S-1/A
As filed with the Securities and Exchange Commission on
July 15, 2005
Registration No. 333-125517
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 1
to
Form S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
ELECTRO-OPTICAL SCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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3841 |
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13-3986004 |
(State or other jurisdiction of
incorporation or organization) |
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(Primary standard industrial
classification code number) |
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(I.R.S. Employer
Identification Number) |
3 West Main Street, Suite 201
Irvington, New York 10533
(914) 591-3783
(Address, including zip code, and telephone number,
including area code, of registrants principal executive
offices)
Joseph V. Gulfo, M.D.
President and Chief Executive Officer
Electro-Optical Sciences, Inc.
3 West Main Street, Suite 201
Irvington, New York 10533
(914) 591-3783
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copies to:
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Valerie A. Price, Esq.
Dreier LLP
499 Park Avenue
New York, New York 10022
(212) 328-6144 (phone)
(212) 652-3789 (facsimile) |
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David C. Peck, Esq.
Greenberg Traurig, LLP
200 Park Avenue
New York, New York 10166
(212) 801-9200 (phone)
(212) 801-6400 (facsimile) |
Approximate date of proposed sale to the public: As soon
as practicable after the effective date of this Registration
Statement.
If any of the securities being registered on this form are to be
offered on a delayed or continuous basis pursuant to
Rule 415 under the Securities Act of 1933, as amended (the
Securities Act) check the following
box. o
If this form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act,
check the following box and list the Securities Act registration
statement number of the earlier effective registration statement
for the same
offering. o
If this form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering. o
If this form is a post-effective amendment filed pursuant to
Rule 462(d) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering. o
If delivery of the prospectus is expected to be made pursuant to
Rule 434, check the following
box. o
CALCULATION OF REGISTRATION FEE
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Title of Each Class of |
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Proposed Maximum Aggregate |
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Amount of |
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Securities to be Registered |
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Offering Price(1) |
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Registration Fee |
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Common stock, par value $0.001 per share
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$33,000,000 |
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$3,884.10 |
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(1) |
Estimated solely for purposes of determining the registration
fee pursuant to Rule 457(o) under the Securities Act. |
The registrant hereby amends this registration statement on
such date or dates as may be necessary to delay its effective
date until the registrant shall file a further amendment which
specifically states that this registration statement shall
thereafter become effective in accordance with Section 8(a)
of the Securities Act or until the registration statement shall
become effective on such date as the Securities and Exchange
Commission, acting pursuant to said Section 8(a), may
determine.
The
information in this prospectus is not complete and may be
changed. We may not sell these securities until the registration
statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these
securities and it is not soliciting an offer to buy these
securities in any state where the offer and sale is not
permitted.
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SUBJECT TO COMPLETION, DATED
JULY 15, 2005
PROSPECTUS
3,000,000 Shares
Electro-Optical Sciences, Inc.
Common Stock
This is the initial public offering of 3,000,000 shares of
common stock of Electro-Optical Sciences, Inc.
We expect the public offering price to be between $10.00 and
$12.00 per share. There presently is no public market for our
securities and we cannot ensure you that a market will develop.
We have applied to list our common stock on the NASDAQ National
Market under the symbol MELA.
Investing in our common stock is highly speculative and
involves a high degree of risk. See Risk Factors
beginning on Page 7.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or passed upon the adequacy or accuracy of this
prospectus. Any representation to the contrary is a criminal
offense.
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Per Share | |
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Total | |
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Public offering price
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$ |
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$ |
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Underwriting discounts and commissions
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$ |
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$ |
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Proceeds, before expenses, to Electro-Optical Sciences,
Inc.
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$ |
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$ |
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To the extent the underwriters sell more than
3,000,000 shares of common stock, the underwriters have the
option to purchase up to an additional 450,000 shares from
us at the public offering price less the underwriting discount,
within 45 days from the date of this prospectus to cover
over-allotments. The underwriters will also receive a
non-accountable expense allowance in the amount of one percent
(1%) of the total public offering price (excluding the
over-allotment option). In addition, upon completion of this
offering, the underwriters will receive warrants to purchase up
to an aggregate of 225,000 shares of our common stock at an
exercise price equal to 125% of the public offering price per
share. The warrants will be exercisable commencing on the first
anniversary of the date of this prospectus and ending on the
fifth anniversary of the date of this prospectus.
The underwriters expect to deliver the shares on or
about ,
2005.
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Ladenburg Thalmann & Co. Inc. |
Stanford Group Company |
The date of this prospectus
is ,
2005.
The MelaFind® System
MelaFind® is a non-invasive system for assisting in the
early detection of melanoma. The MelaFind®
system is comprised of a point-of-care, hand-held imaging device
that, in commercial use, is intended to be connected via the
internet to a central server located at EOS. When marketed, a
report will be transmitted to the physicians office
containing MelaFind®s recommendation of whether the
lesion should be biopsied.
Traditional visual clinical examination is limited to the
surface appearance of the suspicious pigmented skin lesion,
whereas MelaFind® utilizes information derived from up to
2.5mm deep into the skin. MelaFind® uses an
illuminator that shines 10 different specific wavelengths of
light (from 430nm to 950nm), including near infra-red
bands, which penetrate to varying depths of skin. The data are
analyzed against our proprietary database of melanomas and
benign lesions using our sophisticated algorithms.
TABLE OF CONTENTS
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Prospectus Summary
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1 |
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Risk Factors
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7 |
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Special Note Regarding Forward-Looking Statements
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29 |
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Use of Proceeds
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30 |
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Dividend Policy
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30 |
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Capitalization
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31 |
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Dilution
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32 |
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Selected Financial Data
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34 |
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Managements Discussion and Analysis of Financial Condition
and Results of Operations
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Our Business
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44 |
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Management
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65 |
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Related Party Transactions
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75 |
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Principal Stockholders
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Description of Capital Stock
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Shares Eligible for Future Sale
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83 |
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Material US Federal Income and Estate Tax Considerations for
Non-US Holders
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85 |
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Underwriting
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88 |
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Legal Matters
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90 |
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Experts
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90 |
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Where You Can Find More Information
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91 |
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Index to Financial Statements
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F-1 |
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You should rely only on the information contained in this
prospectus. We have not authorized anyone to provide you with
information different from that contained in this prospectus. We
are offering to sell shares of our common stock and seeking
offers to buy shares of our common stock only in jurisdictions
where offers and sales are permitted. The information contained
in this prospectus is accurate only as of the date of this
prospectus, regardless of the time of delivery of this
prospectus or any sale of the common stock.
For investors outside the US: Neither we nor any of the
underwriters have done anything that would permit this offering
or possession or distribution of this prospectus in any
jurisdiction where action for that purpose is required, other
than in the US. You are required to inform yourselves about, and
to observe any restrictions relating to, this offering and the
distribution of this prospectus.
We obtained statistical data and certain other industry
forecasts used throughout this prospectus from market research,
publicly available information and industry publications.
Industry publications generally state that they obtain their
information from sources that they believe to be reliable, but
they do not guarantee the accuracy and completeness of the
information. Similarly, while we believe that the statistical
and industry data and forecasts and market research used herein
are reliable, we have not independently verified such data. We
have not sought the consent of the sources to refer to their
reports in this prospectus.
PROSPECTUS SUMMARY
This summary highlights information contained elsewhere in
this prospectus. It does not contain all of the information you
should consider before buying shares of our common stock. You
should read this entire prospectus carefully, especially the
Risk Factors section and our financial statements
and the related notes appearing at the end of this prospectus,
before deciding to invest in shares of our common stock. Unless
otherwise stated or the context otherwise requires, reference in
this prospectus to EOS, we,
us, our and similar references refer to
Electro-Optical Sciences, Inc.
Our Business
We are a medical device company focused on the design and
development of a non-invasive, point-of-care instrument to
assist in the early diagnosis of melanoma. Our flagship product,
MelaFind®, features a hand-held imaging device that emits
multiple wavelengths of light to capture images of suspicious
pigmented skin lesions and extract data. The data are then
analyzed against our proprietary database of melanomas and
benign lesions using our sophisticated algorithms in order to
provide information to the physician and produce a
recommendation of whether the lesion should be biopsied.
The components of the MelaFind® system include:
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a hand-held imaging device, which employs high precision
optics and multi-spectral illumination (multiple colors of light
including near infra-red); |
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our proprietary database of pigmented skin lesions, which
we believe to be the largest in the US; |
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our lesion classifiers, which are sophisticated
mathematical algorithms that extract lesion feature information
and classify lesions; and |
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a central server in our offices that is intended to
perform quality control functions and provide reports to the
physician and in commercial use, will be connected to
physicians offices via the internet. |
We have entered into a binding Protocol Agreement with the US
Food and Drug Administration (FDA), which is an agreement for
the conduct of the pivotal trial in order to establish the
safety and effectiveness of MelaFind®. We believe the
presence of the Protocol Agreement significantly enhances our
ability to expedite the FDA approval process. We stopped a study
that was initiated in late 2004 under the Protocol Agreement due
to technical difficulties with some of the MelaFind®
clinical trial instruments. The FDA has provided confirmation
that our plan to correct the technical issues and start a new
pivotal trial to satisfy the Protocol Agreement is acceptable.
Management estimates that the pivotal trial will commence in
early 2006 at over 20 US clinical study sites, and
anticipates premarket approval (PMA) to commercialize
MelaFind® in 2007.
To date, we have not generated any revenues from MelaFind®.
All of our historical revenues have come from activities and
products that have since been discontinued, including our
DIFOTI® product, a non-invasive imaging device for the
detection of dental cavities. We decided to discontinue all
operations associated with our DIFOTI® product, effective
as of April 5, 2005, in order to focus our resources on the
development and commercialization of MelaFind®.
The Market Opportunity
Cancer of the skin has a higher incidence than all other cancers
combined, and the rates are rising dramatically. In 2005, over
120,000 new cases of melanoma are projected. Melanoma is
responsible for approximately 80% of skin cancer fatalities and
is the deadliest of all skin cancers as there is currently no
cure for advanced stage melanoma. However, early detection of
melanoma can lead to virtually a 100% cure rate. Therefore, the
need for medical practitioners to be able to examine individuals
during a routine annual exam, resulting in early detection and
treatment of skin cancer cannot be overstated. Advanced stage
melanoma is costly to treat and is responsible for approximately
90% of the total spending on
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melanoma treatment in the US, costing up to $170,000 per
patient. If diagnosed early, however, melanoma is almost always
cured by simple resection at a cost of approximately
$1,800 per patient.
Melanoma is currently the subject of significant attention in
the medical community. In part, this attention is due to the
fact that it is the fastest growing cancer. It is also the most
common cancer in young adults ages 20-30, and currently
there are more new cases of melanoma than HIV/ AIDS. In women
ages 25-30, melanoma is the primary cause of cancer death.
In women ages 30-35, melanoma is the second leading cause
of death after breast cancer. Recent published papers identify a
strong correlation between breast cancer and melanoma.
Because early detection is critical to survival, the American
Cancer Society recommends that individuals 40 years and
older have complete skin examinations on an annual basis.
According to the 2000 US Census data, over 100 million
Americans in the US are over age 40. Furthermore, there are
more than 20 million individuals in the US who have
dysplastic nevi, a type of pigmented skin lesion that when
present is associated with an increased risk of melanoma. These
individuals warrant more frequent observation.
Limitations of Current Melanoma Diagnosis
Melanomas are mainly diagnosed by dermatologists and/or primary
care physicians using only visual clinical evaluation.
Physicians assess pigmented skin lesions using the
ABCDE criteria, Asymmetry, Border
irregularity, Color variation, Diameter greater
than 6 mm, and Evolving change in ABCD over
time. This assessment is subjective and results in missed
melanomas, as well as a ratio of benign lesions biopsied to
melanomas confirmed that is highly variable and as high as 40 to
1 for dermatologists and as high as 50 to 1 for primary care
physicians.
Dermatologists who specialize in the management of pigmented
skin lesions may also use dermoscopy, a method of viewing
lesions under magnification. Approximately 25% of dermatologists
use dermoscopy. Although dermoscopy provides more information
than unaided visual examination, mastery of the technique
necessitates many years of training and experience. Proper use
of dermoscopy can reduce the number of unnecessary biopsies of
benign lesions, but even dermoscopy experts biopsy 3-10 benign
lesions for every melanoma detected.
In contrast, MelaFind® delivers an objective assessment
based on numerical scores assigned to the suspicious skin lesion
under evaluation and does not require extensive physician
training to operate. Further, visual clinical evaluation is
limited to the surface appearance of the suspicious pigmented
skin lesion, whereas MelaFind® utilizes information derived
from up to 2.5 mm deep into the skin. In clinical trials to
date, this objective assessment has resulted in a ratio of
benign lesions biopsied to melanomas confirmed as low as almost
2 to 1.
Clinical Results to Date
To date, MelaFind® has been studied on over 5,000 skin
lesions from over 3,500 patients at over 20 clinical
centers. Our clinical studies have demonstrated that
MelaFind® missed fewer melanomas and produced fewer false
positives than were experienced by study dermatologists, who are
skin cancer specialists. The performance of a diagnostic is
measured in terms of sensitivity (the ability to
detect disease when disease is present) and
specificity (the ability to exclude disease when
disease is not present). In the largest blinded trial that we
have performed to date on 352 suspicious pigmented skin lesions,
MelaFind® did not miss a melanoma (measured sensitivity of
100%) and achieved 48.4% specificity, compared to the study
dermatologists sensitivity of 96.4% and specificity of
28.4%.
We believe that with the assistance provided by MelaFind®,
physicians could diagnose more melanomas at the earliest,
curable stage, which would reduce both treatment costs and the
number of unnecessary biopsies, and improve quality of life.
2
Our Strategy
Our objective is for MelaFind® to become an integral part
of the standard of care in melanoma detection. To achieve this
objective, we are pursuing the following strategy:
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Pursue timely FDA approval of MelaFind®: We have
entered into a binding Protocol Agreement with the FDA for the
conduct of the pivotal trial of MelaFind®. Management
estimates that the study will commence in early 2006 at over 20
US clinical study sites, and anticipates PMA approval to
commercialize MelaFind® in 2007. |
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Establish MelaFind® as the leading technology for
assisting in the detection of melanoma: We have invested
considerable capital and expertise into developing our core
technology platform, which is protected by six US patents. We
will continue to refine and optimize this technology to ensure
that MelaFind® is the leading system for assisting in the
detection of melanoma. |
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Obtain third party payor reimbursement to support our
recurring revenue pricing model: We intend to offer
MelaFind® on a per patient basis, creating a recurring
revenue stream. To do so, we will seek to obtain third party
reimbursement as well as private pay alternatives. We are
working with experts to create an evidence-based medicine
evaluation model consistent with those used to support positive
coverage decisions by the federal Centers for
Medicare & Medicaid Services (CMS) and private
payors for similar products. The value drivers in the model
include the treatment and diagnostic cost savings associated
with early detection (approximately $168,000 per
patient) and fewer biopsies. We believe that the use of
MelaFind® could result in substantial savings to the US
healthcare system. |
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Commercialize MelaFind® using multiple sales and
marketing strategies: Our sales and marketing effort will
focus initially on high volume/key opinion leader
dermatologists with specialties in the diagnosis and treatment
of melanoma. To enter the larger US markets of general
dermatologists, plastic surgeons, and primary care physicians,
and for international markets, we intend to establish
partnerships with pharmaceutical and/or diagnostic device
companies with an established presence in these markets. While
we believe obtaining a positive coverage decision from CMS may
take an additional 18 to 36 months following PMA approval, and
obtaining a positive coverage decision from private payors,
managed care organizations and state Medicare administrative
contractors may take at least 6 to 12 months following PMA
approval, we intend to commence sales of MelaFind®
immediately upon receiving PMA approval for physicians to offer
MelaFind® to their patients on a self-pay basis. |
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Company Information
We were incorporated under the laws of the State of New York in
1989 and subsequently reincorporated under the laws of the State
of Delaware in 1997. Our executive offices are located at 3 West
Main Street, Suite 201, Irvington, New York 10533. Our
telephone number is (914) 591-3783. Our websites include
www.eo-sciences.com and www.melafind.com. The information
contained on our websites is not a part of this prospectus and
should not be relied upon. We have included our website
addresses in this document as inactive textual references only.
This prospectus contains references to our US registered
trademarks: MelaFind®, DIFOTI®, and the corporate logo
for eos electro-optical sciences, inc.
All other trademarks, tradenames and service marks appearing in
this prospectus are the property of their respective owners.
3
THE OFFERING
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Common stock offered by us |
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3,000,000 shares |
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Common stock outstanding after the offering |
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9,513,164 shares |
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Use of proceeds |
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We estimate that our net proceeds from this offering will be
approximately $29.0 million at an assumed initial public
offering price of $11.00 per share, which is the mid-point
of our filing range, after deducting estimated underwriting
discounts and commissions and offering expenses payable by us.
We intend to use these net proceeds to fund our research and
development activities, including our clinical studies, to build
our sales and marketing capabilities, and for general corporate
purposes, including working capital needs, facilities expansion
and potential acquisitions. See Use of Proceeds. |
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Risk factors |
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You should read the Risk Factors section of this
prospectus for a discussion of factors to consider carefully
before deciding to invest in shares of our common stock. |
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Proposed NASDAQ National Market symbol |
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MELA |
The number of shares of our common stock to be outstanding after
this offering is based on 6,513,164 shares outstanding as
of June 30, 2005, and unless otherwise indicated, excludes:
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899,875 shares of common stock issuable as of the date of
this prospectus upon the exercise of outstanding stock options
under our 2003 Stock Incentive Plan and our 1996 Stock Option
Plan, respectively, at a weighted average exercise price of
approximately $0.64 per share; |
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up to 1,000,000 shares of common stock reserved for future
grants under our 2005 Stock Incentive Plan; |
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75,000 shares of common stock issuable upon exercise of
outstanding warrants to purchase common stock at an exercise
price of $7.00 per share; |
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73,280 shares of common stock issuable upon exercise of
outstanding warrants to purchase our Series C preferred
stock (assuming conversion of our Series C preferred stock)
at an exercise price of $4.52 per share; and |
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225,000 shares of common stock issuable upon exercise of
warrants to be issued to the underwriters upon completion of
this offering at an exercise price equal to 125% of the public
offering price per share. |
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Unless we specifically state otherwise, all information in this
prospectus assumes:
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that all outstanding shares of our Series A preferred
stock, Series B preferred stock and Series C preferred
stock are converted into shares of our common stock immediately
prior to completion of this offering; |
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that all outstanding warrants to purchase our common stock with
an exercise price of $13.00 per share have been exchanged
for our common stock based on an exchange rate of one share of
common stock for every two shares of common stock purchasable
under such warrants in a cashless exchange. See the full
discussion in Related Party Transactions
Warrants to Purchase Common Stock; |
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no exercise of the underwriters over-allotment option; |
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the adoption of our fourth amended and restated certificate of
incorporation and third amended and restated bylaws; and |
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a 1-for-2 reverse stock split of our common stock which was
approved by our board of directors on May 13, 2005,
effective upon the earlier of the conversion of our preferred
stock or September 30, 2005. |
4
SUMMARY FINANCIAL DATA
The following summary financial data for the fiscal years ended
December 31, 2002, 2003 and 2004 have been derived from our
historical audited financial statements. The summary financial
data for the six month periods ended June 30, 2004 and 2005
have been derived from our unaudited financial statements. The
unaudited summary financial data include, in our opinion, all
adjustments, consisting only of normal, recurring adjustments,
necessary to present fairly the financial position and results
of operations for the periods presented. Our historical results
for any prior or interim period are not necessarily indicative
of results to be expected for a full fiscal year or for any
future period. The summary financial data shown below account
for the revenues and related expenses for our DIFOTI®
product, a non-invasive imaging device for the detection of
dental cavities, as a discontinued operation. We decided to
discontinue all operations associated with our DIFOTI®
product, effective as of April 5, 2005, in order to focus
our resources on the development and commercialization of
MelaFind®. See the footnote to the Financial Statements
relating to discontinued operations and assets held for sale
included elsewhere in this prospectus. You should read this
information together with our financial statements and the
related notes appearing at the end of this prospectus and the
Managements Discussion and Analysis of Financial
Condition and Results of Operations section of this
prospectus.
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Six Months Ended | |
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Year Ended December 31, | |
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June 30, | |
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2002 | |
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2003 | |
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2004 | |
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2004 | |
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2005 | |
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(unaudited) | |
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(In thousands, except share and per share data) | |
Statement of Operations Data:
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Revenue from grants
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$ |
547 |
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$ |
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Operating expenses:
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Cost of grant revenue
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564 |
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General and administrative expenses
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511 |
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1,034 |
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1,234 |
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639 |
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996 |
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Research and development
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404 |
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828 |
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1,892 |
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693 |
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1,546 |
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Operating loss from continuing operations
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(932 |
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(1,862 |
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(3,126 |
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(1,332 |
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(2,542 |
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Interest (income)/expense
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8 |
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76 |
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67 |
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82 |
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(63 |
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|
|
|
|
|
|
Loss from continuing operations
|
|
|
(940 |
) |
|
|
(1,938 |
) |
|
|
(3,193 |
) |
|
|
(1,414 |
) |
|
|
(2,479 |
) |
Loss from discontinued operations
|
|
|
(201 |
) |
|
|
(12 |
) |
|
|
(426 |
) |
|
|
(102 |
) |
|
|
(330 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(1,141 |
) |
|
|
(1,950 |
) |
|
|
(3,619 |
) |
|
|
(1,516 |
) |
|
|
(2,809 |
) |
Preferred stock deemed dividends
|
|
|
214 |
|
|
|
322 |
|
|
|
676 |
|
|
|
243 |
|
|
|
719 |
|
Preferred stock accretion
|
|
|
180 |
|
|
|
25 |
|
|
|
323 |
|
|
|
25 |
|
|
|
842 |
|
Stock distribution of preferred Series B shares
|
|
|
|
|
|
|
102 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders
|
|
$ |
(1,535 |
) |
|
$ |
(2,399 |
) |
|
$ |
(4,618 |
) |
|
$ |
(1,784 |
) |
|
$ |
(4,370 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
$ |
(0.87 |
) |
|
$ |
(1.48 |
) |
|
$ |
(2.37 |
) |
|
$ |
(0.98 |
) |
|
$ |
(2.23 |
) |
Discontinued operations
|
|
|
(0.13 |
) |
|
|
(0.01 |
) |
|
|
(0.24 |
) |
|
|
(0.06 |
) |
|
|
(0.18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$ |
(1.00 |
) |
|
$ |
(1.49 |
) |
|
$ |
(2.61 |
) |
|
$ |
(1.04 |
) |
|
$ |
(2.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average number of shares outstanding
|
|
|
1,534,760 |
|
|
|
1,614,897 |
|
|
|
1,766,608 |
|
|
|
1,722,743 |
|
|
|
1,809,758 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per common share
(unaudited)(1)
|
|
|
|
|
|
|
|
|
|
$ |
(0.91 |
) |
|
|
|
|
|
$ |
(0.43 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted weighted average number of common
shares outstanding (unaudited)(1)
|
|
|
|
|
|
|
|
|
|
|
3,967,024 |
|
|
|
|
|
|
|
6,513,164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5
|
|
(1) |
Pro forma basic and diluted net loss per common share reflects
the effect of the assumed conversion of our preferred stock, as
if this offering had occurred at the date of original issuance
into 3,398,105 shares of our common stock for the year
ended December 31, 2004 and six months ended June 30,
2005 which will occur upon closing of this public offering.
Additionally, it is assumed that 2,610,643 warrants to
purchase the companys common stock will be exchanged for a
total of 1,305,321 shares of our common stock based on an
exchange ratio of one share of our common stock for every two
shares of our common stock purchasable under the warrants and
will occur prior to the closing of this offering. The net loss
attributable to our common stockholders used in the computation
of basic and diluted net loss per share to compute the unaudited
pro forma net loss attributable to common stockholders, has been
adjusted to reverse the accretion on our preferred stock and
also excludes the preferred stock dividends for the respective
period. |
The following table presents summary balance sheet data, derived
from our historical audited financial statements, as of
December 31, 2003 and December 31, 2004. The table
also presents summary balance sheet data, derived from our
historical unaudited financial statements, as of June 30,
2005:
|
|
|
|
|
On an actual basis; and |
|
|
|
|
On an as adjusted basis to give effect to (1) the
conversion of all outstanding shares of our convertible
preferred stock into an aggregate of 3,398,105 shares of
common stock upon the completion of this offering; (2) the
exchange of 2,610,643 warrants to purchase the
companys common stock for a total of 1,305,321 shares
of our common stock based on an exchange ratio of one share of
our common stock for every two shares of our common stock
purchaseable under the warrants that is assumed to occur prior
to the closing of this offering; and (3) the sale of
3,000,000 shares of common stock in this offering at an
assumed initial public offering price of $11.00 per share, after
deducting estimated underwriting discounts and commissions and
offering expenses paid and payable by us. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, | |
|
As of June 30, 2005 | |
|
|
| |
|
| |
|
|
2003 | |
|
2004 | |
|
|
|
|
| |
|
| |
|
|
|
Pro Forma | |
|
|
Actual | |
|
Actual | |
|
Actual | |
|
As Adjusted | |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
(unaudited) | |
|
|
(In thousands) | |
Balance sheet data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$ |
117 |
|
|
$ |
6,703 |
|
|
$ |
3,794 |
|
|
$ |
32,794 |
|
Working capital
|
|
|
(433 |
) |
|
|
6,122 |
|
|
|
3,480 |
|
|
|
32,480 |
|
Total assets
|
|
|
432 |
|
|
|
7,096 |
|
|
|
4,997 |
|
|
|
33,997 |
|
Total liabilities
|
|
|
650 |
|
|
|
691 |
|
|
|
1,245 |
|
|
|
1,245 |
|
Redeemable convertible preferred stock
|
|
|
4,067 |
|
|
|
8,585 |
|
|
|
9,427 |
|
|
|
|
|
Total stockholders (deficiency)/equity
|
|
|
(4,285 |
) |
|
|
(2,180 |
) |
|
|
(5,675 |
) |
|
|
32,752 |
|
6
RISK FACTORS
Investing in our common stock involves a high degree of risk.
You should carefully consider the following risk factors, as
well as the other information in this prospectus, before
deciding whether to invest in shares of our common stock. If any
of the following risks actually occur, our business, financial
condition and results of operations would suffer. In that case,
the trading price of our common stock would likely decline and
you might lose all or part of your investment in our common
stock.
Risks Relating to Our Business
We currently do not have,
and may never develop, any commercialized products.
We currently do not have any commercialized products or any
significant source of revenue. We have invested substantially
all of our time and resources over the last five years in
developing MelaFind®. MelaFind® will require
additional development, clinical evaluation, regulatory
approval, significant marketing efforts and substantial
additional investment before it can provide us with any revenue.
Our efforts may not lead to commercially successful products for
a number of reasons, including:
|
|
|
|
|
we may not be able to obtain regulatory approvals for
MelaFind®, or the approved indication may be narrower than
we seek; |
|
|
|
MelaFind® may not prove to be safe and effective in
clinical trials; |
|
|
|
physicians may not receive any reimbursement from third-party
payors, or the level of reimbursement may be insufficient to
support widespread adoption of MelaFind®; |
|
|
|
we may experience delays in our development program; |
|
|
|
any products that are approved may not be accepted in the
marketplace by physicians or patients; |
|
|
|
we may not have adequate financial or other resources to
complete the development and commercialization of MelaFind®
or other products; |
|
|
|
we may not be able to manufacture our products in commercial
quantities or at an acceptable cost; and |
|
|
|
rapid technological change may make our technology and products
obsolete. |
We do not expect to be able to commercialize MelaFind®
before 2007. If we are unable to develop, obtain regulatory
approval for or successfully commercialize MelaFind®, we
will be unable to generate revenue.
We have not received, and
may never receive, FDA approval to market MelaFind®.
We do not have the necessary regulatory approvals to market
MelaFind® in the US or in any foreign market. We have not
filed, and currently do not have plans to file, for regulatory
approval in any foreign market. We plan initially to launch
MelaFind®, once approved, in the US. The regulatory
approval process for MelaFind® in the US involves, among
other things, successfully completing clinical trials and
obtaining PMA approval from the FDA. We commenced the PMA
application process for MelaFind® by filing a proposed
outline for a Modular PMA application (a compilation of
well-delineated components submitted separately) on
September 30, 2002. The PMA process requires us to prove
the safety and effectiveness of MelaFind® to the FDAs
satisfaction. This process is expensive and uncertain, and
requires detailed and comprehensive scientific and human
clinical data. FDA review may take years after a PMA application
is filed. The FDA may never grant approval. The FDA can delay,
limit or deny approval of a PMA application for many reasons,
including:
|
|
|
|
|
MelaFind® may not be safe or effective to the FDAs
satisfaction; |
|
|
|
the data from our pre-clinical studies and clinical trials may
be insufficient to support approval; |
|
|
|
the manufacturing process or facilities we use may not meet
applicable requirements; and |
7
|
|
|
|
|
changes in FDA approval policies or adoption of new regulations
may require additional data. |
No precedent has been established for FDA approval of a device
such as MelaFind® to assist in determining the
appropriateness of biopsies of suspicious pigmented skin
lesions. Before submitting a PMA application (the final module),
we must successfully complete a pivotal clinical trial to
demonstrate that MelaFind® is safe and effective. Product
development, including clinical trials, is a long, expensive and
uncertain process, and is subject to delays and failure at any
stage. Furthermore, the data obtained from the trial may be
inadequate to support approval of a PMA application. While we
obtained a Protocol Agreement from the FDA, FDA approval of a
Protocol Agreement does not mean that the FDA will consider the
data gathered in the trial sufficient to support approval of a
PMA application, even if the trials intended endpoints are
achieved. There may be unexpected findings, particularly those
that may only become evident from the larger scale of the
pivotal clinical trial, as compared with the smaller scale tests
done to date. For example, we initiated a clinical trial and
encountered several technical problems which required us to
refine the MelaFind® system. The data obtained in the
pivotal trial may not be sufficient to support the anticipated
indication for use, and may not support a more limited
indication for use. The occurrence of unexpected findings in
connection with the pivotal trial or any subsequent clinical
trial required by the FDA may prevent or delay obtaining PMA
approval, and may adversely affect coverage or reimbursement
determinations. The FDA may also determine that additional
clinical trials are necessary, in which case the PMA approval
may be delayed for several months or even years while the trials
are conducted and the data acquired are submitted in an
amendment to the PMA. If we are unable to complete the clinical
trials necessary to successfully support the MelaFind® PMA
application, our ability to commercialize MelaFind®, and
our business, financial condition, and results of operations
would be materially adversely affected, thereby threatening our
ability to continue operations.
If MelaFind®
is approved by the FDA, it may be approved only for narrow
indications.
Even if approved, MelaFind® may not be approved for the
indications that are necessary or desirable for successful
commercialization. Our preference is to obtain a broad
indication for use in diagnosing almost all pigmented melanomas
(other than those on palms, soles of the feet, in or near the
eye, and inaccessible areas such as the edge of the nose). The
final MelaFind® lesion classifier should be able to
identify the maximum number of types of melanoma possible. The
indications for use must specify those lesion types for which
the classifier has not been trained. Approximately five percent
of melanoma lesions may be amelanotic, meaning they are not
pigmented. These lesions cannot be differentiated by
MelaFind®, which will be restricted to pigmented lesions.
Approximately ten percent of pigmented melanoma lesions are
nodular, a type of melanoma that is often missed by
dermatologists in early stages. If nodular melanoma lesions are
not sufficiently well-represented in the MelaFind® training
database, the classifier may not differentiate nodular melanomas
from non-melanomas with sufficient sensitivity and specificity.
If we restrict the indications for use of MelaFind® to
exclude certain melanoma lesion types, in addition to the other
restrictions, then the size of the market for MelaFind® and
the rate of acceptance of MelaFind® by physicians may be
adversely affected.
If we wish to modify MelaFind® after receiving FDA
approval, including changes in indications or other
modifications that could affect safety and effectiveness,
additional approvals could be required from the FDA. We may be
required to submit extensive pre-clinical and clinical data,
depending on the nature of the changes. Any request by the FDA
for additional data, or any requirement by the FDA that we
conduct additional clinical studies, could delay the
commercialization of MelaFind® and require us to make
substantial additional research, development and other
expenditures. We may not obtain the necessary regulatory
approvals to market MelaFind® in the US or anywhere else.
Any delay in, or failure to receive or maintain, approval for
MelaFind® could prevent us from generating revenue or
achieving profitability, and our business, financial condition,
and results of operations would be materially adversely affected.
8
|
|
|
MelaFind® may not be commercially
viable if we fail to obtain an adequate level of reimbursement
by Medicare and other third party payors. The markets for
MelaFind® may also be limited by the
indications for which its use may be reimbursed. |
The availability of medical insurance coverage and reimbursement
for newly approved medical devices is uncertain. In the US,
physicians and other healthcare providers performing biopsies
for suspicious skin lesions are generally reimbursed for all or
part of the cost of the diagnosis and biopsy by Medicare,
Medicaid, or other third-party payors. The commercial success of
MelaFind® in both domestic and international markets will
significantly depend on whether third-party coverage and
reimbursement are available for services involving
MelaFind®. Medicare, Medicaid, health maintenance
organizations and other third-party payors are increasingly
attempting to contain healthcare costs by limiting both the
scope of coverage and the level of reimbursement of new medical
devices, and as a result, they may not cover or provide adequate
payment for the use of MelaFind®. In order to obtain
satisfactory reimbursement arrangements, we may have to agree to
a fee or sales price lower than the fee or sales price we might
otherwise charge. Even if Medicare and other third-party payors
decide to cover procedures involving our product, we cannot be
certain that the reimbursement levels will be adequate.
Accordingly, even if MelaFind® or future products we
develop are approved for commercial sale, unless government and
other third-party payors provide adequate coverage and
reimbursement for our products, some physicians may be
discouraged from using them, and our sales would suffer.
Medicare reimburses for medical devices in a variety of ways,
depending on where and how the device is used. However, Medicare
only provides reimbursement if CMS determines that the device
should be covered and that the use of the device is consistent
with the coverage criteria. A coverage determination can be made
at the local level by the Medicare administrative contractor
(formerly called carriers and fiscal intermediaries), a private
contractor that processes and pays claims on behalf of CMS for
the geographic area where the services were rendered, or at the
national level by CMS through a national coverage determination.
There are new statutory provisions intended to facilitate
coverage determinations for new technologies, but it is unclear
how these new provisions will be implemented. Coverage
presupposes that the device has been cleared or approved by the
FDA and further, that the coverage will be no broader than the
approved intended uses of the device as approved or cleared by
the FDA, but coverage can be narrower. A coverage determination
may be so limited that relatively few patients will qualify for
a covered use of the device. Should a very narrow coverage
determination be made for MelaFind®, it may undermine the
commercial viability of MelaFind®.
Obtaining a coverage determination, whether local or national,
is a time-consuming, expensive and highly uncertain proposition,
especially for a new technology, and inconsistent local
determinations are possible. On average, according to an
industry report, Medicare coverage determinations for medical
devices lag 15 months to five years or more behind FDA
approval for that device. The Medicare statutory framework is
also subject to administrative rulings, interpretations and
discretion that affect the amount and timing of reimbursement
made under Medicare. Medicaid coverage determinations and
reimbursement levels are determined on a state by state basis,
because Medicaid, unlike Medicare, is administered by the states
under a state plan filed with the Secretary of the US Department
of Health and Human Services (HHS). Medicaid generally
reimburses at lower levels than Medicare. Moreover, Medicaid
programs and private insurers are frequently influenced by
Medicare coverage determinations.
|
|
|
Any adverse results in our clinical trials, or
difficulties in conducting our clinical trials, could have a
material adverse effect on our business. |
Clinical studies in the US have been ongoing for over five
years, and we have a Protocol Agreement with the FDA, but we
have not conducted the pivotal clinical trial required for PMA
approval. We initiated a trial under the terms of the Protocol
Agreement at the end of 2004. However, technical operational
issues with the systems were experienced, requiring further
refinement. We are currently refining the hardware systems and
expect to have new systems available in order to start the
pivotal clinical trial in early 2006. However, we cannot provide
any assurances that we will have these systems available on a
timely basis. In addition, the pivotal clinical trial and
supporting clinical studies will require
9
the involvement of larger numbers of clinical sites than we have
previously engaged at any single time, and the recruitment of
large numbers of patients. If the clinical sites, which enroll
patients on a best efforts basis, do not provide cases at rates
anticipated for any reason (such as, for example, lower than
forecasted clinical site productivity), we may face delays or
may be unable to complete the development of MelaFind®.
Risk of delay in product
development.
We could encounter delays in our pivotal trial or in obtaining
PMA approval because of a number of factors. We will require the
receipt of all information specified in our Protocol Agreement
on the required number of melanomas before the pivotal clinical
trial can be concluded. The MelaFind® classifier will then
be utilized to evaluate the lesions acquired during the pivotal
trial, and the results will be analyzed to determine if we have
achieved the endpoints specified in the Protocol Agreement.
The final training of the classifier, required to be completed
before the classifier is utilized as described above, is
expected to take approximately two months. Accordingly, the
classifier must be ready for final training two months before
the end of the pivotal trial. For the classifier to be ready for
final training, approximately 300 melanoma lesions are targeted
to have been received. Therefore, in addition to acquiring the
melanoma lesions required to complete the pivotal trial
(approximately 100), we must have completed the acquisition of
approximately 300 training melanoma lesions on schedule.
Currently, approximately 225 melanoma lesions are in the
training database. The current classifier has been trained on
113 of these melanoma lesions.
Our schedule for the acquisition of these lesions is based upon
the projected numbers of imaging devices to be located at
participating sites, the projected productivity of those sites
in terms of melanomas and other lesions biopsied per month, and
the projected efficiency of the study pathologists in
classifying the lesion slides presented for histological
analysis (the microscopic examination of excised or biopsied
tissue specimens) and reporting their results. If we are unable
to produce and maintain a sufficient number of imaging devices
at participating sites, if the clinicians do not maintain
sufficient productivity, or if the pathologists do not produce
reports with sufficient efficiency, then our ability to maintain
our schedule will be adversely affected, the start or conclusion
of the pivotal trial may be delayed, and the submission of the
completed PMA will be delayed.
To date, the lesion images in the training database have been
acquired using first-generation hand-held devices, which also
extract data from the lesions that are used by the classifiers.
Pre-commercialization hand-held devices are being developed for
use in the pivotal trial. If the lesion data obtained with
pre-commercialization devices are not consistent with data from
the first generation hand-held devices, the classifier will need
to be trained solely on lesions imaged using only one or the
other generation of hand-held devices. Were this need to arise,
significant delay and expense could be incurred, which could
jeopardize our ability to complete the development of
MelaFind®.
|
|
|
We have incurred losses for a number of years, and
anticipate that we will incur continued losses for the
foreseeable future. |
We began operations in December 1989. At that time we provided
research services, mostly to US government agencies, on
classified projects. We have financed our operations since 1999
primarily through private placements of our equity securities,
and have devoted substantially all of our resources to research
and development relating to MelaFind®. Our net loss for the
six months ended June 30, 2005 was $2.8 million, and
as of June 30, 2005, we had an accumulated deficit of
approximately $16.7 million. We expect our research and
development expenses to increase in connection with our clinical
trials and other development activities related to
MelaFind®. If we receive PMA approval for MelaFind®
from the FDA, we expect to incur significant sales and marketing
expenses, and manufacturing expenses. Additionally, if we
complete our initial public offering, we expect that our general
and administrative expenses will increase due to the additional
operational and regulatory burdens applicable to public
companies. As a result, we expect to continue to incur
significant and increasing operating losses for the foreseeable
future.
10
These losses, among other things, have had and will continue to
have an adverse effect on our stockholders equity.
|
|
|
We expect to operate in a highly competitive market, we
may face competition from large, well-established medical device
manufacturers with significant resources, and we may not be able
to compete effectively. |
We do not know of any product possessing the diagnostic
assistance capabilities of MelaFind®. We believe that
electro-optical products designed to enhance the visualization
and analysis of potential melanomas have been approved or are
under development by: Welch Allyn, Inc.; Heine Optotechnik;
3Gen, LLC; Derma Medical Systems, Inc.; Medical High
Technologies S.p.A.; ZN Vision Technologies AG; Polartechnics,
Ltd.; Astron Clinica, Ltd.; LINOS Photonics, Inc.; and Biomips
Engineering. The broader market for precision optical imaging
devices used for medical diagnosis is intensely competitive,
subject to rapid change, and significantly affected by new
product introductions and other market activities of industry
participants. If our products are approved for marketing, we
will potentially be subject to competition from major optical
imaging companies, such as: General Electric Co.; Siemens AG;
Bayer AG; Eastman Kodak Company; Welch Allyn, Inc.; Olympus
Corporation; Carl Zeiss AG Deutschland; and others, each of
which manufactures and markets precision optical imaging
products for the medical market, and could decide to develop or
acquire a product to compete with MelaFind®. These
companies enjoy numerous competitive advantages, including:
|
|
|
|
|
significantly greater name recognition; |
|
|
|
established relations with healthcare professionals, customers
and third-party payors; |
|
|
|
established distribution networks; |
|
|
|
additional lines of products, and the ability to offer rebates,
higher discounts or incentives to gain a competitive advantage; |
|
|
|
greater experience in conducting research and development,
manufacturing, clinical trials, obtaining regulatory approval
for products, and marketing approved products; and |
|
|
|
greater financial and human resources for product development,
sales and marketing, and patent litigation. |
As a result, we may not be able to compete effectively against
these companies or their products.
|
|
|
Technological breakthroughs in the diagnosis or treatment
of melanoma could render MelaFind®
obsolete. |
The precision optical imaging field is subject to rapid
technological change and product innovation. MelaFind® is
based on our proprietary technology, but a number of companies
and medical researchers are pursuing new technologies. Companies
in the medical device industry with significantly greater
financial, technical, research, marketing, sales and
distribution and other resources have expertise and interest in
the exploitation of computer-aided diagnosis, medical imaging,
and other technologies MelaFind® utilizes. Some of these
companies are working on potentially competing products or
therapies, including confocal microscopy (a type of scanning
microscopy for 3-dimensional specimens, which produces blur-free
images at various depths), various forms of spectroscopy (a
study of the way molecules absorb and emit light), other imaging
modalities, and molecular and genetic screening tests. In
addition, the National Institutes of Health and other supporters
of cancer research are presumptively seeking ways to improve the
diagnosis or treatment of melanoma by sponsoring corporate and
academic research. There can be no assurance that one or more of
these companies will not succeed in developing or marketing
technologies and products or services that demonstrate better
safety or effectiveness, superior clinical results, greater ease
of use or lower cost than MelaFind®, or that such
competitors will not succeed in obtaining regulatory approval
for introducing or commercializing any such products or services
prior to us. FDA approval of a commercially viable alternative
to MelaFind® produced by a competitor could significantly
reduce market acceptance of
11
MelaFind®. Any of the above competitive developments could
have a material adverse effect on our business, financial
condition, and results of operations. There is no assurance that
products, services, or technologies introduced prior to or
subsequent to the commercialization of MelaFind® will not
render MelaFind® less marketable or obsolete.
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We depend on clinical investigators and clinical sites to
enroll patients in our clinical trials and other third parties
to manage the trials and to perform related data collection and
analysis, and, as a result, we may face costs and delays that
are outside of our control. |
We rely on clinical investigators and clinical sites, some of
which are private practices, and some of which are research
university or government-affiliated, to enroll patients in our
clinical trials. We rely on: pathologists and pathology
laboratories; a contract research organization to assist in
monitoring, collection of data, and ensuring FDA Good Clinical
Practices (GCP) are observed at our sites; a consultant
biostatistician; and other third parties to manage the trial and
to perform related data collection and analysis. However, we may
not be able to control the amount and timing of resources that
clinical sites and other third parties may devote to our
clinical trials. If these clinical investigators and clinical
sites fail to enroll a sufficient number of patients in our
clinical trials, or if the clinical sites fail to comply
adequately with the clinical protocols, we will be unable to
complete these trials, which could prevent us from obtaining
regulatory approvals for MelaFind®. Our agreements with
clinical investigators and clinical sites for clinical testing
place substantial responsibilities on these parties and, if
these parties fail to perform as expected, our trials could be
delayed or terminated. If these clinical investigators, clinical
sites or other third parties do not carry out their contractual
duties or obligations or fail to meet expected deadlines, or if
the quality or accuracy of the clinical data they obtain are
compromised due to their failure to adhere to our clinical
protocols or for other reasons, our clinical trials may be
extended, delayed or terminated, and we may be unable to obtain
regulatory approval for, or successfully commercialize,
MelaFind®.
In addition to the foregoing, our clinical trial may be delayed
or halted, or be inadequate to support approval of a PMA
application, for numerous other reasons, including, but not
limited to, the following:
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the FDA, an Institutional Review Board (IRB), or other
regulatory authorities place our clinical trial on hold; |
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patients do not enroll in clinical trials at the rate we expect; |
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patient follow-up is not at the rate we expect; |
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IRBs and third-party clinical investigators delay or reject our
trial protocol; |
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third-party organizations do not perform data collection and
analysis in a timely or accurate manner; |
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regulatory inspections of our clinical trials or manufacturing
facilities, among other things, require us to undertake
corrective action or suspend or terminate our clinical trials,
or invalidate our clinical trials; |
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changes in governmental regulations or administrative actions;
and |
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the interim or final results of the clinical trial are
inconclusive or unfavorable as to safety or effectiveness. |
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If MelaFind® is approved for
reimbursement, we anticipate experiencing significant pressures
on pricing. |
Even if Medicare covers a device for certain uses, that does not
mean that the level of reimbursement will be sufficient for
commercial success. We expect to experience pricing pressures in
connection with the commercialization of MelaFind® and our
future products due to efforts by private and government-funded
payors to reduce or limit the growth of healthcare costs, the
increasing influence of health maintenance organizations, and
additional legislative proposals to reduce or limit increase in
public funding for
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healthcare services. Private payors, including managed care
payors, increasingly are demanding discounted fee structures and
the assumption by healthcare providers of all or a portion of
the financial risk. Efforts to impose greater discounts and more
stringent cost controls upon healthcare providers by private and
public payors are expected to continue. Payors frequently review
their coverage policies for existing and new diagnostic tools
and can, sometimes without advance notice, deny or change their
coverage policies. Significant limits on the scope of services
covered or on reimbursement rates and fees on those services
that are covered could have a material adverse effect on our
ability to commercialize MelaFind® and therefore, on our
liquidity and our business, financial condition, and results of
operations.
In some foreign markets, which we may seek to enter in the
future, pricing and profitability of medical devices are subject
to government control. In the US, we expect that there will
continue to be federal and state proposals for similar controls.
Also, the trends toward managed healthcare in the US and
proposed legislation intended to control the cost of publicly
funded healthcare programs could significantly influence the
purchase of healthcare services and products, and may force us
to reduce prices for MelaFind® or result in the exclusion
of MelaFind® from reimbursement programs.
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MelaFind® may never achieve market
acceptance even if we obtain regulatory approvals. |
To date, only those patients who were treated by physicians
involved in our clinical trials have been evaluated using
MelaFind® and even if we obtain regulatory approval
patients with suspicious lesions and physicians evaluating
suspicious lesions may not endorse MelaFind®. Physicians
tend to be slow to change their diagnostic and medical treatment
practices because of perceived liability risks arising from the
use of new products and the uncertainty of third party
reimbursement. Physicians may not utilize MelaFind® until
there is long-term clinical evidence to convince them to alter
their existing methods of diagnosing or evaluating suspicious
lesions and there are recommendations from prominent physicians
that MelaFind® is effective. We cannot predict the speed at
which physicians may adopt the use of MelaFind®. If
MelaFind® receives the appropriate regulatory approvals but
does not achieve an adequate level of acceptance by patients,
physicians and healthcare payors, we may not generate
significant product revenue and we may not become profitable.
The degree of market acceptance of MelaFind® will depend on
a number of factors, including:
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perceived effectiveness of MelaFind®; |
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convenience of use; |
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cost of the use of MelaFind®; |
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availability and adequacy of third-party coverage or
reimbursement; |
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approved indications and product labeling; |
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publicity concerning MelaFind® or competitive products; |
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potential advantages over alternative diagnostic methodologies; |
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introduction and acceptance of competing products or
technologies; and |
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extent and success of our sales, marketing and distribution
efforts. |
The identification and screening of melanomas is now dominated
by visual clinical evaluation, with a minority of dermatologists
using dermoscopy. Even if MelaFind® proves to be as
effective as visual inspection by an expert dermatologist, and
if all approvals are obtained, the success of MelaFind®
will depend upon the acceptance by dermatologists and other
physicians who perform skin examinations and treat skin
disorders, including industry opinion leaders, that the
diagnostic information provided by MelaFind® is medically
useful and reliable. We will be subject to intense scrutiny
before physicians will be comfortable incorporating
MelaFind® in their diagnostic approaches. We believe that
recommendations by respected physicians will be essential for
the development and successful marketing of MelaFind®, and
there can be no assurance that any such recommendations will be
obtained. To date, the medical community outside the limited
circle of certain dermatologists specializing in melanoma has
had little
13
exposure to us and MelaFind®. Because the medical community
is often skeptical of new companies and new technologies, we may
be unable to gain access to potential customers in order to
demonstrate the operation and effectiveness of MelaFind®.
Even if we gain access to potential customers, no assurance can
be given that members of the dermatological, or later the
general practice, medical community will perceive a need for or
accept MelaFind®. In particular, given the potentially
fatal consequences of failing to detect melanoma at the early,
curable stages, practitioners may remain reluctant to rely upon
MelaFind® even after we receive approval from the FDA for
marketing the product.
Any of the foregoing factors, or other currently unforeseen
factors, could limit or detract from market acceptance of
MelaFind®. Insufficient market acceptance of MelaFind®
would have a material adverse effect on our business, financial
condition and results of operations.
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We may be unable to complete the development and
commercialization of MelaFind® or other
products without additional funding. |
We currently believe that our available cash, cash equivalents
and marketable securities, together with our net proceeds from
this offering, will be sufficient to fund our anticipated levels
of operations through mid 2008. However, our operations have
consumed substantial amounts of cash for each of the last six
years. We expect to continue to spend substantial amounts on
research and development, including conducting a clinical trial
for MelaFind®. Even before we receive approval to market
MelaFind®, we expect to spend significant additional
amounts to ready the product for commercial distribution
following FDA approval, including development of a direct sales
force and expansion of manufacturing capacity. We expect that
our cash used by operations will increase significantly in each
of the next several years, and should we encounter any material
delays or impediments, we may need additional funds to complete
the development and commercialization of MelaFind®. Any
additional financing may be dilutive to stockholders, or may
require us to grant a lender a security interest in our assets.
The amount of funding we will need will depend on many factors,
including:
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the schedule, costs, and results of our clinical trials; |
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the success of our research and development efforts; |
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the costs and timing of regulatory approval; |
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reimbursement amounts for the use of MelaFind® that we are
able to obtain from Medicare and third party payors, or the
amount of direct payments we are able to obtain from patients
and/or physicians utilizing MelaFind®; |
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the cost of commercialization activities, including product
marketing and building a domestic direct sales force; |
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the emergence of competing or complementary technological
developments; |
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the costs of filing, prosecuting, defending and enforcing any
patent claims and other rights, including litigation costs and
the results of such litigation; |
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the costs involved in defending any patent infringement actions
brought against us by third parties; and |
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our ability to establish and maintain any collaborative,
licensing or other arrangements, and the terms and timing of any
such arrangements. |
Additional financing may not be available to us when we need it,
or it may not be available on favorable terms. If we are unable
to obtain adequate financing on a timely basis, we may be
required to significantly curtail or cease one or more of our
development and marketing programs. We could be required to seek
funds through arrangements with collaborators or others that may
require us to relinquish rights to some of our technologies,
product candidates or products that we would otherwise pursue on
our own. We also may have to reduce marketing, customer support
and other resources devoted to our products. If we raise
additional funds by issuing equity securities, our then-existing
stockholders will
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experience ownership dilution, could experience declines in our
share price and the terms of any new equity securities may have
preferences over our common stock.
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If we are unable to establish sales, marketing and
distribution capabilities or enter into and maintain
arrangements with third parties to sell, market and distribute
MelaFind®, our business may be harmed. |
We do not have a sales organization, and have no experience as a
company in the marketing and distribution of devices such as
MelaFind®. To achieve commercial success for
MelaFind®, we must develop a sales and marketing force and
enter into arrangements with others to market and sell our
products. Following product approval, we currently plan to
establish a small direct sales force to market MelaFind® in
the US, focused on introducing it at high volume
dermatologists offices and training their staff in its
use, but we have not made any final determinations regarding the
use of a particular marketing channel. Developing such a sales
force is expensive and time consuming, and could delay or limit
the success of any product launch. We may not be able to develop
this capacity on a timely basis or at all. Qualified direct
sales personnel with experience in the medical device market are
in high demand, and there is no assurance that we will be able
to hire or retain an effective direct sales team. Similarly,
qualified, independent medical device representatives both
within and outside the US are in high demand, and we may not be
able to build an effective network for the distribution of our
product through such representatives. We have no assurance that
we will be able to enter into contracts with representatives on
terms acceptable or reasonable to us. Similarly, there is no
assurance that we will be able to build an alternate
distribution framework, should we attempt to do so.
We will need to contract with third parties in order to sell and
install our products in larger markets, including non-specialist
dermatologists and primary care physicians. To the extent that
we enter into arrangements with third parties to perform
marketing and distribution services in the US, our product
revenue could be lower and our costs higher than if we directly
marketed MelaFind®. Furthermore, to the extent that we
enter into co-promotion or other marketing and sales
arrangements with other companies, any revenue received will
depend on the skills and efforts of others, and we do not know
whether these efforts will be successful. If we are unable to
establish and maintain adequate sales, marketing and
distribution capabilities, independently or with others, we will
not be able to generate product revenue, and may not become
profitable.
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We have limited manufacturing capabilities and
manufacturing personnel, and if our manufacturing capabilities
are insufficient to produce an adequate supply of
MelaFind®, our growth could be limited and our business
could be harmed. |
We have not yet completed the development and testing of
MelaFind®, and as a result have no experience in
manufacturing MelaFind® for commercial distribution. We
currently have limited resources, facilities and experience to
commercially manufacture MelaFind®. In order to produce
MelaFind® in the quantities we anticipate to meet market
demand, we will need to increase our manufacturing capacity by a
significant factor over the current level, or procure
manufacturing services from others. There are technical
challenges to increasing manufacturing capacity, including
equipment design and automation, material procurement, problems
with production yields, and quality control and assurance.
Developing commercial-scale manufacturing facilities that meet
FDA requirements would require the investment of substantial
additional funds and the hiring and retaining of additional
management and technical personnel who have the necessary
manufacturing experience.
We currently plan to outsource certain production aspects to
contract manufacturers. Any difficulties in the ability of
third-party manufacturers to supply devices of the quality, at
the times, and in the quantities we need, could have a material
adverse effect on our business, financial condition, and results
of operations. Similarly, if we enter into contracts for third
party manufacture of our devices, any revenue received will
depend on the skills and efforts of others, and we do not know
whether these efforts will be successful. Manufacturers often
encounter difficulties in scaling up production of new products,
including problems involving product yields, controlling and
anticipating product costs, quality control and assurance,
component supply, and shortages of qualified personnel. We
cannot assure you that the third-party contract
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manufacturers with whom we are developing relationships will
have or sustain the ability to produce the quantities of
MelaFind® needed for development or commercial sales, or
will be willing to do so at prices that allow MelaFind® to
compete successfully in the market.
Assuming that MelaFind® receives regulatory approval, if we
are unable to manufacture or obtain a sufficient supply of
product, maintain control over expenses, or otherwise adapt to
anticipated growth, or if we underestimate growth, we may not
have the capability to satisfy market demand, and our business
will suffer. Additionally, if MelaFind® receives regulatory
approval and we then need to make manufacturing changes, we may
need to obtain additional approval for these changes.
MelaFind® is complex and may contain undetected design
defects and errors when first introduced, or errors that may be
introduced when enhancements are released. Such defects and
errors may occur despite our testing, and may not be discovered
until after our devices have been shipped to and used by our
customers. The existence of these defects and errors could
result in costly repairs, returns of devices, diversion of
development resources and damage to our reputation in the
marketplace. Any of these conditions could have a material
adverse impact on our business, financial condition and results
of operations. In addition, if we contract with third-party
manufacturers for the production of our products, these
manufacturers may inadvertently produce devices that vary from
devices we have produced in unpredictable ways that cause
adverse consequences.
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Our manufacturing operations are dependent upon
third-party suppliers, making us vulnerable to supply problems
and price fluctuations, which could harm our business. We
anticipate contracting for final device assembly and
integration, but no contract for such services on a commercial
basis has yet been procured. |
Our manufacturing efforts currently rely on FillFactory, a
subsidiary of Cypress Semiconductor Corp., to manufacture and
supply the complementary metal oxide semiconductor sensor in
MelaFind®, on Pracownia Optyki Instrumentalnej (Optyka) for
lens elements and on Fairchild Semiconductor Corp., Panasonic
Corp., and others for light-emitting diodes, or LEDs, printed
circuit boards, and other elements or components of our devices.
We have written agreements with several of these vendors, under
which the vendor is obligated to perform services or produce
components for us. There can be no assurance that these third
parties will meet their obligations under the agreements. Each
of these suppliers is a sole-source supplier. Our contract
manufacturers also rely on sole-source suppliers to manufacture
some of the components used in our products. Our manufacturers
and suppliers may encounter problems during manufacturing due to
a variety of reasons, including failure to follow specific
protocols and procedures, failure to comply with applicable
regulations, equipment malfunction and environmental factors,
any of which could delay or impede their ability to meet our
demand. Our reliance on these outside manufacturers and
suppliers also subjects us to other risks that could harm our
business, including:
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suppliers may make errors in manufacturing components that could
negatively affect the effectiveness or safety of our products,
or cause delays in shipment of our products; |
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we may not be able to obtain adequate supply in a timely manner
or on commercially reasonable terms; |
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we may have difficulty locating and qualifying alternative
suppliers for our sole-source suppliers; |
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switching components may require product redesign and submission
to the FDA of a PMA supplement or possibly a separate PMA,
either of which could significantly delay production; |
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our suppliers manufacture products for a range of customers, and
fluctuations in demand for the products these suppliers
manufacture for others may affect their ability to deliver
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our suppliers may encounter financial hardships unrelated to our
demand for components, which could inhibit their ability to
fulfill our orders and meet our requirements. |
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Any interruption or delay in the supply of components or
materials, or our inability to obtain components or materials
from alternate sources at acceptable prices in a timely manner,
could impair our ability to meet the demand of our customers and
cause them to cancel orders.
We have entered into a development agreement with ASKION GmbH
(ASKION) to complete developmental engineering and testing
of our hand-held imaging device, and have entered into a
non-binding Letter of Intent with ASKION to assemble the
components and produce initial quantities of our hand-held
imaging devices for clinical trials. We intend to enter into a
contract for commercial production of the hand-held imaging
devices once specifications for MelaFind® have been
finalized, but we may not be able to enter such an agreement on
mutually acceptable terms. Failure to enter into such an
agreement with ASKION would require us to expand our own
manufacturing facilities or obtain such services elsewhere. Our
planned reliance upon an outside provider for assembly and
production services subjects us to the risk of adverse
consequences from delays and defects caused by the failure of
such outside supplier to meet its contractual obligations. The
failure by us or our supplier to produce a sufficient number of
hand-held imaging devices that can operate according to our
specifications could delay the pivotal clinical trial and/or the
commercial sale of MelaFind®, and would adversely affect
both our ability to successfully commercialize MelaFind®
and our business, financial condition and results of operations.
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We will not be able to sell MelaFind®
unless and until its design is verified and validated in
accordance with current good manufacturing practices as set
forth in the US medical device Quality System Regulation. |
We are in the process, but have not yet successfully completed,
all the steps necessary to verify and validate the design of the
MelaFind® system that are required to be performed prior to
commercialization. If we are delayed or unable to complete
verification and validation successfully, we will not be able to
sell MelaFind®, and we will not be able to meet our plans
for the commercialization of MelaFind® in 2007.
Assuming that regulatory approval of MelaFind® is granted,
the approval may be subject to limitations on the indicated uses
for which the product may be marketed, or may contain
requirements for costly post-marketing testing and surveillance
to monitor the safety or effectiveness of the device. Later
discovery of previously unknown problems with MelaFind®,
including manufacturing problems, or failure to comply with
regulatory requirements such as the Quality System Regulation (a
set of current good manufacturing practice requirements put
forth by the FDA which govern the methods used in, and the
facilities and controls used for, the design, manufacture,
packaging, labeling, storage, installation and servicing of
finished devices) (QSR), may result in restrictions on
MelaFind® or its manufacturing processes, withdrawal of
MelaFind® from the market, patient or physician
notification, voluntary or mandatory recalls, fines, withdrawal
of regulatory approvals, refusal to approve pending applications
or supplements to approved applications, refusal to permit the
import or export of our products, product seizures, injunctions
or the imposition of civil or criminal penalties. Should any of
these enforcement actions occur, our business, financial
condition and results of operations could be materially and
adversely affected.
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Assuming that MelaFind® is approved by
regulatory authorities, if we or our suppliers fail to comply
with ongoing regulatory requirements, or if we experience
unanticipated problems with MelaFind®, it could be subject
to restrictions or withdrawal from the market. |
Any product for which we obtain marketing approval, along with
the manufacturing processes, post-approval clinical data and
promotional activities for such product, will be subject to
continuous review and periodic inspections by the FDA and other
regulatory bodies. In particular, we and our suppliers are
required to comply with the QSR and other regulations which
cover the methods and documentation of the design, testing,
production, control, quality assurance, labeling, packaging,
storage, promotion, distribution, and shipping of
MelaFind®, and with record keeping practices. We also will
be subject to ongoing FDA requirements, including required
submissions of safety and other post-market information and
reports and registration and listing requirements. To the extent
that we contract with third parties to manufacture some of our
products, our manufacturers will be required to adhere to
current Good Manufacturing Practices (cGMP) requirements
enforced by the FDA as part of QSR, or similar regulations
required by regulatory agencies in other countries. The
manufacturing facilities of our contract
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manufacturers must be inspected or must have been inspected, and
must be in full compliance with cGMP requirements before
approval for marketing. The FDA enforces the QSR and other
regulatory requirements through unannounced inspections. We have
not yet been inspected by the FDA for MelaFind®, and will
have to complete such an inspection successfully before we ship
any commercial MelaFind® devices. However, we were
previously inspected in connection with DIFOTI®, which we
have discontinued for business reasons, and were cited for
failures to comply fully with QSR mandated procedures. We have
discussed the findings in a subsequent meeting with the FDA and
are in the process of addressing the deficiencies. The FDA
inspectors observed deficiencies that were documented on FDA
Form 483 that was issued to us following the inspection. We
have had a follow-up meeting with the FDA, and are working with
the FDA and consultants to address the inspectional findings,
particularly as they relate to current MelaFind® design
development and ultimate MelaFind® commercial
manufacturing. If we are not successful in convincing the FDA
that we are capable of addressing its concerns, or if our
efforts to address the deficiencies should prove unsuccessful,
we might be subject to additional FDA action of a type described
below, which could negatively affect our ability to
commercialize MelaFind®.
There can be no assurance that the future interpretations of
legal requirements made by the FDA or other regulatory bodies
with possible retroactive effect, or the adoption of new
requirements or policies, will not adversely affect us. We may
be slow to adapt, or may not be able to adapt to these changes
or new requirements. Failure by us or one of our suppliers to
comply with statutes and regulations administered by the FDA and
other regulatory bodies, or failure to take adequate response to
any observations, could result in, among other things, any of
the following actions:
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warning letters; |
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fines and civil penalties; |
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unanticipated expenditures; |
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delays in approving or refusal to approve MelaFind®; |
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withdrawal of approval by the FDA or other regulatory bodies; |
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product recall or seizure; |
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interruption of production; |
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operating restrictions; |
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injunctions; and |
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criminal prosecution. |
If any of these actions were to occur, it would harm our
reputation and cause our product sales and profitability to
suffer.
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We are involved in a heavily regulated sector, and our
ability to remain viable will depend on favorable government
decisions at various points by various agencies. |
From time to time, legislation is introduced in the US Congress
that could significantly change the statutory provisions
governing the approval, manufacture and marketing of a medical
device. Additionally, healthcare is heavily regulated by the
federal government, and by state and local governments. The
federal laws and regulations affecting healthcare change
constantly, thereby increasing the uncertainty and risk
associated with any healthcare related venture, including our
business and MelaFind®. In addition, FDA regulations and
guidance are often revised or reinterpreted by the agency in
ways that may significantly affect our business and our
products. It is impossible to predict whether legislative
changes will be enacted or FDA regulations, guidance, or
interpretations changed, and what the impact of such changes, if
any, may be.
The federal government regulates healthcare through various
agencies, including but not limited to the following:
(i) the FDA, which administers the Food, Drug, and Cosmetic
Act (FD&C Act), as well as other relevant laws;
(ii) CMS, which administers the Medicare and Medicaid
programs; (iii) the Office of Inspector General
(OIG) which enforces various laws aimed at curtailing
fraudulent or abusive practices,
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including by way of example, the Anti-Kickback Law, the
Anti-Physician Referral Law, commonly referred to as Stark, the
Anti-Inducement Law, the Civil Money Penalty Law, and the laws
that authorize the OIG to exclude healthcare providers and
others from participating in federal healthcare programs; and
(iv) the Office of Civil Rights, which administers the
privacy aspects of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA). All of the aforementioned
are agencies within HHS. Healthcare is also provided or
regulated, as the case may be, by the Department of Defense
through its TriCare program, the Public Health Service within
HHS under the Public Health Service Act, the Department of
Justice through the Federal False Claims Act and various
criminal statutes, and state governments under Medicaid and
other state sponsored or funded programs and their internal laws
regulating all healthcare activities.
In addition to regulation by the FDA as a medical device
manufacturer, we are subject to general healthcare industry
regulations. The healthcare industry is subject to extensive
federal, state and local laws and regulations relating to:
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billing for services; |
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quality of medical equipment and services; |
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confidentiality, maintenance and security issues associated with
medical records and individually identifiable health information; |
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false claims; and |
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labeling products. |
These laws and regulations are extremely complex and, in some
cases, still evolving. In many instances, the industry does not
have the benefit of significant regulatory or judicial
interpretation of these laws and regulations. If our operations
are found to be in violation of any of the federal, state or
local laws and regulations that govern our activities, we may be
subject to the applicable penalty associated with the violation,
including civil and criminal penalties, damages, fines or
curtailment of our operations. The risk of being found in
violation of these laws and regulations is increased by the fact
that many of them have not been fully interpreted by the
regulatory authorities or the courts, and their provisions are
open to a variety of interpretations. Any action against us for
violation of these laws or regulations, even if we successfully
defend against it, could cause us to incur significant legal
expenses and divert our managements time and attention
from the operation of our business.
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We must comply with complex statutes prohibiting fraud and
abuse, and both we and physicians utilizing
MelaFind® could be subject to significant
penalties for noncompliance. |
There are extensive federal and state laws and regulations
prohibiting fraud and abuse in the healthcare industry that can
result in significant criminal and civil penalties. These
federal laws include: the anti-kickback statute which prohibits
certain business practices and relationships, including the
payment or receipt of remuneration for the referral of patients
whose care will be paid by Medicare or other federal healthcare
programs; the physician self-referral prohibition, commonly
referred to as the Stark Law; the anti-inducement law, which
prohibits providers from offering anything to a Medicare or
Medicaid beneficiary to induce that beneficiary to use items or
services covered by either program; the Civil False Claims Act,
which prohibits any person from knowingly presenting or causing
to be presented false or fraudulent claims for payment by the
federal government, including the Medicare and Medicaid programs
and; the Civil Monetary Penalties Law, which authorizes HHS to
impose civil penalties administratively for fraudulent or
abusive acts.
Sanctions for violating these federal laws include criminal and
civil penalties that range from punitive sanctions, damage
assessments, money penalties, imprisonment, denial of Medicare
and Medicaid payments, or exclusion from the Medicare and
Medicaid programs, or both. As federal and state budget
pressures continue, federal and state administrative agencies
may also continue to escalate investigation and enforcement
efforts to root out waste and to control fraud and abuse in
governmental healthcare programs. Private enforcement of
healthcare fraud has also increased, due in large part to
amendments to
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the Civil False Claims Act in 1986 that were designed to
encourage private persons to sue on behalf of the government. A
violation of any of these federal and state fraud and abuse laws
and regulations could have a material adverse effect on our
liquidity and financial condition. An investigation into the use
of MelaFind® by physicians may dissuade physicians from
either purchasing or using MelaFind®, and could have a
material adverse effect on our ability to commercialize
MelaFind®.
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The application of the privacy provisions of HIPAA is
uncertain. |
HIPAA, among other things, protects the privacy and security of
individually identifiable health information by limiting its use
and disclosure. HIPAA directly regulates covered
entities (insurers, clearinghouses, and most healthcare
providers) and indirectly regulates business
associates with respect to the privacy of patients
medical information. All entities that receive and process
protected health information are required to adopt certain
procedures to safeguard the security of that information. It is
uncertain whether we would be deemed to be a covered entity
under HIPAA, and it is unlikely that based on our current
business model, we would be a business associate. Nevertheless,
we will likely be contractually required to physically safeguard
the integrity and security of the patient information that we or
our physician customers receive, store, create or transmit. If
we fail to adhere to our contractual commitments, then our
physician customers may be subject to civil monetary penalties,
and this could adversely affect our ability to market
MelaFind®. We also may be liable under state laws governing
the privacy of health information.
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We may become subject to claims of infringement or
misappropriation of the intellectual property rights of others,
which could prohibit us from shipping affected products, require
us to obtain licenses from third parties or to develop
non-infringing alternatives, and subject us to substantial
monetary damages and injunctive relief. Our patents may also be
subject to challenge on validity grounds, and our patent
applications may be rejected. |
Third parties could, in the future, assert infringement or
misappropriation claims against us with respect to our current
or future products. Whether a product infringes a patent
involves complex legal and factual issues, the determination of
which is often uncertain. Therefore, we cannot be certain that
we have not infringed the intellectual property rights of such
third parties. Our potential competitors may assert that some
aspect of MelaFind® infringes their patents. Because patent
applications may take years to issue, there also may be
applications now pending of which we are unaware that may later
result in issued patents that MelaFind® infringes. There
also may be existing patents of which we are unaware that one or
more components of our MelaFind® system may inadvertently
infringe.
Any infringement or misappropriation claim could cause us to
incur significant costs, could place significant strain on our
financial resources, divert managements attention from our
business and harm our reputation. If the relevant patents were
upheld as valid and enforceable and we were found to infringe,
we could be prohibited from selling our product that is found to
infringe unless we could obtain licenses to use the technology
covered by the patent or are able to design around the patent.
We may be unable to obtain a license on terms acceptable to us,
if at all, and we may not be able to redesign MelaFind® to
avoid infringement. A court could also order us to pay
compensatory damages for such infringement, plus prejudgment
interest and could, in addition, treble the compensatory damages
and award attorney fees. These damages could be substantial and
could harm our reputation, business, financial condition and
operating results. A court also could enter orders that
temporarily, preliminarily or permanently enjoin us and our
customers from making, using, selling, offering to sell or
importing MelaFind®, and/or could enter an order mandating
that we undertake certain remedial activities. Depending on the
nature of the relief ordered by the court, we could become
liable for additional damages to third parties.
We also may rely on our patents, patent applications and other
intellectual property rights to give us a competitive advantage.
Whether a patent is valid, or whether a patent application
should be granted, is a complex matter of science and law, and
therefore we cannot be certain that, if challenged, our patents,
patent applications and/or other intellectual property rights
would be upheld. If one or more of those
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patents, patent applications and other intellectual property
rights are invalidated, rejected or found unenforceable, that
could reduce or eliminate any competitive advantage we might
otherwise have had.
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New product development in the medical device industry is
both costly and labor intensive with very low success rates for
successful commercialization; if we cannot successfully develop
or obtain future products, our growth would be delayed. |
Our long-term success is dependent, in large part, on the
design, development and commercialization of MelaFind® and
other new products and services in the medical device industry.
The product development process is time-consuming, unpredictable
and costly. There can be no assurance that we will be able to
develop or acquire new products, successfully complete clinical
trials, obtain the necessary regulatory clearances or approvals
required from the FDA on a timely basis, or at all, manufacture
our potential products in compliance with regulatory
requirements or in commercial volumes, or that MelaFind® or
other potential products will achieve market acceptance. In
addition, changes in regulatory policy for product approval
during the period of product development, and regulatory agency
review of each submitted new application, may cause delays or
rejections. It may be necessary for us to enter into licensing
arrangements, in order to market effectively any new products or
new indications for existing products. There can be no assurance
that we will be successful in entering into such licensing
arrangements on terms favorable to us or at all. Failure to
develop, obtain necessary regulatory clearances or approvals
for, or successfully market potential new products could have a
material adverse effect on our business, financial condition and
results of operations.
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We face the risk of product liability claims and may not
be able to obtain or maintain adequate insurance. |
Our business exposes us to the risk of product liability claims
that is inherent in the testing, manufacturing and marketing of
medical devices, including those which may arise from the misuse
or malfunction of, or design flaws in, our products. We may be
subject to product liability claims if MelaFind® causes, or
merely appears to have caused, an injury or if a patient alleges
that MelaFind® failed to provide appropriate diagnostic
information on a lesion where melanoma was subsequently found to
be present. Claims may be made by patients, healthcare providers
or others involved with MelaFind®. MelaFind® will
require PMA approval prior to commercialization in the US. The
clinical studies of MelaFind® are considered by the FDA as
Non-Significant Risk (NSR). Consequently, the trials are
conducted under the auspices of an abbreviated Investigational
Device Exemption (IDE). We therefore do not maintain domestic
clinical trial liability insurance. We have obtained clinical
trial liability insurance in certain European countries where
required by statute or clinical site policy. Although we have
general liability insurance that we believe is appropriate, and
anticipate obtaining adequate product liability insurance before
commercialization of MelaFind®, this insurance is and will
be subject to deductibles and coverage limitations. Our
anticipated product liability insurance may not be available to
us in amounts and on acceptable terms, if at all, and if
available, the coverages may not be adequate to protect us
against any future product liability claims. If we are unable to
obtain insurance at an acceptable cost or on acceptable terms
with adequate coverage, or otherwise protect against potential
product liability claims, we will be exposed to significant
liabilities, which may harm our business. A product liability
claim, recall or other claim with respect to uninsured
liabilities or for amounts in excess of insured liabilities
could result in significant costs and significant harm to our
business.
We may be subject to claims against us even if the apparent
injury is due to the actions of others. For example, we rely on
the expertise of physicians, nurses and other associated medical
personnel to operate MelaFind®. If these medical personnel
are not properly trained or are negligent, we may be subjected
to liability. These liabilities could prevent or interfere with
our product commercialization efforts. Defending a suit,
regardless of merit, could be costly, could divert management
attention and might result in adverse publicity, which could
result in the withdrawal of, or inability to recruit, clinical
trial volunteers, or result in reduced acceptance of
MelaFind® in the market.
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Insurance and surety companies have reassessed many aspects of
their business and, as a result, may take actions that could
negatively affect our business. These actions could include
increasing insurance premiums, requiring higher self-insured
retentions and deductibles, reducing limits, restricting
coverages, imposing exclusions, and refusing to underwrite
certain risks and classes of business. Any of these actions may
adversely affect our ability to obtain appropriate insurance
coverage at reasonable costs, which could have a material
adverse effect on our business, financial condition and results
of operations.
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We may be adversely affected by a data center
failure. |
The success of MelaFind® is dependent upon our ability to
protect our data center against damage from fire, power loss,
telecommunications failure, natural disaster, sabotage or a
similar catastrophic event. Substantially all of our computer
equipment and data operations are located in a single facility.
Our prospective failure to maintain off-site copies of
information contained in our MelaFind® database, or our
inability to use alternative sites in the event we experience a
natural disaster, hardware or software malfunction or other
interruption of our data center, or any interruption in the
ability of physicians to obtain access to our MelaFind®
server and its database could adversely impact our business,
financial condition and results of operations.
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We may be adversely affected by breaches of online
security. |
Our MelaFind® database does not contain any information
that allows us to identify specific patients. However, we must
identify certain data as belonging to or as derived from
specific patients for billing purposes. To the extent that our
activities involve the storage and transmission of confidential
information, security breaches could damage our reputation and
expose us to a risk of loss, or to litigation and possible
liability. Our business may be materially adversely affected if
our security measures do not prevent security breaches. In
addition, such information may be subject to HIPAA privacy and
security regulations, the potential violation of which may
trigger concerns by healthcare providers, which may adversely
impact our business, financial condition and results of
operations.
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We are dependent upon telecommunications and the
internet. |
The connection between the MelaFind® hand-held imaging
device and the central server in our offices will be dependent
on the internet. Our success will depend in large part on the
continued availability of electronic means for storing and
transmitting encoded compressed diagnostic information, and
storing and transmitting the results of the comparison of such
information with our electronically-maintained database through
the internet. If the domestic and international
telecommunications infrastructure required for these
transmissions fails, our business could be materially adversely
affected.
We plan to use the internet as a medium to provide diagnostic
assistance services to physicians. We also plan to use the
internet to inform the public about the availability of our
products and to market to and communicate with physicians who
are potential or actual customers. Our success will therefore
depend in part on the continued growth and use of the internet.
If our ability to use the internet fails, it may materially
adversely affect our business.
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We will be obligated to comply with Federal Communications
Commission regulations for radio transmissions used by our
products. |
Versions of MelaFind® may rely on radio transmissions from
the hand-held imaging device to a base station that is connected
to the internet. Applicable requirements will restrict us to a
particular band of frequencies allocated to low power radio
service for transmitting data in support of specific diagnostic
or therapeutic functions. Failure to comply with all applicable
restrictions on the use of such frequencies, or unforeseeable
difficulties with the use of such frequencies, could impede our
ability to commercialize MelaFind®.
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All of our operations are conducted at a single location.
Any disruption at our facility could increase our
expenses. |
All of our operations are conducted at two adjacent buildings in
Irvington, New York. We take precautions to safeguard our
facility, including insurance, health and safety protocols,
contracted off-site engineering services, provision for off-site
manufacturing, and storage of computer data. However, a natural
disaster, such as a fire, flood or earthquake, could cause
substantial delays in our operations, damage or destroy our
manufacturing equipment or inventory, and cause us to incur
additional expenses. The insurance we maintain against fires,
floods, earthquakes and other natural disasters may not be
adequate to cover our losses in any particular case.
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We may be liable for contamination or other harm caused by
materials that we handle, and changes in environmental
regulations could cause us to incur additional expense. |
Our manufacturing, research and development and clinical
processes do not generally involve the handling of potentially
harmful biological materials or hazardous materials, but they
may occasionally do so. We are subject to federal, state and
local laws and regulations governing the use, handling, storage
and disposal of hazardous and biological materials. If
violations of environmental, health and safety laws occur, we
could be held liable for damages, penalties and costs of
remedial actions. These expenses or this liability could have a
significant negative impact on our business, financial condition
and results of operations. We may violate environmental, health
and safety laws in the future as a result of human error,
equipment failure or other causes. Environmental laws could
become more stringent over time, imposing greater compliance
costs and increasing risks and penalties associated with
violations. We may be subject to potentially conflicting and
changing regulatory agendas of political, business and
environmental groups. Changes to or restrictions on permitting
requirements or processes, hazardous or biological material
storage or handling might require an unplanned capital
investment or relocation. Failure to comply with new or existing
laws or regulations could harm our business, financial condition
and results of operations.
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Failure to obtain and maintain regulatory approval in
foreign jurisdictions will prevent us from marketing
abroad. |
Following commercialization of MelaFind® in the US, we may
market MelaFind® internationally. Outside the US, we can
market a product only if we receive a marketing authorization
and, in some cases, pricing approval, from the appropriate
regulatory authorities. The approval procedure varies among
countries and can involve additional testing, and the time
required to obtain approval may differ from that required to
obtain FDA approval. The foreign regulatory approval process may
include all of the risks associated with obtaining FDA approval,
in addition to other risks. Foreign regulatory bodies have
established varying regulations governing product standards,
packaging requirements, labeling requirements, import
restrictions, tariff regulations, duties and tax requirements.
We may not obtain foreign regulatory approvals on a timely
basis, if at all. Foreign regulatory agencies, as well as the
FDA, periodically inspect manufacturing facilities both in the
US and abroad. Approval by the FDA does not ensure approval by
regulatory authorities in other countries, and approval by one
foreign regulatory authority does not ensure approval by
regulatory authorities in other foreign countries or by the FDA.
We have not taken any significant actions to obtain foreign
regulatory approvals. We may not be able to file for regulatory
approvals and may not receive necessary approvals to
commercialize MelaFind® in any market on a timely basis, or
at all. Our inability or failure to comply with varying foreign
regulation, or the imposition of new regulations, could restrict
our sale of products internationally.
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Our success will depend on our ability to attract and
retain our personnel. |
We are highly dependent on our senior management, especially
Joseph V. Gulfo, M.D., our President and Chief Executive
Officer, and Dina Gutkowicz-Krusin, Ph.D., our Director of
Clinical Studies. Our success will depend on our ability to
retain our current management and to attract and retain
qualified personnel in the future, including scientists,
clinicians, engineers and other highly skilled personnel.
Competition for senior management personnel, as well as
scientists, clinicians, engineers, and experienced
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sales and marketing individuals, is intense, and we may not be
able to retain our personnel. The loss of the services of
members of our senior management, scientists, clinicians or
engineers could prevent the implementation and completion of our
objectives, including the development and introduction of
MelaFind®. The loss of a member of our senior management or
our professional staff would require the remaining executive
officers to divert immediate and substantial attention to
seeking a replacement. Each of our officers may terminate their
employment at any time without notice and without cause or good
reason.
We expect to expand our operations and grow our research and
development, product development and administrative operations.
This expansion is expected to place a significant strain on our
management, and will require hiring a significant number of
qualified personnel. Accordingly, recruiting and retaining such
personnel in the future will be critical to our success. There
is competition from other companies and research and academic
institutions for qualified personnel in the areas of our
activities. If we fail to identify, attract, retain and motivate
these highly skilled personnel, we may be unable to continue our
development and commercialization activities.
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Our financial results for future periods may be adversely
affected by changes required by financial and accounting
regulatory agencies. |
Our reported financial results may be adversely affected by
changes in accounting principles generally accepted in the US.
Generally accepted accounting principles in the US are subject
to interpretation by the Financial Accounting Standards Board
(FASB), the American Institute of Certified Public Accountants,
the Securities and Exchange Commission (SEC), and various bodies
formed to promulgate and interpret appropriate accounting
principles. A change in these principles or interpretations
could have a significant effect on our reported financial
results, and could affect the reporting of transactions
completed before the announcement of a change.
For example, we currently are not required to record stock-based
compensation charges if the employees stock option
exercise price is equal to or exceeds the fair value of our
common stock at the date of grant. However, several companies
have recently elected to change their accounting policies, and
have begun to record the fair value of stock options as an
expense. New FASB Statement of Financial Accounting Standards
No. 123 (revised 2004), Share-Based Payment (FASB Statement
No. 123R), requires companies to recognize in the income
statement the grant-date fair value of stock options and other
equity-based compensation issued to employees. Under FASB
Statement No. 123R, SEC registrants would have been
required to implement this standard for interim or annual
periods beginning after June 15, 2005, or after
December 15, 2005 for small business issuers. On
April 14, 2005, the SEC adopted a new rule amending the
compliance dates for FASB Statement No. 123R. The
SECs new rule permits companies to implement FASB
Statement No. 123R at the beginning of their next fiscal
year, instead of the next reporting period that begins after
June 15, 2005, or December 15, 2005 for small business
issuers. Awards to most non-employee directors will be accounted
for as employee awards. All public companies must use either the
modified prospective or the modified retrospective transition
method. Under the modified prospective method, awards that are
granted, modified, or settled after the date of adoption should
be measured and accounted for in accordance with FASB Statement
No. 123R. Under the modified retrospective method, the
previously-reported amounts are restated to either the beginning
of the year of adoption or for all periods presented. If we
elect to adopt the retroactive provisions and to restate all
prior periods presented our operating expenses and reported
losses will increase. Although we believe that our accounting
practices are consistent with current accounting pronouncements,
changes to or interpretations of accounting methods or policies
in the future may require us to reclassify, restate or otherwise
change or revise our financial statements.
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Our financial results for future periods will be affected
by the attainment of milestones. |
We have granted to certain employees stock options that vest
with the attainment of various performance milestones. Upon the
attainment of these milestones we will be required to recognize
a stock based compensation expense in an amount based on the
then current fair market value of our common
24
stock underlying the options which vest when the milestone is
attained. Assuming that all shares offered are sold in this
public offering at a price of $11.00 per share, the
mid-point of our filing range, that upon the attainment of each
of the relevant milestones such offering price remains the fair
market value per share of our common stock, and that the number
of shares of our common stock outstanding after this offering
remains 9,513,164 then we will record a compensation expense:
(1) upon completion of this offering of $1,301,570 with
respect to 125,000 shares underlying options with an exercise
price of $0.46 per share; (2) upon filing our
MelaFind® PMA with the FDA of $527,000 with respect to
50,000 shares underlying options with an exercise price of $0.46
per share; and (3) upon our receipt of PMA approval for
MelaFind® of $528,000 with respect to 50,000 shares
underlying options with a weighted average exercise price of
$0.44 per share and of $3,643,667 with respect to 345,699 shares
underlying options with an exercise price of $0.46 per share.
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If we fail to maintain the adequacy of our internal
controls, our ability to provide accurate financial statements
could be impaired and any failure to maintain our internal
controls and provide accurate financial statements could cause
our stock price to decrease substantially. |
We will face increased legal, accounting, administrative and
other costs and expenses as a public company that we did not
incur as a private company. The Sarbanes-Oxley Act of 2002
(SOX), as well as new rules subsequently implemented by the SEC,
the Public Company Accounting Oversight Board and the NASDAQ
National Market, require changes in the corporate governance
practices of public companies. We expect these new rules and
regulations to increase our legal and financial compliance
costs, to divert management attention from operations and
strategic opportunities, and to make legal, accounting and
administrative activities more time-consuming and costly. We
also expect to incur substantially higher costs to maintain
directors and officers insurance. We are in the
process of instituting changes to our internal procedures to
satisfy the requirements of the SOX. We are evaluating our
internal controls systems in order to allow us to report on, and
our independent registered public accounting firm to attest to,
our internal controls, as required by Section 404 of the
SOX. While we anticipate being able to fully implement the
requirements relating to internal controls and all other aspects
of Section 404 of the SOX in a timely fashion, we cannot be
certain as to the timing of completion of our evaluation,
testing and remediation actions or the impact of the same on our
operations, since there is no precedent available by which to
measure compliance adequacy. As a small company with limited
capital and human resources, we will need to divert
managements time and attention away from our business in
order to ensure compliance with these regulatory requirements.
As a public company, we will require greater financial resources
than we have had as a private company. Implementing these
changes may require new information technologies systems, the
auditing of our internal controls, and compliance training for
our directors, officers and personnel. Such efforts would
require a potentially significant expense. If we fail to
maintain the adequacy of our internal controls as such standards
are modified, supplemented or amended from time to time, we may
not be able to provide accurate financial statements and comply
with the SOX. Any failure to maintain the adequacy of our
internal controls and provide accurate financial statements
could cause the trading price of our common stock to decrease
substantially.
Risks Relating to this Offering
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An active trading market for our common stock may not
develop. |
Prior to this offering, there has been no public market for our
common stock. Although we are seeking approval for listing of
our common stock on the NASDAQ National Market, an active
trading market for our shares may never develop or be sustained
following this offering. Further, we cannot be certain that the
market price of our common stock will not decline below the
initial public offering price or below the amount required by
Nasdaq to maintain a listing on its National Market. Should we
fail to meet the minimum standards established by Nasdaq for its
National Market, we could be de-listed, meaning shareholders
might be subject to limited liquidity. The initial public
offering price for our
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common stock will be determined through negotiations with the
underwriters. This initial public offering price may vary from
the market price of our common stock after the offering and
investors may therefore be unable to sell their common stock at
or above the initial public offering price.
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Our stock price will be volatile, meaning purchasers of
our common stock could incur substantial losses. |
Our stock price is likely to be volatile. The stock market in
general and the market for medical technology companies in
particular have experienced extreme volatility that has often
been unrelated to the operating performance of particular
companies. As a result of this volatility, investors may not be
able to sell their common stock at or above the initial public
offering price. The following factors, in addition to other risk
factors described in this section and general market and
economic conditions, may have a significant impact on the market
price of our common stock:
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results of our research and development efforts and our clinical
trials; |
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the timing of regulatory approval for our products; |
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failure of any of our products, if approved, to achieve
commercial success; |
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the announcement of new products or product enhancements by us
or our competitors; |
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regulatory developments in the US and foreign countries; |
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ability to manufacture our products to commercial standards; |
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developments concerning our clinical collaborators, suppliers or
marketing partners; |
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changes in financial estimates or recommendations by securities
analysts; |
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public concern over our products; |
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developments or disputes concerning patents or other
intellectual property rights; |
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product liability claims and litigation against us or our
competitors; |
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the departure of key personnel; |
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the strength of our balance sheet; |
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variations in our financial results or those of companies that
are perceived to be similar to us; |
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changes in the structure of and third-party reimbursement in the
US and other countries; |
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changes in accounting principles or practices; |
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general economic, industry and market conditions; and |
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future sales of our common stock. |
A decline in the market price of our common stock could cause
you to lose some or all of your investment and may adversely
impact our ability to attract and retain employees and raise
capital. In addition, stockholders may initiate securities class
action lawsuits if the market price of our stock drops
significantly. Whether or not meritorious, litigation brought
against us could result in substantial costs and could divert
the time and attention of our management. Our insurance to cover
claims of this sort may not be adequate.
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We have broad discretion in the use of the net proceeds
from this offering and may not use them effectively. |
We cannot specify with certainty the particular uses of the net
proceeds we will receive from this offering. Our management will
have broad discretion in the application of the net proceeds,
including for any of the purposes described in Use of
Proceeds. Accordingly, you will have to rely upon the
judgment of our management with respect to the use of the
proceeds, with only limited information concerning
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managements specific intentions. Our management may spend
a portion or all of the net proceeds from this offering in ways
that our stockholders may not desire or that may not yield a
favorable return. The failure by our management to apply these
funds effectively could harm our business and financial
condition. Pending their use, we may invest the net proceeds
from this offering in a manner that does not produce income or
that loses value.
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Concentration of ownership among our directors, executive
officers, and principal stockholders may prevent new investors
from influencing significant corporate decisions. |
Upon closing of this offering, based upon beneficial ownership
as of June 30, 2005, our directors, executive officers,
holders of more than 5% of our common stock, and their
affiliates will, in the aggregate, beneficially own
approximately 31% of our outstanding common stock. As a result,
these stockholders, subject to any fiduciary duties owed to our
other stockholders under Delaware law, will be able to exercise
a controlling influence over matters requiring stockholder
approval, including the election of directors and approval of
significant corporate transactions, and will have significant
control over our management and policies. Some of these persons
or entities may have interests that are different from yours.
For example, these stockholders may support proposals and
actions with which you may disagree or which are not in your
interests. The concentration of ownership could delay or prevent
a change in control of our company or otherwise discourage a
potential acquirer from attempting to obtain control of our
company, which in turn could reduce the price of our common
stock. In addition, these stockholders, some of whom have
representatives sitting on our board of directors, could use
their voting influence to maintain our existing management and
directors in office, delay or prevent changes of control of our
company, or support or reject other management and board
proposals that are subject to stockholder approval, such as
amendments to our employee stock plans and approvals of
significant financing transactions.
If there are substantial
sales of our common stock, our stock price could decline.
If our existing stockholders sell a large number of shares of
our common stock or the public market perceives that these sales
may occur, the market price of our common stock could decline.
Based on shares outstanding on June 30, 2005, upon the
closing of this offering, assuming no outstanding options are
exercised prior to the closing of this offering, we will have
approximately 9,513,164 shares of common stock outstanding.
All of the shares offered under this prospectus will be freely
tradable without restriction or further registration under the
federal securities laws, unless purchased by our affiliates.
Taking into consideration the effect of lock-up agreements that
will be entered into by our stockholders, we estimate that the
remaining 6,513,164 shares outstanding upon the closing of
this initial public offering will be available for sale pursuant
to Rules 144 and 701, and the volume, manner of sale and
other limitations under these rules, as follows:
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approximately 6,386,000 shares of common stock will be
eligible for sale in the public market, beginning 270 days
after the effective date of this prospectus, unless the lock-up
period is otherwise extended pursuant to its terms; and |
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the remaining approximately 128,000 shares of common stock
will become eligible for sale in the public market after
October 26, 2005. |
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Existing stockholders holding an aggregate of
5,090,001 shares of common stock (including shares of our
common stock purchasable pursuant to warrants to purchase our
common stock) based on shares outstanding as of June 30,
2005 have rights with respect to the registration of these
shares of common stock with the SEC. See Description of
Capital Stock Registration Rights. If we
register these shares of common stock, they can immediately sell
those shares in the public market.
Within nine months following this offering, we intend to
register up to 1,899,875 shares of common stock that are
authorized for issuance under our stock option plans. As of
June 30, 2005, 899,875 shares were subject to outstanding
options, of which 446,675 shares were vested. Once we register
these shares, they can be freely sold in the public market upon
issuance, subject to the lock-up agreements referred to above
and restrictions on our affiliates.
27
You will incur immediate and
substantial dilution as a result of this offering.
The initial public offering price is substantially higher than
the book value per share of our common stock. As a result,
purchasers in this offering will experience immediate and
substantial dilution of $7.56 per share in the tangible book
value of our common stock from the initial public offering
price, based on the number of shares outstanding as of
June 30, 2005. This is due in large part to earlier
investors in the company having paid substantially less than the
initial public offering price when they purchased their shares.
Investors who purchase shares of common stock in this offering
will contribute approximately 62% of the total amount we
have raised to fund our operations but will own only
approximately 32% of our common stock, based on the number
of shares outstanding as of June 30, 2005. In addition, the
exercise of currently outstanding options and warrants to
purchase common stock and future equity issuances, including
future public or private securities offerings and any additional
shares issued in connection with acquisitions, will result in
further dilution.
|
|
|
Our charter documents and Delaware law may inhibit a
takeover that stockholders consider favorable and could also
limit the market price of our stock. |
Upon the closing of this offering, provisions of our restated
certificate of incorporation and bylaws and applicable
provisions of Delaware law may make it more difficult for or
prevent a third party from acquiring control of us without the
approval of our board of directors. These provisions:
|
|
|
|
|
set limitations on the removal of directors; |
|
|
|
limit who may call a special meeting of stockholders; |
|
|
|
establish advance notice requirements for nominations for
election to our board of directors or for proposing matters that
can be acted upon at stockholder meetings; |
|
|
|
do not permit cumulative voting in the election of our
directors, which would otherwise permit less than a majority of
stockholders to elect directors; |
|
|
|
prohibit stockholder action by written consent, thereby
requiring all stockholder actions to be taken at a meeting of
our stockholders; and |
|
|
|
|
provide our board of directors the ability to designate the
terms of and issue a new series of preferred stock without
stockholder approval. |
|
In addition, Section 203 of the Delaware General
Corporation Law generally limits our ability to engage in any
business combination with certain persons who own 15% or more of
our outstanding voting stock or any of our associates or
affiliates who at any time in the past three years have owned
15% or more of our outstanding voting stock. These provisions
may have the effect of entrenching our management team and may
deprive you of the opportunity to sell your shares to potential
acquirors at a premium over prevailing prices. This potential
inability to obtain a control premium could reduce the price of
our common stock.
28
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, included in this prospectus
regarding our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and
objectives of management are forward-looking statements. The
words anticipates, believes,
estimates, expects, intends,
may, plans, projects,
will, would and similar expressions are
intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Although we do not make forward-looking statements unless we
believe we have a reasonable basis for doing so, we cannot
guarantee their accuracy. We may not actually achieve the plans,
intentions or expectations disclosed in our forward-looking
statements and you should not place undue reliance on our
forward-looking statements. Actual results or events could
differ materially from the plans, intentions and expectations
stated in the forward-looking statements we make. We have
included important factors in the cautionary statements included
in this prospectus, particularly in the Risk Factors
section, that we believe could cause actual results or events to
differ materially from the forward-looking statements that we
make. Additional risks, uncertainties and factors, other than
those discussed under Risk Factors, could also cause
our actual results to differ materially from those projected in
any forward-looking statements we make. We operate in a very
competitive and rapidly changing environment in which new risks
emerge from time to time and it is not possible for us to
predict all risk factors, nor can we address the impact of all
factors on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking
statements. Our forward-looking statements do not reflect the
potential impact of any future acquisitions, mergers,
dispositions, joint ventures or investments we may make. We do
not assume any obligation to update or revise any
forward-looking statements, or to so update the reasons actual
results could differ materially from those anticipated in these
forward-looking statements, even if new information becomes
available in the future.
29
USE OF PROCEEDS
We estimate that we will receive net proceeds of approximately
$29.0 million from our sale of 3,000,000 shares of
common stock at an assumed initial public offering price of
$11.00 per share, the mid-point of our filing range, after
deducting underwriting discounts and commissions and estimated
expenses of approximately $4.0 million, which includes our
underwriters non-accountable expense allowance, legal,
accounting, printing costs and expenses, and various fees
associated with the registration and listing of our securities
payable by us. If the underwriters exercise their over-allotment
option in full, we will receive an additional $4,603,500 after
deducting $346,500 for underwriting discounts and commissions.
We intend to use these net proceeds approximately as follows:
|
|
|
|
|
|
60% ($17.4 million) to fund our research and development
activities, including our clinical studies; |
|
|
|
|
|
22% ($6.4 million) to develop our sales and marketing
capabilities; and |
|
|
|
|
|
18% ($5.2 million) for general corporate purposes,
including working capital, and capital expenditures made in the
ordinary course of business. |
|
The amounts that we actually expend for working capital purposes
will vary significantly depending on a number of factors. As a
result, we will retain broad discretion in the allocation of the
net proceeds of this offering. While we have no present
understandings, commitments or agreements to enter into any
potential acquisitions, we may also use a portion of the net
proceeds for the acquisition of, or investment in, technologies
or products that complement our business. Pending the uses
described above, we intend to invest the net proceeds of this
offering in short-term, investment-grade, interest-bearing
securities. We cannot predict whether the proceeds which we
invest will yield a favorable return.
DIVIDEND POLICY
We have never declared or paid cash dividends on our common
stock. We currently intend to retain our cash for the
development of our business. We do not intend to pay cash
dividends to our stockholders in the foreseeable future.
Any future determination relating to our dividend policy will be
made at the discretion of our board of directors and will depend
on then existing conditions, including our earnings, financial
condition, results of operations, level of indebtedness,
contractual restrictions, capital requirements, business
prospects and other factors our board of directors may deem
relevant. Our board of directors ability to declare a
dividend is also subject to limits imposed by Delaware law.
30
CAPITALIZATION
You should read this capitalization table together with the
sections of this prospectus entitled Managements
Discussions and Analysis of Financial Condition and Results of
Operations and with the financial statements and related
notes to those statements included elsewhere in this prospectus.
The following table sets forth our capitalization as of
June 30, 2005:
|
|
|
|
|
on an actual basis; and |
|
|
|
|
on a pro forma as adjusted basis to reflect the conversion of
all our outstanding shares of convertible preferred stock into
shares of common stock immediately prior to completion of this
offering, the assumed conversion of 2,610,643 warrants to
purchase the companys common stock to be exchanged for a
total of 1,305,321 shares of the companys common
stock based on an exchange ratio of one share of our common
stock for every two shares of our common stock purchasable under
the warrants to occur prior to the closing of this offering and
the receipt of the estimated net proceeds from the sale of
3,000,000 shares of our common stock in this offering at the
assumed initial public offering price of $11.00 per share, the
mid-point of our filing range, after deducting the underwriting
discounts and commissions and estimated offering expenses
payable by us. |
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2005 | |
|
|
| |
|
|
|
|
Pro Forma(1) | |
|
|
|
|
As Adjusted | |
|
|
Actual | |
|
(unaudited) | |
|
|
| |
|
| |
|
|
(In thousands, except share | |
|
|
and per share data) | |
Redeemable Convertible Preferred Stock:
|
|
|
|
|
|
|
|
|
Redeemable Preferred Stock Series B convertible;
992,986 shares designated (liquidation preference
$2.26 per share); issued and outstanding
992,986 shares at December 31, 2003 and 2004 and
June 30, 2005 and 0 shares at June 30, 2005, pro
forma as adjusted
|
|
$ |
2,244 |
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable Preferred Stock Series C convertible
5,744,340 shares designated (liquidation preference
$2.26 per share); issued and outstanding
907,077 shares at December 31, 2003 and
5,414,779 shares at December 31, 2004 and
June 30, 2005 and 0 shares at June 30, 2005, pro
forma as adjusted
|
|
|
7,183 |
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders (Deficiency) Equity:
|
|
|
|
|
|
|
|
|
Preferred stock $.10 par value; authorized
16,936,704 shares:
|
|
|
|
|
|
|
|
|
|
Series A Convertible Preferred Stock, 199,380 shares
designated (liquidation preference $5.00 per share); issued
and outstanding 198,000 shares at December 31, 2003
and 2004 and June 30, 2005 and 0 shares at
June 30, 2005, pro forma as adjusted
|
|
|
972 |
|
|
|
|
|
Common stock $.001 par value; authorized
30,000,000 shares; issued and outstanding
1,684,760 shares at December 31, 2003 and
1,809,758 shares at December 31, 2004 and
June 30, 2005 and 9,513,164 shares at June 30,
2005, pro forma as adjusted
|
|
|
2 |
|
|
|
10 |
|
Additional paid-in capital
|
|
|
10,210 |
|
|
|
49,601 |
|
Deferred compensation
|
|
|
(143 |
) |
|
|
(143 |
) |
Accumulated deficit
|
|
|
(16,716 |
) |
|
|
(16,716 |
) |
|
|
|
|
|
|
|
Stockholders (Deficiency) Equity
|
|
|
(5,675 |
) |
|
|
32,752 |
|
|
|
|
|
|
|
|
Total Capitalization
|
|
$ |
3,752 |
|
|
|
32,752 |
|
|
|
|
|
|
|
|
None of the columns shown above reflect the following:
|
|
|
|
|
899,875 shares of common stock issuable as of the date of
this prospectus upon the exercise of outstanding stock options
under our 2003 Stock Incentive Plan and our 1996 Stock Option
Plan, |
31
|
|
|
|
|
|
respectively, at a weighted average exercise price of
approximately $0.64 per share; |
|
|
|
|
up to 1,000,000 shares of common stock reserved for future
grants under our 2005 Stock Incentive Plan; |
|
|
|
75,000 shares of common stock issuable upon exercise of
outstanding warrants to purchase our common stock at an exercise
price of $7.00 per share; |
|
|
|
|
73,280 shares of common stock issuable upon exercise of
outstanding warrants to purchase our Series C preferred
stock (assuming conversion of our Series C preferred stock)
at an exercise price of $4.52 per share; and |
|
|
|
|
|
225,000 shares of common stock issuable upon exercise of
warrants to be issued to the underwriters upon completion of
this offering at an exercise price equal to 125% of the public
offering price per share. |
|
|
|
(1) |
Excludes the impact of 125,000 options that vest upon
consummation of the offering, which will have no effect on total
stockholders equity but will require an expense of
$1,301,570 to be recorded if such options vested at the assumed
initial public offering price of $11.00 per share, which is the
mid-point of our filing range. |
DILUTION
If you invest in our common stock, your interest will be diluted
to the extent of the difference between the public offering
price per share of our common stock and the net tangible book
value per share of our common stock immediately after this
offering. Net tangible book value per share represents the
amount of our common stockholders equity, less intangible
assets, divided by the number of shares of our common stock
outstanding. As of June 30, 2005, we had a net tangible
book value of approximately $(5,675,314) or $(3.14) per share of
common stock. Pro forma net tangible book value as of
June 30, 2005 is $3,751,758 or $0.58 per common share.
Assuming the sale by us of 3,000,000 shares of common stock
offered in this offering at an assumed initial public offering
price of $11.00 per share, the mid-point of our filing
range, and after deducting the underwriting discounts and
commissions and estimated offering expenses, our as adjusted pro
forma net tangible book value as of June 30, 2005, would
have been $32,751,758, or $3.44 per share of common stock. This
represents an immediate increase in pro forma net tangible book
value of $2.86 per share of common stock to our existing
stockholders and an immediate dilution of $7.56 per share to the
new investors purchasing shares in this offering. The following
table illustrates this per share dilution:
|
|
|
|
|
Assumed initial public offering price per share
|
|
$ |
11.00 |
|
Net tangible book value per share as of June 30, 2005
|
|
$ |
(3.14 |
) |
Pro forma net tangible book value per share as of June 30,
2005
|
|
$ |
0.58 |
|
Increase in pro forma net tangible book value per share
attributable to new investors
|
|
$ |
2.86 |
|
Pro forma net tangible book value per share after the offering
|
|
$ |
3.44 |
|
Dilution per share to new investors
|
|
$ |
7.56 |
|
The following table sets forth on a pro forma as adjusted basis,
as of June 30, 2005, the number of shares of common stock
purchased from us (assuming conversion of all preferred stock
into common stock), the total consideration paid and the average
price per share paid by existing holders of common stock
(assuming conversion of all preferred stock into common stock)
and by the new investors in this
32
initial public offering, before deducting the underwriting
discounts and commissions and estimated offering expenses
payable by us.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average | |
|
|
Shares Purchased | |
|
Total Consideration | |
|
Consideration | |
|
|
| |
|
| |
|
| |
|
|
Number | |
|
Percent | |
|
Amount | |
|
Percent | |
|
Per Share | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Existing Investors
|
|
|
6,513,164 |
|
|
|
68.5 |
% |
|
$ |
20,033,573 |
|
|
|
37.8 |
% |
|
$ |
3.08 |
|
New Investors
|
|
|
3,000,000 |
|
|
|
31.5 |
|
|
|
33,000,000 |
|
|
|
62.2 |
|
|
|
11.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
9,513,164 |
|
|
|
100.0 |
% |
|
$ |
53,033,573 |
|
|
|
100.0 |
% |
|
|
|
|
Assuming all our outstanding options and the outstanding
warrants are fully exercised, the shares purchased by the new
investors would constitute 28.4% of all shares purchased from
us, and the total consideration paid by new investors would
constitute 60.5% of the total consideration paid for all shares
purchased from us. In addition, the average price per share paid
by new investors would be $11.00, and the average price per
share paid by existing stockholders would be $3.08.
If the underwriters exercise their over-allotment in full, the
following will occur:
|
|
|
|
|
|
The pro forma as adjusted percentage of shares of our common
stock held by existing stockholders will decrease to
approximately 65.4% of the total number of pro forma as adjusted
shares of our common stock outstanding after this offering; and |
|
|
|
|
|
The pro forma as adjusted number of shares of our common stock
held by new public investors will increase to 3,450,000, or
approximately 34.6% of the total pro forma as adjusted number of
shares of our common stock outstanding after this offering. |
|
In addition, upon completion of this offering, the underwriters
will receive warrants to purchase up to an aggregate of 225,000
shares of our common stock at an exercise price equal to 125% of
the public offering price per share. The warrants will be
exercisable commencing on the first anniversary of the date of
this prospectus and ending on the fifth anniversary of the date
of this prospectus.
In the preceding tables, the shares of our common stock exclude,
as of June 30, 2005:
|
|
|
|
|
|
899,875 shares of common stock issuable as of the date of
this prospectus upon the exercise of outstanding stock options
under our 2003 Stock Incentive Plan and our 1996 Stock Option
Plan, respectively, at a weighted average exercise price of
approximately $0.64 per share; |
|
|
|
|
up to 1,000,000 shares of common stock reserved for future
grants under our 2005 Stock Incentive Plan; |
|
|
|
75,000 shares of common stock issuable upon exercise of
outstanding warrants to purchase common stock at an exercise
price of $7.00 per share; |
|
|
|
|
73,280 shares of common stock issuable upon exercise of
outstanding warrants to purchase our Series C preferred
stock (assuming conversion of our Series C preferred stock)
at an exercise price of $4.52 per share; and |
|
|
|
|
|
225,000 shares of common stock issuable upon exercise of
warrants to be issued to the underwriters upon completion of
this offering at an exercise price equal to 125% of the public
offering price per share. |
|
33
SELECTED FINANCIAL DATA
The following summary financial data for the fiscal years ended
December 31, 2000, 2001, 2002, 2003 and 2004 have been
derived from our historical audited financial statements. The
summary financial data for the six months periods ended
June 30, 2004 and 2005 have been derived from our unaudited
financial statements. The unaudited summary financial data
include, in our opinion, all adjustments, consisting only of
normal, recurring adjustments, necessary to present fairly the
financial position and results of operations for the periods
presented. Our historical results for and prior or interim
period are not necessarily indicative of results to be expected
for a full fiscal year or for any future period. The selected
financial data shown below accounts for the revenues and related
expenses for our DIFOTI® product, a non-invasive imaging
device for the detection of dental cavities, as a discontinued
operation. We decided to discontinue all operations associated
with our DIFOTI® product, effective as of April 5,
2005, in order to focus our resources and attention on the
development and commercialization of MelaFind®. See the
footnote to the Financial Statements relating to discontinued
operations and assets held for sale included elsewhere in this
prospectus. You should read the following selected financial
information together with the financial statements and the
related notes appearing at the end of this prospectus and the
Managements Discussion and Analysis of Financial
Condition and Results of Operations section of this
prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended | |
|
|
Year Ended December 31, | |
|
June 30, | |
|
|
| |
|
| |
|
|
2000 | |
|
2001 | |
|
2002 | |
|
2003 | |
|
2004 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
|
(In thousands, except share and per share data) | |
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from grants
|
|
$ |
210 |
|
|
$ |
290 |
|
|
$ |
547 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of grant revenue
|
|
|
248 |
|
|
|
193 |
|
|
|
564 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses
|
|
|
1,061 |
|
|
|
2,563 |
|
|
|
511 |
|
|
|
1,034 |
|
|
|
1,234 |
|
|
|
639 |
|
|
|
996 |
|
Research and development
|
|
|
726 |
|
|
|
144 |
|
|
|
404 |
|
|
|
828 |
|
|
|
1,892 |
|
|
|
693 |
|
|
|
1,546 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss from continuing operations
|
|
|
(1,825 |
) |
|
|
(2,610 |
) |
|
|
(932 |
) |
|
|
(1,862 |
) |
|
|
(3,126 |
) |
|
|
(1,332 |
) |
|
|
(2,542 |
) |
Interest (income)/expense
|
|
|
(79 |
) |
|
|
(85 |
) |
|
|
8 |
|
|
|
76 |
|
|
|
67 |
|
|
|
82 |
|
|
|
(63 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
|
(1,746 |
) |
|
|
(2,525 |
) |
|
|
(940 |
) |
|
|
(1,938 |
) |
|
|
(3,193 |
) |
|
|
(1,414 |
) |
|
|
(2,479 |
) |
Loss from discontinued operations
|
|
|
(534 |
) |
|
|
(343 |
) |
|
|
(201 |
) |
|
|
(12 |
) |
|
|
(426 |
) |
|
|
(102 |
) |
|
|
(330 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(2,280 |
) |
|
|
(2,868 |
) |
|
|
(1,141 |
) |
|
|
(1,950 |
) |
|
|
(3,619 |
) |
|
|
(1,516 |
) |
|
|
(2,809 |
) |
Preferred stock deemed dividends
|
|
|
85 |
|
|
|
213 |
|
|
|
214 |
|
|
|
322 |
|
|
|
676 |
|
|
|
243 |
|
|
|
719 |
|
Preferred stock accretion
|
|
|
143 |
|
|
|
180 |
|
|
|
180 |
|
|
|
25 |
|
|
|
323 |
|
|
|
25 |
|
|
|
842 |
|
Stock distribution of preferred Series B shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders
|
|
$ |
(2,508 |
) |
|
$ |
(3,261 |
) |
|
$ |
(1,535 |
) |
|
$ |
(2,399 |
) |
|
$ |
(4,618 |
) |
|
$ |
(1,784 |
) |
|
$ |
(4,370 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
$ |
(1.29 |
) |
|
$ |
(1.90 |
) |
|
$ |
(0.87 |
) |
|
$ |
(1.48 |
) |
|
$ |
(2.37 |
) |
|
$ |
(0.98 |
) |
|
$ |
(2.23 |
) |
Discontinued operations
|
|
|
(0.35 |
) |
|
|
(0.23 |
) |
|
|
(0.13 |
) |
|
|
(0.01 |
) |
|
|
(0.24 |
) |
|
|
(0.06 |
) |
|
|
(0.18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$ |
$(1.64 |
) |
|
$ |
(2.13 |
) |
|
$ |
(1.00 |
) |
|
$ |
(1.49 |
) |
|
$ |
(2.61 |
) |
|
$ |
(1.04 |
) |
|
$ |
(2.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average number of shares outstanding
|
|
|
1,529,471 |
|
|
|
1,534,760 |
|
|
|
1,534,760 |
|
|
|
1,614,897 |
|
|
|
1,766,608 |
|
|
|
1,722,743 |
|
|
|
1,809,758 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per common share
(unaudited)(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(0.91 |
) |
|
|
|
|
|
$ |
(0.43 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted weighted average number of common
shares outstanding (unaudited)(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,967,024 |
|
|
|
|
|
|
|
6,513,164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34
|
|
(1) |
Pro forma basic and diluted net loss per common share reflects
the effect of the assumed conversion of the companys
preferred stock, as if this offering had occurred at the date of
original issuance, into 3,398,105 shares of our common
stock for the year ended December 31, 2004 and six months
ended June 30, 2005 which will occur upon closing of this
offering. Additionally, it is assumed that 2,610,643 warrants to
purchase the Companys common stock will be exchanged for a
total of 1,305,321 shares of the companys common
stock based on an exchange ratio of one share of our common
stock for every two shares of our common stock purchaseable
under the warrants and will occur prior to the closing of this
offering. The net loss attributable to our common stockholders
used in the computation of basic and diluted net loss per share
for the unaudited pro forma net loss attributable to common
stockholders has been adjusted to reverse the accretion on our
preferred stock and also excludes the preferred stock dividends
for the respective period. |
The following table presents summary balance sheet data, derived
from our historical audited financial statements. The table also
presents summary balance sheet, derived from our historical
unaudited financial statements, as of June 30, 2004 and
June 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, | |
|
As of June 30, | |
|
|
| |
|
| |
|
|
2000 | |
|
2001 | |
|
2002 | |
|
2003 | |
|
2004 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
|
(In thousands, except share and per share data) | |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
$ |
3,513 |
|
|
$ |
867 |
|
|
$ |
111 |
|
|
$ |
217 |
|
|
$ |
6,813 |
|
|
$ |
877 |
|
|
$ |
4,726 |
|
Total assets
|
|
|
3,814 |
|
|
|
1,131 |
|
|
|
344 |
|
|
|
432 |
|
|
|
7,096 |
|
|
|
1,086 |
|
|
|
4,997 |
|
Total liabilities
|
|
|
211 |
|
|
|
247 |
|
|
|
529 |
|
|
|
650 |
|
|
|
691 |
|
|
|
1,571 |
|
|
|
1,246 |
|
Redeemable convertible preferred stock
|
|
|
2,058 |
|
|
|
2,155 |
|
|
|
2,244 |
|
|
|
4,067 |
|
|
|
8,585 |
|
|
|
5,167 |
|
|
|
9,427 |
|
Accumulated deficit
|
|
|
(4,148 |
) |
|
|
(7,197 |
) |
|
|
(8,518 |
) |
|
|
(10,288 |
) |
|
|
(13,907 |
) |
|
|
(11,804 |
) |
|
|
(16,716 |
) |
Total stockholders (deficiency)/equity
|
|
|
(498 |
) |
|
|
(3,408 |
) |
|
|
(4,657 |
) |
|
|
(4,285 |
) |
|
|
(2,180 |
) |
|
|
(5,652 |
) |
|
|
(5,675 |
) |
35
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our
financial condition and results of operations together with our
financial statements and the related notes appearing at the end
of this prospectus. Some of the information contained in this
discussion and analysis or set forth elsewhere in this
prospectus, including information with respect to our plans and
strategy for our business and related financing, includes
forward-looking statements that involve risks and uncertainties.
You should review the Risk Factors section of this
prospectus for a discussion of important factors that could
cause actual results to differ materially from the results
described in or implied by the forward-looking statements
contained in the following discussion and analysis.
Overview
We are a medical device company focused on the design and
development of a non-invasive, point-of-care instrument to
assist in the early diagnosis of melanoma. Our flagship product,
MelaFind® features a hand-held imaging device that emits
multiple wavelengths of light to capture images of suspicious
pigmented skin lesions and extract data. We currently do not
have any commercialized products or any significant source of
revenue; however, the financial results for all periods
discussed below account for the revenues and the related
expenses associated with our DIFOTI® product, a
non-invasive imaging device for the detection of dental
cavities, as a discontinued operation. We decided to discontinue
all operations associated with our DIFOTI® product
effective as of April 5, 2005, in order to focus our
resources and attention on the development and commercialization
of MelaFind®. We are currently seeking an acquirer for the
DIFOTI® assets, and we do not expect to have any
significant continuing responsibility for the DIFOTI®
business after its disposition. Unless otherwise indicated, the
following discussion relates to our continuing operations.
Our revenue for the foreseeable future will depend on the
commercialization of MelaFind® and may vary substantially
from year to year and quarter to quarter. Our operating expenses
may also vary substantially from year to year and quarter to
quarter based on the timing of the clinical trial and patient
enrollment. We believe that period-to-period comparisons of our
results of operations are not meaningful and should not be
relied on as indicative of our future performance.
We commenced operations in December 1989 as a New York
corporation and re-incorporated as a Delaware corporation in
September 1997. Since our inception, we have generated
significant losses. As of June 30, 2005, we had an
accumulated deficit of $16.7 million. We expect to continue
to spend significant amounts on the development of
MelaFind®. We expect to incur significant commercialization
costs when we begin to introduce MelaFind® into the US
market. Accordingly, we will need to generate significant
revenues to achieve and then maintain profitability.
Most of our expenditures to date have been for research and
development activities and general and administrative expenses.
Research and development expenses represent costs incurred for
product development, clinical trials and activities relating to
regulatory filings and manufacturing development efforts. We
expense all of our research and development costs as they are
incurred.
Our research and development expenses incurred through
June 30, 2005 were expenses related primarily to the
development of MelaFind®. We expect to incur additional
research and development expenses relating to MelaFind®
prior to its commercial launch in the US and selected markets
outside the US. These additional expenses are subject to the
risks and uncertainties associated with clinical trials and the
FDA regulatory review and approval process. As a result, these
additional expenses could exceed our estimated amounts, possibly
materially.
General and administrative expenses consist primarily of
salaries and related expenses, general corporate activities and
costs associated with our efforts to obtain PMA approval for
MelaFind® and building a commercial infrastructure to
market and sell MelaFind®. We anticipate that general and
administrative expenses will increase as a result of the
expected expansion of our operations, facilities and
36
other activities associated with the planned expansion of our
business, together with the additional costs associated with
operating as a public company. We expect selling, general and
administrative expenses to increase as we build our sales force
and marketing capabilities to support placing MelaFind® in
selected markets.
At December 31, 2004 and June 30, 2005, we had
available a net operating loss carry forward for federal income
tax reporting purposes of approximately $12.2 million and
$15.0 million, respectively. The net operating loss carry
forward may be available to offset future taxable income
expiring at various dates through the year 2025. The
Companys ability to utilize its net operating losses may
be significantly limited due to changes in the companys
ownership as defined by federal income tax regulations.
Critical Accounting Policies and Significant Judgments and
Estimates
Our managements discussion and analysis of our financial
condition and results of operations are based on our financial
statements, which have been prepared in accordance with
accounting principles generally accepted in the US. The
preparation of these financial statements requires us to make
estimates and assumptions that affect the reported amounts of
assets and liabilities and the disclosure of contingent assets
and liabilities at the date of the financial statements as well
as the reported revenues and expenses during the reporting
periods. On an ongoing basis, we evaluate our judgments related
to accounting estimates. We base our estimates on historical
experience and on various other factors that we believe are
reasonable under the circumstances, the results of which form
the basis for making judgments about the carrying value of
assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimates under
different assumptions or conditions.
While our significant accounting policies are more fully
described in Note 1 to our financial statements appearing
at the end of this prospectus, we believe that the following
accounting policies and significant judgments and estimates
relating to revenue recognition, stock-based compensation
charges, and accrued expenses are most critical to aid you in
fully understanding and evaluating our reported financial
results.
Revenue Recognition
We decided to discontinue all operations associated with our
DIFOTI® product effective as of April 5, 2005, and
account for the DIFOTI® revenue and expenses as a
discontinued operation. Revenue from the DIFOTI® product
sales had been recognized at the time of delivery and
acceptance, after consideration of all the terms and conditions
of the customer contract. The DIFOTI® products which were
being sold prior to December 31, 2004 included a 30-day
return policy. Revenue on these products was recognized after
the shipment was made and the 30-day return period had elapsed.
DIFOTI® products sold subsequent to December 31, 2004
were sold without a right of return and revenue was therefore
recognized after the shipment was made. Deferred revenues at
each respective balance sheet date consisted of revenues that
were billed or paid in advance of the shipment of the product.
We currently do not have any commercialized products or any
significant source of revenue.
Stock-Based Compensation
We account for non-employee stock-based awards in which goods or
services are the consideration received for the equity
instruments issued based on the fair value of the equity
instruments issued in accordance with the Emerging Issues Task
Force Issue No. 96-18, Accounting for Equity
Instruments That Are Issued to Other Than Employees for
Acquiring, or in Conjunction With Selling, Goods or
Services.
We account for stock-based compensation to employees under the
intrinsic-value-based method of accounting prescribed by
Accounting Principles Board (APB) Opinion No. 25,
Accounting for Stock Issued to Employees, and
disclose the effect of the differences which would result had we
applied the fair-value-based method of accounting, on a pro
forma basis, as required by FASB Statement No. 123,
37
Accounting for Stock-Based Compensation, as amended by
Statement of Financial Accounting Standards
(SFAS) No. 148, Accounting for Stock-Based
Compensation, Transition and Disclosure. In December 2004,
FASB issued FASB Statement No. 123R, which addresses the
accounting for share-based awards to employees and requires
companies to recognize the fair value of stock options and other
stock-based compensation to employees in their statement of
operations. Because we currently account for our stock-based
compensation plans in accordance with APB Opinion No. 25,
the adoption of FASB Statement No. 123R will have a
material effect on our financial statements in future accounting
periods.
Our common stock has not been publicly traded and the
determination of the fair value of our common stock involves
considerable judgment. In making this determination, we
evaluated, among other things, our common stock transactions,
the pricing of private equity sales, the rights and preferences
of the security being valued, current market conditions, and
company specific operational milestones.
During the twelve months ended June 30, 2005, we used two
different fair values for our common stock in determining
recorded compensation expense for stock options and warrants
granted to employees, non-employee directors, and consultants.
For the period July 2004 through September 2004, the fair value
of our common stock as determined by management took into
consideration market, income, and asset based approaches to
valuation as set forth in the AICPA Audit and Accounting
Practice Aid for Valuation of Privately Held Company
Equity Securities Issued as Compensation. We relied most
heavily on the income approach utilizing a discounted cash flow
method and also utilized the value derived from the market
approach. The weighted value range of our common stock for this
period was determined to be $0.78 to $1.38 per share and we
concluded the fair value was $1.10 per share.
During the fourth quarter of 2004, the fair value of our common
stock as determined by management increased from $1.10 per
share to $4.00. This change in valuation from the third quarter
2004 to the fourth quarter 2004 reflected the operational
progress as noted below.
During October 2004, we completed the second private placement
of Series C preferred stock units for gross proceeds of
$8.1 million at a price of $2.26 per unit (the post
reverse split common stock equivalent value was $4.52 per
unit). Each unit consisted of one share of Series C
preferred stock and one warrant to purchase one share of common
stock at an exercise price of $13.00 per share. Since no
additional consideration was received for the warrant, the
consideration for the preferred stock was less than
$2.26 per share. Approximately 35% of the Series C
preferred stock units were acquired by new unaffiliated
investors. The common stock warrants attached to this issuance
were valued at approximately $1.48 per warrant using the
Black-Scholes model with a fair value of $4.00 per share of
our common stock.
During October 2004, we received a binding Protocol Agreement
from the FDA defining the endpoints of the pivotal clinical
trial for MelaFind® approval. We believe that the presence
of a Protocol Agreement significantly enhances our ability to
expedite the FDA approval process. To support our future growth
and the commercialization of MelaFind®, our board of
directors approved in December 2004, the appointment of key
executives. In addition, our board of directors approved the
issuance of 75,000 warrants to Allen & Co. to purchase
common stock with an exercise price of $7.00 per share in
exchange for financing advice, acknowledging the need for
additional capital to support MelaFind® development. The
fair value of the Allen & Co. warrant was determined to
be $1.60 per warrant using the Black-Scholes method with
the following assumptions: common stock value per share $4.00,
warrant life of 5 years, a risk-free interest rate of
3.67%, and an expected volatility of 60%. For these reasons, we
believe the fair value of our common stock during this period
was $4.00 per common share, and accordingly the valuation
of options and warrants issued during December 2004 was based
upon the $4.00 per share common stock value.
During the first quarter of 2005, we encountered operational
issues and management believes these difficulties negatively
impacted the fair value of our common stock for this period.
Specifically, a study that was initiated in late 2004 under the
Protocol Agreement was stopped due to technical difficulties
with some of the MelaFind® clinical trial instruments. In
addition, we were inspected by the FDA in connection with its
DIFOTI® product in March 2005, and we were cited in a FDA
Form 483 for failures to comply fully with the FDAs
QSR. Since no equity transactions were consummated during this
period, we did not determine a new estimated fair value of our
common stock during this calendar quarter.
38
During the second quarter of 2005, progress was made in
addressing the issues that we encountered during the first
quarter of 2005. With respect to the MelaFind® clinical
instruments, we engaged a consultant to direct the
MelaFind® product development efforts and oversee the
manufacturing process. In addition, we entered into an agreement
with ASKION, a precision optics specialty manufacturer, to
develop methods for optimizing the design of the MelaFind®
hardware. We provided a report to the FDA outlining our plan to
address the technical difficulties with the MelaFind®
instruments through a design modification and optimization
process with ASKION. On June 30, 2005, we received written
confirmation from the FDA that our plan is acceptable. These
pre-commercialization instruments will be assembled by ASKION
and are expected to be available for the pivotal trial we
estimate will commence in early 2006.
We decided to discontinue all operations associated with our
DIFOTI® product effective as of April 5, 2005, in
order to focus our resources and attention on the development
and commercialization of MelaFind®. We are currently
seeking an acquirer for the DIFOTI® assets, and we do not
expect to have any significant continuing responsibility for the
DIFOTI® business after its disposition. In addition, the
inspectional findings identified in the FDA Form 483 were
discussed in a subsequent meeting with the FDA on April 28,
2005 and did not result in a product recall. We are in the
process of addressing the deficiencies noted.
Based on our operational progress during the second quarter of
2005, we determined, in consultation with our underwriters, the
fair value of our common stock for our proposed initial public
offering to be in the range of $10.00 to $12.00 per share.
In May 2005, we amended stock option agreements for
125,000 shares of our common stock in the aggregate, of
three key employees to immediately vest upon the completion of
this offering. We will record a charge to operations in the
amount of $1.3 million.
We have granted to certain employees stock options that vest
with the attainment of various performance milestones. Upon the
attainment of these milestones, we will be required to recognize
a stock based compensation expense in an amount based on the
then current market value of our common stock underlying the
options which vest when the milestone is attained. Assuming that
all shares offered are sold in this public offering at a price
of $11.00 per share, the mid-point of our filing range,
that upon the attainment of each of the relevant milestones such
offering price remains the fair market value per share of our
common stock, that the number of shares of our common stock
outstanding after this offering remains 9,513,164, then we will
record a compensation expense upon filing our MelaFind® PMA
with the FDA of $0.5 million with respect to
50,000 shares underlying options, and upon our receipt of
PMA approval for MelaFind® of $0.5 million with
respect to 50,000 shares underlying options. The employment
agreement with Dr. Gulfo includes three separate grants of
common stock options. The first two stock option grants for a
total of 81,753 shares of our common stock have fully
vested. The number of shares of our common stock subject to the
third stock option can only be calculated at the time of PMA
approval of MelaFind®. The number of shares under this
option is equal to that number of shares of our common stock
equal to four percent of our fully diluted capital stock at the
time of PMA approval of MelaFind® minus the
81,753 options granted to Dr. Gulfo under the
employment agreement. Assuming that 9,513,164 shares are
outstanding as of the completion of this offering and remain the
total number of shares outstanding on the date we receive PMA
approval, the number of shares subject to this option would be
345,699. This third stock option grant vests 50% at the time of
PMA approval of MelaFind®, and the remaining 50% vest in
four equal installments over the one year period following such
PMA approval of MelaFind®. We will recognize compensation
expense in the amount of $3.6 million over the vesting
periods.
Accrued Expenses
As part of the process of preparing financial statements, we are
required to estimate accrued expenses. This process involves
identifying services that have been performed on our behalf and
estimating the level of service performed and the associated
cost incurred for such service where we have not been invoiced or
39
otherwise notified of the actual cost. This is done as of each
balance sheet date in our financial statements. Examples of
estimated accrued expenses include:
|
|
|
|
|
professional service fees; |
|
|
|
contract clinical service fees; |
|
|
|
fees paid to contract manufacturers in conjunction with the
production of clinical components or materials; and |
|
|
|
fees paid to third party data collection organizations and
investigators in conjunction with the clinical trials. |
In connection with such service fees, our estimates are most
affected by our projections of the timing of services provided
relative to the actual level of services incurred by such
service providers. The majority of our service providers invoice
us monthly in arrears for services performed. In the event that
we do not identify certain costs that have begun to be incurred
or we under or over estimate the level of services performed or
the costs of such services, our actual expenses could differ
from such estimates. The date on which certain services
commence, the level of services performed on or before a given
date, and the cost of such services are often subjective
determinations. We make these judgments based upon the facts and
circumstances known to us in accordance with accounting
principles generally accepted in the US.
Results of Operations (in thousands)
|
|
|
Six Months Ended June 30, 2005 Compared to Six Months
Ended June 30, 2004 (Unaudited) |
Research and Development Expense. Research and
development expense increased by $853 to $1,546 for the six
months ended June 30, 2005 from $693 for the six months
ended June 30, 2004. Of this increase, $410 was
attributable to higher personnel and personnel related costs as
we increased headcount to support our research and development
programs and $418 relates to increased consulting and outside
research fees for the development of our MelaFind® product.
General and Administrative Expense. General and
administrative expense increased by $357 to $996 for the six
months ended June 30, 2005 from $639 for the six months
ended June 30, 2004. The increase is primarily due to
higher personnel and personnel related costs of $140 associated
with the addition of key management positions, $44 related to
rent and moving expenses on the additional office space,
share-based compensation expense of $86, and general office
related expenses of $79.
Interest (Income)/Expense. Interest (income)/
expense for the six months ended June 30, 2005 was ($63)
compared to $82 for the corresponding period in 2004. The
increase in income for the six months ended June 30, 2005
was due to the higher average cash, cash equivalents and
marketable securities balance compared to the prior year period.
The interest expense for the six months ended June 30, 2004
principally relates to an imputed interest charge of $80 in
connection with financings from related parties.
|
|
|
Year Ended December 31, 2004 Compared to Year Ended
December 31, 2003 |
Research and Development Expense. Research and
development expenses increased by $1,064, from $828 for the year
ended December 31, 2003 to $1,892 for the year ended
December 31, 2004. This increase relates to increased
headcount to support our research and development programs in
the amount of $715, and $332 represents increased consulting and
outside research fees related to the development of
MelaFind®. For the year ended December 31, 2004
research and development costs were approximately 60% of total
operating expenses. Clinical and regulatory expense, a component
of research and development expense totaled approximately $797
for the year ended December 31, 2004. We expect our
research and development expenses to increase in connection with
our clinical trials and other development activities as we
advance our MelaFind® pivotal study and complete the PMA
regulatory approval process.
General and Administrative Expense. General and
administrative expenses increased by $200, to $1,234 for the
year ended December 31, 2004 from $1,034 for the year ended
December 31, 2003. The increase was principally
attributable to $150 in stock-based compensation to non-employee
board members, an increase in personnel costs of $63,
MelaFind® reimbursement and pre-marketing costs of $69,
offset in part by lower consulting fees of $82. For the year
ended December 31, 2004, general and administrative
40
expenses were approximately 40% of total operating expenses. We
expect that our general and administrative expenses will
increase to support the additional costs associated with being a
public company. In the future, we will also incur selling and
marketing expenses to support the commercialization of
MelaFind®.
Interest (Income)/ Expense. Interest (income)/
expense for the year ended December 31, 2004 was $67
compared to $76 for the corresponding period in 2003. The
decrease was due principally to higher interest income in 2004
associated with a higher average cash, cash equivalents and
marketable securities balance compared to the prior year.
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Year Ended December 31, 2003 Compared to Year Ended
December 31, 2002 |
Revenue. Grant revenue generated in 2002 in the
amount of $547 represents federal grants received in conjunction
with an undertaking to perform certain research.
Cost of Grant Revenue. The cost of grant revenue
for the year ended December 31, 2002 represents the
expenses attributable to the grant revenue and consists
primarily of payroll and related costs amounting to $564.
Research and Development Expense. Research and
development expenses increased $424 to $828 for the year ended
December 31, 2003 from $404 for the year ended
December 31, 2002. This increase was principally
attributable to personnel and personnel related costs that
specifically supported the grant program in 2002, and were
classified as cost of grant revenue in 2002 and $93 related to
an increase in other consulting and outside research fees
supporting the development of our MelaFind® product. For
the year ended December 31, 2003 research and development
costs were approximately 45% of total operating expenses.
Clinical and regulatory expense, a component of research and
development expense totaled approximately $50 for the year ended
December 31, 2003.
General and Administrative Expense. General and
administrative expenses increased by $523 to $1034 for the year
ended December 31, 2003 from $511 for the year ended
December 31, 2002. The increase was principally
attributable to personnel and personnel related costs of $488
and an increase in consulting fees of $35. For the year ended
December 31, 2003 general and administrative expenses were
approximately 55% of total operating expenses.
Interest (Income)/ Expense. Interest (income)/
expense for the year ended December 31, 2003 was $76
compared to $8 for the corresponding period in 2002. The
increase was due to a charge of $45 associated with the value of
the beneficial conversion feature for a promissory note during
2003.
Liquidity and Capital Resources (in thousands)
From inception, we have financed our operations primarily
through the use of working capital from private placements of
equity securities and by applying for and obtaining a series of
National Institute of Health Small Business Innovative Research
grants and similar grants. To date, we have not borrowed (other
than by issuing convertible notes, all of which have been
converted into equity) or financed our operations through
significant equipment leases, financing loans or other debt
instruments. As of June 30, 2005, we had $3,794 in cash,
cash equivalents and marketable securities as compared to $6,703
at December 31, 2004. Our cash, cash equivalents and
marketable securities are liquid investments with a maturity
within one year and consist of investments in money market funds
with a commercial bank and short-term US Treasury obligations
and federal agency notes.
Cash Flows from Operating Activities. Net cash
used in operations was $2,890 for the six months ended
June 30, 2005. For the years ended December 31, 2002,
2003 and 2004 the net cash used in operations was $684, $1,699,
and $3,065 respectively. For all periods, cash used in
operations was attributable primarily to net losses after
adjustment for non-cash charges related to depreciation and
other changes in operating assets and liabilities.
Cash from Investing Activities. Net cash provided
by our investing activities was $2,923 for the six months ended
June 30, 2005 principally relating to the redemption of
investments. For the years ended December 31, 2002, 2003
and 2004 the net cash provided by (used in) investing activities
was $518, $(8)
41
and $(6,677) respectively. The increase in cash used in
investing activities in the years ended December 31, 2003
and 2004 was principally related to the net purchase of
investments and equipment from the proceeds of our private
placement financings. Cash used in investing activities for the
year ended December 31, 2002 reflected the redemption of
investments.
Cash Flows from Financing Activities. Net cash
provided by financing activities was $35 for the six months
ended June 30, 2005. For the years ended December 31,
2002, 2003 and 2004 the net cash flows provided by financing
activities was zero, $1,816 and $9,733 respectively. For these
periods, financing cash flows reflected the proceeds from the
issuance of common stock, and preferred stock.
Operating Capital and Capital Expenditure Requirements
To date, we have not commercialized our principal product,
MelaFind®. We anticipate that we will continue to incur net
losses for the foreseeable future as we continue to develop the
MelaFind® system, expand our clinical development team and
corporate infrastructure, and prepare for the potential
commercial launch of MelaFind®. We do not expect to
generate significant product revenue until we successfully
obtain PMA approval for and begin selling MelaFind®. We
believe that the net proceeds from this offering, together with
our current cash, cash equivalents and marketable securities and
interest we earn on these balances, will be sufficient to meet
our anticipated cash needs for working capital and capital
expenditures through mid 2008. If existing cash and cash
generated from this offering are insufficient to satisfy our
liquidity requirements, or if we develop additional products, we
may seek to sell additional equity or debt securities or obtain
a credit facility. If additional funds are raised through the
issuance of debt securities, these securities could have rights
senior to those associated with our common stock, and could
contain covenants that would restrict our operations. Any
additional financing may not be available in amounts or on terms
acceptable to us, or at all. If we are unable to obtain this
additional financing, we may be required to reduce the scope of,
delay or eliminate some or all of planned product research
development and commercialization activities, which could harm
our business.
Because of the numerous risks and uncertainties associated with
the development of medical devices such as MelaFind®, we
are unable to estimate the exact amounts of capital outlays and
operating expenditures associated with our current and
anticipated clinical trials. Our future funding requirements
will depend on many factors, including, but not limited to:
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the schedule, costs, and results of our clinical trials; |
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the success of our research and development efforts; |
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the costs and timing of regulatory approval; |
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reimbursement amounts for the use of MelaFind® that we are
able to obtain from Medicare and third party payors, or the
amount of direct payments we are able to obtain from patients
and/or physicians utilizing MelaFind®; |
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the cost of commercialization activities, including product
marketing and building a domestic direct sales force; |
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the emergence of competing or complementary technological
developments; |
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the costs of filing, prosecuting, defending and enforcing any
patent claims and other rights, including litigation costs and
the results of such litigation; |
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the costs involved in defending any patent infringement actions
brought against us by third parties; and |
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our ability to establish and maintain any collaborative,
licensing or other arrangements, and the terms and timing of any
such arrangements. |
42
Contractual Obligations
The following table summarizes our outstanding contractual
obligations as of December 31, 2004 and the effect those
obligations are expected to have on our liquidity and cash flows
in future periods:
Payments Due by Period
(dollars in thousands)
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Less than | |
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More than | |
Contractual Obligations |
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Total | |
|
1 Year | |
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1-3 Years | |
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4-5 Years | |
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5 Years | |
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| |
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| |
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| |
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| |
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| |
Operating Leases
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|
$ |
1,114 |
|
|
$ |
205 |
|
|
$ |
634 |
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$ |
275 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Total
|
|
$ |
1,114 |
|
|
$ |
205 |
|
|
$ |
634 |
|
|
$ |
275 |
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Our long-term obligations are two non-cancelable operating
leases for space expiring June 2009 and November 2010.
The lease on 3,700 square feet of office, laboratory and
assembly space expires in June 2009 and the lease on
2,800 square feet of office space expires
November 2010.
Related Party Transactions
For a description of our related party transactions, see the
Related Party Transactions section of this
prospectus and the related notes to our financial statements
appearing at the end of this prospectus.
Off-Balance Sheet Arrangements
We do not currently have, nor have we ever had, any
relationships with unconsolidated entities or financial
partnerships, such as entities often referred to as structured
finance or special purpose entities, which would have been
established for the purpose of facilitating off-balance sheet
arrangements or other contractually narrow or limited purposes.
In addition, we do not engage in trading activities involving
non-exchange traded contracts. As such, we are not materially
exposed to any financing, liquidity, market or credit risk that
could arise if we had engaged in these relationships.
Quantitative and Qualitative Disclosures about Market Risk
Our exposure to market risk is confined to our cash equivalents
and short-term investments. We invest in high-quality financial
instruments; primarily money market funds, federal agency notes,
and US Treasury obligations, with the effective duration of the
portfolio within one year which we believe are subject to
limited credit risk. We currently do not hedge interest rate
exposure. Due to the short-term nature of our investments, we do
not believe that we have any material exposure to interest rate
risk arising from our investments.
Recent Accounting Pronouncements
In May 2003, FASB issued Accounting for Certain Financial
Instruments with Characteristics of both Liabilities and Equity
(SFAS No. 150). This statement establishes how a
company classifies and measures certain financial instruments
with characteristics of both liabilities and equity, including
redeemable convertible preferred stock. This statement is
effective for financial instruments entered into or modified
after May 31, 2003, and is otherwise effective at the
beginning of the interim period commencing July 1, 2003,
except for mandatorily redeemable financial instruments of
nonpublic companies. FASB has indefinitely deferred
implementation of some provisions of SFAS No. 150. The
adoption of SFAS No. 150 did not have a material
effect on our financial position or results of operations.
43
OUR BUSINESS
Overview
We are a medical device company focused on the design and
development of a non-invasive, point-of-care instrument to
assist in the early diagnosis of melanoma. Our flagship product,
MelaFind® features a hand-held imaging device that emits
multiple wavelengths of light to capture images of suspicious
pigmented skin lesions and extract data. The data are then
analyzed against our proprietary database of melanomas and
benign lesions using our sophisticated algorithms in order to
provide information to the physician and produce a
recommendation of whether the lesion should be biopsied.
The components of the MelaFind® system include:
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a hand-held imaging device, which employs high precision
optics and multi-spectral illumination (multiple colors of light
including near infra-red); |
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our proprietary database of pigmented skin lesions, which
we believe to be the largest in the US; |
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our lesion classifiers, which are sophisticated
mathematical algorithms that extract lesion feature information
and classify lesions; and |
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a central server in our offices that is intended to
perform quality control functions and provide reports to the
physician and in commercial use, will be connected to
physicians offices via the internet. |
We have entered into a binding Protocol Agreement with the FDA
which is an agreement for the conduct of the pivotal trial in
order to establish the safety and effectiveness of
MelaFind®. We believe the presence of the Protocol
Agreement significantly enhances our ability to expedite the FDA
approval process. We stopped a study that was initiated in late
2004 under the Protocol Agreement due to technical difficulties
with some of the MelaFind® clinical trial instruments. The
FDA has provided confirmation that our plan to correct the
technical issues and start a new pivotal trial to satisfy the
Protocol Agreement is acceptable. Management estimates that the
pivotal trial will commence in early 2006 at over 20 US clinical
study sites, and anticipates PMA approval to commercialize
MelaFind® in 2007.
To date, we have not generated any revenues from MelaFind®.
All of our historical revenues have come from activities and
products that have since been discontinued, including our
DIFOTI® product, a non-invasive imaging device for the
detection of dental cavities. We decided to discontinue all
operations associated with our DIFOTI® product, effective
as of April 5, 2005, in order to focus our resources on the
development and commercialization of MelaFind®.
Cancers of the skin have a higher incidence than all other
cancers combined, and the rates are rising dramatically. In
2005, over 120,000 new cases of melanoma are projected. Melanoma
is responsible for approximately 80% of skin cancer fatalities
and is the deadliest of all skin cancers as there is currently
no cure for advanced stage melanoma. However, early detection of
skin cancers like melanoma can lead to virtually a 100% cure
rate. Advanced stage melanoma is costly to treat and is
responsible for approximately 90% of the total spending on
melanoma treatment in the US, costing up to $170,000 per
patient. If diagnosed early, however, melanoma is almost always
cured by simple resection at a cost of approximately $1,800 per
patient.
Because early detection is critical to survival, the American
Cancer Society recommends that individuals age 40 years and
older have complete skin examinations on an annual basis.
According to the 2000 US Census data, over 100 million
Americans in the US are over age 40. Furthermore, there are more
than 20 million individuals in the US who have dysplastic
nevi, a type of pigmented skin lesion that when present is
associated with an increased risk of melanoma. These individuals
warrant more frequent observation.
Melanomas are mainly diagnosed by dermatologists and/or primary
care physicians using visual clinical evaluation. Physicians
assess pigmented skin lesions using the ABCDE
criteria, Asymmetry, Border irregularity,
Color variation, Diameter greater than 6 mm, and
Evolving change in ABCD over time. This
assessment is subjective and results in missed melanomas, as
well as a ratio of benign lesions
44
biopsied to melanomas confirmed that is highly variable and as
high as 40 to 1 for dermatologists and as high as 50 to 1 for
primary care physicians.
To date, MelaFind® has been studied on over 5,000 skin
lesions from over 3,500 patients at over 20 clinics. Our
clinical studies have demonstrated that MelaFind® missed
fewer melanomas and produced fewer false positives than
experienced by study dermatologists, who are skin cancer
specialists. The performance of a diagnostic is measured in
terms of sensitivity (the ability to detect
disease when disease is present) and
specificity (the ability to exclude disease
when disease is not present). In the largest blinded trial that
we have performed to date on 352 suspicious pigmented skin
lesions, using our most advanced system, MelaFind® did not
miss a melanoma (measured sensitivity of 100%) and achieved
48.4% specificity compared to the study dermatologists
sensitivity of 96.4% and specificity of 28.4%.
We believe that with the assistance provided by MelaFind®,
physicians could diagnose more melanomas at the earliest,
curable stage, which would reduce both treatment costs and the
number of unnecessary biopsies, and improve quality of life.
Our objective is for MelaFind® to become an integral part
of the standard of care in melanoma detection.
The Market Opportunity
Cancer of the skin (nonmelanoma and melanoma skin cancers
combined) is the most common of all cancers, projected to be
over 1.3 million cases in 2005 and estimated to account for
more than 50% of all cancers. In 2005, over 120,000 new cases of
melanoma are projected. There are three significant forms of
skin cancer: basal cell, accounting for approximately 75% of
skin cancer; squamous cell, totaling approximately 20%; and
melanoma, which accounts for an estimated 4% of skin cancer
cases, but is responsible for approximately 80% of all deaths
from skin cancer. The American Cancer Society projects 10,600
deaths from skin cancer in 2005 7,800 from melanoma
and 2,800 from other skin cancers. Since 1973, the mortality
rate for melanoma has increased by 50%. Since approximately 62%
of melanomas and 45% of melanoma deaths occur prior to age 65,
melanoma places significant burdens on the healthcare system
well beyond Medicare.
Melanoma, if left untreated, can be fatal. If diagnosed and
removed early in its evolution, when confined to the outermost
skin layer and deemed to be in situ, it is virtually
100% curable. Invasive melanomas that are thin and extend into
the uppermost regions of the second skin layer still have
excellent cure rates (greater than 90%). However, once the
cancer advances into the deeper layers of skin, the risk of
metastasis (spreading to other parts of the body) increases.
Metastases can occur when the tumor enters into lymphatic
channels and newly formed blood vessels, potentially resulting
in significant morbidity (illness) and mortality (death).
Once the cancer has advanced and metastasized to other parts of
the body, it is difficult to treat. At this advanced stage, the
five year survival rate is reported to be only 10%. Moreover,
survival prospects for those with advanced melanoma have not
improved over the past three decades.
Melanoma is currently the subject of significant attention in
the medical community. In part, this attention is due to the
fact that it is the fastest growing cancer. It is also the most
common cancer in young adults ages 20-30, and currently there
are more new cases of melanoma than HIV/ AIDS. In women
ages 25-30, melanoma is the primary cause of cancer death.
In women ages 30-35, melanoma is the second leading cause of
death after breast cancer. Recent published papers identify a
strong correlation between breast cancer and melanoma.
Because early detection is critical to survival, the American
Cancer Society recommends that individuals 40 years and
older have complete skin examinations on an annual basis. The
2000 US Census indicates that there are over 100 million
Americans over the age of 40 in the US. Furthermore, there are
more than 20 million individuals in the US who have
dysplastic nevi, a type of pigmented skin lesion that
45
when present is associated with an increased risk of melanoma.
Such individuals warrant more frequent observation.
Our Strategy
Our objective is for MelaFind® to become an integral part
of the standard of care in melanoma detection. To achieve this
objective, we are pursuing the following strategy:
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Pursue the timely FDA approval of MelaFind®: We have
entered into a binding Protocol Agreement with the FDA for the
conduct of the pivotal trial of MelaFind®. Management
estimates that the study will commence in early 2006 at over 20
US clinical study sites, and anticipates PMA approval to
commercialize MelaFind® in 2007. |
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Establish MelaFind® as the leading technology for
assisting in the detection of melanoma: We have invested
considerable capital and expertise into developing our core
technology platform, which is protected by six US patents. We
will continue to refine and optimize this technology to ensure
that MelaFind® is the leading system for assisting in the
detection of melanoma. |
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Obtain third party payor reimbursement to support our
recurring revenue pricing model: We intend to offer
MelaFind® on a per patient basis, creating a recurring
revenue stream. To do so, we will seek to obtain third party
reimbursement as well as private pay alternatives. We are
working with experts to create an evidence-based medicine
evaluation model consistent with those used to support positive
coverage decisions by CMS and private payors for similar
products. The value drivers in the model include the cost
savings associated with early detection (approximately $168,000
per patient) and fewer biopsies. We believe that the use of
MelaFind® could result in substantial savings to the US
healthcare system. |
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Commercialize MelaFind® using multiple sales and
marketing strategies: Our internal sales and marketing
effort will focus initially on high volume/key opinion
leader dermatologists with specialties in the diagnosis
and treatment of melanoma. To enter the larger US markets of
general dermatologists, plastic surgeons, and primary care
physicians, and for international markets, we intend to
establish partnerships with pharmaceutical and/or diagnostic
device companies with an established presence in these markets.
While we believe obtaining a positive coverage decision from CMS
may take an additional 18 to 36 months following PMA approval,
and obtaining a positive coverage decision from private payors,
managed care organizations and state Medicare administrative
contractors may take at least 6 to 12 months following PMA
approval, we intend to commence sales of MelaFind®
immediately upon receiving PMA approval for physicians to offer
MelaFind® to their patients on a self-pay basis. |
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Limitations of Current Melanoma Diagnosis
The current primary method for detecting melanoma is based on
physicians ability to recognize patterns using the naked
eye; this is known as clinical examination. Physicians assess
pigmented skin lesions using the ABCDE criteria,
Asymmetry, Border irregularity, Color
variation, Diameter greater than 6 mm, and
Evolving change in ABCD over time. This
subjective interpretation relies on physician experience and
skill. The ratio of benign lesions biopsied to melanomas
confirmed can be variable, ranging as high as 40 to 1 for
dermatologists and as high as 50 to 1 for primary care
physicians. In contrast, MelaFind® delivers an objective
assessment based on numerical scores assigned to the suspicious
skin lesion under evaluation. Further, clinical examination is
limited to the surface appearance of the suspicious pigmented
skin lesion, whereas MelaFind® utilizes information derived
from up to 2.5 mm deep into the skin.
Dermatologists who specialize in the management of pigmented
skin lesions may also use dermoscopy, a method of viewing
lesions under magnification. Although dermoscopy provides more
information than unaided visual examination, mastery of the
technique necessitates many years of training
46
and experience. Proper use of dermoscopy can reduce the number
of unnecessary biopsies of benign lesions, but even dermoscopy
experts biopsy 3-10 benign lesions for every melanoma detected.
Most dermatologists generally use only visual clinical
evaluation for melanoma detection. Consequently, they biopsy up
to 40 benign lesions for every melanoma detected. While many
primary care physicians immediately refer patients with
suspicious pigmented skin lesions to a specialist, an increasing
number perform biopsies on skin lesions themselves. Their lack
of specialist training in identifying suspect lesions makes
their diagnostic accuracy much lower in terms of both
sensitivity and specificity. This results in 40% misdiagnosed
melanomas and a ratio of benign lesions biopsied to melanomas
confirmed of up to 50 to 1.
MelaFind® Product Description
MelaFind® is a non-invasive system for assisting in the
early detection of melanoma. The MelaFind® system is
comprised of a point-of-care, hand-held imaging device that, in
commercial use, is intended to be connected via the internet to
a central server in our offices. MelaFind® employs multiple
wavelengths of light to obtain data from images of suspicious
lesions; the data are analyzed against our proprietary database
of melanomas and benign lesions using our sophisticated
algorithms. When marketed, a report will be transmitted to the
physicians office containing MelaFind®s
recommendation of whether the lesion should be biopsied. The key
components of the MelaFind® system are listed below:
A hand-held imaging device, which is comprised of
several components:
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an illuminator that shines 10 different specific wavelengths of
light, including near infra-red bands; |
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a lens system composed of nine elements that creates images of
the light reflected from the lesions; |
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a photon (light) sensor; and |
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an image processor employing proprietary algorithms to extract
many discrete characteristics or features from the images. |
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Our proprietary database of pigmented skin
lesions, which includes in vivo MelaFind®
images and corresponding histological results of over 5,000
biopsied lesions from over 3,500 patients, which we believe to
be the largest such database in the US and a substantial barrier
to competition. |
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Our lesion classifiers, which are sophisticated
mathematical algorithms that analyze the MelaFind®
images and extract lesion feature information from the images;
the features are used to classify the lesions as either
suspicious for melanoma or not suspicious for melanoma. |
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A central server located in our offices, which is
intended to perform quality control functions and provide
diagnostic reports to the physician. |
The brain of the MelaFind® system, the
Lesion Classifier, distinguishes melanoma from
non-melanoma using the lesion features extracted and measured by
the hand-held imaging device. The Lesion Classifiers are
developed from our proprietary database of pigmented skin
lesions and sophisticated mathematical algorithms. The
mathematical formulas and algorithms used by the Lesion
Classifiers are devised and optimized through the process of
classifier training using lesions from our
proprietary database. Lesion Classifier development and
training is an iterative process involving: (1) selection
of the lesion features that provide for optimal lesion
discrimination; (2) optimization of the mathematical
formulas to differentiate benign lesions from melanoma; and
(3) expansion of the size and diversity of our proprietary
lesion database. The performance of the Lesion Classifiers
is directly related to the size of the database used in
classifier training, as well as the degree to which the training
database is representative of the lesions that will be evaluated
by MelaFind® in commercial use.
As with many diagnostic systems, the diagnostic performance of
MelaFind® is characterized using two measures: (1)
sensitivity the ability to detect
disease when it is present; and (2) specificity
the ability to exclude disease when it is
not present. Since sensitivity and specificity are typically
trade-offs, meaning that as one parameter increases the other
decreases, the MelaFind® Lesion Classifier is
developed
47
and trained with the intention that MelaFind® will detect
all melanomas in the training data set with the highest possible
specificity.
Reliable functioning of the MelaFind® system is critical to
its utility and success in the marketplace. Automated
self-calibration tests are performed by the hand-held device to
ensure proper functionality. When marketed, the central server
will also perform tests on the hand-held device to determine
whether its functioning is within appropriate limits, that is,
that the quantitative data on lesion and calibration image
features provided by MelaFind® are within a pre-determined
expected range of values. The server will not permit
MelaFind® to provide diagnostic information unless the
hand-held device is functioning properly.
MelaFind® Regulatory Status
In late 2004, we entered into a binding Protocol Agreement with
the FDA for our pivotal clinical study. A pivotal trial is a
clinical study that is used by the FDA as the basis for
determining the effectiveness of a device in a PMA application.
The Protocol Agreement specified the inclusion criteria
(description of patients and lesions eligible for the trial),
sample size, endpoints, and performance criteria necessary to
establish the safety and effectiveness of MelaFind®. The
Protocol Agreement requires that the study include at least
1,200 pigmented skin lesions, and at least 93 eligible
melanomas for analysis.
The primary endpoints of the study include: (1) greater
than 95% (lower confidence bound (a statistically derived lower
limit of a measured or observed value based on the number of
observations used to derive the measured or observed value))
sensitivity for detection of melanoma (99% observed
sensitivity); and (2) statistically significant greater
specificity in ruling out melanoma when compared to study
dermatologists. The lower confidence bound of 95% sensitivity is
a statistically-derived lower limit of sensitivity based on an
observed sensitivity of 99%. This means that in order to satisfy
the sensitivity requirement, MelaFind® must correctly
identify at least 92 of the 93 melanomas, that is, miss either
none or one melanoma in the pivotal trial. In order to satisfy
the specificity requirement, MelaFind® must demonstrate a
higher specificity than study dermatologists at a level where
the probability of obtaining such a result by chance is less
than 5%. For illustrative purposes, assuming a specificity of
25% for study dermatologists, the specificity of MelaFind®
would need to be at least 32% in order for the difference to be
statistically significant at the 95% confidence level.
We initiated a clinical trial under the terms of the Protocol
Agreement at the end of 2004. However, technical operational
issues with the systems were experienced, requiring further
refinement. We are continuing this study as a supportive pilot
study. A pilot study is one that provides information regarding
the operation of a device in the clinical setting as well as the
feasibility of various clinical trial evaluations. Pilot studies
are often used to help refine certain elements of a planned
pivotal trial and serve to train study personnel in advance of a
pivotal trial.
We are currently refining the hardware systems and expect to
have new systems available in order to start the pivotal trial
in early 2006. The pivotal trial for PMA approval of
MelaFind® will be conducted under the terms of the Protocol
Agreement. We have reviewed our strategy with the FDA and have
obtained confirmation from the FDA that our plan to correct the
technical issues by refining the hardware systems and to start a
new pivotal trial to satisfy the Protocol Agreement is
acceptable.
For commercialization outside the US, approvals from appropriate
regulatory bodies within other countries will be required. Once
PMA approval is obtained, we may proceed with applications to
commercialize in various countries pending further assessment of
market opportunities and the possible identification of
strategic partners.
Clinical Studies of MelaFind®
Goals and Objectives
MelaFind® has been studied on over 5,000 skin lesions from
over 3,500 patients during the past five years at over 20
clinical sites in the US, as well as two sites in Europe and one
in Australia. We aim to
48
develop a system with a sensitivity of at least 95% in detecting
melanoma. Our goals are to complete pre-commercialization design
and testing of the hand-held imaging device and its associated
software, as well as to establish a database of approximately
300 melanomas, including in vivo MelaFind® images
and biopsy results, for MelaFind® Lesion Classifier
algorithm development and training. Statistically, in order
to have a high level of confidence of success, we set the lower
confidence bound at 99%, which requires approximately 300
melanomas in the classifier training database. To date, the
MelaFind® lesion database includes 225 melanomas.
We are developing in parallel several MelaFind® Lesion
Classifiers, which differ in the algorithms, as well as in
the specific lesion features and relative weights used in the
mathematical formulas. Prior to conducting the analysis of the
data from the pivotal trial under the Protocol Agreement, the
optimal Lesion Classifier will be selected. The primary
means by which the performance of the MelaFind® Lesion
Classifiers is evaluated is through measures of
sensitivity (the ability to detect disease when
present) and specificity (the ability to exclude
disease when not present).
The reference standard used for comparison of the results of
MelaFind® and study dermatologists is histological analysis
of the biopsied lesions by a group of expert pathologists.
MelaFind® images of pigmented skin lesions (melanomas and
non-melanomas) and the histological results of the corresponding
biopsied lesions comprise our training database of lesions. When
the Lesion Classifiers are tested on the database used in
training, this is called a training study. When the
Lesion Classifiers are tested on a set of lesions not
used in training, this is called a blinded test,
which is a simulation of anticipated real-life prospective
classifier performance.
Our ultimate goal for MelaFind® is to demonstrate
sensitivity of at least 95%, and superior specificity as
compared to study dermatologists in the pivotal blinded test for
PMA approval.
MelaFind®
Development History Hardware and
Software
In developing the MelaFind® system we have tested both a
first and second generation hand-held imaging device, and are in
the process of developing a pre-commercialization version for
use in our pivotal clinical trial. Our research, development and
clinical testing efforts have been designed to improve our
MelaFind® technology platform, including the imaging device
and lesion classifiers, and to enhance our lesion database.
We began using first generation hand-held imaging devices in
clinical studies in 2001. In 2002, we expanded the clinical
research program to additional study sites equipped with second
generation hand-held imaging devices. The aim of the study,
which is ongoing, is to build the MelaFind® proprietary
lesion database for use in Lesion Classifier training.
The study calls for the MelaFind® hand-held imaging device
to acquire images of pigmented skin lesions scheduled for
biopsy. After biopsy, the histological slides are collected and
sent for central histological review by a panel of experts.
The results of initial training studies and blinded tests were
not to the expected level of performance. We determined the
cause to be a flaw in the second generation hand-held imaging
devices, which were subsequently shown to exhibit highly
variable levels of stray light, an optical artifact. Therefore,
we ceased producing this generation of hand-held imaging devices
and purged the training database of lesion images acquired with
them. We also incorporated a manufacturing specification for
stray light which, prior to this time, was not included.
Subsequent training studies and blinded tests performed using
only first generation hand-held imaging devices confirmed our
earlier favorable results: MelaFind® missed none or very
few melanomas, and was shown to have higher specificity than
study dermatologists, as shown in the tables below. See
Our Business Clinical Studies of
MelaFind® Results of Training Studies and
Blinded Tests.
We initiated a clinical study under the terms of the Protocol
Agreement with the FDA in late 2004 using first generation
hand-held imaging devices. However, several technical operating
issues with these older systems were experienced, requiring
further refinement. Third generation hand-held imaging devices
were produced in 2004 and early 2005. These serve as the basis
of the design that is currently being used
49
to generate final, pre-commercialization hand-held imaging
devices, which will be utilized in the pivotal study for PMA
approval under the terms of the Protocol Agreement.
Along with hardware development efforts, we have also developed,
tested, and continue to refine the software components of the
system, including lesion filters, calibration algorithms, lesion
classification algorithms, and hardware normalization software.
We plan to finalize these key elements of the software prior to
the analysis of the data obtained from the pivotal trial for PMA
approval.
Results of Training Studies
and Blinded Tests
The first iteration of MelaFind® Lesion Classifiers,
Lesion Classifiers A-1 and B, employed a single-step
process, that is, an algorithm that differentiates melanoma from
all other pigmented skin lesions. These MelaFind®
classifiers were trained on a total of 1,129
lesions 109 melanomas, 70 high grade dysplastic
nevi, and 950 other pigmented skin lesions. For the blinded
test, a different group of 477 pigmented skin lesions, including
26 melanomas, 11 high grade dysplastic nevi, and 440 other
lesions were included. None of these lesions were used in
classifier training. The results of the training study and
blinded tests for MelaFind® Lesion Classifiers A-1
and B, as well as study dermatologists, are
summarized below.
August 2003 Training Study and Blinded Test
Results
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Training Study | |
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Blinded Test | |
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Sensitivity | |
|
Specificity | |
|
Sensitivity | |
|
Specificity | |
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| |
|
| |
|
| |
|
| |
MelaFind® Lesion Classifier A-1
|
|
|
100 |
% |
|
|
45.6 |
% |
|
|
80.8 |
% |
|
|
44.3 |
% |
MelaFind® Lesion Classifier B
|
|
|
96.3 |
% |
|
|
21.9 |
% |
|
|
80.8 |
% |
|
|
25.5 |
% |
Study Dermatologists
|
|
|
N/A |
|
|
|
N/A |
|
|
|
96.2 |
% |
|
|
17.3 |
% |
The performance of the MelaFind® Lesion Classifiers
on the blinded data set was significantly below results from
the training study. The first attempt to improve the performance
was by developing a new MelaFind® Lesion Classifier
A, employing a three-step process (A-3), which was
accomplished in November 2003. A three-step process employs
algorithms that differentiate melanoma from three other classes
of pigmented skin lesions. The new classifier was re-trained on
the original data set of lesions (109 melanomas, 70 high grade
dysplastic nevi, and 950 other pigmented skin lesions), tested
on the training set and then tested on the same blinded data set
used in August 2003 (26 melanomas, 11 high grade dysplastic
nevi, and 440 other lesions). The following table summarizes the
results of the tests on the training and blinded data sets. Note
that MelaFind® Lesion Classifier B, which
accommodates a single-step process only, was not evaluated in
these exercises.
November 2003 Training Study and Blinded Test
Results
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|
Training Study | |
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Blinded Test | |
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| |
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| |
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|
Sensitivity | |
|
Specificity | |
|
Sensitivity | |
|
Specificity | |
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| |
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| |
|
| |
|
| |
MelaFind® Lesion Classifier A-3
|
|
|
100 |
% |
|
|
28.5 |
% |
|
|
100 |
% |
|
|
25.7 |
% |
Study Dermatologists
|
|
|
N/A |
|
|
|
N/A |
|
|
|
96.2 |
% |
|
|
17.3 |
% |
Review of the data indicated that the three-step MelaFind®
Lesion Classifier A-3, which was trained with lesions
acquired from first and second generation MelaFind®
hand-held imaging devices, was much less specific on the
training database (28.5%) than the single-step classifier
MelaFind® Lesion Classifier A-1, which was trained
on lesions acquired using only first generation hand-held
imaging devices (45.6%). A complete analysis of all
MelaFind® devices from the clinical sites indicated a
systematic difference between the first generation and second
generation MelaFind® hand-held imaging devices. The second
generation hand-held imaging devices exhibited a significantly
greater amount of stray light than the first generation
hand-held imaging devices. Stray light induces variable imaging
artifacts that cannot be predicted or accounted for in the
software algorithms, and introduces higher probability for
error. Therefore, in February 2004, all lesions acquired using
second generation hand-held imaging devices were
50
removed from the training and testing databases. The three-step
MelaFind® Lesion Classifier A-3 was then trained on
a set of lesions acquired solely from first generation hand-held
imaging devices including 113 melanomas, 69 high grade
dysplastic nevi, and 987 other pigmented skin lesions. A blinded
test was conducted on 262 lesions (21 melanoma, 8 high grade
dysplastic nevi, and 233 other lesions) not used in classifier
training and acquired using first generation hand-held imaging
devices only. The following table summarizes the results.
February 2004 Results of Training Study and
Blinded Test after Removing Lesions
Obtained from Second Generation Hand-Held Imaging Devices
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|
Training Study | |
|
Blinded Test | |
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| |
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| |
|
|
Sensitivity | |
|
Specificity | |
|
Sensitivity | |
|
Specificity | |
|
|
| |
|
| |
|
| |
|
| |
MelaFind® Lesion Classifier A-3
|
|
|
100 |
% |
|
|
43.8 |
% |
|
|
100 |
% |
|
|
44.2 |
% |
Study Dermatologists
|
|
|
N/A |
|
|
|
N/A |
|
|
|
95.0 |
% |
|
|
28.3 |
% |
These results demonstrated the importance of minimizing stray
light and establishing a product specification for stray light.
This specification was instituted in our assembly process
following this analysis. As part of the continued development, a
four-step MelaFind® Lesion Classifier A-4 was
introduced in March 2004. A four-step process employs algorithms
that differentiate melanoma from four other classes of pigmented
skin lesions. This classifier performed better compared with the
three-step classifier, as summarized in the following table.
March 2004 MelaFind® Lesion
Classifiers: Three-step vs. Four-step
Training Study and Blinded Test Results
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|
Training Study | |
|
Blinded Test | |
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| |
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| |
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|
Sensitivity | |
|
Specificity | |
|
Sensitivity | |
|
Specificity | |
|
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| |
|
| |
|
| |
|
| |
MelaFind® Lesion Classifier A-3
|
|
|
100 |
% |
|
|
43.8 |
% |
|
|
100 |
% |
|
|
44.2 |
% |
MelaFind® Lesion Classifier A-4
|
|
|
100 |
% |
|
|
48.9 |
% |
|
|
100 |
% |
|
|
48.1 |
% |
Study Dermatologists
|
|
|
N/A |
|
|
|
N/A |
|
|
|
95.0 |
% |
|
|
28.3 |
% |
Due to the enhanced specificity of the four-step classifier
A-4 compared to the three-step classifier A-3, as
seen in the preceding table, the four-step classifier was
selected for further development and testing. In May 2004, the
largest blinded test was performed on a separate set of 352
lesions (including 28 melanomas, 14 high grade dysplastic nevi,
and 310 other pigmented skin lesions) that were not used in
classifier training. The results of sensitivity and specificity
of MelaFind® Lesion Classifiers A-4 and B and study
dermatologists are summarized in the following table.
May 2004 Training Study and Blinded Test
Results
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|
Training Study | |
|
Blinded Test | |
|
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| |
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| |
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|
Sensitivity | |
|
Specificity | |
|
Sensitivity | |
|
Specificity | |
|
|
| |
|
| |
|
| |
|
| |
MelaFind® Lesion Classifier A-4
|
|
|
100 |
% |
|
|
53.2 |
% |
|
|
100 |
% |
|
|
48.4 |
% |
MelaFind® Lesion Classifier B
|
|
|
100 |
% |
|
|
38.0 |
% |
|
|
96.4 |
% |
|
|
32.9 |
% |
Study Dermatologists
|
|
|
N/A |
|
|
|
N/A |
|
|
|
96.4 |
% |
|
|
28.4 |
% |
In January 2005, with no additional classifier training and in
an effort to rigorously test the limits of the MelaFind®
Lesion Classifiers, another blinded test was performed on
228 new lesions (28 melanomas, 4 high grade dysplastic nevi, and
196 other pigmented skin lesions). The lesions in this blinded
test were acquired from the first generation MelaFind®
hand-held imaging devices that had been at the clinical sites
for a longer period of time than in any blinded test to date.
Lesion Classifier training was not performed using
MelaFind® hand-held imaging devices that had been at the
clinical sites for longer periods of time. A new four-step
MelaFind® Lesion Classifier C-4 with a revised step
was also evaluated in the blinded test. The results are
summarized in the following table.
51
January 2005 Second Blinded Test Results using
March 2004 Classifiers
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|
Sensitivity | |
|
Specificity | |
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| |
|
| |
MelaFind® Lesion Classifier A-4
|
|
|
82.1 |
% |
|
|
37.2 |
% |
MelaFind® Lesion Classifier B
|
|
|
96.4 |
% |
|
|
21.0 |
% |
MelaFind® Lesion Classifier C-4
|
|
|
92.9 |
% |
|
|
35.7 |
% |
Study Dermatologists
|
|
|
92.9 |
% |
|
|
23.0 |
% |
In evaluating the MelaFind® hand-held imaging devices used
in the January 2005 blinded test, we found that several
MelaFind® devices were not performing within
specifications. Certain lesions had some feature measurements
significantly outside of the range of the previous data. This
led to the identification of specific problems with the
hardware, which enabled a new and more robust design of
MelaFind® hand-held imaging devices. Had these devices
performed within specifications, we believe that the sensitivity
of MelaFind® Lesion Classifiers A-4 and C-4 would
have been 96.4%, that is, they would have missed one melanoma,
compared to study dermatologists who missed two melanomas.
We are utilizing the findings of the blinded tests to refine the
design of hardware to further develop the lesion classification
algorithms, to expand the training database, and to develop
improved calibration methods to ensure appropriate functioning
of each hand-held imaging device. As demonstrated in the January
2005 blinded test, melanomas can be missed when MelaFind®
systems that do not meet specifications are used to acquire
images, and when melanoma lesion types (for instance, nodular
melanomas, a melanoma type that is often missed by
dermatologists in early stages) are not adequately represented
in the training database. In order to address these situations,
we have: (1) incorporated a weekly field calibration test
to evaluate system performance in order to identify and disable
MelaFind® systems that are not functioning within
specifications; (2) intensified our effort to obtain images
of nodular melanomas for inclusion in the targeted 300 melanoma
database for the final Lesion Classifier; and
(3) refined our algorithms to result in either a positive
reading of melanoma when MelaFind® images reveal
characteristics well outside the ranges of lesions in the final
training database, or to report that MelaFind® cannot
provide a diagnosis in this circumstance. As mentioned above,
had these devices performed within specifications, we believe
that the sensitivity of MelaFind® Lesion Classifiers A-4
and C-4 would have been 96.4%, that is, they would have
missed one melanoma, compared to study dermatologists who missed
two melanomas.
In the largest clinical study performed to date on
352 pigmented skin lesions, MelaFind® identified all
melanomas (100% measured sensitivity) and had a specificity
superior to study dermatologists on a statistically significant
basis (48.4% versus 28.4%; the probability of obtaining this
result by chance was less than 0.0001). Taken together, we
believe the clinical studies performed to date demonstrate that
MelaFind® hardware systems that are functioning within
specifications and that use the most advanced MelaFind®
software and classifiers, provide results consistent with the
requirements of the Protocol Agreement, that is, specificity
that is superior to study dermatologists on a statistically
significant basis, and observed sensitivity of at least 99%.
The studies performed to date have been executed with prototype
hardware systems as well as MelaFind® classifiers and
software that were under development. We believe that results
similar or superior to the results obtained in the largest study
will be observed in the pivotal clinical study for PMA approval,
which will employ pre-commercialization hardware systems with
the most advanced software and MelaFind® classifiers. We
believe that the pivotal study will demonstrate specificity
superior to study dermatologists on a statistically significant
basis and satisfy the requirements of the Protocol Agreement.
Sales and Marketing
We plan to offer MelaFind® as a point-of-care online
service. This approach is intended to provide us with the
advantage of recurring revenues corresponding to the number of
patients examined and to provide the physician with access to
our technology without having to make a significant capital
investment.
52
Our sales and marketing strategy is to initially establish
focused sales, marketing, and distribution organization in North
America. We plan to focus our commercialization efforts
initially on high volume/key opinion leader
dermatologists who are strongly focused on the diagnosis and
treatment of melanoma. For the expansion to the larger US
markets of general dermatologists, plastic surgeons, and primary
care physicians, and for international markets, we intend to
establish development and commercialization partnerships with
pharmaceutical and/or diagnostic device companies with an
established competency in the market to accelerate the product
introduction and to maximize the breadth of the commercial
opportunity. At this time, we have not yet established any
commercialization partnerships.
We believe that the ultimate market for MelaFind® is in the
primary care setting. When used by primary care physicians,
MelaFind® could have a significant public health benefit
and a favorable impact on healthcare costs. Primary care
physicians are at the front line of early detection, but their
lack of specialist training in identifying suspect lesions makes
the achievement of a high level of diagnostic accuracy
challenging. We believe that MelaFind® can significantly
assist primary care physicians in improving their diagnostic
acumen.
The MelaFind®
Value Proposition for the Healthcare System
We are currently working with experts on a quantitative analysis
of the value proposition of the use of MelaFind® by both
dermatologists and primary care physicians using Evidence-Based
Medicine evaluation techniques. This strategy is consistent with
the approach that has been used to support positive coverage
decisions by CMS and private payors for other products. The
value drivers include: (1) the diagnosis of melanoma at the
early curable stages, as opposed to advanced stages, allowing
for both a greater opportunity to cure and a reduction in
treatment costs by approximately 99%; and (2) reduced
number of referrals for evaluation and biopsy of benign
pigmented skin lesions. We believe that the use of
MelaFind® could result in substantial savings to the US
healthcare system.
Our Reimbursement
Strategy
We are aware of no Current Procedural Terminology
(CPT) code that is specifically applicable to the use of
MelaFind®. Therefore, we have engaged the services of
expert consultants with extensive experience in the CPT and
coverage decision processes to assist us in the submission of
appropriate applications to obtain a CPT code(s) and positive
coverage decisions from CMS and private payors.
In advance of obtaining a CPT code, we intend to extend our
efforts to secure coverage by private payors and state Medicare
administrative contractors. Securing coverage first through
private payors and state Medicare administrative contractors is
a common strategy for facilitating national Medicare coverage.
Our efforts to secure reimbursement for services using
MelaFind® will focus first on private payors and state
Medicare administrative contractors, particularly in sunbelt
locations and in areas that have been shown to be underserved by
dermatologists.
In the US, healthcare providers that utilize medical systems
such as MelaFind®, generally rely on third-party payors,
including Medicare, Medicaid, private health insurance carriers,
and managed care organizations, to reimburse part, but not
necessarily all, of the costs and fees associated with the
procedures performed using these devices. Public and
professional concern about the cost of medical care and new
technologies has evoked a variety of remedies. Third-party
payors are increasingly challenging the pricing of medical
products and procedures. Guidelines have been established that
recognize the need for clinical strategies to assess the
cost-effectiveness of new diagnostic tools or procedures
(Evidence-Based Medicine), in the hope of reducing the
variations in diagnostic and treatment protocols and reducing
healthcare expenditures.
Insurers are also attempting to curb utilization by applying a
rational analysis of the costs versus benefits of new
technologies.
The Evidence-Based Medicine evaluation that we are undertaking
is central to our efforts to obtain positive coverage decisions
from CMS and private insurers. The importance of Evidence-Based
Medicine is underscored by recent actions by CMS, including its
proposed Covered with Evidence Development
53
initiative designed to provide quicker access to new
technologies for beneficiaries while assuring that appropriate
evidence for final coverage decisions will be obtained.
Assuming FDA approval of MelaFind® in 2007, we anticipate
submitting an application for a new CPT code to the
American Medical Association (AMA) CPT Editorial Panel in
late 2007, anticipating possible issuance of a new CPT code and
positive national or regional Medicare coverage determinations
in the first or second quarter of 2009. The Evidence-Based
Medicine evaluation will be included in the application. If the
CPT Editorial Panel concurs that a new CPT code is needed and
appropriate, and we are able to demonstrate that MelaFind®
is reasonable and necessary for the Medicare population, we
anticipate that the new code would be referred to the AMAs
Relative Value Scale Update Committee (RUC) to determine
the appropriate level of Medicare Part B reimbursement for
the procedure, relative to other physician services. This
analysis would include a survey of physicians utilizing
MelaFind® in the commercial setting. In setting Medicare
reimbursement rates, CMS is generally guided, though not bound,
by the recommendation of the RUC. Medicare coverage and payment
policies significantly influence the practices and policies of
private payors, managed care organizations, and state Medicaid
agencies. We expect to commence efforts to obtain positive
coverage decisions from private payors, managed care
organizations, Medicaid agencies, and state Medicare
administrative contractors following the completion of the
pivotal clinical trial or PMA submission. Presentations to the
various committees that evaluate new technologies will be made.
These will include the Evidence-Based Medicine evaluation and
value proposition. We believe it is likely that the private
payors, managed care organizations, and state Medicare
administrative contractors will desire to establish pilot
programs of MelaFind® to determine the impact of the
product in their systems following PMA approval. In the case of
private payors, managed care organizations and state Medicare
administrative contractors, we anticipate that obtaining a
positive coverage decision for MelaFind® may take at least
6 to 12 months following PMA approval.
One of the keys to securing reimbursement is the desire of
physicians to use a new technology in order to enhance their
diagnostic acumen and improve the standard of care. Likewise, we
believe that once patients become aware of the availability of
MelaFind®, they may demand that their physicians utilize
MelaFind®. We believe that MelaFind® will represent an
improvement in the standard of care for the detection of
melanoma. As such, we anticipate that its adoption by physicians
and reimbursement by payors will be facilitated by medical and
scientific evidence published in peer-reviewed journals and
presentations at scientific and medical meetings including the
American Academy of Dermatology annual and regional meetings. We
plan to execute a publication strategy and to provide
information for continuing medical education efforts in order to
communicate the potential of MelaFind® to improve patient
care. We also plan to sponsor clinical trials following PMA
approval in order to evaluate MelaFind® in additional
settings. We anticipate that the results of these studies will
also be published in peer-reviewed journals and presented at
scientific and medical meetings. We anticipate that these
studies will help to demonstrate the potential of MelaFind®
to improve patient care.
We recognize that a favorable reimbursement environment will
have a significant impact on MelaFind®s adoption and
commercial success. Even if a procedure is eligible for
reimbursement, the level of reimbursement may not be adequate.
In addition, third-party payors may deny reimbursement if they
determine that the device used in the treatment was not
cost-effective or was used for a non-approved indication. We
have anticipated this need and have employed an active strategy
to obtain medical coverage, identify appropriate coding and
establish adequate payment.
Pending approval of a CPT code and the availability of third
party reimbursement, we plan to offer MelaFind® to
physicians, who would pay for using MelaFind®, and may or
may not charge patients directly for its use. For example, in
capitated systems such as certain managed care plans (where
physicians cannot pass costs on to patients, but rather are paid
a fixed amount per patient managed under the plan, whether or
not treated) physicians may conclude that it is cost-effective
to use MelaFind® in order to reduce utilization of other
services such as biopsies, for example, when the MelaFind®
result indicates biopsy is not recommended. In addition, we
believe that roughly ten percent of all dermatological practices
are focused on cosmetic dermatology. Most procedures performed
in cosmetic dermatological practices and Medi-Spas are provided
on a patient self-pay basis. Medi-Spas are health and beauty
clubs and spas in which medical care and supervision by licensed
medical practitioners such as doctors, nurses and physicians
assistants is provided; they specialize in
54
aesthetic medicine. We believe that healthcare consumers that
seek these services are likely to pay for MelaFind®, as
well.
Competition
We are not aware of any direct competitors to MelaFind®. A
number of systems for visualization and assessment of pigmented
skin lesions are in use or in development. These include
clinical (naked eye) examination, whole body mole mapping
systems, dermoscopes (also known as dermatoscopes),
digital dermoscopes, spectrophotometric intercutaneous analysis
(analysis of skin structures through measurement of how they
absorb light of different wavelengths), confocal microscopy, and
spectrophotometric (color) analysis. These systems rely on
physician experience and expertise in recognizing patterns that
are associated with melanoma and non-melanoma in order to render
an interpretation and diagnosis.
The current primary method for detecting melanoma relies on
physicians to interpret whether a pigmented skin lesion is
suspicious for melanoma (thereby requiring biopsy) based on
their ability to recognize patterns using clinical examination.
Physicians use the ABCDE criteria, Asymmetry,
Border irregularity, Color variation,
Diameter greater than 6 mm, and Evolving in ABCD,
in their assessment. Whole body mole mapping consists of
periodic photography of patients, typically those at high risk
for developing melanoma. The pictures are reviewed clinically.
This service is provided at some diagnostic imaging centers and
dermatology offices. DigitalDerm, Inc. offers a computerized
system for acquisition, storage, and review of the pictures.
Dermoscopy, or epiluminescence microscopy, allows for
non-invasive visualization of colors and microstructures of the
epidermis, the dermal-epidermal junction, and the papillary
dermis not visible to the naked eye. Manufacturers of
dermoscopes include (but are not limited to) Welch Allyn, Inc.
(US), Heine Optotechnik (Germany), and 3Gen, LLC (US). Digital
dermoscopes allow for dermoscopic images to be visualized on a
computer screen at larger magnification. In addition, images may
be stored and compared to images taken previously. Manufacturers
of digital dermoscopes include (but are not limited to) Derma
Medical Systems, Inc. (Austria), ZN Vision Technologies AG
(Germany), Polartechnics, Ltd. (Australia), Linos Photonics,
Inc. (Germany), and Biomips Engineering (Italy). Dermoscopy is a
tool used by approximately 25% of dermatologists in the US and
is associated with a long learning curve. Physicians experienced
in the use of dermoscopy have been shown to have an increased
diagnostic accuracy of 10 to 20% over clinical examination.
Although some digital dermoscopes provide information regarding
the probability that a lesion may be melanoma compared to a
database of lesions, no system, to our knowledge, is under PMA
development for objective interpretation.
A recent published article describes the results of a study
utilizing the DB-Mips system from Biomips Engineering. The
database of lesions used in this study differs significantly
from our proprietary database. For example, our database
includes a substantial number of lesions such as seborrheic
keratoses and pigmented basal cell carcinomas, which can be
difficult to differentiate from melanoma. The DB-Mips database
included none of these lesions. Further, our database includes
many more melanomas that are minimally invasive as well as a
much higher percentage of dysplastic nevi compared to the
DB-Mips database. Minimally invasive melanomas are more
difficult to diagnose than melanomas that have significantly
invaded the skin, and dysplastic nevi can be very difficult to
differentiate from melanoma. Thus, we believe that the DB-Mips
database does not include as many pigmented lesions that are
difficult to differentiate from melanoma as our database. This
is further confirmed by the fact that the specificity of
dermatologists in other DB-Mips studies was reported to be over
80% while the specificity of dermatologists in MelaFind®
studies is typically under 30%. The DB-Mips system has a
reported specificity of up to 79%, which is roughly equivalent
to the specificity of the dermatologists in DB-Mips studies. The
DB-Mips system has a reported sensitivity to melanoma of about
95%. We believe that because the DB-Mips database includes
relatively few early melanomas, direct comparison with
MelaFind®s sensitivity is not meaningful.
Spectrophotometric intercutaneous analysis is a technique of
visualizing collagen, blood, and pigment. Astron Clinica
(UK) manufactures a device utilizing this technique.
Confocal microscopy is an
55
experimental approach for non-invasive visualization of skin
structures at the cellular level; such a device utilizing this
technique is in development by Lucid (US).
A spectrophotometer (an instrument for measuring absorption of
light of different wavelengths) is offered by Medical High
Technologies S.p.A. (Switzerland). In contrast to
MelaFind®, the product does not perform automatic quality
control of images and has an external light source. We believe
that the reported sensitivity of 80.4% would not gain market
approval. Further, we are not aware of comparative data on
physicians performance in corresponding data sets. The
system does not have PMA approval, nor are we aware of efforts
directed to obtain PMA approval of the product.
The broad market for precision optical imaging devices used for
medical diagnosis is intensely competitive, subject to rapid
change and significantly affected by new product introductions
and other market activities of industry participants. If our
products are approved for marketing, we will potentially be
subject to competition from major optical imaging companies,
such as General Electric Co., Siemens AG, Bayer AG, Eastman
Kodak Company, Olympus Corporation, Carl Zeiss AG Deutschland
and others, each of which manufactures and markets precision
optical imaging products for the medical market and could decide
to develop or acquire a product to compete with MelaFind®.
Manufacturing
We are currently focusing our manufacturing efforts on hardware
engineering in order to make the functioning of the
MelaFind® hand-held imaging devices more consistent and
robust, and to facilitate larger-scale manufacturing methods of
the pre-commercialization devices that will be used in the
pivotal clinical trial. Data from the clinical studies as well
as from engineering tests under stress and different
environmental conditions are being used to refine appropriate
manufacturing and field specifications before the design is
fixed.
For this crucial phase in development, we have contracted with a
third-party vendor, ASKION (Gera, Germany), which specializes in
precision optics. The pre-commercialization hand-held imaging
devices to be assembled by ASKION are expected to be available
for pivotal trial initiation planned for early 2006. The
pre-commercialization hand-held imaging devices are expected to
be more robust while having at least the same or better
performance than the hand-held imaging devices used in the
clinical program to date.
We have recently been inspected by the FDA for the manufacturing
and commercialization of DIFOTI®, our dental cavities
detection product that has been discontinued for business
reasons. The FDA inspectors observed deficiencies that were
documented on FDA Form 483 that was issued to us following
the inspection. We have had a follow-up meeting with the FDA and
are working with the FDA and consultants to address the
inspectional findings, particularly as they relate to current
MelaFind® design development and ultimate MelaFind®
commercial manufacturing. We believe that the issues can be
addressed to the satisfaction of the FDA and will not materially
adversely effect our operations.
Research and Development Efforts
Our research and development efforts are currently focused on
finalization and validation of the pre-commercialization
hand-held imaging device, and completion of the development of
the MelaFind® Lesion Classifiers. To date, we have
developed and tested four-step classifiers (see Results of
Training Studies and Blinded Tests), and we are currently
working on five-step versions. The classifiers have been trained
on 113 melanomas to date, and our goal is to use 300 melanomas
(and over 4,000 non-melanoma pigmented lesions) for training. To
date we have collected over 225 melanomas, which are available
for classifier training.
We have engaged Battelle Memorial Institute to perform specific
technical services supporting our algorithm and software
development and other efforts.
Our R&D plan also includes further improvements such as
incorporating wireless technology and an internet connection for
hand-held imaging device quality monitoring, as well as faster
and easier software
56
downloads for future software versions. The internet based
monitoring of the performance of our hand-held imaging device,
known as Intelligent Device Management, is intended to enable us
to continuously monitor our hand-held imaging device, advise the
user of errors in handling, and thus enhance customer
satisfaction and loyalty.
We have performed feasibility studies of a MelaFind®
software add-on feature called
MelaMetertm,
an enhancement to MelaFind® that provides information
regarding the depth of penetration of a pigmented skin lesion.
This information may be useful to physicians in determining the
necessary depth and breadth of biopsy of a pigmented skin
lesion. Initial clinical studies of
MelaMetertm
demonstrate the ability of
MelaMetertm
to non-invasively estimate the Breslow thickness (the thickness
of a cutaneous malignant melanoma measured from the epidermis to
the deepest malignant cells present) comparably to histological
examination of excised lesions. We plan to continue the
development of
MelaMetertm
and seek its FDA approval after receiving PMA approval of
MelaFind®.
Following commercialization of MelaFind®, we intend to
evaluate the potential use of our light based computer vision
platform in other applications, including the non-invasive
detection of basal cell carcinoma, the most common skin cancer.
New hardware systems for the imaging of blood and blood vessel
patterns are needed since the majority of basal cell carcinomas
are not pigmented and, accordingly, the MelaFind® system as
currently developed is not appropriate for this use. However, we
believe MelaFind®s software programs and algorithms
will be applicable.
Intellectual Property
Our policy is to protect our intellectual property by obtaining
US and foreign patents to protect technology, inventions and
improvements important to the development of our business. To
date we have been awarded 14 US patents with numerous foreign
counterparts, of which six US patents and two Australian patents
relate to various aspects of MelaFind®. In addition, we
have applied for two additional US patents and have filed
certain foreign patent applications relating to MelaFind®,
of which two foreign patent applications are currently in the
European regional phase. Also, we have obtained non-exclusive
licenses from several of our suppliers for critical components
of MelaFind®. We have not granted any significant licenses
with respect to our intellectual property.
We cannot be certain that our patents will not be challenged or
circumvented by competitors. Whether a patent is infringed and
is valid, or whether a patent application should be granted, are
all complex matters of science and law, and therefore we cannot
be certain that, if challenged, our patents, patent applications
and/or other intellectual property rights would be upheld. If
one or more of those patents, patent applications and other
intellectual property rights are invalidated, rejected or found
unenforceable, that could reduce or eliminate any competitive
advantage.
We also rely on trade secrets and technical know-how in the
manufacture and marketing of MelaFind®. We require our
employees, consultants and contractors to execute
confidentiality agreements with respect to our proprietary
information.
We have obtained US trademark registrations for the following
marks: MelaFind® and DIFOTI®,
as well as the corporate logo for eos-electro-optical
sciences, inc.® The goods covered by these
registrations are in International Class 010 and US
Classes 26, 39 and 44. For MelaFind®, the description
of goods and services covered by the trademark is: medical
devices, namely, electro-optical devices incorporating hardware
for obtaining images in different spectral bands and software
for analyzing the images for use in analyzing skin lesions and
determining the existence of melanoma. For DIFOTI®,
the description of goods and services covered by the trademark
is: electro-optical apparatus to diagnose dental
conditions. For eos-electro-optical sciences,
inc.®, the description of goods and services covered
by the trademark is: instrumentation comprising computer
assisted optical imagers and image analyzers for use in the
detection of dental cavities, cutaneous melanoma, and other
pathologies of the teeth, skin and other tissues. We also
have registered the internet domain names: www.eo-sciences.com,
www.eosciences.com, www.melafind.com, www.difoti.com,
www.smartlightsensors.com, and www.skinsurf.com.
57
The following table lists the fundamental US patents that cover
the MelaFind® methodology, apparatus, and systems:
US Patents Relating to MelaFind®
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Patent # |
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Title |
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Issued | |
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Expiration | |
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6,081,612
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Systems and Methods for the Multispectral Imaging and |
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06/27/00 |
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02/27/17 |
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Characterization of Skin Tissue |
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6,208,749
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Systems and Methods for the Multispectral Imaging and |
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03/27/01 |
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02/27/17 |
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Characterization of Skin Tissue |
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6,307,957
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Multispectral Imaging and Characterization of Biological Tissue |
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10/23/01 |
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02/27/17 |
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6,626,558
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Apparatus for Uniform Illumination of an Object |
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09/30/03 |
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08/31/21 |
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6,657,798
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Method for Optimizing the Number of Good Assemblies |
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12/02/03 |
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02/10/23 |
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Manufacturable From a Number of Parts |
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6,710,947
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Method for Assembling Lens Elements |
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03/23/04 |
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02/27/23 |
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The first two listed patents improve the specificity and
sensitivity of the software algorithms that classify lesions as
suspicious for melanoma or as not suspicious. The third patent
extends the prior patents for potential use in evaluating
gastro-intestinal lesions. The fourth patent covers a novel way
of providing illumination with which to capture images. The
fifth and sixth patents describe cost-saving methods of lens
assembly. We believe that our patented methods and apparatus,
together with unpatented related trade-secret technology, give
us a competitive advantage; however, we cannot be certain that,
if challenged, our patented methods and apparatus and/or
trade-secret technology would be upheld. If one or more of our
patented methods, patented apparatus or trade secret technology
rights are invalidated, rejected or found unenforceable, that
could reduce or eliminate any competitive advantage we might
otherwise have had.
US patent No. 6,081,612 relates to the MelaFind®
system and methods employed in building MelaFind®
classification algorithms involving the use of novel
multi-spectral lesion features by means of wavelet maxima
representations. Wavelet maxima representations use specific
types of mathematical transformations called wavelets to
represent a signal, such as an image of a lesion taken by the
MelaFind® system, at different detail levels. The wavelet
maxima representation retains information of potential
diagnostic value. This information is quantified in the form of
statistical features used for automatic classification. Patent
No. 6,208,749 relates to methods employed in building
MelaFind® classification algorithms involving the use of
novel features of multispectral lesion images that do not
involve the use of wavelet transformations to determine whether
the lesion is or is not a melanoma. We believe the inclusion of
the described wavelets and non-wavelets features improves
significantly the sensitivity and specificity of the melanoma
classifiers. Patent No. 6,307,957 extends the use of the
novel features of the MelaFind® system to endoscopy
(examination of gastro-intestinal tissues using fiber-optic
probes). We have no present plans to develop endoscopy
applications of our technology.
Patent 6,626,558 covers the array of numerous light-emitting
diodes (LEDs) that are used in the MelaFind®
hand-held device to provide uniform illumination of lesions in
multiple spectral bands of illumination. Patent 6,657,798
involves the use of a computer algorithm to optimize the number
of lens assemblies possible from a given number of sets of lens
elements. Patent 6,710,947 describes a method for the economical
assembly of the nine elements of the MelaFind® hand-held
devices optical lens apparatus.
We also have developed trade secret calibration methods,
classifier programs, and search engines; these programs have
been developed over many years and incorporate decades of
experience in optical computer vision. In addition, our
proprietary MelaFind® database of over 5,000 lesions has
been compiled over a number of years and would be difficult to
replicate.
58
FDA Regulation
Our product, MelaFind®, is regulated as a medical device
and is subject to extensive regulation by the FDA and other
regulatory authorities in the US. The FD&C Act and other
federal and state statutes and regulations govern the research,
design, development, preclinical and clinical testing,
manufacturing, safety, approval or clearance, labeling,
packaging, storage, record keeping, servicing, promotion, import
and export, and distribution of medical devices.
Unless an exemption applies, each medical device we wish to
commercially distribute in the US will require either prior
premarket notification, or 510(k) clearance, or PMA approval,
from the FDA. The FDA classifies medical devices into one of
three classes. Devices requiring fewer controls because they are
deemed to pose lower risk are placed in Class I or II.
Class I devices are subject to general controls such as
labeling, premarket notification, and adherence to the
FDAs QSR. Class II devices are subject to special
controls such as performance standards, postmarket surveillance,
FDA guidelines, as well as general controls. Some Class I
and Class II devices are exempted by regulation from the
premarket notification, or 510(k), clearance requirement or the
requirement of compliance with certain provisions of the QSR.
Devices are placed in Class III, which requires approval of
a PMA application, if insufficient information exists to
determine that the application of general controls or special
controls are sufficient to provide reasonable assurance of
safety and effectiveness, or they are life-sustaining,
life-supporting or implantable devices, or the FDA deems these
devices to be not substantially equivalent either to
a previously 510(k) cleared device or to a
preamendment Class III device in commercial
distribution before May 28, 1976, for which PMA
applications have not been required. The FDA classifies
MelaFind® as a Class III device, requiring PMA
approval.
A PMA application must be supported by valid scientific
evidence, which typically requires extensive data, including
technical, pre-clinical, clinical, manufacturing and labeling
data, to demonstrate to the FDAs satisfaction the safety
and effectiveness of the device. A PMA application must include,
among other things, a complete description of the device and its
components, a detailed description of the methods, facilities
and controls used to manufacture the device, and proposed
labeling. A PMA application also must be accompanied by a user
fee, unless exempt. For example, the FDA does not require the
submission of a user fee for a small businesss first PMA.
After a PMA application is submitted and found to be
sufficiently complete, the FDA begins an in-depth review of the
submitted information. During this review period, the FDA may
request additional information, or clarification of information
already provided. Also during the review period, the FDA has
informed us that an advisory panel of experts from outside the
FDA will be convened to review and evaluate the application and
provide recommendations to the FDA as to the approvability of
the device. In addition, the FDA generally will conduct a
pre-approval inspection of the manufacturing facility to ensure
compliance with the QSR, which requires manufacturers to follow
design, testing, control, documentation and other quality
assurance procedures.
We commenced the PMA application process for MelaFind® by
filing a proposed Shell (an outline of a PMA) for a three module
PMA on September 30, 2002. We filed as a Small Business
Entity exempt from the user fee requirement. The Shell was
accepted and two Modules have been filed and reviewed. The third
Module will include the results of the pivotal clinical study,
and cannot be filed until after that study is complete and its
results have been evaluated. The FDA can delay, limit or deny
approval of a PMA application for many reasons, including:
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MelaFind® may not be safe or effective to the FDAs
satisfaction; |
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the data from our pre-clinical studies and clinical trials may
be insufficient to support approval; |
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the manufacturing process or facilities we use may not meet
applicable requirements; and |
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changes in FDA approval policies or adoption of new regulations
may require additional data. |
If the FDA evaluations of both the PMA application and the
manufacturing facilities are favorable, the FDA will either
issue an approval letter, or approvable letter, which usually
contains a number of conditions which must be met in order to
secure final approval of the PMA. When and if those conditions
59
have been fulfilled to the satisfaction of the FDA, the agency
will issue a PMA approval letter authorizing commercial
marketing of the device for certain indications. If the
FDAs evaluation of the PMA or manufacturing facilities is
not favorable, the FDA will deny approval of the PMA or issue a
not approvable letter. The FDA may also determine that
additional clinical trials are necessary, in which case the PMA
approval may be delayed while the trials are conducted and the
data acquired is submitted in an amendment to the PMA. Even with
additional trials, the FDA may not approve the PMA application.
The PMA process can be expensive, uncertain and lengthy and a
number of devices for which FDA approval has been sought by
other companies have never been approved for marketing.
New PMA applications or PMA supplements may be required for
modifications to the manufacturing process, labeling and device
specifications, materials or design of a device that is approved
through the PMA process. PMA supplements often require
submission of the same type of information as an initial PMA
application, except that the supplement is limited to
information needed to support any changes from the device
covered by the original PMA application, and may not require as
extensive clinical data or the convening of an advisory panel.
Clinical trials are almost always required to support a PMA
application, and are sometimes required for a 510(k) clearance.
These trials generally require submission of an application for
an IDE to the FDA. We have not been required to file an IDE
application for the MelaFind® clinical studies because FDA
has considered the trials non-significant risk
(NSR) studies subject to abbreviated IDE regulations, which
do not require formal IDE submission. An IDE application must be
supported by appropriate data, such as animal and laboratory
testing results, showing that it is safe to test the device in
humans and that the testing protocol is scientifically sound.
The IDE application must be approved in advance by the FDA for a
specified number of patients, unless the product is deemed a
non-significant risk device and eligible for more abbreviated
IDE requirements. Generally, clinical trials for a significant
risk device may begin once the IDE application is approved by
the FDA and the study protocol and informed consent form are
approved by appropriate institutional review boards at the
clinical trial sites. The FDAs approval of an IDE allows
clinical testing to go forward, but does not bind the FDA to
accept the results of the trial as sufficient to prove the
products safety and effectiveness, even if the trial meets
its intended success criteria. All clinical trials must be
conducted in accordance with the FDAs IDE regulations that
govern investigational device labeling, prohibit promotion of
the investigational device, and specify an array of
recordkeeping, reporting and monitoring responsibilities of
study sponsors and study investigators. As stated above, the
clinical studies of MelaFind® are considered by the FDA as
NSR. Consequently, the trials are conducted under the auspices
of an abbreviated IDE. Clinical trials must further comply with
the FDAs regulations for IRB approval and for informed
consent. Required records and reports are subject to inspection
by the FDA. The results of clinical testing may be unfavorable
or, even if the intended safety and effectiveness success
criteria are achieved, may not be considered sufficient for the
FDA to grant approval or clearance of a product. The
commencement or completion of any of our clinical trials may be
delayed or halted, or be inadequate to support approval of a PMA
application, or 510(k) clearance, for numerous reasons,
including, but not limited to, the following:
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the FDA, other regulatory authorities, or an IRB do not approve
a clinical trial protocol or a clinical trial, or place a
clinical trial on hold; |
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patients do not enroll in clinical trials at the rate we expect; |
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physicians do not comply with trial protocols; |
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patient follow-up is not at the rate we expect; |
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patients experience adverse events; |
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IRBs and third-party clinical investigators may delay or reject
our trial protocol; |
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third-party clinical investigators decline to participate in a
trial or do not perform a trial on our anticipated schedule or
consistent with the clinical trial protocol, GCPs or other FDA
requirements; |
60
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third-party organizations do not perform data collection and
analysis in a timely or accurate manner; |
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regulatory inspections of our clinical trials or manufacturing
facilities may, among other things, require us to undertake
corrective action or suspend or terminate our clinical trials,
or invalidate our clinical trials; |
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changes in governmental regulations or administrative actions;
and |
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the interim or final results of the clinical trial are
inconclusive or unfavorable as to safety or effectiveness. |
Our clinical trials may not generate favorable data to support
any PMA applications, and we may not be able to obtain such
approvals on a timely basis, or at all. Delays in receipt of or
failure to receive such approvals, the withdrawal of previously
received approvals, or failure to comply with existing or future
regulatory requirements would have a material adverse effect on
our business, financial condition and results of operations.
Even if granted, the approvals may include significant
limitations on the intended use and indications for use for
which our products may be marketed.
After a device is approved or cleared and placed in commercial
distribution, numerous regulatory requirements apply. These
include:
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establishment registration and device listing; |
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QSR, which requires manufacturers to follow design, testing,
control, documentation and other quality assurance procedures; |
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labeling regulations, which prohibit the promotion of products
for unapproved or off-label uses and impose other
restrictions on labeling; |
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medical device reporting regulations, which require that
manufacturers report to the FDA if a device may have caused or
contributed to a death or serious injury or malfunctioned in a
way that would likely cause or contribute to a death or serious
injury if it were to recur; and |
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corrections and removal reporting regulations, which require
that manufacturers report to the FDA field corrections and
product recalls or removals if undertaken to reduce a risk to
health posed by the device or to remedy a violation of the
FD&C Act that may present a risk to health. |
Also, the FDA may require us to conduct postmarket surveillance
studies or order us to establish and maintain a system for
tracking our products through the chain of distribution to the
patient level. The FDA enforces regulatory requirements by
conducting periodic, unannounced inspections and market
surveillance. Inspections may include the manufacturing
facilities of our subcontractors. Thus, we must continue to
spend time, money, and effort to maintain compliance.
Failure to comply with applicable regulatory requirements,
including those applicable to the conduct of our clinical
trials, can result in enforcement action by the FDA, which may
lead to any of the following sanctions:
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warning letters; |
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fines and civil penalties; |
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unanticipated expenditures; |
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delays in approving or refusal to approve our applications,
including supplements; |
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withdrawal of FDA approval; |
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product recall or seizure; |
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interruption of production; |
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operating restrictions; |
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injunctions; and |
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criminal prosecution. |
We and our contract manufacturers, specification developers, and
some suppliers of components, are also required to manufacture
our products in compliance with cGMP requirements set forth in
the QSR. The QSR requires a quality system for the design,
manufacture, packaging, labeling, storage, installation and
servicing of marketed devices, and includes extensive
requirements with respect to quality management and
organization, device design, equipment, purchase and handling of
components, production and process controls, packaging and
labeling controls, device evaluation, distribution,
installation, complaint handling, servicing, and record keeping.
The FDA enforces the QSR through periodic unannounced
inspections that may include the manufacturing facilities of our
subcontractors. We expect that our manufacturing facility and
those of our subcontractors will be subject to domestic and
international regulatory inspection and review. If the FDA
believes we or any of our contract manufacturers or regulated
suppliers are not in compliance with these requirements, it can
shut down our manufacturing operations, require recall of our
products, refuse to approve new marketing applications,
institute legal proceedings to detain or seize products, enjoin
future violations, or assess civil and criminal penalties
against us or our officers or other employees. Any such action
by the FDA would have a material adverse effect on our business.
We cannot assure you that we will be able to comply with all
applicable FDA regulations.
Government Regulation
The advertising of our MelaFind® product will be subject to
both FDA and Federal Trade Commission regulations. In addition,
the sale and marketing of MelaFind® will be subject to a
complex system of federal and state laws and regulations
intended to deter, detect, and respond to fraud and abuse in the
healthcare system. These laws and regulations restrict and may
prohibit pricing, discounting, commissions and other commercial
practices that may be typical outside of the healthcare
business. In particular, anti-kickback and self-referral laws
and regulations will limit our flexibility in crafting
promotional programs and other financial arrangements in
connection with the sale of our products and related services,
especially with respect to physicians seeking reimbursement
through Medicare or Medicaid. These federal laws include, by way
of example, the following:
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the anti-kickback statute prohibits certain business practices
and relationships that might affect the provision and cost of
healthcare services reimbursable under Medicare, Medicaid and
other federal healthcare programs, including the payment or
receipt of remuneration for the referral of patients whose care
will be paid by Medicare or other federal healthcare programs; |
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the physician self-referral prohibition, commonly referred to as
the Stark Law, which prohibits referrals by physicians of
Medicare or Medicaid patients to providers of a broad range of
designated healthcare services in which the physicians or their
immediate family members have ownership interests or with which
they have certain other financial arrangements; |
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the anti-inducement law, which prohibits providers from offering
anything to a Medicare or Medicaid beneficiary to induce that
beneficiary to use items or services covered by either program; |
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the Civil False Claims Act, which prohibits any person from
knowingly presenting or causing to be presented false or
fraudulent claims for payment by the federal government,
including the Medicare and Medicaid programs; and |
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the Civil Monetary Penalties Law, which authorizes HHS to impose
civil penalties administratively for fraudulent or abusive acts. |
Sanctions for violating these federal laws include criminal and
civil penalties that range from punitive sanctions, damage
assessments, money penalties, imprisonment, denial of Medicare
and Medicaid payments, or exclusion from the Medicare and
Medicaid programs, or both. These laws also impose an
affirmative duty on those receiving Medicare or Medicaid funding
to ensure that they do not employ or contract with persons
excluded from the Medicare and other government programs.
62
Many states have adopted or are considering legislative
proposals similar to the federal fraud and abuse laws, some of
which extend beyond the Medicare and Medicaid programs to
prohibit the payment or receipt of remuneration for the referral
of patients and physician self-referrals regardless of whether
the service was reimbursed by Medicare or Medicaid. Many states
have also adopted or are considering legislative proposals to
increase patient protections, such as limiting the use and
disclosure of patient-specific health information. These state
laws typically impose criminal and civil penalties similar to
the federal laws.
In the ordinary course of their business, medical device
manufacturers and suppliers have been and are subject regularly
to inquiries, investigations and audits by federal and state
agencies that oversee these laws and regulations. Recent federal
and state legislation has greatly increased funding for
investigations and enforcement actions, which have increased
dramatically over the past several years. This trend is expected
to continue. Private enforcement of healthcare fraud also has
increased, due in large part to amendments to the Civil False
Claims Act in 1986 that were designed to encourage private
persons to sue on behalf of the government. These whistleblower
suits by private persons, known as qui tam relators, may
be filed by almost anyone, including physicians and their
employees and patients, our employees, and even competitors.
HIPAA, in addition to its privacy provisions, created a series
of new healthcare-related crimes.
Environmental Regulation
Our research and development and clinical processes involve the
handling of potentially harmful biological materials as well as
hazardous materials. We and our investigators and vendors are
subject to federal, state and local laws and regulations
governing the use, handling, storage and disposal of hazardous
and biological materials and we incur expenses relating to
compliance with these laws and regulations. If violations of
environmental, health and safety laws occur, we could be held
liable for damages, penalties and costs of remedial actions.
These expenses or this liability could have a significant
negative impact on our financial condition. We may violate
environmental, health and safety laws in the future as a result
of human error, equipment failure or other causes. Environmental
laws could become more stringent over time, imposing greater
compliance costs and increasing risks and penalties associated
with violations. We are subject to potentially conflicting and
changing regulatory agendas of political, business and
environmental groups. Changes to or restrictions on permitting
requirements or processes, hazardous or biological material
storage or handling might require an unplanned capital
investment or relocation. Failure to comply with new or existing
laws or regulations could harm our business, financial condition
and results of operations.
International Regulation
International sales of medical devices are subject to foreign
government regulations, which may vary substantially from
country to country from having no regulations to having a
premarket notice or premarket acceptance. The time required to
obtain approval in a foreign country may be longer or shorter
than that required for FDA approval, and the requirements may
differ. There is a trend towards harmonization of quality system
standards among the European Union, US, Canada and various other
industrialized countries.
The European Union, which includes most of the major countries
in Europe, has adopted numerous directives and standards
regulating the design, manufacture, clinical trials, labeling
and adverse event reporting for medical devices. Devices that
comply with the requirements of a relevant directive will be
entitled to bear the CE conformity marking, indicating that the
device conforms to the essential requirements of the applicable
directives and, accordingly, can be commercially distributed
throughout Europe. The method of assessing conformity varies
depending on the class of the product, but normally involves a
combination of self-assessment by the manufacturer and a third
party assessment by a Notified Body. This third
party assessment may consist of an audit of the
manufacturers quality system and specific testing of the
manufacturers product. An assessment by a Notified Body of
one country within the European Union is required in order for a
manufacturer to commercially distribute the product throughout
63
the European Union. As part of the CE compliance, manufacturers
are required to comply with the ISO 9000 series of standards for
quality operations (an international standard for quality
management requirements maintained by the International
Organization for Standardization (ISO)). Other countries, such
as Switzerland, have voluntarily adopted laws and regulations
that mirror those of the European Union with respect to medical
devices. Outside of the European Union, regulatory approval
needs to be sought on a country-by-country basis in order for us
to market our products.
Product Liability and Insurance
Our business exposes us to the risk of product liability claims
that is inherent in the testing, manufacturing and marketing of
medical devices, including those which may arise from the misuse
or malfunction of, or design flaws in, our products. We may be
subject to product liability claims if MelaFind® causes, or
merely appears to have caused, an injury. Claims may be made by
patients, healthcare providers or others involved with
MelaFind®. MelaFind® will require from the FDA
approval prior to commercialization in the US. The clinical
studies of MelaFind® are considered by the FDA as NSR.
Consequently, the trials are conducted under the auspices of an
abbreviated IDE. We therefore do not maintain domestic clinical
trial liability insurance. We have placed clinical trial
liability insurance in certain European countries where required
by statute or clinical site policy. Although we have general
liability insurance that we believe is appropriate, and
anticipate obtaining adequate product liability insurance before
commercialization of MelaFind®, this insurance is and will
be subject to deductibles and coverage limitations. Our
anticipated product liability insurance may not be available to
us in amounts and on acceptable terms, if at all, and, if
available, the coverages may not be adequate to protect us
against any future product liability claims. If we are unable to
obtain insurance at an acceptable cost or on acceptable terms
with adequate coverage or otherwise protect against potential
product liability claims, we will be exposed to significant
liabilities, which may harm our business.
Employees
As of June 30, 2005, we had 27 full-time and two part-time
employees, of whom 13 were engaged in research and development
(including clinical and regulatory affairs), seven in production
(including document control and quality assurance) and nine in
marketing, sales and administrative activities. We believe that
our relationship with our employees is good.
Facilities
We lease approximately 2,800 square feet of office space at 3
West Main Street, Suite 201, Irvington, New York, and an
additional 3,700 square feet of office, laboratory, and assembly
space in an adjacent building with the street address of 1
Bridge Street, Suite 15, Irvington, New York. The lease on
the 2,800 square feet of space expires in November 2010. The
lease on the 3,700 square feet of space expires in June 2009. We
believe that these facilities are adequate to meet our current
and reasonably foreseeable requirements. We believe that we will
be able to obtain additional space, if required, on commercially
reasonable terms.
Legal Proceedings
We are not currently a party to any legal proceedings.
Discontinued Business
As of April 5, 2005, we decided to discontinue all
operations associated with our DIFOTI® product, a
non-invasive imaging device for the detection of dental
cavities, in order to focus our resources on the development and
commercialization of MelaFind®. We are currently seeking an
acquirer for the DIFOTI® assets. Once a disposition
relating to the DIFOTI® assets is complete, we do not
expect to have any significant continuing responsibility for the
DIFOTI® business.
64
MANAGEMENT
Executive Officers and Directors
The following table sets forth the names, ages as of
June 30, 2005 and a brief account of the business
experience of each person who is a current executive officer or
director of our company and each person who has been elected to
serve as a director effective upon the close of this offering.
Each director of our company will hold office until the next
annual meeting of shareholders of our company or until his
successor has been elected and qualified.
|
|
|
|
|
|
|
Name |
|
Age | |
|
Position |
|
|
| |
|
|
Joseph V. Gulfo, M.D.
|
|
|
42 |
|
|
Director, President and Chief Executive Officer |
Karen Krumeich
|
|
|
51 |
|
|
Vice President, Finance, Chief Financial Officer and Treasurer |
Jon I. Klippel
|
|
|
50 |
|
|
Vice President, Marketing and Sales |
William R. Bronner
|
|
|
59 |
|
|
Vice President, Legal Counsel and Compliance |
Breaux Castleman(1)(2)
|
|
|
64 |
|
|
Director, Chairman of the Board of Directors |
Sidney Braginsky(1)
|
|
|
68 |
|
|
Director |
George C. Chryssis(1)
|
|
|
58 |
|
|
Director |
Martin D. Cleary(2)(3)(4)
|
|
|
59 |
|
|
Director Elect |
Dan W. Lufkin(2)(3)
|
|
|
73 |
|
|
Director |
Gerald Wagner, Ph.D.
|
|
|
62 |
|
|
Director |
|
|
(1) |
Member of Compensation Committee |
|
(2) |
Member of Nominating and Governance Committee |
|
(3) |
Member of Audit Committee |
|
(4) |
Director elected to serve effective as of the completion of this
offering |
Executive Officers
Joseph V. Gulfo, M.D., M.B.A. has served as
our President and Chief Executive Officer and a member of our
board of directors since January 2004. From May 1999 to November
2004, he served as Chairman, Chief Executive Officer and
President of Antigen Express, Inc., a development-stage company
developing immunodiagnostics and therapeutics for cancer.
Dr. Gulfo serves as a director of ProCertus BioPharm, Inc.,
a privately-held company. Dr. Gulfo received a B.S. in
Biology from Seton Hall University, an M.D. from the University
of Medicine and Dentistry of New Jersey and an M.B.A. in Finance
from Seton Hall University.
Karen Krumeich has served as our Vice President,
Finance and Chief Financial Officer since January 2005 and
Treasurer since May 2005. From August 2004 to January 2005 she
served as a financial consultant with Horn Murdock Cole, a
financial consulting firm. From September 2002 to July 2004, she
served as divisional Chief Financial Officer of the hospital
group division of Henry Schein, Inc., a publicly-held medical
and dental products distributor. From March 2000 to August 2002,
she served as a financial consultant with Consulting Associates,
a financial consulting firm. Ms. Krumeich received her B.S.
in Pharmacy from the University of Toledo College of Pharmacy
and completed additional coursework in accounting at Cleveland
State University.
Jon I. Klippel has served as our Vice President,
Marketing and Sales since December 2004. From April 2004 to
November 2004, he was a marketing and sales consultant. From
January 2003 to March 2004, he served as Senior Marketing
Manager of PDI, Inc., a publicly-traded company offering
outsourced marketing, sales and sale support services to
biopharmaceutical and medical device companies. From February
2002 to December 2002, he was a marketing and sales consultant.
From July 2000 to February 2002, he served as Director of
Marketing and Business Development at National Imaging
Associates, Inc.,
65
a privately-held diagnostic imaging management company.
Mr. Klippel received a B.A. in Political Science from
Albright College and an M.B.A. from Rutgers University Graduate
School of Business.
William R. Bronner has served as our Vice
President, Legal Counsel and Compliance since July 2000 and as
our Secretary since May 2002. From 1986 to July 2000,
Mr. Bronner served as Vice President, General Counsel and
Secretary of Kronos, Inc. Mr. Bronner received a B.A. in
Government from Dartmouth College and a J.D. from Columbia
University Law School.
Our executive officers are elected by, and serve at the
discretion of our board of directors. There are no family
relationships between our directors and executive officers.
Non-Executive Directors
Breaux Castleman has served as a member of our
board of directors and Chairman of our board since July 2003.
Since August 2001, he has served as President, Chief Executive
Officer and Chairman of Syntiro Healthcare Services, Inc.
Mr. Castleman also serves as a director of FemPartners,
Inc., Integrated Diagnostic Centers, Inc. and Radiology Practice
Management, Inc., each of which are privately-held companies.
From December 1999 to July 2001, he served as Chief Executive
Officer of Physia Corp. He served as President of Scripps Clinic
from July 1996 to October 1999. He holds a B.A. in economics
from Yale University and attended New York University Graduate
School of Business Administration.
Sidney Braginsky has served as a member of our
board of directors since 2001. He also currently serves as the
Chairman and Chief Executive Officer of Digilab, LLC (a
spectroscopy instruments manufacturer), Chief Executive Officer
and President of Ineedmd, Ltd., Chairman of Double D Venture
Fund, LLC, Chairman of the Board of the City University of New
York Robert Chambers Laboratory and Trustee on the Boards of
Long Island High Tech Incubator and the Long Island Museum of
Science and Technology. He formerly served as President of
Olympus America and Mediscience Corp., Chairman of Atropos
Technologies, LLC and International Standards Organization
Optics, and a director for Noven Pharmaceuticals, Inc.
Mr. Braginsky received his B.S. in biology from Queens
College.
George C. Chryssis has served as a member of our
board of directors since 2001. Since 2003, he has served as
President, Chief Executive Officer and Chairman of the Board of
MISTsoft Corp., a privately-held software company which he
founded. Since 2000, he has served as the Managing Member of
Arcadian Capital Management, LLC, and General Partner of
Arcadian Venture Partners, LP, a venture capital firm with
investments in early stage technology companies, including EOS.
Since 2003, he has also served as Chairman of the Board of
Directors of DelCom Corp., a privately-held telecommunications
software company. Mr. Chryssis received a B.S. and M.S. in
electrical engineering from Northeastern University.
Martin D. Cleary will become a member of our board
of directors upon completion of this offering. Since February
2003, he has served as the President and Chief Executive Officer
of Juvaris Biotherapeutics, Inc., a company engaged in the
development of therapeutic vaccines for cancer and infectious
diseases. From September 1999 to May 2002, he served as the
President and Chief Executive Officer of Genteric, Inc., a
company engaged in non-viral gene delivery. Mr. Cleary
received a B.S. in accounting from Rutgers University in 1971,
and a certificate in international studies from Columbia
University in 1973.
Dan W. Lufkin has served as a member of our board
of directors since July 2003. He is also a co-founder and former
Chairman of the investment banking firm, Donaldson, Lufkin &
Jenrette, Inc. Mr. Lufkin currently serves as a consultant
to and/or board member of a number of private companies and
non-profit endeavors. Mr. Lufkin received a B.A. degree
from Yale University and an M.B.A. from Harvard Business School.
Gerald Wagner, Ph.D. was appointed as a member of
our board of directors in May 2005. Since 2002, he has owned and
operated Gerald Wagner Consulting LLC, an international
consulting company specializing in: international project
management; technology and application consulting; and company
assessments. From March 1992 to September 2003, he was a Senior
Vice President, Lab Testing Systems, at Bayer, Inc.
Mr. Wagner received a Masters and Ph.D. in
electro-mechanical design from Technical University, Darmstadt,
Germany.
66
Board of Directors Composition
Our current charter documents and the charter documents we
expect to be in effect upon completion of this offering
authorize up to nine (9) directors. We currently have six
(6) directors and expect to have seven (7) directors
upon completion of the initial public offering. Joseph V. Gulfo,
M.D., Breaux Castleman, Dan W. Lufkin and George C. Chryssis
were elected pursuant to voting provisions contained in a voting
agreement that we entered into with certain holders or our
common stock and preferred stock. Upon the closing of this
offering, the voting agreement will be terminated and none of
our stockholders will have any special rights regarding board
representation. See Related Party
Transactions Voting Agreement for
additional information regarding the voting agreement.
Board Committees
Audit Committee. The current members of our audit
committee are Messrs. Braginsky and Lufkin, each of whom we
believe satisfies the independence requirements of the NASDAQ
National Market and the SEC. Mr. Cleary will join the audit
committee upon completion of the offering and will chair the
committee. We believe Mr. Cleary satisfies the independence
requirements of the NASDAQ National Market and the SEC. In
addition, we believe Mr. Cleary is qualified as an audit
committee financial expert under the regulations of the SEC, and
has the accounting and related financial management expertise
required by the NASDAQ National Market. Our audit committee
assists our board in its oversight of:
|
|
|
|
|
the integrity of our financial statements; |
|
|
|
our independent registered public accounting firms
qualifications and independence; and |
|
|
|
the performance of our independent auditors. |
The audit committee has the sole and direct responsibility for
appointing, evaluating and retaining our independent registered
public accounting firm and for overseeing their work. All audit
services to be provided to us and all non-audit services, other
than de minimis non-audit services, to be provided to us by our
independent auditors must be approved in advance by our audit
committee.
Compensation Committee. The members of our compensation
committee are Messrs. Castleman, Braginsky and Chryssis,
each of whom we believe satisfies the independence requirements
of the NASDAQ National Market and the SEC. Mr. Castleman
chairs this committee. The purpose of our compensation committee
is to discharge the responsibilities of our board of directors
relating to compensation of our executive officers. Specific
responsibilities of our compensation committee include:
|
|
|
|
|
reviewing and recommending compensation of our executive
officers; |
|
|
|
administering our stock incentive plans; and |
|
|
|
reviewing and recommending incentive compensation and equity
plans. |
Nominating and Governance Committee. The members of our
nominating and governance committee are Messrs. Lufkin and
Castleman, each of whom we believe satisfies the independence
requirements of the NASDAQ National Market. Mr. Lufkin will
chair this committee. Mr. Cleary will join the nominating
and governance committee upon completion of the offering. Our
nominating and governance committee:
|
|
|
|
|
identifies and recommends nominees for election to our board of
directors; |
|
|
|
develops and recommends our corporate governance principles; and |
|
|
|
oversees the evaluation of our board of directors and management. |
Compensation Committee Interlocks and Insider
Participation
We did not have a compensation committee until May 2005.
Dr. Gulfo, our Chief Executive Officer, previously
participated in the deliberations regarding executive
compensation. None of our executive officers has served as a
member of the compensation committee, or other committee serving
an equivalent function, of any other entity, one of whose
executive officers served as a member of our compensation
committee.
67
Election of Directors
The number of directors is determined by the stockholders at
their annual meeting, subject to the right of the stockholders
to change such number between annual meetings and to the right
of our board to increase such number between annual meetings.
Director Compensation
After completion of this offering, in addition to reimbursement
of expenses incurred in attending meetings of our board of
directors and committees of our board, our non-employee
directors will receive an annual fee of $10,000 for serving as
directors and an additional $500 per meeting for each meeting
attended, whether in person or by telephone. In addition, after
completion of this offering, the chairman of our board of
directors, the chairman of our audit committee and the chairman
of our nominating and governance committee will each receive an
annual fee of $10,000. After completion of this offering, each
member of our board who is not a company employee will receive
an annual stock option grant to purchase up to 5,000 shares of
common stock. Such stock options will vest in full upon the
first anniversary of issuance and have an exercise price equal
to the fair market value of our common stock on the date of the
grant. In addition, we reimburse each member of our Board who is
not a company employee for reasonable travel and other expenses
in connection with attending meetings of the Board.
Scientific and Medical Advisory Committee
We have established a Scientific and Medical Advisory Committee
made up of leading experts in the fields of dermatology and
oncology. Members of our Scientific and Medical Advisory
Committee consult with us regularly on matters relating to:
|
|
|
|
|
our research and development programs; |
|
|
|
the design and implementation of our clinical trials; |
|
|
|
market opportunities from a clinical perspective; |
|
|
|
new technologies relevant to our research and development
programs; and |
|
|
|
scientific and technical issues relevant to our business. |
The current members of our Scientific and Medical Advisory
Committee are:
|
|
|
Name |
|
Professional Affiliation |
|
|
|
Jeffrey P. Callen, M.D.
|
|
Professor and Chief of the Division of Dermatology, University
of Louisville School of Medicine; Member of the Board of
Directors of the American Board of Dermatology, Inc. |
Armand B. Cognetta, Jr., M.D.
|
|
Dermatologist in private practice with Dermatology Associates of
Tallahasee; Member, American Academy of Dermatology; former
President of Florida Society of Dermatology; former President of
Dermatology Photography Society. |
Robert Friedman, M.D.
|
|
Clinical Assistant Professor, Department of Dermatology, New
York University School of Medicine; Past Director, American
Cancer Society, New York City Division, and Member, Professional
Education Committee; American Academy of Dermatology: Member,
Skin Cancer/ Melanoma Committee, Past Chairman, Industry Liaison
Committee. |
68
|
|
|
Name |
|
Professional Affiliation |
|
|
|
Martin C. Mihm, Jr., M.D., Chairman
|
|
Professor and Chief of Dermatopathology at Harvard Medical
School; Chief of Dermatopathology at Massachusetts General
Hospital; Co-Director of the Pigmented Skin Lesion Clinic at
Massachusetts General Hospital; Co-Chairman of the Melanoma
Pathology Program of the World Health Organization; Co-Director
of the Rare Tumor Institute of the World Health Organization;
member of the editorial and advisory board of the American
Journal of Dermatopathology and the International Journal of
Surgical Pathology; Member of the American Academy of
Dermatology; New England Pathology Society; American Society of
Dermatopathology; American Society of Clinical Oncology; and
College of American Pathologists. |
Harold S. Rabinovitz, M.D.
|
|
Dermatologist in private practice with Skin and Cancer
Associates in Plantation, Florida; Voluntary Professor of
Dermatology at the University of Miami-School of Medicine;
Associate Editor of the Journal of Dermatologic Surgery; member
of the Board of Directors of the South Florida Dermatology
Foundation. |
Darrell S. Rigel, M.D.
|
|
Clinical Professor of Dermatology, New York University Medical
Center; Secretary and Treasurer of the American Dermatological
Association; Past President, American Academy of Dermatology;
Member, Board of Directors of the American Cancer Society New
York City Division and Chairman of its Subcommittee on Skin
Cancer. |
Arthur J. Sober, M.D.
|
|
Professor of Dermatology, Harvard Medical School; Director of
Dermatology Clinical Investigation Unit, Massachusetts General
Hospital; Member, American Joint Commission on Cancer. |
Medical Advisor and Liaison to Our Board of Directors
Robert Friedman, M.D., a member of our Scientific and Medical
Advisory Committee, serves as a medical advisor to our board of
directors and a liaison between our Scientific and Medical
Advisory Committee and our board of directors. See
Consulting Agreements Consulting Agreement
with Robert Friedman, M.D.
69
Executive Compensation
The following table sets forth summary compensation information
for the years ended December 31, 2002, December 31,
2003 and December 31, 2004 for our chief executive officer
and each of our two other most highly compensated executive
officers whose salary and bonus for 2004 was more than $100,000.
As of December 31, 2004, there were no other persons
serving as executive officers. We have also included summary
compensation information for two executive officers who would
have been among the four other most highly compensated executive
officers whose salary and bonus for 2004 would have been more
than $100,000 had they served as executive officers for the full
year. We refer to these officers collectively as our named
executive officers.
Summary Compensation Table
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long Term | |
|
|
|
|
|
|
Annual Compensation | |
|
Compensation | |
|
|
|
|
|
|
| |
|
| |
|
|
|
|
|
|
|
|
Securities | |
|
|
|
|
|
|
|
|
Underlying | |
|
All Other | |
Name and Principal Position |
|
Year | |
|
Salary ($) | |
|
Bonus ($) | |
|
Options | |
|
Compensation | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Joseph V. Gulfo, M.D.
|
|
|
2004 |
|
|
$ |
173,656 |
|
|
|
|
|
|
|
81,753 |
(1) |
|
$ |
19,880 |
(1) |
|
President and Chief |
|
|
2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Executive Officer |
|
|
2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marek Elbaum, Ph.D.
|
|
|
2004 |
|
|
|
173,549 |
|
|
|
|
|
|
|
10,000 |
|
|
|
|
|
|
Founder and former Chief Science |
|
|
2003 |
|
|
|
81,085 |
|
|
|
|
|
|
|
29,071 |
|
|
|
|
|
|
and Technology Officer |
|
|
2002 |
|
|
|
30,204 |
|
|
|
|
|
|
|
|
|
|
|
|
|
William Bronner
|
|
|
2004 |
|
|
|
132,612 |
|
|
|
|
|
|
|
37,000 |
|
|
|
|
|
|
Vice President, Legal Counsel |
|
|
2003 |
|
|
|
106,255 |
|
|
|
|
|
|
|
32,161 |
|
|
|
|
|
|
and Compliance |
|
|
2002 |
|
|
|
26,444 |
|
|
|
|
|
|
|
1,875 |
|
|
|
|
|
Karen Krumeich(2)
|
|
|
2004 |
|
|
|
|
|
|
|
|
|
|
|
60,000 |
|
|
|
|
|
|
Vice President Finance, Chief |
|
|
2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial Officer |
|
|
2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jon I. Klippel(3)
|
|
|
2004 |
|
|
|
9,346 |
|
|
|
|
|
|
|
45,000 |
|
|
|
|
|
|
Vice President Marketing |
|
|
2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and Sales |
|
|
2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Dr. Gulfo has been granted another stock option which is
not reflected in this table because the number of shares
purchasable under the option can only be calculated at the time
of PMA approval of MelaFind®. The number of shares granted
under this option is equal to that number of shares of our
common stock equal to four percent of our fully-diluted capital
stock at that time of PMA approval of MelaFind® minus
81,753 shares of our common stock. The exercise price of this
option is $0.46 per share. |
|
(2) |
Ms. Krumeichs employment with us began in January
2005 at an annual salary of $165,000. |
|
(3) |
Mr. Klippels employment with us began in December
2004 at an annual salary of $135,000. |
70
Stock Options Granted in 2004
The following table provides information regarding stock options
granted during 2004 to the named executive officers in that
period. We have not granted any stock appreciation rights.
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Potential Realizable | |
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Value of Assumed | |
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Annual Rates of Stock | |
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Number of | |
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% of Total Options | |
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Price Appreciation for | |
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Securities | |
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Granted to | |
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Exercise or Base | |
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Option Term(2) | |
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Underlying | |
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Employees in | |
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Price Per | |
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Expiration | |
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Name |
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Options Granted | |
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Fiscal Year | |
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Share(1) | |
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Date | |
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5% | |
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10% | |
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Joseph V. Gulfo, M.D.(3)
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75,227 |
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11.07 |
% |
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$ |
0.46 |
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2/02/09 |
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$ |
1,021,515 |
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$ |
1,298,088 |
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6,526 |
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0.09 |
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0.46 |
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2/02/09 |
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88,617 |
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112,610 |
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Marek Elbaum, Ph.D.(4)
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10,000 |
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1.47 |
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0.46 |
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2/02/09 |
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135,791 |
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172,556 |
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Karen Krumeich
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60,000 |
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8.82 |
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0.46 |
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12/17/09 |
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814,746 |
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1,035,337 |
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William R. Bronner
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17,000 |
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2.50 |
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0.46 |
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2/02/09 |
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230,845 |
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293,345 |
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20,000 |
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2.94 |
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0.46 |
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12/17/09 |
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271,582 |
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345,112 |
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Jon I. Klippel
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45,000 |
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6.62 |
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0.46 |
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12/17/09 |
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611,059 |
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776,502 |
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(1) |
Exercise price is equal to the fair market value on the date of
grant as determined by our board of directors. |
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(2) |
The dollar amounts under these columns are the result of
calculations at rates set by the SEC and, therefore, are not
intended to forecast possible future appreciation, if any, in
the price of the underlying common stock. The potential
realizable values are calculated using an assumed initial public
offering price of $11.00 per share, the mid-point of our filing
range, and assuming that the market price appreciates from this
price at the indicated rate for the entire term of each option
and that each option is exercised and sold on the last day of
its term at the assumed appreciated price. Actual gains, if any,
on stock option exercises depend on the future performance of
the common stock and overall stock market conditions. The
amounts reflected in the following table may not necessarily be
achieved. |
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(3) |
Dr. Gulfo has been granted another stock option which is
not reflected in this table because the number of shares
purchasable under the option can only be calculated at the time
of PMA approval of MelaFind®. The number of shares granted
under this option is equal to that number of shares of our
common stock equal to four percent of our fully-diluted capital
stock at that time of PMA approval of MelaFind® minus
81,753 shares of our common stock. |
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(4) |
Formerly our Chief Science and Technology Officer. |
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Aggregated Option Exercises in 2004 and Year-End Option
Values |
The following table provides information about the number of
shares issued upon option exercises by our named executive
officers as of December 31, 2004 and the value realized by
our named executive officers. The table also provides
information about the number and value of options held by our
named executive officers at December 31, 2004.
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Number of Unexercised | |
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Securities Underlying | |
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Value of Unexercised | |
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Options at | |
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In-the-Money Options at | |
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December 31, 2004 | |
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December 31, 2004(1) | |
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Name |
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Exercisable | |
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Unexercisable | |
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Exercisable | |
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Unexercisable | |
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Joseph V. Gulfo, M.D.(2)
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71,535 |
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10,218 |
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$ |
753,979 |
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$ |
107,698 |
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Marek Elbaum, Ph.D.(3)
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14,070 |
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25,000 |
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$ |
140,700 |
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$ |
264,400 |
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Karen Krumeich
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0 |
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60,000 |
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$ |
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$ |
632,400 |
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William R. Bronner
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49,160 |
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21,875 |
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$ |
500,940 |
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$ |
229,469 |
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Jon I. Klippel
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0 |
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45,000 |
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$ |
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$ |
474,300 |
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71
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(1) |
There was no public trading market for our common stock as of
December 31, 2004. Accordingly, as permitted by the rules
of the SEC, we have calculated the value of unexercised
in-the-money options assuming an initial public offering price
of $11.00 per share, the mid-point of our filing range, less the
aggregate exercise price, without taking into account any taxes
that might be payable in connection with the transaction. |
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(2) |
Dr. Gulfo has been granted another stock option which is
not reflected in this table because the number of shares
purchasable under the option can only be calculated at the time
of PMA approval of MelaFind®. The number of shares granted
under this option is equal to that number of shares of our
common stock equal to four percent of our fully-diluted capital
stock at that time of PMA approval of MelaFind® minus
81,753 shares of our common stock. |
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(3) |
Formerly our Chief Science and Technology Officer. |
Equity Compensation Plans
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2005 Stock Incentive Plan |
In 2005, we adopted our 2005 Stock Incentive Plan (2005 Plan).
The 2005 Plan permits the granting of awards to key employees,
directors, officers, consultants and scientific collaborators in
the form of incentive or nonqualified stock options and
equity-based awards. Stock options granted under the 2005 Plan
may be incentive stock options meeting the
requirements of Section 422 of the Code or nonqualified
stock options, which do not meet the requirements of
Section 422. Stock awards granted under the 2005 Plan to
eligible participants may take the form of the issuance and
transfer to the recipient of shares of common stock or a grant
of stock units representing a future right to such shares of
common stock. As of the date of this offering, there are
1,000,000 shares of our common stock authorized and reserved for
issuance upon exercise of options which may be granted under the
2005 Plan and no options or other equity based awards have been
issued under the 2005 Plan. Pursuant to the 2005 Plan on each of
January 1, 2006 and January 1, 2007, the number of
shares of common stock authorized for issuance will be
automatically increased by an amount equal to 3% of the then
outstanding shares of common stock unless the board decides to
reduce the amount of the increase.
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2003 Stock Incentive Plan |
In 2003, we adopted our 2003 Stock Incentive Plan, as amended
(2003 Plan). The 2003 Plan permitted the granting of awards to
our employees and other key persons (including directors,
officers, consultants and scientific collaborations) in the form
of restricted stock, and incentive or nonqualified stock
options. Stock options granted under the 2003 Plan may be
incentive stock options meeting the requirements of
Section 422 of the Code or nonqualified stock options which
do not meet the requirements of Section 422. As of
June 30, 2005, options to purchase 639,697 shares of our
common stock are outstanding under the 2003 Plan. No options or
other equity-based awards have been granted under the 2003 Plan
since the adoption of the 2005 Plan, and no further options or
other equity-based awards are issuable under the 2003 Plan. As
of June 30, 2005, no options granted under the 2003 Plan
have been exercised.
In 1996, we adopted our 1996 Stock Option Plan (1996 Plan). The
1996 Plan permitted the granting of awards to our officers, key
employees, directors and collaborating scientists in the form of
incentive or nonqualified stock options. Stock options granted
under the 1996 Plan may be incentive stock options
meeting the requirements of Section 422 of the Code or
nonqualified stock options which do not meet the requirements of
Section 422. Since the adoption of the 2003 Plan, we have
not granted any stock options under the 1996 Plan. As of
June 30, 2005, options to purchase 260,178 shares of our
common stock are outstanding under the 1996 Plan. No further
options or other equity-based awards are issuable under the 1996
Plan. As of June 30, 2005, no options granted under the
1996 Plan have been exercised.
72
Employment Agreement
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Employment Agreement with Joseph V. Gulfo, M.D. |
On January 5, 2004, we entered into an employment agreement
with Dr. Joseph V. Gulfo, our President and Chief
Executive Officer. Pursuant to the agreement, Dr. Gulfo is
required to devote substantially all of his business time,
attention and efforts to the performance of his duties under the
agreement. The initial term of the employment agreement extends
until December 31, 2005 and will automatically renew for
successive twelve-month (12) terms unless either party
sends a written notice of termination within 90 days of the
expiration of the initial term or renewal term, as the case may
be.
The employment agreement provides Dr. Gulfo with an annual
base salary of $175,000 subject to periodic review by our board
of directors. Our board of directors has determined that
Dr. Gulfo was entitled to a review and salary increase in
an amount to be agreed by Dr. Gulfo and the Company as a
result of the equity financing consummated in October 2004, but
to date our board of directors has not conducted a review or
granted a salary increase. Dr. Gulfo is also entitled to
receive yearly bonuses at the discretion of our board of
directors. The target for such bonuses is 50% of
Dr. Gulfos then current base salary.
In addition, Dr. Gulfo is entitled to be reimbursed for
certain travel expenses up to $1,100 per month, $2,000 per month
for lodging expenses and for certain communication expenses,
including cellular phone service and broadband internet service.
If Dr. Gulfos employment is terminated by us without
cause or Dr. Gulfo resigns for good reason, then
Dr. Gulfo would be entitled to receive severance pay equal
to 15 months of his then current base salary and, if
Dr. Gulfo is then covered by health insurance provided by
us, the cost to Dr. Gulfo of COBRA coverage for
15 months. If we elect not to renew Dr. Gulfos
employment agreement, Dr. Gulfo is entitled to an amount
equal to his then current base salary for nine months and, if
Dr. Gulfo is covered by our health insurance policy at such
time, the cost of COBRA for nine months (subject to reduction to
the extent Dr. Gulfo received comparable benefits from a
subsequent employer during such nine month period).
Dr. Gulfo is subject to a non-compete covenant upon
termination of his employment by us or him. The term of
Dr. Gulfos non-compete covenant is one (1) year,
which can be extended to two (2) years in the event we
elect to pay him additional severance equal to twelve
(12) months of his base salary at the time of termination
and his most recent bonus (if any).
The employment agreement provides for three separate grants of
stock options. As of May 15, 2005, the first two stock
option grants for the purchase of a total of 81,753 shares of
our common stock at an exercise price of $0.46 per share have
fully vested. The number of shares of our common stock subject
to the third stock option can only be calculated at the time of
PMA approval of MelaFind®. The number of shares purchasable
under this option at an exercise price of $0.46 per share is
equal to that number of shares of our common stock equal to four
percent of our fully-diluted capital stock at the time of PMA
approval of MelaFind® minus the number of shares of common
stock underlying options granted to Dr. Gulfo under the
employment agreement, which is 81,753. Assuming that 9,513,164
shares are outstanding as of the completion of this offering and
remain the total number of shares outstanding on the date we
receive PMA approval of MelaFind®(assuming in both cases
the exercise of all outstanding options and warrants and the
conversion of all convertible securities), the number of shares
subject to this option would be 345,699. This third stock option
grant vests 50% at the time of PMA approval of MelaFind®,
and the remaining 50% vests in four equal installments over the
one year period following such PMA approval of MelaFind®.
Consulting Agreements
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Consulting Agreement with Breaux Castleman |
In June 2003, we entered into a consulting agreement with Breaux
Castleman for consulting services related to FDA approval of
MelaFind®, administrative matters, financial reporting, and
our business and
73
financial strategy. Under this agreement, Mr. Castleman
receives compensation for each month of services rendered.
During 2003 Mr. Castleman was paid at the rate of $8,000
for each month of services rendered and thereafter from 2004
onward he has been paid at the rate of $2,000 for each month of
services rendered. We made payments pursuant to this consulting
agreement of $48,000 in 2003, $22,000 in 2004, and $12,000 in
2005. These payments did not exceed $60,000 in any twelve-month
period since June 2003. In connection with our consulting
agreement with Mr. Castleman, we granted Mr. Castleman
a restricted stock award of 75,000 shares of our common stock
under our 2003 Plan for an aggregate purchase price of $34,500.
Mr. Castleman issued an interest-bearing promissory note in
the principal amount of $34,500 as payment for these shares.
During the second quarter of 2005, this note was repaid in full.
Our consulting agreement with Mr. Castleman is terminable
by either party on 30 days written notice.
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Consulting Agreement with Marek Elbaum, Ph.D. |
Pursuant to a consulting agreement effective as of May 31,
2005, we retained Marek Elbaum, Ph.D., our founder and former
Chief Science and Technology Officer, as our Chief Scientist to
provide services relating to the integration of our product
development, mentoring and advising our staff scientists,
providing new product vision, supporting of our research and
development and providing such other services as assigned to him
by our Chief Executive Officer. Pursuant to the consulting
agreement, Dr. Elbaum will provide us with a majority of
his business time in consideration of a monthly fee of
approximately $14,500. The term of such agreement extends for a
period of two years and is automatically renewable for an
additional one year period unless either Dr. Elbaum or we
decide to not so renew. In the event of a non-renewal, and in
the event that Dr. Elbaums services terminate as a
result of his death or disability, we will pay to
Dr. Elbaum a termination fee of $100,000. In addition, upon
termination of the consulting agreement for any reason other
than a termination by us for cause, we will pay to
Dr. Elbaum for 18 months an amount equal to what
Dr. Elbaum would have had to pay to extend his insurance
coverage under COBRA. Dr. Elbaum is subject to a
non-compete covenant during the term of the consulting agreement
and for a period of two years after the term of the consulting
agreement. We have also agreed that all stock options previously
granted to Dr. Elbaum will continue to vest in accordance
with their original terms.
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Consulting Agreement with Robert Friedman, M.D. |
Pursuant to a consulting agreement effective as of June 1,
2005, we have retained the services of Robert Friedman, M.D. for
an initial term of one year as a consultant, medical advisor to
our board of directors, and as a liaison between our board of
directors and our Scientific and Medical Advisory Committee, and
in connection with the clinical testing of MelaFind®. In
consideration of rendering of these services, Dr. Friedman
will be paid at a rate of $5,000 per day (assuming an eight-hour
day) for up to 30 days of service. The consulting agreement
is automatically renewed for successive one-year terms unless
either party terminates the agreement at least 30 days
prior to the expiration of the agreement.
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Consulting Agreement with Gerald Wagner, Ph.D. |
Pursuant to a consulting agreement dated as of June 1, 2005
with Gerald Wagner Consulting LLC (GWC), a company owned and
operated by Dr. Gerald Wagner, GWC has agreed to direct our
MelaFind® product development efforts and oversee the
manufacturing process for a period that began June 1, 2005
and ends three months following the initiation of our pivotal
clinical trial of MelaFind®. The consulting agreement
provides for a flat fee of $150,000, payable ratably over the
course of the term, and the grant to Dr. Wagner immediately
after completion of this offering of a non-qualified stock
option to purchase up to 50,000 shares of our common stock at
the public offering price per share.
Limitation of Liability and Indemnification of Directors and
Officers
Our fourth amended and restated certificate of incorporation and
third amended and restated bylaws provide that we will indemnify
our directors and executive officers and may indemnify our other
officers and employees and other agents to the fullest extent
permitted by law. Our fourth amended and restated
74
certificate of incorporation and third amended and restated
bylaws also permit us to secure insurance on behalf of any
officer, director, employee or other agent for any liability
arising out of his or her actions in such capacity, regardless
of whether the bylaws would permit indemnification. We maintain
directors and officers liability insurance. We
believe that these provisions and agreements are necessary to
attract and retain qualified persons as directors and executive
officers.
RELATED PARTY TRANSACTIONS
We also describe below certain other transactions with our
directors, executive officers and stockholders.
Common Stock
In June 2003, we sold 75,000 shares of our common stock at a
price of $0.46 per share to Dr. Robert Friedman, a former
member of our board of directors, and 75,000 shares of our
common stock at a price of $0.46 per share to Breaux Castleman,
a member of our board of directors, and the chairman of our
board. In May 2004, we issued 125,000 shares of our common stock
at a per share purchase price of $0.46 to investors who loaned
an aggregate of $1,000,000 to the Company, which loans were
evidenced by convertible promissory notes, all of which
converted into shares of our Series C preferred stock on
October 26, 2004.
Preferred Stock
All share numbers and share prices presented below for our
preferred stock and Series C preferred stock warrants do
not reflect the 1-for-2 reverse stock split approved by our
board of directors on May 13, 2005 with respect to our
common stock. The reverse split will be effective after the
conversion of our preferred stock and thus the shares of our
common stock into which our preferred stock will convert will be
subject to the reverse stock split.
In 1998, we issued 198,000 shares of our Series A preferred
stock at a per share purchase price of $5.00 to 22 accredited
investors for an aggregate consideration of $990,000. All shares
of Series A preferred stock will convert into an aggregate
of 115,201 shares of our common stock upon completion of this
offering.
In 2000 and 2001, we issued an aggregate of 947,986 shares of
our Series B preferred stock in three transactions at per
share purchase prices of $5.1282 and $6.50 to 149 accredited
investors for an aggregate consideration of $5,894,409. The
rights of the holders of Series B preferred stock were
identical except for the purchase prices paid for such stock.
The purchasers of our Series B preferred stock included
Arcadian Venture Partners L.P., a venture fund with which George
C. Chryssis, a member of our board of directors, is affiliated,
and Double D Venture Fund, LLC, a venture fund with which Sidney
Braginsky, a member of our board of directors, is affiliated.
On June 20, 2003, we issued an aggregate of 45,000 shares
of our Series B preferred stock to the original
Series B preferred stock investors in consideration of
certain amendments to their investment agreements, bringing the
total number of shares of our Series B preferred stock
outstanding to 992,986. All shares of our Series B
preferred stock will convert into an aggregate of 575,532 shares
of our common stock upon completion of this offering.
From June 2003 to October 2004, we sold an aggregate of
5,414,779 shares of our Series C preferred stock (together
with warrants to purchase an aggregate of 2,610,643 shares of
our common stock, all of which warrants will be converted into
an aggregate of 1,305,321 shares of our common stock pursuant to
the warrant exchange described below under Warrants to
Purchase Common Stock) to 73 accredited investors for an
aggregate consideration of $12,191,480. These investors
included: Breaux Castleman, a member of our board of directors
and chairman of our board; Dr. Robert Friedman, a member of
our scientific and medical advisory committee and former member
of our board of directors; Double D Venture Fund, LLC, a venture
fund with which Sidney Braginsky, a member of our board of
directors, is affiliated; and Dan W. Lufkin, a member of our
board of directors. All shares of our Series C preferred
75
stock will convert into an aggregate of 2,707,372 shares of our
common stock upon completion of this offering.
Warrants to Purchase
Preferred Stock
In June 2003, we issued a warrant to purchase up to 24,890
shares of our Series C preferred stock at an exercise price
of $2.26 per share to Koji Miyazaki, one of our Series C
preferred stock investors.
In February 2004, we issued a warrant to purchase up to 121,681
shares of our Series C preferred stock with an exercise
price of $2.26 per share to Health Partners I, LLC (HP I). In
November 2004, HP I was dissolved and this warrant, together
with all shares of our Series C preferred stock and
warrants to purchase our common stock previously issued to HP I,
were distributed to HP Is members, which included:
Dr. Robert Friedman, a member of our scientific and medical
advisory committee and a former member of our board of
directors; Breaux Castleman, a member of our board of directors
and chairman of our board; and Dan W. Lufkin, a member of our
board of directors. Assuming conversion of our preferred stock
immediately prior to completion of this offering, these warrants
and the warrant issued to Mr. Miyazaki will be exercisable
for an aggregate of 73,280 shares of our common stock at an
exercise price of $4.52 per share.
Warrants to Purchase
Common Stock
Prior to the closing of this offering, we will consummate an
exchange of warrants to purchase our common stock for shares of
our common stock under a plan of recapitalization to be adopted
by our board of directors. During the period from June 2003
through October 2004, we issued warrants to purchase an
aggregate of up to 2,610,643 shares of our common stock to
certain holders of our Series C preferred stock. All of
these warrants have an exercise price of $13.00 per share. In
June 2003, we also issued a warrant to Dr. Marek Elbaum,
our former Chief Science and Technology Officer, to purchase up
to 25,000 shares of our common stock at per share exercise price
of $13.00. In December 2004, we issued a warrant to Allen &
Company LLC to purchase up to 75,000 shares of our common stock
at an exercise price of $7.00 per share (Allen & Company
Warrant) in consideration of Allen & Companys
agreement to provide certain advisory services to us. Warrants
to purchase a total of 2,610,643 shares of our common stock will
be exchanged for a total of 1,305,321 shares of our common stock
based on an exchange ratio of one share of our common stock for
every two shares of our common stock purchasable under the
warrants (Warrant Exchange).
After completion of the Warrant Exchange, the only warrants that
will remain outstanding as of the date of this offering are the
Allen & Company Warrant, the underwriters warrant (see
Underwriting) and warrants to purchase an aggregate
of 146,571 shares of our Series C preferred stock, which
assuming conversion of such Series C preferred stock will
be exercisable for an aggregate of 73,280 shares of our common
stock.
Options
From inception to June 30, 2005, we have granted an
aggregate of 525,989 options to our current directors and named
executive officers, with exercise prices ranging from $0.46 to
$10.00 per share.
Voting Agreement
We entered into a voting agreement with certain holders of our
common stock and preferred stock, which fixes the size of our
board of directors at nine and entitles the holders of a
majority of our common stock to designate two directors, the
holders of a majority of our Series B preferred stock to
designate one director and the holders of a majority of our
Series C preferred stock to designate four directors.
Currently, Joseph V. Gulfo, M.D. is the sole designee of the
holders of our common stock, George C. Chryssis is the designee
of the holders of our Series B preferred stock, and Breaux
Castleman and Dan W. Lufkin are the sole designees of the
holders of our Series C preferred stock. Upon the closing
of this offering, the voting agreement will be terminated and
none of our stockholders will have any special rights regarding
board representation.
76
PRINCIPAL STOCKHOLDERS
The following tables set forth as of June 30, 2005, and as
adjusted to reflect the sale of the shares offered hereby,
certain information regarding beneficial ownership of our common
stock by:
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each person or group of affiliated persons known to us to
beneficially own more than 5% of our common stock; |
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each named executive officer; |
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each of our directors; and |
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all of our executive officers and directors as a group. |
The percentage of ownership indicated in the following table is
based on 6,513,164 shares of common stock outstanding on
June 30, 2005 and 9,513,164 shares of common stock
outstanding immediately following the completion of this
offering, each of which assumes the conversion of all
outstanding shares of our preferred stock and consummation of
the Warrant Exchange. The table assumes no exercise of the
underwriters over-allotment option.
Information with respect to beneficial ownership has been
furnished by each director, officer, beneficial owner of more
than 5% of our common stock or selling stockholder and is
determined in accordance with the rules of the SEC. Except as
indicated by footnote and subject to community property laws
where applicable, to our knowledge, the persons named in the
table below have sole voting and investment power with respect
to all shares of common stock shown as beneficially owned by
them. In computing the number of shares beneficially owned by a
person and the percentage of ownership of that person, shares of
common stock subject to options or warrants held by that person
that are currently exercisable or will become exercisable within
60 days after June 30, 2005 are deemed outstanding,
while such shares are not deemed outstanding for purposes of
computing percentage ownership of any other person.
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Number of | |
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|
|
|
|
Shares of Common | |
|
|
|
|
Stock Beneficially | |
|
Percentage of Shares | |
|
|
Owned | |
|
Beneficially Owned | |
|
|
| |
|
| |
|
|
|
|
Options and | |
|
|
|
|
|
|
Warrants | |
|
|
|
|
|
|
Exercisable | |
|
|
|
|
|
|
Within 60 | |
|
Before the | |
|
After the | |
Name of Beneficial Owner |
|
Shares | |
|
Days | |
|
Offering | |
|
Offering | |
|
|
| |
|
| |
|
| |
|
| |
Named Executive Officers
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Joseph V. Gulfo, M.D.
|
|
|
|
|
|
|
81,753 |
|
|
|
1.2 |
% |
|
|
* |
|
Marek Elbaum, Ph.D.(1)
|
|
|
462,500 |
|
|
|
14,070 |
|
|
|
7.3 |
|
|
|
5.0 |
% |
Karen Krumeich
|
|
|
|
|
|
|
60,000 |
|
|
|
* |
|
|
|
* |
|
William R. Bronner
|
|
|
4,850 |
|
|
|
70,285 |
|
|
|
1.1 |
|
|
|
* |
|
Jon I. Klippel
|
|
|
|
|
|
|
45,000 |
|
|
|
* |
|
|
|
* |
|
|
Directors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breaux Castleman
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|
|
91,570 |
|
|
|
6,168 |
|
|
|
1.5 |
|
|
|
1.0 |
|
Sidney Braginsky(2)
|
|
|
51,500 |
|
|
|
5,000 |
|
|
|
* |
|
|
|
* |
|
George C. Chryssis(3)
|
|
|
94,717 |
|
|
|
12,500 |
|
|
|
1.6 |
|
|
|
1.1 |
|
Dan W. Lufkin(4)
|
|
|
356,231 |
|
|
|
29,187 |
|
|
|
5.9 |
|
|
|
4.0 |
|
Gerald Wagner, Ph.D.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All directors and named executive
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
officers as a group (all 10 persons)
|
|
|
1,061,368 |
|
|
|
323,963 |
|
|
|
20.3 |
% |
|
|
14.1 |
% |
|
Holders of more than 5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patricia and Stanley Brilliant(5)
|
|
|
349,532 |
|
|
|
2,342 |
|
|
|
5.4 |
|
|
|
3.7 |
|
S. Donald Sussman(6)
|
|
|
917,767 |
|
|
|
11,693 |
|
|
|
14.2 |
|
|
|
9.8 |
|
Eric Dobkin(7)
|
|
|
351,523 |
|
|
|
7,015 |
|
|
|
5.5 |
|
|
|
3.8 |
|
77
|
|
(1) |
Marek Elbaum, Ph.D. resigned as a director and our Chief Science
and Technology Officer effective as of May 31, 2005. |
|
|
(2) |
Includes 51,500 shares of common stock held by Double D Venture
Fund, LLC, an investment fund with which Mr. Braginsky is
affiliated. Mr. Braginsky expressly disclaims ownership of these
shares except to the extent of his pecuniary interest in Double
D Venture Fund, LLC |
|
|
|
(3) |
Includes 94,717 shares of common stock held by Arcadian Venture
Partners, L.P., an investment fund with which Mr. Chryssis
is affiliated. Mr. Chryssis expressly disclaims ownership of
these shares except to the extent of his pecuniary interest in
Arcadian Venture Partners, L.P. |
|
|
(4) |
Includes 140,570 shares of common stock held by trusts the
beneficiaries of which are family members of Mr. Lufkin and
5,840 shares of common stock issuable upon exercise of
Series C preferred stock warrants. Mr. Lufkin
expressly disclaims ownership of the shares held by these trusts. |
|
(5) |
Patricia and Stanley Brilliant are husband and wife. Their
business address is: 180 East End Avenue, Apt. 4A, New
York, NY 10128. |
|
|
(6) |
The business address of S. Donald Sussman is: 2 American
Lane, Greenwich, CT 06836. |
|
|
(7) |
The business address of Eric Dobkin is: 160 Old Church Lane,
Pound Ridge, NY 10576. |
78
DESCRIPTION OF CAPITAL STOCK
The following information describes our common stock and
preferred stock and provisions of our fourth amended and
restated certificate of incorporation and our third amended and
restated bylaws as in effect upon the closing of this offering.
This description is only a summary. You should also refer to the
fourth restated certificate of incorporation and third amended
and restated bylaws which will be filed with the SEC as exhibits
to our registration statement of which this prospectus forms a
part. The descriptions of the common stock and preferred stock
reflect changes to our capital structure that will occur upon
the receipt of the requisite board and stockholder approvals and
upon the closing of this offering in accordance with the terms
of the fourth amended and restated certificate of incorporation.
Upon completion of this offering, and after giving effect to the
conversion of all outstanding convertible preferred stock into
common stock and the amendment of our fourth amended and
restated certificate of incorporation, our authorized capital
stock will consist of 30,000,000 shares of common stock, $0.001
par value per share, and 10,000,000 shares of preferred stock,
$0.10 par value per share. As of June 30, 2005, there were
6,513,164 shares of our common stock outstanding held of record
by 242 stockholders.
Common Stock
Subject to preferences that may be applicable to any shares of
preferred stock outstanding at the time, the holders of common
stock are entitled to the following:
Dividends. The holders of outstanding shares of our
common stock are entitled to receive dividends out of assets
legally available for the payment of dividends at the times and
in the amounts as our board of directors from time to time may
determine, subject to any preferential dividend rights of any
holder of outstanding shares of our preferred stock.
Voting. Each holder of common stock is entitled to one
vote for each share of common stock held on all matters
submitted to a vote of stockholders, including the election of
directors. We have not provided for cumulative voting for the
election of directors in our fourth restated certificate of
incorporation. This means that the holders of a majority of the
shares voted can elect all of the directors then standing for
election.
Preemptive rights, conversion and redemption. Our common
stock is not entitled to preemptive rights and is not subject to
conversion or redemption.
Liquidation, dissolution and winding-up. Upon our
liquidation, dissolution or winding-up, the holders of common
stock are entitled to share ratably in all assets remaining
after payment of liabilities and the liquidation preferences of
any preferred stock.
Each outstanding share of common stock is, and all shares of
common stock to be issued in this offering when they are paid
for, will be duly and validly issued, fully paid and
non-assessable.
Options
As of June 30, 2005, options to purchase a total of 899,875
shares of common stock were outstanding. All options issued
under the 2003 Plan or issuable under the 2005 Plan are subject
to 180-day lock-up provisions under the terms of the 2003 Plan
and the 2005 Plan, respectively. Options to purchase a total of
1,000,000 shares of common stock remain available for grant
under the 2005 Plan. Following this offering, no options to
purchase, or other equity-based awards with respect to shares of
our common stock, will be available under the 2003 Plan or the
1996 Plan.
Preferred Stock
Upon the closing of this offering, all outstanding shares of our
preferred stock will convert into an aggregate of 3,398,105
shares of common stock.
Following the offering, our board of directors will be
authorized, subject to the limits imposed by the Delaware
General Corporation Law, to issue 10,000,000 shares of preferred
stock in one or more series, to establish from time to time the
number of shares to be included in each series, to fix the
rights, preferences and privileges of the shares of each wholly
unissued series and any of its qualifications,
79
limitations and restrictions. Our board of directors can also
increase or decrease the number of shares of any series, but not
below the number of shares of that series then outstanding,
without any further vote or action by our stockholders.
Our board of directors may authorize the issuance of preferred
stock with voting or conversion rights that adversely affect the
voting power or other rights of our common stockholders. The
issuance of preferred stock, while providing flexibility in
connection with possible acquisitions, financings and other
corporate purposes, could have the effect of delaying, deferring
or preventing a change in control and may cause the market price
of our common stock to decline or impair the voting and other
rights of the holders of our common stock. We have no current
plans to issue shares of preferred stock.
Warrants
See Related Party Transactions Warrants
to Purchase Preferred Stock and Related Party
Transactions Warrants to Purchase Common
Stock.
Registration Rights
Under a second amended and restated investors rights
agreement, following this offering, the holders of
5,090,001 shares of common stock (including shares of our
common stock purchasable pursuant to warrants to purchase our
common stock) have the right to require us to register their
shares with the SEC so that those shares may be publicly resold
or to include their shares in any registration statement we file
with the SEC.
Demand Rights
At any time after the earlier of October 26, 2009 or the
date which is one year after the effective date of this
offering, if the holders of more than 20% of the outstanding
shares of common stock issued or issuable upon conversion of our
existing Series B preferred stock or Series C
preferred stock or upon exercise of warrants to purchase our
common stock held by holders of our existing Series B
preferred stock or Series C preferred stock, request that
we file a registration statement with the SEC having an
aggregate offering price to the public (after deduction of
underwriters discounts and expenses) of not less than
$2,000,000, we are obligated to use our commercially reasonable
efforts to cause such shares to be registered and to include in
such registration, if requested, additional shares of our common
stock requested to be included by holders of registration rights
who deliver a written notice to us within 20 days of our
receipt of notice from the initiating holders. We are only
required to effect two such registrations, and we are not
required to effect any such registration during period
commencing 90 days before a company initiated registration
and ending 90 days after a company initiated registration.
Our board of directors has the right to defer for not more than
90 days and not more than twice in any 12-month period any
such registration if in its good faith judgment such
registration would be detrimental to us and not in our best
interest.
If we are eligible to file a registration statement on
Form S-3, holders of shares having registration rights have
the right to demand on or prior to the fifth anniversary of the
effective date of this offering that we file a registration
statement on Form S-3. We are only required to effect two
such registrations in any 12-month period, and we are not
required to effect any such registration during period
commencing 90 days before a company-initiated registration
and ending 90 days after a company-initiated registration.
Piggy Back Registration
Rights
The holders of shares having registration rights are entitled to
unlimited piggy-back registration rights on all
registrations of our stock other than a registration relating
solely to employee benefit plans, a registration on
Form S-4 or any other form that does not permit secondary
sales or a registration pursuant to the demand rights described
above. Pursuant to the lock-up agreements we expect to enter
into with our directors, officers and certain stockholders, any
such person holding piggy-back registration rights
will waive such rights with respect to this offering.
80
Limitations on
Registration Rights
We and the underwriters of any underwritten offering will have
the right to limit the number of shares having registration
rights to be included in the registration statement. The
underwriters have excluded any sales by existing investors in
this offering.
Expenses of
Registration
We shall bear all registration expenses, exclusive of
underwriting discounts, selling commissions, stock transfer
taxes and fees and disbursements of counsel for the holders of
registration rights (other than customary fees of one counsel in
the case of a demand registration), of all demand and piggy-back
registrations.
Delaware Anti-Takeover Law
We are subject to the provisions of Section 203 of the
Delaware General Corporation Law, or Delaware law, regulating
corporate takeovers. In general, these provisions prohibit a
Delaware corporation from engaging in any business combination
with any interested stockholder for a period of three years
following the date that the stockholder became an interested
stockholder, unless:
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|
|
|
|
the transaction is approved by the board of directors before the
date the interested stockholder attained that status; |
|
|
|
upon consummation of the transaction that resulted in the
stockholder becoming an interested stockholder, the interested
stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction commenced; or |
|
|
|
on or after the date the business combination is approved by the
board of directors and authorized at a meeting of stockholders,
by at least two-thirds of the outstanding voting stock that is
not owned by the interested stockholder. |
Section 203 defines business combination to
include the following:
|
|
|
|
|
any merger or consolidation involving the corporation and the
interested stockholder; |
|
|
|
any sale, transfer, pledge or other disposition of 10% or more
of the assets of the corporation involving the interested
stockholder; |
|
|
|
subject to certain exceptions, any transaction that results in
the issuance or transfer by the corporation of any stock of the
corporation to the interested stockholder; |
|
|
|
|
any transaction involving the corporation that has the effect of
increasing the proportionate share of the stock of any class or
series of the corporation beneficially owned by the interested
stockholder; or |
|
|
|
|
the receipt by the interested stockholder of the benefit of any
loans, advances, guarantees, pledges or other financial benefits
provided by or through the corporation. |
In general, Section 203 defines an interested stockholder
as any entity or person beneficially owning 15% or more of the
outstanding voting stock of the corporation and any entity or
person affiliated with or controlling or controlled by any of
these entities or persons.
A Delaware corporation may opt out of this provision either with
an express provision in its original certificate of
incorporation or in an amendment to its certificate of
incorporation or bylaws approved by its stockholders. However,
we have not opted out of this provision. The statute could
prohibit or delay mergers or other takeover or change in control
attempts and, accordingly, may discourage attempts to acquire us.
81
Provisions of our Certificate of Incorporation and Bylaws and
Certain Regulatory Requirements That May Have an Anti-Takeover
Effect or Entrench Current Management
Our fourth amended and restated certificate of incorporation and
third amended and restated bylaws will contain certain
provisions that are intended to enhance the likelihood of
continuity and stability in the composition of our board of
directors and the policies formulated by our board of directors.
These provisions are also expected to discourage certain types
of coercive takeover practices and inadequate takeover bids and
to encourage persons seeking to acquire control of us to first
negotiate with us. These provisions, as well as certain
provisions of contracts to which we are a party, may discourage
or hinder attempts to acquire us or remove incumbent directors
or management even if some, or a majority, of our stockholders
believe that such action is in their best interest.
Certificate of Incorporation
and Bylaws.
The provisions in our fourth amended and restated certificate of
incorporation and third amended and restated bylaws with the
intent described above include:
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|
Vacancies Filled by the Board. Vacancies on our board of
directors may be filled by a majority of the remaining directors
(even if they constitute less than a quorum), or by a sole
remaining director. |
|
|
|
Removal of Directors. None of our directors may be
removed other than for cause. |
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|
Stockholder Meetings. Only our board of directors, the
chairman of our board of directors or our chief executive
officer may call special meetings of stockholders. Stockholders
cannot call special meetings of stockholders. |
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|
No Action by Written Consent. Stockholders may take
action only at an annual or special meeting of stockholders.
Stockholders may not act by written consent. |
|
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|
Requirements for Advance Notification of Stockholder
Proposals and Director Nominations. Stockholders must comply
with advance notice procedures with respect to stockholder
proposals and the nomination of candidates for election as
directors. In general, these provisions will provide that notice
of intent to nominate a director or raise matters at such
meetings must be received in writing by us not less than 90 nor
more than 120 days prior to the anniversary of the date of
the proxy statement for the previous years annual meeting
of stockholders, and must contain certain information concerning
the person to be nominated or the matters to be brought before
the meeting and concerning the stockholder submitting the
proposal. |
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|
No Cumulative Voting. There is no cumulative voting in
the election of directors. |
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|
Blank Check Preferred Stock. We will be
authorized to issue, without any further vote or action by the
stockholders, up to 10,000,000 shares of preferred stock in one
or more classes or series and, with respect to each such class
or series, to fix the number of shares constituting the class or
series and the designation of the class or series, the voting
powers (if any) of the shares of the class or series, and the
preferences and relative, participating, optional and other
special rights, if any, and any qualifications, limitations or
restrictions, of the shares of such class or series. |
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|
Regulatory Approval. We are also required to obtain the
approval of certain regulatory agencies, such as the NASD, for
certain transactions that could result in a change of control.
See Our Business Regulation. |
Transfer Agent and Register
The transfer agent and registrar for the common stock is the
American Stock Transfer and Trust Company.
82
Listing
We have applied to have our common stock approved for listing,
subject to official notice of issuance, on the NASDAQ National
Market under the symbol MELA. We have not applied to
list our common stock on any other exchange or quotation system.
SHARES ELIGIBLE FOR FUTURE SALE
Prior to this offering, there has been no market for our common
stock, and a liquid trading market for our common stock may not
develop or be sustained after this offering. Future sales of
substantial amounts of our common stock, including shares issued
upon exercise of outstanding options and warrants or in the
public market after this offering, or the anticipation of those
sales, could adversely affect the price of our common stock from
time to time and could impair our ability to raise capital
through sales of our equity securities. Upon completion of this
offering, we will have outstanding an aggregate of
9,513,164 shares of common stock, after giving effect to
the issuance of 3,000,000 shares of common stock in this
offering and the conversion of all outstanding shares of our
convertible preferred stock into an aggregate of 3,398,105
shares of our common stock.
Sales of Restricted Shares
Of the shares to be outstanding after the completion of this
offering, the 3,000,000 shares sold in this offering will
be freely tradable without restriction under the Securities Act
of 1933, as amended (Securities Act) unless purchased by our
affiliates, as that term is defined in Rule 144
under the Securities Act. Of the remaining 6,513,164 shares
of common stock, 598,868 are held by affiliates. The
shares of common stock held by affiliates and all other shares
of common stock other than those sold in this offering are
restricted securities within the meaning of
Rule 144. All of the shares of common stock held by
affiliates will be subject to the 270-day lock-up period
described below. After the 270-day lock-up period, these
restricted securities may be sold in the public market only if
registered or if they qualify for an exemption from registration
under Rules 144, 144(k) or 701 promulgated under the
Securities Act, which are summarized below. Sales of the
restricted securities in the public market, or the availability
of such shares for sale, could adversely affect the market price
of our common stock.
Our directors, officers and certain significant stockholders
intend to enter into lock-up agreements in connection with the
offering generally providing that they will not offer, sell,
contract to sell or grant any option to purchase or otherwise
dispose of our common stock or any securities exercisable for or
convertible into our common stock owned by them for a period of
270 days after the date of this prospectus without the
prior written consent of the underwriters, which consent may be
withheld in their sole discretion. Such shareholders may make
gifts of our common stock within the restricted period provided
the recipient agrees in advance to be bound by the lock-up
restrictions. Taking into account the lock-up agreements, and
assuming the underwriters do not release any stockholders from
these agreements, we estimate that the number of restricted
shares that will be available for sale in the public market
under the provisions of Rule 144 and 144(k) will be
approximately as follows:
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|
beginning on the effective date of this prospectus, in addition
to the shares sold in the offering, approximately 1,306,000
shares of our restricted shares will be eligible for sale
subject to the volume, manner of sale and other limitations
under Rule 144; |
|
|
|
|
|
beginning 270 days after the effective date, approximately
6,386,000 shares of our restricted shares will be eligible
for sale subject to the volume, manner of sale and other
limitations under Rule 144; and |
|
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|
|
beginning 270 days after the effective date, approximately
3,026,000 shares of our restricted shares will be eligible
for sale as unrestricted shares under Rule 144(k). |
|
83
In general, under Rule 144 as currently in effect, after
the expiration of the lock-up agreements, a person who has
beneficially owned restricted securities for at least one year
would be entitled to sell within any three-month period a number
of shares that does not exceed the greater of:
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|
one percent of the number of shares of common stock then
outstanding, which will equal approximately 95,136 shares
immediately after the offering; or |
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|
the average weekly trading volume of our common stock during the
four calendar weeks preceding the filing of a notice on
Form 144 with respect to that sale. |
Sales under Rule 144 are also subject to requirements with
respect to manner of sale, notice and the availability of
current public information about us. Under Rule 144(k),
generally, a person who is not deemed to have been our affiliate
at any time during the three months preceding a sale and who has
beneficially owned the shares proposed to be sold for at least
two years, is entitled to sell such shares without complying
with the manner of sale, public information, volume limitation
or notice provisions of Rule 144.
Rule 701
In general, under Rule 701 of the Securities Act as
currently in effect, any of our employees, directors or
consultants who purchased shares of our common stock from us in
connection with our stock option plans before the effective date
of the registration statement of which this prospectus is a
part, or who hold stock options as of that date, may rely on the
resale provisions of Rule 701. Under Rule 701, these
persons who are not our affiliates may generally sell their
eligible securities, commencing 90 days after the effective
date of the registration statement in reliance on Rule 144,
but without compliance with some of the restrictions, including
the holding period and volume limitations contained in
Rule 144. Rule 152 under the Securities Act provides a
safe harbor for transactions not involving any public offering
even if the issuer subsequently files a registration statement.
Also, Rule 701 states that offers and sales exempt under
Rule 701 are deemed to be part of a single, discrete
offering and are not subject to integration with other offers or
sales (whether registered or not). We therefore believe that the
issuance of common stock upon the exercise of options by our
employees, directors or consultants should not be integrated
with the issuance of common stock in this offering.
Subject to the 270-day lock-up period described above, as of the
date 90 days after the effective date of this offering,
holders of vested options exercisable for approximately
573,550 shares of our common stock will be eligible to
exercise their options and to sell their shares in accordance
with Rule 701.
Stock Options
We intend to file a registration statement under the Securities
Act covering the shares of common stock reserved for issuance
upon exercise of outstanding options under our 2005 Plan, our
2003 Plan and our 1996 Plan. The registration statement is
expected to be filed 270 days after the closing of this
offering and become effective as soon as practicable after
filing. Accordingly, shares registered under the registration
statement will be available for sale in the open market after
the effective date of the registration statement subject to
manner of sale, public information, volume limitation and notice
provisions of Rule 144 applicable to our affiliates, and
any limitations on sale under the applicable option plan and the
lock-up agreements described above. See Risk
Factors If there are substantial sales of our common
stock, our stock price could decline.
84
MATERIAL US FEDERAL INCOME AND
ESTATE TAX CONSIDERATIONS FOR NON-US HOLDERS
The following is a general discussion of the material US federal
income and estate tax consequences of the ownership and
disposition of our common stock by a non-US holder that
purchases shares pursuant to this offer. As used in this
discussion, the term non-US holder means a beneficial owner of
our common stock that is not, for US federal income tax purposes:
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an individual who is a citizen or resident of the US; |
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a corporation or partnership (including any entity treated as a
corporation or partnership for US federal income tax purposes)
created or organized in or under the laws of the US or any State
thereof or the District of Columbia, other than a partnership
treated as foreign under US Treasury regulations; |
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an estate whose income is includible in gross income for US
federal income tax purposes regardless of its source; or |
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|
a trust (1) if a US court is able to exercise primary
supervision over the administration of the trust and one or more
US persons have authority to control all substantial decisions
of the trust, or (2) that has a valid election in effect
under applicable Treasury regulations to be treated as a US
person. |
This discussion does not consider:
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US federal gift tax consequences, US state or local or non-US
tax consequences; |
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specific facts and circumstances that may be relevant to a
particular non-US holders tax position, including, if the
non-US holder is a partnership or trust that the US tax
consequences of holding and disposing of our common stock may be
affected by certain determinations made at the partner or
beneficiary level; |
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the tax consequences for the stockholders, partners or
beneficiaries of a non-US holder; |
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special tax rules that may apply to particular non-US holders,
such as financial institutions, insurance companies, tax-exempt
organizations, hybrid entities, US expatriates, broker-dealers,
and traders in securities; or |
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special tax rules that may apply to a non-US holder that holds
our common stock as part of a straddle, hedge, conversion
transaction, synthetic security or other integrated investment. |
The following discussion is based on provisions of the Code,
applicable US Treasury regulations and administrative and
judicial interpretations, all as in effect on the date of this
prospectus, and all of which are subject to change,
retroactively or prospectively. The following summary assumes
that a non-US holder holds our common stock as a capital
asset within the meaning of section 1221 of the Code
(generally, property held for investment). Each non-US holder
should consult a tax advisor regarding the US federal, state,
local and non-US income and other tax consequences of acquiring,
holding and disposing of shares of our common stock.
Dividends
We do not plan to pay any dividends on our common stock for the
foreseeable future. However, in the event that we pay dividends
on our common stock, we will have to withhold a US federal
withholding tax at a rate of 30%, or a lower rate under an
applicable income tax treaty, from the gross amount of dividends
paid to a non-US holder.
Dividends that are effectively connected with a non-US
holders conduct of a trade or business in the US or, if an
income tax treaty applies, attributable to a permanent
establishment in the US (effectively connected income or ECI),
are taxed on a net income basis at the regular graduated rates
and in the manner applicable to US persons. In that case, we
will not have to withhold US federal withholding tax if
85
the non-US holder complies with applicable certification and
disclosure requirements. In addition to the US tax on ECI, in
the case of a holder that is a foreign corporation and has ECI,
a branch profits tax may be imposed at a 30% rate, or a lower
rate under an applicable income tax treaty, on the dividend
equivalent amount.
In order to claim the benefit of an income tax treaty or claim
exemption from withholding because the income is effectively
connected with the conduct of a trade or business in the US, the
non-US holder must provide a properly executed Form W-8BEN,
for treaty benefits, or W-8ECI, for effectively connected
income, prior to the payment of dividends. These forms must be
periodically updated. Non-US holders should consult their tax
advisors regarding their entitlement to benefits under a
relevant income tax treaty and their ability to claim exemption
from withholding because the income is effectively connected
with the conduct of a trade or business in the US, and related
certification requirements.
A non-US holder that is eligible for a reduced rate of US
federal withholding tax under an income tax treaty may obtain a
refund or credit of any excess amounts withheld by filing an
appropriate claim for a refund with the US Internal Revenue
Service (IRS) in a timely manner.
Gain on Disposition of Common Stock
A non-US holder generally will not be taxed on gain recognized
on a disposition of our common stock unless:
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|
|
|
|
the gain is effectively connected with a non-US holders
conduct of a trade or business in the US or, alternatively, if
an income tax treaty applies, is attributable to a permanent
establishment maintained by the non-US holder in the US; in
these cases, the gain will be taxed on a net income basis at the
regular graduated rates and in the manner applicable to US
persons, unless an applicable treaty provides otherwise, and, if
the non-US holder is a foreign corporation, the branch profits
tax described above may also apply; |
|
|
|
the non-US holder is an individual who holds our common stock as
a capital asset, is present in the US for 183 days or more
in the taxable year of the disposition and meets other
requirements; in this case, the non-US holder will be subject to
a 30% tax on the gain derived from the disposition; or |
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|
|
we are or have been a US real property holding corporation
(USRPHC) for US federal income tax purposes at any time during
the shorter of the five-year period ending on the date of
disposition or the period that the non-US holder held our common
stock; in this case, the non-US holder may be subject to US
federal income tax on its net gain derived from the disposition
of our common stock at regular graduated rates. Generally, a
corporation is a USRPHC if the fair market value of its US real
property interests equals or exceeds 50% of the sum of the fair
market value of its worldwide real property interests plus its
other assets used or held for use in a trade or business. If we
are, or were to become, a USRPHC, gain realized upon disposition
of our common stock by a non-US holder that did not directly or
indirectly own more than 5% of our common stock during the
shorter of the five-year period ending on the date of
disposition or the period that the non-US holder held our common
stock generally would not be subject to US federal income tax,
provided that our common stock is regularly traded on an
established securities market within the meaning of
Section 897(c)(3) of the Code. We believe that we are not
currently, and we do not anticipate becoming in the future, a
USRPHC. |
Federal Estate Tax
Common stock owned or treated as owned by an individual who is a
non-US holder at the time of death, unless an applicable estate
tax or other treaty provides otherwise, will be included in the
individuals gross estate for US federal estate tax
purposes, and therefore may be subject to US federal estate tax.
86
Information Reporting and Backup Withholding Tax
We must report annually to the IRS and to each non-US holder the
amount of dividends paid to that holder and the tax withheld
from those dividends. These reporting requirements apply
regardless of whether withholding was reduced or eliminated by
an applicable income tax treaty. Copies of the information
returns reporting those dividends and withholding may also be
made available to the tax authorities in the country in which
the non-US holder is a resident under the provisions of an
applicable income tax treaty or agreement.
Under some circumstances, US Treasury regulations require
additional information reporting and backup withholding
(currently at a rate of 28%) on some payments on our common
stock. The gross amount of dividends paid to a non-US holder
that fails to certify its non-US holder status in accordance
with applicable US Treasury regulations generally will be
reduced by backup withholding at the applicable rate.
The payment of the proceeds of the disposition of our common
stock by a non-US holder to or through the US office of any
broker generally will be reported to the IRS and reduced by
backup withholding unless the non-US holder either certifies its
status as a non-US holder under penalties of perjury or
otherwise establishes an exemption. The payment of the proceeds
of the disposition of our common stock by a non-US holder to or
through a non-US office of a non-US broker generally will not be
reduced by backup withholding or reported to the IRS unless the
non-US broker has certain enumerated connections with the US. In
general, the payment of proceeds from the disposition of our
common stock by or through a non-US office of a broker that is a
US person or that has certain enumerated connections with the US
will be reported to the IRS and may, in limited circumstances,
be reduced by backup withholding, unless the broker receives a
statement from the non-US holder, signed under penalty of
perjury, certifying its non-US status or the broker has
documentary evidence in its files that the holder is a non-US
holder.
Non-US holders should consult their own tax advisors regarding
the application of the information reporting and backup
withholding rules to them.
Backup withholding is not an additional tax. Any amounts
withheld under the backup withholding rules from a payment to a
non-US holder will be refunded, or credited against the
holders US federal income tax liability, if any, provided
that the required information or appropriate claim for refund is
furnished to the IRS in a timely manner.
87
UNDERWRITING
Under the terms and subject to the conditions in an underwriting
agreement
dated ,
2005, we have agreed to sell to the underwriters named below,
for whom Ladenburg Thalmann & Co. Inc. and Stanford
Group Company are acting as the representatives, the following
respective numbers of shares of common stock:
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Underwriters |
|
Number of Shares | |
|
|
| |
Ladenburg Thalmann & Co. Inc.
|
|
|
|
|
Stanford Group Company
|
|
|
|
|
|
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|
|
Total
|
|
|
3,000,000 |
|
|
|
|
|
Subject to the terms and conditions of the underwriting
agreement, the underwriters have agreed to purchase from us
3,000,000 shares of our common stock at the public offering
price, less the underwriting discounts and commissions set forth
on the cover page of this prospectus. The underwriting agreement
provides that the underwriters obligations to purchase our
shares are subject to approval of legal matters by counsel and
to the satisfaction of other conditions. The underwriters are
obligated to purchase all of the shares (other than those
covered by the over-allotment option described below) if they
purchase any shares. The underwriting agreement also provides
that, if an underwriter defaults, the purchase commitments of
non-defaulting underwriters may be increased or this offering
may be terminated.
Commissions and Expenses
The underwriters propose to offer the shares to the public at
the public offering price set forth on the cover of this
prospectus. The underwriters may offer the shares to securities
dealers at the price to the public less a concession not in
excess of
$ per
share. Securities dealers may reallow a concession not in excess
of
$ per
share to other dealers. After the shares are released for sale
to the public, the underwriters may vary the offering price and
other selling terms from time to time. The underwriters will
also receive a nonaccountable expense allowance equal to 1% of
the public offering price set forth on the cover of this
prospectus for the sale of all the shares sold (excluding shares
sold pursuant to the overallotment option, if any).
The following table shows the underwriting discounts and
commissions that we are to pay to the underwriters in connection
with this offering. These amounts are shown assuming no exercise
and full exercise of the underwriters over-allotment
option to purchase additional shares.
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|
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|
No Exercise | |
|
Full Exercise | |
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| |
|
| |
Per Share
|
|
$ |
|
|
|
$ |
|
|
Total
|
|
$ |
|
|
|
$ |
|
|
We estimate that the total expenses of this offering, excluding
underwriting discounts and commissions, will be approximately
$ .
Warrant
We have agreed to sell to the representatives, for nominal
consideration, a warrant (Underwriters Warrant) to
purchase up to a total of 225,000 shares of our common
stock. The Underwriters Warrant is not exercisable during
the first year after the date of this prospectus and thereafter
is exercisable at an exercise price equal to 125% of the public
offering price per share set forth on the cover of this
prospectus for a period commencing on the first anniversary of
the date of this prospectus and ending on the fifth anniversary
of the date of this prospectus. The Underwriters Warrant
contains customary antidilution provisions and certain demand
and participatory registration rights. The Underwriters
Warrant also includes a cashless exercise provision
entitling the holder to convert the Underwriters Warrant
into shares of our common stock. The Underwriters Warrant
may not be sold, transferred, assigned or hypothecated for a
period of one year from the date of this prospectus, except to
officers or partners of the underwriters and members of the
selling group and/or their officers or partners.
88
Over-Allotment Option
We have granted to the underwriters an option, exercisable not
later than 45 days after the date of this prospectus, to
purchase up to an aggregate of 450,000 additional shares of
common stock at the public offering price set forth on the cover
page of this prospectus less the underwriting discounts and
commissions. The underwriters may exercise this option in whole
or in part only to cover over-allotments, if any, made in
connection with the sale of shares offered hereby.
Lock-Up and Related Agreements
Except as noted below, our directors, executive officers and
principal stockholders will agree with the representatives that
for a period of 270 days following the date of this
prospectus, they will not offer, sell, assign, transfer, pledge,
contract to sell or otherwise dispose of or hedge any of our
shares of common stock or any securities convertible into or
exchangeable for shares of common stock. Such shareholders may
make gifts of our common stock within the restricted period
provided the recipient agrees in advance to be bound by the
lock-up restrictions. The representatives may, in their sole
discretion, at any time without prior notice, release all or any
portion of the shares from the restrictions in any such
agreement. We have entered into an agreement with the
representatives, stating that we will not issue additional
shares (with the exception of shares issued pursuant to the
over-allotment option) of our common stock prior to the end of
the 270 day period following the date of this prospectus,
other than with respect to our issuing shares pursuant to
employee benefit plans, qualified option plans or other employee
compensation plans already in existence, or pursuant to
currently outstanding options, warrants or other rights to
acquire shares of our common stock. There are no agreements
between the representatives and any of our directors, executive
officers or principal stockholder releasing them from these
lock-up agreements, or with us pertaining to our issuance of
additional shares, prior to the expiration of the 270 day
period.
Indemnification
We have agreed to indemnify the underwriters against certain
civil liabilities, including liabilities under the Securities
Act and liabilities arising from breaches of representations and
warranties contained in the underwriting agreement, and to
contribute to payments the underwriters may be required to make
in respect of any such liabilities.
Stabilization, Short Positions and Penalty Bids
The representatives may engage in over-allotment, stabilizing
transactions, syndicate covering transactions, and penalty bids
or purchases for the purpose of pegging, fixing or maintaining
the price of the common stock, in accordance with
Regulation M under the Securities Exchange Act of 1934:
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|
|
Over-allotment transactions involve sales by the underwriters of
shares in excess of the number of shares the underwriters are
obligated to purchase, which creates a syndicate short position.
The short position may be either a covered short position or a
naked short position. In a covered short position, the number of
shares over-allotted by the underwriters is not greater than the
number of shares that they may purchase in the over-allotment
option. In a naked short position, the number of shares involved
is greater than the number of shares in the over-allotment
option. The underwriters may close out any short position by
either exercising their over-allotment option and/or purchasing
shares in the open market. |
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|
|
Stabilizing transactions permit bids to purchase the underlying
security so long as the stabilizing bids do not exceed a
specific maximum. |
|
|
|
Syndicate covering transactions involve purchases of the common
stock in the open market after the distribution has been
completed in order to cover syndicate short positions. In
determining the source of shares to close out the short
position, the underwriters will consider, among other things,
the price of shares available for purchase in the open market as
compared to the price at which they may purchase shares through
the over-allotment option. If the underwriters sell more shares |
89
|
|
|
|
|
than could be covered by the over-allotment option, a naked
short position, the position can only be closed out by buying
shares in the open market. A naked short position is more likely
to be created if the underwriters are concerned that there could
be downward pressure on the price of the shares in the open
market after pricing that could adversely affect investors who
purchase in the offering. |
|
|
|
Penalty bids permit the representatives to reclaim a selling
concession from a syndicate member when the common stock
originally sold by the syndicate member is purchased in a
stabilizing or syndicate covering transaction to cover syndicate
short positions. |
These stabilizing transactions, syndicate covering transactions
and penalty bids may have the effect of raising or maintaining
the market price of our common stock or preventing or retarding
a decline in the market price of our common stock. As a result,
the price of our common stock may be higher than the price that
might otherwise exist in the open market. These transactions may
be effected on the NASDAQ National Market or otherwise and, if
commenced, may be discontinued at any time. Neither we nor any
of the underwriters make any representation or prediction as to
the direction or magnitude of any effect that the transactions
described above may have on the price of our common stock. In
addition, neither we nor any of the underwriters make any
representation that the representatives will engage in these
stabilizing transactions or that any transaction, once
commenced, will not be discontinued without notice.
Offering Price Determination
Prior to this offering, there has been no market for our common
stock. The public offering price has been, due to our lack of
operating history, arbitrarily determined by negotiations
between us and the representatives, bears no relationship to our
earnings, book value, net worth or other financial criteria of
value and may not be indicative of the market price for the
common stock after this offering. After completion of this
offering, the market price of the common stock will be subject
to change as a result of market conditions and other factors.
Discretionary Accounts
The representatives of the underwriters have advised us that
they do not intend to confirm sales of the shares to
discretionary accounts.
LEGAL MATTERS
The validity of the common stock being offered hereby is being
passed upon for us by Dreier LLP. We have received certain
advice from our legal counsel in connection with the matters
described herein. Certain legal matters relating to the offering
will be passed upon for the underwriters by Greenberg Traurig,
LLP, New York, New York. Prospective investors should consult
with their own legal and other counsel.
EXPERTS
The financial statements of Electro-Optical Sciences, Inc. as of
December 31, 2003 and 2004, and for each of the three years
in the period ended December 31, 2004, as set forth in
their report, have been included herein and in the Registration
Statement in reliance upon the report of Eisner LLP, independent
registered public accounting firm, appearing elsewhere herein,
and upon the authority of said firm as experts in accounting and
auditing.
90
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on
Form S-1 under the Securities Act with respect to the
shares of common stock we are offering to sell. This prospectus,
which constitutes part of the registration statement, does not
include all of the information contained in the registration
statement. You should refer to the registration statement and
its exhibits for additional information. Whenever we make
reference in this prospectus to any of our contracts, agreements
or other documents, the references are not necessarily complete
and you should refer to the exhibits attached to the
registration statement for copies of the actual contract,
agreement or other document. When we complete this offering, we
will also be required to file annual, quarterly and special
reports, proxy statements and other information with the SEC. We
anticipate making these documents publicly available, free of
charge, on our website at www.eo-sciences.com as soon as
reasonably practicable after filing such documents with the
Securities and Exchange Commission.
You can read the registration statement and our future filings
with the SEC, over the internet at the SECs website at
http://www.sec.gov. You may also read and copy any document that
we file with the Securities and Exchange Commission at its
public reference room at 450 Fifth Street, N.W.,
Washington, DC 20549.
You may also obtain copies of the documents at prescribed rates
by writing to the Public Reference Section of the SEC at 450
Fifth Street, NW, Washington, DC 20549. Please call the SEC
at 1-800-SEC-0330 for further information on the operation of
the public reference room.
91
ELECTRO-OPTICAL SCIENCES, INC.
CONTENTS
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Financial Statements:
|
|
|
|
|
Report of Independent Registered Public Accounting Firm
|
|
|
F-2 |
|
|
Balance sheets as of December 31, 2004 and 2003 and
June 30, 2005 (unaudited)
|
|
|
F-3 |
|
|
Statements of operations for the years ended December 31,
2004, 2003 and 2002 and six months ended June 30, 2004 and
2005 (unaudited)
|
|
|
F-4 |
|
|
Statements of changes in stockholders (deficiency) equity
for the years ended December 31, 2004, 2003 and 2002 and
six months ended June 30, 2005 (unaudited)
|
|
|
F-5 |
|
|
Statements of cash flows for the years ended December 31,
2004, 2003 and 2002 and six months ended June 30, 2004 and
2005 (unaudited)
|
|
|
F-6 |
|
|
Notes to financial statements
|
|
|
F-7 |
|
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders
Electro-Optical Sciences, Inc.
The following report is in the form that will be signed upon the
effectiveness of the one-for-two reverse common stock split
described in Note 1 to the financial statements.
/s/ Eisner LLP
New York, New York
July 15, 2005
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders
Electro-Optical Sciences, Inc.
We have audited the accompanying balance sheets of
Electro-Optical Sciences, Inc. (the Company) as of
December 31, 2004 and 2003, and the related statements of
operations, stockholders (deficiency) equity and cash
flows for each of the years in the three year period ended
December 31, 2004. 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. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes 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 financial statements referred to above
present fairly, in all material respects, the financial position
of Electro-Optical Sciences, Inc. as of December 31, 2004
and 2003, and the results of its operations and its cash flows
for each of the years in the three year period ended
December 31, 2004, in conformity with accounting principles
generally accepted in the United States of America.
Eisner LLP
New York, New York
May 31, 2005
F-2
ELECTRO-OPTICAL SCIENCES, INC.
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December | |
|
December | |
|
|
|
Pro-Forma | |
|
|
31, 2003 | |
|
31, 2004 | |
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
June 30, | |
|
|
|
|
|
|
2005 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(audited) | |
|
(audited) | |
|
(unaudited) | |
|
(unaudited) | |
|
|
|
|
|
|
|
|
(Note 1) | |
ASSETS |
Current Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
116,691 |
|
|
$ |
108,705 |
|
|
$ |
176,208 |
|
|
$ |
176,208 |
|
|
Marketable securities
|
|
|
|
|
|
|
6,594,751 |
|
|
|
3,617,713 |
|
|
|
3,617,713 |
|
|
Accounts receivable, net
|
|
|
16,679 |
|
|
|
7,128 |
|
|
|
|
|
|
|
|
|
|
Inventories
|
|
|
72,865 |
|
|
|
69,755 |
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
10,697 |
|
|
|
32,844 |
|
|
|
23,550 |
|
|
|
23,550 |
|
|
Assets held for sale
|
|
|
|
|
|
|
|
|
|
|
156,677 |
|
|
|
156,677 |
|
|
Deferred registration costs
|
|
|
|
|
|
|
|
|
|
|
752,042 |
|
|
|
752,042 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Current Assets
|
|
|
216,932 |
|
|
|
6,813,183 |
|
|
|
4,726,190 |
|
|
|
4,726,190 |
|
Property and equipment, net
|
|
|
18,418 |
|
|
|
89,306 |
|
|
|
154,510 |
|
|
|
154,510 |
|
Patents and trademarks, net
|
|
|
178,157 |
|
|
|
163,459 |
|
|
|
86,517 |
|
|
|
86,517 |
|
Other assets
|
|
|
18,248 |
|
|
|
30,201 |
|
|
|
30,201 |
|
|
|
30,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$ |
431,755 |
|
|
$ |
7,096,149 |
|
|
$ |
4,997,418 |
|
|
$ |
4,997,418 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS
(DEFICIENCY) EQUITY |
Current Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable (includes related parties of $2,000 as of
December 31, 2004, and $79,645 as of June 30, 2005)
|
|
$ |
211,810 |
|
|
$ |
338,821 |
|
|
$ |
233,504 |
|
|
$ |
233,504 |
|
|
Accrued expenses
|
|
|
363,270 |
|
|
|
228,583 |
|
|
|
339,283 |
|
|
|
339,283 |
|
|
Accrued registration costs
|
|
|
|
|
|
|
|
|
|
|
672,873 |
|
|
|
672,873 |
|
|
Deferred revenues
|
|
|
|
|
|
|
106,335 |
|
|
|
|
|
|
|
|
|
|
Notes payable stockholders and employees
|
|
|
48,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes payable other
|
|
|
15,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other current liabilities
|
|
|
11,976 |
|
|
|
17,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Current Liabilities
|
|
|
650,056 |
|
|
|
691,023 |
|
|
|
1,245,660 |
|
|
|
1,245,660 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REDEEMABLE CONVERTIBLE PREFERRED STOCK
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable preferred stock Series B convertible
992,986 shares designated (liquidation preference
$2.26 per share); issued and outstanding
992,986 shares at December 31, 2003 and 2004 and
June 30, 2005 and 0 shares at June 30, 2005, pro
forma
|
|
|
2,244,147 |
|
|
|
2,244,147 |
|
|
|
2,244,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable preferred stock Series C convertible
5,744,340 shares designated (liquidation preference
$2.26 per share); issued and outstanding
907,077 shares at December 31, 2003 and
5,414,779 shares at December 31, 2004 and
June 30, 2005 and 0 shares at June 30, 2005, pro
forma
|
|
|
1,822,950 |
|
|
|
6,340,666 |
|
|
|
7,182,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders (Deficiency) Equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock $.10 par value; authorized
16,936,704 shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A convertible preferred stock, 199,380 shares
designated (liquidation preference $5.00 per
share); issued and outstanding 198,000 shares at
December 31, 2003 and 2004 and June 30, 2005 and
0 shares at June 30, 2005, pro forma
|
|
|
972,311 |
|
|
|
972,311 |
|
|
|
972,311 |
|
|
|
|
|
|
Common stock $.001 par value; authorized
30,000,000 shares; issued and outstanding
1,684,760 shares at December 31, 2003 and
1,809,758 shares at December 31, 2004 and
June 30, 2005 and 6,513,164 shares at June 30,
2005, pro forma
|
|
|
1,685 |
|
|
|
1,810 |
|
|
|
1,810 |
|
|
|
6,513 |
|
|
Additional paid-in capital
|
|
|
5,119,923 |
|
|
|
10,981,455 |
|
|
|
10,209,995 |
|
|
|
20,604,675 |
|
|
Notes receivable for stock subscriptions
|
|
|
(69,000 |
) |
|
|
(69,000 |
) |
|
|
|
|
|
|
|
|
|
Deferred compensation
|
|
|
(22,500 |
) |
|
|
(159,300 |
) |
|
|
(143,370 |
) |
|
|
(143,370 |
) |
|
Accumulated deficit
|
|
|
(10,287,817 |
) |
|
|
(13,906,963 |
) |
|
|
(16,716,060 |
) |
|
|
(16,716,060 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders (Deficiency) Equity
|
|
|
(4,285,398 |
) |
|
|
(2,179,687 |
) |
|
|
(5,675,314 |
) |
|
|
3,751,758 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities and Stockholders (Deficiency)
Equity
|
|
$ |
431,755 |
|
|
$ |
7,096,149 |
|
|
$ |
4,997,418 |
|
|
$ |
4,997,418 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements
F-3
ELECTRO-OPTICAL SCIENCES, INC.
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended | |
|
Six Months Ended | |
|
|
| |
|
| |
|
|
December 31, | |
|
December 31, | |
|
December 31, | |
|
June 30, | |
|
June 30, | |
|
|
2002 | |
|
2003 | |
|
2004 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(audited) | |
|
(audited) | |
|
(audited) | |
|
(unaudited) | |
|
(unaudited) | |
Revenue from grants
|
|
$ |
547,290 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of grant revenue
|
|
|
563,598 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses
|
|
|
511,225 |
|
|
|
1,034,397 |
|
|
|
1,234,210 |
|
|
|
639,079 |
|
|
|
995,931 |
|
|
Research and development
|
|
|
404,331 |
|
|
|
828,239 |
|
|
|
1,891,551 |
|
|
|
693,052 |
|
|
|
1,545,824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss from continuing operations
|
|
|
(931,864 |
) |
|
|
(1,862,636 |
) |
|
|
(3,125,761 |
) |
|
|
(1,332,131 |
) |
|
|
(2,541,755 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
(2,189 |
) |
|
|
(1,373 |
) |
|
|
(27,935 |
) |
|
|
(543 |
) |
|
|
(62,769 |
) |
Interest expense
|
|
|
10,117 |
|
|
|
76,923 |
|
|
|
94,976 |
|
|
|
82,340 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,928 |
|
|
|
75,550 |
|
|
|
67,041 |
|
|
|
81,797 |
|
|
|
(62,769 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
|
(939,792 |
) |
|
|
(1,938,186 |
) |
|
|
(3,192,802 |
) |
|
|
(1,413,928 |
) |
|
|
(2,478,986 |
) |
Loss from discontinued operations
|
|
|
(201,259 |
) |
|
|
(11,917 |
) |
|
|
(426,344 |
) |
|
|
(101,853 |
) |
|
|
(330,111 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(1,141,051 |
) |
|
|
(1,950,103 |
) |
|
|
(3,619,146 |
) |
|
|
(1,515,781 |
) |
|
|
(2,809,097 |
) |
Less:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock deemed dividends
|
|
|
214,245 |
|
|
|
321,830 |
|
|
|
676,218 |
|
|
|
242,693 |
|
|
|
719,064 |
|
|
Preferred stock accretion
|
|
|
180,009 |
|
|
|
25,228 |
|
|
|
322,800 |
|
|
|
25,228 |
|
|
|
842,260 |
|
Stock distribution of preferred Series B shares
|
|
|
|
|
|
|
101,700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss Attributable to Common Stockholders
|
|
$ |
(1,535,305 |
) |
|
$ |
(2,398,861 |
) |
|
$ |
(4,618,164 |
) |
|
$ |
(1,783,702 |
) |
|
$ |
(4,370,421 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
|
(0.87 |
) |
|
|
(1.48 |
) |
|
|
(2.37 |
) |
|
|
(0.98 |
) |
|
|
(2.23 |
) |
Discontinued operations
|
|
|
(0.13 |
) |
|
|
(0.01 |
) |
|
|
(0.24 |
) |
|
|
(0.06 |
) |
|
|
(0.18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$ |
(1.00 |
) |
|
$ |
(1.49 |
) |
|
$ |
(2.61 |
) |
|
$ |
(1.04 |
) |
|
$ |
(2.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average number of shares outstanding
|
|
|
1,534,760 |
|
|
|
1,614,897 |
|
|
|
1,766,608 |
|
|
|
1,722,743 |
|
|
|
1,809,758 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per common share (unaudited)
|
|
|
|
|
|
|
|
|
|
$ |
(0.91 |
) |
|
|
|
|
|
$ |
(0.43 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted weighted average number of common
shares outstanding (unaudited)
|
|
|
|
|
|
|
|
|
|
|
3,967,024 |
|
|
|
|
|
|
|
6,513,164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements
F-4
ELECTRO-OPTICAL SCIENCES, INC.
STATEMENT OF STOCKHOLDERS (DEFICIENCY) EQUITY
Years ended December 31, 2002, 2003 and 2004, and the
six months ended June 30, 2005 (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A | |
|
Common Stock | |
|
Additional | |
|
|
|
|
|
|
|
Total | |
|
|
| |
|
| |
|
Paid-In | |
|
Notes | |
|
Deferred | |
|
Accumulated | |
|
Stockholders | |
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
Receivable | |
|
Compensation | |
|
Deficit | |
|
(Deficiency) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Balance at January 1, 2002
|
|
|
198,000 |
|
|
$ |
972,311 |
|
|
|
1,534,760 |
|
|
$ |
1,535 |
|
|
$ |
2,932,174 |
|
|
|
|
|
|
$ |
(117,000 |
) |
|
$ |
(7,196,663 |
) |
|
$ |
(3,407,643 |
) |
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
72,000 |
|
|
|
|
|
|
|
72,000 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,141,051 |
) |
|
|
(1,141,051 |
) |
Preferred stock accretion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(180,009 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(180,009 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
198,000 |
|
|
$ |
972,311 |
|
|
|
1,534,760 |
|
|
$ |
1,535 |
|
|
$ |
2,752,165 |
|
|
|
|
|
|
$ |
(45,000 |
) |
|
$ |
(8,337,714 |
) |
|
$ |
(4,656,703 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock accretion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(25,228 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(25,228 |
) |
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,500 |
|
|
|
|
|
|
|
22,500 |
|
Issuance of common stock in exchange for notes receivable
|
|
|
|
|
|
|
|
|
|
|
150,000 |
|
|
|
150 |
|
|
|
68,850 |
|
|
|
(69,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Adjustment for reduction to liquidation value of Series B
preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,329,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,329,000 |
|
Stock distribution of preferred Series B shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(101,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(101,700 |
) |
Common stock options issued for consulting fees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
96,836 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
96,836 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,950,103 |
) |
|
|
(1,950,103 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
198,000 |
|
|
$ |
972,311 |
|
|
|
1,684,760 |
|
|
$ |
1,685 |
|
|
$ |
5,119,923 |
|
|
$ |
(69,000 |
) |
|
$ |
(22,500 |
) |
|
$ |
(10,287,817 |
) |
|
$ |
(4,285,398 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock
|
|
|
|
|
|
|
|
|
|
|
124,998 |
|
|
|
125 |
|
|
|
137,375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
137,500 |
|
Deferred compensation-stock option awards to employees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
159,300 |
|
|
|
|
|
|
|
(159,300 |
) |
|
|
|
|
|
|
|
|
Issuance of options to non-employee directors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
150,450 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
150,450 |
|
Preferred stock accretion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(322,800 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(322,800 |
) |
Warrants issued in connection with preferred Series C stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,158,948 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,158,948 |
|
Beneficial conversion feature in connection with preferred
Series C stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,385,063 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,385,063 |
|
Issuance of options to consultants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
72,800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
72,800 |
|
Issuance of warrants to consultant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
120,396 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
120,396 |
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,500 |
|
|
|
|
|
|
|
22,500 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,619,146 |
) |
|
|
(3,619,146 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
198,000 |
|
|
$ |
972,311 |
|
|
|
1,809,758 |
|
|
$ |
1,810 |
|
|
$ |
10,981,455 |
|
|
$ |
(69,000 |
) |
|
$ |
(159,300 |
) |
|
$ |
(13,906,963 |
) |
|
$ |
(2,179,687 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock accretion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(842,260 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(842,260 |
) |
Value of options vesting on attainment of milestone
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
70,800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
70,800 |
|
Retirement of note receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
69,000 |
|
|
|
|
|
|
|
|
|
|
|
69,000 |
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,930 |
|
|
|
|
|
|
|
15,930 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,809,097 |
) |
|
|
(2,809,097 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2005 (unaudited)
|
|
|
198,000 |
|
|
$ |
972,311 |
|
|
|
1,809,758 |
|
|
$ |
1,810 |
|
|
$ |
10,209,995 |
|
|
$ |
|
|
|
$ |
(143,370 |
) |
|
$ |
(16,716,060 |
) |
|
$ |
(5,675,314 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements
F-5
ELECTRO-OPTICAL SCIENCES, INC.
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended | |
|
Six Months Ended | |
|
|
| |
|
| |
|
|
December 31, | |
|
December 31, | |
|
December 31, | |
|
June 30, | |
|
June 30, | |
|
|
2002 | |
|
2003 | |
|
2004 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(audited) | |
|
(audited) | |
|
(audited) | |
|
(unaudited) | |
|
(unaudited) | |
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$ |
(939,792 |
) |
|
$ |
(1,938,186 |
) |
|
$ |
(3,192,802 |
) |
|
$ |
(1,413,928 |
) |
|
$ |
(2,478,986 |
) |
|
Loss from discontinued operations
|
|
|
(201,259 |
) |
|
|
(11,917 |
) |
|
|
(426,344 |
) |
|
|
(101,853 |
) |
|
|
(330,111 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(1,141,051 |
) |
|
$ |
(1,950,103 |
) |
|
$ |
(3,619,146 |
) |
|
$ |
(1,515,781 |
) |
|
$ |
(2,809,097 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts
|
|
|
|
|
|
|
(13,288 |
) |
|
|
(9,000 |
) |
|
|
|
|
|
|
(1,000 |
) |
|
|
|
Depreciation and amortization
|
|
|
33,329 |
|
|
|
30,987 |
|
|
|
35,860 |
|
|
|
14,578 |
|
|
|
25,098 |
|
|
|
|
Noncash compensation and amortization of deferred compensation
|
|
|
72,000 |
|
|
|
22,500 |
|
|
|
172,950 |
|
|
|
11,250 |
|
|
|
86,730 |
|
|
|
|
Common stock options and warrant issued for consulting fees
|
|
|
|
|
|
|
96,836 |
|
|
|
193,196 |
|
|
|
|
|
|
|
|
|
|
|
|
Retirement of stock subscription receivable for consulting
services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34,500 |
|
|
|
|
Amortization of discount on marketable securities
|
|
|
|
|
|
|
|
|
|
|
(10,001 |
) |
|
|
|
|
|
|
(30,072 |
) |
|
|
|
Imputed interest expense attributable to preferred Series C
|
|
|
|
|
|
|
45,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Imputed interest expense on bridge loan
|
|
|
|
|
|
|
|
|
|
|
80,000 |
|
|
|
80,000 |
|
|
|
|
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in receivables
|
|
|
(3,326 |
) |
|
|
53,585 |
|
|
|
20,662 |
|
|
|
(64,794 |
) |
|
|
8,128 |
|
|
|
|
|
Decrease (increase) in inventories
|
|
|
67,279 |
|
|
|
(39,296 |
) |
|
|
3,110 |
|
|
|
(8,826 |
) |
|
|
(16,122 |
) |
|
|
|
|
Decrease (increase) in prepaid expenses and other current assets
|
|
|
6,060 |
|
|
|
(3,464 |
) |
|
|
(36,211 |
) |
|
|
(4,768 |
) |
|
|
9,293 |
|
|
|
|
|
Deferred registration costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(79,169 |
) |
|
|
|
|
Increase (decrease) in accounts payable and accrued expenses
|
|
|
237,660 |
|
|
|
137,414 |
|
|
|
(7,676 |
) |
|
|
(76,936 |
) |
|
|
5,382 |
|
|
|
|
|
(Decrease) increase in deferred revenues
|
|
|
|
|
|
|
(57,300 |
) |
|
|
106,335 |
|
|
|
10,000 |
|
|
|
(106,335 |
) |
|
|
|
|
Increase (decrease) in other current liabilities
|
|
|
44,373 |
|
|
|
(21,879 |
) |
|
|
5,308 |
|
|
|
(11,976 |
) |
|
|
(17,284 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(683,676 |
) |
|
|
(1,699,008 |
) |
|
|
(3,064,613 |
) |
|
|
(1,567,253 |
) |
|
|
(2,889,948 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patent costs
|
|
|
|
|
|
|
(5,986 |
) |
|
|
(3,166 |
) |
|
|
(2,712 |
) |
|
|
(2,822 |
) |
|
Purchases of property and equipment
|
|
|
|
|
|
|
(2,432 |
) |
|
|
(88,884 |
) |
|
|
(6,050 |
) |
|
|
(81,337 |
) |
|
Redemption (purchase) of marketable securities
|
|
|
518,050 |
|
|
|
|
|
|
|
(6,584,750 |
) |
|
|
|
|
|
|
3,007,110 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
518,050 |
|
|
|
(8,418 |
) |
|
|
(6,676,800 |
) |
|
|
(8,762 |
) |
|
|
2,922,951 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of Series C preferred stock
|
|
|
|
|
|
|
1,500,000 |
|
|
|
9,171,480 |
|
|
|
1,100,000 |
|
|
|
|
|
|
Expenses related to Series C preferred stock offering
|
|
|
|
|
|
|
(252,278 |
) |
|
|
(447,553 |
) |
|
|
|
|
|
|
|
|
|
Proceeds from (repayment of) notes payable to stockholders
|
|
|
|
|
|
|
48,000 |
|
|
|
(48,000 |
) |
|
|
|
|
|
|
|
|
|
Proceeds from issuance of notes payable
|
|
|
|
|
|
|
520,000 |
|
|
|
920,000 |
|
|
|
920,000 |
|
|
|
|
|
|
Proceeds from sale of common stock
|
|
|
|
|
|
|
|
|
|
|
137,500 |
|
|
|
137,500 |
|
|
|
|
|
|
Payment for stock subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
|
|
|
|
1,815,722 |
|
|
|
9,733,427 |
|
|
|
2,157,500 |
|
|
|
34,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(165,626 |
) |
|
|
108,296 |
|
|
|
(7,986 |
) |
|
|
581,485 |
|
|
|
67,503 |
|
Cash and cash equivalents at beginning of period
|
|
|
174,021 |
|
|
|
8,395 |
|
|
|
116,691 |
|
|
|
116,691 |
|
|
|
108,705 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$ |
8,395 |
|
|
$ |
116,691 |
|
|
$ |
108,705 |
|
|
$ |
698,176 |
|
|
$ |
176,208 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Cash Flow Information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$ |
|
|
|
$ |
24,378 |
|
|
$ |
14,976 |
|
|
$ |
|
|
|
$ |
|
|
Supplemental Schedule of Noncash Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes payable exchanged for Series C preferred stock
|
|
$ |
|
|
|
$ |
505,000 |
|
|
$ |
1,015,000 |
|
|
$ |
|
|
|
$ |
|
|
Notes receivable received for common stock
|
|
$ |
|
|
|
$ |
69,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Preferred stock accretion
|
|
$ |
180,009 |
|
|
$ |
25,228 |
|
|
$ |
322,800 |
|
|
$ |
25,228 |
|
|
$ |
842,260 |
|
Reduction to liquidation value Series B preferred stock
|
|
|
|
|
|
$ |
2,329,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Beneficial conversion feature in connection with Series C
preferred stock
|
|
|
|
|
|
|
|
|
|
$ |
2,385,063 |
|
|
|
|
|
|
|
|
|
Fair value of warrants issued in connection with Series C
preferred stock
|
|
|
|
|
|
|
|
|
|
$ |
3,158,948 |
|
|
|
|
|
|
|
|
|
Accrued registration costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
672,873 |
|
Reclassification of inventories and patents to assets held for
sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
156,677 |
|
See accompanying notes to financial statements
F-6
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS
(In thousands, except for share and per share data)
(Information for the six months ended June 30, 2004 and
2005 is unaudited)
|
|
1. |
PRINCIPAL BUSINESS ACTIVITIES AND SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES: |
Organization and Business
Electro-Optical Sciences, Inc., a Delaware corporation (the
Company) is focused on the design and development of
a non-invasive, point-of-care instrument for assisting in the
early diagnosis of melanoma. The Company has entered into a
Protocol Agreement with the Food and Drug Administration
(FDA) which is an agreement for the conduct of the pivotal
trial and to establish the safety and effectiveness of the
MelaFind® device. Upon obtaining premarket approval, or
PMA, from the FDA, the Company plans to launch MelaFind® in
the United States.
To date the Company has not generated any revenues from
MelaFind®. All of the Companys historical revenues
have come from activities and products that have since been
discontinued, including our DIFOTI® product, a non-invasive
imaging device for the detection of dental cavities. The Company
discontinued all operations associated with its DIFOTI®
product effective as of April 5, 2005, in order to focus
its resources on the development and commercialization of
MelaFind®. The Company is currently seeking a buyer for the
DIFOTI® assets, and does not expect to have any significant
continuing responsibility for the DIFOTI® business after
the sale of the DIFOTI® assets. (See note 12)
Interim Financial Statements
The accompanying balance sheet as of June 30, 2005, and the
statements of operations, stockholders equity
(deficiency) and cash flows for the six months ended
June 30, 2004 and 2005 are unaudited. The unaudited interim
financial statements have been prepared on the same basis as the
annual financial statements and, in the opinion of management,
reflect all adjustments, which include only normal recurring
adjustments necessary to present fairly the Companys
financial position and results of operations and cash flows for
the six months ended June 30, 2004 and 2005. The financial
data and other information disclosed in these notes to financial
statements related to the six month periods are unaudited. The
results for the six months ended June 30, 2005 are not
necessarily indicative of the results to be expected for the
year ending December 31, 2005.
Pro Forma Balance Sheet
The Pro Forma Balance Sheet gives effect as of June 30,
2005 to the conversion of all of the Companys outstanding
preferred stock into 3,398,105 shares of common stock which
will occur upon the closing of the proposed initial public
offering. Upon such conversion, the deemed dividends on the
convertible preferred stock will be forfeited. Additionally, it
is assumed for pro forma purposes that 2,610,643 of the
Companys warrants to purchase the Companys common
stock will be exchanged for a total of 1,305,321 shares of
the Companys common stock based on an exchange ratio of
one share of the Companys common stock for every two
shares of the Companys common stock purchaseable under the
warrants and will occur prior to the closing of the proposed
initial public offering.
Reverse Stock Split
The Board of Directors approved on May 13, 2005, a
one-for-two reverse stock split, which will become effective
upon the earlier of the conversion of the preferred stock or
September 30, 2005. All references to common stock, common
shares outstanding, average number of common shares outstanding,
per share amounts, common stock options and warrants in these
financial statements and notes to financial statements have been
restated to reflect the one-for-two common stock reverse split
on a retroactive basis.
F-7
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Cash and Cash Equivalents
The Company maintains cash in bank deposit accounts which, at
times, may exceed federally insured limits. The Company has not
experienced any losses on these accounts. Cash equivalents
include all highly-liquid debt instruments with an original
maturity of three months or less at the date of acquisition.
Marketable Securities
Marketable securities consist of debt securities that the
Company has the intent and ability to hold to maturity. The
Company classifies the marketable securities as held-to-maturity
in accordance SFAS No. 115, Accounting for Certain
Investments in Debt and Equity Securities.
Held-to-maturity securities are recorded at amortized cost.
Accounts Receivable
Accounts receivable are reported at their outstanding unpaid
principal balances reduced by an allowance for doubtful
accounts. The Company estimates doubtful accounts based on
historical bad debts, factors related to specific
customers ability to pay and current economic trends. The
Company writes off accounts receivable against the allowance
when a balance is determined to be uncollectible.
Inventories
Inventories, which consist primarily of DIFOTI® supplies,
are stated at the lower of cost, determined by the first-in,
first-out method, or market.
Assets Held for Sale
Assets held for sale at June 30, 2005 consisted of
DIFOTI® related inventories and patents.
Deferred Registration Costs
The costs associated with the Companys proposed initial
public offering have been recorded as deferred registration
costs and will reduce additional paid-in capital if the offering
is effective. Should the offering not be consummated, the
deferred registration costs will be recognized as a charge to
operations.
Property and Equipment
Depreciation of property and equipment is provided for by the
straight-line method over the estimated useful lives of the
related assets. Leasehold improvements are amortized over the
lesser of the assets useful lives or the remaining term of
the lease.
Patents
Patents are carried at cost less accumulated amortization which
is calculated on a straight-line basis over a period of
15 years.
Revenue Recognition
During April 2005, the Company discontinued the sale of the
DIFOTI® product line. (Note 12). Revenue from
DIFOTI® product sales was recognized at the time of
delivery and acceptance, and after consideration of all the
terms and conditions of the customer contract. Certain of the
Companys products which were being sold prior to
December 31, 2004 included a 30-day return policy. Revenue
on these products was recognized after the shipment was made and
the 30-day return period had elapsed. Effective January 1,
2005 all products were sold without a right of return and
revenue was therefore recognized
F-8
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
upon shipment. Deferred revenues at December 31, 2004
consisted of revenues that were billed and paid in advance of
the shipment of the product.
The Company has not received FDA approval for the sale of
MelaFind® and has had no revenues from products other than
DIFOTI®.
Grant revenue generated in 2002 represents federal grants
received by the Company in conjunction with an undertaking to
perform certain research. The cost of grant revenue consists
primarily of payroll and related costs amounting to $564.
Warranty Costs
The Company generally warranted its only commercialized product,
DIFOTI®, for one year after the sale had been completed.
Through March 31, 2005, warranty costs were
de minimus, and were recorded by the Company as incurred.
During the quarter ended June 30, 2005, in connection with
the discontinuance of its DIFOTI® product line, the Company
recorded a reserve for warranty expense in accordance with the
requirements of Statement of Financial Accounting Standards
No. 5 Accounting for Contingencies (SFAS
No. 5), in the amount of $20 since the Company believes it
is probable that such discontinuance will lead to warranty
claims. As of June 30, 2005, prior sales of approximately
$200 were subject to possible warranty claims.
Income Taxes
Deferred tax assets and liabilities are recognized for the
estimated future tax consequences attributable to differences
between the amounts of existing assets and liabilities recorded
in the financial statements and their respective tax bases and
the benefits arising from the realization of operating loss and
tax credit carryforwards. Deferred tax assets and liabilities
are measured using tax rates in effect for the year in which
those temporary differences are expected to be recovered or
settled. A valuation allowance is established when necessary to
reduce deferred tax assets to the amount expected to be realized.
Estimates
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States of
America requires the use of estimates and assumptions by
management that affect 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. Actual
results could differ from these estimates.
Long-lived Assets
The Company reviews long-lived assets for impairment whenever
events or changes in circumstances indicate that the carrying
amount of an asset may not be recoverable. An asset is
considered to be impaired when the sum of the undiscounted
future net cash flows expected to result from the use of the
asset and its eventual disposition exceeds its carrying amount.
The amount of impairment loss, if any, is measured as the
difference between the net book value of the asset and its
estimated fair value.
Research and Development
Research and development costs are expensed as incurred.
F-9
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Stock-Based Compensation
The Company applies the intrinsic-value method of accounting
prescribed by the Accounting Principles Board (APB) Opinion
No. 25 and related interpretations to account for the
Companys fixed-plan employee stock options. Under this
method, compensation expense is recorded on the date of grant
only if the then current market price of the underlying stock
exceeded the exercise price. Statement of Financial Accounting
Standards (SFAS) No. 123, Accounting for Stock-Based
Compensation, as amended by SFAS No. 148,
Accounting for Stock-Based Compensation, Transition and
Disclosure, established accounting and disclosure
requirements using a fair-value based method of accounting for
stock-based employee compensation plans. As allowed by
SFAS No. 123 and No. 148, the Company has elected
to continue to apply the intrinsic-value based method of
accounting for employee stock options described above, and has
adopted only the disclosure requirements of
SFAS No. 123. Had the Company elected to recognize
compensation cost based on the fair value of the options granted
at the grant date, as prescribed by SFAS No. 123, the
Companys net loss and net loss per share would have been
adjusted to the pro forma amounts indicated below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
June 30, | |
|
|
| |
|
| |
|
|
2002 | |
|
2003 | |
|
2004 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Net loss attributable to common stockholders, as reported
|
|
$ |
(1,535 |
) |
|
$ |
(2,399 |
) |
|
$ |
(4,618 |
) |
|
$ |
(1,784 |
) |
|
$ |
(4,370 |
) |
Add: stock-based employee compensation included in reported net
loss, net of income tax effect
|
|
|
72 |
|
|
|
23 |
|
|
|
173 |
|
|
|
11 |
|
|
|
87 |
|
Deduct: stock-based employee compensation expense determined
under fair-value-based method, net of related tax effect
|
|
|
(75 |
) |
|
|
(65 |
) |
|
|
(186 |
) |
|
|
(8 |
) |
|
|
(90 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss
|
|
$ |
(1,538 |
) |
|
$ |
(2,441 |
) |
|
$ |
(4,631 |
) |
|
|
(1,781 |
) |
|
$ |
(4,373 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share, as reported
|
|
$ |
(1.00 |
) |
|
$ |
(1.49 |
) |
|
$ |
(2.61 |
) |
|
$ |
(1.04 |
) |
|
$ |
(2.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share, pro forma
|
|
$ |
(1.00 |
) |
|
$ |
(1.51 |
) |
|
$ |
(2.62 |
) |
|
$ |
(1.04 |
) |
|
$ |
(2.42 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The per share weighted-average fair value of stock options
granted during 2002, 2003 and 2004 was $.26, $.34, and $3.00,
respectively, on the dates of grant using the Black-Scholes
option-pricing model.
During the six months ended June 30, 2005, the Company did
not grant any stock options. The per share weighted average fair
value of stock options granted during the six months ended
June 30, 2004 was determined using the Black-Scholes option
pricing model resulting in a weighted average fair value of
$0.25 per share. The following weighted-average assumptions
were used:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
June 30, | |
|
|
| |
|
| |
|
|
2002 | |
|
2003 | |
|
2004 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Expected volatility
|
|
|
1 |
% |
|
|
1 |
% |
|
|
60 |
% |
|
|
60 |
% |
|
|
|
|
Risk-free interest rate
|
|
|
4.52 |
% |
|
|
4.52 |
% |
|
|
3.17 |
% |
|
|
3.39 |
% |
|
|
|
|
|
|
|
to |
|
|
|
to |
|
|
|
to |
|
|
|
|
|
|
|
|
|
|
|
|
5.43 |
% |
|
|
5.43 |
% |
|
|
3.94 |
% |
|
|
|
|
|
|
|
|
Expected option life (in years)
|
|
|
10 |
|
|
|
10 |
|
|
|
5 |
|
|
|
5 |
|
|
|
|
|
Expected dividend yield
|
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
|
|
F-10
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Options or warrants issued to non-employees for services are
recorded at fair value and accounted for in accordance with
Emerging Issues Task Force (EITF) No. 96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services. For equity instruments that are not
immediately vested, compensation cost is measured on the date
such instruments vest or a performance commitment, as defined in
EITF 96-18, is reached. The costs are classified in the
accompanying statements of operations based on the nature of the
services performed.
Deferred Compensation
Deferred compensation attributable to unvested common stock
options is measured at the measurement date for the respective
grants, and reflected as a deduction from stockholders
equity. Compensation expense is recognized ratably over the
vesting period.
Financial Instruments
The Companys financial instruments consist principally of
cash and cash equivalents, marketable securities, accounts
receivable and accounts payable. The Company believes the
financial instruments recorded values approximate current
values because of their nature and respective durations. The
Company maintains cash in bank deposit accounts, which, at
times, may exceed federally insured limits. The Company has not
experienced any losses on these accounts.
Net Loss per Common Share
Net loss per share is presented in accordance with the
provisions of SFAS No. 128, Earnings Per
Share (EPS). Basic EPS excludes dilution for potentially
dilutive securities and is computed by dividing loss
attributable to common stockholders by the weighted average
number of common shares outstanding during the period. Diluted
EPS gives effect to dilutive options, warrants and other
potential common shares outstanding during the period. Diluted
net loss per common share is equal to basic net loss per common
share since all potentially dilutive securities are
anti-dilutive for each of the periods presented. Diluted net
loss per common share for the years ended December 31,
2002, 2003 and 2004 does not include the effects of options to
purchase 142,581, 290,678 and 965,203 shares of common
stock, respectively and 407,182 and 899,875 shares for the
six months ended June 30, 2004 and 2005 respectively; 690,
369,993 and 2,758,923 common stock warrants for the years ended
December 31, 2002, 2003 and 2004, respectively, and 673,662
and 2,758,923 common stock warrants for the six months ended
June 30, 2004 and 2005, respectively.
The pro forma basic and diluted net loss per common share for
the year ended December 31, 2004 and for the six months
ended June 30, 2005 gives effect to the conversion of the
existing shares of preferred stock into 3,398,105 shares of
common stock at the conversion ratios which would apply upon
consummation of the proposed initial public offering and the
exchange of 2,610,643 warrants for 1,305,321 shares of
common stock as described in Note 9. In addition, the net
loss attributable to the Companys common stockholders used
in the computation of basic and diluted net loss per share for
the unaudited pro forma net loss attributable to the
Companys common stockholders has been adjusted to reverse
the accretion on the Companys preferred stock and also
excludes the preferred stock dividends for the respective
periods.
Recently Issued Pronouncements
In December 2004, the Financial Accounting Standards Board
(FASB) issued the revised SFAS No. 123,
Share-Based Payment (SFAS 123R), which addresses the
accounting for share-based payment transactions in which the
Company obtains employee services in exchange for
(a) equity instruments of the Company or
(b) liabilities that are based on the fair value of the
Companys equity instruments or that may be settled by the
issuance of such equity instruments. SFAS 123R eliminates
the
F-11
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
ability to account for employee share-based payment transactions
using APB No. 25 and requires instead that such
transactions be accounted for using the grant-date fair value
based method. SFAS 123R will be effective as of the
beginning of the first interim or annual reporting period that
begins after December 15, 2005 (January 1, 2006 for
the Company) and applies to all awards granted or modified after
the effective date. In addition, compensation cost for the
unvested portion of previously granted awards that remain
outstanding on the effective date shall be recognized on or
after the effective date, as the related services are rendered,
based on the awards grant-date fair value as previously
calculated for the pro-forma disclosure under SFAS 123. The
Company expects that upon the adoption of SFAS 123R it will
apply the modified prospective application transition method, as
permitted by the statement. Under such transition method, upon
the adoption of SFAS 123R, the Companys financial
statements for periods prior to the effective date of the
statement will not be restated. The impact of this statement on
the Companys financial statements or its results of
operations in 2005 and beyond will depend upon various factors,
among them, its future compensation strategy. The Company
expects that the effect of applying this statement on its
results of operations in 2005 as it relates to existing option
plans would not be materially different from the SFAS 123
pro forma effect previously reported.
In March 2004, the FASB issued EITF Issue No. 03-1,
The Meaning of Other-Than-Temporary Impairment and Its
Application to Certain Investments, which provides new
guidance for assessing impairment losses on debt and equity
investments. Additionally, EITF Issue No. 03-1 includes new
disclosure requirements for investments that are deemed to be
temporarily impaired. In September 2004, the FASB delayed the
accounting provisions of EITF Issue No. 03-1; however, the
disclosure requirements remain effective and have been adopted
by the Company in the financial statements. The Company will
evaluate the effect, if any, of EITF Issue No. 03-1 when
final guidance is released.
|
|
2. |
MARKETABLE SECURITIES: |
The Companys investments mature within one year.
Investments in marketable securities are summarized as follows
at December 31, 2004 and June 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004 | |
|
June 30, 2005 | |
|
|
| |
|
| |
|
|
Gross | |
|
|
|
Gross | |
|
|
|
|
Unrealized | |
|
Fair | |
|
Amortized | |
|
Unrealized | |
|
Fair | |
|
Amortized | |
|
|
Loss | |
|
Value | |
|
Cost | |
|
Loss | |
|
Value | |
|
Cost | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Corporate commercial paper
|
|
$ |
|
|
|
$ |
2,500 |
|
|
$ |
2,500 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Corporate debt
|
|
|
(10 |
) |
|
|
2,497 |
|
|
|
2,507 |
|
|
|
(2 |
) |
|
|
2,024 |
|
|
|
2,026 |
|
United States Treasury note
|
|
|
(8 |
) |
|
|
1,580 |
|
|
|
1,588 |
|
|
|
(7 |
) |
|
|
1,585 |
|
|
|
1,592 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(18 |
) |
|
$ |
6,577 |
|
|
$ |
6,595 |
|
|
$ |
(9 |
) |
|
$ |
3,609 |
|
|
$ |
3,618 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3. |
PROPERTY AND EQUIPMENT: |
Property and equipment, at cost, consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
|
|
|
|
| |
|
June 30, | |
|
Estimated | |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
Useful Life | |
|
|
| |
|
| |
|
| |
|
| |
Leasehold improvements
|
|
$ |
23 |
|
|
$ |
32 |
|
|
$ |
65 |
|
|
|
5-10 years |
|
Laboratory and research equipment
|
|
|
61 |
|
|
|
119 |
|
|
|
119 |
|
|
|
5 years |
|
Office furniture and equipment
|
|
|
113 |
|
|
|
135 |
|
|
|
184 |
|
|
|
5 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
197 |
|
|
|
286 |
|
|
|
368 |
|
|
|
|
|
Less accumulated depreciation and amortization
|
|
|
179 |
|
|
|
197 |
|
|
|
213 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
18 |
|
|
|
89 |
|
|
$ |
155 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-12
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Depreciation expense amounted to approximately $16, $15 and $18,
for the years ended December 31, 2002, 2003 and 2004,
respectively and $6 and $15 for the six months ended
June 30 2004 and 2005 respectively.
Patents are shown in the accompanying balance sheets net of
accumulated amortization of $83 and $101 at December 31,
2003 and 2004, respectively. At June 30, 2005, accumulated
amortization applicable to patents in use amounted to $61. In
connection with the discontinuance of DIFOTI® operations in
April 2005, patents with a net book value of $71 have been
reclassified as assets held for sale. Amortization expense
related to the patents was approximately $17, $17 and $18 for
the years ended December 31, 2002, 2003 and 2004,
respectively and $9 and $10 for the six months ended
June 30, 2004 and 2005, respectively.
The estimated future amortization expense related to the patents
is as follows:
|
|
|
|
|
|
Year ended December 31,
|
|
|
|
|
|
2005
|
|
$ |
14 |
|
|
2006
|
|
|
10 |
|
|
2007
|
|
|
10 |
|
|
2008
|
|
|
10 |
|
|
2009
|
|
|
10 |
|
Thereafter
|
|
|
40 |
|
|
|
|
|
|
|
$ |
94 |
|
|
|
|
|
|
|
5. |
NOTES PAYABLE-STOCKHOLDERS: |
During 2003, the Company had notes payable to two of its
stockholders totaling $48. These notes were payable in October
2004, bore interest at 6%, and were repaid during 2004. Interest
expense amounted to approximately $1 and $2 for the years ended
December 31, 2003 and 2004, respectively. In addition, the
Company had a demand note payable to one of its stockholders in
the amount of $15 with interest accruing at 12% per annum.
During October 2004, the note and accrued interest of $1 were
converted into 6,999 shares of Series C preferred
stock.
|
|
6. |
COMMITMENTS AND CONTINGENCIES: |
The Company is obligated under two non cancelable operating
leases for office space expiring June 2009 and November 2010.
The leases are subject to escalations for increases in operating
expenses. The approximate aggregate minimum future payments
under these leases are due as follows:
|
|
|
|
|
|
Year ended December 31,
|
|
|
|
|
|
2005
|
|
$ |
205 |
|
|
2006
|
|
|
204 |
|
|
2007
|
|
|
213 |
|
|
2008
|
|
|
217 |
|
|
2009
|
|
|
170 |
|
Thereafter
|
|
|
105 |
|
|
|
|
|
|
|
$ |
1,114 |
|
|
|
|
|
F-13
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Rent expense charged to operations amounted to approximately
$88, $113 and $110 for the years ended December 31, 2002,
2003 and 2004, respectively, and $54 and $94 for the six months
ended June 30, 2004 and 2005, respectively.
During January 2004, the Company entered into an employment
agreement with its President and Chief Executive Officer through
December 31, 2005, which provides for a base salary of
$175, stock options and performance bonuses. The agreement
provides for automatic one year renewal terms.
During January 2004 the Company amended its employment agreement
with its former president, who now holds the title Chief Science
and Technology Officer. The agreement was originally entered
into in May 2003 with a three-year term. The agreement now
includes a salary of $175 and provides for stock options and
performance bonuses. As of May 31, 2005, this former
employee is now a consultant to the Company.
The Company had been involved in various claims and legal
actions arising in the ordinary course of business. The ultimate
outcome of these matters did not have a material adverse impact
on the financial position of the Company or the results of its
operations.
|
|
7. |
EMPLOYEE BENEFIT PLAN: |
The Company has a defined contribution plan under
Section 401(k) of the Internal Revenue Code covering all
qualified employees. An officer of the Company serves as trustee
of the plan. The Company provides a matching contribution of up
to 3% of each employees salary. Contributions to this plan
amounted to approximately $29, $12 and $25 for the years ended
December 31, 2002, 2003 and 2004, respectively, and $11 and
$15 for the six months ended June 30, 2004 and 2005,
respectively.
|
|
8. |
STOCKHOLDERS (DEFICIENCY) EQUITY AND REDEEMABLE
PREFERRED STOCK: |
During January 2003, the Company received $180 in exchange for
issuing a convertible promissory note bearing interest at
10% per annum, The note was convertible at a discount of
20% on the next round of financing. In June 2003, the note was
converted into Series C redeemable convertible preferred
stock. (See discussion below.) Upon conversion of the note the
Company recorded a charge of $45 to reflect the value of the
beneficial conversion of the shares since the shares were
converted at $1.81 per share, a 20% discount. In addition,
the Company granted the note holder five-year warrants to
purchase 25% of the total number of securities issued upon
conversion of the note, which amounted to 99,558 shares (or
24,890 warrants), at an exercise price equal to the per
share price of the next financing as defined in the loan
agreement. The value of these warrants was de minimus. For
the year ended December 31, 2003, interest on these notes
amounted to approximately $8.
During February 2003, certain stockholders loaned the Company
$325 bearing interest at 12% per annum. In June 2003, these
loans were converted into 143,802 shares of Series C
redeemable convertible preferred stock at $2.26 per share.
For the year ended December 31, 2003, interest on these
notes amounted to approximately $21.
During June 2003, the Company completed a private placement
whereby investors agreed to acquire up to 1,400,000 preferred
Series C units. Each unit consists of one share of
Series C redeemable convertible preferred stock and one
warrant to purchase one share of common stock at an exercise
price of $13.00 per share. Of the 1,400,000 units, the
first tranche of 663,717 units was sold for an aggregate of
$1,500. Costs associated with this issuance amounted to $252.
This amount will be accreted to the Series C over the
redemption period. For the year ended December 31, 2003,
$25 was accreted. The value of the warrants was de minimus.
F-14
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
In order to complete the June 2003 private placement, the
Series A and B stockholders consented to modifications to
certain of their rights, preferences, and privileges. The
Series A preferred shares were split 1,000 for 1 and due to
the anti-dilution provision, the conversion ratio of
Series A was changed to 0.5818 to 1 (totaling
16,202 shares of common stock). Additionally, the Company
granted a stock distribution of 45,000 shares of Series B
preferred stock to the Series B stockholders, valued at
$102 or $2.26 per share. As a result of these
modifications, the Company adjusted the carrying amount of the
Series B preferred stock. Due to the anti-dilution
provision, the conversion ratio of Series B was changed to
0.5796 to 1 (totaling 79,043 shares of common stock). The
Series C redeemable convertible preferred stock converts to
common stock at a ratio of 0.50 to 1.
In connection with the private placement, 150,000 shares of
common stock were sold to the promoters, who are related
parties, at $.46 per share. Notes of $69 were received for
this purchase and is shown as a reduction in stockholders
equity (deficiency). The note bears interest at 3.06% and is due
June 20, 2008. Interest income amounted to approximately $2
and $1 for the years ended December 31, 2004 and 2003,
respectively. During June 2005, the notes of $69 were retired by
a cash payment and consulting services rendered.
During 2004, the second tranche of the Series C private
placement was completed and an additional 486,725 of
Series C units were issued for total proceeds of $1,100. An
additional 427 units were distributed in order to comply
with minimum ownership provisions. The value of the distribution
was de minimus. In order to induce the investment in this
second tranche, the Company issued additional warrants to
purchase 60,840 shares of Series C redeemable
convertible preferred stock at a price of $4.52 per share.
These warrants were valued at $179.
During May 2004, the Company obtained bridge loans in the amount
of $1,000 from related parties. The loans bear interest at 1.57%
and were payable on December 31, 2004. During October 2004
these loans were converted into 442,469 preferred Series C
units at a price of $2.26 per unit. The warrants were
valued at $327. The Company also sold approximately
125,000 shares of common stock to the lenders at
$.46 per share for $57. The Company ascribed a value to the
common stock and recorded an imputed interest charge of $80.
During October 2004, the Company completed a second private
placement and sold 3,578,081 preferred Series C units for
total proceeds of approximately $8,100 at a price of
$2.26 per unit. The warrants were valued at $2,653. Costs
of the Series C private placement amounted to approximately
$448. This amount will be accreted to the Series C over the
redemption period. For the year ended December 31, 2004,
$71 was accreted.
During 2004, the Company issued 4,507,702 shares of
Series C redeemable convertible preferred stock with
2,253,792 warrants to purchase common stock at $13.00 per
share and 60,840 Series C redeemable convertible preferred
stock warrants at an exercise price of $4.52 per share for
gross proceeds of $10,186. The net proceeds of $9,738 were
allocated to redeemable convertible preferred stock and
additional paid-in capital based on the relative fair values of
the preferred stock and warrants. The fair value of the warrants
was determined using the Black-Scholes method. The assumptions
used to value these warrants are described in Note 9. The
Company recorded a beneficial conversion feature of $2,385 which
is being accreted to redemption for the Series C redeemable
convertible preferred stock based on the earliest redemption
date of June 2008.
The total accretion to redemption value for the Series C
amounted to $25, $323, and $842 for the years ended
December 31, 2003 and 2004 and the six months ended
June 30, 2005, respectively.
F-15
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
The rights, preferences, and privileges of the Series B and
C redeemable preferred stock are as follows:
Voting Rights
All holders of redeemable convertible preferred stock have
voting rights equal to the number of shares of common stock into
which the respective preferred stock is convertible.
Liquidation Preference
In the event of liquidation, dissolution, or winding-up of the
Company, and before any distribution to common stockholders, the
holders of Series B and C redeemable convertible preferred
stock are entitled to receive $2.26 per share plus all
accrued but unpaid dividends.
Deemed Dividends
Dividends on the Series B and Series C redeemable
convertible preferred stock may be declared at the discretion of
the board of directors at an annual rate equal to 10%, as
adjusted, of the accreted value per share and shall be payable
in preference and priority to any declaration or payment of any
distribution on Series A preferred stock or common stock
and will be cumulative. At December 31, 2004 and
June 30, 2005 there are approximately $1,510 and $2,229 of
deemed but unpaid dividends. In the event the preferred stock is
converted into common stock, any related deemed dividends would
be forfeited.
Redemption Provisions
Pursuant to the modification of the Series B preferred
stock terms adopted at the closing of the Series C private
placement, the requirement to redeem the preferred shares, at
the option of the holder, has been extended to June 2008. The
redemption of Series B requires approval of the
Series C shareholders. The preferred Series C stock is
redeemable at the option of the holder, on the fifth and sixth
anniversary of the first issuance of Series C preferred
stock (June 2003). Series B has been classified as temporary
equity at its redemption value; Series C has been so classified
at its accreted value.
|
|
9. |
STOCK OPTIONS AND WARRANTS: |
Warrants
Warrants outstanding consist principally of warrants issued in
connection with the Companys Series C financing and
generally expire seven years from the date of grant.
During 2003, in connection with the sale of Series C
redeemable convertible preferred stock, 356,851 warrants to
purchase common stock at an exercise price of $13.00 per
share were issued. The fair value of these warrants was
determined to be de minimus using the Black-Scholes method.
The assumptions used in determining the fair value were the
following: common stock value per share of $0.46, warrant life
of 7 years, a risk-free interest rate of 3.67%, and an
expected volatility of 1%. The Company also issued
12,445 warrants to purchase shares of Series C
redeemable convertible preferred stock at an exercise price of
$4.52. The fair value of these warrants was determined to be
de minimus using the Black-Scholes method assuming a stock
price of $4.52 per share, warrant life of 5 years, a
risk-free interest rate of 3.67%, and an expected volatility of
1%.
During 2004, in connection with the sale of Series C
redeemable convertible preferred stock, 2,253,792 warrants to
purchase common stock at an exercise price of $13.00 per
share were issued. The fair value of these warrants ranged from
$0.02 to $1.48 using the Black-Scholes method. The assumptions
used in determining the fair value were the following: common
stock value per share ranged from $0.46 to
F-16
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
$4.00, warrant life of 7 years, a risk-free interest rate
of 3.67%, and an expected volatility of 60%. The Company also
issued 60,840 warrants to purchase shares of Series C
redeemable convertible preferred stock at an exercise price of
$4.52. The fair value of these warrants was determined to be
$2.94 using the Black-Scholes method assuming a stock price of
$4.52 per share, warrant life of 7 years, a risk-free
interest rate of 3.67%, and an expected volatility of 60%. The
total fair value of the aforementioned warrants issued in 2004
aggregated $3,159.
During 2004, the Company issued a 5 year warrant to
purchase 75,000 shares of common stock at an exercise
price of $7.00 per share to one of its consultants. These
warrants have been valued at $120 using the Black-Scholes method
and was recorded as compensation expense. The assumptions used
in determining the fair value were the following: common stock
value per share of $4.00, warrant life of 5 years, a
risk-free interest rate of 3.67%, and an expected volatility
of 60%.
Warrant activity during the periods indicated is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- | |
|
|
|
|
Average | |
|
|
|
|
Exercise | |
|
|
Warrants | |
|
Price | |
|
|
| |
|
| |
Outstanding at January 1, 2002
|
|
|
10,505 |
|
|
$ |
10.00 |
|
Expired
|
|
|
(9,815 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2002
|
|
|
690 |
|
|
$ |
10.00 |
|
Granted
|
|
|
369,303 |
|
|
|
12.72 |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2003
|
|
|
369,993 |
|
|
|
12.70 |
|
Granted
|
|
|
2,389,620 |
|
|
|
12.60 |
|
Expired
|
|
|
(690 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2004
|
|
|
2,758,923 |
|
|
$ |
12.61 |
|
|
|
|
|
|
|
|
There was no warrant activity during the six months ended
June 30, 2005.
On April 5, 2005, the Board of Directors approved, subject
to stockholder approval, the issuance of 1,305,321 shares
of the Companys common stock in exchange for
2,610,643 outstanding warrants (a conversion ratio of one
share of common stock for two warrants.) The Company considers
this transaction to be an exchange of equity instruments at fair
value which will have no net effect on stockholders
equity. The fair value of the warrants was determined using the
Black-Scholes method and assumed the following: common stock
value of $10.00 per share, remaining warrant life of
6.25 years, risk-free interest rate of 3.2%, and an
expected volatility of 60%.
Stock Options
The Company has three stock option plans (the Plans)
which allow the board of directors to grant incentives to
employees, directors and collaborating scientists in the form of
incentive stock options, nonqualified stock options and
restricted stock. At December 31, 2004 and June 30,
2005, options to purchase 965,203 and 899,875 shares
of common stock, respectively, at exercise prices ranging from
$.40 to $10.00 per share are outstanding and are
exercisable at various dates through 2013. The total number of
shares reserved under the Companys stock option plans is
1,000,000.
In January 2003, the Company issued an option to acquire
24,209 shares of common stock at an exercise price of
$1.00 per share valued at approximately $97 to outside
consultants. During 2004, the Company issued options to acquire
27,750 shares of common stock at an exercise price of
$.46 per share valued at approximately $73 to outside
consultants. The fair value for these options granted to outside
F-17
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
consultants was calculated using the Black-Scholes method. For
the options granted during 2004 to outside consultants, the
assumptions used in the Black-Scholes model were: common stock
valued ranged from $0.46 to $4.00, expected life of
5 years, risk-free interest rate ranged from 3.39% to
3.94%, and an expected volatility of 60%.
During 2004 the Company issued 262,500 options to certain
employees and Board members. The value of the options resulted
in a charge to operations in the amount of $150 and $71 during
the year ended December 31, 2004 and for the six months
ended June 30, 2005, respectively. The share based
compensation expense for these option grants represent the
amount by which the fair value per common share of $4.00 exceeds
the exercise price per share of $0.46.
Stock option activity during the periods indicated is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- | |
|
|
|
|
average | |
|
|
Number | |
|
Exercise | |
|
|
of Shares | |
|
Price | |
|
|
| |
|
| |
Outstanding at January 1, 2002
|
|
|
128,050 |
|
|
$ |
2.28 |
|
Granted
|
|
|
14,531 |
|
|
|
1.00 |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2002
|
|
|
142,581 |
|
|
|
2.16 |
|
Granted
|
|
|
158,565 |
|
|
|
.94 |
|
Expired/ Forfeited
|
|
|
(10,468 |
) |
|
|
.96 |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2003
|
|
|
290,678 |
|
|
|
1.12 |
|
Granted
|
|
|
679,525 |
|
|
|
.46 |
|
Expired/ Forfeited
|
|
|
(5,000 |
) |
|
|
1.00 |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2004
|
|
|
965,203 |
|
|
|
.66 |
|
Expired/ Forfeited
|
|
|
(65,328 |
) |
|
|
.89 |
|
|
|
|
|
|
|
|
Outstanding at June 30, 2005
|
|
|
899,875 |
|
|
$ |
.64 |
|
|
|
|
|
|
|
|
Options exercisable at December 31, 2004
|
|
|
428,729 |
|
|
$ |
.89 |
|
|
|
|
|
|
|
|
Options exercisable at June 30, 2005
|
|
|
446,675 |
|
|
|
.82 |
|
|
|
|
|
|
|
|
The following table summarizes information about fixed stock
options outstanding at December 31, 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
|
|
|
| |
|
Options Exercisable | |
|
|
|
|
Weighted- | |
|
|
|
| |
|
|
|
|
average | |
|
Weighted- | |
|
|
|
Weighted- | |
|
|
|
|
Remaining | |
|
average | |
|
|
|
average | |
Range of |
|
Number | |
|
Contractual | |
|
Exercise | |
|
Number | |
|
Exercise | |
Exercise Prices |
|
Outstanding | |
|
Life | |
|
Price | |
|
Exercisable | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$.01-$.46
|
|
|
694,525 |
|
|
|
4.7 years |
|
|
$ |
.46 |
|
|
|
173,989 |
|
|
$ |
.46 |
|
$.47-$1.00
|
|
|
265,678 |
|
|
|
6.5 years |
|
|
|
1.00 |
|
|
|
249,740 |
|
|
|
1.00 |
|
$1.01-$10.00
|
|
|
5,000 |
|
|
|
.4 years |
|
|
|
10.00 |
|
|
|
5,000 |
|
|
|
10.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$.01-$10.00
|
|
|
965,203 |
|
|
|
5.7 years |
|
|
$ |
.66 |
|
|
|
428,729 |
|
|
$ |
.89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2005, of the total 899,875 options
outstanding, 445,701 of these options will vest upon the
attainment of certain milestones and will be charged to
operations based on the then current Companys market price
per share.
The employment agreement with Dr. Gulfo includes three
separate grants of common stock options. The first two stock
option grants for a total of 81,753 shares of the
Companys common stock have fully
F-18
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
vested. The number of shares of the Companys common stock
subject to the third stock option can only be calculated at the
time of PMA approval of MelaFind®. The number of shares
under this option is equal to that number of shares of our
common stock equal to four percent of the Companys fully
diluted capital stock at the time of PMA approval of
MelaFind® minus the 81,753 options granted to
Dr. Gulfo under the employment agreement.
In May 2005, the Company amended option agreements for
125,000 shares in the aggregate of three key employees to
immediately vest upon the completion of a successful initial
public offering. The Company will record a charge to operations
based upon the initial public offering price.
10. INCOME TAXES:
At December 31, 2004 and June 30, 2005, the Company
had net operating loss carryforwards of approximately $12,208
and $15,017, respectively, available to offset future taxable
income expiring at various dates through the year 2025. The
Companys ability to utilize its net operating losses may
be significantly limited due to changes in the Companys
ownership as defined by federal income tax regulations. Without
regard to any such limitations, the Company had a deferred tax
asset of approximately $3,443, $4,883 and $6,007 at
December 31, 2003, 2004 and June 30, 2005,
respectively. Because the Company anticipates continued losses
for the foreseeable future, the Company has recorded a 100%
valuation allowance against its deferred income tax assets for
all periods. The increase in the valuation allowance for the
years ended December 31, 2002, 2003, 2004 and six months
ended on June 30, 2005 amounted to $428, $753, $1,440 and
$1,124, respectively.
11. RELATED PARTY CONSULTING
AGREEMENTS:
The Company has in place the following consulting agreements
with related parties.
Consulting Agreement with Breaux Castleman
In June 2003, the Company entered into a consulting agreement
with Breaux Castleman, the Chairman of the Companys Board
of Directors, for consulting services related to the FDA
approval of MelaFind®, and the Companys business and
financial strategy. Under this agreement, Mr. Castleman
receives compensation for each month of services rendered. The
Company made payments pursuant to this consulting agreement $48
in 2003, $22 in 2004, and $12 through June 30, 2005. This
consulting agreement is terminable by either party on
30 days written notice.
Consulting Agreement with Marek Elbaum, Ph.D.
Pursuant to a consulting agreement effective as of May 31,
2005, the Company retained Marek Elbaum, Ph.D., the
Companys founder and former Chief Science and Technology
Officer, as the Companys Chief Scientist. In consideration
of the services to be provided, the Company has agreed to pay
Dr. Elbaum a monthly fee of $15. The term of this agreement
extends for a period of two years and is automatically renewable
for an additional one year period. In the event of a
non-renewal, and in the event that Dr. Elbaums
services terminate as a result of his death or disability, we
will pay to Dr. Elbaum a termination fee of $100.
Consulting Agreement with Robert Friedman, M.D.
Effective as of June 1, 2005, the Company retained the
services of Robert Friedman, M.D., for an initial term of
one year as a consultant, medical advisor to our Board of
Directors, and in connection with the clinical testing of
MelaFind®. In consideration for these services,
Dr. Friedman will be paid at a rate of $5,000 per day.
This consulting agreement is automatically renewed for
successive one-year terms unless either party terminates the
agreement at least 30 days prior to the expiration of the
agreement.
F-19
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Consulting Agreement with Gerald Wagner, Ph.D.
On June 1, 2005, the Company entered into a consulting
agreement with Gerald Wagner, Ph.D., a member of the
Companys Board of Directors, to direct our MelaFind®
product development efforts and oversee the manufacturing
process. The agreement ends three months following the
initiation of the Companys pivotal clinical trial of
MelaFind®. The consulting agreement provides for a flat fee
of $150,000, payable ratably over the course of the term, and a
stock option grant to purchase 50,000 shares of the
Companys common stock, subject to and immediately after
completion of the Companys initial public offering at the
public offering price per share.
12. DISCONTINUED OPERATIONS AND
ASSETS HELD FOR SALE:
On March 9 through March 21, 2005, the Company was
inspected by the FDA in connection with its DIFOTI®
product, a non-invasive imaging device for the detection of
dental cavities. On March 21, 2005, the Company was cited
for failures to comply fully with FDA quality system regulation,
or QSR, mandated procedures. These inspectional findings were
discussed in a subsequent meeting with the FDA on April 28,
2005.
The Company is in the process of addressing the deficiencies
noted.
The Company decided to discontinue all operations associated
with its DIFOTI® product effective as of April 5,
2005, in order to focus its resources and attention on the
development and commercialization of MelaFind®. The Company
is currently seeking an acquirer for the DIFOTI® assets,
and does not expect to have any significant continuing
responsibility for the DIFOTI® business after its
disposition.
Losses attributable to DIFOTI® operations discontinued in
April 2005 amounted to $201, $12, $426, $102, and $330 for the
years ended December 31, 2002, 2003, 2004, and the six
months ended June 30, 2004 and 2005, respectively.
SFAS No. 144 requires that long-lived assets to be
disposed by sale be measured at the lower of carrying amount or
fair value less cost to sell. SFAS No. 144 also
broadened the reporting of discontinued operations to include
all components of an entity with operations that will be
eliminated from ongoing operations of the entity in a disposal
transaction. At June 30, 2005, assets held for sale
consisted of DIFOTI® related inventories and patents.
In accordance with the provisions of SFAS No. 144, the
results of operations of the discontinued business have been
reported as discontinued operations for all periods presented in
the accompanying financial statements.
F-20
3,000,000 Shares
Electro-Optical Sciences, Inc.
Common Stock
PROSPECTUS
Until ,
2005, all dealers that effect transactions in these securities,
whether or not participating in this offering, may be required
to deliver a prospectus. This is in addition to the
dealers obligation to deliver a prospectus when acting as
underwriters and with respect to their unsold allotments or
subscriptions.
|
|
Ladenburg Thalmann & Co. Inc. |
Stanford Group Company |
,
2005
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
|
|
ITEM 13. |
Other Expenses of Issuance and Distribution. |
The following table sets forth the costs and expenses to be paid
by the Registrant in connection with the sale of the shares of
common stock being registered hereby. All amounts are estimates
except for the SEC registration fee, the NASD filing fee and the
NASDAQ National Market filing fee.
|
|
|
|
|
|
Securities and Exchange Commission registration fee
|
|
$ |
3,884 |
|
NASD filing fee
|
|
|
4,640 |
|
NASDAQ National Market filing fee
|
|
|
5,000 |
|
Accounting fees and expenses
|
|
|
275,000 |
|
Legal fees and expenses
|
|
|
585,000 |
|
One percent nonaccountable underwriters expense
|
|
|
330,000 |
|
Printing and engraving expenses
|
|
|
270,000 |
|
Blue sky fees and expenses
|
|
|
10,000 |
|
Transfer agent and registrar fees and expenses
|
|
|
15,000 |
|
Miscellaneous
|
|
|
191,476 |
|
|
|
|
|
|
Total
|
|
$ |
1,690,000 |
|
|
|
|
|
|
|
* |
To be completed by amendment. |
|
|
ITEM 14. |
Indemnification of Directors and Officers. |
Section 145 of the Delaware General Corporation Law permits
a corporation to include in its charter documents, and in
agreements between the corporation and its directors and
officers, provisions expanding the scope of indemnification
beyond that specifically provided by the current law.
Article VIII of our third amended and restated certificate
of incorporation provides for the indemnification of directors
to the fullest extent permissible under Delaware law. Our fourth
amended and restated certification of incorporation to be filed
upon completion of this offering will contain similar
indemnification provisions.
Article IX of our second amended and restated bylaws
provides for the indemnification of officers, directors or other
agents acting on our behalf if such person acted in good faith
and in a manner reasonably believed to be in and not opposed to
our best interest and, with respect to any criminal action or
proceeding, the indemnified party had no reason to believe his
or her conduct was unlawful. Our third amended and restated
bylaws to be filed upon completion of this offering will contain
similar indemnification provisions.
Prior to the completion of the offering, the Registrant intends
to enter into Indemnification Agreements with each of its
current directors and officers to provide such directors and
officers additional contractual assurances regarding the scope
of the indemnification set forth in the Registrants
restated certificate of incorporation and amended and restated
bylaws and to provide additional procedural protections. At
present, there is no pending litigation or proceeding involving
a director, officer or employee of the Registrant regarding
which indemnification is sought. Reference is also made to
Section 7 of the Underwriting Agreement, which provides for
the indemnification of officers, directors and controlling
persons of the Registrant against certain liabilities. The
indemnification provision in the Registrants restated and
amended certificate of incorporation, amended and restated
bylaws and the indemnification agreements to be entered into
between the Registrant and each of its directors and officers
may be sufficiently broad to permit indemnification of the
Registrants directors and officers for liabilities arising
under the Securities Act.
II-1
The Registrant has directors and officers liability
insurance for securities matters prior to the closing of this
offering.
See also the undertakings set out in response to Item 17.
Reference is made to the following documents filed as exhibits
to this Registration Statement regarding relevant
indemnification provisions described above and elsewhere herein:
|
|
|
|
|
Exhibit Document |
|
Number | |
|
|
| |
Underwriting Agreement
|
|
|
1.1 |
* |
Registrants Third Amended and Restated Certificate of
Incorporation
|
|
|
3.1 |
|
Registrants Second Amended and Restated Bylaws
|
|
|
3.3 |
|
Second Amended and Restated Investors Rights Agreement
dated October 26, 2004
|
|
|
4.2 |
|
Form of Indemnification Agreement
|
|
|
10.1 |
* |
|
|
* |
To be filed by amendment. |
|
|
ITEM 15. |
Recent Sales of Unregistered Securities. |
|
|
|
|
|
On June 20, 2003, we sold 75,000 shares of our common
stock at a price of $0.46 per share to Dr. Robert
Friedman, a former member of our board of directors, and
75,000 shares of our common stock at a price of
$0.46 per share to Breaux Castleman, a member of our board
of directors, and the chairman of our board. |
|
|
|
|
On June 20, 2003, we issued an aggregate of
45,000 shares of our Series B preferred stock to the
149 Series B preferred stock investors who originally
purchased our Series B preferred stock in 2000 in
consideration of certain amendments to their investment
agreements. |
|
|
|
|
|
On June 20, 2003, we issued a warrant to purchase up to
24,890 shares of our Series C preferred stock at an
exercise price of $2.26 per share to Koji Miyazaki, one of
our Series C preferred stock investors. |
|
|
|
|
On June 20, 2003, we also issued a warrant to
Dr. Marek Elbaum, a former member of our board of directors
and former Chief Science and Technology Officer, to purchase up
to 25,000 shares of our common stock at per share exercise
price of $13.00. |
|
|
|
|
From June 20, 2003 through October 26, 2004, we issued
an aggregate of 5,414,779 shares of our Series C
preferred stock to 73 accredited investors for an aggregate
consideration of $12,191,480. |
|
|
|
|
|
From June 20, 2003 through October 26, 2004, we issued
warrants to purchase up to an aggregate of 2,610,643 shares
of our common stock with an exercise price of $13.00 per
share to certain purchasers of our Series C preferred stock. |
|
|
|
|
|
On February 2, 2004, we issued a warrant to purchase up to
121,681 shares of our Series C preferred stock with an
exercise price $2.26 per share to Health Partners I,
LLC. |
|
|
|
|
|
In May 2004, we issued 125,000 shares of our common stock
at a per share purchase price of $0.46 to accredited investors
who loaned an aggregate of $1,000,000 to the company, which
loans were evidenced by convertible promissory notes, all of
which converted into shares of our Series C preferred stock
on October 26, 2004. |
|
|
|
|
On December 10, 2004, we issued a warrant to
Allen & Company LLC to purchase up to
75,000 shares of our common stock at an exercise price of
$7.00 per share in consideration of Allen &
Companys agreement to provide certain advisory services to
us. |
|
|
|
From January 1, 2002 to May 15, 2005 we granted
options to purchase 852,621 shares of our common stock
to employees, directors and consultants under our 1996 Plan and
2003 Plan. |
II-2
The sales of the above securities were deemed to be exempt from
registration under the Securities Act in reliance on
Section 4(2) of the Securities Act, or Regulation D
promulgated thereunder, or Rule 701 promulgated under
Section 3(b) of the Securities Act, as transactions by an
issuer not involving a public offering or transactions pursuant
to compensatory benefit plans and contracts relating to
compensation as provided under Rule 701. The recipients of
securities in each of these transactions represented their
intention to acquire the securities for investment only and not
with view to or for sale in connection with any distribution
thereof and appropriate legends were affixed to the share
certificates and instruments issued in such transactions. The
sales of these securities were made without general solicitation
or advertising. All recipients had adequate access, through
their relationship with the Registrant, to information about the
Registrant.
|
|
ITEM 16. |
Exhibits and Financial Statement Schedules. |
(a) The following exhibits are filed herewith:
|
|
|
|
|
Number |
|
Exhibit Title |
|
|
|
|
1 |
.1* |
|
Form of Underwriting Agreement. |
|
|
3 |
.1** |
|
Third Amended and Restated Certificate of Incorporation. |
|
|
3 |
.2 |
|
Form of Amended and Restated Certificate of Incorporation of
Registrant to be effective upon closing of the offering. |
|
|
3 |
.3** |
|
Second Amended and Restated Bylaws of the Registrant as
currently in effect. |
|
|
3 |
.4* |
|
Form of Amended and Restated Bylaws of the Registrant to be
effective upon closing of the offering. |
|
|
4 |
.1* |
|
Specimen Stock Certificate. |
|
|
4 |
.2** |
|
Second Amended and Restated Investors Rights Agreement
dated as of October 26, 2004 by and among the Registrant
and the parties listed therein. |
|
|
5 |
.1* |
|
Opinion of Dreier LLP. |
|
|
10 |
.1* |
|
Form of Indemnification Agreement for directors and executive
officers. |
|
|
10 |
.2** |
|
1996 Stock Option Plan. |
|
|
10 |
.3** |
|
2003 Stock Incentive Plan, as amended. |
|
|
10 |
.4 |
|
2005 Stock Incentive Plan. |
|
|
10 |
.5** |
|
Employment Agreement dated as of January 5, 2004 between
the Registrant and Joseph V. Gulfo. |
|
|
10 |
.6** |
|
Consulting Agreement dated as of May 31, 2005 between the
Registrant and Marek Elbaum. |
|
|
10 |
.7** |
|
Lease Agreement dated as of December 16, 1998, by and
between the Registrant and Bridge Street Properties LLC, for
office space located at One Bridge Street, Irvington, New York. |
|
|
10 |
.8** |
|
First Amendment to the Lease Agreement dated as of May 17,
2001 by and between the Registrant and Bridge Street Properties
LLC. |
|
|
10 |
.9** |
|
Second Amendment to the Lease Agreement dated as of
June 19, 2003 by and between the Registrant and Bridge
Street Properties LLC. |
|
|
10 |
.10** |
|
Lease Agreement dated as of November 23, 2004, by and
between the Registrant and Bridge Street Properties LLC, for
office space located at 3 West Main Street, Irvington, New York. |
|
|
10 |
.11 |
|
Consulting Agreement dated as of June 1, 2005 between the
Registrant and Gerald Wagner Consulting, LLC. |
|
|
10 |
.12 |
|
Consulting Agreement dated as of June 20, 2003 between the
Registrant and Breaux Castleman, as amended. |
|
|
10 |
.13 |
|
Consulting Agreement dated as of June 1, 2005 between the
Registrant and Robert Friedman, M.D. |
|
|
10 |
.14* |
|
Task Order Agreement dated as of July 13, 2005 between the
Registrant and Battelle Memorial Institute. |
|
|
10 |
.15 |
|
Third Amendment dated as of June 6, 2005, by and between
the Registrant and Bridge Street Properties LLC, for office
space located at 1 Bridge Street, Irvington, New York. |
|
|
14 |
.1 |
|
Code of Business Conduct and Ethics. |
II-3
|
|
|
|
|
Number |
|
Exhibit Title |
|
|
|
|
|
23 |
.1 |
|
Consent of Eisner LLP, Independent Registered Public Accounting
Firm. |
|
|
23 |
.2* |
|
Consent of Counsel (included in Exhibit 5.1). |
|
|
24 |
.1** |
|
Power of Attorney. |
|
|
* |
To be filed by amendment. |
|
|
|
(b) |
|
Financial statement schedules are omitted because the
information called for is not required or is shown either in the
financial statements or the notes thereto. |
The undersigned Registrant hereby undertakes to provide to the
underwriters at the closing specified in the Underwriting
Agreement certificates in such denominations and registered in
such names as required by the Underwriters to permit prompt
delivery to each purchaser.
Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers and
controlling persons of the Registrant pursuant to the provisions
described under Item 14 above, or otherwise, the Registrant
has been advised that in the opinion of the SEC such
indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other
than the payment by the Registrant of expenses incurred or paid
by a director, officer or controlling person of the Registrant
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 Registrant
will, unless in the opinion of its 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.
The undersigned Registrant hereby undertakes that:
|
|
|
(1) For purposes of determining any liability under the
Securities Act, the information omitted from the form of
prospectus filed as part of this Registration Statement in
reliance upon Rule 430A and contained in a form of
prospectus filed by the Registrant pursuant to
Rule 424(b)(1) or (4) or 497(h) under the
Securities Act shall be deemed to be part of this Registration
Statement as of the time it was declared effective. |
|
|
(2) For the purpose of determining any liability under the
Securities Act, each post-effective amendment that contains a
form of prospectus shall be deemed to be a new registration
statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof. |
II-4
SIGNATURES
Pursuant to the requirements of the Securities Act, the
Registrant has duly caused this Registration Statement to be
signed on its behalf by the undersigned, thereunto duly
authorized, in the City of New York, New York, on this
15th
day of July, 2005.
|
|
|
ELECTRO-OPTICAL SCIENCES, INC. |
|
|
|
Joseph V. Gulfo |
|
President and Chief Executive Officer |
Pursuant to the requirements of the Securities Act, this
Registration Statement has been signed by the following persons
in the capacities and on the date indicated.
|
|
|
|
|
|
|
Name |
|
Title |
|
Date |
|
|
|
|
|
|
Principal Executive Officer: |
|
|
|
|
|
/s/ Joseph V. Gulfo
Joseph
V. Gulfo |
|
President , Chief Executive Officer and Director |
|
July 15, 2005 |
|
Principal Financial Officer and Principal Accounting
Officer: |
|
|
|
|
|
/s/ Karen Krumeich
Karen
Krumeich |
|
Vice President, Finance and Chief Financial Officer |
|
July 15, 2005 |
|
Additional Directors: |
|
|
|
|
|
*
Breaux
Castleman |
|
Director, Chairman of the Board of Directors |
|
July 15, 2005 |
|
*
Sidney
Braginsky |
|
Director |
|
July 15, 2005 |
|
*
George
C. Chryssis |
|
Director |
|
July 15, 2005 |
|
*
Dan
W. Lufkin |
|
Director |
|
July 15, 2005 |
|
*
Gerald
Wagner |
|
Director |
|
July 15, 2005 |
|
*By: |
|
/s/ Joseph V. Gulfo
Joseph
V. Gulfo
Attorney-in-fact |
|
|
|
|
II-5
EXHIBIT INDEX
|
|
|
|
|
Number |
|
Exhibit Title |
|
|
|
|
1 |
.1* |
|
Form of Underwriting Agreement. |
|
|
3 |
.1** |
|
Third Amended and Restated Certificate of Incorporation. |
|
|
3 |
.2 |
|
Form of Amended and Restated Certificate of Incorporation of
Registrant to be effective upon closing of the offering. |
|
|
3 |
.3** |
|
Second Amended and Restated Bylaws of the Registrant as
currently in effect. |
|
|
3 |
.4* |
|
Form of Amended and Restated Bylaws of the Registrant to be
effective upon closing of the offering. |
|
|
4 |
.1* |
|
Specimen Stock Certificate. |
|
|
4 |
.2** |
|
Second Amended and Restated Investors Rights Agreement
dated as of October 26, 2004 by and among the Registrant
and the parties listed therein. |
|
|
5 |
.1* |
|
Opinion of Dreier LLP. |
|
|
10 |
.1* |
|
Form of Indemnification Agreement for directors and executive
officers. |
|
|
10 |
.2** |
|
1996 Stock Option Plan. |
|
|
10 |
.3** |
|
2003 Stock Incentive Plan, as amended. |
|
|
10 |
.4 |
|
2005 Stock Incentive Plan. |
|
|
10 |
.5** |
|
Employment Agreement dated as of January 5, 2004 between
the Registrant and Joseph V. Gulfo. |
|
|
10 |
.6** |
|
Consulting Agreement dated as of May 31, 2005 between the
Registrant and Marek Elbaum. |
|
|
10 |
.7** |
|
Lease Agreement dated as of December 16, 1998, by and
between the Registrant and Bridge Street Properties LLC, for
office space located at One Bridge Street, Irvington, New York. |
|
|
10 |
.8** |
|
First Amendment to the Lease Agreement dated as of May 17,
2001 by and between the Registrant and Bridge Street Properties
LLC. |
|
|
10 |
.9** |
|
Second Amendment to the Lease Agreement dated as of
June 19, 2003 by and between the Registrant and Bridge
Street Properties LLC. |
|
|
10 |
.10** |
|
Lease Agreement dated as of November 23, 2004, by and
between the Registrant and Bridge Street Properties LLC, for
office space located at 3 West Main Street, Irvington, New York. |
|
|
10 |
.11 |
|
Consulting Agreement dated as of June 1, 2005 between the
Registrant and Gerald Wagner Consulting, LLC. |
|
|
10 |
.12 |
|
Consulting Agreement dated as of June 20, 2003 between the
Registrant and Breaux Castleman, as amended. |
|
|
10 |
.13 |
|
Consulting Agreement dated as of June 1, 2005 between the
Registrant and Robert Friedman, M.D. |
|
|
10 |
.14* |
|
Task Order Agreement dated as of July 13, 2005 between the
Registrant and Battelle Memorial Institute. |
|
|
10 |
.15 |
|
Third Amendment dated as of June 6, 2005, by and between
the Registrant and Bridge Street Properties LLC, for office
space located at 1 Bridge Street, Irvington, New York. |
|
14 |
.1 |
|
Code of Business Conduct and Ethics. |
|
|
23 |
.1 |
|
Consent of Eisner LLP, Independent Registered Public Accounting
Firm. |
|
|
23 |
.2* |
|
Consent of Counsel (included in Exhibit 5.1). |
|
|
24 |
.1** |
|
Power of Attorney. |
|
|
|
|
* |
To be filed by amendment. |
EXHIBIT 3.2
FOURTH AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION OF
ELECTRO-OPTICAL SCIENCES, INC.
Electro-Optical Sciences, Inc., a corporation organized and existing under
the laws of the State of Delaware (the "Corporation"), certifies that:
A. The name of the Corporation is Electro-Optical Sciences, Inc. The
Corporation's original Certificate of Incorporation was filed with the Secretary
of State of the State of Delaware on September 3, 1997.
B. The Corporation's Amended and Restated Certificate of Incorporation was
filed with the Secretary of State of the State of Delaware on June 19, 2003.
C. The Corporation's Second Amended and Restated Certificate of
Incorporation was filed with the Secretary of State of the State of Delaware on
April 7, 2004.
D. The Corporation's Third Amended and Restated Certificate of
Incorporation was filed with the Secretary of State of the State of Delaware on
October 26, 2004.
E. This Fourth Amended and Restated Certificate of Incorporation of the
Corporation was duly adopted in accordance with Sections 242 and 245 of the
General Corporation Law of the State of Delaware (the "DGCL"), and restates,
integrates and further amends the provisions of the Corporation's Third Amended
and Restated Certificate of Incorporation as follows:
ARTICLE I
The name of the Corporation is Electro-Optical Sciences, Inc.
ARTICLE II
The purpose of the Corporation is to engage in any lawful act or activity
for which corporations may be organized under the DGCL.
The address of the Corporation's registered office in the State of
Delaware is c/o United Corporate Services, Inc., 15 East North Street, in the
City of Dover, County of Kent, State of Delaware. The name of the registered
agent at such address is United Corporate Services, Inc.
ARTICLE III
The total number of shares of stock that the corporation shall have
authority to issue is 40,000,000 consisting of 30,000,000 shares of Common
Stock, $0.001 par value per share, and 10,000,000 shares of Preferred Stock,
$0.10 par value per share.
1
The Preferred Stock may be issued in one or more series at such time
or times and for such consideration or considerations as the Board of Directors
of the Corporation may determine. Each series shall be so designated as to
distinguish the shares thereof from the shares of all other series and classes.
Except as to the relative preferences, powers, qualifications, rights and
privileges which may be determined by the Board of Directors of the Corporation
as described below, all shares of Preferred Stock shall be identical. Except as
and to the extent otherwise specified herein, different series of Preferred
Stock shall not be construed to constitute different classes of shares for the
purpose of voting by class.
The Board of Directors of the Corporation is expressly authorized by
a vote of all of the members of the Board of Directors then in office, subject
to the limitations prescribed by law and the provisions of this Fourth Amended
and Restated Certificate of Incorporation, as amended from time to time, to
provide by adopting a vote or votes, a certificate of which shall be filed in
accordance with the DGCL, for the issue of the Preferred Stock in one or more
classes or series, each with the designations, rights and privileges that shall
be stated in the vote or votes creating such classes or series. The authority of
the Board of Directors of the Corporation with respect to each such class or
series of Preferred Stock shall include, without limitation of the foregoing,
the right to determine and fix:
(a) The distinctive designation of such class or series and the
number of shares to constitute such class or series;
(b) The rate at which dividends on the shares of such class or
series shall be declared and paid, or set aside for payment, whether
dividends at the rate so determined shall be cumulative, and whether the
shares of such class or series shall be entitled to any participating or
other dividends in addition to dividends at the rate so determined, and if
so on what terms;
(c) The right, if any, of the Corporation to redeem shares of the
particular class or series and, if redeemable, the price, terms and manner
of such redemption;
(d) The special and relative rights and preferences, if any, and the
amount or amounts per share, which the shares of such class or series
shall be entitled to receive upon any voluntary or involuntary
liquidation, dissolution or winding up of the Corporation;
(e) The terms and conditions, if any, upon shares of such class or
series shall be convertible into, or exchangeable for, shares of stock, or
any other class or classes, including the price or prices or the rate or
rates of conversion or exchange and the terms of adjustment, if any;
(f) The obligation, if any, of the Corporation to retire or purchase
shares of such class or series pursuant to a sinking fund or fund of a
similar nature or otherwise, and the terms and conditions of such
obligation;
(g) The voting rights, if any, including special voting rights with
respect to the election of directors and matters adversely affecting any
such class or series;
2
(h) The limitations, if any, on the issuance of additional shares of
such class or series or any shares of any other class or series of
Preferred Stock; and
(i) Any other preferences, powers, qualifications, special or
relative rights and privileges thereof that the Board of Directors of the
Corporation may deem advisable and that are not inconsistent with law and
the provisions of this Fourth Amended and Restated Certificate of
Incorporation.
ARTICLE IV
The Corporation reserves the right to amend, alter, change, or repeal any
provision contained in this Fourth Amended and Restated Certificate of
Incorporation, in the manner now or hereafter prescribed by statute, and all
rights conferred upon the stockholders herein are granted subject to this right.
ARTICLE V
The Corporation is to have perpetual existence.
ARTICLE VI
1. The number of directors which constitutes the whole Board of Directors
of the Corporation shall be designated in the Bylaws of the Corporation.
Any director may be removed from office by the stockholders of the
Corporation only for cause. Vacancies occurring on the Board of Directors for
any reason and newly created directorships resulting from an increase in the
authorized number of directors may be filled only by vote of a majority of the
remaining members of the Board of Directors, although less than a quorum, or by
a sole remaining director, at any meeting of the Board of Directors. A person so
elected by the Board of Directors to fill a vacancy or newly created
directorship shall hold office until his or her successor shall have been duly
elected and qualified.
2. Elections of directors need not be by written ballot unless the Bylaws
of the Corporation shall so provide.
ARTICLE VII
In furtherance and not in limitation of the powers conferred by statute,
the Board of Directors of the Corporation is expressly authorized to make,
alter, amend or repeal the Bylaws of the Corporation.
ARTICLE VIII
No action shall be taken by the stockholders of the Corporation except at
an annual or special meeting of the stockholders called in accordance with the
Bylaws and no action shall be taken by the stockholders by written consent.
3
ARTICLE IX
1. To the fullest extent permitted by the Delaware General Corporation Law
as the same exists or as may hereafter be amended, a director of the Corporation
shall not be personally liable to the Corporation or its stockholders for
monetary damages for a breach of fiduciary duty as a director.
2. The Corporation may indemnify to the fullest extent permitted by law
any person made or threatened to be made a party to an action or proceeding,
whether criminal, civil, administrative or investigative, by reason of the fact
that he, his testator or intestate is or was a director, officer or employee of
the Corporation or any predecessor of the Corporation or serves or served at any
other enterprise as a director, officer or employee at the request of the
Corporation or any predecessor to the Corporation.
3. Neither any amendment nor repeal of this Article IX, nor the adoption
of any provision of this Fourth Amended and Restated Certificate of
Incorporation inconsistent with this Article IX, shall eliminate or reduce the
effect of this Article IX, in respect of any matter occurring, or any action or
proceeding accruing or arising or that, but for this Article IX, would accrue or
arise, prior to such amendment, repeal or adoption of an inconsistent provision.
ARTICLE X
Meetings of stockholders may be held within or without the State of
Delaware, as the Bylaws may provide. The books of the Corporation may be kept
(subject to any provision contained in the statutes) outside of the State of
Delaware at such place or places as may be designated from time to time by the
Board of Directors or in the Bylaws of the Corporation.
4
IN WITNESS WHEREOF, the undersigned has executed this Fourth Amended and
Restated Certificate of Incorporation this ____ day of ________, 2005.
By:
--------------------
Joseph V. Gulfo, M.D.
Chief Executive Officer
5
EXHIBIT 10.4
ELECTRO-OPTICAL SCIENCES, INC.
2005 STOCK INCENTIVE PLAN
1. Purpose. The purpose of the Electro-Optical Sciences, Inc. 2005 Stock
Incentive Plan (the "Plan") is to establish a flexible vehicle through which
Electro-Optical Sciences, Inc. (the "Company"), may offer equity-based
compensation incentives to key employees and other persons (including, without
limitation, directors, officers, consultants and scientific collaborators)
employed or engaged by the Company and/or its subsidiaries (collectively,
"Eligible Persons") to attract, motivate, reward and retain such Eligible
Persons and to further align the interests of such Eligible Persons with those
of the stockholders of the Company.
2. Types of Awards. Awards under the Plan may be in the form of (a)
options to purchase shares of the Company's common stock, no par value per share
(the "Common Stock") granted pursuant to Section 6 below, including options
intended to qualify as "incentive stock options" ("ISOs") within the meaning of
Section 422 of the Internal Revenue Code of 1986, as amended (the "Code") and
options which do not qualify as ISOs, and (b) stock awards granted pursuant to
Section 7 below (collectively, "Awards").
3. Administration.
(a) Compensation Committee. The Plan shall be administered by the
Compensation Committee of the Board of Directors of the Company (the
"Compensation Committee"). The Compensation Committee shall be comprised of
independent outside directors.
(b) Authority of Compensation Committee. Subject to the limitations
of the Plan, the Compensation Committee, acting in its sole and absolute
discretion, shall have full power and authority to administer the Plan,
including, without limitation, the power to (i) determine the eligibility and
the particular persons to whom awards shall be made under the Plan, (ii) grant
awards to such persons and prescribe the terms and conditions of such awards,
(iii) construe, interpret and apply the provisions of the Plan and of any
agreement or other instrument evidencing an award granted under the Plan, (iv)
cancel, modify or waive the Company's rights with respect to, or modify,
discontinue, suspend or terminate any or all outstanding Awards held by
Participants, subject to any required consent under Paragraph 11, (v) prescribe,
amend and rescind rules and regulations relating to the Plan, including rules
governing its own operations, (vi) amend the Plan in any respect, including,
without limitation, to correct any defect, supply any omission and reconcile any
inconsistency in the Plan, (vii) amend any outstanding Award in any respect,
including, without limitation, to accelerate the time or times at which the
Award becomes vested or exercisable, (viii) carry out any responsibility or duty
specifically reserved to the Compensation Committee under the Plan, and (ix)
make any and all determinations and interpretations and take such other actions
as may be necessary or desirable in order to carry out the provisions, intent
and purposes of the Plan.
All decisions of the Compensation Committee, shall be reasonable and
made in good faith and shall be conclusive and binding on all Participants in
the Plan.
(c) Procedures. A majority of the members of the Compensation
Committee shall constitute a quorum. The Compensation Committee may act by the
vote of a majority of its members present at a meeting at which there is a
quorum or by unanimous written consent. Members of the Compensation Committee
shall abstain from participating in and deciding matters which directly affect
their individual ownership interest under the Plan.
(d) Indemnification. The Company shall indemnify and hold harmless
each member of the Compensation Committee and any employee or director of the
Company to whom any duty or power relating to the administration or
interpretation of the Plan is delegated from and against any loss, cost,
liability (including any sum paid in settlement of a claim with the approval of
the Board of Directors of the Company (the "Board"), damage and expense
(including legal and other expenses incident thereto) arising out of or incurred
in connection with the Plan, unless and except to the extent attributable to
such person's fraud or willful misconduct.
(e) Compliance with Code Section 162(m). In the event the Company
becomes a "publicly-held corporation" as defined in Code Section 162(m)(2), the
Company may establish a Compensation Committee of outside directors meeting the
requirements of CoDe Section 162(m)(2) to (i) approve Awards that might
reasonably be anticipated to result in the payment of employee remuneration that
would otherwise exceed the limit on employee remuneration deductible for income
tax purposes by the Company pursuant to Code Section 162(m); and (ii) administer
the Plan. In such event, Awards under the Plan shall be granted upon
satisfaction of the conditions to such grants provided pursuant to Code
Section 162(m) and any Treasury Regulations promulgated thereunder.
4. Share Limitations. Subject to adjustment pursuant to Section 9 below,
the maximum number of shares of Common Stock that may be issued under the Plan
is 1,000,000. The number of shares authorized for issuance under this Plan and
all other share amounts set forth in this Plan reflect the 1-for-2 reverse split
of the Company's Common Stock authorized by the Board of Directors of the
Company on May 13, 2005. In determining the number of shares that remain
issuable under the Plan at any time after the date the Plan is adopted, the
following shares will be deemed not to have been issued (and will be deemed to
remain available for issuance) under the Plan: (i) shares remaining under an
Award made under the Plan that terminates or is canceled without having been
exercised or earned in full; (ii) shares subject to an award under the Plan
where cash is delivered to the holder of the Award in lieu of such shares; (iii)
shares of restricted stock awarded under the Plan that are forfeited in
accordance with the terms of the applicable Award; and (iv) shares that are
withheld in order to pay the purchase price of shares acquired upon the exercise
of Awards granted under the Plan or to satisfy the tax withholding obligations
associated with such exercise. The number of shares of Common Stock issued in
connection with an award under the Plan will be determined net of any
previously-owned shares tendered by the holder of the Award in payment of the
exercise price or of applicable withholding taxes. The number of shares
available for grant and issuance under the Plan shall automatically be increased
on the first day of each of January 2006 and January 2007 by the lesser of: (i)
three percent (3%) of the number of shares of Common Stock issued and
outstanding on the preceding December 31, and (ii) a lesser number of shares of
Common Stock determined by the Board of Directors of the Company.
2
5. Eligibility. Awards under the Plan may be made to any Eligible Person
as the Compensation Committee may select. Each such person to whom an Award is
granted under the Plan is referred to herein as a "Participant".
6. Stock Options. Subject to the provisions of the Plan, the Compensation
Committee may grant options to eligible personnel upon such terms and conditions
as the Compensation Committee deems appropriate. Each option granted under the
Plan shall be designated as either statutory or non-statutory and each option
designated as a statutory option shall be further designated as qualified or
non-qualified. The terms and conditions of any option shall be evidenced by a
written option agreement or other instrument approved for this purpose by the
Compensation Committee ("Option Agreement").
(a) Date of Grant. Except as may be otherwise provided in an Option
Agreement, the date of grant of an option under this Plan shall be the date as
of which the Compensation Committee approves the grant.
(b) Exercise Price. The exercise price per share of Common Stock
covered by an option granted under the Plan may not be less than the Fair Market
Value (as defined below) per share of the Common Stock at the time of grant (or,
in the case of an ISO granted to a Participant who, at the time the option is
granted, owns stock possessing more than 10% of the total combined voting power
of all classes of stock of the Company or a "subsidiary" of the Company within
the meaning of Section 424 of the Code, 110% of the Fair Market Value per
share).
(c) Option Term. No option granted under the Plan may be exercisable
(if at all) more than ten years after the date the option is granted (or, in the
case of an ISO granted to a ten percent stockholder described in Section 422 of
the Code, five years after the date the option is granted).
(d) Vesting and Exercise of Options. The Compensation Committee, in
its sole discretion, may establish such vesting and other conditions and
restrictions on the exercise of an option and/or upon the issuance of Common
Stock in connection with the exercise of an option as it deems appropriate.
Subject to satisfaction of applicable withholding requirements, once vested and
exercisable, an option may be exercised by delivering a written notice (the
"Notice") to the Secretary of the Company. The Notice shall state: (i) that the
Participant elects to exercise the option; (ii) the number of shares with
respect to which the option is being exercised (the "Option Shares"); (iii) the
method of payment for the Option Shares; (iv) the date upon which the
Participant desires to consummate the purchase of the Option Shares (which date
must be prior to the termination of such option); and (v) any additional
provisions consistent with the Plan as the Compensation Committee may from time
to time require. The exercise date of an option shall be the date on which the
Company receives the Notice from the Participant. The Compensation Committee,
acting in its sole discretion, may permit the exercise price to be paid in whole
or in part in cash or by check, by means of a cashless exercise procedure to the
extent permitted by law, in the form of unrestricted shares of Common Stock (to
the extent of the Fair Market Value thereof) or, subject to applicable law, by
any other form of consideration deemed appropriate.
(e) Rights as a Stockholder. No shares of Common Stock shall be
issued in respect of the exercise of an option until full payment of the
exercise price and the applicable tax withholding obligation with respect to
such exercise has been made or provided for. The holder
3
of an option shall have no rights as a stockholder with respect to any shares
covered by the option until the option is validly exercised, the exercise price
is paid fully and applicable withholding obligations are satisfied.
(f) Termination of Employment or other Service. Unless otherwise
determined by the Compensation Committee at grant or, if no rights of the
Participant are reduced, thereafter, and subject to earlier termination in
accordance with the provisions hereof, the following rules apply with regard to
options held by a Participant at the time of his or her termination of
employment or other service with the Company and its subsidiaries.
(i) Termination by Reason of Death or Disability. If a
Participant's employment or other service terminates by reason of death or
Disability (as defined below), then (1) any portion of an option held by the
Participant which is not then exercisable shall thereupon terminate, and (2) any
portion of an option held by the Participant which is then exercisable shall
remain exercisable by the Participant (or beneficiary) for a period of one year
following such termination of employment or other service or, if sooner, until
the expiration of the term of the option, and, to the extent not exercised
within such period, shall thereupon terminate. For purposes of the Plan, the
term Disability shall mean, unless the Compensation Committee determines
otherwise at the time of grant, the inability of a person to perform the
essential functions of his or her position, with or without reasonable
accommodation, by reason of a physical or mental incapacity or illness which is
expected to result in death or to be of indefinite duration of not less than 12
months.
(ii) Termination for Cause. If a Participant's employment or
other service is terminated by the Company or any of its subsidiaries for Cause
(as defined below), then any option held by the Participant, whether or not then
exercisable, shall immediately terminate and cease to be exercisable. For
purposes of the Plan, a termination for "Cause" means (1) in the case where
there is no employment, consulting or similar service agreement between the
Participant and the Company or any of its subsidiaries or where such an
agreement exists but does not define "cause" (or words of like import), a
termination classified by the Company or any of its subsidiaries, as a
termination due to the Participant's (i) commission of, or entry of a plea of
guilty or no contest to any felony, fraud, misappropriation, embezzlement or
other crime of moral turpitude; (ii) commission of, or entry of a plea of guilty
or no contest to any crime or offense involving money or property of the
Company; (iii) dishonesty or fraud; or (iv) insubordination, willful misconduct,
refusal to perform services or materially unsatisfactory performance of duties,
or (2) in the case where there is an employment, consulting or similar service
agreement between the Participant and the Company or any of its subsidiaries
that defines "cause" (or words of like import), a termination that is or would
be deemed for "cause" (or words of like import) under such agreement.
(iii) Other Termination. If a Participant's employment or
other service terminates for any reason (other than death, Disability or Cause)
or no reason, then (1) any portion of an option held by the Participant which is
not then exercisable shall thereupon terminate, and (2) any portion of an option
held by the Participant which is then exercisable shall remain exercisable
during the ninety (90) day period following such termination or, if sooner,
until the expiration of the term of the option and, to the extent not exercised
within such period, shall thereupon terminate.
4
(g) Nontransferability. No option shall be assignable or
transferable except upon the Participant's death to a beneficiary designated by
the Participant in a manner prescribed or approved for this purpose by the
Compensation Committee or, if no designated beneficiary shall survive the
Participant, pursuant to the Participant's will or by the laws of descent and
distribution. During a Participant's lifetime, options may be exercised only by
the Participant or the Participant's guardian or legal representative.
Notwithstanding the foregoing, the Compensation Committee may permit the inter
vivos transfer of a Participant's options (other than options designated as
ISOs) by gift to such persons and on such terms and conditions as the
Compensation Committee deems appropriate.
7. Stock Awards. Subject to the provisions of the Plan, the Compensation
Committee may grant stock awards to eligible Participants upon such terms and
conditions as the Compensation Committee deems appropriate. The terms and
conditions of any stock award shall be evidenced by a written stock award
agreement or other instrument approved for this purpose by the Compensation
Committee. A stock award may take the form of the issuance and transfer to the
recipient of shares of Common Stock or a grant of stock units representing a
right to receive shares of Common Stock in the future and, in either case, may
be subject to designated vesting conditions and transfer restrictions.
(a) Purchase Price. The purchase price payable for shares of Common
Stock transferred pursuant to a stock award must be at least equal to their Fair
Market Value on the date of the grant.
(b) Stock Certificates for Non-Vested Stock. Shares of Common Stock
issued pursuant to a non-vested stock award may be evidenced by book entries on
the Company's stock transfer records pending satisfaction of the applicable
vesting conditions. If a stock certificate for shares is issued before the stock
award vests, the certificate will bear an appropriate legend to reflect the
nature of the conditions and restrictions applicable to the shares, and the
Company may require that any or all such stock certificates be held in custody
by the Company until the applicable conditions are satisfied and other
restrictions lapse. The Compensation Committee may establish such other
conditions as it deems appropriate in connection with the issuance of
certificates for shares issued pursuant to non-vested stock awards, including,
without limitation, a requirement that the recipient deliver a duly signed stock
power, endorsed in blank, for the shares covered by the award.
(c) Stock Certificates for Vested Stock. The recipient of a vested
stock award will be entitled to receive a certificate, free and clear of
conditions and restrictions (except as may be imposed in order to comply with
applicable law or the terms of any stockholders' agreement), for vested shares
covered by the award, subject, however, to the payment or satisfaction of
withholding tax obligations in accordance with Section 10.
(d) Rights as a Stockholder. Unless otherwise determined by the
Compensation Committee, (i) the recipient of a stock award will be entitled to
receive dividend payments, if any (or, in the case of an award of stock units,
dividend equivalent payments), on or with respect to the shares that remain
covered by the award (which the Compensation Committee may specify are payable
on a deferred basis and are forfeitable to the same extent as the underlying
award), (ii) the recipient of a non-vested stock award may exercise voting
rights if and to the extent that shares of Common Stock have been issued to him
pursuant to the award, and (iii) the
5
recipient will have no other rights as a stockholder with respect to such shares
unless and until the shares are issued to him free of all conditions and
restrictions under the Plan.
(e) Termination of Employment or other Service Before Vesting;
Forfeiture. Unless the Compensation Committee determines otherwise, a non-vested
stock award will be forfeited upon the termination of a recipient's employment
or other service with the Company and its subsidiaries. If a non-vested stock
award is forfeited, any certificate representing shares subject to such award
will be canceled on the books of the Company and the recipient will be entitled
to receive from the Company an amount equal to any cash purchase price paid by
him for such shares. If an award of stock units is forfeited, the recipient will
have no further right to receive the shares of Common Stock represented by such
units.
(f) Nontransferability. With respect to any stock Award, unless and
until all applicable vesting conditions, if any, are satisfied and vested shares
are issued, neither the stock Award nor any shares of Common Stock issued
pursuant to the Award may be sold, assigned, transferred, disposed of, pledged
or otherwise hypothecated other than to the Company in accordance with the terms
of the Award or the Plan. Any attempt to do any of the foregoing before such
time shall be null and void and, unless the Compensation Committee determines
otherwise, shall result in the immediate forfeiture of the shares or the Award,
as the case may be.
8. Fair Market Value. For purposes of the Plan, the Fair Market Value of a
share of Common Stock, as of any date shall mean, unless otherwise required by
other applicable law, the closing sale price per share of Common Stock as
published by the principal national securities exchange on which the Common
Stock is traded on such date or, if there is no sale of Common Stock on such
date, the average of the bid and asked prices on such exchange at the close of
trading on such date, or if shares of the Common Stock are not listed on a
national securities exchange on such date, the closing price or, if none, the
average of the bid and asked prices in the over-the-counter market at the close
of trading on such date, or if the Common Stock is not traded on a national
securities exchange or the over-the-counter market, the Compensation Committee
shall determine its Fair Market Value in such a manner as it deems appropriate
(such determination will be made in good faith as required by Section 422(c)(1)
of the Code, may be based on the advice of an independent investment banker or
appraiser recognized to be an expert in making such valuations and will take
into consideration the factors listed in 26 C.F.R.Section 20.2031.2).
9. Capital Changes; Acquisition Events.
(a) Capital Changes. The maximum number and class of shares that may
be issued under the Plan, the number and class of shares covered by each
outstanding Award and, if applicable, the exercise price per share shall all be
adjusted proportionately or as otherwise appropriate to reflect any increase or
decrease in the number of issued shares of Common Stock resulting from a
split-up or consolidation of shares or any like capital adjustment, or the
payment of any stock dividend, and/or to reflect a change in the character or
class of shares covered by the Plan arising from a readjustment or
recapitalization of the Company's capital stock.
(b) Acquisition Events. In the event of a merger, consolidation,
mandatory share exchange or other similar business combination of the Company
with or into any other entity ("Successor Entity") or any transaction in which a
Successor Entity acquires all the issued and outstanding capital stock of the
Company, or all or substantially all the assets of the Company
6
(each, an "Acquisition Event"), outstanding options may be assumed or an
equivalent option may be substituted by the Successor Entity or a parent of the
Successor Entity. If and to the extent that outstanding options are not assumed
or replaced with substantially equivalent options in connection with an
Acquisition Event, then each Participant shall have the right to exercise in
full all of his or her outstanding options, whether or not such options are
otherwise vested or exercisable, but contingent upon the occurrence of the
Acquisition Event, for a period of at least twenty (20) days prior to the
consummation of the Acquisition Event, in which case the Company shall notify
the Participant in writing or electronically that his or her options shall
become fully exercisable at least thirty (30) days prior to the consummation of
the Acquisition Event, and any outstanding options which are not exercised prior
to the consummation of the Acquisition Event shall thereupon terminate.
Notwithstanding the preceding sentence, if and to the extent outstanding options
are not assumed or replaced with substantially equivalent options in connection
with an Acquisition Event, the Compensation Committee, acting in its sole
discretion and without the consent of any Participant, may provide for the
cancellation of any outstanding options in exchange for payment in cash or other
property of the Fair Market Value of the shares of Common Stock covered by such
options (whether or not otherwise vested or exercisable), reduced by the
exercise price thereof (and any applicable withholdings thereon). The
Compensation Committee, acting in its sole discretion, may accelerate vesting of
non-vested stock awards, provide for cash settlement and/or make such other
adjustments to the terms of any outstanding stock award as it deems appropriate
in the context of an Acquisition Event.
(c) Fractional Shares. In the event of any adjustment in the number
of shares covered by any option pursuant to the provisions hereof, any
fractional shares resulting from such adjustment shall be disregarded, and each
such option shall cover only the number of full shares resulting from the
adjustment.
(d) Determinations Final. All adjustments under this Section 9 shall
be made by the Compensation Committee, and its determination as to what
adjustments shall be made, and the extent thereof, shall be final, binding and
conclusive.
10. Tax Withholding. As a condition to the exercise of any Award or the
delivery of any shares of Common Stock pursuant to any Award or the lapse of
restrictions on any Award, or in connection with any other event that gives rise
to a federal or other governmental tax withholding obligation on the part of the
Company or any of its subsidiaries relating to an Award (including, without
limitation, an income tax deferral arrangement pursuant to which employment tax
is payable currently), the Company and/or the subsidiary may (a) deduct or
withhold (or cause to be deducted or withheld) from any payment or distribution
to an award recipient whether or not pursuant to the Plan or (b) require the
recipient to remit cash (through payroll deduction or otherwise), in each case
in an amount sufficient in the opinion of the Company to satisfy such
withholding obligation. If the event giving rise to the withholding obligation
involves a transfer of shares of Common Stock, then, at the sole discretion of
the Compensation Committee, the recipient may satisfy the withholding obligation
described under this Section by electing to have the Company withhold shares of
Common Stock or by tendering previously-owned shares of Common Stock, in each
case having a Fair Market Value equal to the amount of tax to be withheld (or by
any other mechanism as may be required or appropriate to conform with local tax
and other rules); provided, however, that no shares may be withheld if and to
the extent that such withholding would result in the recognition of additional
accounting expense by the Company.
7
11. Amendment and Termination. The Board may amend or terminate the Plan,
provided, however, that no such action may adversely affect the rights of the
holder of any outstanding Award in a material way without the written consent of
the holder. Except as otherwise provided in Section 9, any amendment which would
increase the number of shares of Common Stock which may be issued under the Plan
or modify the class of persons eligible to receive Awards under the Plan shall
be subject to the approval of the Company's stockholders if and to the extent
that such approval is necessary or desirable to comply with applicable law or
exchange or listing requirements. The Board or the Compensation Committee may
amend the terms of any agreement or certificate made or issued hereunder at any
time and from time to time, provided, however, that any amendment which would
adversely affect the rights of the holder in a material way may not be made
without his or her written consent.
12. No Rights Conferred. Nothing contained in the Plan or in any Option
Agreement shall confer upon any recipient of an Award any right with respect to
the continuation of his employment or other service with the Company or its
subsidiaries or interfere in any way with the right of the Company and its
subsidiaries at any time to terminate such employment or other service or to
increase or decrease, or otherwise adjust, the other terms and conditions of the
recipient's employment or other service.
13. Compliance with Law.
(a) Compliance with Securities Laws. No Awards shall be granted and
no shares of Common Stock shall be issued or delivered pursuant to the Plan,
unless the issuance and delivery of such shares complies with applicable law,
including, without limitation, the Securities Act of 1933, as amended, the
Securities Exchange Act of 1934, as amended, and the requirements of any stock
exchange or market upon which the Common Stock may then be listed, and shall be
further subject to the approval of counsel for the Company with respect to such
compliance.
The Compensation Committee in its discretion may, as a condition to
the delivery of any shares pursuant to any Award granted under the Plan, require
the applicable Participant (i) to represent in writing that the shares received
pursuant to such Award are being acquired for investment and not with a view to
distribution and (ii) to make such other representations and warranties as are
deemed reasonably appropriate by the Compensation Committee. Stock certificates
representing shares acquired under the Plan that have not been registered under
the Securities Act shall, if required by the Compensation Committee, bear such
legends as may be required by the applicable Option Agreement, if any.
(b) No Right to an Award or Grant. Neither the adoption of the Plan
nor any action of the Compensation Committee shall be deemed to give an
employee, director or consultant any right to be granted an Award to purchase
Common Stock, receive an Award under the Plan except as may be evidenced by an
Option Agreement duly executed on behalf of the Company, and then only to the
extent of and on the terms and conditions expressly set forth in the Option
Agreement. The Plan will be unfunded. The Company will not be required to
establish any special or separate fund or to make any other segregation of funds
or assets to assure the payment of any Award.
(c) No Restriction of Corporate Action. Nothing contained in the
Plan or in any Option Agreement will be construed to prevent the Company or any
Subsidiary or Affiliate of
8
the Company from taking any corporate action which is deemed by the Company or
by its Subsidiaries and Affiliates to be appropriate or in its best interest,
whether such action would have an adverse effect on the Plan or any Award made
under the Plan. No Participant or beneficiary of a Participant will have any
claim against the Company or any affiliate as a result of any corporate action.
14. Transfer Orders; Placement of Legends. All certificates for shares of
Common Stock delivered under the Plan shall be subject to such stock-transfer
orders and other restrictions as the Company may deem advisable under the rules,
regulations, and other requirements of the Securities and Exchange Commission,
any stock exchange or market upon which the Common Stock may then be listed, and
any applicable federal or state securities law. The Company may cause a legend
or legends to be placed on any such certificates to make appropriate reference
to such restrictions.
15. Decisions and Determinations to be Final. All decisions and
determinations made by the Compensation Committee pursuant to the provisions
hereof shall be final, binding and conclusive.
16. Governing Law. All rights and obligations under the Plan and each
Option Agreement or instrument shall be governed by and construed in accordance
with the laws of the State of New York, without regard to its principles of
conflict of laws.
17. Term of the Plan. The Plan shall become effective on the date of its
adoption by the Board, subject to the approval of the Company's stockholders
within 12 months of such date. Unless sooner terminated by the Compensation
Committee, the Plan shall terminate on the tenth anniversary of the date of its
adoption by the Board. The rights of any person with respect to an Award granted
under the Plan that is outstanding at the time of the termination of the Plan
shall not be affected solely by reason of the termination of the Plan and shall
continue in accordance with the terms of the Award (as then in effect or
thereafter amended) and the Plan.
18. Supersession. This Plan supersedes the Electro-Optical Sciences, Inc.
2003 Stock Incentive Plan, as amended, (the "Prior Plan). Although options may
be outstanding under the Prior Plan, no Awards will be granted under the Prior
Plan after December 31, 2004.
19. Code Section 409A Compliance. This Plan is intended to provide for
statutory and non-statutory stock option benefits that are not deemed to be
deferred compensation and thus are not subject to the provisions of Code
Section 409A. If the Plan is deemed to be subject to Code Section 409A, however,
the Company may modify the Plan and any Awards granted under the Plan to comply
with Code Section 409A guidance; provided, however, that the present value of
Awards granted to Participants after such modification shall not be less than
the present value of the Awards granted to Participants prior to the
modification.
20. Section 16 Compliance. It is intended that the Plan and any Award made
to a Participant subject to Section 16 of the Exchange Act meet all of the
requirements of Rule 16b-3. If any provisions of the Plan or any Award would
disqualify the Plan or the Award, or would otherwise not comply with Rule 16b-3,
such provision or Award will be construed or deemed amended to conform to Rule
16b-3.
21. Related Agreements: Lock-Up.
(a) As a condition to the issuance of shares of Common Stock
pursuant to a stock
9
award or upon exercise of an option granted pursuant to the Plan, the recipient
shall, at the request of the Board, be required to become a party to any
stockholders' or similar agreement(s) to which the Company and some or all of
its stockholders may from time to time be party.
(b) As a condition to the issuance of shares of Common Stock
pursuant to a stock award or upon exercise of an option granted pursuant to the
Plan, the recipient shall, at the request of the Compensation Committee, agree
that he or she will not, without the prior written consent of the managing
underwriter, if any, for any public offering of the Company's securities, during
the period commencing. on the date of the final prospectus relating to such
public offering and ending on the date specified by the Company and the managing
underwriter (such period not to exceed one hundred eighty (180) days), (i) lend,
offer, pledge, sell, contract to sell, sell any option or contract to purchase,
purchase any option or contract to sell, grant any option, right or warrant to
purchase, or otherwise transfer or dispose of, directly or indirectly, any
shares of Common Stock or any securities convertible into or exercisable or
exchangeable for Common Stock (whether such shares or any such securities are
then owned by the recipient or are thereafter acquired), or (ii) enter into any
swap or other arrangement that transfers to another, in whole or in part, any of
the economic consequences of ownership of the Common Stock, whether any such
transaction described in clause (i) or (ii) above is to be settled by delivery
of Common Stock or such other securities, in cash or otherwise. In order to
enforce the foregoing covenant, the Company may impose stop-transfer
instructions with respect to the securities of the recipient (and the shares or
securities of every other person subject to the foregoing restriction) until the
end of such period.
10
EXHIBIT 10.11
CONSULTING AGREEMENT
This Agreement is made as of June 1, 2005 (the "Effective Date"), between
Electro-Optical Sciences, Inc, a Delaware corporation (the "COMPANY") and Gerald
Wagner Consulting LLC (the "CONSULTANT").
The Consultant and the Company are parties to a certain Consulting Agreement
dated as of March 17, 2005 (the "Prior Agreement.") Services rendered by the
Consultant thereunder have primarily related to facilitation of the
restructuring of the Company so as to enable it to make appropriate arrangements
for the completion of developmental engineering of its MelaFind device. The
arrangements have been effectuated with an appropriate third party, and the
internal restructuring is now sufficiently along, so as to enable the parties to
the Prior Agreement to revise their relationship so as to provide for the
provision of services of an anticipated longer duration period. Accordingly, the
parties agree as follows:
1. Services. The Field of Interest for consulting hereunder is the continued
direction of the Company's MelaFind product development effort and the
implementation of the manufacturing process once production of clinical trial
prototypes becomes feasible.
The Consultant will make himself available in person at the Company's offices or
other locations as agreed upon during the term of this Agreement, as reasonably
requested by the Company
2. Consideration. In consideration for the services provided by Consultant
under the terms of this Agreement, Consultant shall be compensated as set forth
below.
2.1 The Company will pay the Consultant an amount of one hundred fifty
thousand dollars ($150,000.00), payable ratably over the course of the project
at such intervals as Consultant and the Company may agree upon. This amount is
considered to approximate the aggregate amount achieved by adding together $2000
for each full day to be spent on the project by Consultant. As a bonus,
Consultant will be granted 50,000 non-qualified stock options to purchase
Company's common stock at its then fair market value immediately after the
effective date of an Initial Public Offering on Registration Statement Form S-1.
The fair market value shall be deemed to be the price at which the Initial
Public Offering became effective.
2.2 The parties shall assess the progress of the project at a point
approximately halfway through the anticipated term. Provided that the
anticipated delivery date for the first twenty-five (25) MelaFind clinical trial
prototypes meeting the then-established Company specifications for such clinical
trial prototypes is still during the first quarter of calendar year 2006,
Consultant shall become entitled to an adjustment of the amount
paid, if necessary, so that the revised amount equals $2,000 per day for each
full day actually spent and to be spent on the project by Consultant.
2.3 Reasonable expenses of the Consultant incurred at the request of the
Company (including travel expenses incurred in connection with Company-related
business) will be reimbursed promptly by the Company, subject to customary
verification, in accordance with the Company's standard expense reimbursement
and travel policy.
3. Term. The term of this Agreement will begin on the Effective Date of this
Agreement and will end three months following the initiation of the pivotal
clinical trial for MelaFind. The parties anticipate that the pivotal clinical
trial will commence in the first quarter of 2006. The parties will negotiate
over an appropriate extension of the term of this agreement starting
approximately 30 days before the anticipated end of the term.
4. Certain Other Contracts.
4.1 The Consultant will not disclose to the Company any information that
the Consultant is obligated to keep secret pursuant to an existing
confidentiality agreement with a third party, and nothing in this Agreement will
impose any obligation on the Consultant to the contrary.
4.2 The consulting work performed hereunder will not be conducted on
time that is required to be devoted to any other third party. The Consultant
shall not use the funding, resources and facilities of any other third party to
perform consulting work hereunder and shall not perform the consulting work
hereunder in any manner that would give any third party rights to the product of
such work.
4.3 The Consultant has disclosed and, during the Term, will disclose to
the Chief Executive Officer of the Company any conflicts between this Agreement
and any other agreements binding the Consultant.
5. Exclusive Services during the Term. The Consultant agrees that during the
Term of this Agreement he will not, exclusive of any research obligations to any
third party, directly or indirectly (i) provide any services to any other
business or commercial entity in the Field of Interest, (ii) participate in the
formation of any business or commercial entity in the Field of Interest or (iii)
solicit or hire away any employee or consultant of the Company. Consultant shall
disclose on Exhibit A attached hereto all other consulting agreements in the
Field of Interest to which Consultant is currently a party.
6. Direction of Projects and Inventions to the Company. Subject to the
Consultant's obligations and confidentiality obligations to third parties,
during the Term of this Agreement, the Consultant will use his best efforts to
disclose to the Chief Executive Officer of the Company, on a confidential basis,
technology and product opportunities which come to the attention of the
Consultant in the Field of Interest, and any invention, improvement, discovery,
process, formula or method or other intellectual property
relating to or useful in, the Field of Interest (collectively "New
Discoveries"), whether or not patentable or copyrightable, to the extent the New
Discoveries do not arise from any research undertaken by the Consultant as an
employee of any third party.
7. Inventions Discovered by the Consultant While Performing Services
Hereunder.
7.1 The Consultant will promptly and fully disclose to the Chief
Executive Officer of the Company any invention, improvement, discovery, process,
formula, technique, method, trade mark, trade secret, mask work, or other
intellectual property, whether or not patentable, whether or not copyrightable
(collectively, "Invention") made, conceived, developed, or first reduced to
practice by the Consultant, either alone or jointly with others, while
performing services hereunder. All such Inventions are work made for hire to the
extent allowed by law and, in addition, Consultant hereby assigns to the Company
all of his right, title and interest in and to any such Inventions. The
Consultant will execute any documents necessary to perfect the assignment of
such Inventions to the Company and to enable the Company to apply for, obtain,
and enforce patents or copyrights in any and all countries on such Inventions.
The Consultant hereby irrevocably designates the Secretary of the Company as his
agent and attorney-in-fact to execute and file any such document and to do all
lawful acts necessary to apply for and obtain patents and copyrights, and to
enforce the Company's rights under this paragraph. This Section 7 will survive
the termination of this Agreement.
7.2 If any part of the Invention is based on, incorporates, or is an
improvement or derivative of, or cannot be reasonably and fully made, used,
reproduced, distributed and otherwise practiced or exploited without using,
infringing or violating technology or intellectual property rights owned or
licensed by Consultant and not assigned hereunder, Consultant hereby grants
Company a perpetual, irrevocable, worldwide royalty-free, non-exclusive, right
and license, with right to sublicense, to exploit and exercise all such
technology and intellectual property rights in support of Company's exercise or
exploitation of the Inventions, other work performed hereunder, or any assigned
rights (including any modifications, improvements and derivatives of any of
them).
8. Confidentiality.
8.1 The Consultant acknowledges that, during the course of performing
his services hereunder, the Company will be disclosing information to the
Consultant, and the Consultant will be developing information related to the
Field of Interest, Inventions, projects, products, potential customers,
personnel, business plans, and finances, as well as other commercially valuable
information (collectively "Confidential Information"). The Consultant
acknowledges that the Company's business is extremely competitive, dependent in
part upon the maintenance of secrecy, and that any disclosure of the
Confidential Information would result in serious harm to the Company.
8.2 The Consultant agrees that the Confidential Information will be used
by the Consultant only in connection with consulting activities hereunder, and
will not be used in any way that is detrimental to the Company.
8.3 The Consultant agrees not to disclose, directly or indirectly, the
Confidential Information to any third person or entity, other than
representatives or agents of the Company. The Consultant will treat all such
information as confidential and proprietary property of the Company.
8.4 The term "Confidential Information" does not include information
that was: (i) publicly known and made generally available in the public domain
prior to the time of disclosure by the disclosing party; (ii) becomes publicly
known and made generally available after disclosure by the disclosing party to
the receiving party through no action or inaction of the receiving party; (iii)
is already in the possession of the receiving party at the time of disclosure by
the disclosing party as shown by the receiving party's files and records
immediately prior to the time of disclosure; (iv) is obtained by the receiving
party from a third party without a breach of such third party's obligations of
confidentiality; and (v) is independently developed by the receiving party
without use of or reference to the disclosing party's Confidential Information,
as shown by documents and other competent evidence in the receiving party's
possession.
8.5 The Consultant may disclose any Confidential Information that is
required to be disclosed by law, government regulation or court order. If
disclosure is required, the Consultant will give the Company advance notice so
that the Company may seek a protective order or take other action reasonable in
light of the circumstances.
8.6 Upon termination of this Agreement, the Consultant will promptly
return to the Company all materials containing Confidential Information as well
as data, records, reports and other property, furnished by the Company to the
Consultant or produced by the Consultant in connection with services rendered
hereunder, together with all copies of any of the foregoing. Notwithstanding
such return, the Consultant shall continue to be bound by the terms of the
confidentiality provisions contained in this Section 8 for a period of three
years after the termination of this Agreement.
9. Use of Name. It is understood that the name of the Consultant and
Consultant's affiliation with any third party will appear in disclosure
documents required by securities laws, and in other regulatory and
administrative filings in the ordinary course of the Company's business. The
above-described uses will be deemed to be noncommercial uses. The name of the
Consultant or any third party will not be used for any commercial purpose
without the Consultant's consent.
10. No Conflict: Valid and Binding. The Consultant represents that neither the
execution of this Agreement nor the performance of the Consultant's obligations
under this Agreement (as modified to the extent required by Section 4) will
result in a violation or breach of any other agreement by which the Consultant
is bound. The Company represents that this Agreement has been duly authorized
and executed and is a valid and legally binding obligation of the Company,
subject to no conflicting agreements.
11. Notices. Any notice provided under this Agreement shall be in writing and
shall be deemed to have been effectively given (i) upon receipt when delivered
personally, (ii) one day after sending when sent by private express mail service
(such as Federal Express), or (iii) 5 days after sending when sent by regular
mail to the following address:
In the case of the Company:
Electro-Optical Sciences, Inc
One Bridge Street, Suite 15
Irvington, NY 10553
In the case of the Consultant:
Name: Gerald Wagner Consulting LLC
Address: 970 Route 9W
Upper Grandview, NY 10960
SSN: 02-0662378
or to other such address as may have been designated by the Company or the
Consultant by notice to the other given as provided herein.
12. Independent Contractor: Withholding. The Consultant will at all times be
an independent contractor, and as such will not have authority to bind the
Company. Consultant will not act as an agent nor shall he be deemed to be an
employee of the Company for the purposes of any employee benefit program,
unemployment benefits, or otherwise. The Consultant recognizes that no amount
will be withheld from his compensation for payment of any federal, state, or
local taxes and that the Consultant has sole responsibility to pay such taxes,
if any, and file such returns as shall be required by applicable laws and
regulations. Consultant shall not enter into any agreements or incur any
obligations on behalf of the Company.
13. Assignment. Due to the personal nature of the services to be rendered by
the Consultant, the Consultant may not assign this Agreement. The Company may
assign all rights and liabilities under this Agreement to a subsidiary or an
affiliate or to a successor to all or a substantial part of its business and
assets without the consent of the Consultant. Subject to the foregoing, this
Agreement will inure to the benefit of and be binding upon each of the heirs,
assigns and successors of the respective parties.
14. Severability. If any provision of this Agreement shall be declared
invalid, illegal or unenforceable, such provision shall be severed and the
remaining provisions shall continue in full force and effect.
15. Remedies. The Consultant acknowledges that the Company would have no
adequate remedy at law to enforce Sections 5, 7 and 8 hereof. In the event of a
violation by the Consultant of such Sections, the Company shall have the right
to obtain injunctive
or other similar relief, as well as any other relevant damages, without the
requirement of posting bond or other similar measures.
16. Governing Law; Entire Agreement; Amendment. This Agreement shall be
governed by the laws of the State of New York applicable to agreements made and
to be performed within such State, represents the entire understanding of the
parties. It supersedes the Prior Agreement except with respect to matters
(payment for subsequent invoices, confidentiality, and the like) which by their
nature should survive the termination of that agreement. It may only be amended
in writing.
IN WITNESS WHEREOF, this Agreement may be executed in counterparts, each of
which shall constitute an original and all of which together shall constitute
one instrument, effective as of the date first above written.
Electro-Optical Sciences, Inc: Consultant: Gerald Wagner
By: /s/ William R. Bronner Signature: /s/ Gerald Wagner
Its: Vice President
EXHIBIT A
OTHER RELATIONSHIPS
NONE
EXHIBIT 10.12
CONSULTING AGREEMENT
Agreement dated and effective as of June 20, 2003, between Electro-Optical
Sciences, a Delaware corporation with its office at 1 Bridge Street, Suite 15,
Irvington, New York 10533 ("EOS" or the "Company") and Breaux Castleman, with an
address at , California ("Consultant"), hereinafter referred to as the
"Agreement."
EOS and Consultant hereby agree as follows:
1 The term of this agreement shall be two years.
2 EOS will grant Consultant a stock award by executing contemporaneously
with this Agreement a Restricted Stock Purchase Agreement substantially in
the form of Exhibit A hereto. the award will allow Consultant to purchase
150,000 shares of EOS common stock @ $0.23 / share, 75,000 shares of which
will vest immediately, and the remaining 75,000 shares of which will vest
after 1 year of service.
3 Services will be provided as the Chief Executive Officer shall direct and
as Consultant shall reasonably find acceptable, within his areas of
expertise. Consultant shall report to the Chief Executive Officer, with
ultimate responsibility to the Board of Directors. For these services,
Consultant will receive $8,000 per month, plus reasonable travel expenses.
4 Consultant is not and shall not become the agent of EOS, and has and shall
have no authority, express or implied, to act as an agent of EOS or to
enter into any agreement or take any action on behalf of EOS. Nothing
contained herein shall constitute an employment agreement. Nothing
contained herein is intended to restrict Consultant's ability to provide
services to others.
5 Consultant shall continue to be obligated under the confidentiality
agreement previously entered into, and Consultant shall execute the
standard EOS invention disclosure agreement, a copy of which is attached
as Exhibit B hereto. Termination of this agreement shall not affect
Consultant's obligations under these agreements.
6 This agreement is to be governed by the substantive laws of the State of
New York without regard to any provisions relating to the conflict of
laws.
Electro-Optical Sciences, Inc: Consultant: Breaux Castleman
By: /s/ William R. Bronner Signature: /s/Breaux Castleman
Its: Vice President
EXHIBIT 10.13
CONSULTING AGREEMENT
This Agreement is made as of June 1, 2005 (the "Effective Date"), between
Electro-Optical Sciences, Inc, a Delaware corporation (the "COMPANY") and Robert
Friedman, M.D. (the "CONSULTANT").
Consultant is retiring as a voting member of the Board of Directors. Consultant
is willing to continue to provide assistance to the Company. The Company wishes
to retain the Consultant in a consulting capacity. Accordingly, the parties
agree as follows:
1. Services. The Field of Interest for consulting includes three areas: (1)
as Medical Advisor to the Board, (2) as Liaison to the Scientific and Medical
Advisory Committee, and (3) in connection with the clinical testing of
MelaFind(R), a melanoma diagnostic device. The Consultant will make himself
available in person at the Company's offices or other locations as agreed upon
during the term of this Agreement, as reasonably requested by the Company,
subject to his need to satisfy other professional commitments, for up to thirty
days.
2. Consideration. In consideration for the services provided by Consultant
under the terms of this Agreement, Consultant shall be compensated at a rate of
$5,000 per day of services rendered to the Company, or a proportionately smaller
amount for less than 8 hours of services. Reasonable expenses of the Consultant
incurred at the request of the Company (including travel expenses incurred in
connection with Company-related business) will be reimbursed promptly by the
Company, subject to customary verification, in accordance with the Company's
standard expense reimbursement and travel policy.
3. Term. The term of this Agreement will begin on the Effective Date of this
Agreement and will end on the one-year anniversary of this Agreement or upon
earlier termination (the "Term"). The Term will be renewed for successive
one-year periods, unless either party provides written notice at least thirty
(30) days prior to the end of the Term that such party does not wish to renew
this Agreement.
4. Exclusive Services during the Term. The Consultant agrees that during the
Term of this Agreement he will not, exclusive of any research obligations to any
third party, directly or indirectly (i) provide any services to any other
business or commercial entity in the Field of Interest, (ii) participate in the
formation of any business or commercial entity in the Field of Interest or (iii)
solicit or hire away any employee or consultant of the Company. Consultant shall
disclose on Exhibit A attached hereto all other consulting agreements in the
Field of Interest to which Consultant is currently a party.
5. Direction of Projects and Inventions to the Company. Subject to the
Consultant's obligations and confidentiality obligations to third parties,
during the Term of this Agreement, the Consultant will use his best efforts to
disclose to the Chief Executive Officer of the Company, on a confidential basis,
technology and product opportunities
which come to the attention of the Consultant in the Field of Interest, and any
invention, improvement, discovery, process, formula or method or other
intellectual property relating to or useful in, the Field of Interest
(collectively "New Discoveries"), whether or not patentable or copyrightable, to
the extent the New Discoveries do not arise from any research undertaken by the
Consultant as an employee of any third party.
6. Inventions Discovered by the Consultant While Performing Services
Hereunder.
6.1 The Consultant will promptly and fully disclose to the Chief
Executive Officer of the Company any invention, improvement, discovery, process,
formula, technique, method, trade mark, trade secret, mask work, or other
intellectual property, whether or not patentable, whether or not copyrightable
(collectively, "Invention") made, conceived, developed, or first reduced to
practice by the Consultant, either alone or jointly with others, while
performing services hereunder. All such Inventions are work made for hire to the
extent allowed by law and, in addition, Consultant hereby assigns to the Company
all of his right, title and interest in and to any such Inventions. The
Consultant will execute any documents necessary to perfect the assignment of
such Inventions to the Company and to enable the Company to apply for, obtain,
and enforce patents or copyrights in any and all countries on such Inventions.
The Consultant hereby irrevocably designates the Secretary of the Company as his
agent and attorney-in-fact to execute and file any such document and to do all
lawful acts necessary to apply for and obtain patents and copyrights, and to
enforce the Company's rights under this paragraph. This Section 7 will survive
the termination of this Agreement.
6.2 If any part of the Invention is based on, incorporates, or is an
improvement or derivative of, or cannot be reasonably and fully made, used,
reproduced, distributed and otherwise practiced or exploited without using,
infringing or violating technology or intellectual property rights owned or
licensed by Consultant and not assigned hereunder, Consultant hereby grants
Company a perpetual, irrevocable, worldwide royalty-free, non-exclusive, right
and license, with right to sublicense, to exploit and exercise all such
technology and intellectual property rights in support of Company's exercise or
exploitation of the Inventions, other work performed hereunder, or any assigned
rights (including any modifications, improvements and derivatives of any of
them).
7. Confidentiality.
7.1 The Consultant acknowledges that, during the course of performing
his services hereunder, the Company will be disclosing information to the
Consultant, and the Consultant will be developing information related to the
Field of Interest, Inventions, projects, products, potential customers,
personnel, business plans, and finances, as well as other commercially valuable
information (collectively "Confidential Information"). The Consultant
acknowledges that the Company's business is extremely competitive, dependent in
part upon the maintenance of secrecy, and that any disclosure of the
Confidential Information would result in serious harm to the Company.
7.2 The Consultant agrees that the Confidential Information will be used
by the Consultant only in connection with consulting activities hereunder, and
will not be used in any way that is detrimental to the Company.
7.3 The Consultant agrees not to disclose, directly or indirectly, the
Confidential Information to any third person or entity, other than
representatives or agents of the Company. The Consultant will treat all such
information as confidential and proprietary property of the Company.
7.4 The term "Confidential Information" does not include information
that was: (i) publicly known and made generally available in the public domain
prior to the time of disclosure by the disclosing party; (ii) becomes publicly
known and made generally available after disclosure by the disclosing party to
the receiving party through no action or inaction of the receiving party; (iii)
is already in the possession of the receiving party at the time of disclosure by
the disclosing party as shown by the receiving party's files and records
immediately prior to the time of disclosure; (iv) is obtained by the receiving
party from a third party without a breach of such third party's obligations of
confidentiality; and (v) is independently developed by the receiving party
without use of or reference to the disclosing party's Confidential Information,
as shown by documents and other competent evidence in the receiving party's
possession.
7.5 The Consultant may disclose any Confidential Information that is
required to be disclosed by law, government regulation or court order. If
disclosure is required, the Consultant will give the Company advance notice so
that the Company may seek a protective order or take other action reasonable in
light of the circumstances.
7.6 Upon termination of this Agreement, the Consultant will promptly
return to the Company all materials containing Confidential Information as well
as data, records, reports and other property, furnished by the Company to the
Consultant or produced by the Consultant in connection with services rendered
hereunder, together with all copies of any of the foregoing. Alternatively,
Consultant may destroy all Confidential Information and certify to the Company
that he has done so. Notwithstanding such return or destruction, the Consultant
shall continue to be bound by the terms of the confidentiality provisions
contained in this Section 8 for a period of three years after the termination of
this Agreement.
8. Use of Name. It is understood that the name of the Consultant and
Consultant's affiliation with any third party will appear in disclosure
documents required by securities laws, and in other regulatory and
administrative filings in the ordinary course of the Company's business. The
above-described uses will be deemed to be noncommercial uses. The name of the
Consultant or any third party will not be used for any commercial purpose
without the Consultant's consent.
9. No Conflict: Valid and Binding. The Consultant represents that neither the
execution of this Agreement nor the performance of the Consultant's obligations
under this Agreement (as modified to the extent required by Section 4) will
result in a violation
or breach of any other agreement by which the Consultant is bound. The Company
represents that this Agreement has been duly authorized and executed and is a
valid and legally binding obligation of the Company, subject to no conflicting
agreements.
10. Notices. Any notice provided under this Agreement shall be in writing and
shall be deemed to have been effectively given (i) upon receipt when delivered
personally, (ii) one day after sending when sent by private express mail service
(such as Federal Express), or (iii) 5 days after sending when sent by regular
mail to the following address:
In the case of the Company:
Electro-Optical Sciences, Inc
One Bridge Street, Suite 15
Irvington, NY 10553
In the case of the Consultant:
Name: Robert Friedman, M. D.
Address: 56 Old Aspetong Road
Katonah, NY 10536
or to other such address as may have been designated by the Company or the
Consultant by notice to the other given as provided herein.
11. Independent Contractor: Withholding. The Consultant will at all times be
an independent contractor, and as such will not have authority to bind the
Company. Consultant will not act as an agent nor shall he be deemed to be an
employee of the Company for the purposes of any employee benefit program,
unemployment benefits, or otherwise. The Consultant recognizes that no amount
will be withheld from his compensation for payment of any federal, state, or
local taxes and that the Consultant has sole responsibility to pay such taxes,
if any, and file such returns as shall be required by applicable laws and
regulations. Consultant shall not enter into any agreements or incur any
obligations on behalf of the Company.
12. Assignment. Due to the personal nature of the services to be rendered by
the Consultant, the Consultant may not assign this Agreement. The Company may
assign all rights and liabilities under this Agreement to a subsidiary or an
affiliate or to a successor to all or a substantial part of its business and
assets without the consent of the Consultant. Subject to the foregoing, this
Agreement will inure to the benefit of and be binding upon each of the heirs,
assigns and successors of the respective parties.
13. Indemnification. The Company hereby indemnifies Contractor to the fullest
extent possible against any third-party claim of any type, excluding only claims
of intentional misconduct, arising with respect to any services performed
hereunder.
14. If any provision of this Agreement shall be declared invalid, illegal or
unenforceable, such provision shall be severed and the remaining provisions
shall continue in full force and effect.
15. Remedies. The Consultant acknowledges that the Company would have no
adequate remedy at law to enforce Sections 5, 7 and 8 hereof. In the event of a
violation by the Consultant of such Sections, the Company shall have the right
to obtain injunctive or other similar relief, as well as any other relevant
damages, without the requirement of posting bond or other similar measures.
16. Governing Law; Entire Agreement; Amendment. This Agreement shall be
governed by the laws of the State of New York applicable to agreements made and
to be performed within such State, represents the entire understanding of the
parties, supersedes all prior agreements between the parties, and may only be
amended in writing.
IN WITNESS WHEREOF, this Agreement may be executed in counterparts, each of
which shall constitute an original and all of which together shall constitute
one instrument, effective as of the date first above written.
Electro-Optical Sciences, Inc: Consultant: Robert Friedman
By: /s/ William R. Bronner Signature: /s/ Robert Friedman
Its: Vice President
EXHIBIT A
OTHER RELATIONSHIPS
NONE
Exhibit 10.15
THIRD AMENDMENT TO ELECTRO-OPTICAL SCIENCES, INC. LEASE
This amendment is made the 6th day of June, 2005, by and between Bridge Street
Properties, LLC, a New York Limited Liability Company having an office at One
Bridge Street, Irvington, New York 10533, and Electro-Optical Sciences, Inc., a
Corporation having an office at One Bridge Street, Irvington, New York 10533.
Witnesseth:
Whereas, Owner (Bridge Street Properties, LLC) and Tenant (Electro-Optical
Sciences, Inc.) entered into a lease dated December 16th, 1998 of certain
premises located at One Bridge Street, Irvington, New York and
Whereas, the term of the lease set forth therein is three years commencing
upon, December 16, 1998 and ending upon December 15, 2001 and
Now, Therefore, the parties hereto agree as follows:
1. The term set forth herein will be four years and commence July 1,
2005, and end on June 30, 2009.
2. The rate to be paid monthly/yearly will be as follows:
Yearly Monthly
------ -------
7/1/05 - 6/30/06 $100,386.00 $8,365.50
7/1/06 - 6/30/07 $103,397.58 $8,616.47
7/1/07 - 6/30/08 $106,499.51 $8,874.96
7/1/08 - 6/30/09 $109,694.49 $9,141.21
3. Clause #81, Termination Option, shall be removed.
4. New HVAC system shall be installed. The system will include 2
thermostatically controlled air dampeners.
5. A $5,100 electric upgrade to be completed as per the specifications
discussed with Andy Lyons.
6. Security Deposit will increase to $17,232.94 equal to last two months
rent.
7. Continuation of Lease Provisions: Except as amended herein, all other
terms and conditions of the Lease shall remain in full force and
effect for the duration of the Lease.
/s/ William Thompson /s/ William Bronner
_____________________________________ __________________________________
Bridge Street Properties, LLC Electro-Optical Science, Inc.
Managing Member Vice President
_____________________________________ __________________________________
Title Title
1
EXHIBIT 14.1
ELECTRO-OPTICAL SCIENCES, INC.
CODE OF BUSINESS CONDUCT AND ETHICS
This Code of Business Conduct and Ethics (the "Code") sets forth legal and
ethical standards of conduct for directors, officers and employees of
Electro-Optical Sciences, Inc. (the "Company"). This Code is intended to deter
wrongdoing and to promote the conduct of all Company business in accordance with
high standards of integrity and in compliance with all applicable laws and
regulations. This Code applies to the Company and all of its subsidiaries (as in
existence from time to time) and other business entities controlled by it
worldwide. All references to employees herein shall be deemed to include
officers and directors unless the context specifically only relates to
employees.
If you have any questions regarding this Code or its application to you in any
situation, you should contact your immediate supervisor or the Company's Chief
Financial Officer (the "CFO").
COMPLIANCE WITH LAWS, RULES AND REGULATIONS
The Company requires that all employees comply with all laws, rules and
regulations applicable to the Company wherever it does business. You are
expected to use good judgment and common sense in seeking to comply with all
applicable laws, rules and regulations and to ask for advice when you are
uncertain about them.
If you become aware of the violation of any law, rule or regulation by the
Company, whether by its officers, employees, directors, or any third party doing
business on behalf of the Company, it is your responsibility to promptly report
the matter to your immediate supervisor or the CFO. While it is the Company's
desire to address matters internally, nothing in this Code should discourage you
from reporting any illegal activity, including any violation of the securities
laws, antitrust laws, environmental laws or any other Federal, state or foreign
law, rule or regulation, to the appropriate regulatory authority. The Company
shall not discharge, demote, suspend, threaten, harass or in any other manner
discriminate or retaliate against an employee because he or she reports any such
violation, unless it is determined that the report was made with knowledge that
it was false. This Code should not be construed to prohibit you from testifying,
participating or otherwise assisting in any state or Federal administrative,
judicial or legislative proceeding or investigation.
CONFLICTS OF INTEREST
Employees must act in the best interests of the Company. You must refrain from
engaging in any activity or having a personal interest that presents a "conflict
of interest." A conflict of interest occurs when your personal interest
interferes, or appears to interfere, with the interests of the Company. A
conflict of interest can arise whenever you, as an employee, take action or have
an interest that prevents you from performing your Company duties and
responsibilities honestly, objectively and effectively. No
1
employee shall use his or her position with the Company to influence a
transaction with a supplier or customer in which such person has any personal
interest, other than a financial interest representing less than one percent
(1%) of the outstanding shares of a publicly-held company.
OUTSIDE EMPLOYMENT STATEMENT
Each employee agrees to devote his or her full business time, attention, skill
and effort exclusively to the performance of the duties that the Company may
assign.
In general, outside work activities are not permitted when they:
- Prevent the employee from fully performing work for which he or she
is employed at the Company, including overtime assignments for
non-exempt employees;
- Involve performing services as a consultant, employee, officer,
director, advisor or in any other capacity for, or have a financial
interest in, a competitor of the Company, other than services
performed at the request of the Company and other than a financial
interest representing less than one percent (1%) of the outstanding
shares of a publicly-held company; and
- Violate provisions of applicable state or Federal law or the
Company's policies or rules.
REPORTING POTENTIAL CONFLICTS
It is your responsibility to disclose any material transaction or relationship
that reasonably could be expected to give rise to a conflict of interest to the
CFO. Approval will not be given unless the relationship will not interfere with
the employee's duties and will not damage the Company's reputation.
INSIDER TRADING
Employees who have material non-public information about the Company or other
companies, including our suppliers and customers, as a result of their
relationship with the Company are prohibited by law and Company policy from
trading in securities of the Company or such other companies, as well as from
communicating such information to others who might trade on the basis of that
information. To help ensure that you do not engage in prohibited insider trading
and avoid even the appearance of an improper transaction, the Company has
adopted an Insider Trading Policy, which employees are required to sign at the
start of their employment.
If you are uncertain about the constraints on your purchase or sale of any
Company securities or the securities of any other company that you are familiar
with by virtue of your relationship with the Company, you should consult with
the CFO before making any such purchase or sale.
2
CONFIDENTIALITY
Employees must maintain the confidentiality of information entrusted to them by
the Company or other companies, including our suppliers and customers, except
when disclosure is authorized by a supervisor or legally mandated. Unauthorized
disclosure of any confidential information is prohibited. Additionally,
employees should take appropriate precautions to ensure that confidential or
sensitive business information, whether it is proprietary to the Company or
another company, is not communicated within the Company except to employees who
have a need to know such information to perform their responsibilities for the
Company.
Employees (other than the Company's authorized spokespersons) must not discuss
internal Company matters with, or disseminate internal Company information to,
anyone outside the Company, except as required in the performance of their
Company duties and after an appropriate confidentiality agreement is in place.
This prohibition applies particularly to inquiries concerning the Company from
the media, market professionals (such as securities analysts, institutional
investors, investment advisers, brokers and dealers) and security holders. All
responses to inquiries on behalf of the Company must be made only by the
Company's authorized spokespersons. If you receive any inquiries of this nature,
you must decline to comment and refer the inquirer to your supervisor or to one
of the Company's authorized spokespersons.
All employees at the start of their employment with the Company are required to
sign an Employee Invention, Non-Disclosure and Non-Compete Agreement (the
"Confidentiality Agreement"). Please keep in mind that the Confidentiality
Agreement is binding and enforceable. Employees unsure about the confidential
nature of specific information must ask their immediate supervisor or the CFO.
Employees will be subject to appropriate disciplinary action, up to and
including termination, for knowingly or unknowingly revealing information of a
confidential nature.
You also must abide by any lawful obligations that you have to your former
employer. These obligations may include restrictions on the use and disclosure
of confidential information, restrictions on the solicitation of former
colleagues to work at the Company and non-competition obligations.
ETHICAL STANDARDS
The Company intends to establish and maintain an outstanding reputation for
conducting its business activities. As an employee you are obligated to uphold
that reputation in every business activity. Employees should endeavor to deal
honestly, ethically and fairly with the Company's suppliers, customers,
competitors and employees. Statements regarding the Company's products and
services must not be untrue, misleading, deceptive or fraudulent. You must not
take unfair advantage of anyone through manipulation, concealment, abuse of
privileged information, misrepresentation of material facts or any other
unfair-dealing practice. If you are ever in doubt as to whether an activity
meets our
3
ethical standards or compromises the Company's reputation, please discuss it
with your immediate supervisor or the CFO.
PROTECTION AND PROPER USE OF CORPORATE ASSETS
Employees should seek to protect the Company's assets. Theft, carelessness and
waste have a direct impact on the Company's financial performance. Employees
must use the Company's assets and services solely for legitimate business
purposes of the Company and not for any personal benefit or the personal benefit
of anyone else.
Employees must advance the Company's legitimate interests when the opportunity
to do so arises. You must not take for yourself personal opportunities that are
discovered through your position with the Company or the use of property or
information of the Company.
GIFTS AND GRATUITIES
The use of Company funds or assets for gifts, gratuities or other favors to
employees or government officials is prohibited, except to the extent such gifts
are in compliance with applicable law, nominal in amount and not given in
consideration or expectation of any action by the recipient.
Employees must not accept, or permit any member of his or her immediate family
to accept, any gifts, gratuities or other favors from any customer, supplier or
other person doing or seeking to do business with the Company, other than items
of nominal value. Any gifts that are not of nominal value should be returned
immediately and reported to your immediate supervisor or the CFO. If immediate
return is not practical, they should be given to the Company for charitable
disposition or such other disposition as the Company believes appropriate in its
sole discretion.
Common sense and moderation should prevail in business entertainment engaged in
on behalf of the Company. Employees should provide, or accept, business
entertainment to or from anyone doing business with the Company only if the
entertainment is infrequent, modest and intended to serve legitimate business
goals.
Bribes and kickbacks are criminal acts, strictly prohibited by law. You must not
offer, give, solicit or receive any form of bribe or kickback anywhere in the
world.
ACCURACY OF BOOKS AND RECORDS AND PUBLIC REPORTS
Employees must honestly and accurately report all business transactions. You are
responsible for the accuracy of your records and reports. Accurate information
is essential to the Company's ability to meet legal and regulatory obligations.
All Company books, records and accounts shall be maintained in accordance with
all applicable regulations and standards and accurately reflect the true nature
of the
4
transactions they record. The financial statements of the Company shall conform
to generally accepted accounting rules and the Company's accounting policies. No
undisclosed or unrecorded account or fund shall be established for any purpose.
No false or misleading entries shall be made in the Company's books or records
for any reason, and no disbursement of corporate funds or other corporate
property shall be made without adequate supporting documentation.
It is the policy of the Company to provide full, fair, accurate, timely and
understandable disclosure in reports and documents filed with, or submitted to,
the Securities and Exchange Commission (the "SEC") and in other public
communications.
CONCERNS REGARDING ACCOUNTING OR AUDITING MATTERS
Employees with concerns regarding questionable accounting or auditing matters or
complaints regarding accounting, internal accounting controls or auditing
matters may confidentially, and anonymously if they wish, submit such concerns
or complaints in writing to the CFO. See "Reporting and Compliance Procedures."
All such concerns and complaints will be forwarded to the Audit Committee of the
Board of Directors, unless they are determined to be without merit by the
Company's Chief Executive Officer (the "CEO") and CFO of the Company. In any
event, a record of all complaints and concerns received will be provided to the
Audit Committee each fiscal quarter. All reports filed regarding questionable
accounting or auditing matters will be automatically directed to the Chairperson
of the Audit Committee.
The Audit Committee will evaluate the merits of any concerns or complaints
received by it and authorize such follow-up actions, if any, as it deems
necessary or appropriate to address the substance of the concern or complaint.
The Company will not discipline, discriminate against or retaliate against any
employee who reports a complaint or concern, unless it is determined that the
report was made with knowledge that it was false.
DEALINGS WITH INDEPENDENT AUDITORS
No employee, officer or director shall, directly or indirectly, make or cause to
be made a materially false or misleading statement to an accountant in
connection with (or omit to state, or cause another person to omit to state, any
material fact necessary in order to make statements made, in light of the
circumstances under which such statements were made, not misleading to, an
accountant in connection with) any audit, review or examination of the Company's
financial statements or the preparation or filing of any document or report with
the SEC. No employee, officer or director shall, directly or indirectly, take
any action to coerce, manipulate, mislead or fraudulently influence any
independent public or certified public accountant engaged in the performance of
an audit or review of the Company's financial statements.
5
WAIVERS OF THIS CODE OF BUSINESS CONDUCT AND ETHICS
While some of the policies contained in this Code must be strictly adhered to
and no exceptions can be allowed, in other cases exceptions may be possible. Any
employee who believes that an exception to any of these policies is appropriate
in his or her case should first contact his or her immediate supervisor. If the
supervisor agrees that an exception is appropriate, the approval of the CFO must
be obtained. The CFO shall be responsible for maintaining a complete record of
all requests for exceptions to any of these policies and the disposition of such
requests.
REPORTING AND COMPLIANCE PROCEDURES
Every employee has the responsibility to ask questions, seek guidance, report
suspected violations and express concerns regarding compliance with this Code.
Any employee who knows or believes that any other employee or representative of
the Company has engaged or is engaging in Company-related conduct that violates
applicable law or this Code should report such information to his or her
immediate supervisor or to the CFO, as described below. You may report such
conduct openly or anonymously without fear of retaliation. The Company will not
discipline, discriminate against or retaliate against any employee who reports
such conduct, unless it is determined that the report was made with knowledge
that it was false, or who cooperates in any investigation or inquiry regarding
such conduct. Any supervisor who receives a report of a violation of this Code
must immediately inform the CFO.
You may report violations of this Code, on a confidential or anonymous basis, by
contacting the CFO or Audit Committee Chairperson by fax, mail or e-mail. While
we prefer that you identify yourself when reporting violations so that we may
follow up with you, as necessary, for additional information, you may do so
anonymously if you wish.
Once information regarding an alleged violation of this Code has been received,
the receiver of such information, the CFO or Audit Committee Chairperson) shall,
as appropriate, (a) evaluate such information, (b) if the alleged violation
involves an executive officer or a director, inform the CEO and Board of
Directors of the alleged violation, (c) determine whether it is necessary to
conduct an informal inquiry or a formal investigation and, if so, initiate such
inquiry or investigation, and (d) report the results of any such inquiry or
investigation, together with a recommendation as to disposition of the matter,
to the CEO for action, or if the alleged violation involves an executive officer
or a director, report the results of any such inquiry or investigation to the
Board of Directors or a committee thereof. Employees are expected to cooperate
fully with any inquiry or investigation by the Company regarding an alleged
violation of this Code. Failure to cooperate with any such inquiry or
investigation may result in disciplinary action, up to and including discharge.
The Company shall determine whether violations of this Code have occurred and,
if so, shall determine the disciplinary measures to be taken against any
employee who has violated this Code. In the event that the alleged violation
involves an executive officer or
6
a director, the CEO and the Board of Directors, respectively, shall determine
whether a violation of this Code has occurred and, if so, shall determine the
disciplinary measures to be taken against such executive officer or director.
Failure to comply with the standards outlined in this Code will result in
disciplinary action, up to and including termination. Certain violations of this
Code may require the Company to refer the matter to the appropriate governmental
or regulatory authorities for investigation or prosecution. Moreover, any
supervisor who directs or approves of any conduct in violation of this Code, or
who has knowledge of such conduct and does not immediately report it, also will
be subject to disciplinary action, up to and including termination.
DISSEMINATION AND AMENDMENT
This Code shall be distributed to each new employee, officer and director of the
Company upon commencement of his or her employment or other relationship with
the Company and shall also be distributed annually to each employee, officer and
director of the Company, and each employee, officer and director shall certify
that he or she has received, read and understood the Code and has complied with
its terms.
The Company reserves the right to amend, alter or terminate this Code at any
time for any reason.
Adopted by the Board of Directors of Electro-Optical Sciences, Inc. on May 13,
2005
7
Exhibit 23.1
The following consent is in the form that will be signed upon the effectiveness
of the one-for-two reverse common stock split described in Note 1 to the
financial statements.
/s/ Eisner LLP
New York, New York
July 15, 2005
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the reference to our firm under the caption "Experts" and to the
use of our report dated May 31, 2005 in the Registration Statement on Form S-1
(No.333-125517) and related Prospectus of Electro-Optical Sciences, Inc.
Eisner LLP
New York, New York