Gadsden Properties, Inc. - Quarter Report: 2007 September (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 September 30, 2007
OR
o |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the transition period from _________ to ___________
Commission
File Number 0-11365
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 November 9,
2007
was 63,032,207 shares.
PHOTOMEDEX,
INC.
INDEX
TO
FORM 10-Q
PAGE
|
||||
Part
I. Financial Information:
|
|
|||
|
|
|
|
|
|
ITEM
1. Financial Statements:
|
|
|
|
|
|
|
|
|
|
a.
|
Consolidated
Balance Sheets, September 30, 2007 (unaudited) and December 31,
2006
|
|
3
|
|
|
|
|
|
|
b.
|
Consolidated
Statements of Operations for the three months ended September 30,
2007 and
2006 (unaudited)
|
|
4
|
|
|
|
|
|
|
c.
|
Consolidated
Statements of Operations for the nine months ended September 30,
2007 and
2006 (unaudited)
|
|
5
|
|
|
|
|
|
|
c.
|
Consolidated
Statement of Stockholders’ Equity for the nine months ended September 30,
2007 (unaudited)
|
|
6
|
|
|
|
|
|
|
d.
|
Consolidated
Statements of Cash Flows for the nine months ended September 30,
2007 and
2006 (unaudited)
|
|
7
|
|
|
|
|
|
|
e.
|
Notes
to Consolidated Financial Statements (unaudited)
|
|
8
|
|
|
|
|
|
|
ITEM
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
|
24
|
|
|
|
|
|
|
|
ITEM
3. Quantitative and Qualitative Disclosure about Market
Risk
|
|
39
|
|
|
|
|
|
|
|
ITEM
4. Controls and Procedures
|
|
39
|
|
|
|
|
|
|
Part
II. Other Information:
|
|
|
||
|
|
|
|
|
|
ITEM
1.
|
Legal
Proceedings
|
|
39
|
|
ITEM
1A.
|
Risk
Factors
|
|
40
|
|
ITEM
6.
|
Exhibits
|
|
40
|
|
|
|
|
|
|
Signatures
|
|
41
|
|
|
Certifications
|
|
|
2
PART
I - Financial Information
ITEM
1. Financial Statements
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
September
30, 2007
|
December
31, 2006
|
||||||
(Unaudited)
|
*
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
8,159,473
|
$
|
12,729,742
|
|||
Restricted
cash
|
117,000
|
156,000
|
|||||
Accounts
receivable, net of allowance for doubtful accounts of $548,446 and
$508,438, respectively
|
5,828,110
|
4,999,224
|
|||||
Inventories
|
7,999,879
|
7,301,695
|
|||||
Prepaid
expenses and other current assets
|
657,993
|
534,135
|
|||||
Total
current assets
|
22,762,455
|
25,720,796
|
|||||
Property
and equipment, net
|
10,056,058
|
9,054,098
|
|||||
Goodwill,
net
|
16,917,808
|
16,917,808
|
|||||
Patents
and licensed technologies, net
|
1,461,103
|
1,695,727
|
|||||
Other
intangible assets, net
|
2,840,125
|
3,537,625
|
|||||
Other
assets
|
499,749
|
555,467
|
|||||
Total
assets
|
$
|
54,537,298
|
$
|
57,481,521
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Current
portion of notes payable
|
$
|
308,505
|
$
|
195,250
|
|||
Current
portion of long-term debt
|
3,601,684
|
3,018,874
|
|||||
Accounts
payable
|
3,778,882
|
3,617,726
|
|||||
Accrued
compensation and related expenses
|
1,327,799
|
1,529,862
|
|||||
Other
accrued liabilities
|
736,957
|
657,293
|
|||||
Deferred
revenues
|
1,110,105
|
632,175
|
|||||
Total
current liabilities
|
10,863,932
|
9,651,180
|
|||||
Long-term
liabilities:
|
|||||||
Notes
payable
|
113,191
|
133,507
|
|||||
Long-term
debt
|
3,514,157
|
3,593,920
|
|||||
Total
liabilities
|
14,491,280
|
13,378,607
|
|||||
Commitments
and Contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Common
stock, $.01 par value, 100,000,000 shares authorized; 63,032,207
and
62,536,054 shares issued and outstanding, respectively
|
630,322
|
625,360
|
|||||
Additional
paid-in capital
|
132,462,910
|
131,152,557
|
|||||
Accumulated
deficit
|
(93,047,214
|
)
|
(87,675,003
|
)
|
|||
Total
stockholders’ equity
|
40,046,018
|
44,102,914
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
54,537,298
|
$
|
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
September
30,
|
|
||||||
|
|
2007
|
|
2006
|
|||
Revenues:
|
|||||||
Product
sales
|
$
|
5,191,918
|
$
|
5,165,901
|
|||
Services
|
3,729,953
|
3,125,646
|
|||||
8,921,871
|
8,291,547
|
||||||
Cost
of revenues:
|
|||||||
Product
cost of revenues
|
2,154,566
|
2,097,500
|
|||||
Services
cost of revenues
|
2,528,223
|
2,561,436
|
|||||
|
4,682,789
|
4,658,936
|
|||||
Gross
profit
|
4,239,082
|
3,632,611
|
|||||
Operating
expenses:
|
|||||||
Selling
and marketing
|
3,157,730
|
2,678,419
|
|||||
General
and administrative
|
2,390,599
|
2,220,985
|
|||||
Engineering
and product development
|
202,163
|
267,062
|
|||||
5,750,492
|
5,166,466
|
||||||
Loss
from operations
|
(1,511,410
|
)
|
(1,533,855
|
)
|
|||
Interest
expense, net
|
(141,562
|
)
|
(159,180
|
)
|
|||
Net
loss
|
($
1,652,972
|
)
|
($
1,693,035
|
)
|
|||
Basic
and diluted net loss per share
|
($0.03
|
)
|
($0.03
|
)
|
|||
Shares
used in computing basic and diluted net loss per share
|
62,956,881
|
52,659,132
|
The
accompanying notes are an integral part of these consolidated financial
statements.
4
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
For
the Nine Months Ended September 30,
|
|||||||
2007
|
2006
|
||||||
Revenues:
|
|||||||
Product
sales
|
$
|
16,464,329
|
$
|
15,418,727
|
|||
Services
|
10,804,831
|
9,177,725
|
|||||
27,269,160
|
24,596,452
|
||||||
Cost
of revenues:
|
|||||||
Product
cost of revenues
|
6,703,250
|
6,374,344
|
|||||
Services
cost of revenues
|
7,788,637
|
7,216,680
|
|||||
|
14,491,887
|
13,591,024
|
|||||
Gross
profit
|
12,777,273
|
11,005,428
|
|||||
Operating
expenses:
|
|||||||
Selling
and marketing
|
9,730,157
|
8,236,179
|
|||||
General
and administrative
|
7,435,744
|
6,969,862
|
|||||
Engineering
and product development
|
603,636
|
764,445
|
|||||
17,769,537
|
15,970,486
|
||||||
Loss
from operations
|
(4,992,264
|
)
|
(4,965,058
|
)
|
|||
Interest
expense, net
|
(379,947
|
)
|
(418,170
|
)
|
|||
Net
loss
|
($
5,372,211
|
)
|
($
5,383,228
|
)
|
|||
Basic
and diluted net loss per share
|
($0.09
|
)
|
($0.10
|
)
|
|||
Shares
used in computing basic and diluted net loss per share
|
62,735,569
|
52,486,758
|
The
accompanying notes are an integral part of these consolidated financial
statements.
5
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
FOR
THE
NINE MONTHS ENDED SEPTEMBER 30, 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
|
)
|
$
|
44,102,914
|
|||||||
Stock
options issued to consultants for services
|
-
|
-
|
93,429
|
-
|
93,429
|
|||||||||||
Stock-based
compensation expense related
to employee options
|
-
|
-
|
827,337
|
-
|
827,337
|
|||||||||||
Exercise
of stock options
|
76,153
|
762
|
85,192
|
-
|
85,954
|
|||||||||||
Issuance
of restricted stock
|
420,000
|
4,200
|
276,384
|
-
|
280,584
|
|||||||||||
Issuance
of warrants for draws under line
of credit
|
-
|
-
|
28,011
|
-
|
28,011
|
|||||||||||
Net
loss for the nine months ended September 31, 2007
|
-
|
-
|
-
|
(5,372,211
|
)
|
(5,372,211
|
)
|
|||||||||
BALANCE,
SEPTEMBER 30, 2007
|
63,032,207
|
$
|
630,322
|
$
|
132,462,910
|
($93,047,214
|
)
|
$
|
40,046,018
|
The
accompanying notes are an integral part of these consolidated financial
statements.
6
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
For
the Nine Months Ended
September
30,
|
|||||||
2007
|
2006
|
||||||
Cash
Flows From Operating Activities:
|
|||||||
Net
loss
|
($
5,372,211
|
)
|
($
5,383,228
|
)
|
|||
Adjustments
to reconcile net loss to net cash (used in) provided by
|
|||||||
operating
activities:
|
|||||||
Depreciation
and amortization
|
3,563,026
|
3,101,689
|
|||||
Stock
options issued to consultants for services
|
93,429
|
111,706
|
|||||
Stock-based
compensation expense related to employee options and restricted
stock
|
1,103,721
|
1,136,405
|
|||||
Amortization
of deferred compensation
|
-
|
44,155
|
|||||
Provision
for bad debts
|
103,064
|
66,211
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable
|
(931,950
|
)
|
(136,471
|
)
|
|||
Inventories
|
(724,448
|
)
|
612,427
|
||||
Prepaid
expenses and other assets
|
648,793
|
710,407
|
|||||
Accounts
payable
|
317,155
|
393,196
|
|||||
Accrued
compensation and related expenses
|
(202,063
|
)
|
110,464
|
||||
Other
accrued liabilities
|
91,286
|
(130,306
|
)
|
||||
Deferred
revenues
|
477,930
|
198,758
|
|||||
Other
liabilities
|
(11,624
|
)
|
(17,415
|
)
|
|||
Net
cash (used in) provided by operating activities
|
(843,892
|
)
|
817,998
|
||||
Cash
Flows From Investing Activities:
|
|||||||
Purchases
of property and equipment
|
(108,640
|
)
|
(60,910
|
)
|
|||
Lasers
placed into service
|
(3,416,732
|
)
|
(3,485,269
|
)
|
|||
Net
cash used in investing activities
|
(3,525,372
|
)
|
(3,546,179
|
)
|
|||
Cash
Flows From Financing Activities:
|
|||||||
Proceeds
from issuance of restricted common stock
|
4,200
|
8,600
|
|||||
Costs
related to issuance of common stock
|
-
|
(7,890
|
)
|
||||
Proceeds
from exercise of options
|
85,954
|
76,180
|
|||||
Proceeds
from exercise of warrants
|
-
|
168,000
|
|||||
Payments
on long-term debt
|
(65,033
|
)
|
(153,597
|
)
|
|||
Payments
on notes payable
|
(501,884
|
)
|
(656,130
|
)
|
|||
Net
advancements on lease lines of credit
|
236,758
|
2,120,508
|
|||||
Decrease
in restricted cash and cash equivalents
|
39,000
|
50,931
|
|||||
Net
cash (used in) provided by financing activities
|
(201,005
|
)
|
1,606,602
|
||||
Net
decrease in cash and cash equivalents
|
(4,570,269
|
)
|
(1,121,579
|
)
|
|||
Cash
and cash equivalents, beginning of period
|
12,729,742
|
5,403,036
|
|||||
Cash
and cash equivalents, end of period
|
$
|
8,159,473
|
$
|
4,281,457
|
The
accompanying notes are an integral part of these consolidated financial
statements.
7
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. At times, 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 Company is now seeking adoption of
this
National Reference Policy by the remaining state Blue Cross Blue Shield Health
Insurance Plans, which currently do not have a positive payment policy for
the
XTRAC. 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
September 30, 2007, the Company had an accumulated deficit of $93,047,214.
Cash
and cash equivalents, including restricted cash of $117,000, was $8,276,473.
The
Company has historically financed its operations with cash provided by equity
financing and from lines of credit and, more recently but not yet consistently,
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 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 the Company’s operating and capital
requirements, at a minimum, beyond the third quarter of 2008.
8
Summary
of Significant Accounting Policies:
Quarterly
Financial Information and Results of Operations
The
financial statements as of September 30, 2007 and for the three and nine months
ended September 30, 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 September
30, 2007, and the results of operations and cash flows for the three and nine
months ended September 30, 2007 and 2006. The results for the three and nine
months ended September 30, 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; and (iv) collection is probable (the
“SAB
104 Criteria”). At times, units are shipped, but revenue is not recognized until
all of the SAB 104 criteria have been met, and until that time, the unit is
carried on the books of the Company as inventory.
The
Company ships most of its products FOB shipping point, although from time to
time certain customers, for example governmental customers, will insist upon
FOB
destination. Among the factors the Company takes into account in determining
the
proper time at which to recognize revenue are when title to the goods transfers
and when the risk of loss transfers. Shipments to distributors or physicians
that do not fully satisfy the collection criterion 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.
9
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.
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 September 30, 2007 and 2006, the Company deferred $899,075
and $512,254, respectively, under this approach.
The
Company has 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 September 30, 2007, the Company deferred an additional $19,494,
under this program, as all the SAB 104 Criteria for revenue recognition had
not
been met. At September 30, 2007, the Company had net deferred revenues of
$177,936 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
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 quarters ended September 30, 2007 and 2006 are 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.
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.
10
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 September 30, 2007 and during
2006, 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
September 30, 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
September 30, 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 September 30, 2007
and
during 2006, no such write-down was required.
Accrued
Warranty Costs
The
Company offers a warranty on product sales generally for a one to two-year
period. 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
nine months ended September 30, 2007 is summarized as follows:
September
30, 2007
|
||||
Accrual
at beginning of period
|
$
|
123,738
|
||
Additions
charged to warranty expense
|
207,500
|
|||
Expiring
warranties
|
(56,388
|
)
|
||
Claims
satisfied
|
(64,065
|
)
|
||
Accrual
at end of period
|
$
|
210,785
|
11
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.
Utilization
of the Company’s net operating loss carryforwards is subject to various
limitations of the Internal Revenue Code, of which the principal constraint
is
Section 382. Loss carryforwards from previous acquisitions (e.g. SLT, ProCyte)
have already been constrained by this provision. If there is a subsequent change
of ownership under Section 382, the utilization of the Company’s loss
carryforwards may be further materially constrained.
Effective
January 1, 2007, the Company adopted Financial Interpretation (“FIN”) No. 48,
“Accounting for Uncertainty in Income Taxes - An Interpretation of FASB
Statement No. 109.” This financial interpretation prescribes a recognition
threshold and measurement attribute for the financial statement recognition
and
measurement of a tax position taken or expected to be taken in a tax return.
The
interpretation contains a two-step approach to recognizing and measuring
uncertain tax positions accounted for in accordance with SFAS No. 109. The
first
step is to evaluate the tax position for recognition by determining if the
weight of available evidence indicates it is more likely than not that the
position will be sustained on audit, including resolution of related appeals
or
litigation processes, if any. The second step is to measure the tax benefit
as
the largest amount which is more than fifty percent likely of being realized
upon ultimate settlement. The interpretation also provides guidance on
derecognition, classification, interest and penalties, and other matters. The
adoption did not have an effect on the consolidated financial statements. There
continues to be no liability related to unrecognized tax benefits at September
30, 2007, and no effect on the effective tax rate. No tax-related interest
and
penalties have been recognized in the financial statements. Virtually all tax
years have net operating losses and therefore remain open to examination by
the
major taxing jurisdictions to which the Company is subject.
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 10,267,093 and 8,195,191 as of September 30, 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.
12
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 and nine months ended September 30, 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 and nine months ended September 30, 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 September 30,
|
Nine
Months Ended September 30,
|
||||||||||||
Assumptions
for Option Grants
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Risk-free
interest rate
|
4.83
|
%
|
4.94
|
%
|
4.78 | % |
4.63
|
%
|
|||||
Volatility
|
85.39
|
%
|
91.01
|
%
|
86.02 | % |
93.27
|
%
|
|||||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
0 | % |
0
|
%
|
|||||
Expected
life
|
8.1
years
|
7.65
years
|
8.1 years |
7.39
years
|
|||||||||
Estimated
forfeiture rate
|
12
|
%
|
11
|
%
|
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 and
nine months ended September 30, 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.
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 second
and
third quarters 2007 with the following weighted average
assumptions:
Assumptions
for Stock Awards
|
Three
and Nine Months Ended September 30, 2007
|
|||
Risk-free
interest rate
|
4.52
|
%
|
||
Volatility
|
74.64
|
%
|
||
Expected
dividend yield
|
0
|
%
|
||
Expected
Life
|
5.07
years
|
13
The
Company calculated expected volatility for restricted stock based on a mirror
approach, where the daily stock price of our common stock during the seven-year
period immediately after the grant will be the mirror of the historic daily
stock price of our common stock during the seven-year period immediately
preceding the grant.
Compensation
expense for the three months ended September 30, 2007 included $275,759 from
stock options grants and $103,623 from restricted stock awards. Compensation
expense for the three months ended September 30, 2006 included $252,740 from
stock options grants and $78,544 from restricted stock awards.
Compensation
expense for the nine months ended September 30, 2007 included $827,337 from
stock options grants and $276,384 from restricted stock awards. Compensation
expense for the nine months ended September 30, 2006 included $900,773 from
stock options grants and $235,632 from restricted stock awards.
Compensation
expense is presented as part of 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 $15,678 and
$93,429 was recognized during the three and nine months ended September 30,
2007, respectively. For stock options granted to consultants an additional
selling, general, and administrative expense in the amount of $18,269 and
$111,706 was recognized during the three and nine months ended September 30,
2006, respectively.
Supplemental
Cash Flow Information
During
the nine months ended September 30, 2007, the Company financed certain credit
facility costs for $36,840, financed insurance policies through notes payable
for $606,180 and issued warrants to a leasing credit facility which are valued
at $28,011, and which offset the carrying value of debt. In addition, the
Company financed vehicle purchases of $71,941 and laser purchases of $156,000
under capital leases.
During
the nine months ended September 30, 2006, the Company financed insurance
policies through notes payable for $763,982, financed certain credit facility
costs for $122,860, financed a license agreement with a note payable of $77,876
and issued warrants to a leasing credit facility which are valued at $82,503,
and which offset the carrying value of debt. During the nine months ended
September 30, 2006, the Company issued 101,010 shares of its restricted common
stock to Stern Laser srl (“Stern”) due upon achievement of another milestone
under the Master Purchase Agreement. The cost associated with this issuance
is
included in the license from Stern, which is found in patents and licensed
technologies. In March 2006, the Company also issued 200,000 shares of its
restricted common stock to AzurTec, Inc. (“AzurTec”) as part of an investment in
the capital stock of AzurTec as well as for a license agreement on AzurTec
technology, both existing and to be developed in the future.
For
the
nine months ended September 30, 2007 and 2006, the Company paid interest of
$700,383 and $475,610, respectively. Income taxes paid in the nine months ended
September 30, 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 the Company beginning with the first quarter of 2008. The Company
has not yet determined the impact of the adoption of SFAS No. 159 on its
financial statements and footnote disclosures.
14
Note
2
Inventories:
Set
forth
below is a detailed listing of inventories:
September
30, 2007
|
December
31, 2006
|
||||||
Raw
materials and work in progress
|
$
|
4,704,944
|
$
|
4,433,917
|
|||
Finished
goods
|
3,294,935
|
2,867,778
|
|||||
Total
inventories
|
$
|
7,999,879
|
$
|
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 September 30,
2007 and December 31, 2006, the Company carried specific reserves for excess
and
obsolete stocks against its inventories of $1,340,340 and $1,354,444,
respectively.
Note
3
Property
and Equipment:
Set
forth
below is a detailed listing of property and equipment:
September
30, 2007
|
December
31, 2006
|
||||||
Lasers
in service
|
$
|
18,934,855
|
$
|
16,234,834
|
|||
Computer
hardware and software
|
341,407
|
334,490
|
|||||
Furniture
and fixtures
|
347,843
|
331,379
|
|||||
Machinery
and equipment
|
849,237
|
738,636
|
|||||
Autos
and trucks
|
454,631
|
382,690
|
|||||
Leasehold
improvements
|
247,368
|
247,368
|
|||||
21,175,341
|
18,269,397
|
||||||
Accumulated
depreciation and amortization
|
(11,119,283
|
)
|
(9,215,299
|
)
|
|||
Property
and equipment, net
|
$
|
10,056,058
|
$
|
9,054,098
|
Depreciation
expense was $2,621,617 and $2,159,912 for the nine months ended September 30,
2007 and 2006, respectively. At September 30, 2007 and December 31, 2006, net
property and equipment included $532,486 and $380,875, respectively, of assets
recorded under capitalized lease arrangements, of which $285,624 and $122,717
was included in long-term debt at September 30, 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:
September
30, 2007
|
December
31, 2006
|
||||||
Patents,
owned and licensed, at gross costs of $510,942 and $501,657, net
of
accumulated amortization of $259,306 and $231,599,
respectively.
|
$
|
251,636
|
$
|
270,058
|
|||
Other
licensed or developed technologies, at gross costs of $2,432,258,
net of
accumulated amortization of $1,222,791 and $1,006,589,
respectively.
|
1,209,467
|
1,425,669
|
|||||
$
|
1,461,103
|
$
|
1,695,727
|
Related
amortization expense was $243,909 and $244,277 for the nine months ended
September 30, 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. 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.
15
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 appraised fair
market values:
September
30, 2007
|
December
31, 2006
|
||||||
Neutrogena
Agreement, at gross cost of $2,400,000 net of accumulated amortization
of
$1,218,000 and $858,000, respectively.
|
|
$
|
1,182,000
|
|
$
|
1,542,000
|
|
Customer
Relationships, at gross cost of $1,700,000 net of accumulated amortization
of $862,740 and $607,743, respectively.
|
|
|
837,260
|
|
|
1,092,257
|
|
Tradename,
at gross cost of $1,100,000 net of accumulated amortization of $279,135
and $196,632, respectively.
|
820,865
|
903,368
|
|||||
$
|
2,840,125
|
$
|
3,537,625
|
Related
amortization expense was $697,500 for the nine months ended September 30, 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:
September
30, 2007
|
December
31, 2006
|
||||||
Accrued
warranty
|
$
|
210,785
|
$
|
123,738
|
|||
Accrued
professional and consulting fees
|
183,425
|
320,331
|
|||||
Accrued
sales taxes and other accrued liabilities
|
222,747
|
213,224
|
|||||
Cash
deposits
|
120,000
|
-
|
|||||
Total
other accrued liabilities
|
$
|
736,957
|
$
|
657,293
|
16
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:
September
30, 2007
|
December
31, 2006
|
||||||
Note
Payable - secured creditor, interest at 6%, payable in monthly principal
and interest installments of $2,880 through June 2012
|
|
$
|
140,078
|
|
$
|
159,213
|
|
|
|
|
|
|
|
|
|
Note
Payable - unsecured creditor, non-interest bearing, payable in 18
equal
monthly installments of $4,326 through October 2007
|
|
|
4,326
|
|
|
43,265
|
|
|
|
|
|
|
|
|
|
Note
Payable - unsecured creditor, interest at 8.72%, payable in monthly
principal and interest installments of $12,120 through November
2007
|
|
|
23,978
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Note
Payable - unsecured creditor, interest at 5.44%, payable in monthly
principal and interest installments of $51,354 through February
2008
|
|
|
253,314
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Note
Payable - unsecured creditor, interest at 7.42%, payable in monthly
principal and interest installments of $61,493 through March
2007
|
-
|
126,279
|
|||||
421,696
|
328,757
|
||||||
Less:
current maturities
|
(308,505
|
)
|
(195,250
|
)
|
|||
Notes
payable, net of current maturities
|
$
|
113,191
|
$
|
133,507
|
Note
8
Long-term
Debt:
In
the
following table is a summary of the Company’s long-term debt.
September
30, 2007
|
December
31, 2006
|
||||||
Total
borrowings on credit facilities
|
$
|
6,830,217
|
$
|
6,490,077
|
|||
Capital
lease obligations (see Note 3)
|
285,624
|
122,717
|
|||||
Less:
current portion
|
(3,601,684
|
)
|
(3,018,874
|
)
|
|||
Total
long-term debt
|
$
|
3,514,157
|
$
|
3,593,920
|
Leasing
Credit Facility
The
long-term debt is comprised largely of borrowings under a leasing credit
facility that the Company entered into with GE Capital Corporation (“GE”) on
June 25, 2004. The credit facility expired on June 25, 2007. The Company
accounted for each draw as funded indebtedness taking the form of a capital
lease, with equitable ownership in the lasers remaining with the Company. GE
retains title as security for the borrowings. The Company depreciates the lasers
generally over their remaining useful lives, as established when originally
placed into service. Each draw against the credit facility has a self-amortizing
repayment period of three years and is secured by specified lasers, which the
Company has sold to GE and leased back for continued deployment in the field.
The Company does not plan on any future draws from GE; the Company will continue
to pay down the outstanding indebtedness to GE.
Draws
under the credit facility were set at an interest rate, which ranged from 577
basis points above the three-year Treasury note rate in the first year of the
term to 400 basis points above the three-year Treasury rate in the third year
of
the term. Each draw in the first year of the term was discounted 7.75%; draws
made by the second and third years were discounted 3.5%. The monthly payment
set
for a draw is self-amortizing.
17
The
following table summarizes the future minimum payments that the Company expects
to make for the 11 draws made under the credit facility:
Quarter
Ending
|
Year
Ending December 31,
|
||||||||||||
12/31/07
|
2008
|
2009
|
2010
|
||||||||||
Future
minimum payments
|
$
|
875,147
|
$
|
3,842,332
|
$
|
2,297,838
|
$
|
457,080
|
18
With
each
draw, the Company issued warrants to purchase shares of the Company’s common
stock which ranged from a high of 5% of the draw in the first year to 3% in
the
third year. The number of warrants was 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 that ranges from17.79% to 12.62%.
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.
In
the
quarter ending June 30, 2007, the Company entered into a term loan with LEAF
Financial Corporation (“LEAF” ) in the amount of $1,755,000. The effective
interest rate was 11.53%. LEAF will be granted a first-priority lien on XTRAC
lasers, and their associated cash flows from consignment agreements, which
are
pledged by the Company and which are free of, or have been released from,
security interests of GE. The Company will retain ownership of all of the lasers
pledged. The term loans are granted with self-amortizing payment terms of 3
years.
The
Company is currently evaluating multiple proposals for future financing for
XTRAC laser placements, one of which is a written commitment for $6 million.
The
Company has secured a separate source to finance the acquisition of surgical
lasers.
Capital
Leases
The
obligations under capital leases are at fixed interest rates and are
collateralized by the related property and equipment (see Note 3).
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. As of September 26, 2007, the stockholders approved an increase
in
the number of shares reserved for the 2005 Equity Compensation Plan and for
the
Outside Director Plan. Under the 2005 Equity Compensation Plan, a maximum of
6,160,000 shares of the Company’s common stock have been reserved for issuance.
At September 30, 2007, 2,995,250 shares were available for future grants under
this plan. Under the Outside Director Plan and under the 2005 Investment Plan,
905,000 shares and 388,000 shares, respectively, were available for issuance
as
of September 30, 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 nine months ended September 30, 2007 was as follows:
Number
of Options
|
Weighted
Average Exercise Price
|
||||||
Outstanding,
January 1, 2007
|
6,093,725
|
$
|
2.09
|
||||
Granted
|
758,000
|
1.13
|
|||||
Exercised
|
(76,153
|
)
|
1.13
|
||||
Cancelled
|
(401,386
|
)
|
1.90
|
||||
Outstanding,
September 30, 2007
|
6,374,186
|
$
|
2.00
|
||||
Options
excercisable at September 30, 2007
|
4,205,610
|
$
|
2.07
|
19
At
September 30, 2007, there was $3,763,525 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 2.63 years. The intrinsic value
of
options outstanding and exercisable at September 30, 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 and nine months ended September 30, 2007 and 2006, the Company
did not have material revenues from any individual customer.
Unallocated
operating expenses include costs that are not specific to a particular segment
but are general to the group; included are expenses 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 from the buy-out of Acculase that was carried
at
$2,944,423 at September 30, 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 buy-out in the amounts of $2,061,096 and $883,327, respectively.
Goodwill of $13,973,385 at September 30, 2007 from the ProCyte acquisition
has
been entirely allocated to the Skin Care segment.
20
The
following tables reflect results of operations from our business segments for
the periods indicated below:
Three
Months Ended September 30, 2007
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
2,025,148
|
$
|
819,442
|
$
|
3,065,905
|
$
|
1,899,200
|
$
|
1,112,176
|
$
|
8,921,871
|
|||||||
Costs
of revenues
|
1,009,237
|
538,292
|
903,688
|
1,545,437
|
686,135
|
4,682,789
|
|||||||||||||
Gross
profit
|
1,015,911
|
281,150
|
2,162,217
|
353,763
|
426,041
|
4,239,082
|
|||||||||||||
Gross
profit %
|
50.2
|
%
|
34.3
|
%
|
70.5
|
%
|
18.6
|
%
|
38.3
|
%
|
47.5
|
%
|
|||||||
Allocated
operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
1,496,326
|
40,809
|
1,323,172
|
170,374
|
144,548
|
3,175,229
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
103,696
|
-
|
98,467
|
202,163
|
|||||||||||||
Unallocated
operating expenses
|
-
|
-
|
-
|
-
|
-
|
2,373,100
|
|||||||||||||
1,496,326
|
40,809
|
1,426,868
|
170,374
|
243,015
|
5,750,492
|
||||||||||||||
Income
(loss) from operations
|
(480,415
|
)
|
240,341
|
735,349
|
183,389
|
183,026
|
(1,511,410
|
)
|
|||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(141,562
|
)
|
||||||||||||
Net
income (loss)
|
($480,415
|
)
|
$
|
240,341
|
$
|
735,349
|
$
|
183,389
|
$
|
183,026
|
($1,652,972
|
)
|
Three
Months Ended September 30, 2006
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
1,601,125
|
$
|
616,342
|
$
|
3,050,249
|
$
|
1,793,088
|
$
|
1,230,743
|
$
|
8,291,547
|
|||||||
Costs
of revenues
|
1,224,007
|
320,502
|
913,012
|
1,409,453
|
791,962
|
4,658,936
|
|||||||||||||
Gross
profit
|
377,118
|
295,840
|
2,137,237
|
383,635
|
438,781
|
3,632,611
|
|||||||||||||
Gross
profit %
|
23.6
|
%
|
48.0
|
%
|
70.1
|
%
|
21.4
|
%
|
35.7
|
%
|
43.8
|
%
|
|||||||
Allocated
operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
987,163
|
60,876
|
1,300,536
|
226,436
|
120,908
|
2,695,919
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
144,996
|
-
|
122,066
|
267,062
|
|||||||||||||
Unallocated
operating expenses
|
-
|
-
|
-
|
-
|
-
|
2,203,485
|
|||||||||||||
987,163
|
60,876
|
1,445,532
|
226,436
|
242,974
|
5,166,466
|
||||||||||||||
Income
(loss) from operations
|
(610,045
|
)
|
234,964
|
691,705
|
157,199
|
195,808
|
(1,533,855
|
)
|
|||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(159,180
|
)
|
||||||||||||
Net
income (loss)
|
($610,045
|
)
|
$
|
234,964
|
$
|
691,705
|
$
|
157,199
|
$
|
195,808
|
($1,693,035
|
)
|
21
Nine
Months Ended September 30, 2007
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
6,048,000
|
$
|
2,117,213
|
$
|
9,646,312
|
$
|
5,727,528
|
$
|
3,730,107
|
$
|
27,269,160
|
|||||||
Costs
of revenues
|
3,117,850
|
1,318,430
|
2,931,419
|
4,809,101
|
2,315,087
|
14,491,887
|
|||||||||||||
Gross
profit
|
2,930,150
|
798,783
|
6,714,893
|
918,427
|
1,415,020
|
12,777,273
|
|||||||||||||
Gross
profit %
|
48.4
|
%
|
37.7
|
%
|
69.6
|
%
|
16.0
|
%
|
37.9
|
%
|
46.9
|
%
|
|||||||
Allocated
operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
4,489,067
|
110,208
|
4,090,291
|
642,006
|
451,085
|
9,782,657
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
294,787
|
-
|
308,849
|
603,636
|
|||||||||||||
Unallocated
operating expenses
|
-
|
-
|
-
|
-
|
-
|
7,383,244
|
|||||||||||||
4,489,067
|
110,208
|
4,385,078
|
642,066
|
759,935
|
17,769,537
|
||||||||||||||
Income
(loss) from operations
|
(1,558,917
|
)
|
688,575
|
2,329,815
|
276,421
|
655,085
|
(4,992,264
|
)
|
|||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(379,947
|
)
|
||||||||||||
Net
income (loss)
|
($1,558,917
|
)
|
$
|
688,575
|
$
|
2,329,815
|
$
|
276,421
|
$
|
655,085
|
($5,372,211
|
)
|
Nine
Months Ended September 30, 2006
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
3,988,970
|
$
|
1,438,023
|
$
|
9,580,637
|
$
|
5,158,437
|
$
|
4,430,385
|
$
|
24,596,452
|
|||||||
Costs
of revenues
|
3,050,083
|
772,861
|
2,905,252
|
4,187,792
|
2,675,036
|
13,591,024
|
|||||||||||||
Gross
profit
|
938,887
|
665,162
|
6,675,385
|
970,645
|
1,755,349
|
11,005,428
|
|||||||||||||
Gross
profit %
|
23.5
|
%
|
46.3
|
%
|
69.7
|
%
|
18.8
|
%
|
39.6
|
%
|
44.7
|
%
|
|||||||
Allocated
operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
3,092,163
|
122,443
|
3,942,482
|
732,085
|
399,506
|
8,288,679
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
377,251
|
-
|
387,194
|
764,445
|
|||||||||||||
Unallocated
operating expenses
|
-
|
-
|
-
|
-
|
-
|
6,917,362
|
|||||||||||||
3,092,163
|
122,443
|
4,319,733
|
732,085
|
786,700
|
15,970,486
|
||||||||||||||
Income
(loss) from operations
|
(2,153,276
|
)
|
542,719
|
2,355,652
|
238,560
|
968,649
|
(4,965,058
|
)
|
|||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(418,170
|
)
|
||||||||||||
Net
income (loss)
|
($2,153,276
|
)
|
$
|
542,719
|
$
|
2,355,652
|
$
|
238,560
|
$
|
968,649
|
($5,383,228
|
)
|
22
September
30, 2007
|
December
31, 2006
|
||||||
Assets:
|
|||||||
Total
assets for reportable segments
|
$
|
45,501,441
|
$
|
43,955,628
|
|||
Other
unallocated assets
|
9,035,857
|
13,525,893
|
|||||
Consolidated
total
|
$
|
54,537,298
|
$
|
57,481,521
|
For
the
three and nine months ended September 30, 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
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Domestic
|
$
|
7,232,506
|
6,731,703
|
$
|
22,614,086
|
$
|
20,524,943
|
||||||
Foreign
|
1,689,365
|
1,559,844
|
4,655,074
|
4,071,509
|
|||||||||
$
|
8,921,871
|
$
|
8,291,547
|
$
|
27,269,160
|
$
|
24,596,452
|
The
Company discusses segmental details in its Management Discussion & Analysis
found elsewhere in its Form 10-Q for the period ending September 30,
2007.
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.
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 (i.e. until December 30, 2007) 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 protocol was originally 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. The
protocol has been revised to be an open-label study in order to facilitate
greater patient recruitment into the study. John Koo, MD, a member of our
Scientific Advisory Board, is guiding the study using our high-powered Ultra™
excimer laser.
23
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.
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 offer the XTRAC
laser
system to targeted dermatologists at no initial capital cost. Under this
contractual arrangement, we maintain ownership of the laser and earn revenue
each time a physician treats a patient with the equipment, and we believe this
arrangement will increase market penetration. At times, however, we sell the
laser directly to the customer for certain reasons, including the costs of
logistical support and customer preference. We
are
finding that through sales of lasers we are able to reach, at respectable
margins, a sector of the market that is better suited to a sale model than
a
per-procedure model.
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 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 during 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. The Blue
Cross Blue Shield Insurance plans have now adopted positive payment policies
in
Illinois, New Mexico, Oklahoma and Texas. The Company is now seeking adoption
of
this National Reference Policy by the remaining state Blue Cross Blue Shield
Health Insurance Plans which currently do not have a positive payment policy
for
the XTRAC.
24
Our
23-person XTRAC sales organization includes 13 sales representatives, 8 clinical
specialists and 2 marketing support personnel. Our 26-person skin care sales
organization includes 19 sales representatives, 5 customer service
representatives and 2 marketing support personnel. The sales representatives
of
each segment provide follow-up sales support and share sales leads to enhance
opportunities for cross-selling.
While
our
sales and marketing expenses have grown faster than the revenues on which the
expenses are targeted to have positive impact, we expect to increase our overall
revenue and productivity as a result of these expenditures in the long term.
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 in periods subsequent to the period in which we incurred the
expense. We have also increased the number of sales representatives and also
established a group 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.
International
Dermatology Equipment
In
the
international market, we derive revenues by selling our dermatology laser
systems to distributors and directly to physicians. In this market, we have
benefited from both our clinical studies and from the improved reliability
and
functionality of the XTRAC laser system. Compared
to the domestic segment, the sales of laser systems in the international segment
is influenced to a greater degree by competition from similar laser technologies
as well as non-laser lamp alternatives. Over time, this competition has reduced
the prices we are able to charge to international distributors for our XTRAC
products. In 2005, as a result of the acquisition of worldwide rights to certain
proprietary light-based technology from Stern, we also explored new product
offerings in the treatment of dermatological conditions. We have expanded the
international marketing of this product, called the VTRAC™, in 2006. The VTRAC
is a lamp-based UVB targeted therapy, positioned at a price point lower than
the
XTRAC laser system so that it will effectively compete with other
non-laser-based therapies for psoriasis and vitiligo.
Due
to
the significant financial investment requirements, we
did
not implement an international XTRAC and/or VTRAC fee-per-use revenue model,
similar to our domestic revenue model. However, as reimbursement in the domestic
market has become more widespread, we have 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. Looking
to the future, we shall seek growth from a stream of new dermatological
products, and support the new products with intellectual property where
appropriate and where feasible. 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.
25
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. We
are
continuing a cautious strategy in this segment 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, including OEM
arrangements.
Critical
Accounting Policies
There
have been no changes to our critical accounting policies in the three and nine
months ended September 30, 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.
26
Results
of Operations
Revenues
The
following table presents revenues from our five business segments for the
periods indicated below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
XTRAC
Domestic Services
|
$
|
2,025,148
|
$
|
1,601,125
|
$
|
6,048,000
|
$
|
3,988,970
|
|||||
International
Dermatology Equipment Products
|
819,442
|
616,342
|
2,117,213
|
1,438,023
|
|||||||||
Skin
Care (ProCyte) Products
|
3,065,905
|
3,050,249
|
9,646,312
|
9,580,637
|
|||||||||
Total
Dermatology Revenues
|
5,910,495
|
5,267,716
|
17,811,525
|
15,007,630
|
|||||||||
Surgical
Services
|
1,899,200
|
1,793,088
|
5,727,528
|
5,158,437
|
|||||||||
Surgical
Products
|
1,112,176
|
1,230,743
|
3,730,107
|
4,430,385
|
|||||||||
Total
Surgical Revenues
|
3,011,376
|
3,023,831
|
9,457,635
|
9,588,822
|
|||||||||
Total
Revenues
|
$
|
8,921,871
|
$
|
8,291,547
|
$
|
27,269,160
|
$
|
24,596,452
|
Domestic
XTRAC Segment
Recognized
treatment revenue for the three months ended September 30, 2007 and 2006 for
domestic XTRAC procedures was $1,716,383 and $1,263,000, respectively,
reflecting billed procedures of 27,858 and 20,043, respectively. In addition,
1,229 and 2,161 procedures were performed in the three months ended September
30, 2007 and 2006, respectively, without billing from us, in connection with
clinical research and customer evaluations of the XTRAC laser. Recognized
treatment revenue for the nine months ended September 30, 2007 and 2006 for
domestic XTRAC procedures was $4,711,075 and $3,650,845, respectively,
reflecting billed procedures of 80,651 and 60,168, respectively. In addition,
3,677 and 4,813 procedures were performed in the nine months ended September
30,
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 periods ended September 30, 2007 compared to the comparable
periods in 2006 was largely related to our continuing progress in securing
favorable reimbursement policies from private insurance plans. Increases in
procedures are dependent upon 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.
We
have 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 September 30, 2007,
we
deferred net revenues of $19,494 under this program compared to $54,211of
additional recognized revenues for the three months ended September 30, 2006.
For the nine months ended September 30, 2007, we deferred net revenues of
$173,369 under this program compared to $102,257 for the nine months ended
September 30, 2006. The change in deferred revenue under this program is
presented in the table below.
For
the
three and nine months ended September 30, 2007, domestic XTRAC laser sales
were
$308,765 and $1,336,925, respectively. There were 5 and 28 lasers sold,
respectively. For the three and nine months ended September 30, 2006 domestic
XTRAC laser sales were $338,125. We began selling lasers in the quarter ended
September 30, 2006, and 8 lasers were sold. Overall, laser sales have been
made
for various reasons, including costs of logistical support and customer
preferences. We
are
finding that through sales of lasers we are able to reach, at respectable
margins, a sector of the market that is better suited to a sale model than
a
per-procedure model.
27
The
following table sets forth the above analysis for the Domestic XTRAC segment
for
the periods reflected below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Total
revenue
|
$
|
2,025,148
|
$
|
1,601,125
|
$
|
6,048,000
|
$
|
3,988,970
|
|||||
Less:
laser sales revenue
|
(308,765
|
)
|
(338,125
|
)
|
(1,336,925
|
)
|
(338,125
|
)
|
|||||
Recognized
treatment revenue
|
1,716,383
|
1,263,000
|
4,711,075
|
3,650,845
|
|||||||||
Change
in deferred program
Revenue
|
19,494
|
(54,211
|
)
|
173,369
|
102,257
|
||||||||
Change
in deferred unused
Treatments
|
71,893
|
114,410
|
392,635
|
200,683
|
|||||||||
Net
billed revenue
|
$
|
1,807,770
|
$
|
1,323,199
|
$
|
5,277,079
|
$
|
3,953,785
|
|||||
Procedure
volume total
|
29,087
|
22,204
|
84,328
|
64,981
|
|||||||||
Less:
Non-billed procedures
|
1,229
|
2,161
|
3,677
|
4,813
|
|||||||||
Net
billed procedures
|
27,858
|
20,043
|
80,651
|
60,168
|
|||||||||
Avg.
price of treatments billed
|
$
|
64.89
|
$
|
66.02
|
$
|
65.43
|
$
|
65.71
|
|||||
Change
in procedures with deferred/(recognized) program revenue,
net
|
300
|
(821
|
)
|
2,650
|
1,556
|
||||||||
Change
in procedures with deferred unused treatments, net
|
1,108
|
1,733
|
6,001
|
3,054
|
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 treatment of
psoriasis by laser, 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 $819,442 for the
three
months ended September 30, 2007 compared to $616,342 for the three months ended
September 30, 2006. We sold 15 and 13 pieces of dermatology equipment (i.e.
lasers and lamps) in the three months ended September 30, 2007 and 2006,
respectively. International sales of our dermatology equipment and related
parts
were $2,117,213 for the nine months ended September 30, 2007 compared to
$1,438,023 for the nine months ended September 30, 2006. We sold 40 and 31
laser
and lamp systems in the nine months ended September 30, 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
began selling refurbished domestic XTRAC laser systems into the
international market. The selling price for used equipment is
substantially less than new equipment. We sold one and four such
used
lasers in the three and nine months ended September 30, 2007,
respectively, and one and six such lasers in the three and nine months
ended September 30, 2006, respectively;
and
|
28
·
|
We
began selling the new VTRAC, a lamp-based, alternative UVB light
source
that has a wholesale sales price that is substantially below our
competitors’ international dermatology equipment. In the three and nine
months ended September 30, 2007, we sold one and ten VTRAC systems,
respectively. In the three and nine months ended September 30, 2006,
we
sold six and ten VTRAC systems,
respectively.
|
The
following table illustrates the key changes in the International Dermatology
Equipment segment for the periods reflected below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Revenues
|
$
|
819,442
|
$
|
616,342
|
$
|
2,117,213
|
$
|
1,438,023
|
|||||
Less:
part sales
|
(112,152
|
)
|
(82,542
|
)
|
(381,223
|
)
|
(232,463
|
)
|
|||||
Laser
revenues
|
707,290
|
533,800
|
1,735,990
|
1,205,560
|
|||||||||
Laser
systems sold
|
15
|
13
|
40
|
31
|
|||||||||
Average
revenue per laser
|
$
|
47,153
|
$
|
41,062
|
$
|
43,400
|
$
|
38,889
|
Skin
Care (ProCyte) Segment
For
the
three months ended September 30, 2007, ProCyte revenues were $3,065,905 compared
to $3,050,249 in the three months ended September 30, 2006. For the nine months
ended September 30, 2007, ProCyte revenues were $9,646,312 compared to
$9,580,637 in the nine months ended September 30, 2006. ProCyte revenues are
generated from the sale of various skin, hair care and wound products, from
the
sale of copper peptide compound and from royalties on licenses, mainly from
Neutrogena.
Bulk
compound sales decreased by $160,400 for the nine months ended September 30,
2007 compared to the nine months ended September 30, 2006. These sales are
mainly from Neutrogena and will affect future royalties earned from Neutrogena.
Minimum contractual royalties from Neutrogena are scheduled to expire in
November 2007.
The
following table illustrates the key changes in the Skin Care (ProCyte) segment
for the periods reflected below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Product
sales
|
$
|
2,894,905
|
$
|
2,901,891
|
$
|
9,085,312
|
$
|
8,818,267
|
|||||
Bulk
compound sales
|
96,000
|
112,400
|
336,000
|
496,400
|
|||||||||
Royalties
|
75,000
|
35,958
|
225,000
|
265,970
|
|||||||||
Total
ProCyte revenues
|
$
|
3,065,905
|
$
|
3,050,249
|
$
|
9,646,312
|
$
|
9,580,637
|
We
engaged a new senior officer to direct the operations of our Skin Care segment.
The new officer has devised plans to increase existing product sales and to
introduce new products of our own (e.g. Neova® Skin Brightening Serum) and
third-party products we have licensed (e.g. MD Lash Factor™ conditioner). Sale
of MD Lash Factor conditioner in the quarter ended September 30, 2007 were
$255,108.
Surgical
Services Segment
In
the
three months ended September 30, 2007 and 2006, surgical services revenues
were
$1,899,200 and $1,793,088, respectively. In the nine months ended September
30,
2007 and 2006, surgical services revenues were $5,727,528 and $5,158,437,
respectively. These increases were primarily due to an increase in revenue
from
urology procedures delivered using a laser system purchased from a third party
manufacturer. Such procedures included a charge to the customer for the use
of
the laser and the technician to operate it, as well as a charge to the customer
for the third party’s proprietary fiber delivery system.
29
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 September 30, 2007, surgical products revenues were
$1,112,176 compared to $1,230,743 in the three months ended September 30, 2006.
The decrease was largely due to a lower average selling price for the 19 lasers
sold in the three months ended September 30, 2007. For the nine months ended
September 30, 2007, surgical products revenues were $3,730,107 compared to
$4,430,385 in the nine months ended September 30, 2006. The decrease was partly
due to $278,800 less laser system revenues, as a result of a decrease in the
number of systems sold (55 vs. 61) and a decrease in the average price per
laser.
The
decrease in average price per laser between the periods was largely due to
the
mix of lasers sold and partly due to the trade level at which the lasers were
sold (i.e. wholesale versus retail). Our diode laser, which has a lower sales
price than our other types of lasers, has largely replaced our Nd:YAG laser,
which had a higher sales price. Included in laser sales during the three and
nine months ended September 30, 2007 were sales of 19 and 47 diode lasers.
There
were sales of 14 and 50 diode lasers, during the three and nine months ended
September 30, 2006. We expect that we will continue to sell more diode lasers
than our other types of lasers in the near future, including under OEM
(“Original Equipment Manufacturer) arrangements.
Fiber
and
other disposables sales decreased 11% and 15% between the comparable three-month
and nine-month periods ended September 30, 2007 and 2006. This is due to the
fact that in the nine months ended September 30, 2006 we had a one-time order
of
approximately $250,000. 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 holmium, 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
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Revenues
|
$
|
1,112,176
|
$
|
1,230,743
|
$
|
3,730,107
|
$
|
4,430,385
|
|||||
Laser
systems sold
|
19
|
16
|
55
|
61
|
|||||||||
Laser
system revenues
|
$
|
285,995
|
$
|
305,625
|
$
|
1,120,035
|
$
|
1,397,965
|
|||||
Average
revenue per laser
|
$
|
15,052
|
$
|
19,102
|
$
|
20,364
|
$
|
22,917
|
Cost
of Revenues
Our
costs
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). Product costs also include XTRAC domestic laser sales. Within
services cost of revenues are the costs associated with the Domestic XTRAC
segment, excluding the laser sales, and the Surgical Services segment, as well
as costs associated with royalties and maintenance.
30
Product
cost of revenues for the three months ended September 30, 2007 was $2,154,566,
which was relatively level with the $2,097,500 of product cost of revenues
for
the three months ended September 30, 2006.
Product
cost of revenues for the nine months ended September 30, 2007 was $6,703,250
compared to $6,374,344 for the nine months ended September 30, 2006. The
increase of $328,906 is proportionate to the increase in revenues between the
periods with slight differences being accounted for by a change in the mix
of
products sold.
Services
cost of revenues was $2,528,222 in the three months ended September 30, 2007
compared to $2,561,436 in the comparable period in 2006 representing a decrease
of $33,214. These costs did not increase proportionate to the increase in
service revenues largely due to the improved manufacturing efficiencies in
our
XTRAC plant.
Services
cost of revenues was $7,788,637 in the nine months ended September 30, 2007
compared to $7,216,680 in the comparable period in 2006. The increase of
$571,957 is proportionate to the increase in revenues between the periods with
slight differences being accounted for by a change in the mix of products sold.
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.
The
following table illustrates the key changes in cost of revenues for the periods
reflected below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Product:
|
|||||||||||||
XTRAC
Domestic
|
$
|
53,295
|
$
|
96,333
|
$
|
219,550
|
$
|
96,333
|
|||||
International
Dermatology
Equipment
|
538,292
|
320,502
|
1,318,430
|
772,861
|
|||||||||
Skin
Care
|
903,688
|
913,012
|
2,931,419
|
2,905,252
|
|||||||||
Surgical
products
|
659,291
|
767,653
|
2,233,851
|
2,599,898
|
|||||||||
Total
Product costs
|
$
|
2,154,566
|
$
|
2,097,500
|
$
|
6,703,250
|
$
|
6,374,344
|
|||||
Services:
|
|||||||||||||
XTRAC
Domestic
|
$
|
955,942
|
$
|
1,127,674
|
$
|
2,898,300
|
$
|
2,953,750
|
|||||
Surgical
Services
|
1,572,280
|
1,433,762
|
4,890,337
|
4,262,930
|
|||||||||
Total
Services costs
|
$
|
2,528,222
|
$
|
2,,561,436
|
$
|
7,788,637
|
$
|
7,216,680
|
|||||
Total
Costs of Revenues
|
$
|
4,682,788
|
$
|
4,658,936
|
$
|
14,491,887
|
$
|
13,591,024
|
Gross
Profit Analysis
Gross
profit increased to $4,239,083 during the three months ended September 30,
2007
from $3,632,611 during the same period in 2006. As a percent of revenues, gross
margin increased to 47.5% for the three months ended September 30, 2007 from
43.8% for the same period in 2006.
Gross
profit increased to $12,777,273 during the nine months ended September 30,
2007
from $11,005,428 during the same period in 2006. As a percent of revenues,
gross
margin increased to 46.9% for the nine months ended June 30, 2007 from 44.7%
for
the same period in 2006.
31
The
following table analyzes changes in our gross profit for the periods reflected
below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
Company
Profit Analysis
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Revenues
|
$
|
8,921,871
|
$
|
8,291,547
|
$
|
27,269,160
|
$
|
24,596,452
|
|||||
Percent
increase
|
7.6
|
%
|
10.9
|
%
|
|||||||||
Cost
of revenues
|
4,682,788
|
4,658,936
|
14,491,887
|
13,591,024
|
|||||||||
Percent
increase
|
0.5
|
%
|
6.6
|
%
|
|||||||||
Gross
profit
|
$
|
4,239,083
|
$
|
3,632,611
|
$
|
12,777,273
|
$
|
11,005,428
|
|||||
Gross
margin percentage
|
47.5
|
%
|
43.8
|
%
|
46.9
|
%
|
44.7
|
%
|
The
primary reasons for the increase in gross profit for the three months ended
September 30, 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.
|
·
|
The
margin on XTRAC lasers sold domestically were higher in the three
months
ended September 30, 2007 (83%) than in the three months ended September
30, 2006 (72%).
|
The
primary reasons for the increase in gross profit for the nine months ended
September 30, 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. Since each incremental treatment procedure
carries
negligible variable cost, this significantly enhanced profit margins.
The
increase in procedure volume was a direct result of improving insurance
reimbursement and increased marketing efforts.
|
·
|
We
sold approximately $1 million more lasers domestically in the nine
months
ended September 30, 2007 at high margins compared to the same period
in
2006. Certain of these lasers were previously being
depreciated.
|
The
following table analyzes the gross profit for our Domestic XTRAC segment for
the
periods presented below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
XTRAC
Domestic Segment
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Revenues
|
$
|
2,025,148
|
$
|
1,60,1125
|
$
|
6,048,000
|
$
|
3,988,970
|
|||||
Percent
increase
|
26.5
|
%
|
51.6
|
%
|
|||||||||
Cost
of revenues
|
1,009,237
|
1,224,007
|
3,117,850
|
3,050,083
|
|||||||||
Percent
(decrease)/increase
|
(17.5
|
%)
|
2.2
|
%
|
|||||||||
Gross
profit
|
$
|
1,015,911
|
$
|
377,118
|
$
|
2,930,150
|
$
|
938,887
|
|||||
Gross
margin percentage
|
50.2
|
%
|
23.6
|
%
|
48.4
|
%
|
23.5
|
%
|
Gross
profit increased for this segment for the three and nine months ended September
30, 2007 from the comparable periods in 2006 by $638,793 and $1,991,263. The
key
factors for the increases were as follows:
·
|
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.
|
32
·
|
Procedure
volume increased 39% from 20,043 to 27,858 billed procedures in the
three
months ended September 30, 2007 compared to the same period in 2006.
Price
per procedure did not change significantly between the periods. Procedure
volume increased 34% from 60,168 to 80,651 billed procedures in the
nine
months ended September 30, 2007 compared to the same period in 2006.
Price
per procedure did not change significantly between the periods. Each
incremental treatment procedure carries negligible variable
cost.
|
·
|
The
margin on XTRAC lasers sold domestically were higher in the three
months
ended September 30, 2007 (83%) than in the three months ended September
30, 2006 (72%). We sold approximately $1 million more lasers domestically
in the nine months ended September 30, 2007 at high margins compared
to
the same period in 2006. Certain of these lasers were previously
being
depreciated.
|
·
|
The
cost of revenues decreased by $214,770 for the three months ended
September 30, 2007. This decrease is due to the absorption of additional
allocable XTRAC manufacturing overhead costs due to the increased
production. In addition, there was a decrease in the cost of sales
for the
lasers sold domestically of $43,038. The cost of revenues increased
by
$67,767 for the nine months ended September 30, 2007, mainly due
to an
increase in the cost of sales for the lasers sold domestically of
$123,217.
|
33
The
following table analyzes the gross profit for our International Dermatology
Equipment segment for the periods presented below:
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
International
Dermatology
Equipment
Segment
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Revenues
|
$
|
819,442
|
$
|
616,342
|
$
|
2,117,213
|
$
|
1,438,023
|
|||||
Percent
increase
|
33.0
|
%
|
47.2
|
%
|
|||||||||
Cost
of revenues
|
538,292
|
320,502
|
1,318,430
|
772,861
|
|||||||||
Percent
increase
|
68.0
|
%
|
70.6
|
%
|
|||||||||
Gross
profit
|
$
|
281,150
|
$
|
295,840
|
$
|
798,783
|
$
|
665,162
|
|||||
Gross
margin percentage
|
34.3
|
%
|
48.0
|
%
|
37.7
|
%
|
46.3
|
%
|
Gross
profit for the three months ended September 30, 2007 decreased by $14,690 from
the comparable period in 2006. The key factors for the decrease were as
follows:
·
|
We
sold fourteen XTRAC laser systems and one VTRAC lamp-based excimer
system
during the three months ended September 30, 2007 and seven XTRAC
laser
systems and six VTRAC systems in the comparable period in 2006. A
new
VTRAC system has a lower price point but a higher gross margin percentage
than a new XTRAC Ultra system.
|
·
|
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 generally to reduce the prices we charge international
distributors for our excimer products.
|
Gross
profit for the nine months ended September 30, 2007 increased by $133,621 from
the comparable periods in 2006. The key factors for the increase were as
follows:
·
|
We
sold thirty XTRAC laser systems and ten VTRAC lamp-based excimer
systems
during the nine months ended September 30, 2007 and twenty-one XTRAC
laser
systems and ten VTRAC systems in the comparable period in 2006.
|
·
|
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 generally to reduce the prices we charge international
distributors for our excimer products.
|
·
|
There
were more new XTRAC lasers sold in the nine months ended September
30,
2007 compared to the nine months ended September 30, 2006 and the
average
selling price was approximately 5%
higher.
|
34
The
following table analyzes the gross profit for our SkinCare (ProCyte) segment
for
the periods presented below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
Skin
Care (ProCyte) Segment
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Product
revenues
|
$
|
2,894,905
|
$
|
2,901,891
|
$
|
9,085,312
|
$
|
8,818,267
|
|||||
Bulk
compound revenues
|
96,000
|
112,400
|
336,000
|
496,400
|
|||||||||
Royalties
|
75,000
|
35,958
|
225,000
|
265,970
|
|||||||||
Total
revenues
|
3,065,905
|
3,050,249
|
9,646,312
|
9,580,637
|
|||||||||
Product
cost of revenues
|
835,336
|
843,253
|
2,699,497
|
2,597,174
|
|||||||||
Bulk
compound cost of revenues
|
68,352
|
69,759
|
231,922
|
308,078
|
|||||||||
Total
cost of revenues
|
903,688
|
913,012
|
2,931,419
|
2,905,252
|
|||||||||
Gross
profit
|
$
|
2,162,217
|
$
|
2,137,237
|
$
|
6,714,893
|
$
|
6,675,385
|
|||||
Gross
margin percentage
|
70.5
|
%
|
70.1
|
%
|
69.6
|
%
|
69.5
|
%
|
Gross
profit for the three and nine months ended September 30, 2007 was relatively
level with the comparable periods in 2006.
The
following table analyzes the gross profit for our Surgical Services segment
for
the periods presented below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
Surgical
Services Segment
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Revenues
|
$
|
1,899,200
|
$
|
1,793,088
|
$
|
5,727,528
|
$
|
5,158,437
|
|||||
Percent
increase
|
5.9
|
%
|
11.0
|
%
|
|||||||||
Cost
of revenues
|
1,545,437
|
1,409,453
|
4,809,101
|
4,187,792
|
|||||||||
Percent
increase
|
9.6
|
%
|
14.8
|
%
|
|||||||||
Gross
profit
|
$
|
353,763
|
$
|
383,635
|
$
|
918,427
|
$
|
970,645
|
|||||
Gross
margin percentage
|
18.6
|
%
|
21.4
|
%
|
16.0
|
%
|
18.8
|
%
|
Gross
profit in the Surgical Services segment for the three and nine months ended
September 30, 2007 decreased by $29,872 and $52,218, respectively, from the
comparable periods in 2006. The key factor impacting gross margin for the
Surgical Services business was:
· |
For
the three months ended September 30, 2007 compared to the three
months
ended September 30, 2006, the Company incurred incremental costs
in
technicians of $43,000, outside contractors of $24,000 and incremental
depreciation of $59,000.
|
· |
For
the nine months ended September 30, 2007 compared to the nine months
ended
September 30, 2006, the Company incurred incremental costs in technicians
of $69,000, repairs of $62,000, outside contractors of $92,000
and
incremental depreciation of
$168,000.
|
35
The
following table analyzes the gross profit for our Surgical Products segment
for
the periods presented below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
Surgical
Products Segment
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Revenues
|
$
|
1,112,176
|
$
|
1,230,743
|
$
|
3,730,107
|
$
|
4,430,385
|
|||||
Percent
decrease
|
(9.6
|
%)
|
(15.8
|
%)
|
|||||||||
Cost
of revenues
|
686,135
|
791,962
|
2,315,087
|
2,675,036
|
|||||||||
Percent
decrease
|
(13.4
|
%)
|
(13.5
|
%)
|
|||||||||
Gross
profit
|
$
|
426,041
|
$
|
438,781
|
$
|
1,415,020
|
$
|
1,755,349
|
|||||
Gross
margin percentage
|
38.3
|
%
|
35.7
|
%
|
37.9
|
%
|
39.6
|
%
|
Gross
profit for the Surgical Products segment in the three and nine months ended
September 30, 2007 compared to the same periods in 2006 decreased by $12,740
and
$340,329. 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.
|
·
|
Revenues
for the three months ended September 30, 2007 decreased by $118,567
from
the three months ended September 30, 2006 while cost of revenues
decreased
by $105,827 between the same periods. There were three more laser
systems
sold in the three months ended September 30, 2007 than in the comparable
period of 2006, although, the lasers sold in the 2007 period were
at lower
prices than in the comparable period in 2006. The decrease in average
price per laser was largely due to the mix of lasers
sold.
|
·
|
Revenues
for the nine months ended September 30, 2007 decreased by $700,278
from
the nine months ended September 30, 2006 while cost of revenues decreased
by $359,949 between the same periods. There were six less laser systems
sold in the nine months ended September 30, 2007 than in the comparable
period of 2006. Additionally, the lasers sold in the 2007 period
were at
lower prices than in the comparable period in 2006. The decrease
in
average price per laser was largely due to the mix of lasers sold.
|
·
|
Additionally
there was a decrease in sales of disposables between the periods.
Disposables, which have a higher gross margin as a percent of revenues
than lasers. Fiber and other disposables sales decreased 11% and
15%
between the comparable three-month and nine-month periods ended September
30, 2007 and 2006. This is due to in part to having a one-time order
of
approximately $250,000 in the nine months ended September 30,
2006.
|
Selling,
General and Administrative Expenses
For
the
three months ended September 30, 2007, selling, general and administrative
expenses increased $648,925 to $5,548,329 from the three months ended September
30, 2006. The increase was caused by higher sales costs due to increased
staffing and related travel of $355,000, and increases in marketing/advertising
expense of $125,000, legal expense of $122,000 and stock-based compensation
expense of $46,000.
For
the
nine months ended September 30, 2007, selling, general and administrative
expenses increased $1,959,860 to $17,165,901 from the nine months ended
September 30, 2006. The increase was caused by higher sales costs due to
increased staffing and related travel of $1,327,000, and increases in consulting
expenses of $100,000 and legal of $430,000.
36
Engineering
and Product Development
Engineering
and product development expenses for the three months ended September 30, 2007
decreased to $202,163 from $267,062 for the three months ended September 30,
2006. Engineering and product development expenses for the nine months ended
September 30, 2007 decreased to $603,636 from $764,445 for the nine months
ended
September 30, 2006. The decreases were due to changes in staffing levels. During
the 2007 and 2006 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.
Interest
Expense, Net
Net
interest expense for the three months ended September 30, 2007 decreased to
$141,562, as compared to $159,180 for the three months ended September 30,
2006.
Net interest expense for the nine months ended September 30, 2007 decreased
to
$379,947, as compared to $418,170 for the nine months ended September 30, 2006.
The change 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 third and fourth quarters of 2006 and the first and
second quarters of 2007.
Net
Loss
The
aforementioned factors resulted in a net loss of $1,652,972 during the three
months ended September 30, 2007, as compared to a net loss of $1,693,035 during
the three months ended September 30, 2006, a decrease of 2.4%. The
aforementioned factors resulted in a net loss of $5,372,211 during the nine
months ended September 30, 2007, as compared to a net loss of $5,383,228 during
the nine months ended September 30, 2006, a decrease of .2%.
The
following table illustrates the impact of major expenses, namely depreciation,
amortization and stock option expense between the periods:
For
the three months ended September 30,
|
||||||||||
2007
|
2006
|
Change
|
||||||||
Net
loss
|
$
|
1,652,972
|
$
|
1,693,035
|
($40,063
|
)
|
||||
Major
expenses included in net loss:
|
||||||||||
Depreciation
and amortization
|
1,231,111
|
1,047,178
|
183,933
|
|||||||
Stock-based
compensation
|
395,058
|
349,553
|
45,505
|
|||||||
Total
major expenses
|
$
|
1,626,169
|
$
|
1,396,731
|
$
|
229,438
|
For
the nine months ended September 30,
|
||||||||||
2007
|
2006
|
Change
|
||||||||
Net
Loss
|
$
|
5,372,211
|
$
|
5,383,228
|
($11,017
|
)
|
||||
Major
Expenses:
|
||||||||||
Depreciation
and amortization
|
3,563,026
|
3,101,689
|
461,337
|
|||||||
Stock-based
compensation
|
1,197,150
|
1,248,111
|
(50,961
|
)
|
||||||
$
|
4,760,176
|
$
|
4,349,800
|
$
|
410,376
|
37
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
September 30, 2007, our current ratio was 2.10 compared to 2.66 at December
31,
2006. As of September 30, 2007, we had $11,898,523 of working capital compared
to $16,069,616 as of December 31, 2006. Cash and cash equivalents were
$8,276,473 as of September 30, 2007, as compared to $12,885,742 as of December
31, 2006. We had $117,000 of cash that was classified as restricted as of
September 30, 2007 compared to $156,000 as of December 31, 2006.
As
of
September 30, 2007, we had an accumulated deficit of $93,047,214, and cash
and
cash equivalents were $8,276,473, including restricted cash of $117,000,
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 but not yet consistently, 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 third quarter of 2008.
On
June
25, 2004, we entered into a leasing credit facility from GE Capital Corporation
(“GE”). The credit facility expired on June 25, 2007. We accounted 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. We continue to make the monthly payments scheduled
for
each outstanding draw. A summary of the activity under the GE leasing credit
facility is presented in Note 8, “Long-term
Debt”.
We do
not plan on any future draws from GE.
In
the
quarter ending June 30, 2007, we entered into a term loan from LEAF in the
amount of $1,755,000. The effective interest rate was 11.53%. LEAF has a first
priority lien on XTRAC lasers, and the associated cash flows from consignment
agreements which are pledged by us. The term loans are granted with
self-amortizing payment terms of 3 years.
We
are
currently evaluating multiple proposals for future financing for XTRAC laser
placements, one of which is a written commitment for $6 million.
Net
cash
used by operating activities was $843,852 for nine months ended September 30,
2007, compared to cash provided by $817,998 for the same period in 2006. The
change was primarily due to an increase in inventory, an increase in accounts
receivable and a decrease in accrued compensation expense.
Net
cash
used in investing activities was $3,525,572 for the nine months ended September
30, 2007 compared to cash used of $3,546,179 for the nine months ended September
30, 2006. This was primarily for the placement of lasers into
service.
Net
cash
used by financing activities was $201,005 for the nine months ended September
30, 2007 compared to cash provided of $1,606,602 for the nine months ended
September 30, 2006. In the nine months ended September 30, 2007 we made payments
of $566,917 on certain notes payable and capital lease. These payments were
offset, in part, by the advances under the lease line of credit, net of
payments, of $236,758.
Commitments
and Contingencies
Except
for items discussed in Legal
Proceedings
below,
during the three and nine months ended September 30, 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.
38
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 effective such that 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.
Change
in Internal Control Over Financial Reporting
No
change
in our internal control over financial reporting occurred during the three
and
nine months ended September 30, 2007 that has materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
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, a new trial
judge
has been assigned to the case. The new judge heard oral argument on defendants’
motion for summary judgment, and on October 29, 2007, granted the motion. We
are
reviewing the judge’s opinion and evaluating our next course of action
based on business and legal factors.
In
the
matter brought by RA Medical and Mr. Irwin against us and removed to the United
States District Court for the Southern District of California, the same new
trial judge in the forgoing action was assigned to this case as well. The new
judge heard oral argument on plaintiffs’ motion to dismiss various counterclaims
brought by us, and on October 29, 2007, granted the motion without prejudice.
Plaintiffs’ claim against us of unfair competition and our counterclaim of
contractual interference against the plaintiffs were not affected by the grant
of the motion. We are reviewing the judge’s opinion and evaluating our next
course of action
based on business and legal factors.
In
the
matter we have brought against our insurance carrier in the United States
District Court for the Eastern District of Pennsylvania for declaratory judgment
and breach of contract, we are awaiting the decision of the trial judge in
the
parties’ cross-motions for summary judgment. Discovery in the case has been
stayed pending the judge’s rulings.
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.
39
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
10.39
|
Restricted
Stock Agreement, dated August 13, 2007, between PhotoMedex, Inc.
and
Michael R. Stewart
|
|
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
|
40
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: November 9, 2007 | By: | /s/ Jeffrey F. O’Donnell |
Jeffrey
F. O’Donnell
President
and Chief Executive Officer
|
Date: November 9, 2007 | By: | /s/ Dennis M. McGrath |
Dennis
M. McGrath
Chief
Financial Officer
|
41