Gadsden Properties, Inc. - Annual Report: 2006 (Form 10-K)
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
x |
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the
fiscal year ended December 31, 2006
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
For
the
transition period from ______________ to _____________
Commission
file number: 0-11635
PHOTOMEDEX,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
(State
or other jurisdiction
of
incorporation or organization)
|
59-2058100
(I.R.S.
Employer
Identification
No.)
|
147
Keystone Drive, Montgomeryville, Pennsylvania 18936
(Address
of principal executive offices, including zip code)
(215)
619-3600
(Issuer’s
telephone number, including area code)
Securities
registered under Section 12(b) of the Exchange Act:
Title
of each class
None
|
Name
of each exchange
on
which registered
None
|
Securities
registered under Section 12(g) of the Exchange Act:
Common
Stock, $0.01 par value per share
(Title
of
Class)
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined
in
Rule 405 of the Securities Act.
Yes
o
No
x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Exchange Act.
Yes
o
No
x
Indicate
by check mark whether the registrant: (i) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (ii) has been subject to such filing requirements
for
the past 90 days.
Yes
x No
o
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein and will not be contained, to the best
of
registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to
this
Form 10-K. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of "accelerated
filer and large accelerated filer" in Rule 12b-2 of the Exchange
Act.
Large
accelerated filer o
Accelerated
filer x Non-accelerated
filer o
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act).
Yes
o
No
x
The
number of shares outstanding of our common stock as of March 15, 2007, was
62,536,054 shares. The aggregate market value of the common stock held by
non-affiliates (53,064,354 shares), based on the closing market price ($1.15)
of
the common stock as of March 15, 2007 was $61,024,007.
Table
of Contents
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Page
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Part I
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Item 1.
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Business
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1
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Item 1A.
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Risk
Factors
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18
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Item 1B.
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Unresolved
Staff Comments
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30
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Item 2.
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Properties
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30
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Item 3.
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Legal
Proceedings
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31
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Item 4.
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Submission
of Matters to a Vote of Security Holders
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32
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Part II
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Item 5.
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Market
for the Registrant's Common Equity, Related Stockholder Matters and
Issuer
Purchases of Equity Securities
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32
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Item 6.
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Selected
Financial Data
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34
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Item 7.
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Management's
Discussion and Analysis of Financial Condition and Results of
Operations
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36
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Item 7A.
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Quantitative
and Qualitative Disclosures About Market Risk
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56
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Item 8.
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Financial
Statements and Supplementary Data
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56
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Item 9.
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Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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56
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Item 9A.
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Controls
and Procedures
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56
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Item 9B.
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Other
Information
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57
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Part III
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Item 10.
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Directors,
Executive Officers and Corporate Governance
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58
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Item 11.
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Executive
Compensation
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63
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Item 12.
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
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74
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Item 13.
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Certain
Relationships and Related Transactions and Director
Independence
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76
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Item 14.
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Principal
Accountant Fees and Services
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76
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Item IV
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Item 15.
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Exhibits
and Financial Statement Schedules
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77
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Signatures
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81
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i
Certain
statements in this Annual Report on Form 10-K, or the Report, are
"forward-looking statements." These forward-looking statements include, but
are
not limited to, statements about the plans, objectives, expectations and
intentions of PhotoMedex, Inc., a Delaware corporation, (referred to in this
Report as “we,” “us,” “our” or “registrant”) and other statements contained in
this Report that are not historical facts. Forward-looking statements in this
Report or hereafter included in other publicly available documents filed with
the Securities and Exchange Commission, or the Commission, reports to our
stockholders and other publicly available statements issued or released by
us
involve known and unknown risks, uncertainties and other factors which could
cause our actual results, performance (financial or operating) or achievements
to differ from the future results, performance (financial or operating) or
achievements expressed or implied by such forward-looking statements. Such
future results are based upon management's best estimates based upon current
conditions and the most recent results of operations. When used in this Report,
the words "expect," "anticipate," "intend," "plan," "believe," "seek,"
"estimate" and similar expressions are generally intended to identify
forward-looking statements, because these forward-looking statements involve
risks and uncertainties. There are important factors that could cause actual
results to differ materially from those expressed or implied by these
forward-looking statements, including our plans, objectives, expectations and
intentions and other factors discussed under "Risk Factors." We undertake no
obligation to update such forward- looking
statements.
PART
I
Item
1. Business
We
are a
medical device and specialty pharmaceutical company focused on facilitating
the
cost-effective use of technologies for doctors, hospitals and surgery centers
to
enable their patients to achieve a higher quality of life.
Our
business operates in five distinct business units: three in Dermatology and
two
in Surgical. Business units, or segments, and are distinguished by our
management structure, products and services offered, markets served or types
of
customers.
The
Domestic XTRAC® segment derives revenues principally from procedures performed
by dermatologists in the United States. Our XTRAC system is generally placed
in
a dermatologist’s office without any initial capital cost and then we charge a
fee-per-use to treat skin disease. On occasion, however, we sell XTRAC lasers
to
customers, due generally to customer circumstances and preferences. Our
International Dermatology Equipment segment, in comparison, generates revenues
from the sale of equipment to dermatologists outside the United States through
a
network of distributors. The Skin Care segment generates revenues by selling
physician-dispensed skincare products worldwide and by earning royalties on
licenses for our patented copper peptide compound.
The
Surgical Services segment generates revenues by providing fee-based procedures
typically using our mobile surgical laser equipment delivered and operated
by a
technician at hospitals and surgery centers in the United States. The Surgical
Products segment generates revenues by selling laser products and disposables
to
hospitals, surgery centers and doctors both domestically and internationally.
The
XTRAC
laser system is designed and manufactured by us to phototherapeutically treat
psoriasis, vitiligo, atopic dermatitis and leukoderma. We have secured specific
510(k) clearances from the United States Food and Drug Administration to market
the XTRAC laser system for treatment of these conditions. Our first XTRAC
phototherapy treatment systems were commercially distributed in the United
States in August 2000 prior to any of its procedures being approved for medical
insurance reimbursement. In the last several years, we have sought to obtain
reimbursement for psoriasis and other inflammatory skin disorders. As a result
of initiatives undertaken by the Company and the physician community, the
ability for physicians to process claims efficiently and with positive payment
decisions for use of the XTRAC system improved significantly during the latter
part of 2005 and 2006. The XTRAC is approved by Underwriters’ Laboratories; it
is also CE-marked, and accordingly a third party; regularly audits our quality
system and manufacturing facility. Our manufacturing facility for the XTRAC
is
located in Carlsbad, California.
Our
Skin
Care business resulted from the acquisition of ProCyte Corporation (“ProCyte”)
on March 18, 2005. ProCyte, located in Redmond, Washington, markets products
for
skin health, hair care and wound care generally distributed by dermatologists
and plastic surgeons. Most of these products incorporate patented copper peptide
technologies. In addition to a diversified product line, ProCyte has provided
a
national sales force and increased our marketing department.
1
The
Surgical businesses were acquired on December 27, 2002 as a result of the
acquisition of Surgical Laser Technologies, Inc. (“SLT”), located in
Montgomeryville, Pennsylvania. In the surgical businesses, we also develop,
manufacture and market proprietary lasers and delivery systems for both contact
and non-contact surgery and provide surgical services utilizing these and other
manufacturers’ products. The Montgomeryville facility also serves as our
corporate headquarters.
Our
Business Strategy: The Dermatology Businesses
Our
short-term goal is to establish the XTRAC system as a preferred treatment
modality for psoriasis and other inflammatory skin disorders through persuasive
clinical evidence and widespread private healthcare reimbursement. Our
acquisition of ProCyte has added a skincare business to our Company and provided
a broadened complementary product line marketed to the same customer base
through a national sales force and marketing organization. Our longer-term
goal
is to be a world-class provider of the highest-quality, cost-effective, medical
technologies, including phototherapy and surgical procedures delivered in
doctors’ offices, hospitals and surgical centers. The following are the key
elements of our strategy:
Establish
Our XTRAC System as a Preferred Treatment Modality for Psoriasis and Other
Inflammatory Skin Disorders.
Several
opinion leaders in the dermatological community have endorsed our XTRAC system
as a preferred treatment modality for the majority of psoriasis and vitiligo
patients. We are using these endorsements to accelerate the acceptance of our
XTRAC system among dermatologists. We have also developed a set of medical
practice tools, such as patient education videos, patient letters, sample press
releases, point-of-sale displays and other advertising literature, to assist
dermatologists in marketing our XTRAC system. As a result of improved
reimbursement together, with the infusion of additional equity capital in
November 2006, we have expanded our sales force, clinical specialists and
marketing initiatives.
Achieve
Widespread Private Healthcare Reimbursement. The
Centers for Medicare and Medicaid Services (CMS) published national Medicare
rates, effective March 1, 2003, for the newly established laser reimbursement
codes for inflammatory skin disorders such as psoriasis. We mailed a data
compendium of clinical and economic evidence establishing the XTRAC system
as
safe, efficacious, and cost-effective, to virtually all insurance plans in
the
United States between December 2003 and February 2004. A critical component
of
the mailing was a psoriasis health economic study, which concluded that the
overall clinical impact of the XTRAC system has proven to be outstanding for
expected treatment-free days and remission days. Further, the data compendium
stated the expected costs are lower than those for other phototherapies and
comparable to the most commonly used second-step topical alternatives. Because
total expected annual per-patient costs, with or without the XTRAC system,
are
equivalent for patients who start on combination first-step therapy, payers
bear
no incremental procedure cost if the excimer laser is included in the overall
mix of second-step care. The economic and clinical data contained therein
supports the establishment of medical policies by private healthcare
reimbursement plans for the treatment of mild to moderate psoriasis. As of
March
15, 2007, we estimate that approximately 80% of people in the United States
who
are covered by a health insurance program have plans that reimburse for the
treatment of psoriasis by means of the XTRAC system. We are continuing to try
to
develop wider private healthcare reimbursement arrangements through this
marketing effort, but can give you no assurances to increasing such
arrangements.
Build
Broad Consumer Awareness Program to Attract Those Not Currently Seeking
Treatment.
Of the
7 million people in the United States who have been diagnosed with psoriasis,
only about 1.5 million seek regular care. We believe that many do not seek
care,
largely due to the frustration caused by the limited effectiveness,
inconvenience and negative side effects of treatment alternatives other than
treatment with the XTRAC system. We have expended funds in print, radio and/or
internet advertising to educate this frustrated segment of the population about
how our XTRAC system enables more convenient and effective psoriasis treatment.
As a result of recent substantive improvement in regional insurance
reimbursement, we have initiated direct-to-consumer advertising efforts in
targeted geographic regions that have benefited by this improvement. We are
continually to evaluate the cost-effectiveness of the various components of
the
program.
2
Increase
Installed Base of Our XTRAC Systems by Minimizing Economic Risk to the
Dermatologists.
In the
United States, we generally place our XTRAC system in dermatologists' offices
on
a fee-per-use basis to the physician. This creates an opportunity for
dermatologists to utilize our system without any up-front capital costs, thereby
eliminating an inherent economic risk to them. Occasionally, favorable economic
circumstances influence our decision to sell the laser system directly to
dermatologists. Longer term, we also intend to market our XTRAC system on a
fee-per-use basis outside of the United States in combination with continuing
to
sell XTRAC systems directly to dermatologists in foreign markets through
distributors.
Sell
the XTRAC System in Foreign Countries to be Utilized to Treat Patients on a
Wider Basis.
We have
entered into a number of distribution relationships or agreements with respect
to the sale of the XTRAC system on an international basis. We have chosen this
marketing approach over a direct marketing approach because of the varying
economic, regulatory, insurance reimbursement and selling channel environments
outside of the United States. We intend to enter into additional agreements
in
other countries. However, we cannot be certain that our international
distributors will be successful in marketing the XTRAC system outside of the
United States or that our distributors will purchase more than the minimum
contractual requirements or expected purchase levels under these agreements
or
relationships. Our international strategy also includes placing XTRAC systems
with dermatologists to provide us a usage-based revenue stream. To date, no
units have been placed in international markets that provide a usage-based
revenue stream. In addition, we have added a non-laser based product line to
our
international offering, called the VTRAC™. This product line is a result of
licensed technologies from Stern Laser srl, our distributor in Italy. The
purpose of this product offering is to provide a best-in-class non-laser
purchase option to compete against lower-priced lamp-based international
competitors.
Our
Solution for Psoriasis
The
XTRAC
308-nanometer (nm) excimer laser has emerged as an important treatment option
for patients with stable localized mild-to-moderate plaque psoriasis (about
80%
of psoriasis cases), especially for patients whose plaques are recalcitrant
to
topical therapy. We believe our XTRAC system should become a preferred treatment
modality for the majority of patients suffering from psoriasis. The XTRAC
excimer laser offers numerous benefits to the patient, the physician, and the
third-party insurance payer, including:
·
|
At
308 nanometers, the excimer laser utilizes an ultra-narrow wavelength
in
the narrowband UVB spectrum with a proven anti-psoriatic action.
In
addition, by focusing the energy exclusively to the psoriasis plaques,
the
laser avoids exposing normal skin to potentially detrimental exposure
to
UVB energy, and with fewer side effects than other treatment
methods.
|
·
|
Unlike
most other lasers, our XTRAC system emits a pulsating beam of light
that
is neither hot nor cold to the touch, resulting in no pain or discomfort
to virtually all patients. Clinical studies have demonstrated the
XTRAC
system to have equal or greater efficacy than the most effective
treatment
alternatives presently available for psoriasis with fewer treatment
visits
than conventional phototherapy.
|
·
|
Our
XTRAC system enables a physician to deliver concentrated doses of
ultraviolet light to the psoriasis-affected skin at a higher intensity
than is possible with traditional ultraviolet light therapy. As a
result,
physicians can use the XTRAC system to treat all degrees of psoriasis
from
mild to moderate cases and even some severe cases. The XTRAC system
has
also proven effective to treat hinged body areas (elbows and knees),
which
previously have been the most difficult areas of the body to effectively
treat with topical treatments and other ultraviolet light
therapy.
|
·
|
Most
patients (84%) will obtain significant improvement (>75%) with 6 to 10
treatments (2 treatments per week for 3 to 5 weeks). These results
have
been demonstrated to be long-lasting as well, with mean remission
rates
reported from 3.5 to 6 months.
|
·
|
The
excimer laser also has an established cost-effectiveness profile.
A
clinical economic analysis, which was completed in 2003, has
demonstrated
that the addition of excimer laser treatment results in no expected
cost
increase to the payer. Additionally, the annual cost of excimer
laser
treatment is comparable to or less than other standard “Step 2” psoriasis
treatment modalities, such as phototherapy treatment alternatives
or
alternative topical therapies. In addition, the cost-effectiveness
of the
excimer laser is superior due to the increased number of expected
clear
days.
|
3
· |
The
acceptance of this procedure has been established by the American
Medical
Association through the establishment of three specific CPT codes
describing this procedure (96920, 96921 and 96922), as well as the
establishment of Relative Value Units adopted by CMS. Since 2003,
rates
set by CMS have trended upward.
|
·
|
Numerous
private payers and CMS carriers have recognized the clinical and
economic
merits of excimer laser treatment and have adopted medical coverage
policies endorsing its use. In addition, approximately 89,000 excimer
laser psoriasis procedures have been performed in the United States
in
2006, approximately 60,000 in 2005 and 53,000 in 2004 (since the
issuance
of relevant CPT codes).
|
Our
Solution for Vitiligo
In
March
2001, the FDA granted 501(k) clearance to market our XTRAC system for the
treatment of vitiligo. In 2006, we secured exclusive rights to U.S. Patent
No.
6,979,327, from the Mount Sinai School of Medicine. The patent covers, among
other things, treatment of vitiligo by means of an excimer laser system.
Vitiligo is a disease in which the skin loses pigment due to destruction of
the
pigment cells, causing areas of the skin to become lighter in color than
adjacent healthy skin. This condition can be distressing to patients. Between
1%
and 2% of the population suffers from the condition, and there is no known
cure.
The principal conventional treatments for symptoms are PUVA radiation and,
to a
lesser extent, topical steroids and combination therapies. According to the
National Vitiligo Foundation, or NVF, the cost of PUVA treatments, over a 12
to
18 month period, can run $6,000 or more and involve 120 clinic visits. Moreover,
according to the NVF, current conventional treatment methods are unsatisfactory
and many patients tend to lose the pigment they were successful in gaining
through PUVA therapy. Our XTRAC system can effectively re-pigment a patient's
skin, allowing treated areas to become homogeneous in pigment to healthy
surrounding skin and restore the patient's skin to its original condition.
As
treatment levels of psoriasis increase, we intend to promote use of the XTRAC
for treatment of vitiligo. As part of that promotion, we shall explore whether
CPT codes specific to vitiligo can be established as well as whether CMS and/or
private insurance plans will establish reimbursement rates for the treatment
of
vitiligo.
Our
Solution for Atopic Dermatitis
In
August
2001, the FDA granted 510(k) clearance to market our XTRAC system for the
treatment of atopic dermatitis. Atopic dermatitis is a common, potentially
debilitating condition that can compromise the quality of life for those it
affects. The condition appears as chronic inflammation of the skin that occurs
in persons of all ages, but is reported to be more common in children. Skin
lesions observed in atopic dermatitis vary greatly, depending on the severity
of
inflammation, different stages of healing, chronic scratching and frequent
secondary infections. It is reported that atopic dermatitis affects some 10%
of
children in the United States alone, and more than $364 million is spent
annually in the treatment of this disease. Treatment options include
corticosteroids, which can have negative side effects, and UVB phototherapy.
The
use of UVB phototherapy in the treatment of atopic dermatitis has been shown
effective in published studies. Because of the controlled and targeted
application provided by our XTRAC system, large areas of healthy skin are not
exposed to UVB light from the XTRAC system and the corresponding potentially
carcinogenic effect of other phototherapy treatments. We believe that the XTRAC
system could be an alternative protocol for treating atopic dermatitis
effectively. However, we do not intend to undertake clinical research that
would
clarify such an alternative protocol until we have secured our primary goal
-
wider private-payer reimbursement and increased treatment levels for
psoriasis.
Our
Solution for Leukoderma
In
May
2002, the FDA granted 510(k) clearance to market our XTRAC system for the
treatment of leukoderma, commonly known as white spots, and skin discoloration
from surgical scars, stretch marks, burns or injury from trauma. The XTRAC
system utilizes UVB light to stimulate melanocytes, or pigment cells, deep
in
the skin. As these cells move closer to the outer layer of skin, re-pigmentation
occurs. As with atopic dermatitis, we do not intend to undertake further
clinical research for leukoderma that would clarify such an alternative protocol
until we have secured our primary goal - wider private-payer reimbursement
and
treatment levels for psoriasis.
4
Our
XTRAC System
Our
XTRAC
system combines the technology of an excimer laser, or "cold" laser system
(already in use for a variety of medical and cosmetic treatments), with the
use
of ultraviolet light therapy. The XTRAC system applies a concentrated dose
of
UVB radiation directly to diseased skin at a higher intensity than traditional
ultraviolet light therapy. Our XTRAC system utilizes a 308-nm light wavelength,
which studies have shown to be the optimal wavelength to treat psoriasis
effectively. Our XTRAC system consists of the laser, which is mobile, and a
hand
piece attached to the laser by a liquid light guide or by a fiber optic cable,
which are designed to permit direct application of the ultraviolet light and
an
aiming beam to psoriasis-affected skin. The XTRAC comes optionally with an
adjustable hand-piece that can decrease the spot size of the operating beam
to
permit precise, operator-controlled irradiation of tissue.
Between
March 1998 and November 1999, we initiated five seminal clinical
trials of our XTRAC system at Massachusetts General Hospital. Our objective
in
these clinical trials was to compare our XTRAC laser technology with standard
ultraviolet light therapy in the treatment of psoriasis. In January 2000, we
received a 510(k) clearance to market the XTRAC system from the FDA based on
the
clinical results from these trials. The Massachusetts General Hospital clinical
trial, which involved 13 patients, concluded that our XTRAC laser made it
possible to treat psoriasis effectively in one session with moderately long
remission. The study also concluded that the number of treatments to remission
depended largely on the intensity of the ultraviolet light used, finding that
medium intensities seemed to provide the best results with a superior balance
between quick clearing and patient comfort. We supported the clinical trials
with research grants of approximately $954,000.
To
support our commercialization strategy, we completed an additional clinical
trial in 2000. The trial was designed to validate the results obtained in
the Massachusetts General Hospital clinical study in mainstream dermatologists'
offices. We established five Beta sites throughout the United States using
our
XTRAC system in a clinical trial of 124 persons. This study examined various
aspects of excimer laser therapy, including the number of treatments necessary
for clearing, the ultraviolet light intensity necessary for clearing and overall
patient satisfaction. Our Beta-Site Clinical Study indicated that:
·
|
approximately
72% of the subjects treated were 75% improved in slightly more than
six
sessions, with minimal and well-tolerated side
effects;
|
·
|
some
subjects were cleared in as little as one session;
and
|
·
|
subjects
were successfully treated who had psoriasis in the hinged body areas
(knees and elbows), which have proven the most difficult for other
alternative therapies to demonstrate any significant remedial
impact.
|
In
the
following years, we received clearance to market our XTRAC system for the
treatment of vitiligo and atopic dermatitis, and in 2002 for the treatment
of
leukoderma. Overall, approximately 49 clinical publications have validated
the
clinical efficacy of our phototherapy treatments for the cleared indications
of
use and have advanced the insurance reimbursement process.
Background
on Psoriasis
Psoriasis
is believed to be a non-contagious, autoimmune medical disorder and a chronic
inflammatory skin disease diagnosed in more than 7 million Americans and between
1% and 3% of the world's population. There is no known cure for psoriasis.
Although clinical symptoms and severity vary greatly between individuals over
periods of time, psoriasis appears most commonly as inflamed swollen lesions
covered with silvery white scales. Psoriasis patients often suffer from
debilitating and painful swelling, itching, bleeding, cracking and burning,
resulting in decreased mobility, depression and low self-esteem. The National
Psoriasis Foundation, or NPF, estimates that, in the United States,
dermatologists treat over 1.5 million psoriasis patients each year.
While
the
exact cause of the disease remains unknown, the emerging consensus among
scientists and physicians characterizes psoriasis as an autoimmune medical
disorder in which excessive "T" cell stimulation in skin cells activates an
inflammatory response and excessive skin cell production. The disease causes
the
rate at which skin cells are produced and pushed to the outer skin layer to
increase seven-fold, from every 28 days to every two to four days. The body
cannot shed the skin cells fast enough and this process results in patches,
or
"lesions," forming on the skin's surface.
Psoriasis cases are classified as mild (less than 2% of the body's surface
area
affected and usually localized on the knees, elbows, scalp, hands and feet),
moderate (between 2% and 10% of the body's surface area affected and usually
appearing on the arms, legs, torso and head) and severe (greater than 10% of
the
body's surface area affected and potentially involving all areas of the skin).
Our initial target market is patients with mild to moderate psoriasis that
represent 80% of all psoriasis cases.
5
Domestic
Commercialization of Our XTRAC System
For
the
past five years, we have sought to clear the path of obstacles and barriers
to a
smooth and orderly roll-out of the XTRAC system in dermatology. In 2000, the
technology, which was originally designed for cardiology applications, was
found
to have significant therapeutic advantages for psoriasis patients who were
treated with the UVB light emitted from the excimer based laser system. For
the
first two years we invested in establishing the clinical efficacy of the product
and mechanical reliability of the equipment. Starting in 2002, under the
technical leadership of Jeffrey Levatter, Ph.D., our chief technical officer,
we
made numerous improvements and corrections to the design of the XTRAC laser
system. In the last three years we pursued - and in a number of regions, have
substantially achieved - widespread reimbursement commencing with obtaining
newly created CPT reimbursement codes.
We
believe, based on our analysis, that the XTRAC system should become a preferred
treatment modality for patients afflicted with psoriasis. Although existing
treatments provide some relief to psoriasis sufferers, they are inconvenient
and
may involve negative side effects. We believe that our patent-protected XTRAC
system will enable more effective and convenient treatment with minimal side
effects.
Treatment
of psoriasis commonly follows a step approach with topical therapy as a
first-step, phototherapy as second-step, and systemic medications reserved
for
when all other treatments fail. The clinical body of evidence developed by
us
and others supports the use of the 308-nm excimer laser as safe and effective
for localized plaque-type psoriasis recalcitrant to other first-step therapies,
such as topical creams and ointments. In addition, an economic analysis
completed in December 2003 has demonstrated that the addition of excimer laser
treatment results in no expected cost increase to the payer. Further, this
analysis demonstrates the cost-effectiveness of the excimer laser is superior
due to the increased number of expected disease-free days and remission
days.
In
the
United States, we are commercializing our XTRAC system in a manner designed
to
provide a recurring revenue stream not only to us, but also to the attending
dermatologist, who would otherwise refer the patient for alternative treatment
and thereby forego associated revenues. Although on occasion we may sell the
laser outright to a dermatologist, typically we place units in the offices
of
dermatologists with high-volume psoriasis practices at no up-front capital
cost
to the dermatologists. We own the equipment and charge the dermatologist on
a
fee-per-treatment basis for the use of the XTRAC system.
A
dermatologist generally takes delivery of our XTRAC system under the terms
of
our standard usage agreement. Our agreements generally do not provide the
dermatologist with any purchase options, but we may offer a purchase option
when
favorable economic conditions exist. Title to the lasers remains either in
our
name or in the name of a third-party who may hold title as collateral within
the
context of an equipment financing transaction. There is generally no fixed
amount that is to be paid over pre-set intervals of time by a dermatologist.
We
reserve the right to remove the laser unit from a dermatologist’s office if the
parties’ economic expectations from the onset of the placement are not borne
out.
Our
agreements do not require the purchase of disposable products or similar items
from us. We make available various accessory products (e.g. canisters of xenon
chloride gas, subject to a special, proprietary formula tied to the
specifications of the XTRAC system), but do not require the purchase of set
amounts of such items. However, we require that only our qualified technicians
maintain the lasers and that the physicians observe the instructions for use
for
the laser.
The
dermatologist has the right to purchase pre-paid treatments, which are generally
ordered telephonically and added to the laser’s computer by way of a random
access code obtained from us and input by the dermatologist. These purchased
treatments may be used for multiple treatments for the same or different
patients, for psoriasis, vitiligo, atopic dermatitis or leukoderma. A single
treatment is then deducted from the laser’s computer upon patient treatment.
Payment for access codes is usually set for 60 days. The agreement does not
provide for delay in payment based on third-party reimbursement. The
dermatologists retain any revenue received from patients or their medical
insurance providers.
6
Generally,
dermatologists who treat psoriasis patients refer their patients to independent
treatment centers for ultraviolet light or write prescriptions for topical
creams or systemic drugs. In such cases, the physician does not ordinarily
share
in any of the revenue generated from providing treatments to the patient.
However, physicians using our XTRAC system will treat the patient in their
own
office and, therefore, will retain revenue that would otherwise be lost to
outside providers. In addition, in most states, a trained technician, rather
than the physician, may apply the treatment under the physician’s supervision,
thus allowing the dermatologist to continue treating other patients, while
at
the same time increasing revenue from treatments using our XTRAC system. We
believe that this will create an attractive incentive for dermatologists to
use
our XTRAC system.
We
promote our XTRAC system through trade shows, advertising in scientific
journals, industry magazines, radio, TV and newsprint, as well as direct mail
programs. Our marketing campaign has been designed to accelerate market
acceptance of our XTRAC system by increasing physician and patient awareness
for
our new technology. Starting in November 2005, we increased the level of our
direct-to-consumer advertising initiatives, given that we had made substantive
progress in obtaining private health plan reimbursement approvals.
International
Commercialization of Our Dermatology Equipment
Our
international dermatology equipment marketing plan is based on the sale of
our
XTRAC system and the newly developed VTRAC system through independent, exclusive
distributors. We have relationships with distributors and end users in more
than
30 countries in Europe, the Middle East, the Far East and Southeast Asia, and
in
Australia, South Africa and parts of Central and South America. We intend to
expand our products in more countries in these markets. In the longer term,
we
anticipate developing relationships in some countries similar to those in the
United States, whereby we, acting through our distributors, place a laser system
in the doctor's office for free or at minimal cost and charge the doctor a
per-treatment fee.
Skin
Care
General
On
March
18, 2005, we completed the acquisition of ProCyte. ProCyte generates revenues
from the sale of skin health, hair care and wound care products; the sale of
copper peptide compound in bulk; and royalties on licenses for the patented
copper peptide compound.
ProCyte’s
focus since 1996 had been to bring unique products to selected markets,
primarily based upon patented technologies such as GHK and AHK copper peptide.
We currently sell products directly to the dermatology, plastic and cosmetic
surgery, and spa markets. We have also expanded the use of our novel copper
peptide technologies into the mass retail market for skin and hair care through
specifically targeted technology licensing and supply agreements.
Products
Our
products address the growing demand for skin health and hair care products,
including products designed to mitigate the effects aging has on the skin and
hair and to enhance appearance. Our products are formulated, branded and
targeted for specific markets. Our initial products were developed to be
dispensed by physicians in the dermatology, plastic and cosmetic surgery markets
for use following various medical procedures. Anti-aging skin care products
were
added to form a comprehensive approach for a patient’s skincare regimen. Certain
of these products incorporate our patented technologies, while others complement
the product line such as our advanced sunscreen products that reduce the effects
of sun damage and aging on the skin.
7
Our
products are well-suited for use in the medical specialties of dermatology,
plastic and cosmetic surgery. Several recent studies presented at the American
Academy of Dermatology and other medical symposia have confirmed the advantages
of products containing copper peptide formulations versus such other
formulations as tretinoin, vitamin C, and other popular anti-aging and skin
rejuvenation products. The actions of wound care gels and creams containing
copper peptide have been documented in the scientific literature for their
ability to stimulate collagen synthesis, new blood vessel growth and tissue
repair. This has led to the development of a variety of products designed to
treat the skin following certain cosmetic procedures such as microdermabrasion,
laser resurfacing and hair transplantation. There are an increasing number
of
these cosmetic procedures performed each year as the baby boomer population
ages
and has a strong desire to look good and feel good. We have a series of products
tailored to the needs of these types of procedures, including the
GraftCyte®
System
and the Complex Cu3®System,
and have developed a series of daily use products that contain our patented
copper peptide compounds to aid in maintaining the quality of the skin and
hair
following these procedures.
Skin
Care.
Our
GraftCyte System was created to address the special tissue repair needs of
patients following hair transplant surgery. This system continues to be the
only
complete solution addressing post-procedure care in the hair restoration market.
We have continued to emphasize our Complex Cu3®
Post
Laser Lotion, Intensive Repair Crème, Cleanser and Hydrating Gel products used
to treat patients following chemical peels, microdermabrasion and laser
treatments. The Complex Cu3
products
provide a comprehensive approach to post-procedure care and allow us to
differentiate our line of skincare products on the basis of our proprietary
copper peptide technologies. Studies have indicated that the skin heals quicker
with the use of copper peptide compounds.
We
launched the successful Neova®
Therapy
line of anti-aging products in response to demand from physician customers
for a
comprehensive approach to medically directed skincare. The Neova Therapy line
of
GHK Copper Peptide Complex®
products
showcase elegant moisturizers and serums complemented by supporting cleansers,
toners, and masks for an integrated approach to anti-aging skincare. Each year
we have added new products to the product line, including Neova
Microdermabrasion Scrub and Neova Therapy Crème de la Copper added in 2003 and
the Neova Therapy Dual Action Lotion, a combination of GHK Copper Peptide
Complex + Retinol in March 2004. The Neova Therapy line is designed to offer
high-performance, cosmetically elegant lifestyle products that are
premium-priced in the market.
Our
line
of advanced sun protection products, marketed under the brand names of
Ti-Silc®
and
Z-Silc®,
are
recommended by dermatologists and plastic surgeons to assist in the prevention
of sun exposure that can lead to a number of problems including age spots,
hyperpigmentation, premature aging and melanoma.
Hair
Care.
We have
marketed our Tricomin®
line of
Triamino Copper Complex™-containing hair care products since 1998 (Tricomin
Shampoos, Conditioners and Follicle Therapy Solution) as a program for the
maintenance of thinning hair in men and women. Hair follicles require high
concentrations of biological copper and the Tricomin products deliver copper
along with amino acids for nourishing and stimulating the hair and scalp for
improved health, strength and appearance. These products provide physicians
with
a non-drug alternative to the problem of thinning hair care for their patients.
We also sell Tricomin products directly via the website, www.tricomin.com.
We
are currently working on the next generation of products to increase the
effectiveness of the Triamino Copper Nutritional Complex™ delivery.
Chronic
Wound Care.
Our
chronic wound care product, marketed under the Iamin®
name,
has met with varying degrees of market success. The wound care market is highly
fragmented, with many competitors, price constraints, and inadequate Medicare
reimbursement. The wound care market also requires a significant investment
in
supporting a large sales organization. For these reasons, ProCyte had
historically attempted to collaborate with partners to market its chronic wound
care product and we will continue to do so. Additionally, we have looked for
other methods of distribution and include Iamin as one of the products in the
GraftCyte System used by patients following hair transplant surgery. A number
of
other programs have been initiated in an effort to increase utilization of
the
Iamin product; however, none have resulted in meaningful revenue increases
to
date.
Markets
and Distribution
The
markets for skincare, hair care and wound care products are global. There are
numerous distinct markets where we have a presence through our own direct sales
efforts or through agreements with others. These include dermatology, plastic
and cosmetic surgery, spa, catalog, and direct mail. We sell our products to
customers utilizing a direct sales force and also generate revenues from
technology licensing.
8
We
emphasize high-quality products and services, technical knowledge, and
responsiveness to customer needs in our marketing activities. We educate our
distributors, customers and prospective customers about our products through
a
series of detailed marketing brochures, technical bulletins and pamphlets,
presentations, news releases and direct mail pieces. We also conduct a series
of
one-day educational symposia around the country to provide product updates
and
marketing ideas to current and potential physician customers. These activities
are supplemented by advertising in industry publications, technical
presentations, and exhibitions at over 30 local, national and international
trade shows.
Technology
Licensing
We
are
continuously seeking partners in the prestige, direct-to-consumer, specialty
retail and home shopping categories. Our skincare business strategy is to
identify skincare markets that would be best served by more established
companies and then target a significant partner in each market to license our
technology.
We
have
operated under a worldwide license agreement with Neutrogena Corporation, a
Johnson & Johnson company (“Neutrogena”), for worldwide use of our patented
copper peptide technology
in products for skin health in the mass retail market. Our current license
agreement continues until April 2010. Neutrogena develops, manufactures and
markets skin and hair care products domestically and internationally. Neutrogena
launched its two initial products using our technology under the brand name
of
Visibly Firm™ with Active Copper™ in April 2001. Since that time, it has
continued to add new products using ProCyte’s patented copper peptide
technology. We receive royalty payments, based on product sales by Neutrogena
and revenue from the sale of the copper peptide compound used in Neutrogena’s
products.
Our
Business Strategy: Surgical Products and Services
We
market
lasers used in surgery in such venues as hospitals, surgi-centers and doctors
offices under the trademark of SLT and, to a lesser degree, the trade name
of
Surgical Innovations & Services. We market many of our surgical laser
products using a similar business model to the marketing of our excimer laser
products by charging a per-procedure fee, thereby limiting the initial outlay
to
the customer for capital expenditure, while ensuring continued revenue flow
to
us. We offer a wide range of laser services in various specialties, including
urology, gynecology, orthopedics and general surgery. We are currently marketing
such services under the trade name PhotoMedex Surgical Services. We also provide
products that we manufacture for use in our surgical services business.
We
also
engage in the development, manufacture and sale of surgical products, including
proprietary Contact and free-beam Laser Systems for surgery and in the provision
of surgical services on a turnkey procedural basis. We introduced Contact Laser™
surgery by combining proprietary Contact Laser Delivery Systems with an Nd:YAG
laser unit to create a multi-specialty surgical instrument that can cut,
coagulate or vaporize tissue. Our Contact Laser Delivery Systems can be used
effectively with any wavelength of laser between 532nm and 1064nm, including
the
KTP laser (532nm), diode laser (various wavelengths) and Nd:YAG laser (1064nm).
We are currently marketing such products under the trade name PhotoMedex
Surgical Products.
Our
proprietary Contact Laser probe and scalpel surface treatments provide the
ability to alter selectively the temperature profile of tissue, replicating
the
clinical effect of many different types of lasers. Through our patented Contact
Laser Delivery Systems, we are able to produce a wide range of temperature
gradients, which address a broad range of surgical procedures within multiple
specialties. Our multiple-specialty capability reduces a hospital’s need to
purchase several lasers to meet its specialists’ varied requirements. These
factors, coupled with the precision, hemostasis, tactile feedback and control
that our Contact Laser Delivery Systems provide, are our primary competitive
strengths in surgical products.
During
2001, we introduced the LaserPro® CTH holmium laser, a versatile and compact
holmium laser for lithotripsy, or fragmentation of calculi of the genito-urinary
tract, as well as a broad range of other surgical applications. We also
introduced a line of fiber-optic laser delivery systems to be used with the
holmium laser. This laser has been used in the provision of surgical services
and has also been offered for sale. In 2004, we introduced our new CO2 laser
system as well as our own Diode laser system, which has replaced the Nd:YAG
laser.
9
Our
surgical revenues will thus continue to be generated primarily
from:
· providing
surgical services;
· the
sale
of Contact Laser Delivery Systems and related accessories;
· the
sale
of Diode laser units; and
· the
sale
of CTH holmium and CO2 units, and related service.
Our
Contact Laser Delivery Systems consist of proprietary fiberoptic delivery
systems which deliver the laser beam from our Diode (or Nd:YAG) laser unit
via
an optical fiber to the tissue, either directly or through a proprietary Laser
Probe or Laser Scalpel. These delivery systems can also be used with the laser
systems of certain other manufacturers. Our holmium laser delivery systems
consist of fiber-optic delivery systems, which deliver the laser beam from
our
CTH holmium laser unit to the surgical site. The CO2 laser system does not
use a
fiberoptic and therefore will have less of a recurrent revenue steam. However,
we anticipate that in conjunction with sales of the CO2 laser, we will sell
more
of our CO2-related Unimax® accessories.
Surgical
Services
We
provide our customers with the ability to utilize our laser systems, as well
as
those of other companies, on a per-procedure basis. We provide these services
through field technicians, called clinical support specialists, for a variety
of
surgical procedures utilizing various laser technologies. The per-procedure
prices we charge for surgical services vary based on the surgical procedure
performed.
Our
primary competitive strengths in surgical services are in the training we
provide to our clinical service specialists, our adherence to quality standards
and our ability to integrate products that we manufacture into the range of
services we provide. These strengths allow us to provide multiple-specialty
capability on a cost-effective basis, which in turn reduces or eliminates a
hospital’s need to purchase laser systems, associated delivery systems and
clinical support to meet its professionals’ requirements.
Most
of
our operations in surgical services are in the southeastern states of the United
States. We also have operations in the Milwaukee, Wisconsin,
Baltimore-Washington DC and Philadelphia, Pennsylvania areas. We intend to
continue to expand the territory where we provide such services and shall
explore how we may expand the range of surgical procedures which we can support.
We see surgical services as a business with favorable prospects for revenue
growth. In 2006, we entered a services contract with a nationwide consortium
of
hospitals which provides for a staged roll-out over the various regions of
the
consortium; we have begun the roll-out and are currently providing our services
in the first region designated under the roll-out.
Surgical
Products
The
following is a summary of our major surgical products:
Fiberoptic
Delivery Systems.
We have
designed disposable optical quartz fibers to
channel the laser beam from our laser unit to the fiber end, the Laser Probe
or
the Laser Scalpel or to one of 24 interchangeable, application-specific
handpieces that hold the Laser Scalpel or Laser Probe. Many of these proprietary
optical fibers and handpieces are intended for single use, while others are
designed to be reusable.
Laser
Probes and Laser Scalpels.
Our
proprietary Laser Probes and Laser Scalpels are made of either synthetic
sapphire or fused silica and have high mechanical strength, high melting
temperature and appropriate thermal conductivity. Most of these Laser Probes
and
Laser Scalpels use our patented Wavelength Conversion Effect treatments. We
offer more than 60 interchangeable Laser Probes and Laser Scalpels that provide
different power densities through various geometric configurations appropriate
for cutting, coagulation or vaporization. Our Laser Probes and Laser Scalpels
are made with varying distal tip diameters and surface treatments, each with
a
different balance between cutting and coagulation, so that the instrument can
be
suited to the particular tissue effect desired. Additionally, but at much lesser
volumes, we market side-firing and direct-firing free-beam laser probes. Instead
of changing laser units, surgeons may choose a different Laser Probe or Laser
Scalpel to perform a different procedure. The Laser Probes and Laser Scalpels
can be re-sterilized and reused.
10
Disposable
Gas or Fluid Cartridge Systems.
Our
proprietary cartridge system provides gas or fluid to cool the junction between
the optical fiber and the Laser Scalpel or the Laser Probe. These cartridges
are
sterile and used in one set of procedures.
Reusable
Laser Aspiration Handpieces.
Our
reusable stainless-steel handpieces are all used with interchangeable laser
aspiration wands and flexible endoscopic fibers. These
proprietary handpieces are intended for intra-nasal/endoscopic sinus and
oropharyngeal procedures requiring smoke and/or fluid evacuation.
Laser
Units.
Our
LaserPro Diode Laser System has replaced our CLMD line of Nd:YAG laser system.
The CLMD line has been largely phased out, although we continue to handle
maintenance and refurbishment of the existing base of Nd:YAG lasers. Like the
Nd:YAG laser, the Diode lasers are designed for use with our Contact Laser
Delivery Systems. The Diode laser unit can provide up to 20 watts of power
to
tissue. The laser has three versions, depending on which wavelength the user
desires to be installed in the laser. The wavelengths are 810-nm, 940-nm and
980-nm. The laser unit is small and portable, but also is designed to be rugged
and dependable. Acting as an original equipment manufacturer (OEM), we have
provided the Diode laser to third parties to market in specialties lying outside
our area of focus. We expect to cultivate additional relationships in the
future.
We
market
the LaserPro CTH holmium laser unit for use with fiber-optic laser delivery
systems. The laser unit delivers 20 watts to tissue, and includes a
variable-speed foot pedal for improved control of energy. It has a superior
duty
cycle. The delivery systems are re-useable.
The
LaserPro CO2 laser unit can provide up to 30 watts of power to tissue at a
wavelength of 10,600-nm. Like the Diode, the CO2 laser is readily transportable
and has been designed for dependable use. This laser was also designed to work
seamlessly with a line of premiere CO2 accessories, including the Unimax®
micromanipulator, which we acquired from Reliant Technologies. As in the case
of
the Diode laser, we have in the case of the CO2 laser undertaken discussions
to
supply the laser on an OEM basis to third parties.
We
manufacture virtually all of our laser systems and laser delivery systems (other
than those manufactured by other companies that are utilized in the provision
of
surgical services) at our Montgomeryville, Pennsylvania facility. The raw
materials we use are generally available in adequate supply from multiple
suppliers. We obtain all of our partially finished Laser Probes and Laser
Scalpels from three suppliers in the United States. We perform materials
processing and final assembly on the Laser Probes and Laser Scalpels using
proprietary and patented treatment processes. We also manufacture the fiberoptic
delivery systems, with and without handpieces. A domestic supplier manufactures
our sterile gas and fluid cartridge systems on an exclusive basis in accordance
with our specifications.
Handheld
Sinus Instrumentation.
We
market
a line of 27 precision thru-cutting instruments used for minimally invasive
sinus surgery. The line includes instruments with cutting tips at several angles
to allow for convenient access to difficult-to-reach anatomy.
Irrigation
and Suction System.
We
manufacture ClearESS®, which provides convenient and effective irrigation and
suction to remove blood and debris for enhanced visualization during endoscopic
sinus surgery. We previously used to supply this product to Linvatec
Corporation, but have now brought the line back for us to market.
Our
Operating Strategies:
Sales
and Marketing
As
of
March 15, 2007, our sales and marketing organization consists of 65 full-time
positions. Of
the 65
direct sales personnel, they are directed to sales in the Dermatology and
Surgical divisions by business segment as follows: Dermatology: A in Domestic
XTRAC; B in Skin Care; C in International Dermatology Equipment; Surgical,
E in
Surgical Services and F in Surgical Products.
11
Our
sales
organization provides consultation and assistance to customers on the effective
use of our products, whether in phototherapy or surgery. The consultative sales
effort varies depending on many factors, which including the nature of the
specialty involved and complexity of the procedures. We believe that maintaining
this consultative effort allows us to develop a long-term relationship with
our
customers.
The
time
between identifying a U.S. customer for the XTRAC system and placing a unit
with
the customer can be from one to several months. The length of the sales cycle
for a laser unit, whether an excimer unit sold internationally or one of our
surgical lasers, varies from one month to one year, with the average sale or
placement requiring approximately six months. The length of the sales cycle
for
the provision of surgical services can range from immediate to several months
depending on the services desired.
Our
sale
and post-sale support personnel includes regional managers and clinical support
specialists and marketing and technical personnel. We train the regional
managers and clinical support specialists in the utilization of our products
and
services, which allows them to provide clinical consultation regarding safety,
efficacy and clinical protocols. Our marketing and technology personnel provide
our link to the customer to create innovative solutions and identify new
applications and product opportunities. In some areas of the United States,
we
use independent distributors to provide this support for surgical products.
We
sell
our surgical products and services to hospitals and surgery centers as well
as
to individual practitioners. We design our products to be cost-effective and,
where applicable, to be accessible and easy to use with various other
technologies or products. Our marketing efforts include activities designed
to
educate physicians and nurses in the use of our products and
services.
Manufacturing
We
manufacture our phototherapy products at our new 8,000 sq. ft. facility in
Carlsbad, California and our
surgical products at our 42,000 sq. ft. facility in Montgomeryville,
Pennsylvania.
Our
California and Pennsylvania facilities are ISO 13485 certified. We believe
that
our present manufacturing capacity at these facilities is sufficient to meet
foreseeable demand for our products. We substantially outsource the manufacture
of our Skin Care products. Our facility in Redmond, Washington is the final
assembly center and primary warehouse for our skincare products, and likewise
is
operated in conformance with a quality system.
We
manufacture most of our own components and utilize certain suppliers for the
manufacture of selected standard components and subassemblies, which are
manufactured, to our specifications. Most major components and raw materials,
including optics and electro-optic devices, are available from a variety of
sources. We conduct all final testing and inspection of our products. We have
established a quality control program, including a set of standard manufacturing
and documentation procedures intended to ensure that, where required, our
instruments are manufactured in accordance with FDA Quality System Requirements
and the comparable requirements of the European Community.
Research
and Development
As
of
March 15, 2007, our research and development team included four full-time
research employees and nine engineers. We conduct research and development
activities at all three of our facilities. Our research and development
expenditures were approximately $1.0 million in 2006, $1.1 million in 2005
and
$1.8 million in 2004.
Our
research and development activities are focused on:
·
|
the
application of our XTRAC system to the treatment of other inflammatory
skin disorders;
|
·
|
the
development of additional devices to further improve the phototherapy
treatments performed with our XTRAC system;
|
·
|
the
development of new lines of phototherapy products for medical
treatments;
|
·
|
the
development of new skin health and hair care
products;
|
12
·
|
the
improvement of surgical products through tissue-effect technologies
that
include laser and non-laser based technologies focused on improving
our
product and service offerings;
|
·
|
the
development of new lines of surgical lasers and related delivery
systems
for medical treatments;
|
·
|
the
development of additional products and applications, whether in
phototherapy or surgery, by working closely with medical centers,
universities and other companies worldwide;
and
|
·
|
the
development of new applications in minimally invasive and open surgery
procedures where precision and hemostasis are critical to the procedure
being performed and where our products and services can demonstrate
distinct clinical advantages and cost-effectiveness relative to
traditional surgical methods.
|
Patents
and Proprietary Technologies
We
intend
to protect our proprietary rights from unauthorized use by third parties to
the
extent that our proprietary rights are covered by valid and enforceable patents
or are effectively maintained as trade secrets.
Patents
and other proprietary rights are an element of our business. Our policy is
to
file patent applications and to protect technology, inventions and improvements
to inventions that are commercially important to the development of our
business. As patents expire and expose our inventions to public use, we seek
to
mitigate the impact of such expirations by improvements on the inventions
embodied in the expiring patents. The patents in our Skin Care segment relate
to
use of our copper peptide-based technology for a variety of healthcare
applications, and to the composition of certain biologically active, synthesized
compounds. Our strategy has been to apply for patent protection for certain
compounds and their discovered uses that are believed to have potential
commercial value in countries that offer significant market potential. As of
March 15, 2007, we have more than 120 domestic and foreign issued patents,
which
serve to help protect the technology of our businesses in phototherapy, skin
health and hair care, and surgical products and services. To the same purpose,
we have 40 patent applications pending in the United States and abroad. We
have
retrenched some applications where we do not foresee meaningful value to us.
We
have
licensed certain of our proprietary technology in phototherapy to Komatsu,
Ltd.
in connection with its manufacture of semi-conductor lithography equipment,
for
which we are entitled to receive royalty fees. We have licensed our copper
peptide technology to Neutrogena, for which we currently receive royalties.
Conversely, from time to time, we seek licenses from third parties for
technology that can broaden our product and service offerings, as for example
a
license we secured from the Mount Sinai School of Medicine granted us for
exclusive rights to a patent covering the use of excimer lasers in the treatment
of vitiligo.
We
also
rely on trade secrets, employee and third-party nondisclosure agreements and
other protective measures to protect our intellectual property rights pertaining
to our products and technology.
Many
of
our products and services are offered under trademarks and service marks, both
registered and unregistered. We believe our trademarks encourage customer
loyalty and aid in the differentiation of our products from competitors’
products, especially in our skin care products. Accordingly, we have registered
more than 30 of our trademarks in the United States. We have other registrations
for our skincare products in foreign jurisdictions.
Government
Regulation
Our
products and research and development activities are regulated by numerous
governmental authorities, principally the Federal Food and Drug Administration
or FDA and corresponding state and foreign regulatory agencies. Any device
manufactured or distributed by us will be subject to pervasive and continuing
regulation by the FDA. The Federal Food, Drug and Cosmetics Act and other
federal and state laws and regulations govern the pre-clinical and clinical
testing, design, manufacture, use and promotion of medical devices and drugs,
including our XTRAC system, surgical lasers and other products currently under
development by us. Product development and approval within this regulatory
framework takes a number of years and involves the expenditure of substantial
resources.
13
In
the
United States, medical devices are classified into three different classes,
Class I, II and III, on the basis of controls deemed reasonably necessary
to ensure the safety and effectiveness of the device. Class I devices are
subject to general controls, such as labeling, pre-market notification and
adherence to the FDA's good manufacturing practices, and quality system
regulations. Class II devices are subject to general as well as special
controls, such as performance standards, post-market surveillance, patient
registries and FDA guidelines. Class III devices are those which must
receive pre-market approval by the FDA to ensure their safety and effectiveness,
such as life-sustaining, life-supporting and implantable devices, or new devices
which have been found not to be substantially equivalent to legally marketed
devices.
Before
a
new medical device can be marketed, marketing clearance must be obtained through
a pre-market notification under Section 510(k) of the Food and Drug
Modernization Act of 1997, or the FDA Act, or through a pre-market approval
application under Section 515 of such FDA Act. The FDA will typically grant
a 510(k) clearance if it can be established that the device is substantially
equivalent to a predicate device that is a legally marketed Class I or II
device or certain Class III devices. We have received FDA 510(k) clearance
to market our XTRAC system for the treatment of psoriasis, vitiligo, atopic
dermatitis and leukoderma. Additionally, the FDA has issued clearances to
commercially market our Contact Laser System, including the laser unit, Laser
Probes and Laser Scalpels and Fiberoptic Delivery Systems, in a variety of
surgical specialties and procedures in gynecology, gastroenterology, urology,
pulmonology, general and plastic surgery, cardio-thoracic surgery, ENT surgery,
ophthalmology, neurosurgery and head and neck surgery. The FDA granted these
clearances under Section 510(k) on the basis of substantial equivalence to
other
laser or electrosurgical cutting devices that had received prior clearances
or
were otherwise permitted to be used in such areas. The range of clearances
for
our Diode laser system is similar to the range of clearances for the CLMD Nd:YAG
laser systems. We have also received FDA clearance under Section 510(k) to
market our holmium laser system, including the laser unit and fiberoptic
delivery systems, in a variety of surgical specialties and procedures in
urology, otorhinolaryngology, discectomy and percutaneous laser disc
decompression.
For
any
devices that are cleared through the 510(k) process, modifications or
enhancements that could significantly affect the safety or effectiveness, or
that constitute a major change in the intended use of the device, will require
new 510(k) submissions. In August 2003, the FDA granted 510(k) clearance for
modifications that had been made to the XTRAC laser, which we have marketed
as
the XTRAC XL Plus excimer laser system. In October 2004, the FDA granted
clearance for the Ultra™ (AL 8000) excimer laser system. We also received in
2004, 510(k) marketing clearance for our Diode and CO2 surgical laser
systems.
A
pre-market approval application may be required if a proposed device is not
substantially equivalent to a legally marketed Class I or II device, or for
certain Class III devices. A pre-market approval application must be
supported by valid scientific evidence to demonstrate the safety and
effectiveness of the device, typically including the results of clinical trials,
bench tests and laboratory and animal studies. In addition, the submission
must
include the proposed labeling, advertising literature and any training
materials. The pre-market approval 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.
We
are
subject to routine inspection by the FDA and have to comply with a number of
regulatory requirements that usually apply to medical devices marketed in the
United States, including labeling regulation, good manufacturing process
requirements, medical device reporting regulation (which requires a manufacturer
to report to the FDA certain types of adverse events involving its products),
and the FDA's prohibitions against promoting products for unapproved or
off-label uses.
We
are
also subject to the Radiation Control for Health and Safety Act with laser
radiation safety regulations administered by the Center for Devices and
Radiological Health, or CDRH, of the FDA. These regulations require laser
manufacturers to file new product reports and annual reports, to maintain
quality control, product testing and sales records, to incorporate certain
design and operating features in lasers sold to end users and to certify and
label each laser sold, except those sold to private-label customers, as
belonging to one of four classes, based on the level of radiation from the
laser
that is accessible to users. Various warning labels must be affixed and certain
protective devices installed, depending on the class of product. The CDRH is
empowered to seek fines and other remedies for violations of the regulatory
requirements. To date, we have filed the documentation with the CDRH for our
laser products requiring such filing, and have not experienced any difficulties
or incurred significant costs in complying with such regulations.
14
We
have
received ISO 13485/EN46001 certification for our XTRAC system and our, Diode,
holmium, CO2 and Nd:YAG laser systems. This certification authorizes us to
affix
a CE Mark to our products as evidence that they meet all European Community,
or
EC, quality assurance standards and compliance with applicable European medical
device directives for the production of medical devices. This will enable us
to
market our approved products in all of the member countries of the European
Union, or EU. We also will be required to comply with additional individual
national requirements that are outside the scope of those required by the EU.
Our products have also met the discrete requirements for marketing in various
other countries. Failure to comply with applicable regulatory requirements
can
result in fines, injunctions, civil penalties, recalls or seizures of products,
total or partial suspensions of production, refusals by foreign governments
to
permit product sales and criminal prosecution.
As
to our
products in the Skin Care business segment, the Federal Food, Drug and Cosmetic
Act, and the regulations promulgated thereunder, and other federal and state
statutes govern the testing, manufacture, safety, labeling, storage,
record-keeping, advertising and promotion of cosmetic products as well. Our
products and product candidates in the Skin Care segment may be regulated by
any
of a number of divisions of the FDA and in other countries by similar health
and
regulatory authorities. The process of obtaining and maintaining regulatory
approvals for the manufacturing or marketing of our existing and potential
skin
care products is costly and time-consuming and is subject to unanticipated
delays. Regulatory requirements ultimately imposed could also adversely affect
our ability to clinically test, manufacture or market products.
In
the
United States, products that do not seek to make effectiveness claims based
on
human clinical evaluation may be subject to review and regulation under the
FDA’s cosmetic, drug or 510(k) medical device guidelines. Similar guidelines
exist for such products in other countries. Such 510(k) products, which include
wound care dressings and certain ointments and gels, must show safety and
substantial equivalency with predicate products already cleared by the FDA
to be
marketed. There can be no assurance that product applications submitted to
the
FDA or similar agencies in other countries will receive clearance to be
marketed, or that the labeling claims sought will be approved, or that, if
cleared, such products will be commercially successful or free from third-party
claims relating to the effectiveness or safety of such products.
We
are
also or may become subject to various other federal, state, local and foreign
laws, regulations and policies relating to, among other things, safe working
conditions, good laboratory practices, and the use and disposal of hazardous
or
potentially hazardous substances used in connection with research and
development. Failure to obtain regulatory approvals where appropriate for our
product candidates or to attain or maintain compliance with quality system
regulations or other manufacturing requirements would have a material adverse
effect on our business, financial condition and results of
operations.
Third-Party
Reimbursement
Our
ability to market our phototherapy products successfully will depend in large
part on the extent to which various third parties are willing to reimburse
patients or providers for the cost of medical procedures utilizing our treatment
products. These third parties include government authorities, private health
insurers and other organizations, such as health maintenance organizations.
Third-party payers are systematically challenging the prices charged for medical
products and services. They may deny reimbursement if they determine that a
prescribed device is not used in accordance with cost-effective treatment
methods as determined by the payer, or is experimental, unnecessary or
inappropriate. Accordingly, if less costly drugs or other treatments are
available, third-party payers may not authorize or may limit reimbursement
for
the use of our products, even if our products are safer or more effective than
the alternatives. Additionally, they may require changes to our pricing
structure and revenue model before authorizing reimbursement.
Reimbursement
systems in international markets vary significantly by country and by region
within some countries, and reimbursement approvals must be obtained on a
country-by-country basis. Many international markets have government-managed
healthcare systems that control reimbursement for new devices and procedures.
In
most markets, there are private insurance systems, as well as government-managed
systems. Our XTRAC products remain substantially without approval for
reimbursement in any international markets under either government or private
reimbursement systems. Reimbursement for the products and services provided
by
our Surgical Services and Surgical Products segments has been generally
well-established and is not viewed as an obstacle to growth in those segments.
Since the skincare products are primarily for cosmetic applications,
reimbursement is not a critical factor in growing revenues for this product
segment.
15
In
2006,
we continued our efforts to secure private, third-party reimbursement in our
domestic XTRAC business segment. Our efforts began in February 2002 when the
Current Procedural Terminology Editorial Board of the American Medical
Association, or AMA, approved the request by the American Academy of Dermatology
to issue reimbursement codes for laser therapies in the treatment of psoriasis
and other inflammatory skin diseases, which would include laser therapy using
our XTRAC system to treat such conditions. In December 2002, the Centers for
Medicare and Medicaid Services, or CMS, published the relative values and
national Medicare reimbursement rates for each of the CPT codes. These
reimbursement rates were effective January 1, 2003. However, they could not
be
paid sooner than March 1, 2003. The designation for laser treatment for
inflammatory skin disease (psoriasis) was broken into three distinct codes,
based on the total skin surface area being treated:
·
96920 -
designated for: the total area less than 250 square centimeters. CMS assigned
a
2007 national payment of approximately $141.00 per treatment;
·
96921 -
designated for: the total area 250 to 500 square centimeters. CMS assigned
a
2007 national payment of approximately $144.00 per treatment; and
·
96922 -
designated for: the total area over 500 square centimeters. CMS assigned a
2007
national payment of approximately $213.00 per treatment.
The
state
rates will vary by overhead factors applicable to each state.
In
addition to Medicare and Medicaid, consistent domestic private healthcare
reimbursement is critical for significant growth in XTRAC system procedures.
There were more than 89,000 XTRAC procedures in 2006, 60,000 XTRAC procedures
in
2005 and more than 50,000 XTRAC procedures in 2004 with the majority being
covered by third-party reimbursement. Historically, it has been our belief
that
a rapid increase in widespread adoption of private healthcare reimbursement
was
being thwarted by a perception that the XTRAC therapy, although widely
publicized as clinically safe and efficacious, was not economically
cost-effective compared to other existing therapies. We sponsored the completion
of an economic and clinical study to review the clinical and economic
effectiveness of the XTRAC laser as a second-step therapy for the treatment
of
psoriasis. The conclusions of the study are: there is no additional cost of
adding XTRAC as second-line therapy in a managed care plan; XRAC is a
cost-effective second-line treatment for mild-to-moderate plaque psoriasis;
XTRAC provides the greatest number of treatment-free days in one year among
all
therapies, except for intralesional corticosteroid injections (“ICI”); XTRAC is
the lowest cost per treatment-free-day with the exception of ICI; XTRAC has
the
lowest cost per remission day among all phototherapies; and XTRAC has the
highest number of remission days among all therapies. The results of this study
were compiled in a data compendium and distributed to all the major health
insurers; the results have also been published in a peer-review journal. In
2005
substantive progress was made in connection with obtaining approvals for
covering medically necessary targeted UVB therapy for psoriasis. As a result
of
certain national insurers approving the XTRAC excimer laser therapy in the
latter part of 2005, we initiated– and have continued in 2006 – a
direct-to-consumer advertising campaign in certain geographic regions.
We
have
been advised in February 2007 that the technology assessment branch of the
Blue
Cross Blue Shield Association has determined that among other things that
phototherapy with the excimer laser is not experimental use in the treatment
of
up to 20% the skin surface area for psoriasis. We conjecture that this
determination will positively influence some remaining subscribing private
plans
to cover treatment of psoriasis with the XTRAC laser. In addition, in 2007
a
bill was introduced in Congress, at the urging of NPF, to increase the patient’s
awareness of available treatments of psoriasis. This too should positively
influence patients suffering from psoriasis to seek treatment.
16
Competition
The
market for our XTRAC system is highly competitive. We compete with other
products and methodologies used to treat the symptoms of psoriasis, vitiligo,
atopic dermatitis and leukoderma, including topical treatments, systemic
medications and other phototherapies. We believe that our XTRAC system will
favorably compete with alternative treatments for these disorders primarily
on
the basis of its effectiveness, as well as on the basis of the lower
out-of-pocket costs, as compared to costs associated with alternative
treatments. Market acceptance of our XTRAC system treatment for these diseases
is dependent on our ability to establish, with the medical and patient
communities, the efficacy of our XTRAC system as a preferred treatment modality.
In addition, all or a portion of patient costs for many of the alternative
treatments are paid or are reimbursable by health insurance coverage or other
third-party payers, such as Medicaid and Medicare. Patient costs for treatments
utilizing our XTRAC system may not be initially eligible for health care
coverage or reimbursement by third-party payers until such payers approve
reimbursement. This may cause some patients or physicians to choose alternative
treatments offered by our competitors.
We
also
face direct competition from other companies, including large pharmaceutical
companies, engaged in the research, development and commercialization of
treatments for psoriasis, atopic dermatitis, vitiligo and leukoderma. In some
cases, those companies have already received FDA approval or commenced clinical
trials for such treatments. Many of these companies have significantly greater
financial resources and expertise in research and development, manufacturing,
conducting pre-clinical studies and clinical trials, and marketing than we
do.
Various
other companies are now marketing laser-based phototherapy treatment products.
One former competitor received FDA clearance to market an excimer laser for
the
treatment of psoriasis in the United States, and another competitor has asserted
that it has such clearance - an assertion we are disputing. There have been
at
least three foreign-based companies which market an excimer laser for the
treatment of skin disorders outside of the United States. Two others have
developed pulse-dye lasers, which are being explored as treatments for
psoriasis. Another company has announced FDA clearance for a standard UVB
light-based system using a fiber-optic delivery system for the treatment of
skin
disorders. We expect that other devices will enter the market, too. All of
these
technologies will continue to evolve with time. We cannot say how much these
technologies will impact us, but we anticipate that competitors that enter
the
US market will predominantly not use a fee-per-procedure model but will use
an
outright sales model, and will likely sell not on claims of superior quality,
but on claims of lower prices and better economic returns.
Competition
in the wound care, skin health and hair care markets is intense. Our competitors
include well-established pharmaceutical, cosmetic and healthcare companies
such
as Obagi, La Roche Posay, Allergan, Pavonia, Declore and Murad. These
competitors have substantially more financial and other resources, larger
research and development staffs, and more experience and capabilities in
researching, developing and testing products in clinical trials, in obtaining
FDA and other regulatory approvals and in manufacturing, marketing and
distribution than we do. In addition, a number of smaller companies are
developing or marketing competitive products. Our competitors may succeed in
developing and commercializing products or obtaining patent protection or other
regulatory approvals for products more rapidly than we can. In addition,
competitive products may be manufactured and marketed more successfully than
our
potential products. Such developments could render our existing or potential
products less competitive or obsolete and could have a material adverse effect
on our business, financial condition and results of operations.
With
regard to surgical lasers, we face substantial competition from other
manufacturers of surgical laser systems, whose identity varies depending on
the
medical application for which the surgical system is being used, and from
traditional surgical methods. Other companies are developing competitive
surgical systems and related technologies. Many of these companies are
substantially larger and have substantially greater resources than we do. These
efforts could result in additional competitive pressures on our
operations.
In
addition, we face competition from other surgical services companies and from
product manufacturers who may offer their products through a similar
per-procedure method. Additionally, we face substantial competition from
well-established manufacturers of non-laser products. These well-established
companies have substantially greater resources than we do and could exert
considerable competitive pressure on us. We continue to monitor the concepts
or
products and services some companies have introduced into the market that draw
on Contact Laser technology. We do not believe, however, that such concepts
or
products will have a significant impact on our sales.
17
In
addition, our competitors compete with us in recruiting and retaining qualified
scientific, management and marketing personnel.
Employees
As
of
March 15, 2007, we had 192 full-time employees, which consisted of 3 executive
officers, 11 other senior officers or managers, 60 sales and marketing staff,
82
people engaged in manufacturing of lasers and laser-related products, 9
customer-field service personnel, 4 people engaged in research and development,
8 engineers and 15 finance and administration staff. We intend to hire
additional personnel as the development of our business makes such action
appropriate. The loss of the services of key employees could have a material
adverse effect on our business. Since there is intense competition for qualified
personnel knowledgeable in our industry, no assurances can be given that we
will
be successful in retaining and recruiting needed personnel.
Our
employees are not represented by a labor union nor covered by a collective
bargaining agreement. We believe that we have good relations with our employees.
We provide our employees with certain benefits, including health
insurance.
Item
1A. Risk
Factors
The
following discussion of risk factors contains forward-looking statements as
discussed on page 1. These risk factors may be important to understanding any
statements in this Annual Report on Form 10-K or elsewhere. Our business
routinely encounters and addresses risks, some of which may cause our future
results to be different - sometimes materially different - than we presently
anticipate.
Risks
Related to Our Business
We
have a history of losses, expect future losses and cannot assure you that we
will become or remain profitable.
Historically,
we have incurred significant losses and have had negative cash flows from our
phototherapy operations. Our surgical products and services business also has
generated losses in recent years. To date, we have dedicated most of our
financial resources to research and development and selling, general and
administrative expenses. As of December 31, 2006, our accumulated deficit was
approximately $87.7million.
Our
future revenues and success depend significantly upon acceptance of our excimer
laser systems for the treatment principally of psoriasis, but also of vitiligo,
atopic dermatitis and leukoderma. Our XTRAC system for the treatment of these
conditions generates revenues, but those revenues are presently insufficient
to
generate positive cash flows from our operations in the two XTRAC-related
business segments. Our future revenues and success also depend on the continued
growth of the revenue from the skin health and hair care products of our
skincare products and of our surgical services business and revenue stability
within our surgical products business. Our ability to market our products and
services successfully and the expected benefits to be obtained from our products
and services may be adversely affected by a number of factors, such as
unforeseen costs and expenses, technological changes, economic downturns,
competitive factors or other events beyond our control.
We
expect
to incur losses as we move into fiscal 2007 because we plan to spend substantial
amounts on expanding, in controlled fashion, our operations in phototherapy,
and
particularly in increasing our customers’ effective utilization of the XTRAC
system. We cannot assure you that we will market any products successfully,
operate profitably in the future, or that we will not require significant
additional financing in order to accomplish our business plan.
18
We
may need additional financing to maintain and expand our business, and such
financing may not be available on favorable terms, if at
all.
We
have
historically financed our activities through working capital provided from
operations, the private placement of equity securities and from lines of credit.
We believe that our cash balance, together with access to lease financing for
capital expenditures and other existing financial resources, and revenues from
sales, distribution, licensing and manufacturing relationships, should be
sufficient to meet our operating and capital requirements beyond the second
quarter of 2008. However, we may have to raise substantial additional capital
if:
·
|
operating
losses continue, because anticipated demand for the XTRAC system
for the
treatment of psoriasis or surgical laser systems does not meet our
current
expectations;
|
·
|
we
fail to maintain existing or develop new customers or corporate partners
for the marketing and distribution of our skincare products;
|
·
|
the
geographic expansion of our surgical services is stymied by competition
and revenue increases do not materialize;
|
·
|
we
need to maintain or accelerate favorable, but costlier, growth of
our
revenues; or
|
·
|
changes
in our research and development plans necessitate unexpected, large
future
expenditures.
|
If
we need additional financing, we cannot assure you that such financing will
be
available on favorable terms, if at all. In addition, any future issuance of
our
securities may result in substantial dilution to existing stockholders. If
we
need funds and cannot raise them on acceptable terms, we may not be able
to:
·
|
execute
our growth plan for the XTRAC system, surgical services and skincare
products;
|
·
|
expand
our manufacturing facilities, if necessary, based on increased demand
for
the XTRAC system or other surgical products or new skincare products,
which may be introduced;
|
·
|
take
advantage of future opportunities, including synergistic
acquisitions;
|
·
|
respond
to customers, competitors or violators of our proprietary and contractual
rights; or
|
·
|
remain
in operation.
|
Our
laser treatments of psoriasis, vitiligo, atopic dermatitis and leukoderma,
our
skincare products and our surgical laser products and any of our future products
or services may fail to gain market acceptance, which could adversely affect
our
competitive position.
No
independent studies with regard to the feasibility of our proposed business
plan
have been conducted by third parties with respect to our present and future
business prospects and capital requirements. We have generated limited
commercial distribution for our XTRAC system and our other products. Skincare
products sales are dependent on existing strategic partners for distributing
and
marketing our products. We may be unsuccessful in continuing existing, or
developing new, strategic partners in order to maintain or expand the markets
for the skincare business’ existing or future products. Our surgical services
may fail to gain market acceptance in new territories into which we expand.
In
addition, our infrastructure to enable such expansion, though stronger than
in
the past, is still limited. Even if adequate financing is available and our
products are ready for market, we cannot assure you that our products and
services will find sufficient acceptance in the marketplace to fulfill our
long
and short-term goals. Our efforts to help physicians increase patient awareness
and interest in the XTRAC system may prove unavailing, as may also our efforts
through our clinical specialists to improve and increase physicians’ effective
utilization of the XTRAC system. We also face a risk that other companies,
not
necessarily direct competitors of ours, are vying for a dermatologist’s time and
attention. If such other companies have products that require less time
commitment from the dermatologist and yield an attractive return on the
dermatologist’s time and investment (e.g. Botox injections may be such a
product), we may find that our efforts to increase our base of users is
hindered, or even if we place a laser with a dermatologist, we may find that
insufficient time is devoted to increasing patient awareness of laser treatment
of psoriasis. We therefore cannot assure you that the marketplace will be
receptive to our excimer laser technology, skincare products, or our surgical
services over competing products, services and therapies or that a cure will
not
be found for the underlying diseases we are focused on treating. Failure
of our
products and surgical services to achieve market acceptance could have a
material adverse effect on our business, financial condition and results
of
operations.
While
we
have engaged in clinical studies for our psoriasis treatment, and based on
these
studies, we have gained FDA clearance, appropriate CPT reimbursement codes
for
treatment and suitable reimbursement rates from CMS for those codes, we may
face
other hurdles to market acceptance if, for example, practitioners in significant
numbers wait to see longer-term studies or if it becomes necessary to conduct
studies corroborating the role of the XTRAC system as a second-line therapy
for
treating psoriasis or if patients do not elect to undergo psoriasis treatment
using the XTRAC system. We have not had sufficient time to observe the long-term
effectiveness or potential side effects of our treatment system for psoriasis,
vitiligo, atopic dermatitis or leukoderma nor to gauge what marketing and sales
programs, if any, are effective in increasing patients’ demand for the treatment
of psoriasis with the XTRAC system.
19
In
2003,
we improved the reliability and functionality of the XTRAC system and upgraded
such lasers both in the United States and overseas. In 2004, we obtained FDA
510(k) marketing clearance for a smaller, faster and more powerful XTRAC system
known as the Ultra™. These efforts should help us gain market acceptance for the
XTRAC system both in the United States and abroad, but do not guarantee such
acceptance or that we may not encounter further problems in reliability. We
have
designed the XTRAC system to be user-friendly, such that a properly in-serviced
medical technician in a physician’s office may, under the physician’s
supervision, safely and effectively administer treatments to a patient. In
fact,
the CMS reimbursement rates are based on the lower labor rates achieved through
such delegation. Nevertheless, whether a treatment may be delegated, and if
so
to whom and to what extent, are matters that may vary state by state, as these
matters are within the province of the state medical boards. In states that
may
be more restrictive in such delegation, a physician may decline to adopt the
XTRAC system into his or her practice, deeming it to be fraught with too many
constraints and finding other outlets for the physician’s time and staff time to
be more remunerative. There can be no assurance that we will be successful
in
persuading such medical boards that a liberal standard for delegation is
appropriate for the XTRAC system, based on its design for ease and safety of
use. If we are not successful, we may find that even if a geographic region
has
wide insurance reimbursement, the region’s physicians may yet balk at adopting
the XTRAC system into their practices.
Our
success is dependent on intellectual property rights held by us, and our
business will be adversely affected by direct competition if we are unable
to
protect these rights.
Our
success will depend, in part, on our ability to maintain and defend our patents.
However, we cannot give you any assurances that the technologies and processes
covered by all of our patents may not be found to be obvious or substantially
similar to prior work, which could render these patents unenforceable. Moreover,
as our patents expire, competitors may utilize the technology found in such
patents to commercialize their own laser systems. In offset to the expiring
patents, we endeavor to secure additional patents on critical, commercially
desirable improvements to the inventions of the expiring patents. There can
be
no assurance that we will be successful in securing such additional patents,
or
that such additional patents will adequately offset the effect of the expiring
patents.
Of
particular note is US Patent No. 4,891,818, the so-called “ ‘818 Patent”, which
covers, among other things, the design of the gas chamber in the XTRAC laser.
The ‘818 Patent will expire on August 31, 2007 and will thereafter no longer
serve as a barrier to entry to the relatively reimbursement-rich US market.
The
additional patent rights we seek may serve less to bar competitors from entry
and may serve more, when aggregated with other clinical and competitive
strengths, to differentiate and distinguish our product (e.g. the Ultra), in
both its utility and its range of applications, from those of competitors.
We
may therefore choose in the U.S. market to broaden our fee-per-procedure
business model to include a standard direct sales option, as we have done and
continue to do in the international market. Where a competitor infringes on
our
patent and other proprietary rights, we are prepared, our financial condition
permitting, to defend those rights vigorously in the U.S. courts. If we unable
through our technological innovations to preserve our proprietary rights, our
ability to market the XTRAC system could be materially and adversely
affected.
A
U.S.
patent relating to a copper peptide compound manufactured and used in products
distributed by Neutrogena under the Neutrogena license agreement expired on
February 5, 2005. Upon expiration of this patent, the agreement specifies that
lower royalty percentages from sales of such products be used for the remaining
term, the impact of which is a reduction in the average effective royalty rate.
The actual amount of royalty income recognized in future periods is dependent
upon the royalty percentages in effect during the period and the actual
applicable sales reported by Neutrogena, which can vary from quarter to quarter.
The expiration of the patent would also allow others, including Neutrogena,
to
apply the technology covered by that patent in their products.
Trade
secrets and other proprietary information which are not protected by patents
are
also critical to our business. We attempt to protect our trade secrets by
entering into confidentiality agreements with third parties, employees and
consultants. However, these agreements can be breached and, if they are and
even
if we are able to prove the breach or that our technology has been
misappropriated under applicable state law, there may not be an adequate remedy
available to us. In addition, costly and time-consuming litigation may be
necessary to enforce and determine the scope of our proprietary rights; even
should we prevail in such litigation, the party we prevail over may have scant
resources available to satisfy a judgment.
20
Further,
our skincare business seeks to establish customer loyalty, in part, by means
of
our use of trademarks. It can be difficult and costly to defend trademarks
from
encroachment or misappropriation overseas. Third parties may also challenge
the
validity of certain of our trademarks. In either eventuality, our customers
may
become confused and direct their purchases to competitors.
Third
parties may independently discover trade secrets and proprietary information
that allow them to develop technologies and products that are substantially
equivalent or superior to our own. Without the protection afforded by our
patent, trade secret and proprietary information rights, we may face direct
competition from others commercializing their products using our technology,
which may have a material adverse effect on our business and our
prospects.
Defending
against intellectual property infringement claims could be time-consuming and
expensive, and if we are not successful, could cause substantial expenses and
disrupt our business.
We
cannot
be sure that the products, services, technologies and advertising we employ
in
our business do not or will not infringe valid patents, trademarks, copyrights
or other intellectual property rights held by third parties. We may be subject
in the ordinary course of our business to legal proceedings and claims from
time
to time relating to the intellectual property or derivative rights of others.
Any legal action against us claiming damages or seeking to enjoin commercial
activities relating to the affected products or our methods or processes could
have a material adverse effect on our business and prospects by:
·
|
requiring
us, or our collaborators, to obtain a license to continue to use,
manufacture or market the affected products, methods or processes,
and
such a license may not be available on commercially reasonable terms,
if
at all;
|
·
|
preventing
us from making, using or selling the subject matter claimed in patents
held by others and subject us to potential liability for
damages;
|
·
|
consuming
a substantial portion of our managerial and financial resources;
or
|
·
|
resulting
in litigation or administrative proceedings that may be costly or
not
covered by our insurance policies, whether we win or
lose.
|
Our
success depends on third-party reimbursement of patients' costs for our XTRAC
system, which could result in potentially reduced prices or reduced
demand.
Our
ability to market the XTRAC system and other treatment products successfully
will depend in large part on the extent to which various third parties are
willing to reimburse patients or providers for the costs of medical procedures
utilizing such products. These third parties include government authorities,
private health insurers and other organizations, such as health maintenance
organizations. Third-party payers are systematically challenging the prices
charged for medical products and services. They may deny reimbursement if they
determine that a prescribed device is not used in accordance with cost-effective
treatment methods as determined by the payer, or is experimental, unnecessary
or
inappropriate. Further, although third-parties may approve reimbursement, such
approvals may be under terms and conditions that discourage use of the XTRAC
laser system. Accordingly, if less costly drugs or other treatments are
available, third-party payers may not authorize or may limit reimbursement
for
the use of its products, even if our products are safer or more effective than
the alternatives.
Although
we have received reimbursement approvals from an increased number of private
healthcare plans, we cannot give assurance that private plans will continue
to
adopt or maintain favorable reimbursement policies or to accept the XTRAC system
in its clinical role as a second-line therapy in the treatment of psoriasis.
Additionally, third party payers may require further clinical studies or changes
to our pricing structure and revenue model before authorizing
reimbursement.
21
As
of
March 15, 2007, we estimate, based on published coverage policies and on payment
practices of private and Medicare insurance plans, that approximately 80% of
the
insured population in the United States is covered by the insurance coverage
or
payment policies that reimburse physicians for using the XTRAC system for
treatment of psoriasis. Based on these reports and estimates, we are continuing
the implementation of a roll-out strategy for the XTRAC system in the United
States in selected areas of the country where reimbursement is widely available.
The success of the roll-out depends on increasing physician and patient demand
for the treatment. We can give no assurance that health insurers will not
adversely modify their reimbursement policies for the use of the XTRAC system
in
the future.
We
intend
to seek coverage and reimbursement for the use of the XTRAC system to treat
other inflammatory skin disorders, after additional clinical studies are
completed. There can be no assurances that we will be in position to expand
coverage for vitiligo or to seek reimbursement for the use of the XTRAC system
to treat atopic dermatitis or leukoderma, or, if we do, that any health insurers
will agree to any reimbursement policy.
Cost
containment measures and any general healthcare reform could adversely affect
our ability to market our products.
Cost
containment measures instituted by healthcare providers and insurers and any
general healthcare reform could affect our ability to receive revenue from
the
use of our XTRAC system or to market our skincare products, and surgical laser
products, and may have a material adverse effect on us. We cannot predict the
effect of future legislation or regulation concerning the healthcare industry
and third-party coverage and reimbursement on our business. In addition,
fundamental reforms in the healthcare industry in the United States and the
European Union continue to be considered, although we cannot predict whether
or
when any healthcare reform proposals will be adopted and what impact such
proposals might have on demand for our products.
The
XTRAC system will continue to be the most promising product that is currently
marketed by us. If physicians do not adopt the XTRAC system, we will not achieve
anticipated revenue growth.
We
commercially introduced the XTRAC system in August 2000, but decelerated that
introduction while we sought appropriate CPT codes and suitable rates of
reimbursement from CMS. After we obtained CPT codes and reimbursement rates
from
CMS for the CPT codes, we began a roll-out strategy for the XTRAC system in
the
United States. To achieve increasing revenue, this product must also gain
recognition and adoption by physicians who treat psoriasis and other skin
disorders. The XTRAC system represents a significant departure from conventional
psoriasis treatment methods. We believe that the recognition and adoption of
the
XTRAC system would be expedited if there were long-term clinical data
demonstrating that the XTRAC system provides an effective and attractive
alternative to conventional means of treatment for psoriasis. Currently,
however, there are still only limited peer-reviewed clinical reports and
short-term clinical follow-up data on the XTRAC system. Physicians are
traditionally cautious in adopting new products and treatment practices,
partially due to the anticipation of liability risks and partially due to
uncertainty of third-party reimbursement. If physicians do not adopt the XTRAC
system, we may never achieve significant revenues or profitability.
If
the effectiveness and safety of our products are not supported by long-term
data, our revenues could decline.
Our
products may not be accepted if we do not produce clinical data supported by
the
independent efforts of clinicians. We received clearance from the FDA for the
use of the XTRAC system to treat psoriasis based upon our study of a limited
number of patients. Safety and efficacy data presented to the FDA for the XTRAC
system was based on studies on these patients. For the treatment of vitiligo,
atopic dermatitis and leukoderma, we have received clearance from the FDA for
the use of the XTRAC system based primarily on equivalence of predicate devices;
we may discover that physicians will expect clinical data on such treatments
with the XTRAC system. We may find that data from longer-term psoriasis patient
follow-up studies may be inconsistent with those indicated by our relatively
short-term data. If longer-term patient studies or clinical experience indicate
that treatment with the XTRAC system does not provide patients with sustained
benefits or that treatment with our product is less effective or less safe
than
our current data suggests, our revenues could decline. We can give no assurance
that we may find that our data is not substantiated in studies involving more
patients; in such a case we may never achieve significant revenues or
profitability.
22
Any
failure in our physician education efforts could significantly reduce product
marketing.
It
is
important to the success of our marketing efforts to educate physicians and
technicians in the techniques of using the XTRAC system. We rely on physicians
to spend their time and money to attend our pre-sale educational sessions.
Positive results using the XTRAC system are highly dependent upon proper
physician and technician technique. If physicians and technicians use the XTRAC
system suboptimally or improperly, they may have unsatisfactory patient outcomes
or cause patient injury, which may give rise to negative publicity or lawsuits
against us, any of which could have a material adverse effect on our reputation
as a medical device company and our revenues and profitability.
Similarly,
it is important to our success that we educate and persuade hospitals, surgery
centers and practitioners of the clinical and economic benefits of our surgical
products and services. If we fail to educate and persuade our customers, we
may
suffer adversely in our reputation and our revenues and our
profitability.
If
revenue from a significant customer continues to decline, we may have difficulty
replacing the lost revenue.
Neutrogena,
one of the customers for the skin health and hair care products segment that
we
acquired from ProCyte, accounts for a significant portion of our net revenue
in
that business segment. ProCyte’s net revenues from Neutrogena in 2004 were
$2,768,072, or approximately 20.8% of ProCyte’s gross revenues of $13,320,200
(revenues which pre-date our acquisition and which are not reflected in our
financial statements). For the year ended December 31, 2005, Skin Care’s
(ProCyte) net revenues from Neutrogena were $1,421,946, or approximately 10.9%
of Skin Care’s (ProCyte) gross revenues of $13,011,694 (revenues which are
reflected in our financial statements to the extent that they were earned since
March 19, 2005). For the year ended December 31, 2006, Skin Care’s net revenues
from Neutrogena were $972,400, approximately 7.7% of Skin Care’s gross revenues
of $12,646,910. We receive royalty revenues on sales of products by Neutrogena
under the terms of a license agreement with
Neutrogena. The royalties from Neutrogena for 2004 and for our fiscal years
ended December 31, 2005 and December 31, 2006, were $1,214,073, $609,946 and
$300,000, respectively. The license agreement expires in April 2010. A U.S.
patent related to the Neutrogena license agreement expired February 5, 2005,
the
effect of which was a reduction in the percentage paid as a royalty during
the
remaining royalty period under the license agreement. We also receive revenues
from sales of copper peptide compound to Neutrogena pursuant to a related supply
agreement. ProCyte’s sales to Neutrogena under the supply agreement for 2004 and
for our fiscal years ended December 31, 2005 and December 31, 2006, were
$1,553,999, $812,000 and $672,400, respectively. Neutrogena has agreed to an
extension of the supply agreement through October 5, 2007, on terms that we
regard as generally favorable to us. We have begun discussions with Neutrogena
concerning continuation of our supply relationship to Neutrogena, although
we
cannot say that such discussions will be successful.
Excluding
niche marketing efforts, the Skin Care segment targets its sales in the U.S.
market to physicians, who then mark the products up for sale to their patients.
No single practice in itself is generally responsible for a significant
disproportion of our sales. However, a number of practices, specializing in
hair
transplants, are united under the management of a single group, and this group
accounts for a disproportion of our hair care products aimed at the care of
a
scalp that has received a hair transplant. Revenues from this customer were
$1,169,892 in 2006 and $811,223 in 2005. We find as well that a few physicians
re-sell our products not just to their own patients, but also at discounted
prices on the internet.
In
the
International Dermatology Equipment segment (as well as in the Surgical Products
segment), we depend in the international arena for a material portion of our
sales on several key distributors, as for example our master distributor in
the
Pacific Rim. If we lose one of these distributors, our sales of phototherapy
and
surgical lasers are likely to suffer in the short term.
In
the
Surgical Services segment, we find that our model works best if we have several
accounts in a territory that have sufficient volume to allow us to be efficient
in the delivery of our services. If we lose one of these anchor accounts, then
we may become less efficient and therefore less competitive.
We
have
acted as contract developer of a system designed to detect cancerous cells
in
human tissue and act as an OEM manufacturer of surgical lasers and/or delivery
systems. Development work is rife with financial risk and technological
uncertainties. OEM work is usually limited to a contracted period of time,
at
the end of which there may be no extension or renewal. In either case, our
aim
to create a strategic partnership may be frustrated.
23
The
loss
or reduction of business from any of our significant customers or strategic
partners in that business segment, Neutrogena in particular, or the failure
to
develop new significant customers or strategic partners could have a material
adverse effect on the results of operations and our overall financial
condition.
We
may not be able to protect our intellectual property rights outside the United
States.
Intellectual
property law outside the United States is uncertain and in many countries is
currently undergoing review and revision. The laws of some countries do not
protect our intellectual property rights to the same extent as laws in the
United States. The intellectual property rights we enjoy in one country or
jurisdiction may be rejected in other countries or jurisdictions, or, if
recognized there, the rights may be significantly diluted. It may be necessary
or useful for us to participate in proceedings to determine the validity of
our
foreign intellectual property rights, or those of our competitors, which could
result in substantial cost and divert our resources, efforts and attention
from
other aspects of our business. If we are unable to defend our intellectual
property rights internationally, we may face increased competition outside
the
United States, which could materially and adversely affect our future business,
prospects, operating results and financial results and financial
condition.
Our
failure to obtain or maintain necessary FDA clearances or approvals could hurt
our ability to distribute and market our products in the United
States.
Our
laser
products are considered medical devices and are subject to extensive regulation
in the United States and in foreign countries where we intend to do business.
In
addition, certain of our skincare products and product candidates may be
regulated by any of a number of divisions of the FDA and in other countries
by
similar health and regulatory authorities. Unless an exemption applies, each
medical device that we wish to market in the United States and certain skincare
products that we may wish to market must first receive either 510(k) clearance
or pre-market approval from the FDA. Either process can be lengthy and
expensive. The FDA's 510(k) clearance process may take from four to twelve
months, or longer. The pre-market application approval process is much more
costly, lengthy and uncertain. It may take one to three years or even longer.
Delays in obtaining regulatory clearance or approval could adversely affect
our
revenues and profitability.
Although
we have obtained 510(k) clearances for our XTRAC system for use in treating
psoriasis, vitiligo, atopic dermatitis and leukoderma, and extensive 510(k)
clearances for our surgical products, our clearances may be subject to
revocation if post-marketing data demonstrates safety issues or lack of
effectiveness. Further, more stringent regulatory requirements and/or safety
and
quality standards may be issued in the future with an adverse effect on our
business. Although we believe that we are in compliance with all material
applicable regulations of the FDA, current regulations depend heavily on
administrative interpretation. Future interpretations made by the FDA or other
regulatory bodies, with possible retroactive effect, may vary from current
interpretations and may adversely affect our business and prospects.
Even
if we obtain the necessary regulatory approvals for our phototherapy products
from foreign governments, market acceptance in international markets may depend
on third-party reimbursement of participants’ costs.
We
have
introduced our XTRAC system through our distributors and to end users into
markets in more than 35 countries in Europe, the Middle East, the Far East
and
Southeast Asia, and in Australia, South Africa and parts of Central and South
America. We intend to expand the number of countries in these markets where
we
distribute our products. We cannot be certain that our distributors will be
successful in marketing XTRAC systems in these or other countries or that our
distributors will purchase more than their contractual obligations or in
accordance with our expectations.
Underlying
our approvals in a number of countries are our quality systems. We are regularly
audited on the compliance of our quality systems with applicable requirements,
which can be extensive and complex and subject to change due to evolving
interpretations and changing requirements. Adverse audit findings could
negatively affect our ability to market our products.
24
Even
if
we obtain and maintain the necessary foreign regulatory registrations or
approvals, market acceptance of our products in international markets may be
dependent, in part, upon the availability of reimbursement within applicable
healthcare payment systems. Reimbursement and healthcare payment systems in
international markets vary significantly by country, and include both
government-sponsored healthcare and private insurance. We may seek international
reimbursement approvals for our products, but we cannot assure you that any
such
approvals will be obtained in a timely manner, if at all. Failure to receive
international reimbursement approvals in any given market could have a material
adverse effect on the acceptance or growth of our products in that market or
others.
We
have limited marketing experience, and our failure to build and manage our
marketing force or to market and distribute our products effectively will hurt
our revenues and profits.
While
we
now have greater financial resources due to the private placement of our
securities in November 2006, we must still use those resources prudently as
we
expand our marketing efforts. Our prudence is heavily influenced by our
marketing experience, which is still relatively limited. To increase acceptance
and utilization of our XTRA system, we may have to expand the number of our
sales and marketing personnel for marketing programs in the United States.
Different programs may call for different strategies and talents. While we
may
be able to draw on currently available personnel within our organization, we
also expect that we will have to increase the number of representatives devoted
to the sales and marketing programs and broaden, through such representatives,
the talents we have at our disposal. In some cases, we may look outside our
organization for assistance in marketing our products, as for example in a
program to market our surgical diode laser through the internet. We cannot
predict whether the anticipated sales and marketing programs will be successful,
either in design or implementation.
In
similar fashion, we cannot predict how successful we may be in expanding our
skincare products or surgical services in the United States, nor can we predict
the success of new skincare or surgical products that we may introduce. There
are, for example, skincare products and diode and CO2 lasers already in the
market against which our comparable products must compete. No assurance can
be
given that we will be successful in marketing and selling our skin health and
hair care products or our diode and CO2 lasers.
There
are
significant risks involved in building and managing our marketing force and
marketing our products, including our ability:
·
|
to
hire, as needed, a sufficient number of qualified marketing people
with
the skills and understanding to market the XTRAC system, our skincare
products and our surgical products services
effectively;
|
·
|
to
adequately train our marketing force in the use and benefits of our
products and services, making them more effective promoters;
|
·
|
to
set the prices and other terms and conditions for treatments using
an
XTRAC system and our surgical services in a complex legal environment
so
that they will be accepted as attractive and appropriate alternatives
to
conventional service modalities and treatments; and
|
·
|
to
cope with employee turnover among the sales force in the skincare
business, which is highly competitive for talented sales
representatives.
|
We
have limited experience manufacturing our products in commercial quantities,
which could adversely impact the rate at which we grow.
We
may
encounter difficulties manufacturing our products for the following reasons:
·
|
we
have limited experience manufacturing our products in significant
commercial quantities; and
|
·
|
we
will, in order to increase our manufacturing output significantly,
have to
attract and retain qualified employees, who are in short supply,
for
assembly and testing operations.
|
Although
we believe that our current manufacturing facilities are adequate to support
our
commercial manufacturing activities for the foreseeable future, we may be
required to expand or restructure our manufacturing facilities to increase
capacity substantially. If we are unable to provide customers with high-quality
products in a timely manner, we may not be able to achieve market acceptance
for
our XTRAC system, to maintain the benefits of vertical integration in the
delivery of our surgical services or to achieve market acceptance and growth
for
our skincare products. Our inability to manufacture or commercialize our devices
successfully could have a material adverse effect on our revenue.
25
We
may have difficulty managing our growth.
If
additional private carriers approve favorable reimbursement policies for
psoriasis and our marketing programs are successful in increasing utilization
of
the XTRAC system, we expect to experience growth in the number of our employees
and customers and the scope of our operations. This growth may place a strain
on
our management and operations. Our ability to manage this growth will depend
upon our ability to broaden our management team and our ability to attract,
hire
and retain skilled employees. We also expect that compliance with the
requirements of governmental and quasi-governmental bodies will grow more
complex and burdensome. Our success will also depend on the ability of our
officers and key employees to continue to implement and improve our operational,
financial and other systems, to manage multiple, concurrent customer
relationships, to respond to increasing compliance requirements and to hire,
train and manage our employees. Our future success is heavily dependent upon
growth and acceptance of our products. If we cannot scale our business
appropriately or otherwise adapt to anticipated growth and complexity and new
product introductions, a key part of our strategy may not be
successful.
In
addition, we may acquire additional companies in the medical products and
services industry. Accordingly, in the ordinary course of our business, we
regularly consider, evaluate and enter into negotiations related to potential
acquisition opportunities. We may pay for these acquisitions in cash or
securities, including equity securities, or a combination of both. We cannot
assure you that attractive acquisition targets will be available at reasonable
prices, that we will have sufficient authorized but unissued securities
available to effect an acquisition, or that we will be successful in any such
transaction. Acquisitions involve a number of special risks,
including:
·
|
diversion
of our management’s attention;
|
·
|
integration
of the acquired business with our business;
and
|
·
|
unanticipated
legal liabilities and other circumstances or
events.
|
The
XTRAC system and other laser systems we manufacture for surgery require specific
component parts that may not be readily available or cost-effective, which
may
adversely affect our competitive position or profitability. Our skincare
products may require compounds that can be efficiently produced by a limited
number of suppliers.
Production
of our XTRAC system requires specific component parts obtained from our
suppliers. Production of our surgical laser systems requires some component
parts that will become harder to procure, as the design of a system ages.
Similarly, our skincare products may require compounds that can be efficiently
produced only by a limited number of suppliers. In the event that our suppliers
cannot meet our needs, we believe that we could find alternative suppliers.
However, a change in suppliers or any significant delay in our ability to have
access to such resources would have a material adverse effect on our delivery
schedules, business, operating results and financial condition.
Our
failure to respond to rapid changes in technology and its applications and
intense competition in the medical devices industry or the development of a
cure
for skin conditions treated by our products could make our treatment system
obsolete.
The
medical devices industry is subject to rapid and substantial technological
development and product innovations. To be successful, we must respond to new
developments in technology, new applications of existing technology and new
treatment methods. Our response may be thwarted if we require, but cannot
secure, rights to essential third-party intellectual property. We compete
against numerous companies offering alternative treatment systems to ours,
some
of which have greater financial, marketing and technical resources to utilize
in
pursuing technological development and new treatment methods. Our financial
condition and operating results could be adversely affected if our medical
devices fail to compete favorably with these technological developments, or
if
we fail to be responsive on a timely and effective basis to competitors’ new
devices, applications, treatments or price strategies. The development of a
cure
for psoriasis, vitiligo, atopic dermatitis or leukoderma would eliminate the
need for our XTRAC system for these diseases and would require us to focus
on
other uses of our technology, which would have a material adverse effect on
our
business or prospects.
26
In
addition, competition in the skin health and hair care markets is intense.
Our
skincare competitors include well-established pharmaceutical, cosmetic and
healthcare companies such as Obagi, La Roche Posay, Allergan, Pevonia, Declore
and Murad. These competitors have substantially more financial and other
resources, larger research and development staffs, and more experience and
capabilities in researching, developing and testing products in clinical trials,
in obtaining FDA and other regulatory approvals and in manufacturing, marketing
and distribution than we do. Further, a number of smaller companies are
developing or marketing competitive products. Our skincare competitors may
succeed in developing and commercializing products or obtaining patent
protection or other regulatory approvals for products more rapidly than we
can.
Further, competitive products may be manufactured and marketed more successfully
than our potential skincare products. Such developments could render our
existing or potential skincare products less competitive or obsolete and could
have a material adverse effect on our business, financial condition and results
of operations.
As
we
develop new products or improve our existing products, we may accelerate the
economic obsolescence of the existing, unimproved products, and their
components. The obsolescent products and related components may have little
to
no resale value, leading to an increase in the reserves we have against our
inventory. On the other side, there is a risk that the new products or improved
existing products may not achieve market acceptance and therefore also lead
to
an increase in the reserves against our inventory.
Our
products may be found defective or physicians and technicians may misuse our
products and damages may exceed our insurance coverage, or we may be subject
to
claims that are not covered by insurance.
One
or
more of our products may be found to be defective after they have been shipped
in volume, and require product replacement. Product returns and the potential
need to remedy defects or provide replacement products or parts could result
in
substantial costs and have a material adverse effect on our business and results
of operations. The clinical testing, manufacturing, marketing and use of our
products and procedures may also expose us to product liability claims. In
addition, the fact that we train technicians whom we do not supervise in the
use
of our XTRAC system when patients are treated and that we train and provide
our
technicians as part of our surgical services business may expose us to
third-party claims if those doing the training are accused of providing
inadequate training or if a technician is accused of negligently applying such
training. We presently maintain liability insurance with coverage limits of
at
least $5,000,000 per occurrence. However, continuing insurance coverage may
not
be available at an acceptable cost, if at all. We thus may not be able to obtain
insurance coverage that will be adequate to satisfy a liability that may arise.
Regardless of merit or eventual outcome, product liability claims may result
in
decreased demand for a product, injury to its reputation, withdrawal of clinical
trial volunteers and loss of revenues. As a result, regardless of whether we
are
insured, a product liability claim or product recall may result in losses that
could have a material adverse effect upon our business, financial condition
and
results of operations.
Similarly,
we may be subjected to third-party claims in the course of our business for
which we have no insurance coverage. If we should be found liable for any such
claim, we may suffer a material adverse effect on the business. We are presently
defending ourselves against a claim of malicious prosecution, for which our
insurance carrier has denied a duty to indemnify us.
If
we use hazardous materials in a manner that causes injury or violates laws,
our
business and operations may suffer.
Our
XTRAC
system utilizes a xenon chloride gas mixture under high pressure, which is
extremely corrosive. While methods for proper disposal and handling of this
gas
are well-known, we cannot completely eliminate the risk of accidental
contamination, which could cause:
·
|
an
interruption of our research and development
efforts;
|
27
·
|
injury
to our employees, physicians, technicians or patients which could
result
in the payment of damages; or
|
·
|
liabilities
under federal, state and local laws and regulations governing the
use,
storage, handling and disposal of these materials and specified waste
products.
|
From
time
to time, customers return to us surgical products that appear not to have
performed to specification. Such products must be decontaminated before being
returned to us. If they are not, our employees may be exposed to dangerous
diseases.
We
depend on our executive officers and key personnel to implement our business
strategy and could be harmed by the loss of their
services.
We
believe that our growth and future success will depend in large part upon the
skills of our management and technical team. The competition for qualified
personnel in the laser industry is intense, and the loss of our key personnel
or
an inability to continue to attract, retain and motivate key personnel could
adversely affect our business. We cannot assure you that we will be able to
retain our existing key personnel or to attract additional qualified personnel.
We do not have key-person life insurance on any of our employees.
Our
success depends in part upon the continued service and performance
of:
·
|
Jeffrey
F. O’Donnell, President and Chief Executive Officer;
|
·
|
Dennis
M. McGrath, Chief Financial Officer;
and
|
·
|
Michael
R. Stewart, Executive Vice President and Chief Operating
Officer;
|
Although
we have employment agreements with Mr. O’Donnell, Mr. McGrath, and Mr.
Stewart, the loss of the services of one or more of our executive officers
could
adversely affect our ability to develop and introduce our new
products.
We
may be unsuccessful in integrating the businesses we acquired, including the
operations of ProCyte, with our other business segments.
As
a part
of our strategy to grow our business, we seek to make strategic acquisitions
of,
or significant investments in, complementary companies, products or
technologies, although no significant acquisition or investments are currently
pending. We may not be successful in the future in identifying companies that
meet out acquisition criteria. The failure to identify such companies may limit
the rate at which we are able to grow our business. Furthermore, any future
acquisitions that we do undertake could be accompanied by risks such
as:
·
|
Difficulties
in integrating the operations and personnel of acquired
companies;
|
·
|
Diversion
of our management's attention from ongoing business
concerns;
|
·
|
Our
potential inability to maximize our financial and strategic position
through the successful incorporation of acquired technology and rights
into our products and services;
|
·
|
Additional
expense associated with amortization of acquired
assets;
|
·
|
Maintenance
of uniform standards, controls, procedures and policies;
and
|
·
|
Impairment
of existing relationships with employees, suppliers and customers
as a
result of the integration of new management
personnel.
|
We
cannot
guarantee that we will be able to successfully integrate any business, products,
technologies or personnel that we might acquire in the future, and our failure
to do so could harm our business.
28
In
particular, with respect to our acquisition of ProCyte, our goals
were:
·
|
that
ProCyte's presence in the skin health and hair care products market
would
present a growth opportunity for PhotoMedex to market its existing
products;
|
·
|
that
the addition of ProCyte's sales and marketing personnel would enhance
our
ability to market the XTRAC system;
|
·
|
that
the addition of ProCyte's operations and existing cash balances would
enhance PhotoMedex's operating results and balance
sheet;
|
·
|
that
the combination of the senior management of ProCyte and PhotoMedex
would
allow complementary skills to strengthen the overall management team;
and
|
·
|
that
the combined company might reap short-term cost savings and have
the
opportunity for additional longer-term cost efficiencies, thus providing
additional cash flow for
operations.
|
We
have
realized on some, but not all of the goals. We have recently engaged a new
senior officer to direct the operations of the skincare business. For the time
being, we shall concentrate less on the cross-integration of the Skin Care
sales
personnel into sales of the XTRAC system and more on focusing the Skin Care
sales personnel on growth of the skincare sales.
Delaware
law and our charter documents have anti-takeover provisions that could delay
or
prevent actual and potential changes in control, even if they would benefit
stockholders.
We
are
subject to Section 203 of the Delaware General Corporation Law, which
prohibits a business combination between a corporation and an interested
stockholder within three years of the stockholder becoming an interested
stockholder, except in limited circumstances. In addition, our bylaws contain
certain provisions which require stockholders' actions to be taken at meetings
and not by written consent, and also require supermajority votes of stockholders
to amend our bylaws and to notice special meetings of stockholders. These
anti-takeover provisions could delay or prevent actual and potential changes
in
control, even if they would benefit our stockholders.
Potential
fluctuations in our operating results could lead to fluctuations in the market
price for our common stock.
Our
results of operations are expected to fluctuate significantly from
quarter-to-quarter, depending upon numerous factors, including:
·
|
healthcare
reform and reimbursement policies;
|
·
|
demand
for our products;
|
·
|
changes
in our pricing policies or those of our
competitors;
|
·
|
increases
in our manufacturing costs;
|
·
|
the
number, timing and significance of product enhancements and new product
announcements by ourselves and our competitors;
|
·
|
the
termination or expiration of significant royalty-generating licensing
contracts to which we are party;
|
·
|
the
expiration of certain of our key
patents;
|
·
|
our
ability to develop, introduce and market new and enhanced versions
of our
products on a timely basis considering, among other things, delays
associated with the FDA and other regulatory approval processes and
the
timing and results of future clinical trials;
and
|
·
|
product
quality problems, personnel changes, and changes in our business
strategy.
|
Our
quarter-to-quarter operating results could also be affected by the timing and
usage of individual laser units in the treatment of patients, since our revenue
model for the excimer laser system for the treatment of psoriasis patients
and
for our surgical services is based on a payment-per-usage plan.
29
Our
stock price has been and continues to be volatile.
The
market price for our common stock could fluctuate due to various factors. These
factors include:
·
|
announcements
related to our efforts to secure favorable reimbursement policies
from
private carriers concerning the treatment of psoriasis with the XTRAC
system or to our efforts to increase utilization of the XTRAC
system;
|
·
|
acquisition-related
announcements;
|
·
|
announcements
by us or our competitors of new contracts, technological innovations
or
new products;
|
·
|
changes
in government regulations;
|
·
|
fluctuations
in our quarterly and annual operating results;
and
|
·
|
general
market conditions.
|
In
addition, the stock markets have, in recent years, experienced significant
price
fluctuations. These fluctuations often have been unrelated to the operating
performance of the specific companies whose stock is traded. Market
fluctuations, as well as economic conditions, have adversely affected, and
may
continue to adversely affect, the market price of our common stock.
Our
ability to pay dividends on our common stock may be
limited.
We
do not
expect to pay any cash dividends in the foreseeable future. We intend to retain
earnings, if any, to provide funds for the expansion of our
business.
Limitations
on director liability may discourage stockholders from bringing suit against
a
director.
Our
certificate of incorporation provides, as permitted by governing Delaware law,
that a director shall not be personally liable to us or our stockholders for
monetary damages for breach of fiduciary duty as a director, with certain
exceptions. These provisions may discourage stockholders from bringing suit
against a director for breach of fiduciary duty and may reduce the likelihood
of
derivative litigation brought by stockholders on our behalf against a director.
In addition, our certificate of incorporation and bylaws provide for mandatory
indemnification of directors and officers to the fullest extent permitted by
Delaware law. In addition, we have agreed to indemnify the past and present
directors, officers and employees of ProCyte for certain matters, to the same
extent such individuals are indemnified by ProCyte, for a period of six years
following the effective date of the merger.
Item
1B. Unresolved
Staff Comments
There
are
no unresolved comments from the staff of the Securities and Exchange
Commission.
Item
2. Properties
We
lease
an 8,000 sq. ft. facility consisting of office, manufacturing and warehousing
space located at 2375 Camino Vida Roble, Suite B, Carlsbad, California 92009.
The lease expires on June 15, 2012. We have a right to cancellation after 5
years, provided that we pay off any remaining obligation for tenant
improvements. The base rent is $6,640 per month. Our Carlsbad facility houses
the manufacturing and development operations for our excimer laser business.
We
lease
a 42,000 sq. ft. facility in Montgomeryville, Pennsylvania that houses our
executive offices and surgical laser manufacturing operations. The term of
the
lease runs until July 2011. In addition to this facility, we also lease several
offices throughout the southeastern United States and other locations elsewhere.
Our marketing and sales representatives use these offices to perform their
sales
and training responsibilities. These offices consist of small one-room
facilities and are leased for various terms and amounts. The base rent is
$20,475 per month.
30
We
lease
a 12,182 sq. ft facility consisting of office and warehousing space located
at
8511 154th
Avenue
NE, Building A, Redmond, Washington 98052. The lease expires on June 30, 2007,
but we are presently negotiating an extension of the lease term. The base rent
is $15,240 per month. Our Redmond facility houses the warehousing operations
for
our skincare business.
Item
3. Legal
Proceedings
In
the
matter brought by us against RA Medical Systems, Inc. and Dean Irwin in the
United States District Court for the Southern District of California, the trial
judge declined to issue to defendants summary judgment based on their theory
of
res judicata. On the other hand, the trial judge declined to issue to us partial
summary judgment for unfair competition, which had been based on the fact that
RA Medical did not have the requisite permission from the State of California
to
market its medical device. The declination of our claim for relief was based
on
reasons that we believe will not bar this claim for relief in the other
pending Federal action, discussed in the paragraph below. The trial judge
further declined to consolidate this Federal action brought by us with the
Federal action brought by RA Medical and Mr. Irwin, discussed below. Pretrial
is
scheduled for the Spring of 2007, but no trial date has been set. In this
action, there are no counterclaims that we must defend against.
In
the
matter brought in California Superior Court by RA Medical and Mr. Irwin against
us for unfair competition, we removed the State action to Federal court.
Plaintiffs claim we did not have the requisite permission from the State of
California to market our excimer medical device from our new facility in
Carlsbad. We counterclaimed for, among other things, contractual interference,
misappropriation of our technology and unfair competition under Federal and
State statutes. The plaintiffs have brought a motion to dismiss the latter
two
counterclaims, based in part on an alleged bar under the applicable statutes
of
limitations. The trial judge has not ruled on the motion. Discovery has been
stayed, pending the judge’s ruling. Among our claims of unfair competition is a
claim based on RA Medical’s lack of requisite permission from the State of
California to market its medical device.
In
the
matter brought for malicious prosecution in California Superior Court by RA
Medical Systems and Mr. Irwin against us, Jenkens & Gilchrist, LLP (our then
outside counsel) and Michael R. Matthias, Esq. (the litigation partner at
Jenkens & Gilchrist), trial is set for May 2007. The parties are conducting
discovery. Morgan, Lewis & Bockius has been engaged to defend us.
In
June
2006, the insurance carrier that had undertaken to indemnify us in the malicious
prosecution action, discussed in the paragraph above, and that had for 18 months
been defending us, recanted its undertaking to indemnify us. The carrier
recanted on two grounds: first, that malicious prosecution is an intentional
tort and therefore is non-indemnifiable, and second, that the alleged tort
occurred after the period of coverage of its underlying policy had expired.
We
notified the subsequent insurance carrier in whose coverage period the alleged
tort occurred. That carrier has undertaken to defend us, but has denied its
duty
to indemnify us, based on the same ground that malicious tort is a
non-indemnifiable tort. We have rejected this ground and brought an action
in
the U.S. District Court for the Eastern District of Pennsylvania for breach
of
contract and for declaratory judgment on the issue whether malicious prosecution
is indemnifiable under our insurance policy.
We
are
involved in certain other legal actions and claims arising in the ordinary
course of business. We believe, based on discussions with legal counsel, that
such litigation and claims will likely be resolved without a material effect
on
our consolidated financial position, results of operations or
liquidity.
31
Item
4. Submission
of Matters to a Vote of Security Holders
None.
PART
II
Item
5. Market
for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases
of Equity Securities
As
of
March 15, 2007, we had 62,536,054 shares of common stock issued and outstanding.
This included 860,000 shares of issued and outstanding restricted stock, options
to purchase 6,730,475 shares of common stock, of which 4,368,516 were vested
as
of March 15, 2007, and warrants to purchase up to 4,746,657 shares of common
stock.
Our
common stock is listed on the Nasdaq National Market under the symbol "PHMD."
The following table sets forth, for the periods indicated, the high and low
closing sale prices of our common stock,
High
|
Low
|
||||||
Year
Ended December 31, 2006:
|
|||||||
Fourth
Quarter
|
$
|
1.85
|
$
|
1.04
|
|||
Third
Quarter
|
1.65
|
0.99
|
|||||
Second
Quarter
|
1.99
|
1.46
|
|||||
First
Quarter
|
2.34
|
1.70
|
|||||
Year
Ended December 31, 2005:
|
|||||||
Fourth
Quarter
|
$
|
2.33
|
$
|
1.50
|
|||
Third
Quarter
|
2.82
|
1.98
|
|||||
Second
Quarter
|
3.09
|
2.00
|
|||||
First
Quarter
|
2.88
|
2.16
|
On
March 15, 2007, the closing market price for our common stock in The Nasdaq
National Market System was $1.15 per share. As of March 15, 2007, we had
approximately 968 stockholders of record, without giving effect to determining
the number of stockholders who held shares in “street name” or other nominee
accounts.
Dividend
Policy
We
have
not declared or paid any dividend since inception on our common stock. We do
not
anticipate that any dividends will be declared or paid in the future on our
common stock.
32
The
following is a summary of all of our equity compensation plans, including plans
that were assumed through acquisitions and individual arrangements that provide
for the issuance of equity securities as compensation, as of December 31, 2006.
See Notes 1 and 12 to the consolidated financial statements for additional
discussion.
(A)
Number
of Securities to be Issued Upon Exercise of Outstanding Options,
Warrants
and Rights
|
(B)
Weighted-Average
Exercise Price of Outstanding Options, Warrants and
Rights
|
(C)
Number
of Securities Remaining Available for Future Issuance Under Equity
Compensation Plans (excluding securities reflected in column
(A))
|
||||||||
Equity
compensation plans
|
||||||||||
approved
by security holders
|
10,789,382
|
$
|
1.94
|
1,356,250
|
||||||
Equity
compensations plan not
|
||||||||||
approved
by security holders
|
51,000
|
$
|
1.66
|
-
|
||||||
Total
|
10,840,382
|
$
|
1.94
|
1,356,250
|
As
of
January 1, 2006, no options will be granted to employees or consultants out
of
any plans except the 2005 Equity Compensation Plan. Options to our outside
directors will be made from the 2000 Non-Employee Director Stock Option Plan;
options under the 2005 Investment Plan may be made only to executive officers.
Most warrants issued by us have been to investors or placement agents, and
none
of them, and nor was any of the warrants issued to GE Capital Corporation,
have
been issued pursuant to equity compensation plans. Additionally, all outstanding
options were granted as compensation for benefits inuring to us other than
for
benefits from capital-raising activities. With limited exceptions under Nasdaq
membership requirements, we intend in the future to issue options pursuant
to
equity compensation plans which have already been approved by our stockholders
without necessity of further, special approval by our stockholders
Recent
Issuances of Unregistered Securities
On
November 3, 2006, we completed a private placement for 9,760,000 shares of
common stock at $1.17 per share resulting in gross proceeds of $11,419,200.
The
closing price of our common stock on November 1, 2006 was $1.27 per share,
the
date we agreed to the private placement. In connection with this private
placement, we paid commissions and other expenses of $864,308, resulting in
net
proceeds of $10,554,892. In addition, the investors received warrants to
purchase 2,440,000 shares of common stock at an exercise price of $1.60 per
share, and Cowen & Company, the placement agent, received warrants to
purchase 244,000 shares of common stock, under the same terms and conditions
as
the warrants issued to the investors. All such the warrants have a five-year
term and will first become exercisable on May 1, 2007. Cowen & Company is
entitled to a 6.5%
commission on any proceeds to us from future exercises by the investors of
their
warrants. The warrants issued to Cowen & Company were in consideration of
its services as the placement agent and have a value under the Black Scholes
method of approximately $200,000. We have used the proceeds of this financing
to
pay for working capital and other general corporate purposes. The shares sold
in
the private placement, including the shares underlying the warrants, have been
registered with the Securities and Exchange Commission.
On
March
31, 2006, we issued to Stern Laser srl (“Stern”) 101,010 of our restricted
common stock, pursuant to a Master Asset Purchase Agreement (the “Master
Agreement”) dated September 7, 2004 with Stern. As of December 31, 2006, we have
issued to Stern an aggregate 589,864 shares of our restricted common stock
in
connection with the Master Agreement. We have also agreed to pay Stern up to
an
additional $250,000 based on the achievement of certain remaining milestones
relating to the development and commercialization of certain licensed technology
and the licensed products which may be developed under such arrangement and
may
have certain other obligations to Stern under these arrangements. We retain
the
right to pay all of these conditional sums in cash or in shares of its common
stock, at our discretion. To secure the latter alternative, we have
reserved for issuance, and placed into escrow, 110,136 shares of our
unregistered stock. The per-share price of any future issued shares will be
based on the closing price of our common stock during the 10 trading days ending
on the date of achievement of a particular milestone under the terms of the
Master Agreement. Stern also has served as the distributor of the XTRAC laser
system in South Africa and Italy since 2000. The primary asset, which we have
acquired from Stern, is a license, which was carried on our books at $1,013,009,
net as of December 31, 2006. Amortization of this intangible is on a
straight-line basis over 10 years, which began in January 2005. As Stern
completes further milestones under the Master Agreement, we expect that the
carrying value of the license will increase.
33
On
March
30, 2006, we closed the transaction provided for in the Investment Agreement
with AzurTec. We issued 200,000 restricted shares of our common stock in
exchange for 6,855,141 shares of AzurTec common stock and 181,512 shares of
AzurTec Class A preferred stock, which represent a 14% interest in AzurTec,
on a
fully diluted basis. In accordance with APB No. 18, and related interpretations,
we account for our investment in AzurTec on the cost basis.
In
2006,
we issued to GE Capital Corporation 20,545; 24,708;, 25,038; and 32,057 warrants
to purchase our common stock issued on March 29, 2006, June 30, 2006, September
29, 2006 and December 28, 2006, respectively, in connection with draws we made
against a Master Lease Agreement.
We
believe that all of the foregoing issuances of securities were made solely
to
accredited investors in transactions exempt from registration under Section
4(2)
of the Securities Act.
Item
6. Selected
Financial Data
You
should read the following selected historical consolidated financial data in
conjunction with our consolidated financial statements included elsewhere in
this Report and “Management’s Discussion and Analysis of Financial Condition and
Results of Operations,” beginning in Item 7 below. The selected historical
consolidated statements of operations data for the years ended December 31,
2006, December 31, 2005 and December 31, 2004, and the selected historical
consolidated balance sheet data as of December 31, 2006 and December 31, 2005,
are derived from our audited consolidated financial statements included in
this
Annual Report on Form 10-K. The selected historical consolidated statements
of
operations data for the years ended December 31, 2003 and December 31, 2002
and
the selected historical consolidated balance sheet data as of December 31,
2004,
December 31, 2003 and December 31, 2002 are derived from our audited
consolidated financial statements not included in this Annual Report on Form
10-K. The historical results presented here are not necessarily indicative
of
future results.
34
Year
Ended December 31,
(In
thousands, except per- share data)
2006
|
2005
|
2004
|
2003
|
2002
|
||||||||||||
Statement
of Operations Data:
|
||||||||||||||||
Revenues
|
$
|
33,190
|
$
|
28,384
|
$
|
17,745
|
$
|
14,319
|
$
|
3,274
|
||||||
Costs
of revenues
|
18,472
|
15,675
|
10,363
|
10,488
|
4,425
|
|||||||||||
Gross
profit (loss)
|
14,718
|
12,709
|
7,382
|
3,831
|
(1,151
|
)
|
||||||||||
Selling,
general and administrative
|
20,682
|
16,477
|
10,426
|
9,451
|
6,191
|
|||||||||||
Engineering
and product development
|
1,006
|
1,128
|
1,802
|
1,777
|
1,757
|
|||||||||||
Loss
from operations before interest and other income, net
|
(6,970
|
)
|
(4,896
|
)
|
(4,846
|
)
|
(7,397
|
)
|
(9,099
|
)
|
||||||
Interest
income
|
149
|
61
|
43
|
50
|
42
|
|||||||||||
Interest
expense
|
(671
|
)
|
(403
|
)
|
(181
|
)
|
(96
|
)
|
(16
|
)
|
||||||
Other
income, net
|
-
|
1,302
|
-
|
-
|
1
|
|||||||||||
Net
loss
|
($7,492
|
)
|
($3,936
|
)
|
($4,984
|
)
|
($7,443
|
)
|
($9,072
|
)
|
||||||
Basic
and diluted net loss per share
|
($0.14
|
)
|
($0.08
|
)
|
($0.13
|
)
|
($0.21
|
)
|
($0.34
|
)
|
||||||
Shares
used in computing basic and diluted net loss per share (1)
|
54,189
|
48,786
|
38,835
|
35,134
|
26,566
|
|||||||||||
Balance
Sheet Data (At Period End):
|
||||||||||||||||
Cash
and cash equivalents
|
$
|
12,886
|
$
|
5,610
|
$
|
3,997
|
$
|
6,633
|
$
|
4,008
|
||||||
Working
capital
|
16,070
|
11,151
|
6,119
|
8,678
|
6,578
|
|||||||||||
Total
assets
|
57,482
|
48,675
|
22,962
|
22,753
|
21,513
|
|||||||||||
Long-term
debt (net of current portion)
|
3,727
|
2,437
|
1,399
|
457
|
900
|
|||||||||||
Stockholders’
equity
|
$
|
44,103
|
$
|
38,417
|
$
|
14,580
|
$
|
15,978
|
$
|
13,309
|
(1)
|
Common
stock equivalents and convertible issues are antidilutive and, therefore,
are not included in the weighted shares outstanding during the years
in
which we incurred net losses.
|
35
Item
7. Management's
Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis should be read in conjunction with the
Consolidated Financial Statements and related notes included elsewhere in this
Report.
Overview
We
view
our business as comprised of the following five business segments:
·
|
Domestic
XTRAC,
|
·
|
International
Dermatology Equipment,
|
·
|
Skin
Care (ProCyte),
|
·
|
Surgical
Services, and
|
·
|
Surgical
Products.
|
Domestic
XTRAC
Our
Domestic XTRAC segment is a U.S. business with revenues primarily derived from
procedures performed by dermatologists. We are engaged in the development,
manufacturing and marketing of our proprietary XTRAC® excimer laser and delivery
systems and techniques used in the treatment of inflammatory skin
disorders, including
psoriasis, vitiligo, atopic dermatitis and leukoderma. In January 2000, we
received approval of our 510(k) submission from the Food and Drug
Administration, or FDA, establishing that our XTRAC laser system is
substantially equivalent to currently marketed devices for the treatment of
psoriasis.
As
part
of our commercialization strategy in the United States, we provide the XTRAC
laser system to targeted dermatologists at no initial capital cost to them.
Unlike our international strategy, we generally do not sell the laser system
domestically, but maintain ownership of the laser and earn revenue each time
a
dermatologist treats a patient with the equipment. We believe that this strategy
will create incentives for physicians to adopt the XTRAC laser system and will
increase market penetration. On occasion we have sold and will sell the laser
directly to a dermatologist for certain reasons, including the costs of
logistical support and customer preference.
For
the
past six years, we have sought to clear the path of obstacles and barriers
to a
roll-out of the XTRAC laser system in dermatology. In 2000, the laser system,
which was originally designed for cardiology applications, was found to have
significant therapeutic advantages for psoriasis patients who were treated
with
the UVB light emitted from the excimer-based laser system. For the first two
years, we invested in establishing the clinical efficacy of the product and
mechanical reliability of the equipment. In the last three years, we have
pursued widespread reimbursement commencing with obtaining newly created Current
Procedure Terminology (“CPT”) reimbursement codes that became effective in 2003.
This was followed by a lengthy process of persuading private medical insurers
to
adopt a positive reimbursement policy for the procedure. Substantive progress
on
reimbursement was achieved in the second half of 2005. In June 2006, we received
approval from Blue Cross and Blue Shield of Florida.
We
increased our dermatology sales force and marketing department as part of the
acquisition of ProCyte in March 2005. We now have 12 sales representatives
in
the domestic XTRAC segment (not including the 9 clinical specialists that we
have recently hired to train and support our customers) and 19 sales
representatives in the Skin Care segment. The sales representatives of each
segment provide follow-up sales support and share sales leads to enhance
opportunities for cross-selling. Our marketing department has been instrumental
in expanding the advertising campaign for the XTRAC laser system. In November
2005, we commenced an advertising campaign in selected regions that have
attained certain levels of reimbursement in order to make consumers aware of
the
technology and therapeutic benefits of targeted UVB laser treatment for
psoriasis. We continue to analyze and adjust this campaign for effectiveness.
We
do,
however, see that some of our sales and marketing expenses have grown faster
than the revenues on which the expenses are targeted to have positive impact.
For example, we have tried various direct-to-consumer marketing programs that
have positively influenced utilization, but the payback in utilization is
expected to be attained over more periods than in just the period in which
we
incurred the expense. We have also increased the number of sales representatives
and also established a cadre of clinical support specialists to optimize
utilization levels and better secure the willingness and interest of patients
to
seek follow-up courses of treatment after the effect of the first battery of
treatment sessions starts to wear off. The efforts of this cadre, if successful,
will likely see the fruits of success over an extended horizon of several fiscal
quarters.
36
International
Dermatology Equipment
In
the
international market, we derive revenues by selling our dermatology laser
systems to distributors and directly to physicians. In this market, we have
benefited from both our clinical studies and from the improved reliability
and
functionality of the XTRAC laser system. Compared
to the domestic segment, the sales of laser systems in the international segment
is influenced to a greater degree by competition from similar laser technologies
as well as non-laser lamp alternatives. Over time, this competition has reduced
the prices we are able to charge to international distributors for our XTRAC
products. In 2005, as a result of the acquisition of worldwide rights to certain
proprietary light-based technology from Stern, we also explored new product
offerings in the treatment of dermatological conditions. We have expanded the
international marketing of this product, called the VTRAC™, in 2006. The VTRAC
is a lamp-based UVB targeted therapy, positioned at a price point lower than
the
XTRAC laser system so that it will effectively compete with other
non-laser-based therapies for psoriasis and vitiligo.
Due
to
the significant financial investment requirements, we
did
not implement an international XTRAC and/or VTRAC fee-per-use revenue model,
similar to our domestic revenue model. However, as reimbursement in the domestic
market has become more widespread, we have made available a version of this
model overseas.
Skin
Care (ProCyte)
On
March
18, 2005, we completed the acquisition of ProCyte Corporation. ProCyte generates
revenues from the sale of skin health, hair care and wound care products; the
sale of copper peptide compound in bulk; and royalties on licenses for the
patented copper peptide compound.
The
operating results of ProCyte for the year ended December 31, 2005 are included
from March 19, 2005 through December 31, 2005. Under purchase accounting rules,
the operating results of ProCyte for prior periods are not included in our
Statement of Operations. A description of transaction and pro-forma operating
results are disclosed as part of Note 2, “Acquisitions”,
to the
financial statements.
ProCyte’s
focus has been to provide unique products, primarily based upon patented
technologies for selected applications in the dermatology, plastic and cosmetic
surgery and spa markets. ProCyte has also expanded the use of its novel copper
peptide technologies into the mass retail market for skin and hair care through
targeted technology licensing and supply agreements.
ProCyte’s
products are aimed at the growing demand for skin health and hair care products,
including products to enhance appearance and address the effects of aging on
skin and hair. ProCyte’s products are formulated, branded and targeted at
specific markets. ProCyte’s initial products addressed the dermatology, plastic
and cosmetic surgery markets for use after various procedures. Anti-aging skin
care products were added to offer a comprehensive approach for a patient’s
skincare regimen.
ProCyte’s
financial and administrative functions were transferred from Redmond, Washington
to Montgomeryville, Pennsylvania in June 2005.
Surgical
Services
The
Surgical Services segment generates revenues by providing fee-based procedures
typically using our mobile surgical laser equipment delivered and operated
by a
technician at hospitals and surgery centers in the United States. Although
we
intend to increase our investment in this business segment, we will continue
to
pursue a cautious growth strategy in order to conserve our cash resources for
the XTRAC business segments.
We
have
limited marketing experience in expanding our surgical services business. The
majority of this business is in the southeastern part of the United States.
New
procedures and geographical expansion, together with new customers and different
business habits and networks, will likely pose different challenges compared
to
those that we have encountered in the past. In 2006, we secured a contract
to
provide our surgical services through a national hospital network, where the
roll-out would be done serially, region by region, each with its own challenges.
37
Surgical
Products
The
Surgical Products segment generates revenues by selling laser products and
disposables to hospitals and surgery centers both inside and outside of the
United States. Also included are various non-laser surgical products (e.g.
the
ClearEss® II suction-irrigation system). Although surgical product revenues
increased in 2006 compared to 2005, we expect that sales of surgical laser
systems and the related disposable base may begin to erode as hospitals continue
to seek outsourcing solutions instead of purchasing lasers and related
disposables for their operating rooms. We are working to offset this erosion
by
cautiously expanding our surgical services segment and by increasing sales
from
the Diode surgical laser introduced in 2004.
Critical
Accounting Policies
The
discussion and analysis of our financial condition and results of operations
in
this Report are based upon our Consolidated Financial Statements, which have
been prepared in accordance with accounting principles generally accepted in
the
United States. The preparation of financial statements requires management
to
make estimates and judgments that affect the reported amounts of assets and
liabilities, revenues and expenses and disclosures at the date of the financial
statements. On an on-going basis, we evaluate our estimates, including, but
not
limited to, those related to revenue recognition, accounts receivable,
inventories, impairment of property and equipment and of intangibles and
accruals for warranty claims. We use authoritative pronouncements, historical
experience and other assumptions as the basis for making estimates. Actual
results could differ from those estimates. Management believes that the
following critical accounting policies affect our more significant judgments
and
estimates in the preparation of our Consolidated Financial Statements. These
critical accounting policies and the significant estimates made in accordance
with these policies have been discussed with our Audit Committee.
Revenue
Recognition
XTRAC-Related
Operations
We
have
two distribution channels for our phototherapy treatment equipment. We either
(i) sell the laser through a distributor or directly to a physician or (ii)
place the laser in a physician’s offices (at no charge to the physician) and
charge the physician a fee for an agreed upon number of treatments. When we
sell
an XTRAC laser to a distributor or directly to a foreign or domestic physician,
revenue is recognized when the following four criteria under Staff Accounting
Bulletin No. 104 have been met: (i) the product has been shipped and we have
no
significant remaining obligations; (ii) persuasive evidence of an arrangement
exists; (iii) the price to the buyer is fixed or determinable; and (iv)
collection is probable (the “SAB 104 Criteria”). At times, units are shipped,
but revenue is not recognized until all of the SAB 104 criteria have been met,
and until that time, the unit is carried on our books as inventory.
We
ship
most of our products FOB shipping point, although from time to time certain
customers, for example governmental customers, will insist upon FOB destination.
Among the factors we take into account in determining the proper time at which
to recognize revenue are when title to the goods transfers and when the risk
of
loss transfers. Shipments to distributors or physicians that do not fully
satisfy the collection criteria are recognized when invoiced amounts are fully
paid.
Under
the
terms of our distributor agreements, distributors do not have a unilateral
right
to return any unit that they have purchased. However, we do allow products
to be
returned by our distributors for product defects or other claims.
When
we
place a laser in a physician’s office, we recognize service revenue based on the
number of patient treatments performed by the physician. Treatments in the
form
of random laser-access codes that are sold to physicians, but not yet used,
are
deferred and recognized as a liability until the physician performs the
treatment. Unused treatments remain an obligation of ours because the treatments
can only be performed on our equipment. Once the treatments are delivered to
a
patient, this obligation has been satisfied.
38
We
exclude all sales of treatment codes made within the last two weeks of the
period in determining the amount of procedures performed by our
physician-customers. Our management believes this approach closely approximates
the actual amount of unused treatments that existed at the end of a period.
For
the years ended December 31, 2006 and 2005, we deferred $506,440 and $311,571,
respectively, under this approach.
In
the
first quarter of 2003, we implemented a program to support certain physicians
in
addressing treatments with the XTRAC laser system that may be denied
reimbursement by private insurance carriers. We recognize service revenue from
the sale of treatment codes to physicians participating in this program only
if
and to the extent the physician has been reimbursed for the treatments. For
the
year ended December 31, 2006, we deferred an additional $124,427 less credits
issued of $151,590, under this program, as all the SAB 104 Criteria for revenue
recognition had not been met. At December 31, 2006, we had net deferred revenues
of $80,697 under this program.
Under
this program, we may reimburse qualifying doctors for the cost of our fee but
only if they are ultimately denied reimbursement after appeal of their claim
with the insurance company. The key components of the program are as
follows:
·
|
The
physician practice must be in an identified location where there
is an
insufficiency of insurance companies reimbursing the procedure or
where a
particular practice faces similar insurance
obstacles;
|
·
|
The
program only covers medically necessary treatments of psoriasis as
determined by the treating
physician;
|
·
|
The
patient must have medical insurance and a claim for the treatment
must be
timely filed with the patient’s insurance company;
|
·
|
Upon
denial by the insurance company (generally within 30 days of filing
a
claim), a standard insurance form called an EOB (“Explanation of
Benefits”) must be submitted to the Company’s in-house appeals group, who
will then prosecute the appeal. The appeal process can take 6 to
9
months;
|
·
|
After
all appeals have been exhausted by us and the claim remains unpaid,
the
physician is entitled to receive credit for the fee for the treatment
he
or she purchased from us on behalf of the patient;
and
|
· |
Physicians
are still obligated to make timely payments for treatments purchased,
irrespective of whether reimbursement is paid or denied. Future
sales of
treatments to a physician can be denied if timely payments are
not made,
even if a patient’s appeal is still in process.
|
We
estimate a contingent liability for potential refunds under this program by
reviewing the history of denied insurance claims and appeals processed. We
estimate that approximately 4% of the revenues under this program for the
quarter ended December 31, 2006 are subject to being credited or refunded to
the
physician. We estimated that 11% of the revenues under this program for the
quarter ended December 31, 2005 were subject to being credited or refunded
to
the physician.
Skin
Care Operations
We
generate revenues from our Skin Care business primarily through three channels.
The first is through product sales for skin health, hair care and wound care;
the second is through sales of the copper peptide compound, primarily to
Neutrogena Corporation, a Johnson & Johnson company; and the third through
royalties generated by our licenses, principally to Neutrogena. We recognize
revenues on the products and copper peptide compound when they are shipped,
net
of returns and allowances. We ship the products FOB shipping point. Royalty
revenues are based upon sales generated by our licensees. We recognize royalty
revenue at the applicable royalty rate applied to shipments reported by our
licensee.
Surgical
Products and Service Operations
We
generate revenues from our Surgical businesses primarily from two channels.
The
first is through product sales of laser systems, related maintenance service
agreements, recurring laser delivery systems and laser accessories, and the
second is through per-procedure surgical services. We recognize revenues from
surgical laser and other product sales, including sales to distributors and
other customers, when the SAB 104 Criteria have been met.
39
For
per-procedure surgical services, we recognize revenue upon the completion of
the
procedure. Revenue from maintenance service agreements is deferred and
recognized on a straight-line basis over the term of the agreements. Revenue
from billable services, including repair activity, is recognized when the
service is provided.
Inventory.
We
account for inventory at the lower of cost (first-in, first-out) or market.
Cost
is determined to be purchased cost for raw materials and the production cost
(materials, labor and indirect manufacturing cost) for work-in-process and
finished goods. Throughout the laser manufacturing process, the related
production costs are recorded within inventory. Work-in-process is immaterial,
given the typically short manufacturing cycle, and therefore is disclosed in
conjunction with raw materials. We perform full physical inventory counts for
XTRAC and cycle counts on the other inventory to maintain controls and obtain
accurate data.
Our
XTRAC
laser is either (i) sold to distributors or physicians directly or (ii) placed
in a physician's office and remains our property. The cost to build a laser,
whether for sale or for placement, is accumulated in inventory. When a laser
is
placed in a physician’s office, the cost is transferred from inventory to
“lasers in service” within property and equipment. At times, units are shipped
to distributors, but revenue is not recognized until all of the SAB 104 Criteria
have been met, and until that time, the unit is carried on our books as
inventory. Revenue is not recognized from these distributors until payment
is
either assured or paid in full.
Reserves
for slow-moving and obsolete inventories are provided based on historical
experience and product demand. Management evaluates the adequacy of these
reserves periodically based on forecasted sales and market trends.
Allowance
for Doubtful Accounts.
Accounts
receivable are reduced by an allowance for amounts that may become uncollectible
in the future. The majority of receivables related to phototherapy sales are
due
from various distributors located outside of the United States and from
physicians located inside the United States. The majority of receivables related
to skincare products, surgical services and surgical products are due from
various customers and distributors located inside the United States. From time
to time, our customers dispute the amounts due to us, and, in other cases,
our
customers experience financial difficulties and cannot pay on a timely basis.
In
certain instances, these factors ultimately result in uncollectible accounts.
The determination of the appropriate reserve needed for uncollectible accounts
involves significant judgment. Such factors include changes in the financial
condition of our customers as a result of industry, economic or
customer-specific factors. A change in the factors used to evaluate
collectibility could result in a significant change in the reserve needed.
Property
and Equipment.
As of
December 31, 2006 and 2005, we had net property and equipment of $9,054,098
and
$7,044,713, respectively. The most significant component of these amounts
relates to the XTRAC lasers placed by us in physicians’ offices. We own the
equipment and charge the physician on a per-treatment basis for use of the
equipment. The recoverability of the net carrying value of the lasers is
predicated on increasing revenues from the physicians’ use of the lasers. In
reflection of their improved reliability, XTRAC lasers placed in service after
December 31, 2005 are depreciated on a straight-line basis over the estimated
useful life of five-years; other XTRAC lasers-in-service continue to be
depreciated over the original useful life of three years. Surgical
lasers-in-service are depreciated on a straight-line basis over an estimated
useful life of seven years if new, five years or less if used equipment. The
straight-line depreciation basis for lasers-in-service is reflective of the
pattern of use. For other property and equipment, including property and
equipment acquired from ProCyte, depreciation is calculated on a straight-line
basis over the estimated useful lives of the assets, primarily three to seven
years for computer hardware and software, furniture and fixtures, automobiles,
and machinery and equipment. Leasehold improvements are amortized over the
lesser of the useful lives or lease terms. Useful lives are determined based
upon an estimate of either physical or economic obsolescence, or
both.
Intangibles.
Our
balance sheet includes goodwill and other intangible assets which affect the
amount of future period amortization expense and possible impairment expense
that we will incur. Management’s judgments regarding the existence of impairment
indicators are based on various factors, including market conditions and
operational performance of our business. As of December 31, 2006 and 2005,
we
had $22,151,160 and $22,420,563, respectively, of goodwill and other
intangibles, accounting for 39% and 46% of our total assets at the respective
dates. The goodwill is not amortizable; the other intangibles are. The
determination of the value of such intangible assets requires management to
make
estimates and assumptions that affect our consolidated financial statements.
We
test our goodwill for impairment, at least annually. This test is usually
conducted in December of each year in connection with the annual budgeting
and
forecast process. Also, on a quarterly basis, we evaluate whether events have
occurred that would negatively impact the realizable value of our intangibles
or
goodwill.
40
There
has
been no change in 2006 and 2005 to the carrying value of goodwill that is
allocated to the XTRAC domestic segment and the XTRAC international segment
in
the amounts of $2,061,096 and $883,327, respectively. The allocation of goodwill
to each segment was based upon the relative fair values of the two segments
as
of August 2000, when we bought out the minority interest in Acculase, Inc.
and
thus recognized the goodwill. In connection with the acquisition of ProCyte
on
March 18, 2005, we acquired certain intangibles recorded at fair value as of
the
date of acquisition and allocated fully to the Skin Care (ProCyte) segment.
In
2006, we adjusted the carrying value of the goodwill from the ProCyte
acquisition reflecting management’s best estimate of pre-acquisition
contingencies based upon plans entered into prior to March 18, 2005. Included
in
these acquired intangibles were the following:
ProCyte
Neutrogena Agreement
|
$
|
2,400,000
|
||
ProCyte
Customer Relationships
|
1,700,000
|
|||
ProCyte
Tradename
|
1,100,000
|
|||
ProCyte
Developed Technologies
|
200,000
|
|||
Goodwill
|
13,973,385
|
|||
Total
|
$
|
19,373,385
|
Deferred
Income Taxes. We
have a
deferred tax asset that is fully reserved by a valuation allowance. We have
not
recognized the deferred tax asset, given our historical losses and the lack
of
certainty of future taxable income. However, if and when we become profitable
and can reasonably foresee continuing profitability, then under SFAS No. 109
we
may recognize some of the deferred tax asset. The recognized
portion may variously reduce acquired goodwill, increase stockholders’ equity
directly and/or benefit the statement of operations.
Warranty
Accruals.
We
establish a liability for warranty repairs based on estimated future claims
for
XTRAC systems and based on historical analysis of the cost of the repairs for
surgical laser systems. However, future returns on defective laser systems
and
related warranty liability could differ significantly from estimates, and
historical patterns, which would adversely affect our operating
results.
Results
of Operations
Revenues
The
following table illustrates revenues from our five business segments for the
periods listed below:
For
the Year Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Dermatology:
|
||||||||||
XTRAC
Domestic Services
|
$
|
5,611,387
|
$
|
3,498,235
|
$
|
3,256,164
|
||||
International
Dermatology Equipment Revenues
|
2,186,424
|
1,404,096
|
1,626,646
|
|||||||
Skin
Care (ProCyte) Revenues
|
12,646,910
|
10,042,132
|
-
|
|||||||
Total
Dermatology Revenues
|
$
|
20,444,721
|
$
|
14,944,463
|
$
|
4,882,810
|
||||
Surgical:
|
||||||||||
Surgical
Services
|
$
|
6,944,292
|
$
|
7,719,529
|
$
|
7,826,519
|
||||
Surgical
Products
|
5,800,864
|
5,720,514
|
5,035,852
|
|||||||
Total
Surgical Revenues
|
$
|
12,745,156
|
$
|
13,440,043
|
$
|
12,862,371
|
||||
Total
Revenues
|
$
|
33,189,877
|
$
|
28,384,506
|
$
|
17,745,181
|
41
Domestic
XTRAC Segment
Recognized
revenue for the years ended December 31, 2006, 2005, and 2004 were $5,611,387,
$3,498,235 and $3,256,164, respectively. This included treatment revenue for
the
years ended December 31, 2006, 2005 and 2004 for domestic XTRAC procedures
of
$5,142,022, $3,498,235 and $3,256,164, respectively, reflecting billed
procedures of 83,272, 54,255 and 47,915, respectively. In addition, 5,168,
6,371
and 4,928 procedures were performed for the years ended December 31, 2006,
2005
and 2004, respectively, without billing from us, in connection with clinical
research and customer evaluations of the XTRAC laser. The increase in procedures
in the year ended December 31, 2006 compared to the comparable periods in 2005
and 2004 was largely related to our continuing progress in securing favorable
reimbursement policies from private insurance plans and to our increased
marketing programs. Increases in revenues are dependent upon more widespread
adoption of the CPT codes with comparable rates by private healthcare insurers
and on instilling confidence in our physician partners that the XTRAC procedures
will benefit their patients and be generally reimbursed to their
practices.
In
the
first quarter of 2003, we implemented a program to support certain physicians
who may be denied reimbursement by private insurance carriers for XTRAC
treatments. In accordance with the requirements of SAB No. 104, we recognize
service revenue during the program only to the extent the physician has been
reimbursed for the treatments. For the year ended December 31, 2006, we deferred
revenues of $124,427 (1,897 procedures) net, under this program, compared to
deferred revenues of $57,302 (873 procedures) net, under this program for the
year ended December 31, 2005. For the year ended December 31, 2004, we
recognized revenues of $303,027, (4,562 procedures) net, under this program
that
were previously deferred. The change in deferred revenue under this program
is
presented in the table below.
For
the
year ended December 31, 2006, domestic XTRAC laser sales were $469,365. There
were 11 lasers sold which were made for various reasons, including costs of
logistical support and customer preferences. We expect we shall continue to
offer XTRAC lasers for sale in 2007.
The
following table illustrates the above analysis for the Domestic XTRAC segment
for the periods reflected below:
For
the Year Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Total
revenue
|
$
|
5,611,387
|
$
|
3,498,235
|
$
|
3,256,164
|
||||
Less:
laser sales revenue
|
(469,365
|
)
|
-
|
-
|
||||||
Recognized
treatment revenue
|
5,142,022
|
3,498,235
|
3,256,164
|
|||||||
Change
in deferred program revenue
|
124,427
|
57,302
|
(303,027
|
)
|
||||||
Change
in deferred unused treatments
|
194,869
|
5,371
|
229,300
|
|||||||
Net
billed treatment revenue
|
5,461,318
|
$
|
3,560,908
|
$
|
3,182,437
|
|||||
Procedure
volume total
|
88,440
|
60,626
|
52,843
|
|||||||
Less:
Non-billed procedures
|
5,168
|
6,371
|
4,928
|
|||||||
Net
billed procedures
|
83,272
|
54,255
|
47,915
|
|||||||
Avg.
price of treatments sold
|
$
|
65.58
|
$
|
65.63
|
$
|
66.42
|
||||
Procedures
with deferred/(recognized)
program
revenue, net
|
1,897
|
873
|
(4,562
|
)
|
||||||
Procedures
with deferred unused
treatments, net |
2,971
|
82
|
3,452
|
The
average price for a treatment varies based upon the mix of mild and moderate
psoriasis patients treated by our physician partners. We charge a higher price
per treatment for moderate psoriasis patients due to the increased body surface
area required to be treated, although there are fewer patients with moderate
psoriasis than there are with mild psoriasis. Due to the length of treatment
time required, it has not been generally practical to use our therapy to treat
severe psoriasis patients. This may change going forward, as our new product,
the XTRAC Ultra, has shorter treatment times. A study undertaken with the
guidance of John Koo, MD, of the University of California at San Francisco,
is
evaluating the effectiveness of the Ultra in treating patients suffering from
severe psoriasis.
42
International
Dermatology Equipment Segment
International
sales of our XTRAC and VTRAC laser systems and related parts were $2,186,424
for
the year ended December 31, 2006 compared to $1,404,096 and $1,626,646 for
the years ended December 31, 2005 and 2004, respectively. We sold 46 laser
systems in the year ended December 31, 2006 compared to 26 laser systems in
each of the years ended December 31, 2005 and 2004. Compared to the
domestic business, the international dermatology equipment operations are more
influenced by competition from similar laser technology from other manufacturers
and from non-laser lamps. Such competition has caused us to reduce the prices
we
charge to international distributors. Furthermore, average selling prices for
international dermatology equipment are influenced by the following two
factors:
·
|
We
began selling refurbished domestic XTRAC laser systems into the
international market in 2005. The selling price for used equipment
is
substantially less than new equipment. We sold six of these used
lasers,
in each year, at an average price of $28,000 and $27,000 for the
years
ended December 31, 2006 and 2005, respectively;
and
|
·
|
We
began selling the new VTRAC, a lamp-based, alternative UVB light
source
that has a wholesale sales price that is substantially below our
competitors’ international dermatology equipment and below our XTRAC
laser. In the year ended December 31, 2006, we sold 12 VTRAC
systems.
|
The
following table illustrates the key changes in the International XTRAC segment
for the periods reflected below:
For
the Year Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Revenues
|
$
|
2,186,424
|
$
|
1,404,096
|
$
|
1,626,646
|
||||
Laser
systems sold
|
46
|
26
|
26
|
|||||||
Average
revenue per laser
|
$
|
47,531
|
$
|
54,004
|
$
|
62,563
|
Skin
Care (ProCyte) Segment
For
the
year ended December 31, 2006, ProCyte revenues were $12,646,910 compared to
$10,042,132 for the year ended December 31, 2005. Inasmuch as ProCyte was
acquired on March 18, 2005, the operating results of ProCyte for the year ended
December 31, 2005 include activity from ProCyte from March 19, 2005 through
December 31, 2005 and there are no corresponding revenues accruing to us for
the
year ended December 31, 2004. Skin Care revenues are generated from the sale
of
various skin and hair care products, from the sale of copper peptide compound
and from royalties on licenses, mainly from Neutrogena. For the full year 2005,
unaudited Skin care revenues were approximately $13 million compared to
unaudited revenues of $13.3 million for 2004.
·
|
Physician
dispensed product revenues, our most strategic and most profitable
revenues, increased approximately 13% in 2006 over 2005, or about
$1,240,000.
|
·
|
Spa
products revenue decreased approximately 31% in 2006 over 2005, or
about
$215,000.
|
·
|
OEM
products revenue decreased approximately 76% in 2006 over 2005, or
about
$718,000.
|
·
|
Bulk
product and royalty revenues decreased approximately 41% in 2006
over
2005, or about $691,000.
|
43
The
following table illustrates the key changes in the Skin Care (ProCyte) segment
for the periods reflected below:
|
For
the Year Ended December 31,
|
|||||||||
2006
|
2005
|
2004
|
||||||||
Product
sales
|
$
|
11,674,510
|
$
|
8,902,615
|
$
|
-
|
||||
Bulk
compound sales
|
672,400
|
679,550
|
-
|
|||||||
Royalties
|
300,000
|
459,967
|
-
|
|||||||
Total
Skin Care revenue
|
$
|
12,646,910
|
$
|
10,042,132
|
$
|
-
|
Surgical
Services Segment
In
the
years ended December 31, 2006, 2005 and 2004, surgical service revenues
were $6,944,292, $7,719,529 and $7,826,519, respectively, representing a 10%
decrease and a 1.4% decrease from the comparable prior year periods. The 2006
decrease was primarily due to the six territories that we closed since January
1, 2005, the largest of which was in the fourth quarter of 2005, and business
interruption in New Orleans and Alabama from the hurricanes in August and
September 2005. Two of our territories were closed on the western side of
Florida due to the termination of a customer contract. We closed the other
four
territories for insufficient profitability. During the first quarter of 2006,
we
have begun to work with a regional hospital system in central Florida, which
we
believe will generate annual revenue exceeding the annual revenue lost in the
western side of the state.
Surgical
Products Segment
Surgical
Products revenues include revenues derived from the sales of surgical laser
systems together with sales of related laser fibers and laser disposables.
Sales
of laser systems create recurring sales of laser fibers and laser disposables
that are more profitable than laser systems.
For
the
year ended December 31, 2006, surgical products revenues were $5,800,864
compared to $5,720,514 in the year ended December 31, 2005. The increase was
almost entirely due to $207,000 in additional laser system revenues reflecting
the increase in the number of systems sold (80 vs. 47), partially offset by
a
decline in the average price per laser sold. This was offset, in part, by a
decrease in disposable and fiber sales of approximately 5%.
For
the
year ended December 31, 2005, surgical products revenues were $5,720,514
compared to $5,035,852 in the year ended December 31, 2004. The increase was
almost entirely due to $685,000 in additional laser system revenues reflecting
the increase in the number of systems sold (47 vs. 17), partially offset by
a
decline in the average price per laser sold.
As
set
forth in the table below, the decrease in average price per laser between the
period was largely due to the mix of lasers sold and partly due to the trade
level at which the lasers were sold (i.e. wholesale versus retail). Our diode
laser has replaced our Nd:YAG laser, which had a higher sales price. Included
in
laser sales during the years ended December 31, 2006, 2005 and 2004 were sales
of 65, 28 and 1 diode lasers, respectively. The diode lasers have lower sales
prices than our other types of lasers, and thus the increase in the number
of
diodes sold reduced the average price per laser. We expect that we will continue
to sell more diode lasers than our other types of lasers into the near
future.
Disposables
and fiber sales decreased approximately 5% from the comparable year ended
December 31, 2005. We have expected that the disposables base may continue
to
erode over time as hospitals continue to seek outsourcing solutions instead
of
purchasing lasers and related disposables for their operating rooms. We have
continued to seek to offset this erosion through expansion of our surgical
services. Similarly, we believe there will be continuing pressure on laser
system sales as hospitals continue to outsource their laser-assisted procedures
to third parties, such as our surgical services business. With the introduction
of our CO2 and diode surgical lasers in the second quarter of 2004, we have
sought to offset the decline in laser and disposables revenues.
44
The
following table illustrates the key changes in the Surgical Products segment
for
the periods reflected below:
|
For
the Year Ended December 31,
|
|||||||||
2006
|
2005
|
2004
|
||||||||
Revenues
|
$
|
5,800,864
|
$
|
5,720,514
|
$
|
5,035,832
|
||||
Percent
increase
|
1.4
|
%
|
13.6
|
%
|
||||||
Laser
systems sold
|
80
|
47
|
17
|
|||||||
Laser
system revenues
|
$
|
1,801,000
|
$
|
1,594,000
|
$
|
989,000
|
||||
Average
revenue per laser
|
$
|
22,513
|
$
|
33,915
|
$
|
58,176
|
Cost
of Revenues
Cost
of
revenues divides into product cost of revenues and service cost of revenues
.
Within product cost of revenues are the costs of products sold in the
International Dermatology Equipment segment, the Skin Care segment (with
royalties being transferred over to the services side), and the Surgical
Products segment (with laser maintenance being transferred over to the services
side). Within services cost of revenues are the costs associated with the
Domestic XTRAC segment and the Surgical Services segment, as well as costs
associated with the royalties and maintenance.
Product
cost of revenues during the year ended December 31, 2006 were $8,628,651,
compared to $7,219,504 for the year ended December 31, 2005. The $1,409,147
increase reflected the cost of sales for the domestic XTRAC laser sales of
$128,840, an increase of $726,412 in costs for the ProCyte business acquired
on
March 18, 2005, and therefore the operating results of ProCyte for the year
ended December 31, 2005 include activity from ProCyte from March 19, 2005
through December 31, 2005. Additionally there was an increase of $216,389 for
surgical products, due to increased laser system sales and a $337,506 increase
in costs associated with sales of XTRAC laser equipment sold outside the United
States.
Product
cost of revenues during the year ended December 31, 2005 were $7,219,504,
compared to $3,324,564 for the year ended December 31, 2004. The $3,894,940
increase reflected $3,132,532 of costs for the ProCyte business acquired on
March 18, 2005. Additionally there was an increase of $1,009,204 for surgical
products, due to increased laser system sales, which was offset, in part by
a
decrease of $246,796 in product cost of sales for the international XTRAC
revenues for the year ended December 31, 2004.
Services
cost of revenues was $9,843,199 and $8,456,001 in the years ended December
31,
2006 and 2005, respectively. Contributing to the $1,387,198 increase was a
$1,345,853 increase in the Domestic XTRAC business segment due to increased
depreciation on the lasers of $629,000, an increase in excess and obsolete
inventory reserve and abnormal gas consumption, which has been corrected by
software modifications. Additionally there was an increase of $41,345 in the
cost of revenues for the Surgical Services business.
Services
cost of revenues was $8,456,001 and $7,038,705 in the years ended December
31,
2005 and 2004, respectively. Contributing to the $1,417,296 increase was a
$616,236 increase in the Surgical Services business associated with the increase
in urological procedures performed with laser systems purchased from a
third-party manufacturer, which carry a higher cost of sale due to the
disposable fiber purchased from the third-party manufacturer than a fiber which
we manufacture. In addition, cost of revenues in the Domestic XTRAC business
segment increased $801,060 due to manufacturing inefficiencies, an increase
in
excess and obsolete inventory reserve and increased depreciation on the lasers
compared to the same period in 2004.
45
Certain
allocable XTRAC manufacturing overhead costs are charged against the XTRAC
service revenues. The manufacturing facility in Carlsbad, California is used
exclusively for the production of the XTRAC lasers, which are placed in
physicians’ offices domestically or sold. The unabsorbed costs, relating to
excess capacity, are allocated to the Domestic XTRAC and the International
Dermatology Equipment segments based on actual production of lasers for each
segment. Included in these allocated manufacturing costs are unabsorbed labor
and direct plant costs.
The
following table illustrates the key changes in cost of revenues for the periods
reflected below:
For
the Year Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Product:
|
||||||||||
XTRAC
Domestic
|
$
|
128,840
|
$
|
-
|
$
|
-
|
||||
International
Dermatology Equipment
|
1,268,080
|
930,574
|
1,177,370
|
|||||||
Skin
Care
|
3,858,944
|
3,132,532
|
-
|
|||||||
Surgical
products
|
3,372,787
|
3,156,398
|
2,147,194
|
|||||||
Total
Product costs
|
$
|
8,628,651
|
$
|
7,219,504
|
$
|
3,324,564
|
||||
Services:
|
||||||||||
XTRAC
Domestic
|
$
|
4,037,359
|
$
|
2,691,506
|
$
|
1,890,446
|
||||
Surgical
Services
|
5,805,840
|
5,764,495
|
5,148,259
|
|||||||
Total
Services costs
|
$
|
9,843,199
|
$
|
8,456,001
|
$
|
7,038,705
|
||||
Total
Costs of Revenues
|
$
|
18,471,850
|
$
|
15,675,505
|
$
|
10,363,269
|
Gross
Margin Analysis
Gross
margin increased to $14,718,027 during the year ended December 31, 2006
from $12,709,001 during the same period in 2005. As a percentage of revenues,
the gross margins for the year ended December 31, 2006, decreased to 44.3%
compared to 44.8% for the same period in 2005.
Gross
margin increased to $12,709,001 during the year ended December 31, 2005
from $7,381,912 during the same period in 2004, primarily reflecting the impact
of the ProCyte acquisition on March 18, 2005. As a percentage of revenues,
the
gross margins for the year ended December 31, 2005, increased to 44.8% compared
to 41.6% for the same period in 2004, largely as a result of the ProCyte’s gross
margin contribution which approximates 68.8%.
The
following table analyzes changes in our gross margin for the periods reflected
below:
Company
Margin Analysis
|
For
the Year Ended December 31,
|
|||||||||
2006
|
2005
|
2004
|
||||||||
Revenues
|
$
|
33,189,877
|
$
|
28,384,506
|
$
|
17,745,181
|
||||
Percent
increase
|
16.9
|
%
|
60.0
|
%
|
||||||
Cost
of revenues
|
18,471,850
|
15,675,505
|
10,363,269
|
|||||||
Percent
increase
|
17.8
|
%
|
51.3
|
%
|
||||||
Gross
profit
|
$
|
14,718,027
|
$
|
12,709,001
|
$
|
7,381,913
|
||||
Percent
of revenue
|
44.3
|
%
|
44.8
|
%
|
41.6
|
%
|
The
primary reasons for changes in gross profit for the year ended December 31,
2006, compared to the same period in 2005 were as follows:
·
|
Our
Skin Care business has the highest gross profit percentage of any
of our
business segments. However, we acquired ProCyte on March 18, 2005,
and, as
such, the operating results of ProCyte for the year ended December
31,
2005 only included activity from March 19, 2005 through December
31, 2005.
|
46
·
|
We
sold a greater number of treatment procedures for the XTRAC laser
systems
in 2006 than in 2005. Each incremental treatment procedure carries
negligible variable cost. The increase in procedure volume was a
direct
result of improving insurance reimbursement and increased marketing
efforts.
|
·
|
We
sold a greater number of surgical laser systems due to the increased
marketing of the Diode laser. These units were primarily sold to
our
master distributor at a gross margin of approximately
36%.
|
·
|
We
sold XTRAC lasers domestically during the year ended December 31,
2006.
The gross margin on these sales is higher, approximately 72%, since
certain of the lasers were previously being
depreciated.
|
·
|
Offsetting
the above was an increase in depreciation of $629,000 included in
the
XTRAC Domestic cost of sales as a result of increasing the overall
placements of new lasers since the year ended December 31,
2005.
|
·
|
In
the Surgical Products segment, unabsorbed labor and overhead plant
costs,
due to lower production levels, accounted for $387,000 of the increase
in
cost of goods sold for the year ended December 31,
2006.
|
·
|
Surgical
services revenues decreased due to lost contracts, while costs related
to
laser repairs increased during the period. Some revenues were lost
due to
hurricanes. While we believe a portion of the loss will be covered
by
insurance, we will not record any expected recovery until we have
greater
assurance of such recovery.
|
The
primary reasons for changes in gross profit for the year ended December 31,
2005, compared to the same period in 2004, were as follows:
·
|
We
acquired ProCyte on March 18, 2005, so only the activity after that
date
is recorded in our financial statements. Consequently, there was
no
activity recorded in our financial statements in 2004 and 2003 from
the
Skin Care business. Additionally, the Skin Care business has the
highest
gross profit margin percentage of any of our business
segments.
|
·
|
We
increased sales on surgical laser systems due to the introduction
of the
diode laser.
|
·
|
Offsetting
the above was an increase in depreciation included with the XTRAC
Domestic
cost of sales as a result of increasing the overall placements of
new
lasers in 2005. In addition, the XTRAC plant was relocated in the
middle
of 2005 causing some inefficiencies in the third quarter. Further,
we
introduced the XTRAC Ultra, a smaller, faster excimer laser. As a
result
of this introduction we increased our reserve for obsolete inventory
related to the older generation
laser.
|
The
following table analyzes the gross profit for our Domestic XTRAC segment for
the
periods reflected below:
XTRAC
Domestic Segment
|
For
the Year Ended December 31,
|
|||||||||
2006
|
2005
|
2004
|
||||||||
Revenues
|
$
|
5,611,387
|
$
|
3,498,235
|
$
|
3,256,164
|
||||
Percent
increase
|
60.4
|
%
|
7.4
|
%
|
||||||
Cost
of revenues
|
4,166,199
|
2,691,506
|
1,890,446
|
|||||||
Percent
increase
|
54.8
|
%
|
42.4
|
%
|
||||||
Gross
profit
|
1,445,188
|
$
|
806,729
|
$
|
1,365,718
|
|||||
Percent
of revenue
|
25.8
|
%
|
23.1
|
%
|
41.9
|
%
|
The
gross
margin increased for this segment for the year ended December 31, 2006 from
the
comparable periods in 2005 by $638,459. The key factors were as
follows:
·
|
We
sold XTRAC lasers domestically during the year ended December 31,
2006.
The gross margin on these sales was approximately 72%, which is
higher
than overall gross margin of 25.8% in this segment and which is
largely
due to the fact that certain of the lasers were previously being
depreciated.
|
47
·
|
A
key driver in increased revenue in this segment is insurance reimbursement
and increased direct-to-consumer advertising in targeted territories.
In
2005, several private health insurance plans adopted a favorable
policy to
cover the medically necessary treatment of psoriasis using our XTRAC
laser
system (e.g. United Healthcare, Highmark, Independence Blue Cross,
Empire
BCBS, Cigna, Premera, Blue Cross of Michigan). These insurers added
to the
group of companies that had already adopted a favorable policy in
2004. In
2006, we increased our level of direct-to-consumer advertising to
recruit
patients to dermatologists’ office to seek treatment with the XTRAC laser
system. While the advertising helped increase revenues, the advertising
is
also costly. We continue to analyze and adjust the advertising campaigns
for cost-effectiveness.
|
·
|
Procedure
volume increased 46% from 60,626 to 88,440 procedures in the year
ended
December 31, 2006 compared to the same period in 2005. Price per
procedure
did not change significantly between the
periods.
|
·
|
Price
per procedure was not a meaningful component of the revenue change
between
the periods.
|
·
|
The
cost of revenues increased by $1,474,693 for the year ended December
31,
2006. This increase is due to the cost of sales for the lasers of
$128,840
and to an increase in depreciation on the lasers-in-service of $629,000
over the comparable prior year period, an increase in excess and
obsolete
inventory reserve and abnormal gas consumption, which has been corrected
by software modification. The depreciation costs will continue to
increase
in subsequent periods as the business grows. In addition, there was
an
increase in certain allocable XTRAC manufacturing overhead costs
that are
charged against the XTRAC service
revenues.
|
The
gross
margin decreased for this segment for the year ended December 31, 2005 from
the
comparable period in 2004 by $558,989. The key factors were as
follows:
·
|
A
key driver in increased revenue in this segment is insurance
reimbursement. In 2004, we focused on encouraging private health
insurance
plans to adopt the XTRAC laser therapy as an approved medical procedure
for the treatment of psoriasis. Since January 2004, several major
health
insurance plans instituted medical policies to pay claims for the
XTRAC
therapy, including Regence, Wellpoint, Aetna, Anthem, Cigna, United
Healthcare, Highmark Blue Cross and Independence Blue Cross of
Pennsylvania.
|
·
|
Procedure
volume increased 14.7% from 52,843 to 60,626 billed procedures in
the year
ended December 31, 2005 compared to the same period in 2004.
|
·
|
Price
per procedure was not a meaningful component of the revenue change
between
the periods.
|
·
|
The
cost of revenues increased by $801,060 for the year ended December
31,
2005. This increase was due to the fact that in 2004, our California
engineering resources dedicated much of their time to product development
for the Ultra, the new, smaller and faster excimer laser. For the
year
ended December 31, 2005, the development of the Ultra was completed,
thus
allowing these California resources to devote more time to manufacturing
(included in cost of revenues).
|
48
The
following table analyzes the gross profit for our International Dermatology
Equipment segment for the periods reflected below:
International
Dermatology Equipment Segment
|
For
the Year Ended December 31,
|
|||||||||
2006
|
2005
|
2004
|
||||||||
Revenues
|
$
|
2,186,424
|
$
|
1,404,096
|
$
|
1,626,646
|
||||
Percent
increase (decrease)
|
55.7
|
%
|
(13.7
|
%)
|
||||||
Cost
of revenues
|
1,268,080
|
930,574
|
1,177,371
|
|||||||
Percent
increase (decrease)
|
36.3
|
%
|
(21.0
|
%)
|
||||||
Gross
profit
|
918,344
|
$
|
473,522
|
$
|
449,275
|
|||||
Percent
of revenue
|
42.0
|
%
|
33.7
|
%
|
27.6
|
%
|
The
gross
profit for the year ended December 31, 2006 increased by $444,822 from the
comparable prior year period. The key factors in this business segment were
as
follows:
·
|
We
sold 34 XTRAC laser systems and 12 VTRAC lamp-based excimer
systems during
the year ended December 31, 2006 and 26 XTRAC laser systems
in the
comparable period in 2005. The VTRAC systems have a higher
gross margin
than the XTRAC laser
systems.
|
· |
The
International Dermatology Equipment operations are influenced
by
competition from similar laser technology from other manufacturers
and
from non-laser lamp alternatives for treating inflammatory
skin disorders,
which has served to reduce the prices we charge international
distributors
for our excimer products. Partially offsetting the increase
in the number
of laser systems sold was a decrease in the average price of
the laser
systems sold. After adjusting the revenue for parts sales of
approximately
$323,000, the average price for lasers sold during this period
was
approximately $40,500 in the year ended December 31, 2006,
down from
$46,000 in the comparable period in 2005. Contributing to the
overall
decrease in the average selling price in the year ended December
31, 2006
was the sale of certain used lasers which were previously deployed
in the
U.S. operations and sold at a discount to the list price for
new
equipment. We sold six of these used lasers in each year at
an average
price of $28,000 and $27,000, respectively for the years ended
December
31, 2006 and 2005. Each of these lasers had a net book value
that was less
than the cost of a new XTRAC laser
system.
|
The
gross
profit for the year ended December 31, 2005 increased by $24,247 from the
comparable prior year period. The key factors in this business segment were
as
follows:
· |
We
sold 26 XTRAC systems during both the years ended December 31,
2005 and
2004.
|
· |
The
International
Dermatology Equipment operations are more widely influenced
by competition
from similar laser technology from other manufacturers and
from non-laser
lamp alternatives for treating inflammatory skin disorders,
which has
served to reduce the prices we charge international distributors
for our
excimer products. After adjusting the revenue for parts sales
of
approximately $209,000, the average price for lasers sold in
the year
ended December 31, 2005 was approximately $46,000, down from
$56,800 in
the comparable period in 2004. Contributing to the overall
average selling
price decrease in 2005 was the sale of certain used lasers
which were
previously deployed in the U.S. operations and sold at a discount
to the
list price for new equipment. We sold six of these used lasers
at an
average price of $27,000. Each of these lasers had a net book
value of
less than standard cost of a new XTRAC system.
|
49
The
following table analyzes our gross margin for our Skin Care (ProCyte) segment
for the periods presented below:
Skin
Care (ProCyte) Segment
|
For
the Year Ended December 31,
|
|||||||||
2006
|
2005
|
2004
|
||||||||
Product
revenues
|
$
|
11,674,510
|
$
|
8,902,615
|
$
|
-
|
||||
Bulk
compound revenues
|
672,400
|
679,550
|
-
|
|||||||
Royalties
|
300,000
|
459,967
|
-
|
|||||||
Total
revenues
|
12,646,910
|
10,042,132
|
-
|
|||||||
Percent
increase
|
25.9
|
%
|
||||||||
Product
cost of revenues
|
3,441,636
|
2,664,959
|
-
|
|||||||
Bulk
compound cost of revenues
|
417,308
|
467,573
|
-
|
|||||||
Total
cost of revenues
|
3,858,944
|
3,132,532
|
-
|
|||||||
Percent
increase
|
23.2
|
%
|
||||||||
Gross
profit
|
$
|
8,787,966
|
$
|
6,909,600
|
$
|
-
|
||||
Percent
of revenue
|
69.5
|
%
|
68.8
|
%
|
-
|
Gross
margin for the year ended December 31, 2006 increased by $1,878,366 over the
comparable period in 2005. The key factors impacting gross margin were as
follows:
· |
Skin
Care (ProCyte) business was acquired on March 18, 2005 and, as such,
the
operating results of ProCyte for the year ended December 31, 2005
only
included activity from March 19, 2005 through December 31,
2005.
|
· |
Copper
peptide bulk compound is sold at a substantially lower gross margin
than
skincare products, while revenues generated from licensees have no
significant costs associated with this revenue
stream.
|
The
following table analyzes the gross profit for our Surgical Services segment
for
the periods reflected below:
Surgical
Services Segment
|
For
the Year Ended December 31,
|
|||||||||
2006
|
2005
|
2004
|
||||||||
Revenues
|
$
|
6,944,292
|
$
|
7,719,529
|
$
|
7,826,519
|
||||
Percent
decrease
|
(10.0
|
%)
|
(1.4
|
%)
|
||||||
Cost
of revenues
|
5,703,925
|
5,675,787
|
5,000,226
|
|||||||
Percent
increase
|
0.5
|
%
|
13.5
|
%
|
||||||
Gross
profit
|
$
|
1,240,367
|
$
|
2,043,742
|
$
|
2,826,293
|
||||
Percent
of revenue
|
17.9
|
%
|
26.5
|
%
|
36.1
|
%
|
Gross
margin in the Surgical Services segment for year ended December 31, 2006
decreased by $803,375, from the comparable period in 2005. The key factors
impacting gross margin for the Surgical Services business were as
follows:
·
|
We
have closed six territories of business due to unacceptable operating
profit and one territory due to competition. Although closing these
unprofitable territories will save costs and improve profitability
over
time, the overall costs saved for the year ended December 31, 2006
have
not kept pace with the revenues lost. Nevertheless, in the case of
the
territory lost to competition, we have opened a new, contiguous territory
in which we have secured a long-term contract from which we anticipate
significant procedure volume. For that reason, we have relocated
our
personnel and materiel from the lost territory to the new
one.
|
50
·
|
Our
product cost percentage has increased due to a change in the mix
of
procedures performed. A certain urological procedure performed on
a laser
purchased from an unrelated party has increased as a percentage of
revenue
from 2005. This procedure has a lower gross margin than margins obtained
from procedures performed on lasers manufactured by
us.
|
Gross
margin in the Surgical Services segment for year ended December 31, 2005
decreased by $782,551, from the comparable period in 2004. The key factors
impacting gross margin for the Surgical Services business were as
follows:
·
|
A
significant part of the revenue was in urological procedures performed
with laser systems we purchased from a third-party manufacturer.
Such
procedures included a charge for the use of the laser and the technician
to operate it, as well as a charge for the third party’s proprietary fiber
delivery system. This procedure has a lower gross margin as a percent
of
revenues than other types of procedures. As the volume of these procedures
increases, the overall gross margin percentage decreases. In 2005,
there
was a 25% price increase on the third party’s proprietary fiber delivery
system, which also contributed to the decrease in gross margin in
2005.
Revenues for this procedure were $2.4 million for the year ended
December
31, 2005 compared to $1.7 million for the same period in
2004.
|
·
|
We
closed four geographic areas of business due to unacceptable operating
profit. Although closing these territories will save costs and improve
profitability over time, the costs saved for the year ended December
31,
2005 have not kept pace with the revenues lost by closing these
territories during the year ended December 31, 2005.
|
·
|
We
suffered business interruption due to hurricanes in the New Orleans
and
Alabama territories during 2005.
|
The
following table analyzes our gross profit for our Surgical Products segment
for
the periods reflected below:
Surgical
Products Segment
|
For
the Year Ended December 31,
|
|||||||||
2006
|
2005
|
2004
|
||||||||
Revenues
|
$
|
5,800,864
|
$
|
5,720,514
|
$
|
5,035,852
|
||||
Percent
increase
|
1.4
|
%
|
13.6
|
%
|
||||||
Cost
of revenues
|
3,474,702
|
3,245,103
|
2,295,226
|
|||||||
Percent
increase
|
7.1
|
%
|
41.4
|
%
|
||||||
Gross
profit
|
$
|
2,326,162
|
$
|
2,475,411
|
$
|
2,740,626
|
||||
Percent
of revenue
|
40.1
|
%
|
43.3
|
%
|
54.4
|
%
|
The
gross
profit for the year ended December 31, 2006 decreased by $149,249 from the
comparable prior year period. The key factors in this business segment were
as
follows:
· |
This
segment includes product sales of surgical laser systems and laser
disposables. Disposables are more profitable than laser systems,
but the
sale of laser systems generates the subsequent recurring sale of
laser
disposables.
|
· |
Revenues
for the year ended December 31, 2006 increased by $80,350
from the year
ended December 31, 2005 while cost of revenues increased
by $229,599
between the same periods. There were 33 more laser systems
sold in the
year ended December 31, 2006 than in the comparable period
of 2005.
However, the lasers sold in the 2005 period were at higher
prices than in
the comparable period in 2006. The decrease in average price
per laser was
largely due to the mix of lasers sold. Included in the laser
sales for the
year ended December 31, 2006 and 2005 were sales of $1,120,000
and
$605,000 of diode lasers, respectively, which have substantially
lower
list sales prices than the other types of surgical
lasers.
|
51
·
|
Unabsorbed
labor and overhead plant costs, due to lower production levels, accounted
for $387,000 of the increase in cost of goods sold for the year ended
December 31, 2006.
|
·
|
This
revenue increase was partly offset by a decrease in AzurTec project
revenues of $156,000 and a decrease in sales of disposables between
the
periods. The AzurTec revenues recognized in 2005 had substantially
no
associated direct costs. Disposables, which have a higher gross margin
as
a percent of revenues than lasers, represented a higher percentage
of
revenue in the year ended December 31, 2006 compared to the same
period in
2005.
|
The
gross
profit for the year ended December 31, 2005 decreased by $265,215 from the
comparable prior-year period. The key factors in this business segment were
as
follows:
·
|
This
segment includes product sales of surgical laser systems and laser
disposables. Disposables are more profitable than laser systems.
However,
the sale of laser systems generates future recurring sales of laser
disposables.
|
·
|
Revenues
for the year ended December 31, 2005 increased by $684,662 from the
year
ended December 31, 2004 while cost of revenues increased by $949,877
between the same periods. There were 30 more laser systems sold in
the
year ended December 31, 2005 than in the comparable period of 2004.
However, the lasers sold in the 2004 period were at higher prices
than in
the comparable period in 2005. The decrease in average price per
laser was
largely due to the mix of lasers sold. Included in the laser sales
for the
years ended December 31, 2005 and 2004 were sales of $532,995 and
$40,000
diode lasers, respectively, which have substantially lower list sales
prices than the other types of surgical lasers.
|
·
|
The
laser revenue increase was partly offset by a decrease in sales of
disposables between the periods. Disposables, which have a higher
gross
margin than lasers, represented a lower percentage of revenue in
the year
ended December 31, 2005 compared to the year ended December 31,
2004.
|
Selling,
General and Administrative Expenses
For
the
year ended December 31, 2006, selling, general and administrative expenses
increased to $20,682,056 from $16,477,322 for the year ended December 31, 2005.
·
|
Selling,
general and administrative expenses related to the ProCyte business
accounted for $1,360,000 of the increase. This is due to the acquisition
which occurred on March 18, 2005, so only expenses from March 19,
2005
through December 31, 2005 were
included.
|
·
|
The
remaining increase related to a $387,000 increase in salaries, benefits
and travel expenses associated with an increase in the sales force,
particularly in the Domestic XTRAC
segment;
|
· |
An
increase in direct-to-consumer advertising of
$676,000;
|
· |
An
increase in royalties to Mount Sinai of
$112,000;
|
· |
An
increase in bonus accrual of
$255,000;
|
· |
An
increase of $210,000 for legal expenses;
and
|
· |
An
increase of $1,304,546 for stock-based compensation expense following
adoption of SFAS No. 123R (see Note 1, “Stock-Based
Compensation”)
and $132,624 for stock options issued to consultants.
|
· |
These
increases were partially offset by a reduction in bad debt expense
of
$213,000.
|
For
the
year ended December 31, 2005, selling, general and administrative expenses
increased to $16,477,322 from $10,426,256 for the year ended December 31,
2004.
52
· |
Selling,
general and administrative expenses related to the Skin Care business
accounted for $5,331,764 of the increase. This is due to the acquisition
which occurred on March 18, 2005, so only expenses from March 19,
2005
through December 31, 2005 were
included.
|
· |
The
remaining increase related to a $485,000 increase in salaries, benefits
and travel expenses associated with an increase in the sales force,
particularly in the Domestic XTRAC segment;
|
· |
A
$151,000 increase in salaries and benefits for general and administrative
expenses;
|
· |
An
increase in consulting expenses of $161,000;
and
|
· |
An
increase in corporate insurance of $229,000.
|
· |
Offsetting
some of the increases for the year ended December 31, 2005, were
reductions in bonus expense of $134,000 and in bad debt expense of
$117,000 in the current year compared to the prior-year
period.
|
Engineering and
Product Development
Engineering
and product development expenses for the year ended December 31, 2006 decreased
to $1,006,600 from $1,127,961 for the year ended December 31, 2005. The decrease
is primarily due to a decrease in salaries due to reduced headcount of $117,000.
During the 2006 and 2005 periods, the engineers at the Carlsbad plant were
primarily focused on manufacturing efforts, and therefore, their costs have
been
reflected in cost of goods sold.
Engineering
and product development expenses for the year ended December 31, 2005 decreased
to $1,127,961 from $1,801,438 for the year ended December 31, 2004. The decrease
was mainly in the XTRAC segments due to product development expenses in 2004
for
the Ultra. In 2005, the development of the Ultra was completed, thus allowing
these California resources to devote more time to manufacturing. This decrease
was offset, in part, by the engineering and product development expenses related
to the Skin Care business of $442,368.
Other
Income
Other
income for the year ended December 31, 2005 was $1,302,537 reflecting the
following components: a litigation settlement, net of expenses, of $968,882,
a
non-monetary exchange of assets during June 2005 of two depreciable engineering
development prototypes in exchange for four product units to be held for sale
for $88,667 and the expiration, and therefore reversal, of the liability for
SLT
subordinated notes of $244,988. There was no other income in the comparable
periods in 2006 and 2004.
Interest
Expense, Net
Net
interest expense for the year ended December 31, 2006 increased to $521,768,
as
compared to $342,299 for the year ended December 31, 2005. The increase in
net
interest expense was the result of the draws on the lease line of credit during
the year ended December 31, 2005 and the first, second and third quarters of
2006.
Net
interest expense for the year ended December 31, 2005 increased to $342,299,
as
compared to $138,414 for the year ended December 31, 2004. The increase in
net
interest expense was the result of the draws on the lease line of credit during
the second, third and fourth quarters of 2004 and the second and third quarters
of 2005.
Net
Loss
The
aforementioned factors resulted in a net loss of $7,492,397 during the year
ended December 31, 2006, as compared to a net loss of $3,936,044 for the year
ended December 31, 2005, an increase of 90.4%. The increase was primarily due
to:
· |
The
result of the other income for the year ended December 31, 2005 of
$1,302,537;
|
53
·
|
The
increase in cost of sales and resulting decrease in gross margin,
due to
stock option expense of $1,437,170 following the adoption of SFAS
No.
123R; and
|
· |
An
increase of $982,110 of depreciation and amortization over the
comparable
period of the prior year.
|
The
following table illustrates the impact of the three components between the
periods:
|
For
the Year ended December 31,
|
|||||||||
2006
|
2005
|
Change
|
||||||||
Net
loss
|
$
|
7,492,398
|
$
|
3,936,044
|
$
|
3,556,354
|
||||
Components
included in net loss:
|
||||||||||
Other
income
|
-
|
1,302,537
|
(1,302,537
|
)
|
||||||
Depreciation
and amortization expense
|
(4,199,047
|
)
|
(3,216,937
|
)
|
(982,110
|
)
|
||||
Stock-based
compensation expense
|
(1,437,170
|
)
|
-
|
(1,437,170
|
)
|
|||||
($5,636,217
|
)
|
($1,914,400
|
)
|
($3,721,817
|
)
|
The
aforementioned factors resulted in a net loss of $3,936,044 during the year
ended December 31, 2005, as compared to a net loss of $4,984,196 for the year
ended December 31, 2004, a decrease of 21.0%. This decrease was primarily the
result of the other income for the year ended December 31, 2005.
Income
taxes were immaterial, given our current period losses and operating loss
carryforwards.
Liquidity
and Capital Resources
We
have
historically financed our operations with cash provided by equity financing
and
from lines of credit and, more recently, from positive cash flow generated
from
operations.
On
March
18, 2005, we acquired ProCyte. The skincare products and royalties provided
by
ProCyte increased revenues for the year ended December 31, 2006. We realized
cost savings from the consolidation of the administrative and marketing
infrastructure of the combined company. Additionally, now that the consolidated
infrastructure is in place, we expect our revenues to grow without
proportionately increasing the rate of growth in our fixed costs.
At
December 31, 2006, our current ratio was 2.66 compared to 2.42 at December
31,
2005. As of December 31, 2006, we had $16,069,615 of working capital compared
to
$11,120,992 as of December 31, 2005. Cash and cash equivalents were $12,885,742
as of December 31, 2006, as compared to $5,609,967 as of December 31, 2005.
We
had $156,000 of cash that was classified as restricted as of December 31, 2006
compared to $206,931 as of December 31, 2005.
We
believe that our existing cash balance together with our other existing
financial resources, including access to lease financing for capital
expenditures, and revenues from sales, distribution, licensing and manufacturing
relationships, will be sufficient to meet our operating and capital requirements
beyond the first quarter of 2008. The 2007 operating plan reflects continuing
cost savings from the integration of ProCyte as well as increases in
per-treatment fee revenues for use of the XTRAC system based on increased
utilization of the XTRAC by physicians and on wider insurance coverage in the
United States. In addition, the 2007 operating plan calls for increased revenues
and profits from our newly acquired Skin Care business. In light of our recent
private placement of approximately $11.4 million worth of our common stock
in
November 2006, we believe that we shall have the necessary financing to meet
our
operating and capital requirements, at a minimum, into 2008.
54
On
June
25, 2004, we entered into a leasing credit facility from GE Capital Corporation
(“GE”). The credit facility has a commitment term of three years, expiring on
June 25, 2007. We account for each draw as funded indebtedness taking the form
of a capital lease, with equitable ownership in the lasers remaining with us.
GE
retains title as a form of security over the lasers. Each draw against the
credit facility has a repayment period of three years and is secured by specific
lasers, which we have sold to GE and leased back for deployment in the field.
A
summary of the activity under the GE leasing credit facility is presented in
Note 9, “Long-term
Debt.”
Net
cash
provided by operating activities was $60,984 for the year ended December 31,
2006, compared to cash used of $1,729,842 for the same period in 2005. The
change was primarily due to a decrease in inventory. In the prior year,
significant inventory purchases were made of copper peptide in the skincare
products segment and in launching the diode program in the surgical products
segment. Increases in sales in these segments in 2006 reduced the inventory
levels.
Net
cash
used in operating activities was $1,729,842 for the year ended December 31,
2005, compared to $2,765,221 for the same period in 2004. The decrease was
mostly due to the payment of various previously recorded costs associated with
the acquisition and increases in inventory.
Net
cash
used in investing activities was $5,026,811 for the year ended December 31,
2006
compared to cash provided by investing activities of $1,993,412 for the year
ended December 31, 2005. This change was mostly the result of receiving cash
of
$5,578,416, net of costs, in the acquisition of ProCyte in 2005. Of this
increase in cash from the acquisition, we used $3,461,803 for production of
our
lasers-in-service compared to $4,931,835 in 2006.
Net
cash
provided by investing activities was $1,993,412 for the year ended December
31,
2005 compared to cash used of $2,677,670 for the year ended December 31, 2004.
During the year ended December 31, 2005, we received cash of $5,578,416, net
of
acquisition costs, in the ProCyte acquisition and used $3,461,803 for production
of our lasers-in-service compared to $1,683,528 for the same period in 2004.
The
retirements of lasers from service have been minor or immaterial over the last
three years and therefore, we have reported them on a net basis.
Net
cash
provided by financing activities was $12,292,533 for the year ended December
31,
2006 compared to $1,254,649 for the year ended December 31, 2005. In the year
ended December 31, 2006 we received $10,449,402, net from the issuance of common
stock, $2,511,437 from the advances under the lease line of credit, net of
payments, $361,469 from the exercise of common stock options and warrants and
a
decrease in restricted cash of $50,931. These cash receipts were offset by
$1,080,706 for the payment of certain notes payable and capital lease
obligations.
Net
cash
provided by financing activities was $1,254,649 for the year ended December
31,
2005 compared to $2,694,240 for the year ended December 31, 2004. In the year
ended December 31, 2005 we made payments of $1,145,474 on certain notes payable
and capital lease obligations and incurred $169,524 in registration costs.
These
payments were offset, in part, by the advances under the lease line of credit,
net of payments, of $1,889,487 and by receipts of $774,891 from the exercise
of
common stock options and warrants. In the year ended December 31, 2004, we
received $3,296,751 from the exercise of common stock options and warrants
and a
net increase of $527,548 from the lapse of the bank line of credit and the
initiation of the leasing line of credit from GE. These cash receipts were
offset by $879,001 for the payment of certain notes payable and capital lease
obligations.
Set
forth
below is a summary of current obligations as of December 31, 2006 to make future
payments due by the period indicated below, excluding payables and accruals.
We
expect to be able to meet our obligations in the ordinary course. The
obligations under the credit facility from GE Capital Corporation are capital
leases. The other capital lease obligations are from transactions entered into
before we entered the credit facility with GE. Operating lease and rental
obligations are respectively for personal and real property which we use in
our
business.
55
|
Payments
due by period
|
||||||||||||
Contractual
Obligations
|
Total
|
Less
than 1 year
|
1
- 3 years
|
4
- 5 years
|
|||||||||
Credit
facility obligations
|
$
|
6,490,077
|
$
|
2,936,215
|
$
|
3,553,862
|
$
|
-
|
|||||
Other
capital lease obligations
|
122,716
|
82,658
|
40,058
|
-
|
|||||||||
Operating
lease obligations
|
50,345
|
32,523
|
17,822
|
-
|
|||||||||
Rental
lease obligations
|
1,795,189
|
470,663
|
1,018,524
|
306,002
|
|||||||||
Notes
payable
|
328,756
|
195,249
|
87,030
|
46,477
|
|||||||||
Total
|
$
|
8,787,895
|
$
|
3,717,308
|
$
|
4,718,108
|
$
|
352,479
|
Our
ability to expand our business operations is currently dependent in significant
part on financing from external sources. There can be no assurance that changes
in our manufacturing and marketing, research and development plans or other
changes affecting our operating expenses and business strategy will not require
financing from external sources before we will be able to develop profitable
operations. There can be no assurance that additional capital will be available
on terms favorable to us, if at all. To the extent that additional capital
is
raised through the sale of additional equity or convertible debt securities,
the
issuance of such securities could result in additional dilution to our
stockholders. Moreover, our cash requirements may vary materially from those
now
planned because of marketing results, product testing, changes in the focus
and
direction of our marketing programs, competitive and technological advances,
the
level of working capital required to sustain our planned growth, litigation,
operating results, including the extent and duration of operating losses, and
other factors. In the event that we experience the need for additional capital,
and are not able to generate capital from financing sources or from future
operations, management may be required to modify, suspend or discontinue our
business plan.
Impact
of Inflation
We
have
not operated in a highly inflationary period, and we do not believe that
inflation has had a material effect on sales or expenses.
Item
7A. Quantitative
and Qualitative Disclosure About Market Risk
We
are
not currently exposed to market risks due to changes in interest rates and
foreign currency rates and, therefore, we do not use derivative financial
instruments to address risk management issues in connection with changes in
interest rates and foreign currency rates.
Item
8. Financial
Statements and Supplementary Data.
The
financial statements required by this Item 8 are included in this Report and
beginning on page F-1.
Item
9. Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
None.
Item
9A. Controls
and Procedures
Controls
and Procedures
As
of
December 31, 2006, we carried out an evaluation, under the supervision and
with the participation of our chief executive officer and chief financial
officer, of the effectiveness of the design and operations of our disclosure
controls and procedures, as defined in Rule 13a-15(e) under the Securities
Exchange Act of 1934.
Our
chief
executive officer and chief financial officer concluded that as of the
evaluation date, such disclosure controls and procedures were effective to
ensure that information required to be disclosed by us in the reports we file
or
submit under the Exchange Act are recorded, processed, summarized and reported
within the time periods specified in the rules and forms of the Securities
and
Exchange Commission, and is accumulated and communicated to our management,
including our chief executive officer and chief financial officer, as
appropriate to allow timely decisions regarding required disclosure.
56
There
were no changes in our internal controls over financial reporting during the
quarter ended December 31, 2006 that materially affected, or were
reasonably likely to materially affect, our internal controls over financial
reporting. As a prophylactic measure and support for our compliance with the
Sarbanes Oxley Act, we adopted an Anti-Fraud Program in January
2007.
Management’s
report on our internal controls over financial reporting can be found with
the
attached financial statements. The Independent Registered Public Accounting
Firm’s attestation report on management’s assessment of the effectiveness of our
internal control over financial reporting can also be found with the attached
financial statements.
Management's
Report on Internal Control Over Financial Reporting
Our
management is responsible for establishing and maintaining an adequate system
of
internal control over financial reporting. Our system of internal control over
financial reporting is designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with accounting principles generally
accepted in the United States of America.
Our
internal control over financial reporting includes those policies and procedures
that:
·
|
pertain
to the maintenance of records that, in reasonable detail, accurately
and
fairly reflect our transactions and dispositions of our
assets;
|
·
|
provide
reasonable assurance that our transactions are recorded as necessary
to
permit preparation of our financial statements in accordance with
accounting principles generally accepted in the United States of
America,
and that our receipts and expenditures are being made only in accordance
with authorizations of our management and our directors;
and
|
·
|
provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of our assets that
could
have a material effect on the financial statements.
|
Because
of its inherent limitations, a system of internal control over financial
reporting can provide only reasonable assurance and may not prevent or detect
misstatements. Further, because of changes in conditions, effectiveness of
internal controls over financial reporting may vary over time. Our system
contains self-monitoring mechanisms, and actions are taken to correct
deficiencies as they are identified.
Our
management conducted an evaluation of the effectiveness of the system of
internal control over financial reporting based on the framework in
Internal Control-Integrated Framework
issued
by the Committee of Sponsoring Organizations of the Treadway Commission. Based
on this evaluation, our management concluded that our system of internal control
over financial reporting was effective as of December 31, 2006. Our management's
assessment of the effectiveness of our internal control over financial reporting
has been audited by Amper, Politziner & Mattia, P.C., an independent
registered public accounting firm, as stated in their report which is included
herein.
Item
9B. Other
Information
None.
57
PART
III
Item
10. Directors,
ExecutiveOfficers and Corporate Governance
Our
directors currently have terms which will end at our next annual meeting of
the
stockholders or until their successors are elected and qualify, subject to
their
prior death, resignation or removal. Officers serve at the discretion of the
Board of Directors. There are no family relationships among any of our directors
and executive officers. Our Board members are encouraged to attend meetings
of
the Board of Directors and the Annual Meeting of Stockholders. The Board of
Directors held eight meetings and three unanimous written consents in lieu
of
meetings in 2006.
The
following sets forth certain biographical information concerning our directors
and our current executive officers.
Name
|
Position
|
Age
|
||
Richard
J. DePiano
|
Non-Executive
Chairman of the Board of Directors
|
65
|
||
Jeffrey
F. O'Donnell
|
Director,
President and Chief Executive Officer
|
47
|
||
Dennis
M. McGrath
|
Chief
Financial Officer and Vice President - Finance and
Administration
|
50
|
||
Michael
R. Stewart
|
Executive
Vice President and Chief Operating Officer
|
49
|
||
Alan
R. Novak
|
Director
|
72
|
||
Warwick
Alex Charlton
|
Director
|
47
|
||
Anthony
J. Dimun
|
Director
|
63
|
||
David
W. Anderson
|
Director
|
54
|
||
Wayne
M. Withrow
|
Director
|
51
|
Directors
and Executive Officers
Richard
J. DePiano
was
appointed to our Board of Directors in May 2000 and was unanimously elected
to
serve as Non-Executive Chairman of the Board on January 31, 2003. Mr. DePiano
has been a director of Escalon Medical Corp., a publicly traded healthcare
business specializing in the development and marketing of ophthalmic devices
and
pharmaceutical and vascular access products, since February 1996, and has served
as its Chairman and Chief Executive Officer since March 1997. Mr. DePiano has
been the Chief Executive Officer of the Sandhurst Company, L.P. and Managing
Director of the Sandhurst Venture Fund since 1986. Mr. DePiano was also the
Chairman of the Board of Directors of SLT prior to our acquisition of
SLT.
Jeffrey
F. O’Donnell
joined
PhotoMedex in 1999 as President and CEO and has served as a member of the Board
of Directors since that date. Prior to PhotoMedex, he joined Radiance Medical
Systems (originally Cardiovascular Dynamics) as Vice President of Sales and
Marketing from 1995 to 1997; from 1997 to 1999 he served as its President and
CEO and subsequently assumed a role as non-executive chairman of the board.
Previously, from 1994 to 1995 Mr. O’Donnell held the position of President and
CEO of Kensey Nash Corporation. Additionally, he has held several senior sales
and marketing management positions at Boston Scientific, Guidant and Johnson
& Johnson Orthopedic. In addition to sitting on the Board of Directors for
PhotoMedex, Mr. O’Donnell is currently an outside Board Member of Endologix,
Inc., Cardiac Sciences and Replication Medical, Inc. and had served until
December 28, 2004 on the Board of Escalon Medical Corp. He had served as an
outside Board member of AzurTec, Inc. but resigned from that board in 2003.
Mr.
O’Donnell graduated from LaSalle University in 1982 with a B.S. in business
administration.
Dennis
M. McGrath
was
appointed Chief Financial Officer and Vice President-Finance and Administration
in January 2000. Mr. McGrath has held several senior level positions including
from February 1999 to January 2000 serving as the Chief Operating Officer of
Internet Practice, the largest division for AnswerThink Consulting Group, Inc.,
a public company specializing in business consulting and technology integration.
Concurrently, from August 1999 until January 2000, Mr. McGrath assumed the
role
of Chief Financial Officer of Think New Ideas, Inc., a public company
specializing in interactive marketing services and business solutions. In
addition to the financial reporting responsibilities, Mr. McGrath was
responsible for the merger integration of Think New Ideas, Inc. and AnswerThink
Consulting Group, Inc. From September 1996 to February 1999, Mr. McGrath was
the
Chief Financial Officer and Executive Vice-President-Operations of TriSpan,
Inc., an internet commerce solutions and technology consulting company, which
was acquired by AnswerThink in 1999. Mr. McGrath is currently an outside Board
member of RICOMM Systems, Inc. and Noninvasive Medical Technologies, Inc. Mr.
McGrath is a certified public accountant and graduated with a B.S. in accounting
from LaSalle University in 1979. Mr. McGrath holds a license from the states
of
Pennsylvania and New Jersey as a certified public accountant.
58
Michael
R. Stewart
was
appointed as our Executive Vice President of Corporate Operations on December
27, 2002, immediately following the acquisition of SLT and on July 19, 2005,
he
was appointed our Chief Operating Officer. From July 1999 to the acquisition,
Mr. Stewart was the President and Chief Executive Officer of SLT, and from
October 1990 to July 1999 he served as SLT’s Vice President Finance and Chief
Financial Officer. Mr. Stewart graduated from LaSalle University with a B.S.
in
accounting and received an M.B.A. from LaSalle University in 1986. Mr. Stewart
passed the CPA examination in New York in 1986.
Alan
R. Novak was
appointed to our Board of Directors in October 1997. Mr. Novak is Chairman
of
Infra Group, L.L.C., an international project finance and development company.
He is also Chairman of Lano International, Inc., a real estate development
company. Mr. Novak is a graduate of Yale University, Yale Law School, and
Oxford University as a Marshall Scholar. Mr. Novak practiced law at Cravath,
Swaine & Moore and Swidler & Berlin, Chartered. His public service
includes three years as an officer in the United States Marine Corps, a U.S.
Supreme Court clerkship with Justice Potter Stewart, Senior Counsel to Senator
Edward M. Kennedy, Senior Executive Assistant to Undersecretary of State, Eugene
Rostow, and the Executive Director of President Johnson’s Telecommunications
Task Force. Mr. Novak was appointed by President Carter and served for five
years as Federal Fine Arts Commissioner.
Warwick
Alex Charlton
was
appointed to our Board of Directors and served as the Non-Executive Chairman
of
the Board of Directors from March 8, 1999 to January 31, 2003.
Mr. Charlton is the Managing Director of True North Partners L.L.C., a
venture capital firm with a specialty in the healthcare field. Mr. Charlton
has 20 years of business experience, of which ten years were line management
experience and nine years were in the consulting profession (previously with
Booz Allen & Hamilton and the Wilkerson Group). Mr. Charlton
received an honors degree in Marketing from the University of Newcastle and
an
M.B.A. from Cranfield Institute of Technology. Mr. Charlton was formerly a
Vice President of CSC Healthcare, Inc. and serves as a member of the Board
of
Directors of Intercure, Inc. and as an advisor to the Board of Directors of
Balance Pharmaceuticals, Inc.
Anthony
J. Dimun
was
appointed to our Board of Directors on October 3, 2003. He has served since
May
2001 as Chairman of Nascent Enterprises, L.L.C., a medical device venture
advisory firm. He also has served since 1987 as the Managing Director and Chief
Executive Officer of Strategic Concepts, Inc., a financial advisory company
with
specific focus on venture capital and acquisition transactions. From March
1991
to May 2001, Mr. Dimun served as Executive Vice President and Chief Financial
Officer of Vital Signs, Inc., a publicly held anesthesia and respiratory medical
device company. Mr. Dimun also serves as a member of the Board of Trustees
of
the New Jersey Center for Biomaterials, a non-profit collaboration of the three
leading New Jersey universities. Prior to 1991, Mr. Dimun held positions as
a
Certified Public Accountant with several national accounting firms and served
as
Senior Vice President for an international merchant-banking firm.
David
W. Anderson
was
appointed to our Board of Directors on September 28, 2004. Mr. Anderson has
been
the President and Chief Executive Officer of Gentis, Inc since November 2004.
He
has over twenty years of entrepreneurial management experience in the medical
device, orthopedics and pharmaceutical field. He has served as President and
CEO
of Sterilox Technologies, Inc., the world’s leader in the development and
marketing of non-toxic biocides; Bionx Implants, Inc., a publicly traded
orthopedic sports medicine and trauma company, and Kensey Nash Corporation,
a
publicly traded cardiology and biomaterials company. In addition, Mr. Anderson
was previously Vice President of LFC Financial Corp., a venture capital and
leasing company, where he was responsible for LFC’s entry into the healthcare
market; and was a founder and Executive Vice President of Osteotech, Inc.,
a
high-technology orthopedic start-up.
Wayne
M. Withrow
was
appointed to our Board of Directors on August 16, 2006. Mr. Withrow is currently
Executive Vice President for SEI Investments Company, a leading global provider
of outsourced asset management, investment processing and investment operation
solutions. He is also the head of SEI’s Investment Advisors Segment, and a
member of its Executive Committee. Mr. Withrow’s broad background was gained
from over 15 years in various senior management positions with SEI Investments.
Formerly, he was with the law firm of Schnader, Harrison, Segal & Lewis,
where he was significantly involved in corporate securities and acquisitions.
His earlier experience also included a federal judicial clerkship with the
Honorable William J. Ditter as well as public accounting experience with
Deloitte & Touche.
59
Director
Compensation
Directors
who are also our employees receive no separate compensation for serving as
directors or as members of Board committees. Directors who are not our employees
are compensated under the 2000 Non-Employee Director Plan. Each director
receives non-qualified options to purchase up to 35,000 shares of common stock
on an annual basis. Each outside director receives an annual cash retainer
of
$20,000 and is also paid $1,000 for personal attendance at each meeting of
the
Board and each committee meeting held not in conjunction with meetings of the
Board itself, and $500 for telephonic attendance at each Board or committee
meeting, excluding meetings of limited scope and duration. We pro-rate the
retainer for a director serving less than a full year. The table below sets
forth non-employee directors’ compensation in 2006.
DIRECTOR
COMPENSATION TABLE
Name
|
Fees
Earned or
Paid
in Cash
($)
|
Option
Awards
($)
(1)
|
|
Total
($)
|
||||||
Richard
J. DePiano
|
29,000
|
43,190(2
|
)
|
72,190
|
||||||
Alan
R. Novak
|
26,500
|
43,190(2
|
)
|
69,690
|
||||||
Warwick
Alex Charlton
|
27,500
|
43,190(2
|
)
|
70,690
|
||||||
Anthony
J. Dimun
|
30,000
|
43,190(2
|
)
|
73,190
|
||||||
David
W. Anderson
|
29,000
|
43,190(2
|
)
|
72,190
|
||||||
Wayne
M. Withrow
|
7,500
|
17,045(3
|
)
|
24,545
|
(1)
The
amounts shown for option awards relate to shares granted under our 2000
Non-Employee Director Plan. These amounts are equal to the dollar amounts
recognized in 2006 with respect to the option awards for financial statement
purposes, computed in accordance with SFAS 123(R), but without giving effect
to
estimated forfeitures. The assumptions used in determining the amounts in this
column are set forth in note 1 to our consolidated financial
statements.
(2)
The
grant date fair value computed in accordance with SFAS 123(R) was
$1.23.
(3)
The
grant date fair value computed in accordance with SFAS 123(R) was
$0.97.
Compensation,
Nominations and Corporate Governance and Audit Committees
General.
The
Board maintains charters for select committees. In addition, the Board has
adopted a written set of corporate governance guidelines and a code of business
conduct and ethics and a code of conduct for our chief executive and senior
financial officers that generally formalize practices that we already had in
place. We have adopted a Code of Ethics on Interactions with Health Care
Professionals and have adopted a related Comprehensive Compliance Program.
To
view the charters of the Audit, Compensation and Nominations and Corporate
Governance Committees, the Code of Ethics and Comprehensive Compliance Program,
the corporate governance guidelines and the codes of conduct and our whistle
blower policy, please visit our website at www.photomedex.com
(this
website address is not intended to function as a hyperlink, and the information
contained on our website is not intended to be a part of this Report). The
Board
determined in 2006 that all members of the Board are independent under the
revised listing standards of The Nasdaq Stock Market, Inc. (“Nasdaq”), except
for Mr. O'Donnell, who is also our Chief Executive Officer.
60
Compensation
Committee.
Our
Compensation Committee discharges the Board’s responsibilities relating to
compensation of our Chief Executive Officer, other executive officers and
directors, produces an annual report on executive compensation for inclusion
in
our annual proxy statement and in this Report, and provides general oversight
of
compensation structure. Other specific duties and responsibilities of the
Compensation Committee include:
· |
reviewing
and approving objectives relevant to executive officer
compensation;
|
·
|
evaluating
performance and determining the compensation of our Chief Executive
Officer and other executive officers in accordance with those
objectives;
|
·
|
reviewing
employment agreements for executive
officers;
|
·
|
recommending
to the Board the compensation for our
directors;
|
·
|
administering
our stock option plans (except the 2000 Non-Employee Director Stock
Option
Plan); and
|
·
|
evaluating
human resources and compensation
strategies.
|
Our
Board
of Directors has adopted a written charter for the Compensation Committee.
The
Compensation Committee is composed of Messrs. Novak, Charlton, DePiano, Dimun
and Withrow. Mr. Dimun serves as the Chairman of the Compensation Committee;
Mr.
Withrow joined the Committee in August 2006. The Board determined in 2006 that
each member of the Compensation Committee satisfies the independence
requirements of the Commission and Nasdaq. The Compensation Committee held
three
meetings during 2006.
The
Compensation Committee reviews executive compensation from time to time and
reports to the Board of Directors, which makes all decisions. The Compensation
Committee adheres to several guidelines in carrying out its responsibilities,
including performance by the employees, our performance, enhancement of
stockholder value, growth of new businesses and new markets and competitive
levels of fixed and variable compensation. The Compensation Committee reviews
and approves the annual salary and bonus for each executive officer (consistent
with the terms of any applicable employment agreement), provides oversight
for
employee benefit plans (and changes thereto) and administers our stock option
plans and such other employee benefit plans as may be adopted by us from time
to
time. The report of the Compensation Committee for 2006 is presented
below.
Nominations
and Corporate Governance Committee.
Our
Board has established a Nominations and Corporate Governance Committee for
the
purpose of reviewing all Board-recommended and stockholder-recommended nominees,
determining each nominee’s qualifications and making a recommendation to the
full Board as to which persons should be our Board’s nominees. Our Board has
adopted a written charter for the Nominations and Corporate Governance
Committee. The Nominations and Corporate Governance Committee is composed of
Messrs. Novak, DePiano and Anderson. Mr. Anderson serves as the Chairman of
the
Nominations and Corporate Governance Committee. The Board of Directors
determined in 2006 that each member of the Nominations and Corporate Governance
Committee satisfies the independence requirements of the Commission and Nasdaq.
The Nominations and Corporate Governance Committee held two meetings during
2006.
The
duties and responsibilities of the Nominations and Corporate Governance
Committee include:
·
|
identifying
and recommending to our Board individuals qualified to become members
of
our Board and to fill vacant Board
positions;
|
·
|
overseeing
the compensation of non-employee directors, including administering
the
2000 Non-Employee Director Stock Option
Plan;
|
·
|
recommending
to our Board the director nominees for the next annual meeting of
stockholders;
|
·
|
recommending
to our Board director committee
assignments;
|
·
|
reviewing
and evaluating succession planning for our Chief Executive Officer
and
other executive officers;
|
·
|
monitoring
the independence of our board
members;
|
61
·
|
developing
and overseeing the corporate governance principles applicable to
our Board
members, officers and employees;
|
·
|
monitoring
the continuing education program for our directors;
and
|
·
|
evaluating
annually the Nominations and Corporate Governance Committee
charter.
|
Our
Board
of Directors believes that it is necessary that the majority of our Board of
Directors be comprised of independent directors and that it is desirable to
have
at least one audit committee financial expert serving on the Audit Committee.
The Nominations and Corporate Governance Committee considers these requirements
when recommending Board nominees. Our Nominations and Corporate Governance
Committee utilizes a variety of methods for identifying and evaluating nominees
for director. Our Nominations and Corporate Governance Committee will regularly
assess the appropriate size of the Board, and whether any vacancies on the
Board
are expected due to retirement or other circumstances. When considering
potential director candidates, the Nominations and Corporate Governance
Committee also considers the candidate’s character, judgment, diversity, age,
skills, including financial literacy, and experience in the context of our
needs, the needs of PhotoMedex and of the existing directors. The Committee
recommended to the Board that Mr. Wayne M. Withrow be invited to join the Board.
The Board accepted the recommendation, and Mr. Withrow accepted the invitation
in August 2006.
Audit
Committee.
Our
Board of Directors has established an Audit Committee to assist the Board in
fulfilling its responsibilities for general oversight of the integrity of our
consolidated financial statements, compliance with legal and regulatory
requirements, the independent auditors’ qualifications and independence, the
performance of our independent auditors and our internal audit function, and
risk assessment and risk management. The duties of the Audit Committee
include:
·
|
appointing,
evaluating and determining the compensation of our independent
auditors;
|
·
|
reviewing
and approving the scope of the annual audit, the audit fee and the
financial statements;
|
·
|
reviewing
disclosure controls and procedures, internal control over financial
reporting, any internal audit function and corporate policies with
respect
to financial information;
|
·
|
reviewing
other risks that may have a significant impact on our financial
statements;
|
·
|
preparing
the Audit Committee report for inclusion in the annual proxy
statement;
|
·
|
establishing
procedures for the receipt, retention and treatment of complaints
regarding accounting and auditing matters;
and
|
·
|
evaluating
annually the Audit Committee
charter.
|
The
Audit
Committee works closely with management as well as our independent auditors.
The
Audit Committee has the authority to obtain advice and assistance from, and
receive appropriate funding from us for, outside legal, accounting or other
advisors as the Audit Committee deems necessary to carry out its
duties.
Our
Board
of Directors has adopted a written charter for the Audit Committee meeting
applicable standards of the Commission and Nasdaq. The members of the Audit
Committee in 2006 were Messrs. DePiano, Dimun and Anderson; Mr. Withrow joined
the Committee in January 2007. Mr. DePiano serves as Chairman of the Audit
Committee. The Audit Committee meets regularly and held eight meetings during
2006.
The
Board
of Directors determined in 2006 that each member of the Audit Committee
satisfies the independence and other composition requirements of the Commission
and Nasdaq. Our Board has determined that each member of the Audit Committee
qualifies as an “audit committee financial expert” under Item 401(h) of
Regulation S-K under the Exchange Act, and has the requisite accounting or
related financial expertise required by applicable Nasdaq rules.
62
Compensation
Committee Interlocks and Insider Participation
No
interlocking relationship exists between any member of our Board or Compensation
Committee and any member of the board of directors or compensation committee
of
any other companies, nor has such interlocking relationship existed in the
past.
Stockholder
Communications with the Board of Directors
Our
Board
of Directors has established a process for stockholders to communicate with
the
Board of Directors or with individual directors. Stockholders who wish to
communicate with our Board of Directors or with individual directors should
direct written correspondence to Davis Woodward, Corporate Counsel at
dwoodward@photomedex.com or to the following address (our principal executive
offices): Board of Directors, c/o Corporate Secretary, 147 Keystone Drive,
Montgomeryville, Pennsylvania 18936. Any such communication must
contain:
·
|
a
representation that the stockholder is a holder of record of our
capital
stock;
|
·
|
the
name and address, as they appear on our books, of the stockholder
sending
such communication; and
|
·
|
the
class and number of shares of our capital stock that are beneficially
owned by such stockholder.
|
Mr.
Woodward or the Corporate Secretary, as the case may be, will forward such
communications to our Board of Directors or the specified individual director
to
whom the communication is directed unless such communication is unduly hostile,
threatening, illegal or similarly inappropriate, in which case Mr. Woodward
or
the Corporate Secretary, as the case may be, has the authority to discard the
communication or to take appropriate legal action regarding such
communication.
Compliance
with Section 16 of the Securities Exchange Act of 1934
Section
16(a) of the Securities Exchange Act of 1934, as amended, (the "Exchange Act")
requires our directors and executive officers and beneficial holders of more
than 10% of our common stock to file with the Commission initial reports of
ownership and reports of changes in ownership of our equity securities. As
of
March 15, 2007, we believe, based solely on a review of the copies of such
reports furnished to us and representations of these persons that no other
reports were filed, that all reports needed to be filed have been filed for
the
year ended December 31, 2006.
Item
11. Executive
Compensation
COMPENSATION
DISCUSSION AND ANALYSIS
Introduction
The
Compensation Committee is responsible for reviewing and approving the annual
compensation of our executive officers, of whom we presently have three, the
fourth having departed from our employ on June 30, 2006. These four current
and
former executive officers are our named executive officers. The Nominations
and
Corporate Governance Committee is responsible for reviewing and approving the
compensation of our non-employee directors.
The
Compensation Committee of the Board of Directors is composed solely of directors
who are not our current or former employees, and each is independent under
the
revised listing standards of The Nasdaq Stock Market, Inc. The Board of
Directors has delegated to the Compensation Committee the responsibility to
review and approve our compensation and benefits plans, programs and policies,
including the compensation of the chief executive officer and our other
executive officers as well as middle-level management and other key employees.
The Compensation Committee administers all of our executive compensation
programs, incentive compensation plans and equity-based plans and provides
oversight for all of our other compensation and benefit programs.
63
The
key
components of the compensation program for executive officers are base salary
and bonus, and long-term incentives in the form of stock options and now, under
the 2005 Equity Compensation Plan, in the form of restricted shares of our
common stock. These components are administered with the goal of providing
total
compensation that is competitive in the marketplace, recognizes meaningful
differences in individual performance and offers the opportunity to earn
superior rewards when merited by individual and corporate
performance.
Objectives
of Compensation Program
The
Compensation Committee intends to govern and administer compensation plans
to
support the achievement of our long-term strategic objectives, to enhance
stockholder value, to attract, motivate and retain highly qualified employees
by
paying them competitively and rewarding them for their own and our success.
We
have
no retirement plans or deferred compensation programs in effect for our
non-employee directors and our executive officers, except for our 401(k) plan
in
which the executive officers are eligible to participate. Compensation is
generally paid as earned. We do not have an exact formula for allocating between
cash and non-cash compensation, which has been in the form of stock options
and
awards of stock. We do not have a Non-Equity Incentive Plan, as that term is
used in SFAS No. 123R, “Share-Based Payment.”
In
order
to assess whether the compensation program we had been providing to our
executive officers was competitive and effective, the Compensation Committee
engaged in 2005 a third-party consulting firm specializing in executive
compensation. The consulting firm advised that our program was within the range
of compensation programs that appeared to be offered by a group of our peer
companies. The consulting firm also counseled the Compensation Committee on
modifications to the compensation program which were under consideration. The
primary consideration was the use of performance-based restricted stock. As
an
ongoing matter, the Committee does not engage a third-party consultant to advise
on our compensation policies. Nor does the Committee delegate its
responsibilities for reviewing and approving executive compensation, except
in
the case of the 2005 Investment Plan, where the Plan has pre-approved the grant
of matching options to an executive who purchases shares of our common stock
in
the open market in accordance with the provisions of the Plan.
To
the
extent consistent with the foregoing objectives, the Compensation Committee
also
intends to maximize the deductibility of compensation for tax purposes. The
Committee may, however, decide to exceed the tax deductible limits established
under Section 162(m) of the Internal Revenue Code of 1986, as amended (the
"Code") when such a decision appears to be warranted based upon competitive
and
other factors.
What
Our Compensation Program is Designed to Reward
The
key
components of the compensation program for executive officers are base salary
and bonus, and long-term incentives in the form of stock options and now, under
the 2005 Equity Compensation Plan, in the form of restricted shares of our
common stock. These components are administered with the goal of providing
total
compensation that is competitive in the marketplace, recognizes meaningful
differences in individual performance and offers the opportunity to earn
superior rewards when merited by individual and corporate
performance.
Stock
price performance has not been a factor in determining annual compensation
insofar as the price of the Company’s common stock is subject to a number of
factors outside our control. We have endeavored through the grants of stock
options to the executive officers to incentivize individual and team
performance, providing a meaningful stake in the Company and linking them to
a
stake in the Company’s overall success. Through the awards of restricted stock,
we have striven to forge a closer link by tying the vesting of the restricted
stock to certain milestone prices of our common stock.
There
are
three primary elements in the compensation package of our executive officers:
base salary, bonus and long-term incentives. Compensation payable in the event
of an executive’s termination from the Company is a secondary, material element
in the package.
64
Base
Salaries. Base
salaries for our executive officers are designed to provide a base pay
opportunity that is appropriately competitive within the marketplace. As an
officer's level of responsibility increases, a greater proportion of his or
her
total compensation will be dependent upon our financial performance and stock
price appreciation rather than base salary. Adjustments to each individual’s
base salary are made in connection with annual performance reviews in addition
to the assessment of market competitiveness.
Bonus.
At
the
outset of a fiscal year, the Compensation Committee establishes a bonus program
for executive officers and other managers and key employees eligible to
participate in the program. The program is based on a financial plan for the
fiscal year and other business factors. The amount of bonus, if any, hinges
on
corporate performance and financial condition and on the performance of the
participant in the program. A program will typically allow some partial or
discretionary awards based on an evaluation of the relevant factors. Provision
for bonus expense is typically made over the course of a fiscal year. The
provision becomes fixed, based on the final review of the Committee, which
is
usually made after the financial results of the fiscal year have been reviewed
by our independent accountants. For 2006, there were three factors of generally
equal weight: Company revenues, the Company’s net loss or profit and a
discretionary component.
Long-Term
Incentives. Grants
of
stock options under our stock option plans are designed to provide executive
officers and other managers and key employees with an opportunity to share,
along with stockholders, in our long-term performance. Stock option grants
are
generally made annually to all executive officers, with additional grants being
made following a significant change in job responsibility, scope or title or
a
significant achievement. The size of the option grant to each executive officer
is set by the Compensation Committee at a level that is intended to create
a
meaningful opportunity for stock ownership based upon the individual's current
position with us, the individual's personal performance in recent periods and
his or her potential for future responsibility and promotion over the option
term. The Compensation Committee also takes into account the number of unvested
options held by the executive officer in order to maintain an appropriate level
of equity incentive for that individual. The relevant weight given to each
of
these factors varies from individual to individual.
Prior
to
2006, stock options granted under the various stock option plans generally
have
had a four-year vesting schedule depending upon the size of the grant, and
generally have been set to expire five years from the date of grant. In 2006,
the Committee determined that such grants would be for ten years and vest over
five years. The exercise price of options granted under the stock option plans
is at no less than 100% of the fair market value of the underlying stock on
the
date of grant. The number of stock options granted to each executive officer
is
determined by the Compensation Committee based upon several factors, including
the executive officer’s salary grade, performance and the estimated value of the
stock at the time of grant, but the Compensation Committee has the flexibility
to make adjustments to those factors at its discretion. The options granted
to
executives as a rule have provisions by which vesting and exercisability are
accelerated in the event of a change of control or a termination of employment
initiated by the Company other than for cause.
Similar
criteria are applied in making awards of restricted shares of our common stock
under the 2005 Equity Compensation Plan, but in the case of restricted stock,
we
have made direct linkage between the price performance of our stock with the
vesting schedule of the restricted stock.
To
encourage our executive officers to have a greater stake in the equity of the
Company, the Committee recommended, and the Board of Directors and the Company
stockholders approved at the 2005 Annual Stockholders’ Meeting, the 2005
Investment Plan.
Compensation
on Termination of Employment or Change of Control. We
have
employment agreements with Messrs. O'Donnell, McGrath and Stewart. These
agreements provide for severance upon termination of employment, whether in
context of a change of control or not. We also had an employment agreement
with
Mr. Clifford, but we mutually agreed to a separation agreement that superseded
his employment agreement, effective June 30, 2006.
In
the
event of a involuntary termination not in connection with a change in control
of
the Company, an executive will be vested in those options that were unvested
as
of the termination but that would have vested in the 12 months following
termination. In the event of a change of control, all of an executive’s unvested
options will vest. As to unvested shares of restricted stock, they will vest
upon a change of control to the extent that the acquisition price exceeds a
milestone price or if the acquirer elects not to continue to employ the services
of the executive.
65
We
also
have arrangements with other key employees under which we would be obliged
to
pay compensation upon their termination outside a context of change of control,
and, for a lesser number of key employees, by virtue of a change of control.
If
all such executive officers and key employees were terminated other than for
cause and not within a change of control, we would have had an aggregate
commitment of approximately $1,677,000 at December 31, 2006 for severance and
related compensation. However, the obligation for such compensation that would
arise in favor of the executive officers and certain key employees by virtue
of
a change of control would have been approximately $2,146,000 at December 31,
2006.
How
Amounts Were Selected for Each Element of an Executive’s Compensation
Each
executive’s current and prior compensation is considered in setting future
compensation. In addition, we review from time to time the compensation
practices of other companies, particularly peer companies. To some extent,
our
compensation plan is based on the market and the companies we compete against
for executives. Base salary and the long-term incentives are not set with
reference to a formula.
An
executive’s
target
bonus amount is set by an executive’s
employment agreement, which was negotiated at arm’s
length.
A target bonus, or portion thereof, is earned, based on fulfillment of
conditions, which are set by the Committee at the outset of a fiscal
year.
As
a
general rule, options and/or restricted stock awards are made in the first
or
second quarter of a year and after the financial results for the prior year
have
been audited and reported to the Board of Directors. Grants and/or awards are
valued, and exercise prices are set, as of the date the grant or award is made.
Exceptions to the general rule may arise for grants made to recognize a
promotion or to address the effect of expiring options. The Committee may elect
to defer a grant until after the Company has made public disclosure of its
financial results, typically in a conference call on earnings; in such a case,
the exercise price is set at the higher of the closing prices on the approval
date or the fixed grant date. In these deliberations, the Compensation Committee
does not delegate any related function, unless to the Board of Directors as
a
whole, and the grants or awards made to executives are valued under the same
measurement standards as for grants made to other grantees.
Accounting
and Tax Considerations
On
January 1, 2006, we adopted SFAS No. 123R. Under this accounting standard,
we
are required to value stock options granted, and restricted stock awarded,
in
2006 and beyond under the fair value method and expense those amounts in the
income statement over the vesting period of the stock option or restricted
stock. We were also required to value unvested stock options granted prior
to
our adoption of SFAS 123R under the fair value method and amortize such expense
in the income statement over the stock option’s remaining vesting period. A
material portion of such amortizing expense relates to option grants made to
our
executive officers, and future option grants and stock awards made in 2006
and
beyond to our executive officers will also have a material impact on such
expense.
Our
compensation program has been structured to comply with Internal Revenue Code
Sections 409A and 162(m). If an executive is entitled to nonqualified deferred
compensation benefits that are subject to Section 409A, and such benefits do
not
comply with Section 409A, then the benefits are taxable in the first year they
are not subject to a substantial risk of forfeiture. In such case, the executive
service-provider is subject to regular federal income tax, interest and an
additional federal income tax of 20% of the benefit includible in income.
Under
Section 162(m) of the Internal Revenue Code, a limitation was placed on tax
deductions of any publicly-held corporation for individual compensation to
certain executives of such corporation exceeding $1,000,000 in any taxable
year,
unless the compensation is performance-based. The Compensation Committee has
been advised that based upon prior stockholder approval of the material terms
of
our stock option plans, compensation under these plans is excluded from this
limitation, provided that the other requirements of Section 162(m) are met.
However, when warranted based upon competitive and other factors, the
Compensation Committee may decide to exceed the tax deductible limits
established under Section 162(m) Code. The base salary provided to each
executive in 2004, 2005 and 2006 did not exceed the limits under Section 162(m)
for tax deductibility; no executive exercised any options in 2004, 2005 or
2006.
66
Employment
Agreement with Jeffrey F. O'Donnell.
In
November 1999, we entered into an employment agreement with Jeffrey F. O'Donnell
to serve as our President and Chief Executive Officer and amended and restated
that agreement in August 2002. This agreement has been renewed through December
31, 2007 and will expire then if due notice is given by December 1, 2007. If
due
notice is not given, then the agreement will renew for an additional year and
thereafter on an annual basis. Mr.
O'Donnell's current base salary is $350,000 per year. If we terminate Mr.
O'Donnell other than for "cause" (which definition includes nonperformance
of
duties or competition of the employee with our business), then he will receive
severance pay equal to $350,000, payable over 12 months. If a change of control
occurs, Mr. O’Donnell becomes entitled to severance pay by virtue of provisions
related to the change of control, then he may become entitled to severance
equal
to 200% of his then base salary in a lump sum.
On
January 15, 2006, Mr. O’Donnell was granted 200,000 incentive stock options
(having an exercise price of $2.50 and a life of 10 years, vesting ratably
over
the first 5 years from the 2005 Equity Compensation Plan. In the event of a
sale
of the Company, the options will become fully vested and exercisable). He was
also awarded from the 2005 Equity Compensation Plan and as of the same date
525,000 restricted shares of our common stock, setting their purchase price
at
$0.01 per share. Shares that are purchased will be held in escrow by us for
as
long as they are subject to our right of repurchase. Our right of repurchase
will continue for such shares for so long as the shares remain subject to
performance restrictions and time restrictions.
As
to the
performance restrictions, our repurchase right will lapse if the trading price
of our common stock attains certain targets above the 2005 Average Price, which
by contract was set at $2.50, being higher than the average fair market value
(generally the closing price of our common stock) for each of the trading days
in the 90-day period ending on December 28, 2005. For the years 2006 through
2010, the Average Price will mean the average fair market value of our common
stock for each of the trading days in the last three months of the calendar
year. Our right of repurchase shall lapse with respect to 20% of the purchased
shares if the 2006 Average Price equals or exceeds the 2006 Target Price, where
the term “2006 Target Price” will equal 125% of the 2005 Average Price, or
$3.13, and where the lapsing shall be effective as of December 31, 2006. The
restrictions did not lapse in 2006 inasmuch as the 2006 Target Price was not
attained.
Likewise,
our right of repurchase will lapse with respect to 20% of the purchased shares
if the 2007 Average Price equals or exceeds the 2007 Target Price, where the
term “2007 Target Price” will equal 125% of the 2006 Target Price, or $3.91, and
so on. For 2010, if the 2010 Average Price equals or exceeds the 2010 Target
Price of $7.64, then our right of repurchase will lapse with respect to all
of
the purchased shares for which our repurchase right has not previously lapsed,
and such lapsing will be effective as of December 31, 2010. As to time
restrictions, to the extent that any of the purchased shares remain subject
to
our right of repurchase and therefore are unvested, they will vest ratably
(i.e.
one-third) on the fifth, sixth and seventh anniversaries of the award of the
restricted shares.
However,
in the event of a transaction that constitutes a change in control of the
Company, our right of repurchase will lapse with respect to the performance
restrictions on the restricted shares that are unvested immediately prior to
the
consummation of such transaction as follows. Where the per-share purchase price
paid or deemed paid in connection with such change in control is equal to or
greater than a Target Price described above, then it shall be deemed that the
Target Price has been attained as of the change in control, and our repurchase
rights applicable to such Target Price will lapse. Shares that have not vested
on a change of control will remain subject to such repurchase restriction.
Such
shares still subject to repurchase shall vest ratably and monthly over the
period of time (but not greater than 36 months) that the acquirer in the change
in control event contracts for Mr. O’Donnell’s services. If the acquirer opts
not to contract for such services, then the unvested balance of shares will
vest
as of the change in control event.
On
May
25, 2006, Mr. O’Donnell was granted 2,000 stock options under the 2005
Investment Plan. The exercise price of the options was set at the price paid
by
Mr. O’Donnell for 2,000 shares of our common stock purchased by Mr. O’Donnell in
the open market.
67
On
November 20, 2006, Mr. O’Donnell was granted stock options on 125,000 shares of
our common stock out of the 2005 Equity Compensation Plan and the exercise
price
was set at the closing price of our stock on the date of grant. This grant
offset the expiry in December 2006 of 125,000 options which had been made to
Mr.
O’Donnell in December 2001 from the now-frozen 2000 Stock Option Plan.
On
March
6, 2007, Mr. O’Donnell was granted 2,000 stock options under the 2005 Investment
Plan to match his purchase on the same date of an equal number of shares
of our
common stock on the open market.
Employment
Agreement with Dennis M. McGrath..
In
November 1999, we entered into an employment agreement with Dennis M. McGrath
to
serve as our Chief Financial Officer and Vice President-Finance and
Administration and amended and restated that agreement in August 2002. This
agreement has been renewed through December 31, 2007 and will expire then if
due
notice is given by December 1, 2007. If due notice is not given, then the
agreement will renew for an additional year and thereafter on an annual basis.
Mr. McGrath's current base salary is $285,000 per year. If
we
terminate Mr. McGrath other than for "cause" (which definition includes
nonperformance of duties or competition of the employee with our business),
then
he will receive severance pay equal to $285,000, payable over 12 months. If
a
change of control occurs, Mr. McGrath becomes entitled to severance pay by
virtue of provisions related to the change of control, then he may become
entitled to severance equal to 200% of his then base salary in a lump sum.
On
January 15, 2006, Mr. McGrath was awarded from the 2005 Equity Compensation
Plan
335,000 restricted shares of our common stock, having a purchase price at $0.01
per share. The terms and conditions applicable to Mr. McGrath’s award of
restricted stock are the same as the terms and conditions applicable to the
award to Mr. O’Donnell, which are discussed above.
On
March
10, 2006, Mr. McGrath was granted 140,000 stock options from the 2005 Equity
Compensation Plan after the audited financial results of the Company had been
reported to the Board of Directors and disclosed in our conference call on
earnings.
On
May
24, 2006 and May 25, 2006, Mr. McGrath was granted 5,000 and 2,000 non-qualified
stock options, respectively, under the 2005 Investment Plan. In accordance
with
the terms of the Investment Plan, the exercise price of each option was set
at
the price paid by Mr. McGrath for each of his discrete purchases of shares
of
our common stock in the open market.
On
November 20, 2006, Mr. McGrath was granted stock options on 110,000 shares
of
our common stock out of the 2005 Equity Compensation Plan; the exercise price
was set at the closing price of our stock on the date of grant. This grant
offset the expiry in December 2006 of 110,000 options which had been granted
to
Mr. McGrath in December 2001 from the now-frozen 2000 Stock Option Plan.
Employment
Agreement with Michael R. Stewart. Effective
December 27, 2002, Michael R. Stewart became the Company’s Executive Vice
President of Corporate Operations, pursuant to an employment agreement. Mr.
Stewart became our Chief Operating Officer on July 19, 2005, at which time
he
was granted 40,000 options. Mr. Stewart’s current base salary is $250,000 per
year. This agreement has renewed through December 31, 2007 and
will
expire then if due notice is given by December 1, 2007. If due notice is not
given, then the agreement will renew for an additional year and thereafter
on an
annual basis. If we terminate Mr. Stewart other than for “cause” (which
definition includes nonperformance of duties or competition of the employee
with
our business), then he will receive severance pay equal to his base pay, payable
over 12 months. If a change of control occurs, Mr. Stewart becomes entitled
to
severance pay by virtue of provisions related to the change of control, then
he
may become entitled to severance equal to 200% of his then base salary, payable
over 12 months.
On
March
10, 2006, Mr. Stewart was granted 100,000 stock options from the 2005 Equity
Compensation Plan, after the audited financial results of the Company had been
reported to the Board of Directors and disclosed in our conference of earnings.
68
SUMMARY
COMPENSATION TABLE
The
following table includes information for the year ended December 31, 2006
concerning compensation for our three incumbent executive officers and our
one
executive
officer who separated from us on June 30, 2006. All of our other officers are
not executive officers, within the meaning ascribed by the Securities and
Exchange Act of 1934.
Name
and Principal Position
|
Year
|
Salary
($)
|
Bonus ($)(1)
|
Option
Awards
($)(3)
|
Equity
Incentive
Plan
Compensation
($)(2)(3)
|
All
Other
Compensation
($)(4)
|
Total
($)
|
|||||||||||||||
Jeffrey
F. O’Donnell, President and Chief Executive Officer
|
2006
|
350,000
|
157,500
|
420,213
|
943,005
|
17,395
|
1,888,113
|
|||||||||||||||
Dennis
M. McGrath, Chief Financial Officer & Vice President -
Finance/Administration
|
2006
|
285,000
|
102,600
|
377,054
|
601,727
|
15,105
|
1,381,486
|
|||||||||||||||
Michael
R. Stewart, Chief Operating Officer and Executive Vice
President
|
2006
|
250,000
|
75,000
|
190,200
|
0
|
18,366
|
533,566
|
|||||||||||||||
John
F. Clifford, former Executive Vice President, Dermatology
|
2006
|
150,000
|
0
|
0
|
0
|
156,000
|
306,000
|
(1)
“Bonus”
in
the foregoing table is the bonus earned in 2006, even though it will have been
paid in a subsequent period.
(2)
The
Company does not have a Non-Equity Incentive Plan. The Equity Incentive Plan
is
comprised of our awards of restricted common stock.
(3)
The
amounts shown for option awards and restricted stock awards relate to
shares granted under our 2005 Equity Compensation Plan and 2005 Investment
Plan.
These amounts are equal to the aggregate grant-date fair value with respect
to
the awards made in 2006, computed in accordance with SFAS 123(R), before
amortization and without giving effect to estimated forfeitures. The assumptions
used in determining the amounts in this column are set forth in Note 1 to our
consolidated financial statements. For information regarding the number of
shares subject to 2006 awards, other features of those awards, and the
grant-date fair value of the awards, see the Grants of Plan-Based Awards Table
on p. 71.
(4)
“All
Other Compensation” includes car allowance ($12,000), premiums for supplementary
life insurance and matching 401(k) plan contributions for Messrs. O’Donnell,
McGrath and Stewart. In Mr. Clifford’s case, it includes severance payment and
allied benefits of $150,000 and car allowance of $6,000.
Non-Qualified
Deferred Compensation
The
Company has no plan or program of non-qualified deferred compensation.
Potential
Payments on Termination of Employment or Change of Control
Potential
payments to our three incumbent executives on termination of employment or
upon
a change of control of the Company are governed by their respective employment
agreements and by the terms of their option agreements and restricted stock
agreements. Mr. Clifford is currently receiving payments by virtue of the
Separation Agreement we entered with him on April 30, 2006.
If
any of
the events set forth in the table had occurred by December 31, 2006, then we
estimate the value of the benefits that would have been triggered and thus
accrued to the three incumbent executives as set forth below. Also set forth
below are the benefits that Mr. Clifford will receive after December 31, 2006.
69
POTENTIAL
PAYMENTS UPON TERMINATION OR CHANGE IN CONTROL TABLE
Name
|
Benefit
|
|
Before Change
in
Control Termination
w/o Cause
or for
Good
Reason
|
|
After Change in
Control Termination
w/o Cause
or
for Good
Reason
|
|
Voluntary
Termination
|
|
Death
(4)
|
|
Disability
(4)
|
|
Change in
Control
|
|||||||||
Jeffrey
F. O’Donnell(1)(2)
|
Severance
|
350,000
|
700,000
|
0
|
0
|
0
|
N/A
|
|||||||||||||||
Health
continuation
|
15,378
|
30,756
|
0
|
0
|
0
|
N/A
|
||||||||||||||||
AD&D
insurance
|
780
|
1,560
|
0
|
0
|
0
|
N/A
|
||||||||||||||||
Executive
life ins.
|
5,355
|
10,711
|
0
|
0
|
0
|
N/A
|
||||||||||||||||
Accelerated
vesting
|
0
|
577,500
|
0
|
0
|
0
|
0
|
||||||||||||||||
Dennis
McGrath(1)(2)
|
Severance
|
285,000
|
570,000
|
0
|
0
|
0
|
N/A
|
|||||||||||||||
Health
continuation
|
15,378
|
30,756
|
0
|
0
|
0
|
N/A
|
||||||||||||||||
AD&D
insurance
|
780
|
1,560
|
0
|
0
|
0
|
N/A
|
||||||||||||||||
Executive
life ins.
|
1,680
|
10,152
|
0
|
0
|
0
|
N/A
|
||||||||||||||||
Accelerated
vesting
|
0
|
368,500
|
0
|
0
|
0
|
0
|
||||||||||||||||
|
||||||||||||||||||||||
Michael
Stewart(2)
|
Severance
|
250,000
|
500,000
|
0
|
0
|
0
|
N/A
|
|||||||||||||||
Health
continuation
|
|
15,378
|
30,756
|
0
|
0
|
0
|
N/A
|
|||||||||||||||
AD&D
insurance
|
780
|
1,560
|
0
|
0
|
0
|
N/A
|
||||||||||||||||
Executive
life ins.
|
5,076
|
10,152
|
0
|
0
|
0
|
N/A
|
||||||||||||||||
Accelerated
vesting
|
0
|
0
|
0
|
0
|
0
|
0
|
||||||||||||||||
|
||||||||||||||||||||||
John
Clifford(3)
|
Severance,
consulting
|
N/A
|
N/A
|
202,500
|
N/A
|
N/A
|
N/A
|
|||||||||||||||
Health
continuation
|
N/A
|
N/A
|
9,430
|
N/A
|
N/A
|
N/A
|
||||||||||||||||
AD&D
insurance
|
N/A
|
N/A
|
0
|
N/A
|
N/A
|
N/A
|
||||||||||||||||
Executive
life ins.
|
N/A
|
N/A
|
0
|
N/A
|
N/A
|
N/A
|
(1) |
If
upon a change of control, the acquirer does not desire the services
of the
executive, then any unvested restricted stock will vest. The closing
price
of our stock on December 29, 2006 (the last trading day of the year)
was
$1.11. All shares were unvested at that date and were purchased for
the
par value of the stock, i.e. $0.01, assuming a change of control
as of
December 31, 2006, each share would return a gain of $1.10.
|
(2) |
All
unvested options become exercisable by reason of a change of control.
However, none of the executives’ unvested options as of December 31, 2006
were in the money, and therefore there would have been no benefit
as of
December 31, 2006. Similarly, in the event of an involuntary termination
without cause, the executive optionee becomes vested in those options
that
would otherwise have vested in twelve months following the date of
termination. As in the hypothetical change of control, so in this
case of
hypothetical involuntary termination, there would have been no benefit
to
the optionee inasmuch as no option was in the money at December 31,
2006.
|
(3) |
Mr.
Clifford resigned on June 30, 2006. After December 31, 2006 and until
June
30, 2007, he will receive severance of $150,000, and he will receive
health continuation benefits until September 30, 2007. For the period
July
1, 2007 to June 30, 2008, Mr. Clifford will continue to act as consultant
for us for $52,500. After June 30, 2008, he may discontinue such
services.
|
(4) |
We
pay an executive’s salary and benefits through the end of the month of
termination due to death or disability, except that we will pay the
disability premiums during the period of disability.
|
STOCK
OPTIONS
The
2005
Equity Compensation Plan is currently the primary vehicle by which stock awards
and option grants are made to the executives and other service-providers. The
Plan has been authorized by the stockholders for 3,160,000 shares of our common
stock. Participation in the 2005 Investment Plan is limited to the executives;
this Plan has been authorized by the stockholders for 400,000 shares of our
common stock.
70
Grants
of Plan-Based Awards Table
The
following table sets forth certain information with respect to the options
granted and
stock
awarded during or for the year ended December 31, 2006 to each of our executive
officers listed in the Summary Compensation Table as shown under the caption
“Executive Compensation.” Stock
awards and option grants made in 2006 were primarily from the 2005 Equity
Compensation Plan. Matching options grants were made out of the 2005 Investment
Plan to Messrs. O’Donnell
and McGrath for 2,000 and 7,000 options, respectively. There were no grants
or
awards to Mr. Clifford in 2006.
GRANTS
OF PLAN-BASED AWARDS TABLE
Estimated Future Payouts Under
Equity
Incentive Plan Awards(2)
|
|
All
Other
Option Awards:
Number
of
Securities
Underlying
|
|
Exercise or
Base
Price
of
Option
|
|
Closing
Price on
Grant Date
|
|
Grant
Date
Fair
Value
of Stock
and
Option
|
||||||||||||||||||||
Name
|
Grant
Date
|
Approval
Date
(1)
|
Threshold
(#)
|
Target
(#)
|
Maximum
(#)
|
Options
(#)
|
Awards
($ / Sh)
|
($ / Sh)(3)
|
Awards
($)(4)
|
|||||||||||||||||||
Jeffrey
O’Donnell
|
1/15/06
|
12/28/05
|
-
|
525,000
|
-
|
200,000
|
2.50
|
1.83
|
1,245,805
|
|||||||||||||||||||
5/24/06
|
5/24/06
|
2,000
|
1.59
|
N/A
|
2,788
|
|||||||||||||||||||||||
11/20/06
|
11/20/06
|
125,000
|
1.11
|
1.11
|
114,625
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||
Dennis
McGrath
|
1/15/06
|
|
12/28/05
|
-
|
335,000
|
-
|
N/A
|
N/A
|
1.83
|
601,727
|
||||||||||||||||||
3/10/06
|
2/28/06
|
140,000
|
2.23
|
1.97
|
266,280
|
|||||||||||||||||||||||
5/24/06
|
5/24/06
|
5,000
|
1.58
|
N/A
|
6,972
|
|||||||||||||||||||||||
5/25/06
|
5/25/06
|
2,000
|
1.63
|
N/A
|
2,932
|
|||||||||||||||||||||||
11/20/06
|
11/13/06
|
110,000
|
1.11
|
1.11
|
100,870
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||
Michael
Stewart
|
3/10/06
|
2/28/06
|
100,000
|
2.23
|
1.97
|
223,000
|
(1) |
On
December 28, 2005, the stockholders approved that the awards to Messrs.
O’Donnell and McGrath should be made on January 15, 2006. The exercise
prices of options granted under the 2005 Investment Plan were set
equal to
the optionee’s purchase price of shares of common stock on the date of the
grant. The grant of options on March 10, 2006 was delayed at the
decision
of the Board on February 28, 2006, until after the conference call
of
earnings had taken place. The exercise price was to be the higher
of the
closing prices on February 28, 2006 (i.e. $2.23) and March 10, 2006
(i.e.
$1.97).
|
(2) |
The
Company does not have a Non-Equity Incentive Plan. The Equity Incentive
Plan is comprised of the restricted shares of common stock issued
to
Messrs. O’Donnell and McGrath under the 2005 Equity Compensation
Plan.
|
(3) |
The
exercise price of options granted on 5/24/06, 5/25/06 and 5/26/06
were set
equal to the optionee’s purchase price of shares of common stock on the
date of the grant.
|
(4) |
Computed
in accordance with FSAS 123 (R).
|
Outstanding
Equity Awards Value at Fiscal Year-End Table
The
following table includes certain information with respect to the value of all
unexercised options previously awarded to the executive officers named above
at
the fiscal year end, December 31, 2006.
71
OUTSTANDING
EQUITY AWARDS AT FISCAL YEAR-END TABLE
Option
Awards
|
Stock
Awards
|
|||||||||||||||||||||||||||
Number
of
Securities
Underlying
Unexercised
Options
(#)
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
|
Equity
Incentive
Plan Awards:
Number
of
Securities
Underlying
Unexercised
Unearned
Options
|
Option
Exercise
Price
|
Option
Expiration
|
Number of
Shares
or
Units
of
Stock That
Have
Not
Vested
|
Market
Value of
Shares or
Units
of
Stock That
Have
Not
Vested
|
Equity Incentive
Plan
Awards:
Number
of
Unearned
Shares,
Units
or
Other
Rights
That
Have
Not
Vested
|
Equity
Incentive
Plan Awards:
Market
or
Payout
Value
of
Unearned
Shares,
Units
or
Other
Rights
That
Have
Not
Vested
|
||||||||||||||||||||
Name
|
Exercisable
|
Unexercisable
|
(#)
|
($)
|
Date
|
(#)
|
($)(1)
|
(#)
|
($)
(1)
|
|||||||||||||||||||
Jeffrey
O’Donnell
|
93,750
|
31,250
|
0
|
1.66
|
1/16/08
|
0
|
0
|
N/A
|
N/A
|
|||||||||||||||||||
75,000
|
75,000
|
0
|
2.14
|
1/22/09
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
112,500
|
37,500
|
0
|
2.45
|
3/1/10
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
0
|
200,000
|
0
|
2.50
|
N/A
|
0
|
0
|
525,000
|
582,750
|
||||||||||||||||||||
0
|
2,000
|
0
|
1.59
|
5/24/16
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
0
|
125,000
|
0
|
1.11
|
11/20/16
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
Dennis
McGrath
|
82,500
|
27,500
|
0
|
1.66
|
1/16/08
|
N/A
|
N/A
|
|||||||||||||||||||||
62,500
|
62,500
|
0
|
2.14
|
1/22/09
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
105,000
|
35,000
|
0
|
2.45
|
3/1/10
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
0
|
N/A
|
0
|
N/A
|
N/A
|
0
|
0
|
335,000
|
371,850
|
||||||||||||||||||||
0
|
140,000
|
0
|
2.23
|
3/10/16
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
0
|
5,000
|
0
|
1.58
|
5/24/16
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
0
|
2,000
|
0
|
1.63
|
5/25/16
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
0
|
110,000
|
0
|
1.11
|
11/20/16
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
Michael
Stewart
|
150,000
|
0
|
0
|
1.85
|
12/27/07
|
0
|
0
|
N/A
|
N/A
|
|||||||||||||||||||
75,000
|
0
|
0
|
1.83
|
1/2/08
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
75,000
|
37,500
|
0
|
2.14
|
1/22/09
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
100,000
|
75,000
|
0
|
2.45
|
3/1/10
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
40,000
|
20,000
|
0
|
2.63
|
7/19/10
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
0
|
100,000
|
0
|
2.23
|
3/10/16
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
John
Clifford
|
33,110
|
0
|
0
|
2.17
|
9/30/08
|
0
|
0
|
N/A
|
N/A
|
|||||||||||||||||||
99,330
|
0
|
0
|
1.16
|
9/30/08
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
66,220
|
0
|
0
|
1.07
|
9/30/08
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
66,220
|
0
|
0
|
1.96
|
9/30/08
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
99,330
|
0
|
0
|
2.76
|
9/30/08
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
27,591
|
5,519
|
0
|
1.65
|
9/30/08
|
0
|
0
|
N/A
|
N/A
|
||||||||||||||||||||
167,500
|
82,500
|
0
|
2.78
|
9/30/08
|
0
|
0
|
N/A
|
N/A
|
(1)
The
market value of unvested shares of restricted stock is based on $1.11 per share,
which was the closing price of our stock on December 29, 2006, the last trading
day of 2006.
Option
Exercises and Stock Vested Table
None.
72
Compensation
Committee Report on Executive Compensation
We
have
reviewed and discussed with management certain Compensation Discussion and
Analysis provisions to be included in the Company’s 2006 Form 10-K Annual. Based
on the reviews and discussions referred to above, we recommend to the Board
of
Directors that the Compensation Discussion and Analysis referred to above be
included in the Company’s Form 10-K. Having joined the Committee in August 2006,
Mr. Withrow has abstained from joining in this report.
Compensation
Committee
Anthony
J. Dimun Richard
DePiano Warwick
Alex Charlton Alan
R.
Novak
Limitation
on Directors' Liabilities; Indemnification of Officers and
Directors
Our
Certificate of Incorporation and Bylaws designate the relative duties and
responsibilities of our officers, establish procedures for actions by directors
and stockholders and other items. Our Certificate of Incorporation and Bylaws
also contain extensive indemnification provisions, which will permit us to
indemnify our officers and directors to the maximum extent, provided by Delaware
law. Pursuant to our Certificate of Incorporation and under Delaware law, our
directors are not liable to us or our stockholders for monetary damages for
breach of fiduciary duty, except for liability in connection with a breach
of
duty of loyalty, for acts or omissions not in good faith or which involve
intentional misconduct or a knowing violation of law, for dividend payments
or
stock repurchases illegal under Delaware law or any transaction in which a
director has derived an improper personal benefit.
We
have
adopted a form of indemnification agreement, which provides the indemnitee
with
the maximum indemnification allowed under applicable law. Since the Delaware
statutes are non-exclusive, it is possible that certain claims beyond the scope
of the statute may be indemnifiable. The indemnification agreement provides
a
scheme of indemnification, which may be broader than that specifically provided
by Delaware law. It has not yet been determined, however, to what extent the
indemnification expressly permitted by Delaware law may be expanded, and
therefore the scope of indemnification provided by the indemnification agreement
may be subject to future judicial interpretation.
The
indemnification agreement provides that we are to indemnify an indemnitee,
who
is or was a party or becomes a party or is threatened to be made a party to
any
threatened, pending or completed action or proceeding whether civil, criminal,
administrative or investigative by reason of the fact that the indemnitee is
or
was one of our directors, officers, key employees or agents. We are to advance
all expenses, judgments, fines, penalties and amounts paid in settlement
(including taxes imposed on indemnitee on account of receipt of such payouts)
incurred by the indemnitee in connection with the investigation, defense,
settlement or appeal of any civil or criminal action or proceeding as described
above. The indemnitee is to repay such amounts advanced only if it shall be
ultimately determined that he or she is not entitled to be indemnified by us.
The advances paid to the indemnitee by us are to be delivered within 20 days
following a written request by the indemnitee. Any award of indemnification
to
an indemnitee, if not covered by insurance, would come directly from our assets,
thereby affecting a stockholder's investment.
Directors'
and Officers' Liability Insurance
We
have
obtained directors' and officers' liability insurance which expires on February
24, 2008.
73
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
The
following table reflects, as of March 15, 2007, the beneficial common stock
ownership of: (a) each of our directors, (b) each executive officer (See Item
11, "Executive Compensation"), (c) each person known by us to be a beneficial
holder of five percent (5%) or more of our common stock, and (d) all of our
executive officers and directors as a group:
Name
and Address Of Beneficial Owner (1)
|
Number
of Shares Beneficially Owned
|
Percentage
of Shares Beneficially Owned (1)
|
|||||
Richard
J. DePiano(2)
|
244,300
|
*
|
|||||
Jeffrey
F. O’Donnell (3)
|
884,500
|
1.41
|
|||||
Dennis
M. McGrath (4)
|
647,750
|
1.03
|
|||||
Michael
R. Stewart (5)
|
372,690
|
*
|
|||||
Alan
R. Novak (6)
|
226,101
|
*
|
|||||
David
W. Anderson (7)
|
105,000
|
*
|
|||||
Warwick
Alex Charlton (8)
|
367,500
|
*
|
|||||
Anthony
J. Dimun (9)
|
276,250
|
*
|
|||||
Wayne
M. Withrow (10)
|
65,004
|
*
|
|||||
Corsair
Reporting Persons (11)
|
4,417,323
|
7.03
|
|||||
Wellington
Management Co., L.P. (12)
|
8,528,259
|
13.57
|
|||||
LB
I Group, Inc.
(13)
|
5,271,154
|
8.31
|
|||||
Prides
Capital Partners, L.L.C.(14)
|
3,569,821
|
5.71
|
|||||
All
directors and officers as a group (9 persons)
(15)
|
3,189,095
|
4.95
|
(1)
|
Beneficial
ownership is determined in accordance with the rules of the SEC.
Shares of
common stock subject to options or warrants currently exercisable
or
exercisable within 60 days of March 15, 2007, are deemed outstanding
for
computing the percentage ownership of the stockholder holding the
options
or warrants, but are not deemed outstanding for computing the percentage
ownership of any other stockholder. Unless otherwise indicated in
the
footnotes to this table, we believe stockholders named in the table
have
sole voting and sole investment power with respect to the shares
set forth
opposite such stockholder's name. Unless otherwise indicated, the
officers, directors and stockholders can be reached at our principal
offices. Percentage of ownership is based on 62,536,054 shares of
common
stock outstanding as of March 15, 2007.
|
(2)
|
Includes
31,800 shares and options to purchase up to 212,500 shares of common
stock. Does not include options to purchase up to 17,500 shares of
common
stock, which may vest more than 60 days after March 15, 2007. Mr.
DePiano's address is Escalon Medical Corporation, 565 East Swedesford
Road, Suite 200, Wayne, PA 19087.
|
(3)
|
Includes
7,000 shares, 525,000 additional shares subject to restriction agreements
with us and options to purchase up to 352,500 shares of common stock.
Does
not include options to purchase up to 401,500 shares of common stock,
which may vest more than 60 days after March 15, 2007.
|
(4)
|
Includes
11,000 shares, 335,000 additional shares subject to restriction agreements
with us and options to purchase up to 301,750 shares of common stock.
Does
not include options to purchase up to 330,250 shares of common stock,
which may vest more than 60 days after March 15,
2007.
|
(5)
|
Includes
1,440 shares, and options to purchase 371,250 shares of common stock.
Does
not include options to purchase up to 168,750 shares of common stock,
which may vest more than 60 days after March 15,
2007.
|
74
(6)
|
Includes
28,601 shares of common stock and options to purchase up to 197,500
shares
of common stock. Does not include options to purchase up to 17,500
shares
of common stock, which may vest more than 60 days after March 15,
2007.
Mr. Novak's address is 3050 K Street, NW, Suite 105, Washington, D.C.
20007.
|
(7)
|
Includes
options to purchase up to 105,000 shares of common stock. Does not
include
options to purchase up to 17,500 shares of common stock, which may
vest
more than 60 days after March 15, 2007. Mr. Anderson's address is
147
Keystone Drive, Montgomeryville, PA
18936.
|
(8)
|
Includes
170,000 shares of common stock owned by True North Partners, L.L.C.,
of
which Mr. Charlton may be deemed to be an affiliate, and options
to
purchase 197,500 shares of common stock. Does not include options
to
purchase up to 17,500 shares of common stock, which may vest more
than 60
days after March 15, 2007. Mr. Charlton's address is 444 Madison
Avenue, Suite 605, New York, New York
10022.
|
(9)
|
Includes
145,000 shares of common stock owned by Mr. Dimun and his wife and
options
to purchase up to 131,250 shares of common stock. Does not include
options
to purchase up to 17,500 shares of common stock, which may vest more
than
60 days after March 15, 2007. Mr. Dimun’s address is 46 Parsonage Hill
Road, Short Hills, New Jersey
07078.
|
(10)
|
Includes
30,004 shares of common stock owned by Mr. Withrow and his wife and
options to purchase up to 35,000 shares of common stock. Does not
include
options to purchase up to 17,500 shares of common stock, which may
vest
more than 60 days after March 15, 2007. Mr. Withrow’s address is 23 Craig
Lane, Malvern, PA 19355.
|
(11)
|
Includes
4,157,029shares of common stock and warrants to purchase up to 260,294
shares. Certain of the shares are held in various denominations by
Corsair
Capital Partners, L.P., a Delaware limited partnership ("Corsair
Capital
Partners"), Corsair Long Short International, Ltd., a Cayman Islands
exempted company ("Corsair International"), Corsair Select, L.P.,
a
Delaware limited partnership ("Corsair Select"), Corsair Capital
Partners
100, L.P., a Delaware limited partnership ("Corsair 100"), Corsair
Capital
Investors, Ltd., a Cayman Islands exempted company ("Corsair Investors",
and together with Corsair Capital Partners, Corsair International,
Corsair
Select and Corsair 100, the "Corsair Entities"), each of which are
private
investment funds. Corsair Capital Management, L.L.C. ("Corsair Capital
Management") is the investment manager of each of the Corsair Entities.
As
the investment manager of the Corsair Entities, and the manager of
such
other separate accounts, Corsair Capital Management has the power
to vote
and/or dispose of those shares of common stock held by such persons
and
accordingly, may be deemed to be the beneficial owner of such shares.
Jay
R. Petschek ("Petschek") and Steven Major ("Major," and together
with the
Corsair Entities, Corsair Capital Management and Petschek, the "Corsair
Reporting Persons") are the controlling principals of Corsair Capital
Management. Mr. Major beneficially owns 21,100 additional shares
of common
stock, and Mr. Petschek beneficially owns 60,000 additional shares
of
common stock. Accordingly, the Corsair Reporting Persons may collectively
be deemed to be the beneficial owners of 4,417,323 shares of common
stock,
including 4,157,029 shares of common stock and warrants to purchase
up to
260,294 shares. Neither the use of the terms "Corsair Entities" or
"Corsair Reporting Persons" nor the aggregation of ownership interests
by
the Corsair Reporting Persons, as described herein, necessarily implies
the existence of a group for purposes
of Section 13(d)(3) of the Exchange Act or any other purpose. The
foregoing information has been derived from a Schedule 13G filed
on behalf
of certain of the Corsair Reporting Persons, on February 14, 2007.
|
(12)
|
Wellington
Management Company, LLP is an investment adviser which has shared
voting
powers with respect to 8,198,859 shares of common stock owned of
record by
its clients and warrants becoming exercisable by May 15, 2007 and
owned of
record by its clients to purchase up to 329,400 shares of common
stock.
The foregoing information has been derived from a Schedule 13G filed
on
behalf of Wellington Management on February 14, 2007 and by a prospectus
filed by us on December 11, 2006.
|
(13)
|
LB
I Group Inc. is a wholly-owned subsidiary of Lehman Brothers Inc,
which is
a wholly-owned subsidiary of Lehman Brothers Holdings Inc. LB I Group
Inc.
owns 4,376,923 shares of common stock and warrants becoming exercisable
by
May 15, 2007 to purchase up to 894,231 shares of common stock. The
foregoing information has been derived from a Schedule 13G filed
on behalf
of LBI Group, Inc. on February 8,
2007.
|
(14)
|
Prides
Capital Partners, L.L.C. is the owner of 3,569,821 shares of common
stock.
The foregoing information has been derived from a Schedule 13D filed
on
behalf of Prides Capital on December 20, 2006.
|
75
(15)
|
Includes
424,845 unrestricted shares, 860,000 restricted shares and options
to
purchase 1,904,250 shares of common stock. Does not include options
to
purchase up to 1,005,500 shares of common stock, which may vest more
than
60 days after March 15, 2007.
|
Item
13. Certain
Relationships and Related Transactions, Director
Independence
As
of
March 15, 2007, Messrs. Michael R. Matthias and Jeffrey P. Berg, shareholders
in
Jenkens & Gilchrist, LLP, our outside counsel, held in the aggregate hold
43,563 shares of our common stock. Messrs. Matthias and Berg acquired such
shares through the exercise of stock options which they accepted from us in
exchange for legal services performed from July 1998 to May 2000.
We
believe that all transactions with our affiliates have been entered into on
terms no less favorable to us than could have been obtained from independent
third parties. We intend that any transactions with officers, directors and
5%
or greater stockholders will be on terms no less favorable to us than could
be
obtained from independent third parties and will be approved by a majority
of
our independent, disinterested directors and will comply with the Sarbanes
Oxley
Act and other securities laws and regulations.
Our
Board
determined in 2006 that all members of our Board are independent under the
applicable Nasdaq listing standards, except for Mr. O'Donnell, who is also
our
Chief Executive Officer.
Item
14. Principal
Accountant Fees and Services
Our
Audit
Committee has appointed Amper, Politziner & Mattia, P.C. as our independent
auditors for the fiscal year ending December 31, 2006 and 2005.
The
following table shows the fees paid or accrued by us for the audit and other
services provided by Amper, Politziner & Mattia for 2006 and
2005:
2006
|
2005
|
||||||
Audit
Fees
|
343,000
|
$
|
343,000
|
||||
Audit-Related
Fees
|
35,000
|
20,000
|
|||||
Tax
Fees
|
-
|
-
|
|||||
All
Other Fees
|
1,250
|
23,000
|
|||||
Total
|
$
|
379,250
|
$
|
386,000
|
As
defined by the Commission, (i) “audit fees” are fees for professional services
rendered by our principal accountant for the audit of our annual financial
statements and review of financial statements included in our Form 10-Q, or
for
services that are normally provided by the accountant in connection with
statutory and regulatory filings or engagements for those fiscal years; (ii)
“audit-related fees” are fees for assurance and related services by our
principal accountant that are reasonably related to the performance of the
audit
or review of our financial statements and are not reported under “audit fees”
(iii) “tax fees” are fees for professional services rendered by our principal
accountant for tax compliance, tax advice, and tax planning; and (iv) “all other
fees” are fees for products and services provided by our principal accountant,
other than the services reported under audit fees,” “audit-related fees,” and
“tax fees.”
Audit
Fees.
The
aggregate fees billed to us in 2006 by the independent auditors, Amper,
Politziner & Mattia, P.C., for professional services rendered in connection
with our Quarterly Reports on Form 10-Q and for the audits of our financial
statements and internal controls included in this Annual Report on Form 10-K
for
2006, totaled approximately $343,000.
The
aggregate fees billed to us in 2005 by the independent auditors, Amper,
Politziner & Mattia, P.C., for professional services rendered in connection
with our Quarterly Reports on Form 10-Q and for the audits of our financial
statements and internal controls included in this Annual Report on Form 10-K
for
2005, totaled approximately $343,000.
76
Audit-Related
Fees. The
aggregate fees billed to us by Amper, Politziner & Mattia, P.C. for
assurance and related services that are reasonably related to the performance
of
the audit and review of our financial statements that are not already reported
in the paragraph immediately above totaled approximately $35,000 for 2006 and
$20,000 for 2005.
All
Other Fees. The
aggregate fees billed to us by Amper, Politziner & Mattia, P.C. for products
and services rendered by Amper, Politziner & Mattia for tax consulting and
other services were for $1,250 for 2006 and $23,000 for 2005.
Engagement
of the Independent Auditor.
The
Audit Committee is responsible for approving every engagement of Amper,
Politziner & Mattia, P.C. to perform audit or non-audit services for us
before Amper, Politziner & Mattia, P.C. is engaged to provide those
services. Under applicable Commission rules, the Audit Committee is required
to
pre-approve the audit and non-audit services performed by the independent
auditors in order to ensure that they do not impair the auditors’ independence.
The Commission’s rules specify the types of non-audit services that an
independent auditor may not provide to its audit client and establish the Audit
Committee’s responsibility for administration of the engagement of the
independent auditors.
Consistent
with the Commission’s rules, the Audit Committee Charter requires that the Audit
Committee review and pre-approve all audit services and permitted non-audit
services provided by the independent auditors to us or any of our subsidiaries.
The Audit Committee may delegate pre-approval authority to a member of the
Audit
Committee and if it does, the decisions of that member must be presented to
the
full Audit Committee at its next scheduled meeting.
The
Audit
Committee’s pre-approval policy provides as follows:
· First,
once a year when the base audit engagement is reviewed and approved, management
will identify all other services (including fee ranges) for which management
knows it will engage Amper, Politziner & Mattia for the next 12 months.
Those services typically include quarterly reviews, specified tax matters,
certifications to the lenders as required by financing documents, consultation
on new accounting and disclosure standards and, in future years, reporting
on
management’s internal controls assessment.
· Second,
if any new “unlisted” proposed engagement arises during the year, the engagement
will require approval of the Audit Committee.
Auditor
Selection for Fiscal 2007
Amper,
Politziner & Mattia, P.C. has
been
selected to serve as our independent auditors for the year ending December
31,
2007, subject to conclusion of an engagement letter and ratification by our
stockholders at the next Annual Meeting.
PART
IV
Item
15 Exhibits
(a)(1)
|
Financial
Statements
|
Consolidated
balance sheet of PhotoMedex, Inc. and subsidiaries as of December 31, 2006
and
2005, and the related consolidated statements of operations, stockholders'
equity, and cash flows for each of the years in the 3-year period ended December
31, 2006.
(a)(2) |
Financial
Statement Schedules
|
All
schedules have been omitted because they are not required, not applicable,
or
the information is otherwise set forth in the consolidated financial statements
or notes thereto.
77
(b) Exhibits
Following
the footnote reference is the number of the exhibit in the original filing
(e.g.
“Exh 10.3”) in which it was submitted to the SEC.
2.1
|
Agreement
and Plan of Merger, dated September 25, 2002, between PhotoMedex,
Inc., J
Merger Corp., Inc. and Surgical Laser Technologies, Inc.
(1)
|
|
2.2
|
Agreement
and Plan of Merger, dated December 1, 2004, between PhotoMedex,
Inc., Gold
Acquisition Merger Corp. and ProCyte Corporation (2)
|
|
2.3
|
Securities
Purchase Agreement, dated October 31, 2006, by and between PhotoMedex,
Inc. and each purchaser a party thereto (3)
|
|
3.1(a)
|
Restated
Certificate of Incorporation, filed on August 8, 2000 (4)(Exh
3.1)
|
|
3.1(b)
|
Amendment
to Restated Certificate of Incorporation, filed on January 6, 2004.
(5)(Exh 3.2)
|
|
3.2
|
Amended
and Restated Bylaws (5)(Exh 3.1E)
|
|
10.1
|
Lease
Agreement dated May 29, 1996, between Surgical Laser Technologies,
Inc.
and Nappen & Associates (Montgomeryville, Pennsylvania) (5)(Exh
10.31)
|
|
10.2
|
Lease
Renewal Agreement, dated January 18, 2001, between Surgical Laser
Technologies, Inc. and Nappen & Associates (5)(Exh
10.32)
|
|
10.3
|
Lease
Agreement, dated July 10, 2006, PhotoMedex, Inc. and Nappen &
Associates (6)(Exh 10.3)
|
|
10.4
|
Lease
Agreement (Carlsbad, California) dated August 4, 1998
(7)
|
|
10.5
|
Standard
Industrial/Commercial Multi-Tenant Lease - Net, dated March 17,
2005
(Carlsbad, California)(8)(Exh 10.52)
|
|
10.6
|
Industrial
Real Estate Lease, dated August 30, 1993, as amended five times
(Redmond,
Washington) (8) (Exh 10.53)
|
|
10.7
|
License
and Development Agreement, dated May 22, 2002, between Surgical
Laser
Technologies, Inc. and Reliant Technologies, Inc. (5)(Exh
10.7)
|
|
10.8
|
Secured
Promissory Note, dated May 22, 2002, between Surgical Laser Technologies,
Inc. and Reliant Technologies, Inc. (5)(Exh 10.8)
|
|
10.9
|
Security
Agreement, dated May 22, 2002, between Surgical Laser Technologies,
Inc.
and Reliant Technologies, Inc. (5)(Exh 10.9)
|
|
10.10
|
Agreement
as to Collateral, dated May 22, 2002, among Surgical Laser Technologies,
Inc., Reliant Technologies, Inc. and AmSouth Bank (5)(Exh
10.10)
|
|
10.11
|
Master
Purchase Agreement, dated September 7, 2004, between PhotoMedex,
Inc. and
Stern Laser, srl (9)
|
|
10.12
|
Master
Lease Agreement, dated June 25, 2004, between PhotoMedex, Inc.
and GE
Capital Corporation. (10)
|
|
10.13
|
Investment
Agreement, dated March 30, 2006, between AzurTec, Inc. and PhotoMedex,
Inc. (11)(Exh 10.56)
|
|
10.14
|
License
Agreement, dated March 30, 3006, between AzurTec, Inc. and PhotoMedex,
Inc. (11)(Exh 10.57)
|
|
10.15
|
License
Agreement, dated March 31, 2006, and effective April 1, 1006, between
Mount Sinai School of Medicine and PhotoMedex, Inc.
(12)
|
|
10.16
|
2005
Equity Compensation Plan, approved December 28, 2005
(13)
|
|
10.17
|
2005
Investment Plan, approved December 28, 2005 (13)
|
|
10.18
|
Amended
and Restated 2000 Non-Employee Director Stock Option Plan
(1)
|
|
10.19
|
Amended
and Restated 2000 Stock Option Plan
(1)
|
78
10.20
|
2004
Stock Option Plan, assumed from ProCyte (14)
|
|
10.21
|
1996
Stock Option Plan, assumed from ProCyte (14)
|
|
10.22
|
1991
Restated Stock Option Plan for Non-Employee Directors, assumed
from
ProCyte (14)
|
|
10.23
|
1989
Restated Stock Option Plan, assumed from ProCyte (14)
|
|
10.24
|
Amended
and Restated Employment Agreement with Jeffrey F. O'Donnell, dated
August
1, 2002 (1)
|
|
10.25
|
Amended
and Restated Employment Agreement with Dennis M. McGrath, dated
August 1,
2002 (1)
|
|
10.26
|
Employment
Agreement of Michael R. Stewart, dated December 27, 2002 (5)(Exh
10.37)
|
|
10.27
|
Employment
Agreement of John F. Clifford, dated March 18, 2005 (2)
|
|
10.28
|
Employment
Agreement of Robin L. Carmichael, dated March 18, 2005
(2)
|
|
10.29
|
Separation
Agreement, effective June 30, 2006, between PhotoMedex, Inc. and
John F.
Clifford. (15)
|
|
10.30
|
Restricted
Stock Purchase Agreement of Jeffrey F. O’Donnell, dated January 15, 2006
(8)(Exh 10.44)
|
|
10.31
|
Restricted
Stock Purchase Agreement of Dennis M. McGrath, dated January 15,
2006
(8)(Exh 10.45)
|
|
10.32
|
Consulting
Agreement dated January 21, 1998 between the Company and R. Rox
Anderson, M.D. (7)(Exh
10.4)
|
|
10.33
|
Letter
Agreement dated October 28, 2003 between PhotoMedex and True North
Capital
Ltd. (16)(Exh 10.41)
|
|
22.1
|
List
of subsidiaries of the Company
|
|
23.1
|
Consent
of Amper, Politziner & Mattia P.C.
|
|
31.1
|
Rule
13a-14(a) Certificate of Chief Executive Officer
|
|
31.2
|
Rule
13a-14(a) Certificate of Chief Financial Officer
|
|
32.1
|
Certificate
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350,
as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
32.2
|
Certificate
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350,
as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
79
(1)
|
Filed
as part of our Registration Statement on Form S-4, as filed with
the
Commission on October 18, 2002, and as
amended.
|
(2)
|
Filed
as part of our Registration Statement on Form S-4/A filed with
the
Commission on January 21, 2005, and as
amended.
|
(3)
|
Filed
as part of our Current Report on Form 8-K, dated November 6,
2006.
|
(4)
|
Filed
as part of our Quarterly Report on Form 10-Q for the quarter ended
June
30, 2000.
|
(5)
|
Filed
as part of our Annual Report on Form 10-K for the year ended December
31,
2002.
|
(6)
|
Filed
as part of our Annual Report on Form 10-K for the year ended December
31,
2006.
|
(7)
|
Filed
as part of our Registration Statement on Form S-1, as filed with
the
Commission on January 28, 1998, as
amended.
|
(8)
|
Filed
as part of our Annual Report on Form 10-K for the year ended December
31,
2005.
|
(9)
|
Filed
as part of our Current Report on Form 8-K, dated September 10,
2004.
|
(10)
|
Filed
as part of our Quarterly Report on Form 10-Q for the quarter ended
June
30, 2004.
|
(11)
|
Filed
as part of our Current Report on Form 8-K, filed on April 6,
2006.
|
(12)
|
Filed
as part of our Current Report on Form 8-K, filed on April 10,
2006.
|
(13)
|
Filed
as part of our Definitive Proxy Statement on Schedule 14A, as filed
with
the Commission on November 15,
2005.
|
(14)
|
Filed
as part of our Registration Statement on Form S-8, as filed with
the
Commission on April 13, 2005.
|
(15)
|
Filed
as part of our Quarterly Report on Form 10-Q for the quarter ended
March
31, 2006.
|
(16)
|
Filed
as part of our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2003.
|
AVAILABLE
INFORMATION
We
are a
reporting company and file annual, quarterly and special reports, proxy
statements and other information with the Commission. You may inspect and copy
these materials at the Public Reference Room maintained by the Commission at
Room 1024, 450 Fifth Street, N.W., Washington, D.C. 20549. Please call the
Commission at 1-800-SEC-0330 for more information on the Public Reference Room.
You can also find our Commission filings at the Commission's website at
www.sec.gov. You may also inspect reports and other information concerning
us at
the offices of the Nasdaq Stock Market at 1735 K Street, N.W., Washington,
D.C.
20006. We intend to furnish our stockholders with annual reports containing
audited financial statements and such other periodic reports as we may determine
to be appropriate or as may be required by law.
Our
primary Internet address is www.photomedex.com.
Corporate information can be located by clicking on the “Investor Relations”
link in the top-middle of the page, and then clicking on “SEC Filing” in the
menu. We make our periodic Commission Reports (Forms 10-Q and Forms 10-K) and
current reports (Form 8-K) available free of charge through our Web site as
soon
as reasonably practicable after they are filed electronically with the
Commission. We may from time to time provide important disclosures to investors
by posting them in the Investor Relations section of our Web site, as allowed
by
Commission’s rules. The information on the website listed above is not and
should not be considered part of this Annual Report on Form 10-K and is intended
to be an inactive textual reference only.
80
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Act of
1934, the registrant has duly caused this Report to be signed on its behalf
by
the undersigned, thereunto duly authorized.
PHOTOMEDEX,
INC.
|
||
|
|
|
Date: March 16, 2007 | By: | /s/ Jeffrey F. O’Donnell |
Jeffrey
F. O’Donnell
President,
Chief Executive Officer
and
Director
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this Report has
been
signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated.
Signature
|
Capacity
in Which Signed
|
Date
|
||
/s/
Richard J. DePiano
|
Chairman
of the Board of Directors
|
March
16, 2007
|
||
Richard J. DePiano |
||||
/s/
Jeffrey F. O’Donnell
|
President,
Chief Executive Officer and Director
|
March
16, 2007
|
||
Jeffrey F. O'Donnell |
||||
/s/
Dennis M. McGrath
|
Chief
Financial Officer
|
March
16, 2007
|
||
Dennis M. McGrath |
||||
/s/
Alan R. Novak
|
Director
|
March
16, 2007
|
||
Alan R. Novak |
||||
/s/
David W. Anderson
|
Director
|
March
16, 2007
|
||
David W. Anderson |
||||
/s/
Warwick Alex Charlton
|
Director
|
March
16, 2007
|
||
Warwick Alex Charlton |
||||
/s/
Anthony J. Dimun
|
Director
|
March
16, 2007
|
||
Anthony J. Dimun |
||||
/s/
Wayne M. Withrow
|
Director
|
March
16, 2007
|
||
Wayne M. Withrow |
81
PHOTOMEDEX,
INC. AND SUBSIDIARIES
Index
to
Consolidated Financial Statements
Page
|
||||
Report
of Independent Registered Public Accounting Firm
|
F-2
|
|||
Report
of Independent Registered Public Accounting Firm
|
F-3
|
|||
Consolidated
Balance Sheets, December 31, 2006 and 2005
|
F-4
|
|||
Consolidated
Statements of Operations, Years ended December 31, 2006, 2005 and
2004
|
F-5
|
|||
Consolidated
Statements of Stockholders’ Equity, Years ended December 31,
2006, 2005 and 2004
|
F-6
|
|||
Consolidated
Statements of Cash Flows, Years ended December 31, 2006, 2005 and
2004
|
F-7
|
|||
Notes
to Consolidated Financial Statements
|
F-8
|
REPORT
OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board
of
Directors and shareholders
PhotoMedex,
Inc. and Subsidiaries
We
have
audited the accompanying consolidated balance sheets of PhotoMedex, Inc. and
Subsidiaries as of December 31, 2006 and 2005, and the related consolidated
statements of operations, stockholders’ equity, and cash flows for the years
ended December 31, 2006 and 2005. These financial statements are the
responsibility of the Company’s management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board of United States of America. 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 consolidated financial statements referred to above present fairly,
in all material respects, the financial position of PhotoMedex, Inc. and
Subsidiaries as of December 31, 2006 and 2005, and the results of its operations
and its cash flows for the years ended December 31, 2006 and 2005, in conformity
with accounting principles generally accepted in the United States of
America.
As
discussed in Note 1 to the consolidated financial statements, the Company
changed its method of accounting for stock-based compensation upon the adoption
of Statement of Financial Accounting Standard No. 123 (R), “Share-Based
Payment”.
We
also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board of the United States of America, the effectiveness of
PhotoMedex, Inc. and Subsidiary’s internal control over financial reporting as
of December 31, 2006, based on criteria established in Internal
Control—Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway Commission and our report dated March 8, 2007 expressed an
unqualified opinion thereon.
/s/
Amper, Politziner & Mattia, P. C.
March
8,
2007
Edison,
New Jersey
F-2
REPORT
OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board
of
Directors and shareholders
PhotoMedex,
Inc. and Subsidiaries
We
have
audited management’s assessment, included in the accompanying Management’s 2006
Annual Report on Internal Controls, that PhotoMedex, Inc. and Subsidiaries
(the
Company) maintained effective internal control over financial reporting as
of
December 31, 2006, based on criteria established in Internal Control—Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (COSO). The Company’s management is responsible for maintaining
effective internal control over financial reporting and for its assessment
of
the effectiveness of internal control over financial reporting. Our
responsibility is to express an opinion on management’s assessment, and an
opinion on the effectiveness of the Company’s internal control over financial
reporting based on our audit.
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 effective
internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control
over
financial reporting, evaluating management’s assessment, testing and evaluating
the design and operating effectiveness of internal control, and performing
such
other procedures as we considered necessary in the circumstances. We believe
that our audits provide a reasonable basis for our opinion.
A
company’s internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (1) pertain
to
the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2)
provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors
of
the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the Company’s
assets that could have a material effect on the financial
statements.
Because
of its inherent limitations, internal control over financial reporting may
not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In
our
opinion, management’s assessment that the Company maintained effective internal
control over financial reporting as of December 31, 2006, is fairly stated,
in
all material respects, based on control criteria established in Internal
Control—Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway Commission (COSO). Also in our opinion, the Company maintained,
in all material respects, effective internal control over financial reporting
as
of December 31, 2006, based on the criteria established in Internal
Control—Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway Commission (COSO).
We
have
also audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated balance sheet of PhotoMedex,
Inc. and Subsidiaries as of December 31, 2006 and the related consolidated
statements of operations, stockholders’ equity and cash flows for the years
ended December 31, 2006 in our report dated March 8, 2007, expressed an
unqualified opinion.
/s/
Amper, Politziner & Mattia, P. C.
March
8,
2007
Edison,
New Jersey
F-3
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
December
31,
|
|||||||
2006
|
2005
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
12,729,742
|
$
|
5,403,036
|
|||
Restricted
cash
|
156,000
|
206,931
|
|||||
Accounts
receivable, net of allowance for doubtful accounts of $508,438 and
$765,440
|
4,999,224
|
4,651,080
|
|||||
Inventories
|
7,301,695
|
8,047,444
|
|||||
Prepaid
expenses and other current assets
|
534,135
|
621,372
|
|||||
Total
current assets
|
25,720,796
|
18,929,863
|
|||||
Property
and equipment, net
|
9,054,098
|
7,044,713
|
|||||
Patents
and licensed technologies, net
|
1,695,727
|
1,577,554
|
|||||
Goodwill,
net
|
16,917,808
|
16,375,384
|
|||||
Other
intangible assets, net
|
3,537,625
|
4,467,625
|
|||||
Other
assets
|
555,467
|
280,467
|
|||||
Total
assets
|
$
|
57,481,521
|
$
|
48,675,606
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Current
portion of notes payable
|
$
|
195,250
|
$
|
228,398
|
|||
Current
portion of long-term debt
|
3,018,874
|
1,749,969
|
|||||
Accounts
payable
|
3,617,726
|
3,572,077
|
|||||
Accrued
compensation and related expenses
|
1,529,862
|
867,427
|
|||||
Other
accrued liabilities
|
657,293
|
924,968
|
|||||
Deferred
revenues
|
632,175
|
466,032
|
|||||
Total
current liabilities
|
9,651,180
|
7,808,871
|
|||||
Notes
payable, net of current maturities
|
133,507
|
159,213
|
|||||
Long-term
debt, net of current maturities
|
3,593,920
|
2,278,871
|
|||||
Other
liabilities
|
-
|
11,623
|
|||||
Total
liabilities
|
13,378,607
|
10,258,578
|
|||||
Commitment
and contingencies
|
|||||||
Stockholders'
Equity:
|
|||||||
Common
Stock, $.01 par value, 75,000,000 shares authorized; 62,536,054 and
51,414,294 shares issued and outstanding at December 31, 2006 and
2005,
respectively
|
625,360
|
514,143
|
|||||
Additional
paid-in capital
|
131,152,557
|
118,140,838
|
|||||
Accumulated
deficit
|
(87,675,003
|
)
|
(80,182,606
|
)
|
|||
Deferred
compensation
|
-
|
(55,347
|
)
|
||||
Total
stockholders' equity
|
44,102,914
|
38,417,028
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
57,481,521
|
$
|
48,675,606
|
The
accompanying notes are an integral part of these consolidated financial
statements.
F-4
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
For
the Year Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Revenues:
|
||||||||||
Product
sales
|
$
|
20,352,905
|
$
|
16,544,894
|
$
|
6,497,397
|
||||
Services
|
12,836,972
|
11,839,612
|
11,247,784
|
|||||||
33,189,877
|
28,384,506
|
17,745,181
|
||||||||
Cost
of revenues:
|
||||||||||
Product
cost of revenues
|
8,628,651
|
7,219,504
|
3,324,564
|
|||||||
Services
cost of revenues
|
9,843,199
|
8,456,001
|
7,038,705
|
|||||||
18,471,850
|
15,675,505
|
10,363,269
|
||||||||
Gross
profit
|
14,718,027
|
12,709,001
|
7,381,912
|
|||||||
Operating
expenses:
|
||||||||||
Selling,
general and administrative
|
20,682,056
|
16,477,322
|
10,426,256
|
|||||||
Engineering
and product development
|
1,006,600
|
1,127,961
|
1,801,438
|
|||||||
21,688,656
|
17,605,283
|
12,227,694
|
||||||||
Loss
from operations
|
(6,970,629)
|
(4,896,282
|
)
|
(4,845,782
|
)
|
|||||
Interest
expense, net
|
(521,768
|
)
|
(342,299
|
)
|
(138,414
|
)
|
||||
Other
income, net
|
-
|
1,302,537
|
-
|
|||||||
Net
loss
|
($
7,492,397
|
)
|
($
3,936,044
|
)
|
($
4,984,196
|
)
|
||||
Basic
and diluted net loss per share
|
($0.14
|
)
|
($0.08
|
)
|
($0.13
|
)
|
||||
Shares
used in computing basic and diluted net loss per share
|
54,188,914
|
48,786,109
|
38,835,356
|
The
accompanying notes are an integral part of these consolidated financial
statements
F-5
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
Common
Stock
|
Additional
Paid-In
|
Accumulated
|
Deferred
|
||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Compensation
|
Total
|
||||||||||||||
BALANCE,
JANUARY 1, 2004
|
37,736,139
|
$
|
377,361
|
$
|
86,871,415
|
($71,262,366
|
)
|
($8,335
|
)
|
$
|
15,978,075
|
||||||||
Sale
of stock, net of expenses
|
-
|
-
|
11,199
|
-
|
-
|
11,199
|
|||||||||||||
Exercise
of warrants
|
2,104,138
|
21,041
|
3,065,427
|
-
|
-
|
3,086,468
|
|||||||||||||
Exercise
of stock options
|
120,865
|
1,209
|
209,074
|
-
|
-
|
210,283
|
|||||||||||||
Stock
options issued to consultants for services
|
-
|
-
|
98,435
|
-
|
-
|
98,435
|
|||||||||||||
Reversal
of unamortized portion of deferred compensation for terminated
employee
|
-
|
-
|
(532
|
)
|
-
|
532
|
-
|
||||||||||||
Registration
expense for acquisition
|
-
|
-
|
(125,914
|
)
|
-
|
-
|
(125,914
|
)
|
|||||||||||
Issuance
of stock for Stern laser assets acquisition, net of
expenses
|
113,877
|
1,139
|
218,066
|
-
|
-
|
219,205
|
|||||||||||||
Issuance
of warrants for draws under line of credit
|
-
|
-
|
80,462
|
-
|
-
|
80,462
|
|||||||||||||
Amortization
of deferred compensation
|
-
|
-
|
-
|
-
|
6,266
|
6,266
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
(4,984,196
|
)
|
-
|
(4,984,196
|
)
|
|||||||||||
BALANCE,
DECEMBER 31, 2004
|
40,075,019
|
400,750
|
90,427,632
|
(76,246,562
|
)
|
(1,537
|
)
|
14,580,283
|
|||||||||||
Exercise
of warrants
|
73,530
|
735
|
146,325
|
-
|
-
|
147,060
|
|||||||||||||
Exercise
of stock options
|
350,189
|
3,502
|
624,329
|
-
|
-
|
627,831
|
|||||||||||||
Issuance
of stock for ProCyte merger, net of expense
|
10,540,579
|
105,406
|
26,197,732
|
-
|
(132,081
|
)
|
26,171,057
|
||||||||||||
Stock
options issued to consultants for services
|
-
|
-
|
123,257
|
-
|
-
|
123,257
|
|||||||||||||
Reversal
of unamortized portion of deferred compensation for terminated
employee
|
-
|
-
|
(1,534
|
)
|
-
|
1,534
|
-
|
||||||||||||
Amortization
of deferred compensation
|
-
|
-
|
-
|
-
|
76,737
|
76,737
|
|||||||||||||
Issuance
of stock for Stern laser assets acquisition, net of
expenses
|
374,977
|
3,750
|
723,300
|
-
|
-
|
727,050
|
|||||||||||||
Registration
expense
|
-
|
-
|
(161,739
|
)
|
-
|
-
|
(161,739
|
)
|
|||||||||||
Issuance
of warrants for draws under line of credit
|
-
|
-
|
61,536
|
-
|
-
|
61,536
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
(3,936,044
|
)
|
-
|
(3,936,044
|
)
|
|||||||||||
BALANCE,
DECEMBER 31, 2005
|
51,414,294
|
514,143
|
118,140,838
|
(80,182,606
|
)
|
(55,347
|
)
|
38,417,028
|
|||||||||||
Reversal
of deferred compensation upon adoption of SFAS 123R
|
-
|
-
|
(55,347
|
)
|
-
|
55,347
|
-
|
||||||||||||
Exercise
of warrants
|
140,000
|
1,400
|
166,600
|
-
|
-
|
168,000
|
|||||||||||||
Exercise
of stock options
|
60,750
|
607
|
86,664
|
-
|
-
|
87,271
|
|||||||||||||
Sale
of stock, net of expenses
|
9,760,000
|
97,600
|
10,449,402
|
-
|
-
|
10,547,002
|
|||||||||||||
Amortization
of deferred compensation
|
-
|
-
|
55,347
|
-
|
-
|
55,347
|
|||||||||||||
Stock
options issued to consultants for service
|
-
|
-
|
132,624
|
-
|
132,624
|
||||||||||||||
Stock-based
compensation expense related to employee options
|
-
|
-
|
990,372
|
-
|
-
|
990,372
|
|||||||||||||
Issuance
of restricted stock
|
860,000
|
8,600
|
314,174
|
-
|
-
|
322,774
|
|||||||||||||
Issuance
of stock for Azurtec agreement
|
200,000
|
2,000
|
381,273
|
-
|
-
|
383,273
|
|||||||||||||
Issuance
of stock for Stern laser assets acquisition, net of
expenses
|
101,010
|
1,010
|
190,725
|
-
|
-
|
191,735
|
|||||||||||||
Stock-based
compensation expense related to severance agreement
|
-
|
-
|
195,497
|
-
|
-
|
195,497
|
|||||||||||||
Issuance
of warrants for draws under line of credit
|
-
|
-
|
104,388
|
-
|
-
|
104,388
|
|||||||||||||
Net
loss
|
-
|
-
|
-
|
(7,492,397
|
)
|
-
|
(7,492,397
|
)
|
|||||||||||
BALANCE,
DECEMBER 31, 2006
|
62,536,054
|
$
|
625,360
|
$
|
131,152,557
|
($87,675,003
|
)
|
-
|
$
|
44,102,914
|
|||||||||
The
accompanying notes are an integral part of these consolidated financial
statements.
F-6
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
For
the Year Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Cash
Flows From Operating Activities:
|
||||||||||
Net
loss
|
($7,492,397
|
)
|
($3,936,044
|
)
|
($4,984,196
|
)
|
||||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
and amortization
|
4,199,047
|
3,217,200
|
1,765,944
|
|||||||
Loss
on disposal of property and equipment
|
7,500
|
101,009
|
-
|
|||||||
Provision
for doubtful accounts
|
66,211
|
373,964
|
459,861
|
|||||||
Stock
options and warrants issued to consultants
for services
|
132,624
|
123,257
|
98,435
|
|||||||
Compensatory
charge for stock options and restricted stock issued to employees
|
1,304,546
|
-
|
-
|
|||||||
Non-monetary
exchange
|
-
|
(88,667
|
)
|
-
|
||||||
Amortization
of deferred compensation
|
55,347
|
76,737
|
6,266
|
|||||||
Changes
in operating assets and liabilities, net of acquisition:
|
||||||||||
Accounts
receivable
|
(414,355
|
)
|
229,768
|
(1,094,230
|
)
|
|||||
Inventories
|
815,766
|
(782,880
|
)
|
(628,257
|
)
|
|||||
Prepaid
expenses and other assets
|
1,138,691
|
1,011,340
|
541,170
|
|||||||
Accounts
payable
|
45,648
|
(518,289
|
)
|
1,273,300
|
||||||
Accrued
compensation and related expenses
|
315,508
|
(246,950
|
)
|
22,718
|
||||||
Other
accrued liabilities
|
(279,295
|
)
|
(1,023,921
|
)
|
(51,482
|
)
|
||||
Deferred
revenues
|
166,143
|
(266,366
|
)
|
(174,750
|
)
|
|||||
Net
cash provided by (used in) operating activities
|
60,984
|
(1,729,842
|
)
|
(2,765,221
|
)
|
|||||
Cash
Flows From Investing Activities:
|
||||||||||
Purchases
of property and equipment
|
(94,976
|
)
|
(123,201
|
)
|
(111,319
|
)
|
||||
Lasers
placed into service
|
(4,931,835
|
)
|
(3,461,803
|
)
|
(1,683,528
|
)
|
||||
Cash
received from acquisition of ProCyte, net of acquisition
costs
|
-
|
5,578,416
|
(882,823
|
)
|
||||||
Net
cash (used in) provided by investing activities
|
(5,026,811
|
)
|
1,993,412
|
(2,677,670
|
)
|
|||||
Cash
Flows From Financing Activities:
|
||||||||||
Proceeds
from issuance of common stock, net
|
10,547,002
|
(169,524
|
)
|
(138,858
|
)
|
|||||
Proceeds
from issuance of restricted common stock
|
8,600
|
-
|
-
|
|||||||
Proceeds
from exercise of options
|
87,271
|
627,831
|
210,283
|
|||||||
Proceeds
from exercise of warrants
|
168,000
|
147,060
|
3,086,468
|
|||||||
Payments
on long-term debt
|
(179,993
|
)
|
(263,442
|
)
|
(291,840
|
)
|
||||
Payments
on notes payable
|
(900,715
|
)
|
(882,032
|
)
|
(587,161
|
)
|
||||
Net
advances on line of credit
|
2,511,437
|
1,889,487
|
527,548
|
|||||||
Decrease
(increase) in restricted cash, cash equivalents and short-term
investments
|
50,931
|
(94,731
|
)
|
(112,200
|
)
|
|||||
Net
cash provided by financing activities
|
12,292,533
|
1,254,649
|
2,694,240
|
|||||||
Net
increase (decrease) in cash and cash equivalents
|
7,326,706
|
1,518,219
|
(2,748,651
|
)
|
||||||
Cash
and Cash Equivalents, Beginning of Year
|
5,403,036
|
3,884,817
|
6,633,468
|
|||||||
Cash
and Cash Equivalents, End of Year
|
$
|
12,729,742
|
$
|
5,403,036
|
$
|
3,884,817
|
The
accompanying notes are an integral part of these consolidated financial
statements.
F-7
PHOTOMEDEX,
INC. AND SUBSIDIARIES
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
Note
1
The
Company and Summary of Significant Accounting Policies:
The
Company:
Background
PhotoMedex,
Inc. (and its subsidiaries) (the “Company”) is a medical device and specialty
pharmaceutical company focused on facilitating the cost-effective use of
technologies for doctors, hospitals and surgery centers to enable their patients
to achieve a higher quality of life. The Company operates in five distinct
business units, or segments (as described in Note 11): three in Dermatology,
-
Domestic XTRAC®, International Dermatology Equipment, and Skin Care (ProCyte®);
and two in Surgical, - Surgical Services (SIS™) and Surgical Products (SLT®).
The segments are distinguished by our management structure, products and
services offered, markets served or types of customers.
The
Domestic XTRAC segment generally derives revenues from procedures performed
by
dermatologists in the United States. The Company’s XTRAC laser system is placed
in a dermatologist’s office without any initial capital cost to the
dermatologist, and then the Company charges a fee-per-use to treat skin disease.
The International Dermatology Equipment segment was formerly called the
International XTRAC segment, but the Company re-named this segment following
the
addition of the VTRAC™ lamp-based system in 2006. In comparison to the Domestic
XTRAC segment, the International Dermatology Equipment segment generates
revenues from the sale of equipment to dermatologists outside the United States
through a network of distributors. The Skin Care segment generates revenues
by
selling physician-dispensed skincare products worldwide and by earning royalties
on licenses for our patented copper peptide compound.
The
Company designed and manufactured the XTRAC laser system to treat psoriasis,
vitiligo, atopic dermatitis and leukoderma phototherapeutically. In January
2000, the Company received the first Food and Drug Administration (“FDA”)
clearance to market an excimer laser system, the XTRAC® laser system, for the
treatment of psoriasis. It was followed by FDA 510(k) clearance to treat
vitiligo in March 2001, atopic dermatitis in August 2001, and leukoderma in
May
2002. The first XTRAC phototherapy treatment systems were commercially
distributed in the United States in August 2000 before any of its procedures
had
been approved for medical insurance reimbursement. In the last several years,
the Company has sought to obtain reimbursement for psoriasis and other
inflammatory skin disorders. By the latter part of 2005, the Company had
received many approvals for the reimbursement for use of the XTRAC system.
In June 2006, the Company received approval from Blue Cross and Blue Shield
of
Florida. The manufacturing facility for the XTRAC laser system is located in
Carlsbad, California.
The
Surgical Services segment generates revenues by providing fee-based procedures
typically using our mobile surgical laser equipment delivered and operated
by a
technician at hospitals and surgery centers in the United States. The Surgical
Products segment generates revenues by selling laser products and disposables
to
hospitals and surgery centers both domestically and internationally. The
Surgical Products segment also sells other non-laser products .
The
Skin
Care business resulted from the acquisition of ProCyte Corporation (“ProCyte”)
on March 18, 2005. ProCyte, located in Redmond, Washington, markets products
for
skin health, hair care and wound care. Many of these products incorporate
patented copper peptide technologies. In addition to a diversified product
line,
ProCyte has provided a national sales force and increased the Company’s
marketing capabilities. (see Note 2).
The
Company also develops, manufactures and markets proprietary lasers and delivery
systems for both contact and non-contact surgery and provides surgical services
utilizing these and other manufacturers’ products. The Montgomeryville facility
also serves as the Company’s corporate headquarters.
F-8
Liquidity
and Going Concern
The
Company has incurred significant losses and negative cash flows from operations.
As of December 31, 2006, the Company had an accumulated deficit of $87,675,003.
The Company has historically financed its activities from operations, the
private placement of equity securities and borrowings under lines of credit.
To
date, the Company has dedicated most of its financial resources to research
and
development, marketing and general and administrative expenses.
Cash
and
cash equivalents as of December 31, 2006 were $12,885,742, including restricted
cash of $156,000. Management believes that the existing cash balance together
with its other existing financial resources, including its leasing credit line
facility with a remaining availability of $1,289,946 (see Note 9), and any
revenues from sales, distribution, licensing and manufacturing relationships,
will be sufficient to meet the Company’s operating and capital requirements
through the end of the first quarter of 2008. The 2007 operating plan reflects
anticipated growth from an increase in per-treatment fee revenues for use of
the
XTRAC laser system based on increased utilization and wider insurance coverage
in the United States and continuing cost savings from the integration of
business operations acquired from ProCyte and the growth of the Company’s
skincare products. In light of the Company’s recent private placement (see Note
12,) of approximately $11.4 million, the Company now believes that it will
have
the necessary financing to meet its operating and capital requirements through
2007 and into 2008, at a minimum.
Since
2002, the Company has made significant progress in obtaining more extensive
reimbursement approval including the Centers for Medicare and Medicaid Services
and various private health plans for the treatment of skin disorders using
the
XTRAC laser system. The Company plans to continue to attempt securing
reimbursement from more private insurers and to concentrate sales and marketing
efforts where such reimbursement has become available. As additional approvals
for reimbursements are obtained, the Company will increase spending on the
marketing and selling of its psoriasis, vitiligo, atopic dermatitis and
leukoderma treatment products and, if necessary, expansion of its manufacturing
facilities. Even with the approval for reimbursement by Centers for Medicare
and
Medicaid Services and recent approvals by certain private insurers, the Company
may continue to face resistance from remaining private healthcare insurers
to
adopt the excimer-laser-based therapy as an approved procedure or to provide
adequate levels of reimbursement.
The
Company’s future success also depends in part upon increased patient acceptance
of its excimer-laser-based systems for the treatment of a variety of skin
disorders. The Company’s ability to introduce successful new products may be
adversely affected by a number of factors, such as unforeseen costs and
expenses, technological change, economic downturns, increased competition,
other
factors beyond the Company’s control or excessive costs in order to market the
product and thus win patient acceptance. The Company is continuing to implement
its rollout strategy for the XTRAC laser system in the United States in selected
areas of the country where reimbursement is widely available. The success of
the
rollout depends on increasing physician and patient demand for the treatment.
Management
cannot provide assurance that the Company will market the XTRAC product
successfully or operate profitably in the future, or that it will not require
significant additional financing in order to accomplish or exceed the objectives
of its business plan. Consequently, the Company’s historical operating results
cannot be relied on to be an indicator of future performance, and management
cannot predict whether the Company will obtain or sustain positive operating
cash flow or generate net income in the future.
F-9
Summary
of Significant Accounting Policies:
Principles
of Consolidation
The
consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries. All significant intercompany balances and
transactions have been eliminated.
Use
of Estimates
The
preparation of the consolidated financial statements in conformity with
accounting principles generally accepted in the United States requires
management to make estimates and assumptions that affect amounts reported in
the
financial statements and accompanying notes. Actual results could differ from
those estimates and be based on events different from those assumptions. Future
events and their effects cannot be perceived with certainty; estimating,
therefore, requires the exercise of judgment. Thus, accounting estimates change
as new events occur, as more experience is acquired, or as additional
information is obtained. See Revenue
Recognition
for
discussion of updates and changes in estimates for XTRAC domestic revenues
in
accordance with Staff Accounting Bulletin Nos. 101 and 104 and SFAS No.
48.
Cash
and Cash Equivalents and Restricted Cash
The
Company invests its excess cash in highly liquid short-term investments. The
Company considers short-term investments that are purchased with an original
maturity of three months or less to be cash equivalents. Cash and cash
equivalents consisted of cash and money market accounts at December 31, 2006
and
2005. Cash that is pledged to secure obligations is disclosed separately as
restricted cash. The Company maintains its cash and cash equivalents in accounts
in several banks, the balances which at times may exceed federally insured
limits.
Accounts
Receivable
The
majority of the Company’s accounts receivables are due from distributors
(domestic and international), hospitals, universities and physicians and other
entities in the medical field. Credit is extended based on evaluation of a
customer’s financial condition and, generally, collateral is not required.
Accounts receivable are most often due within 30 to 90 days and are stated
at
amounts due from customers net of an allowance for doubtful accounts. Accounts
outstanding longer than the contractual payment terms are considered past due.
The Company determines its allowance by considering a number of factors,
including the length of time trade accounts receivable are past due, the
Company’s previous loss history, the customer’s current ability to pay its
obligation to the Company, and the condition of the general economy and the
industry as a whole. The Company writes-off accounts receivable when they become
uncollectible, and payments subsequently received on such receivables are
credited to the allowance for doubtful accounts. The Company does not accrue
interest on accounts receivable past due.
Inventories
Inventories
are stated at the lower of cost (first-in, first-out basis) or market. Cost
is
determined to be purchased cost for raw materials and the production cost
(materials, labor and indirect manufacturing cost) for work-in-process and
finished goods. Throughout the laser manufacturing process, the related
production costs are recorded within inventory. Work-in-process is immaterial,
given the typically short manufacturing cycle, and therefore is disclosed in
conjunction with raw materials.
The
Company's skin disorder treatment equipment will either (i) be sold to
distributors or physicians directly or (ii) be placed in a physician's office
and remain the property of the Company. The cost to build a laser, whether for
sale or for placement, is accumulated in inventory. When a laser is placed
in a
physician’s office, the cost is transferred from inventory to “lasers in
service” within property and equipment. At times, units are shipped to
distributors, but revenue is not recognized until all of the criteria of Staff
Accounting Bulletin No. 104 have been met, and until that time, the unit is
carried on the books of the Company as inventory. Revenue is not recognized
from
these distributors until payment is either assured or paid in full. Until this
time, the cost of these shipments continues to be recorded as finished goods
inventory.
Reserves
for slow moving and obsolete inventories are provided based on historical
experience and product demand. Management evaluates the adequacy of these
reserves periodically based on forecasted sales and market trend.
Property,
Equipment and Depreciation
Property
and equipment are recorded at cost. Excimer lasers-in-service are depreciated
on
a straight-line basis over the estimated useful life of three years. In
reflection of their improved reliability, XTRAC lasers placed in service after
December 31, 2005 are depreciated on a straight-line basis over the estimated
useful life of five-years; other XTRAC lasers-in-service continue to be
depreciated over the original useful life of three years. Surgical
lasers-in-service are depreciated on a straight-line basis over an estimated
useful life of seven years if new, and five years or less if used equipment.
The
straight-line depreciation basis for lasers-in-service is reflective of the
pattern of use. For other property and equipment, depreciation is calculated
on
a straight-line basis over the estimated useful lives of the assets, primarily
three to seven years for computer hardware and software, furniture and fixtures,
automobiles, and machinery and equipment. Leasehold improvements are amortized
over the lesser of the useful lives or lease terms. Expenditures for major
renewals and betterments to property and equipment are capitalized, while
expenditures for maintenance and repairs are charged to operations as incurred.
Upon retirement or disposition, the applicable property amounts are deducted
from the accounts and any gain or loss is recorded in the consolidated
statements of operations. Useful lives are determined based upon an estimate
of
either physical or economic obsolescence or both.
F-10
Laser
units and laser accessories located at medical facilities for sales evaluation
and demonstration purposes or those units/accessories used for development
and
medical training are included in property and equipment under the caption
“machinery and equipment”. These units and accessories are being depreciated
over a period of up to five years. Laser units utilized in the provision of
surgical services are included in property and equipment under the caption
“lasers in service” and are depreciated over a five year life, given the
additional wear and tear that is incurred with movement from site to site.
Management
evaluates the realizability of property and equipment based on estimates of
undiscounted future cash flows over the remaining useful life of the asset.
If
the amount of such estimated undiscounted future cash flows is less than the
net
book value of the asset, the asset is written down to the net realizable value.
As of December 31, 2006, no such write-down was required (see Impairment
of Long-Lived Assets
below).
Patent
Costs and Licensed Technologies
Costs
incurred to obtain or defend patents and licensed technologies are capitalized
and amortized over the shorter of the remaining estimated useful lives or eight
to 12 years. Developed technology was recorded in connection with the purchase
in August 2000 of the minority interest of Acculase, a former subsidiary of
the
Company, and is being amortized on a straight-line basis over seven years.
Developed technology was also recorded in connection with the acquisition of
ProCyte in March 2005 and is being amortized on a straight-line basis over
seven
years. Other licenses, for example, the AzurTec, Stern and Mount Sinai licenses,
are capitalized and amortized over the estimated useful lives of 10
years.
Management
evaluates the realizability of intangible assets based on estimates of
undiscounted future cash flows over the remaining useful life of the asset.
If
the amount of such estimated undiscounted future cash flows is less than net
book value of the asset, the asset is written down to fair value. As of December
31, 2006, no such write-down was required (see Impairment
of Long-Lived Assets
below).
Other
Intangible Assets
Other
intangible assets were recorded in connection with the acquisition of ProCyte
in
March 2005. The assets are being amortized on a straight-line basis over 5
to 10
years.
Management
evaluates the recoverability of such other intangible assets based on estimates
of undiscounted future cash flows over the remaining useful life of the asset.
If the amount of such estimated undiscounted future cash flows is less than
the
net book value of the asset, the asset is written down to fair value. As of
December 31, 2006, no such write-down was required.
Goodwill
Goodwill
was recorded in connection with the acquisition of ProCyte in March 2005 and
the
acquisition of Acculase in August 2000.
Management
evaluates the recoverability of such goodwill based on estimates of undiscounted
future cash flows over the remaining useful life of the asset. If the amount
of
such estimated undiscounted future cash flows is less than the net book value
of
the asset, the asset is written down to fair value. As of December 31, 2006,
no
such write-down was required.
Accrued
Warranty Costs
The
Company offers a warranty on product sales generally for a one to two-year
period. The Company provides for the estimated future warranty claims on the
date the product is sold. The activity in the warranty accrual during the years
ended December 31, 2006 and 2005 is summarized as follows:
December
31,
|
|||||||
2006
|
2005
|
||||||
Accrual
at beginning of year
|
$
|
204,708
|
$
|
196,890
|
|||
Additions
charged to warranty expense
|
105,000
|
105,000
|
|||||
Expiring
warranties
|
(87,426
|
)
|
(15,308
|
)
|
|||
Claims
satisfied
|
(98,544
|
)
|
(81,874
|
)
|
|||
Accrual
at end of year
|
$
|
123,738
|
$
|
204,708
|
F-11
Revenue
Recognition
The
Company has two distribution channels for its phototherapy treatment equipment.
The Company either (i) sells the laser through a distributor or directly to
a
physician or (ii) places the lasers in physician’s offices (at no charge to the
physician) and charges the physician a fee for an agreed upon number of
treatments. When the Company sells an XTRAC laser to a distributor or directly
to a foreign or domestic physician, revenue is recognized when the following
four criteria under Staff Accounting Bulletin No. 104 have been met: (i) the
product has been shipped and the Company has no significant remaining
obligations; (ii) persuasive evidence of an arrangement exists; (iii) the price
to the buyer is fixed or determinable; and (iv) collection is probable (the
“SAB
104 Criteria”). At times, units are shipped, but revenue is not recognized until
all of the SAB 104 criteria have been met, and until that time, the unit is
carried on the books of the Company as inventory.
The
Company ships most of its products FOB shipping point, although from time to
time certain customers, for example governmental customers, will insist upon FOB
destination. Among the factors the Company takes into account in determining
the
proper time at which to recognize revenue are when title to the goods transfers
and when the risk of loss transfers. Shipments to distributors or physicians
that do not fully satisfy the collection criteria are recognized when invoiced
amounts are fully paid
Under
the
terms of the Company’s distributor agreements, distributors do not have a
unilateral right to return any unit that they have purchased. However, the
Company does allow products to be returned by its distributors for product
defects or other claims.
When
the
Company places a laser in a physician’s office, it recognizes service revenue
based on the number of patient treatments performed by the physician. Treatments
in the form of random laser-access codes that are sold to physicians, but not
yet used, are deferred and recognized as a liability until the physician
performs the treatment. Unused treatments are deemed to remain an obligation
of
the Company because the treatments can only be performed on Company-owned
equipment. Once the treatments are delivered to a patient, this obligation
has
been satisfied.
The
Company excludes all sales of treatment codes made within the last two weeks
of
the period in determining the amount of procedures performed by its
physician-customers. Management believes this approach closely approximates
the
actual amount of unused treatments that existed at the end of a period. For
the
year ended December 31, 2006 and 2005, the Company deferred $506,440 and
$311,571, respectively, under this approach.
In
the
first quarter of 2003, the Company implemented a program to support certain
physicians in addressing treatments with the XTRAC laser system that may be
denied reimbursement by private insurance carriers. The Company recognizes
service revenue from the sale of treatment codes to physicians participating
in
this program only if and to the extent the physician has been reimbursed for
the
treatments. For the year ended December 31, 2006, the Company deferred an
additional $124,427, under this program, as all the SAB 104 Criteria for revenue
recognition had not been met. At December 31, 2006, the Company had net deferred
revenues of $80,697 under this program.
Under
this program, the Company may reimburse qualifying doctors for the cost of
the
Company’s fee but only if they are ultimately denied reimbursement after appeal
of their claim with the insurance company. The key components of the program
are
as follows:
·
|
The
physician practice must be in an identified location where there
is an
insufficiency of insurance companies reimbursing the procedure or
where a
particular practice faces similar insurance
obstacles;
|
·
|
The
program only covers medically necessary treatments of psoriasis as
determined by the treating
physician;
|
F-12
·
|
The
patient must have medical insurance and a claim for the treatment
must be
timely filed with the patient’s insurance company;
|
·
|
Upon
denial by the insurance company (generally within 30 days of filing
a
claim), a standard insurance form called an EOB (“Explanation of
Benefits”) must be submitted to the Company’s in-house appeals group, who
will then prosecute the appeal. The appeal process can take 6 to
9
months;
|
·
|
After
all appeals have been exhausted by the Company and the claim remains
unpaid, the physician is entitled to receive credit for the fee for
the
treatment he or she purchased from the Company on behalf of the patient;
and
|
· |
Physicians
are still obligated to make timely payments for treatments purchased,
irrespective of whether reimbursement is paid or denied. Future sales
of
treatments to a physician can be denied if timely payments are not
made,
even if a patient’s appeal is still in process.
|
The
Company estimates a contingent liability for potential refunds under this
program by reviewing the history of denied insurance claims and appeals
processed. The Company estimates that approximately 4% of the revenues under
this program for the quarter ended December 31, 2006 are subject to being
credited or refunded to the physician. The Company estimated that 11% of the
revenues under this program for the quarter ended December 31, 2005 were subject
to being credited or refunded to the physician.
The
Company generates revenues from its Skin Care business primarily through three
channels. The first is through product sales for skin health, hair care and
wound care; the second is through sales of the copper peptide compound,
primarily to Neutrogena Corporation, a Johnson & Johnson company; and the
third is through royalties generated by our licenses, principally to Neutrogena.
The Company recognizes revenues on the products and copper peptide compound
when
they are shipped, net of returns and allowances. The Company ships the products
FOB shipping point. Royalty revenues are based upon sales generated by our
licensees. The Company recognizes royalty revenue at the applicable royalty
rate
applied to shipments reported by our licensee.
The
Company generates revenues from its Surgical businesses primarily from two
channels. The first is through product sales of laser systems, related
maintenance service agreements, recurring laser delivery systems and laser
accessories, and the second is through per-procedure surgical services. The
Company recognizes revenues from surgical laser and other product sales,
including sales to distributors and other customers, when the SAB 104 Criteria
have been met.
For
per-procedure surgical services, the Company recognizes revenue upon the
completion of the procedure. Revenue from maintenance service agreements is
deferred and recognized on a straight-line basis over the term of the
agreements. Revenue from billable services, including repair activity, is
recognized when the service is provided.
Product
Development Costs
Costs
of
research, new product development and product redesign are charged to expense
as
incurred.
Income
Taxes
The
Company accounts for income taxes in accordance with SFAS No. 109, “Accounting
for Income Taxes.” Under SFAS No. 109, the liability method is used for income
taxes. Under this method, deferred tax assets and liabilities are determined
based on differences between the financial reporting and tax basis of assets
and
liabilities and are measured using enacted tax rates and laws that are expected
to be in effect when the differences reverse.
The
Company’s deferred tax asset has been fully reserved under a valuation
allowance, reflecting the uncertainties as to realizability evidenced by the
Company’s historical results and restrictions on the usage of the net operating
loss carryforwards. Consistent with the rules of purchase accounting, the
historical deferred tax asset of ProCyte was valued at zero when the Company
acquired ProCyte. If and when components of that asset are realized in future,
the goodwill recognized in the acquisition of ProCyte will be reduced.
Net
Loss Per Share
The
Company computes net loss per share in accordance with SFAS No. 128, "Earnings
Per Share." In accordance with SFAS No. 128, basic net loss per share is
calculated by dividing net loss available to common stockholders by the weighted
average number of common shares outstanding for the period. Diluted net loss
per
share reflects the potential dilution from the conversion or exercise of
securities into common stock, such as stock options and warrants.
F-13
In
these
consolidated financial statements, diluted net loss per share is the same as
basic net loss per share. No additional shares for the potential dilution from
the conversion or exercise of securities into common stock are included in
the
denominator since the result would be anti-dilutive. Common stock options and
warrants of 10,840,382, 7,177,955 and 6,464,140 as of December 31, 2006, 2005
and 2004, respectively, were thus excluded from the calculation of fully diluted
earnings per share.
Exchanges
of Nonmonetary Assets
Exchanges
under SFAS No. 153, “Exchanges of Nonmonetary Assets,” are measured based on the
fair value of the assets exchanged. Further, SFAS No. 153 eliminates the
previous narrow exception for nonmonetary exchanges of similar productive assets
and replaces it with a broader exception for exchanges of nonmonetary assets
that do not have “commercial substance.” The Company elected to adopt this
Statement in fiscal year 2005. For the year ended December 31, 2006, the Company
has not recognized any income or expense in accordance with this Statement.
For
the year ended December 31, 2005, the Company has recognized $88,667 recorded
as
Other Income in accordance with this Statement.
Fair
Value of Financial Instruments
The
estimated fair values for financial instruments under SFAS No. 107, “Disclosures
about Fair Value of Financial Instruments,” are determined at discrete points in
time based on relevant market information. These estimates involve uncertainties
and cannot be determined with precision. The fair value of cash is based on
its
demand value, which is equal to its carrying value. The fair values of notes
payable are based on borrowing rates that are available to the Company for
loans
with similar terms, collateral and maturity. The estimated fair values of notes
payable approximate the carrying values. Additionally, the carrying value of
all
other monetary assets and liabilities is estimated to be equal to their fair
value due to the short-term nature of these instruments.
Impairment
of Long-Lived Assets
In
accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of
Long-Lived Assets,” long-lived assets, such as property and equipment, and
purchased intangibles subject to amortization, are reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount
of
an asset may not be recoverable. Recoverability of assets to be held and used
is
measured by a comparison of the carrying amount of an asset to estimated
undiscounted future cash flows expected to be generated by the asset. If the
carrying amount of an asset exceeds its estimated future cash flows, an
impairment charge is recognized in the amount by which the carrying amount
of
the asset exceeds the fair value of the asset. Assets to be disposed of would
be
separately presented in the balance sheet and reported at the lower of the
carrying amount or fair value less costs to sell, and would no longer be
depreciated. The assets and liabilities of a disposed group classified as held
for sale would be presented separately in the appropriate asset and liability
sections of the balance sheet. As of December 31, 2006, no such impairment
exists.
Share-Based
Compensation
On
January 1, 2006, The Company adopted SFAS No. 123R, “Share-Based Payment,” which
requires all companies to measure and recognize compensation expense at fair
value for all stock-based payments to employees and directors. SFAS No. 123R
is
being applied on the modified prospective basis. Prior to the adoption of SFAS
No. 123R, the Company accounted for its stock-based compensation plans for
employees and directors under the recognition and measurement principles of
Accounting Principles Board (APB) Opinion No. 25, “Accounting for Stock Issued
to Employees”, and related interpretations, and accordingly, the Company
recognized no compensation expense related to the stock-based plans for grants
to employees or directors. Grants to consultants under the plans were recorded
under SFAS No. 123.
Under
the
modified prospective approach, SFAS No. 123R applies to new grants of options
and awards of stock as well as to grants of options that were outstanding on
January 1, 2006 and that may subsequently be repurchased, cancelled or
materially modified. Under the modified prospective approach, compensation
cost
recognized for the year ended December 31, 2006 includes compensation cost
for
all share-based payments granted prior to, but not yet vested on, January 1,
2006, based on fair value as of the prior grant-date and estimated in accordance
with the provisions of SFAS No. 123R. Prior periods were not required to be
restated to reflect the impact of adopting the new standard.
F-14
SFAS
No.
123R also requires companies to calculate an initial "pool" of excess tax
benefits available at the adoption date to absorb any tax deficiencies that
may
be recognized under SFAS No. 123R. The pool includes the net excess tax benefits
that would have been recognized if the Company had adopted SFAS No. 123 for
recognition purposes on its effective date. The Company has elected to calculate
the pool of excess tax benefits under the alternative transition method
described in FASB Staff Position ("FSP") No. FAS 123(R)-3, "Transition Election
Related to Accounting for Tax Effects of Share-Based Payment Awards," which
also
specifies the method to calculate excess tax benefits reported on the statement
of cash flows. The Company is in a net operating loss position; therefore,
no
excess tax benefits from share-based payment arrangements have been recognized
for the year ended December 31, 2006.
The
pro-forma information presented in the following table illustrates the effect
on
net income and net income per share if the Company had applied the fair value
recognition provisions of SFAS No. 123, “Accounting for Stock-Based
Compensation,” as amended SFAS No. 148, “Accounting for Stock-Based Compensation
- Transition and Disclosure,” to stock-based employee compensation for the years
ended December 31, 2005 and 2004:
Year
Ended December 31,
|
|||||||
2005
|
2004
|
||||||
Net
loss:
|
|||||||
As
reported
|
($3,936,044
|
)
|
($4,984,196
|
)
|
|||
Less:
stock-based employee compensation expense included in reported net
loss
|
76,737
|
6,266
|
|||||
Impact
of total stock-based compensation expense determined under
fair-value-based method for all grants and awards
|
(1,718,296
|
)
|
(1,540,636
|
)
|
|||
Pro-forma
|
($5,577,603
|
)
|
($6,518,566
|
)
|
|||
Net
loss per share:
|
|||||||
As
reported
|
($0.08
|
)
|
($0.13
|
)
|
|||
Pro-forma
|
($0.11
|
)
|
($0.17
|
)
|
The
Company uses the Black-Scholes option-pricing model to estimate fair value
of
grants of stock options with the following weighted average
assumptions:
|
Year
Ended December 31,
|
|||||||||
Assumptions
for Option Grants
|
2006
|
2005
|
2004
|
|||||||
Risk-free
interest rate
|
4.62
|
%
|
4.04
|
%
|
3.20
|
%
|
||||
Volatility
|
92.48
|
%
|
97.81
|
%
|
99.3
|
%
|
||||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||
Expected
life
|
7.50
years
|
5
years
|
5
years
|
|||||||
Estimated
forfeiture rate
|
16
|
%
|
N/A
|
N/A
|
The
Company calculates expected volatility for a share-based grant based on historic
daily stock price observations of our common stock during the period immediately
preceding the grant that is equal in length to the expected term of the grant.
For estimating the expected term of share-based grants made in the year ended
December 31, 2006, the Company has adopted the simplified method authorized
in
Staff Accounting Bulletin No. 107. SFAS No. 123R also requires that estimated
forfeitures be included as a part of the estimate of expense as of the grant
date. The Company has used historical data to estimate expected employee
behaviors related to option exercises and forfeitures. Prior to our adoption
of
SFAS No. 123R, the Company reduced pro-forma share-based compensation expense,
presented in the notes to its financial statements, for actual forfeitures
as
they occurred.
With
respect to both grants of options and awards of restricted stock, the risk
free
rate of interest is based on the U.S. Treasury rates appropriate for the
expected term of the grant or award.
With
respect to awards of restricted stock, the Company uses the Monte-Carlo pricing
model to estimate fair value of restricted stock awards made in the first
quarter 2006 with the following weighted average assumptions:
Assumptions
for Stock Awards
|
Year
Ended December 31, 2006
|
|||
Risk-free
interest rate
|
4.32
|
%
|
||
Volatility
|
70
|
%
|
||
Expected
dividend yield
|
0
|
%
|
||
Expected
Life
|
4.92
years
|
F-15
The
Company calculated expected volatility for restricted stock based on historic
daily stock price observations of our common stock during the three-year period
immediately preceding the award.
Options
that were assumed from ProCyte and that were unvested as of March 18, 2005
were
re-measured as of March 18, 2005 under intrinsic-value-based accounting.
Unearned or deferred compensation of $132,084 was recorded and is being
amortized over the remaining vesting period, which is an average of two years.
The Company recognized $55,347 and $76,737 of such expense in the years ended
December 31, 2006 and 2005, respectively.
There
was
$990,372 and $314,174 of compensation expense related to stock options granted
and restricted stock awarded, respectively, in the year ended December 31,
2006.
This expense is recognized in the operating results in selling, general and
administrative expenses. For stock options granted to consultants, an additional
selling, general, and administrative expense in the amount of $132,624, $123,257
and $98,435 was recognized during the years ended December 31, 2006, 2005 and
2004, respectively.
Supplemental
Cash Flow Information
During
the year ended December 31, 2006, the Company financed insurance policies
through notes payable for $763,982, financed certain credit facility costs
for
$160,279, financed a license agreement with a note payable of $77,876 and issued
warrants to a leasing credit facility which are valued at $104,388, and which
offset the carrying value of debt. In March 2006, the Company issued 101,010
shares of its restricted common stock to Stern Laser srl (“Stern”) due upon
achievement of a milestone under the Master Purchase Agreement with Stern.
The
cost associated with this issuance is included in the license from Stern, which
is found in patents and licensed technologies. In March 2006, the Company also
issued 200,000 shares of its restricted common stock to AzurTec, Inc.
(“AzurTec”) as part of an investment in the capital stock of AzurTec as well as
for a license agreement on AzurTec technology, both existing and to be developed
in the future.
In
connection with the purchase of ProCyte in March 2005, the Company issued
10,540,579 shares of common stock and assumed options to purchase 1,354,973
shares of its own common stock (see Note 2).
During
the year ended December 31, 2005, the Company financed insurance policies
through notes payable for $978,252. During the year ended December 31, 2005,
the
Company issued 345,477 shares of its restricted common stock to Stern upon
attainment of certain milestones, which is included in patents and licensed
technologies.
During
the year ended December 31, 2004, the Company financed insurance policies
through notes payables for $530,977, financed vehicle purchases of $181,578
under capital leases, financed certain credit facility costs for $217,695 and
issued warrants to a leasing credit facility which were valued at $80,462,
and
which offset the carrying value of debt. In connection with the purchase of
the
Stern license and prototypes, the company issued 113,877 shares of common
stock.
For
the
years ended December 31, 2006, 2005 and 2004, the Company paid interest of
$670,839, $403,376 and $181,115, respectively. Income taxes paid in the years
ended December 31, 2006, 2005 and 2004 were immaterial.
Recent
Accounting Pronouncements
In
February 2007, the Financial Accounting Standards Board (“FASB”) issued SFAS No.
159, "The Fair Value Option for Financial Assets and Financial Liabilities."
This Statement permits entities to choose to measure many financial instruments
and certain other items at fair value that are not currently required to be
measured at fair value. The objective is to improve financial reporting by
providing entities with the opportunity to mitigate volatility in reported
earnings caused by measuring related assets and liabilities differently without
having to apply complex hedge accounting provisions. This statement also
establishes presentation and disclosure requirements designed to facilitate
comparisons between entities that choose different measurement attributes for
similar types of assets and liabilities. This Statement is effective for
financial statements issued for fiscal years beginning after November 15, 2007
and will become effective for us beginning with the first quarter of 2008.
We
have not yet determined the impact of the adoption of SFAS No. 159 on our
financial statements and footnote disclosures.
F-16
In
September 2006, the
FASB
issued
SFAS No. 157, “Fair Value Measurements,” which is effective for the Company on
January 1, 2008. The Statement defines fair value, establishes a framework
for
measuring fair value in accordance with generally accepted accounting
principles, and expands disclosures about fair value measurements. The Statement
codifies the definition of fair value as the price that would be received to
sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. The standard clarifies the
principle that fair value should be based on the assumptions market participants
would use when pricing the asset or liability and establishes a fair value
hierarchy that prioritizes the information used to develop those assumptions.
The
adoption of this Statement is not expected to have a material effect on the
Company’s consolidated financial statements.
In
September 2006, the SEC staff issued Staff Accounting Bulletin (SAB) Topic
1N
(SAB No. 108), “Financial Statements — Considering the Effects of Prior Year
Misstatements when Quantifying Misstatements in Current Year Financial
Statements,” which is effective for calendar year companies as of December 31,
2006. SAB No. 108 provides guidance on how prior-year misstatements should
be
taken into consideration when quantifying misstatements in current-year
financial statements for purposes of determining whether the financial
statements are materially misstated. Under this guidance, companies should take
into account both the effect of a misstatement on the current-year balance
sheet
as well as the impact upon the current-year income statement in assessing the
materiality of a current-year misstatement. Once a current-year misstatement
has
been quantified, the guidance in SAB Topic 1M, “Financial Statements —
Materiality,” (SAB No. 99) will be applied to determine whether the misstatement
is material. The
adoption of this Statement has not had a material effect on the Company’s
consolidated financial statements.
In
July
2006, the FASB issued FASB Interpretation No. 48, “Accounting for Uncertainty in
Income Taxes - an Interpretation of FASB Statement No. 109”. This Interpretation
prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to
be
taken in a tax return. This Interpretation also provides guidance on
derecognition, classification, interest and penalties, accounting in interim
periods, disclosure, and transition. The Interpretation is effective for fiscal
years beginning after December 15, 2006. The
Company does not believe that its historical or expected tax reporting
positions, which considered before application of the valuation allowance,
will
have a material impact on its consolidated financial statements.
See
Note 13, Income Taxes.
Note
2
Acquisitions:
ProCyte
Transaction
On
March
18, 2005, the Company completed the acquisition of ProCyte Corporation, which
was organized in 1986. ProCyte develops, manufactures and markets products
for
skin health, hair care and wound care. Many of the Company’s products
incorporate its patented copper peptide technologies.
The
aggregate purchase price of $28,086,208 consisted of the issuance of 10,540,579
shares of the Company’s common stock valued at $2.29 per share, the assumption
of 1,354,973 common stock options valued at $2,033,132 net of deferred
compensation of $132,084, and the incurrence of $1,915,150 of transaction costs.
The merger consideration was based on a fixed exchange ratio of 0.6622 shares
of
PhotoMedex common stock for each share of ProCyte common stock. As the exchange
ratio was fixed, the fair value of PhotoMedex’s common stock for accounting
purposes was based on a stock price of $2.29 per share, which was the average
of
the closing prices on the date of the announcement of the planned merger and
the
two days prior and afterwards.
F-17
Based
on
the purchase price allocation, the following table summarizes the estimated
fair
value of the assets acquired and liabilities assumed at the date of acquisition:
Cash
and cash equivalents
|
$
|
6,272,540
|
||
Accounts
receivable
|
1,137,413
|
|||
Inventories
|
2,845,698
|
|||
Prepaid
expenses and other current assets
|
134,574
|
|||
Property
and equipment
|
340,531
|
|||
Patents
and licensed technologies
|
200,000
|
|||
Other
intangible assets
|
5,200,000
|
|||
Other
assets
|
38,277
|
|||
Total
assets acquired
|
16,169,033
|
|||
Accounts
payable
|
(605,520
|
)
|
||
Accrued
compensation and related expenses
|
(158,610
|
)
|
||
Other
accrued liabilities
|
(1,143,761
|
)
|
||
Deferred
revenues
|
(95,436
|
)
|
||
Other
liabilities
|
(52,883
|
)
|
||
Total
liabilities assumed
|
(2,056,210
|
)
|
||
Net
assets acquired
|
$
|
14,112,823
|
The
purchase price exceeded the fair value of the net assets acquired by
$13,973,385, which was recorded as goodwill. The increase in goodwill recognized
in the year ended December 31, 2006 reflects management’s best estimate of
pre-acquisition contingencies based upon plans entered into prior to March
18,
2006.
The
accompanying consolidated financial statements do not include any revenues
or
expenses related to the acquisition on or prior to March 18, 2005, the closing
date. Following are the Company’s unaudited pro-forma results for the years
ended December 31, 2006 and 2005, assuming the acquisition had occurred on
January 1, 2005:
Year
Ended December 31,
|
|||||||
2006
|
2005
|
||||||
Net
revenues
|
$
|
33,189,877
|
$
|
31,354,068
|
|||
Net
loss
|
($7,492,397
|
)
|
($4,038,193
|
)
|
|||
Basic
and diluted loss per share
|
($0.14
|
)
|
($0.08
|
)
|
|||
Shares
used in calculating basic and diluted loss per share
|
54,188,914
|
50,932,410
|
These
unaudited pro-forma results have been prepared for comparative purposes only
and
do not purport to be indicative of the results of operations which would have
actually resulted had the acquisition occurred on January 1, 2005, nor to be
indicative of future results of operations.
The
Company has realized on some, but not all of these goals. The Company has
recently engaged a new senior officer to direct the operations of the Skin
Care
business. For the time being, the Company will concentrate less on the
cross-integration of the ProCyte sales personnel into sales of the XTRAC system
and more on focusing the ProCyte sales personnel on growth of the skincare
sales.
Stern
Laser Transaction
On
September 7, 2004, the Company closed the transactions provided for in the
Master Asset Purchase Agreement (the “Master Agreement”) with Stern. In March
2006, the Company issued an additional 101,010 shares of its restricted common
stock to Stern based on a milestone set forth in the Master Agreement. As of
December 31, 2006, the Company has issued an aggregate of 589,854 shares of
its
restricted common stock to Stern in connection with the Master Agreement. The
Company also agreed to pay Stern up to an additional $250,000 based on the
achievement of two remaining milestones. The Company retains the right to pay
these conditional sums in cash or in shares of its common stock, at its sole
discretion. To provide for the issuance of shares, the Company has reserved
for
issuance, and placed into escrow, 110,136 shares of its unregistered stock.
The
per-share price of any shares issued in the future will be the average closing
price of the Company’s common stock during the 10 trading days ending on the
date of achievement of a particular milestone. Stern also has served as the
distributor of the Company’s XTRAC laser system in South Africa and Italy since
2000. The primary asset acquired from Stern in the transaction is a license
for
Stern’s lamp-based technology, which was carried on the Company’s books at
$1,013,009, net, as of December 31, 2006. Amortization of this intangible is
on
a straight-line basis over 10 years and began in January 2005. In the year
ended
December 31, 2006, Stern purchased $35,333 of products from the
Company.
F-18
AzurTec
Transaction
On
March
30, 2006, the Company closed the transaction provided for in the Investment
Agreement with AzurTec. The Company issued 200,000 shares of its restricted
common stock in exchange for 6,855,141 shares of AzurTec common stock and
181,512 shares of AzurTec Class A preferred stock, which represents a 14%
interest in AzurTec, on a fully diluted basis. In accordance with APB No. 18,
and related interpretations, the Company accounts for its investment in AzurTec
on the cost basis.
The
Company also received a license from AzurTec with respect to its existing and
future technology for the MetaSpex Laboratory System. The license gives the
Company rights to manufacture and market the ex vivo versions of the MetaSpex
product in exchange for certain royalty obligations. The license also provides
the Company certain rights on a potential in situ version of the MetaSpex
product. AzurTec remains responsible for the development and clinical trial
costs of the MetaSpex products, for which AzurTec is committed to raise
additional equity capital. AzurTec has contracted with the Company to resume
development work of the ex vivo versions of the MetaSpex product. The Company
will resume, and be paid for, such work once AzurTec has raised additional
equity capital and has settled its prior indebtedness owed to the Company for
development work. The Company has extended by 12 months the time in which
AzurTex may raise such additional capital.
The
Company assigned $268,291 as the fair value of the investment in AzurTec. It
also assigned $114,982 as the fair value of the license it acquired from
AzurTec, which is carried on the Company’s books at $106,358, net at December
31, 2006. Amortization of this intangible is on a straight-line basis over
10
years, which began in April 2006.
Mount
Sinai License
On
March
31, 2006, the Mount Sinai School of Medicine of New York University granted
the
Company an exclusive license, effective April 1, 2006, to use Mount Sinai's
patented methodology for utilization of ultraviolet laser light for the
treatment of vitiligo. The licensed patent is US Patent No. 6,979,327, Treatment
of Vitiligo. It was issued December 27, 2005, and the inventor is James M.
Spencer, MD, a member of the Company’s Scientific Advisory Board. The license is
carried on the Company’s books at $72,035, net at December 31, 2006.
Amortization of this intangible is on a straight-line basis over 10 years,
which
began in April 2006.
Note
3
Inventories:
Set
forth
below is a detailed listing of inventories.
December
31,
|
|||||||
2006
|
2005
|
||||||
Raw
materials and work-in-process
|
$
|
4,433,917
|
$
|
4,998,847
|
|||
Finished
goods
|
2,867,778
|
3,048,597
|
|||||
Total
inventories
|
$
|
7,301,695
|
$
|
8,047,444
|
Work-in-process
is immaterial given the typically short manufacturing cycle, and therefore
is
disclosed in conjunction with raw materials. Finished goods includes $0 and
$69,963 as of December 31, 2006 and 2005, respectively, for laser systems
shipped to distributors, but not recognized as revenue until all the criteria
of
Staff Accounting Bulletin No. 104 have been met. At times, units are shipped
but
revenue is not recognized until all of the criteria are met, and until that
time, the unit is carried on the books of the Company as inventory. The Company
ships most of its products FOB shipping point, although from time to time
certain customers, for example governmental customers, will insist on FOB
destination. Among the factors the Company takes into account in determining
the
proper time at which to recognize revenue are when title to the goods transfers
and when the risk of loss transfers. Shipments to the distributors that do
not
fully satisfy the collection criteria are recognized when invoiced amounts
are
fully paid. As of December 31, 2006 and 2005, the Company carried reserves
against its inventories of $1,354,444 and $931,719, respectively.
F-19
Note
4
Property
and Equipment:
Set
forth
below is a detailed listing of property and equipment.
December
31,
|
|||||||
2006
|
2005
|
||||||
Lasers
in service
|
$
|
16,234,834
|
$
|
12,657,701
|
|||
Computer
hardware and software
|
334,490
|
334,490
|
|||||
Furniture
and fixtures
|
331,379
|
338,089
|
|||||
Machinery
and equipment
|
738,636
|
755,565
|
|||||
Autos
and trucks
|
382,690
|
382,690
|
|||||
Leasehold
improvements
|
247,368
|
238,276
|
|||||
18,269,397
|
14,706,811
|
||||||
Accumulated
depreciation and amortization
|
(9,215,299
|
)
|
(7,662,098
|
)
|
|||
Property
and equipment, net
|
$
|
9,054,098
|
$
|
7,044,713
|
Depreciation
expense was $2,939,909 in 2006, $2,226,933 in 2005 and $1,596,154 in 2004.
At
December 31, 2006 and 2005, net property and equipment included $380,875 and
$530,191, respectively, of assets recorded under capitalized lease arrangements,
of which $122,717 and $302,710, respectively, of the capital lease obligation
was included in long-term debt at December 31, 2006 and 2005 (see Note
9).
Note
5
Patents
and Licensed Technologies:
Set
forth
below is a detailed listing of patents and licensed technologies.
December
31,
|
|||||||
2006
|
2005
|
||||||
Patents,
owned and licensed, at gross costs of $501,657 and $438,939 net of
accumulated amortization of $231,599 and $194,659,
respectively
|
$
|
270,058
|
$
|
244,280
|
|||
Other
licensed and developed technologies, at gross costs of $2,432,258
and
$2,047,665, net of accumulated amortization of $1,006,589 and $714,391,
respectively
|
1,425,669
|
1,333,274
|
|||||
Total
patents and licensed technologies, net
|
$
|
1,695,727
|
$
|
1,577,554
|
Related
amortization expense was $329,138, $257,894 and $169,790 for the years ended
December 31, 2006, 2005 and 2004, respectively. Included in other licensed
and developed technologies is $200,000 in developed technologies acquired from
ProCyte and $114,982 for the license with AzurTec (see Note 2). On March 31,
2006, the Company closed the transaction provided for in the License Agreement
with Mount Sinai School of Medicine of New York University (“Mount Sinai”).
Pursuant to the license agreement, the Company must reimburse $77,876 to Mount
Sinai, over the first 18 months of the license term and at no interest, for
patent prosecution costs incurred. The Company is also obligated to pay Mount
Sinai a royalty on a combined base of domestic sales of XTRAC treatment codes
used for psoriasis as well as for vitiligo. In the first four years of the
license, however, Mount Sinai may elect to be paid royalties on an alternate
base, comprised simply of treatments for vitiligo, but at a higher royalty
rate
than the rate applicable to the combined base. This technology is for the laser
treatment of vitiligo and is included in other licensed and developed
technologies.
Estimated
amortization expense for amortizable intangible assets for the next five years
is $275,000 in 2007, $190,000 in 2008, $190,000 in 2009, $190,000 in 2010,
$190,000 in 2011 and $663,000 thereafter.
F-20
Note
6
Other
Intangible Assets:
Set
forth
below is a detailed listing of other intangible assets, all of which were
acquired from ProCyte and which have been recorded at their appraised fair
market values:
December
31,
|
|||||||
2006
|
2005
|
||||||
Neutrogena
Agreement, at gross cost of $2,400,000 net of accumulated amortization
of
$858,000 and $378,000, respectively.
|
$
|
1,542,000
|
$
|
2,022,000
|
|||
Customer
Relationships, at gross cost of $1,700,000 net of accumulated amortization
of $607,743 and $267,747, respectively.
|
1,092,257
|
1,432,253
|
|||||
Tradename,
at gross cost of $1,100,000 net of accumulated amortization of $196,632
and $86,628, respectively.
|
903,368
|
1,013,372
|
|||||
$
|
3,537,625
|
$
|
4,467,625
|
Related
amortization expense was $930,000 and $732,375 for 2006 and 2005, respectively.
Estimated amortization expense for amortizable intangible assets for the next
five years is $930,000 in 2007, $930,000 in 2008, $930,000 in 2009, $284,000
in
2010, $110,000 in 2011 and $353,000 thereafter. Under the Neutrogena Agreement,
the Company has licensed to Neutrogena rights to its copper peptide technology
and for which the Company receives royalties. Customer Relationships embody
the
value to the Company of relationships that ProCyte had formed with its
customers. Tradename includes the name of “ProCyte” and various other trademarks
associated with ProCyte’s products.
Note
7
Other
Accrued Liabilities:
Set
forth
below is a detailed listing of other accrued liabilities.
December
31,
|
|||||||
|
2006
|
|
2005
|
||||
Accrued
professional and consulting fees
|
$
|
320,331
|
$
|
437,396
|
|||
Accrued
warranty
|
123,738
|
204,708
|
|||||
Accrued
sales taxes and other expenses
|
213,224
|
282,864
|
|||||
Total
other accrued liabilities
|
$
|
657,293
|
$
|
924,968
|
F-21
Note
8
Notes
Payable:
Set
forth
below is a detailed listing of notes payable. The stated interest rate
approximates the effective cost of funds from the notes.
December
31,
|
|||||||
2006
|
2005
|
||||||
Note
payable - secured creditor, interest at 16.47%, payable in monthly
principal and interest installments of $2,618 through December
2006.
|
$
|
-
|
$
|
26,736
|
|||
Note
payable - unsecured creditor, interest at 7.42%, payable in monthly
principal and interest installments of $61,493 through February
2007.
|
126,279
|
177,450
|
|||||
Note
payable - unsecured creditor, interest at 6%, payable in monthly
principal
and interest installments of $2,880 through June 2012.
|
159,213
|
183,425
|
|||||
Note
payable - unsecured creditor, interest at 0%, payable in monthly
principal
installments of $4,326 through October 2007
|
43,265
|
-
|
|||||
328,757
|
387,611
|
||||||
Less:
current maturities
|
(195,250
|
)
|
(228,398
|
)
|
|||
Notes
payable, net of current maturities
|
$
|
133,507
|
$
|
159,213
|
Aggregate
maturities of the notes payable as of December 31, 2006 are $195,250 in 2007,
$27,292 in 2008, $28,975 in 2009, $30,762 in 2010 and $46,477
thereafter.
F-22
Note
9
Long-term
Debt:
Set
forth
below is a detailed listing of the Company’s long-term debt:
December
31, 2006
|
December
31, 2005
|
||||||
Borrowings
on credit facility:
|
|||||||
Draw
1 - effective interest at 17.79%, payable in monthly principal and
interest installments of $48,156 through June 2007.
|
$
|
279,396
|
$
|
792,362
|
|||
Draw
2 - effective interest at 17.14%, payable in monthly principal and
interest installments of $9,957 through September 2007.
|
85,646
|
189,543
|
|||||
Draw
3 - effective interest at 17.61%, payable in monthly principal and
interest installments of $4,797 through December 2007.
|
54,150
|
102,541
|
|||||
Draw
4 - effective interest at 12.62%, payable in monthly principal and
interest installments of $34,859 through June 2008.
|
580,501
|
922,350
|
|||||
Draw
5 - effective interest at 12.94%, payable in monthly principal and
interest installments of $28,757 through September 2008.
|
550,546
|
823,810
|
|||||
Draw
6 - effective interest at 13.36%, payable in monthly principal and
interest installments of $28,923 through December 2008.
|
622,508
|
895,524
|
|||||
Draw
7 - effective interest at 13.74%, payable in monthly principal and
interest installments of $40,887 through March 2009.
|
973,474
|
-
|
|||||
Draw
8 - effective interest at 13.45%, payable in monthly principal and
interest installments of $40,155 through June 2009.
|
1,052,037
|
-
|
|||||
Draw
9 - effective interest at 13.10%, payable in monthly principal
and interest installments of $40,193 through September
2009.
|
1,148,960
|
-
|
|||||
Draw
10 - effective interest at 12.69%, payable in monthly principal
and interest installments of $36,580 through December
2009.
|
1,142,859
|
-
|
|||||
Total
borrowings on credit facility
|
$
|
6,490,077
|
$
|
3,726,130
|
|||
Capital
lease obligations (see Note 4)
|
122,717
|
302,710
|
|||||
Less:
current portion
|
(3,018,874
|
)
|
(1,749,969
|
)
|
|||
Total
long-term debt
|
$
|
3,593,920
|
$
|
2,278,871
|
Leasing
Credit Facility
The
Company entered into a leasing credit facility with GE Capital Corporation
(“GE”) on June 25, 2004. The credit facility has a commitment term of three
years, expiring on June 25, 2007. For each year of the term, called a “tranche,”
various parameters are set or re-set. The Company accounts for each draw as
funded indebtedness taking the form of a capital lease, with equitable ownership
in the lasers remaining with the Company. GE retains title as security for
the
borrowings. The Company depreciates the lasers generally over their remaining
useful lives, as established when originally placed into service. Each draw
against the credit facility has a self-amortizing repayment period of three
years and is secured by specified lasers, which the Company has sold to GE
and
leased back for continued deployment in the field.
Under
the
first tranche, GE made available $2,500,000 under the line. A draw under that
tranche is set at an interest rate based on 522 basis points above the
three-year Treasury note rate. Each such draw is discounted by 7.75%; the first
monthly payment is applied directly to principal. With each draw, the Company
agreed to issue warrants to purchase shares of the Company’s common stock equal
to 5% of the draw. The number of warrants is determined by dividing 5% of the
draw by the average closing price of the Company’s common stock for the ten days
preceding the date of the draw. The warrants have a five-year term from the
date
of each issuance and bear an exercise price set at 10% over the average closing
price of the Company’s common stock for the ten days preceding the date of the
draw.
F-23
For
reporting purposes, the carrying value of the liability is reduced at the time
of each draw by the value ascribed to the warrants. This reduction will be
amortized at the effective interest rate to interest expense over the term
of
the draw.
The
Company has accounted for these warrants as equity instruments in accordance
with EITF 00-19, "Accounting for Derivative Financial Instruments Indexed to,
and Potentially Settled in, a Company's Own Stock" since there is no option
for
cash or net-cash settlement when the warrants are exercised.
The
Company obtained a second tranche under the leasing credit facility for
$5,000,000 on June 28, 2005. The Company accounts for draws under this second
tranche in the same manner as under the first tranche except that: (i) the
stated interest rate is set at 477 basis points above the three-year Treasury
note rate; (ii) each draw is discounted by 3.50%; and (iii) with each draw,
the
Company has agreed to issue warrants to purchase shares of the Company’s common
stock equal to 3% of the draw. The number of warrants is determined by dividing
3% of the draw by the average closing price of the Company’s common stock for
the ten trading days preceding the date of the draw.
The
Company obtained a third tranche under the leasing credit facility for
$5,000,000 on June 30, 2006. The Company accounts for draws under the third
tranche in the same manner as under the second tranche except that the stated
interest rate is set at 400 basis points above the three-year Treasury note
rate. Draws 8, 9 and 10 were taken against the third tranche.
The
Company made the following draws against the line for 2006, as follows:
Draw
7
|
Draw
8
|
Draw
9
|
Draw
10
|
||||||||||
Date
of draw
|
3/29/06
|
6/30/06
|
9/29/06
|
12/29/06
|
|||||||||
Amount
of draw
|
$
|
1,287,487
|
$
|
1,268,362
|
$
|
1,276,949
|
$
|
1,164,743
|
|||||
Stated
interest rate
|
9.45
|
%
|
9.22
|
%
|
8.80
|
%
|
8.64
|
%
|
|||||
Effective
interest rate
|
13.74
|
%
|
13.45
|
%
|
13.10
|
%
|
12.69
|
%
|
|||||
Number
of warrants issued
|
20,545
|
24,708
|
25,038
|
32,057
|
|||||||||
Exercise
price of warrants per share
|
$
|
2.06
|
$
|
1.69
|
$
|
1.68
|
$
|
1.20
|
|||||
Fair
value of warrants
|
$
|
27,853
|
$
|
26,548
|
$
|
28,103
|
$
|
21,884
|
|||||
The
fair
value of the warrants granted under the draws is estimated using the
Black-Scholes option-pricing model with the following weighted average
assumptions applicable to the warrants granted:
Warrants
granted under Draw 7
|
Warrants
granted under Draw 8
|
Warrants
granted under Draw 9
|
Warrants
granted under Draw 10
|
||||||||||
Risk-free
interest rate
|
4.79
|
%
|
5.18
|
%
|
4.59
|
%
|
4.69
|
%
|
|||||
Volatility
|
87.16
|
%
|
84.17
|
%
|
84.52
|
%
|
72.53
|
%
|
|||||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
0
|
%
|
|||||
Expected
warrant life
|
5
years
|
5
years
|
5
years
|
5
years
|
As
of
December 31, 2006, the Company had available $1,289,946 from the third tranche
of the line of credit from which to draw on in the future.
Future
minimum payments for draws under the lease credit facility are as
follows:
Year
Ending December 31,
|
||||
2007
|
$
|
3,390,008
|
||
2008
|
2,653,838
|
|||
2009
|
1,156,660
|
|||
Total
minimum lease obligation
|
7,200,506
|
|||
Less:
interest
|
(710,429
|
)
|
||
Present
value of total minimum lease obligation
|
$
|
6,490,077
|
F-24
GE
Capital Corporation has proposed a fourth tranche under the leasing credit
facility for 2007. The tranche would be for $6,000,000, would bear interest
at
375 basis points above the three-year Treasury rate, and would reduce warrants
to 2% of a draw. The Company has accepted the proposal. Consummation of the
transaction is expected to close during the first quarter of 2007.
Capital
Leases
The
obligations under capital leases are at fixed interest rates of 7.06% to 10.68%
and are collateralized by the related property and equipment (see Note
4).
Future
minimum payments for property under capital leases are as follows:
Year
Ending December 31,
|
||||
2007
|
$
|
89,742
|
||
2008
|
40,952
|
|||
Total
minimum lease obligation
|
130,694
|
|||
Less:
interest
|
(7,977
|
)
|
||
Present
value of total minimum lease obligation
|
$
|
122,717
|
Note
10
Warrant
Exercises:
In
the
year ended December 31, 2006, the Company received $168,000 from the exercise
of
140,000 warrants. The warrants were issued in connection with a private
placement of securities in June 2002 and bore an exercise price of
$2.00.
In
the
year ended December 31, 2005, the Company received $147,060 from the exercise
of
73,530 warrants. The warrants were issued in connection with a private placement
of securities in June 2002 and bore an exercise price of $2.00.
In
the
year ended December 31, 2004, 2,104,147 warrants on the common stock of the
Company were exercised, resulting in an increase to the Company’s shares
outstanding as of the end of the period by the same amount. The Company received
$3,086,468 in cash proceeds from the exercises. Of these proceeds, $803,456
was
from the exercise of warrants that were exercisable at $1.77 per share and
were
set to expire on March 31, 2004 and $1,226,112 was from the exercise of warrants
that were exercisable at $1.16 per share and were set to expire on
September 30, 2004. See also Common
Stock Warrants
in
Note
12.
F-25
Note
11
Commitments
and Contingencies:
Leases
The
Company has entered into various non-cancelable operating leases for personal
property that expire at various dates through 2011. Rent expense was $601,062,
$558,683 and $456,077 for the years ended December 31, 2006, 2005 and 2004,
respectively. The future annual minimum payments under these non-cancelable
operating leases are as follows:
Year
Ending December 31,
|
||||
2007
|
$
|
503,186
|
||
2008
|
373,788
|
|||
2009
|
337,178
|
|||
2010
|
325,380
|
|||
Thereafter
|
306,002
|
|||
Total
|
$
|
1,845,534
|
Litigation
In
the
matter brought by the Company against RA Medical Systems, Inc. (“RA Medical”)
and Dean Irwin in the United States District Court for the Southern District
of
California, the trial judge declined to issue to defendants summary judgment
based on their theory of res judicata. On the other hand, the trial judge
declined to issue to the Company partial summary judgment for unfair
competition, which had been based on the fact that RA Medical did not have
the
requisite permission from the State of California to market its medical device.
The declination of the Company’s claim for relief was based on reasons that the
Company believes will not bar this claim for relief in the other pending
Federal action, discussed in the paragraph below. The trial judge further
declined to consolidate this Federal action brought by the Company with the
Federal action brought by RA Medical and Mr. Irwin, discussed below. Pretrial
is
scheduled for the Spring of 2007, but no trial date has been set. In this
action, there are no counterclaims that the Company must defend against.
In
the
matter brought in California Superior Court by RA Medical and Mr. Irwin against
the Company for unfair competition, the Company removed the State action to
Federal court. Plaintiffs’ claim is that the Company did not have the requisite
permission to market its excimer medical device from its new facility in
Carlsbad The Company has counterclaimed for, among other things, contractual
interference, misappropriation of our technology and unfair competition under
Federal and State statutes. The plaintiffs brought a motion to dismiss the
latter two counterclaims, based in part on an alleged bar under the applicable
statutes of limitations. The trial judge has not ruled on the motion. Discovery
has been stayed, pending the judge’s ruling. Among the Company’s claims of
unfair competition is a claim based on RA Medical’s lack of requisite permission
from the State of California to market its medical device.
In
the
matter brought for malicious prosecution in California Superior Court by RA
Medical Systems and Mr. Irwin against the Company, Jenkens & Gilchrist, LLP
(the Company’s then outside counsel) and Michael R. Matthias, Esq. (the
litigation partner at Jenkens & Gilchrist), trial is set for May 2007. The
parties are conducting discovery. Morgan, Lewis & Bockius has been engaged
to defend the Company.
In
June
2006, the insurance carrier that had undertaken to indemnify the Company in
the
malicious prosecution action, discussed in the paragraph above, and that had
for
18 months been defending the Company, recanted its undertaking to indemnify
the
Company. It recanted on two grounds: first, that malicious prosecution is an
intentional tort and therefore is non-indemnifiable, and then later on a second
ground that the alleged tort occurred after the period of coverage of its
underlying policy had expired. The Company notified the subsequent insurance
carrier in whose coverage period the alleged tort occurred. That carrier has
undertaken to defend the Company, but has denied its duty to indemnify the
Company, based on the same ground that malicious tort is a non-indemnifiable
tort. The Company has rejected this ground and brought, through Morgan, Lewis
& Bockius, an action in the U.S. District Court for the Eastern District of
Pennsylvania for breach of contract and for declaratory judgment on the issue
whether malicious prosecution is indemnifiable under our insurance policy.
Counsel for the carrier has agreed with the Company’s counsel at Morgan, Lewis
that the issue for declaratory judgment is a question of law.
F-26
The
Company is involved in certain other legal actions and claims arising in the
ordinary course of business. Management believes, based on discussions with
legal counsel, that such litigation and claims will be resolved without a
material effect on the Company's consolidated financial position, results of
operations or liquidity.
Employment
Agreements
The
Company has severance agreements with certain key executives and employees
that
create certain liabilities in the event of their termination of employment
without cause, or following a change in control of the Company. The aggregate
commitment under these executive severance agreements, should all covered
executives and employees be terminated other than for cause, was approximately
$1,676,843 as of December 31, 2006. Should all covered executives be terminated
following a change in control of the Company, the aggregate commitment under
these executive severance agreements at December 31, 2006 was approximately
$2,146,482.
Restricted
Securities and Warrants
If
Stern
Laser fulfills the either or both of the two remaining milestones under the
Master Asset Purchase Agreement, then the Company will be obliged to issue
to
Stern Laser restricted shares of its common stock. Against this contingency,
an
escrow agent holds 110,136 shares of the Company’s common stock. The Company
deems it to be remote that Stern Laser will fulfill one milestone valued in
the
Master Agreement at $150,000, and deems it to be reasonably possible that the
other milestone, valued in the Agreement at $100,000, will be attained.
If
AzurTec succeeds in raising the additional equity capital called for in the
Investment Agreement, then the Company will be obliged to issue to AzurTec
warrants on 100,000 shares of the Company’s common stock. Such warrants will
have a five-year
life and be exercisable in full but the first six months of the life; the
warrants will have an exercise price equal to 90% of the mean of the closing
prices of PhotoMedex common stock on Nasdaq for the 30 trading days preceding
the issuance of the warrants.
If
an
investor participating in the November 2006 private placement exercises a
warrant received in the placement, then Cowen & Company is entitled to a
6.5% commission on the gross proceeds to the Company from such exercise. If
all
such warrants are exercised, then the Company will receive $3,904,000 and will
owe Cowen & Company $253,760 in commissions.
The
Company is obliged to use reasonable efforts to register the shares underlying
the warrants issued to GE Capital Corporation under Draws 8, 9 and
10.
Note
12
Stockholders’
Equity:
Common
Stock
As
of
December 31, 2006, the Company had issued 589,864 shares of its restricted
common stock in connection with the Asset Purchase agreement with Stern Laser
Srl, or Stern, of which 113,877 shares had been issued in September 2004 and
248,395 in June 2005, 126,582 in December 2005 and 101,010 in March
2006.
On
November 3, 2006, the Company closed on a private placement for 9,760,000 shares
of common stock at $1.17 per share resulting in gross proceeds of $11,419,200.
The closing price of the Company’s common stock on November 1, 2006 was $1.27
per share. In connection with this private placement, the Company paid
commissions and other expenses of $864,308, resulting in net proceeds of
$10,554,892. In addition, the investors received warrants to purchase 2,440,000
shares of common stock at an exercise price of $1.60 per share, and Cowen &
Company, the placement agent, received warrants to purchase 244,000 shares
of
common stock, under the same terms and conditions as the warrants issued to
the
investors. As such the warrants have a five-year term and will become
exercisable on May 1, 2007 (see Common
Stock Warrants
below).
Cowen & Company is entitled to a 6.5%
commission on any proceeds to the Company from future exercises by the investors
of their warrants. The warrants issued to Cowen & Company were in
consideration of its services as the placement agent and have a value under
the
Black Scholes method of approximately $200,000. The Company has used the
proceeds of this financing to pay for working capital and other general
corporate purposes. The shares sold in the private placement, including the
shares underlying the warrants, have been registered with the Securities and
Exchange Commission.
On
March
18, 2005, the Company completed the acquisition of ProCyte Corporation, paid
through the issuance of 10,540,579 shares of common stock valued at $2.29 per
share. The merger consideration resulted in the equivalent of a fixed ratio
of
0.6622 shares of PhotoMedex common stock for each share of ProCyte common
stock.
Common
Stock Options
In
January 1996, the Company adopted the 1995 Non-Qualified Option Plan (the “1995
Plan”) for key employees, officers, directors, and consultants, and initially
provided for up to 500,000 options to be issued thereunder.
F-27
On
April
10, 1998, the Company created a stock option plan for outside/non-employee
members of the Board of Directors. Pursuant to the stock plan, each
outside/non-employee director was to receive an annual grant of options, in
addition to any other consideration he or she may receive, to purchase up to
20,000 shares of common stock as compensation, at an exercise price equal to
the
market price of the common stock on the last trading day of the preceding year.
The options granted pursuant to this plan vested at the rate of 5,000 options
per quarter during each quarter in which such person had served as a member
of
the Board of Directors. Since the date of adoption of the Non-Employee Director
Stock Option Plan (discussed below), the Company no longer grants options to
members of the Board of Directors under this plan. At December 31, 2006, the
plan had 15,000 options outstanding.
In
May
2000, the Company adopted the 2000 Stock Option Plan (the “2000 Plan”). The 2000
Plan initially reserved for issuance up to 1,000,000 shares of the Company’s
common stock, which was increased to 2,000,000 shares pursuant to the
affirmative vote of the stockholders on June 10, 2002 and to 3,350,000 shares
on
December 16, 2003. The reserved shares are to be used for granting of incentive
stock options (“ISOs”) to employees of the Company and for granting of
non-qualified stock options (“NSOs”) and other stock-based awards to employees
and consultants. The option exercise price for ISOs shall not be less than
the
fair market value of the Company’s stock on the date of grant. All ISOs granted
to less than ten-percent stockholders may have a term of up to 10 years, while
ISOs granted to greater than ten-percent stockholders shall have a term of
up to
five years. The option exercise price for NSOs shall not be less than 85% of
the
fair market value of the Company’s stock on the date of grant. No NSOs shall be
exercisable for more than 10 years after the date of the respective grant.
The
plan became inactive on December 28, 2005, and had 2,316,730 options outstanding
at December 31, 2006.
In
May
2000, the Company also adopted the Non-Employee Director Stock Option Plan
(the
“Non-Employee Director Plan”). The Non-Employee Director Plan reserved for
issuance up to 250,000 shares of the Company’s common stock for the granting of
non-qualified options to members of the Company’s Board of Directors. In
consideration for services rendered, each director received on each of January
1, 2001 and 2002 an option to purchase 20,000 shares of the Company’s common
stock. The Company’s stockholders voted on June 10, 2002 to increase the number
of reserved shares to 650,000 and also to increase the annual grant to each
director from 20,000 to 35,000. On December 16, 2003, the stockholders voted
to
increase the number of reserved shares to 1,000,000 and on December 28, 2005,
they voted to increase the number of reserved shares to 1,400,000. The plan
is
active and had 903,750 options outstanding at December 31, 2006.
In
March
2005, the Company assumed four option plans from ProCyte: the 2004 Stock Option
Plan, the 1996 Stock Option Plan, the 1991 Restated Stock Option Plan for
Non-Employee Directors and the 1989 Restated Stock Option Plan.
On
December 28, 2005, the stockholders approved the 2005 Equity Compensation Plan,
authorizing 3,160,000 shares thereto. The plan is active and had 2,300,000
options outstanding at December 31, 2006.
On
December 28, 2005, the stockholders approved the 2005 Investment Plan,
authorizing 400,000 shares thereto. The plan is active and had 9,000 options
outstanding at December 31, 2006.
In
January 2006 and August 2006, the Company issued 175,000 and 17,500 options,
respectively, to purchase common stock to non-employee directors, in accordance
with the terms of the Non-Employee Director Plan.
On
January 15, 2006, the Company awarded 860,000 restricted shares of our common
stock to two of the Company’s executive officers, and 200,000 stock options to
one of the two executive officers.
Also,
during the course of 2006, the Company granted an aggregate of 1,238,500 options
to purchase common stock to a number of employees and consultants at the market
value at the date of grant. The options vest over five years and expire ten
years from the date of grant.
In
January 2006, the Company granted 42,000 options to purchase common stock to
the
various members of the Company’s Scientific Advisory Board for services rendered
at the market value at the date of grant. The options have an exercise price
of
$1.72 per share. The options vest upon issuance and will expire ten years from
the date of the grant.
F-28
In
May
2006, the Company granted 9,000 options to purchase common stock to executives
in accordance with the terms of the 2005 Investment Plan.
In
January 2005, the Company issued 210,000 options to purchase common stock to
non-employee directors, in accordance with the terms of the Non-Employee
Director Plan.
Also,
during the course of 2005, the Company granted an aggregate of 1,182,000 options
to purchase common stock to a number of employees at the market value at the
date of grant. The options vest over four years and expire five years from
the
date of grant.
In
February 2005, the Company granted 18,000 options to purchase common stock
to
the various members of the Company’s Scientific Advisory Board for services
rendered at the market value at the date of grant. The options have an exercise
price of $2.35 per share. The options vest over three years and will expire
five
years from the date of the grant. The Company recorded $31,859 of expense
relating to these options for the year ended December 31, 2005.
On
March
18, 2005, the Company agreed to assume up to 2,063,000 common stock options
associated with the acquisition of ProCyte Corporation valued at $2,033,132.
These ProCyte common stock options were converted into 1,366,131 common stock
options for PhotoMedex common stock.
In
July
and October 2005, the Company granted 25,000 options, each, to purchase common
stock to consultants for services rendered. The options have an exercise price
of $2.66 and $2.30 per share, respectively. The options vest over four years
and
will expire five years from the date of the grant. The Company recorded $49,120
and $42,278, respectively, of expense relating to these options for the year
ended December 31, 2005.
In
January 2004, the Company agreed to extend the life, by one year, of 525,000
options granted to Mr. O’Donnell in November 1999 as part of a bloc of 650,000
options, bearing an exercise price of $4.65 per share. In January 2004, the
Company also agreed to extend the life, by one year, of 350,000 options granted
to Mr. McGrath in November 1999, bearing an exercise price of $5.50 per share.
Neither extension had any impact on the consolidated financial statements.
The
options lapsed in 2005.
In
January 2004, the Company issued 210,000 options to purchase common stock to
non-employee directors, in accordance with the terms of the Non-Employee
Director Plan. In September 2004, 17,500 options were issued to a new
non-employee director in accordance with the terms of the Non-Employee Director
Plan.
Also
in
January, July, September and December 2004, the Company granted an aggregate
of
776,000 options to purchase common stock to a number of employees pursuant
to
the 2000 Plan at the market value at the date of grant. The options vest over
four years and expire five years from the date of grant. Also in 2004, the
Company issued 66,666 options from the 2000 Stock Option Plan with an extended
exercise period in replacement of options that had been granted outside of
a
plan in 1999, and those replacement options expired unexercised in
2004.
In
January 2004, the Company granted 30,000 options to purchase common stock to
the
various members of the Company’s Scientific Advisory Board for services rendered
pursuant to the 2000 Plan at the market value at the date of grant. The options
have an exercise price of $2.14 per share. The options vested on grant and
will
expire five years from the date of the grant. The Company recorded $48,192
of
expense relating to these options for the year ended December 31,
2004.
In
December 2004, the Company granted 27,000 options to purchase common stock
to
the various consultants and members of the Company’s Scientific Advisory Board
for services rendered pursuant to the 2000 Plan at the market value at the
date
of grant. The options have an exercise price of $2.46 per share. The options
vested immediately and will expire 5 years from the date of the grant. The
Company recorded $50,243 of expense relating to these options for the year
ended
December 31, 2004.
F-29
A
summary
of option transactions for all of the Company’s options during the years ended
December 31, 2006, 2005 and 2004 is as follows:
Number
of Shares
|
Weighted
Average Exercise Price
|
||||||
Outstanding
at January 1, 2004
|
4,130,196
|
$
|
3.87
|
||||
Granted
|
1,127,166
|
2.50
|
|||||
Exercised
|
(120,865
|
)
|
1.75
|
||||
Expired/cancelled
|
(925,957
|
)
|
6.39
|
||||
Outstanding
at December 31, 2004
|
4,210,540
|
3.48
|
|||||
Granted
|
1,460,000
|
2.57
|
|||||
Assumed
from acquisition
|
1,366,131
|
1.73
|
|||||
Exercised
|
(350,189
|
)
|
1.80
|
||||
Expired/cancelled
|
(1,608,836
|
)
|
5.83
|
||||
Outstanding
at December 31, 2005
|
5,077,646
|
2.11
|
|||||
Granted
|
1,682,000
|
1.92
|
|||||
Exercised
|
(60,750
|
)
|
1.44
|
||||
Expired/cancelled
|
(605,171
|
)
|
1.92
|
||||
Outstanding
at December 31, 2006
|
6,093,725
|
$
|
2.09
|
As
of
December 31, 2006, 3,670,083 options to purchase common stock were vested and
exercisable at prices ranging from $0.74 to $9.50 per share. As of December
31,
2005, 3,108,379 options to purchase common stock were vested and exercisable
at
prices ranging from $0.74 to $9.50 per share. Options are issued with exercise
prices equal to the market price on the date of issue, so the weighted-average
exercise price equals the weighted-average fair value price.
The
aggregate intrinsic value for options outstanding and exercisable at December
31, 2006 was approximately $6,460.
The
weighted
average grant date fair value of options was $1.52 and $2.09 for options granted
during the years ended December 31, 2006 and 2005, respectively. The total
intrinsic value of options exercised during the years ended December 31, 2006
and 2005 was $31,494 and $292,577, respectively.
At
December 31, 2006, there was $4,174,105 of total unrecognized compensation
cost
related to non-vested option grants and stock awards that is expected to be
recognized over a weighted-average period of 2.70 years.
The
outstanding options, including options exercisable at December 31, 2006, have
a
range of exercise prices and associated weighted remaining contractual life
and
weighted average exercise price as follows:
Options
Range of Exercise Prices
|
Outstanding
Number of Shares
|
Weighted
Average Remaining Contractual Life (years)
|
Weighted
Average Exercise Price
|
Exercisable
Number of Shares
|
Exercisable
Weighted Avg. Exercise Price
|
|||||||||||
$0
- $2.50
|
5,445,725
|
5.10
|
$
|
1.95
|
3,143,333
|
$
|
1.86
|
|||||||||
$2.51
- $5.00
|
553,000
|
3.64
|
$
|
2.74
|
431,750
|
$
|
2.75
|
|||||||||
$5.01
- $7.50
|
80,000
|
4.01
|
$
|
5.63
|
80,000
|
$
|
5.63
|
|||||||||
$7.51
- up
|
15,000
|
3.34
|
$
|
9.50
|
15,000
|
$
|
9.50
|
|||||||||
Total
|
6,093,725
|
4.95
|
$
|
2.09
|
3,670,083
|
$
|
2.08
|
The
outstanding options will expire as follows:
Year
Ending
|
Number
of Shares
|
Weighted
Average Exercise Price
|
Exercise
Price
|
|||||||
2007
|
379,530
|
$
|
1.72
|
$
|
1.26
- $1.89
|
|||||
2008
|
604,382
|
1.72
|
$
|
0.74
- $2.17
|
||||||
2009
|
1,000,473
|
1.97
|
$
|
1.41
- $2.70
|
||||||
2010
|
1,151,662
|
2.47
|
$
|
1.07
- $9.50
|
||||||
2011
and later
|
2,957,678
|
2.10
|
$
|
1.06
- $5.63
|
||||||
6,093,725
|
$
|
2.09
|
$
|
0.74
- $5.63
|
F-30
Common
Stock Warrants
In
November 2006, in addition to receiving common stock in the Company’s private
placement, the investors and placement agent received warrants to purchase
2,684,000 shares of common stock at an exercise price of $1.60 per share. The
warrants have a five-year term, expiring in November 2011.
In
2006,
the Company issued warrants to purchase common stock to GE Capital Corporation
related to the leasing credit facility in the following manner: on March 29,
2006, 20,545 shares at an exercise price of $2.06; on June 30, 2006, 24,708
shares at an exercise price of $1.69 per share; on September 29, 2006, 25,038
shares at an exercise price of $1.53 per share; and on December 28, 2006, 32,057
at an exercise price of $1.20 per share. The warrants have a five-year
term.
In
2005,
the Company issued warrants to purchase common stock to GE Capital Corporation
related to the leasing credit facility in the following manner: on June 28,
2005, 14,714 shares at an exercise price of $2.50 per share; on September 26,
2005, 13,921 shares at an exercise price of $2.29 per share; and on December
27,
2005, 15,830 at an exercise price of $1.90 per share. The warrants have a
five-year term.
In
2004,
the Company issued warrants to purchase common stock to GE Capital Corporation
related to the leasing credit facility in the following manner: on June 30,
2004, 23,903 shares at an exercise price of $3.54 per share; on September 24,
2004, 6,656 shares at an exercise price of $2.64 per share; on December 30,
2004, 3,102 at an exercise price of $2.73 per share. The warrants have a
five-year term.
A
summary
of warrant transactions for the years ended December 31, 2006, 2005 and 2004
is
as follows:
Number
of Warrants
|
|
Weighted
Average
Exercise
Price
|
|||||
Outstanding
at January 1, 2004
|
4,251,083
|
$
|
1.90
|
||||
Issued
|
33,661
|
3.29
|
|||||
Exercised
|
(2,104,147
|
)
|
1.47
|
||||
Expired/cancelled
|
(11,998
|
)
|
2.08
|
||||
Outstanding
at December 31, 2004
|
2,168,599
|
2.34
|
|||||
Issued
|
43,765
|
2.22
|
|||||
Exercised
|
(73,530
|
)
|
2.00
|
||||
Expired/cancelled
|
(38,525
|
)
|
13.43
|
||||
Outstanding
at December 31, 2005
|
2,100,309
|
1.98
|
|||||
Issued
|
2,786,348
|
1.60
|
|||||
Exercised
|
(140,000
|
)
|
2.00
|
||||
Expired/cancelled
|
-
|
-
|
|||||
Outstanding
at December 31, 2006
|
4,746,657
|
$
|
1.75
|
At
December 31, 2006, all outstanding warrants were exercisable at prices ranging
from $1.20 to $3.54 per share.
If
not
previously exercised, the outstanding warrants will expire as
follows:
Year
Ending December 31,
|
Number
of Warrants
|
Weighted
Average
Exercise
Price
|
|||||
2007
|
888,350
|
$
|
1.89
|
||||
2008
|
994,533
|
2.00
|
|||||
2009
|
33,661
|
3.29
|
|||||
2010
|
43,765
|
2.22
|
|||||
2011
|
2,786,348
|
1.60
|
|||||
4,746,657
|
$
|
1.75
|
F-31
Note
13
Income
Taxes:
The
Company accounts for income taxes pursuant to Statement of Financial Accounting
Standards No. 109 "Accounting for Income Taxes" ("SFAS No. 109"). SFAS No.
109
is an asset-and-liability approach that requires the recognition of deferred
tax
assets and liabilities for the expected tax consequences of events that have
been recognized in the Company's financial statements or tax
returns.
The
Company recorded no provisions in 2006, 2005 and 2004 due to losses incurred.
Any other provisions, including accrual adjustments for prior periods, were
completely offset by changes in the deferred tax valuation
allowance.
Income
tax expense (benefit) consists of the following. Because the Company acquired
ProCyte Corporation on March 18, 2005, the effect of ProCyte’s deferred tax
asset is included for 2006 and only a part of 2005 and not at all in 2004.
Year
Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Federal,
including AMT tax:
|
||||||||||
Current
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
Deferred
|
(1,805,000
|
)
|
8,887,000
|
(2,114,000
|
)
|
|||||
State:
|
||||||||||
Current
|
-
|
-
|
-
|
|||||||
Deferred
|
(2,131,000
|
)
|
68,000
|
(174,000
|
)
|
|||||
(3,936,000
|
)
|
8,955,000
|
(2,288,000
|
)
|
||||||
Change
in valuation allowance
|
3,936,000
|
8,955,000
|
(2,288,000
|
)
|
||||||
Income
tax expense
|
$
|
-
|
$
|
-
|
$
|
-
|
A
reconciliation of the effective tax rate with the Federal statutory tax rate
of
34% follows:
Year
Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Expected
Federal tax benefit at statutory rate
|
$
|
2,547,000
|
$
|
1,338,000
|
$
|
1,701,000
|
||||
Gross
change in valuation allowance
|
3,936,000
|
(8,955,000
|
)
|
2,288,000
|
||||||
Adjustments
of temporary differences and net operating loss expirations and
limitations
|
(4,460,000
|
)
|
7,652,000
|
(3,792,000
|
)
|
|||||
State
income taxes
|
278,000
|
68,000
|
(174,000
|
)
|
||||||
Other,
including adjustment due to State loss carryforwards
|
(2,301,000
|
)
|
(103,000
|
)
|
(23,000
|
)
|
||||
Income
tax expense
|
$
|
-
|
$
|
-
|
$
|
-
|
In
2006,
the deferred benefit from net operating loss carryforwards was reduced to
rationalize expirations with cumulative Federal limitations as well as to
harmonize the lesser State loss carryforwards with the Federal carryforwards.
As
of
December 31, 2006, the Company had approximately $176 million of federal net
operating loss carryforwards. Included in the aggregate net operating loss
carryforward are approximately $23 million of losses sustained by SLT prior
to
the tax-free acquisition on December 27, 2002 and approximately $62 million
of
losses sustained by ProCyte prior to the tax-free acquisition on March 18,
2005.
As of December 31, 2006, the Company has estimated that only $4 million of
the
net operating loss from SLT and $13 million of the loss from ProCyte can be
realized upon, based on Federal limitations on the useabililty of such expiring
losses. There have been no other changes of ownership identified by management
that materially constrain the Company’s utilization of loss carryforwards. If
the Company undergoes a change or ownership in the future, the utilization
of
the Company’s loss carryforwards may be materially constrained.
F-32
In
addition, the Company had approximately $2.7 million of Federal tax credit
carryforwards as of December 31, 2006. The credit carryforwards have begun,
and
continue, to expire over the ensuing 20 years. Under Federal rules applicable
to
the acquisition of SLT and ProCyte, the research credit carryforwards from
these
companies which are from years prior to their respective acquisitions and which
approximate $2.0 million, are subject to severe utilization constraints and
accordingly have been ascribed no value in the deferred tax asset.
Net
deductible, or favorable, temporary differences were approximately $20,814,000
at December 31, 2006.
The
changes in the deferred tax asset are as follows.
December
31,
|
|||||||
2006
|
2005
|
||||||
Beginning
balance, gross
|
$
|
50,051,000
|
$
|
41,095,000
|
|||
Net
changes due to:
|
|||||||
Operating
loss carryforwards
|
(6,687,000
|
)
|
9,688,000
|
||||
Temporary
differences
|
2,643,000
|
(630,000
|
)
|
||||
Carryforward
and AMT credits
|
108,000
|
(102,000
|
)
|
||||
Ending
balance, gross
|
46,115,000
|
50,051,000
|
|||||
Less:
valuation allowance
|
(46,115,000
|
)
|
(50,051,000
|
)
|
|||
Ending
balance, net
|
$
|
-
|
$
|
-
|
The
ending balances of the deferred tax asset have been fully reserved, reflecting
the uncertainties as to realizability evidenced by the Company’s historical
results and restrictions on the usage of the net operating loss carryforwards.
Deferred
tax assets (liabilities) are comprised of the following. The deferred tax asset
from the SLT acquisition is reflected in the activity in each of the years,
but
only in 2006 and in part of 2005 for ProCyte.
December
31,
|
|||||||
2006
|
2005
|
||||||
Loss
carryforwards
|
$
|
37,456,000
|
$
|
44,143,000
|
|||
Carryforward
and AMT credits
|
750,000
|
642,000
|
|||||
Accrued
employment expenses
|
557,000
|
176,000
|
|||||
Amortization
and write-offs
|
1,336,000
|
(107,000
|
)
|
||||
Bad
debts
|
292,000
|
390,000
|
|||||
Deferred
R&D costs
|
3,049,000
|
2,607,000
|
|||||
Deferred
revenues
|
240,000
|
177,000
|
|||||
Depreciation
|
1,533,000
|
1,152,000
|
|||||
Inventoriable
costs
|
81,000
|
140,000
|
|||||
Inventory
reserves
|
567,000
|
395,000
|
|||||
Other
accruals and reserves
|
254,000
|
335,000
|
|||||
Gross
deferred tax asset
|
46,115,000
|
50,051,000
|
|||||
Less:
valuation allowance
|
(46,115,000
|
)
|
(50,051,000
|
)
|
|||
Net
deferred tax asset
|
$
|
-
|
$
|
-
|
F-33
Benefits
that may be realized from components in the deferred tax asset that were
contributed by Acculase from periods prior to the buy-out of the minority
interest in August 2000 and that approximate $3.1 million in benefit, or that
were contributed by ProCyte from periods prior to the acquisition in March
2005
and that approximate $6.5 million in benefit will first be taken to reduce
the
carrying value of goodwill and other intangibles that were recorded in the
respective transactions. Only after such values have been fully reduced will
any
remaining benefit be reflected in the Company’s Statement of Operations. It is
not expected that any material tax benefit from the Acculase and ProCyte
acquisitions will be reflected in the Statement of Operations. Within the net
operating loss carryforward as of December 31, 2006 are approximately $17.5
million of tax deductions from the exercise of Company stock options. The
preponderance of these options were to employees and therefore no book expense
was recognized on their grant under APB No. 25.
Note
14
Significant
Alliances/Agreements:
On
March
31, 2005, the Company entered into a Sales and Marketing Agreement with
GlobalMed (Asia) Technologies Co., Inc. (“GlobalMed”). Under this agreement,
GlobalMed acts as master distributor in the Pacific Rim for the Company’s XTRAC
excimer laser and for the Company’s LaserPro® diode surgical laser system. The
Company’s diode laser will be marketed for, among other things, use in a
gynecological procedure pioneered by David Matlock, MD. The
Company has engaged Dr. Matlock as a consultant to explore further business
opportunities for the Company. In connection with this engagement, Dr. Matlock
received options to purchase up to 25,000 shares of the Company’s common stock
at an exercise price which was the market value of the Company’s common stock on
the date of the grant. In July 2006, the Company broadened the territory covered
by the Sales and Marketing Agreement to include the United States and added
Innogyn, Inc., a related party of GlobalMed, as co-distributor under the
agreement.
On
July
27, 2005, the Company entered into a Marketing Agreement with KDS Marketing,
Inc. (“KDS”). Using money invested by each party, KDS has researched market
opportunities for the Company’s diode laser and related delivery systems, and
KDS is now marketing the diode laser primarily through a website that physicians
may access for information about purchasing the lasers. KDS began marketing
the
laser in the first quarter 2006 but has faced difficult market conditions and
therefore has yet to achieve meaningful results. In light of this, the Company
has written down its investment in the program.
On
March
30, 2006, the Company entered a strategic relationship with AzurTec to resume
development, and to undertake the manufacture and distribution, of AzurTec's
MetaSpex Laboratory System, a light-based system designed to detect certain
cancers of the skin. The Company issued 200,000 shares of its restricted common
stock in exchange for 6,855,141 shares of AzurTec common stock and 181,512
shares of AzurTec Class A preferred stock, which represent a 14% interest in
AzurTec on a fully diluted basis. The Company will assist
in
the development of FDA-compliant prototypes for AzurTec’s product. Continuing
development of this project requires additional investment by AzurTec, which
AzurTec has undertaken to raise. The Company will resume development once the
additional investment has been raised, and AzurTec has settled its prior
indebtedness to the Company for development work. The Company has granted
AzurTec an additional 12 months in which to raise the additional
investment.
On
March
31, 2006, the Mount Sinai School of Medicine of New York University granted
the
Company an exclusive license, effective April 1, 2006, to use Mount Sinai's
patented methodology for utilization of ultraviolet laser light for the
treatment of vitiligo. The licensed patent is US Patent No. 6,979,327, Treatment
of Vitiligo. It was issued December 27, 2005, and the inventor is James M.
Spencer, MD, a member of the Company’s Scientific Advisory Board.
On
April
14, 2006, the Company entered into a Clinical Trial Agreement protocol with
the
University of California at San Francisco. The
agreement covers a protocol for a phase 4, randomized, double-blinded study
to
evaluate the safety and efficacy of the XTRAC laser system in the treatment
of
moderate to severe psoriasis. John Koo, MD, a member of our Scientific Advisory
Board, is guiding the study using our high-powered Ultra™ excimer
laser.
Edwards
Agreement
In
August 1997, the Company entered into an agreement with Edwards
LifeSciences Corporation, or Edwards. Under the terms of this agreement, the
Company granted Edwards exclusive worldwide rights to sell our modified excimer
laser and associated disposable products, for the treatment of cardiovascular
and vascular disease using the surgical procedure known as transmyocardial
revascularization, or TMR.
F-34
The
Company’s strategic relationship with Edwards was terminated in early 2001. The
termination was the subject of certain disputes and litigation between Edwards
and the Company. All disputes and litigation have been resolved in December
2005.
Note
15
Significant
Customer Concentration:
No
one
customer represented 10% or more of total revenues for the year ended December
31, 2006, 2005 and 2004.
Note
16
Business
Segment and Geographic Data:
Segments
are distinguished by the Company’s management structure, products and services
offered, markets served and types of customers. The Domestic XTRAC business
derives its primary revenues from procedures performed by dermatologists in
the
United States. The International Dermatology Equipment segment, in comparison,
generates revenues from the sale of equipment to dermatologists outside the
United States through a network of distributors. The Skin Care (ProCyte) segment
generates revenues by selling skincare products and by earning royalties on
licenses for the Company’s patented copper peptide compound. The Surgical
Services segment generates revenues by providing fee-based procedures typically
using the Company’s mobile surgical laser equipment delivered and operated by a
technician at hospitals and surgery centers in the United States. The Surgical
Products segment generates revenues by selling laser products and disposables
to
hospitals and surgery centers on both a domestic and international basis. For
the years ended December 31, 2006, 2005 and 2004, the Company did not have
material revenues from any individual customer.
Unallocated
operating expenses include costs incurred for administrative and accounting
staff, general liability and other insurance, professional fees and other
similar corporate expenses. Unallocated assets include cash, prepaid expenses
and deposits. Goodwill that was carried at $2,944,423 at December 31, 2006
and 2005 has been allocated to the domestic and international XTRAC segments
based upon its fair value as of the date of the Acculase buy-out in the amounts
of $2,061,096 and $883,327, respectively. Goodwill of $13,973,385 at December
31, 2006 from the ProCyte acquisition has been entirely allocated to the Skin
Care segment. The following tables reflect results of operations from our
business segments for the periods indicated below:
F-35
Year
Ended December 31, 2006
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
5,611,387
|
2,186,424
|
$
|
12,646,910
|
$
|
6,944,292
|
$
|
5,800,864
|
$
|
33,189,877
|
||||||||
Costs
of revenues
|
4,166,199
|
1,268,080
|
3,858,944
|
5,703,925
|
3,474,702
|
18,471,850
|
|||||||||||||
Gross
profit
|
1,445,188
|
918,344
|
8,787,966
|
1,240,367
|
2,326,162
|
14,718,027
|
|||||||||||||
Allocated
operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
4,408,753
|
77,639
|
5,580,985
|
959,848
|
552,824
|
11,580,049
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
498,602
|
-
|
507,998
|
1,006,600
|
|||||||||||||
Unallocated
operating expenses
|
-
|
-
|
-
|
-
|
-
|
9,102,007
|
|||||||||||||
4,408,753
|
77,639
|
6,079,587
|
959,848
|
1,060,822
|
21,688,656
|
||||||||||||||
Loss
from operations
|
(2,963,565
|
)
|
840,705
|
2,708,379
|
280,519
|
1,265,340
|
(6,970,629
|
)
|
|||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(521,768
|
)
|
||||||||||||
Net
loss
|
($2,963,565
|
)
|
$
|
840,705
|
$
|
2,708,379
|
$
|
280,519
|
$
|
1,265,340
|
($7,492,397
|
)
|
|||||||
Segment
assets
|
$
|
11,143,750
|
$
|
1,838,558
|
$
|
21,750,716
|
$
|
4,450,302
|
$
|
4,772,302
|
$
|
43,955,628
|
|||||||
Capital
expenditures
|
$
|
2,933,680
|
$
|
885
|
$
|
-
|
$
|
998,541
|
$
|
70,215
|
$
|
4,003,321
|
Year
Ended December 31, 2005
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
3,498,235
|
$
|
1,404,096
|
$
|
10,042,133
|
$
|
7,719,529
|
$
|
5,720,513
|
$
|
28,384,506
|
|||||||
Costs
of revenues
|
2,691,506
|
930,574
|
3,132,532
|
5,675,787
|
3,245,106
|
15,675,505
|
|||||||||||||
Gross
profit
|
806,729
|
473,522
|
6,909,601
|
2,043,742
|
2,475,407
|
12,709,001
|
|||||||||||||
Allocated
operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
2,692,388
|
313,713
|
5,331,764
|
1,192,911
|
582,366
|
10,113,142
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
442,367
|
-
|
685,594
|
1,127,961
|
|||||||||||||
Unallocated
operating expenses
|
-
|
-
|
-
|
-
|
-
|
6,364,180
|
|||||||||||||
2,692,388
|
313,713
|
5,774,131
|
1,192,911
|
1,267,960
|
17,605,283
|
||||||||||||||
Loss
from operations
|
(1,885,659
|
)
|
159,809
|
1,135,470
|
850,831
|
1,207,447
|
(4,896,282
|
)
|
|||||||||||
Other
Income
|
-
|
-
|
-
|
-
|
-
|
1,302,537
|
|||||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(342,299
|
)
|
||||||||||||
Net
loss
|
($1,885,659
|
)
|
$
|
159,809
|
$
|
1,135,470
|
$
|
850,831
|
$
|
1,207,447
|
($3,936,044
|
)
|
|||||||
Segment
assets
|
$
|
8,936,793
|
$
|
2,523,953
|
$
|
22,585,592
|
$
|
4,118,909
|
$
|
4,176,741
|
$
|
42,341,988
|
|||||||
Capital
expenditures
|
$
|
3,391,376
|
$
|
14,327
|
$
|
-
|
$
|
216,633
|
$
|
80,552
|
$
|
3,702,888
|
F-36
Year
Ended December 31, 2004
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
3,256,164
|
$
|
1,626,646
|
-
|
$
|
7,826,519
|
$
|
5,035,852
|
$
|
17,745,181
|
||||||||
Costs
of revenues
|
1,890,446
|
1,177,371
|
-
|
5,000,226
|
2,295,226
|
10,363,269
|
|||||||||||||
Gross
profit
|
1,365,718
|
449,275
|
-
|
2,826,293
|
2,740,626
|
7,381,912
|
|||||||||||||
Allocated
operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
1,836,165
|
314,849
|
-
|
1,364,684
|
642,751
|
4,158,449
|
|||||||||||||
Engineering
and product development
|
711,384
|
445,338
|
-
|
-
|
644,716
|
1,801,438
|
|||||||||||||
Unallocated
operating expenses
|
-
|
-
|
-
|
-
|
-
|
6,267,807
|
|||||||||||||
2,547,549
|
760,187
|
-
|
1,364,684
|
1,287,467
|
12,227,694
|
||||||||||||||
Loss
from operations
|
(1,181,831
|
)
|
(310,912
|
)
|
-
|
1,461,609
|
1,453,159
|
(4,845,782
|
)
|
||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(138,414
|
)
|
||||||||||||
Net
loss
|
($1,181,831
|
)
|
($310,912
|
)
|
-
|
$
|
1,461,609
|
$
|
1,453,159
|
($4,984,196
|
)
|
||||||||
Segment
assets
|
$
|
6,160,831
|
$
|
2,934,306
|
-
|
$
|
5,012,728
|
$
|
4,440,260
|
$
|
18,547,510
|
||||||||
Capital
expenditures
|
$
|
873,723
|
$
|
4,090
|
-
|
$
|
826,242
|
$
|
90,793
|
$
|
1,794,848
|
December
31,
|
|
||||||
Assets:
|
|
|
2006
|
|
|
2005
|
|
Total
assets for reportable segments
|
$
|
43,955,628
|
$
|
42,341,988
|
|||
Other
unallocated assets
|
13,525,893
|
6,333,618
|
|||||
Consolidated
total
|
$
|
57,481,521
|
$
|
48,675,606
|
For
the
years ended December 31, 2005, 2004 and 2003, there were no material net
revenues attributed to an individual foreign country. Net revenues by geographic
area were as follows:
Year
Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Domestic
|
$
|
27,691,157
|
$
|
24,667,314
|
$
|
15,460,793
|
||||
Foreign
|
5,498,720
|
3,717,192
|
2,284,388
|
|||||||
$
|
33,189,877
|
$
|
28,384,506
|
$
|
17,745,181
|
F-37
Note
17
Quarterly
Financial Data (Unaudited):
For
the Quarter Ended
|
|||||||||||||
2006
|
Mar.
31
|
Jun.
30
|
Sep.
30
|
Dec.
31
|
|||||||||
Revenues
|
$
|
8,081,000
|
$
|
8,224,000
|
$
|
8,292,000
|
$
|
8,593,000
|
|||||
Gross
profit
|
3,373,000
|
4,000,000
|
3,633,000
|
3,712,000
|
|||||||||
Net
loss
|
(2,350,000
|
)
|
(1,340,000
|
)
|
(1,693,000
|
)
|
(2,109,000
|
)
|
|||||
Basic
and diluted net loss per share
|
($0.05
|
)
|
($0.03
|
)
|
($0.03
|
)
|
($0.03
|
)
|
|||||
Shares
used in computing basic and diluted net loss per share
|
52,173,618
|
52,622,189
|
52,659,132
|
59,239,878
|
|||||||||
2005
|
Mar.
31
|
Jun.
30
|
Sep.
30
|
Dec.
31
|
|||||||||
Revenues
|
$
|
4,983,000
|
$
|
8,055,000
|
$
|
7,624,000
|
$
|
7,722,000
|
|||||
Gross
profit
|
2,351,000
|
3,833,000
|
3,320,000
|
3,205,000
|
|||||||||
Net
loss
|
(1,128,000
|
)
|
(661,000
|
)
|
(1,350,000
|
)
|
(797,000
|
)
|
|||||
Basic
and diluted net loss per share
|
($0.03
|
)
|
($0.01
|
)
|
($0.03
|
)
|
($0.01
|
)
|
|||||
Shares
used in computing basic and diluted net loss per share
|
41,755,950
|
50,859,562
|
51,198,095
|
51,322,000
|
|||||||||
2004
|
Mar.
31
|
Jun.
30
|
Sep.
30
|
Dec.
31
|
|||||||||
Revenues
|
$
|
4,025,000
|
$
|
4,323,000
|
$
|
4,455,000
|
$
|
4,942,000
|
|||||
Gross
profit
|
1,531,000
|
1,692,000
|
1,954,000
|
2,205,000
|
|||||||||
Net
loss
|
(1,363,000
|
)
|
(1,207,000
|
)
|
(1,156,000
|
)
|
(1,258,000
|
)
|
|||||
Basic
and diluted net loss per share
|
($0.04
|
)
|
($0.03
|
)
|
($0.03
|
)
|
($0.03
|
)
|
|||||
Shares
used in computing basic and diluted net loss per share
|
37,773,301
|
38,546,338
|
38,960,250
|
40,059,503
|
Note
18
Valuation
and Qualifying Accounts:
Additions
Charged to
Description
|
Balance
at Beginning of Period
|
Cost
and Expenses
|
Other
Accounts (1)
|
Deductions
(2)
|
Balance
at End of Period
|
|||||||||||
For
The Year Ended December 31, 2006:
|
||||||||||||||||
Reserve
for Doubtful Accounts
|
$
|
765,440
|
$
|
66,211
|
$
|
-
|
$
|
323,213
|
508,438
|
|||||||
For
The Year Ended December 31, 2005:
|
||||||||||||||||
Reserve
for Doubtful Accounts
|
$
|
736,505
|
$
|
373,964
|
$
|
121,633
|
$
|
466,662
|
$
|
765,440
|
||||||
For
The Year Ended December 31, 2004:
|
||||||||||||||||
Reserve
for Doubtful Accounts
|
$
|
698,044
|
$
|
459,861
|
$
|
-
|
$
|
421,400
|
$
|
736,505
|
(1)
|
Represents
allowance for doubtful accounts related to the acquisition of
ProCyte.
|
(2)
|
Represents
write-offs of specific accounts
receivable.
|
F-38