 30
and December 31, 2008 resulted in a net increase in the estimated fair value of
the put option liabilities of $20,000 which was recorded as non-cash expense
during 2008. The estimated fair value of the put option liabilities
related to the Series B Note of $277,000 remained classified as derivative
liabilities as of December 31, 2008.
The
initial aggregate fair value of the beneficial conversion feature and put
options related to the Series B Note, and the fair value of the Series X warrant
of $2.98 million were recorded as discounts on the note and are being amortized
over the term of the note using the effective interest method. During
2008, we recorded interest expense of $33,000 related to the amortization of the
debt discount. We incurred $188,000 of costs related to completing
the second Montaur financing, which were recorded in other assets on the
consolidated balance sheet. The deferred financing costs are being
amortized using the effective interest method over the term of the
note. During 2008, we recorded interest expense of $2,000 related to
the amortization of the deferred financing costs.
In
connection with the second closing, we also amended the SPA with respect to the
milestone that would trigger the third closing for an additional $3 million
investment from Montaur. The milestone was revised from the accrual
of 200 patients in a Phase 3 trial for Lymphoseek to obtaining 135 vital blue
dye lymph nodes from patients with breast cancer or melanoma who have completed
surgery with the injection of the drug in a Phase 3 clinical trial of
Lymphoseek.
In
connection with the SPA, Montaur requested that the term of the $1.0 million
Bupp Note be extended until at least one day following the maturity date of the
Montaur Notes. In consideration for the Bupp Investors’ agreement to
extend the term of the Bupp Note pursuant to an Amendment to the Bupp Purchase
Agreement, dated December 26, 2007, we agreed to provide security for
the obligations evidenced by the Amended 10% Convertible Note in the principal
amount of $1,000,000, due December 31, 2011, executed by Neoprobe in favor
of the Bupp Investors (the Amended Bupp Note), under the terms of a Security
Agreement, dated December 26, 2007, by and between Neoprobe and the Bupp
Investors (the Bupp Security Agreement). As further consideration for
extending the term of the Bupp Note, we issued the Bupp Investors Series V
warrants to purchase 500,000 shares of our common stock at an exercise price of
$0.32 per share, expiring in December 2012. The fair value of the
warrants issued to the Bupp Investors was approximately $96,000 on the date of
issuance and was determined using the Black-Scholes option pricing model with
the following assumptions: an average risk-free interest rate of
3.72%, volatility of 94% and no expected dividend rate. The fair
value of the warrants was recorded as a discount on the note and is being
amortized over the term of the note using the effective interest
method. We treated the amendment to the Bupp Note as an
extinguishment of debt for accounting purposes. As such, the
remaining discount resulting from the fair value of the warrants and the value
of the beneficial conversion feature and the remaining unamortized deferred
financing costs associated with the original note were written off as a loss on
extinguishment of debt in December 2007.
Notes
to the Consolidated Financial Statements
We
applied $5,725,000 from the proceeds of our issuance of the Series A Note
and Series W warrant to the complete and total satisfaction of our outstanding
obligations under the Replacement Series A Convertible Promissory Notes
issued to the Great Point Funds and David C. Bupp as of November 30, 2006,
pursuant to the Securities Purchase Agreement, dated as of December 13,
2004, by and among Neoprobe, the Great Point Funds and Mr. Bupp, as amended
by the Amendment dated as of November 30, 2006 (the Amended GPP Purchase
Agreement). We treated the early repayment of the notes as an
extinguishment of debt for accounting purposes. As such, the
remaining discount resulting from the fair value of the warrants and the value
of the beneficial conversion feature associated with the original notes was
written off as a loss on extinguishment of debt in December 2007. We
applied an additional $675,000 from the proceeds of our issuance of the
Series A Note and Series W warrant to the redemption of Series T
warrants to purchase 10,000,000 shares of our common stock at an exercise price
of $0.46 per share, issued to the Great Point Funds pursuant to the Amended GPP
Purchase Agreement. In connection with the consummation of the
Montaur Purchase Agreement and amendment of the Bupp Purchase Agreement,
Mr. Bupp agreed to the cancellation of Series T warrants to purchase
125,000 shares of our common stock at an exercise price of $0.46 per share,
originally issued to Mr. Bupp pursuant to the Amended GPP Purchase
Agreement. The combined events retired all of the Series T warrants
issued to the Great Point Funds and Mr. Bupp.
As of
December 31, 2008 and 2007, our deferred tax assets in the U.S. were
approximately $37.8 million and $40.1 million, respectively, prior to any
limitations under Sections 382 and 383 of the Internal Revenue Code (IRC), as
discussed below. The components of our deferred tax assets, pursuant
to SFAS No. 109, Accounting
for Income Taxes, are summarized as follows:
|
|
As
of December 31,
|
|
|
|
2008
|
|
|
2007
|
|
Deferred
tax assets:
|
|
|
|
|
|
|
Federal
net operating loss carryforwards
|
|
$ |
30,071,041 |
|
|
$ |
32,428,173 |
|
State
net operating loss carryforwards
|
|
|
1,945,601 |
|
|
|
2,229,635 |
|
R&D
credit carryforwards
|
|
|
4,781,584 |
|
|
|
4,906,697 |
|
Temporary
differences
|
|
|
979,828 |
|
|
|
552,981 |
|
Deferred
tax assets before valuation allowance
|
|
|
37,778,055 |
|
|
|
40,117,486 |
|
Valuation
allowance
|
|
|
(37,778,055 |
) |
|
|
(40,117,486 |
) |
Net
deferred tax assets
|
|
$ |
- |
|
|
$ |
- |
|
SFAS No.
109 requires a valuation allowance against deferred tax assets if, based on the
weight of available evidence, it is more likely than not that some or all of the
deferred tax assets may not be realized. Due to the uncertainty
surrounding the realization of these deferred tax assets in future tax returns,
all of the deferred tax assets have been fully offset by a valuation allowance
at December 31, 2008 and 2007.
As of
December 31, 2008 and 2007, Cardiosonix had deferred tax assets in Israel of
approximately $2 million, primarily related to net operating loss carryforwards
available to offset future taxable income, if any. Under current
Israeli tax law, net operating loss carryforwards do not expire. Due
to the uncertainty surrounding the realization of these deferred tax assets in
future tax returns, all of the deferred tax assets have been fully offset by a
valuation allowance at December 31, 2008 and 2007. Since a valuation
allowance was recognized for the deferred tax asset for Cardiosonix’ deductible
temporary differences and operating loss carryforwards at the acquisition date,
the tax benefits for those items that are first recognized (i.e., by elimination
of the valuation allowance) in financial statements after the acquisition date
shall be applied (a) first to reduce to zero other noncurrent intangible assets
related to the acquisition and (b) second to reduce income tax expense. As of
January 1, 2009, SFAS No. 141(R), Business Combinations, amends
the income tax accounting guidance to require that reduction in the amount of an
acquired valuation allowance be recorded as a reduction of income tax
expense.
Notes
to the Consolidated Financial Statements
Under
Sections 382 and 383 of the IRC of 1986, as amended, the utilization of U.S. net
operating loss and tax credit carryforwards may be limited under the change in
stock ownership rules of the IRC. As a result of ownership changes as
defined by Sections 382 and 383, which have occurred at various points in our
history, we believe utilization of our net operating loss carryfowards and tax
credit carryforwards will likely be significantly limited under certain
circumstances.
Reconciliations
between the statutory federal income tax rate and our effective tax rate are as
follows:
|
|
Years
Ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
Amount
|
|
|
%
|
|
|
Amount
|
|
|
%
|
|
Benefit
at statutory rate
|
|
$ |
(1,756,517 |
) |
|
|
(34.0 |
)% |
|
$ |
(1,729,992 |
) |
|
|
(34.0 |
)% |
Adjustments
to valuation allowance
|
|
|
1,582,238 |
|
|
|
30.6 |
% |
|
|
1,502,950 |
|
|
|
29.5 |
% |
Other
|
|
|
174,279 |
|
|
|
3.4 |
% |
|
|
227,042 |
|
|
|
4.5 |
% |
Benefit
per financial statements
|
|
$ |
- |
|
|
|
|
|
|
$ |
- |
|
|
|
- |
|
Deferred
tax assets of $3.7 million related to net operating loss carryforwards and
$657,000 related to R&D credit carryforwards expired during
2008.
In
December 2007, we entered into a SPA with Montaur, pursuant to which we issued
Montaur a 10% Series A Note in the principal amount of $7,000,000, due December
26, 2011, and a five-year Series W warrant to purchase 6,000,000 shares of our
common stock at an exercise price of $0.32 per share. Montaur may
convert $3.5 million of the Series A Note into shares of common stock at the
conversion price of $0.26 per share. The SPA also provided for two
further tranches of financing, a second tranche of $3 million in exchange for a
10% Series B Note along with a five year Series X warrant to purchase shares of
our common stock, and a third tranche of $3 million in exchange for 3,000 shares
of our 8% Preferred Stock and a five-year Series Y warrant to purchase shares of
our common stock. Closing of the second and third tranches were
subject to the satisfaction by the Company of certain milestones related to the
progress of the Phase 3 clinical trials of our Lymphoseek radiopharmaceutical
product. See Notes 7 and 10(a).
In
December 2008, after we obtained 135 vital blue dye lymph nodes from patients
who had completed surgery and the injection of the drug in a Phase 3 clinical
trial of Lymphoseek in patients with breast cancer or melanoma, we issued
Montaur 3,000 shares of our 8% Preferred Stock and a five-year Series Y warrant
to purchase 6,000,000 shares of our common stock, at an exercise price of $0.575
per share, for an aggregate purchase price of $3,000,000. Montaur may
convert each share of the Preferred Stock into a number of shares of our common
stock equal to the quotient of (a) the Liquidation Preference Amount of the
shares of Preferred Stock by (b) the Conversion Price. The
“Liquidation Preference Amount” for the Preferred Stock is $1,000 and the
“Conversion Price” of the Preferred Stock was set at $0.50 on the date of
issuance, thereby making the shares of Preferred Stock convertible into an
aggregate 6,000,000 shares of our common stock, subject to adjustment as
described in the Certificate of Designations. We may elect to
pay dividends due to Montaur on the shares of Preferred Stock in registered
shares of common stock. The number of shares of common stock to be
applied against any such dividend payment will be determined by reference to the
quotient of (a) the applicable dividend payment by (b) the average daily volume
weighted average price of our common stock on the OTC Bulletin Board (or
national securities exchange, if applicable) as reported by Bloomberg Financial
L.P. for the five days upon which our common stock is traded on the OTC Bulletin
Board immediately preceding the date of the dividend payment.
Notes
to the Consolidated Financial Statements
Pursuant
to the terms of a Registration Rights Agreement, dated December 26, 2007, as
amended by the Amendment to Registration Rights Agreement, dated February 7,
2008, Second Amendment to Registration Rights Agreement, dated April 16, 2008,
Third Amendment to Registration Rights Agreement, dated July 10, 2008, and
Fourth Amendment to Registration Rights Agreement, dated December 5, 2008, we
agreed to file a post-effective amendment to the registration statement
providing for the: (a) deregistration of shares of common stock issuable upon
the conversion of the Series B Note and the shares of common stock issuable upon
the exercise of the Series X warrant; and (b) registration of the resale of: (i)
the shares of common stock issuable upon conversion of the Preferred Stock; (ii)
the shares of common stock issuable upon exercise of the Series Y warrant; (iii)
3,500,000 shares of common stock issuable as interest or dividends on the
Montaur Notes and the Preferred Stock; and (iv) up to 4,666,666 shares issuable
upon the conversion of the Series B Note, provided that the total number of
shares of common stock registered would not exceed
20,166,666. Additionally, we agreed that within thirty-five days of
receipt from Montaur of written request therefor, we would prepare and file an
additional “resale” registration statement providing for the resale of: (i) the
shares of common stock issuable upon the conversion of the Series A Note; (ii)
the shares of common stock issuable upon the exercise of the Series W warrant;
(iii) any unregistered shares of common stock issuable upon the conversion of
the Series B Note; and (iv) the shares of common stock issuable upon the
exercise of the Series X warrant, provided, however, that we are not required to
file such additional registration statement, or may exclude shares from such
additional registration statement, if we believe in good faith, based upon
advice from the Securities and Exchange Commission’s Staff, that application of
Rule 415 would not permit registration of all or the excluded portion of such
shares.
The fair
value of the Series Y warrant was approximately $2.07 million on the date of
issuance and was determined using the Black-Scholes option pricing model with
the following assumptions: an average risk-free interest rate of
1.7%, volatility of 74% and no expected dividend rate. The relative
fair value of the warrant, the amount recorded to equity in accordance with
Accounting Principles Board Opinion No. 14, Accounting for Convertible Debt and
Debt Issued with Stock Purchase Warrants, was $1.13
million. The value of the beneficial conversion feature of the
Preferred Stock was estimated at $1.55 million based on the effective conversion
price at the date of issuance. The put option was considered a
derivative instrument and was required to be bifurcated from the Preferred Stock
and accounted for separately. The fair value of the bifurcated put
option was approximately $216,000 on the date of issuance. Changes in
the fair value of the derivative liability are recorded in the consolidated
statement of operations. The estimated fair value of the put option
liability related to the Preferred Stock of $216,000 remained classified as a
derivative liability as of December 31, 2008.
In
accordance with EITF Topic D-98, Classification and Measurement of
Redeemable Securities, the preferred stock was classified as temporary
equity as the shares are subject to redemption under the contingent put
option. The initial relative fair value of the Series Y warrant of
$1.13 million and the initial intrinsic value of the beneficial conversion
feature and put option related to the Preferred Stock were recorded as deemed
distributions and added to the accumulated deficit. We incurred
$180,000 of costs related to completing the third Montaur financing, which were
recorded as a reduction of additional paid-in capital on the consolidated
balance sheet.
|
a.
|
Stock
Warrants: At December 31, 2008, there are 23.4 million
warrants outstanding to purchase our common stock. The warrants
are exercisable at prices ranging from $0.31 to $0.85 per share with a
weighted average exercise price per share of
$0.45.
|
The following table summarizes
information about our outstanding warrants at December 31, 2008:
|
|
Exercise
Price
|
|
|
Number
of
Warrants
|
|
Expiration
Date
|
Series
Q
|
|
$ |
0.50 |
|
|
|
375,000 |
|
March
2009
|
Series
U
|
|
$ |
0.46 |
|
|
|
1,600,000 |
|
December
2009
|
Series
V
|
|
$ |
0.31 |
|
|
|
500,000 |
|
July
2012
|
Series
V
|
|
$ |
0.32 |
|
|
|
500,000 |
|
December
2012
|
Series
W
|
|
$ |
0.32 |
|
|
|
6,000,000 |
|
December
2012
|
Series
X
|
|
$ |
0.46 |
|
|
|
8,333,333 |
|
April
2013
|
Series
Y
|
|
$ |
0.575 |
|
|
|
6,000,000 |
|
December
2013
|
Series
Z
|
|
$ |
0.70 |
|
|
|
60,000 |
|
August
2013
|
Series
Z
|
|
$ |
0.85 |
|
|
|
60,000 |
|
August
2013
|
|
|
$ |
0.45 |
|
|
|
23,428,333 |
|
|
Notes
to the Consolidated Financial Statements
In April
2003, we completed bridge loans with our President and CEO, David Bupp, and an
outside investor. In connection with these loans, we issued a total
of 875,000 Series Q warrants to purchase our common stock at an exercise price
of $0.13 per share, expiring in April 2008. In March 2004, at the
request of our Board of Directors, Mr. Bupp agreed to extend the due date of his
loan. In exchange for extending the due date of his loan, we issued
Mr. Bupp an additional 375,000 Series Q warrants to purchase our common stock at
an exercise price of $0.50 per share, expiring in March 2009. During
2008, Mr. Bupp exercised 375,000 Series Q warrants in exchange for issuance of
375,000 shares of our common stock, resulting in gross proceeds of
$48,750. In addition, the outside investor exercised 500,000 Series Q
warrants in exchange for issuance of 500,000 shares of our common stock,
resulting in gross proceeds of $65,000. At December 31, 2008, 375,000
Series Q warrants related to the bridge loan from Mr. Bupp remained
outstanding. See Note 17(b).
In November 2003, we
executed common stock purchase agreements with certain investors. In
connection with these agreements, we issued the purchasers 6,086,959 Series R
warrants to purchase our common stock at an exercise price of $0.28 per share,
expiring in October 2008, and issued the placement agents 1,354,348 Series S
warrants to purchase our common stock on similar terms. During 2008,
an outside investor exercised a total of 200,200 Series R warrants in exchange
for issuance of 200,200 shares of our common stock, resulting in gross proceeds
of $56,056. In addition, certain outside investors exercised a total
of 2,658,698 Series R warrants and 644,565 Series S warrants on a cashless basis
in exchange for issuance of 1,289,990 shares of our common stock. No
Series R or Series S warrants were exercised during 2007. At December
31, 2008, no Series R or Series S warrants remained outstanding.
In August
2008, we executed consulting agreements with certain investor advisory service
firms. In connection with these agreements, we issued the consultants
60,000 Series Z warrants to purchase our common stock at an exercise price of
$0.70 per share and 60,000 Series Z warrants to purchase our common stock at an
exercise price of $0.85 per share, expiring in August 2013. All
120,000 Series Z warrants remained outstanding at December 31,
2008.
See Note
7 for a discussion of Series U, V, W and X warrants. See Notes 7 and
9 for a discussion of the Series Y warrant.
|
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
7,568,671 shares for proceeds of $1.9 million under the
agreement. We have not sold any shares under the agreement
since November 13, 2007. 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 to Fusion Capital before March 1,
2011, an additional $6.0 million of our common stock 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 agreement prior to the First
Amendment. After giving effect to the First Amendment, the
remaining aggregate amount of our common stock we can now sell to Fusion
Capital is $10.1 million. In respect of sales to Fusion Capital
that we may make in the future under the agreement as amended, we have
authorized a total of 10,654,000 shares of our common stock for sale to
Fusion Capital.
|
In
December 2006, we issued to Fusion Capital 720,000 shares of our common stock as
a commitment fee upon execution of the agreement. In connection with
sales of our common stock, we issued an additional 234,000 shares of our common
stock to Fusion Capital as an additional commitment fee. In
connection with entering into the First Amendment, we issued an additional
360,000 shares in consideration for Fusion Capital’s entering into the
amendment. Also, under the agreement, as an additional commitment fee
we have agreed to issue to Fusion Capital pro rata an additional 486,000 shares
of our common stock as we sell the first $4.1 million of our common stock to
Fusion Capital under the agreement as amended.
Notes
to the Consolidated Financial Statements
|
c.
|
Common Stock
Reserved: As of December 31, 2008, we have reserved
59,793,178 shares of authorized common stock for the exercise of all
outstanding options, warrants, convertible debt, and convertible preferred
stock.
|
11.
|
Segments
and Subsidiary Information:
|
|
a.
|
Segments: We
report information about our operating segments using the “management
approach” in accordance with SFAS No. 131, Disclosures about Segments of
an Enterprise and Related Information. This information
is based on the way management organizes and reports the segments within
the enterprise for making operating decisions and assessing
performance. Our reportable segments are identified based on
differences in products, services and markets served. There
were no inter-segment sales. We own or have rights to
intellectual property involving two primary types of medical device
products, including gamma detection instruments currently used primarily
in the application of SLNB, and blood flow measurement
devices. We also own or have rights to intellectual property
related to several drug and therapy
products.
|
The
information in the following table is derived directly from each reportable
segment’s financial reporting.
($
amounts in thousands)
2008
|
|
Gamma
Detection
Devices
|
|
|
Blood
Flow
Devices
|
|
|
Drug
and
Therapy
Products
|
|
|
Corporate
|
|
|
Total
|
|
Net
sales:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United
States1
|
|
$ |
7,422 |
|
|
$ |
101 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
7,523 |
|
International
|
|
|
167 |
|
|
|
196 |
|
|
|
- |
|
|
|
- |
|
|
|
363 |
|
Research
and development expenses
|
|
|
949 |
|
|
|
219 |
|
|
|
3,338 |
|
|
|
- |
|
|
|
4,506 |
|
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
|
|
17 |
|
|
|
188 |
|
|
|
- |
|
|
|
2,798 |
|
|
|
3,004 |
|
Depreciation
and amortization
|
|
|
120 |
|
|
|
241 |
|
|
|
2 |
|
|
|
46 |
|
|
|
408 |
|
Income
(loss) from operations3
|
|
|
3,658 |
|
|
|
(516 |
) |
|
|
(3,340 |
) |
|
|
(2,844 |
) |
|
|
(3,042 |
) |
Other
income (expense)4
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,124 |
) |
|
|
(2,124 |
) |
Total
assets, net of depreciation and amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United
States operations
|
|
|
2,410 |
|
|
|
491 |
|
|
|
25 |
|
|
|
5,336 |
|
|
|
8,262 |
|
Israeli
operations (Cardiosonix Ltd.)
|
|
|
- |
|
|
|
1,357 |
|
|
|
- |
|
|
|
- |
|
|
|
1,357 |
|
Capital
expenditures
|
|
|
9 |
|
|
|
- |
|
|
|
18 |
|
|
|
89 |
|
|
|
116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($
amounts in thousands)
2007
|
|
Gamma
Detection
Devices
|
|
|
Blood
Flow Devices
|
|
|
Drug
and
Therapy
Products
|
|
|
Corporate
|
|
|
Total
|
|
Net
sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United
States1
|
|
$ |
6,577 |
|
|
$ |
166 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
6,743 |
|
International
|
|
|
197 |
|
|
|
185 |
|
|
|
- |
|
|
|
- |
|
|
|
382 |
|
Research
and development expenses
|
|
|
680 |
|
|
|
359 |
|
|
|
1,827 |
|
|
|
- |
|
|
|
2,866 |
|
Selling,
general and administrative expenses, excluding depreciation and
amortization2
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,432 |
|
|
|
2,432 |
|
Depreciation
and amortization
|
|
|
99 |
|
|
|
262 |
|
|
|
- |
|
|
|
44 |
|
|
|
405 |
|
Income
(loss) from operations3
|
|
|
3,093 |
|
|
|
(552 |
) |
|
|
(1,827 |
) |
|
|
(2,477 |
) |
|
|
(1,763 |
) |
Other
income (expense)
4
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3,325 |
) |
|
|
(3,325 |
) |
Total
assets, net of depreciation and amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United
States operations
|
|
|
2,280 |
|
|
|
703 |
|
|
|
186 |
|
|
|
2,334 |
|
|
|
5,503 |
|
Israeli
operations (Cardiosonix Ltd.)
|
|
|
- |
|
|
|
1,560 |
|
|
|
- |
|
|
|
- |
|
|
|
1,560 |
|
Capital
expenditures
|
|
|
16 |
|
|
|
9 |
|
|
|
- |
|
|
|
16 |
|
|
|
41 |
|
1 All
sales to EES are made in the United States. EES distributes the
product globally through its international affiliates.
2 General
and administrative costs, excluding depreciation and amortization, represent
costs that relate to the general administration of the Company and as such are
not currently allocated to our individual reportable
segments. Beginning in 2008, marketing and selling costs were
allocated to our individual reportable segments.
3 Income
(loss) from operations does not reflect the allocation of selling, general and
administrative costs to our individual reportable segments.
4 Amounts
consist primarily of interest income and interest expense which are currently
not allocated to our individual reportable segments.
Notes
to the Consolidated Financial Statements
|
b.
|
Subsidiary: On
December 31, 2001, we acquired 100 percent of the outstanding common
shares of Cardiosonix, an Israeli company. We accounted for the
acquisition under SFAS No. 141, Business Combinations,
and certain provisions of SFAS No. 142, Goodwill and Other Intangible
Assets. The results of Cardiosonix’s operations have
been included in our consolidated results from the date of
acquisition.
|
|
a.
|
Supply Agreement: 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
2008, but was automatically extended through February 2009, 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 and $1.2 million for the years ended December 31, 2008 and
2007, respectively. As of December 31, 2008, we have issued
purchase orders under the agreement with TriVirix for $1.7 million of our
products for delivery through December
2009.
|
|
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.
|
EES may
terminate the agreement if we fail to supply products for specified periods,
commit a material breach of the agreement, suffer a change of control to a
competitor of EES, or become insolvent. If termination were due to
failure to supply or a material breach by us, EES would have the right to use
our intellectual property and regulatory information to manufacture and sell the
products exclusively on a global basis for the remaining term of the agreement
with no additional financial obligation to us. If termination is due
to insolvency or a change of control that does not affect supply of the
products, EES has the right to continue to sell the products on an exclusive
global basis for a period of six months or require us to repurchase any unsold
products in its inventory.
Under the
agreement, EES received a non-exclusive worldwide license to our SLNB
intellectual property to make and sell other products that may be developed
using our SLNB intellectual property. The term of the license is the
same as that of the agreement. EES paid us a non-refundable license
fee of $4 million. We recognized the license fee as revenue on a
straight-line basis over the five-year initial term of the agreement, and the
license fee was fully amortized into income as of the end of September
2004. As consideration for extending the distribution agreement
through the end of 2013, EES paid us $500,000 in December 2007, representing a
non-refundable license fee and reimbursement of past research and development
expenses. We intend to recognize the $500,000 payment as revenue on a
straight-line basis over the extended term of the agreement, or January 2009
through December 2013. If we terminate the agreement as a result of a
material breach by EES, they would be required to pay us a royalty on all
products developed and sold by EES using our SLNB intellectual
property. In addition, we are entitled to a royalty on any SLNB
product commercialized by EES that does not infringe any of our existing
intellectual property.
Notes
to the Consolidated Financial Statements
|
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, 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. 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 2008, we have paid the OCS a total of
$66,000 in royalties related to sales of products developed under this
program. As of December 31, 2008, we have accrued obligations
for royalties totaling $6,000.
|
During
January 2002, we completed a license agreement with the University of
California, San Diego (UCSD) for a proprietary compound that we believe could be
used as a lymph node locating agent in SLNB procedures. The license
agreement is effective until the later of the expiration date of the
longest-lived underlying patent or January 30, 2023. Under the terms
of the license agreement, UCSD has granted us the exclusive rights to make, use,
sell, offer for sale and import licensed products as defined in the agreement
and to practice the defined licensed methods during the term of the
agreement. We may also sublicense the patent rights, subject to the
approval of certain sublicense terms by UCSD. In consideration for
the license rights, we agreed to pay UCSD a license issue fee of $25,000 and
license maintenance fees of $25,000 per year. We also agreed to pay
UCSD milestone payments related to commencement of clinical trials and
successful regulatory clearance for marketing of the licensed products, a
royalty on net sales of licensed products subject to a $25,000 minimum annual
royalty, fifty percent of all sublicense fees and fifty percent of sublicense
royalties. We also agreed to reimburse UCSD for all patent-related
costs. Total costs related to the UCSD license agreement were $35,000
and $45,000 in 2008 and 2007, respectively, and were recorded in research and
development expenses.
UCSD has
the right to terminate the agreement or change the nature of the agreement to a
non-exclusive agreement if it is determined that we have not been diligent in
developing and commercializing the covered products, marketing the products
within six months of receiving regulatory approval, reasonably filling market
demand or obtaining all the necessary government approvals.
During
April 2005, we completed an evaluation license agreement with UCSD expanding the
field of use for the proprietary compound developed by UCSD
researchers. The expanded field of use will allow Lymphoseek to be
developed as an optical or ultrasound agent. The evaluation license
agreement was effective until March 31, 2007. Under the terms of the
agreement, UCSD granted us limited rights to make and use licensed products as
defined in the agreement and to practice the defined licensed methods during the
term of the agreement for the sole purpose of evaluating our interest in
negotiating a commercial license. We may also sublicense the patent
rights, subject to the approval of certain sublicense terms by
UCSD. In consideration for the license rights, we agreed to pay UCSD
an initial evaluation license fee of $36,000 and evaluation license maintenance
fees of $9,000 payable on the first year anniversary of the effective date,
$9,000 payable on the eighteen-month anniversary of the effective date, and
$18,000 payable prior to termination. We also agreed to pay UCSD
fifty percent of any sublicense fees and to reimburse UCSD for all
patent-related costs. In March 2007, we executed a second evaluation
license agreement which was effective until March 31, 2008. In
consideration for the license rights, we agreed to pay UCSD an initial
evaluation license fee of $20,000 and evaluation license maintenance fees of
$10,000 payable on the six-month anniversary of the effective date and $10,000
payable on the twelve-month anniversary of the effective date. We
also agreed to pay UCSD fifty percent of any sublicense fees and to reimburse
UCSD for all patent-related costs. Total costs related to the UCSD
evaluation license agreements were $10,000 and $53,000 in 2008 and 2007,
respectively, and were recorded in research and development
expenses.
Notes
to the Consolidated Financial Statements
During
April 2008, we completed a license agreement with UCSD for an expanded field of
use allowing Lymphoseek to be developed as an optical or ultrasound
agent. The license agreement is effective until the expiration date
of the longest-lived underlying patent. Under the terms of the
license agreement, UCSD has granted us the exclusive rights to make, use, sell,
offer for sale and import licensed products as defined in the agreement and to
practice the defined licensed methods during the term of the
agreement. We may also sublicense the patent rights, subject to
certain sublicense terms as defined in the agreement. In
consideration for the license rights, we agreed to pay UCSD a license issue fee
of $25,000 and license maintenance fees of $25,000 per year. We also
agreed to pay UCSD milestone payments related to commencement of clinical trials
and successful regulatory clearance for marketing of the licensed products, a
royalty on net sales of licensed products subject to a $25,000 minimum annual
royalty, fifty percent of all sublicense fees and fifty percent of sublicense
royalties. We also agreed to reimburse UCSD for all patent-related
costs. Total costs related to the UCSD license agreement were $37,000
in 2008 and were recorded in research and development expenses.
During
January 2005, we executed a license agreement with The Ohio State University
(OSU), Cira LLC, and Cira Bio for certain technology relating to activated
cellular therapy. The license agreement is effective until the
expiration date of the longest-lived underlying patent. Under the
terms of the license agreement, OSU has granted the licensees the exclusive
rights to make, have made, use, lease, sell and import licensed products as
defined in the agreement and to utilize the defined licensed
practices. We may also sublicense the patent rights. In
consideration for the license rights, we agreed to pay OSU a license fee of
$5,000 on January 31, 2006. We also agreed to pay OSU additional
license fees related to initiation of Phase 2 and Phase 3 clinical trials, a
royalty on net sales of licensed products subject to a minimum annual royalty of
$100,000 beginning in 2012, and a percentage of any non-royalty license
income. Also during January 2005, we completed a business venture
agreement with Cira LLC that defines each party’s responsibilities and
commitments with respect to Cira Bio and the license agreement with
OSU. In connection with the execution of the option, Cira Ltd. also
agreed to assign all interests in the ACT technology in the event of the closing
of such a financing transaction.
|
d.
|
Employment
Agreements: We maintain employment agreements with five
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 our company (as defined) and their employment
terminates. As of December 31, 2008, our maximum contingent
liability under these agreements in such an event is approximately $2.0
million. The employment agreements also provide for severance,
disability and death benefits. See Note
17(c).
|
We lease
certain office equipment under capital leases which expire from 2009 to
2011. We also lease office space under an operating lease that
expires in January 2013.
Notes
to the Consolidated Financial Statements
The
future minimum lease payments for the years ending December 31 are as
follows:
|
|
Capital
Leases
|
|
|
Operating
Leases
|
|
2009
|
|
$ |
10,382 |
|
|
$ |
98,465 |
|
2010
|
|
|
7,897 |
|
|
|
101,285 |
|
2011
|
|
|
3,948 |
|
|
|
104,105 |
|
2012
|
|
|
- |
|
|
|
106,925 |
|
2013
|
|
|
- |
|
|
|
8,930 |
|
|
|
|
22,227 |
|
|
$ |
419,710 |
|
Less
amount representing interest
|
|
|
2,048 |
|
|
|
|
|
Present
value of net minimum lease payments
|
|
|
20,179 |
|
|
|
|
|
Less
current portion
|
|
|
9,084 |
|
|
|
|
|
Capital
lease obligations, excluding current portion
|
|
$ |
11,095 |
|
|
|
|
|
Total
rental expense was $108,000 and $153,000 for the years ended December 31, 2008
and 2007, respectively.
14.
|
Employee
Benefit Plan:
|
We
maintain an employee benefit plan under Section 401(k) of the Internal Revenue
Code. The plan allows employees to make contributions and we may, but
are not obligated to, match a portion of the employee’s contribution with our
common stock, up to a defined maximum. We accrued expenses of $33,000
and $30,000 during 2008 and 2007, respectively, related to common stock
contributed to the plan in 2009 and 2008, respectively.
15.
|
Supplemental
Disclosure for Statements of Cash
Flows:
|
We paid
interest aggregating $1.0 million and $869,000 for the years ended December 31,
2008 and 2007, respectively. During 2008 and 2007, we transferred
$182,000 and $84,000, respectively, in inventory to fixed assets related to the
creation and maintenance of a pool of service loaner equipment. Also
during 2008 and 2007, we prepaid $171,000 and $160,000, respectively, in
insurance through the issuance of notes payable to finance companies with
weighted average interest rates of 6.6%. The note payable to a
finance company issued in 2008 matures in July 2009. During 2008, we
purchased equipment under a capital lease totaling $20,000. No new
equipment was leased during 2007.
We are
subject to legal proceedings and claims that arise in the ordinary course of
business. In our opinion, the amount of ultimate liability, if any,
with respect to these actions will not materially affect our financial
position.
|
a.
|
Stock-Based
Compensation: On January 5, 2009, the Compensation,
Nominating and Governance (CNG) Committee of the Board of Directors
granted 165,000 stock options with an exercise price of $0.59 to employees
and directors. Also on January 5, 2009, the CNG Committee
granted 400,000 shares of restricted stock that will vest based on certain
defined performance objectives to David C. Bupp, our President and
CEO. In addition, on February 16, 2009, we granted 50,000 stock
options with an exercise price of $0.65 and 100,000 shares of restricted
stock that will vest based on certain defined performance objectives to
Frederick O. Cope, our Vice President, Pharmaceutical Research and
Clinical Development. On February 27, 2009, the CNG Committee
granted 68,000 stock options with an exercise price of $0.55 to
employees. See Note
1(o).
|
Notes
to the Consolidated Financial Statements
|
b.
|
Warrant
Exercises: During the first quarter of 2009, David C.
Bupp, our President and CEO, exercised Series Q warrants resulting in the
issuance of 50,000 shares of our common stock and from which we received
gross proceeds of $25,000. See Note
10(a).
|
|
c.
|
Employment
Agreements: During January 2009, we entered into new
employment agreements with six officers. The new agreements
have substantially similar terms to the officers’ previous
agreements. See Note
12(d).
|
18.
|
Supplemental
Information (Unaudited):
|
The
following summary financial data are derived from our consolidated financial
statements that have been audited by our independent registered public
accounting firm. These data are qualified in their entirety by, and
should be read in conjunction with, our Consolidated Financial Statements and
Notes thereto included herein.
(Amounts
in thousands, except per share data)
|
|
Years
Ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
Statement
of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales
|
|
$ |
7,715 |
|
|
$ |
7,125 |
|
|
$ |
6,051 |
|
|
$ |
5,919 |
|
|
$ |
5,353 |
|
License
and other revenue
|
|
|
172 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
600 |
|
Gross
profit
|
|
|
4,876 |
|
|
|
3,940 |
|
|
|
3,419 |
|
|
|
3,543 |
|
|
|
3,608 |
|
Research
and development expenses
|
|
|
4,506 |
|
|
|
2,866 |
|
|
|
3,803 |
|
|
|
4,032 |
|
|
|
2,454 |
|
Selling,
general and administrative expenses
|
|
|
3,413 |
|
|
|
2,837 |
|
|
|
3,076 |
|
|
|
3,156 |
|
|
|
3,153 |
|
Loss
from operations
|
|
|
(3,042 |
) |
|
|
(1,763 |
) |
|
|
(3,460 |
) |
|
|
(3,644 |
) |
|
|
(1,999 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
expenses, net
|
|
|
(2,124 |
) |
|
|
(3,325 |
) |
|
|
(1,281 |
) |
|
|
(1,285 |
) |
|
|
(1,542 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(5,166 |
) |
|
$ |
(5,088 |
) |
|
$ |
(4,741 |
) |
|
$ |
(4,929 |
) |
|
$ |
(3,541 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.06 |
) |
Diluted
|
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
used in computing loss per common
share: (1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
68,594 |
|
|
|
62,921 |
|
|
|
58,587 |
|
|
|
58,434 |
|
|
|
56,764 |
|
Diluted
|
|
|
68,594 |
|
|
|
62,921 |
|
|
|
58,587 |
|
|
|
58,434 |
|
|
|
56,764 |
|
|
|
As
of December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
Balance
Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$ |
9,619 |
|
|
$ |
7,063 |
|
|
$ |
8,034 |
|
|
$ |
11,570 |
|
|
$ |
15,366 |
|
Long-term
obligations
|
|
|
7,323 |
|
|
|
8,836 |
|
|
|
4,922 |
|
|
|
6,052 |
|
|
|
8,192 |
|
Accumulated
deficit
|
|
|
(148,840 |
) |
|
|
(140,777 |
) |
|
|
(135,688 |
) |
|
|
(130,947 |
) |
|
|
(126,018 |
) |
|
|
Basic
earnings (loss) per share are calculated using the weighted average number
of common shares outstanding during the periods. Diluted
earnings (loss) per share is calculated using the weighted average number
of common shares outstanding during the periods, adjusted for the effects
of unvested restricted stock, convertible securities, options and
warrants, if dilutive.
|