NEOPROBE CORPORATION 424B3
Filed Pursuant to Rule 424(b)(3)
Registration No. 333-121673
SECOND AMENDED
PROSPECTUS
NEOPROBE CORPORATION
32,350,000 Shares of Common Stock
This prospectus relates to the sale of up to 32,350,000 shares of our common stock by persons who
have purchased shares of our common stock or who may purchase shares of our common stock through
the conversion of debt or the exercise of warrants as more fully described herein. The
aforementioned persons are sometimes referred to in this prospectus as the selling stockholders.
The prices at which the selling stockholders may sell the shares will be determined by the
prevailing market price for the shares or in negotiated transactions. We will not receive
proceeds from the sale of our shares by the selling stockholders.
Our common stock is quoted on the OTC Bulletin Board under the symbol NEOP. On September 14,
2007, the last reported sale price for our common stock as reported on the OTC Bulletin Board was
$0.31 per share.
Each selling stockholder may be considered an underwriter within the meaning of the Securities
Act of 1933, as amended.
THE SECURITIES OFFERED IN THIS PROSPECTUS INVOLVE A HIGH DEGREE OF RISK. YOU SHOULD CONSIDER THE
RISK FACTORS BEGINNING ON PAGE 4 BEFORE PURCHASING OUR COMMON STOCK.
Neither the Securities and Exchange Commission nor any state securities commission has approved or
disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any
representation to the contrary is a criminal offense.
The date of this prospectus is October 2, 2007.
Table of Contents
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F-1 |
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Unless otherwise specified, the information in this prospectus is set forth as of October 2,
2007, and we anticipate that changes in our affairs will occur after such date. We have not
authorized any person to give any information or to make any representations, other than as
contained in this prospectus, in connection with the offer contained in this prospectus. If any
person gives you any information or makes representations in connection with this offer, do not
rely on it as information we have authorized. This prospectus is not an offer to sell our common
stock in any state or other jurisdiction to any person to whom it is unlawful to make such offer.
1
PROSPECTUS SUMMARY
The following summary highlights selected information from this prospectus and may not contain
all the information that is important to you. To understand our business and this offering fully,
you should read this entire prospectus carefully, including the financial statements and the
related notes beginning on page F-1. When we refer in this prospectus to the company, we, us,
and our, we mean Neoprobe Corporation, a Delaware corporation, together with our subsidiaries.
This prospectus contains forward-looking statements and information relating to Neoprobe
Corporation. See Cautionary Note Regarding Forward Looking Statements on page 15.
Our Company
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. At that point, an evaluation of the status of the regulatory
pathway for our RIGS products coupled with our limited financial resources caused us to suspend
development activities related to our radiopharmaceutical business and to retrench our organization
to focus on our medical device business. After achieving profitability in 2000 following this
retrenchment, we set out on a growth strategy centered around medical device products. In December
2001, we acquired Biosonix Ltd., a private Israeli company limited by shares, which we subsequently
renamed Cardiosonix Ltd. (Cardiosonix). Since 2001 through early 2007, we devoted substantial time
and resources to commercializing Cardiosonix Quantix® line of blood flow measurement
devices for a variety of diagnostic and surgical applications in the cardiac and vascular
management arena. The results of Cardiosonixs efforts to date have not met with our expectations
and we are in the process of critically evaluating the prospects for this business line.
Although our strategic focus expanded in 2001 to include blood flow measurement devices, we
continued to look for other avenues to reinvigorate our radiopharmaceutical development. During
2004, our efforts resulted in a number of positive events that caused us to take steps to
re-activate development of our radiopharmaceutical and therapeutic initiatives. As a result, in
2007 we have one of our radiopharmaceutical products, Lymphoseek®, involved in a variety
of clinical evaluations including a recently completed successful Phase 2 multi-center clinical
trial, and a second, RIGScan® CR, for which we are clarifying the regulatory pathway and
identifying potential sources of funding. In early 2005, we also formed a subsidiary, Cira
Biosciences, Inc. (Cira Bio), to evaluate the current market opportunities for another technology
platform, activated cellular therapy (ACT). Our unique virtual business model combines revenue
generation from medical devices that contributes to covering our corporate overhead while we devote
capital raised through financing efforts to incremental development such as Lymphoseek and look for
development partners to assist us in the clinical and commercial development for RIGScan CR and
ACT.
The Offering
During April 2003, we completed a bridge loan agreement with our President and CEO, David C. Bupp.
Under the terms of the agreement, Mr. Bupp advanced us $250,000. In consideration for the loan, we
issued a note to Mr. Bupp in the principal amount of $250,000. The note was secured by general
assets of the company, excluding accounts receivable. In addition, we issued Mr. Bupp 375,000
warrants to purchase our common stock at an exercise price of $0.13 per share, expiring in April
2008. The note bore interest at 8.5% per annum, payable monthly, and was originally due on June 30,
2004. On March 8, 2004, at the request of the Board of Directors, Mr. Bupp agreed to extend the
due date of the note from June 30, 2004 to June 30, 2005. In exchange for extending the due date
of the note, we issued Mr. Bupp an additional 375,000 warrants to purchase our common stock at an exercise price of $0.50 per
share,
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expiring in March 2009. On December 13, 2004, we repaid the balance of the note to Mr.
Bupp. The shares covered by this prospectus include the 375,000 shares of common stock issuable
pursuant to the warrants granted to Mr. Bupp in March 2004.
In December 2004, we completed a private placement of four-year convertible promissory notes in an
aggregate principal amount of $8.1 million 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. We modified
the convertible notes on November 30, 2006, to eliminate the revenue and cash covenants, modify the
repayment schedule of the notes, eliminate certain anti-dilution rights, and avoid potential future
violations of the debt covenants. The notes originally bore interest at 8% per annum and were
originally due on December 13, 2008. In connection with the November 30, 2006 amendment, we
cancelled the original notes and issued to the noteholders replacement notes which bear interest at
12% per annum. Instead of the notes being due on December 13, 2008 per the original agreement, due
dates of the principal payments were revised as follows: $500,000 due January 8, 2007; $1,250,000
due July 9, 2007; $1,750,000 due January 7, 2008; $2,000,000 due July 7, 2008; and the remaining
$2,600,000 due January 7, 2009. Additionally, as part of the amendment we agreed to use our best
efforts to offer and sell equity securities with gross proceeds of up to $10 million and apply not
less than 50% of the net proceeds of any such sales to the repayment of the principal on the notes,
and to apply at least 50% of the proceeds of any permitted asset disposition or any permitted
licensing, distribution or similar strategic alliance agreement to the repayment of principal on
the notes. The notes are freely convertible into shares of our common stock at a price of $0.40
per share. Neoprobe may force conversion of the notes prior to their stated maturity under certain
circumstances. As part of the original transaction, we issued the investors 10,125,000 Series T
warrants to purchase our common stock at an exercise price of $0.46 per share, expiring in December
2009. The shares covered by this prospectus include 20,250,000 shares of common stock issuable
upon conversion of the notes, and the 10,125,000 shares of our common stock issuable upon the
exercise of the Series T warrants.
During 2004 we engaged the services of two investment banking firms to assist us in raising
capital, Roth Capital Partners, LLC (Roth) and Laidlaw & Co. (Laidlaw). In exchange for the
services of Roth, we agreed to pay $320,000 in cash, plus warrants to purchase 800,000 shares of
our common stock. The warrants have an exercise price of $0.46 per share. This prospectus covers
the resale of the shares of common stock issuable upon the exercise of these warrants.
In exchange for the services of Laidlaw, we agreed to pay $320,000 in cash, plus warrants to
purchase 800,000 shares of our common stock. The warrants have an exercise price of $0.46 per
share. This prospectus covers the resale of the shares of common stock issuable upon the exercise
of warrants by the underwriters which received warrants to purchase shares of our common stock as a
result of their participation in the offering on behalf of Laidlaw.
With the exception of the warrants granted to Mr. Bupp in March 2004, all warrants issued in
connection with this transaction expire in December 2009. This prospectus covers the resale of
shares of common stock issuable upon conversion of the convertible promissory notes, warrants
issued to Mr. Bupp in exchange for extending the due date of the note executed in his favor in
connection with the April 2003 bridge loan agreement, and the shares of common stock issuable
pursuant to the warrants granted to the parties to the Securities Purchase Agreement and the
placement agents and their assignees.
Through August 31, 2007, we have repaid the noteholders, excluding Mr. Bupp, a total of $2.0
million through both scheduled principal repayments and mandatory principal repayments. This has
decreased the total shares of common stock issuable upon conversion of the notes from 20,250,000 to
15,000,000.
An investment in our common stock is highly speculative and involves a high degree of risk. See
Risk Factors beginning on page 4.
3
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 prospectus, 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 $138 million and have an overall deficit in
stockholders equity as of June 30, 2007. Although we were profitable in 2000 and in 2001, we
incurred substantial losses in the years prior to that, and again in 2002 through June 30, 2007.
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 the Quantix product line. 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, sentinel lymph node biopsy (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
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 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 Cardiosonixs products have met with limited success. The long-term
commercial success of the Cardiosonix 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
Cardiosonix 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 will likely 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
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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 through 2007. We expect to raise additional capital during 2007 in
order to continue executing on our current business plan. However, if we are unsuccessful in
raising additional capital, 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 Fund II,
LLC (Fusion) that allows us to sell shares of common stock for up to $6.0 million in proceeds. We
have authorized up to 12,000,000 shares of our common stock for sale to Fusion under the agreement,
and have issued 720,000 shares as a commitment fee. Up to an additional 720,000 shares of our
common stock may be issued to Fusion as an additional commitment fee as shares are sold to Fusion.
Our right to make sales under the agreement is limited to $50,000 every four business days, unless
our stock price equals or exceeds $0.30 per share, in which case we can sell greater amounts to
Fusion as the price of our common stock increases. Fusion does not have the right or the obligation
to purchase any shares on any business day that the market price of our common stock is less than
$0.20 per share. Through August 31, 2007, we have sold Fusion 5.1 million shares of common stock
and issued 870,000 shares of stock as commitment fees to Fusion. Assuming the remaining 6.8
million shares are sold, the selling price per share would have to average at least $0.69 for us to
receive the maximum proceeds from this offering of $6.0 million. Assuming a purchase price of $0.27
per share (the closing sale price of the common stock on August 31, 2007) and the purchase by
Fusion of the entire 12,000,000 shares, proceeds to us would only be $3.2 million.
The extent to which we rely on Fusion 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. Specifically,
Fusion 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. To the extent
that we are unable to make sales to Fusion 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
$6.0 million potentially available under the agreement with Fusion, 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. We recently completed patient enrollment in a
Phase 2 clinical trial for our most advanced radiopharmaceutical product candidate, Lymphoseek, and
are preparing to commence two pivotal Phase 3 trials for this product in breast cancer and
melanoma. We are also taking steps to obtain FDA approval of a Phase 3 clinical protocol for our
next radiopharmaceutical candidate, RIGScan CR. 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 or FDA 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. |
The results of the clinical trials may 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. |
We recently executed a non-binding term sheet 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 reaching
definitive terms with the potential U.S. distribution partner for Lymphoseek or 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
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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 candidates 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. |
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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warning letters; |
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civil or criminal penalties; |
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fines; |
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injunctions; |
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product seizures or detentions; |
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import bans; |
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voluntary or mandatory product recalls and publicity requirements; |
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suspension or withdrawal of regulatory approvals; |
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total or partial suspension of production; and |
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refusal to approve pending applications for marketing approval of new drugs or
supplements to approved applications. |
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 two blood flow products, the Quantix/ND and 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 neo2000 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 QSR 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 Ethicon Endo-Surgery, Inc.
(EES), a Johnson & Johnson company, 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 in part 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
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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, control the escalation of healthcare expenditures
within the economy and 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 sale of our common stock to Fusion may cause dilution and the sale of common stock acquired by
Fusion could cause the price of our common stock to decline.
In connection with our agreement with Fusion, we have authorized the sale of up to 12,000,000
shares of our common stock and the issuance of 1,440,000 shares in commitment fees, and we filed a
registration statement with the SEC for the sale to the public of the entire 13,440,000 shares. The
number of shares ultimately offered for sale to the public will be dependent upon the number of
shares purchased by Fusion under the agreement. It is anticipated that these shares will be sold
over a period of up to 24 months from the date of the agreement, at prices that will fluctuate
based on changes in the market price of our common stock over that period. Depending upon market
liquidity at the times sales are made, these sales could cause the market price of our common stock
to decline. Consequently, sales to Fusion may result in substantial dilution to the interests of
other holders of our common stock. The sale of a substantial number of shares of our common stock
by Fusion, 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. However, we have the right to control the timing and amount of any sales of our
shares to Fusion and the agreement may be terminated by us at any time at our discretion without
any cost to us.
9
The sale of the shares of common stock acquired in private placements could cause the price of our
common stock to decline.
During 2003 and 2004, we completed several financings in which we issued common stock, convertible
notes, warrants and other securities convertible into common stock to certain private investors and
as required under the terms of those transactions, we filed registration statements with the
Securities and Exchange Commission (SEC) 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.
The selling stockholders under these registration statements 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 the shares covered by these registration statements. Depending upon
market liquidity at the time, a sale of shares covered by these registration statements 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 under these registration statements, 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.
10
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 patents underlying our radiopharmaceutical products and ACT technology are exclusively licensed
to us by third parties, and the relevant license agreements require us to use diligence in the
development and commercialization of products using the licensed patents. Our failure to meet the
diligence requirements in any license agreement may result in our loss of some or all of our
license rights to the patents licensed thereunder.
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 Office of the Chief Scientist
(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.
11
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 Bios rights to certain applications of the ACT technology may be affected by its
failure to achieve certain capital raising milestones by December 31, 2006 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 trouble 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, except the intellectual property associated with our Lymphoseek, RIGS
and ACT products under development, have been pledged as collateral for the remaining $6.2 million
in principal amount of our Series A Convertible Notes, issued to funds managed by Great Point
Capital Partners and to our CEO under an agreement dated December 13, 2004, as amended November 30,
2006, and a Series B Convertible Note issued to our CEO and members of his family dated July 3,
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:
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we pay all principal (as of August 31, 2007: $1,500,000 due January 7, 2008,
$2,000,000 due July 7, 2008, $1,000,000 due July 8, 2008 and $2,600,000 due January 7,
2009), interest (10 -12% per annum, payable on March 31, June 30, September 30, and
December 31 of each year) and other charges on the Notes when due; |
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we use the proceeds from the sale of the Notes only for permitted purposes, such as
Lymphoseek development and general corporate purposes; |
12
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we nominate and recommend for election as a director a person designated by the
holders of the Series A Notes (as of August 31, 2007, the holders of the Series A Notes
have not designated a potential board member); |
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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; |
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we indemnify the purchasers of the Notes against certain liabilities; and |
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we use our best efforts to offer and sell equity securities with gross proceeds of
up to $10 million and apply not less than 50% of the net proceeds of such sales to the
repayment of principal on the Series A Notes. |
Additionally, with certain exceptions, the Notes prohibit us from:
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amending our organizational or governing agreements and documents, entering into any
merger or consolidation, dissolving the company or liquidating its assets, or acquiring
all or any substantial part of the business or assets of any other person; |
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engaging in transactions with any affiliate; |
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entering into any agreement inconsistent with our obligations under the Notes and
related agreements; |
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incurring any indebtedness, capital leases, or contingent obligations outside the
ordinary course of business; |
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granting or permitting liens against or security interests in our assets; |
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making any material dispositions of our assets outside the ordinary course of business; |
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declaring or paying any dividends or making any other restricted payments; or |
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making any loans to or investments in other persons outside of the ordinary course
of business. |
Further, the Series A Notes require us to apply at least 50% of the proceeds of any equity
financing, permitted asset disposition or licensing, distribution or similar strategic alliance
agreement to the repayment of principal on the Notes.
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. As such, our common stock may have fewer
market makers, lower trading volumes and larger spreads between bid and asked 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.
13
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 purchasers 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-dealers 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 $0.19 per share and as high as $0.50 per share during the
twelve-month period ended August 31, 2007. 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; |
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public concern as to the safety of products that we or others develop; and |
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fluctuations in market demand for and supply of our products. |
An investors 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 August 31, 2007 was
approximately 120,000 shares.
14
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, 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.
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. |
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.
USE OF PROCEEDS
This prospectus relates to shares of our common stock that may be offered and sold from time to
time by the selling stockholders. We will receive no proceeds from the sale of shares of common
stock in this offering.
15
MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Our common stock trades on the 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 completed fiscal years and for the current fiscal year through September 14, 2007, 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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Close |
Fiscal Year 2007: |
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First Quarter |
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$ |
0.28 |
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$ |
0.20 |
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$ |
0.24 |
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Second Quarter |
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0.32 |
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0.19 |
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0.27 |
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Third Quarter through
September 14, 2007 |
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0.50 |
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0.20 |
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0.31 |
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Fiscal Year 2006: |
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First Quarter |
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$ |
0.36 |
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$ |
0.25 |
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$ |
0.29 |
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Second Quarter |
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0.30 |
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0.23 |
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0.26 |
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Third Quarter |
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0.33 |
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0.23 |
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0.33 |
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Fourth Quarter |
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0.34 |
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0.22 |
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0.24 |
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Fiscal Year 2005: |
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First Quarter |
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$ |
0.72 |
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$ |
0.37 |
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$ |
0.46 |
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Second Quarter |
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0.46 |
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0.30 |
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0.35 |
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Third Quarter |
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0.40 |
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0.25 |
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0.30 |
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Fourth Quarter |
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0.32 |
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0.20 |
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0.25 |
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As of September 14, 2007, we had approximately 796 holders of common stock of record.
We have not paid any dividends on our common stock and do not anticipate paying cash dividends 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 Managements Discussion and Analysis of Financial Condition
and Results of Operations, below.
16
DESCRIPTION OF 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. At that point, an evaluation of the status of the regulatory
pathway for our RIGS products coupled with our limited financial resources caused us to suspend
development activities related to our radiopharmaceutical business and to retrench our organization
to focus on our medical device business. After achieving profitability in 2000 following this
retrenchment, we set out on a growth strategy centered around medical device products. In December
2001, we acquired Biosonix Ltd., a private Israeli company limited by shares, which we subsequently
renamed Cardiosonix Ltd. (Cardiosonix). Since 2001 through early 2007, we devoted substantial time
and resources to commercializing Cariosonix Quantix® line of blood flow measurement
devices for a variety of diagnostic and surgical applications in the cardiac and vascular
management arena. The results of Cardiosonixs efforts to date have not met with our expectations
and we are in the process of critically evaluating the prospects for this business line.
Although our strategic focus expanded in 2001 to include blood flow measurement devices, we
continued to look for other avenues to reinvigorate our radiopharmaceutical development. During
2004, our efforts resulted in a number of positive events that caused us to take steps to
re-activate development of our radiopharmaceutical and therapeutic initiatives. As a result, in
2007 we have one of our radiopharmaceutical products, Lymphoseek®, involved in a variety
of clinical evaluations including a recently completed successful Phase 2 multi-center clinical
trial, and a second, RIGScan® CR, for which we are clarifying the regulatory pathway and
identifying potential sources of funding. In early 2005, we also formed a subsidiary, Cira
Biosciences, Inc. (Cira Bio), to evaluate the current market opportunities for another technology
platform, activated cellular therapy (ACT). Our unique virtual business model combines revenue
generation from medical devices that contributes to covering our corporate overhead while we devote
capital raised through financing efforts to incremental development such as Lymphoseek and look for
development partners to assist us in the clinical and commercial development for RIGScan CR and
ACT.
Our Technology
Gamma Detection Devices
Through the second quarter of 2007, substantially all of our revenue has been generated from the
sale of a line of gamma radiation detection devices and related products 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 the U.S. Food and Drug Administration (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
pocket flashlight. The neo2000® Gamma Detection System, originally released in 1998, is
the third generation of our gamma detection systems. The neo2000 is designed as a platform for
future growth of our instrument business. The neo2000 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
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features, including our most recent release that enables our entire installed base of neo2000 users
to use our Bluetooth® wireless gamma detection probes which were commercially launched
in late 2006. 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). SLNB helps trace the lymphatic 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 patients 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 if it had metastasized. The surgeon
may then track the agents 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.
Numerous clinical studies, involving a total of nearly 2,000 patients and published in
peer-reviewed medical journals such 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 two years ago and preliminary results may be available in the next year or two.
Accrual on the second trial was halted early, 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 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.
In addition to lymphatic mapping, surgeons are investigating the use of our devices for other
gamma-guided surgery applications, such as evaluating the thyroid function, in determining the
state of disease in patients with vulvar and penile cancers, and for SLNB in prostate, gastric,
colon, head and neck, and non-small cell lung cancers. Expanding the application of SLNB beyond the
current primary uses in the treatment of breast cancer and melanoma is the primary focus of our
strategy regarding our gamma-guided surgery products. To support that expansion, we continue to
work with our marketing and distribution partners to develop additional software-based enhancements
to the neo2000 platform as well as our new Bluetooth wireless probes introduced in late 2006. To
that end, our goals for our gamma detection device business for the remainder of 2007 center around
working with our marketing partners to further penetrate the breast care market and identify ways
to expand the application of SLNB to other indications beyond breast cancer and melanoma. We also
believe that our development of Lymphoseek could be an integral step in helping expand the
application of SLNB.
18
Blood Flow Measurement Devices
Accurate blood flow measurement is essential for a variety of clinical needs, including:
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real-time monitoring; |
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intra-operative quantification; |
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non-invasive diagnostics; and |
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evaluation of cardiac function. |
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.
Cardiosonix has developed and is commercializing the Quantix line of products that employ a unique
and proprietary technology that allows for measurement of blood flow volume, velocity and several
other hemodynamic parameters that permit 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 devices use 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. At present, Cardiosonix has two products in the early stages of commercialization
designed to provide blood flow measurement and cardiac output information to physicians in
cardiac/vascular surgery and neurosurgery. The technology also has the potential to be applied in
other healthcare settings where measurement of blood flow may be beneficial.
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 generally 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.
19
The initial physician and distributor evaluation of the flagship product, the Quantix/OR, during
2004 indicated a number of design deficiencies that needed to be corrected before further
commercial distribution of the product was advisable. The development activities for the Quantix/OR
over the last year have therefore involved modification of the user interface software functions
and a redesign of the Quantix/OR probe ergonomics to enhance system performance, improve ease of
measurement and expand physician acceptance of the system. The Quantix/OR device has received CE
mark regulatory clearance for marketing in the European Union (EU) as well as FDA 510(k) clearance
for marketing in the United States.
Quantix/NDTM is intended to allow neurosurgeons and neurologists, as well as intensive
care unit or emergency room physicians, to non-invasively measure the internal carotid artery blood
flow in a simple, real-time manner. Quantix/ND consists of a control unit and an ultrasound probe
that obtains signals directly from the carotid artery in a non-invasive manner. Quantix/ND is
designed primarily for use in monitoring head trauma patients in neuro-intensive care units and
emergency rooms. Periodic blood flow measurements may minimize the risk of brain impairment. To
date, we have placed the Quantix/ND device with only a limited number of thought leaders. While we
are unaware of any competitive measurement system on the market today that provides real-time,
bedside, non-invasive, continuous, direct and accurate measurements of a complete suite of
hemodynamic parameters including blood flow, we also believe that the current market for the
Quantix/ND may be primarily as a research tool until additional feedback is received from those who
are evaluating the device. The Quantix/ND device has received CE mark regulatory clearance for
marketing in the EU as well as FDA 510(k) clearance for marketing in the United States.
Our strategy related to Cardiosonix products for the remainder 2007 is to work with our marketing
and distribution partners to close on sales leads generated over the course of the year and to work
to increase the number of competitive product evaluations to which we are invited. We cannot assure
you, however, that any of Cardiosonixs products will achieve market acceptance. 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 were used. The product we are working on with the greatest
near-term potential in this area involves a proprietary drug compound under exclusive worldwide
license from the University of California, San Diego (UCSD) that we refer to as Lymphoseek. 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 specifically designed and labeled for the
targeting of lymphatic tissue.
Neoprobe and UCSD completed the initial pre-clinical evaluations of Lymphoseek in 2001. Since that
time, UCSD has initiated five Phase I clinical trials involving Lymphoseek. The status of these
trials is listed below:
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Number of |
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Indication |
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Patients |
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Status |
Breast (peritumoral injection) |
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24 |
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Completed |
Melanoma |
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24 |
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Completed |
Breast (intradermal injection, next day surgery) |
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60 |
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Completed |
Prostate |
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20 |
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Ongoing |
Colon |
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20 |
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Ongoing |
20
These Phase I studies have been 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 these clinical evaluations of
Lymphoseek have been presented at recent meetings of the Society of Nuclear Medicine, the Society
of Surgical Oncology and the World Sentinel Node Congress. The prostate and colon studies are being
conducted under Neoprobes 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
(Interagency Council), 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 the first quarter of 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, Neoprobes 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 the fourth quarter of 2005 and the reports were filed with
FDA in December. 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 early in 2005 and engaged Cardinal Health 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 April 2006.
We received clearance from FDA in May 2006 to move forward with activities to commence patient
enrollment for a 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 have announced
positive efficacy results in our Phase 2 Lymphoseek trial in June 2007. Localization of Lymphoseek
to lymphoid tissue was observed in over 94% of the sentinel lymph node biopsy (SLNB) procedures
performed during the Phase 2 trial. 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 recent discussions with FDA, we have proposed to the agency that we conduct two
separate Phase 3 studies, each of which would involve approximately 200 evaluable patients with
either melanoma or breast cancer. We expect the study protocol to provide for patients in these
trials to receive both Lymphoseek and a non-radiopharmaceutical agent that is currently used as a
marker in lymphatic mapping procedures. Our discussions with FDA also suggest that the Phase 3
trials will be structured to support a specific intended use of Lymphoseek in SLNB procedures. We
believe such an indication would be beneficial to the marketing and commercial adoption of
Lymphoseek.
21
We will hold an end of Phase 2 meeting with FDA before the Phase 3 trials can be initiated.
This will likely mean that, although we continue to project that the Phase 3 trials will commence
during the fourth quarter of 2007, it will likely be closer to the end of the year than previously
thought. We plan to have approximately 35 participating institutions in each Phase 3 trial, which
should enable us to enroll patients at a more rapid rate than we experienced with the Phase 2
study. Our goal is to file the new drug application for Lymphoseek during the second half of 2008,
which will be dependent upon our ability to commence and 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 can be commercialized in 2009.
As a result of the modifications made to the development and regulatory pathway over Lymphoseeks
development cycle, we estimate total out-of-pocket development costs to bring Lymphoseek to market
have increased to approximately $9 to $10 million. In addition, Neoprobe has discussed the drug
approval and registration process through the centralized European drug evaluation procedures with
the European Medicinal Evaluation Agency (EMEA) in London. We plan to use the results from the
Phase 3 clinical evaluation of Lymphoseek, which we currently intend to include sites in the EU, to
support the drug registration application process with the EMEA. 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 patients body and binds specifically to cancer cell antigens or receptors. Concentrations of
the targeting agent are then located during surgery by Neoprobes gamma detection device, which
emits an audible tone to direct the surgeon to targeted tissue.
RIGScan CR is an intraoperative agent consisting of a radiolabeled murine monoclonal antibody (MAb
CC49). The radiolabel used is 125I, a 27 35 KeV emitting isotope. The MAb used in
RIGScan CR is the CC49 MAb developed by the NCI and 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
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.
22
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 United States, Israel, and
Europe. 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., surgeons 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 the 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 FDAs 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 Neoprobes 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 the EMEA. Both FDA and
the 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. FDAs 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 the 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 institutions RIGS trial patients
with apparently favorable results relating to the long -
23
term survival prognosis of patients who were treated with RIGS. In addition, we learned that FDA has held the BLA originally filed with FDA in
1996 open. Based primarily on these pieces of information, we requested a meeting with FDA 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 we believe it is likely we would have to perform some additional work related to ensuring
the drug cell line is still viable and submit this data to FDA for their evaluation before approval
could be considered. 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 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 I
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 I 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 I study.
Over the past few years, we have made progress 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. We believe there are development milestones that can be achieved prior to the need for
significant capital investment in RIGScan CR such as preparing the request for a protocol
assessment and completing a final protocol review. At present, we plan to submit a clinical
development plan for RIGScan CR to FDA and to request a meeting to review the development plan and
clinical protocol as part of the development plan in the fourth quarter of 2007. The clinical
protocol envisioned would involve approximately 300 patients in a randomized trial of patients with
primary 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. However, 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 have
engaged in discussions with various parties regarding such a partnership. At the present time,
while we have parties who have indicated an interest
24
in entering into a development relationship, we do not believe these efforts will result in a partnership until further clarity can be added to
the RIGScan regulatory approval pathway, such as obtaining a positive protocol determination from
FDA. 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 for the RIGS technology and do not know if a partner will be obtained on
a timely basis on terms acceptable to us, or at all. We also cannot assure you that FDA or the
EMEA will clear our RIGS products for marketing or that any such products will be successfully
introduced or achieve market acceptance. See Risk Factors.
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 patients 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 patients 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 I 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.
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. The means by which this
funding is obtained will likely dilute Neoprobes 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 additional funding, on terms acceptable to us, or at
all.
In addition, although the prospects for ACT may be improved depending on the outcome of a decision
to renew development efforts for RIGS, we currently do not intend to fund any significant
ACT-related research and development beyond the evaluation work already performed until a source of
further funding is identified. We cannot assure you that we will be successful in obtaining
additional funding, or if obtained, that any ACT products will be successfully developed, tested or
licensed, or that any such products will gain market acceptance. See Risk Factors.
25
Market Overviews
The medical device marketplace is a fast growing market. Medical Device & Diagnostic Industry
magazine reports an annual medical device and diagnostic market of $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 is responsible for
over 500,000 deaths annually in the U.S. alone. The NIH estimates the overall annual costs for
cancer (the primary focus of our gamma detection and pharmaceutical products) for the U.S. in the
year 2006 at $206.3 billion: $78.2 billion for direct medical costs, $17.9 billion for indirect
morbidity, and $110.2 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
the ACS, are expected to account for 12% and 4%, respectively, of new cancer cases in the U.S. in
2006.
The NIH has estimated that breast cancer will annually affect approximately 500,000 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. According to the ACS, nearly 181,000 new
cases of invasive breast cancer were expected to be diagnosed and approximately 41,000 women were
expected to die from the disease during 2007 in the U.S. alone. The incidence of breast cancer
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. Thus, we believe that the significant aging of the population, combined
with improved education and awareness of breast cancer and diagnostic methods, will 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
currently treat the majority of breast cancer patients. Over 10,000 hospitals are located in the
markets targeted for our gamma detection SLNB products. While we are aware of no published
statistics on the number of institutions that are currently using gamma detection devices in SLNB,
we believe that approximately 50% of the total potential global market for gamma detecting devices
remains to be penetrated at this time. However, 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 $200 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 estimates that nearly 154,000 new incidences of colon and rectal cancers will occur in the
U.S. in 2007. 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 $3 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.
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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 over 6.3 million inpatient cardiovascular procedures in the U.S. during
2004 with a primary dignosis of cardiovascular disease. In the U.S. in 2004, the NCHS estimates
that there were 427,000 coronary artery bypass surgeries performed on 249,000 patients. We, as well
as our competitors and other industry analysts, generally estimate the rest of the worlds
incidence of such modalities at approximately equal to as much as two time U.S. estimates.
The American Heart Association (AHA) estimates the total cost of cardiovascular diseases and stroke
in the United States will exceed $431 billion in 2007. A substantial portion of these expenditures
is expected to be for non-invasive image and intravascular examination. We are focused on two
distinct markets within the hospital setting for Cardiosonix products:
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intraoperative blood flow assessment (Quantix/OR); and |
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non-invasive diagnostic blood flow assessment (Quantix/ND). |
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.
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. At present, we would estimate that less than 25% of by-pass procedures involve
blood flow measurement. We believe that gaining a modest share of the potential penetrable market
could result in meaningful supplemental annual revenues for our company. We cannot assure you,
however, that Cardiosonix products will achieve market acceptance and generate the level of sales
or prices anticipated.
Marketing and Distribution
Gamma Detection Devices
We began marketing the current generation of our gamma detection systems, the neo2000, 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 the neo2000 system is a control unit that is software-upgradeable, permitting product
enhancements without costly remanufacturing. Since the original launch of the neo2000 system, we
have introduced an enhanced version of our 14mm reusable probe optimized for lymphatic mapping
procedures, a laparoscopic probe intended for certain minimally invasive procedures, and two
Bluetooth wireless probes for a variety of applications. We have also developed four major software
version 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 SLNB 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.
27
We entered into our current 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 current agreement through
December 31, 2008. 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 as outlined in the distribution agreement. 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
We recently executed a non-binding term sheet 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 reaching
definitive terms with the potential U.S. distribution partner for Lymphoseek or in securing
collaborative partners for other 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, 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 preparing the request for a SPA and completing a final protocol review. However, 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 positive SPA is obtained. We
anticipate continuing discussions for both Lymphoseek and RIGScan CR as we move forward with the
clinical development for each product; however, we cannot assure you that we will be able to secure
marketing and distribution partners for either product, or if secured, that such arrangements will
result in significant sales of either product.
Blood Flow Measurement Devices
Both of our blood flow measurement devices, the Quantix/ND and Quantix/OR have 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. Currently, we have in place or have
executed or reached agreement in principle with distributors and/or master distributors for the
Quantix/OR covering the United States, all major market countries in the EU, and substantially all
countries that comprise the Pacific Rim of Asia. In addition, we have distribution arrangements in
place covering major portions of Central and South America.
Our time and effort in in the marketing and sales of blood flow devices thus far in 2007 has been
to work to close on leads generated regarding the Quantix/OR and to develop new sales leads. The
sales cycle for medical devices such as our blood flow products is typically a four- to six-month
cycle. Despite the greater number of leads we have generated over the last year, the results of
our efforts to close on these leads has thus far been disappointing. We continue to investigate
alternative pricing strategies such as per-use fees or leasing that may affect the adoption rates
for our blood flow measurement devices. As a result, we anticipate that the product development and
market support costs we will incur in 2007 will be greater than the revenue we generate from the
sales of blood flow devices. We continue to evaluate our outlook for our blood flow business but
believe the coming quarters are important to demonstrating the ultimate viability of this product
line.
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Manufacturing
Gamma Detection 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 for our gamma
detection systems at qualified contract manufacturers. Production of the neo2000 control unit, the
14mm probe, the 11mm laparoscopic probe, and the Bluetooth probes involve the manufacture of
components by a combination of subcontractors, including but not limited to eV Products, a division
of II-VI Corporation (eV), and TriVirix International, Inc. (TriVirix). We also purchase certain
accessories for our line of gamma detection systems from other qualified manufacturers.
In December 1997, we entered into a supply agreement with eV for the supply of certain crystals and
associated electronics to be used in the manufacture of our proprietary line of hand-held gamma
detection probes. The original term of the agreement with eV expired on December 31, 2002 and was
automatically extended through December 31, 2005. Since the expiration of the agreement with eV,
they have continued to supply crystals under purchase orders. eV supplies 100% of the crystals used
in our products. While eV is not the only potential supplier of such crystals, 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 of the
neo2000, 14mm probe and 11mm laparoscopic probe. The original term of this agreement expired in
February 2007 but was automatically extended through February 2008. The Agreement is automatically
extended for successive one-year periods unless six months notice is provided by either party.
We cannot assure you that we will be able to maintain agreements 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 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 Biopharmaceutical
Corporation (Reliable) has produce the basic chemical compound and Catalent Pharma Solutions
(Catalent), formerly a Cardinal Health Pharmaceutical Technology and Services, 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 Catalent have been validated and
both organizations have assisted Neoprobe in the preparation of the chemistry, manufacturing and
control sections of our submissions to FDA. Both Reliable and Catalent are registered manufacturers
with FDA. At this point, drug product produced by Reliable and Catalent has been produced under
clinical development agreements. Commercial supply and distribution agreements have yet to be
negotiated with both Reliable and Catalent. We cannot assure you that we will be successful in
reaching such agreements with Reliable or Catalent on terms satisfactory to us or at all.
29
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 product; however, we have not yet finalized agreements with these
entities. We anticipate finalizing these discussions following securing a development partner in
order to accommodate 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.
Blood Flow Measurement Devices
The Quantix blood flow measurement devices distributed through early 2006 were manufactured by our
subsidiary, Cardiosonix Ltd. In early 2006, we received approval from the Office of the Chief
Scientist in 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
devices. 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. (Vermon) of France
under purchase orders. The ultrasound probe assemblies are then completed by Technical Services for
Electronics, Inc. (TSE), also under purchase orders.
We cannot assure you that we will be able to finalize supply and service agreements with Vermon,
TSE or other subcontractors for the Quantix products, that we will be able to maintain our
agreement with TriVirix, 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.
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.
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Gamma Detection Devices
With the emergence of ILM, 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 (distributed by GE Healthcare), RMD Instruments, LLC, SenoRx, Pol.Hi.Tech. Srl, 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 a large
corporation or privately held corporations, whose sales revenue or volume data is, therefore, 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 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 that Lymphoseek is intended for 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 (i.e., they are not
specifically indicated for use as a lymphatic targeting agent). As such, we believe that
Lymphoseek, if ultimately approved, would be the first drug specifically labeled for use as a
lymphatic tissue 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 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 which 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
technician-dependent, often cumbersome and does not offer monitoring capabilities. Plain Doppler
systems provide only blood flow velocity rather than volume flow.
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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 these markets, the following
companies compete most directly with Cardiosonix: 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 SLNB 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. 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.
We continue to maintain 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. The original
methodology aspects of our RIGS technology are claimed in the United States in U.S. Patent No.
4,782,840, which expired in August 2005. However, Neoprobe has recently gained access to additional
methodology applications related to our RIGS technology that are covered by patents that provide
additional patent coverage through 2018, unless extended. In addition to the RIGS methodology
patents, 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.
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 Bios. The oncology applications of
Cira Bios 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.
32
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. See Risk Factors.
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.
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.
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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 companys 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 to manufacture
the devices under quality system regulations (QSR) and maintain appropriate technical files and
quality records. Our medical devices are regulated in the United States by FDA and in the EU
according to the Medical Device Directive (93/42/EEC). Under this regulation, we must obtain CE
Mark status for all products exported to the EU.
Our initial generation gamma detection instruments received 510(k) marketing clearance from FDA in
December 1986 with modified versions receiving similar clearances in 1992 through 1997. In 1998,
FDA reclassified nuclear uptake detectors as being exempt from the 510(k) process. We believe the
neo2000 device is exempt from the 510(k) process because it is substantially equivalent to
previously cleared predecessor devices. We obtained the CE Mark for the neo2000 device in January
1999, and therefore, must continue to manufacture the devices under a quality system compliant to
the requirements of ISO 9001/EN 46001 and maintain appropriate technical files. We maintain a
license to import our gamma detection devices into Canada, and therefore must continue to
manufacture the devices under a quality system compliant to the requirements of ISO 13485 and
relevant Canadian regulations.
Cardiosonix has received 510(k) and CE mark clearance to market the Quantix/ND device in the U.S.
and EU for non-invasive applications. The Quantix/OR has also received CE Mark clearance to market
in the EU and 510(k) clearance to market in the U.S. Our distribution partners in certain foreign
markets other than the EU are seeking marketing clearances, as required, for both the Quantix/ND
and Quantix/OR.
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
34
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.
Employees
As of September 14, 2007, we had 20 full-time employees. We consider our relations with our
employees to be good.
35
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion should be read together with our Financial Statements and the Notes
related to those statements, as well as the other financial information included in this
Post-effective Amendment No. 2 to Registration Statement on Form SB-2, of which this prospectus is
a part. 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 the Risk Factors section of this prospectus beginning on page 4.
The Company
Neoprobe Corporation is a biomedical technology company that provides innovative surgical and
diagnostic products that enhance patient care. We currently market two lines of medical devices;
our neo2000® 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, RIGScan® CR and Lymphoseek®, in the
advanced phases of clinical development. We are also exploring the development of our activated
cellular therapy (ACT) technology for patient-specific disease treatment through our majority-owned
subsidiary, Cira Biosciences, Inc. (Cira Bio).
Executive Summary
This Executive Summary section contains a number of forward-looking statements, all of which are
based on current expectations. Actual results may differ materially. Our financial performance is
highly dependent on our ability to continue to generate income and cash flow from our gamma device
product line and on our ability to successfully commercialize the blood flow products of our
subsidiary, Cardiosonix. We cannot assure you, however, 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 other
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 2007. 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 lines of business. We expect revenue from our gamma device line to continue to provide a strong
revenue base during 2007. Sales of our blood flow measurement devices also continue to be below our
expectations. While we have seen enough instances of success when the products have been
demonstrated to cardiovascular surgeons to give us cause for optimism, these product demonstrations
have not yet translated into significant sales for the Company. As a result, we currently expect
that blood flow-related revenue for 2007 may fall below 2006 levels. Over the past few years, we
have also made progress on our oncology drug development initiatives. We recently completed patient
enrollment in a Phase 2 clinical trial for Lymphoseek in breast cancer and melanoma.
The majority of our development expenses over the next 12 to 18 months will be devoted to our
Lymphoseek efforts to complete manufacturing validation and scale-up, to complete Phase 3 clinical
trials and to prepare for the submission of a new drug application to the U.S. Food and Drug
Administration (FDA) which we expect to submit in 2008 subject to clearance from FDA to commence
the Phase 3 studies in a timely fashion. We anticipate the total outsourced out-of-pocket costs for
Lymphoseek to be approximately $9 10 million. We also expect to incur development expenses in
2007 as we continue to innovate our device product lines, although we do not currently expect our
out-of-pocket expenses to exceed $1 million related to these projects in 2007. We are currently
devoting minimal incremental resources and funding to support our blood flow measurement business
beyond that needed to support our gamma device line and believe we are not far from a breakeven
point for the blood flow line based on the incremental investment anticipated in our current
expectations. We will continue to monitor the state of market development and success for our
blood flow measurement business and adjust our business plans accordingly. We may also incur some
minor development expenses in 2007 related to our RIGS radiopharmaceutical product development
although we intend to defer any major
36
expenses until we identify a partner to assist us in the
development and commercialization of RIGScan CR. We will likely show a loss for fiscal year 2007
primarily due to our drug product development efforts.
As of June 30, 2007 our cash on hand totaled $1.2 million. We believe our currently available
capital resources will be adequate to sustain our operations at planned levels through the end of
2007. We intend to raise additional funds through our stock purchase agreement with Fusion to
supplement our capital needs until we are able to generate positive cash flow from Lymphoseek and
our medical device product lines. However, the extent to which we rely on Fusion 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. Specifically, Fusion 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. If we decide to seek additional funding from other sources to
support the development of our products and additional financing is not available when required or
is not available on acceptable terms, or we are unable to arrange a suitable strategic opportunity,
we may need to modify our business plan. We cannot assure you that the additional capital we
require will be available on acceptable terms, if at all. We cannot assure you that we will be able
to successfully commercialize products or that we will achieve significant product revenues from
our current or potential new products. In addition, we cannot assure you that we will achieve or
sustain profitability in the future.
Our Outlook for our Gamma Detection Device Products
We believe our core gamma detection device business line will continue to achieve positive results.
Our belief is based on continued interest in the research community in lymphatic mapping. The
National Cancer Institute (NCI) has sponsored two large randomized clinical trials (research
studies) for breast cancer comparing sentinel lymph node biopsy (SLNB) with conventional axillary
lymph node dissection. The trials were conducted by the National Surgical Adjuvant Breast and Bowel
Project (NSABP) and the American College of Surgeons Oncology Group (ACOSOG). NSABP and ACOSOG are
both NCI-sponsored Clinical Trials Cooperative Groups, which are networks of institutions and
physicians across the country who jointly conduct trials. Although several studies have examined
the correlation between the sentinel node and the remaining axillary nodes, these are the first two
large randomized multi-center trials 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, final data
from these studies likely will not be presented for another year or so. We expect the results from
these clinical trials, when announced, will have a positive impact on helping us to penetrate the
remaining market for breast cancer and melanoma. We also believe that the surgical community will
continue to adopt the 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
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 neo2000. As a
result, we may be reaching saturation within this segment of the market, except for potential
replacement sales. As such, our marketing focus in all major global markets for gamma detection
devices will continue to be among local/regional hospitals, which typically lag behind leading
research centers and major hospitals in adapting to new technologies. A decline in the adoption
rate of SLNB at these institutions 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 introduced a new gamma detection probe at
the American College of Surgeons 92nd Annual Clinical Congress meeting in Chicago in
October 2006. The new probe uses Bluetooth® wireless technology to communicate gamma
radiation counts to our neo2000 control unit. The wireless probe eliminates cumbersome cables that
can complicate the surgical field and provides the surgeon with operative field flexibility. The
new probe is designed to be used with all existing models of our neo2000 system (Models 2000, 2100
and 2200). The wireless probe is available with either a straight or angled detection tip.
37
During March 2006, our primary gamma device marketing partner, Ethicon Endo-Surgery, Inc. (EES), a
Johnson & Johnson company, exercised the second of its two options to extend the termination date
of our distribution agreement with them through the end of 2008. We believe that total quantities
of base neo2000 systems expected to be purchased by EES during 2007 should be consistent
with 2005 and 2006 purchase levels. We cannot assure you, however, that EES product purchases
beyond those firmly committed through late 2007 will indeed occur or that the prices we realize
will not be affected by increased competition.
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 sales price, 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 average end-customer sales prices received by EES for our gamma
detection devices declined less than 3% in 2006 as compared to 2005; however, the transfer price
that we received from selling to EES during 2006 remained approximately 18% above the floor pricing
for the base system configuration. While we continue to believe in the technical and user-friendly
superiority of our products, the competitive landscape continues to evolve and we may lose market
share or experience price erosion as a result. A loss of market share or significant price erosion
would have a direct negative impact on net income. If price erosion continues into 2007, there is a
risk associated with future sales 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. We anticipate generating a
net profit from the sale of our gamma detection devices in 2007, excluding the allocation of any
corporate general and administrative costs. We also believe the anticipated volumes would result
in continued profitability for our gamma device business line for 2007, even at floor prices.
However, we cannot assure you that sales will occur at the expected levels or prices or that such
sales will ultimately result in profitability of the product line.
Our Outlook for our Drugs and Therapeutics
The primary focus of our drug and therapeutic development efforts through mid-2007 has centered
around completing the Phase 2 clinical trial for Lymphoseek for patients with breast cancer or
melanoma. Lymphoseek is intended to be used in biopsy 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 lymphatic tissue.
Based on recent discussions with FDA, we plan to propose to the agency that we conduct two separate
Phase 3 studies, each of which would involve approximately 200 evaluable patients with either
melanoma or breast cancer. We expect the study protocol to provide for patients in these trials to
receive both Lymphoseek and a non-radiopharmaceutical agent that is currently used as a marker in
lymphatic mapping procedures. Our discussions with FDA also suggest that the Phase 3 trials will
be structured to support a specific intended use of Lymphoseek in SLNB procedures. We believe such
an indication would be beneficial to the marketing and commercial adoption of Lymphoseek.
We will hold an end of Phase 2 meeting with FDA before the Phase 3 trials can be initiated. This
will likely mean that, although we continue to project that the Phase 3 trials will commence during
the fourth quarter of 2007, it will likely be closer to the end of the year than previously
thought. We plan to have approximately 35 participating institutions in each Phase 3 trial, which
should enable us to enroll patients at a more rapid rate than we experienced with the Phase 2
study. Our goal is to file the new drug application for Lymphoseek during the second half of 2008,
which will be dependent upon our ability to commence and 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 can be commercialized in 2009.
In early 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.
38
As a result of the cross-license agreements, Cira Bio has the 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 licenses to several pending patent
applications.
Cira Bio intends to raise the necessary capital to move this technology platform forward; however,
Cira Bio has not yet identified a potential source of capital. Obtaining this funding would likely
dilute Neoprobes 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 addition, because Cira Bio was not
successful in obtaining sufficient capital by December 31, 2006, 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.
Our Outlook for our Blood Flow Measurement Products
We have two blood flow measurement devices, the Quantix/ORTM and the
Quantix/NDTM, that have regulatory clearance to market in the U.S. and European Union
(EU) as well as certain other foreign markets. The Quantix/OR is primarily intended to measure
blood flow in cardiac bypass graft and other similar procedures while the Quantix/ND is designed to
measure blood flow in neurovascular settings. Currently, we have in place or have executed or
reached agreement in principle with distributors and/or master distributors for the Quantix/OR
covering the United States, all major market countries in the EU, and substantially all countries
that comprise the Pacific Rim of Asia. In addition, we have distribution arrangements in place
covering major portions of Central and South America. Our goal is to secure and maintain marketing
and distribution arrangements with partners who possess appropriate expertise in marketing medical
devices, preferably ultrasound or cardiac care devices, into our primary target markets, the
cardiovascular, vascular surgery and neurosurgical markets.
Our strategy related to Cardiosonix products for the remainder 2007 is to close on sales leads
generated over the course of the year and to work to increase the number of competitive product
evaluations to which we are invited. The sales cycle for medical devices such as our blood flow
products is typically a four to six month cycle. This sales cycle, coupled with the timetable
necessary to train the new distributors we engaged during 2006 has resulted in disappointing sales
levels of our blood flow measurement equipment to date. We are also investigating alternative
pricing strategies such as per-use fees or leasing that may affect the adoption rates for our blood
flow measurement devices. However, we anticipate that the product development and market support
costs we will incur in 2007 will be greater than the revenue we generate from the sales of blood
flow devices. As a result, we expect to show a loss for our blood flow measurement device product
line for 2007 due to ongoing development and marketing support that is required to expand market
acceptance for the product line. We are currently devoting minimal incremental resources and
funding to support our blood flow measurement business and believe we are not far from a breakeven
point for the blood flow line based on the incremental investment anticipated in our current
expectations. We will continue to monitor the state of market development and success for our
blood flow measurement business and adjust our business plans accordingly.
Summary
The strength of our oncology product (device and drug) portfolio should position us to eventually
achieve profitable operating performance for our device product lines. However, overall profitable
operational results will be significantly affected by our decision to fund drug and therapeutic
development activities internally.
We anticipate generating a net profit from the sale of our gamma detection devices in 2007,
excluding the allocation of any corporate general and administrative costs; however, we expect to
show a loss for our blood flow device product line for 2007 due to ongoing research and development
and increased marketing and administrative support costs that may be required to expand market
acceptance for the product line. Our overall operating results for 2007 will also be greatly
affected by the amount of development of our radiopharmaceutical products.
39
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
2007. In addition, our net loss and loss per share will likely be significantly impacted by the
non-cash interest expense we expect to record related to the accounting treatment for the
beneficial conversion feature of the convertible debt and for the warrants issued in connection
with the private placement we completed in December 2004 and modified in November 2006. 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.
YEARS ENDED DECEMBER 31, 2006 AND 2005
Results of Operations
Revenue for 2006 increased to $6.1 million from $5.9 million in the prior year. The increase was
due to increased blood flow device sales of $263,000, offset by a decrease of $134,000 in sales of
gamma detection devices and extended service contracts.
Gross profit for 2006 decreased $124,000 or 4% as compared to 2005. The decrease in gross profit on
net sales of our medical devices in 2006 was primarily due to the decline in gross margin
percentage related to our blood flow product line. The decline in blood flow gross margin
percentage resulted from $129,000 of inventory impairments related to design changes to our Quantix
products in 2006 coupled with lower margins on blood flow sales due to a greater proportion of
blood flow devices being sold on a wholesale basis to distributors as opposed to on a retail basis
to end customers. By comparison, we recorded $45,000 of inventory impairments related to our
laparoscopic gamma detection probe and $13,000 of inventory impairments related to our blood flow
product line in 2005.
Results for 2006 also reflect significant expenditures made in the development of Lymphoseek and in
continuing to innovate our gamma detection device line with the introduction of a Bluetooth
wireless probe. Despite these development advances, our research and development costs for 2006
decreased to $3.8 million compared to $4.0 million in 2005. Consolidated general and administrative
expenses decreased slightly to $3.1 million in 2006 from $3.2 million in 2005.
Net Sales and Margins. Net sales, primarily of our gamma detection systems, increased $132,000, or
2%, to $6.1 million in 2006 from $5.9 million in 2005. Gross margins on net sales decreased to 57%
of net sales for 2006 compared to 60% of net sales for 2005.
The increase in net sales was the result of increased blood flow device sales of $263,000, offset
by a decrease of $134,000 in sales of gamma detection devices and extended service contracts. The
price at which we sell our gamma detection products to EES is based on a percentage of the global
average selling price received by EES on sales of Neoprobe products to end customers, subject to a
minimum floor price. The base system price at which we sold neo2000 systems to EES decreased
approximately 3% from 2005 to 2006.
The decrease in gross margins on net product sales was primarily the result of a greater proportion
of blood flow devices being sold on a wholesale basis to distributors as opposed to on a retail
basis to end customers. Gross margins in 2006 were also adversely affected by inventory impairments
of $129,000 related to design changes to our Quantix products. Gross margins in 2005 were adversely
affected by inventory impairments of $45,000 related to our laparoscopic gamma detection probe and
$13,000 related to our blood flow measurement products.
Research and Development Expenses. Research and development expenses decreased $229,000, or 6%, to
$3.8 million during 2006 from $4.0 million in 2005. Research and development expenses in 2006
included approximately $2.1 million in drug and therapy product development costs, $952,000 in
gamma detection device development costs, and $708,000 in product design activities for the Quantix
products. This compares to expenses of $2.3 million, $276,000 and $1.4 million in these respective
product categories in 2005. The changes in each category were primarily due to (i) efforts to move
development of Lymphoseek forward offset by decreased activities related to RIGScan CR and our
therapeutic products, (ii) development of our Bluetooth wireless gamma detection probe, and (iii)
decreased product refinement activities related to the Quantix/OR, respectively.
40
Selling, General and Administrative Expenses. Selling, general and administrative expenses
decreased $79,000, or 3%, to $3.1 million during 2006 from $3.2 million in 2005. Decreases in
amortization of intangible assets, professional services and insurance were offset by increases in
base compensation, including $156,000 of non-cash stock compensation required to be expensed
starting in 2006 under SFAS No. 123(R), Share-Based Payment, coupled with increases in marketing
and recruiting expenses.
Other Income (Expenses). Other expenses remained steady at $1.3 million during 2006 and 2005.
Interest expense increased $146,000 to $1.5 million during 2006 from $1.4 million during 2005
related to the convertible debt agreements we completed in December 2004. Of this interest expense,
$809,000 and $687,000 in 2006 and 2005, respectively, was non-cash in nature related to the
amortization of debt issuance costs and discounts resulting from the warrants and beneficial
conversion features of the convertible debt. This increase was offset by the first quarter 2005
increase in warrant liability of $142,000 resulting from the accounting treatment for the warrants
we issued in connection with the convertible debt.
Liquidity and Capital Resources
Operating Activities. Cash used in operations increased $556,000 to $3.6 million during 2006 from
$3.0 million during 2005. Working capital decreased $5.0 million to $1.9 million at December 31,
2006 as compared to $6.9 million at December 31, 2005. The current ratio decreased to 1.6:1 at
December 31, 2006 from 5.6:1 at December 31, 2005. The decrease in working capital was primarily
related to $3.6 million used in operations coupled with the classification of $1.7 million of
convertible debt as a current liability following modification of the debt terms in November 2006,
as compared to no current convertible debt at December 31, 2005.
Cash and investment balances decreased to $2.5 million at December 31, 2006 from $6.5 million at
December 31, 2005, primarily as a result of cash used to fund operating activities and service our
debt during 2006.
Accounts receivable increased to $1.2 million at December 31, 2006 from $673,000 at December 31,
2005. The increase was primarily a result of normal fluctuations in timing of purchases and
payments by EES. We expect overall receivable levels will continue to fluctuate in 2007 depending
on the timing of purchases and payments by EES. However, on average, we expect accounts receivable
balances will increase commensurate with anticipated increases in sales of blood flow measurement
products to our distributors. Such increases, if any, may require the increased use of our cash
resources over time. Inventory levels increased to $1.2 million at December 31, 2006 from $804,000
at December 31, 2005. Finished gamma detection device inventories increased as we built up of our
safety stock levels, and materials and work-in-process inventories increased in connection with the
start-up of Bluetooth wireless gamma detection probe production. In addition, we capitalized
$48,000 of Lymphoseek materials inventory during 2006. During 2006, we also recorded inventory
impairment charges totaling $129,000, primarily related to our Quantix products. We expect
inventory levels to decrease during 2007 as we convert our Bluetooth inventory into sales and
reassess our gamma detection and blood flow measurement device safety stock levels.
Prepaid expenses and other assets decreased to $431,000 at December 31, 2006 from $502,000 at
December 31, 2005. The net decrease was primarily the result of decreases in various prepaid assets
such as prepaid production costs and prepaid insurance which were offset by net increases in
certain non-cash items such as deferred stock offering costs.
Accounts payable increased to $668,000 at December 31, 2006 from $208,000 at December 31, 2005,
primarily due to the timing of purchases and payments to vendors.
Investing Activities. Investing activities provided $1.4 million in cash during 2006 versus $1.6
million used during 2005. We received $1.5 million from maturities of available-for-sale securities
during 2006. We purchased $5.5 million and received $4.0 million from maturities of
available-for-sale securities during 2005. Capital expenditures during 2006 were primarily for
software and production tools and equipment in preparation for Bluetooth wireless gamma detection
probe production at our contract manufacturers. Capital expenditures during 2005 were primarily
related to purchases of production tools and equipment
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in preparation for blood flow measurement device production. We expect our overall capital expenditures for 2007 will be lower than for 2006.
Financing Activities. Cash used in financing activities decreased $33,000 to $240,000 during 2006
from $273,000 during 2005. Proceeds from the issuance of common stock were $50,000 and $58,000 in
2006 and 2005, respectively. Payments of common stock and debt issuance costs were $36,000 and
$30,000 in 2006 and 2005, respectively. Payments of notes payable were $235,000 and $286,000 during
2006 and 2005, respectively.
In December 2006, we entered into a common stock purchase agreement with Fusion Capital Fund II,
LLC (Fusion). We have authorized up to 12,000,000 shares of our common stock for sale to Fusion
under the agreement. Under the terms of the agreement, in December 2006, we issued 720,000 shares
of our common stock as an initial commitment fee. We are also required to issue to Fusion up to an
additional 720,000 shares of our common stock as an additional commitment fee in connection with
future purchases made by Fusion. The additional 720,000 shares will be issued pro rata as we sell
our common stock to Fusion under the agreement, resulting in a total commitment fee of 1,440,000
shares of our common stock if the entire $6.0 million in value of stock is sold. The price of
shares sold to Fusion will be determined based upon the market price of our shares without any
fixed discount at the time of each sale. Fusion shall not have the right nor the obligation to
purchase any shares of our common stock on any business day that the price of our common stock is
below $0.20. During 2006, we sold a total of 208,333 shares of our common stock under the
agreement, realized gross proceeds of $50,000 from such sales, and issued Fusion 6,000 shares of
our common stock as additional commitment fees related to such sales.
During 2005, certain investors and placement agents who received warrants to purchase our common
stock in connection with a November 2003 financing exercised a total of 206,865 warrants in
exchange for 206,865 shares of our common stock, resulting in net proceeds of $57,922.
In December 2004, we completed a private placement of four-year convertible promissory notes in an
aggregate principal amount of $8.1 million 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. We modified
the convertible notes on November 30, 2006 to eliminate the revenue and cash covenants, modify the
repayment schedule of the notes, eliminate certain anti-dilution rights, and avoid potential future
violations of the debt covenants. The notes originally bore interest at 8% per annum and were
originally due on December 13, 2008. In connection with the November 30, 2006 amendment, we
cancelled the original notes and issued to the noteholders replacement notes which bear interest at
12% per annum. Instead of the notes being due on December 13, 2008, the principal is now due as
follows: $500,000 due January 8, 2007; $1,250,000 due July 9, 2007; $1,750,000 due January 7, 2008;
$2,000,000 due July 7, 2008; and the remaining $2,600,000 due January 7, 2009. Additionally, as
part of the amendment we agreed to use our best efforts to offer and sell equity securities with
gross proceeds of up to $10 million and apply not less than 50% of the net proceeds of any such
sales to the repayment of the principal on the notes, and to apply at least 50% of the proceeds of
any permitted asset disposition or any permitted licensing, distribution or similar strategic
alliance agreement to the repayment of principal on the notes. The notes are freely convertible
into shares of our common stock at a price of $0.40 per share. Neoprobe may force conversion of the
notes prior to their stated maturity under certain circumstances. As part of the original
transaction, we issued the investors 10,125,000 Series T warrants to purchase our common stock at
an exercise price of $0.46 per share, expiring in December 2009. In connection with the original
placement of this financing, we issued 1,600,000 Series U warrants to purchase our common stock to
the placement agents, containing substantially identical terms to the warrants issued to the
investors. The convertible promissory note issued to Mr. Bupp in connection with this transaction
had an outstanding principal amount of $100,000 on December 31, 2006, and an outstanding principal
amount of $100,000 as of March 14, 2007. We made interest payments due under the note to Mr. Bupp
totaling $8,333 during the fiscal year ended December 31, 2006.
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THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2007 AND 2006
Overview
This Overview section contains a number of forward-looking statements, all of which are based on
current expectations. Actual results may differ materially from the anticipated results discussed
herein. Our financial performance is highly dependent on our ability to continue to generate
income and cash flow from our gamma detection device product line and on our ability to
successfully commercialize the blood flow measurement products of Cardiosonix. 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 other proprietary, procedural-based technologies such as
Lymphoseek, RIGS® (radioimmunoguided surgery) and ACT; however, these technologies are
not anticipated to generate any significant revenue for us during 2007. In addition, we cannot
assure you that these products will ever obtain marketing clearance from the appropriate regulatory
bodies.
Our revenue for the first six months of 2007 was consistent overall with our original expectations.
Gamma detection device revenue was buoyed by sales of our Bluetooth® probes to our
primary gamma detection device marketing partner, Ethicon Endo-Surgery, Inc. (EES), a Johnson &
Johnson company. Higher than expected unit sales and unit prices of our Bluetooth probes were
offset by lower unit sales and declines in unit prices of our base neo2000 system and accessories.
We expect that revenue from our gamma detection systems for 2007 will be slightly higher than 2006;
however, continued price declines for these base systems in international markets may adversely
affect our gamma detection device revenue for the remainder of 2007 as compared to 2006. Sales of
our blood flow measurement devices also continue to be below our expectations. While we have seen
enough instances of success when the products have been demonstrated to cardiovascular surgeons to
give us cause for optimism, these product demonstrations have not yet translated into significant
sales for the company. As a result, we currently expect that blood flow-related revenue for 2007
may fall below 2006 levels. Future sales of Quantix devices are highly dependent upon our ability
to maintain our blood flow measurement device marketing and distribution partners, the success of
our distribution partners in generating sales leads, our distribution partners ability to
negotiate within the constraints of current hospital purchasing practices, and ultimately on
physician response to these products and procedures themselves.
Our operating expenses during the first six months of 2007 were focused primarily on support of
Lymphoseek product development. In addition, we continued to modestly invest in our neo2000 gamma
detection device line related to completing the technology transfer of our Bluetooth probes into
commercial manufacturing. We expect our drug-related development expenses to decrease over the
next few months until we initiate the multi-center Phase 3 clinical evaluations of Lymphoseek. We
expect to continue to incur development expenses to support our gamma detection device product line
as well as move our other product initiatives forward. We also expect to continue to modestly
invest in marketing and clinical development support for our blood flow measurement products during
the remainder of 2007 as we work with our distribution partners to expand market penetration of our
Quantix product lines.
Our efforts thus far in 2007 have resulted in the following research and development and business
milestone achievements:
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Granted authorization by the U.S. Food and Drug Administration (FDA) to commence patient
enrollment in two Phase 1 clinical studies to evaluate the safety and efficacy of
Lymphoseek in prostate and colon cancers. |
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Achieved and reported positive preliminary results from the Phase 2 Lymphoseek trial in
breast cancer and melanoma. Based on pathology confirmed results, Lymphoseek identified
lymphatic tissue in over 94% of the surgically treated patients, which exceeded the trials
objective of 90% efficacy. |
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Extended the companys option agreement with the University of California, San Diego
covering the potential use of Lymphoseek as an optical or ultrasound agent. |
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Filed an updated chemistry, manufacturing and control (CMC) amendment on Lymphoseek and
an expanded non-clinical study package with FDA in preparation for the next phase of
Lymphoseek clinical development program. |
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Commenced development activities for the Phase 3 clinical studies of Lymphoseek,
including holding a successful preliminary meeting with FDA. |
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Completed the second of three current Good Manufacturing Practices (cGMP) production
runs of Lymphoseek. |
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Closed on a $1.0 million investment in the company led by our President and CEO, David
Bupp. |
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Executed a term sheet for the marketing and distribution of Lymphoseek in the United
States with the nuclear pharmacy division of Cardinal Health, Inc. |
We received clearance from FDA in May 2006 to move forward with activities to commence patient
enrollment for a 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 have announced
positive efficacy results in our Phase 2 Lymphoseek trial. Localization of Lymphoseek to lymphoid
tissue was observed in over 94% of the sentinel lymph node biopsy (SLNB) procedures performed
during the Phase 2 trial. 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 recent discussions with FDA, we plan to propose to the agency that we conduct two separate
Phase 3 studies, each of which would involve approximately 200 evaluable patients with either
melanoma or breast cancer. We expect the study protocol to provide for patients in these trials to
receive both Lymphoseek and a non-radiopharmaceutical agent that is currently used as a marker in
lymphatic mapping procedures. Our discussions with FDA also suggest that the Phase 3 trials will
be structured to support a specific intended use of Lymphoseek in SLNB procedures. We believe such
an indication would be beneficial to the marketing and commercial adoption of Lymphoseek.
We will hold an end of Phase 2 meeting with FDA before the Phase 3 trials can be initiated. This
will likely mean that, although we continue to project that the Phase 3 trials will commence during
the fourth quarter of 2007, it will likely be closer to the end of the year than previously
thought. We plan to have approximately 35 participating institutions in each Phase 3 trial, which
should enable us to enroll patients at a more rapid rate than we experienced with the Phase 2
study. Our goal is to file the new drug application for Lymphoseek during the second half of 2008,
which will be dependent upon our ability to commence and 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 can be commercialized in 2009.
As a result of the modifications made to the development and regulatory pathway over Lymphoseeks
development cycle, we estimate total out-of-pocket development costs to bring Lymphoseek to market
have increased to approximately $9 to $10 million. In addition, Neoprobe has discussed the drug
approval and registration process through the centralized European drug evaluation procedures with
the European Medicinal Evaluation Agency (EMEA) in London. We plan to use the results from the
Phase 3 clinical evaluation of Lymphoseek, which we currently intend to include sites in the EU, to
support the drug registration application process with the EMEA. We cannot assure you, however,
that this product will achieve regulatory approval, or if approved, that it will achieve market
acceptance.
Over the past few years, we have made progress 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. We believe there are development milestones that can be achieved prior to the need for
significant capital investment in RIGScan CR such as preparing the request for a protocol
assessment and completing a final protocol review. At present, we plan to submit a clinical
development plan for RIGScan CR to FDA and to request a meeting to review the development plan and
clinical protocol as part of the development plan in the fourth quarter of 2007. The clinical
protocol envisioned would involve approximately 300 patients in a randomized trial of patients with
primary colorectal cancer. The participants in the trial would be
44
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. However, 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 have
engaged in discussions with various parties regarding such a partnership. 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 partnership until further clarity can be added to
the RIGScan regulatory approval pathway, such as obtaining a positive protocol determination from
FDA. 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 for the RIGS technology and do not know if a partner will be obtained on
a timely basis on terms acceptable to us, or at all. We also cannot assure you that FDA or the
EMEA will clear our RIGS products for marketing or that any such products will be successfully
introduced or achieve market acceptance.
Cira Bio was formed to raise the necessary capital to move the ACT technology platform forward;
however, Cira Bio has not yet identified a potential source of capital. Obtaining this funding
would likely dilute Neoprobes ownership interest in Cira Bio. While we believe that moving
forward such a promising technology will only yield positive results for the Neoprobe stockholders
and the patients who could benefit from these treatments, we do not know if we will be successful
in obtaining funding on terms acceptable to us, or at all. In addition, because Cira Bio was not
successful in obtaining sufficient capital by December 31, 2006, 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 Bios minority shareholder, Cira LLC, upon
notice by either party.
We anticipate generating a net profit from the sale of our gamma detection devices in 2007,
excluding the allocation of any corporate general and administrative costs; however, we expect to
show a loss for our blood flow measurement device product line for 2007 due to ongoing development
and marketing support that is required to expand market acceptance for the product line. We are
currently devoting minimal incremental resources and funding to support our blood flow measurement
business beyond that needed to support our gamma device line and believe we are not far from a
breakeven point for the blood flow line based on the incremental investment anticipated in our
current expectations. We will continue to monitor the state of market development and success for
our blood flow measurement business and adjust our business plans accordingly. Our overall
operating results for 2007 will also be greatly affected by the amount of development of our
radiopharmaceutical products.
Primarily as a result of the significant development costs we expect to incur related to the
continued clinical development of Lymphoseek, we do not expect to achieve operating profit during
2007. In addition, our net loss and loss per share will likely be significantly impacted by the
non-cash interest expense we expect to record related to the accounting treatment for the
beneficial conversion feature of the convertible debt and for the warrants issued in connection
with the private placement we completed in December 2004 and modified in November 2006. We cannot
assure you that our current or potential new products will be successfully commercialized, that we
will achieve significant product revenues, or that we will achieve or be able to sustain
profitability in the future.
Results of Operations
Revenue for the first six months of 2007 increased to $3.3 million from $3.2 million during the
same period in 2006. Research and development expenses, as a percentage of net sales, increased to
53% during the first six months of 2007 from 46% during the same period in 2006. Selling, general
and administrative expenses, as a percentage of net sales, decreased to 44% during the first six
months of 2007 from 50% during the same period in 2006. Due to the ongoing development activities
of the
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company, research and development expenses as a percentage of sales are expected to be
higher in 2007 than they were in 2006. In addition, should we be successful in our ongoing
commercialization activities related to the Quantix product line, and in achieving increased sales
of our Bluetooth probes in 2007, selling, general and administrative expenses as a percentage of
sales are expected to continue to decrease in 2007 compared to 2006.
Three Months Ended June 30, 2007 and 2006
Net Sales and Margins. Net sales, comprised primarily of sales of our gamma detection systems,
increased $83,000, or 6%, to $1.5 million during the second quarter of 2007 from $1.4 million
during the same period in 2006. Gross margins on net sales decreased to 54% of net sales for the
second quarter of 2007 compared to 58% of net sales for the same period in 2006.
The increase in net sales was the result of increased gamma detection device sales of $83,000 and
increased gamma detection device extended service contract revenue of $32,000, offset by decreases
of $23,000 in gamma detection device service-related revenue and $9,000 in blood flow measurement
device sales. Revenue from our new Bluetooth wireless probes more than offset unit sales and price
declines on our base gamma detection systems. The price at which we sell our gamma detection
products to EES is based on a percentage of the global average selling price received by EES on
sales of Neoprobe products to end customers, subject to a minimum floor price. The base system
price at which we sold neo2000 systems to EES decreased approximately 4% during the second quarter
of 2007 compared to the same period in 2006.
The decrease in gross margins on net product sales was primarily due to a combination of factors
including lower margins on sales of Bluetooth probe demonstration units during the second quarter
of 2007, a price decline on base systems sold by EES, higher than expected production costs on our
initial production runs of Bluetooth probes, and increased estimated warranty costs related to the
commercial launch of our new Bluetooth probe products. Gross margins in the second quarter of 2007
were also adversely affected by inventory impairments of $29,000 related to our Quantix products.
Research and Development Expenses. Research and development expenses increased $233,000 or 36% to
$875,000 during the second quarter of 2007 from $643,000 during the same period in 2006. Research
and development expenses in the second quarter of 2007 included approximately $611,000 in drug and
therapy product development costs, $163,000 in gamma detection device development costs, and
$101,000 in product design activities for the Quantix products. This compares to expenses of
$207,000, $235,000 and $201,000 in these relative segment categories during the same period in
2006. The changes in each category were primarily due to (i) efforts to move development of
Lymphoseek forward offset by decreased activities related to RIGScan CR and our therapeutic
products, (ii) decreased product development activities related to our Bluetooth wireless gamma
detection probes, and (iii) decreased product refinement activities related to the
Quantix/ORTM, respectively.
Selling, General and Administrative Expenses. Selling, general and administrative expenses
decreased $104,000 or 14% to $650,000 during the second quarter of 2007 from $754,000 during the
same period in 2006. The net difference was due primarily to decreases in marketing, insurance,
and the timing of professional services.
Other Income (Expenses). Other expenses increased $128,000 to $427,000 during the second quarter
of 2007 from $298,000 during the same period in 2006. Interest expense related to the convertible
debt agreements we completed in December 2004 increased $81,000 to $445,000 during the second
quarter of 2007 from $363,000 for the same period in 2006. Of this interest expense, $221,000 and
$198,000 in the second quarters of 2007 and 2006, respectively, was non-cash in nature related to
the amortization of debt issuance costs and discounts resulting from the warrants and beneficial
conversion features of the convertible debt. In addition, we recorded a decrease of $43,000 in
interest income related to lower balances of cash and investments during the second quarter of 2007
compared to the same period in 2006.
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Six Months Ended June 30, 2007 and 2006
Net Sales and Margins. Net sales, comprised primarily of sales of our gamma detection systems,
increased $39,000, or 1%, to $3.3 million during the first six months of 2007 from $3.2 million
during the same period in 2006. Gross margins on net sales decreased to 54% of net sales for the
first six months of 2007 compared to 58% of net sales for the same period in 2006.
The increase in net sales was the result of increased gamma detection device sales of $130,000 and
increased gamma detection device extended service contract revenue of $43,000, offset by decreases
of $116,000 in blood flow measurement device sales and $18,000 in gamma detection device
service-related revenue. Revenue from our new Bluetooth wireless probes more than offset unit
sales and price declines on our base gamma detection systems. The price at which we sell our gamma
detection products to EES is based on a percentage of the global average selling price received by
EES on sales of Neoprobe products to end customers, subject to a minimum floor price. The base
system price at which we sold neo2000 systems to EES decreased approximately 4% during the first
six months of 2007 compared to the same period in 2006.
The decrease in gross margins on net product sales was primarily due to a combination of factors
including lower margins on sales of Bluetooth probe demonstration units during the first six months
of 2007, a price decline on base systems sold by EES, higher than expected production costs on our
initial production runs of Bluetooth probes, and increased warranty estimates related to our new
Bluetooth probe products. Gross margins in the first six months of 2007 were also adversely
affected by inventory impairments of $46,000 related to our Quantix products.
Research and Development Expenses. Research and development expenses increased $262,000 or 18% to
$1.7 million during the first six months of 2007 from $1.5 million during the same period in 2006.
Research and development expenses in the first six months of 2007 included approximately $1.2
million in drug and therapy product development costs, $377,000 in gamma detection device
development costs and $207,000 in product design activities for the Quantix products. This
compares to expenses of $672,000, $347,000 and $458,000 in these relative segment categories during
the same period in 2006. The changes in each category were primarily due to (i) efforts to move
development of Lymphoseek forward offset by decreased activities related to RIGScan CR and our
therapeutic products, (ii) development of our Bluetooth wireless gamma detection probes, and (iii)
decreased product refinement activities related to the Quantix/OR, respectively.
Selling, General and Administrative Expenses. Selling, general and administrative expenses
decreased $173,000 or 11% to $1.4 million during the first six months of 2007 from $1.6 million
during the same period in 2006. The net difference was due primarily to decreases in marketing,
insurance, and other personnel-related expenses, partially offset by increased costs related to
completing the technology transfer of our Bluetooth probes into commercial manufacturing.
Other Income (Expenses). Other expenses increased $255,000 to $845,000 during the first six months
of 2007 from $590,000 during the same period in 2006. Interest expense related to the convertible
debt agreements we completed in December 2004 increased $167,000 to $887,000 during the first six
months of 2007 from $720,000 for the same period in 2006. Of this interest expense, $431,000 and
$389,000 in the first six months of 2007 and 2006, respectively, was non-cash in nature related to
the amortization of debt issuance costs and discounts resulting from the warrants and beneficial
conversion features of the convertible debt. In addition, we recorded a decrease of $84,000 in
interest income related to lower balances of cash and investments during the first six months of
2007 compared to the same period in 2006.
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Liquidity and Capital Resources
Operating Activities. Cash used in operations decreased $623,000 to $938,000 during the first six
months of 2007 compared to $1.6 million during the same period in 2006. The current ratio
decreased to 0.8:1 at June 30, 2007 from 1.6:1 at December 31, 2006. Cash and investment balances
decreased to $1.2 million at June 30, 2007 from $2.5 million at December 31, 2006, primarily as a
result of cash used in operations, mainly for research and development activities, and to service
our debt during the first six months of 2007.
Accounts receivable decreased to $1.1 million at June 30, 2007 from $1.2 million at December 31,
2006. The decrease was primarily a result of normal fluctuations in timing of purchases and
payments by EES. We expect overall receivable levels will continue to fluctuate during 2007
depending on the timing of purchases and payments by EES.
Inventory levels decreased to $1.1 million at June 30, 2007 as compared to $1.2 million at December
31, 2006. Gamma detection device materials and work-in-process inventories decreased as we
completed and sold the initial production runs of Bluetooth wireless probes, while finished device
inventories increased due to normal fluctuations in timing of sales to EES. Blood flow measurement
device materials and finished device inventories decreased, primarily due to recording inventory
impairment charges totaling $46,000 during the first six months of 2007. These decreases were
partially offset by increases in drug work-in-process inventories as we completed the second
commercial production run of Lymphoseek. We expect inventory levels to decrease during 2007 as we
convert our Bluetooth inventory into sales and reassess our gamma detection and blood flow
measurement device safety stock levels.
Investing Activities. Investing activities used $38,000 during the first six months of 2007 versus
$1.5 million provided during the same period in 2006. We received $1.5 million from maturities of
available-for-sale securities during the first six months of 2006. Capital expenditures during the
first six months of 2007 were primarily for production tools and equipment and software. Capital
expenditures during the first six months of 2006 were primarily for software. We expect our
overall capital expenditures for 2007 will be lower than for 2006.
Financing Activities. Cash used in financing activities increased $175,000 to $320,000 during the
first six months of 2007 from $145,000 during the same period in 2006. Proceeds from the issuance
of common stock were $650,000 during the first six months of 2007. Payments of common stock
offering costs were $20,000 during the first six months of 2007. Payments of notes payable were
$942,000 and $130,000 during the first six months of 2007 and 2006, respectively.
In December 2004, we completed a private placement of four-year convertible promissory notes in an
aggregate principal amount of $8.1 million 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. We modified
the convertible notes in November 2006 to eliminate the revenue and cash covenants, modify the
repayment schedule of the notes, eliminate certain anti-dilution rights, and avoid potential future
violations of the debt covenants. The notes originally bore interest at 8% per annum and were
originally due on December 13, 2008. In connection with the November 2006 amendment, we cancelled
the original notes and issued to the noteholders replacement notes which bear interest at 12% per
annum. Instead of the principal being due on December 13, 2008, the principal is now due as
follows: $500,000 due January 8, 2007; $1,250,000 due July 9, 2007; $1,750,000 due January 7,
2008; $2,000,000 due July 7, 2008; and the remaining $2,600,000 due January 7, 2009. Additionally,
as part of the amendment we agreed to use our best efforts to offer and sell equity securities with
gross proceeds of up to $10 million and apply not less than 50% of the net proceeds of any such
sales to the repayment of the principal on the notes, and to apply at least 50% of the proceeds of
any permitted asset disposition or any permitted licensing, distribution or similar strategic
alliance agreement to the repayment of principal on the notes. The notes are freely convertible
into shares of our common stock at a price of $0.40 per share. Neoprobe may force conversion of
the notes prior to their stated maturity under certain circumstances. As part of the original
transaction, we issued the investors 10,125,000 Series T warrants to purchase our common stock at
an exercise price of $0.46 per share, expiring in December 2009. In connection with the original
placement of this financing, we issued 1,600,000 Series U warrants to purchase our common stock to
the placement
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agents, containing substantially identical terms to the warrants issued to the investors. During
the first six months of 2007, we timely paid the $500,000 that was due on January 8, 2007, and made
additional principal payments totaling $325,000 related to sales of equity securities. The
convertible promissory note issued to Mr. Bupp in connection with this transaction had an
outstanding principal amount of $100,000 on June 30, 2007, and an outstanding principal amount of
$100,000 as of August 7, 2007. During the first six months of 2007 and 2006, we made interest
payments due under the note to Mr. Bupp totaling $3,000 and $4,000, respectively.
In December 2006, we entered into a common stock purchase agreement with Fusion Capital Fund II,
LLC (Fusion). We have authorized up to 12,000,000 shares of our common stock for sale to Fusion
under the agreement. Under the terms of the agreement, in December 2006, we issued 720,000 shares
of our common stock as an initial commitment fee. We are also required to issue to Fusion up to an
additional 720,000 shares of our common stock as an additional commitment fee in connection with
future purchases made by Fusion. The additional 720,000 shares will be issued pro rata as we sell
our common stock to Fusion under the agreement, resulting in a total commitment fee of 1,440,000
shares of our common stock if the entire $6.0 million in value of stock is sold. The price of
shares sold to Fusion will be determined based upon the market price of our shares without any
fixed discount at the time of each sale. Fusion shall not have the right nor the obligation to
purchase any shares of our common stock on any business day that the price of our common stock is
below $0.20. We filed a registration statement covering sales to Fusion and shares issued as
additional commitment fees under the agreement, which became effective on December 28, 2006.
During the first six months of 2007, we sold a total of 3,060,039 shares of our common stock under
the agreement, realized gross proceeds of $650,000 from such sales, and issued 78,000 shares of our
common stock to Fusion as additional commitment fees related to such sales. All of such sales and
issuances were made pursuant to the registration statement.
In July 2007, David C. Bupp (our President and CEO) and certain members of his family purchased a
$1.0 million convertible note and warrants. The note bears interest at 10% per annum during its
one-year term 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 purchasers 500,000 Series V warrants to purchase our common
stock at an exercise price of $0.31 per share, expiring in July 2012. The convertible promissory
note issued to Mr. Bupp in connection with this transaction had an outstanding principal amount of
$1.0 million as of August 15, 2007.
Our future liquidity and capital requirements will depend on a number of factors, including our
ability to raise additional capital in a timely manner through additional investment, expanded
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
near-term development priorities are to complete the Lymphoseek Phase 2 clinical study and to
subsequently commence Phase 3 clinical trials for Lymphoseek. We timely paid the mandatory
principal repayment that was due on July 9, 2007 under our amended 2004 convertible note agreement;
however, we have significant principal repayments due under this agreement starting with a January
7, 2008 payment of $1.7 million and continuing at increasing amounts approximately every six months
thereafter through early 2009 that, based on our current operating plan, will require us to raise
additional capital. Although we have a potential source of capital through our common stock
purchase agreement with Fusion and believe we have adequate capital to carry us through to the
point of commencing the Phase 3 clinical trials for Lymphoseek, it is unlikely at current stock
prices that we will be able to raise sufficient capital through this facility alone to fully fund
the Phase 3 clinical development plan. We are actively soliciting and evaluating other potential
sources of equity and debt funding; however, we may also be forced to seek relief from our current
debt obligations and/or make significant modifications to our business plan in order to meet our
obligations as currently anticipated. We cannot assure you that we will be successful in raising
additional capital through Fusion or any other sources at terms acceptable to the company, or at
all. In addition, we cannot assure you that we will be able to achieve significant product
revenues from our current or potential new products. We also cannot assure you that we will
achieve profitability again.
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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 is effective for fiscal years beginning after November 15, 2007, and is required to be adopted
by Neoprobe beginning January 1, 2008. We do not expect the adoption of SFAS No. 157 to have a
material impact on 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. Early adoption is permitted as of the beginning of a
fiscal year that begins on or before November 15, 2007, provided the entity also elects to apply
the provisions of SFAS No. 157, Fair Value Measurements. We have not completed our review of the
new guidance; however, we do not expect the adoption of SFAS No. 159 to have a material impact on
our consolidated results of operations or financial condition.
In June 2007, the FASB ratified the consensus reached by the Emerging Issues Task Force (EITF) on
Issue 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services to be Used in
Future Research and Development Activities (EITF 07-3). The scope of EITF 07-3 is focused on the
accounting for non-refundable advance payments for goods that will be used or services that will be
performed in future research and development activities. The FASB concluded that these types of
payments should be deferred and capitalized until the goods have been delivered or the related
services have been rendered. EITF 07-3 is effective for financial statements issued for fiscal
years beginning after December 15, 2007, and interim periods within those fiscal years. We do not
expect EITF 07-3 to have a material effect on our consolidated results of operations or financial
condition.
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 8% of total revenues for the first six months of 2007 and are expected to increase in
the future. 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.
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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. Effective January 1, 2006, we adopted SFAS No. 123(R),
Share-Based Payment, which is a revision of SFAS No. 123, Accounting for Stock-Based
Compensation. SFAS No. 123(R) supersedes APB Opinion No. 25, Accounting for Stock Issued
to Employees, and amends SFAS No. 95, Statement of Cash Flows. 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 used the modified prospective application method in adopting
SFAS No. 123 (R). 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. Prior to the adoption of SFAS No. 123(R), we followed the guidance in APB No. 25
which resulted in disclosure only of the financial impact of stock options. Financial
statements of the company for periods prior to January 1, 2006 do not reflect any recorded
stock-based compensation expense. In adopting SFAS No. 123(R), we made no modifications to
outstanding stock options, nor do we have any other outstanding share-based payment
instruments subject to SFAS No. 123(R). Based in part on the anticipated adoption of SFAS
No. 123(R), the company generally reduced number of stock options issued by individual in
2005 and shortened the vesting periods, with a portion of the options vesting immediately
and the remainder vesting over a two-year period as compared to our previous practice of
issuing stock options that vested over a three-year period. We will continue to evaluate
compensation trends and may further revise our option granting practices in future years. |
|
|
|
|
Inventory Valuation. We value our inventory at the lower of cost (first-in, first-out
method) or market. Our valuation reflects our estimates of excess, slow moving and
obsolete inventory as well as inventory with a carrying value in excess of its net
realizable value. Write-offs are recorded when product is removed from saleable inventory.
We review inventory on hand at least quarterly and record provisions for excess and
obsolete inventory based on several factors, including current assessment of future product
demand, anticipated release of new products into the market, historical experience and
product expiration. Our industry is characterized by rapid product development and
frequent new product introductions. Uncertain timing of product approvals, variability in
product launch strategies, product recalls and variation in product utilization all impact
the estimates related to excess and obsolete inventory. |
51
|
|
|
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 June 30, 2007, the most significant long-lived assets on our balance sheet
relate to assets recorded in connection with the acquisition of Cardiosonix and gamma
detection device patents related to ILM. The recoverability of these assets is based on the
financial projections and models related to the future sales success of Cardiosonix
products and the continuing success of our gamma detection product line. As such, these
assets could be subject to significant adjustment should the Cardiosonix technology not be
successfully commercialized or the sales amounts in our current projections not be realized. |
|
|
|
|
Product Warranty. We warrant our products against defects in design, materials, and
workmanship generally for a period of one year from the date of sale to the end customer.
Our accrual for warranty expenses is adjusted periodically to reflect actual experience.
EES also reimburses us for a portion of warranty expense incurred based on end customer
sales they make during a given fiscal year. |
Other Items Affecting Financial Condition
At December 31, 2006, we had deferred tax assets in the U.S. related to net operating tax loss
carryforwards and tax credit carryforwards of approximately $34.9 million and $4.7 million,
respectively, available to offset or reduce future income tax liability, if any, through 2026.
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.
DESCRIPTION OF PROPERTY
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 $7,900 during 2007. 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, but that 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.
52
OUR MANAGEMENT
Directors, Executive Officers, Promoters and Control Persons
Directors
Directors whose terms continue until the 2008 Annual Meeting:
Carl J. Aschinger, Jr., age 68, 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 and Chief Executive Officer
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 67, 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 Sr. Medical Director of
United HealthCare 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. 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 68, 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.
Directors whose terms continue until the 2009 Annual Meeting:
Kirby I. Bland, M.D., age 65, 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.
53
J. Frank Whitley, Jr., age 65, 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 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 55, has served as a director of our company since January 2002. Mr. Avital is a
partner and general manager of MaAragim 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 58, 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 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.
Director Independence
Our Board of Directors has adopted the definition of independence as described under Section 301
of the Sarbanes-Oxley Act of 2002 (Sarbanes-Oxley), 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 and Whitley, and Drs. Bland and Johnson meet the
independence requirements.
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
|
|
|
47 |
|
|
Vice President, Manufacturing Operations |
|
Rodger A. Brown
|
|
|
56 |
|
|
Vice President, Regulatory Affairs and
Quality Assurance |
|
Brent L. Larson
|
|
|
44 |
|
|
Vice President, Finance; Chief Financial
Officer; Treasurer and Secretary |
|
Douglas L. Rash
|
|
|
64 |
|
|
Vice President, Marketing |
54
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 Operations 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.
Brent L. Larson has served as Vice President, Finance and Chief Financial Officer of our company
since February 1999. 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 Neoprobes 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.
Family Relationships
There are no family relationships among the directors and executive officers of the company.
Code of 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.
55
Executive Compensation
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 Executive Officers) for the last two fiscal years.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(b) |
|
(c) |
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Option |
|
All Other |
|
Total |
Name and Principal Position |
|
Year |
|
Salary |
|
Bonus |
|
Awards |
|
Compensation |
|
Compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Carl M. Bosch (d) |
|
|
2006 |
|
|
$ |
160,000 |
|
|
$ |
6,000 |
|
|
$ |
16,175 |
|
|
$ |
4,558 |
|
|
$ |
186,733 |
|
Vice
President,
Research and Development |
|
|
2005 |
|
|
|
149,000 |
|
|
|
7,500 |
|
|
|
|
|
|
|
4,107 |
|
|
|
160,607 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David C. Bupp |
|
|
2006 |
|
|
$ |
305,000 |
|
|
$ |
20,000 |
|
|
$ |
60,006 |
|
|
$ |
8,099 |
|
|
$ |
393,105 |
|
President
and
Chief Executive Officer |
|
|
2005 |
|
|
|
290,000 |
|
|
|
45,000 |
|
|
|
|
|
|
|
7,789 |
|
|
|
342,789 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brent L. Larson |
|
|
2006 |
|
|
$ |
160,000 |
|
|
$ |
5,000 |
|
|
$ |
16,175 |
|
|
$ |
4,576 |
|
|
$ |
185,751 |
|
Vice
President, Finance and
Chief Financial Officer |
|
|
2005 |
|
|
|
149,000 |
|
|
|
7,500 |
|
|
|
|
|
|
|
4,113 |
|
|
|
160,613 |
|
|
|
|
(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 123(R). Assumptions made in the valuation of stock option awards are
disclosed in Item 1(l) of the Notes to the Consolidated Financial Statements in our Annual
Report on Form 10-KSB for the fiscal year ended December 31, 2006. Prior to 2006, the company
accounted for stock option awards under APB Opinion No. 25s intrinsic value method and, as
such, generally recognized no compensation cost for employee stock options. |
|
(c) |
|
Amount represents life insurance premiums paid during the fiscal year for the benefit of the
Named Executive Officers 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 employees contribution,
up to five percent of the employees 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. |
|
(d) |
|
On April 25, 2007, Carl M. Bosch resigned as an officer of the company. |
56
Outstanding Equity Awards at Fiscal Year End
The following table presents certain information concerning outstanding equity awards held by the
Named Executive Officers as of December 31, 2006.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities Underlying |
|
|
|
|
|
|
|
|
Unexercised Options (#) |
|
Option Exercise |
|
Option Expiration |
|
|
Name |
|
Exercisable |
|
Unexercisable |
|
Price |
|
Date |
|
Note |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Carl M. Bosch |
|
|
10,000 |
|
|
|
|
|
|
$ |
1.50 |
|
|
|
9/28/2008 |
|
|
|
(b) , |
(n) |
|
|
|
20,000 |
|
|
|
|
|
|
$ |
1.25 |
|
|
|
2/11/2009 |
|
|
|
(c) , |
(n) |
|
|
|
45,000 |
|
|
|
|
|
|
$ |
0.50 |
|
|
|
1/4/2010 |
|
|
|
(d) , |
(n) |
|
|
|
45,000 |
|
|
|
|
|
|
$ |
0.41 |
|
|
|
1/3/2011 |
|
|
|
(e) , |
(n) |
|
|
|
50,000 |
|
|
|
|
|
|
$ |
0.42 |
|
|
|
1/7/2012 |
|
|
|
(f) , |
(n) |
|
|
|
40,000 |
|
|
|
|
|
|
$ |
0.14 |
|
|
|
1/15/2013 |
|
|
|
(g) , |
(n) |
|
|
|
30,000 |
|
|
|
|
|
|
$ |
0.13 |
|
|
|
2/15/2013 |
|
|
|
(h) , |
(n) |
|
|
|
46,667 |
|
|
|
23,333 |
|
|
$ |
0.30 |
|
|
|
1/7/2014 |
|
|
|
(i) , |
(n) |
|
|
|
33,333 |
|
|
|
16,667 |
|
|
$ |
0.49 |
|
|
|
7/28/2014 |
|
|
|
(j) , |
(n) |
|
|
|
33,333 |
|
|
|
16,667 |
|
|
$ |
0.39 |
|
|
|
12/10/2014 |
|
|
|
(k) , |
(n) |
|
|
|
26,667 |
|
|
|
13,333 |
|
|
$ |
0.26 |
|
|
|
12/27/2015 |
|
|
|
(l) , |
(n) |
|
|
|
|
|
|
|
50,000 |
|
|
$ |
0.27 |
|
|
|
12/15/2016 |
|
|
|
(m) , |
(n) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David C. Bupp |
|
|
180,000 |
|
|
|
|
|
|
$ |
0.50 |
|
|
|
1/4/2010 |
|
|
|
(d |
) |
|
|
|
180,000 |
|
|
|
|
|
|
$ |
0.41 |
|
|
|
1/3/2011 |
|
|
|
(e |
) |
|
|
|
180,000 |
|
|
|
|
|
|
$ |
0.42 |
|
|
|
1/7/2012 |
|
|
|
(f |
) |
|
|
|
100,000 |
|
|
|
|
|
|
$ |
0.14 |
|
|
|
1/15/2013 |
|
|
|
(g |
) |
|
|
|
70,000 |
|
|
|
|
|
|
$ |
0.13 |
|
|
|
2/15/2013 |
|
|
|
(h |
) |
|
|
|
100,000 |
|
|
|
50,000 |
|
|
$ |
0.30 |
|
|
|
1/7/2014 |
|
|
|
(i |
) |
|
|
|
100,000 |
|
|
|
50,000 |
|
|
$ |
0.49 |
|
|
|
7/28/2014 |
|
|
|
(j |
) |
|
|
|
133,333 |
|
|
|
66,667 |
|
|
$ |
0.39 |
|
|
|
12/10/2014 |
|
|
|
(k |
) |
|
|
|
133,333 |
|
|
|
66,667 |
|
|
$ |
0.26 |
|
|
|
12/27/2015 |
|
|
|
(l |
) |
|
|
|
|
|
|
|
300,000 |
|
|
$ |
0.27 |
|
|
|
12/15/2016 |
|
|
|
(m |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brent L. Larson |
|
|
7,200 |
|
|
|
|
|
|
$ |
5.63 |
|
|
|
1/28/2008 |
|
|
|
(a |
) |
|
|
|
25,000 |
|
|
|
|
|
|
$ |
1.50 |
|
|
|
9/28/2008 |
|
|
|
(b |
) |
|
|
|
25,000 |
|
|
|
|
|
|
$ |
1.25 |
|
|
|
2/11/2009 |
|
|
|
(c |
) |
|
|
|
60,000 |
|
|
|
|
|
|
$ |
0.50 |
|
|
|
1/4/2010 |
|
|
|
(d |
) |
|
|
|
60,000 |
|
|
|
|
|
|
$ |
0.41 |
|
|
|
1/3/2011 |
|
|
|
(e |
) |
|
|
|
50,000 |
|
|
|
|
|
|
$ |
0.42 |
|
|
|
1/7/2012 |
|
|
|
(f |
) |
|
|
|
40,000 |
|
|
|
|
|
|
$ |
0.14 |
|
|
|
1/15/2013 |
|
|
|
(g |
) |
|
|
|
30,000 |
|
|
|
|
|
|
$ |
0.13 |
|
|
|
2/15/2013 |
|
|
|
(h |
) |
|
|
|
46,667 |
|
|
|
23,333 |
|
|
$ |
0.30 |
|
|
|
1/7/2014 |
|
|
|
(i |
) |
|
|
|
33,333 |
|
|
|
16,667 |
|
|
$ |
0.49 |
|
|
|
7/28/2014 |
|
|
|
(j |
) |
|
|
|
33,333 |
|
|
|
16,667 |
|
|
$ |
0.39 |
|
|
|
12/10/2014 |
|
|
|
(k |
) |
|
|
|
26,667 |
|
|
|
13,333 |
|
|
$ |
0.26 |
|
|
|
12/27/2015 |
|
|
|
(l |
) |
|
|
|
|
|
|
|
50,000 |
|
|
$ |
0.27 |
|
|
|
12/15/2016 |
|
|
|
(m |
) |
|
|
|
(a) |
|
Options were granted 1/28/1998 and vested as to one-third immediately and on each of the
first two anniversaries of the date of grant. |
|
(b) |
|
Options were granted 9/28/1998 and vested as to one-thirtieth (1/30) per month for thirty
(30) months after the date of grant. |
|
(c) |
|
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. |
|
(d) |
|
Options were granted 1/4/2000 and vested as to one-third on each of the first three
anniversaries of the date of grant. |
|
(e) |
|
Options were granted 1/3/2001 and vested as to one-third on each of the first three
anniversaries of the date of grant. |
|
(f) |
|
Options were granted 1/7/2002 and vested as to one-third on each of the first three
anniversaries of the date of grant. |
|
(g) |
|
Options were granted 1/15/2003 and vested as to one-third on each of the first three
anniversaries of the date of grant. |
|
(h) |
|
Options were granted 2/15/2003 and vested as to one-third on each of the first three
anniversaries of the date of grant. |
|
(i) |
|
Options were granted 1/7/2004 and vest as to one-third on each of the first three
anniversaries of the date of grant. |
|
(j) |
|
Options were granted 7/28/2004 and vest as to one-third on each of the first three
anniversaries of the date of grant. |
|
(k) |
|
Options were granted 12/10/2004 and vest as to one-third on each of the first three
anniversaries of the date of grant. |
|
(l) |
|
Options were granted 12/27/2005 and vest as to one-third immediately and on each of the first
two anniversaries of the date of grant. |
|
(m) |
|
Options were granted 12/15/2006 and vest as to one-third on each of the first three
anniversaries of the date of grant. |
|
(n) |
|
On April 25, 2007, Carl M. Bosch submitted his resignation as an officer of the company,
to be effective May 10, 2007. Under the terms of the Plans, all unexercised options are
forfeited as of the date of termination. All of these options have therefore expired. |
57
Employment and Other Compensation Agreements
Our Named Executive Officers are employed under employment agreements of varying terms as
outlined below. In addition, the Compensation, Nominating and Governance Committee of the Board of
Directors will, on an annual basis, review the performance of our company and may pay bonuses to
our executives as the Compensation, Nominating and Governance Committee deems appropriate, in its
discretion. Such review and bonus will be consistent with any bonus plan adopted by the
Compensation, Nominating and Governance Committee that covers Mr. Bupp as well as the executive
officers of our company generally.
David C. Bupp
Employment Agreement. David C. Bupp is employed under a thirty-six (36) month employment agreement
effective January 1, 2007. The employment agreement provides for an annual base salary of
$305,000.
The Board of Directors 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 Compensation, Nominating and Governance
Committee that covers the executive officers of our company generally.
If a change in control occurs with respect to our company and the employment of Mr. Bupp is
concurrently or subsequently terminated:
|
|
|
by our 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. Bupps employment agreement; or |
|
|
|
|
by the resignation of Mr. Bupp because his title, authority, responsibilities or
compensation have materially diminished, a material adverse change occurs in his
working conditions or we breach the agreement; |
then, Mr. Bupp will be paid a severance payment of $762,500 (less amounts paid as Mr. Bupps salary
and benefits that continue for the remaining term of the agreement if his employment is terminated
without cause).
For purposes of Mr. Bupps employment agreement, a change in control includes:
|
|
|
the acquisition, directly or indirectly, by a person (other than our company or an
employee benefit plan established by the Board of Directors) of beneficial ownership of
thirty percent (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 eighty percent (80%)
or more of the voting power for all purposes of the surviving or resulting corporation;
or |
58
|
|
|
our stockholders approve a transfer of substantially all of our assets to another
person other than a transfer to a transferee, eighty percent (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 thirty-six (36) months or the full term of the agreement.
Brent L. Larson
Employment Agreement. Brent L. Larson is employed under a twenty-four (24) month employment
agreement effective January 1, 2007. The employment agreement provides for an annual base salary
of $170,000.
The Compensation, Nominating and Governance Committee will, on an annual basis, review the
performance of our company and of Mr. Larson and we may pay a bonus to Mr. Larson as we deem
appropriate, in our discretion. Such review and bonus will be consistent with any bonus plan
adopted by the Compensation, Nominating and Governance Committee that covers the executive officers
of our company generally.
If a change in control occurs with respect to our company and the employment of Mr. Larson is
concurrently or subsequently terminated:
|
|
|
by our company without cause (cause is defined as any willful breach of a material duty
by Mr. Larson 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. Larsons employment agreement; or |
|
|
|
|
by the resignation of Mr. Larson because his title, authority, responsibilities or
compensation have materially diminished, a material adverse change occurs in his working
conditions or we breach the agreement; |
then, Mr. Larson will be paid a severance payment of $340,000 and will continue his benefits for
the longer of twelve (12) months or the remaining term of his employment agreement.
For purposes of Mr. Larsons employment agreement, a change in control includes:
|
|
|
the acquisition, directly or indirectly, by a person (other than our company or an
employee benefit plan established by the Board of Directors) of beneficial ownership of
thirty percent (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 eighty percent (80%) or more of the
voting power for all purposes of the surviving or resulting corporation; or |
59
|
|
|
our stockholders approve a transfer of substantially all of the assets of our company to
another person other than a transfer to a transferee, eighty percent (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. Larson will be paid a severance amount of $170,000 if his employment is terminated at the
end of his employment agreement or without cause. If Mr. Larson is terminated without cause, his
benefits will continue for the longer of twelve (12) months or the full term of the agreement.
Carl M. Bosch
Employment Agreement. Carl M. Bosch was employed under a twenty-four (24) month employment
agreement effective January 1, 2007. The employment agreement provided for an annual base salary
of $170,000. On April 25, 2007, Mr. Bosch submitted his resignation as an officer of the company.
The Compensation, Nominating and Governance Committee reviewed the performance of our company and
of Mr. Bosch on an annual basis and paid a bonus to Mr. Bosch as we deemed appropriate, in our
discretion. Such review and bonus was consistent with any bonus plan adopted by the Compensation,
Nominating and Governance Committee that covers the executive officers of our company generally.
The terms of Mr. Boschs employment agreement were substantially identical to those of Mr. Larsons
employment agreement.
Compensation of Directors
Non-employee directors received a quarterly retainer of $3,000 and earned $1,000 per board meeting
attended in person or $500 per telephonic board meeting. The Chairman of the Board and the
Chairman of the Audit Committee each received an additional quarterly retainer of $1,250 for their
services in those capacities during 2006. The Chairman of the Audit Committee also earned an
additional $500 per Audit Committee meeting attended in person or $250 per telephonic Audit
Committee meeting. In addition, members of the Audit Committee received a quarterly retainer of
$625 and earned $250 per Audit Committee meeting attended, whether in person or telephonically. We
also reimbursed non-employee directors for travel expenses for meetings attended during 2006.
Each non-employee director also received 20,000 options to purchase common stock as a part of our
annual stock incentive grants. Options granted to purchase common stock vest on the first
anniversary of the date of grant and have an exercise price equal to not less than the closing
market price of common stock at the date of grant. Directors who are also officers or employees of
Neoprobe do not receive any compensation for their services as directors.
60
The following table sets forth certain information concerning the compensation of Directors for the
fiscal year ended December 31, 2006.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
|
|
|
|
|
Fees Earned |
|
|
|
|
|
|
or Paid in |
|
(b) |
|
Total |
Name |
|
Cash |
|
Option Awards |
|
Compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
Carl J. Aschinger, Jr. (c) |
|
$ |
19,750 |
|
|
$ |
9,099 |
|
|
$ |
28,849 |
|
Reuven Avital (d) |
|
|
20,250 |
|
|
|
9,099 |
|
|
|
29,349 |
|
Kirby I. Bland, M.D. (e) |
|
|
17,000 |
|
|
|
9,988 |
|
|
|
26,988 |
|
Julius R. Krevans, M.D. (f) |
|
|
21,500 |
|
|
|
10,366 |
|
|
|
31,866 |
|
Fred B. Miller (g) |
|
|
23,500 |
|
|
|
10,366 |
|
|
|
33,866 |
|
J. Frank Whitley, Jr. (h) |
|
|
20,250 |
|
|
|
9,099 |
|
|
|
29,349 |
|
|
|
|
(a) |
|
Amount represents fees earned during the fiscal year ended December 31, 2006 (i.e., the year
to which the service relates). Quarterly retainers are paid during the quarter in which they
are earned. 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 123(R). Assumptions made in the valuation of stock option awards are
disclosed in Item 1(l) of the Notes to the Consolidated Financial Statements in our Annual
Report on Form 10-KSB for the fiscal year ended December 31, 2006. Prior to 2006, the company
accounted for stock option awards under APB Opinion No. 25s intrinsic value method and, as
such, generally recognized no compensation cost for employee stock options. |
|
(c) |
|
As of December 31, 2006, Mr. Aschinger held options to purchase a total of 130,000 shares of
our common stock. |
|
(d) |
|
As of December 31, 2006, Mr. Avital held options to purchase a total of 175,000 shares of our
common stock. |
|
(e) |
|
As of December 31, 2006, Dr. Bland held options to purchase a total of 160,000 shares of our
common stock. |
|
(f) |
|
Effective July 26, 2007, Dr. Krevans retired from his position as Chairman and as a director
of the company. As of December 31, 2006, Dr. Krevans held options to purchase a total of
410,000 shares of our common stock. |
|
(g) |
|
As of December 31, 2006, Mr. Miller held options to purchase a total of 235,000 shares of our
common stock. |
|
(h) |
|
As of December 31, 2006, Mr. Whitley held options to purchase a total of 265,000 shares of
our common stock. |
61
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Security Ownership of Principal Stockholders, Directors, Nominees and Executive Officers and
Related Stockholder Matters
The following table sets forth, as of August 31, 2007, 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 percent of our outstanding shares of common stock, (ii) each
director or nominee for director of our company, (iii) each of the Named Executive Officers (see
Executive Compensation Summary Compensation Table), and (iv) our directors and executive
officers as a group.
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
|
|
Shares |
|
|
|
|
Beneficially |
|
Percent |
Beneficial Owner |
|
Owned(*) |
|
of Class(**) |
Carl J. Aschinger, Jr. |
|
|
236,200 |
(a) |
|
|
(m |
) |
Reuven Avital |
|
|
294,256 |
(b) |
|
|
(m |
) |
Kirby I. Bland |
|
|
140,000 |
(c) |
|
|
(m |
) |
Carl M. Bosch |
|
|
103,845 |
(d) |
|
|
(m |
) |
David C. Bupp |
|
|
6,672,740 |
(e) |
|
|
9.5 |
% |
Owen E. Johnson |
|
|
|
(f) |
|
|
(m |
) |
Brent L. Larson |
|
|
641,429 |
(g) |
|
|
1.0 |
% |
Fred B. Miller |
|
|
296,000 |
(h) |
|
|
(m |
) |
J. Frank Whitley, Jr. |
|
|
246,000 |
(i) |
|
|
(m |
) |
All
directors and officers as a group (12 persons) |
|
|
9,289,969 |
(j)(k) |
|
|
12.9 |
% |
|
|
|
|
|
|
|
|
|
Great Point
Partners, L.P.
2 Pickwick Plaza, Suite 450
Greenwich, CT 06830 |
|
|
25,309,005 |
(l) |
|
|
29.0 |
% |
|
|
|
(*) |
|
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 persons household. |
|
(**) |
|
Percent of class is calculated on the basis of the number of shares outstanding on August 31,
2007, plus the number of shares the person has the right to acquire within 60 days of August
31, 2007. |
|
(a) |
|
This amount includes 110,000 shares issuable upon exercise of options which are exercisable
within 60 days, but does not include 20,000 shares issuable upon exercise of options which are
not exercisable within 60 days. |
62
|
|
|
(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 155,000
shares issuable upon exercise of options which are exercisable within 60 days but does not
include 20,000 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 MaAragim Enterprise Ltd. (MaAragim), another investment fund under the
management and control of Mr. Avital. On February 28, 2005, MaAragim 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
MaAragim, 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 MaAragim based on the satisfaction of certain developmental milestones on
December 30, 2002, associated with our acquisition of Cardiosonix. |
|
(c) |
|
This amount includes 140,000 shares issuable upon exercise of options which are exercisable
within 60 days but does not include 20,000 shares issuable upon exercise of options which are
not exercisable within 60 days. |
|
(d) |
|
On April 25, 2007, Carl M. Bosch submitted his resignation as an officer of the company. This
amount includes 63,845 shares remaining in Mr. Boschs account in the 401(k) Plan. |
|
(e) |
|
This amount includes 1,276,666 shares issuable upon exercise of options which are exercisable
within 60 days, 1,195,000 warrants held by Mr. Bupp which are exercisable within 60 days, a
promissory note convertible into 250,000 shares of our common stock, a promissory note
convertible into 3,225,806 shares of our common stock, 175,511 shares that are held by Mr.
Bupps wife for which he disclaims beneficial ownership, 20,000 warrants held by Mr. Bupps
wife for which he disclaims beneficial ownership which are exercisable within 60 days and
91,257 shares in Mr. Bupps account in the 401(k) Plan, but it does not include 483,334 shares
issuable upon exercise of options which are not exercisable within 60 days. |
|
(f) |
|
This amount does not include 20,000 shares issuable upon the exercise of options which are
not exercisable within 60 days. |
|
(g) |
|
This amount includes 472,200 shares issuable upon exercise of options which are exercisable
within 60 days and 64,229 shares in Mr. Larsons account in the 401(k) Plan, but it does not
include 96,667 shares issuable upon exercise of options which are not exercisable within 60
days. |
|
(h) |
|
This amount includes 215,000 shares issuable upon exercise of options which are exercisable
within 60 days and 31,000 shares held by Mr. Millers wife for which he disclaims beneficial
ownership, but does not include 20,000 shares issuable upon the 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, but does not include 20,000 shares issuable upon exercise of options which are
not exercisable within 60 days. |
|
(j) |
|
This amount includes 3,200,033 shares issuable upon exercise of options which are exercisable
within 60 days and 240,663 shares held in the 401(k) Plan on behalf of certain officers and
former officers, but it does not include 890,001 shares issuable upon the exercise of options
which are not exercisable within 60 days. The company itself is the administrator of the
Neoprobe 401(k) Plan and may, as such, share investment power over common stock held in such
plan. The administrator disclaims any beneficial ownership of shares held by the 401(k) Plan.
The 401(k) Plan holds an aggregate total of 444,536 shares of common stock. |
|
(k) |
|
The address of all directors and executive offices is c/o Neoprobe Corporation, 425 Metro
Place North, Suite 300, Dublin, Ohio 43017-1367. |
|
(l) |
|
This amount includes 8,387,500 shares issuable upon conversion of promissory notes in the
principal amount of $3,355,000 held by Biomedical Value Fund, L.P. (BVF) that are convertible
within 60 days, 6,862,500 shares issuable upon conversion of promissory notes in the original
principal amount of $2,745,000 held by Biomedical Offshore Value Fund, Ltd. (BOVF) that are
convertible within 60 days, 5,500,000 warrants held by BVF that are exercisable within 60 days
and 4,500,000 warrants held by BOVF that are exercisable within 60 days. BVF and BOVF are
investment funds managed by Great Point Partners, LLP. |
|
(m) |
|
Less than one percent. |
63
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
In December 2004, we completed a private placement of four-year convertible promissory notes in an
aggregate principal amount of $8.1 million 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. We modified
the convertible notes on November 30, 2006, to eliminate the revenue and cash covenants, modify the
repayment schedule of the notes, eliminate certain anti-dilution rights, and avoid potential future
violations of the debt covenants. The notes originally bore interest at 8% per annum and were
originally due on December 13, 2008. In connection with the November 30, 2006 amendment, we
cancelled the original notes and issued to the noteholders replacement notes which bear interest at
12% per annum. Instead of the notes being due on December 13, 2008, the principal is now due as
follows: $500,000 due January 8, 2007; $1,250,000 due July 9, 2007; $1,750,000 due January 7, 2008;
$2,000,000 due July 7, 2008; and the remaining $2,600,000 due January 7, 2009. Additionally, as
part of the amendment we agreed to use our best efforts to offer and sell equity securities with
gross proceeds of up to $10 million and apply not less than 50% of the net proceeds of any such
sales to the repayment of the principal on the notes, and to apply at least 50% of the proceeds of
any permitted asset disposition or any permitted licensing, distribution or similar strategic
alliance agreement to the repayment of principal on the notes. The notes are freely convertible
into shares of our common stock at a price of $0.40 per share. Neoprobe may force conversion of
the notes prior to their stated maturity under certain circumstances. As part of the original
transaction, we issued the investors 10,125,000 Series T warrants to purchase our common stock at
an exercise price of $0.46 per share, expiring in December 2009. In connection with the original
placement of this financing, we issued 1,600,000 Series U warrants to purchase our common stock to
the placement agents, containing substantially identical terms to the warrants issued to the
investors. The convertible promissory note issued to Mr. Bupp in connection with this transaction
had an outstanding principal amount of $100,000 on December 31, 2006, and at the end of the six
month period ended June 30, 2007. This convertible promissory note also had an outstanding
principal amount of $100,000 on August 31, 2007. The largest aggregate amount of principal
outstanding on the convertible promissory note issued to Mr. Bupp was $100,000 during the fiscal
year ended December 31, 2006, and for the six month period ended June 30, 2007. We made interest
payments due under the convertible promissory note to Mr. Bupp totaling $8,333 during the fiscal
year ended December 31, 2006, and $4,000 during the sixth month period ended June 30, 2007.
In July 2007, David C. Bupp (our President and CEO) and certain members of his family purchased a
$1.0 million convertible note and warrants. The note bears interest at 10% per annum during its
one-year term 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 purchasers 500,000 Series V warrants to purchase our common
stock at an exercise price of $0.31 per share, expiring in July 2012. The convertible promissory
note issued to Mr. Bupp and certain members of his family had an outstanding principal amount of
$1.0 million on August 31, 2007. As of August 31, 2007, we have made no interest payments due under
the convertible promissory note. The largest aggregate amount of principal outstanding on the
convertible promissory note was $1.0 million during the period beginning July 1, 2007, and ending
August 31, 2007.
64
DESCRIPTION OF CAPITAL STOCK
Authorized and Issued Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares at August 31, 2007 |
Title of Class |
|
Authorized |
|
Outstanding |
|
Reserved |
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock, $0.001 par
value per share |
|
|
150,000,000 |
|
|
|
64,779,458 |
|
|
|
41,470,655 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock, $0.001
par value per share |
|
|
5,000,000 |
|
|
|
0 |
|
|
|
5,000,000 |
|
Common Stock
Dividends
Each share of common stock is entitled to receive an equal dividend, if one is declared, which is
unlikely. We have never paid dividends on our common stock and do not intend to do so in the
foreseeable future. We intend to retain any future earnings to finance our growth. See Risk
Factors.
Liquidation
If our company is liquidated, any assets that remain after the creditors are paid, and the owners
of preferred stock receive any liquidation preferences, will be distributed to the owners of our
common stock pro-rata.
Voting Rights
Each share of our common stock entitles the owner to one vote. There is no cumulative voting. A
simple majority can elect all of the directors at a given meeting and the minority would not be
able to elect any directors at that meeting.
Preemptive Rights
Owners of our common stock have no preemptive rights. We may sell shares of our common stock to
third parties without first offering it to current stockholders.
Redemption Rights
We do not have the right to buy back shares of our common stock except in extraordinary
transactions such as mergers and court approved bankruptcy reorganizations. Owners of our common
stock do not ordinarily have the right to require us to buy their common stock. We do not have a
sinking fund to provide assets for any buy back.
Conversion Rights
Shares of our common stock can not be converted into any other kind of stock except in
extraordinary transactions, such as mergers and court approved bankruptcy reorganizations.
Preferred Stock
Our certificate of incorporation authorizes our board of directors to issue blank check preferred
stock. The board of directors may divide this stock into series and set their rights. To date, our
board of directors has created two series of preferred stock. The board of directors had designated
500,000 shares of preferred stock as Series A Junior Participating Preferred Stock. However, upon
the August 28, 2005, expiration of our companys Stockholder Rights Plan the board of directors
determined that our company had no further reason to have the Series A Junior Participating
Preferred Stock authorized in our companys certificate of incorporation. Accordingly, our company
filed a certificate of elimination removing
65
from the companys certificate of incorporation all reference to the Series A Junior Participating
Preferred Stock. Additionally, The board of directors had previously designated 63,000 shares of
preferred stock as 5% Series B Convertible Preferred Stock, but these shares have been redeemed and
returned to the status of unissued shares. The board of directors may, without prior stockholder
approval, issue any of the 5,000,000 shares of 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. Although we have no present intention of issuing any shares
of preferred stock, our board of directors may do so in the future. If we do issue preferred stock
in the future, it could have a dilutive effect upon the common stock. See Risk Factors.
Anti-Takeover Charter Provisions and Laws
Some features of our certificate of incorporation and by-laws and the Delaware General Corporation
Law (DGCL), which are further described below, 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.
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. See Risk Factors.
Limitations on Stockholder Actions
Our certificate of incorporation provides that stockholder action may only be taken at a meeting of
the stockholders. Thus, an owner of a majority of the voting power could not take action to replace
the board of directors, or any class of directors, without a meeting of the stockholders, nor could
he amend the by-laws without presenting the amendment to a meeting of the stockholders.
Furthermore, under the provisions of the certificate of incorporation and by-laws, only the board
of directors has the power to call a special meeting of stockholders. Therefore, a stockholder,
even one who owns a majority of the voting power, may neither replace sitting board of directors
members nor amend the by-laws before the next annual meeting of stockholders.
Advance Notice Provisions
Our by-laws establish advance notice procedures for the nomination of candidates for election as
directors by stockholders, as well as for other stockholder proposals to be considered at annual
meetings. Generally, we must receive a notice of intent to nominate a director or raise any other
matter at a stockholder meeting not less than 120 days before the first anniversary of the mailing
of our proxy statement for the previous years annual meeting. The notice must contain required
information concerning the person to be nominated or the matters to be brought before the meeting
and concerning the stockholder submitting the proposal.
Delaware Law
We are incorporated in Delaware, and as such are subject to Section 203 of the DGCL, which provides
that a corporation may not engage in any business combination with an interested stockholder during
the three years after he becomes an interested stockholder unless:
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|
the corporations board of directors approved in advance either the business
combination or the transaction which resulted in the stockholder becoming an interested
stockholder; |
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|
the interested stockholder owned at least 85 percent of the corporations voting
stock at the time the transaction commenced; or |
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|
|
the business combination is approved by the corporations board of directors and the
affirmative vote of at least two-thirds of the voting stock which is not owned by the
interested stockholder. |
66
An interested stockholder is anyone who owns 15 percent or more of a corporations voting stock, or
who is an affiliate or associate of the corporation and was the owner of 15 percent or more of the
corporations voting stock at any time within the previous three years; and the affiliates and
associates of any those persons. Section 203 of the DGCL makes it more difficult for an interested
stockholder to implement various business combinations with our company for a three-year period,
although our stockholders may vote to exclude it from the laws restrictions.
Classified Board
Our certificate of incorporation and by-laws divide our board of directors into three classes with
staggered three year terms. There are currently seven directors, three in one class and two in each
of two additional classes. At each annual meeting of stockholders, the terms of one class of
directors will expire and the newly nominated directors of that class will be elected for a term of
three years. The board of directors will be able to determine the total number of directors
constituting the full board of directors and the number of directors in each class, but the total
number of directors may not exceed 17 nor may the number of directors in any class exceed six.
Subject to these rules, the classes of directors need not have equal numbers of members. No
reduction in the total number of directors or in the number of directors in a given class will have
the effect of removing a director from office or reducing the term of any then sitting director.
Stockholders may only remove directors for cause. If the board of directors increases the number of
directors in a class, it will be able to fill the vacancies created for the full remaining term of
a director in that class even though the term may extend beyond the next annual meeting. The
directors will also be able to fill any other vacancies for the full remaining term of the director
whose death, resignation or removal caused the vacancy.
A person who has a majority of the voting power at a given meeting will not in any one year be able
to replace a majority of the directors since only one class of the directors will stand for
election in any one year. As a result, at least two annual meeting elections will be required to
change the majority of the directors by the requisite vote of stockholders. The purpose of
classifying the board of directors is to provide for a continuing body, even in the face of a
person who accumulates a sufficient amount of voting power, whether by ownership or proxy or a
combination, to have a majority of the voting power at a given meeting and who may seek to take
control of our company without paying a fair premium for control to all of the owners of our common
stock. This will allow the board of directors time to negotiate with such a person and to protect
the interests of the other stockholders who may constitute a majority of the shares not actually
owned by that person. However, it may also 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.
67
ACQUISITION OF COMMON STOCK BY SELLING STOCKHOLDERS
During April 2003, we completed a bridge loan agreement with our President and CEO, David Bupp.
Under the terms of the agreement, Mr. Bupp advanced us $250,000. In consideration for the loan, we
issued a note to Mr. Bupp in the principal amount of $250,000. The note was secured by general
assets of the company, excluding accounts receivable. In addition, we issued Mr. Bupp 375,000
warrants to purchase our common stock at an exercise price of $0.13 per share, expiring in April
2008. The note bore interest at 8.5% per annum, payable monthly, and was originally due on June 30,
2004. On March 8, 2004, at the request of the Board of Directors, Mr. Bupp agreed to extend the
due date of the note from June 30, 2004 to June 30, 2005. In exchange for extending the due date
of the note, we issued Mr. Bupp an additional 375,000 warrants to purchase our common stock at an
exercise price of $0.50 per share, expiring in March 2009. On December 13, 2004, we repaid the
balance of the note to Mr. Bupp. The shares covered by this prospectus include the 375,000 shares
of common stock issuable pursuant to the warrants granted to Mr. Bupp in March 2004.
In December 2004, we completed a private placement of four-year convertible promissory notes in an
aggregate principal amount of $8.1 million 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. We modified
the convertible notes on November 30, 2006, to eliminate the revenue and cash covenants, modify the
repayment schedule of the notes, eliminate certain anti-dilution rights, and avoid potential future
violations of the debt covenants. The notes originally bore interest at 8% per annum and were
originally due on December 13, 2008. In connection with the November 30, 2006 amendment, we
cancelled the original notes and issued to the noteholders replacement notes which bear interest at
12% per annum. Instead of the notes being due on December 13, 2008 as per the original agreement,
the principal payments were revised as follows: $500,000 due January 8, 2007; $1,250,000 due July
9, 2007; $1,750,000 due January 7, 2008; $2,000,000 due July 7, 2008; and the remaining $2,600,000
due January 7, 2009. Additionally, as part of the amendment we agreed to use our best efforts to
offer and sell equity securities with gross proceeds of up to $10 million and apply not less than
50% of the net proceeds of any such sales to the repayment of the principal on the notes, and to
apply at least 50% of the proceeds of any permitted asset disposition or any permitted licensing,
distribution or similar strategic alliance agreement to the repayment of principal on the notes.
The notes are freely convertible into shares of our common stock at a price of $0.40 per share.
Neoprobe may force conversion of the notes prior to their stated maturity under certain
circumstances. As part of the original transaction, we issued the investors 10,125,000 Series T
warrants to purchase our common stock at an exercise price of $0.46 per share, expiring in December
2009. The shares covered by this prospectus include 20,250,000 shares of common stock issuable
upon conversion of the notes, and the 10,125,000 shares of our common stock issuable upon the
exercise of the Series T warrants.
During 2004 we engaged the services of two investment banking firms to assist us in raising
capital, Roth Capital Partners, LLC (Roth) and Laidlaw & Co. (Laidlaw). In exchange for the
services of Roth, we agreed to pay $320,000 in cash, plus warrants to purchase 800,000 shares of
our common stock. The warrants have an exercise price of $0.46 per share. This prospectus covers
the resale of the shares of common stock issuable upon the exercise of warrants.
In exchange for the services of Laidlaw, we agreed to pay $320,000 in cash, plus warrants to
purchase 800,000 shares of our common stock. The warrants have an exercise price of $0.46 per
share. This prospectus covers the resale of the shares of common stock issuable upon the exercise
of warrants by the underwriters which received warrants to purchase shares of our common stock as a
result of their participation in the offering on behalf of Laidlaw.
With the exception of the warrants granted to Mr. Bupp in March 2004, all warrants issued in
connection with this transaction expire in December 2009. This prospectus covers the resale of
shares of common stock issuable upon conversion of the convertible promissory notes, warrants
issued to Mr. Bupp in exchange for extending the due date of the note executed in his favor in
connection with the April 2003 bridge loan agreement, and the shares of common stock issuable
pursuant to the warrants granted to the parties to the Securities Purchase Agreement and the
placement agents and their assignees.
68
SELLING STOCKHOLDERS
The following table presents information regarding the selling stockholders and the shares that may
be sold by them pursuant to this prospectus. See also Security Ownership of Certain Beneficial
Owners and Management.
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Shares |
|
Percentage of |
|
|
|
|
|
Percentage of |
|
|
Owned |
|
Outstanding Shares |
|
Shares to |
|
Outstanding Shares |
Selling |
|
Before |
|
Owned Before |
|
be Sold |
|
Owned After |
Stockholders |
|
Offering |
|
Offering (1) |
|
in the Offering |
|
Offering (1) |
David C. Bupp (2)
|
|
|
2,674,542 |
|
|
|
4.4 |
% |
|
|
750,000 |
|
|
|
8.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Great Point Partners, LLC (3)
|
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|
30,000,000 |
|
|
|
33.8 |
% |
|
|
25,559,500 |
|
|
|
0 |
% |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Roth Capital Partners, LLC (4)
|
|
|
800,000 |
|
|
|
1.3 |
% |
|
|
800,000 |
|
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Bonanza Trust (5)
|
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200,000 |
|
|
|
* |
|
|
|
200,000 |
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|
|
0 |
% |
KWG Trust (6)
|
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200,000 |
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|
* |
|
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|
200,000 |
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|
|
0 |
% |
Linda Sterling (7)
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120,000 |
|
|
|
* |
|
|
|
120,000 |
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|
|
0 |
% |
Aharon Orlansky (8)
|
|
|
140,000 |
|
|
|
* |
|
|
|
140,000 |
|
|
|
0 |
% |
Jonathan Lawrence (9)
|
|
|
140,000 |
|
|
|
* |
|
|
|
140,000 |
|
|
|
0 |
% |
|
|
|
* |
|
Represents beneficial ownership of less than 1% of our outstanding common stock. |
|
(1) |
|
The number of shares listed in these columns include all shares beneficially owned and all
options or warrants to purchase shares held, whether or not deemed to be beneficially owned,
by each selling stockholder. The ownership percentages listed in these columns include only
shares beneficially owned by the listed selling stockholder. Beneficial ownership is
determined in accordance with the rules of the Securities and Exchange Commission. In
computing the percentage of shares beneficially owned by a selling stockholder, shares of
common stock subject to options or warrants held by that selling stockholder that were
exercisable on or within 60 days after August 31, 2007, were deemed outstanding for the
purpose of computing the percentage ownership of that selling stockholder. The ownership
percentages are calculated assuming that that 64,779,458 shares of common stock were
outstanding on August 31, 2007. Subsequent to the commencement of the offering Mr. Bupp
acquired beneficial ownership of an additional 4 million shares of the Companys common stock.
The percentage of outstanding shares owned after the offering by Mr. Bupp reflected in this
column was calculated based on the total number of shares beneficially owned by Mr. Bupp as of
August 31, 2007. |
|
(2) |
|
Mr. Bupp is a director of the company, and also serves as our President and Chief Executive
Officer. Prior to giving effect to the offering, Mr. Bupp held 1,276,666 shares issuable upon
exercise of options which are exercisable within 60 days, 1,195,000 warrants which are
exercisable within 60 days, a promissory note convertible into 250,000 shares of our common
stock, a promissory note convertible into 3,225,406 shares of our common stock, 175,511 shares
that are held by Mr. Bupps wife for which he disclaims beneficial ownership, 20,000 warrants
held by Mr. Bupps wife for which he disclaims beneficial ownership which are exercisable
within 60 days and 91,257 shares in Mr. Bupps account in the 401(k) Plan. After giving effect
to the offering Mr. Bupp will hold 1,226,666 shares issuable upon exercise of options which
are exercisable within 60 days, 1,070,000 warrants which are exercisable within 60 days, a
promissory note convertible into 3,225,406 shares of our common stock, 175,511 shares that are
held by Mr. Bupps wife for which he disclaims beneficial ownership, 20,000 warrants held by
Mr. Bupps wife for which he disclaims beneficial ownership which are exercisable within 60
days and 91,257 shares in Mr. Bupps account in the 401(k) Plan. As of August 31, 2007, Mr.
Bupp had sold none of the shares of our common stock that he may sell pursuant to this
prospectus. |
69
|
|
|
|
(3) |
|
Prior to giving effect to the offering, Great Point Partners, LLC held exercisable warrants
to purchase 10,000,000 shares of our common stock and promissory notes convertible into
20,000,000 shares of our common stock. This amount consists of exercisable warrants to
purchase 5,500,000 shares of our common stock, and a promissory note convertible into
11,000,000 shares of our common stock, held by Biomedical Value Fund, L.P., an investment fund
under the management and control of Great Point Partners, LLC; and, exercisable warrants to
purchase 4,500,000 shares of our common stock, and a promissory note convertible into
9,000,000 shares of our common stock, held by Biomedical Offshore Value Fund, Ltd., an
investment fund also under the management and control of Great Point Partners, LLC. Following
the offering Great Point Partners, LLC will not hold any warrants to purchase shares of our
common stock or any convertible shares of our common stock. As of August 31, 2007, Great Point
Partners, LLC had sold none of the shares of our common stock that it may sell pursuant to
this prospectus. Through August 31, 2007, we have repaid the Great Point funds a total of $2
million through both scheduled principal repayments and mandatory principal repayments. This
has decreased the total shares of common stock issuable to the Great Point funds upon
conversion of the notes from 20,000,000 to 15,000,000. |
|
(4) |
|
Prior to giving effect to the offering, Roth Capital Partners, LLC held exercisable warrants
to purchase 800,000 shares of our common stock. Following the offering Roth Capital Partners,
LLC will not hold any warrants to purchase shares of our common stock. As of August 31, 2007,
Roth Capital Partners, LLC had sold none of the shares of our common stock that it may sell
pursuant to this prospectus. |
|
(5) |
|
Prior to giving effect to the offering, Bonanza Trust held exercisable warrants to purchase
200,000 shares of our common stock. Following the offering, Bonanza Trust will not hold any
warrants to purchase shares of our common stock. As of August 31, 2007, Bonanza Trust had sold
none of the shares of our common stock that it may sell pursuant to this prospectus. |
|
(6) |
|
Prior to giving effect to the offering, KWG Trust held exercisable warrants to purchase
200,000 shares of our common stock. Following the offering, KWG Trust will not hold any
warrants to purchase shares of our common stock. As of August 31, 2007, KWG Trust had sold
none of the shares of our common stock that it may sell pursuant to this prospectus. |
|
(7) |
|
Prior to giving effect to the offering, Ms. Sterling held exercisable warrants to purchase
120,000 shares of our common stock. Following the offering, Ms. Sterling will not hold any
warrants to purchase shares of our common stock. As of August 31, 2007, Ms. Sterling had sold
none of the shares of our common stock that she may sell pursuant to this prospectus. |
|
(8) |
|
Prior to giving effect to the offering, Mr. Orlansky held exercisable warrants to purchase
140,000 shares of our common stock. Following the offering, Mr. Orlansky will not hold any
warrants to purchase shares of our common stock. As of August 31, 2007, Mr. Orlansky had sold
none of the shares of our common stock that he may sell pursuant to this prospectus. |
|
(9) |
|
Prior to giving effect to the offering, Mr. Lawrence held exercisable warrants to purchase
140,000 shares of our common stock. Following the offering, Mr. Lawrence will not hold any
warrants to purchase shares of our common stock. As of August 31, 2007, Mr. Lawrence had sold
none of the shares of our common stock that he may sell pursuant to this prospectus. |
70
PLAN OF DISTRIBUTION
The Selling Stockholders and any of their pledgees, donees, transferees, assignees and
successors-in-interest may, from time to time, sell any or all of their shares of common stock on
any stock exchange, market or trading facility on which the shares are traded or in private
transactions. These sales may be at fixed or negotiated prices. The Selling Stockholders may use
any one or more of the following methods when selling shares:
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|
ordinary brokerage transactions and transactions in which the broker-dealer solicits
investors; |
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|
block trades in which the broker-dealer will attempt to sell the shares as agent but may
position and resell a portion of the block as principal to facilitate the transaction; |
|
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|
purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
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|
an exchange distribution in accordance with the rules of the applicable exchange; |
|
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|
privately negotiated transactions; |
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|
to cover short sales made after the date that this Registration Statement is declared
effective by the Commission; |
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|
broker-dealers may agree with the Selling Stockholders to sell a specified number of
such shares at a stipulated price per share; |
|
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|
a combination of any such methods of sale; and |
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|
any other method permitted pursuant to applicable law. |
The Selling Stockholders may also sell shares under Rule 144 promulgated under the Securities Act,
if available, rather than under this prospectus.
Broker-dealers engaged by the Selling Stockholders may arrange for other brokers-dealers to
participate in sales. Broker-dealers may receive commissions or discounts from the Selling
Stockholders (or, if any broker-dealer acts as agent for the purchaser of shares, from the
purchaser) in amounts to be negotiated. The Selling Stockholders do not expect these commissions
and discounts to exceed what is customary in the types of transactions involved.
The Selling Stockholders may from time to time pledge or grant a security interest in some or all
of the Shares owned by them and, if they default in the performance of their secured obligations,
the pledgees or secured parties may offer and sell shares of common stock from time to time under
this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable
provision of the Securities Act of 1933 amending the list of selling stockholders to include the
pledgee, transferee or other successors in interest as selling stockholders under this prospectus.
Upon the company being notified in writing by a Selling Stockholder that any material arrangement
has been entered into with a broker-dealer for the sale of common stock through a block trade,
special offering, exchange distribution or secondary distribution or a purchase by a broker or
dealer, a supplement to this prospectus will be filed, if required, pursuant to Rule 424(b) under
the Securities Act, disclosing (i) the name of each such Selling Stockholder and of the
participating broker-dealer(s), (ii) the number of shares involved, (iii) the price at which such
the shares of common stock were sold, (iv)the commissions paid or discounts or concessions allowed
to such broker-dealer(s), where applicable, (v) that such broker-dealer(s) did not conduct any
investigation to verify the information set out or incorporated by reference in this prospectus,
and (vi) other facts material to the transaction. In addition, upon the company being notified in
writing by a Selling Stockholder that a donee or pledgee intends to sell more than 500 shares of
common stock, a supplement to this prospectus will be filed if then required in accordance with
applicable securities law.
The Selling Stockholders also may transfer the shares of common stock in other circumstances, in
which case the transferees, pledgees or other successors in interest will be the selling beneficial
owners for purposes of this prospectus.
71
The Selling Stockholders and any broker-dealers or agents that are involved in selling the shares
may be deemed to be underwriters within the meaning of the Securities Act in connection with such
sales. In such event, any commissions received by such broker-dealers or agents and any profit on
the resale of the shares purchased by them may be deemed to be underwriting commissions or
discounts under the Securities Act. Discounts, concessions, commissions and similar selling
expenses, if any, that can be attributed to the sale of Securities will be paid by the Selling
Stockholder and/or the purchasers. Each Selling Stockholder has represented and warranted to the
company that it acquired the securities subject to this registration statement in the ordinary
course of such Selling Stockholders business and, at the time of its purchase of such securities
such Selling Stockholder had no agreements or understandings, directly or indirectly, with any
person to distribute any such securities.
The company has advised each Selling Stockholder that it may not use shares registered on this
Registration Statement to cover short sales of Common Stock made prior to the date on which this
Registration Statement shall have been declared effective by the Commission. If a Selling
Stockholder uses this prospectus for any sale of the common stock, it will be subject to the
prospectus delivery requirements of the Securities Act. The Selling Stockholders will be
responsible to comply with the applicable provisions of the Securities Act and Exchange Act, and
the rules and regulations thereunder promulgated, including, without limitation, Regulation M, as
applicable to such Selling Stockholders in connection with resales of their respective shares under
this Registration Statement.
The company is required to pay all fees and expenses incident to the registration of the shares,
but the company will not receive any proceeds from the sale of the common stock. The company has
agreed to indemnify the Selling Stockholders against certain losses, claims, damages and
liabilities, including liabilities under the Securities Act.
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES
Section 145 of the General Corporation Law of the State of Delaware (Section 145) provides that
directors and officers of Delaware corporations may, under certain circumstances, be indemnified
against expenses (including attorneys fees) and other liabilities actually and reasonably incurred
by them as a result of any suit brought against them in their capacity as a director or officer, if
they acted in good faith and in a manner they reasonably believed to be in or not opposed to the
best interests of the corporation, and, with respect to any criminal action or proceeding, if they
had no reasonable cause to believe their conduct was unlawful. Section 145 also provides that
directors and officers may also be indemnified against expenses (including attorneys fees)
incurred by them in connection with a derivative suit if they acted in good faith and in a manner
they reasonably believed to be in or not opposed to the best interests of the corporation, except
that no indemnification may be made without court approval if such person was adjudged liable to
the corporation.
Article V of the Companys By-laws contains provisions which require that the Company indemnify its
officers, directors, employees and agents, in substantially the same language as Section 145.
Article Nine, section (b), of the Companys Certificate of Incorporation further provides that no
director will be personally liable to the Company or its stockholders for monetary damages or for
any breach of fiduciary duty except for breach of the directors duty of loyalty to the Company or
its stockholders, for acts or omissions not in good faith or involving intentional misconduct or a
knowing violation of law, pursuant to Section 174 of the Delaware General Corporation Law (which
imposes liability in connection with the payment of certain unlawful dividends, stock purchases or
redemptions), or any amendment or successor provision thereto, or for any transaction from which a
director derived an improper personal benefit.
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to the directors, officers, and controlling persons of the small business issuer pursuant
to the foregoing provisions, or otherwise, the small business issuer has been advised that in the
opinion of the Commission such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable.
72
In the event that a claim for indemnification against such liabilities (other than the payment by
the small business issuer of expenses incurred or paid by a directors, officers or controlling
person of the small business issuer in the successful defense of any action, suit or proceeding) is
asserted by such director, officer, or controlling person in connection with the securities being
registered, the small business issuer will, unless in the opinion of counsel the matter has been
settled by controlling precedent, submit to a court of appropriate jurisdiction the question
whether such indemnification by it is against public policy as expressed in the Securities Act and
will be governed by the final adjudication of such issue.
LEGAL OPINION
The validity of the shares offered hereby has been passed upon for us by Porter, Wright, Morris &
Arthur LLP, 41 South High Street, Columbus, Ohio 43215.
EXPERTS
The consolidated financial statements included in this Prospectus for the years ended December 31,
2006 and 2005 have been audited by BDO Seidman, LLP, an independent registered public accounting
firm, to the extent and for the periods set forth in their report appearing elsewhere herein and
are included in reliance upon such report given upon the authority of said firm as experts in
auditing and accounting.
ADDITIONAL INFORMATION
We are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended,
and file reports, proxy statements and other information with the Securities and Exchange
Commission. These reports, proxy statements and other information may be inspected and copied at
the public reference facilities maintained by the Securities and Exchange Commission at 100 F
Street, N.E., Washington, D.C. 20549 and at the Securities and Exchange Commissions regional
offices located at the Northwestern Atrium Center, 500 West Madison Street, Suite 1400, Chicago,
Illinois 60661 and 233 Broadway, New York, New York 10279. You can obtain copies of these
materials from the Public Reference Section of the Securities and Exchange Commission upon payment
of fees prescribed by the Securities and Exchange Commission. You may obtain information on the
operation of the Public Reference Room by calling the Securities and Exchange Commission at
1-800-SEC-0330. The Securities and Exchange Commissions Web site contains reports, proxy and
information statements and other information regarding registrants that file electronically with
the Securities and Exchange Commission. The address of that site is http://www.sec.gov.
We have filed a Registration Statement on Form SB-2 with the Securities and Exchange Commission
under the Securities Act with respect to the securities offered in this prospectus. This
prospectus, which is filed as part of a Registration Statement, does not contain all of the
information set forth in the Registration Statement, some portions of which have been omitted in
accordance with the Securities and Exchange Commissions rules and regulations. Statements made in
this prospectus as to the contents of any contract, agreement or other document referred to in this
prospectus are not necessarily complete and are qualified in their entirety by reference to each
such contract, agreement or other document which is filed as an exhibit to the Registration
Statement. The Registration Statement may be inspected without charge at the public reference
facilities maintained by the Securities and Exchange Commission, and copies of such materials can
be obtained from the Public Reference Section of the Securities and Exchange Commission at
prescribed rates. You may also obtain additional information regarding the company on our website,
located at http://www.neoprobe.com
73
NEOPROBE CORPORATION and SUBSIDIARIES
Index to Financial Statements
|
|
|
Consolidated Financial Statements of Neoprobe Corporation |
|
|
|
|
|
|
|
F-2 |
|
|
|
|
|
F-3 |
|
|
|
|
|
F-5 |
|
|
|
|
|
F-6 |
|
|
|
|
|
F-7 |
|
|
|
|
|
F-8 |
|
|
|
Unaudited Consolidated Financial Statements of Neoprobe Corporation |
|
|
|
|
|
|
|
F-29 |
|
|
|
|
|
F-31 |
|
|
|
|
|
F-32 |
|
|
|
|
|
F-33 |
F-1
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, 2006 and 2005 and the related consolidated statements of operations, stockholders equity
(deficit), and cash flows for the two years then ended. These financial statements are the
responsibility of the companys 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 audit 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 companys 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, 2006 and 2005 and
the results of its operations and its cash flows for the two years then ended in conformity with
accounting principles generally accepted in the United States of America.
As discussed in Note 1 to the consolidated financial statements, effective January 1, 2006, the
company adopted Statement of Financial Accounting Standards No. 123(R), Share-Based Payment,
using the modified prospective transition method.
Chicago, Illinois
March 14, 2007
F-2
Neoprobe Corporation and Subsidiaries
Consolidated Balance Sheets
December 31, 2006 and 2005
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
2,502,655 |
|
|
$ |
4,940,946 |
|
Available-for-sale securities |
|
|
|
|
|
|
1,529,259 |
|
Accounts receivable, net |
|
|
1,246,089 |
|
|
|
673,008 |
|
Inventory |
|
|
1,154,376 |
|
|
|
803,703 |
|
Prepaid expenses and other |
|
|
430,623 |
|
|
|
501,557 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
5,333,743 |
|
|
|
8,448,473 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment |
|
|
2,238,050 |
|
|
|
2,051,793 |
|
Less accumulated depreciation and amortization |
|
|
1,882,371 |
|
|
|
1,768,558 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
355,679 |
|
|
|
283,235 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and trademarks |
|
|
3,131,391 |
|
|
|
3,162,547 |
|
Acquired technology |
|
|
237,271 |
|
|
|
237,271 |
|
|
|
|
|
|
|
|
|
|
|
3,368,662 |
|
|
|
3,399,818 |
|
Less accumulated amortization |
|
|
1,540,145 |
|
|
|
1,300,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,828,517 |
|
|
|
2,098,910 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
515,593 |
|
|
|
739,823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
8,033,532 |
|
|
$ |
11,570,441 |
|
|
|
|
|
|
|
|
Continued
F-3
Neoprobe Corporation and Subsidiaries
Consolidated Balance Sheets, continued
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
LIABILITIES AND STOCKHOLDERS (DEFICIT) EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
668,288 |
|
|
$ |
207,824 |
|
Accrued liabilities and other |
|
|
544,215 |
|
|
|
821,781 |
|
Capital lease obligations |
|
|
14,841 |
|
|
|
19,530 |
|
Deferred revenue |
|
|
348,568 |
|
|
|
252,494 |
|
Notes payable to finance companies |
|
|
136,925 |
|
|
|
200,054 |
|
Notes payable to investors, current portion, net of discount of $53,585 |
|
|
1,696,415 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
3,409,252 |
|
|
|
1,501,683 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligations |
|
|
17,014 |
|
|
|
31,855 |
|
Deferred revenue |
|
|
40,495 |
|
|
|
41,132 |
|
Notes payable to CEO, net of discounts of $19,030
and $26,249, respectively |
|
|
80,970 |
|
|
|
73,751 |
|
Notes payable to investors, net of discounts of $1,468,845
and $2,099,898, respectively |
|
|
4,781,155 |
|
|
|
5,900,102 |
|
Other liabilities |
|
|
2,673 |
|
|
|
5,122 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
8,331,559 |
|
|
|
7,553,645 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders (deficit) equity: |
|
|
|
|
|
|
|
|
Preferred stock; $.001 par value; 5,000,000 shares authorized
at December 31, 2006 and 2005; none issued and outstanding |
|
|
|
|
|
|
|
|
Common stock; $.001 par value; 150,000,000 shares authorized;
59,624,379 and 58,622,059 shares issued and outstanding at
December 31, 2006 and 2005, respectively |
|
|
59,624 |
|
|
|
58,622 |
|
Additional paid-in capital |
|
|
135,330,668 |
|
|
|
134,903,259 |
|
Accumulated deficit |
|
|
(135,688,319 |
) |
|
|
(130,947,103 |
) |
Accumulated other comprehensive income |
|
|
|
|
|
|
2,018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders (deficit) equity |
|
|
(298,027 |
) |
|
|
4,016,796 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders (deficit) equity |
|
$ |
8,033,532 |
|
|
$ |
11,570,441 |
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-4
Neoprobe Corporation and Subsidiaries
Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
Net sales |
|
$ |
6,051,071 |
|
|
$ |
5,919,473 |
|
Cost of goods sold |
|
|
2,632,131 |
|
|
|
2,376,211 |
|
|
|
|
|
|
|
|
Gross profit |
|
|
3,418,940 |
|
|
|
3,543,262 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
3,803,060 |
|
|
|
4,031,790 |
|
Selling, general and administrative |
|
|
3,076,379 |
|
|
|
3,155,674 |
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
6,879,439 |
|
|
|
7,187,464 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(3,460,499 |
) |
|
|
(3,644,202 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
225,468 |
|
|
|
226,663 |
|
Interest expense |
|
|
(1,496,332 |
) |
|
|
(1,350,592 |
) |
Increase in warrant liability |
|
|
|
|
|
|
(142,427 |
) |
Other |
|
|
(9,853 |
) |
|
|
(18,392 |
) |
|
|
|
|
|
|
|
Total other expenses |
|
|
(1,280,717 |
) |
|
|
(1,284,748 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,741,216 |
) |
|
$ |
(4,928,950 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
Diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
|
58,586,593 |
|
|
|
58,433,895 |
|
Diluted |
|
|
58,586,593 |
|
|
|
58,433,895 |
|
See accompanying notes to consolidated financial statements.
F-5
Neoprobe Corporation and Subsidiaries
Consolidated Statements of Stockholders Equity (Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Accumulated |
|
|
Comprehensive |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Income |
|
|
Total |
|
Balance, December 31, 2004 |
|
|
58,378,143 |
|
|
$ |
58,378 |
|
|
$ |
132,123,605 |
|
|
$ |
(126,018,153 |
) |
|
$ |
|
|
|
$ |
6,163,830 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued stock upon exercise of warrants |
|
|
206,865 |
|
|
|
207 |
|
|
|
57,715 |
|
|
|
|
|
|
|
|
|
|
|
57,922 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued stock to 401(k) plan at $0.39 |
|
|
37,051 |
|
|
|
37 |
|
|
|
19,205 |
|
|
|
|
|
|
|
|
|
|
|
19,242 |
|
Reclassified liability related to warrants
to purchase common stock |
|
|
|
|
|
|
|
|
|
|
2,702,734 |
|
|
|
|
|
|
|
|
|
|
|
2,702,734 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,928,950 |
) |
|
|
|
|
|
|
(4,928,950 |
) |
Unrealized gain on available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,018 |
|
|
|
2,018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,926,932 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2005 |
|
|
58,622,059 |
|
|
|
58,622 |
|
|
|
134,903,259 |
|
|
|
(130,947,103 |
) |
|
|
2,018 |
|
|
|
4,016,796 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued stock to 401(k) plan at $0.39 |
|
|
67,987 |
|
|
|
68 |
|
|
|
26,545 |
|
|
|
|
|
|
|
|
|
|
|
26,613 |
|
Issued stock as a commitment fee in
connection with stock purchase
agreement |
|
|
720,000 |
|
|
|
720 |
|
|
|
179,280 |
|
|
|
|
|
|
|
|
|
|
|
180,000 |
|
Issued stock in connection with stock
purchase agreement, net of costs |
|
|
214,333 |
|
|
|
214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option expense |
|
|
|
|
|
|
|
|
|
|
221,584 |
|
|
|
|
|
|
|
|
|
|
|
221,584 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,741,216 |
) |
|
|
|
|
|
|
(4,741,216 |
) |
Realized gain on available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,018 |
) |
|
|
(2,018 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,743,234 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2006 |
|
|
59,624,379 |
|
|
$ |
59,624 |
|
|
$ |
135,330,668 |
|
|
$ |
(135,688,319 |
) |
|
$ |
|
|
|
$ |
(298,027 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-6
Neoprobe Corporation and Subsidiaries
Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,741,216 |
) |
|
$ |
(4,928,950 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation of property and equipment |
|
|
148,934 |
|
|
|
163,121 |
|
Amortization of intangible assets |
|
|
262,802 |
|
|
|
440,629 |
|
Loss on disposal and abandonment of assets |
|
|
39,031 |
|
|
|
6,650 |
|
Amortization of debt discount and debt offering costs |
|
|
808,916 |
|
|
|
687,370 |
|
Stock compensation expense |
|
|
221,584 |
|
|
|
|
|
Increase in warrant liability |
|
|
|
|
|
|
142,427 |
|
Other |
|
|
22,854 |
|
|
|
(8,199 |
) |
Change in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(573,081 |
) |
|
|
(261,152 |
) |
Inventory |
|
|
(428,202 |
) |
|
|
34,163 |
|
Prepaid expenses and other assets |
|
|
408,918 |
|
|
|
257,005 |
|
Accounts payable |
|
|
460,463 |
|
|
|
8,912 |
|
Accrued liabilities and other liabilities |
|
|
(284,212 |
) |
|
|
396,201 |
|
Deferred revenue |
|
|
95,437 |
|
|
|
59,843 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(3,557,772 |
) |
|
|
(3,001,980 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of available-for-sale securities |
|
|
|
|
|
|
(5,480,787 |
) |
Maturities of available-for-sale securities |
|
|
1,531,000 |
|
|
|
3,950,000 |
|
Purchases of property and equipment |
|
|
(144,022 |
) |
|
|
(86,004 |
) |
Proceeds from sales of property and equipment |
|
|
4,097 |
|
|
|
11,092 |
|
Patent and trademark costs |
|
|
(31,163 |
) |
|
|
(20,625 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
1,359,912 |
|
|
|
(1,626,324 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
50,000 |
|
|
|
57,922 |
|
Payment of stock offering costs |
|
|
(35,570 |
) |
|
|
|
|
Payment of debt issuance costs |
|
|
|
|
|
|
(29,635 |
) |
Payment of notes payable |
|
|
(235,330 |
) |
|
|
(286,035 |
) |
Payments under capital leases |
|
|
(19,530 |
) |
|
|
(15,680 |
) |
Other |
|
|
|
|
|
|
20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in financing activities |
|
|
(240,430 |
) |
|
|
(273,408 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash |
|
|
(2,438,290 |
) |
|
|
(4,901,712 |
) |
|
|
|
|
|
|
|
|
|
Cash, beginning of year |
|
|
4,940,946 |
|
|
|
9,842,658 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end of year |
|
$ |
2,502,656 |
|
|
$ |
4,940,946 |
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-7
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, 2006 and 2005, 84% and 92% of net sales, respectively, were
made to EES. The loss of this customer would have a significant adverse effect on our
operating results. |
|
|
|
|
Our blood flow measurement device product line is in the early stages of commercialization.
Our activity with this product line was initiated with 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
might be used in connection with gamma detection devices in cancer surgeries. The first,
Lymphoseek®, is intended to be used in tracing the spread of certain solid tumor
cancers. The second, RIGScan® CR, is intended to be used to help surgeons locate
cancerous 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. |
|
|
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. |
|
Fair Value of Financial Instruments: The following methods and assumptions were used to
estimate the fair value of each class of financial instruments: |
|
(1) |
|
Cash and cash equivalents, 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, net of the related tax effect, 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- |
F-9
|
|
|
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 classified as current based on our intent to use them
to fund short-term working capital needs. |
|
|
(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,
2006 and 2005, 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 notes less the unamortized discounts related to the value of the
beneficial conversion features and the initial estimated fair value of the warrants to
purchase common stock issued in connection with the notes. At December 31, 2006 and
2005, the carrying value of the note payable to our CEO approximates fair value. |
|
|
(5) |
|
Note 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 value of
the beneficial conversion features and the initial estimated fair value of the warrants
to purchase common stock issued in connection with the notes. At December 31, 2006 and
2005, the carrying value of the note payable to outside investors approximates fair
value. |
|
d. |
|
Cash and Cash Equivalents: There were no cash equivalents at December 31, 2006 or 2005.
No cash was restricted as of December 31, 2006. As of December 31, 2005, $8,000 was
restricted to secure bank guarantees related to sub-lease agreements for Cardiosonix
office space. |
|
|
e. |
|
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 2006 and 2005, we wrote off $129,000 and
$58,000, respectively, of excess and obsolete materials, primarily due to design changes to
our Quantix® product line and reduced demand for our laparoscopic probes. |
|
|
|
|
We capitalize certain inventory costs associated with our Lymphoseek® product
prior to regulatory approval and product launch, based on managements judgment of probable
future commercial use and net realizable value. 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 2006, we capitalized $48,000 in inventory costs
associated with our Lymphoseek product. |
|
|
|
|
The components of net inventory at December 31, 2006 and 2005 are as follows: |
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Materials and component parts |
|
$ |
522,225 |
|
|
$ |
461,218 |
|
Work-in-process |
|
|
167,188 |
|
|
|
|
|
Finished goods |
|
|
464,963 |
|
|
|
324,485 |
|
|
|
|
|
|
|
|
|
|
$ |
1,154,376 |
|
|
$ |
803,703 |
|
|
|
|
|
|
|
|
|
f. |
|
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 |
F-10
|
|
|
are capitalized. Property and equipment includes $78,000 of
equipment under capital leases with accumulated amortization of $53,000 and $33,000 at
December 31, 2006 and 2005, respectively. During 2006 and 2005, we recorded losses of
$2,000 and $7,000, respectively, on the disposal of property and equipment. |
|
|
|
|
The major classes of property and equipment are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Useful Life |
|
|
2006 |
|
|
2005 |
|
Production machinery and equipment |
|
5 years |
|
$ |
1,107,278 |
|
|
$ |
999,106 |
|
Other machinery and equipment, primarily
computers and research equipment |
|
2 5 years |
|
|
598,555 |
|
|
|
543,313 |
|
Furniture and fixtures |
|
7 years |
|
|
336,537 |
|
|
|
334,275 |
|
Leasehold improvements |
|
Life of Lease1 |
|
|
74,682 |
|
|
|
74,682 |
|
Software |
|
3 years |
|
|
120,998 |
|
|
|
100,417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,238,050 |
|
|
$ |
2,051,793 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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. |
|
g. |
|
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. |
|
|
|
|
The major classes of intangible assets are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
December 31, 2005 |
|
|
|
Wtd |
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Avg |
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
Accumulated |
|
|
|
Life |
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
Amortization |
|
Patents and trademarks |
|
9.7 yrs |
|
$ |
3,131,391 |
|
|
$ |
1,370,291 |
|
|
$ |
3,162,547 |
|
|
$ |
1,164,763 |
|
Acquired technology |
|
2.0 yrs |
|
|
237,271 |
|
|
|
169,854 |
|
|
|
237,271 |
|
|
|
136,145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
$ |
3,368,662 |
|
|
$ |
1,540,145 |
|
|
$ |
3,399,818 |
|
|
$ |
1,300,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During 2006 and 2005, we recorded $263,000 and $440,000, respectively, of intangible asset
amortization in general and administrative expenses. Of those amounts, $2,000 and $11,000,
respectively, were related to the abandonment of gamma detection patents and patent
applications that were deemed no longer recoverable or part of our ongoing business. |
|
|
|
|
The estimated future amortization expenses for the next five fiscal years are as follows: |
|
|
|
|
|
|
|
Estimated |
|
|
Amortization |
|
|
Expense |
For the year ended 12/31/2007 |
|
$ |
222,709 |
|
For the year ended 12/31/2008 |
|
|
216,116 |
|
For the year ended 12/31/2009 |
|
|
170,852 |
|
For the year ended 12/31/2010 |
|
|
170,033 |
|
For the year ended 12/31/2011 |
|
|
168,581 |
|
F-11
|
h. |
|
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 2005, we incurred $10,000 of debt issuance costs related to
notes payable. See Note 6. |
|
|
i. |
|
Revenue Recognition: |
|
(1) |
|
Product Sales: We derive revenues primarily from sales of our medical devices.
Our standard shipping terms are FOB shipping point, and title and risk of loss passes
to the customer upon delivery to a common carrier. We generally recognize sales revenue
when the products are shipped and the earnings process has been completed. However, in
cases where product is shipped but the earnings process is not yet completed, revenue
is deferred until it has been determined that the earnings process has been completed.
Our customers generally have no right to return products purchased in the ordinary
course of business. |
|
|
|
|
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. |
|
j. |
|
Research and Development Costs: All costs related to research and development are
expensed as incurred. |
|
|
k. |
|
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, 2006 and 2005. |
F-12
|
l. |
|
Stock-Based Compensation: At December 31, 2006, 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 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 awards may be granted to our consultants and agents. Total shares authorized under each plan
are 2 million shares, 1.5 million shares and 5 million shares, respectively. The Amended
Plan was approved by the stockholders in 1994, and although options are still outstanding
under this plan, the Amended Plan is considered expired and no new grants may be made from
it. Under all three plans, the exercise price of each option is greater than or equal to the
closing market price of our common stock on the day prior to the date of the grant. |
|
|
|
|
Options granted under the Amended Plan, the 1996 Plan and the 2002 Plan generally vest on an
annual basis over one to three years. Outstanding options under the plans, if not exercised,
generally expire ten years from their date of grant or 90 days from the date of an
optionees separation from employment with us. |
|
|
|
|
Effective January 1, 2006, we adopted Statement of Financial Accounting Standards (SFAS) No.
123(R), Share-Based Payment, which is a revision of SFAS No. 123, Accounting for Stock-Based
Compensation. SFAS No. 123(R) supersedes APB Opinion No. 25, Accounting for Stock Issued to
Employees, and amends SFAS No. 95, Statement of Cash Flows. Generally, the approach in SFAS
No. 123(R) is similar to the approach described in SFAS No. 123. However, 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. |
|
|
|
|
We are applying the modified prospective method for recognizing the expense over the
remaining vesting period for awards that were outstanding but unvested as of January 1,
2006. Under the modified prospective method, we have not adjusted the financial statements
for periods ending prior to January 1, 2006. Under the modified prospective method, the
adoption of SFAS No. 123(R) applies to new awards and to awards modified, repurchased, or
cancelled after December 31, 2005, as well as to the unvested portion of awards outstanding
as of January 1, 2006. |
|
|
|
|
Compensation cost arising from stock-based awards is recognized as expense using the
straight-line method over the vesting period. As of December 31, 2006, there was
approximately $160,000 of total unrecognized compensation cost related to unvested
stock-based awards, which we expect to recognize over remaining weighted average vesting
terms of 1.4 years. For the year ended December 31, 2006, our total stock-based compensation
expense was approximately $222,000. We have not recorded any income tax benefit related to
stock-based compensation for the year ended December 31, 2006. |
|
|
|
|
As permitted by SFAS No. 123, prior to 2006 Neoprobe accounted for share-based payments to
employees using APB Opinion No. 25s intrinsic value method and, as such, generally
recognized no compensation cost for employee stock options. The following table illustrates
the effect on net loss and net loss per share for the year ended December 31, 2005 as if
compensation cost for our stock-based compensation plans had been determined based on the
fair value at the grant dates for awards under those plans consistent with SFAS No. 123. |
F-13
|
|
|
|
|
|
|
Year Ended |
|
|
|
December 31, 2005 |
|
Net loss, as reported |
|
$ |
(4,928,950 |
) |
Deduct: Total stock-based employee compensation expense
determined under fair value based method for all awards |
|
|
(511,712 |
) |
|
|
|
|
|
|
|
|
|
Pro forma net loss |
|
$ |
(5,440,662 |
) |
|
|
|
|
|
|
|
|
|
Loss per common share: |
|
|
|
|
As reported (basic and diluted) |
|
$ |
(0.08 |
) |
Pro forma (basic and diluted) |
|
$ |
(0.09 |
) |
|
|
|
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 companys 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, 2006 and 2005 are noted in the following table: |
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
Expected term |
|
5.9 years |
|
10 years |
Expected volatility |
|
|
105 |
% |
|
|
79 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
Risk-free rate |
|
|
4.7 |
% |
|
|
4.3 |
% |
|
|
|
A summary of stock option activity under our stock option plans as of December 31, 2006, and
changes during the year then ended is presented below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Options |
|
|
Price |
|
|
Life |
|
|
Value |
|
Outstanding, January 1, 2006 |
|
|
5,523,974 |
|
|
$ |
0.44 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
620,000 |
|
|
$ |
0.27 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(168,501 |
) |
|
$ |
0.32 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2006 |
|
|
5,975,473 |
|
|
$ |
0.42 |
|
|
6.1 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, December 31, 2006 |
|
|
4,643,640 |
|
|
$ |
0.45 |
|
|
5.6 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average grant-date fair value of options granted in 2006 and 2005 was $0.19 and
$0.32, respectively. |
F-14
|
|
|
A summary of the status of our restricted stock as of December 31, 2006, and changes during
the year then ended is presented below: |
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
|
December 31, 2006 |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
Number of |
|
|
Grant-Date |
|
|
|
Shares |
|
|
Fair Value |
|
Outstanding, January 1, 2006 |
|
|
130,000 |
|
|
$ |
7.84 |
|
Granted |
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
Forfeited |
|
|
|
|
|
|
|
|
Expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2006 |
|
|
130,000 |
|
|
$ |
7.84 |
|
|
|
|
|
|
|
|
|
|
|
All of our outstanding restricted shares are pending cancellation due to failure to vest
under the terms of issuance of these shares. Restricted shares, if any, generally vest on a
change of control of our company as defined in the specific grant agreements. As a result,
we have not recorded any deferred compensation related to past grants of restricted stock
due to the inability to assess the probability of the vesting event. |
|
|
m. |
|
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. |
|
|
n. |
|
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.
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. |
|
|
o. |
|
Recent Accounting Developments: In February 2006, the Financial Accounting Standards
Board (FASB) issued SFAS No. 155, Accounting for Certain Hybrid Financial Instruments An
Amendment of FASB Statements No. 133 and 140 (SFAS No. 155). SFAS No. 155 amends SFAS No.
133, Accounting for Derivative Instruments and Hedging Activities, and SFAS No. 140,
Accounting for Transfers and Servicing of Financial Assets and Extinguishments of
Liabilities. SFAS No. 155 (a) permits fair value remeasurement for any hybrid financial
instrument that contains an embedded derivative that otherwise would require bifurcation,
(b) clarifies which interest-only strips and principal-only strips are not subject to the
requirements of SFAS No. 133, (c) establishes a requirement to evaluate interests in
securitized financial assets to identify interests that are freestanding derivatives or
that are hybrid financial instruments that contain an embedded derivative requiring
bifurcation, (d) clarifies that concentrations of credit risk in the form of subordination
are not embedded derivatives, and (e) amends SFAS No. 140 to eliminate the prohibition on a
qualifying special-purpose entity from holding a derivative financial instrument that
pertains to a beneficial interest other than another derivative financial instrument. SFAS
No. 155 is effective for all financial instruments acquired or issued after the beginning
of an entitys first fiscal year that begins after September 15, 2006 and is required to be
adopted by Neoprobe beginning January 1, 2007. We do not expect the adoption of SFAS No.
155 to have a material impact on our consolidated results of operations or financial
condition. |
F-15
|
|
|
In March 2006, the FASB issued SFAS No. 156,
Accounting for Servicing of Financial Assets
An Amendment of FASB Statement No. 140 (SFAS No. 156). SFAS No. 156 amends SFAS No. 140,
Accounting for Transfers and Servicing of Financial Assets and Extinguishments of
Liabilities. SFAS No. 156 (a) requires recognition of a servicing asset or servicing
liability each time an obligation to service a financial asset is undertaken by entering
into a servicing contract in certain circumstances, (b) requires measurement at fair value
of all separately recognized servicing assets and servicing liabilities, (c) permits the use
of either the amortization method or the fair value measurement method for each class of
separately recognized servicing assets and servicing liabilities, (d) permits a one-time
reclassification of available-for-sale securities to trading securities at initial adoption,
and (e) requires separate presentation of servicing assets and servicing liabilities
subsequently measured at fair value in the statement of financial position and additional
disclosures for all separately recognized servicing assets and servicing liabilities. SFAS
No. 156 is effective for fiscal years beginning after September 15, 2006, and is required to
be adopted by Neoprobe beginning January 1, 2007. We do not expect the adoption of SFAS No.
156 to have a material impact on our consolidated results of operations or financial
condition. |
|
|
|
|
In June 2006, the FASB issued Financial Interpretation (FIN) No. 48, Accounting for
Uncertainty in Income Taxes an Interpretation of FASB Statement No. 109 (FIN 48). FIN 48
clarifies the accounting for uncertainty in income taxes recognized in an enterprises
financial statements in accordance with SFAS No. 109, Accounting for Income Taxes. FIN 48
outlines a recognition threshold and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected to be taken in a tax return.
FIN 48 also provides guidance on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure, and transition. FIN 48 is effective for fiscal
years beginning after December 15, 2006, and is required to be adopted by Neoprobe beginning
January 1, 2007. We are currently evaluating the effect that FIN 48 may have on our results
of operations and financial condition, but we do not expect the adoption to have a material
impact. |
|
|
|
|
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 is effective for fiscal
years beginning after November 15, 2007, and is required to be adopted by Neoprobe beginning
January 1, 2008. We do not expect the adoption of SFAS No. 157 to have a material impact on
our consolidated results of operations or financial condition. |
|
|
|
|
In September 2006, the FASB also issued SFAS No. 158, Employers Accounting for Defined
Benefit Pension and Other Postretirement Plans an Amendment of FASB Statements No. 87, 88,
106, and 132(R) (SFAS No. 158). SFAS No. 158 requires an employer to recognize the
overfunded or underfunded status of a defined benefit postretirement plan (other than a
multiemployer plan) as an asset or liability in its statement of financial position and to
recognize changes in that funded status in the year in which the changes occur through
comprehensive income of a business entity or changes in unrestricted net assets of a
not-for-profit organization. SFAS No. 158 also requires an employer to measure the funded
status of a plan as of the date of its year-end statement of financial position, with
limited exceptions. SFAS No. 158 is effective for employers with publicly traded equity
securities as of the end of the fiscal year ending after December 15, 2006, and for
employers without publicly traded equity securities as of the end of the fiscal year ending
after June 15, 2007. Neoprobe is required to adopt SFAS No. 158 beginning January 1, 2007.
We do not expect the adoption of SFAS No. 158 to have a material impact on 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 |
F-16
|
|
|
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.
Early adoption is permitted as of the beginning of a fiscal year that begins on or before
November 15, 2007, provided the entity also elects to apply the provisions of SFAS No. 157,
Fair Value Measurements. We have not completed our review of the new guidance; however, we
do not expect the adoption of SFAS No. 159 to have a material impact on our consolidated
results of operations or financial condition. |
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
convertible securities, options and warrants, if dilutive.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
Year Ended |
|
|
|
December 31, 2006 |
|
|
December 31, 2005 |
|
|
|
Basic |
|
|
Diluted |
|
|
Basic |
|
|
Diluted |
|
|
|
Earnings |
|
|
Earnings |
|
|
Earnings |
|
|
Earnings |
|
|
|
Per Share |
|
|
Per Share |
|
|
Per Share |
|
|
Per Share |
|
Outstanding shares |
|
|
59,624,379 |
|
|
|
59,624,379 |
|
|
|
58,622,059 |
|
|
|
58,622,059 |
|
Effect of weighting changes
in outstanding shares |
|
|
(907,786 |
) |
|
|
(907,786 |
) |
|
|
(58,164 |
) |
|
|
(58,164 |
) |
Contingently issuable shares |
|
|
(130,000 |
) |
|
|
(130,000 |
) |
|
|
(130,000 |
) |
|
|
(130,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted shares |
|
|
58,586,593 |
|
|
|
58,586,593 |
|
|
|
58,433,895 |
|
|
|
58,433,895 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There is no difference in basic and diluted loss per share related to 2006 or 2005. The net
loss per common share for 2006 and 2005 excludes the effects of 41,873,016 and 40,648,684,
respectively, common shares issuable upon exercise of outstanding stock options and warrants into
our common stock or upon the conversion of convertible debt since such inclusion would be
anti-dilutive.
3. |
|
Accounts Receivable and Concentrations of Credit Risk: |
Accounts receivable at December 31, 2006 and 2005, net of allowance for doubtful accounts of $0 and
$1,000, respectively, consist of the following:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Trade |
|
$ |
1,243,114 |
|
|
$ |
663,898 |
|
Other |
|
|
2,975 |
|
|
|
9,110 |
|
|
|
|
|
|
|
|
|
|
$ |
1,246,089 |
|
|
$ |
673,008 |
|
|
|
|
|
|
|
|
At December 31, 2006 and 2005, approximately 86% and 91%, respectively, of net accounts
receivable are 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.
F-17
Accrued liabilities at December 31, 2006 and 2005 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Contracted services and other |
|
$ |
401,224 |
|
|
$ |
540,932 |
|
Compensation |
|
|
91,167 |
|
|
|
204,421 |
|
Warranty reserve |
|
|
44,858 |
|
|
|
41,185 |
|
Inventory purchases |
|
|
6,966 |
|
|
|
35,243 |
|
|
|
|
|
|
|
|
|
|
$ |
544,215 |
|
|
$ |
821,781 |
|
|
|
|
|
|
|
|
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. 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, 2006 and 2005 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Warranty reserve at beginning of year |
|
$ |
41,185 |
|
|
$ |
66,000 |
|
Provision for warranty claims and
changes in reserve for warranties |
|
|
40,103 |
|
|
|
24,539 |
|
Payments charged against the reserve |
|
|
(36,430 |
) |
|
|
(49,354 |
) |
|
|
|
|
|
|
|
Warranty reserve at end of year |
|
$ |
44,858 |
|
|
$ |
41,185 |
|
|
|
|
|
|
|
|
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 (the 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 originally due on December 13, 2008.
All of our material assets, except the intellectual property associated with our Lymphoseek and
RIGS ® products under development, have been pledged as collateral for these
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, interest and other charges on the notes when due; we use the proceeds from the sale of
the notes only for permitted purposes such as Lymphoseek development and general corporate
purposes; we nominate and recommend for election as a director a person designated by the holders
of the notes (as of December 31, 2006, the holders of the notes have not designated a potential
board member); 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
F-18
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.
As part of the original transaction, we issued the investors 10,125,000 Series T warrants to
purchase our common stock at an exercise price of $0.46 per share, expiring in December 2009. The
fair value of the warrants issued to the investors was $1,315,000 on the date of issuance and was
determined by a third-party valuation expert using the Black-Scholes option pricing model with the
following assumptions: an average risk-free interest rate of 3.4%, volatility of 50% and no
expected dividend rate. In connection with this financing, we also issued 1,600,000 Series U
warrants to purchase 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
placement agents was $208,014 using the Black-Scholes option pricing model with the same
assumptions used to determine the fair value of the warrants issued to the investors. The value of
the beneficial conversion feature of the notes was estimated at $1,315,000 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 and were
being amortized over the term of the notes using an effective interest rate of 19.8%. The fair
value of the warrants issued to the placement agents was recorded as a deferred debt issuance cost
and was being amortized over the term of the notes.
U.S. generally accepted accounting principles also required us at the time of the original
transaction to classify the warrants issued in connection with the placement as a liability due to
penalty provisions contained in the securities purchase agreement. The penalty provisions could
have required us to pay a penalty of 0.0667% per day of the total debt amount if we failed to meet
certain registration deadlines, or if our stock was suspended from trading for more than 30 days.
As a liability, the warrants were considered a derivative instrument that were required to be
periodically marked to market on our consolidated balance sheet. We estimated the fair value of
the warrants at December 31, 2004 using the Black-Scholes option pricing model with the following
assumptions: an average risk-free interest rate of 3.4%, volatility of 50% and no expected dividend
rate. On February 16, 2005, Neoprobe and the investors confirmed in writing their intention that
the penalty provisions which led to this accounting treatment were intended to apply only to the
$8.1 million principal balance of the promissory notes and underlying conversion shares and not to
the warrant shares. Because the value of our stock increased $0.02 per share from $0.59 per share
at December 31, 2004 to $0.61 per share at February 16, 2005, the effect of marking the warrant
liability to market resulted in an increase in the estimated fair value of the warrant liability
of $142,427 which was recorded as non-cash expense during the first quarter of 2005. The estimated
fair value of the warrant liability was then reclassified to additional paid-in capital during the
first quarter of 2005.
In November 2006, we amended the Agreement and modified several of the key terms in the related
notes. The original notes were thereby cancelled and replacement notes were issued to the
noteholders which bear interest at 12% per annum, payable on March 31, June 30, September 30 and
December 31 of each year. The maturity of the notes was modified as follows: $500,000 due January
8, 2007; $1,250,000 due July 9, 2007; $1,750,000 due January 7, 2008; $2,000,000 due July 7, 2008
and the remaining $2,600,000 due January 7, 2009. Neoprobe is also required to make mandatory
repayments of principal to the Great Point Funds under certain circumstances such as asset
dispositions, partnering transactions and sales of equity. Such mandatory repayments are applied
against future scheduled principal payments. In exchange for the increased interest rate and
accelerated principal repayment schedule, the noteholders 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. In addition, Neoprobe may make optional
prepayments to the Great Point Funds by giving them ten (10) business days notice during which time
the noteholders may decide to convert the notes into common stock of the company. The new notes
remain freely convertible into shares of our common stock at a price of $0.40 per share. Neoprobe
may force conversion of the notes prior to their stated maturity under certain circumstances.
F-19
As of December 31, 2006 and 2005, our deferred tax assets in the U.S. were approximately $39.6
million and $39.3 million, respectively. The components of our deferred tax assets, pursuant to
SFAS No. 109, Accounting for Income Taxes, are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
|
2006 |
|
|
2005 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Federal net operating loss carryforwards |
|
$ |
32,227,107 |
|
|
$ |
32,247,897 |
|
State net operating loss carryforwards |
|
|
2,273,948 |
|
|
|
2,304,919 |
|
R&D credit carryforwards |
|
|
4,722,457 |
|
|
|
4,418,656 |
|
Temporary differences |
|
|
354,340 |
|
|
|
325,077 |
|
Deferred tax assets before valuation allowance |
|
|
39,577,852 |
|
|
|
39,296,549 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance |
|
|
(39,577,852 |
) |
|
|
(39,296,549 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 2006 and 2005.
As of December 31, 2006 and 2005, 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, 2006
and 2005. 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 (that is, 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.
Under Sections 382 and 383 of the Internal Revenue Code (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.
F-20
Reconciliations between the statutory federal income tax rate and our effective tax rate are
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
Amount |
|
|
% |
|
|
Amount |
|
|
% |
|
Benefit at statutory rate |
|
$ |
(1,612,013 |
) |
|
|
(34.0 |
%) |
|
$ |
(1,675,843 |
) |
|
|
(34.0 |
%) |
Adjustments to valuation allowance |
|
|
1,462,443 |
|
|
|
30.8 |
% |
|
|
1,442,711 |
|
|
|
29.3 |
% |
Other |
|
|
149,570 |
|
|
|
3.2 |
% |
|
|
233,132 |
|
|
|
4.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefit per financial statements |
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax assets of $1.1 million related to net operating loss carryforwards and $98,000 related
to R&D credit carryforwards expired during 2006.
|
a. |
|
Stock Warrants: At December 31, 2006, there are 17.0 million warrants outstanding to
purchase our common stock. The warrants are exercisable at prices ranging from $0.13 to
$0.50 per share with a weighted average exercise price per share of $0.40. |
|
|
|
|
The following table summarizes information about our outstanding warrants at December 31,
2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise |
|
Number of |
|
|
|
|
Price |
|
Warrants |
|
Expiration Date |
Series Q |
|
$0.13 |
|
|
875,000 |
|
|
April 2008 |
Series Q |
|
$0.50 |
|
|
375,000 |
|
|
March 2009 |
Series R |
|
$0.28 |
|
|
2,808,898 |
|
|
October 2008 |
Series S |
|
$0.28 |
|
|
1,195,478 |
|
|
October 2008 |
Series T |
|
$0.46 |
|
|
10,125,000 |
|
|
December 2009 |
Series U |
|
$0.46 |
|
|
1,600,000 |
|
|
December 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.40 |
|
|
16,979,376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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. All 1,250,000 Series Q warrants
related to the bridge loans remain outstanding at December 31, 2006. |
|
|
b. |
|
Private Placement: In November 2003, we executed common stock purchase agreements with
certain investors for the purchase of 12,173,914 shares of our common stock at a price of
$0.23 per share for net proceeds of $2.4 million. In addition, 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 2005, certain investors and
placement agents exercised a total of 206,865 warrants related to this placement, resulting
in the issuance of 206,865 shares of our common stock and we realized net proceeds of
$57,922. No warrants were exercised during 2006. |
|
|
c. |
|
Common Stock Purchase Agreement: In December 2006, we entered into a common stock
purchase agreement with Fusion Capital Fund II, LLC (Fusion). A registration statement |
F-21
|
|
|
registering for resale up to 12,000,000 shares of our common stock became effective on
December 28, 2006. We have authorized up to 12,000,000 shares of our common stock for sale
to Fusion under the agreement. Under the terms of the agreement, in December 2006, we issued
720,000 shares of common stock as an initial commitment fee. We are also required to issue
to Fusion up to an additional 720,000 shares of our common stock as an additional commitment
fee in connection with future purchases made by Fusion. The additional 720,000 shares will
be issued pro rata as we sell our common stock to Fusion under the agreement, resulting in a
total commitment fee of 1,440,000 shares of our common stock if the entire $6.0 million in
value of stock is sold. Under the terms of the agreement, generally we have the right but
not the obligation from time to time to sell our shares to Fusion in amounts between $50,000
and $1.0 million depending on certain conditions set forth in the agreement. We have the
right to control the timing and amount of any sales of our shares to Fusion. The price of shares sold to Fusion will generally be based on market prices for purchases that are not
subject to the floor price of $0.20 per share. The common stock purchase agreement may be
terminated by us at any time at our discretion without any cost to us. During 2006, we sold
a total of 208,333 shares of our common stock under the agreement, realized gross proceeds
of $50,000 from such sales, and issued Fusion 6,000 shares of our common stock as additional
commitment fees related to such sales. |
|
|
d. |
|
Common Stock Reserved: We have reserved 43,204,849 shares of authorized common stock
for the exercise of all outstanding options, warrants, and convertible debt. |
9. |
|
Shareholder Rights Plan: |
During July 1995, our Board of Directors adopted a shareholder rights plan. Under the plan, one
Right was to be distributed for each share of common stock held by shareholders on the close of
business on August 28, 1995. The Rights were exercisable only if a person and its affiliate
commenced a tender offer or exchange offer for 15% or more of our common stock, or if there was a
public announcement that a person and its affiliate had acquired beneficial ownership of 15% or
more of the common stock, and if we did not redeem the Rights during the specified redemption
period. Initially, each Right, upon becoming exercisable, would have entitled the holder to
purchase from us one unit consisting of 1/100 th of a share of Series A Junior
Participating preferred stock at an exercise price of $35 (which was subject to adjustment). Once
the Rights became exercisable, if any person, including its affiliate, acquired 15% or more of our
common stock, each Right other than the Rights held by the acquiring person and its affiliate would
have become a right to acquire common stock having a value equal to two times the exercise price of
the Right. We were entitled to redeem the Rights for $0.01 per Right at any time prior to the
expiration of the redemption period. The shareholder rights plan and the Rights expired on August
28, 2005.
10. |
|
Segments and Subsidiary Information: |
|
a. |
|
Segments: We report information about our operating segments using the management
approach in accordance with SFAS No. 131, Disclosures about Segments of an Enterprise and
Related Information. This information is based on the way management organizes and reports
the segments within the enterprise for making operating decisions and assessing
performance. Our reportable segments are identified based on differences in products,
services and markets served. There were no inter-segment sales. We own or have rights to
intellectual property involving two primary types of medical device products, including
gamma detection instruments currently used primarily in the application of SLNB, and blood
flow measurement devices. We also own or have rights to intellectual property related to
several drug and therapy products. |
F-22
|
|
|
The information in the following table is derived directly from each reportable segments
financial reporting. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gamma |
|
|
Blood |
|
|
Drug and |
|
|
|
|
|
|
|
|
|
Detection |
|
|
Flow |
|
|
Therapy |
|
|
|
|
|
|
|
($ amounts in thousands) |
|
Devices |
|
|
Devices |
|
|
Products |
|
|
Corporate |
|
|
Total |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States1 |
|
$ |
5,214 |
|
|
$ |
80 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5,294 |
|
International |
|
|
231 |
|
|
|
526 |
|
|
|
|
|
|
|
|
|
|
|
757 |
|
Research and development expenses |
|
|
952 |
|
|
|
708 |
|
|
|
2,143 |
|
|
|
|
|
|
|
3,803 |
|
Selling, general and administrative expenses,
excluding depreciation and
amortization2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,664 |
|
|
|
2,664 |
|
Depreciation and amortization |
|
|
103 |
|
|
|
250 |
|
|
|
|
|
|
|
59 |
|
|
|
412 |
|
Income (loss) from operations3 |
|
|
2,237 |
|
|
|
(831 |
) |
|
|
(2,143 |
) |
|
|
(2,723 |
) |
|
|
(3,460 |
) |
Other income (expense)4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,281 |
) |
|
|
(1,281 |
) |
Total assets, net of depreciation and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States operations |
|
|
1,961 |
|
|
|
612 |
|
|
|
57 |
|
|
|
3,510 |
|
|
|
6,140 |
|
Israeli operations (Cardiosonix Ltd.) |
|
|
|
|
|
|
1,894 |
|
|
|
|
|
|
|
|
|
|
|
1,894 |
|
Capital expenditures |
|
|
102 |
|
|
|
7 |
|
|
|
|
|
|
|
35 |
|
|
|
144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States1 |
|
$ |
5,459 |
|
|
$ |
58 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5,517 |
|
International |
|
|
120 |
|
|
|
282 |
|
|
|
|
|
|
|
|
|
|
|
402 |
|
Research and development expenses |
|
|
276 |
|
|
|
1,414 |
|
|
|
2,342 |
|
|
|
|
|
|
|
4,032 |
|
Selling, general and administrative expenses,
excluding depreciation and
amortization2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,552 |
|
|
|
2,552 |
|
Depreciation and amortization |
|
|
137 |
|
|
|
408 |
|
|
|
1 |
|
|
|
58 |
|
|
|
604 |
|
Income (loss) from operations3 |
|
|
2,943 |
|
|
|
(1,634 |
) |
|
|
(2,343 |
) |
|
|
(2,610 |
) |
|
|
(3,644 |
) |
Other income (expense) 4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,285 |
) |
|
|
(1,285 |
) |
Total assets, net of depreciation and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States operations |
|
|
1,171 |
|
|
|
318 |
|
|
|
28 |
|
|
|
7,734 |
|
|
|
9,251 |
|
Israeli operations (Cardiosonix Ltd.) |
|
|
|
|
|
|
2,319 |
|
|
|
|
|
|
|
|
|
|
|
2,319 |
|
Capital expenditures |
|
|
|
|
|
|
64 |
|
|
|
1 |
|
|
|
21 |
|
|
|
86 |
|
|
|
|
1 |
|
All sales to EES are made in the United States. EES distributes the product globally through its international affiliates. |
|
2. |
|
Selling, 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. |
|
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. |
F-23
|
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 operations have been included in our
consolidated results from the date of acquisition. |
|
|
|
|
As a part of the acquisition, we also entered into a royalty agreement with the three
founders of Cardiosonix. Under the terms of the royalty agreement, which expired December
31, 2006, we are obligated to pay the founders an aggregate one percent royalty on up to
$120 million in net revenue generated by the sale of Cardiosonix blood flow products through
2006. As of December 31, 2006, approximately $2,000 of founders royalties were accrued
under the royalty agreement. |
|
a. |
|
Supply Agreements: In December 1997, we entered into an exclusive supply agreement
with eV Products (eV), a division of II-VI Incorporated, for the supply of certain crystals
and associated electronics to be used in the manufacture of our proprietary line of
hand-held gamma detection instruments. The original term of the agreement expired on
December 31, 2002 and was automatically extended during 2002 through December 31, 2005;
however, the agreement was no longer exclusive throughout the extended period. Total
purchases were $770,000 and $430,000 for the years ended December 31, 2006 and 2005,
respectively. We have issued purchase orders under the same terms as the original agreement
for $409,000 of crystal modules for delivery of product through December 2007. |
|
|
|
|
In February 2004, we entered into a product supply agreement with TriVirix International
(TriVirix) for the manufacture of the neo2000 control unit, 14mm probe,
Bluetooth® wireless probes, 11mm laparoscopic probe,
Quantix/ORTM control unit and Quantix/NDTM control
unit. The initial term of the agreement expires in January 2007, but may be automatically
extended for successive one-year periods. Either party has the right to terminate the
agreement at any time upon one hundred eighty (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 $1.1 million for the years
ended December 31, 2006 and 2005. We have issued purchase orders under the agreement for
$1.4 million of our products for delivery through May 2008. |
|
|
b. |
|
Marketing and Distribution Agreement: During 1999, we entered into a distribution
agreement with EES covering our gamma detection devices used in SLNB. 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. Under the agreement, we manufacture and
sell our current line of SLNB 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. |
F-24
|
|
|
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. 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. |
|
|
c. |
|
Research and Development Agreements: Cardiosonix 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 $775,000 in grants from the OCS. In return for the OCSs 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 2006, we have paid the OCS
a total of $36,000 in royalties related to sales of products developed under this program.
As of December 31, 2006, we have accrued obligations for royalties totaling $10,000. |
|
|
|
|
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 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 $91,000
and $44,000 in 2006 and 2005, 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 is effective until March 31, 2007. Under the terms of the
agreement, UCSD has granted us limited rights to make and use licensed products as defined
in the agreement and to |
F-25
|
|
|
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
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. Total costs related to the UCSD evaluation
license agreement were $18,000 and $36,000 in 2006 and 2005, respectively, 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 partys responsibilities and
commitments with respect to Cira Bio and the license agreement with OSU. Total costs related
to the OSU license agreement were $9,000 in 2006, and were recorded as research and
development expenses. |
|
|
d. |
|
Employment Agreements: We maintain employment agreements with six of our officers. The
employment agreements contain change in control provisions that would entitle each of the
officers to one to two 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. Our maximum
contingent liability under these agreements in such an event is approximately $1.9 million.
The employment agreements also provide for severance, disability and death benefits. See
Note 16(a). |
We lease certain office equipment under capital leases which expire from 2007 to 2009. In August
2003, we entered into an operating lease agreement for office space, which originally expired in
September 2006. In February 2005, we entered into another operating lease agreement for additional
office space expiring in January 2008. The February 2005 lease agreement also extended the term of
the original lease through January 2008.
In June 2004, Cardiosonix entered into an operating sublease agreement for office space that
expired in June 2005. In July 2004, Cardiosonix entered into a sublease agreement for parking space
that expired in June 2005, and automatically renewed until either party terminated the agreement.
The Cardiosonix office space and parking space subleases expired in January 2006.
F-26
The future minimum lease payments for the years ending December 31 are as follows:
|
|
|
|
|
|
|
|
|
|
|
Capital |
|
|
Operating |
|
|
|
Leases |
|
|
Leases |
|
2007 |
|
$ |
18,008 |
|
|
$ |
100,129 |
|
2008 |
|
|
15,889 |
|
|
|
8,561 |
|
2009 |
|
|
2,485 |
|
|
|
|
|
2010 |
|
|
|
|
|
|
|
|
2011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36,382 |
|
|
$ |
108,690 |
|
|
|
|
|
|
|
|
|
Less amount representing interest |
|
|
4,527 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Present value of net minimum
lease payments |
|
|
31,855 |
|
|
|
|
|
Less current portion |
|
|
14,841 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligations,
excluding current portion |
|
$ |
17,014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total rental expense was $163,000 and $221,000 for the years ended December 31, 2006 and 2005,
respectively.
13. |
|
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
employees contribution with our common stock, up to a defined maximum. We accrued expenses of
$30,000 and $27,000 during 2006 and 2005, respectively, related to common stock to be subsequently
contributed to the plan.
14. |
|
Supplemental Disclosure for Statements of Cash Flows: |
We paid interest aggregating $687,000 and $677,000 for the years ended December 31, 2006 and 2005,
respectively. During 2005, we purchased equipment under capital leases totaling $23,000. No new
equipment was leased during 2006. During 2006 and 2005, we transferred $96,000 and $17,000,
respectively, in inventory to fixed assets related to the creation and maintenance of a pool of
service loaner equipment. Also during 2006 and 2005, we prepaid $175,000 and $243,000,
respectively, in insurance through the issuance of notes payable to finance companies with weighted
average interest rates of 6%. The notes payable to a finance company issued in 2006 mature in July
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.
Effective January 1, 2007, we entered into new employment agreements with six executive officers.
The new agreements have substantially similar terms to the previous agreements. See Note 11(d).
F-27
17. |
|
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
(Amounts in thousands, except per share data) |
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
Statement of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
6,051 |
|
|
$ |
5,919 |
|
|
$ |
5,353 |
|
|
$ |
5,564 |
|
|
$ |
3,383 |
|
License and other revenue |
|
|
|
|
|
|
|
|
|
|
600 |
|
|
|
946 |
|
|
|
1,538 |
|
Gross profit |
|
|
3,419 |
|
|
|
3,543 |
|
|
|
3,608 |
|
|
|
3,385 |
|
|
|
2,570 |
|
Research and development expenses |
|
|
3,803 |
|
|
|
4,032 |
|
|
|
2,454 |
|
|
|
1,894 |
|
|
|
2,324 |
|
Selling, general and administrative expenses |
|
|
3,076 |
|
|
|
3,156 |
|
|
|
3,153 |
|
|
|
3,103 |
|
|
|
3,267 |
|
Acquired in-process research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(28 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(3,460 |
) |
|
|
(3,644 |
) |
|
|
(1,999 |
) |
|
|
(1,611 |
) |
|
|
(2,993 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expenses) income |
|
|
(1,281 |
) |
|
|
(1,285 |
) |
|
|
(1,542 |
) |
|
|
(188 |
) |
|
|
29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,741 |
) |
|
$ |
(4,929 |
) |
|
$ |
(3,541 |
) |
|
$ |
(1,799 |
) |
|
$ |
(2,964 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
Diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing loss per
common share: (1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
58,587 |
|
|
|
58,434 |
|
|
|
56,764 |
|
|
|
40,338 |
|
|
|
36,045 |
|
Diluted |
|
|
58,587 |
|
|
|
58,434 |
|
|
|
56,764 |
|
|
|
40,338 |
|
|
|
36,045 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
2006 |
|
2005 |
|
2004 |
|
2003 |
|
2002 |
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
8,034 |
|
|
$ |
11,570 |
|
|
$ |
15,366 |
|
|
$ |
7,385 |
|
|
$ |
7,080 |
|
Long-term obligations |
|
|
4,922 |
|
|
|
6,052 |
|
|
|
8,192 |
|
|
|
585 |
|
|
|
1,169 |
|
Accumulated deficit |
|
|
(135,688 |
) |
|
|
(130,947 |
) |
|
|
(126,018 |
) |
|
|
(122,477 |
) |
|
|
(120,678 |
) |
|
|
|
(1) |
|
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 convertible securities, options and warrants, if
dilutive. |
F-28
Neoprobe Corporation and Subsidiaries
Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
ASSETS |
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
1,207,011 |
|
|
$ |
2,502,655 |
|
Accounts receivable, net |
|
|
1,143,268 |
|
|
|
1,246,089 |
|
Inventory |
|
|
1,138,892 |
|
|
|
1,154,376 |
|
Prepaid expenses and other |
|
|
141,490 |
|
|
|
430,623 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
3,630,661 |
|
|
|
5,333,743 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment |
|
|
2,310,700 |
|
|
|
2,238,050 |
|
Less accumulated depreciation and amortization |
|
|
1,967,741 |
|
|
|
1,882,371 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
342,959 |
|
|
|
355,679 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and trademarks |
|
|
3,124,296 |
|
|
|
3,131,391 |
|
Acquired technology |
|
|
237,271 |
|
|
|
237,271 |
|
|
|
|
|
|
|
|
|
|
|
3,361,567 |
|
|
|
3,368,662 |
|
Less accumulated amortization |
|
|
1,650,343 |
|
|
|
1,540,145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,711,224 |
|
|
|
1,828,517 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
398,829 |
|
|
|
515,593 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
6,083,673 |
|
|
$ |
8,033,532 |
|
|
|
|
|
|
|
|
F-29
Neoprobe Corporation and Subsidiaries
Consolidated Balance Sheets, continued
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS
DEFICIT |
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(unaudited) |
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
820,772 |
|
|
$ |
668,288 |
|
Accrued liabilities and other |
|
|
870,382 |
|
|
|
544,215 |
|
Capital lease obligations |
|
|
14,400 |
|
|
|
14,841 |
|
Deferred revenue |
|
|
232,470 |
|
|
|
348,568 |
|
Notes payable to finance companies |
|
|
19,847 |
|
|
|
136,925 |
|
Notes payable to investors, current portion, net of discounts
of $102,480 and $53,585, respectively |
|
|
2,572,520 |
|
|
|
1,696,415 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
4,530,391 |
|
|
|
3,409,252 |
|
|
|
|
|
|
|
|
|
Capital lease obligations |
|
|
9,582 |
|
|
|
17,014 |
|
Deferred revenue |
|
|
43,655 |
|
|
|
40,495 |
|
Notes payable to CEO, net of discounts of $15,167
and $19,030, respectively |
|
|
84,833 |
|
|
|
80,970 |
|
Notes payable to investors, net of discounts of $1,109,506
and $1,468,845, respectively |
|
|
3,390,494 |
|
|
|
4,781,155 |
|
Other liabilities |
|
|
7,484 |
|
|
|
2,673 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
8,066,439 |
|
|
|
8,331,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders deficit: |
|
|
|
|
|
|
|
|
Preferred stock; $.001 par value; 5,000,000 shares
authorized at June 30, 2007 and December 31, 2006;
none issued and outstanding |
|
|
|
|
|
|
|
|
Common stock; $.001 par value; 150,000,000 shares
authorized, 62,739,731 and 59,624,379 shares issued and
outstanding at June 30, 2007 and December 31, 2006,
respectively |
|
|
62,740 |
|
|
|
59,624 |
|
Additional paid-in capital |
|
|
135,888,352 |
|
|
|
135,330,668 |
|
Accumulated deficit |
|
|
(137,933,858 |
) |
|
|
(135,688,319 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders deficit |
|
|
(1,982,766 |
) |
|
|
(298,027 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders deficit |
|
$ |
6,083,673 |
|
|
$ |
8,033,532 |
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
F-30
Neoprobe Corporation and Subsidiaries
Consolidated Statements of Operations
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
1,517,430 |
|
|
$ |
1,433,991 |
|
|
$ |
3,260,750 |
|
|
$ |
3,221,909 |
|
Cost of goods sold |
|
|
699,844 |
|
|
|
600,762 |
|
|
|
1,489,336 |
|
|
|
1,337,982 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
817,586 |
|
|
|
833,229 |
|
|
|
1,771,414 |
|
|
|
1,883,927 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
875,304 |
|
|
|
642,573 |
|
|
|
1,739,145 |
|
|
|
1,476,756 |
|
Selling, general and administrative |
|
|
650,293 |
|
|
|
753,812 |
|
|
|
1,432,869 |
|
|
|
1,606,295 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
1,525,597 |
|
|
|
1,396,385 |
|
|
|
3,172,014 |
|
|
|
3,083,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(708,011 |
) |
|
|
(563,156 |
) |
|
|
(1,400,600 |
) |
|
|
(1,199,124 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expenses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
19,199 |
|
|
|
61,788 |
|
|
|
44,257 |
|
|
|
127,991 |
|
Interest expense |
|
|
(444,702 |
) |
|
|
(363,426 |
) |
|
|
(886,847 |
) |
|
|
(719,960 |
) |
Other |
|
|
(1,128 |
) |
|
|
3,325 |
|
|
|
(2,349 |
) |
|
|
2,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other expenses |
|
|
(426,631 |
) |
|
|
(298,313 |
) |
|
|
(844,939 |
) |
|
|
(589,947 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,134,642 |
) |
|
$ |
(861,469 |
) |
|
$ |
(2,245,539 |
) |
|
$ |
(1,789,071 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.02 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.03 |
) |
Diluted |
|
$ |
(0.02 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
61,608,782 |
|
|
|
58,560,046 |
|
|
|
60,635,448 |
|
|
|
58,535,631 |
|
Diluted |
|
|
61,608,782 |
|
|
|
58,560,046 |
|
|
|
60,635,448 |
|
|
|
58,535,631 |
|
See accompanying notes to the consolidated financial statements.
F-31
Neoprobe Corporation and Subsidiaries
Consolidated Statements of Cash Flows
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,245,539 |
) |
|
$ |
(1,789,071 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
207,508 |
|
|
|
196,668 |
|
Amortization of debt discount and debt offering costs |
|
|
431,071 |
|
|
|
388,627 |
|
Stock compensation expense |
|
|
67,224 |
|
|
|
138,526 |
|
Other |
|
|
34,020 |
|
|
|
21,019 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
102,821 |
|
|
|
(238,235 |
) |
Inventory |
|
|
(28,544 |
) |
|
|
(64,773 |
) |
Prepaid expenses and other assets |
|
|
123,349 |
|
|
|
261,208 |
|
Accounts payable |
|
|
152,484 |
|
|
|
74,099 |
|
Accrued liabilities and other liabilities |
|
|
330,978 |
|
|
|
(534,451 |
) |
Deferred revenue |
|
|
(112,938 |
) |
|
|
(14,107 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(937,566 |
) |
|
|
(1,560,490 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Maturities of available-for-sale securities |
|
|
|
|
|
|
1,531,000 |
|
Purchases of property and equipment |
|
|
(36,202 |
) |
|
|
(23,057 |
) |
Proceeds from sales of property and equipment |
|
|
|
|
|
|
4,097 |
|
Patent and trademark costs |
|
|
(1,885 |
) |
|
|
(20,846 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
|
(38,087 |
) |
|
|
1,491,194 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
650,000 |
|
|
|
|
|
Payment of stock offering costs |
|
|
(20,040 |
) |
|
|
|
|
Payment of debt issuance costs |
|
|
|
|
|
|
(5,000 |
) |
Payment of notes payable |
|
|
(942,078 |
) |
|
|
(130,435 |
) |
Payments under capital leases |
|
|
(7,873 |
) |
|
|
(9,496 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in financing activities |
|
|
(319,991 |
) |
|
|
(144,931 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash |
|
|
(1,295,644 |
) |
|
|
(214,227 |
) |
|
|
|
|
|
|
|
|
|
Cash, beginning of period |
|
|
2,502,655 |
|
|
|
4,940,946 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end of period |
|
$ |
1,207,011 |
|
|
$ |
4,726,719 |
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
F-32
Notes to the Consolidated Financial Statements
(Unaudited)
1. |
|
Basis of Presentation |
|
|
|
The information presented as of June 30, 2007 and for the three-month and six-month periods
ended June 30, 2007 and June 30, 2006 is unaudited, but includes all adjustments (which consist
only of normal recurring adjustments) that the management of Neoprobe Corporation (Neoprobe,
the company, or we) believes to be necessary for the fair presentation of results for the
periods presented. Certain information and footnote disclosures normally included in financial
statements prepared in accordance with U.S. generally accepted accounting principles have been
condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange
Commission. The results for the interim periods are not necessarily indicative of results to
be expected for the year. The consolidated financial statements should be read in conjunction
with Neoprobes audited consolidated financial statements for the year ended December 31, 2006,
which were included as part of our Annual Report on Form 10-KSB. |
|
|
|
Our consolidated financial statements include the accounts of Neoprobe, our wholly-owned
subsidiary, Cardiosonix Ltd. (Cardiosonix), and our 90%-owned subsidiary, Cira Biosciences,
Inc. (Cira Bio). All significant inter-company accounts were eliminated in consolidation. |
|
2. |
|
Stock-Based Compensation |
|
|
|
At June 30, 2007, 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 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 awards may be granted to our consultants and
agents. Total shares authorized under each plan are 2 million shares, 1.5 million shares and 5
million shares, respectively. Although options are still outstanding under the Amended Plan
and the 1996 Plan, these plans are considered expired and no new grants may be made from them.
Under all three plans, the exercise price of each option is greater than or equal to the
closing market price of our common stock on the day prior to the date of the grant. |
|
|
|
Options granted under the Amended Plan, the 1996 Plan and the 2002 Plan generally vest on an
annual basis over one to three years. Outstanding options under the plans, if not exercised,
generally expire ten years from their date of grant or 90 days from the date of an optionees
separation from employment with us. |
|
|
|
Compensation cost arising from stock-based awards is recognized as expense using the
straight-line method over the vesting period. As of June 30, 2007, there was approximately
$84,000 of total unrecognized compensation cost related to unvested stock-based awards, which
we expect to recognize over remaining weighted average vesting terms of 1.5 years. For the
three-month periods ended June 30, 2007 and 2006, our total stock-based compensation expense
was approximately $33,000 and $59,000, respectively. For the six-month periods ended June 30,
2007 and 2006, our total stock-based compensation expense was approximately $67,000 and
$139,000, respectively. We have not recorded any income tax benefit related to stock-based
compensation in any of the three-month and six-month periods ended June 30, 2007 and 2006. |
|
|
|
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
companys 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. |
F-33
|
|
A summary of stock option activity under our stock option plans as of June 30, 2007, and
changes during the six-month period then ended is presented below: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
Number |
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
of |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Options |
|
|
Price |
|
|
Life |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, January 1, 2007 |
|
|
5,975,473 |
|
|
$ |
0.42 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(96,667 |
) |
|
$ |
0.32 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, June 30, 2007 |
|
|
5,878,806 |
|
|
$ |
0.42 |
|
|
5.2 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, June 30, 2007 |
|
|
4,888,806 |
|
|
$ |
0.44 |
|
|
4.8 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3. |
|
Comprehensive Income (Loss) |
|
|
|
We had no accumulated other comprehensive income (loss) activity during the three-month and
six-month periods ended June 30, 2007. Due to our net operating loss position, there are no
income tax effects on comprehensive income (loss) components for the three-month and six-month
periods ended June 30, 2007 and 2006. |
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
June 30, 2006 |
|
|
June 30, 2006 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(861,469 |
) |
|
$ |
(1,789,071 |
) |
Unrealized gains (losses) on securities |
|
|
55 |
|
|
|
(2,018 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss |
|
$ |
(861,414 |
) |
|
$ |
(1,791,089 |
) |
|
|
|
|
|
|
|
4. |
|
Earnings Per Share |
|
|
|
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 convertible securities, options and warrants, if dilutive. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
June 30, 2007 |
|
|
June 30, 2006 |
|
|
|
Basic |
|
|
Diluted |
|
|
Basic |
|
|
Diluted |
|
|
|
Earnings |
|
|
Earnings |
|
|
Earnings |
|
|
Earnings |
|
|
|
Per Share |
|
|
Per Share |
|
|
Per Share |
|
|
Per Share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding shares |
|
|
62,739,731 |
|
|
|
62,739,731 |
|
|
|
58,690,046 |
|
|
|
58,690,046 |
|
Effect of weighting changes
in outstanding shares |
|
|
(1,130,949 |
) |
|
|
(1,130,949 |
) |
|
|
|
|
|
|
|
|
Contingently issuable shares |
|
|
|
|
|
|
|
|
|
|
(130,000 |
) |
|
|
(130,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted shares |
|
|
61,608,782 |
|
|
|
61,608,782 |
|
|
|
58,560,046 |
|
|
|
58,560,046 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-34
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2007 |
|
|
June 30, 2006 |
|
|
|
Basic |
|
|
Diluted |
|
|
Basic |
|
|
Diluted |
|
|
|
Earnings |
|
|
Earnings |
|
|
Earnings |
|
|
Earnings |
|
|
|
Per Share |
|
|
Per Share |
|
|
Per Share |
|
|
Per Share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding shares |
|
|
62,739,731 |
|
|
|
62,739,731 |
|
|
|
58,690,046 |
|
|
|
58,690,046 |
|
Effect of weighting changes
in outstanding shares |
|
|
(2,104,283 |
) |
|
|
(2,104,283 |
) |
|
|
(24,415 |
) |
|
|
(24,415 |
) |
Contingently issuable shares |
|
|
|
|
|
|
|
|
|
|
(130,000 |
) |
|
|
(130,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted shares |
|
|
60,635,448 |
|
|
|
60,635,448 |
|
|
|
58,535,631 |
|
|
|
58,535,631 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There is no difference in basic and diluted loss per share related to the three-month and
six-month periods ended June 30, 2007 and 2006. The net loss per common share for these
periods excludes the effects of 40,055,682 and 41,242,351, respectively, common shares issuable
upon exercise of outstanding stock options and warrants into our common stock or upon the
conversion of convertible debt since such inclusion would be anti-dilutive. |
|
5. |
|
Inventory |
|
|
|
We capitalize certain inventory costs associated with our Lymphoseek® product prior
to regulatory approval and product launch, based on managements judgment of probable future
commercial use and net realizable value. We could be required to permanently write down
previously capitalized costs related to pre-approval or pre-launch inventory upon a change in
such judgment, due to a denial or delay of approval by regulatory bodies, a delay in
commercialization, or other potential factors. Conversely, our gross margins may be favorably
impacted if some or all of the inventory previously written down becomes available and is used
for commercial sale. During the three-month period ended June 30, 2007, we capitalized
$150,000 in inventory costs associated with our Lymphoseek product. During the second half of
2006, we capitalized $48,000 in inventory costs associated with our Lymphoseek product. |
|
|
|
The components of inventory are as follows: |
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and component parts |
|
$ |
404,186 |
|
|
$ |
522,225 |
|
Work-in-process |
|
|
151,741 |
|
|
|
167,188 |
|
Finished goods |
|
|
582,965 |
|
|
|
464,963 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,138,892 |
|
|
$ |
1,154,376 |
|
|
|
|
|
|
|
|
F-35
6. |
|
Intangible Assets |
|
|
|
The major classes of intangible assets are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
December 31, 2006 |
|
|
|
Wtd Avg |
|
|
Gross Carrying |
|
|
Accumulated |
|
|
Gross Carrying |
|
|
Accumulated |
|
|
|
Life |
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and
trademarks |
|
9.2 yrs |
|
$ |
3,124,296 |
|
|
$ |
1,463,635 |
|
|
$ |
3,131,391 |
|
|
$ |
1,370,291 |
|
Acquired technology |
|
1.5 yrs |
|
|
237,271 |
|
|
|
186,708 |
|
|
|
237,271 |
|
|
|
169,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
$ |
3,361,567 |
|
|
$ |
1,650,343 |
|
|
$ |
3,368,662 |
|
|
$ |
1,540,145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The estimated amortization expenses for the next five fiscal years are as follows: |
|
|
|
|
|
|
|
Estimated |
|
|
Amortization |
|
|
Expense |
|
|
|
|
|
For the year ended 12/31/2007 |
|
$ |
222,709 |
|
For the year ended 12/31/2008 |
|
|
216,116 |
|
For the year ended 12/31/2009 |
|
|
170,852 |
|
For the year ended 12/31/2010 |
|
|
170,033 |
|
For the year ended 12/31/2011 |
|
|
168,581 |
|
7. |
|
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. Our primary marketing partner, Ethicon Endo-Surgery, Inc. (EES), a
Johnson & Johnson company, also reimburses us for a portion of warranty expense incurred based
on end customer sales they make during a given fiscal year. Payments charged against the
reserve are disclosed net of EES estimated reimbursement. |
|
|
|
The activity in the warranty reserve account for the three-month and six-month periods ended
June 30, 2007 and 2006 is as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Warranty reserve at
beginning of period |
|
$ |
67,401 |
|
|
$ |
43,725 |
|
|
$ |
44,858 |
|
|
$ |
41,185 |
|
Provision for warranty claims and
changes in reserve for warranties |
|
|
39,153 |
|
|
|
9,823 |
|
|
|
71,905 |
|
|
|
23,274 |
|
Payments charged against the
reserve |
|
|
(16,378 |
) |
|
|
(10,883 |
) |
|
|
(26,587 |
) |
|
|
(21,794 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warranty reserve at end of period |
|
$ |
90,176 |
|
|
$ |
42,665 |
|
|
$ |
90,176 |
|
|
$ |
42,665 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-36
8. |
|
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 originally due on December 13, 2008. |
|
|
|
All of our material assets, except the intellectual property associated with our Lymphoseek and
RIGS® products under development, have been pledged as collateral for these 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, interest and other charges on the notes when due; we use the proceeds from the sale
of the notes only for permitted purposes such as Lymphoseek development and general corporate
purposes; we nominate and recommend for election as a director a person designated by the
holders of the notes (as of June 30, 2007, the holders of the notes have not designated a
potential board member); 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. |
|
|
|
As part of the original transaction, we issued the investors 10,125,000 Series T warrants to
purchase our common stock at an exercise price of $0.46 per share, expiring in December 2009.
The fair value of the warrants issued to the investors was $1,315,000 on the date of issuance
and was determined by a third-party valuation expert using the Black-Scholes option pricing
model with the following assumptions: an average risk-free interest rate of 3.4%, volatility of
50% and no expected dividend rate. In connection with this financing, we also issued 1,600,000
Series U warrants to purchase 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 placement agents was $208,014 using the Black-Scholes option pricing model with the same
assumptions used to determine the fair value of the warrants issued to the investors. The value
of the beneficial conversion feature of the notes was estimated at $1,315,000 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 and were being amortized over the term of the notes using an effective interest rate of
19.8%. The fair value of the warrants issued to the placement agents was recorded as a deferred
debt issuance cost and was being amortized over the term of the notes. |
|
|
|
In November 2006, we amended the Agreement and modified several of the key terms in the related
notes. The original notes were thereby cancelled and replacement notes were issued to the
noteholders which bear interest at 12% per annum, payable on March 31, June 30, September 30 and
December 31 of each year. The maturity of the notes was modified as follows: $500,000 due
January 8, 2007; $1,250,000 due July 9, 2007; $1,750,000 due January 7, 2008; $2,000,000 due
July 7, 2008 and the remaining $2,600,000 due January 7, 2009. Neoprobe is also required to
make mandatory repayments of principal to the Great Point Funds under certain circumstances such
as asset dispositions, partnering transactions and sales of equity. Such mandatory repayments
are applied against future scheduled principal payments. In exchange for the increased interest
rate and accelerated principal repayment schedule, the noteholders eliminated the financial
covenants under |
F-37
|
|
the original notes and eliminated certain conversion price adjustments from the original notes
related to sales of equity securities by Neoprobe. In addition, Neoprobe may make optional
prepayments to the Great Point Funds by giving them ten (10) business days notice during which
time the noteholders may decide to convert the notes into common stock of the company. The new
notes remain freely convertible into shares of our common stock at a price of $0.40 per share.
Neoprobe may force conversion of the notes prior to their stated maturity under certain
circumstances. During the six-month period ended June 30, 2007, we timely paid the $500,000
that was due on January 8, 2007, and made additional principal payments totaling $325,000
related to sales of equity. |
|
9. |
|
Stock Warrants |
|
|
|
At June 30, 2007 there are 17.0 million warrants outstanding to purchase our common stock. The
warrants are exercisable at prices ranging from $0.13 to $0.50 per share with a weighted average
exercise price $0.40 per share. |
|
10. |
|
Income Taxes |
|
|
|
Effective January 1, 2007, we adopted Financial Interpretation (FIN) No. 48, Accounting for
Uncertainty in Income Taxes an Interpretation of FASB Statement No. 109 (FIN 48). FIN 48
clarifies the accounting for uncertainty in income taxes recognized in an enterprises financial
statements in accordance with SFAS No. 109, Accounting for Income Taxes. FIN 48 outlines a
recognition threshold and measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax return. FIN 48 also
provides guidance on derecognition, classification, interest and penalties, accounting in
interim periods, disclosure, and transition. The adoption of FIN 48 had no effect on our
results of operations and financial condition. |
|
11. |
|
Segment and Subsidiary Information |
|
|
|
We report information about our operating segments using the management approach in accordance
with SFAS No. 131, Disclosures about Segments of an Enterprise and Related Information. This
information is based on the way management organizes and reports the segments within the
enterprise for making operating decisions and assessing performance. Our reportable segments
are identified based on differences in products, services and markets served. There were no
inter-segment sales. We own or have rights to intellectual property involving two primary types
of medical device products, including oncology instruments currently used primarily in the
application of sentinel lymph node biopsy (SLNB), and blood flow measurement devices. We also
own or have rights to intellectual property related to several drug and therapy products. |
F-38
The information in the following table is derived directly from each reportable segments
financial reporting. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug and Therapy |
|
|
|
|
($ amounts in thousands) |
|
Oncology Devices |
|
Blood Flow Devices |
|
Products |
|
Corporate |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States1 |
|
$ |
1,338 |
|
|
$ |
115 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,453 |
|
International |
|
|
40 |
|
|
|
24 |
|
|
|
|
|
|
|
|
|
|
|
64 |
|
Research and development expenses |
|
|
163 |
|
|
|
101 |
|
|
|
611 |
|
|
|
|
|
|
|
875 |
|
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
548 |
|
|
|
548 |
|
Depreciation and amortization |
|
|
25 |
|
|
|
66 |
|
|
|
|
|
|
|
11 |
|
|
|
102 |
|
Income (loss) from operations3 |
|
|
576 |
|
|
|
(114 |
) |
|
|
(611 |
) |
|
|
(559 |
) |
|
|
(708 |
) |
Other income (expenses)4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(427 |
) |
|
|
(427 |
) |
Total assets, net of depreciation
and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States operations |
|
|
1,759 |
|
|
|
698 |
|
|
|
161 |
|
|
|
1,804 |
|
|
|
4,422 |
|
Israeli operations (Cardiosonix Ltd.) |
|
|
|
|
|
|
1,662 |
|
|
|
|
|
|
|
|
|
|
|
1,662 |
|
Capital expenditures |
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States1 |
|
$ |
1,252 |
|
|
$ |
17 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,269 |
|
International |
|
|
33 |
|
|
|
132 |
|
|
|
|
|
|
|
|
|
|
|
165 |
|
Research and development expenses |
|
|
235 |
|
|
|
201 |
|
|
|
207 |
|
|
|
|
|
|
|
643 |
|
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
658 |
|
|
|
658 |
|
Depreciation and amortization |
|
|
22 |
|
|
|
59 |
|
|
|
|
|
|
|
15 |
|
|
|
96 |
|
Income (loss) from operations3 |
|
|
513 |
|
|
|
(196 |
) |
|
|
(207 |
) |
|
|
(673 |
) |
|
|
(563 |
) |
Other income (expenses)4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(298 |
) |
|
|
(298 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets, net of depreciation
and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States operations |
|
|
1,285 |
|
|
|
523 |
|
|
|
35 |
|
|
|
5,658 |
|
|
|
7,501 |
|
Israeli operations (Cardiosonix Ltd.) |
|
|
|
|
|
|
2,105 |
|
|
|
|
|
|
|
|
|
|
|
2,105 |
|
Capital expenditures |
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
5 |
|
|
|
6 |
|
F-39
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology |
|
|
|
|
|
Drug and Therapy |
|
|
|
|
($ amounts in thousands) |
|
Devices |
|
Blood Flow Devices |
|
Products |
|
Corporate |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States1 |
|
$ |
2,890 |
|
|
$ |
160 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
3,050 |
|
International |
|
|
125 |
|
|
|
86 |
|
|
|
|
|
|
|
|
|
|
|
211 |
|
Research and development expenses |
|
|
377 |
|
|
|
207 |
|
|
|
1,155 |
|
|
|
|
|
|
|
1,739 |
|
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,225 |
|
|
|
1,225 |
|
Depreciation and amortization |
|
|
51 |
|
|
|
132 |
|
|
|
|
|
|
|
25 |
|
|
|
208 |
|
Income (loss) from operations3 |
|
|
1,251 |
|
|
|
(247 |
) |
|
|
(1,155 |
) |
|
|
(1,250 |
) |
|
|
(1,401 |
) |
Other income (expenses) 4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(845 |
) |
|
|
(845 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets, net of depreciation
and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States operations |
|
|
1,759 |
|
|
|
698 |
|
|
|
161 |
|
|
|
1,804 |
|
|
|
4,422 |
|
Israeli operations (Cardiosonix Ltd.) |
|
|
|
|
|
|
1,662 |
|
|
|
|
|
|
|
|
|
|
|
1,662 |
|
Capital expenditures |
|
|
16 |
|
|
|
9 |
|
|
|
|
|
|
|
11 |
|
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States1 |
|
$ |
2,731 |
|
|
$ |
52 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,783 |
|
International |
|
|
128 |
|
|
|
311 |
|
|
|
|
|
|
|
|
|
|
|
439 |
|
Research and development expenses |
|
|
347 |
|
|
|
458 |
|
|
|
672 |
|
|
|
|
|
|
|
1,477 |
|
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,409 |
|
|
|
1,409 |
|
Depreciation and amortization |
|
|
50 |
|
|
|
118 |
|
|
|
|
|
|
|
29 |
|
|
|
197 |
|
Income (loss) from operations3 |
|
|
1,306 |
|
|
|
(395 |
) |
|
|
(672 |
) |
|
|
(1,438 |
) |
|
|
(1,199 |
) |
Other income (expenses) 4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(590 |
) |
|
|
(590 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets, net of depreciation
and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States operations |
|
|
1,285 |
|
|
|
523 |
|
|
|
35 |
|
|
|
5,658 |
|
|
|
7,501 |
|
Israeli operations (Cardiosonix Ltd.) |
|
|
|
|
|
|
2,105 |
|
|
|
|
|
|
|
|
|
|
|
2,105 |
|
Capital expenditures |
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
21 |
|
|
|
23 |
|
|
|
|
1 |
|
All sales to EES are made in the United States. EES distributes the product
globally through its international affiliates. |
|
2 |
|
Selling, general and administrative expenses, excluding depreciation and
amortization, represent expenses that relate to the general administration of the company
and as such are not currently allocated to our individual reportable segments. |
|
3 |
|
Income (loss) from operations does not reflect the allocation of selling, general
and administrative expenses to the operating segments. |
|
4 |
|
Amounts consist primarily of interest income and interest expense which are not
currently allocated to our individual reportable segments. |
12. |
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Supplemental Disclosure for Statements of Cash Flows |
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|
|
During the six-month periods ended June 30, 2007 and 2006, we paid interest aggregating $234,000
and $331,000, respectively. During the six-month periods ended June 30, 2007 and 2006, we
transferred $44,000 and $73,000, respectively, in inventory to fixed assets related to the
creation and maintenance of a pool of service loaner equipment. During the six-month period
ended June 30, |
F-40
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|
2007, we netted $166,000 of stock offering costs that were paid on 2006 against the proceeds
from issuance of common stock. Also during the six-month period ended June 30, 2007, we
amortized $117,000 of debt issuance costs related to the convertible debt entered into in
December 2004 into interest expense. |
|
13. |
|
Subsequent Event |
|
|
|
In July 2007, David C. Bupp (our President and CEO) and certain members of his family
purchased a $1.0 million convertible note and warrants. The note bears interest at 10% per annum
during its one-year term 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 purchasers 500,000 Series V warrants to
purchase our common stock at an exercise price of $0.31 per share, expiring in July 2012. |
F-41