Gadsden Properties, Inc. - Annual Report: 2005 (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, 2005
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
[_]
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
[_]
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
[_]
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. [_]
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 [_]
Accelerated
filer [X]
Non-accelerated
filer [_]
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act).
Yes
[_]
No
[X]
The
number of shares outstanding of our common stock as of March 15, 2006, was
52,319,294
shares.
The aggregate market value of the common stock held by non-affiliates
(43,717,655 shares), based on the closing market price $1.98
of the
common stock as of March 15, 2006 was $86,560,957
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. | Risk Factors |
18
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Item 1B. | Unresolved Staff Comments |
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 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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36
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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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37
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Item 7A.
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Quantitative
and Qualitative Disclosure 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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57
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Item 9A.
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Controls
and Procedures
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57
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Item 9B. | Other Information |
58
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Part III
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Item 10.
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Directors
and Executive Officers of Registrant
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59
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Item 11.
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Executive
Compensation
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64
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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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84
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Item 13.
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Certain
Relationships and Related Transactions
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85
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Item 14.
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Principal
Accountant Fees and Services
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86
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Item IV
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Item 15.
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Exhibits
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88
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Signatures
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92
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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."
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, are distinguished by our management
structure, products and services offered, markets served or types of customers.
The
Domestic XTRAC segment derives revenues from procedures performed by
dermatologists in the United States. Our XTRAC system is placed in a
dermatologist’s office without any initial capital cost and then we charge a
fee-per-use to treat skin disease. The International XTRAC 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 and surgery centers on both a domestic and international basis.
The
XTRAC
is designed and manufactured by us to phototherapeutically treat psoriasis,
vitiligo, atopic dermatitis and leukoderma. In January 2000, we received the
first Food and Drug Administration (“FDA”) clearance to market an excimer laser
system, the XTRAC® 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 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. Obtaining reimbursement for new technologies
is a major challenge for any company and in the latter part of 2005 we
experienced many approvals for the reimbursement for use of the XTRAC
system. 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. Many of these products incorporate
patented copper peptide technologies. In addition to our diversified product
line, ProCyte has provided a national sales force and increased our marketing
department for us.
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 business, 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 skin care 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
the
dermatologists in marketing our XTRAC system.
Achieve
Widespread Private Healthcare Reimbursement. The
Centers for Medicare and Medicaid Services (CMS) published national Medicare
rates, effective January 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, it
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 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, 2006, we estimate that more
than
75% 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
4.5 million adults in the United States who have been diagnosed with psoriasis,
only about 1.5 million seek regular care. 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 evaluating the cost-effectiveness of
the
various components of the program.
Increase
Installed Base of Our XTRAC Systems by Minimizing Economic Risk to the
Dermatologists.
In the
United States, we place our XTRAC system in dermatologists' offices free of
charge 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. Longer term, we also intend to ultimately market
our XTRAC system in this manner outside of the United States in combination
with
continuing to sell XTRAC systems directly to dermatologists in foreign markets
through distributors.
2
Generate
Recurring Revenue by Charging the Dermatologist a Per-Treatment
Fee.
Because
there is no known cure for psoriasis, which is a chronic condition, we generate,
and expect to continue to generate recurring revenue in the United States from
patients utilizing our XTRAC system. We charge the dermatologist a per-treatment
fee. Additionally, we intend to increase our recurring revenue by targeting
dermatologists whose practices are located in geographic regions with the
largest concentration of psoriasis and vitiligo patients and areas with
favorable private healthcare reimbursement.
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 the 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 potentially detrimental exposure of normal skin 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 the 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. 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.
|
· |
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.
|
· |
Numerous
private payers and CMS carriers have recognized the clinical
and economic
merits of this treatment and have adopted medical coverage
policies
endorsing its use. In addition, approximately 60,000 excimer
laser
psoriasis procedures have been performed in the United States
in 2005 and
approximately 53,000 in 2004 (since the issuance of relevant
CPT
codes).
|
3
Our
Solution for Vitiligo
In
March
2001, the FDA granted 501(k) clearance to market our XTRAC system for the
treatment of vitiligo. 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 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 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.
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 to
psoriasis-affected skin.
4
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 year, 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 44 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 4.5 million adult 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. 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. 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
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 do not provide the dermatologist
with any purchase options. Title to the lasers remains either in our name or
in
the name of a third-party who may hold title as a security device within the
context of an equipment financing transaction. There is no fixed amount that
is
to be paid over pre-set intervals of time by the 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 purchases 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 insist 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
dermatologist retains any revenue received from patients or their medical
insurance providers.
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, under the physician’s supervision, apply the treatment,
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 the dermatologists
to
use our XTRAC system. We designed the XTRAC system to make such delegations
safe.
6
We
have
promoted 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. In November 2005, we increased our level of direct to
consumer advertising initiatives, given that we had made substantive progress
in
obtaining private health plan reimbursement approvals.
International
Commercialization of Our XTRAC System
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 some countries in
the
longer term, we anticipate developing relationships 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-procedure fee.
Skin
Care
General
On
March
18, 2005, we completed the acquisition of ProCyte Corporation (“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, primarily based upon
patented technologies such as GHK and AHK copper peptide, to selected markets.
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 address the effects aging has on the skin and
hair and to enhance appearance. Our products are formulated, branded for and
targeted at 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 patients’ skin care 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.
Our
products are well suited for use in the medical specialties of dermatology,
plastic and cosmetic surgery. Many of the products developed by ProCyte
incorporate our clinically tested copper peptide technologies. 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.
7
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 skin care products on the basis of our proprietary
copper peptide technologies. Studies have indicated that the skin heals more
quickly 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 skin care. 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 skin care. 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 skin care, 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.
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.
8
Technology
Licensing
Technology
licensing generated $459,967, representing 1.6% percent of our total revenues
in
2005. We are continuously seeking partners in the prestige, direct-to-consumer,
specialty retail and home shopping categories. ProCyte’s strategy is to identify
skin care 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 has a two-year term remaining. 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. Neutrogena began expanding the sale of these products into some
of
its international markets during 2003 and has indicated plans to continue such
expansion. 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 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 we anticipate over time
will
replace the Nd:YAG laser.
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 Nd:YAG and CTH holmium laser units;
and
|
· |
the
sale of CO2 and diode units, and related
service.
|
9
Our
Contact Laser Delivery Systems consist of proprietary fiberoptic delivery
systems which deliver the laser beam from our Nd:YAG or diode 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 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 Milwaukee, Baltimore-Washington DC and
Philadelphia 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.
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.
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.
10
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.
We
market
the CLMD line of Nd:YAG laser units for use with our Contact Laser Delivery
Systems. The line consists of 4 units:
·
|
the
CLMD 25-watts to tissue, on 110
volts;
|
·
|
the
CLMD 40-watts to tissue, on 110
volts;
|
·
|
the
CLMD Dual which operates up to 40-watts to tissue on 110 volts and
up to
60-watts to tissue on 220 volts; and
|
·
|
the
CLMD 100-watts to tissue, on 220
volts.
|
The
laser
units feature a modular design that allows the customer to upgrade from the
25-watt laser to the 40-watt or Dual laser and from the 40-watt laser to the
Dual laser. This modularity provides the customer the flexibility and
versatility to change its laser system easily to meet its changing surgery
needs. We have discontinued production of the 100-watt unit but will continue
in
the near term to refurbish such units. In 2004, we began phasing out the other
CLMD units and replacing the line with our diode laser unit.
We
market
the 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
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 more such relationships in the future.
The
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.
The
holmium, diode and CO2 lasers are marketed under the trademark
”LaserPro.”
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
different angles to allow for convenient access to difficult-to-reach anatomy.
11
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 supplied 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, 2006, our sales and marketing organization contains the following
full-time positions. These have expanded significantly as a result of the
ProCyte acquisition:
·
|
Executive
Level
|
2
|
·
|
XTRAC
Regional Sales Managers
|
2
|
·
|
Skin
Care Regional Sales Managers
|
2
|
·
|
XTRAC
Account Representatives
|
8
|
·
|
XTRAC
Clinical Support Staff
|
2
|
·
|
Skin
Care Representatives
|
20
|
·
|
Marketing
Support
|
7
|
·
|
International
Skin Care Sales Director
|
1
|
·
|
International
Dermatology Equipment Director
|
1
|
·
|
Worldwide
Surgical Sales
|
1
|
·
|
Surgical
Services Director and Regional Mgrs
|
5
|
·
|
Customer
Service Representatives
|
8
|
Our
sales
organization provides consultation and assistance to customers on the effective
use of our products, whether in phototherapy or in surgery. The consultative
sales effort varies depending on many factors, which include the nature of
the
specialty involved and complexity of the procedures. 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.
12
Manufacturing
We
manufacture our phototherapy products at our 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 skin care 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, 2006, our research and development team included four full-time
research employees and 10 engineers. We conduct research and development
activities at all three of our facilities: Carlsbad, California, Redmond,
Washington and Montgomeryville, Pennsylvania. Our research and development
expenditures were approximately $1.1 million in 2005, $1.8 million in 2004
and
$1.8 million in 2003.
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;
|
· |
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 hemeostasis 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, 2006, we have more than 130 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 more than 70 patent applications pending in the United States and
abroad.
13
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 Massachusetts General Hospital related to the treatment
of psoriasis.
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
in the United States 34 of our trademarks in the United States. We have other
registrations for our skin care products in foreign jurisdictions.
Government
Regulation
Our
products and research and development activities are regulated by numerous
governmental authorities, principally the 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.
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 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 System, 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. 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.
14
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.
We
have
received ISO 13485/EN46001 certification for our XTRAC system and our Nd:YAG,
holmium, diode and CO2 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.
15
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 skin care products are primarily for cosmetic applications, reimbursement
is
not a critical factor in growing revenues for this product segment.
Our
primary focus in 2005 was to amplify our efforts on third-party reimbursement
in
our domestic XTRAC business segment. In February 2002, 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
2006 national payment of approximately $141.00 per treatment;
·
96921 -
designated for: the total area 250 to 500 square centimeters. CMS assigned
a
2006 national payment of approximately $144.00 per treatment; and
·
96922 -
designated for: the total area over 500 square centimeters. CMS assigned a
2006
national payment of approximately $213.00 per treatment.
16
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 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 lower 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 a direct-to-consumer advertising campaign in certain geographic
regions.
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
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 had 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. At least
three foreign-based companies are currently marketing 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. All of these technologies will continue to evolve with time. We
cannot say how much these technologies will impact on 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 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, 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 us. 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 us. 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.
17
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.
In
addition, our competitors compete with us in recruiting and retaining qualified
scientific, management and marketing personnel.
Employees
As
of
March 15, 2006, we had 180 full-time employees, which consisted of 7 executive
personnel (6 executive personnel at our Montgomeryville, Pennsylvania facility
and 1 at our Carlsbad, California facility), 55 sales and marketing staff,
80
people engaged in manufacturing of lasers and laser-related products, 8
customer-field service personnel, 4 people engaged in research and development,
10 engineers and 16 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
Certain
statements in this Report are "forward-looking statements." These
forward-looking statements include, but are not limited to, statements about
our
plans, objectives, expectations and intentions 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 in the risk factors, described
below.
18
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, 2005, our accumulated deficit was
approximately $80.2 million.
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 depends on the continued
revenue 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 2006 because we plan to spend substantial
amounts on expanding, in controlled fashion, our operations in phototherapy.
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.
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 into the second
quarter of 2007. However, we may have to raise substantial additional capital
if:
· |
operating
losses continue, if anticipated demand for the XTRAC system for the
treatment of psoriasis or surgical laser systems do 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 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.
|
19
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 its 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. We 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.
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 and faster 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 too much 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, given 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.
20
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
system. 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 US market to broaden our
fee-per-procedure business model to include a 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 US
courts. If we unable through these 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
of approximately 50%. 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, it is costly and time-consuming litigation may
be
necessary to enforce and determine the scope of our proprietary rights, and
even
if we prevail in litigation, the party we prevail over may have scant resources
available to satisfy a judgment.
Further,
our skin care business seeks to establish customer loyalty, to 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 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:
21
· |
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, 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.
As
of
March 16, 2006, we estimate, based on published coverage policies and on payment
practices of private and Medicare insurance plans, that more than 75% of the
insured population in the United States are 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 rollout strategy for the XTRAC 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. 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
EU
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. If physicians do not adopt the XTRAC system, we will not achieve
anticipated revenue growth.
22
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 rollout 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.
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 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), and 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). 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 the year ended
December 31, 2005, were $1,214,073 and $609,946, 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 the year ended
December 31, 2005, were $1,553,999 and $812,000, 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.
23
Excluding
niche marketing efforts, the Skin Care segment targets its sales in the US
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.
In
the
International XTRAC 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 fraught 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.
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.
24
Although
we have obtained 510(k) clearances for our XTRAC system for use in treating
psoriasis, vitiligo, atopic dermatitis and leukoderma, and 510(k) clearances
for
our surgical products, our clearances can be revoked 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.
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 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.
We
have
limited marketing experience and limited marketing resources. However, we expect
that we will have to expand the number of our sales and marketing personnel
in
order to implement our marketing programs and strategy so as to increase
utilization of the XTRAC system 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.
25
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 and
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 skin care
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 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 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 for our skincare
products. Our inability to manufacture or commercialize our devices successfully
could have a material adverse effect on our revenue.
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 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.
|
26
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 skin
care 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 the system ages.
Similarly, our skin care 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 stymied 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.
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.
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. Continuing insurance coverage may not be
available at an acceptable cost, if at all. We may not be able to obtain
insurance coverage that will be adequate to satisfy any 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.
27
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;
|
· |
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;
|
· |
Michael
R. Stewart, Executive Vice President and Chief Operating
Officer;
|
· |
John
F. Clifford, Executive Vice President Dermatology
and
|
· |
Robin
L. Carmichael, Vice President -
Marketing
|
28
Although
we have employment agreements with Mr. O’Donnell, Mr. McGrath, Mr.
Stewart, Mr. Clifford and Ms. Carmichael, the loss of the services of one or
more of our officers could adversely affect our ability to develop and
introduce our new products.
We
may be unsuccessful in integrating the operations of ProCyte with our other
business segments.
We
acquired ProCyte with the following goals in mind:
· |
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 may reap short-term cost savings and have the
opportunity for additional longer-term cost efficiencies, thus providing
additional cash flow for
operations.
|
While
we
have begun to realize each of these goals, we have not fully realized on all
of
the goals. For example, we are seeking the optimal balance and cross-integration
of the ProCyte sales and marketing personnel into the sales and marketing of
the
XTRAC system. If we fail to attain some of the goals, our overall business
and
financial health could be materially and adversely affected.
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;
|
· |
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, however, a right to cancellation
after 5 years, provided 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 2006, and has an option to renew for an additional five
years. We are presently negotiating the renewal. 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.
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.
The base rent is $15,240 per month. Our Redmond facility houses the warehousing
operations for our skincare business.
We
lease
a 2,500 sq. ft. facility consisting of warehousing space located at 120 Francis
Street, Unit #10, Keyport, New Jersey 07735. The lease has been extended until
May 31, 2006. The base rent is $1,269 per month. Our Keyport facility houses
our
warehouse for our spa skincare business. In the short term, we intend to move
the operations of this facility and incorporate them into the Montgomeryville
operations.
30
Item 3. |
Legal
Proceedings
|
In
the
action we brought against Edwards LifeSciences Corporation and Baxter Healthcare
Corporation in January 2004, the parties reached a settlement in December
2005,
terminating all prior dealings between the parties with respect to
transmyocardial revascularization, and providing for payment to us of an amount
that may not be disclosed in accordance with the confidentiality restrictions
of
the settlement.
In
the
matter brought against us by City National Bank of Florida, our former landlord
in Orlando, Florida, our motion for summary judgment was heard in limine and
denied. Judgment was awarded to the landlord in the amount of $77,023.
Offsetting the judgment are proceeds, approximating $45,000, which are held
by
the landlord from the sale of assets left on the leased premises by the party
that bought the assets from us. We have paid the net judgment amount pursuant
to
a settlement that was reached with the landlord which embodies terms which
we
deem favorable and which have mooted post-trial motions and
appeals.
In
the
matter brought by us against RA Medical Systems, Inc. and Dean Stewart Irwin
in
the United States District Court for the Southern District of California, a
new
magistrate judge appointed in 2005 to the case has ruled that discovery will
continue to be stayed until the trial judge rules on the defendants’ motion for
summary judgment, based on a theory of res judicata. Notwithstanding the
abeyance of the case, we have brought in March 2006 a motion for partial summary
judgment, based on a theory that defendants have not had, until January 2006,
a
license from the State of California to manufacture or market their medical
devices, and therefore have unfairly competed against us by unlawfully
manufacturing, marketing and selling medical devices that were misbranded.
In
the
matter brought by us against RA Medical Systems, Inc. and Dean Stewart Irwin
in
the Superior Court for San Diego County, California, we have elected in February
2006 to discontinue our motions and appeals in the matter, and thus bring
closure to this action.
On
January 25, 2005, RA Medical Systems, Inc. and Dean Stewart Irwin brought an
action against PhotoMedex, Inc., Jeffrey Levatter Ph.D. (our Chief Technology
Officer), Jenkens & Gilchrist, LLP (our outside counsel) and Michael R.
Matthias, Esq. (litigation partner at our outside counsel). The action was
brought in the Superior Court for San Diego County, California and based on
allegations that we and the other defendants had engaged in malicious
prosecution in bringing and maintaining the action brought by PhotoMedex in
April 2003. We and the other defendants filed a motion to strike the actions,
based on California Code of Civil Procedure section 425.16, their, so-called
SLAPP statute. Our motion to strike was denied; we appealed the denial. The
appellate court heard oral argument on the matter on March 14, 2006, taking
the matter under advisement. We are being defended by our insurance
carrier.
On
May
13, 2005, Vida Brown brought suit in the Circuit Court, 20th
Judicial
Circuit for Charlotte County, Florida, for injuries sustained during a surgical
laser procedure on her lower back. Ms. Brown has sued, among others, the
surgeon, the anesthesiologist, the supplier of the laser delivery system (viz.
Clarus Medical LLC), a person holding himself out as a representative of Clarus,
and the supplier of the holmium laser system and technician (viz. our former
subsidiary, Surgical Innovations & Services, Inc.). The laser delivery
system supplied by Clarus proved defective in the course of the procedure,
notwithstanding which the surgeon continued to perform the procedure. The
holmium laser provided by SIS did not perform deficiently. Ms. Brown has alleged
that we failed to provide a properly trained operator for the holmium laser
and
that our operator failed to warn the surgeon of the danger of continuing to
use
a defective laser delivery system, allegations which we deny. Our insurance
carrier is providing a defense for us in this matter.
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 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
|
We
held
our Annual Meeting of Stockholders on December 28, 2005. Richard J. DePiano,
Jeffrey F. O’Donnell, Alan R. Novak, Warwick Alex Charlton, Anthony J. Dimun and
David Anderson, the director nominees set forth in the Notice of Annual Meeting,
were elected to serve as directors. The vote tally is set forth below:
Votes
For
|
Votes
Against
|
Votes
Abstaining
|
||||
Richard
J. DePiano
|
44,258,351
|
0
|
2,545,117
|
|||
Jeffrey
F. O’Donnell
|
44,759,140
|
0
|
2,044,328
|
|||
Warwick
Alex Charlton
|
44,852,104
|
0
|
1,951,364
|
|||
Alan
R. Novak
|
45,016,265
|
0
|
1,787,203
|
|||
Anthony
J. Dimun
|
45,025,510
|
0
|
1,777,958
|
|||
David
W. Anderson
|
45,016,544
|
0
|
1,786,924
|
Amper,
Politziner & Mattia, P.C. was ratified to be our independent auditors for
the year ending December 31, 2005, with 46,320,693 votes for, 417,563 votes
against and 65,210 votes abstaining.
An
amendment to the Amended and Restated 2000 Non-Employee Director Stock Option
Plan to increase the number of shares of our common stock reserved for issuance
thereunder from 1,000,000 to 1,400,000 was approved with 19,450,508 votes for,
2,849,026 votes against and 288,804 votes abstaining.
The
2005
Equity Compensation Plan was adopted to reserve up to 3,160,000 shares of common
stock for issuance under the Plan, with 19,312,983 votes for, 3,023,256 votes
against and 252,099 votes abstaining. The 2005 Investment Plan was adopted
to
reserve up to 400,000 shares of common stock for issuance under the Plan, with
19,402,038 votes for, 2,851,646 votes against and 334,654 votes
abstaining.
An
award
under the 2005 Equity Compensation Plan of 525,000 and 335,000 restricted shares
of our common stock to Messrs. O’Donnell and McGrath, respectively, and a grant
under the 2005 Equity Compensation Plan of an incentive stock option of 200,000
shares of our common stock to Mr. O’Donnell, at an exercise price no less than
$2.50 per share, was approved with 17,518,407 votes for, 4,770,054 votes against
and 299,877 votes abstaining. The award and grant were made on January 15,
2006,
in conformance with the intentions set forth in our Proxy
Statement.
PART
II
Item 5. |
Market
for Registrant's Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity
Securities
|
As
of
March 15, 2006, we had 52,319,294 shares of common stock issued and outstanding.
Further, we had issued and outstanding options to purchase 6,176,646 shares
of
common stock, of which 3,632,220 were vested as of March 15, 2006, and warrants
to purchase up to 2,100,309 shares of common stock.
32
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, 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
|
||||
Year
Ended December 31, 2004:
|
||||||
Fourth
Quarter
|
$
|
2.73
|
$
|
1.86
|
||
Third
Quarter
|
3.26
|
1.89
|
||||
Second
Quarter
|
3.99
|
2.54
|
||||
First
Quarter
|
2.69
|
1.63
|
||||
Year
Ended December 31, 2003:
|
||||||
Fourth
Quarter
|
$
|
2.54
|
$
|
1.66
|
||
Third
Quarter
|
2.95
|
2.15
|
||||
Second
Quarter
|
2.30
|
1.39
|
||||
First
Quarter
|
1.85
|
1.22
|
On
March
15, 2006, the closing market price for our common stock in The Nasdaq National
Market System was $1.98
per
share. As of March 15, 2006, we had approximately 945 stockholders of
record, without giving effect to determining the number of stockholders who
hold
shares in “street name” or other nominee accounts.
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, 2005.
See Notes 1 and 13 to the consolidated financial statements for additional
discussion. The awards of restricted stock to Messrs. O’Donnell and McGrath were
made on January 15, 2006 and therefore are not included in the table
below.
(A)
|
(B)
|
(C)
|
|||||||
|
|||||||||
Number
of Securities to be Issued Upon Exercise of Outstanding Options,
Warrants
and Rights
|
Weighted-Average
Exercise Price of Outstanding Options, Warrants and
Rights
|
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 |
4,947,646
|
$
|
2.12
|
2,021,750
|
|||||
|
|||||||||
Equity
compensations plan not approved
by security holders |
130,000
|
$
|
1.88
|
—
|
|||||
Total
|
5,077,646
|
$
|
2.11
|
2,021,750
|
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 and none have been issued
pursuant to equity compensation plans. Additionally, virtually all options
have
been 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.
33
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.
Certain
Business Combinations and Other Provisions of the Certificate of
Incorporation
As
a
Delaware corporation, we are currently subject to the anti-takeover provisions
of Section 203 of the Delaware General Corporation Law. Section 203 provides,
with certain exceptions, that a Delaware corporation may not engage in any
of a
broad range of business combinations with a person or an affiliate, or associate
of such person, who is an interested stockholder for a period of three years
from the date that such person became an interested stockholder
unless:
· |
the
transaction resulting in a person becoming an interested stockholder,
or
the business combination, is approved by the Board of Directors of
the
corporation before the person becomes an interested
stockholder;
|
· |
the
interested stockholder acquired 85% or more of the outstanding voting
stock of the corporation in the same transaction that makes such
person an
interested stockholder (excluding shares owned by persons who are
both
officers and directors of the corporation, and shares held by certain
employee stock ownership plans); or
|
· |
on
or after the date the person becomes an interested stockholder, the
business combination is approved by the corporation's board of directors
and by the holders of at least 66-2/3% of the corporation's outstanding
voting stock at an annual or special meeting, excluding shares owned
by
the interested stockholder.
|
Under
Section 203, an interested stockholder is defined as any person: (i) who is
the
owner of 15% or more of the outstanding voting stock of the corporation; or
(ii)
who is an affiliate or associate of the corporation and who was the owner of
15%
or more of the outstanding voting stock of the corporation at any time within
the three-year period immediately prior to the date on which it is sought to
be
determined whether such person is an interested stockholder.
A
corporation may, at its option, exclude itself from the coverage of Section
203
by amending its certificate of incorporation or bylaws by action of its
stockholders to exempt itself from coverage, provided that such amendment to
its
certificate of incorporation or bylaws shall not become effective until 12
months after the date it is adopted. We have not adopted such an amendment
to
our certificate of incorporation or bylaws.
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.
Recent
Issuances of Unregistered Securities
On
September 7, 2004, the Company closed the transactions set forth in a Master
Asset Purchase Agreement (the “Master Agreement”) with Stern Laser srl
(“Stern”). We have issued to Stern in June and December 2005 248,395 and 126,582
shares, respectively, of our restricted common stock; as of December 31, 2005,
we have issued to Stern an aggregate 488,854 shares of our restricted common
stock in connection with the Master Agreement. We have also agreed to pay Stern
up to an additional $450,000 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, in our discretion. To secure the latter
alternative, we have reserved for issuance, and placed into escrow, 211,146
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 $942,422, net as of December 31, 2005. 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.
34
In
2005,
we issued to GE Capital Corporation 14,714, 13,191 and 15,860 warrants to
purchase our common stock issued on June 28, 2005, September 26, 2005 and
December 27, 2005, 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.
Shares
Eligible for Future Sale
As
of
March 15, 2006, we had 52,319,294 issued and outstanding shares of common stock.
All of these shares are either covered by currently effective registration
statements or are eligible for resale in accordance with the provisions of
Rule
144. Further, as of March 15, 2006, we had issued and outstanding options to
purchase 6,170,646 shares of common stock, of which 3,626,220 were vested,
and
currently exercisable warrants to purchase up to 2,100,309 shares of common
stock.
Holders
of restricted securities must comply with the requirements of Rule 144 in order
to sell their shares in the open market. In general, under Rule 144, as
currently in effect, any of our affiliates and any person (or persons whose
sales are aggregated) who has beneficially owned his or her restricted shares
for at least one year, may be entitled to sell in the open market, within any
three-month period, in brokerage transactions or to market makers a number
of
shares that does not exceed the greater of: (i) 1% of the then outstanding
shares of our common stock (now approximately 401,685 shares), or (ii) the
average weekly trading volume reported in the principal market for our common
stock during the four calendar weeks preceding such sale. Sales under Rule
144
are also subject to certain limitations on manner of sale, a notice requirement
and the availability of current public information about us. Non-affiliates
who
have held their restricted shares for two years are entitled to sell their
shares under Rule 144(k), without regard to any of the above limitations,
provided they have not been one of our affiliates for the three months preceding
such sale.
We
can
make no prediction as to the effect, if any, that sales of shares of common
stock or the availability of shares for sale will have on the market price
of
our common stock. Nevertheless, sales of significant amounts of our common
stock
could adversely affect the prevailing market price of the common stock, as
well
as impair our ability to raise capital through the issuance of additional equity
securities.
As
of
March 15, 2006, the average weighted exercise prices of our outstanding and
fully vested options and warrants were $2.12 and $1.98, respectively. The shares
underlying all of the warrants and the options granted to employees, directors
and other non-employees and outstanding as of December 31, 2005 have been
registered with the SEC. In April 2005, we filed a registration statement with
the SEC for stock option plans we assumed from ProCyte Corporation. We expect
to
register in 2006 the 3,160,000 shares authorized under the 2005 Equity
Compensation Plan and the 400,000 shares authorized to the 2005 Investment
Plan.
The exercise of the options and warrants and the sale of the underlying shares
in the public market may cause additional dilution to our existing stockholders
and may cause the price of our common stock to fluctuate.
35
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 statement of operations data for the five-year period ended
December 31, 2005 and the selected historical consolidated balance sheet data
as
of December 31, 2001, 2002, 2003, 2004 and 2005 have been derived from our
consolidated financial statements:
Year
Ended December 31,
(In
thousands, except per share data)
|
|
2005
|
2004
|
2003
|
2002
|
2001
|
|||||||||||
Statement
of Operations Data:
|
||||||||||||||||
Revenues
|
$
|
28,384
|
$
|
17,745
|
$
|
14,319
|
$
|
3,274
|
$
|
4,730
|
||||||
Costs
of revenues
|
15,675
|
10,363
|
10,488
|
4,425
|
4,952
|
|||||||||||
Gross
profit (loss)
|
12,709
|
7,382
|
3,831
|
(1,151
|
)
|
(222
|
)
|
|||||||||
Selling,
general and administrative
|
16,477
|
10,426
|
9,451
|
6,191
|
10,519
|
|||||||||||
Research
and development
|
1,128
|
1,802
|
1,777
|
1,757
|
3,329
|
|||||||||||
Asset
impairment charge
|
—
|
—
|
—
|
—
|
1,958
|
|||||||||||
Loss
from operations before interest and other income, net
|
(4,896
|
)
|
(4,846
|
)
|
(7,397
|
)
|
(9,099
|
)
|
(16,028
|
)
|
||||||
Interest
income
|
61
|
43
|
50
|
42
|
238
|
|||||||||||
Interest
expense
|
(403
|
)
|
(181
|
)
|
(96
|
)
|
(16
|
)
|
(25
|
)
|
||||||
Other
income, net
|
1,302
|
—
|
—
|
1
|
77
|
|||||||||||
Net
loss
|
($3,936
|
)
|
($4,984
|
)
|
($7,443
|
)
|
($9,072
|
)
|
($15,738
|
)
|
||||||
Basic
and diluted net loss per share
|
($0.08
|
)
|
($0.13
|
)
|
($0.21
|
)
|
($0.34
|
)
|
($0.80
|
)
|
||||||
Shares
used in computing basic and diluted net loss per share (1)
|
48,786
|
38,835
|
35,134
|
26,566
|
19,771
|
|||||||||||
Balance
Sheet Data (At Period End):
|
||||||||||||||||
Cash
and cash equivalents
|
$
|
5,610
|
$
|
3,997
|
$
|
6,633
|
$
|
4,008
|
$
|
4,067
|
||||||
Working
capital
|
11,151
|
6,119
|
8,678
|
6,578
|
5,546
|
|||||||||||
Total
assets
|
48,675
|
22,962
|
22,753
|
21,513
|
15,585
|
|||||||||||
Long-term
debt (net of current portion)
|
2,437
|
1,399
|
457
|
900
|
—
|
|||||||||||
Stockholders’
equity
|
$
|
38,417
|
$
|
14,580
|
$
|
15,978
|
$
|
13,309
|
$
|
12,710
|
(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.
|
36
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.
Introduction,
Outlook and Overview of Business Operations
We
view
our business as comprised of the following five business segments:
· |
Domestic
XTRAC,
|
· |
International
XTRAC,
|
· |
Skin
Care (ProCyte),
|
· |
Surgical
Services, and
|
· |
Surgical
Products.
|
Domestic
XTRAC
The
Domestic XTRAC segment is a U.S. business with revenues 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 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
system to targeted dermatologists at no initial capital cost to them. We
maintain ownership of the laser and earn revenue each time the physician treats
a patient with the equipment. We believe that this strategy will create
incentives for these dermatologists to adopt the XTRAC system and will increase
market penetration.
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 the company invested in establishing the clinical efficacy
of
the product and mechanical reliability of the equipment. In the last three
years
we pursued widespread reimbursement commencing with obtaining newly created
CPT
reimbursement codes that became effective in 2003. This was followed by the
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. We increased our dermatology sales
force as part of the acquisition of ProCyte in March 2005. In November 2005,
we
commenced an advertising campaign in selected regions to make consumers aware
of
the technology and therapeutic benefits of targeted UVB laser treatment for
psoriasis.
International
XTRAC
In
the
international market, we derive revenues from the XTRAC system by selling
the dermatology laser system 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 system. Compared
to the domestic segment, the international XTRAC business is more influenced
by
competition from similar laser technologies as well as non-laser lamp
alternatives. Over time, this competition has reduced the prices we charge
to
international distributors for our XTRAC products.
While
the
number of lasers sold was the same for the year ended December 31, 2005 compared
to the same period for 2004, the average price per laser system and parts was
less in the 2005 period ($54,004) than in the 2004 period ($62,563). For the
year ended December 31, 2004, the number of lasers sold was greater compared
to
the same period in 2003, although the average price per laser system and parts
was greater in 2004 ($62,563) compared to 2003 ($64,807). In addition, of the
26
lasers recognized as sold in the year ended December 31, 2004, six of those
lasers had been shipped in 2003, but were not recognized as sales in
2003 due to the application of the criteria of Staff Accounting Bulletin
No. 104.
37
Due
to
the significant financial investment requirements, we
were
reluctant previously to implement an international XTRAC fee-per-use revenue
model, similar to the domestic revenue model. However, as reimbursement in
the
domestic market has become more widespread, we have recently started to offer
a version of this model overseas, but have not to date concluded such an
arrangement.
In
2005,
as a result of the acquisition of worldwide rights to certain proprietary
light-based technology from Stern Laser, we also explored new product offerings
in the treatment of dermatological conditions to our international customers.
We
intend to expand the international marketing of this product, called the VTRAC™,
in 2006. The VTRAC is designed to be a best-in-class lamp-based UVB targeted
therapy, positioned at a price point lower than the XTRAC so that it will
effectively compete with other non-laser based therapies for psoriasis and
vitiligo.
Skin
Care (ProCyte)
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.
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 the transaction and proforma 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 skin
care regimen.
Our
goals
for this acquisition are summarized below:
· |
the
addition of ProCyte's sales and marketing personnel should enhance
our
ability to market the XTRAC system;
|
· |
ProCyte's
presence in the skin health and hair care products market should
present a
growth opportunity for PhotoMedex to market its existing
products;
|
· |
the
addition of ProCyte's operations and existing cash balances would
improve
PhotoMedex's operating results and strengthen its balance
sheet;
|
· |
the
combination of the senior management of ProCyte and PhotoMedex should
allow complementary skills to strengthen the overall management team;
and
|
· |
the
combined company may reap short-term cost savings and have the opportunity
for additional longer-term cost efficiencies.
|
38
Since
the
acquisition date, we have made progress toward the achievement of these goals.
Financial and administrative functions were transferred from Redmond to
Montgomeryville in June 2005. Integration of and coordination between the sales
forces of the Skin Care and Domestic XTRAC business units is an ongoing process.
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 for 2006, we will
continue to pursue a very 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. There can be no assurance that
we
will be able to overcome such challenges.
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. Although surgical product revenues increased in 2005 compared
to
2004, 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 at offsetting this erosion by expanding our surgical services
segment and by increasing sales from the CO2 and diode surgical lasers
introduced in 2004.
In
the
second quarter 2004, we received from the FDA concurrence to market two new
surgical lasers: the LaserPro® Diode Laser System and the LaserPro® CO2 Laser
System. Each system has been designed for rugged use in our Surgical Services
business and will assist us in finding end-user buyers domestically and
overseas. We are also actively exploring opportunities to supply on an OEM
basis
or under manufacturing-marketing collaborations.
In
July
2004, we entered into an agreement with AzurTec, Inc. to develop a device that
rapidly and accurately detects the presence of cancerous cells in excised
tissue. We assisted in the development of FDA-compliant prototypes for AzurTec’s
product and have collected payments under the agreement aggregating $240,000
through December 31, 2005. Continuing development of this project requires
additional investment by AzurTec. We will resume development once this
investment has been satisfied.
In
March
2005, we entered into a Sales and Marketing Agreement with GlobalMed (Asia)
Technologies Co., Inc. Under this Agreement, GlobalMed will act as master
distributor in the Pacific Rim for our XTRAC excimer laser, including the Ultra™
excimer laser, as well as for our LaserPro® diode surgical laser system. The
diode laser will be marketed for, among other things, use in a gynecological
procedure pioneered by David Matlock, MD. We have engaged Dr. Matlock as our
consultant to explore further business opportunities. In connection with this
engagement, he has received options to purchase 25,000 shares of our common
stock.
In
July
2005, we entered a four year Marketing Agreement with KDS Marketing, Inc. Using
money invested by each party, KDS will research market opportunities for our
LaserPro® diode laser and related delivery systems; based on such research, KDS
will market the diode laser, subject to guidelines which we establish. The
hub
of the marketing program will be a website which physicians may access for
information about the laser and which they may use to purchase the laser. KDS’s
return on its investment will be based primarily on commissions earned on diode
lasers that are sold under the program.
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.
39
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 office (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 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
(“SAB 104 Criteria”). 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
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 on 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 the distributors that do not fully satisfy the
collection criteria are recognized when invoiced amounts are fully
paid.
Under
the
terms of the distributor agreements, our distributors do not have the right
to
return any unit that they have purchased. However, we allow products to be
returned by our distributors in redress of 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 used 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 our obligation inasmuch as the treatments
can only be performed on equipment made by us. Once the treatments are delivered
to a patient, this obligation has been satisfied.
The
calculation of unused treatments prior to 2004 was based upon an estimate that
at the end of each accounting period, 15 unused treatments existed at each
laser
location. This was based upon the reasoning that we generally sell treatments
in
packages of 30 treatments. Fifteen treatments generally represent about one-half
the purchase quantity by a physician or approximately a one-week supply for
6-8
patients. This policy had been used on a consistent basis. We believed this
approach to have been reasonable and systematic given that: (a) physicians
have
little motivation to purchase quantities (which they are obligated to pay for
irrespective of actual use and are generally unable to seek a refund for unused
treatments) that will not be used in a relatively short period of time,
particularly since in most cases they can obtain incremental treatments
instantaneously over the phone; and (b) senior management regularly reviews
purchase patterns by physicians to identify unusual buildup of unused treatment
codes at a laser site. Moreover, we continually look at our estimation model
based upon data received from our customers.
In
the
fourth quarter of 2004, we updated the calculations for the estimated amount
of
unused treatments to reflect recent purchasing patterns by physicians near
year-end. We estimated the amount of unused treatments at December 31, 2004
to
include all sales of treatment codes made within the last two weeks of the
period. We believe this approach more closely approximates the actual amount
of
unused treatments that existed at that date than the previous approach. APB
No.
20 provides that accounting estimates change as new events occur, as more
experience is acquired, or as additional information is obtained and that the
effect of the change in accounting estimate should be accounted for in the
current period and the future periods that it affects. We accounted for this
change in the estimate of unused treatments in accordance with APB No. 20 and
SFAS No. 48. Accordingly, our change in accounting estimate was reported in
revenues for the fourth quarter of 2004 and was not accounted for by restating
amounts reported in financial statements of prior periods or by reporting
proforma amounts for prior periods.
40
We
have
continued this approach or method for estimating the amount of unused treatments
at December 31, 2005. Had we applied the approach used in 2003 to estimating
unused treatments, XTRAC domestic revenues would have increased by $73,000
for
the year ended December 31, 2005 and decreased by $271,000 for the year ended
December 31, 2004, as compared to the prior method of estimation.
In
the
first quarter of 2003, we implemented a program to support certain physicians
in
addressing treatments with the XTRAC 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, 2005, we deferred revenues of $57,300 under this program as all
the
criteria for revenue recognition had not been met. At December 31, 2005, we
had
net deferred revenues of $107,860 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
are still
challenges by insurance companies to reimbursing the
procedure;
|
· |
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
the
claim), a standard insurance form called an EOB (“Explanation of
Benefits”) must be submitted to our in-house appeals group, who will then
prosecute the appeal. The appeal process can take 6-9
months;
|
· |
After
all appeals have been exhausted by us and the claim remains unpaid,
the
physician is entitled to receive credit for the treatment he or she
purchased from us (our fee only) 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 sale
of
treatments to the physician can be denied if timely payments are
not made,
even if a patient’s appeal is still in
process.
|
Prior
to
2004, we estimated a contingent liability for potential refunds under this
program by estimating when the physician was paid for the insurance claim.
In
the absence of a two-year historical trend and a large pool of homogeneous
transactions to reliably predict the estimated claims for refund as required
by
Staff Accounting Bulletin Nos. 101 and 104, we previously deferred revenue
recognition of 100% of the current quarter revenues from the program to allow
for the actual denied claims to be identified after processing with the
insurance companies. After more than 144,000 treatments in the last 3 years
and
detailed record keeping of denied insurance claims and appeals processed, we
have estimated that approximately 4% of the revenues under this program for
the
quarter ended December 31, 2005 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, 2004 were subject to being credited or refunded
to
the physician.
We
updated our analysis to reflect this level of estimated refunds. This change
from the past process of deferring 100% of the current quarter revenues from
the
program represents a change in accounting estimate, and we recorded this change
in accordance with the relevant provisions of SFAS No. 48 and APB No. 20. These
pronouncements state that the effect of a change in accounting estimate should
be accounted for in the current period and the future periods that it affects.
A
change in accounting estimate should not be accounted for by restating amounts
reported in financial statements of prior periods or by reporting proforma
amounts for prior periods. Due to this updated approach in estimates, domestic
XTRAC revenues were increased by $261,000 and $98,000 for the years ended
December 31, 2005 and 2004, respectively as compared to the prior method of
estimation.
41
The
net
impact on revenue recognized for the XTRAC domestic segment as a result of
the
above two changes in accounting estimate was to increase revenues by
approximately $333,000 for the year ended December 31, 2005 and decrease
revenues $278,000 for the year ended December 31, 2004. We expect that this
program will wind down in those geographic regions where there is a high
percentage of covered lives.
Skin
Care Operations
Through
the acquisition of ProCyte, we generate revenues primarily through product
sales
for skin health, hair care and wound care; sales of the copper peptide compound,
primarily to Neutrogena; and royalties generated by our licenses, principally
to
Neutrogena.
We
recognize revenues on the products and copper peptide compound when they are
shipped. 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
recognize revenues from surgical lasers and other product sales, including
sales
to distributors, when the SAB 104 Criteria 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 our books of as inventory. We ship
most
of our products FOB shipping point, although from time to time certain
customers, for example governmental customers, will insist on 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.
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 No. 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 trend.
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 skin care products, surgical services and surgical product 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. A change in the factors used to evaluate
collectibility could result in a significant change in the reserve needed.
Such
factors include changes in the financial condition of our customers as a result
of industry, economic or customer-specific factors.
42
Property
and Equipment.
As of
December 31, 2005 and 2004, we had net property and equipment of $7,044,713
and
$4,996,688, 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. XTRAC
lasers-in-service are depreciated on a straight-line basis over the estimated
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.
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, 2005 and 2004,
we
had $22,420,563 and $3,873,857, respectively, of goodwill and other intangibles,
accounting for 46% and 17% of our total assets at the respective dates. 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.
There
has
been no change in 2005 and 2004 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 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. 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
|
13,430,961
|
||
Total
|
$
|
18,830,961
|
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.
43
Results
of Operations
Revenues
The
following table illustrates revenues from our five business segments for the
periods listed below:
For
the Years Ended December 31,
|
|||||||||
2005
|
2004
|
2003
|
|||||||
Dermatology:
|
|||||||||
XTRAC
Domestic Services
|
$
|
3,498,235
|
$
|
3,256,164
|
$
|
1,325,024
|
|||
XTRAC
International Products
|
1,404,096
|
1,626,646
|
1,166,520
|
||||||
Skin
Care (ProCyte) Revenues
|
10,042,132
|
—
|
—
|
||||||
Total
Dermatology Revenues
|
$
|
14,944,463
|
$
|
4,882,810
|
$
|
2,491,544
|
|||
Surgical:
|
|||||||||
Surgical
Services
|
$
|
7,719,529
|
$
|
7,826,519
|
$
|
5,953,462
|
|||
Surgical
Products
|
5,720,514
|
5,035,852
|
5,873,787
|
||||||
Total
Surgical Revenues
|
$
|
13,440,043
|
$
|
12,862,371
|
$
|
11,827,249
|
|||
Total
Revenues
|
$
|
28,384,506
|
$
|
17,745,181
|
$
|
14,318,793
|
Domestic
XTRAC Segment
Recognized
revenue for the years ended December 31, 2005, 2004 and 2003 for domestic XTRAC
procedures was $3,498,235, $3,256,164 and $1,325,024, respectively, reflecting
billed procedures of 54,255, 47,915 and 29,113, respectively. In addition,
6,371, 4,928 and 2,566 procedures were performed for the years ended December
31, 2005, 2004 and 2003, 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, 2005 compared to the comparable
periods in 2004 and 2003 was largely related to our continuing progress in
securing favorable reimbursement policies from private insurance plans.
Increases in these levels 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, 2005, we deferred
revenues of $57,302 (873 procedures) net, under this program, compared to the
year ended December 31, 2004, when we recognized revenues of $303,027 from
revenues (4,562 procedures) which had been previously deferred under this
program. For the year ended December 31, 2003, we deferred revenues of
$744,830, (10,737 procedures) net, under this program. The change in deferred
revenue under this program is presented in the table below.
In
the
years ended December 31, 2005 and 2004, recognized revenues for the domestic
XTRAC segment increased by approximately $261,000 and $98,000, respectively,
due
to a change in accounting estimate for potential credits or refunds under the
reimbursement program. In addition, in the years ended December 31, 2005 and
2004, recognized revenues for the domestic XTRAC segment increased by
approximately $73,000 and decreased by approximately $271,000, respectively,
due
to a change in the accounting estimate for unused physician treatments that
existed for the same periods. The net impact on revenue recognized for the
XTRAC
domestic segment as a result of the above two changes in accounting estimate
was
to increase revenues by approximately $334,000 for the year ended December
31,
2005 and decrease revenues by approximately $173,000 for the year ended December
31, 2004.
44
The
following table illustrates the above analysis for the Domestic XTRAC segment
for the periods reflected below:
For
the Years Ended December 31,
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Recognized
revenue
|
$
|
3,498,235
|
$
|
3,256,164
|
$
|
1,325,024
|
||||
Change
in deferred program revenue
|
57,302
|
(303,027
|
)
|
744,830
|
||||||
Change
in deferred unused treatments
|
5,371
|
229,300
|
(50,225
|
)
|
||||||
Net
billed revenue
|
$
|
3,560,908
|
$
|
3,182,437
|
$
|
2,019,629
|
||||
Procedure
volume total
|
60,626
|
52,843
|
31,679
|
|||||||
Less:
Non-billed procedures
|
6,371
|
4,928
|
2,566
|
|||||||
Net
billed procedures
|
54,255
|
47,915
|
29,113
|
|||||||
Avg.
price of treatments sold
|
$
|
65.63
|
$
|
66.42
|
$
|
69.37
|
||||
Procedures
with deferred/(recognized) program
revenue, net
|
873
|
(4,562
|
)
|
10,737
|
||||||
Procedures
with deferred/(recognized) unused
treatments, net
|
82
|
3,452
|
(724
|
)
|
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.
International
XTRAC Segment
International
XTRAC sales of our excimer laser system and related parts were $1,404,096 for
the year ended December 31, 2005 compared to $1,626,646 and $1,166,520 for
the years ended December 31, 2004 and 2003, respectively. We sold 26 laser
systems in the year ended December 31, 2005 compared to 26 and 18 laser
systems in the years ended December 31, 2004 and 2003, respectively.
Compared to the domestic business, the international XTRAC operations are more
widely influenced by competition from similar laser technology from other
manufacturers and from non-laser lamps which over time, has also served to
reduce the prices we charge international distributors for our excimer products.
While the average revenue per laser was less in the year ended December 31,
2005 than in the same period of 2004, the number of lasers sold was the same
as
in the prior period.
Contributing
to the overall average selling price decrease in 2005 was the sale of certain
used lasers which were previously deployed in the US operations and sold at
a
discount to the list price for new equipment. We sold 6 of these used lasers
at
an average price of $27,000. While the average revenue per laser was less in
the
year ended December 31, 2004 than in the same period of 2003, the number of
lasers sold was greater than in the prior period. In addition, of the 26 lasers
recognized as sales in the year ended December 31, 2004, six of those
lasers had been shipped in 2003, but not recognized as sales at that time due
to
the application of the recognition criteria of Staff Accounting Bulletin No.
104. Four of the six lasers were recognized in the first quarter of 2004 and
the
other two lasers were recognized in the second quarter of 2004.
45
The
following table illustrates the key changes in the International XTRAC segment
for the periods reflected below:
For
the Years Ended December 31,
|
|||||||||
2005
|
2004
|
2003
|
|||||||
Revenues
|
$
|
1,404,096
|
$
|
1,626,646
|
$
|
1,166,520
|
|||
Laser
systems sold
|
26
|
26
|
18
|
||||||
Average
revenue per laser
|
$
|
54,004
|
$
|
62,563
|
$
|
64,807
|
Skin
Care (ProCyte) Segment
For
the
year ended December 31, 2005, ProCyte revenues were $10,042,132. Inasmuch as
ProCyte was acquired on March 18, 2005, there are no corresponding revenues
accruing to us for the years ended December 31, 2004 or 2003. 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.
The
following table illustrates the key changes in the Skin Care (ProCyte) segment
for the periods reflected below:
For
the Year Ended December 31,
|
|||||||||
2005
|
2004
|
2003
|
|||||||
Product
sales
|
$
|
8,902,615
|
$
|
—
|
$
|
—
|
|||
Bulk
compound sales
|
679,550
|
—
|
—
|
||||||
Royalties
|
459,967
|
—
|
—
|
||||||
Total
Skincare revenue
|
$
|
10,042,132
|
$
|
—
|
$
|
—
|
Surgical
Services Segment
In
the
years ended December 31, 2005, 2004 and 2003, surgical service revenues
were $7,719,529, $7,826,519 and $5,953,462, respectively. Revenues in surgical
services stayed relatively flat for the year ended December 31, 2005 compared
to
2004. During 2005 we closed four geographic areas of business due to
unacceptable operating profit, which we had revenues in 2004. In addition,
we
have suffered business interruption due to hurricanes in New Orleans and Alabama
territories, in the third and fourth quarter of 2005. Revenues in surgical
services grew for the year ended December 31, 2004 from 2003 by 31.5%,
primarily due to growth in urological procedures performed with laser systems
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.
The
following table illustrates the key changes in the Surgical Services segment
for
the periods reflected below:
For
the Years Ended December 31,
|
|||||||||||
2005
|
2004
|
2003
|
|||||||||
Revenues
|
$
|
7,719,529
|
$
|
7,826,519
|
$
|
5,953,462
|
|||||
Percent
(decrease)/ increase
|
(1.4
|
%)
|
31.5
|
%
|
|||||||
Cost
of revenues
|
5,675,787
|
5,000,226
|
3,899,714
|
||||||||
Gross
profit
|
$
|
2,043,742
|
$
|
2,826,293
|
$
|
2,053,748
|
46
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, 2005, surgical products revenues were $5,720,514
compared to $5,035,832 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.
For
the
year ended December 31, 2004, surgical products revenues were $5,035,832
compared to $5,873,787 in the year ended December 31, 2003. The decrease was
due
to fewer laser systems sold (17 vs. 38) partially offset by an increase in
the
average price per laser sold.
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.
There were no sales of these lasers for the year ended December 31, 2003, since
they were introduced in June 2004.
Disposables
and fiber sales were relatively level between the comparable years ended
December 31, 2005 and 2004. 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 hope to offset the decline in laser and disposables revenues.
The
following table illustrates the key changes in the Surgical Products segment
for
the periods reflected below:
For
the Year Ended December 31,
|
|||||||||||
2005
|
2004
|
2003
|
|||||||||
Revenues
|
$
|
5,720,514
|
$
|
5,035,832
|
$
|
5,873,787
|
|||||
Percent
increase/(decrease)
|
13.6
|
%
|
(14.3
|
%)
|
|||||||
Laser
systems sold
|
47
|
17
|
38
|
||||||||
Laser
system revenues
|
$
|
1,594,000
|
$
|
989,000
|
$
|
1,611,000
|
|||||
Average
revenue per laser
|
$
|
33,915
|
$
|
58,203
|
$
|
42,395
|
Cost
of Revenues
Cost
of
revenues divides into product cost of revenues and service cost of revenues.
Within product costs of revenues are the costs of products sold in the
International XTRAC 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, 2005 were $7,219,504,
compared to $3,324,564 for the year ended December 31, 2004. The $3,894,940
increase reflected the inclusion of $3,132,532 of costs for the ProCyte business
acquired in 2005, and an increase of $1,009,503 for surgical products, due
to
increased laser system sales offset, in part, by a $246,796 decrease in costs
associated with sales of XTRAC laser equipment sold outside the United
States.
47
Product
cost of revenues during the year ended December 31, 2004 were $3,324,564,
compared to $3,732,109 for the year ended December 31, 2003. The $407,843
decrease reflected a decrease of $768,139 for surgical products, due to a
decrease in surgical laser sales. This decrease was offset by an increase in
product cost of sales for the international XTRAC revenues for the year ended
December 31, 2004. This increase was primarily related to an increase in
sales for the year. Additionally, we implemented a planned quality upgrade
of
all units in the field during 2003. The impact of this upgrade served to reduce
field service costs and warranty claims for 2004.
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.
Services
cost of revenues was $7,038,705 and $6,755,499 in the years ended December
31,
2004 and 2003, respectively. Contributing to the $283,206 increase was a
$1,288,545 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 decreased $1,005,339 due to the improvements made to the
lasers.
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 internationally. The unabsorbed costs,
relating to excess capacity, are allocated to the Domestic XTRAC and the
International XTRAC segments based on actual production of lasers for each
segment. Included in these allocated manufacturing costs are unabsorbed labor
and direct plant costs.
Gross
Margin Analysis
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%.
Gross
margin increased to $7,381,912 during the year ended December 31, 2004 from
$3,831,185 during the same period in 2003. As a percentage of revenues, the
gross margins for the year ended December 31, 2004, increased to 41.6% compared
to 26.8% for the same period in 2003.
The
following table analyzes changes in our gross profit for the periods reflected
below:
Company
Margin Analysis
|
For
the Year Ended December 31,
|
|||||||||||
2005
|
2004
|
2003
|
||||||||||
Revenues
|
$
|
28,384,506
|
$
|
17,745,181
|
$
|
14,318,793
|
||||||
Percent
increase
|
60.0
|
%
|
23.9
|
%
|
||||||||
Cost
of revenues
|
15,675,505
|
10,363,269
|
10,487,608
|
|||||||||
Percent
increase (decrease)
|
51.3
|
%
|
(1.2
|
%)
|
||||||||
Gross
profit
|
$
|
12,709,001
|
$
|
7,381,913
|
$
|
3,831,185
|
||||||
Percent
of revenue
|
44.8
|
%
|
41.6
|
%
|
26.8
|
%
|
48
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
primary reasons for improvement in gross margin for the year ended
December 31, 2004, compared to the same period in 2003, were as
follows:
· |
We
increased treatment procedures and lowered field service costs for
the
XTRAC system. The increase in procedure volume was a direct result
of
improving insurance reimbursement. The lower field service costs
were a
direct result of the planned quality upgrades in 2003 for all
lasers-in-service.
|
· |
We
continued to increase the volume of sales to existing customers and
add
new customers to our existing base.
|
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,
|
|||||||||
2005
|
2004
|
2003
|
||||||||
Revenues
|
$
|
3,498,235
|
$
|
3,256,164
|
$
|
1,325,024
|
||||
Percent
increase
|
7.4
|
%
|
145.7
|
%
|
||||||
Cost
of revenues
|
2,691,506
|
1,890,446
|
2,795,786
|
|||||||
Percent
increase (decrease)
|
42.4
|
%
|
(32.4
|
%)
|
||||||
Gross
profit (loss)
|
$
|
806,729
|
$
|
1,365,718
|
($1,470,762
|
)
|
||||
Percent
of revenue
|
23.1
|
%
|
41.9
|
%
|
(111.0
|
%)
|
The
gross
margin decreased for this segment for the year ended December 31, 2005 from
the
comparable periods 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).
|
49
The
most
significant improvement for the year ended December 31, 2004 came from our
Domestic XTRAC segment. We increased the gross profit for this segment for
the
year ended December 31, 2004 over the comparable period in 2003 by
$2,836,480, primarily due to increases in revenues and decreases in the costs
in
the two periods.
· |
A
key driver in increased revenue in Domestic XTRAC segment is insurance
reimbursement. In 2004, we focused on private health insurance plans’
adopting the XTRAC laser therapy for psoriasis as an approved medical
procedure. In 2004, several major health insurance plans instituted
medical policies to pay claims for the XTRAC therapy including Regence,
Wellpoint, Aetna and Anthem.
|
· |
Procedure
volume increased 65% from 29,113 to 47,915 billed procedures in the
year
ended December 31, 2004 compared to the same period in
2003.
|
· |
Price
per procedure was not a meaningful component of the revenue change
between
the periods.
|
· |
In
the first quarter of 2003, we implemented a limited program to support
certain physicians in addressing treatments with the XTRAC system
that may
be denied reimbursement by private insurance carriers. We recognize
service revenue under the program for 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, 2004, we recognized revenues of $303,027, net, from
revenues under the program which had been previously deferred but
which
could be recognized in the current year’s revenues as all the criteria for
revenue recognition had been met. For the year ended December 31,
2003, we deferred revenues of $744,830 under this program.
|
· |
The
cost of revenues decreased by $905,340 for the year ended
December 31, 2004. An incremental procedure at a physician’s office
does not substantively increase our operating costs associated with
that
laser. This, combined with the improvement in the reliability of
the
lasers in 2004 from 2003 and the resulting reduction in field service
costs, served to reduce costs associated with the domestic
segment.
|
The
following table analyzes the gross profit for our International XTRAC segment
for the periods reflected below:
XTRAC
International Segment
|
For
the Year Ended December 31,
|
|||||||||||
2005
|
2004
|
2003
|
||||||||||
Revenues
|
$
|
1,404,096
|
$
|
1,626,646
|
$
|
1,166,520
|
||||||
Percent
(decrease) increase
|
(13.7
|
%)
|
39.4
|
%
|
||||||||
Cost
of revenues
|
930,574
|
1,177,371
|
817,075
|
|||||||||
Percent
(decrease) increase
|
(21.0
|
%)
|
44.1
|
%
|
||||||||
Gross
profit
|
$
|
473,522
|
$
|
449,275
|
$
|
349,445
|
||||||
Percent
of revenue
|
33.7
|
%
|
27.6
|
%
|
30.0
|
%
|
The
gross
profit for the years ended December 31, 2005 and 2004 increased by $24,247
and $99,830, respectively, from the comparable prior year periods. The key
factors in this business segment were as follows:
· |
We
sold 26 XTRAC systems during both the year ended December 31, 2005
and
2004. We sold 26 XTRAC systems during the year ended December 31,
2004 and 18 lasers in the comparable period in 2003. We shipped $541,000
of lasers to a master distributor in 2003, but did not recognize
revenue
at the time. We recognized revenue in the amount of $420,000 in 2004
when
all collections from the shipments became
certain.
|
· |
The
International XTRAC 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 US operations and sold at a discount to
the
list price for new equipment. We sold 6 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. After adjusting the revenue
for the
year ended December 31, 2004 for parts sales of approximately $149,000,
the average price for lasers sold during this period was approximately
$56,800 compared to $62,400 in the same period in 2003.
|
50
The
following table analyzes our gross margin for our SkinCare (ProCyte) segment
for
the periods presented below:
Skin
Care (ProCyte) Segment
|
For
the Year Ended December 31,
|
|||||||||
2005
|
2004
|
2003
|
||||||||
Produce
revenues
|
$
|
8,902,615
|
$
|
—
|
$
|
—
|
||||
Bulk
compound revenues
|
679,550
|
—
|
—
|
|||||||
Royalties
|
459,967
|
—
|
—
|
|||||||
Total
revenues
|
10,042,132
|
—
|
—
|
|||||||
Product
cost of revenues
|
2,664,959
|
—
|
—
|
|||||||
Bulk
compound cost of revenues
|
467,573
|
—
|
—
|
|||||||
Total
cost of revenues
|
3,132,532
|
—
|
—
|
|||||||
Gross
profit
|
$
|
6,909,600
|
$
|
—
|
$
|
—
|
||||
Percent
of revenue
|
68.8
|
%
|
—
|
—
|
The
key
factors in skincare business segment were as follows:
· |
Copper
Peptide bulk compound is sold at a substantially lower gross margin
than
skin care products, while revenues generated from licensees have
no
significant costs associated with this revenue
stream.
|
· |
Product
revenues come primarily from U.S.
dermatologists.
|
· |
Lesser
product revenues come from sales directed to consumers at spas and
from
marketing directly to the consumer (e.g.
infomercials).
|
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,
|
|||||||||
2005
|
2004
|
2003
|
||||||||
Revenues
|
$
|
7,719,529
|
$
|
7,826,519
|
$
|
5,953,462
|
||||
Percent
(decrease) increase
|
(1.4
|
%)
|
31.5
|
%
|
||||||
Cost
of revenues
|
5,675,787
|
5,000,226
|
3,899,714
|
|||||||
Percent
increase
|
13.5
|
%
|
28.2
|
%
|
||||||
Gross
profit
|
$
|
2,043,742
|
$
|
2,826,293
|
$
|
2,053,748
|
||||
Percent
of revenue
|
26.5
|
%
|
36.1
|
%
|
34.5
|
%
|
51
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
have 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
have suffered business interruption due to hurricanes in the New
Orleans
and Alabama territories.
|
Gross
profit in the Surgical Services segment for the year ended December 31,
2004 increased by $775,545 from the comparable period in 2003. The key factors
impacting gross margin for the Surgical Services business were as
follows:
· |
Increased
procedure volume was the primary reason for improvements in this
business.
We continue to experience growth in our surgical services business,
particularly within existing customers and existing
geographies.
|
· |
A
significant part of the growth was an increase in urological procedures
performed with laser systems we have 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. In the year ended
December 31, 2004, we increased the amount we charge customers for
the fibers used with this procedure without a commensurate increase
in the
cost of these fibers. This accounted for the increase in the margin
to
36.1% from 34.5% in the year ended December 31, 2004 from the
comparable period in 2003.
|
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,
|
|||||||||
2005
|
2004
|
2003
|
||||||||
Revenues
|
$
|
5,720,514
|
$
|
5,035,852
|
$
|
5,873,787
|
||||
Percent
increase (decrease)
|
13.6
|
%
|
(14.3
|
%)
|
||||||
Cost
of revenues
|
3,245,103
|
2,295,226
|
2,975,034
|
|||||||
Percent
increase (decrease)
|
41.4
|
%
|
(22.9
|
%)
|
||||||
Gross
profit
|
$
|
2,475,411
|
$
|
2,740,626
|
$
|
2,898,753
|
||||
Percent
of revenue
|
43.3
|
%
|
54.4
|
%
|
49.4
|
%
|
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.
|
52
· |
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. There were no sales
of
these lasers for the year ended December 31, 2003, since they were
introduced in June 2004.
|
· |
The
laser revenue increase was partly offset by a decrease in sales
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.
|
The
gross
profit for the year ended December 31, 2004 decreased by $158,127 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 the sale of laser
disposables.
|
· |
Revenues
for the year ended December 31, 2004 decreased by $837,935 from the
year
ended December 31, 2003 while cost of revenues decreased by $679,808
between the same periods. There were 11 fewer laser systems sold
in the
year ended December 31, 2004 than in the comparable period of 2003.
However, the lasers sold in the 2004 period were at higher prices
than in
the comparable period in 2005.
|
· |
Disposables,
which have a higher gross margin than lasers, represented a higher
percentage of revenue in the year ended December 31, 2004 compared to
the year ended December 31,
2003.
|
Selling,
General and Administrative Expenses
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.
Selling, general and administrative expenses related to the Skin Care business
accounted for $5,331,764 of the increase. 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 and increases in consulting expenses of $161,000 and 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.
For
the
year ended December 31, 2004, selling, general and administrative expenses
increased to $10,426,256 from $9,451,224 for the year ended December 31, 2003.
The overall increase related to several expenses during the 2004 year. We have
incurred $400,000 in expenses with respect to compliance obligations under
Sarbanes Oxley. We had incremental bad debt expense and legal expense of
$159,000 and $200,000, respectively, over the 2003 levels. The bad debt expense
relating to the international XTRAC sales has been lower due to the lower sales
volume which contributes to lower potential sales at risk of collection. In
addition, more of our international sales have been paid with cash in advance
or
letters of credit inasmuch as such payment terms are more suitable for the
geographic mix of countries where we presently do business. This decrease was
offset by an increase in bad debt expense relating to the domestic XTRAC. These
expenses related to prior insurance reimbursement issues.
Selling,
general and administrative expenses as a percentage of revenues have improved
over the past three years from 66% in 2003, 59% in 2004 and 58% in
2005.
53
Engineering and
Product Development
Engineering
and product development expenses for the years 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. Engineering and product development
expenses for the years ended December 31, 2004 increased to $1,801,438 from
$1,776,480 for 2003.
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 of the liability for SLT subordinated notes
of
$244,988. There was no other income in the comparable periods in 2004 and 2003.
Interest
Expense, Net
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
interest expense for the year ended December 31, 2004 increased to $138,414,
as
compared to $46,330 for the year ended December 31, 2003. The increase in net
interest expense is a direct result of the draws on our lease line of credit
during 2004. The initial draw on the lease line of credit in the second quarter
of 2004 was used to replace the expired $1,000,000 bank line of credit.
Net
Loss
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.
The
aforementioned factors resulted in a net loss of $4,984,196 during the year
ended December 31, 2004, as compared to a net loss of $7,442,849 during the
year
ended December 31, 2003, a decrease of 33%. This decrease was primarily the
result of the increase in revenues and resulting gross margin.
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 from equity financing
and lines of credit and, recently, from cash-flow positive results 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, 2005 as compared
to
2004. We expect to realize cost savings from the consolidation of the
administrative and marketing infrastructure of the combined company.
Additionally, once 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, 2005, the ratio of current assets to current liabilities was 2.42
to 1.00 compared to 1.88 to 1.00 at December 31, 2004. As of December 31, 2005,
we had $11,120,992 of working capital compared to $6,119,248 as of December
31,
2004. Cash and cash equivalents were $5,609,967 as December 31, 2005, as
compared to $3,997,017 as of December 31, 2004. These increases were mainly
due
to the acquisition of ProCyte. Cash of $206,931 was classified as restricted
as
of December 31, 2005 compared to $112,200 at December 31, 2004. Restricted
cash increased due to collaterization of a stand-by letter of credit securing
for the landlord at the Carlsbad facility our obligation to fund our share
of
the tenant improvements.
54
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
into the second quarter of 2007. The 2006 operating plan reflects costs savings
from the integration of ProCyte and PhotoMedex as well as increases in
per-treatment fee revenues for use of the XTRAC system based on wider insurance
coverage in the United States. In addition, the 2006 operating plan calls for
increased revenues and profits from our newly acquired Skin Care business.
We
cannot give assurances that our business plan will not encounter obstacles
which
may require us to obtain additional equity or debt financing to meet our working
capital requirements or capital expenditure needs. Also, if our growth exceeds
the business plan projections, we may require additional equity or debt
financing. There can be no assurance that additional financing, if needed,
will
be available when required or, if available, will be on terms satisfactory
to
us.
In
addition, there may be insufficient authorized shares available for issuance
in
connection with additional equity financing. As of March 15, 2006, we had
75,000,000 shares of common stock authorized, 52,319,294 shares issued and
outstanding, and approximately 10,599,307 shares reserved for expected or
possible issuances. Potential issuances include: (i) 10,347,705 shares reserved
for issuance in connection with outstanding PhotoMedex warrants and options
granted or grantable under the PhotoMedex stock option plans, (ii) 211,146
shares reserved for issuance in connection with the technology license from
Stern Laser, and (iii) nearly 40,456 warrants that may be issued to GE Capital
Corporation in connection with additional draws under our lease line of credit.
In
any of
such events, we would be forced to modify our plans and operations to seek
to
balance cash inflows and outflows or increase our authorized
capital.
Set
forth
below is a summary of current obligations as of December 31, 2005 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.
Payments
due by period
|
|||||||||||||
Contractual
Obligations
|
Total
|
Less
than 1 year
|
1
-
3 years
|
3
-
5 years
|
|||||||||
Credit
facility obligations
|
$
|
3,726,130
|
$
|
1,548,838
|
$
|
2,177,293
|
$
|
—
|
|||||
Other
capital lease obligations
|
302,709
|
179,993
|
122,716
|
—
|
|||||||||
Operating
lease obligations
|
78,672
|
30,017
|
48,655
|
—
|
|||||||||
Rental
lease obligations
|
1,033,982
|
569,146
|
366,228
|
98,608
|
|||||||||
Notes
payable
|
387,611
|
228,398
|
81,974
|
77,239
|
|||||||||
Total
|
$
|
5,529,104
|
$
|
2,556,392
|
$
|
2,796,866
|
$
|
175,847
|
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
specified 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.”
The
obligations under capital leases are at fixed interest rates and are
collateralized by the related property and equipment (see Note 4).
Net
cash
used in operating activities was $1,729,841 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.
55
Net
cash
used in operating activities was $2,765,221 for the year ended December 31,
2004, compared to $5,134,161 for the same period in 2003. The decrease was
mostly due to the decrease in net loss and increases in accounts receivables
and
inventory, offset by decreases in accounts payable.
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.
Net
cash
provided by investing activities was $2,677,670 for the year ended December
31,
2004 compared to cash used of $1,607,757 for the year ended December 31, 2004.
During the year ended December 31, 2004, we used $1,683,528 for production
of
our lasers in service compared to $1,556,654 for the same period in 2003. In
2004, we had net acquisition costs of $882,823 related to the Stern and ProCyte
acquisitions.
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 $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.
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 elsewhere in this
Report and incorporated herein by this reference.
56
Item 9. |
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
At
the
direction and approval of our Audit Committee, we terminated the engagement
of
KPMG LLP (“KPMG”) as our principal independent accountants, to take effect June
9, 2004.
In
connection with the audit for the year ended December 31, 2003 and the
subsequent interim period through June 9, 2004, except as described in the
following paragraph, there were no disagreements with KPMG on any matter of
accounting principles or practices, financial statement disclosure, or auditing
scope or procedures, which if not resolved to the satisfaction of KPMG, would
have caused KPMG to make reference to the subject matter of such disagreements
in connection with its reports on our consolidated financial statements for
such
years. Management and the Audit Committee have adhered, and will adhere, to
the
policy to issue only financial reports which conform to the accounting positions
recommended by our independent accountants.
During
its review of our interim consolidated financial statements for the quarter
ended September 30, 2003, KPMG identified an issue related to material
transactions for which we had initially recorded revenue on shipments of lasers
to an international distributor. Based on its review and analysis of the
collectibility of the revenue from such shipments, KPMG determined that the
revenue related to these particular shipments should be accounted for utilizing
the “sell-through” method of accounting, provided the other criteria for revenue
recognition under applicable accounting standards were met. The issue was
discussed with management and with our Audit Committee. Upon consideration
of
additional facts relevant to the issue, management and the Audit Committee
agreed with KPMG’s position. Consistent with our Company policy, this issue was
resolved to the satisfaction of KPMG, and, in accordance with the “sell-through”
method, we did not include the revenue under discussion in the reported
quarterly results. If this issue had not been resolved to the satisfaction
of
KPMG, it would have caused KPMG to make reference to the subject matter of
such
disagreement in connection with its reports on our consolidated financial
statements for applicable periods.
There
were no reportable events as defined in Item 304(a)(1)(v) of Regulation S-K,
except for an event related to the “sell-through” method of accounting discussed
above. KPMG issued a letter identifying a material weakness in our internal
controls as a result of our 2003 audit. The material weakness in our internal
controls related to recognition of revenue on the sale of lasers under the
collectibility criterion of Staff Accounting Bulletin No. 104. While we believed
that we had adequate policies for proper recognition of revenue, we agreed
with
KPMG that our implementation of those policies, especially in evaluating the
collectibility of discrete sales of laser units, needed to be improved. We
re-evaluated the various factors, and the relative weights we ascribe to the
factors, which we take into account in determining collectibility. By December
31, 2003, we had implemented these and additional procedures to evaluate not
only new distributors and customers, but past customers as well.
The
reports of KPMG on our consolidated financial statements, as of and for the
year
ended December 31, 2003, did not contain any adverse opinion or disclaimer
of
opinion, nor were they qualified or modified as to uncertainty, audit scope
or
accounting principles.
The
Audit
Committee of our Board of Directors recommended and approved the engagement
of
Amper, Politziner & Mattia, P.C. as our independent accountants, effective
June 9, 2004. The stockholders ratified the engagement of Amper, Politziner
& Mattia at the annual meeting on December 28, 2004.
During
the year ended December 31, 2003 and through June 9, 2004, neither we nor anyone
on our behalf consulted Amper, Politziner & Mattia, P.C. regarding the
application of accounting principles to a specified transaction, either
completed or proposed, or the type of audit opinion that might be rendered
on
our financial statements, or any other matters or reportable events, as set
forth in Items 304(a)(2)(i) and (ii) of Regulation S-K.
Item
9A. Controls
and Procedures
Controls
and Procedures
As
of
December 31, 2005, 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.
57
In
making
this evaluation, we considered the material weakness identified by our
independent auditors relating to our internal controls as they relate to
recognition of revenue on the sale of lasers under the collectibility criterion
of Staff Accounting Bulletin No. 104. In connection with this evaluation, we
also considered the development and implementation of improvements in our
internal control procedures described above with respect to the identified
weakness.
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.
With
regard to the material weakness identified in 2003, we did not restate any
financial results for any prior periods and believe that the identified material
weakness did not have any material effect on the accuracy of our financial
statements prepared with respect to any prior fiscal period.
There
were no changes in our internal controls over financial reporting during the
quarter ended December 31, 2005 that materially affected, or were
reasonably likely to materially affect, our internal controls over financial
reporting, except for the addition of ProCyte’s internal control structures.
Management processed ProCyte transactions through existing ProCyte internal
control structures through the second quarter of 2005, and began to process
such
transactions through existing PhotoMedex internal control structures in the
third quarter of the year. Management evaluated in 2005 the other ProCyte
internal control structures and determined what structures should be adopted,
conformed or eliminated.
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, 2005. 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
There
is
nothing to report under “Other Information.”
58
PART
III
Item
10. Directors
and Executive Officers of Registrant
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 nine meetings and three unanimous written consents in lieu of
meetings in 2005.
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
|
64
|
||
Jeffrey
F. O'Donnell
|
Director,
President and Chief Executive Officer
|
46
|
||
Dennis
M. McGrath
|
Chief
Financial Officer and Vice President - Finance and
Administration
|
49
|
||
Michael
R. Stewart
|
Executive
Vice President and Chief Operating Officer
|
48
|
||
John
F. Clifford
|
Executive
Vice President, Dermatology
|
63
|
||
Alan
R. Novak
|
Director
|
71
|
||
Warwick
Alex Charlton
|
Director
|
46
|
||
Anthony
J. Dimun
|
Director
|
62
|
||
David
W. Anderson
|
Director
|
53
|
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.
59
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. 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.
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.
John
F Clifford was
appointed as our Executive Vice President on March 18, 2005, immediately
following the acquisition of ProCyte Corporation. Mr. Clifford manages the
sales
of the domestic XTRAC business segment and the skincare business segment we
acquired from ProCyte Corporation. Mr. Clifford was President and Chief
Executive Officer and the Chairman of the Board of Directors of ProCyte
Corporation prior to March 18, 2005. He joined ProCyte in August 1996. Before
joining ProCyte, Mr. Clifford was from 1994 to 1996 the President of Orthofix,
Inc. and American Medical Electronics, Dallas-area healthcare companies in
the
orthopedic market. From 1984 to 1994, he was employed by American Cyanamid’s
Davis and Geck Division, a medical device company, initially as the Vice
President of Sales and Marketing and later as Division Vice President. From
1964
to 1989, Mr. Clifford held various sales and marketing positions in Ethicon,
Inc. and Iolab Corp., both Johnson & Johnson companies. Mr. Clifford holds a
B.S. in Economics from Villanova University and an M.B.A in Finance from Drexel
University.
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.
60
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.
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.
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 have
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
has determined in 2005 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.
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 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 and
Dimun. Mr. Dimun serves as the Chairman of the Compensation Committee. The
Board
determined in 2005 that each member of the Compensation Committee is
"independent" under the revised listing standards of Nasdaq. The Compensation
Committee held 14 meetings during 2005.
61
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 2005 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, Mr. McAtee having retired from
the Board in December 2005. The Board of Directors determined in 2005 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 3 meetings during 2005.
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;
|
· |
developing
and overseeing our 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 the existing directors. While the Nominations
and Corporate Governance Committee has the authority to do so, we have not,
as
of the date of this Report, paid any third party to assist in identifying and
evaluating Board nominees.
62
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 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, the 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 are Messrs. DePiano, Dimun and Anderson. Mr. DePiano serves as
Chairman of the Audit Committee. The Audit Committee meets regularly and held
8
meetings during 2005.
The
Board
of Directors determined in 2005 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.
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.
However, Mr. DePiano, the Chief Executive Officer of Escalon Medical Corp.
and
Mr. O’Donnell, our Chief Executive Officer, also have served on the board of
directors of Escalon Medical Corp. Neither of Mr. DePiano nor Mr. O'Donnell
has
served on the compensation committee of the board of directors of either
PhotoMedex, Inc. or Escalon Medical Corp. Mr. O’Donnell resigned from the board
of directors of Escalon on December 28, 2004.
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.
|
63
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, 2006, we believe that all reports needed to be filed have been filed
for the year ended December 31, 2005. In one instance, a report evidencing
a
director’s exercise of warrants was not filed within the two business days
prescribed by SEC rules.
Item
11. Executive
Compensation
Summary
Compensation Table
The
following table sets forth certain information concerning compensation of our
Chief Executive Officer and each of the other highly compensated executive
officers whose total compensation exceeds $100,000 (the “Named Executive
Officers”), for the years ended December 31, 2005, 2004 and 2003:
Annual
Compensation
|
Long
Term Compensation Awards
|
||||||||||||||||||||||||
Name
|
Year
|
Salary
($)
|
Bonus ($)
|
Other
Annual
Compensation ($)
|
Restricted
Stock Awards ($)
|
Securities
Underlying
Options/
SARs
(#)
|
LTIP
Payouts
($)
|
Payouts
All
other
Compensation
($)
|
|||||||||||||||||
Jeffrey
F. O'Donnell (CEO)
|
2005
|
350,000
|
92,000
|
12,000
|
0
|
150,000
|
0
|
0
|
|||||||||||||||||
2004
|
350,000
|
150,000
|
12,000
|
0
|
150,000
|
0
|
0
|
||||||||||||||||||
2003
|
350,000
|
150,000
|
12,000
|
0
|
125,000
|
0
|
0
|
||||||||||||||||||
Dennis
M. McGrath
|
2005
|
285,000
|
60,000
|
12,000
|
0
|
140,000
|
0
|
0
|
|||||||||||||||||
2004
|
285,000
|
100,000
|
12,000
|
0
|
125,000
|
0
|
0
|
||||||||||||||||||
2003
|
285,000
|
100,000
|
12,000
|
0
|
110,000
|
0
|
0
|
||||||||||||||||||
Michael
R. Stewart
|
2005
|
255,671
|
43,750
|
12,000
|
0
|
140,000
|
0
|
0
|
|||||||||||||||||
2004
|
235,000
|
70,000
|
12,000
|
0
|
75,000
|
0
|
0
|
||||||||||||||||||
2003
|
235,000
|
70,000
|
12,000
|
0
|
75,000
|
0
|
0
|
||||||||||||||||||
John
F. Clifford
|
2005
|
228,860
|
0
|
9,000
|
0
|
250,000
|
0
|
0
|
“Bonus”
in the foregoing table is the bonus earned in the period, even though it will
have been paid in a subsequent period. “Other Annual Compensation” includes a
car allowance. “Stock
Options” are reflected in the year in which the options were granted.
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, 2006 and will expire then if due notice is given by December 1, 2006. 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.
64
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, having a 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 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.
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.
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, 2006 and will expire then if
due
notice is given by December 1, 2006. 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.
65
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, 2006 and
will
expire then if due notice is given by December 1, 2006. 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.
Employment
Agreement with John F. Clifford. Effective
March 18, 2005, John
F.
Clifford became our Executive Vice President, Dermatology, pursuant to a
three-year employment agreement. Mr. Clifford’s base salary is $300,000. He will
be eligible to receive an annual bonus of up to 50% of his annual base salary,
subject to criteria established by the Board of Directors, and an automobile
allowance of $1,000 per month. If Mr. Clifford's employment is terminated due
to
expiration of the three-year employment term under the agreement, he will,
in
addition to compensation and benefits due on the last day of actual employment,
receive $300,000 in twelve monthly installments. In the event that his
employment is terminated before the end of the three-year employment term,
other
than for cause, death, disability, or resignation without good reason (in each
case, as those terms are defined in the agreement), Mr. Clifford would be
entitled, absent other circumstances, to receive severance benefits,
including: payment of an amount equal to the greater of the amount of two years'
base salary at the date of termination or the remaining amount of unpaid base
salary that he would have received if the agreement did not terminate before
the
end of the three-year employment term; payment of the amount of bonus that
would
have been due during the year of termination; payment or reimbursement of health
care benefits for the remainder of the three-year employment term; and immediate
vesting of all incentive stock options. In the event that a change of control
of
the Company occurs during the three-year employment term and Mr. Clifford is
thereafter terminated other than for cause or voluntarily resigns within 60
days
after there occurs a material reduction in compensation or benefits, a material
change in status, working conditions or management, or a material change in
business objectives and policies, Mr. Clifford would be entitled to receive,
as
severance, a payment over twelve months equal to 200%, of his current
compensation, including the base salary, bonus and other benefits.
Termination
of Employment and Change of Control Agreements
We
have
employment agreements with Messrs. O'Donnell, McGrath, Stewart and Clifford.
These agreements provide for severance upon termination of employment, whether
in context of a change of control or not. 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
$2,460,000 at December 31, 2005 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 $2,549,000 at December 31, 2005.
66
Option/SAR
Grants Table
The
following table sets forth certain information concerning grants of stock
options to our executive officers for the year ended December 31, 2005. It
does
not include restricted shares of common stock which were granted to Messrs.
O’Donnell and McGrath on January 15, 2006:
Individual
Grants
|
Potential
Realizable Value
at
Assumed Annual Rate of
Stock
Price Appreciation
For
Option Term (1)
|
|||||||||||||||||||
(a)
|
(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
(g)
|
||||||||||||||
Name
|
Number
of Securities Underlying Options/SARs Granted
(#)
|
%
of Total Options/SARs Granted to Employees In
Fiscal
Year
|
Exercise
Or
Base
Price ($/Share)
(1)
|
Expiration
Date
(1)
|
5%
($)
|
10%
($)
|
||||||||||||||
Jeffrey
F. O’Donnell
|
150,000
|
10.27%
|
|
$
|
2.45
|
3/1/10
|
$
|
—
|
$
|
55,716
|
||||||||||
Dennis
M. McGrath
|
140,000
|
9.59%
|
|
$
|
2.45
|
3/1/10
|
$
|
—
|
$
|
51,889
|
||||||||||
Michael
R. Stewart
|
100,000
|
6.85%
|
|
$
|
2.45
|
3/1/10
|
$
|
—
|
$
|
37,063
|
||||||||||
Michael
R. Stewart
|
40,000
|
2.45%
|
|
$
|
2.63
|
7/19/10
|
$
|
—
|
$
|
3,301
|
||||||||||
John
F. Clifford
|
250,000
|
17.12%
|
|
$
|
2.78
|
4/4/10
|
$
|
—
|
$
|
4,802
|
1. |
This
chart assumes a market price of $1.78 for the common stock, the closing
sale price for our common stock in the Nasdaq National Market System
as of
December 31, 2005, as the assumed market price for the common stock
with
respect to determining the "potential realizable value" of the shares
of
common stock underlying the options described in the chart, as reduced
by
any lesser exercise price for such options. Further, the chart assumes
the
annual compounding of such assumed market price over the relevant
periods,
without giving effect to commissions or other costs or expenses relating
to potential sales of such securities. Our common stock has a limited
trading history. These values are not intended to forecast the possible
future appreciation, if any, price or value of the common
stock.
|
Option
Exercises and Year-End Values
The
following table sets forth information with respect to the exercised and
unexercised options to purchase shares of common stock for our executive
officers held by them at December 31, 2005:
Number
of Securities
Underlying
Unexercised
Options
at
December
31, 2005
|
Value
of Unexercised
In
the Money Options at
December
31, 2005 (2)
|
||||||||||||||||||
Name
|
Shares
Acquired
on Exercise
|
Value
Realized
(1)
|
Exercisable
|
Unexercisable
|
Exercisable
|
Unexercisable
|
|||||||||||||
Jeffrey
F. O’Donnell
|
0
|
0
|
300,000
|
250,000
|
$
|
98,750
|
$
|
7,500
|
|||||||||||
Dennis
M. McGrath
|
0
|
0
|
196,250
|
288,750
|
$
|
86,900
|
$
|
6,600
|
|||||||||||
Michael
R. Stewart
|
0
|
0
|
225,000
|
215,000
|
$
|
—
|
$
|
—
|
|||||||||||
John
F. Clifford
|
0
|
0
|
397,320
|
250,000
|
$
|
112,905
|
$
|
—
|
(1)
|
Represents an amount equal to the number of options multiplied by the difference between the closing price for the common stock in the Nasdaq National Market System on the date of exercise and any lesser exercise price. |
(2)
|
Represents an amount equal to the number of options multiplied by the difference between the closing price for the common stock in the Nasdaq National Market System on December 31, 2005 ($1.78 per share) and any lesser exercise price. Only “in the money” options are included. |
67
Compensation
Committee Report on Executive Compensation
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.
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,
and,
to the extent consistent with these objectives, to maximize the deductibility
of
compensation for tax purposes. However, the Compensation Committee may 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.
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.
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.
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. 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. Going forward, the Committee intends that such
grants will be for 10 years and vest over 5 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. Similar criteria are applied in making awards of restricted
shares of our common stock for the 2005 Equity Compensation Plan. 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, the 2005 Investment Plan.
68
CEO
Compensation For
2005,
Mr. O'Donnell's base salary and stock option grant were determined in accordance
with the criteria described above. Mr. O'Donnell earned $350,000 in base salary
compensation during 2005. He was awarded a bonus of $92,000 for
2005.
In
March
2005, Mr. O'Donnell was granted an option to purchase 150,000 shares of our
common stock at 100% of fair market value on the date of grant, or $2.45 per
share. The grant reflects the Compensation Committee’s assessment of the
substantial contributions made by Mr. O'Donnell to the long-term growth and
performance of the Company. During 2005, options granted to Mr. O’Donnell in
1999 and 2000, amounting to 650,000 options, expired. The Committee recommended,
and the Board of Directors and Company stockholders approved, an award of
525,000 restricted shares of our common stock and a grant of 200,000 options
form the 2005 Equity Compensation Plan. The award and grant were effected on
January 15, 2006.
Tax
Deductibility Considerations
Section
162(m) of the Code places a $1,000,000 limit on the amount of other than
performance-based compensation for the chief executive officer and each of
the
other four most highly compensated executed officers that we may deduct for
tax
purposes. It is the Compensation Committee's general objective to administer
compensation programs that are in compliance with the provisions of Section
162(m). 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 Mr. O'Donnell in 2005 did not exceed the limits under Section
162(m) for tax deductibility, and he exercised no options in 2005 or 2004.
Compensation
Committee
Anthony
J. Dimun
|
Richard
DePiano
|
Warwick
Alex Charlton
|
Alan
R. Novak
|
Stock
Option Plans - General
At
the
Annual Meeting of Stockholders on December 28, 2005, the stockholders adopted
the 2005 Equity Compensation Plan, which will be the principal means by which
officers, other employees and consultants will receive equity-based compensation
in PhotoMedex. The stockholders also adopted the 2005 Investment Plan, which
is
reserved for executive officers. The 2000 Non-Employee Director Stock Option
Plan will continue as the means by which outside directors are granted
equity-based compensation. With respect to all other equity-based plans were,
as
of December 28, 2005, we intend that such plans will continue until they expire
or all options outstanding under than have either expired or been canceled
or
exercised and that no new grants may be made from these plans in the future.
All
plans were amended to conform to the requirements of Section 409A of the Code.
The Compensation Committee administers all plans, but for the 2000 Non-Employee
Director Stock Option Plan, which is administered by the Nominations and
Corporate Governance Committee.
2005
Equity Compensation Plan
General
Purpose.
The
general purposes of the 2005 Equity Compensation Plan (the “2005 Equity Plan”)
are to establish incentives designed to attract, recognize, reward and retain
competent executive and key employees, as well as independent consultants,
whose
performance, contribution and skills are critical to us, and to promote the
increased ownership of common stock among our executives and key employees
in
order to increase their proprietary interest in our business. Our independent
directors will not receive awards under the 2005 Equity Plan, but rather will
continue to be compensated under the 2000 Non-Employee Director Stock Option
Plan. The 2005 Equity Plan was adopted by the Board of Directors on November
9,
2005 and approved by the stockholders on December 28, 2005. The Plan will
continue for ten years after it was first approved by the stockholders, i.e.
until December 28, 2015. The following discussion summarizes certain aspects
of
the 2005 Equity Plan, but is qualified in its entirety by reference to the
2005
Equity Compensation Plan, which was attached as “Exhibit A” to our Proxy
Statement filed with the Commission on November 15, 2005.
69
Shares
Subject to the 2005 Equity Plan.
We have
reserved for issuance up to 3,160,000 shares of common stock under the 2005
Equity Plan. If shares of common stock are forfeited for any reason, prior
to
the lapsing of the applicable restrictions, the forfeited shares will become
available for new awards in accordance with the terms of the 2005 Equity Plan.
If any award granted under the 2005 Equity Plan for any reason expires or
otherwise terminates without having vested in full, the common stock not vested
under such award will again become available for new awards under the 2005
Equity Plan. We have awarded 860,000 shares of restricted stock and 200,000
stock options out of the 2005 Equity Plan on March 15, 2006, and have
granted various consultants and employees 882,000 stock options between January
1, 2006 and March 15, 2006.
Administration
of and Eligibility under 2005 Equity Plan.
The 2005
Equity Plan, as adopted, provides for the award of shares of common stock to
our
executive and other key employees, including those of our subsidiaries, as
an
incentive to remain in the employ of or to provide services to us and our
subsidiaries, as well as awards to independent consultants. The 2005 Equity
Plan
authorizes the issuance of awards to be awarded by a committee (the “Plan
Committee”) established by the Board of Directors to administer the 2005 Equity
Plan. The Plan Committee will be the Compensation Committee of the Board of
Directors or such other similar committee as may in the future be designated
by
the Board of Directors to perform those functions presently being performed
by
the Compensation Committee. The Plan Committee will consist of at least three
members, each of whom will be a non-employee director, as such term is defined
under Rule 16b-3 of the Exchange Act, will qualify as an outside director,
for
purposes of Section 162(m) of the Code and will comply with the listing
standards of the primary trading market or securities exchange on which the
common stock then trades.
The
terms
and conditions of each award will be determined by the Plan Committee, in its
sole and absolute discretion, and may change from time to time. Our officers
and
key employees, as well as independent consultants, are eligible to receive
awards under the 2005 Equity Plan. However, the Plan Committee will have sole
and absolute discretion to determine the persons to whom awards will be made.
The terms and conditions of separate awards need not be identical, but awards
will include (through incorporation of provisions of the 2005 Equity Plan by
reference in the agreement embodying the award or otherwise) the substance
of
the terms and conditions of the 2005 Equity Plan.
Subject
to the terms and conditions of the 2005 Equity Plan, the Plan Committee will
have the sole authority to: (a) interpret conclusively the provisions of the
2005 Equity Plan and decide all questions of fact arising in its application;
(b) adopt, amend and rescind rules and regulations relating to the 2005 Equity
Plan; (c) determine the executive and other key employees, as well as
independent consultants, to whom awards may be made and the timing, method
and
amount of each such award; and (d) make any other determinations, exercise
such
powers and perform such acts the Plan Committee deems necessary or advisable,
subject only to those determinations, powers and acts which may be reserved
to
the Board of Directors. The Board of Directors, in the exercise of this power,
may correct any defect, omission or inconsistency in the 2005 Equity Plan or
in
any award, in a manner and to the extent it deems necessary or expedient to
conform them to applicable provisions of law or to make the 2005 Equity Plan
fully effective.
Recipient
Agreements.
The Plan
Committee may require that each recipient enter into a written agreement with
us, which will set forth all the terms and conditions of the award. The award
agreement will contain such other terms, provisions and conditions not
inconsistent herewith, as shall be determined by the Plan Committee. Following
is a description of terms and conditions that are expected to apply to the
various forms of awards.
Stock
Options. The
Plan
Committee may grant incentive stock options (“ISOs”) under Section 422 of the
Code. Except
for ISOs granted to stockholders possessing more than ten percent (10%) of
the
total combined voting power of all classes of the securities of PhotoMedex
or
its subsidiaries to whom such ownership is attributed on the date of grant
("Ten
Percent Stockholders"), the exercise price of each ISO must be at least 100%
of
the fair market value of our common stock, based on the closing sales price
of
the common stock as of the date prior to the date of grant. ISOs granted to
Ten
Percent Stockholders must be at an exercise price of not less than 110% of
such
fair market value. ISOs will vest in accordance with a schedule set by the
Plan
Committee; if the Committee sets no schedule, then the 2005 Equity Plan provides
as a benchmark that ISOs will vest ratably as of the first five anniversaries
of
the date of grant. Each ISO must be exercised, if at all, within ten (10) years
from the date of grant, but, within five (5) years of the date of grant in
the
case of ISO's granted to Ten Percent Stockholders. The aggregate fair market
value (determined as of the time of the grant of the ISO) of the common stock
with respect to which the ISOs are exercisable for the first time by the
optionee during any calendar year shall not exceed $100,000. If this threshold
is exceeded, the ISOs accounting for the excess are automatically converted
to
non-statutory (non-qualified) stock options (“NSOs”).
70
The
Plan
Committee may also grant NSOs. Consistent with Section 409A of the Code, the
exercise price of a NSO will never be less than 100% of the fair market value,
based on the closing sales price of the common stock on the date prior to the
date of grant of the option. The exercise period for each NSO will be determined
by the Committee at the time such option is granted, but in no event will such
exercise period exceed 10 years from the date of grant. NSOs will vest in
accordance with a schedule set by the Plan Committee; if the Committee sets
no
schedule, then the 2005 Equity Plan provides as a benchmark that NSOs will
vest
ratably as of the first five anniversaries of the date of grant.
The
Committee may allow an optionee to pay the exercise price of any option, and
any
associated withholding taxes, not only by means of cash but also by means of
shares of our common stock.
Stock
Appreciation Rights.
Each
stock appreciation right (“SAR”) granted under the 2005 Equity Plan will entitle
the holder thereof, upon the exercise of the SAR, to receive from the Company,
in exchange therefore, an amount equal in value to the excess of the fair market
value of one share of common stock on the date of exercise over the fair market
value of one share of our common stock on the date of grant (or in the case
of
an SAR granted in connection or tandem with an option, the excess of the fair
market of one share of common stock at the time of exercise over the option
exercise price per share under the option to which the SAR relates), multiplied
by the number of shares of common stock covered by the SAR or the option, or
portion thereof, that is surrendered.
SARs
will
be exercisable only at the time or times established by the Plan Committee.
If
an SAR is granted in connection with an option, the SAR will be exercisable
only
to the extent and on the same conditions that the related option could be
exercised. The Plan Committee may impose any conditions upon the exercise of
an
SAR or adopt rules and regulations from time to time affecting the rights of
holders of SARs.
Restricted
Stock.
The Plan
Committee may award shares of our common stock to participants in the 2005
Equity Plan. The purchase price of the stock, if any, will be set by the
Committee, but shall never be less than the par value of the shares. Awards
may
be subject to restrictions conditioned on the lapse of time and/or conditioned
on the attainment of performance standards, and if both types of conditions
are
imposed, the Plan Committee may provide that upon the fulfillment of the
performance conditions, the time conditions may lapse. Subject to the discretion
of the Committee, the conditions applicable to an award of shares will lapse
ratably (i.e. one-third) on the fifth, sixth and seventh anniversaries of the
award. Although we will hold restricted shares in escrow so long as the shares
remain subject to forfeiture, the shares may be voted by the recipient and
will
be treated as outstanding.
Stock
Purchase Rights.
The
Plan Committee may award to a participant the right to purchase shares of our
common stock. We shall retain the right to repurchase any such shares, at the
same price paid by the recipient, after the recipient is terminated. Our
retained repurchase right will lapse ratably over the first five anniversaries
of the award of the purchase right to the recipient. Notwithstanding the above,
we shall have no rights to repurchase any such shares if such rights or such
repurchase would trigger taxation to the participant under Section 409A of
the
Code. The Committee shall not enter into any such repurchase arrangement except
upon the written advice of counsel.
Unrestricted
Stock. The
Committee may award to a participant shares of our common stock, with no
restrictions.
71
Adjustments
Resulting from Changes in Capitalization.
If any
change is made in the common stock subject to the 2005 Equity Plan, or subject
to any award granted under the 2005 Equity Plan (through reclassification,
stock
dividend, stock split, combination of shares, exchange of shares, change in
corporate structure or other transaction not involving the receipt of
consideration by us), the maximum number of shares subject to the 2005 Equity
Plan, the maximum number of shares which may be granted to a recipient in a
calendar year, and the class(es) and number of shares and price per share of
stock subject to outstanding awards shall be proportionately adjusted. Such
adjustment shall be made by the Board of Directors or the Plan Committee, the
determination of which shall be final, binding and conclusive. (The conversion
of any of our convertible securities will not be treated as a “transaction not
involving the receipt of consideration.”)
Termination
and Amendment of the 2005 Equity Plan.
The
Board of Directors may terminate or amend the 2005 Equity Plan at any time,
except that awards then outstanding will not be adversely affected thereby
without the written consent of the respective recipients holding such awards.
The Board of Directors may make such amendments to the 2005 Equity Plan as
it
shall deem advisable, except that the approval by our stockholders in accordance
with the laws of Delaware within 12 months after the adoption of the amendment
will be required for any amendment which would: (i) materially modify the
requirements as to eligibility for awards under the 2005 Equity Plan; (ii)
materially increase the benefits accruing to recipients under the 2005 Equity
Plan; or (iii) be required under applicable law or the listing standards of
the
market or exchange on which the common stock then trades. The Board may in
its
sole discretion submit any other amendment to the 2005 Equity Plan for
stockholder approval, including, but not limited to, amendments to the Plan
intended to satisfy the requirements of Section 162(m) of the Code regarding
the
exclusion of performance-based compensation from the limit on corporate
deductibility of compensation to certain executive officers.
In
the
event of a transaction involving our dissolution or liquidation, recipients
of
options, SARs or stock purchase rights may exercise their rights until 10 days
before the transaction. The Committee in its discretion may provide that any
restrictions on shares acquired from such exercise will lapse and may further
provide that rights not otherwise exercisable may become so. Any rights not
exercised by the transaction will terminate immediately before the
transaction.
In
the
event of a change in control of PhotoMedex, all rights of recipients of awards
shall become fully exercisable and immediately vested, except that in the case
of restricted stock that is subject to a performance restriction based on the
price (the “Milestone Price”) of our common stock, our repurchase rights
applicable to such restricted stock shall lapse with respect to a change in
control event only if the price per share to be paid in connection with such
change in control event is equal to or greater than the Milestone Price.
The unvested balance of such shares 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 the services of the person who was awarded the
restricted stock. If the acquirer opts not to contract for such services, then
the unvested balance of shares shall vest as of the change in control event.
A
change in control results from the acquisition by any one person, or group
of
persons acting in concert, of more than 50% of the voting power of our capital
stock. A change in control also results from a “Sale of the Company.” A Sale of
the Company occurs on: (a) our consolidation or merger into or with a successor
entity such that our stockholders own less than a majority of the shares of
stock of such entity; or (b) a sale or other disposition of all, or
substantially all, of our assets to a successor entity. In the event of a Sale
of the Company, awards made under the 2005 Equity Plan are to be assumed, or
substituted with equivalent rights, by the successor entity. If the successor
entity declines to do so, then each holder of an award shall have not less
than
20 days before the consummation of the Sale of the Company to exercise his
or
her rights, and all such rights shall become fully exercisable during such
20
day period.
Effect
of Termination of Recipient.
An award
under the 2005 Equity Plan is generally subject to the condition that the
recipient continue to provide services to us. For purposes of the 2005 Equity
Plan, the term “termination” means the ceasing to be a service provider to us,
whether as an employee or as a consultant.
Options.
If a
recipient is terminated for cause, all unexercised options are forfeited. If
a
recipient is terminated under other circumstances, he or she will have generally
three months in which to exercise any vested options, except in the case of
termination due to disability or death, in which cases the vested options many
be exercised for 12 months.
72
Stock
Appreciation Rights.
The
Committee has the power to terminate any SARs in the event of a recipient’s
termination.
Restricted
Stock.
If a
recipient voluntarily terminates his or her employment or consultancy with
us or
if we terminate such employment or consultancy for cause, then any shares of
restricted stock still subject to forfeiture shall revert to us; if the
employment or consultancy is terminated for any other reason, then any shares
still subject to forfeiture shall also revert to us, unless the Plan Committee,
in its discretion, decides otherwise.
Stock
Purchase Rights.
Under
the 2005 Equity Plan, we have the right, in the event of a recipient’s voluntary
or involuntary termination to repurchase stock which a recipient purchased
under
a stock purchase agreement. We may do so at the same consideration paid by
the
recipient to the extent that the purchased shares remain subject to our right
of
repurchase.
Certain
Federal Income Tax Considerations.
Awards
granted under the 2005 Equity Plan generally have the federal income tax
consequences discussed below.
Corporate
business deduction. Generally,
we will be entitled to a tax deduction in the same amount as the ordinary income
recognized by a recipient with regard to the award. In order to secure such
deduction in the case of the exercise of NSOs, we must fulfill such withholding
tax obligations as may be imposed on us.
However,
Section 162(m) of the Code imposes a limit on corporate tax deductions for
compensation in excess of $1 million per year paid by a public company to its
Chief Executive Officer or any of the next four highest paid executive officers
as listed in the proxy statement. For this purpose, compensation includes gains
arising from stock option exercises, vesting of restricted stock and the award
of stock bonuses. An exception to this limitation is provided for “qualified
performance-based compensation.” The Section 162(m) provisions generally require
that affected executives’ compensation satisfy certain conditions in order to
qualify as “qualified performance-based compensation.” Section 162(m) denies a
deduction to any publicly held corporation for compensation paid to certain
employees in a taxable year to the extent that compensation exceeds $1,000,000.
It is possible that compensation attributable to awards made under this Plan,
when combined with all other types of compensation received by a covered
employee from us, may cause this limitation to be exceeded in any particular
year.
Accordingly,
in order to permit the Board of Directors and the Plan Committee to grant awards
that qualify as “qualified performance-based compensation” under Section 162(m)
and therefore to be deductible by us without regard to the $1 million deduction
limit of Section 162(m), the 2005 Equity Plan provides, subject to stockholder
approval, for authority in the Board of Directors or the Plan Committee to
condition the grant or vesting of such awards and authorizes the Board of
Directors or the Plan Committee to establish any other terms and conditions
required to qualify such awards as “qualified performance-based compensation.”
The Board of Directors may in its sole discretion submit any other amendment
to
the Plan for stockholder approval, including, but not limited to, amendments
to
the Plan intended to satisfy the requirements of Section 162(m) regarding the
exclusion of performance-based compensation from the limit on corporate
deductibility of compensation to certain executive officers.
In
order
to exclude compensation resulting from options granted under the 2005 Equity
Plan from the $1,000,000 limit on deductibility, the Board of Directors has
approved a provision in the Plan which will place a 500,000 share limit on
the
number of options and SARs that may be granted under the Plan to a service
provider in any fiscal year. This is subject to appropriate adjustment in
the case of stock splits, reverse stock splits and the like. The purpose of
this
provision, which is intended to comply with Section 162(m) of the Code and
the
regulations thereunder, is to preserve our ability to deduct in full any
compensation expense related to stock options and SARs.
Tax
consequences of deferred compensation.
The American Jobs Creation Act of 2004 added Section 409A to the Internal
Revenue Code, generally effective January 1, 2005. In September 2005, the
Treasury Department issued detailed Proposed Regulations under this statute,
but
a number of issues remain unresolved. Section 409A covers most programs that
defer the receipt of compensation to a succeeding year. It provides strict
rules
for elections to defer (if any) and for timing of payouts. There are significant
penalties placed on the individual employee for failure to comply with Section
409A. However, it generally does not affect our ability to deduct deferred
compensation at some point in time.
73
Section
409A does not apply to incentive stock options, non-qualified stock options
(that are not and can never later be discounted) and restricted stock (provided
there is no deferral of income beyond the vesting date). Section 409A also
does
not cover stock appreciation right (SAR) plans if (i) the exercise price can
never be less than the fair market value of the underlying stock on the date
of
grant (ii) no features defer the recognition of income beyond the exercise
date,
and (iii) there are no other rights granted beyond the SAR itself.
Section
409A does apply to restricted stock units, performance units and performance
shares. Grants under such plans will continue to be taxed at vesting but will
be
subject to new limits on plan terms governing when vesting may
occur.
Tax
consequences to recipient from ISOs.
An
optionee who is granted an incentive stock option will not recognize taxable
income either at the time the option is granted or upon its exercise, although
the exercise may subject the optionee to the alternative minimum tax. Upon
the
sale or exchange of the shares more than two years after grant of the option
and
one year after exercising the option, any gain or loss will be treated as
long-term capital gain or loss. If these holding periods are not satisfied,
the
optionee will recognize ordinary income at the time of sale or exchange equal
to
the difference between the exercise price and the lower of: (i) the fair market
value of the shares at the date of the option exercise, or (ii) the sale price
of the shares. A different rule for measuring ordinary income upon such a
premature disposition may apply if the optionee is also an officer, director
or
Ten Percent Stockholder of the Company. Generally, the Company will be entitled
to a deduction in the same amount as the ordinary income recognized by the
optionee. Any gain or loss recognized on such a premature disposition of the
shares in excess of the amount treated as ordinary income will be characterized
as long-term or short-term capital gain or loss, depending on the holding
period.
Tax
consequences to recipient from NSOs and SARs.
All
other options that do not qualify as incentive options are referred to as
nonstatutory options. An optionee will not recognize any taxable income at
the
time he or she is granted a non-statutory option. However, upon its exercise,
the optionee will recognize taxable income generally measured as the excess
of
the then fair market value of the shares purchased over the purchase price.
Any
taxable income recognized in connection with an option exercise by an optionee
who is also our employee will be subject to tax withholding by us. Upon the
resale of such shares by the optionee, any difference between the sale price
and
the optionee's purchase price, to the extent not recognized as taxable income
as
described above, will be treated as long-term capital gain or loss, depending
on
the holding period. The tax consequences to the holder of a SAR will be similar
to the consequences from an NSO.
Tax
consequences from award of stock and from stock purchase
rights.
Upon
acquisition of stock under an award made under this Plan, the recipient normally
will recognize taxable ordinary income equal to the excess of the stock’s fair
market value over the purchase price, if any. However, to the extent the stock
is subject to certain types of vesting restrictions, the taxable event will
be
delayed until the vesting restrictions lapse and the shares become transferable,
unless the recipient makes a specific tax election to be taxed on receipt of
the
stock. The tax consequences to the holder of a stock purchase right who has
exercised his or her right will generally be similar to those of a holder of
restricted stock.
Later
disposition of stock. Upon
disposition of stock, the recipient will recognize a capital gain or loss equal
to the difference between the selling price and the sum of the amount paid
for
such stock, if any, plus any amount recognized as ordinary income upon
acquisition (or vesting) of the stock. Such gain or loss will be long or
short-term depending on whether the stock was held for more than one year from
the date ordinary income is measured. Slightly different rules may apply to
persons who are subject to Section 16(b) of the Exchange Act.
The
foregoing is only a summary of the effect of federal income taxation upon a
recipient under the 2005 Equity Plan. It does not purport to be complete, and
does not discuss the tax consequences of the recipient’s death or the income tax
laws of any municipality, state or foreign country in which a recipient may
reside. Recipients of options, rights and awards granted under the 2005 Equity
Plan are advised to consult their personal tax advisors before exercising an
option, right or award or disposing of any stock received pursuant to the
exercise of an option right or award.
Circular
230 Disclaimer.
Nothing
contained in this discussion of certain federal income tax considerations is
intended or written to be used, and cannot be used, for the purpose of (i)
avoiding tax-related penalties under the Code or (ii) promoting, marketing,
or
recommending to another party any transactions or tax-related matters addressed
herein.
74
Performance
Measures.
The
Board of Directors or the Plan Committee will have the power to condition the
grant or vesting of awards under the 2005 Equity Plan upon the attainment of
performance goals, determined by the Board of Directors or the Plan Committee
in
their respective sole discretion. With respect to any awards granted to persons
who are or who may be “covered employees” within the meaning of Section 162(m)
of the Code, the Board of Directors or the Plan Committee will have the power
to
grant such awards upon terms and conditions that qualify such awards as
“qualified performance-based compensation” within the meaning of Section 162(m)
of the Code.
Restrictions
on Transfer.
In
addition to the restrictions set forth under applicable law, the shares of
common stock awarded pursuant to the 2005 Equity Plan are subject to the
following additional restrictions: (i) stock certificates evidencing such shares
will be issued in the sole name of the recipient (but shall be held by us,
subject to the terms and conditions of the award) and may bear any legend which
the Plan Committee deems appropriate to reflect any rights of repurchase or
forfeiture or other restrictions on transfer hereunder or under the award
agreement, or as the Plan Committee may otherwise deem appropriate; and (ii)
no
awards granted under the 2005 Equity Plan may be assignable by any recipient
under the 2005 Equity Plan, either voluntarily or by operation of law, except
by
will or by the laws of descent and distribution or where such assignment is
expressly authorized by the terms of the recipient agreement embodying the
terms
and conditions of the award. Participants are also obliged to comply with our
Securities Trading Policy and rules of the Securities and Exchange Commission.
2005
Investment Plan
General
Description. The
PhotoMedex, Inc. 2005 Investment Plan (the “2005 Investment Plan”) was adopted
by the Board of Directors on November 9, 2005 and approved by the stockholders
on December 28, 2005. We have reserved for issuance thereunder an aggregate
of
400,000 shares of common stock. The 2005 Investment Plan provides for the award
to our executive officers of shares of our common stock in the form of
non-statutory (non-qualified) stock options. The award matches with options
an
executive officer’s purchase of our common stock in the open market on a share
for share basis, where the options will have an exercise price equal to the
purchase price of the matched stock. However, an executive officer will not,
during the life of the Investment Plan, receive matching options for open market
purchases that exceed, in the aggregate, $250,000. The 2005 Investment Plan
will
expire 10 years after its approval by the stockholders, namely on December
28,
2015.
The
purpose of the 2005 Investment Plan is to promote the success of our business
and to enhance the value of the business by linking the personal interests
of
the executive officers participating in the Plan to the interests of our
stockholders. Our Board of Directors believes that the reservation of 400,000
shares of common stock for issuance under the 2005 Investment Plan would provide
an adequate reserve of shares for issuance under the 2005 Investment Plan in
order to achieve the aims of the Plan.
A
description of the 2005 Investment Plan is set forth below. The description
is
intended to be a summary of the material provisions of the 2005 Investment
Plan
and does not purport to be complete. The following discussion summarizes certain
aspects of the 2005 Investment Plan, but is qualified in its entirety by
reference to the 2005 Investment Plan, which was attached as “Exhibit B” to our
Proxy Statement filed with the Commission on November 15, 2005.
General
Purpose. The
general purpose of the 2005 Investment Plan is to link the personal interests
of
our executive officers to the success of our business and thereby to the value
of our business. Our independent directors will not receive awards under the
2005 Investment Plan, but rather will continue to be compensated under the
2000
Non-Employee Director Plan. The 2005 Investment Plan provides that, subject
to
an overall limit for each participating executive officer, non-statutory options
may be granted to executive officers, on a share for share basis, for shares
of
our common stock that the executive officer may purchase in the open market.
Shares
Subject to the 2005 Investment Plan.
We have
reserved for issuance up to 400,000 shares of common stock under the 2005
Investment Plan. If shares of common stock underlying the matching options
are
forfeited for any reason, prior to exercise, the forfeited shares will become
available for new awards in accordance with the terms of the 2005 Investment
Plan. No awards have been awarded under the 2005 Investment Plan as of the
date
of this Report.
75
Administration
of and Eligibility under 2005 Investment Plan.
The 2005
Investment Plan, as adopted, provides for the grant of options to those
executive officers who are subject to reporting to the Commission under Section
16(a) of the Exchange Act. The 2005 Investment Plan authorizes the grant of
options by a committee (the “Plan Committee”) to be established by the Board of
Directors to administer the 2005 Investment Plan. The Plan Committee will be
the
Compensation Committee of the Board of Directors or such other similar committee
as may in the future be designated by the Board of Directors to perform those
functions presently being performed by the Compensation Committee. The Plan
Committee will consist of at least three members, each of whom will be a
non-employee director, as such term is defined under Rule 16b-3 of the Exchange
Act, will qualify as an outside director, for purposes of Section 162(m) of
the
Code and will comply with the listing standards of the primary trading market
or
securities exchange on which the common stock then trades.
The
Plan
Committee will determine the terms and conditions of options granted under
the
2005 Investment Plan, consistent with the terms of the Plan, will interpret
the
Plan and establish rules for the Plan’s administration.
Matching
Provision. Each
executive officer may purchase shares of our common stock in the open market
(the “Open Market Shares”). Upon due notification to the Plan Committee,
non-statutory options will be granted under the Plan to the officer. The grant
will match in the number of options the number of Open Market Shares; each
option will have an exercise price equal to the price paid by the executive
officer for his or her Open Market Shares, subject to the following limitations:
(a) options covering no more than 200,000 shares may be granted to any one
executive officer in any one calendar year, (b) each executive officer will
not
be granted options for open market purchases that exceed $250,000 in the
aggregate during the term of the Plan, and (c) matching options will otherwise
be issued on a “first come, first served” basis: the Plan is not required to
increase the number of shares of common stock authorized under the Plan in
the
event that the demand for matching options exceeds the supply.
Open
Market Shares will be held by us in escrow for a holding period equal to the
lesser of three years from the date the Shares were purchased in the open market
or the occurrence of a change in control of PhotoMedex. If the officer sells
any
Open Market Shares before the completion of the holding period, he or she may
do
so, but the matching options will thereupon be canceled. At the end of the
holding period, the Open Market Shares will be released from escrow and the
matching options will be fully vested and exercisable.
Recipient
Agreements.
The Plan
Committee may require that each recipient enter into a written agreement with
us, which will set forth all the terms and conditions of the grant. The award
agreement will contain such other terms, provisions and conditions not
inconsistent herewith, as shall be determined by the Plan Committee. Unless
the
Committee determines otherwise, each matching option will have a life of 10
years. The Committee may allow payment of the exercise price of the matching
options, and of any associated withholding taxes, by means of shares of our
common stock.
Adjustments
Resulting from Changes in Capitalization.
If any
change is made in the common stock subject to the 2005 Investment Plan, or
subject to any option granted under the 2005 Investment Plan (through merger,
consolidation, reorganization, recapitalization, stock dividend, stock split,
liquidating dividend, combination of shares, exchange of shares, or other change
in corporate structure or other transaction not involving the receipt of
consideration by us), the class(es) and maximum number of shares subject to
the
2005 Investment Plan, the maximum number of shares which may be granted to
a
recipient in a calendar year, the class(es) and number of shares and exercise
price per share of outstanding options shall be adjusted to prevent the dilution
or enlargement of rights. Such adjustment shall be made by the Board of
Directors or the Plan Committee, the determination of which shall be final,
binding and conclusive. (The conversion of any of our convertible securities
will not be treated as a “transaction not involving the receipt of
consideration.”)
Termination
and Amendment of the 2005 Investment Plan.
The
Board of Directors may terminate or amend the 2005 Investment Plan at any time,
except that options then outstanding will not be adversely affected thereby
without the written consent of the respective recipients holding such options.
The Board of Directors may make such amendments to the 2005 Investment Plan
as
it shall deem advisable, except that the approval by our stockholders in
accordance with the laws of Delaware within 12 months after the adoption of
the
amendment will be required for any amendment which would: (i) materially modify
the requirements as to eligibility for option under the 2005 Investment Plan;
(ii) materially increase the benefits accruing to recipients under the 2005
Investment Plan; or (iii) be required under applicable law or the listing
standards of the market or exchange on which the common stock then trades.
The
Board may in its sole discretion submit any other amendment to the Plan for
stockholder approval, including, but not limited to, amendments to the Plan
intended to satisfy the requirements of Section 162(m) of the Code regarding
the
exclusion of performance-based compensation from the limit on corporate
deductibility of compensation to certain executive officers.
76
In
the
event of a transaction involving our dissolution or liquidation, recipients
of
matching options may exercise their rights as soon as practicable before the
effective date of the transaction. The Committee in its discretion may provide
that any restrictions on matching options may lapse and may further provide
that
options not otherwise exercisable may become so. Any options not exercised
by
the transaction will terminate immediately before the transaction.
In
the
event of a change in control of PhotoMedex, all options granted under the 2005
Investment Plan shall become fully exercisable and immediately vested. A change
in control results from the acquisition by any one person, or group of persons
acting in concert, of more than 50% of the voting power of our capital stock.
A
change in control also results from a “Sale of the Company.” A Sale of the
Company occurs on: (a) our consolidation or merger into or with a successor
entity such that our stockholders own less than a majority of the shares of
stock of such entity; or (b) a sale or other disposition of all, or
substantially all, of our assets to a successor entity. In the event of a Sale
of the Company, options granted under the 2005 Investment Plan are to be
assumed, or substituted with equivalent rights, by the successor entity. If
the
successor entity declines to do so, then each holder of an option shall have
not
less than 20 days before the consummation of the Sale of the Company to exercise
his or her options, and all such rights shall become fully exercisable during
such 20-day period.
Effect
of Termination of Recipient.
A grant
of matching options under the 2005 Investment Plan is generally subject to
the
condition that the executive officer continue to remain in our employ, whether
as an executive officer or otherwise. Unless a different period is provided
by
the Plan Committee, a vested matching option shall be exercisable for three
months following the optionee’s termination of employment, subject to the
following exceptions. In the event of the optionee’s termination due to
disability or death, the exercise period will be 12 months; in event of the
optionee’s termination for cause, the matching options shall cease to be
exercisable in any respect as of the date of termination. For purposes of the
2005 Investment Plan, the term “termination” means the ceasing to be an employee
of ours.
Certain
Federal Income Tax Considerations.
Awards
granted under the 2005 Investment Plan generally have the federal income tax
consequences discussed below.
Corporate
business deduction. Generally,
we will be entitled to a tax deduction in the same amount as the ordinary income
recognized by a recipient with regard to the award. In order to secure such
deduction in the case of exercise of the matching options, we must fulfill
such
withholding tax obligations as may be imposed on us.
However,
Section 162(m) of the Code imposes a limit on corporate tax deductions for
compensation in excess of $1 million per year paid by a public company to its
Chief Executive Officer or any of the next four highest paid executive officers
as listed in the proxy statement. For this purpose, compensation includes gains
arising from stock option exercises, vesting of restricted stock and the award
of stock bonuses. An exception to this limitation is provided for “qualified
performance-based compensation.” The Section 162(m) provisions generally require
that affected executives’ compensation satisfy certain conditions in order to
qualify as “qualified performance-based compensation.” Section 162(m) denies a
deduction to any publicly held corporation for compensation paid to certain
employees in a taxable year to the extent that compensation exceeds $1,000,000.
It is possible that compensation attributable to awards made under this Plan,
when combined with all other types of compensation received by a covered
employee from us, may cause this limitation to be exceeded in any particular
year.
Accordingly,
in order to permit the Board of Directors and the Plan Committee to grant awards
that qualify as “qualified performance-based compensation” under Section 162(m)
and therefore to be deductible by us without regard to the $1 million deduction
limit of Section 162(m), the 2005 Investment Plan provides, subject to
stockholder approval, for authority in the Board of Directors or the Plan
Committee to condition the grant or vesting of such awards and authorizes the
Board of Directors or the Plan Committee to establish any other terms and
conditions required to qualify such awards as “qualified performance-based
compensation.” The Board of Directors may in its sole discretion submit any
other amendment to the Plan for stockholder approval, including, but not limited
to, amendments to the Plan intended to satisfy the requirements of Section
162(m) regarding the exclusion of performance-based compensation from the limit
on corporate deductibility of compensation to certain executive officers. In
conformance to the provisions of Section 162(m), the Committee will grant
matching options in a given year on no more than 200,000 shares of our common
stock reserved for issuance under the 2005 Investment Plan. In addition, as
noted above, each executive officer will be granted no more than $250,000 of
options under the Plan, where the value of an option is based on the exercise
price of the option.
77
Tax
consequences of deferred compensation.
The American Jobs Creation Act of 2004 added Section 409A to the Internal
Revenue Code, generally effective January 1, 2005. In September, 2005, the
Treasury Department issued detailed Proposed Regulations under this statute,
but
a number of issues remain unresolved. Section 409A covers most programs that
defer the receipt of compensation to a succeeding year. It provides strict
rules
for elections to defer (if any) and for timing of payouts. There are significant
penalties placed on the individual employee for failure to comply with Section
409A. However, it generally does not affect our ability to deduct deferred
compensation at some point in time.
Section
409A does not apply to incentive stock options, non-qualified stock options
(that are not and can never later be discounted) and restricted stock (provided
there is no deferral of income beyond the vesting date). Section 409A also
does
not cover stock appreciation right (SAR) plans if (i) the exercise price can
never be less than the fair market value of the underlying stock on the date
of
grant (ii) no features defer the recognition of income beyond the exercise
date,
and (iii) there are no other rights granted beyond the SAR itself.
Section
409A does apply to restricted stock units, performance units and performance
shares. Grants under such plans will continue to be taxed at vesting but will
be
subject to new limits on plan terms governing when vesting may
occur.
Tax
consequences to recipient from NSOs.
An
optionee will not recognize any taxable income at the time he or she is granted
a non-statutory option. However, upon its exercise, the optionee will recognize
taxable income generally measured as the excess of the then fair market value
of
the shares purchased over the purchase price, if any. Any taxable income
recognized in connection with an option exercise by an optionee who is also
our
employee will be subject to tax withholding by us. Upon the resale of such
shares by the optionee, any difference between the sale price and the optionee's
purchase price, to the extent not recognized as taxable income as described
above, will be treated as long-term capital gain or loss, depending on the
holding period.
Later
disposition of stock. Upon
disposition of stock acquired from exercise of a matching option, the recipient
will recognize a capital gain or loss equal to the difference between the
selling price and the sum of the amount paid for such stock, if any, plus any
amount recognized as ordinary income upon acquisition (or vesting) of the stock.
Such gain or loss will be long or short-term depending on whether the stock
was
held for more than one year from the date ordinary income is measured. Slightly
different rules may apply to persons who are subject to Section 16(b) of the
Exchange Act.
The
foregoing is only a summary of the effect of federal income taxation upon a
recipient under the 2005 Investment Plan. It does not purport to be complete,
and does not discuss the tax consequences of the recipient’s death or the income
tax laws of any municipality, state or foreign country in which a recipient
may
reside. Recipients of options granted under the 2005 Investment Plan are advised
to consult their personal tax advisors before exercising an option or disposing
of any stock received pursuant to the exercise of an option.
Circular
230 Disclaimer.
Nothing
contained in this discussion of certain federal income tax considerations is
intended or written to be used, and cannot be used, for the purpose of (i)
avoiding tax-related penalties under the Code or (ii) promoting, marketing,
or
recommending to another party any transactions or tax-related matters addressed
herein.
78
Restrictions
on Transfer. In
addition to the restrictions set forth under applicable law, the Open Market
Shares and the options granted pursuant to the 2005 Investment Plan are subject
to the following additional restrictions: (i) stock certificates evidencing
such
Open Market Shares will be issued in the sole name of the recipient (but shall
be held by us, subject to the terms and conditions of 2005 Investment Plan)
and
may bear any legend which the Plan Committee deems appropriate to reflect any
restrictions on transfer under the Plan, or as the Plan Committee may otherwise
deem appropriate; and (ii) no options granted under the 2005 Investment Plan
may
be assignable by any recipient under the Plan, either voluntarily or by
operation of law, except by will or the laws of descent and distribution or
with
the approval of the Plan Committee. Participants are also obliged to comply
with
our Securities Trading Policy and rules of the Securities and Exchange
Commission.
2000
Non-Employee Director Stock Option Plan
General.
The
2000 Non-Employee Director Stock Option Plan, or the Non-Employee Director
Plan,
was adopted by the Board of Directors on May 15, 2000, to be effective as of
June 1, 2000, and was approved by our stockholders on July 18, 2000. We
initially reserved for issuance an aggregate of 250,000 shares of common stock
under the Non-Employee Director Plan. We increased this to 650,000 shares of
common stock, pursuant to the affirmative vote of the stockholders on June
10,
2002 and increased this number to 1,000,000 shares of common stock, pursuant
to
the affirmative vote of the stockholders on December 16, 2003. We further
increased this number to 1,400,000 shares of common stock, pursuant to the
affirmative vote of the stockholders on December 28, 2005. It continues as
an
active plan.
A
description of the Non-Employee Director Plan is set forth below. The
description is intended to be a summary of the material provisions of the
Non-Employee Director Plan and does not purport to be complete.
Purpose
of the Plan.
The
purposes of the Non-Employee Director Plan are to enable us to attract, retain,
and motivate our non-employee directors and to create a long-term mutuality
of
interest between the non-employee directors and our stockholders by granting
options to purchase common stock.
Administration.
The
Non-Employee Director Plan will be administered by a committee of the Board
of
Directors, appointed from time to time by the Board of Directors. The
Nominations and Corporate Governance Committee has been charged with this task.
The Committee has full authority to interpret the Non-Employee Director Plan
and
decide any questions under the Non-Employee Director Plan and to make such
rules
and regulations and establish such processes for administration of the
Non-Employee Director Plan as it deems appropriate subject to the provisions
of
the Non-Employee Director Plan.
Available
Shares.
The
Non-Employee Director Plan authorizes the issuance of up to 1,000,000 shares
of
common stock upon the exercise of non-qualified stock options granted to our
non-employee directors. In general, if options are for any reason canceled,
or
expire or terminate unexercised, the shares covered by such options will again
be available for the grant of options.
The
Non-Employee Director Plan provides that appropriate adjustments will be made
in
the number and kind of securities receivable upon the exercise of options in
the
event of a stock split, stock dividend, merger, consolidation or
reorganization.
Eligibility.
All of
our non-employee directors are eligible to be granted options under the
Non-Employee Director Plan. A non-employee director is a director serving on
the
Board of Directors who is not then one of our current employees, as defined
in
Sections 424(e) and 424(f) of the Code.
Grant
of Options.
As of
each January 1 following the effective date of the Non-Employee Director Plan,
commencing January 1, 2001, or the Initial Grant Date, each non-employee
director was automatically granted an option to purchase 20,000 shares of common
stock in respect of services to be rendered to us as a director during the
forthcoming calendar year, subject to the terms of the Non-Employee Director
Plan. Each non-employee director who was first elected to the Board of Directors
after June 1, 2000, but prior to January 1, 2001, was granted, as of the date
of
his election, or First Grant Date, an option to purchase that number of shares
equal to the product of (i) 5,000 and (ii) the number of fiscal quarters
remaining in our then current fiscal year (including the quarter in which the
date of such director's election falls), subject to the terms of the
Non-Employee Director Plan. As of January 1, 2002 or the First Grant Date,
as
the case may be, each non-employee director was automatically granted an option
to purchase 20,000 shares of common stock, or the Annual Grant. Commencing
January 1, 2003, the annual grant was to be a nonqualified stock option of
35,000 shares of common stock, pursuant to the approval of the stockholders
on
June 10, 2002. In other respects, the Plan will operate as before January 1,
2003. As of March 15, 2006, we have granted 886,250 options to our eligible
directors under the Non-Employee Director Plan. We have 513,750 shares available
for grant under option under the plan as of the date of this
Report.
79
The
purchase price per share deliverable upon the exercise of an option will be
100%
of the fair market value of such shares as follows:
(i) For
options issued on the Initial Grant Date, the fair market value will be measured
by the closing sales price of the common stock as of the last trading date
of
the fiscal quarter prior to the Initial Grant Date;
(ii) For
options issued on the First Grant Date, the fair market value will be measured
by the closing sales price of the common stock as of the First Grant Date;
and
(iii) For
grants of options issued as of January 1 of any fiscal year, the fair market
value will be measured by the closing sales price of the common stock as of
the
last trading date of the prior year.
Vesting
of Options.
Options
granted under the Non-Employee Director Plan will vest and become exercisable
to
the extent of 5,000 shares for each fiscal quarter prior to fiscal 2003, in
which such director shall have served at least one day as our director and
8,750
shares for each quarter in fiscal 2003 and beyond.
Options
that are exercisable upon a non-employee director's termination of directorship
for any reason excluding termination for cause or in the event of a
reorganization (both as described below) prior to the complete exercise of
an
option (or deemed exercise thereof), will remain exercisable following such
termination for the remaining term of the option. Upon a non-employee director's
removal from the Board of Directors for cause or failure to be re-nominated
for
cause, or if we obtain or discover information after termination of directorship
that such non-employee director had engaged in conduct during such directorship
that would have justified a removal for cause during such directorship, all
outstanding options of such non-employee director will immediately terminate
and
will be null and void. The 2000 Non-Employee Director Plan also provides that
all outstanding options will terminate effective upon the consummation of a
merger, liquidation or dissolution, or consolidation in which we are not the
surviving entity, subject to the right of non-employee director to exercise
all
outstanding options prior to the effective date of the merger, liquidation,
dissolution or consolidation. All options granted to a non-employee director
and
not previously exercisable become vested and fully exercisable immediately
upon
the occurrence of a change in control (as defined in the 2000 Non-Employee
Director Plan).
Amendments.
The
Non-Employee Director Plan provides that it may be amended by the Committee
or
the Board of Directors at any time, and from time to time to effect (i)
amendments necessary or desirable in order that the Non-Employee Director Plan
and the options granted thereunder conform to all applicable laws, and (ii)
any
other amendments deemed appropriate. Notwithstanding the foregoing, to the
extent required by law, no amendment may be made that would require the approval
of our stockholders under applicable law or under any regulation of a principal
national securities exchange or automated quotation system sponsored by the
National Association of Securities Dealers unless such approval is obtained.
The
Non-Employee Director Plan may be amended or terminated at any time by our
stockholders.
Miscellaneous.
Non-employee directors may be limited under Section 16(b) of the Exchange Act
to
certain specific exercise, election or holding periods with respect to the
options granted to them under the Non-Employee Director Plan. Options granted
under the Non-Employee Director Plan are subject to restrictions on transfer
and
exercise. No option granted under the Non-Employee Director Plan may be
exercised prior to the time period for exercisability, subject to acceleration
in the event of our change in control (as defined in the Non-Employee Director
Plan). Although options will generally be nontransferable (except by will or
the
laws of descent and distribution), the Committee may determine at the time
of
grant or thereafter that an option that is otherwise nontransferable is
transferable in whole or in part and in such circumstances, and under such
conditions, as specified by the committee.
80
2000
Stock Option Plan
This
Plan
was frozen as of December 28, 2005. As of March 15, 2006, we had 2,632,304
options outstanding under the 2000 Stock Option Plan. All underlying shares
have
been registered with the SEC. Any unexpired options granted under this Plan
will
terminate: (a) in the event of death or disability, pursuant to the terms of
the
option agreement, but not less than 6 months or more than 12 months after the
applicable date of such event, (b) in the event of retirement, pursuant to
the
terms of the option agreement, but not less than 30 days or more than 3 months
after such retirement date, or (c) in the event of termination of such person
other than for death, disability or retirement, until 30 days after the date
of
such termination. However, the Committee may in its sole discretion accelerate
or extend the exercisability of any or all options upon termination of
employment or cessation of services. The 2000 Stock Option Plan will terminate
on May 14, 2010, the 10th anniversary date of the effectiveness of the 2000
Stock Option Plan.
1995
Non-Qualified Option Plan
On
January 2, 1996, we adopted our 1995 Non-Qualified Option Plan for key
employees, officers, directors and consultants, and reserved up to 500,000
options to be granted thereunder. The option exercise price is not less than
100% of market value on the date granted; 40% of granted options vest
immediately; 30% vest beginning one year after grant; and the remaining 30%
vest
and may be exercised beginning two years from grant. No options may be exercised
more than 10 years after grant, options are not transferable (other than at
death), and in the event of complete termination for cause (other than death
or
disability) or voluntary termination, all unvested options automatically
terminate. Options are no longer granted out of this Plan and as of March 15,
2006 no options remain outstanding under this plan, which is otherwise inactive
and remains frozen.
Other
Non-Employee Director Stock Option Plan
On
April
10, 1998, our Board of Directors adopted a resolution creating a stock option
plan for outside/non-employee members of the Board of Directors. Pursuant to
the
stock plan, each outside/non-employee director is 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 vest at the rate
of 5,000 options per quarter during each quarter in which such person has served
as a member of the Board of Directors. Since we have adopted the 2000
Non-Employee Director Stock Option Plan, we no longer grant options to members
of our Board of Directors under this plan, and as of March 15, 2006 15,000
options remain outstanding under this plan, which is otherwise inactive and
remains frozen.
2004
Stock Option Plan
The
2004
Stock Option Plan was adopted by the Board of Directors of ProCyte on April
l2,
2004, and was approved by ProCyte shareholders on May 19, 2004. An aggregate
of
2,000,000 shares of ProCyte common stock were reserved under the 2004 Stock
Option Plan. PhotoMedex assumed the 2004 Stock Option Plan as part of the
acquisition on March 18, 2005. The number of shares reserved under the plan
was
adjusted downward to 1,324,400 shares of PhotoMedex common stock, to reflect
the
acquisition exchange ratio of 0.6622 shares of PhotoMedex common stock for
each
share of ProCyte common stock. The number of options then outstanding under
the
plan and their exercise prices were also adjusted in accordance with the
exchange ratio.
As
of
March 15, 2006, we had 419,500 options outstanding under the 2004 Stock Option
Plan. This Plan was frozen as of December 28, 2005. Unless sooner terminated
by
the Board of Directors, the Plan will terminate on April 12, 2014, the 10th
anniversary date of its effective date. In general, any unexpired options
granted under this Plan will terminate: (a) immediately on optionee’s
termination from service for cause; (b) in the event of retirement, pursuant
to
the terms of the option agreement, and generally three months after the
termination of service to us; and (c) in the event of death or disability,
pursuant to the terms of the option agreement, and generally 12 months after
the
termination of service to us. In the event of our merger, consolidation or
other
reorganization in which we are not the surviving or continuing corporation
(as
determined by the Committee) or in the event of our liquidation or dissolution,
all options granted under this Plan will terminate on the effective date of
the
merger, consolidation, reorganization, liquidation or dissolution, unless there
is an agreement with respect to such transition which expressly provides for
the
assumption of such options by the continuing or surviving corporation. Options
that are not assumed by the surviving corporation will become 100% vested before
the effective date. If the surviving corporation assumes the options of a
participant, and within two years of the effective date the employment or
services of the participant should terminate (excluding termination for cause
or
termination initiated by the participant for certain reasons), then the
participant’s assumed options will become 100% vested as of such
termination.
81
1996
Stock Option Plan
The
1996
Stock Option Plan was adopted by the Board of Directors of ProCyte on July
23,
1996 and was approved by ProCyte shareholders on May 15, 1997. The plan was
amended on March 2, 1999 and May 26, 1999 to provide for grants to non-employee
directors of ProCyte Corporation. An aggregate of 1,750,000 shares of ProCyte
common stock were reserved under the 1996 Stock Option Plan. PhotoMedex assumed
the 1996 Stock Option Plan as part of the acquisition on March 18, 2005. The
number of shares reserved under the plan was adjusted downward to 1,088,500
shares of PhotoMedex common stock, to reflect the acquisition exchange ratio
of
0.6622 shares of PhotoMedex common stock for each share of ProCyte common stock.
The number of options then outstanding under the Plan and their exercise prices
are also adjusted in accordance with the exchange ratio.
As
of
March 15, 2006, we had 783,472 options outstanding under the 1996 Stock Option
Plan. This Plan was frozen as of December 28, 2005. Unless sooner terminated
by
the Board of Directors, the 1996 Stock Option Plan will terminate on July 23,
2006, the 10th anniversary date of its effective date. Any unexpired options
granted under this Plan will terminate: (a) immediately on an optionee’s
termination from service for cause; (b) in the event of retirement, pursuant
to
the terms of the option agreement, and generally three months after the
termination of service to us; (c) in the event of disability, pursuant to the
terms of the option agreement, and generally 12 months after the termination
of
service to us; and (d) in the event of death, pursuant to the terms of the
option agreement, and generally 12 months from the date of death. In the event
of our merger, consolidation or other reorganization in which we are not the
surviving or continuing corporation (as determined by the Committee) or in
the
event of our liquidation or dissolution, all options granted under the 1996
Stock Option Plan will terminate on the effective date of the merger,
consolidation, reorganization, liquidation or dissolution, unless there is
an
agreement with respect to such transition which expressly provides for the
assumption of such options by the continuing or surviving corporation. Options
that are not assumed by the surviving corporation will become 100% vested before
the effective date. If the surviving corporation assumes the options of a
participant, and within two years of the effective date the employment or
services of the participant should terminate (excluding termination for cause
or
termination initiated by the participant for certain reasons), then the
participant’s assumed options will become 100% vested as of such termination.
1991
Restated Stock Option Plan for Non Employee Directors
On
September 27, 1991, the Board of Directors of ProCyte Corporation adopted the
1991 Stock Option Plan for Non-employee Directors. The Plan was later amended
and restated on February 24, 1994 and September 4, 1996, and each restatement
was approved by the shareholders. The Plan has expired. Any former director
of
ProCyte Corporation holding options under this Plan may exercise his other
options for three years following the date of resignation from the Board of
ProCyte, but in no event later than 10 years from the date of grant of an option
granted to him or her. Options are no longer granted out of this Plan and as
of
March 15, 2006, 22,514 options remain outstanding (and are fully vested) under
this Plan, which is otherwise inactive and remains frozen.
1989
Restated Stock Option Plan
On
September 15, 1989, the Board of Directors of ProCyte Corporation adopted the
1989 Stock Option Plan. The Plan was restated on February 21, 1992 and was
approved by the shareholders. The Plan has expired. Options are no longer
granted out of this Plan and as of March 15, 2006, 305,606 options remain
outstanding (and are fully vested) under this Plan, which is otherwise inactive
and remains frozen.
Other
Stock Options
As
of
March 15, 2006, we had granted, net of cancellations, options to purchase
up to
3,684.962 shares of common stock to certain of our employees, directors and
consultants outside of a formal plan, of which 3,554,962 had been exercised
and
130,000 remained unexercised. There
were no grants of options outside of a formal plan in 2005.
82
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, 2007.
83
Item
12. Security
Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters
The
following table reflects, as of March 15, 2006, 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)
|
209,300
|
*
|
||
Jeffrey
F. O’Donnell (3)
|
859,250
|
1.64
|
||
Dennis
M. McGrath (4)
|
629,000
|
1.21
|
||
Michael
R. Stewart(5)
|
298,940
|
*
|
||
John
F. Clifford(6)
|
699,079
|
1.35
|
||
Alan
R. Novak (7)
|
191,101
|
*
|
||
David
Anderson (8)
|
70,000
|
*
|
||
Warwick
Alex Charlton (9)
|
332,500
|
*
|
||
Anthony
J. Dimun (10)
|
191,250
|
*
|
||
Corsair
Reporting Persons (11)
|
3,418,794
|
6.61
|
||
Wellington
Management Co., L.P. (12)
|
7,180,002
|
13.96
|
||
All
directors and officers as a group (9 persons)
(13)
|
3,480,420
|
6.40
|
*
|
Less
than 1%.
|
(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, 2006, 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 52,319,294 shares of
common
stock outstanding as of March 15,
2006.
|
(2) |
Includes
31,800 shares and options to purchase up to 177,500 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, 2006. Mr.
DePiano's address is 351 East Conestoga Road, Wayne, Pennsylvania
19087.
|
(3) |
Includes
3,000 shares, 525,000 additional shares subject to restriction agreement
with us and options to purchase up to 331,250 shares of common stock.
Does
not include options to purchase up to 418,750 shares of common stock,
which may vest more than 60 days after March 15, 2006.
|
(4) |
Includes
4,000 shares, 335,000 additional shares subject to restriction agreement
with us and options to purchase up to 290,000 shares of common stock.
Does
not include options to purchase up to 335,000 shares of common stock,
which may vest more than 60 days after March 15,
2006.
|
(5) |
Includes
1,440 shares and options to purchase 297,500 shares of common stock.
Does
not include options to purchase up to 242,500 shares of common stock,
which may vest more than 60 days after March 15,
2006.
|
(6) |
Includes
227,796 shares and options to purchase up to 471,283 shares of common
stock. Does not include options to purchase up to 176,037 shares
of common
stock, which may vest more than 60 days after March 15, 2006.
|
84
(7) |
Includes
28,601 shares of common stock and options to purchase up to 162,500
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,
2006.
Mr. Novak's address is 3050 K Street, NW, Suite 105, Washington, D.C.
20007.
|
(8) |
Includes
options to purchase up to 70,000 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, 2006. Mr. Anderson's address is
147
Keystone Drive, Montgomeryville, PA
18936.
|
(9) |
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 162,500 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, 2006. Mr. Charlton's address is 444 Madison
Avenue, Suite 605, New York, New York
10022.
|
(10) |
Includes
95,000 shares of common stock owned by Mr. Dimun and his wife and
options
to purchase up to 96,250 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, 2006. Mr. Dimun’s address is 46 Parsonage Hill
Road, Short Hills, New Jersey
07078.
|
(11) |
Includes
3,158,500shares 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,
and also is the manager of certain other separately managed accounts
which
hold 487,307 additional shares. 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. Accordingly,
the Corsair Reporting Persons may collectively be deemed to be the
beneficial owners of 3,418,794 shares of common stock, including
3,158,500
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, 2006.
|
(12) |
Wellington
Management Company, LLP is an investment adviser which has shared
voting
powers with respect to 7,180,002 shares of common stock owned of
record by
its clients. The foregoing information has been derived from a Schedule
13G filed on behalf of Wellington Management on February 14, 2006.
|
(13) |
Includes 561,637
unrestricted shares, 860,000 restricted shares and options to purchase
2,058,783 shares of common stock. Does not include options to purchase
up
to 1,259,787 shares of common stock, which may vest more than 60
days
after March 15, 2006.
|
Item
13. Certain
Relationships and Related Transactions
In
the
year ended December 31, 2002, we engaged True North Partners, LLC, or True
North Partners, to perform marketing consulting services for us, and we also
engaged True North Capital Ltd., or True North Capital, to perform financial
consulting services for us. In the year ended December 31, 2003, we incurred
charges of $18,128 and $20,000 for the marketing and financial services from
True North Partners and True North Capital, respectively. We are advised that
the aggregate fees paid to True North Partners and True North Capital in the
year December 31, 2003 constituted less than 5% of the consolidated revenues
of
each of True North Partners and True North Capital during the same period.
We
did not pay any fees to True North Partners or True North Capital in 2004.
True
North Capital is a fund management group which provides management and
acquisition advisory services with a specialty in the healthcare industry,
and
True North Partners is a consulting group which has served as the fund advisor
for True North Capital. We are advised that True North Partners and True North
Capital have common equity ownership, but separate management groups and
operations.
85
We
entered into an agreement with True North Capital (the "TNC Agreement"), dated
as of October 28, 2003, pursuant to which True North Capital agreed to assist
us
in identifying and evaluating proposed strategic growth transactions relating
to
the healthcare industry and under that agreement TNC North Capital could earn
a
“success fee.” In 2003, we paid True North Capital a one-time $20,000 expense
reimbursement for the deployment of its personnel and resources in the
fulfillment of the goals set forth in the TNC Agreement. In May 2004, the TNC
Agreement was modified to provide that any success fee under the agreement
would
be divided equally between True North Capital and True North Partners. However,
we canceled the TNC Agreement in October 2004 in accordance with the terms
of
the agreement. No success fee was earned or paid under the TNC Agreement. We
have no plans to enter such an agreement in the future with True North Capital
or True North Partners.
During
the relevant periods from 2003 through 2004, one of our directors, Warwick
Alex
Charlton, was a senior member of the executive management staff of True North
Partners and also of True North Capital until November 10, 2003. Mr. Charlton
also held approximately 20.3% equity interests in each of True North Partners
and True North Capital. During the relevant periods from 2002 through 2004,
another of our directors, John J. McAtee, Jr., held equity interests of less
than 1.0% in each of True North Partners and True North Capital. Mr. McAtee
resigned from the Investment Advisory Board of True North Capital on April
14,
2003.
As
of
March 15, 2006, 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.
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, 2005.
The
Audit
Committee had appointed KPMG LLP to be our independent auditors for 2004.
However, after reviewing the costs incurred in the audit of the 2003 financial
statements and the costs forecasted for the audit of the 2004 financial
statements, the Audit Committee terminated the engagement of KPMG LLP as our
independent auditors, effective June 9, 2004. The Audit Committee recommended
and approved the engagement of Amper, Politziner & Mattia, P.C. as our
principal independent accountants, effective June 9, 2004. Accordingly, we
engaged Amper, Politziner & Mattia, P.C. as our principal independent
accountants for 2004. The following table shows the fees paid or accrued by
us
for the audit and other services provided by Amper, Politziner & Mattia for
2005 and 2004:
86
2005
|
2004
|
||||||
Audit
Fees
|
$
|
343,000
|
$
|
201,000
|
|||
Audit-Related
Fees
|
20,000
|
—
|
|||||
Tax
Fees
|
—
|
—
|
|||||
All
Other Fees
|
23,000
|
—
|
|||||
Total
|
$
|
386,000
|
$
|
201,000
|
The
following table shows the fees paid or accrued by us for the audit and other
services provided by KPMG, LLP for 2005 and 2004:
2005
|
2004
|
||||||
Audit
Fees
|
$
|
$
—
|
$
|
23,000
|
|||
Audit-Related
Fees
|
41,250
|
74,000-
|
|||||
Tax
Fees
|
—
|
—
|
|||||
All
Other Fees
|
—
|
—
|
|||||
Total
|
$
|
41,250
|
$
|
97,000
|
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 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.
The
aggregate fees billed to us in 2004 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
2004, totaled approximately $201,000.
We
incurred fees to KPMG for services rendered for the year ended December 31,
2004, of which approximately $23,000 that was incurred in fiscal
2004 related to the audit and review work for the year ended December
31, 2003.
Audit-Related
Fees. The
aggregate fees billed to us by Amper, Politziner & Mattia 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 $20,000 for 2005. The
aggregate fees billed to us by KPMG for assurance and related services that
are
not related to the performance of the audit and review of our financial
statements that are already reported in the paragraph immediately above totaled
approximately $41,250 and $74,000 for 2005 and 2004, respectively. These costs
primarily related to services provided in connection with the filing of
registration statements.
All
Other Fees. The
aggregate fees billed to us by Amper, Politziner & Mattia for products and
services rendered by Amper, Politziner & Mattia for tax consulting and other
services were for $23,000 for 2005 and negligible for 2004. The aggregate fees
billed to us by KPMG for products and services rendered by KPMG for tax
consulting were negligible for 2004.
87
Engagement
of the Independent Auditor.
The
Audit Committee is responsible for approving every engagement of Amper,
Politziner & Mattia to perform audit or non-audit services for us before
Amper, Politziner & Mattia 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 2006
Amper,
Politziner & Mattia has
been
selected to serve as our independent auditors for the year ending December
31,
2006, 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, 2005
and
2004, 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, 2005.
(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.
(a)(3) Other
Exhibits
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)
|
3.1(a)
|
Certificate
of Incorporation, filed on November 3, 1987 (3)
|
3.1(b)
|
Amendment
to Certificate of Incorporation, filed on July 19, 1999
(3)
|
3.1(c)
|
Amendment
to Certificate of Incorporation, filed on July 22, 1999
(3)
|
3.1(d)
|
Restated
Certificate of Incorporation, filed on August 8, 2000
(4)
|
3.1(e)
|
Amendment
to Restated Certificate of Incorporation, filed on January 6, 2004.
(11)
|
3.2
|
Amended
and Restated Bylaws (5)
|
88
10.1
|
Lease
Agreement (Carlsbad, California) dated August 4, 1998
(3)
|
10.2
|
Patent
License Agreement between the Company and Patlex Corporation
(6)
|
10.3
|
Clinical
Trial Agreement between Massachusetts General Hospital, R. Rox Anderson
and the Company, dated March 17, 1998 (3)
|
10.4
|
Consulting
Agreement dated as of January 21, 1998 between the Company and R. Rox
Anderson, M.D. (3)
|
10.5
|
Amended
and Restated Employment Agreement with Jeffrey F. O'Donnell, dated
August
1, 2002 (1)
|
10.6
|
Amended
and Restated Employment Agreement with Dennis M. McGrath, dated August
1,
2002 (1)
|
10.7
|
Lease
between the Company and Radnor Center Associates, dated April 1, 2000
(3)
|
10.8
|
Healthworld
Agreement, dated May 11, 1999 (3)
|
10.9
|
Clinical
Trial Agreement, dated July 27, 1999 (Scalp Psoriasis)
(3)
|
10.10
|
Clinical
Trial Agreement, dated July 27, 1999, and Amendment dated
March 1, 2000 (Plaque
Psoriasis) (3)
|
10.11
|
Clinical
Trial Agreement, dated July 27, 1999 (High Fluence)
(3)
|
10.12
|
Clinical
Trial Agreement, dated November 15, 1999 (Vitiligo)
(3)
|
10.13
|
Massachusetts
General Hospital License Agreement, dated November 26, 1997
(3)
|
10.14
|
Asset
Purchase Agreement with Laser Components GmbH, dated February 29,
2000 (3)
|
10.15
|
Amended
and Restated 2000 Stock Option Plan (1)
|
10.16
|
Amended
and Restated 2000 Non-Employee Director Stock Option Plan
(1)
|
10.17
|
Revolving
Loan Agreement, dated May 31, 2000, between Surgical Laser Technologies,
Inc. and AmSouth Bank (7)
|
10.18
|
First
Amendment to Revolving Loan Agreement, dated February 20, 2002, between
Surgical Laser Technologies, Inc. and AmSouth Bank (7)
|
10.19
|
Second
Amendment to Revolving Loan Agreement, dated June 26, 2002, between
Surgical Laser Technologies, Inc. and AmSouth Bank (7)
|
10.20
|
Third
Amendment to Revolving Loan Agreement, dated February 27, 2003, between
Surgical Laser Technologies, Inc. and AmSouth Bank (7)
|
10.21
|
Fourth
Amendment to Revolving Loan Agreement, dated February 27, 2003, between
Surgical Laser Technologies, Inc. and AmSouth Bank (7)
|
10.22
|
Fifth
Amendment to Revolving Loan Agreement, dated February 27, 2003, between
Surgical Laser Technologies, Inc. and AmSouth Bank (7)
|
10.23
|
Sixth
Amendment to Revolving Loan Agreement, dated February 27, 2003, between
Surgical Laser Technologies, Inc. and AmSouth Bank (7)
|
10.24
|
Note
for Business and Commercial Loans, dated March 26, 2003, made by
Surgical
Laser Technologies, Inc. in favor of AmSouth Bank (7)
|
10.25
|
Addendum
to Note for Business and Commercial Loans LIBOR rate, dated March
26,
2003, made by Surgical Laser Technologies, Inc. in favor of AmSouth
Bank
(7)
|
10.26
|
Security
Agreement (Accounts, Inventory and General Intangibles), dated May
31,
2000, granted by Surgical Laser Technologies, Inc. to AmSouth Bank
(7)
|
10.27
|
Security
Agreement for Tangible Personal Property, dated May 31, 2000, granted
by
Surgical Laser Technologies, Inc. to AmSouth Bank (7)
|
10.28
|
Limited
Security Agreement (Alabama), dated May 31, 2000, granted by Surgical
Laser Technologies, Inc. to AmSouth Bank (7)
|
10.29
|
Letter
of waiver from AmSouth Bank, dated February 27, 2003
(6)
|
10.30
|
Continuing
Guaranty Agreement, dated March 26, 2003, by PhotoMedex, Inc. in
favor of
AmSouth Bank (7)
|
10.31
|
Lease
Agreement dated May 29, 1996, between Surgical Laser Technologies,
Inc.
and Nappen & Associates (Montgomeryville, Pennsylvania)
(7)
|
10.32
|
Lease
Renewal Agreement, dated January 18, 2001, between Surgical Laser
Technologies, Inc. and Nappen & Associates (7)
|
10.33
|
License
and Development Agreement, dated May 22, 2002, between Surgical Laser
Technologies, Inc. and Reliant Technologies, Inc. (7)
|
10.34
|
Secured
Promissory Note, dated May 22, 2002, between Surgical Laser Technologies,
Inc. and Reliant Technologies, Inc. (7)
|
10.35
|
Security
Agreement, dated May 22, 2002, between Surgical Laser Technologies,
Inc.
and Reliant Technologies, Inc. (7)
|
89
10.36
|
Agreement
as to Collateral, dated May 22, 2002, among Surgical Laser Technologies,
Inc., Reliant Technologies, Inc. and AmSouth Bank (7)
|
10.37
|
Employment
Agreement of Michael R. Stewart, dated December 27, 2002
(7)
|
10.38
|
Seventh
Amendment to Revolving Loan Agreement and related agreements, dated
March
10, 2004, among Surgical Laser Technologies, Inc., PhotoMedex, Inc
and
AmSouth Bank (11)
|
10.39
|
Note
for Business and Commercial Loans, dated May 13, 2003, made by Surgical
Laser Technologies, Inc. in favor of AmSouth Bank (8)
|
10.40
|
Addendum
to Note for Business and Commercial Loans, LIBOR rate, dated May
13, 2003,
made by Surgical Laser Technologies, Inc. in favor of AmSouth Bank
(8)
|
10.41
|
Letter
Agreement dated October 28, 2003 between PhotoMedex and True North
Capital
Ltd. (9)
|
10.42
|
Employment
Agreement of John F. Clifford, dated March 18, 2005 (2)
|
10.43
|
Employment
Agreement of Robin L. Carmichael, dated March 18, 2005
(2)
|
10.44
|
Restricted
Stock Purchase Agreement of Jeffrey F. O’Donnell, dated January 15,
2006
|
10.45
|
Restricted
Stock Purchase Agreement of Dennis M. McGrath, dated January 15,
2006
|
10.46
|
2005
Equity Compensation Plan, approved December 28, 2005
(13)
|
10.47
|
2005
Investment Plan, approved December 28, 2005 (13)
|
10.48
|
2004
Stock Option Plan, assumed from ProCyte (12)
|
10.49
|
1996
Stock Option Plan, assumed from ProCyte (12)
|
10.50
|
1991
Restated Stock Option Plan for Non-Employee Directors, assumed from
ProCyte (12)
|
10.51
|
1989
Restated Stock Option Plan, assumed from ProCyte (12)
|
10.52
|
Standard
Industrial/Commercial Multi-Tenant Lease - Net, dated March 17, 2005
(Carlsbad, California)
|
10.53
|
Industrial
Real Estate Lease, dated August 30, 1993, as amended five times (Redmond,
Washington)
|
10.54
|
Master
Purchase Agreement, dated September 7, 2004, between PhotoMedex,
Inc. and
Stern Laser, srl
(14)
|
10.55
|
Master
Lease Agreement, dated June 25, 2004, between PhotoMedex, Inc.
and GE
Capital Corporation. (15)
|
16.1
|
Letter
re Change in Certifying Accountant (10)
|
22.1
|
List
of subsidiaries of the Company
|
23.1
|
Consent
of Amper, Politziner & Mattia P.C.
|
23.2
|
Consent
of KPMG LLP
|
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
|
|
(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 Registration Statement on Form S-1, as filed with
the
Commission on January 28, 1998, and as
amended.
|
(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 Quarterly Report on Form 10-Q for the quarter ended
March
31, 2003.
|
(6) |
Filed
as part of our Annual Report on Form 10-K for the year ended
December 31, 1987.
|
(7) |
Filed
as part of our Annual Report on Form 10-K for the year ended December
31,
2002.
|
(8) |
Filed
as part of our Quarterly Report on Form 10-Q for the quarter ended
June
30, 2003.
|
(9) |
Filed
as part of our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2003.
|
(10) |
Filed
as part of our Current Report on Form 8-K, dated May 9, 2000, and as
amended.
|
(11) |
Filed
as part of our Annual Report on Form 10-K for the year ended December
31,
2003.
|
(12) |
Filed
as part of our Registration Statement on Form S-8, as filed with
the
Commission on April 13, 2005.
|
(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 Current Report on Form 8-K, dated September 10,
2004.
|
(15)
|
Filed
as part of our Quarterly Report on Form 10-Q for the quarter ended
June
30, 2004.
|
90
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.
DOCUMENTS
INCORPORATED BY REFERENCE
Certain
documents listed above in Part IV, Item 15 of this Report, as exhibits to this
Report on Form 10-K, are incorporated by reference from other documents
previously filed by us.
91
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, 2006 | 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, 2006
|
||
Richard
J. DePiano
|
||||
/s/
Jeffrey F. O’Donnell
|
President,
Chief Executive Officer and Director
|
March
16, 2006
|
||
Jeffrey
F. O'Donnell
|
||||
/s/
Dennis M. McGrath
|
Chief
Financial Officer
|
March
16, 2006
|
||
Dennis
M. McGrath
|
||||
/s/
Alan R. Novak
|
Director
|
March
16, 2006
|
||
Alan
R. Novak
|
||||
/s/
David W. Anderson
|
Director
|
March
16, 2006
|
||
David
W. Anderson
|
||||
/s/
Warwick Alex Charlton
|
Director
|
March
16, 2006
|
||
Warwick
Alex Charlton
|
||||
/s/
Anthony J. Dimun
|
Director
|
March
16, 2006
|
||
Anthony
J. Dimun
|
92
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
|
Report
of Independent Registered Public Accounting Firm
|
F-4
|
Consolidated
Balance Sheets, December 31, 2005 and 2004
|
F-5
|
Consolidated
Statements of Operations, Years ended December 31, 2005, 2004 and
2003
|
F-6
|
Consolidated
Statements of Stockholders’ Equity, Years ended December 31,
2005,
|
|
2004
and 2003
|
F-7
|
Consolidated
Statements of Cash Flows, Years ended December 31, 2005, 2004 and
2003
|
F-8
|
Notes
to Consolidated Financial Statements
|
F-9
|
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, 2005 and 2004, and the related consolidated
statements of operations, stockholders’ equity, and cash flows for the years
ended December 31, 2005 and 2004. These financial statements are the
responsibility of the Company’s management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. 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, 2005 and 2004, and the results of its operations
and its cash flows for the years ended December 31, 2005 and 2004, in conformity
with United States generally accepted accounting principles.
We
also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the effectiveness of PhotoMedex, Inc. and
Subsidiary’s internal control over financial reporting as of December 31, 2005,
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 10, 2006 expressed an unqualified opinion
thereon.
/s/ Amper, Politziner & Mattia, P. C. | |||
March
10, 2006
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 2005
Annual Report on Internal Controls, that PhotoMedex, Inc. and Subsidiaries
(the
Company) maintained effective internal control over financial reporting as
of
December 31, 2005, 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, 2005, 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, 2005, 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, 2005 and the related consolidated
statements of operations, stockholders’ equity and cash flows for the years
ended December 31, 2005 in our report dated March 10, 2006, expressed an
unqualified opinion.
/s/ Amper, Politziner & Mattia, P. C. | |||
March
10, 2006
Edison,
New Jersey
|
F-3
REPORT
OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
Board
of Directors and Stockholders
PhotoMedex,
Inc. and Subsidiaries:
We
have
audited the 2003 consolidated financial statements of PhotoMedex, Inc. and
subsidiaries as listed in the accompanying index. These consolidated financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these consolidated financial
statements based on our audit.
We
conducted our audit in accordance with the standards of the Public Company’s
Accounting Oversight Board (United States). Those standards require that
we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining,
on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used
and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In
our
opinion, the 2003 consolidated financial statements referred to above present
fairly, in all material respects, the results of the operations, changes
in
stockholders’ equity, and cash flows of PhotoMedex, Inc. and subsidiaries for
the year ended December 31, 2003 in conformity with United States generally
accepted accounting principles.
As
discussed in Note 1 to the consolidated financial statements, effective January
1, 2002, the Company adopted Statement of Financial Accounting Standards
No.
142, “Goodwill and Other Intangible Assets.”
/s/
KPMG
LLP
Philadelphia,
Pennsylvania
February
18, 2004 (except with respect to the eleventh paragraph
of
note
10, as to which the date is March 10, 2004)
F-4
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
ASSETS
|
December
31,
|
||||||
2005
|
2004
|
||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
5,403,036
|
$
|
3,884,817
|
|||
Restricted
cash
|
206,931
|
112,200
|
|||||
Accounts
receivable, net of allowance for doubtful accounts of $765,440 and
$736,505
|
4,651,080
|
4,117,399
|
|||||
Inventories
|
8,047,444
|
4,585,631
|
|||||
Prepaid
expenses and other current assets
|
621,372
|
401,989
|
|||||
Total
current assets
|
18,929,863
|
13,102,036
|
|||||
Property
and equipment, net
|
7,044,713
|
4,996,688
|
|||||
Patents
and licensed technologies, net
|
1,577,554
|
929,434
|
|||||
Goodwill,
net
|
16,375,384
|
2,944,423
|
|||||
Other
intangible assets, net
|
4,467,625
|
—
|
|||||
Capitalized
acquisition costs
|
—
|
762,477
|
|||||
Other
assets
|
280,467
|
226,868
|
|||||
Total
assets
|
$
|
48,675,606
|
$
|
22,961,926
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Current
portion of notes payable
|
$
|
228,398
|
$
|
69,655
|
|||
Current
portion of long-term debt
|
1,749,969
|
873,754
|
|||||
Accounts
payable
|
3,572,077
|
3,515,293
|
|||||
Accrued
compensation and related expenses
|
867,427
|
963,070
|
|||||
Other
accrued liabilities
|
924,968
|
924,054
|
|||||
Deferred
revenues
|
466,032
|
636,962
|
|||||
Total
current liabilities
|
7,808,871
|
6,982,788
|
|||||
Notes
payable, net of current maturities
|
159,213
|
26,736
|
|||||
Long-term
debt, net of current maturities
|
2,278,871
|
1,372,119
|
|||||
Other
liabilities
|
11,623
|
—
|
|||||
Total
liabilities
|
10,258,578
|
8,381,643
|
|||||
Commitment
and contingencies
|
|||||||
Stockholders'
Equity:
|
|||||||
Common
Stock, $.01 par value, 75,000,000 shares authorized; 51,414,294 and
40,075,019 shares
issued
and outstanding at December 31, 2005 and 2004,
respectively
|
514,143
|
400,750
|
|||||
Additional
paid-in capital
|
118,140,838
|
90,427,632
|
|||||
Accumulated
deficit
|
(80,182,606
|
)
|
(76,246,562
|
)
|
|||
Deferred
compensation
|
(55,347
|
)
|
(1,537
|
)
|
|||
Total
stockholders'
equity
|
38,417,028
|
14,580,283
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
48,675,606
|
$
|
22,961,926
|
The accompanying notes are an integral part of these consolidated financial statements.
F-5
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
For
the Year Ended December 31,
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Revenues:
|
||||||||||
Product
sales
|
$
|
16,544,894
|
$
|
6,497,397
|
$
|
6,870,570
|
||||
Services
|
11,839,612
|
11,247,784
|
7,448,223
|
|||||||
28,384,506
|
17,745,181
|
14,318,793
|
||||||||
Cost
of revenues:
|
||||||||||
Product
cost of revenues
|
7,219,504
|
3,324,564
|
3,732,109
|
|||||||
Services
cost of revenues
|
8,456,001
|
7,038,705
|
6,755,499
|
|||||||
15,675,505
|
10,363,269
|
10,487,608
|
||||||||
Gross
profit
|
12,709,001
|
7,381,912
|
3,831,185
|
|||||||
Operating
expenses:
|
||||||||||
Selling,
general and administrative
|
16,477,322
|
10,426,256
|
9,451,224
|
|||||||
Engineering
and product development
|
1,127,961
|
1,801,438
|
1,776,480
|
|||||||
17,605,283
|
12,227,694
|
11,227,704
|
||||||||
Loss
from operations
|
(4,896,282
|
)
|
(4,845,782
|
)
|
(7,396,519
|
)
|
||||
Interest
expense, net
|
(342,299
|
)
|
(138,414
|
)
|
(46,330
|
)
|
||||
Other
income, net
|
1,302,537
|
—
|
—
|
|||||||
Net
loss
|
($
3,936,044
|
)
|
($
4,984,196
|
)
|
($
7,442,849
|
)
|
||||
Basic
and diluted net loss per share
|
($0.08
|
)
|
($0.13
|
)
|
($0.21
|
)
|
||||
Shares
used in computing basic and diluted net loss per share
|
48,786,109
|
38,835,356
|
35,134,378
|
The
accompanying notes are an integral part of these consolidated financial
statements
F-6
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
Common
Stock
|
|
||||||||||||||||||
Shares
|
Amount
|
Additional
Paid-In
Caital
|
Accumulated
Deficit |
Deferred
Compensation |
Total
|
||||||||||||||
BALANCE,
DECEMBER 31, 2002
|
31,439,058
|
$
|
314,391
|
$
|
76,828,582
|
($63,819,517
|
)
|
($14,834
|
)
|
$
|
13,308,622
|
||||||||
Sale
of stock, net of expenses
|
5,982,352
|
59,824
|
9,417,722
|
—
|
—
|
9,477,546
|
|||||||||||||
Exercise
of warrants
|
253,271
|
2,532
|
460,316
|
—
|
—
|
462,848
|
|||||||||||||
Exercise
of stock options
|
61,458
|
614
|
63,918
|
—
|
—
|
64,532
|
|||||||||||||
Stock
options issued to consultants for services
|
—
|
—
|
38,164
|
—
|
—
|
38,164
|
|||||||||||||
Stock
options issued to former employee
|
—
|
—
|
62,713
|
—
|
—
|
62,713
|
|||||||||||||
Amortization
of deferred compensation
|
—
|
—
|
—
|
—
|
6,499
|
6,499
|
|||||||||||||
Net
loss
|
—
|
—
|
—
|
(7,442,849
|
)
|
—
|
(7,442,849
|
)
|
|||||||||||
BALANCE,
DECEMBER 31, 2003
|
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
|
146,3254
|
—
|
—
|
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
|
The
accompanying notes are an integral part of these consolidated financial
statements.
F-7
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
For
the Year Ended December 31,
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Cash
Flows From Operating Activities:
|
||||||||||
Net
loss
|
($3,936,044
|
)
|
($4,984,196
|
)
|
($7,442,849
|
)
|
||||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
and amortization
|
3,217,200
|
1,765,944
|
2,186,743
|
|||||||
Loss
on disposal of property and equipment
|
101,009
|
—
|
7,574
|
|||||||
Provision
for doubtful accounts
|
373,964
|
459,861
|
254,429
|
|||||||
Stock
options issued to former employee
|
—
|
—
|
62,713
|
|||||||
Stock
options and warrants issued to
consultants
for services
|
123,257
|
98,435
|
38,164
|
|||||||
Non-monetary
exchange
|
(88,667
|
)
|
—
|
—
|
||||||
Amortization
of deferred compensation
|
76,737
|
6,266
|
6,499
|
|||||||
Changes
in operating assets and liabilities, net of acquisition:
|
||||||||||
Accounts
receivable
|
229,768
|
(1,094,230
|
)
|
(1,201,125
|
)
|
|||||
Inventories
|
(782,880
|
)
|
(628,257
|
)
|
485,694
|
|||||
Prepaid
expenses and other assets
|
1,011,340
|
541,170
|
436,672
|
|||||||
Accounts
payable
|
(518,289
|
)
|
1,273,300
|
(443,368
|
)
|
|||||
Accrued
compensation and related expenses
|
(246,950
|
)
|
22,718
|
117,353
|
||||||
Other
accrued liabilities
|
(1,023,921
|
)
|
(51,482
|
)
|
(270,897
|
)
|
||||
Deferred
revenues
|
(266,366
|
)
|
(174,750
|
)
|
628,237
|
|||||
Net
cash used in operating activities
|
(1,729,842
|
)
|
(2,765,221
|
)
|
(5,134,161
|
)
|
||||
Cash
Flows From Investing Activities:
|
||||||||||
Purchases
of property and equipment
|
(123,201
|
)
|
(111,319
|
)
|
(51,103
|
)
|
||||
Lasers
placed into service
|
(3,461,803
|
)
|
(1,683,528
|
)
|
(1,556,654
|
)
|
||||
Cash
received from acquisition of ProCyte, net of acquisition
costs
|
5,578,416
|
(882,823
|
)
|
—
|
||||||
Net
cash provided by (used in) investing activities
|
1,993,412
|
(2,677,670
|
)
|
(1,607,757
|
)
|
|||||
Cash
Flows From Financing Activities:
|
||||||||||
Proceeds
from issuance of common stock, net
|
(169,524
|
)
|
(138,858
|
)
|
9,477,546
|
|||||
Proceeds
from exercise of options
|
627,831
|
210,283
|
64,532
|
|||||||
Proceeds
from exercise of warrants
|
147,060
|
3,086,468
|
462,848
|
|||||||
Payments
on long-term debt
|
(263,442
|
)
|
(291,840
|
)
|
(218,829
|
)
|
||||
Payments
on notes payable
|
(882,032
|
)
|
(587,161
|
)
|
(648,494
|
)
|
||||
Net
advances (repayments) on line of credit
|
1,889,487
|
527,548
|
(1,770,268
|
)
|
||||||
(Increase)
decrease in restricted cash, cash equivalents and short-term
investments
|
(94,731
|
)
|
(112,200
|
)
|
2,000,000
|
|||||
Net
cash provided by financing activities
|
1,254,649
|
2,694,240
|
9,367,335
|
|||||||
Net
increase (decrease) in cash and cash equivalents
|
1,518,219
|
(2,748,651
|
)
|
2,625,417
|
||||||
Cash
and Cash Equivalents, Beginning of Year
|
3,884,817
|
6,633,468
|
4,008,051
|
|||||||
Cash
and Cash Equivalents, End of Year
|
$
|
5,403,036
|
$
|
3,884,817
|
$
|
6,633,468
|
The
accompanying notes are an integral part of these consolidated financial
statements.
F-8
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 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 develops, manufactures and
markets excimer-laser-based instrumentation designed to phototherapeutically
treat psoriasis, vitiligo, atopic dermatitis and leukoderma. In January 2000,
the Company received the first Food and Drug Administration (“FDA”) clearance to
market an excimer laser system, the XTRAC® system, for the treatment of
psoriasis. In March 2001, the Company received FDA clearance to treat vitiligo;
in August 2001, the Company received FDA clearance to treat atopic dermatitis;
and in May 2002, the FDA granted 510(k) clearance to market the XTRAC system
for
the treatment of leukoderma. The Company launched the XTRAC phototherapy
treatment system commercially in the United States in August 2000.
As
a
result of the acquisition of Surgical Laser Technologies, Inc. (“SLT”) on
December 27, 2002, 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.
Through
the acquisition of ProCyte Corporation (“ProCyte”) on March 18, 2005, the
Company also 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. See Note
2.
The
Company operates in five segments (as described in Note
17):
Domestic XTRAC, International XTRAC, Skin Care (ProCyte), surgical services
(SLT) and surgical products and other (SLT).
Liquidity
and Going Concern
The
Company has incurred significant losses and negative cash flows from operations
since emerging from bankruptcy in May 1995. As of December 31, 2005, the Company
had an accumulated deficit of $80,182,606. The Company has reduced its net
loss
for 2005 by $1,048,152, a 21% improvement, compared to 2004. The Company has
historically financed its activities from operations, the private placement
of
equity securities and from 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, 2005 were $5,609,967, including restricted
cash of $206,931. Management believes that the existing cash balance together
with its existing financial resources, including the leasing credit line
facility with a remaining availability of $2,229,960 (see Note
10),
and
any revenues from sales, distribution, licensing and manufacturing
relationships, will be sufficient to meet the Company’s operating and capital
requirements into the second quarter of 2007. The 2006 operating plan reflects
anticipated growth from an increase in per-treatment fee revenues for use of
the
XTRAC system based on wider insurance coverage in the United States and
continuing cost savings from the integration of business operations acquired
from ProCyte. In addition, the 2006 operating plan calls for increased revenues
and profits from the Domestic XTRAC segment and the continued growth of our
skin
care products. However, depending upon the Company’s rate of growth and other
operating factors, the Company may require additional equity or debt financing
to meet its working capital requirements or capital expenditure needs for 2006.
There can be no assurance that additional financing, if needed, will be
available when required or, if available, can be obtained on terms satisfactory
to the Company.
Since
2002, the Company has made significant progress in obtaining more extensive
reimbursement approval from the Centers for Medicare and Medicaid Services
and
various private health plans for the treatment of skin disorders using the
XTRAC
system.
The
Company plans to continue to focus on securing reimbursement from more private
insurers and to devote sales and marketing efforts where such reimbursement
has
become available. As approvals for reimbursement are obtained, the Company
will
increase spending on the marketing of its psoriasis, vitiligo, atopic dermatitis
and leukoderma treatment products and, if necessary, expansion of its
manufacturing facilities. Notwithstanding 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 some private
healthcare insurers to adopt the excimer-laser-based therapy as an approved
procedure or to provide adequate levels of reimbursement. Management cannot
provide assurance that the Company will market the product successfully or
operate profitably in the future, or that it will not require significant
additional financing in order to accomplish its business plan objectives.
F-9
The
Company’s future success 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 or
other factors beyond the Company’s control. 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.
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, 2005
and
2004. 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.
F-10
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. 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.
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, 2005, 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.
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, 2005, 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, 2005, no such write-down was required.
F-11
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, 2005 and 2004 is summarized as follows:
December
31,
|
|||||||
2005
|
2004
|
||||||
Accrual
at beginning of year
|
$
|
196,890
|
$
|
316,714
|
|||
Additions
charged to warranty expense
|
105,000
|
408,093
|
|||||
Claims
paid and expiring warranties
|
(97,182
|
)
|
(527,917
|
)
|
|||
Accrual
at end of year
|
$
|
204,708
|
$
|
196,890
|
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 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; (iv) and collection is probable (the “SAB 104 Criteria”).
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 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 that do not
fully
satisfy the collection criteria are recognized when invoiced amounts are fully
paid.
Under
the
terms of the distributor agreements, the distributors do not have the right
to
return any unit that they have purchased. However, the Company does allow
products to be returned by its distributors in redress of 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 used 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 the Company inasmuch
as
the treatments can only be performed on Company-owned equipment. Once the
treatments are delivered to a patient, this obligation has been satisfied.
The
calculation of unused treatments prior to the fourth quarter of 2004 was based
upon an estimate that at the end of each accounting period, 15 unused treatments
existed at each laser location. This was based upon the reasoning that the
Company generally sells treatments in packages of 30 treatments. Fifteen
treatments generally represents about one-half the quantity purchased by a
physician or approximately a one-week supply for 6 to 8 patients. This policy
had been used on a consistent basis, prior to the fourth quarter of 2004. The
Company believed this approach to have been reasonable and systematic given
that: (a) physicians have little motivation to purchase quantities (which they
are obligated to pay for irrespective of actual use and are generally unable
to
seek a credit or refund for unused treatments) that will not be used in a
relatively short period of time, particularly since in most cases they can
obtain incremental treatments instantaneously over the phone; and (b) senior
management regularly reviews purchase patterns by physicians to identify unusual
buildup of unused treatment codes at a laser site. Moreover, the Company
continually looks at its estimation model based upon data received from its
customers.
In
the
fourth quarter of 2004, the Company updated the calculations for the estimated
amount of unused treatments to reflect recent purchasing patterns by physicians
near year-end. The Company estimated the amount of unused treatments at December
31, 2004 to include all sales of treatment codes made within the last two weeks
of the period. Management believes this approach more closely approximates
the
actual amount of unused treatments that existed at that date than the previous
approach. Accounting Principles Board (“APB”) Opinion No. 20 provides that
accounting estimates change as new events occur, as more experience is acquired,
or as additional information is obtained and that the effect of the change
in
accounting estimate should be accounted for in the current period and the future
periods that it affects. The Company accounted for this change in the estimate
of unused treatments in accordance with APB No. 20 and SFAS No. 48. Accordingly,
the Company’s change in accounting estimate was reported in revenues for the
fourth quarter of 2004, and was not accounted for by restating amounts reported
in financial statements of prior periods or by reporting pro-forma amounts
for
prior periods.
F-12
The
Company has continued this approach or method for estimating the amount of
unused treatments at December 31, 2005. Had the Company applied the
approach used in 2003 to estimating unused treatments, XTRAC domestic revenues
would have increased by $73,000 for the year ended December 31, 2005 and
decreased by $271,000 for the year ended December 31, 2004 as compared to the
prior method of estimation.
In
the
first quarter of 2003, the Company implemented a program to support certain
physicians in addressing treatments with the XTRAC 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, 2005, the Company deferred an
additional $57,300, under this program as all the criteria for revenue
recognition had not been met.
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
are still
challenges by insurance companies to reimbursing the
procedure;
|
· |
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
the
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 treatment
he
or she purchased from the Company (our fee only) 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 sale
of
treatments to a physician can be denied if timely payments are not
made,
even if a patient’s appeal is still in
process.
|
Prior
to
the fourth quarter of 2004, the Company estimated its liability for potential
refunds under this program by estimating when the physician would be paid for
the insurance claim. In the absence of a two-year historical trend and a large
pool of homogeneous transactions to reliably predict the estimated claims for
refund as required by Staff Accounting Bulletin Nos. 101 and 104, the Company
previously deferred revenue recognition of 100% of the current quarter revenues
from the program to allow for the actual denied claims to be identified after
processing with the insurance companies.
As
of
December 31, 2004, the Company updated its analysis of its estimated refunds
liability. After more than 143,000 treatments in the last 3 years and detailed
record keeping of denied insurance claims and appeals processed, the Company
has
estimated that approximately 4% of the revenues under this program for the
quarter ended December 31, 2005 are subject to being credited or refunded to
the
physician. The Company estimated that the 11% of the revenues under this program
for the quarter ended December 31, 2004 were subject to being credited or
refunded to the physician. This change from the past process of deferring 100%
of the current quarter revenues from the program represents a change in
accounting estimate, and management recorded this change in accordance with
the
relevant provisions of SFAS No. 48 and APB No. 20. These pronouncements state
that the effect of a change in accounting estimate should be accounted for
in
the current period and the future periods that it affects. A change in
accounting estimate should not be accounted for by restating amounts reported
in
financial statements of prior periods or by reporting proforma amounts for
prior
periods. Due to this updated approach in estimates, XTRAC domestic revenues
were
increased by $260,000 and $98,000 for the years ended December 31, 2005 and
2004
as compared to the prior method of estimation.
F-13
The
net
impact on revenue recognized for the XTRAC domestic segment as a result of
the
above two changes in accounting estimate was to increase revenues by
approximately $333,000 for the year ended December 31, 2005 and decreased
revenues $173,000 for the year ended December 31,2004.
The
Company generates revenues from the acquired business of ProCyte 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; 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 the Company's licensee.
Through
its surgical businesses, the Company generates revenues primarily from two
channels. The first is through product sales of laser systems, related
maintenance service agreements, recurring laser delivery systems and laser
accessories; the second is through per-procedure surgical services. The Company
recognizes revenues from surgical laser and other product sales, including
sales
to distributors, when the criteria of SAB 104 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 acquired goodwill 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.
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 7,177,955, 6,464,140 and 8,381,279 as of December 31, 2005, 2004
and
2003, 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.” Although SFAS No. 153 is generally
effective for financial statements for fiscal years beginning after June 15,
2005, the Company elected to adopt this Statement for the current fiscal year.
For 2005, the Company has recognized $88,667 recorded as Other Income in
accordance with this Statement.
F-14
Reclassifications
The
2003
consolidated statements of operations have been revised to present product
and
services cost of revenues and operating expenses to the current presentation
format.
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 its 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 by 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, 2005, no such impairment
exists.
Stock
Options
The
Company applies the intrinsic-value-based method of accounting prescribed by
APB
Opinion No. 25, “Accounting for Stock Issued to Employees,” and related
interpretations, to account for its fixed-plan stock options. Under this method,
compensation expense is recorded on the date of grant only if the current market
price of the underlying stock exceeds the exercise price. Under the provisions
of SFAS No. 123 (revised 2004), “Share Based Payment,” the Company will,
starting January 1, 2006, discontinue intrinsic-value-based accounting and
recognize compensation expense for stock options under fair-value-based
accounting.
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 compensation of $132,081 was recorded and will be amortized over the
remaining vesting period, which is an average of two years.
Had
stock
compensation cost for the Company’s common stock options been determined based
upon the fair value of the options at the date of grant, as prescribed under
SFAS No. 123, the Company’s net loss and net loss per share would have been
increased to the following pro-forma amounts:
Year
Ended December 31,
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Net
loss:
|
||||||||||
As
reported
|
($3,936,044
|
)
|
($4,984,196
|
)
|
($7,442,849
|
)
|
||||
Less:
stock-based employee compensation expense
included
in reported net loss
|
76,737
|
6,266
|
6,499
|
|||||||
Impact
of total stock-based compensation expense determined
under
fair value based method for all awards
|
(1,718,296
|
)
|
(1,540,636
|
)
|
(1,485,378
|
)
|
||||
Pro-forma
|
($5,577,603
|
)
|
($6,518,566
|
)
|
($8,921,728
|
)
|
||||
Net
loss per share:
|
||||||||||
As
reported
|
($0.08
|
)
|
($0.13
|
)
|
($0.21
|
)
|
||||
Pro-forma
|
($0.11
|
)
|
($0.17
|
)
|
($0.25
|
)
|
The
above
pro forma amounts may not be indicative of future amounts because future options
are expected to be granted.
F-15
The
fair
value of the options granted is estimated using the Black-Scholes option-pricing
model with the following weighted average assumptions applicable to options
granted during the years:
Year
Ended December 31,
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Risk-free
interest rate
|
4.04
|
%
|
3.20
|
%
|
2.98
|
%
|
||||
Volatility
|
97.81
|
%
|
99.3
|
%
|
98.9
|
%
|
||||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||
Expected
option life
|
5
years
|
5
years
|
5
years
|
We
account for stock options granted to non-employees on a fair value basis in
accordance with SFAS No. 123 and Emerging Issues Task Force No. 96-18,
"Accounting for Equity Instruments that are issued to other than employees
for
acquiring or in conjunction with selling goods or services," and recognize
expense over the applicable service period.
Supplemental
Cash Flow Information
In
connection with the purchase of ProCyte in March 2005, the Company issued
10,540,579 shares of common stock and assumed options of 1,354,973 shares of
common stock (see Note
2).
During
the year ended December 31, 2005, the Company financed insurance policies
through notes payables for $978,252, financed leasehold improvements through
a
note payable for $195,000, financed certain credit facility costs for $102,988
and issued warrants to a leasing credit facility which were valued at $61,536,
and which offset the carrying value of debt. The Company issued 374,977 shares
of common stock to Stern Laser srl (“Stern”) upon attainment of certain
milestones under a Master Purchase Agreement, 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.
During
the year ended December 31, 2003, the Company financed vehicle and equipment
purchases of $703,482 under capital leases, financed insurance policies through
notes payable for $479,788 and financed certain acquisition costs which were
included in accounts payable at December 31, 2002, through a note payable for
$171,000.
For
the
years ended December 31, 2005, 2004 and 2003, the Company paid interest of
$403,376, $181,115, and $105,634, respectively. Income taxes paid in 2005,
2004
and 2003 were immaterial.
Recent
Accounting Pronouncements
In
May
2005, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 154,
“Accounting Changes and Error Corrections - replacement of APB Opinion No. 20
and FASB Statement No. 3,” was issued. SFAS No. 154 changes the accounting for
and reporting of a change in accounting principle by requiring retrospective
application to prior periods’ financial statements of changes in accounting
principle unless impracticable. SFAS No. 154 is effective for accounting changes
made in fiscal years beginning after December 15, 2005. Management believes
the
adoption of this Statement will not have an effect on the consolidated financial
statements.
On
December 16, 2004, the FASB issued SFAS No. 123(R), “Share-Based Payment,” which
is a revision of SFAS No. 123 and supersedes APB Opinion No. 25. In March 2005
the SEC issued Staff Accounting Bulletin No. 107 (“SAB 107”). SAB 107 expresses
views of the SEC staff regarding the interaction between SFAS No. 123(R) and
certain SEC rules. SFAS No. 123(R) requires all share-based payments to
employees, including grants of employee stock options, to be valued at fair
value on the date of grant, and to be expensed over the applicable vesting
period. Pro-forma disclosure of the income statement effects of share-based
payments will no longer be an alternative. SFAS No. 123(R) is effective for
all
stock-based awards granted on or after January 1, 2006. In addition, companies
must also recognize compensation expense related to any awards that are not
fully vested as of the effective date. Compensation expense for the unvested
awards will be measured based on the fair value of the awards previously
calculated in developing the pro-forma disclosures in accordance with the
provisions of SFAS No. 123.
F-16
The
Company plans to adopt SFAS No. 123(R) on January 1, 2006 and to conform to
SAB
No. 107. As of December 31, 2005, there are 1,969,267 unvested options,
approximately $2.6 million in fair value, which will be amortized to expense
pro
rata over the next three years. The
Company intends to account for the effect of forfeited options as the
forfeitures are incurred, on a quarter by quarter basis. The Company
currently accounts for share-based payments to its employees using the intrinsic
value method; consequently, the results of operations have not included the
recognition of compensation expense for the issuance of stock option awards
to
employees, but only to consultants or in connection with respect of unvested
stock options assumed by the Company from ProCyte.
On
November 24, 2004, the FASB issued SFAS No. 151, “Inventory Costs,” which is an
amendment to ARB No. 43, Chapter 4. It clarifies the accounting for abnormal
amounts of idle facility expense, freight, handling costs, and wasted material
(spoilage). Under this Statement, these costs should be expensed as incurred
and
not included in overhead. Further, SFAS No. 151 requires that allocation of
fixed production overheads to conversion costs should be based on normal
capacity of the production facilities. SFAS No. 151 is effective for inventory
costs incurred during fiscal years beginning after June 15, 2005. Management
believes the adoption of this Statement will not have a material effect on
the
consolidated financial statements.
In
December 2003, the FASB issued FASB Interpretation No. 46 (revised December
2003), “Consolidation of Variable Interest Entities,” (“VIEs”) (“FIN 46R”) which
addresses how a business enterprise should evaluate whether it has a controlling
financial interest in an entity through means other than voting rights and
accordingly should consolidate the entity. FIN 46R replaces FASB Interpretation
No. 46, “Consolidation of Variable Interest Entities,” which was issued in
January 2003. For any VIEs that were created before January 1, 2004 and that
must therefore be consolidated under FIN 46R, the assets, liabilities and
noncontrolling interests of the VIE initially would be measured at their
carrying amounts with any difference between the net amount added to the balance
sheet and any previously recognized interest being recognized as the cumulative
effect of an accounting change. If determining the carrying amounts is not
practicable, fair value at the date FIN 46R first applies may be used to measure
the assets, liabilities and noncontrolling interest of the VIE. The Company
has
adopted FIN 46R as of March 31, 2004. The adoption of FIN 46R did not have
an
effect on the consolidated financial statements inasmuch as the Company has
no
interests in any VIEs.
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. ProCyte’s
focus since 1996 has been to provide unique products primarily based upon
patented technologies for selected applications in the dermatology, plastic
and
cosmetic surgery and spa markets. The Company 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 address the growing demand for skin health and hair care products,
including products designed to enhance appearance and to address the effects
of
aging on the skin and hair. ProCyte’s products are formulated, branded for 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 later added to expand into a
comprehensive approach for incorporation into a patient’s skin care regimen.
The
aggregate purchase price of $27,543,784 consisted of the issuance of 10,540,579
shares of 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
$132,081, and $1,372,726 of transaction costs. 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. As the exchange ratio was fixed, the
fair value of PhotoMedex common stock for accounting purposes was based upon
a
five-day average stock price of $2.29 per share. The five-day average included
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
$13,430,961, which was recorded as goodwill.
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 year ended
December 31, 2005 and 2004, assuming the acquisition had occurred on January
1,
2004:
Year
Ended December 31,
|
|||||||
2005
|
2004
|
||||||
Net
revenues
|
$
|
31,354,068
|
$
|
31,066,181
|
|||
Net
loss
|
($4,038,193
|
)
|
($5,507,196
|
)
|
|||
Basic
and diluted loss per share
|
($0.08
|
)
|
($0.11
|
)
|
|||
Shares
used in calculating basic and diluted loss per share
|
50,932,410
|
49,375,935
|
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, 2004, nor to be
indicative of future results of operations.
Stern
Laser Transaction
On
September 7, 2004, the Company closed the transactions set forth in a Master
Asset Purchase Agreement (the “Master Agreement”) with Stern Laser srl
(“Stern”). As of December 31, 2005, the Company has issued to Stern in June and
December 2005 248,395 and 126,582 shares, respectively, of its restricted common
stock; as of December 31, 2005, the Company has issued to Stern an aggregate
488,854 shares of its restricted common stock in connection with the Master
Agreement. The Company also agreed to pay Stern up to an additional $450,000
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. The Company retains
the right to pay all of these conditional sums in cash or in shares of its
common stock, in its discretion. To secure the latter alternative, the Company
has reserved for issuance, and placed into escrow, 211,146 shares of its
unregistered stock. The per-share price of any future issued shares will be
based on the closing price of the Company’s 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
Company’s XTRAC laser system in South Africa and Italy since 2000. The primary
asset which the Company have acquired from Stern is a license, which was carried
on the Company’s books at $942,422 as of December 31, 2005. Amortization of this
intangible is on a straight-line basis over 10 years, which began in January
2005. In 2005, Stern Laser purchased $183,000 of product from the
Company.
F-18
Note
3
Inventories:
Set
forth
below is a detailed listing of inventories.
December
31,
|
|||||||
2005
|
2004
|
||||||
Raw
materials and work-in-process
|
$
|
4,998,847
|
$
|
2,968,728
|
|||
Finished
goods
|
3,048,597
|
1,616,903
|
|||||
Total
inventories
|
$
|
8,047,444
|
$
|
4,585,631
|
Work-in-process
is immaterial given the typically short manufacturing cycle, and therefore
is
disclosed in conjunction with raw materials. Finished goods includes $69,963
and
$84,000 as of December 31, 2005 and 2004, 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, 2005 and December 31, 2004, the
Company carried reserves against our inventories of $931,719 and $770,989,
respectively.
Note
4
Property
and Equipment:
Set
forth
below is a detailed listing of property and equipment.
December
31,
|
|||||||
2005
|
2004
|
||||||
Lasers
in service
|
$
|
12,657,701
|
$
|
9,333,591
|
|||
Computer
hardware and software
|
334,490
|
256,340
|
|||||
Furniture
and fixtures
|
338,089
|
239,520
|
|||||
Machinery
and equipment
|
755,565
|
522,643
|
|||||
Autos
and trucks
|
382,690
|
400,570
|
|||||
Leasehold
improvements
|
238,276
|
110,441
|
|||||
14,706,811
|
10,863,105
|
||||||
Accumulated
depreciation and amortization
|
(7,662,098
|
)
|
(5,866,417
|
)
|
|||
Property
and equipment, net
|
$
|
7,044,713
|
$
|
4,996,688
|
Depreciation
expense was $2,226,933 in 2005, $1,596,154 in 2004 and $2,011,596 in 2003.
At
December 31, 2005 and 2004, net property and equipment included $530,191 and
$666,326, respectively, of assets recorded under capitalized lease arrangements,
of which $302,710 and $565,245, respectively, of the capital lease obligation
was included in long-term debt at December 31, 2005 and 2004 (see Note
10).
F-19
Note
5
Patents
and Licensed Technologies:
Set
forth
below is a detailed listing of patents and licensed technology.
December
31,
|
|||||||
2005
|
2004
|
||||||
Patents,
owned and licensed, at gross costs of $438,940 and $403,023 net of
accumulated
amortization
of $194,660 and $155,522, respectively
|
$
|
244,280
|
$
|
247,501
|
|||
Other
licensed and developed technologies, at gross costs of $2,047,665
and
$1,177,568,
net
of accumulated amortization of $714,391 and $495,635,
respectively
|
1,333,274
|
681,933
|
|||||
Total
patents and licensed technologies, net
|
$
|
1,577,554
|
$
|
929,434
|
As
of
December 31, 2004, the Company had assigned $809,515 to the license it acquired
from Stern Laser, which is included in other licensed and developed
technologies. Amortization of this intangible is on a straight-line basis over
10 years, which began in January 2005. As Stern Laser completes further
milestones under the Master Agreement, the Company expects to increase the
carrying value of the license. As of December 31, 2005 the assigned value of
the
Stern license is $1,010,665. Amortization expense was $257,894 in 2005, $169,790
in 2004 and $175,147 in 2003. Estimated amortization expense for amortizable
intangible assets for the next five years is $298,000 in 2006, $256,000 in
2007,
$170,000 in 2008, $170,000 in 2009, $170,000 in 2010 and $513,000
thereafter.
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,
|
||||||
2005
|
2004
|
|||||
Neutrogena
Agreement, at gross cost of $2,400,000 net
of
accumulated amortization of $378,000.
|
$
|
2,022,000
|
$
|
—
|
||
Customer
Relationships, at gross cost of $1,700,000 net of
accumulated
amortization of $267,747.
|
1,432,253
|
—
|
||||
Tradename,
at gross cost of $1,100,000 net of accumulated amortization of
$86,628.
|
1,013,372
|
—
|
||||
$
|
4,467,625
|
$
|
—
|
Related
amortization expense was $732,375 for 2005. Estimated amortization expense
for
amortizable intangible assets for the next five years is $930,000 in 2006,
$930,000 in 2007, $930,000 in 2008, $930,000 in 2009, $284,000 in 2010 and
$463,000 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
Capitalized
Acquisition Costs:
The
balance of capitalized acquisition costs as of December 31, 2004 of $762,477
was
transferred to Goodwill upon the completion of the merger of ProCyte (see
Note
2).
F-20
Note
8
Other
Accrued Liabilities:
Set
forth
below is a detailed listing of other accrued liabilities.
December
31,
|
||||||
2005
|
2004
|
|||||
Accrued
professional and consulting fees
|
$
|
437,396
|
$
|
412,019
|
||
Accrued
warranty
|
204,708
|
196,890
|
||||
Accrued
liability from matured notes
|
—
|
245,849
|
||||
Accrued
sales taxes
|
184,764
|
61,142
|
||||
Other
accrued expenses
|
98,100
|
8,154
|
||||
Total
other accrued liabilities
|
$
|
924,968
|
$
|
924,054
|
During
2002, SLT resumed direct control of $223,000 of funds previously set aside
for
the payment of SLT’s subordinated notes, which matured and ceased to bear
interest on July 30, 1999, and $31,000 of funds set aside to pay related accrued
interest. As of December 31, 2005 and 2004, the matured principal and related
interest was $0 and $245,849, respectively. The Company’s liability expired as
of July 30, 2005 and the balance was recorded as other income in the year ended
December 31, 2005.
Note
9
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,
|
||||||||
2005
|
2004
|
|||||||
Note
payable - secured creditor, interest at 16.47%, payable
in
monthly principal and interest installments of $2,618 through December
2006.
|
$
|
26,736
|
$
|
51,489
|
||||
Note
payable - unsecured creditor, interest at 7.42%, payable
in
monthly principal and interest installments of $61,493 through March
2006.
|
177,450
|
—
|
||||||
Note
payable - unsecured creditor, interest at 5.75%, payable
in
monthly principal and interest installments of $44,902 through January
2005.
|
—
|
44,902
|
||||||
Note
payable - unsecured creditor, interest at 6%, payable
in
monthly principal and interest installments of $2,880 through June
2012.
|
183,425
|
—
|
||||||
387,611
|
96,391
|
|||||||
Less:
current maturities
|
(228,398
|
)
|
(69,655
|
)
|
||||
Notes
payable, net of current maturities
|
$
|
159,213
|
$
|
26,736
|
Aggregate
maturities of the notes payable as of December 31, 2005 are $228,398 in 2006,
$25,706 in 2007, $27,292 in 2008, $28,975 in 2009 and $77,239
thereafter.
F-21
Note
10
Long-term
Debt:
Set
forth
below is a detailed listing of the Company’s long-term debt.
December
31,
|
|||||||
2005
|
2004
|
||||||
Borrowings
on a credit facility
|
$
|
3,726,130
|
$
|
1,680,627
|
|||
Capital
lease obligations (see Note 4)
|
302,710
|
565,246
|
|||||
Less:
current portion
|
(1,749,969
|
)
|
(873,754
|
)
|
|||
Total
long-term debt
|
$
|
2,278,871
|
$
|
1,372,119
|
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 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 a form of security
over the lasers. The Company depreciates the lasers 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 for the ten days preceding the date of the draw.
As
of
December 31, 2005, the Company had made three draws under the first tranche
of
the line.
Draw
1
|
Draw
2
|
Draw
3
|
||||||||
Date
of draw
|
June
30, 2004
|
September
24, 2004
|
December
30, 2004
|
|||||||
Amount
of draw
|
$
|
1,536,950
|
$
|
320,000
|
$
|
153,172
|
||||
Stated
interest rate
|
8.47
|
%
|
7.97
|
%
|
8.43
|
%
|
||||
Effective
interest rate
|
17.79
|
%
|
17.41
|
%
|
17.61
|
%
|
||||
Number
of warrants issued
|
23,903
|
6,656
|
3,102
|
|||||||
Exercise
price of warrants per share
|
$
|
3.54
|
$
|
2.64
|
$
|
2.73
|
||||
Fair
value of warrants
|
$
|
62,032
|
$
|
13,489
|
$
|
5,946
|
The
fair
value of the warrants granted is estimated using the Black-Scholes
option-pricing model with the following weighted average assumptions applicable
to the warrants granted:
Warrants
granted under:
|
||||||||||
Draw
1
|
Draw
2
|
Draw
3
|
||||||||
Risk-free
interest rate
|
3.81
|
%
|
3.70
|
%
|
3.64
|
%
|
||||
Volatility
|
99.9
|
%
|
100
|
%
|
99.3
|
%
|
||||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||
Expected
warrant life
|
5
years
|
5
years
|
5
years
|
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 obtained from GE 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 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 for the ten days preceding the date of the draw.
F-22
As
of
December 31, 2005, the Company had made 3 draws against the second tranche,
as
follows:
Draw
4
|
Draw
5
|
Draw
6
|
||||||||
Date
of draw
|
June
28, 2005
|
September
26, 2005
|
December
27, 2005
|
|||||||
Amount
of draw
|
$
|
1,113,326
|
$
|
914,592
|
$
|
914,592
|
||||
Stated
interest rate
|
8.42
|
%
|
8.42
|
%
|
9.14
|
%
|
||||
Effective
interest rate
|
12.63
|
%
|
12.94
|
%
|
13.36
|
%
|
||||
Number
of warrants issued
|
14,714
|
13,191
|
15,860
|
|||||||
Exercise
price of warrants per share
|
$
|
2.50
|
$
|
2.29
|
$
|
1.90
|
||||
Fair
value of warrants
|
$
|
23,257
|
$
|
19,106
|
$
|
19,067
|
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
4
|
Draw
5
|
Draw
6
|
||||||||
Risk-free
interest rate
|
3.76
|
%
|
4.11
|
%
|
4.30
|
%
|
||||
Volatility
|
94.6
|
%
|
93.75
|
%
|
91.09
|
%
|
||||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||
Expected
warrant life
|
5
years
|
5
years
|
5
years
|
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.
As
of
December 31, 2005 the Company had available $2,057,490 from the second tranche
of the line of credit with GE 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,
|
||||
2006
|
$
|
1,830,650
|
||
2007
|
1,517,133
|
|||
2008
|
799,046
|
|||
Total
minimum lease obligation
|
4,146,829
|
|||
Less:
interest
|
(420,699
|
)
|
||
Present
value of total minimum lease obligation
|
$
|
3,726,130
|
Concurrent
with the SLT acquisition, the Company assumed a $3,000,000 credit facility
from
a bank. The credit facility had a commitment term of four years, which expired
May 31, 2004, permitted deferment of principal payments until the end of the
commitment term, and was secured by SLT’s business assets, including
collateralization (until May 13, 2003) of $2,000,000 of SLT’s cash and cash
equivalents and short-term investments. The bank agreed to allow the Company
to
apply the cash collateral to pay down of the facility in 2003. The credit
facility had an interest rate of the 30-day LIBOR plus 2.25%. The credit
facility was subject to certain restrictive covenants at the SLT level and
at
the group level and borrowing base limitations. The group did not meet the
covenants set by the bank at December 31, 2003. On March 10, 2004, the bank
waived the non-compliance with the covenants as of December 31,
2003.
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,
|
||||
2006
|
$
|
197,821
|
||
2007
|
89,742
|
|||
2008
|
40,952
|
|||
Total
minimum lease obligation
|
328,515
|
|||
Less:
interest
|
(25,805
|
)
|
||
Present
value of total minimum lease obligation
|
$
|
302,710
|
F-23
Note
11
Warrant
Exercises:
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
13.
Note
12
Commitments
and Contingencies:
Leases
The
Company has entered into various non-cancelable operating leases for personal
property that expire at various dates through 2008. Rent expense was $558,683,
$456,077 and $517,662 for the years ended December 31, 2005, 2004 and 2003,
respectively. The future annual minimum payments under these non-cancelable
operating leases are as follows:
Year
Ending December 31,
|
|||
2006
|
$
|
599,163
|
|
2007
|
220,901
|
||
2008
|
107,502
|
||
2009
|
79,680
|
||
Thereafter
|
105,408
|
||
Total
|
$
|
1,112,654
|
Litigation
In
the
action which the Company brought against Edwards LifeSciences Corporation and
Baxter Healthcare Corporation in January 2004, the parties reached a settlement
in December 2005, terminating all prior dealings between themselves with respect
to transmyocardial revascularization, and providing for payment to the Company
of an amount that may not be disclosed in accordance with the confidentiality
restrictions of the settlement. Such settlement, net of directly attributable
legal expense, is included in other income in the year ended December 31,
2005.
In
the
matter brought against the Company by City National Bank of Florida, the
Company's former landlord in Orlando, Florida, the Company’s motion for
summary judgment was heard in limine and denied. Judgment was awarded to the
landlord in the amount of $77,023. Offsetting the judgment are proceeds,
approximating $45,000, which are held by the landlord from the sale of assets
left on the leased premises by the party that bought the assets from the
Company. The Company has paid the net judgment amount pursuant to a settlement
that was reached with the landlord which embodies terms which the Company deems
favorable and which have mooted post-trial motions and appeals.
In
the
matter brought by the Company against RA Medical Systems, Inc. and Dean Stewart
Irwin in the United States District Court for the Southern District of
California, a new magistrate judge appointed in 2005 to the case has ruled
that
discovery will continue to be stayed until the trial judge rules on the
defendants’ motion for summary judgment, based on a theory of res judicata.
Notwithstanding the abeyance of the case, the Company has brought in March
2006
a motion for partial summary judgment, based on a theory that defendants have
not had, until January 2006, a license from the State of California to
manufacture or market their medical devices, and therefore have unfairly
competed against the Company by unlawfully manufacturing, marketing and selling
medical devices that were misbranded.
In
the
matter brought by the Company against RA Medical Systems, Inc. and Dean Stewart
Irwin in the Superior Court for San Diego County, California, the
Company elected in February 2006 to discontinue its motions and appeals in
the matter, and thus bring closure to this action.
F-24
On
January 25, 2005, RA Medical Systems, Inc. and Dean Stewart Irwin brought an
action against PhotoMedex, Inc., Jeffrey Levatter Ph.D. (the
Company's Chief Technology Officer), Jenkens & Gilchrist, LLP (the
Company's outside counsel) and Michael R. Matthias, Esq. (litigation
partner at the Company's outside counsel). The action was brought in
the Superior Court for San Diego County, California and based on allegations
that the Company and the other defendants had engaged in malicious prosecution
in bringing and maintaining the action brought by PhotoMedex in April 2003.
The
Company and the other defendants filed a motion to strike the actions, based
on
California Code of Civil Procedure section 425.16, the so-called SLAPP statute.
The motion to strike was denied; the Company appealed the denial. The appellate
court heard oral argument on the matter on March 14, 2006, taking the matter
under advisement. We are being defended by our insurance carrier.
On
May
13, 2005, Vida Brown brought suit in the Circuit Court, 20th
Judicial
Circuit for Charlotte County, Florida, for injuries sustained during a surgical
laser procedure on her lower back. Ms. Brown has sued, among others, the
surgeon, the anesthesiologist, the supplier of the laser delivery system (viz.
Clarus Medical LLC), a person holding himself out as a representative of Clarus,
and the supplier of the holmium laser system and technician (viz. the Company’s
former subsidiary, Surgical Innovations & Services, Inc. or “SIS”). The
laser delivery system supplied by Clarus proved defective in the course of
the
procedure, notwithstanding which the surgeon continued to perform the procedure.
The holmium laser provided by SIS did not perform deficiently. Ms. Brown has
alleged that SIS failed to provide a properly trained operator for the holmium
laser and that SIS’s operator failed to warn the surgeon of the danger of
continuing to use a defective laser delivery system. The Company’s insurance
carrier is providing a defense for SIS in this matter.
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
$2,459,653 as of December 31, 2005. 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, 2005 was approximately
$2,549,061.
Note
13
Stockholders’
Equity:
Common
Stock
As
of
December 31, 2005, the Company had issued 488,854 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 and 126,582 in December 2005.
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.
On
May
28, 2003, the Company closed on a private placement for 5,982,352 shares of
common stock at $1.70 per share resulting in gross proceeds of $10,170,000.
The
closing price of the Company’s common stock on May 28, 2003 was $2.07 per share.
In connection with this private placement, the Company paid commissions and
other expenses of $692,454, resulting in net proceeds of $9,477,546. In
addition, the investors received warrants to purchase 1,495,588 shares of common
stock at an exercise price of $2.00 per share. The warrants have a five-year
term and became exercisable on November 29, 2003 (see Common
Stock Warrants
below).
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.
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. The exercise price
of each option granted under the 1995 Plan could not be less than the fair
market value on the date granted. Options under the Plan generally vested 40%
upon grant, 30% on the first anniversary of the grant and the remaining 30%
on
the second anniversary. No options could be exercised more than 10 years after
the grant date. Options are not transferable (other than at death), and in
the
event of termination for cause (other than death or disability) or voluntary
termination, all unvested options automatically terminate. The plan is inactive
at December 31, 2005 and had 39,000 options outstanding.
F-25
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, 2005, 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 2,651,304 options outstanding
at December 31, 2005.
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 711,250 options outstanding at December 31, 2005.
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, and approved the 2005 Investment Plan,
authorizing 400,000 shares thereto. 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. On
January 10, 2006, February 14, 2006 and February 28, 2006, the
Company granted, in the aggregate, 882,000 stock options to various
employees and consultants. The stockholders also approved the increase of shares
authorized to the 2000 Non-Employee Director Stock Option Plan to 1,400,000
shares.
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.
F-26
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.
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.
In
January 2003, the Company issued 175,000 options to purchase common stock to
non-employee directors, in accordance with the terms of the Non-Employee
Director Plan. In October 2003, 8,750 options were issued to a new non-employee
director in accordance with the terms of the Non-Employee Director
Plan.
Also
in
January and April 2003, the Company granted an aggregate of 614,000 options
to
purchase common stock to several 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.
In
April
2003, 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 $1.53 per share. The options vested immediately and
will expire 10 years from the date of the grant. The Company recorded $38,164
of
expense relating to these options for the year ended December 31,
2003.
F-27
A
summary
of option transactions for all of the Company’s options during the years ended
December 31, 2005, 2004 and 2003 is as follows:
Number
of Shares
|
Weighted
Average
Exercise
Price
|
|||||
Outstanding
at January 1, 2003
|
3,877,045
|
$
|
4.65
|
|||
Granted
|
827,750
|
1.73
|
||||
Exercised
|
(61,458
|
)
|
1.05
|
|||
Expired/cancelled
|
(513,141
|
)
|
5.77
|
|||
Outstanding
at December 31, 2003
|
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
|
(1,608,837
|
)
|
5.83
|
|||
Outstanding
at December 31, 2005
|
5,077,646
|
$
|
2.11
|
As
of
December 31, 2005, 3,108,379 options to purchase common stock were vested and
exercisable at prices ranging from $0.95 to $9.50 per share. As of December
31,
2004, 2,905,108 options to purchase common stock were vested and exercisable
at
prices ranging from $0.95 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
outstanding options, including options exercisable at December 31, 2005, 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
|
4,264,271
|
3.96
|
$
|
1.89
|
2,820,379
|
$
|
1.75
|
||||||||||
$2.51
- $5.00
|
699,375
|
4.51
|
$
|
2.78
|
174,000
|
$
|
2.84
|
||||||||||
$5.01
- $7.50
|
97,000
|
4.15
|
$
|
5.79
|
97,000
|
$
|
5.79
|
||||||||||
$7.51
- up
|
17,000
|
3.83
|
$
|
9.32
|
17,000
|
$
|
9.32
|
||||||||||
Total
|
5,077,646
|
4.03
|
$
|
2.11
|
3,108,379
|
$
|
1.98
|
The
outstanding options will expire as follows:
Year
Ending
|
Number
of Shares
|
Weighted
Average
Exercise
Price
|
Exercise
Price
|
||||||||
2006
|
429,199
|
$
|
1.56
|
|
$0.95
- $8.00
|
||||||
2007
|
379,530
|
1.72
|
|
$1.26
- $1.89
|
|||||||
2008
|
613,132
|
1.72
|
|
$0.74
- $2.17
|
|||||||
2009
|
1,006,348
|
1.97
|
|
$0.99
- $2.70
|
|||||||
2010
and later
|
2,649,437
|
2.41
|
|
$1.07
- $9.50
|
|||||||
5,077,646
|
$
|
2.11
|
|
$0.95
- $9.50
|
F-28
Common
Stock Warrants
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.
In
May
2003, in addition to receiving common stock in the Company’s private placement,
the investors received warrants to purchase 1,495,588 shares of common stock
at
an exercise price of $2.00 per share. The warrants have a five-year term,
expiring in November 2008.
A
summary
of warrant transactions for the years ended December 31, 2005, 2004 and 2003
is
as follows:
Number
of Warrants
|
Weighted
Average
Exercise
Price
|
||||||
Outstanding
at January 1, 2003
|
2,960,804
|
$
|
1.62
|
||||
Issued
|
1,551,302
|
1.93
|
|||||
Exercised
|
(253,271
|
)
|
1.85
|
||||
Expired
|
(7,752
|
)
|
2.00
|
||||
Outstanding
at December 31, 2003
|
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
|
At
December 31, 2005, all outstanding warrants were exercisable at prices ranging
from $1.40 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
|
1,134,533
|
2.00
|
|||||
2009
|
33,661
|
3.29
|
|||||
2010
|
43,765
|
2.22
|
|||||
2,100,309
|
$
|
1.98
|
Note
14
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.
F-29
The
Company recorded no provisions in 2005, 2004 and 2003 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 only a part of 2005 and not at all in 2004 and 2003.
Year
Ended December 31,
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Federal,
including AMT tax:
|
||||||||||
Current
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
Deferred
|
8,887,000
|
(2,114,000
|
)
|
1,536,000
|
||||||
State:
|
||||||||||
Current
|
—
|
—
|
—
|
|||||||
Deferred
|
68,000
|
(174,000
|
)
|
179,000
|
||||||
8,955,000
|
(2,288,000
|
)
|
1,715,000
|
|||||||
Change
in valuation allowance
|
8,955,000
|
(2,288,000
|
)
|
1,715,000
|
||||||
Income
tax expense
|
$
|
—
|
$
|
—
|
$
|
—
|
A
reconciliation of the effective tax rate with the Federal statutory tax rate
of
34% follows:
Year
Ended December 31,
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Expected
Federal tax benefit at statutory rate
|
$
|
1,338,000
|
$
|
1,701,000
|
$
|
2,512,000
|
||||
Gross
change in valuation allowance
|
(8,955,000
|
)
|
2,288,000
|
(1,715,000
|
)
|
|||||
Adjustments
of temporary differences and net
operating
loss expirations and limitations
|
7,652,000
|
(3,792,000
|
)
|
(950,000
|
)
|
|||||
State
income taxes
|
68,000
|
(174,000
|
)
|
178,000
|
||||||
Other
|
(103,000
|
)
|
(23,000
|
)
|
(25,000
|
)
|
||||
Income
tax expense
|
$
|
—
|
$
|
—
|
$
|
—
|
As
of
December 31, 2005, the Company had approximately $180 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 $69 million
of
losses sustained by ProCyte prior to the tax-free acquisition on March 18,
2005.
As of December 31, 2005, the Company has estimated that only $5 million of
the
loss from SLT and $25 million of the loss from ProCyte can be realized upon,
based on Federal limitations on the useabililty of such 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.
In
addition, the Company had approximately $2.8 million of Federal tax credit
carryforwards as of December 31, 2005. 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 $2.2 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 $13,857,000
at December 31, 2005.
F-30
The
changes in the deferred tax asset are as follows.
December
31,
|
|||||||
2005
|
2004
|
||||||
Beginning
balance, gross
|
$
|
41,095,000
|
$
|
43,383,000
|
|||
Net
changes due to:
|
|||||||
Operating
loss carryforwards
|
9,688,000
|
(1,521,000
|
)
|
||||
Temporary
differences
|
(630,000
|
)
|
(128,000
|
)
|
|||
Carryforward
and AMT credits
|
(102,000
|
)
|
(639,000
|
)
|
|||
Ending
balance, gross
|
50,051,000
|
41,095,000
|
|||||
Less:
valuation allowance
|
50,051,000
|
41,095,000
|
|||||
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 2005 for ProCyte.
December
31,
|
|||||||
2005
|
2004
|
||||||
Loss
carryforwards
|
$
|
44,143,000
|
$
|
34,455,000
|
|||
Carryforward
and AMT credits
|
642,000
|
745,000
|
|||||
Accrued
employment expenses
|
176,000
|
202,000
|
|||||
Amortization
|
(808,000
|
)
|
30,000
|
||||
Bad
debts
|
390,000
|
378,000
|
|||||
Deferred
R&D costs
|
2,607,000
|
2,368,000
|
|||||
Deferred
revenues
|
177,000
|
242,000
|
|||||
Depreciation
|
1,152,000
|
1,064,000
|
|||||
Inventoriable
costs
|
58,000
|
118,000
|
|||||
Inventory
reserves
|
140,000
|
302,000
|
|||||
License
write-off
|
701,000
|
802,000
|
|||||
Other
accruals and reserves
|
335,000
|
399,000
|
|||||
Gross
deferred tax asset
|
50,051,000
|
41,095,000
|
|||||
Less:
Valuation allowance
|
(50,051,000
|
)
|
(41,095,000
|
)
|
|||
Net
deferred tax asset
|
$
|
—
|
$
|
—
|
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 $3.6 million in benefit, or that
were contributed by ProCyte from periods prior to the acquisition in March
2005
and that approximate $8.4 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 of the benefit from ProCyte net operating loss
carryforwards will be reflected in the Statement of Operations.
Within
the net operating loss carryforward as of December 31, 2005 are approximately
$17.4 million of tax deductions from the exercise of Company stock options.
The
preponderance of these options were to employees and therefore under APB No.
25,
no book expense was recognized on their grant. Benefits that may be realized
from such deductions will not benefit the Statement of Operations but will
directly benefit Stockholders’ Equity.
F-31
Note
15
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 will act as master distributor in the Pacific Rim for the Company’s
XTRAC excimer laser, (including the Ultra™ 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 consultant to explore further business
opportunities for the Company. In connection with this engagement, the
consultant has received options to purchase up to 25,000 shares of the common
stock of the Company, granted with an exercise price based on fair market
value.
On
July
27, 2005, the Company entered a four-year Marketing Agreement with KDS
Marketing, Inc. (“KDS”). Using money invested by each party, KDS will research
market opportunities for the Company’s diode laser and related delivery systems,
and KDS will then market the diode laser, primarily through a website on which
physicians may access for information about the lasers and which they may use
to
purchase the lasers. KDS’s return on its investment will be based primarily on
commissions earned on diode lasers that are sold under the program.
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.
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. See Litigation
in
Note
11.
Note
16
Significant
Customer Concentration:
No
one
customer represented 10% or more of total revenues for the year ended December
31, 2005, 2004 and 2003.
Note
17
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 revenues from procedures performed by dermatologists in the United
States. The International XTRAC 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.
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 is carried at $2,944,423 at December 31, 2005
and 2004 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 $13,430,961 at December
31, 2005 from the ProCyte acquisition has been entirely allocated to the Skin
Care (ProCyte) segment.
F-32
Year
Ended December 31, 2005
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
XTRAC
|
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
|
1,207,448
|
(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
|
$
|
1,207,448
|
($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
|
Year
Ended December 31, 2004
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
XTRAC
|
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
|
F-33
Year
Ended December 31, 2003
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
XTRAC
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
1,325,024
|
$
|
1,166,520
|
—
|
$
|
5,953,462
|
$
|
5,873,787
|
$
|
14,318,793
|
||||||||
Costs
of revenues
|
2,795,785
|
817,075
|
—
|
3,899,714
|
2,975,034
|
10,487,608
|
|||||||||||||
Gross
profit
|
(1,470,761
|
)
|
349,445
|
—
|
2,053,748
|
2,898,753
|
3,831,185
|
||||||||||||
Allocated
operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
1,668,819
|
666,131
|
—
|
1,108,878
|
659,812
|
4,103,640
|
|||||||||||||
Engineering
and product development
|
893,277
|
347,386
|
—
|
—
|
535,817
|
1,776,480
|
|||||||||||||
Unallocated
operating expenses
|
—
|
—
|
—
|
—
|
—
|
5,347,584
|
|||||||||||||
2,562,096
|
1,013,517
|
—
|
1,108,878
|
1,195,629
|
11,227,704
|
||||||||||||||
Loss
from operations
|
(4,032,857
|
)
|
(664,072
|
)
|
—
|
944,870
|
1,703,124
|
(7,396,519
|
)
|
||||||||||
Interest
expense, net
|
—
|
—
|
—
|
—
|
—
|
46,330
|
|||||||||||||
Net
loss
|
($4,032,857
|
)
|
($664,072
|
)
|
—
|
$
|
944,870
|
$
|
1,703,124
|
($7,442,849
|
)
|
||||||||
Segment
assets
|
$
|
5,758,496
|
$
|
2,924,131
|
—
|
$
|
3,493,914
|
$
|
3,704,781
|
$
|
15,881,322
|
||||||||
Capital
expenditures
|
$
|
1,436,109
|
$
|
5,417
|
—
|
$
|
121,451
|
$
|
44,780
|
$
|
1,607,757
|
December
31,
|
|||||||
Assets:
|
2005
|
2004
|
|||||
Total
assets for reportable segments
|
$
|
42,341,988
|
$
|
18,547,510
|
|||
Other
unallocated assets
|
6,333,618
|
4,414,416
|
|||||
Consolidated
total
|
$
|
48,675,606
|
$
|
22,961,926
|
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,
|
||||||||||
2005
|
2004
|
2003
|
||||||||
Domestic
|
$
|
24,667,314
|
$
|
15,460,793
|
$
|
12,011,280
|
||||
Foreign
|
3,717,192
|
2,284,388
|
2,307,513
|
|||||||
$
|
28,384,506
|
$
|
17,745,181
|
$
|
14,318,793
|
F-34
Note
18
Quarterly
Financial Data (Unaudited):
For
the Quarter Ended
|
|||||||||||||
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
|
|||||||||
2003
|
Mar.
31
|
Jun.
30
|
Sep.
30
|
Dec.
31
|
|||||||||
Revenues
|
$
|
3,473,000
|
$
|
3,843,000
|
$
|
3,299,000
|
$
|
3,704,000
|
|||||
Gross
profit
|
1,063,000
|
1,176,000
|
812,000
|
780,000
|
|||||||||
Net
loss
|
(1,674,000
|
)
|
(1,686,000
|
)
|
(1,913,000
|
)
|
(2,170,000
|
)
|
|||||
Basic
and diluted net loss per share
|
($0.05
|
)
|
($0.05
|
)
|
($0.05
|
)
|
($0.06
|
)
|
|||||
Shares
used in computing basic and
diluted
net loss per share
|
31,439,058
|
33,644,326
|
37,622,358
|
37,735,242
|
Note
19
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, 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
|
||||||
FOR
THE YEAR ENDED DECEMBER 31, 2003:
|
||||||||||||||||
Reserve
for Doubtful Accounts
|
$
|
1,169,486
|
$
|
254,429
|
$
|
—
|
$
|
725,871
|
$
|
698,044
|
(1) |
Represents
allowance for doubtful accounts related to the acquisition of
ProCyte.
|
(2) |
Represents
write-offs of specific accounts
receivable.
|
F-35