Gadsden Properties, Inc. - Quarter Report: 2007 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10 - Q
x |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE
|
SECURITIES
EXCHANGE ACT OF
1934
For
the quarterly period ended March 31, 2007
OR
¨ |
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 0-11365
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
(Registrant's
telephone number, including area code)
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 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 Exchange Act.)
Yes
¨
No x
The
number of shares outstanding of the issuer's Common Stock as of May 10, 2007
was
62,798,554 shares.
PHOTOMEDEX,
INC.
INDEX
TO
FORM 10-Q
PAGE
|
||
Part
I. Financial Information:
|
||
ITEM
1. Financial Statements:
|
||
a.
|
Consolidated
Balance Sheets, March 31, 2007 (unaudited) and
|
|
December
31, 2006
|
3
|
|
b.
|
Consolidated
Statements of Operations for the three months
|
|
ended
March 31, 2007 and 2006 (unaudited)
|
4
|
|
c.
|
Consolidated
Statement of Stockholders’ Equity for the three months
|
|
ended
March 31, 2007 (unaudited)
|
5
|
|
d.
|
Consolidated
Statements of Cash Flows for the three months
|
|
ended
March 31, 2007 and 2006 (unaudited)
|
6
|
|
e.
|
Notes
to Consolidated Financial Statements (unaudited)
|
7
|
ITEM
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
19
|
|
ITEM
3. Quantitative and Qualitative Disclosure about Market
Risk
|
31
|
|
ITEM
4. Controls and Procedures
|
31
|
|
Part
II. Other Information:
|
||
ITEM
1. Legal Proceedings
|
32
|
|
ITEM
1A. Risk Factors
|
32
|
|
ITEM
6. Exhibits
|
32
|
|
Signatures
|
33
|
|
Certifications
|
34
|
2
PART
I - Financial Information
ITEM
1. Financial Statements
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
March
31, 2007
|
December
31, 2006
|
||||||
(Unaudited)
|
*
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
12,046,678
|
$
|
12,729,742
|
|||
Restricted
cash
|
156,000
|
156,000
|
|||||
Accounts
receivable, net of allowance for doubtful accounts of $508,438 for
each
period
|
5,594,227
|
4,999,224
|
|||||
Inventories
|
7,823,935
|
7,301,695
|
|||||
Prepaid
expenses and other current assets
|
490,145
|
534,135
|
|||||
Total
current assets
|
26,110,985
|
25,720,796
|
|||||
Property
and equipment, net
|
9,026,327
|
9,054,098
|
|||||
Goodwill,
net
|
16,917,808
|
16,917,808
|
|||||
Patents
and licensed technologies, net
|
1,610,869
|
1,695,727
|
|||||
Other
intangible assets, net
|
3,305,125
|
3,537,625
|
|||||
Other
assets
|
600,995
|
555,467
|
|||||
Total
assets
|
$
|
57,572,109
|
$
|
57,481,521
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Current
portion of notes payable
|
$
|
150,241
|
$
|
195,250
|
|||
Current
portion of long-term debt
|
3,242,492
|
3,018,874
|
|||||
Accounts
payable
|
4,914,657
|
3,617,726
|
|||||
Accrued
compensation and related expenses
|
1,272,903
|
1,529,862
|
|||||
Other
accrued liabilities
|
697,785
|
657,293
|
|||||
Deferred
revenues
|
789,681
|
632,175
|
|||||
Total
current liabilities
|
11,067,759
|
9,651,180
|
|||||
Long-term
liabilities:
|
|||||||
Notes
payable
|
126,836
|
133,507
|
|||||
Long-term
debt
|
3,703,752
|
3,593,920
|
|||||
Total
liabilities
|
14,898,347
|
13,378,607
|
|||||
Commitments
and Contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Common
stock, $.01 par value, 75,000,000 shares authorized; 62,536,054 shares
issued and outstanding, for each period
|
625,360
|
625,360
|
|||||
Additional
paid-in capital
|
131,606,887
|
131,152,557
|
|||||
Accumulated
deficit
|
(89,558,485
|
)
|
(87,675,003
|
)
|
|||
Total
stockholders’ equity
|
42,673,762
|
44,102,914
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
57,572,109
|
$
|
57,481,521
|
*
The
December 31, 2006 balance sheet was derived from the Company’s audited financial
statements.
The
accompanying notes are an integral part of these consolidated financial
statements.
3
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
For
the Three Months Ended March 31,
|
|||||||
2007
|
2006
|
||||||
Revenues:
|
|||||||
Product
sales
|
$
|
7,252,586
|
$
|
5,243,912
|
|||
Services
|
1,775,982
|
2,837,250
|
|||||
9,028,568
|
8,081,162
|
||||||
Cost
of revenues:
|
|||||||
Product
cost of revenues
|
2,137,012
|
2,321,669
|
|||||
Services
cost of revenues
|
2,643,557
|
2,386,229
|
|||||
|
4,780,569
|
4,707,898
|
|||||
Gross
profit
|
4,247,999
|
3,373,264
|
|||||
Operating
expenses:
|
|||||||
Selling
and marketing
|
3,329,315
|
2,952,939
|
|||||
General
and administrative
|
2,477,677
|
2,407,239
|
|||||
Engineering
and product development
|
248,070
|
242,204
|
|||||
6,055,062
|
5,602,382
|
||||||
Loss
from operations
|
(1,807,063
|
)
|
(2,229,118
|
)
|
|||
Interest
expense, net
|
(76,419
|
)
|
(121,143
|
)
|
|||
Net
loss
|
($
1,883,482
|
)
|
($
2,350,261
|
)
|
|||
Basic
and diluted net loss per share
|
($0.03
|
)
|
($0.05
|
)
|
|||
Shares
used in computing basic and diluted net loss per share
|
62,536,054
|
52,173,618
|
The
accompanying notes are an integral part of these consolidated financial
statements.
4
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FOR
THE
THREE MONTHS ENDED MARCH 31, 2007
(Unaudited)
Additional
|
||||||||||||||||
Common
Stock
|
Paid-In
|
Accumulated
|
||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||
BALANCE,
DECEMBER 31, 2006
|
62,536,054
|
$
|
625,360
|
$
|
131,152,557
|
($87,675,003
|
)
|
$
|
44,102,913
|
|||||||
Stock
options issued to consultants for services
|
-
|
-
|
46,626
|
-
|
46,626
|
|||||||||||
Stock-based
compensation expense related
to employee options
|
-
|
-
|
301,150
|
-
|
301,150
|
|||||||||||
Issuance
of restricted stock
|
-
|
-
|
78,544
|
-
|
78,544
|
|||||||||||
Issuance
of warrants for draws under line of credit
|
-
|
-
|
28,011
|
-
|
28,011
|
|||||||||||
Net
loss for the three months ended March 31, 2007
|
-
|
-
|
-
|
(1,883,482
|
)
|
(1,883,482
|
)
|
|||||||||
BALANCE,
MARCH 31, 2007
|
62,536,054
|
$
|
625,360
|
$
|
131,606,887
|
($89,558,485
|
)
|
$
|
42,673,762
|
The
accompanying notes are an integral part of these consolidated financial
statements.
5
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
For
the Three Months Ended
March
31,
|
|||||||
2007
|
2006
|
||||||
Cash
Flows From Operating Activities:
|
|||||||
Net
loss
|
($
1,883,482
|
)
|
($
2,350,261
|
)
|
|||
Adjustments
to reconcile net loss to net cash provided by
|
|||||||
operating
activities:
|
|||||||
Depreciation
and amortization
|
1,149,200
|
1,017,095
|
|||||
Stock
options issued to consultants for services
|
46,626
|
76,622
|
|||||
Stock-based
compensation expense related to employee options and restricted
stock
|
379,693
|
390,168
|
|||||
Amortization
of deferred compensation
|
-
|
14,718
|
|||||
Provision
for bad debts
|
-
|
58,246
|
|||||
Loss
on disposal of assets
|
40,424
|
-
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable
|
(595,002
|
)
|
(144,649
|
)
|
|||
Inventories
|
(456,920
|
)
|
528,890
|
||||
Prepaid
expenses and other assets
|
180,769
|
93,236
|
|||||
Accounts
payable
|
1,296,932
|
615,905
|
|||||
Accrued
compensation and related expenses
|
(256,959
|
)
|
336,962
|
||||
Other
accrued liabilities
|
46,294
|
(188,825
|
)
|
||||
Cash
deposits
|
-
|
(27,000
|
)
|
||||
Deferred
revenues
|
157,506
|
106,092
|
|||||
Other
liabilities
|
(5,806
|
)
|
(5,805
|
)
|
|||
Net
cash provided by operating activities
|
99,275
|
521,394
|
|||||
Cash
Flows From Investing Activities:
|
|||||||
Purchases
of property and equipment
|
(10,108
|
)
|
(11,366
|
)
|
|||
Lasers
placed into service
|
(899,707
|
)
|
(1,079,167
|
)
|
|||
Net
cash used in investing activities
|
(909,815
|
)
|
(1,090,533
|
)
|
|||
Cash
Flows From Financing Activities:
|
|||||||
Proceeds
from issuance of restricted common stock
|
-
|
8,600
|
|||||
Costs
related to issuance of common stock
|
-
|
(7,890
|
)
|
||||
Proceeds
from exercise of options
|
-
|
68,400
|
|||||
Payments
on long-term debt
|
(145,541
|
)
|
(58,725
|
)
|
|||
Payments
on notes payable
|
(20,131
|
)
|
(205,718
|
)
|
|||
Net
advancements on lease line of credit
|
293,148
|
819,867
|
|||||
Increase
in restricted cash and cash equivalents
|
-
|
(119
|
)
|
||||
Net
cash provided by financing activities
|
127,476
|
624,415
|
|||||
Net
(decrease) increase in cash and cash equivalents
|
(683,064
|
)
|
55,276
|
||||
Cash
and cash equivalents, beginning of period
|
12,729,742
|
5,403,036
|
|||||
Cash
and cash equivalents, end of period
|
$
|
12,046,678
|
$
|
5,458,312
|
The
accompanying notes are an integral part of these consolidated financial
statements.
6
PHOTOMEDEX,
INC. AND SUBSIDIARIES
NOTES
TO
UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
Note
1
Basis
of Presentation:
The
Company:
Background
PhotoMedex,
Inc. (and its subsidiaries) (the “Company”) is a medical device and specialty
pharmaceutical company focused on facilitating the cost-effective use of
technologies for doctors, hospitals and surgery centers to enable their patients
to achieve a higher quality of life. The Company operates in five distinct
business units, or segments (as described in Note 10): three in Dermatology,
-
Domestic XTRAC®, International Dermatology Equipment, and Skin Care (ProCyte®);
and two in Surgical, - Surgical Services (SIS™) and Surgical Products (SLT®).
The segments are distinguished by our management structure, products and
services offered, markets served or types of customers.
The
Domestic XTRAC segment generally derives revenues from procedures performed
by
dermatologists in the United States. Under these circumstances, the Company’s
XTRAC laser system is placed in a dermatologist’s office without any initial
capital cost to the dermatologist, and the Company charges a fee-per-use to
treat skin disease. On occasion, however, the Company sells XTRAC lasers to
customers, due generally to customer circumstances and preferences. In
comparison to the Domestic XTRAC segment, the International Dermatology
Equipment segment generates revenues from the sale of equipment to
dermatologists outside the United States through a network of distributors.
The
Skin Care segment generates revenues by selling physician-dispensed skincare
products worldwide and by earning royalties on licenses for our patented copper
peptide compound.
The
Surgical Services segment generates revenues by providing fee-based procedures
typically using our mobile surgical laser equipment delivered and operated
by a
technician at hospitals and surgery centers in the United States. The Surgical
Products segment generates revenues by selling laser products and disposables
to
hospitals and surgery centers both domestically and internationally. The
Surgical Products segment also sells other non-laser products (e.g., the
ClearESS® II suction-irrigation system).
The
Company designed and manufactured the XTRAC laser system to treat psoriasis,
vitiligo, atopic dermatitis and leukoderma phototherapeutically. The Company
has
received clearances from the U.S. Food and Drug Administration (“FDA”) to market
the XTRAC laser system for each of these indications. The first XTRAC
phototherapy treatment systems were commercially distributed in the United
States in August 2000 before any of its procedures had been approved for medical
insurance reimbursement. In the last several years, the Company has sought
to
obtain reimbursement for psoriasis and other inflammatory skin disorders. As
a
result of initiatives undertaken by the Company and by the physician community,
the ability for physicians to process claims efficiently and receive positive
payment decisions for use of the XTRAC system improved significantly during
the
latter part of 2005 and 2006. In March 2007, the Blue Cross Blue Shield
Association (“BCBSA”) published a National Reference Policy that now recommends
reimbursement coverage for treatment of psoriasis by means of lasers, including
the XTRAC, as first-step therapy for moderate to severe psoriasis comprising
less than 20% of body surface area. The XTRAC is approved by Underwriters’
Laboratories; it is also CE-marked, and accordingly a third party regularly
audits the Company’s quality system and manufacturing facility. The
manufacturing facility for the XTRAC is located in Carlsbad,
California.
Liquidity
and Going Concern
As
of
March 31, 2007, the Company had an accumulated deficit of $89,558,485 and cash
and cash equivalents $12,202,678, including restricted cash of $156,000, as
a
result of the private placement of the Company’s common stock in November 2006.
The Company has historically financed its operations with cash provided by
equity financing and from lines of credit and, more recently, from positive
cash
flow generated from operations. The 2007 operating plan reflects increases
in
per-treatment fee revenues for use of the XTRAC system based on increased
utilization of the XTRAC by physicians and on wider insurance coverage in the
United States. In addition, the 2007 operating plan reflects increased revenues
and profits from the Skin Care business. Management of the Company believes
that
the Company’s existing cash balance together without 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 the Company’s operating and capital requirements, at
a minimum, beyond the second quarter of 2008.
7
Summary
of Significant Accounting Policies:
Quarterly
Financial Information and Results of Operations
The
financial statements as of March 31, 2007 and for the three months ended March
31, 2007 and 2006, are unaudited and, in the opinion of management, include
all
adjustments (consisting only of normal recurring adjustments) necessary to
present fairly the financial position as of March 31, 2007, and the results
of
operations and cash flows for the three months ended March 31, 2007 and 2006.
The results for the three months ended March 31, 2007 are not necessarily
indicative of the results to be expected for the entire year. While management
of the Company believes that the disclosures presented are adequate to make
the
information not misleading, these consolidated financial statements should
be
read in conjunction with the consolidated financial statements and the notes
included in the Company's Annual Report on Form 10-K for the year ended December
31, 2006.
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 predicted 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
“Summary of Significant Accounting Policies” in the Company’s 2006 Annual Report
on Form 10-K for a discussion of the estimates and judgments necessary in the
Company’s accounting for cash and cash equivalents, accounts receivable,
inventories, property, equipment and depreciation, product development costs
and
fair value of financial instruments.
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 laser in a physician’s office (at no charge to the
physician) and charges the physician a fee for an agreed upon number of
treatments. When the Company sells an XTRAC laser to a distributor or directly
to a foreign or domestic physician, revenue is recognized when the following
four criteria under Staff Accounting Bulletin No. 104 have been met: (i) the
product has been shipped and the Company has no significant remaining
obligations; (ii) persuasive evidence of an arrangement exists; (iii) the price
to the buyer is fixed or determinable; (iv) and collection is probable (the
“SAB
104 Criteria”). At times, units are shipped, but revenue is not recognized until
all of the SAB 104 criteria have been met, and until that time, the unit is
carried on the books of the Company as inventory.
The
Company ships most of its products FOB shipping point, although from time to
time certain customers, for example governmental customers, will insist upon
FOB
destination. Among the factors the Company takes into account in determining
the
proper time at which to recognize revenue are when title to the goods transfers
and when the risk of loss transfers. Shipments to distributors or physicians
that do not fully satisfy the collection criteria are recognized when invoiced
amounts are fully paid.
Under
the
terms of the Company’s distributor agreements, distributors do not have a
unilateral right to return any unit that they have purchased. However, the
Company does allow products to be returned by its distributors for product
defects or other claims.
When
the
Company places a laser in a physician’s office, it recognizes service revenue
based on the number of patient treatments performed by the physician. Treatments
in the form of random laser-access codes that are sold to a physician, 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
because the treatments can only be performed on Company-owned equipment. Once
the treatments are delivered to a patient, this obligation has been satisfied.
8
The
Company excludes all sales of treatment codes made within the last two weeks
of
the period in determining the amount of procedures performed by its
physician-customers. Management believes this approach closely approximates
the
actual amount of unused treatments that existed at the end of a period. For
the
three months ended March 31, 2007 and 2006, the Company deferred $634,613 and
$421,624, respectively, under this approach.
In
the
first quarter of 2003, the Company implemented a program to support certain
physicians in addressing treatments with the XTRAC laser system that may be
denied reimbursement by private insurance carriers. The Company recognizes
service revenue from the sale of treatment codes to physicians participating
in
this program only if and to the extent the physician has been reimbursed for
the
treatments. For the three months ended March 31, 2007, the Company recognized
an
additional $65,950, under this program, as all the SAB 104 Criteria for revenue
recognition had been met. At March 31, 2007, the Company had net deferred
revenues of $123,832 under this program.
Under
this program, the Company may reimburse qualifying doctors for the cost of
the
Company’s fee but only if they are ultimately denied reimbursement after appeal
of their claim with the insurance company. The key components of the program
are
as follows:
· |
The
physician practice must be in an identified location where there
is an
insufficiency of insurance companies reimbursing the procedure or
where a
particular practice faces similar insurance
obstacles;
|
· |
The
program only covers medically necessary treatments of psoriasis as
determined by the treating
physician;
|
· |
The
patient must have medical insurance and a claim for the treatment
must be
timely filed with the patient’s insurance company;
|
· |
Upon
denial by the insurance company (generally within 30 days of filing
a
claim), a standard insurance form called an EOB (“Explanation of
Benefits”) must be submitted to the Company’s in-house appeals group, who
will then prosecute the appeal. The appeal process can take 6 to
9
months;
|
· |
After
all appeals have been exhausted by the Company and the claim remains
unpaid, the physician is entitled to receive credit for the fee for
the
treatment he or she purchased from the Company on behalf of the patient;
and
|
· |
Physicians
are still obligated to make timely payments for treatments purchased,
irrespective of whether reimbursement is paid or denied. Future sales
of
treatments to a physician can be denied if timely payments are not
made,
even if a patient’s appeal is still in
process.
|
The
Company estimates a contingent liability for potential refunds under this
program by reviewing the history of denied insurance claims and appeals
processed. The Company estimates that approximately 4% of the revenues under
this program for the quarter ended March 31, 2007 are subject to being credited
or refunded to the physician. Likewise the Company estimated that 4% of the
revenues under this program for the quarter ended March 31, 2006 were subject
to
being credited or refunded to the physician.
The
Company generates revenues from its Skin Care business primarily through three
channels. The first is through product sales for skin health, hair care and
wound care; the second is through sales in bulk of the copper peptide compound,
primarily to Neutrogena Corporation, a Johnson & Johnson company; and the
third is through royalties generated by our licenses, principally to Neutrogena.
The Company recognizes revenues on the products and copper peptide compound
when
they are shipped, net of returns and allowances. The Company ships the products
FOB shipping point. Royalty revenues are based upon sales generated by our
licensees. The Company recognizes royalty revenue at the applicable royalty
rate
applied to shipments reported by our licensee.
9
The
Company generates revenues from its Surgical businesses primarily from two
channels. The first is through product sales of laser systems, related
maintenance service agreements, recurring laser delivery systems and laser
accessories, and the second is through per-procedure surgical services. The
Company recognizes revenues from surgical laser and other product sales,
including sales to distributors and other customers, when the SAB 104 Criteria
have been met.
For
per-procedure surgical services, the Company recognizes revenue upon the
completion of the procedure. Revenue from maintenance service agreements is
deferred and recognized on a straight-line basis over the term of the
agreements. Revenue from billable services, including repair activity, is
recognized when the service is provided.
Impairment
of Long-Lived Assets and Intangibles
In
accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of
Long-Lived Assets”, long-lived assets, such as property and equipment, and
purchased intangibles subject to amortization, are reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount
of
an asset may not be recoverable. Recoverability of assets to be held and used
is
measured by a comparison of the carrying amount of an asset to estimated
undiscounted future cash flows expected to be generated by the asset. If the
carrying amount of an asset exceeds its estimated future cash flows, an
impairment charge is recognized in the amount by which the carrying amount
of
the asset exceeds the fair value of the asset. Assets to be disposed of would
be
separately presented in the balance sheet and reported at the lower of the
carrying amount or the fair value less costs to sell, and would no longer be
depreciated. The assets and liabilities of a disposed group would be classified
as held for sale and would be presented separately in the appropriate asset
and
liability sections of the balance sheet. As of March 31, 2007, no such
impairment existed.
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 8
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
the
skincare business (ProCyte) in March 2005 and is being amortized on a
straight-line basis over seven years.
Management
evaluates the recoverability 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 the
net
book value of the asset, the asset is written down to fair value. As of March
31, 2007, no such write-down was required. (See Impairment
of Long-Lived Assets and Intangibles).
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
March 31, 2007, no such write-down was required.
Goodwill
Goodwill
was recorded in connection with the acquisition of ProCyte in March 2005 and
the
acquisition of Acculase in August 2000.
Management
evaluates the recoverability of such goodwill based on estimates of undiscounted
future cash flows over the remaining useful life of the asset. If the amount
of
such estimated undiscounted future cash flows is less than the net book value
of
the asset, the asset is written down to fair value. As of March 31, 2007 and
during 2006, no such write-down was required.
10
Accrued
Warranty Costs
The
Company offers a warranty on product sales generally for a one to two-year
period. In some cases, however, the Company offers longer periods in order
to
meet competition. The Company provides for the estimated future warranty claims
on the date the product is sold. The activity in the warranty accrual during
the three months ended March 31, 2007 is summarized as
follows:
March
31, 2007
|
||||
Accrual
at beginning of period
|
$
|
123,738
|
||
Additions
charged to warranty expense
|
46,250
|
|||
Expiring
warranties
|
(12,036
|
)
|
||
Claims
satisfied
|
(17,722
|
)
|
||
Accrual
at end of period
|
$
|
140,230
|
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 realization 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 written off when the Company
acquired ProCyte. If and when components of that asset are realized in the
future, the acquired goodwill of ProCyte will be reduced. With reference to
FASB
Interpretation No. 48, “Accounting for Uncertainty in Income Taxes - an
Interpretation of FASB Statement No. 109”, the Company does not believe that its
historical or expected tax reporting positions, when considered before
application of the valuation allowance, have had or will have a material impact
on its consolidated financial statements.
In
June
2006, the FASB issued FASB Interpretation No. (“FIN”) 48 “Accounting for
Uncertainty in Income Taxes” (“FIN 48”). FIN 48 sets forth a recognition
threshold and measurement attribute for financial statement recognition of
positions taken or expected to be taken in income tax returns. FIN 48 is
effective for fiscal years beginning after December 15, 2006. The adoption
of
FIN 48 had no material impact on the Company’s consolidated financial
statements.
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 of common shares outstanding for the period. Diluted net loss per share
reflects the potential dilution from the conversion or exercise into common
stock of securities 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 11,232,972 and 8,373,000 as of March 31, 2007 and 2006,
respectively, were excluded from the calculation of fully diluted earnings
per
share since their inclusion would have been anti-dilutive.
Share-Based
Compensation
On
January 1, 2006, The Company adopted SFAS No. 123R, “Share-Based Payment,” which
requires all companies to measure and recognize compensation expense at fair
value for all stock-based payments to employees and directors. SFAS No. 123R
is
being applied on the modified prospective basis. Prior to the adoption of SFAS
No. 123R, the Company accounted for its stock-based compensation plans for
employees and directors under the recognition and measurement principles of
Accounting Principles Board (APB) Opinion No. 25, “Accounting for Stock Issued
to Employees”, and related interpretations, and accordingly, the Company
recognized no compensation expense related to the stock-based plans for grants
to employees or directors. Grants to consultants under the plans were recorded
under SFAS No. 123.
11
Under
the
modified prospective approach, SFAS No. 123R applies to new grants of options
and awards of stock as well as to grants of options that were outstanding on
January 1, 2006 and that may subsequently be repurchased, cancelled or
materially modified. Under the modified prospective approach, compensation
cost
recognized for the three ended March 31, 2007 and 2006 includes compensation
cost for all share-based payments granted prior to, but not yet vested on,
January 1, 2006, based on fair value as of the prior grant-date and estimated
in
accordance with the provisions of SFAS No. 123R. Prior periods were not required
to be restated to reflect the impact of adopting the new standard.
SFAS
No.
123R also requires companies to calculate an initial "pool" of excess tax
benefits available at the adoption date to absorb any tax deficiencies that
may
be recognized under SFAS No. 123R. The pool includes the net excess tax benefits
that would have been recognized if the Company had adopted SFAS No. 123 for
recognition purposes on its effective date. The Company has elected to calculate
the pool of excess tax benefits under the alternative transition method
described in FASB Staff Position ("FSP") No. FAS 123(R)-3, "Transition Election
Related to Accounting for Tax Effects of Share-Based Payment Awards," which
also
specifies the method to calculate excess tax benefits reported on the statement
of cash flows. The Company is in a net operating loss position; therefore,
no
excess tax benefits from share-based payment arrangements have been recognized
for the three months ended March 31, 2007.
The
Company uses the Black-Scholes option-pricing model to estimate fair value
of
grants of stock options with the following weighted average
assumptions:
Three
Months Ended March 31,
|
|||||||
Assumptions
for Option Grants
|
2007
|
2006
|
|||||
Risk-free
interest rate
|
4.78
|
%
|
4.58
|
%
|
|||
Volatility
|
86.35
|
%
|
93.51
|
%
|
|||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
|||
Expected
life
|
8.1
years
|
7.4years
|
|||||
Estimated
forfeiture rate
|
12
|
%
|
11
|
%
|
The
Company calculates expected volatility for a share-based grant based on historic
daily stock price observations of our common stock during the period immediately
preceding the grant that is equal in length to the expected term of the grant.
For estimating the expected term of share-based grants made in the three months
ended March 31, 2007, the Company has adopted the simplified method authorized
in Staff Accounting Bulletin No. 107. SFAS No. 123R also requires that estimated
forfeitures be included as a part of the estimate of expense as of the grant
date. The Company has used historical data to estimate expected employee
behaviors related to option exercises and forfeitures.
With
respect to both grants of options and awards of restricted stock, the risk-free
rate of interest is based on the U.S. Treasury rates appropriate for the
expected term of the grant or award.
12
With
respect to awards of restricted stock, the Company uses the Monte-Carlo pricing
model to estimate fair value of restricted stock awards made in the first
quarter 2006 with the following weighted average assumptions:
Assumptions
for Stock Awards
|
Three
Months Ended March 31, 2007
|
|||
Risk-free
interest rate
|
4.32
|
%
|
||
Volatility
|
70
|
%
|
||
Expected
dividend yield
|
0
|
%
|
||
Expected
Life
|
4.92
years
|
The
Company calculated expected volatility for restricted stock based on historic
daily stock price observations of our common stock during the three-year period
immediately preceding the grant.
There
was
$301,149 and $78,544 of compensation expense related to stock options granted
and restricted stock awarded, respectively, in the three months ended March
31,
2007. For the three months ended March 31, 2006, there was $311,624 and $78,544
of compensation expense related to stock options granted and restricted stock
awarded, respectively. This expense is recognized in the operating results
in
selling, general and administrative expenses. For stock options granted to
consultants, an additional selling, general, and administrative expense in
the
amount of $46,626 was recognized during the three months ended March 31, 2007,
respectively. For stock options granted to consultants an additional selling,
general, and administrative expense in the amount of $76,622 was recognized
during the three months ended March 31, 2006.
Supplemental
Cash Flow Information
During
the three months ended March 31, 2007, the Company financed certain credit
facility costs for $36,840 and issued warrants to a leasing credit facility
which are valued at $28,011, and which offset the carrying value of debt.
During
the three months ended March 31, 2006, the Company financed insurance
policies through notes payable for $143,775. During the three months ended
March
31, 2006, the Company issued 101,010 shares of its restricted common stock
to
Stern Laser srl (“Stern”) due under another milestones under the Master
Purchase; the cost associated with this issuance is included in the license
from
Stern, which is found in patents and licensed technologies. The Company also
issued 200,000 shares of its restricted common stock to AzurTec, Inc.
(“AzurTec”) as part of an investment in the capital stock of AzurTec as well as
for a license agreement on AzurTec technology, both existing and to be developed
in the future.
For
the
three months ended March 31, 2007 and 2006, the Company paid interest of
$202,662 and $138,144, respectively. Income taxes paid in the three months
ended
March 31, 2007 and 2006 were immaterial.
Recent
Accounting Pronouncements
In
February 2007, the Financial Accounting Standards Board (“FASB”) issued SFAS No.
159, "The Fair Value Option for Financial Assets and Financial Liabilities."
This Statement permits entities to choose to measure many financial instruments
and certain other items at fair value that are not currently required to be
measured at fair value. This Statement is effective for financial statements
issued for fiscal years beginning after November 15, 2007 and will become
effective for us beginning with the first quarter of 2008. The Company
has not yet determined the impact of the adoption of SFAS No. 159 on our
financial statements and footnote disclosures. It is not expected that the
adoption of this Statement will have a material effect on the Company's
consolidated financial statements.
Note
2
Inventories:
Set
forth
below is a detailed listing of inventories:
March 31, 2007
|
December
31, 2006
|
||||||
Raw
materials and work in progress
|
$
|
5,122,836
|
$
|
4,433,917
|
|||
Finished
goods
|
2,701,099
|
2,867,778
|
|||||
Total
inventories
|
$
|
7,823,935
|
$
|
7,301,695
|
Work-in-process
is immaterial, given the Company’s typically short manufacturing cycle, and
therefore is disclosed in conjunction with raw materials. As of March 31, 2007
and December 31, 2006, the Company carried specific reserves for excess and
obsolete stocks against its inventories of $1,352,148 and $1,354,444,
respectively.
13
Note
3
Property
and Equipment:
Set
forth
below is a detailed listing of property and equipment:
March
31, 2007
|
December
31, 2006
|
||||||
Lasers
in service
|
$
|
16,737,359
|
$
|
16,234,834
|
|||
Computer
hardware and software
|
334,490
|
334,490
|
|||||
Furniture
and fixtures
|
335,551
|
331,379
|
|||||
Machinery
and equipment
|
679,252
|
738,636
|
|||||
Autos
and trucks
|
382,690
|
382,690
|
|||||
Leasehold
improvements
|
247,368
|
247,368
|
|||||
18,716,710
|
18,269,397
|
||||||
Accumulated
depreciation and amortization
|
(9,690,383
|
)
|
(9,215,299
|
)
|
|||
Property
and equipment, net
|
$
|
9,026,327
|
$
|
9,054,098
|
Depreciation
expense was $831,841 and $710,036 for the three months ended March 31, 2007
and 2006, respectively. At March 31, 2007 and December 31, 2006, net
property and equipment included $338,325 and $380,875, respectively, of assets
recorded under capitalized lease arrangements, of which $100,317 and $122,717
was included in long-term debt at March 31, 2007 and December 31, 2006,
respectively (see Note 8).
Note
4
Patents
and Licensed Technologies:
Set
forth
below is a detailed listing of patents and licensed technologies:
March
31, 2007
|
December
31, 2006
|
||||||
Patents,
owned and licensed, at gross costs of $501,657 and $501,657, net
of
accumulated amortization of $240,835 and $231,599,
respectively.
|
$
|
260,822
|
$
|
270,058
|
|||
Other
licensed or developed technologies, at gross costs of $2,432,258
and
$2,432,258, net of accumulated amortization of $1,082,211 and $1,006,589,
respectively.
|
1,350,047
|
1,425,669
|
|||||
$
|
1,610,869
|
$
|
1,695,727
|
Related
amortization expense was $84,859 and $74,559 for the three months ended
March 31, 2007 and 2006, respectively. Included in other licensed and
developed technologies is $200,000 in developed technologies acquired from
ProCyte and $114,982 for the license with AzurTec (see Note 1). On March 31,
2006, the Company closed the transaction provided for in the License Agreement
with Mount Sinai School of Medicine of New York University (“Mount Sinai”).
Pursuant to the license agreement, the Company must reimburse $77,876 to Mount
Sinai, over the first 18 months of the license term and at no interest, for
patent prosecution costs incurred. The Company is also obligated to pay Mount
Sinai a royalty on a combined base of domestic sales of XTRAC treatment codes
used for psoriasis as well as for vitiligo. In the first four years of the
license, however, Mount Sinai may elect to be paid royalties on an alternate
base, comprised simply of treatments for vitiligo, but at a higher royalty
rate
than the rate applicable to the combined base. This technology is for the laser
treatment of vitiligo and is included in other licensed or developed
technologies.
14
Note
5
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 initial appraised
fair market values:
March
31, 2007
|
December
31, 2006
|
||||||
Neutrogena
Agreement, at gross cost of $2,400,000 net of accumulated amortization
of
$978,000 and $858,000, respectively.
|
$
|
1,422,000
|
$
|
1,542,000
|
|||
Customer
Relationships, at gross cost of $1,700,000 net of accumulated amortization
of $692,742 and $607,743, respectively.
|
1,007,258
|
1,092,257
|
|||||
Tradename,
at gross cost of $1,100,000 net of accumulated amortization of $224,133
and $196,632, respectively.
|
875,867
|
903,368
|
|||||
$
|
3,305,125
|
$
|
3,537,625
|
Related
amortization expense was $232,500 and $232,500 for the three months ended
March 31, 2007 and 2006, respectively. Under the Neutrogena Agreement, the
Company licenses to Neutrogena rights to its copper peptide technology 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
6
Other
Accrued Liabilities:
Set
forth
below is a detailed listing of other accrued liabilities:
March
31, 2007
|
December
31, 2006
|
||||||
Accrued
warranty
|
$
|
140,230
|
$
|
123,738
|
|||
Accrued
professional and consulting fees
|
318,678
|
320,331
|
|||||
Accrued
sales taxes
|
238,877
|
213,224
|
|||||
Total
other accrued liabilities
|
$
|
697,785
|
$
|
657,293
|
Note
7
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:
March
31, 2007
|
December
31, 2006
|
||||||
Note
Payable - secured creditor, interest at 6%, payable in monthly principal
and interest installments of $2,880 through June 2012
|
$
|
152,930
|
$
|
159,213
|
|||
Note
Payable - unsecured creditor, non-interest bearing, payable in 18
equal
monthly installments of $4,326 through October 2007
|
30,285
|
43,265
|
|||||
Note
Payable - unsecured creditor, interest at 8.72%, payable in monthly
principal and interest installments of $12,119.61 through November
2007
|
93,862
|
-
|
|||||
Note
Payable - unsecured creditor, interest at 7.42%, payable in monthly
principal and interest installments of $61,493 through March
2006
|
-
|
126,279
|
|||||
277,077
|
328,757
|
||||||
Less:
current maturities
|
(150,241
|
)
|
(195,250
|
)
|
|||
Notes
payable, net of current maturities
|
$
|
126,836
|
$
|
133,507
|
15
Note
8
Long-term
Debt:
In
the
following table is a summary of the Company’s long-term debt.
March
31, 2007
|
December
31, 2006
|
||||||
Total
borrowings on credit facility
|
$
|
6,845,927
|
$
|
6,490,077
|
|||
Capital
lease obligations (see Note 3)
|
100,317
|
122,717
|
|||||
Less:
current portion
|
(3,242,492
|
)
|
(3,018,874
|
)
|
|||
Total
long-term debt
|
$
|
3,703,752
|
$
|
3,593,920
|
Leasing
Credit Facility
The
long-term debt is comprised largely of borrowings under a leasing credit
facility which the Company entered into with GE Capital Corporation (“GE”) on
June 25, 2004. The credit facility has a commitment term of three years,
which
is set to expire on June 25, 2007. For each year of the term various parameters
are set or re-set. The Company accounts for each draw as a collateralized
borrowing, taking the form of a capital lease, with equitable ownership in
the
lasers remaining with the Company and GE retaining title as security for
the
borrowings. The Company depreciates the lasers generally over their remaining
useful lives, as established when originally placed into service. Each draw
against the credit facility has a self-amortizing repayment period of three
years and is secured by specified lasers, which the Company has sold to GE
and
leased back for continued deployment in the field.
Each
draw
under the credit facility has been set at an interest rate which in the first
year of the term were set at 577 basis points above the three-year Treasury
note
rate, and by the third year were set at 400 basis points above the three-year
Treasury rate. Each draw in the first year of the term was discounted 7.75%;
draws made by the third year were discounted 3.5%. The monthly payment set
for a
draw is self-amortizing. The first monthly payment is applied against principal.
The
following table summarizes the monthly payments that the Company expects
to make
for the 11 draws made under the credit facility:
Quarter
ending
|
|||||||||||||||||||
6/30/07
|
9/30/07
|
12/31/07
|
2008
|
2009
|
2010
|
||||||||||||||
Minimum
monthly payments
|
$
|
1,049,763
|
$
|
905,018
|
$
|
875,147
|
$
|
3,147,557
|
$
|
1,603,063
|
$
|
109,693
|
Furthermore,
with each draw, the Company has issued warrants to purchase shares of the
Company’s common stock equal to from a high of 5%, now in the third year to 3%,
of the draw. The number of warrants is determined by dividing either 3% or
5% of the draw by the average closing price of the Company’s common stock for
the ten days preceding the date of the draw. The warrants have a five-year
term
from the date of each issuance and bear an exercise price set at 10% over
the
average closing price of the Company’s common stock for the ten days preceding
the date of the draw. Taking the above factors into account, each draw
has an
effective interest rate. The effective interest rates are within the range
of
17.79% and 12.62%.
In
the
quarter ending March 31, 2007, the Company made a draw against the line
in the
amount of $1,166,331. The stated interest rate was 8.51%; the effective
interest
rate was 12.96%. The Company issued 33,927 warrants to purchase shares of
the Company’s common stock at an exercise price of $1.28 per share. The
warrants have a fair value of $28,011 using the Black-Scholes option-pricing
model.
For
reporting purposes, the carrying value of the liability is reduced at the
time
of each draw by the value ascribed to the warrants. This reduction will
be
amortized at the effective interest rate to interest expense over the term
of
the draw. The Company has accounted for these warrants as equity
instruments in accordance with EITF 00-19, "Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company's Own Stock"
since
there is no option for cash or net-cash settlement when the warrants are
exercised. Future exercises and forfeitures will reduce the amount of warrants
outstanding. Exercises will increase the amount of common stock outstanding
and
additional paid in capital.
GE
has
proposed an incremental $6,000,000 to the leasing credit facility to begin
in
2007. This increase to the line would bear interest at 375 basis points
above
the three-year Treasury rate, and would reduce warrants to 2% of a draw.
The
Company has accepted the proposal. The Company expects that this increase
will
be in place for a draw in the second quarter of 2007.
Capital
Leases
The
obligations under capital leases are at fixed interest rates and are
collateralized by the related property and equipment (see Note
3).
16
Note
9
Employee
Stock Benefit Plans
The
Company has three active, stock-based compensation plans available to grant,
among other things, incentive and non-incentive stock options to employees,
directors and third-party service-providers as well as restricted stock to
key
employees. Under the 2005 Equity Compensation Plan, a maximum of 3,160,000
shares of the Company’s common stock were reserved for issuance. At March 31,
2007, 421,000 shares were available for future grants under this Plan. Under
the
Outside Director Plan and under the 2005 Investment Plan, 286,250 shares and
388,000 shares, respectively, were available for issuance as of March 31, 2007.
The other stock options plans are frozen and no further grants will be made
from
them.
Stock
option activity under all of the Company’s share-based compensation plans for
the three months ended March 31, 2007 was as follows:
Number
of Options
|
Weighted
Average Exercise Price
|
||||||
Outstanding,
January 1, 2007
|
6,093,725
|
$
|
2.09
|
||||
Granted
|
685,000
|
1.13
|
|||||
Exercised
|
-
|
-
|
|||||
Cancelled
|
(292,410
|
)
|
1.82
|
||||
Outstanding,
March 31, 2007
|
6,486,315
|
$
|
2.00
|
||||
Options
excercisable at March 31, 2007
|
4,114,856
|
$
|
2.08
|
At
March
31, 2007, there was $4,289,175 of total unrecognized compensation cost related
to non-vested option grants and stock awards that is expected to be recognized
over a weighted-average period of 2.13 years. The intrinsic value of options
outstanding and exercisable at March 31, 2007 was not significant.
Note
10
Business
Segment and Geographic Data:
Segments
are distinguished by the Company’s management structure, products and services
offered, markets served and types of customers. The Domestic XTRAC business
derives its primary revenues from procedures performed by dermatologists in
the
United States. The International Dermatology Equipment segment, in comparison,
generates revenues from the sale of equipment to dermatologists outside the
United States through a network of distributors. The Skin Care (ProCyte) segment
generates revenues by selling skincare products and by earning royalties on
licenses for the Company’s patented copper peptide compound. The Surgical
Services segment generates revenues by providing fee-based procedures typically
using the Company’s mobile surgical laser equipment delivered and operated by a
technician at hospitals and surgery centers in the United States. The Surgical
Products segment generates revenues by selling laser products and disposables
to
hospitals and surgery centers on both a domestic and international basis. For
the three months ended March 31, 2007 and 2006, the Company did not have
material revenues from any individual customer.
Unallocated
operating expenses include costs incurred for administrative and accounting
staff, general liability and other insurance, professional fees and other
similar corporate expenses. Unallocated assets include cash, prepaid expenses
and deposits. Goodwill that was carried at $2,944,423 at March 31, 2007 and
December 31, 2006 has been allocated to the domestic and international XTRAC
segments based upon its fair value as of the date of the Acculase buy-out in
the
amounts of $2,061,096 and $883,327, respectively. Goodwill of $13,973,385 at
March 31, 2007 from the ProCyte acquisition has been entirely allocated to
the
Skin Care segment.
The
following tables reflect results of operations from our business segments for
the periods indicated below:
Three
Months Ended March 31, 2007
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
1,806,926
|
$
|
678,818
|
$
|
3,485,710
|
$
|
1,820,205
|
$
|
1,236,909
|
$
|
9,028,568
|
|||||||
Costs
of revenues
|
1,049,421
|
450,446
|
1,026,648
|
1,565,638
|
688,416
|
4,780,569
|
|||||||||||||
Gross
profit
|
757,505
|
228,372
|
2,459,062
|
254,567
|
548,493
|
4,247,999
|
|||||||||||||
Gross
profit %
|
41.9
|
%
|
33.6
|
%
|
70.5
|
%
|
14.0
|
%
|
44.3
|
%
|
47.0
|
%
|
|||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
1,537,152
|
24,920
|
1,408,564
|
236,904
|
139,275
|
3,346,815
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
96,102
|
-
|
151,968
|
248,070
|
|||||||||||||
Unallocated
Operating expenses
|
-
|
-
|
-
|
-
|
-
|
2,460,177
|
|||||||||||||
1,537,152
|
24,920
|
1,504,666
|
236,904
|
291,243
|
6,055,062
|
||||||||||||||
Income
(loss) from operations
|
(779,647
|
)
|
203,452
|
954,396
|
17,663
|
257,250
|
(1,807,063
|
)
|
|||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(76,419
|
)
|
||||||||||||
Net
income (loss)
|
($779,647
|
)
|
$
|
203,452
|
$
|
954,396
|
$
|
17,663
|
$
|
257,250
|
($1,883,482
|
)
|
17
Three
Months Ended March 31, 2006
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
1,059,630
|
$
|
531,065
|
$
|
3,460,561
|
$
|
1,616,034
|
$
|
1,413,872
|
$
|
8,081,162
|
|||||||
Costs
of revenues
|
946,612
|
330,290
|
1,052,444
|
1,414,578
|
963,974
|
4,707,898
|
|||||||||||||
Gross
profit
|
113,018
|
200,775
|
2,408,117
|
201,456
|
449,898
|
3,373,264
|
|||||||||||||
Gross
profit %
|
10.7
|
%
|
37.8
|
%
|
69.6
|
%
|
12.5
|
%
|
31.8
|
%
|
41.7
|
%
|
|||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
1,131,951
|
17,431
|
1,428,174
|
252,076
|
140,807
|
2,970,439
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
105,735
|
-
|
136,469
|
242,204
|
|||||||||||||
Unallocated
Operating expenses
|
-
|
-
|
-
|
-
|
-
|
2,389,739
|
|||||||||||||
1,131,951
|
17,431
|
1,533,909
|
252,076
|
277,276
|
5,602,382
|
||||||||||||||
Income
(loss) from operations
|
(1,018,933
|
)
|
183,344
|
874,208
|
(50,620
|
)
|
172,622
|
(2,229,118
|
)
|
||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(121,143
|
)
|
||||||||||||
Net
income (loss)
|
($1,018,933
|
)
|
$
|
183,344
|
$
|
874,208
|
$
|
(50,620
|
)
|
$
|
172,622
|
($2,350,261
|
)
|
March
31, 2007
|
December
31, 2006
|
||||||
Assets:
|
|||||||
Total
assets for reportable segments
|
$
|
44,807,348
|
$
|
43,955,628
|
|||
Other
unallocated assets
|
12,764,761
|
13,525,893
|
|||||
Consolidated
total
|
$
|
57,572,109
|
$
|
57,481,521
|
For
the
three months ended March 31, 2007 and 2006 there were no material net
revenues attributed to any individual foreign country. Net revenues by
geographic area were, as follows:
Three
Months Ended March 31,
|
|||||||
2007
|
2006
|
||||||
Domestic
|
$
|
7,588,240
|
$
|
6,659,378
|
|||
Foreign
|
1,440,328
|
1,421,784
|
|||||
$
|
9,028568
|
$
|
8,081,162
|
Note
11
Significant
Alliances/Agreements:
On
March
31, 2005, the Company entered into a Sales and Marketing Agreement with
GlobalMed (Asia) Technologies Co., Inc. (“GlobalMed”). Under this agreement,
GlobalMed acts as master distributor in the Pacific Rim for the Company’s XTRAC
excimer laser and for the Company’s LaserPro® diode surgical laser system. The
Company’s diode laser will be marketed for, among other things, use in a
gynecological procedure pioneered by David Matlock, MD. The
Company has engaged Dr. Matlock as a consultant to explore further business
opportunities for the Company. In connection with this engagement, Dr. Matlock
received options to purchase up to 25,000 shares of the Company’s common stock
at an exercise price, which was the market value of the Company’s common stock
on the date of the grant. In July 2006, the Company broadened the territory
covered by the Sales and Marketing Agreement to include the United States and
added Innogyn, Inc., a related party of GlobalMed, as co-distributor under
the
agreement.
18
On
July
27, 2005, the Company entered into a Marketing Agreement with KDS Marketing,
Inc. (“KDS”). Using money invested by each party, KDS has researched market
opportunities for the Company’s diode laser and related delivery systems, and
KDS is now marketing the diode laser primarily through a website that physicians
may access for information about purchasing the lasers. KDS began marketing
the
laser in the first quarter 2006 but has faced difficult market conditions and
has yet to achieve meaningful results.
On
March
30, 2006, the Company entered a strategic relationship with AzurTec to resume
development, and to undertake the manufacture and distribution, of AzurTec's
MetaSpex Laboratory System, a light-based system designed to detect certain
cancers of the skin. The Company issued 200,000 shares of its restricted common
stock in exchange for 6,855,141 shares of AzurTec common stock and 181,512
shares of AzurTec Class A preferred stock, which represent a 14% interest in
AzurTec on a fully diluted basis. The Company will assist
in
the development of FDA-compliant prototypes for AzurTec’s product. Continuing
development of this project requires additional investment by AzurTec, which
AzurTec has undertaken to raise. The Company has granted AzurTec an additional
12 months in which to raise the additional investment. The Company will resume
development once the additional investment has been raised, and AzurTec has
settled its prior indebtedness to the Company for development work.
On
March
31, 2006, the Mount Sinai School of Medicine of New York University granted
the
Company an exclusive license, effective April 1, 2006, to use Mount Sinai's
patented methodology for utilization of ultraviolet laser light for the
treatment of vitiligo. The licensed patent is US Patent No. 6,979,327, Treatment
of Vitiligo. It was issued December 27, 2005, and the inventor is James M.
Spencer, MD, a member of the Company’s Scientific Advisory Board.
On
April
14, 2006, the Company entered into a Clinical Trial Agreement protocol with
the
University of California at San Francisco. The agreement covers a protocol
for a
phase 4, randomized, double-blinded study to evaluate the safety and efficacy
of
the XTRAC laser system in the treatment of moderate to severe psoriasis. John
Koo, MD, a member of our Scientific Advisory Board, is guiding the study using
our high-powered Ultra™ excimer laser.
ITEM
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
Certain
statements in this Quarterly Report on Form 10-Q, 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 that are discussed under the section entitled
“Risk
Factors,” in our Annual Report on Form 10-K for the year ended December 31,
2006.
The
following discussion and analysis should be read in conjunction with the
consolidated financial statements and related notes included elsewhere in this
Report.
19
Introduction,
Outlook and Overview of Business Operations
We
view
our business as comprised of the following five business segments:
· |
Domestic
XTRAC,
|
· |
International
Dermatology Equipment,
|
· |
Skin
Care (ProCyte),
|
· |
Surgical
Services, and
|
· |
Surgical
Products.
|
Domestic
XTRAC
Our
Domestic XTRAC segment is a U.S. business with revenues primarily derived from
procedures performed by dermatologists. We are engaged in the development,
manufacturing and marketing of our proprietary XTRAC® excimer laser and delivery
systems and techniques used in the treatment of inflammatory skin
disorders, including
psoriasis, vitiligo, atopic dermatitis and leukoderma.
As
part
of our commercialization strategy in the United States, we provide the XTRAC
laser system to targeted dermatologists at no initial capital cost. Unlike
our
international strategy, we generally do not sell the laser system domestically,
but maintain ownership of the laser and earn revenue each time a physician
treats a patient with the equipment. We believe that this strategy will create
incentives for physicians to adopt the XTRAC laser system and will increase
market penetration. On occasion we have sold and will sell the laser directly
to
the customer for certain reasons, including the costs of logistical support
and
customer preference.
For
the
past six years, we have sought to clear the path of obstacles and barriers
to a
roll-out of the XTRAC laser system in dermatology. In 2000, the laser system,
which was originally designed for cardiology applications, was found to have
significant therapeutic advantages for psoriasis patients who were treated
with
the UVB light emitted from the excimer-based laser system. For the first two
years, we invested in establishing the clinical efficacy of the product and
mechanical reliability of the equipment. In the last three years, we have
pursued widespread reimbursement commencing with obtaining newly created Current
Procedure Terminology (“CPT”) reimbursement codes that became effective in 2003.
This was followed by a lengthy process of persuading private medical insurers
to
adopt a positive reimbursement policy for the procedure. As a result of
initiatives undertaken by the Company and by the physician community, the
ability for physicians to process claims efficiently and receive positive
payment decisions for use of the XTRAC system improved significantly during
the
latter part of 2005 and 2006. In March 2007, the Blue Cross Blue Shield
Association (BCBSA) published a National Reference Policy that now recommends
positive reimbursement coverage for psoriasis, including the XTRAC as first
step
therapy for moderate to severe psoriasis comprising less than 20% body area.
We
increased our dermatology sales force and marketing department as part of the
acquisition of ProCyte in March 2005. We now have 11 sales representatives
in
the domestic XTRAC segment (not including the 9 clinical specialists that we
have recently hired to train and support our customers) and 20 sales
representatives in the Skin Care segment. The sales representatives of each
segment provide follow-up sales support and share sales leads to enhance
opportunities for cross-selling. Our marketing department has been instrumental
in expanding the advertising campaign for the XTRAC laser system. In November
2005, we commenced an advertising campaign in selected regions that have
attained certain levels of reimbursement in order to make consumers aware of
the
technology and therapeutic benefits of targeted UVB laser treatment for
psoriasis. We continue to analyze and adjust this campaign for effectiveness.
However,
we do see that some of our sales and marketing expenses have grown faster than
the revenues on which the expenses are targeted to have positive impact. For
example, we have tried various direct-to-consumer marketing programs that have
positively influenced utilization, but the payback in utilization is expected
to
be attained over more periods than in just the period in which we incurred
the
expense. We have also increased the number of sales representatives and also
established a cadre of clinical support specialists to optimize utilization
levels and better secure the willingness and interest of patients to seek
follow-up courses of treatment after the effect of the first battery of
treatment sessions starts to wear off. The efforts of this cadre, if successful,
will likely realize benefits over several fiscal quarters.
20
International
Dermatology Equipment
In
the
international market, we derive revenues by selling the dermatology laser
systems to distributors and directly to physicians. In this market, we have
benefited from both our clinical studies and from the improved reliability
and
functionality of the XTRAC laser system. Compared
to the domestic segment, the sales of laser systems in the international segment
is influenced to a greater degree by competition from similar laser technologies
as well as non-laser lamp alternatives. Over time, this competition has reduced
the prices we are able to charge to international distributors for our XTRAC
products. In 2005, as a result of the acquisition of worldwide rights to certain
proprietary light-based technology from Stern, we also explored new product
offerings in the treatment of dermatological conditions. We have expanded the
international marketing of this product, called the VTRAC™, in 2006. The VTRAC
is a lamp-based UVB targeted therapy, positioned at a price point lower than
the
XTRAC laser system so that it will effectively compete with other
non-laser-based therapies for psoriasis and vitiligo.
Due
to
the significant financial investment requirements, we
did
not implement an international XTRAC and/or VTRAC fee-per-use revenue model,
similar to our domestic revenue model. However, as reimbursement in the domestic
market has become more widespread, we have recently started to offer a version
of this model overseas.
Skin
Care (ProCyte)
Skin
Care
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 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.
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 during 2007, we will continue
to pursue a cautious growth strategy in order to conserve our cash resources
for
the XTRAC business segments.
Surgical
Products
The
Surgical Products segment generates revenues by selling laser products and
disposables to hospitals and surgery centers both inside and outside of the
United States. Also included are various non-laser surgical products (e.g.
the
ClearEss® II suction-irrigation system). We expect that sales of surgical laser
systems and the related disposable base may begin to erode as hospitals continue
to seek outsourcing solutions instead of purchasing lasers and related
disposables for their operating rooms. We are working to offset this erosion
by
cautiously expanding our surgical services segment and by increasing sales
from
the diode surgical laser introduced in 2004.
21
Critical
Accounting Policies
There
have been no changes to our critical accounting policies in the three months
ended March 31, 2007. Critical accounting policies and the significant estimates
made in accordance with them are regularly discussed with our Audit Committee.
Those policies are discussed under “Critical Accounting Policies” in our
“Management’s Discussion and Analysis of Financial Condition and Results of
Operations” included in Item 7 of our Annual Report on Form 10-K for the year
ended December 31, 2006.
Results
of Operations
Revenues
The
following table presents revenues from our five business segments for the
periods indicated below:
Three
Months Ended March 31,
|
|||||||
2007
|
2006
|
||||||
XTRAC
Domestic Services
|
$
|
1,806,926
|
$
|
1,059,630
|
|||
International
Dermatology Equipment Products
|
678,818
|
531,065
|
|||||
Skin
Care (ProCyte) Products
|
3,485,710
|
3,460,561
|
|||||
Total
Dermatology Revenues
|
5,971,454
|
5,051,256
|
|||||
Surgical
Services
|
1,820,205
|
1,616,034
|
|||||
Surgical
Products
|
1,236,909
|
1,413,872
|
|||||
Total
Surgical Revenues
|
3,057,114
|
3,029,906
|
|||||
Total
Revenues
|
$
|
9,028,568
|
$
|
8,081,162
|
Domestic
XTRAC Segment
Recognized
treatment revenue for the three months ended March 31, 2007 and 2006 for
domestic XTRAC procedures was $1,806,926 and $1,059,630, respectively,
reflecting billed procedures of 25,016 and 18,760, respectively. In addition,
1,261 and 1,173 procedures were performed in the three months ended March 31,
2007 and 2006, respectively, without billing from us, in connection with
clinical research and customer evaluations of the XTRAC laser. The increase
in
procedures in the period ended March 31, 2007 compared to the comparable period
in 2006 was largely related to our continuing progress in securing favorable
reimbursement policies from private insurance plans. Increases in procedures
are
dependent upon more widespread adoption of CPT codes with comparable rates
by
private healthcare insurers and on building market acceptance through marketing
programs with our physician partners and their patients that the XTRAC
procedures will be of clinical benefit and be generally reimbursed.
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 Staff Accounting Bulletin
No.
104, we recognize service revenue during this program from the sale of XTRAC
procedures or equivalent treatments to physicians participating in this program
only to the extent the physician has been reimbursed for the treatments. For
the
three months ended March 31, 2007, we recognized net revenues of $65,950 under
this program compared to $51,080 for the three months ended March 31, 2006.
The
change in deferred revenue under this program is presented in the table
below.
22
For
the
three months ended March 31, 2007, domestic XTRAC laser sales were $348,760.
There were eight lasers sold which were made for various reasons, including
costs of logistical support and customer preferences. There were no domestic
XTRAC laser sales for the three months ended March 31, 2006.
The
following table sets forth the above analysis for the Domestic XTRAC segment
for
the periods reflected below:
Three
Months Ended March 31,
|
|||||||
2007
|
2006
|
||||||
Total
revenue
|
$
|
1,806,926 |
$
|
1,059,630 | |||
Less:
laser sales revenue
|
(348,760
|
)
|
-
|
||||
Recognized
treatment revenue
|
1,458,166
|
1,059,630
|
|||||
Change
in deferred program revenue
|
65,950
|
51,080
|
|||||
Change
in deferred unused treatments
|
128,173
|
110,053
|
|||||
Net
billed treatment revenue
|
$
|
1,652,289
|
$
|
1,220,763
|
|||
Procedure
volume total
|
26,277
|
19,933
|
|||||
Less:
Non-billed procedures
|
1,261
|
1,173
|
|||||
Net
billed procedures
|
25,016
|
18,760
|
|||||
Avg.
price of treatments billed
|
$
|
66.05
|
$
|
65.07
|
|||
Change
in procedures with (recognized)/deferred program revenue,
net
|
998
|
785
|
|||||
Change
in procedures with deferred/(recognized) unused treatments,
net
|
1,941
|
1,691
|
The
average price for a treatment may be reduced in some instances based on the
volume of treatments performed. The average price for a treatment also 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 generally been practical to use our therapy to treat severe psoriasis
patients, but this may change as our new product, the XTRAC Ultra, has shorter
treatment times. A study undertaken with the guidance of John Koo, MD, of the
University of California at San Francisco, is evaluating the effectiveness
of
the Ultra in treating patients suffering from severe psoriasis. In March 2007,
the Blue Cross Blue Shield Association (BCBSA) published a National Reference
Policy that now recommends positive reimbursement coverage for psoriasis,
including the XTRAC as first step therapy for moderate to severe psoriasis
comprising less than 20% body area.
International
Dermatology Equipment Segment
International
sales of our dermatology equipment and related parts were $678,818 for the
three
months ended March 31, 2007 compared to $531,065 for the three months ended
March 31, 2006. We sold 21 and 12 laser systems in the three months ended
March
31, 2007 and 2006, respectively. Compared to the domestic business, the
international dermatology equipment operations are more influenced by
competition from similar laser technology from other manufacturers and from
non-laser lamps. Such competition has caused us to reduce the prices we charge
to international distributors. Furthermore, average selling prices for
international dermatology equipment are influenced by the following two
factors:
· |
We
have begun selling refurbished domestic XTRAC laser systems into
the
international market. The selling price for used equipment is
substantially less than new equipment. We sold three such used lasers
in
the three months ended March 31, 2006, and only one such laser in
the
three months ended March 31, 2007;
and
|
23
· |
We
have begun selling the new VTRAC, a lamp-based, alternative UVB light
source that has a wholesale sales price that is substantially below
our
competitors’ international dermatology equipment. In the three months
ended March 31, 2007, we sold one VTRAC
system.
|
The
following table illustrates the key changes in the International Dermatology
Equipment segment for the periods reflected below:
Three
Months Ended March 31,
|
|||||||
2007
|
2006
|
||||||
Gross
Revenues
|
$
|
678,818
|
$
|
531,065
|
|||
Less:
parts revenues
|
(151,918
|
)
|
(87,267
|
)
|
|||
Revenues
from laser systems
|
526,900
|
443,798
|
|||||
Laser
systems sold
|
11
|
12
|
|||||
Average
revenue per laser
|
$
|
47,900
|
$
|
36,983
|
Skin
Care (ProCyte) Segment
For
the
three months ended March 31, 2007, ProCyte revenues were $3,485,710 compared
to
$3,460,561 in the three months ended March 31, 2006. ProCyte 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.
Revenues
from Neutrogena decreased by $228,000 for the three months ended March 31,
2007
compared to the three months ended March 31, 2006. Included in the decrease
were
$52,000 in royalties and $176,000 in bulk compound.
The
following table illustrates the key changes in the Skin Care (ProCyte) segment
for the periods reflected below:
Three
Months Ended March 31,
|
||||||||||
2007
|
2006
|
%
Change
|
||||||||
Product
sales
|
$
|
3,330,710
|
$
|
3,077,561
|
8.2
|
%
|
||||
Bulk
compound sales
|
80,000
|
256,000
|
(68.7
|
%)
|
||||||
Royalties
|
75,000
|
127,000
|
(40.9
|
%)
|
||||||
Total
ProCyte revenues
|
$
|
3,485,710
|
$
|
3,460,561
|
0.7
|
%
|
Surgical
Services Segment
In
the
three months ended March 31, 2007 and 2006, surgical services revenues were
$1,820,205 and $1,616,034, respectively. This increase was primarily due to
the
fact that during the first quarter of 2006, we began to work with a regional
hospital system in central Florida, which has continued to show business growth.
24
The
following table illustrates the key changes in the Surgical Services segment
for
the periods reflected below:
Three
Months Ended March 31,
|
||||||||||
2007
|
2006
|
%
Change
|
||||||||
Revenues
|
$
|
1,820,205
|
$
|
1,616,034
|
12.6
|
%
|
Surgical
Products Segment
Surgical
Products revenues include revenues derived from the sale 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
three months ended March 31, 2007, surgical products revenues were $1,236,909
compared to $1,413,872 in the three months ended March 31, 2006. The decrease
was due to $147,100 less laser system revenues, as a result of a decrease in
the
number of systems sold (11 vs. 18).
The
increase in average price per laser between the period was largely due to the
mix of lasers sold and partly due to the trade level at which the laser were
sold (i.e. wholesale versus retail). Our diode laser has largely replaced our
Nd:YAG laser, which had a higher sales price. Included in laser sales during
the
three months ended March 31, 2007 were sales of 6 diode lasers. There were
sales
of 13 diode lasers, during the three months ended March 31, 2006. The diode
lasers have lower sales prices than our other types of lasers. We expect that
we
will continue to sell more diode lasers than our other types of lasers into
the
near future.
Fiber
and
other disposables sales decreased 3% between the comparable three-month periods
ended March 31, 2007 and 2006. We expect that our disposables base may erode
over time as hospitals continue to seek outsourcing solutions instead of
purchasing lasers and related disposables for their operating rooms. We continue
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. Any decline in laser and
disposables revenues is partly offset by sales of CO2 and diode surgical
lasers.
The
following table illustrates the key changes in the Surgical Products segment
for
the periods reflected below:
Three
Months Ended March 31,
|
||||||||||
2007
|
2006
|
%
Change
|
||||||||
Revenues
|
$
|
1,236,909
|
$
|
1,413,872
|
(12.5
|
%)
|
||||
Laser
systems sold
|
11
|
18
|
(38.9
|
%)
|
||||||
Laser
system revenues
|
$
|
320,500
|
$
|
467,600
|
(31.4
|
%)
|
||||
Average
revenue per laser
|
$
|
29,136
|
$
|
25,978
|
12.2
|
%
|
Cost
of Revenues
Our
cost
of revenues are comprised of product cost of revenues and service cost of
revenues. Within product cost of revenues are the costs of products sold in
the
International Dermatology Equipment segment, the Skin Care segment (with
royalties included in the services side of the segment), and the Surgical
Products segment (with laser maintenance fees included in the services side
of
this segment). 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 royalties and maintenance.
25
Product
cost of revenues for the three months ended March 31, 2007 was $2,137,012
compared to $2,321,669 for the three months ended March 31, 2006. Contributing
to the decrease of $184,657 was a decrease in the cost of sales for Surgical
Products in the amount of $279,018, reflecting a lower sales volume in the
current quarter compared to the prior year. Furthermore, the current quarter’s
sales represent a more favorable mix of disposable units, which are more
profitable than laser units. Offsetting this decrease in the current quarter
are
incremental costs of sales of $120,156 for international XTRAC laser sales.
This
is a direct result of an increase in sales volume.
Services
cost of revenues was $2,643,557 in the three months ended March 31, 2007
compared to $2,386,229 in the comparable period in 2006. Contributing to the
$257,328 decrease was a $151,060 increase in the surgical services business
segment due to increased revenues. This was partially offset by an increase
of
$102,809 in the cost of revenues for the domestic XTRAC services business.
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. The unabsorbed costs are
allocated to the domestic XTRAC and the international dermatology equipment
segments based on actual production of lasers for each segment. Included in
these allocated manufacturing costs are unabsorbed labor and direct plant costs.
Gross
Margin Analysis
Gross
margin increased to $4,247,999 during the three months ended March 31, 2007
from
$3,373,264 during the same period in 2006. As a percent of revenues, gross
margin increased to 47.1% for the three months ended March 31, 2007 from 41.7%
for the same period in 2006.
The
following table analyzes changes in our gross margin for the periods reflected
below:
Three
Months Ended March 31,
|
||||||||||
Company
Margin Analysis
|
2007
|
2006
|
%
Change
|
|||||||
Revenues
|
$
|
9,028,568
|
$
|
8,081,162
|
11.7
|
%
|
||||
Cost
of revenues
|
4,780,569
|
4,707,898
|
1.5
|
%
|
||||||
Gross
profit
|
$
|
4,247,999
|
$
|
3,373,264
|
25.9
|
%
|
||||
Gross
profit percentage
|
47.1
|
%
|
41.7
|
%
|
The
primary reasons for the increases in gross margin for the three months ended
March 31, 2007, compared to the same period in 2006 were as follows
· |
We
sold a greater number of treatment procedures for the XTRAC laser
systems
in 2007 than in 2006. Each incremental treatment procedure carries
negligible variable cost. The increase in procedure volume was a
direct
result of improving insurance reimbursement and increased marketing
efforts.
|
· |
We
sold XTRAC lasers domestically during the three months ended March
31,
2007. The gross margin on these sales are higher, approximately 83%,
since
certain of the lasers were previously being
depreciated.
|
· |
Surgical
services revenues increased, and costs related to laser repairs increased
during the period as well. Overall, the margins improved to 14.0%
from
12.5% in 2006.
|
· |
In
the surgical products segment, absorbed labor and overhead plant
costs,
due to higher production levels, accounted for $148,000 of the decrease
in
cost of goods sold for the three months ended March 31,
2007
|
· |
Partially
offsetting the above was an increase in depreciation of $69,000 included
in the XTRAC domestic cost of sales as a result of increasing the
overall
placements of new lasers since the period ended March 31,
2006.
|
26
The
following table analyzes our gross margin for our Domestic XTRAC segment for
the
periods presented below:
Three
Months Ended March 31,
|
||||||||||
XTRAC
Domestic Segment
|
2007
|
2006
|
%
Change
|
|||||||
Revenues
|
$
|
1,806,926
|
$
|
1,059,630
|
70.5
|
%
|
||||
Cost
of revenues
|
1,049,421
|
946,612
|
10.9
|
%
|
||||||
Gross
profit
|
$
|
757,505
|
$
|
113,018
|
||||||
Gross
profit percentage
|
41.9
|
%
|
10.7
|
%
|
Gross
margin increased for this segment for the three months ended March 31, 2007
from
the comparable period in 2006 by $644,487. The key factors for the increases
were as follows:
· |
We
sold XTRAC lasers domestically during the three months ended March
31,
2007. The gross margins on these sales are higher, approximately
83%,
since certain of the lasers were previously being
depreciated.
|
· |
Key
drivers in increased revenue in this segment are insurance reimbursement
and increased direct-to-consumer advertising in targeted territories.
Improved insurance reimbursement, together with greater consumer
awareness
of the XTRAC therapy, increased treatment revenue accordingly. Our
clinical support specialists have also begun to show favorable impact
on
increasing physicians’ utilization of the XTRAC laser
system.
|
· |
Procedure
volume increased 33% from 18,760 to 25,016 billed procedures in the
three
months ended March 31, 2007 compared to the same period in 2006.
Price per
procedure did not change significantly between the
periods.
|
· |
The
cost of revenues increased by $102,809 for the three months ended
March
31, 2007. This increase is due primarily to an increase in depreciation
on
the lasers in service of $69,000 over the comparable prior year period.
The depreciation costs will continue to increase in subsequent periods
as
the business grows thereby increasing the installed base of lasers.
In
addition, there was an increase in certain allocable XTRAC manufacturing
overhead costs that are charged against the XTRAC service
revenues.
|
· |
During
the three months ended March 31, 2007, the cost of revenues increased
by
approximately $90,000, net of an estimated recovery, as a result
of
contaminated laser gas obtained from a vendor and introduced into
the
production process.
|
The
following table analyzes our gross margin for our International Dermatology
Equipment segment for the periods presented below:
|
Three
Months Ended March
31,
|
|||||||||
International
Dermatology
Equipment
Segment
|
2007
|
2006
|
%
Change
|
|||||||
Revenues
|
$
|
678,818
|
$
|
531,065
|
27.8
|
%
|
||||
Cost
of revenues
|
450,446
|
330,290
|
36.4
|
%
|
||||||
Gross
profit
|
$
|
228,372
|
$
|
200,775
|
13.7
|
%
|
||||
Gross
profit percentage
|
33.6
|
%
|
37.8
|
%
|
Gross
margin for the three months ended March 31, 2007 increased by $27,597, from
the
comparable period in 2006. The key factors for the increase were as
follows:
· |
We
sold ten XTRAC laser systems and one VTRAC lamp-based excimer system
during the three months ended March 31, 2007 and ten XTRAC laser
systems
and two VTRAC systems in the comparable period in 2006. The VTRAC
systems
have a higher gross margin than the XTRAC laser
systems.
|
27
· |
The
International dermatology equipment operations are influenced by
competition from similar laser technology from other manufacturers
and
from non-laser lamp alternatives for treating inflammatory skin disorders,
which has served to reduce the prices we charge international distributors
for our excimer products. Partially offsetting the decrease in the
number
of laser systems sold was an increase in the average price of the
laser
systems sold. After adjusting the revenue for parts sales of approximately
$152,000, the average price for lasers sold during this period was
approximately $47,900 in the three months ended March 31, 2007, up
from
$37,000 in the comparable period in 2006.
|
The
following table analyzes our gross margin for our SkinCare (ProCyte) segment
for
the periods presented below:
Three
Months Ended March 31,
|
||||||||||
Skin
Care Segment
|
2007
|
2006
|
%
Change
|
|||||||
Product
revenues
|
$
|
3,330,710
|
$
|
3,077,561
|
8.2
|
%
|
||||
Bulk
compound revenues
|
80,000
|
256,000
|
(68.8
|
%)
|
||||||
Royalties
|
75,000
|
127,000
|
(40.9
|
%)
|
||||||
Total
revenues
|
3,485,710
|
3,460,561
|
0.7
|
%
|
||||||
Product
cost of revenues
|
976,998
|
893,564
|
9.3
|
%
|
||||||
Bulk
compound cost of revenues
|
49,650
|
158,880
|
(68.8
|
%)
|
||||||
Total
cost of revenues
|
1,026,648
|
1,052,444
|
(2.5
|
%)
|
||||||
Gross
profit
|
$
|
2,459,062
|
$
|
2,408,117
|
8.1
|
%
|
||||
Gross
profit percentage
|
70.5
|
%
|
69.6
|
%
|
Gross
margin for the three months ended March 31, 2007 increased by $50,945, for
the
comparable periods in 2006. The key factor impacting gross margin was that
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.
The
following table analyzes our gross margin for our Surgical Services segment
for
the periods presented below:
Three
Months Ended March 31,
|
||||||||||
Surgical
Services Segment
|
2007
|
2006
|
%
Change
|
|||||||
Revenues
|
$
|
1,820,205
|
$
|
1,616,034
|
12.6
|
%
|
||||
Cost
of revenues
|
1,565,638
|
1,414,578
|
10.7
|
%
|
||||||
Gross
profit
|
$
|
254,567
|
$
|
201,456
|
26.4
|
%
|
||||
Gross
profit percentage
|
14.0
|
%
|
12.5
|
%
|
Gross
margin in the Surgical Services segment for the three months ended March 31,
2007 increased by $53,111, from the comparable periods in 2006. The key factor
impacting gross margin for the Surgical Services business was that we have
opened a new, contiguous territory in which we have secured a long-term contract
from which we anticipate growth in procedure volume. For that reason, we have
relocated our personnel and material from a territory lost in 2005 to the new
one.
28
The
following table analyzes our gross margin for our Surgical Products segment
for
the periods presented below:
Three
Months Ended
March
31,
|
||||||||||
Surgical
Products Segment
|
2007
|
2006
|
%
Change
|
|||||||
Revenues
|
$
|
1,236,909
|
$
|
1,413,872
|
(12.5
|
%)
|
||||
Cost
of revenues
|
688,416
|
963,974
|
(28.9
|
%)
|
||||||
Gross
profit
|
$
|
548,493
|
$
|
449,898
|
21.9
|
%
|
||||
Gross
profit percentage
|
44.3
|
%
|
31.8
|
%
|
Gross
margin for the Surgical Products segment in the three months ended March 31,
2007 compared to the same periods in 2006 increased by $98,595. The key factors
impacting gross margin were as follows:
· |
This
segment includes product sales of surgical laser systems and laser
disposables. Disposables are more profitable than laser systems,
but the
sale of laser systems generates the subsequent recurring sale of
laser
disposables. The current quarter’s sales represent a more favorable mix of
the more profitable disposables.
|
· |
Revenues
for the three months ended March 31, 2007 decreased by $176,963 from
the
three months ended March 31, 2006 while cost of revenues decreased
by
$275,558 between the same periods. There were seven less laser systems
sold in the three months ended March 31, 2007 than in the comparable
period of 2006. However, the lasers sold in the 2007 period were
at higher
prices than in the comparable period in 2006. The increase in average
price per laser was largely due to the mix of lasers sold. Included
in the
laser sales for the three months ended March 31, 2007 and 2006 were
sales
of $78,500 and $230,500 of diode lasers, respectively, which have
substantially lower list sales prices than the other types of surgical
lasers.
|
· |
Labor
and overhead plant costs, due to higher production levels, accounted
for
$148,000 of the decrease in cost of goods sold for the three months
ended
March 31, 2007.
|
· |
This
revenue increase was partly offset by a decrease in sales of disposables
between the periods. Disposables, which have a higher gross margin
as a
percent of revenues than lasers, represented a lower percentage of
revenue
in the three months ended March 31, 2007 compared to the same period
in
2006.
|
Selling,
General and Administrative Expenses
For
the
three months ended March 31, 2007, selling, general and administrative expenses
increased $446,814 to $5,806,992 from the three months ended March 31, 2006.
The
increase was caused by higher sales costs due to increased staffing and related
travel of $437,000 and $46,626 for stock options issued to consultants.
Offsetting a portion of the increases for the three months ended March 31,
2007,
was a decrease of $40,471 for stock-based compensation expense and a reduction
of general administrative employee related costs of $99,000 compared to the
prior year period.
Engineering
and Product Development
Engineering
and product development expenses for the three months ended March 31, 2007
increased to $248,070 from $242,204 for the three months ended March 31, 2006.
During the 2006 and 2007 periods, the engineers at the Carlsbad plant were
primarily focused on manufacturing efforts, and therefore, their costs have
been
reflected in cost of goods sold.
29
Interest
Expense, Net
Net
interest expense for the three months ended March 31, 2007 decreased to $76,419,
as compared to $121,143 for the three months ended March 31, 2006. The decrease
in net interest expense was the result of the interest earned on cash reserves
offsetting an increase in interest expense due to draws on the lease line of
credit during the second, third and fourth quarters of 2006.
Net
Loss
The
aforementioned factors resulted in a net loss of $1,883,482 during the three
months ended March 31, 2007, as compared to a net loss of $2,350,261 during
the
three months ended March 31, 2006, a decrease of 20%. This decrease was
primarily the result of increased revenues along with the decrease in cost
of
sales and resulting increase in gross margin. This was partially offset by
an
increase of $132,105 of depreciation and amortization over the comparable three
month period of the prior year.
Contributing
to the reduction in the net loss during the three months ended March 31,
2007
compared to the net loss during the three months ended March 31, 2006 was
a 31%
improvement in the operating results of the combined XTRAC business units
(Domestic XTRAC plus International Dermatology Equipment).
The
following table illustrates the impact of major expenses, namely depreciation,
amortization and stock option expense between the periods:
For
the three months ended March 31,
|
||||||||||
2007
|
2006
|
Change
|
||||||||
Net
loss
|
$
|
1,883,482
|
$
|
2,350,261
|
$
|
467,920
|
||||
Major
expenses included in net loss:
|
||||||||||
Depreciation
and amortization
|
1,149,200
|
1,017,095
|
132,105
|
|||||||
Stock-based
compensation
|
426,319
|
466,790
|
(40,471
|
)
|
||||||
Total
major expenses
|
$
|
1,575,519
|
$
|
1,483,885
|
$
|
91,634
|
Liquidity
and Capital Resources
We
have
historically financed our operations with cash provided by equity financing
and
from lines of credit and, more recently, from positive cash flows from
operations.
At
March
31, 2007, our current ratio was 2.36 compared to 2.66 at December 31, 2006.
As
of March 31, 2007, we had $15,043,226 of working capital compared to $16,069,616
as of December 31, 2006. Cash and cash equivalents were $12,202,678 as of March
31, 2007, as compared to $12,885,742 as of December 31, 2006. We had $156,000
of
cash that was classified as restricted as of March 31, 2007 compared to $156,000
as of December 31, 2006.
As
of
March 31, 2007, we had an accumulated deficit of $89,558,485 and cash and cash
equivalents $12,202,678, including restricted cash of $156,000, reflecting
the
private placement of our common stock in November 2006. We have historically
financed our operations with cash provided by equity financing and from lines
of
credit and, more recently, from positive cash flow generated from
operations.
The
2007
operating plan reflects increases in per-treatment fee revenues for use of
the
XTRAC system based on increased utilization of the XTRAC by physicians and
on
wider insurance coverage in the United States. In addition, the 2007 operating
plan calls for increased revenues and profits from the Skin Care business.
Management of the Company believes that our existing cash balance together
with
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, at a minimum, beyond the second quarter of 2008.
On
June
25, 2004, we entered into a leasing credit facility from GE Capital Corporation
(“GE”). The credit facility has a commitment term of three years, expiring on
June 25, 2007. We account for each draw as funded indebtedness taking the form
of a capital lease, with equitable ownership in the lasers remaining with us.
GE
retains title as a form of security over the lasers. Each draw against the
credit facility has a repayment period of three years and is secured by specific
lasers, which we have sold to GE and leased back for deployment in the field.
A
summary of the activity under the GE leasing credit facility is presented in
Note 8, “Long-term
Debt”.
We
have accepted a proposal from GE to increase the leasing line of credit under
a
fourth tranche. We expect the tranche to be in place in the second quarter
of
2007. Net cash provided by operating activities was $99,275 for three months
ended March 31, 2007, compared to cash provided of $521,394 for the same period
in 2006. The change was primarily due to an increase in inventory, an
increase in accounts receivable, a decrease in accrued compensation expense
and an increase in accounts payable.
30
Net
cash
used in investing activities was $909,815 for the three months ended March
31,
2007 compared to cash used of $1,090,533 for the three months ended March 31,
2006. This was primarily for the placement of lasers into service.
Net
cash
provided by financing activities was $127,476 for the three months ended March
31, 2007 compared to $624,415 for the three months ended March 31, 2006. In
the
three months ended March 31, 2007 we made payments of $165,672 on certain notes
payable and capital lease. These payments were offset by the advances under
the
lease line of credit, net of payments, of $293,148.
Commitments
and Contingencies
During
the three months ended March 31, 2007, there were no other items that
significantly impacted our commitments and contingencies as discussed in the
notes to our 2006 annual financial statements included in our Annual Report
on
Form 10-K. In addition, we have no significant off-balance sheet
arrangements.
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
3. 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 treasury risk management issues in connection with
changes in interest rates and foreign currency rates.
ITEM
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief
Financial Officer, evaluated the effectiveness of our disclosure controls and
procedures as of the end of the period covered by this Report. Based on that
evaluation, the Chief Executive Officer and Chief Financial Officer concluded
that our disclosure controls and procedures as of the end of the period covered
by this Report are functioning effectively to provide reasonable assurance
that
the information required to be disclosed by us in reports filed under the
Securities Exchange Act of 1934 is (i) recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange
Commission’s rules and forms and (ii) accumulated and communicated to our
management, including the Chief Executive Officer and Chief Financial Officer,
as appropriate to allow timely decisions regarding disclosure. A control system
cannot provide absolute assurance, however, that the objectives of the control
system are met and no evaluation of controls can provide absolute assurance
that
all control issues and instances of fraud, if any, within a company have been
detected.
Change
in Internal Control Over Financial Reporting
No
change
in our internal control over financial reporting occurred during the three
months ended March 31, 2007 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial
reporting.
31
PART
II - Other Information
ITEM
1. Legal Proceedings
Reference
is made to Item 3, Legal
Proceedings,
in our
Annual Report on Form 10-K for the year ended December 31, 2006 for descriptions
of our legal proceedings.
In
the
matter we brought against RA Medical Systems, Inc. and Dean Irwin in the United
States District Court for the Southern District of California, the discovery
process is concluding. We have replied to the Defendants’ motion for summary
judgment. The motion is to be heard on May 21, 2007. It is not expected that
this matter will be brought to trial before the fall of 2007.
In
the
matter brought for malicious prosecution in California Superior Court by RA
Medical Systems and Mr. Irwin against us, Jenkens & Gilchrist, LLP and
Michael R. Matthias, Esq., trial is set for May 11, 2007, subject to possible
scheduling changes. Trial will be to a jury. The plaintiffs are claiming that
the defendants have injured them and caused economic damages from lost profits
amounting to $9.5 million. Our defenses to the claims of injury and economic
and
punitive damages will rely on fact witnesses as well as on expert witnesses.
We
intend to defend against these claims vigorously but cannot guarantee that
our
defenses will prevail.
In
the
matter we have brought against our insurance carrier in the U.S. District Court
for the Eastern District of Pennsylvania for declaratory judgment and breach
of
contract, the parties have cross-moved for summary judgment on the issue whether
malicious prosecution is indemnifiable under our insurance policy. We expect
that this cross-motion will be heard in the latter part of May 2007. In this
matter too, we intend to argue our motion vigorously but cannot guarantee that
our motion will prevail.
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.
ITEM
1A. Risk Factors
There
have been no material changes in our risk factors from those disclosed in our
Annual Report on Form 10-K for the year ended December 31,
2006.
ITEM
6. Exhibits
31.1
|
Rule 13a-14(a)/15d-14(a) Certificate of Chief Executive Officer
|
31.2
|
Rule 13a-14(a)/15d-14(a) Certification 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
|
32
SIGNATURES
Pursuant
to the requirements 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: May 10, 2007 | By: | /s/ Jeffrey F. O’Donnell |
Jeffrey F. O’Donnell |
||
President and Chief Executive Officer |
Date: May 10, 2007 | By: | /s/ Dennis M. McGrath |
Dennis M. McGrath |
||
Chief Financial Officer |
33