Gadsden Properties, Inc. - Quarter Report: 2008 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10 - Q
ý QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2008
OR
¨ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For
the transition period from _________ to ___________
Commission
File Number 0-11365
PHOTOMEDEX,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
(State
or other jurisdiction
of
incorporation or organization)
|
59-2058100
(I.R.S.
Employer
Identification
No.)
|
147
Keystone Drive, Montgomeryville, Pennsylvania 18936
(Address
of principal executive offices, including zip code)
(215)
619-3600
(Registrant's
telephone number, including area code)
Indicate
by check mark whether the registrant: (i) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (ii) has been subject to such filing requirements
for
the past 90 days.
Yes
ý
No
¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
definitions of " large accelerated filer," “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer o | Accelerated filer o | |
Non-accelerated filer o | Smaller reporting company ý |
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act.)
Yes
¨
No
ý
The
number of shares outstanding of the issuer's Common Stock as of November 7,
2008
was 63,032,207 shares.
1
PHOTOMEDEX,
INC.
INDEX
TO
FORM 10-Q
Part
I. Financial Information:
|
PAGE
|
||
ITEM
1.
|
Financial
Statements:
|
||
a.
|
Consolidated
Balance Sheets, September 30, 2008 (unaudited) and
|
||
|
December
31, 2007
|
3
|
|
b.
|
Consolidated
Statements of Operations for the three months
|
||
|
ended
September 30, 2008 and 2007 (unaudited)
|
4
|
|
c.
|
Consolidated
Statements of Operations for the nine months
|
||
|
ended
September 30, 2008 and 2007 (unaudited)
|
5
|
|
c.
|
Consolidated
Statement of Stockholders’ Equity for the nine months
|
||
|
ended
September 30, 2008 (unaudited)
|
6
|
|
d.
|
Consolidated
Statements of Cash Flows for the nine months
|
||
|
ended
September 30, 2008 and 2007 (unaudited)
|
7
|
|
e.
|
Notes
to Consolidated Financial Statements (unaudited)
|
8
|
|
ITEM
2.
|
Management’s
Discussion and Analysis of Financial Condition
|
||
and
Results of Operations
|
25
|
||
ITEM
3.
|
Quantitative
and Qualitative Disclosure about Market Risk
|
40
|
|
ITEM
4.
|
Controls
and Procedures
|
41
|
|
Part
II. Other Information:
|
|||
ITEM
1.
|
Legal
Proceedings
|
41
|
|
ITEM
1A.
|
Risk Factors |
42
|
|
ITEM
5.
|
Other
Information
|
42
|
|
ITEM
6.
|
Exhibits
|
42
|
|
Signatures
|
43
|
||
Certifications
|
44
|
2
PART
I - Financial Information
ITEM
1. Financial Statements
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
September
30, 2008
|
December
31, 2007
|
||||||
(Unaudited)
|
*
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
6,730,793
|
$
|
9,837,303
|
|||
Restricted
cash
|
78,000
|
117,000
|
|||||
Accounts
receivable, net of allowance for doubtful accounts of $521,000 and
$526,000, respectively
|
6,721,994
|
5,797,620
|
|||||
Inventories,
net
|
7,185,888
|
6,980,180
|
|||||
Prepaid
expenses and other current assets
|
589,389
|
508,384
|
|||||
Current
assets held for sale
|
-
|
1,910,802
|
|||||
Total
current assets
|
21,306,064
|
25,151,289
|
|||||
Property
and equipment, net
|
9,893,399
|
8,024,461
|
|||||
Patents
and licensed technologies, net
|
1,307,756
|
1,408,248
|
|||||
Goodwill,
net
|
16,917,808
|
16,917,808
|
|||||
Other
intangible assets, net
|
1,910,125
|
2,607,625
|
|||||
Deferred
costs on proposed acquisition
|
1,762,501
|
-
|
|||||
Other
assets
|
431,709
|
448,046
|
|||||
Assets
held for sale
|
-
|
2,129,226
|
|||||
Total
assets
|
$
|
53,529,362
|
$
|
56,686,703
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Current
portion of notes payable
|
$
|
260,518
|
$
|
129,305
|
|||
Current
portion of long-term debt
|
4,997,958
|
4,757,133
|
|||||
Accounts
payable
|
4,869,361
|
3,634,519
|
|||||
Accrued
compensation and related expenses
|
1,480,317
|
1,581,042
|
|||||
Other
accrued liabilities
|
1,045,424
|
674,374
|
|||||
Deferred
revenues
|
1,140,948
|
668,032
|
|||||
Total
current liabilities
|
13,794,526
|
11,444,405
|
|||||
Long-term
liabilities:
|
|||||||
Notes
payable
|
84,646
|
106,215
|
|||||
Long-term
debt
|
4,921,364
|
5,602,653
|
|||||
Total
liabilities
|
18,800,536
|
17,153,273
|
|||||
Commitments
and Contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Common
stock, $.01 par value, 100,000,000 shares authorized; 63,032,207
shares
issued and outstanding
|
630,322
|
630,322
|
|||||
Additional
paid-in capital
|
134,064,422
|
132,932,357
|
|||||
Accumulated
deficit
|
(99,965,918
|
)
|
(94,029,249
|
)
|
|||
Total
stockholders’ equity
|
34,728,826
|
39,533,430
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
53,529,362
|
$
|
56,686,703
|
*
The
December 31, 2007 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,
|
|||||||
2008
|
2007
|
||||||
Revenues:
|
|||||||
Product
sales
|
$
|
6,789,127
|
$
|
5,191,918
|
|||
Services
|
2,077,999
|
1,830,753
|
|||||
8,797,126
|
7,022,671
|
||||||
Cost
of revenues:
|
|||||||
Product
cost of revenues
|
2,828,986
|
2,154,567
|
|||||
Services
cost of revenues
|
1,240,670
|
982,786
|
|||||
|
4,069,656
|
3,137,353
|
|||||
Gross
profit
|
4,727,470
|
3,885,318
|
|||||
Operating
expenses:
|
|||||||
Selling
and marketing
|
3,622,002
|
2,987,356
|
|||||
General
and administrative
|
2,587,099
|
2,390,599
|
|||||
Engineering
and product development
|
224,236
|
202,163
|
|||||
6,433,337
|
5,580,118
|
||||||
Loss
from continuing operations before interest expense, net
|
(1,705,867
|
)
|
(1,694,800
|
)
|
|||
Interest
expense, net
|
(251,883
|
)
|
(141,562
|
)
|
|||
Loss
from continuing operations
|
(1,957,750
|
)
|
(1,836,362
|
)
|
|||
Discontinued
operations:
|
|||||||
Income
from discontinued operations, net of nil in taxes
|
39,059
|
183,390
|
|||||
Decrease
in estimated loss on sale of discontinued operations
|
131,186
|
-
|
|||||
Net
loss
|
($
1,787,505
|
)
|
($
1,652,972
|
)
|
|||
Basic
and diluted net loss per share:
|
|||||||
Continuing
operations
|
($0.03
|
)
|
($0.03
|
)
|
|||
Discontinued
operations
|
($0.00
|
)
|
($0.00
|
)
|
|||
Basic
and diluted net loss per share
|
($0.03
|
)
|
($0.03
|
)
|
|||
Shares
used in computing basic and diluted net loss per share
|
63,032,207
|
62,956,881
|
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,
|
|||||||
2008
|
2007
|
||||||
Revenues:
|
|||||||
Product
sales
|
$
|
20,549,712
|
$
|
16,464,329
|
|||
Services
|
5,968,027
|
5,077,303
|
|||||
26,517,739
|
21,541,632
|
||||||
Cost
of revenues:
|
|||||||
Product
cost of revenues
|
8,682,917
|
6,703,251
|
|||||
Services
cost of revenues
|
3,539,872
|
2,979,536
|
|||||
|
12,222,789
|
9,682,787
|
|||||
Gross
profit
|
14,294,950
|
11,858,845
|
|||||
Operating
expenses:
|
|||||||
Selling
and marketing
|
11,490,801
|
9,088,150
|
|||||
General
and administrative
|
6,968,801
|
7,435,744
|
|||||
Engineering
and product development
|
881,268
|
603,636
|
|||||
19,340,870
|
17,127,530
|
||||||
Loss
from continuing operations before interest expense, net
|
(5,045,920
|
)
|
(5,268,685
|
)
|
|||
Interest
expense, net
|
(761,020
|
)
|
(379,947
|
)
|
|||
Loss
from continuing operations
|
(5,806,940
|
)
|
(5,648,632
|
)
|
|||
Discontinued
operations:
|
|||||||
Income
from discontinued operations, net of nil in taxes
|
284,929
|
276,421
|
|||||
Loss
on sale of discontinued operations
|
(414,658
|
)
|
-
|
||||
Net
loss
|
($
5,936,669
|
)
|
($
5,372,211
|
)
|
|||
Basic
and diluted net loss per share:
|
|||||||
Continuing
operations
|
($0.09
|
)
|
($0.09
|
)
|
|||
Discontinued
operations
|
($0.00
|
)
|
($0.00
|
)
|
|||
Basic
and diluted net loss per share
|
($0.09
|
)
|
($0.09
|
)
|
|||
Shares
used in computing basic and diluted net loss per share
|
63,032,207
|
62,735,569
|
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, 2008
(Unaudited)
Additional
|
||||||||||||||||
Common
Stock
|
Paid-In
|
Accumulated
|
||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||
BALANCE,
DECEMBER 31, 2007
|
63,032,207
|
$
|
630,322
|
$
|
132,932,357
|
($94,029,249
|
)
|
$
|
39,533,430
|
|||||||
Stock
options issued to consultants for services
|
-
|
-
|
78,015
|
-
|
78,015
|
|||||||||||
Stock-based
compensation expense related
to employee options
|
-
|
-
|
698,816
|
-
|
698,816
|
|||||||||||
Issuance
of restricted stock and amortization of expense for restricted
stock
|
-
|
-
|
310,868
|
-
|
310,868
|
|||||||||||
Issuance
of warrants for draws under line
of credit
|
44,366
|
44,366
|
||||||||||||||
Net
loss for the nine months ended September 30, 2008
|
-
|
-
|
-
|
(5,936,669
|
)
|
(5,936,669
|
)
|
|||||||||
BALANCE,
SEPTEMBER 30, 2008
|
63,032,207
|
$
|
630,322
|
$
|
134,064,422
|
($99,965,918
|
)
|
$
|
34,728,826
|
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,
|
|||||||
2008
|
2007
|
||||||
Cash
Flows From Operating Activities:
|
|||||||
Net
loss
|
($
5,936,669
|
)
|
($
5,372,211
|
)
|
|||
Adjustments
to reconcile net loss to net cash used in operating activities-continuing
operations:
|
|||||||
Depreciation
and amortization
|
3,078,475
|
2,827,620
|
|||||
Loss
on sale of discontinued operations
|
414,658
|
-
|
|||||
Stock
options issued to consultants for services
|
78,015
|
93,429
|
|||||
Stock-based
compensation expense related to employee options and restricted
stock
|
1,009,684
|
1,103,721
|
|||||
Provision
for bad debts
|
89,259
|
103,064
|
|||||
Changes
in operating assets and liabilities, net of effects from discontinued
operations:
|
|||||||
Accounts
receivable
|
(1,013,633
|
)
|
(919,636
|
)
|
|||
Inventories
|
(254,490
|
)
|
(608,398
|
)
|
|||
Prepaid
expenses and other assets
|
642,448
|
649,637
|
|||||
Accounts
payable
|
1,053,352
|
317,155
|
|||||
Accrued
compensation and related expenses
|
(100,725
|
)
|
(202,063
|
)
|
|||
Other
accrued liabilities
|
371,049
|
91,285
|
|||||
Deferred
revenues
|
472,916
|
477,930
|
|||||
Other
liabilities
|
-
|
(11,623
|
)
|
||||
Net
cash used in operating activities - continuing operations
|
(95,661
|
)
|
(1,450,090
|
)
|
|||
Net
cash provided by operating activities - discontinued
operations
|
766,328
|
606,198
|
|||||
Net
cash provided by operating activities
|
670,667
|
(843,892
|
)
|
||||
Cash
Flows From Investing Activities:
|
|||||||
Purchases
of property and equipment
|
(229,942
|
)
|
(108,640
|
)
|
|||
Lasers
placed into service
|
(3,852,917
|
)
|
(3,159,739
|
)
|
|||
Proceeds
from disposition of discontinued operations
|
3,149,736
|
-
|
|||||
Deferred
costs on proposed acquisition
|
(1,762,501
|
)
|
-
|
||||
Net
cash used in investing activities - continuing operations
|
(2,695,624
|
)
|
(3,268,379
|
)
|
|||
Net
cash used in investing activities - discontinued
operations
|
(68,462
|
)
|
(256,993
|
)
|
|||
Net
cash used in investing activities
|
(2,764,086
|
)
|
(3,525,372
|
)
|
|||
Cash
Flows From Financing Activities:
|
|||||||
Proceeds
from issuance of restricted common stock
|
-
|
4,200
|
|||||
Proceeds
from exercise of options
|
-
|
85,954
|
|||||
Payments
on long-term debt
|
(107,376
|
)
|
(65,033
|
)
|
|||
Payments
on notes payable
|
(672,399
|
)
|
(501,884
|
)
|
|||
Net
(repayments)/advances on lease lines of credit
|
(272,316
|
)
|
236,758
|
||||
Decrease
in restricted cash and cash equivalents
|
39,000
|
39,000
|
|||||
Net
cash used in financing activities - continuing operations
|
(1,013,091
|
)
|
(201,005
|
)
|
|||
Net
cash used in financing activities - discontinued
operations
|
-
|
-
|
|||||
Net
cash used in financing activities
|
(1,013,091
|
)
|
(201,005
|
)
|
|||
Net
decrease in cash and cash equivalents
|
(3,106,510
|
)
|
(4,570,269
|
)
|
|||
Cash
and cash equivalents, beginning of period
|
9,837,303
|
12,729,742
|
|||||
Cash
and cash equivalents, end of period
|
$
|
6,730,793
|
$
|
8,159,473
|
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 currently operates in four
distinct business units, or segments (as described in Note 10): three in
Dermatology, - Domestic XTRAC®, International Dermatology Equipment, and Skin
Care (ProCyte®); and one in Surgical, - Surgical Products (SLT®). The segments
are distinguished by our management structure, products and services offered,
markets served or types of customers. A fifth segment of business, the Surgical
Services segment, is reported as a discontinued operation, and its related
assets as held for sale, in these financial statements.
Surgical
Services is a fee-based procedures business using mobile surgical laser
equipment operated by Company technicians at hospitals and surgery centers
in
the United States. After preliminary investigations and discussions, the Board
of Directors of the Company decided on June 13, 2008 to develop plans for
implementing a disposal of the assets and operations of the business. The
Company accordingly classified this former segment as held for sale in
accordance with SFAS No. 144. On August 1, 2008, the Company entered into a
definitive agreement to sell specific assets of the business including accounts
receivable, inventory and equipment, for $3,500,000, subject to certain closing
adjustments. See Note 2, Discontinued
Operations.
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
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 solely 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, now to a markedly lesser degree, by earning royalties
on
licenses for our patented copper peptide compound.
The
Company designed and manufactured the XTRAC laser system to treat psoriasis,
vitiligo, atopic dermatitis and leukoderma phototherapeutically. 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 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.
For
the
last several years the Company has sought to obtain health insurance coverage
for its XTRAC laser therapy to treat inflammatory skin disease, particularly
psoriasis. With the addition of new positive payment policies from Blue Cross
Blue Shield plans from certain states during the first nine months of 2008,
the
Company now benefits from the fact that more than 90% of the insured United
States population has policies that provide nearly full reimbursement for the
treatment of psoriasis by means of an excimer laser (XTRAC). The Company is
now
focusing its efforts on accelerating the adoption of the XTRAC laser therapy
for
psoriasis and vitiligo by doctors and patients. Consequently, the Company has
increased the size of its sales force and clinical technician personnel together
with increased expenditures for marketing and advertising.
8
Liquidity
and Going Concern
As
of
September 30, 2008, the Company had an accumulated deficit of $99,965,918.
Cash
and cash equivalents, including restricted cash of $78,000, was $6,808,793.
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 Company is exploring
expressions of interest from third party lenders, including CIT Healthcare,
to
offer further debt financing for the domestic XTRAC program, thought there
can
be no assurance that any such expressions of interest will materialize on terms
favorable to the Company. Management believes that the existing cash balance
together with its other existing potential financial resources and any revenues
from sales, distribution, licensing and manufacturing relationships, will be
sufficient to meet the Company’s operating and capital requirements beyond the
end of the fourth quarter of 2009. The 2008 operating plan reflects anticipated
growth from both increased fee revenues for use of the XTRAC laser system based
on increased utilization and wider insurance coverage in the United States
and
anticipated growth in revenues of the Company’s skincare products.
Summary
of Significant Accounting Policies:
Quarterly
Financial Information and Results of Operations
The
financial statements as of September 30, 2008 and for the three and nine months
ended September 30, 2008 and 2007, 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, 2008, and the results of operations and cash flows for the three and nine
months ended September 30, 2008 and 2007. The results for the three and nine
months ended September 30, 2008 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, 2007. The surgical services
business segment is presented as discontinued operations for all periods
presented.
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 2007 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. In some cases, the Company and the customer stipulate to a quarterly
target of procedures to be performed. 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.
9
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 or fully assured.
Under
the
terms of the Company’s distributor agreements, distributors do not have a
unilateral right to return any unit that they have purchased. However, the
Company does allow products to be returned by its distributors for product
defects or other claims.
When
the
Company places a laser in a physician’s office, it recognizes service revenue
based on the number of patient treatments performed by the physician. Treatments
in the form of random laser-access codes that are sold to a physician, but
not
yet used, are deferred and recognized as a liability until the physician
performs the treatment. Unused treatments remain an obligation of the Company
because the treatments can only be performed on Company-owned equipment. Once
the treatments are delivered to a patient, this obligation has been satisfied.
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 and nine months ended September 30, 2008 and 2007, the Company deferred
$1,038,213 and $899,075, respectively, under this approach.
The
Company generates revenues from its Skin Care business primarily through two
channels. The first is through product sales for skin health, hair care and
wound care and the second is through sales in bulk of the copper peptide
compound, primarily to Neutrogena Corporation, a Johnson & Johnson company.
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 its
licensees. The Company recognizes royalty revenue at the applicable royalty
rate
applied to shipments reported by its licensee.
The
Company generates revenues from its Surgical Products business primarily from
product sales of laser systems, related maintenance service agreements,
recurring laser delivery systems and laser accessories. Domestic sales generally
are direct to the end-user, though the Company has some sales to or through
a
small number of domestic distributors; foreign sales are to distributors. 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.
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 are
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 Surgical Services segment are
classified as held for sale for the December 31, 2007 period and are presented
separately in the appropriate asset and liability sections of the balance sheet.
As of September 30, 2008 and December 31, 2007, no such impairment existed
related to continuing operations.
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 acquisition
of the skincare business (ProCyte) in March 2005 and is being amortized on
a
straight-line basis over seven years.
10
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 September
30, 2008, 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, 2008 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, 2008
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 the case of domestic sales of XTRAC lasers, however, the Company
offers longer periods in order to meet competition or meet customer demands.
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, 2008 is summarized as follows:
September
30, 2008
|
||||
Accrual
at beginning of period
|
$
|
218,587
|
||
Additions
charged to warranty expense
|
255,600
|
|||
Expiring
warranties
|
(17,861
|
)
|
||
Claims
satisfied
|
(65,518
|
)
|
||
Accrual
at end of period
|
$
|
390,808
|
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, principally Section 382. Utilization
of loss carryforwards from previous acquisitions (e.g. Acculase, SLT, ProCyte)
have already been limited by this provision by the acquisition itself and by
any
later changes of ownership in the parent company. If the Company should undergo
a further change of ownership under Section 382, the utilization of the
Company’s loss carryforwards may be materially limited.
11
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 from continuing
operations is the same as basic net loss per share. Thus, no additional shares
for the potential dilution from the conversion or exercise of securities into
common stock are included in the denominator of this calculation, since the
result would be anti-dilutive. Common stock options and warrants of 9,417,772
and 10,267,093 as of September 30, 2008 and 2007, respectively, were excluded
from the calculation of fully diluted earnings per share from continuing
operations since their inclusion would have been anti-dilutive. The same
considerations apply to net loss per share from discontinued operations for
the
three and nine months ended September 30, 2008. For the three and nine months
ended September 30, 2007, however, there was income from discontinued
operations, but basic net income per share and diluted net income per share
from
discontinued operations for these periods were both immaterial.
Share-Based
Compensation
The
Company measures and recognizes compensation expense at fair value for all
stock-based payments to employees and directors as required by SFAS No. 123R
applied on the modified prospective basis.
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, the date of adoption, 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,
2008 and 2007 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.
The
Company uses the Black-Scholes option-pricing model to estimate fair value
of
grants of stock options with the following weighted average
assumptions:
Assumptions
for Option Grants
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Risk-free
interest rate
|
3.86
|
%
|
4.83
|
%
|
3.73
|
%
|
4.78
|
%
|
|||||
Volatility
|
82.14
|
%
|
85.39
|
%
|
84.13
|
%
|
86.02
|
%
|
|||||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
0
|
%
|
|||||
Expected
life
|
8.1
years
|
8.1
years
|
8.1
years
|
8.1
years
|
|||||||||
Estimated
forfeiture rate
|
12
|
%
|
12
|
%
|
12
|
%
|
12
|
%
|
The
Company calculates expected volatility for a share-based grant based on historic
daily stock price observations of its 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, 2008 and 2007, the Company has adopted the
simplified method authorized in Staff Accounting Bulletin No. 107. SFAS No.
123R
also requires that estimated forfeitures be included as a part of the estimate
of expense as of the grant date. The Company has used historical data to
estimate expected employee behaviors related to option exercises and
forfeitures.
With
respect to both grants of options and awards of restricted stock, the risk-free
rate of interest is based on the U.S. Treasury rates appropriate for the
expected term of the grant or award.
12
With
respect to awards of restricted stock, the Company uses the Monte-Carlo pricing
model to estimate fair value of restricted stock awards. There were no
restricted stock awards for the three and nine months ended September 30, 2008.
The awards made in the first and second quarters 2007 were estimated 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
|
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 would 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, 2008 included $262,971 from
stock options grants and $103,623 from restricted stock awards. 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 nine months ended September 30, 2008 included $698,816 from
stock options grants and $310,868 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 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 $15,635 and
$78,015 was recognized during the three and nine months ended September 30,
2008. 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.
Supplemental
Cash Flow Information
During
the nine months ended September 30, 2008, the Company financed certain insurance
policies through notes payable for $635,243 and issued warrants to a leasing
credit facility which are valued at $44,366, and which offset the carrying
value
of debt.
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.
For
the
nine months ended September 30, 2008 and 2007, the Company paid interest of
$892,932 and $700,383, respectively. Income taxes paid in the nine months ended
September 30, 2008 and 2007 were immaterial.
Recent
Accounting Pronouncements
In
October 2008, the FASB issued FSP No. 157-3, “Determining the Fair Value of a
Financial Asset When the Market for That Asset Is Not Active” (“FSP 157-3”). FSP
157-3 clarifies the application of SFAS 157 in a market that is not active
and
provides an example to illustrate key considerations in determining the fair
value of a financial asset when the market for that financial asset is not
active. FSP 157-3 was effective for us on September 30, 2008 for all financial
assets and liabilities recognized or disclosed at fair value in our Condensed
Consolidated Financial Statements on a recurring basis (at least annually).
In
May
2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted
Accounting Principles. The statement is intended to improve financial reporting
by identifying a consistent hierarchy for selecting accounting principles to
be
used in preparing financial statements that are presented in conformity with
GAAP. Prior to the issuance of SFAS No. 162, GAAP hierarchy was defined in
the
American Institute of Certified Public Accountants (“AICPA”)
Statement on Auditing Standards (SAS) No. 69, The Meaning of Present Fairly
in
Conformity With Generally Accepted Accounting Principles. Unlike SAS No. 69,
SFAS No. 162 is directed to the entity rather than the auditor. Statement No.
162 is effective 60 days following the SEC’s
approval of the Public Company Accounting Oversight Board Auditing amendments
to
AU Section 411, The Meaning of Present Fairly in Conformity with Generally
Accepted Accounting Principles. SFAS No. 162 is not
expected
to have any material impact on the Company’s
results
of operations, financial condition or liquidity.
13
Effective
January 1, 2008, the Company adopted SFAS No. 157, "Fair Value Measurements".
In
February 2008, the Financial Accounting Standards Board (“FASB”) issued FASB
Staff Position No. FAS 157-2, "Effective Date of FASB Statement No. 157", which
provides a one year deferral of the effective date of SFAS No. 157 for
non-financial assets and non-financial liabilities, except those that are
recognized or disclosed in the financial statements at fair value at least
annually. Therefore, the Company has adopted the provisions of SFAS No. 157
with
respect to its financial assets and liabilities only. SFAS No. 157 defines
fair
value, establishes a framework for measuring fair value under generally accepted
accounting principles and enhances disclosures about fair value measurements.
Fair value is defined under SFAS No. 157 as the exchange price that would be
received for an asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in an orderly
transaction between market participants on the measurement date. Valuation
techniques used to measure fair value under SFAS No. 157 must maximize the
use
of observable inputs and minimize the use of unobservable inputs. The standard
describes a fair value hierarchy based on three levels of inputs, of which
the
first two are considered observable and the last unobservable, that may be
used
to measure fair value. The input levels are as follows:
Level
1—Quoted prices in active markets for identical assets or liabilities.
Level
2—Inputs other than Level 1 that are observable, either directly or indirectly,
such as quoted prices for similar assets or liabilities; quoted prices in
markets that are not active; or other inputs that are observable or can be
corroborated by observable market data for substantially the full term of the
assets or liabilities.
Level
3—Unobservable inputs that are supported by little or no market activity and
that are significant to the fair value of the assets or liabilities.
The
adoption of this Statement did not have a material impact on the Company's
consolidated results of operations and financial condition.
In
December 2007, the FASB
issued
SFAS No. 141 (revised 2007), “Business Combinations”, or SFAS No. 141R. SFAS No.
141R replaces SFAS No. 141. This Statement establishes principles and
requirements for how an acquirer recognizes and measures in its financial
statements the identifiable assets acquired, the liabilities assumed, any
non-controlling interest in the acquiree and the goodwill acquired. This
statement also establishes disclosure requirements which will enable users
to
evaluate the nature and financial effects of the business combination. This
Statement is effective for business combinations for which the acquisition
date
is on or after the beginning of the first annual reporting period beginning
on
or after December 15, 2008. This Statement will have an impact on future
acquisitions. If, for example, the proposed acquisition of the subsidiaries
of
Photo Therapeutics Group Ltd. should be consummated after December 31, 2008,
then the Company will be obliged to record an estimate of the earn-out payment
the Company expects to pay and to expense its costs incurred in the acquisition.
As of September 30, 2008, these costs amounted to $1,762,501 and are under
the
balance sheet caption “deferred costs on proposed acquisition”. If the proposed
acquisition is consummated prior to December 31, 2008, the costs incurred in
the
transaction will be capitalized as part of the purchase price.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in
Consolidated Financial Statements—an Amendment of Accounting Research Bulletin
No. 51.” SFAS No. 160 establishes accounting and reporting standards for
ownership interests in subsidiaries held by parties other than the parent,
the
amount of consolidated net income attributable to the parent and to the
noncontrolling interest, changes in a parent’s ownership interest and the
valuation of retained noncontrolling equity investments when a subsidiary is
deconsolidated. This Statement also establishes reporting requirements that
provide sufficient disclosures that clearly identify and distinguish between
the
interests of the parent and the interests of the noncontrolling owners. This
Statement is effective for fiscal years, and interim periods within those fiscal
years, beginning on or after December 15, 2008. The Company does not expect
the
adoption of this Statement to have a material impact, if any, on the Company's
consolidated financial statements.
14
Note
2
Discontinued
Operations:
Surgical
Services is a fee-based procedures business using mobile surgical laser
equipment operated by Company technicians at hospitals and surgery centers
in
the United States. The Company decided to sell this division primarily because
the growth rates and operating margins of the division have decreased as the
business had changed to rely more heavily upon procedures performed using
equipment from third-party suppliers, thereby limiting the profit potential
of
these services. After preliminary investigations and discussions, the Board
of
Directors of the Company decided on June 13, 2008 to enter into, with the aid
of
its investment banker, substantive, confidential discussions with potential
third-party buyers and began to develop plans for implementing a disposal of
the
assets and operations of the business. The Company accordingly classified this
former segment as held for sale in accordance with SFAS No. 144. On August
1,
2008, the Company entered into a definitive agreement to sell specific assets
of
the business including accounts receivable, inventory and equipment, for
$3,500,000, subject to certain closing adjustments. Such closing adjustments
resulted in net proceeds to the Company of $3,149,737. The transaction closed
on
August 8, 2008. No income tax benefit was recognized by the Company from the
loss on the sale of discontinued operations.
The
accompanying consolidated financial statements reflect the operating results
and
balance sheet items of the discontinued operations separately from continuing
operations. Prior year financial statements for 2007 have been restated in
conformity with generally accepted accounting principles to present the
operations of Surgical Services as a discontinued operation. The Company
recognized a loss of $414,658 on the sale of the discontinued operations in
the
nine months ended September 30, 2008, representing the difference between the
adjusted net purchase price and the carrying value of the assets being sold.
Revenues
from Surgical Services for the three months ended September 30, 2008 and 2007
were $736,298 and $1,899,200, respectively. Income from surgical services for
the three months ended September 30, 2008 and 2007 were $39,059 and $183,390,
respectively.
Revenues
from Surgical Services for the nine months ended September 30, 2008 and 2007
were $4,398,047 and $5,727,528, respectively. Income from surgical services
for
the nine months ended September 30, 2008 and 2007 were $284,929 and $276,421,
respectively. No income tax provision was recognized by the Company against
income from Surgical Services over the two comparable nine-month
periods.
The
net
assets of Surgical Services are classified as assets held for sale. The net
assets, after recognition of the write-down to estimated recoverable value,
were
comprised of the following:
December
31, 2007
|
||||
Current
assets held for sale:
|
||||
Accounts
receivable
|
$
|
961,440
|
||
Inventories
|
949,362
|
|||
Total
current assets held for sale
|
1,910,802
|
|||
Long
term assets held for sale:
|
||||
Property,
plant and equipment, net
|
2,119,347
|
|||
Deposits
|
9,879
|
|||
Total
long term assets held for sale
|
2,129,226
|
|||
Total
net assets held for sale
|
$
|
4,040,028
|
15
Note
3
Inventories:
Set
forth
below is a detailed listing of inventories:
September
30, 2008
|
December
31, 2007
|
||||||
Raw
materials and work in progress
|
$
|
4,585,998
|
$
|
4,527,708
|
|||
Finished
goods
|
2,599,890
|
2,452,472
|
|||||
Total
inventories
|
$
|
7,185,888
|
$
|
6,980,180
|
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,
2008 and December 31, 2007, the Company carried specific reserves for excess
and
obsolete stocks against its inventories of $1,254,350 and $1,124,345,
respectively.
Note
4
Property
and Equipment:
Set
forth
below is a detailed listing of property and equipment:
September
30, 2008
|
December
31, 2007
|
||||||
Lasers
in service
|
$
|
18,375,245
|
$
|
15,055,730
|
|||
Computer
hardware and software
|
341,407
|
341,407
|
|||||
Furniture
and fixtures
|
539,885
|
361,174
|
|||||
Machinery
and equipment
|
836,896
|
870,986
|
|||||
Leasehold
improvements
|
247,369
|
247,368
|
|||||
20,340,802
|
16,876,665
|
||||||
Accumulated
depreciation and amortization
|
(10,447,403
|
)
|
(8,852,204
|
)
|
|||
Property
and equipment, net
|
$
|
9,893,399
|
8,024,461
|
Depreciation
and related amortization expense was $2,221,936 and $1,886,221 for the nine
months ended September 30, 2008 and 2007, respectively.
Note
5
Patents
and Licensed Technologies:
Set
forth
below is a detailed listing of patents and licensed technologies:
September
30, 2008
|
December
31, 2007
|
||||||
Patents,
owned and licensed, at gross costs of $561,617 and $510,942, net
of
accumulated amortization of $296,241 and $268,540,
respectively.
|
$
|
265,375
|
$
|
242,402
|
|||
Other
licensed or developed technologies, at gross costs of $1,603,124
and
$1,595,258, net of accumulated amortization of $560,743 and $429,412,
respectively.
|
1,042,381
|
1,165,846
|
|||||
$
|
1,307,756
|
$
|
1,408,248
|
Related
amortization expense was $159,037 and $243,909 for the nine months ended
September 30, 2008 and 2007, respectively. Included in other licensed and
developed technologies is $200,000 in developed technologies acquired from
ProCyte, $114,982 for the license with AzurTec and $85,742 for the license
from
the Mount Sinai School of Medicine of New York University. 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.
16
Note
6
Other
Intangible Assets:
Set
forth
below is a detailed listing of other intangible assets, all of which were
acquired from ProCyte and which recorded at their appraised fair market values
at the date of the acquisition:
September
30, 2008
|
December
31, 2007
|
||||||
Neutrogena
Agreement, at gross cost of $2,400,000 net of accumulated amortization
of
$1,698,000 and 1,338,000, respectively.
|
$
|
702,000
|
$
|
1,062,000
|
|||
Customer
Relationships, at gross cost of $1,700,000 net of accumulated amortization
of $1,202,736 and $947,739, respectively.
|
497,264
|
752,261
|
|||||
Tradename,
at gross cost of $1,100,000 net of accumulated amortization of $389,139
and $306,636, respectively.
|
710,861
|
793,364
|
|||||
$
|
1,910,125
|
$
|
2,607,625
|
Related
amortization expense was $697,500 for the nine months ended September 30, 2008
and 2007, 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
7
Other
Accrued Liabilities:
Set
forth
below is a detailed listing of other accrued liabilities:
September
30, 2008
|
December
31, 2007
|
||||||
Accrued
warranty
|
$
|
390,808
|
$
|
218,587
|
|||
Accrued
professional and consulting fees
|
427,700
|
225,820
|
|||||
Accrued
sales taxes and other accrued liabilities
|
226,916
|
229,967
|
|||||
Total
other accrued liabilities
|
$
|
1,045,424
|
$
|
674,374
|
Note
8
Notes
Payable:
Set
forth
below is a detailed listing of notes payable. The stated interest rate
approximates the effective cost of funds from the notes:
September
30, 2008
|
December
31, 2007
|
||||||
Note
Payable - secured creditor, interest at 6%, payable in monthly principal
and interest installments of $2,880 through June 2012
|
$
|
113,191
|
$
|
133,507
|
|||
Note
Payable - unsecured creditor, interest at 5.44%, payable in monthly
principal and interest installments of $51,354 through February
2008
|
-
|
102,013
|
|||||
Note
Payable - unsecured creditor, interest at 4.8%, payable in monthly
principal and interest installments of $65,736 through December
2008
|
195,657
|
-
|
|||||
Note
Payable - unsecured creditor, interest at 4.8%, payable in monthly
principal and interest installments of $12,202 through December
2008
|
36,316
|
-
|
|||||
345,164
|
235,520
|
||||||
Less:
current maturities
|
(260,518
|
)
|
(129,305
|
)
|
|||
Notes
payable, net of current maturities
|
$
|
84,646
|
$
|
106,215
|
17
Note
9
Long-term
Debt:
In
the
following table is a summary of the Company’s long-term debt.
September
30, 2008
|
December
31, 2007
|
||||||
Total
borrowings on credit facilities
|
$
|
9,919,322
|
$
|
10,105,608
|
|||
Capital
lease obligations
|
-
|
254,178
|
|||||
Less:
current portion
|
(4,997,958
|
)
|
(4,757,133
|
)
|
|||
Total
long-term debt
|
$
|
4,921,364
|
$
|
5,602,653
|
Leasing
Credit Facility, Term Note Facility
The
Company entered into a leasing credit facility with GE Capital Corporation
(“GE”) on June 25, 2004. Eleven draws were made against the facility, the last
of which was in March 2007. In June 2007, the Company entered a term-note
facility with Leaf Financial Corporation (“Leaf”) and made its single draw
against that facility. In December 2007, the Company extinguished its
outstanding indebtedness under the GE and Leaf facilities, recognizing as costs
(including termination costs and acceleration of the amortization of debt
issuance costs and the debt discount) of such extinguishments as a refinancing
charge under APB No. 26 of $441,956, including $178,699 related to the premium
paid for the buyback of its warrants issued to GE. The GE warrants issued
through the date of extinguishments were redeemed and reflected as part of
the
refinancing charge.
In
connection with the pay-off of the GE and Leaf facilities, on December 31,
2007,
the Company entered a term-note facility with CIT Healthcare LLC and Life
Sciences Capital LLC, as equal participants (collectively, “CIT”), for which CIT
Healthcare acts as the agent. The facility is for $12 million. The Company
may
draw against it for one year. The stated interest rate for any draw is set
at
675 basis points above the three-year Treasury rate. Each draw is secured by
certain XTRAC laser systems consigned under usage agreements with
physician-customers and the stream of payments generated from such lasers. Each
draw has a repayment period of three years.
The
first
draw had three discrete components: carryover debt attributable to the former
GE
borrowings, as increased by extinguishment costs (including redemption of the
GE
warrants) which CIT financed; carryover debt attributable to former Leaf
borrowings, as increased by extinguishment costs which CIT financed; and debt
newly incurred to CIT on newly placed XTRAC units not pledged to GE or Leaf.
The
carryover components maintained the monthly debt service payments from GE and
Leaf with increases to principal and changes in the stated interest rates
causing minor changes in the number of months set to pay off the discrete draws.
The third component will be self-amortized over three years.
The
beginning principal of each component was $4,724,699, $1,612,626, and
$3,990,000, respectively. The effective interest rate for the first draw was
12.50%. The pay-off of each component is 27, 30, and 36 months, respectively.
On
March 31, 2008, the Company made a draw under the credit facility for $840,000.
This draw is amortized over 36 months at an effective interest rate of 8.55%.
On
June 30, 2008, the Company made a draw under the credit facility for $832,675
based on the limitations on gross borrowings under the facility. This draw
is
amortized over 36 months at an effective interest rate of 9.86%.
On
September 30, 2008, CIT amended the credit facility to increase the amount
the
Company could draw on the credit facility by $1,927,534. The interest rate
for
draws against this amount was set at 850 basis points above the LIBOR rate
two
days prior to the draw. Each draw is secured by certain XTRAC laser systems
consigned under usage agreements with physician-customers and the stream of
payments generated from such lasers. Each draw has a repayment period of three
years. On September 30, 2008, the Company made a draw under the credit facility
for the maximum amount allowable under the credit facility. This draw is
amortized over 36 months at an effective interest rate of 12.90%. The Company
has used its entire availability under the CIT credit facility and is
considering multiple written proposals for additional debt financing but there
can be no assurance whether any such proposals will materialize on terms
favorable to the Company.
18
In
connection with the CIT facility, the Company issued 235,525 warrants to each
of
CIT Healthcare and Life Sciences Capital in December 2007. In connection with
the amendment to the CIT facility, the Company issued 192,753 warrants to CIT
Healthcare in September 2008. The warrants are treated as a discount to the
debt
and are amortized under the effective interest method over the repayment term
of
36 months. The Company has accounted for these warrants as equity instruments
in
accordance with EITF 00-19, "Accounting for Derivative Financial Instruments
Indexed to, and Potentially Settled in, a Company's Own Stock" since there
is no
option for cash or net-cash settlement when the warrants are exercised. The
Company computed the value of the warrants using the Black-Scholes method.
The
key assumptions used to value the warrants are as follows:
December
2007
|
March
2008
|
||||||
Number
of warrants
|
235,525
|
192,753
|
|||||
Exercise
price
|
$
|
1.12
|
$
|
0.44
|
|||
Fair
Value of warrants
|
$
|
110,858
|
$
|
44,366
|
|||
Volatility
|
59.44
|
%
|
60.92
|
%
|
|||
Risk-free
interest rate
|
3.45
|
%
|
2.98
|
%
|
|||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
|||
Expected
warrant life
|
5
years
|
5
years
|
The
following table summarizes the future minimum payments that the Company expects
to make for the draws made under the credit facility:
Three
months ended December 31, 2008
|
$
|
1,627,216
|
||
Year
Ended December 31,
|
||||
2009
|
5,375,788
|
|||
2010
|
3,444,782
|
|||
2011
|
811,059
|
|||
Total
minimum payments
|
11,258,845
|
|||
Less:
interest
|
(1,184,561
|
)
|
||
Less:
warrant discount
|
(154,962
|
)
|
||
Present
value of total minimum obligations
|
$
|
9,919,322
|
Capital
Leases
The
obligations under capital leases are at fixed interest rates and are
collateralized by the related property and equipment. The Company paid off
the
capital leases on equipment that the Company sold in connection with its
discontinued operations.
Note
10
Employee
Stock Benefit Plans
The
Company has three active, stock-based compensation plans available to grant,
among other things, incentive and non-qualified 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, 2008, 2,103,750 shares were available for future grants under
this plan. Under the Outside Director Plan and under the 2005 Investment Plan,
695,000 shares and 388,000 shares, respectively, were available for issuance
as
of September 30, 2008. The other stock options plans are frozen and no further
grants will be made from them.
19
Stock
option activity under all of the Company’s share-based compensation plans for
the nine months ended September 30, 2008 was as follows:
Number
of Options
|
Weighted
Average Exercise Price
|
||||||
Outstanding,
January 1, 2008
|
6,129,671
|
$
|
2.00
|
||||
Granted
|
1,158,200
|
0.90
|
|||||
Cancelled
|
(1,217,902
|
)
|
1.85
|
||||
Outstanding,
September 30, 2008
|
6,069,969
|
$
|
1.82
|
||||
Options
excercisable at September 30, 2008
|
3,817,591
|
$
|
2.05
|
At
September 30, 2008, there was $3,175,125 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 2.36 years. The intrinsic value
of
options outstanding and exercisable at September 30, 2008 was not
significant.
Note
11
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
Products segment generates revenues by selling laser products and disposables
to
hospitals and surgery centers on both a domestic and an international basis.
For
the three and nine months ended September 30, 2008 and 2007, 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, 2008 and December 31, 2007 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, 2008 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, 2008
|
||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||
Revenues
|
$
|
3,001,878
|
$
|
1,096,853
|
$
|
3,627,940
|
$
|
1,070,455
|
$
|
8,797,126
|
||||||
Costs
of revenues
|
1,620,060
|
586,865
|
1,288,946
|
573,785
|
4,069,656
|
|||||||||||
Gross
profit
|
1,381,818
|
509,988
|
2,338,994
|
496,670
|
4,727,470
|
|||||||||||
Gross
profit %
|
46.0
|
%
|
46.5
|
%
|
64.5
|
%
|
46.4
|
%
|
53.7
|
%
|
||||||
Allocated
operating expenses:
|
||||||||||||||||
Selling,
general and administrative
|
1,933,848
|
68,665
|
1,486,800
|
151,690
|
3,641,003
|
|||||||||||
Engineering
and product development
|
-
|
-
|
114,336
|
109,900
|
224,236
|
|||||||||||
Unallocated
operating expenses
|
-
|
-
|
-
|
-
|
2,568,098
|
|||||||||||
1,933,848
|
68,665
|
1,601,136
|
261,590
|
6,433,337
|
||||||||||||
Income
(loss) from operations
|
(552,030
|
)
|
441,323
|
737,858
|
235,080
|
(1,705,867
|
)
|
|||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
(251,883
|
)
|
||||||||||
(Loss)
income from continuing operations
|
(552,030
|
)
|
441,323
|
737,858
|
235,080
|
(1,957,750
|
)
|
|||||||||
Discontinued
operations:
|
||||||||||||||||
Income
from discontinued operations
|
-
|
-
|
-
|
-
|
39,059
|
|||||||||||
Sale
of discontinued operations
|
-
|
-
|
-
|
-
|
131,186
|
|||||||||||
Net
(loss) income
|
($552,030
|
)
|
$
|
441,323
|
$
|
737,858
|
$
|
235,080
|
($1,787,505
|
)
|
Three
Months Ended September 30, 2007
|
||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||
Revenues
|
$
|
2,025,148
|
$
|
819,442
|
$
|
3,065,905
|
$
|
1,112,176
|
$
|
7,022,671
|
||||||
Costs
of revenues
|
1,009,237
|
538,292
|
903,688
|
686,136
|
3,137,353
|
|||||||||||
Gross
profit
|
1,015,911
|
281,150
|
2,162,217
|
426,040
|
3,885,318
|
|||||||||||
Gross
profit %
|
50.2
|
%
|
34.3
|
%
|
70.5
|
%
|
38.3
|
%
|
55.3
|
%
|
||||||
Allocated
operating expenses:
|
||||||||||||||||
Selling,
general and administrative
|
1,496,326
|
40,809
|
1,323,172
|
144,548
|
3,004,855
|
|||||||||||
Engineering
and product development
|
-
|
-
|
103,696
|
98,467
|
202,163
|
|||||||||||
Unallocated
operating expenses
|
-
|
-
|
-
|
-
|
2,373,100
|
|||||||||||
1,496,326
|
40,809
|
1,426,868
|
243,015
|
5,580,118
|
||||||||||||
Income
(loss) from operations
|
(480,415
|
)
|
240,341
|
735,349
|
183,025
|
(1,694,800
|
)
|
|||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
(141,562
|
)
|
||||||||||
(Loss)
income from continuing operations
|
(480,415
|
)
|
240,341
|
735,349
|
183,025
|
(1,836,362
|
)
|
|||||||||
Discontinued
operations:
|
||||||||||||||||
Income
from discontinued operations
|
-
|
-
|
-
|
-
|
183,390
|
|||||||||||
Net
(loss) income
|
($480,415
|
)
|
$
|
240,341
|
$
|
735,349
|
$
|
183,025
|
($1,652,972
|
)
|
21
Nine
Months Ended September 30, 2008
|
||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||
Revenues
|
$
|
8,546,583
|
$
|
2,963,031
|
$
|
10,327,189
|
$
|
4,680,936
|
$
|
26,517,739
|
||||||
Costs
of revenues
|
4,534,644
|
1,493,553
|
3,429,410
|
2,765,182
|
12,222,789
|
|||||||||||
Gross
profit
|
4,011,939
|
1,469,478
|
6,897,779
|
1,915,754
|
14,294,950
|
|||||||||||
Gross
profit %
|
46.9
|
%
|
49.6
|
%
|
66.8
|
%
|
40.9
|
%
|
54.0
|
%
|
||||||
Allocated
operating expenses:
|
||||||||||||||||
Selling,
general and administrative
|
5,989,789
|
206,546
|
4,891,899
|
459,568
|
11,547,802
|
|||||||||||
Engineering
and product development
|
168,214
|
20,790
|
361,970
|
330,294
|
881,268
|
|||||||||||
Unallocated
operating expenses
|
-
|
-
|
-
|
-
|
6,911,800
|
|||||||||||
6,158,003
|
227,336
|
5,253,869
|
789,862
|
19,340,870
|
||||||||||||
Income
(loss) from operations
|
(2,146,064
|
)
|
1,242,142
|
1,643,910
|
1,125,892
|
(5,045,920
|
)
|
|||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
(761,020
|
)
|
||||||||||
(Loss)
income from continuing operations
|
(2,146,064
|
)
|
1,242,142
|
1,643,910
|
1,125,892
|
(5,806,940
|
)
|
|||||||||
Discontinued
operations:
|
||||||||||||||||
Income
from discontinued operations
|
-
|
-
|
-
|
-
|
284,929
|
|||||||||||
Sale
of discontinued operations
|
-
|
-
|
-
|
-
|
(414,658
|
)
|
||||||||||
Net
(loss) income
|
($2,146,064
|
)
|
$
|
1,242,142
|
$
|
1,643,910
|
$
|
1,125,892
|
($5,936,669
|
)
|
Nine
Months Ended September 30, 2007
|
||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
DERM.
EQUIPMENT
|
SKIN
CARE
|
SURGICAL
PRODUCTS
AND
OTHER
|
TOTAL
|
||||||||||||
Revenues
|
$
|
6,048,000
|
$
|
2,117,213
|
$
|
9,646,312
|
$
|
3,730,107
|
$
|
21,541,632
|
||||||
Costs
of revenues
|
3,117,850
|
1,318,430
|
2,931,419
|
2,315,088
|
9,682,787
|
|||||||||||
Gross
profit
|
2,930,150
|
798,783
|
6,714,893
|
1,415,019
|
11,858,845
|
|||||||||||
Gross
profit %
|
48.4
|
%
|
37.7
|
%
|
69.6
|
%
|
37.9
|
%
|
55.1
|
%
|
||||||
Allocated
operating expenses:
|
||||||||||||||||
Selling,
general and administrative
|
4,489,067
|
110,208
|
4,090,291
|
451,085
|
9,140,651
|
|||||||||||
Engineering
and product development
|
-
|
-
|
294,787
|
308,849
|
603,636
|
|||||||||||
Unallocated
operating expenses
|
-
|
-
|
-
|
-
|
7,383,243
|
|||||||||||
4,489,067
|
110,208
|
4,385,078
|
759,934
|
17,127,530
|
||||||||||||
Income
(loss) from operations
|
(1,558,917
|
)
|
688,575
|
2,329,815
|
655,085
|
(5,268,685
|
)
|
|||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
(379,947
|
)
|
||||||||||
(Loss)
income from continuing operations
|
(1,558,917
|
)
|
688,575
|
2,329,815
|
655,085
|
(5,648,632
|
)
|
|||||||||
Discontinued
operations:
|
||||||||||||||||
Income
from discontinued operations
|
-
|
-
|
-
|
-
|
276,421
|
|||||||||||
Net
(loss) income
|
($1,558,917
|
)
|
$
|
688,575
|
$
|
2,329,815
|
$
|
655,085
|
($5,372,211
|
)
|
22
September
30, 2008
|
December
31, 2007
|
||||||
Assets:
|
|||||||
Total
assets for reportable segments
|
$
|
44,379,024
|
$
|
42,171,948
|
|||
Assets
held for sale
|
-
|
4,040,028
|
|||||
Other
unallocated assets
|
9,150,338
|
10,474,727
|
|||||
Consolidated
total
|
$
|
53,529,362
|
$
|
56,686,703
|
For
the
three and nine months ended September 30, 2008 and 2007 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,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Domestic
|
$
|
6,702,085
|
$
|
5,333,306
|
$
|
20,766,092
|
$
|
16,886,558
|
|||||
Foreign
|
2,095,041
|
1,689,365
|
5,751,647
|
4,655,074
|
|||||||||
$
|
8,797,126
|
$
|
7,022,671
|
$
|
26,517,739
|
$
|
21,541,632
|
The
Company discusses segmental details in its Management Discussion & Analysis
found elsewhere in its Form 10-Q for the period ending September 30,
2008.
Note
12
Significant
Alliances/Agreements:
The
Company continues in alliance with GlobalMed (Asia) Technologies Co., Inc.
as
well as with the Mount Sinai School of Medicine and with AzurTec, Inc., as
described in our Annual Report on Form 10-K for the year ended December 31,
2007.
With
respect to the Clinical Trial Agreement protocol with the University of
California at San Francisco, Dr. Koo presented the favorable findings of the
study at the Hawaii Dermatology Seminar in March 2008. Dr. Koo concluded that
the
XTRAC
Excimer Laser may be appropriate for the majority of moderate to severe
psoriasis sufferers. It also allows dermatologists to treat those patients
with
a high level of safety, as opposed to the use of many systemic products. Other
phototherapy treatments such as broadband or narrow band UVB can also be used;
however, undesirable aspects of these treatments include exposure of healthy
skin to UVB light, and the inconvenience of extended treatment periods, which
are often necessary for moderate to severe patients.
We
expensed $189,000 in the nine months ended September 30, 2008 in payment for
this study.
Note
13
Pending
Acquisition and Financing:
On
August
4, 2008, the Company entered into a Purchase Agreement with Photo Therapeutics
Group, Limited (“Photo
Therapeutics”) and
a
Securities Purchase Agreement with an affiliate of Perseus, L.L.C. (“Perseus”).
Under
the
Purchase Agreement with Photo Therapeutics, the Company will acquire from Photo
Therapeutics the common stock of its subsidiaries (Photo Therapeutics Limited
in
the United Kingdom and Photo Therapeutics, Inc. in California) for $13 million
in cash at closing, and up to an additional $7 million in cash if certain gross
profit milestones are met by the Photo Therapeutics subsidiaries between July
1,
2008 and June 30, 2009, subject to customary adjustments. Under the Securities
Purchase Agreement with Perseus, an investment fund managed by Perseus will
fund
the acquisition of the Photo Therapeutics subsidiaries through a convertible
debt investment of up to $25 million (with associated warrants), to be made
in
two tranches as described below.
Photo
Therapeutics had unaudited revenues of approximately $6.3 million for the year
ended December 31, 2007 and approximately $6.9 million for the nine months
ended
September 30, 2008.
23
The
proposed acquisition and investment are subject to customary closing conditions,
including approval by the shareholders of Photo Therapeutics of the proposed
acquisition and approval by the Company’s stockholders of the proposed
investment by Perseus and of a reverse split of the outstanding shares of the
Company’s common stock at a ratio as may be agreed between the Company and
Perseus. The shareholders of Photo Therapeutics have approved the transaction.
The proposed acquisition and the first tranche of the proposed investment by
Perseus are expected to close concurrently in the first quarter of 2009. If
the
closing is held in 2009, then the provisions of SFAS No. 141R will apply,
obliging us to estimate and record the expected payment for the earnout and
to
expense, rather than capitalize, costs related to the acquisition. Such costs
amount to $1,762,501 as of September 30, 2008.
The
Company has agreed under its Securities Purchase Agreement, subject to
stockholder approval, to issue to Perseus (i) convertible promissory notes
(the
“Notes”) in the aggregate principal amount of up to $25 million, convertible
into shares of the Company’s common stock, (ii) warrants to purchase shares of
common stock (the “Warrants”), and (iii) 327,521 shares of common stock (the
“First Tranche Shares” and together with the Warrants, the Notes and any shares
of the Company’s common stock issued upon conversion of the Notes or exercise of
the Warrants, the “Securities”), in exchange for Perseus’ payment to the Company
of an aggregate purchase price of up to $25 million (the “Financing
Transaction”). The consummation of the Financing Transaction will occur in two
tranches.
The
closing of the first tranche of the Financing Transaction (the “First Tranche
Closing”) will occur simultaneously with the closing of the Photo Therapeutics
closing. In the event that the First Tranche Closing occurs, in exchange for
Perseus’ investment of $18 million, the Company will issue to Perseus (i) a Note
in the principal amount of $18 million (the “First Tranche Note”), convertible
into 24,411,414 shares of its common stock at a conversion price per share
equal
to $0.73736 (the “First Tranche Conversion Price”), each subject to adjustment
upon certain conditions, (ii) a Warrant to purchase 7,323,424 shares of the
Company’s common stock (the “First Tranche Warrant”), at an exercise price per
share equal to the First Tranche Conversion Price, each subject to adjustment
upon certain conditions, and (iii) the First Tranche Shares. The First Tranche
Conversion Price is subject to anti-dilution provisions in connection with
certain future issuances of our securities as well as adjustments for stock
splits and similar actions. The First Tranche Note will mature on the fifth
anniversary of the date of the First Tranche Closing and will accrue interest
at
8% per annum. Interest is payable in cash or through our issuance of an
additional Note at the Company’s election, on the six-month anniversary of the
date of the First Tranche Closing and on each six-month period
thereafter.
In
the
event that the Second Tranche Closing occurs, in exchange for Perseus’
investment of a maximum of $7 million, the Company will issue to Perseus (i)
a
Note (the “Second Tranche Note”) in the principal amount of the investment
amount, convertible into a number of shares of the Company’s common stock at the
Second Tranche Conversion Price (as defined below), subject to adjustment upon
certain conditions, and (ii) a Warrant to purchase a number of shares of its
common stock equal to 30% of the shares of its common stock into which the
Second Tranche Note is convertible, at an exercise price per share equal to
the
Second Tranche Conversion Price, subject to adjustment upon certain conditions
(the “Second Tranche Warrant”). The “Second Tranche Conversion Price” will equal
the lesser of (i) 150% of the conversion price then in effect with respect
to
the First Tranche Note, and (ii) the market price of the Company’s common stock
measured in accordance with the terms of the Securities Purchase Agreement.
The
Second Tranche Conversion Price is subject to anti-dilution provisions in
connection with certain future issuances of our securities at a lower price
per
share of common stock as well as adjustments for stock splits and similar
actions. The Second Tranche Note will mature on the fifth anniversary
of the date of the First Tranche Closing and will accrue interest at 8% per
annum. Interest is payable in cash or through our issuance of an additional Note
at the Company’s election, on the six-month anniversary of the date of the
Second Tranche Closing and on each six-month period thereafter.
Each
of
the First Tranche Note and the Second Tranche Note will provide that if on
any date that occurs 31 trading days after the date of issuance, the market
price for the Company’s common stock, as determined in accordance with the terms
and conditions of the Securities Purchase Agreement, exceeds 300% of the
then-effective conversion price of each Note, then the entire principal amount
and all accrued but unpaid interest under such Note will automatically convert
into shares of the Company’s common stock at the then-effective conversion price
(the “Mandatory Conversion Feature”).
The
First
Tranche Warrant and the Second Tranche Warrant are exercisable at any time
after
the issue date for a period of 8 years thereafter.
24
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,
2007.
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 current business as comprised of the following four business segments:
· |
Domestic
XTRAC,
|
· |
International
Dermatology Equipment,
|
· |
Skin
Care (ProCyte), 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. 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 as well as a means of addressing
under-performing accounts while still preserving a vendor-customer relationship.
We are finding that through sales of lasers we are able to reach, at reasonable
margins, a sector of the market that is better suited to a sale model than
a
per-procedure model.
For
the
last several years we have sought to obtain health insurance coverage for XTRAC
laser therapy to treat inflammatory skin disease, particularly psoriasis. With
the addition of new positive payment policies from Blue Cross Blue Shield plans
from certain states in 2008, we now benefit from the fact that more than 90%
of
the insured United States population has policies that provide nearly full
reimbursement for the treatment of psoriasis by means of an excimer laser.
We
are now focusing our efforts on accelerating the adoption of the XTRAC laser
therapy for psoriasis and vitiligo by doctors and patients. Consequently, we
have increased the size of our sales force and clinical technician personnel
together with increased expenditures for marketing and advertising.
25
Our
32-person XTRAC sales organization includes 20 sales representatives, 9 clinical
specialists and 3 marketing support personnel. Our 25-person skin care sales
organization includes 19 sales representatives, 4 customer service
representatives and 2 marketing support personnel. The sales representatives
in
each segment provide follow-up sales support and share sales leads to enhance
opportunities for cross-selling. Our marketing department has been instrumental
in expanding the advertising campaign for the XTRAC laser system.
While
our
sales and marketing expenses have grown at nearly the same rate as 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 increase
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 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 and replacement parts 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
are 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. To compete with other non-laser UVB products, we offer
a
lower-priced, lamp-based system called the VTRAC. We expanded the international
marketing of the VTRAC since its introduction in 2006. The VTRAC is used to
treat psoriasis and vitiligo.
Skin
Care (ProCyte)
Skin
Care
generates revenues from the sale of skin health, hair care and wound care
products; the sale of copper peptide compound in bulk; and royalties on licenses
for the patented copper peptide compound.
ProCyte’s
focus has been to provide unique products, primarily based upon patented
technologies for selected applications in the dermatology, plastic and cosmetic
surgery and spa markets. ProCyte has also expanded the use of its novel copper
peptide technologies into the mass retail market for skin and hair care through
targeted technology licensing and supply agreements.
ProCyte’s
products are aimed at the growing demand for skin health and hair care products,
including products to enhance appearance and address the effects of aging on
skin and hair. ProCyte’s products are formulated, branded and targeted at
specific markets. ProCyte’s initial products addressed the dermatology, plastic
and cosmetic surgery markets for use after various procedures. Anti-aging skin
care products were added to offer a comprehensive approach for a patient’s skin
care regimen.
Our
customers have displayed strong interest in MD Lash Factor™ eyelash conditioner.
The growth in revenues from this product, however, have been offset, in part,
by
legal costs we incurred in the suit brought by Allergan against us and other
companies marketing eyelash conditioners.
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). Surgical product revenues decreased,
reflecting we believe that sales of surgical laser systems and the related
disposable base have eroded 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 increasing sales from the Diode
surgical laser introduced in 2004, including OEM arrangements.
26
In
September 2007, we entered into a three-year OEM agreement with AngioDynamics
under which we manufacture for AngioDynamics, on a non-exclusive basis, a
private-label, 980-nanometer diode laser system. The OEM agreement provides
that
we shall supply this laser on an exclusive basis to AngioDynamics, should
AngioDynamics meet certain purchase requirements. Through September 30, 2008
shipments to AngioDynamics exceeded the minimum purchase requirement for
delivery of lasers over the first contract year and therefore triggering
exclusivity for worldwide sale in the peripheral vascular treatment field.
Recently, however, AngioDynamics purchased the assets of a competitive diode
laser company, and if it elects to source its diodes through the assets so
purchased, our future sales of diode lasers to AngioDynamics under this
exclusive arrangement may be severely limited. There were no shipments to
AngioDynamics in the quarter ended September 30, 2008.
Sale
of Surgical Services Business
Surgical
Services is a fee-based procedures business using mobile surgical laser
equipment operated by our technicians at hospitals and surgery centers in the
United States. We decided to sell this division primarily because the growth
rates and operating margins of the division have decreased as the business
had
changed to rely more heavily upon procedures performed using equipment from
third-party suppliers, thereby limiting the profit potential of these services.
After preliminary investigations and discussions, our Board of Directors decided
on June 13, 2008 to enter into, with the aid of its investment banker,
substantive, confidential discussions with potential third-party buyers and
began to develop plans for implementing a disposal of the assets and operations
of the business. On August 1, 2008, we entered into a definitive agreement
to
sell specific assets of the business including accounts receivable, inventory
and equipment, for $3,500,000, subject to certain closing adjustments. The
sale
closed on August 8, 2008 and such closing adjustments resulted in net proceeds
to us of $3,149,737.
Proposed
Acquisition of the Subsidiaries of Photo Therapeutics Group, Limited and
Proposed Investment by Perseus, L.L.C.
On
August
4, 2008, we entered into a Purchase Agreement with Photo Therapeutics Group,
Limited (“Photo
Therapeutics”) and
a
Securities Purchase Agreement with an affiliate of Perseus, L.L.C. (“Perseus”).
Under
the
Purchase Agreement with Photo Therapeutics, we will acquire from Photo
Therapeutics the common stock of its subsidiaries (Photo Therapeutics Limited
in
the United Kingdom and Photo Therapeutics, Inc. in California) for $13 million
in cash at closing, and up to an additional $7 million in cash if certain gross
profit milestones are met by the Photo Therapeutics subsidiaries between July
1,
2008 and June 30, 2009, subject to customary adjustments. Under the Securities
Purchase Agreement with Perseus, an investment fund managed by Perseus will
fund
the acquisition of the Photo Therapeutics subsidiaries through a convertible
debt investment of up to $25 million (with associated warrants), to be made
in
two tranches as described below.
The
proposed acquisition and investment are subject to customary closing conditions,
including approval by the shareholders of Photo Therapeutics of the proposed
acquisition and approval by our stockholders of the proposed investment by
Perseus and of a reverse split of the outstanding shares of our common stock
at
a ratio as may be agreed between us and Perseus. The shareholders of Photo
Therapeutics have approved the transaction. The proposed acquisition and the
first tranche of the proposed investment by Perseus are expected to close
concurrently, most likely in the first quarter of 2009.
We
have
agreed under our Securities Purchase Agreement, subject to stockholder approval,
to issue to Perseus (i) convertible promissory notes (the “Notes”) in the
aggregate principal amount of up to $25 million, convertible into shares of
our
common stock, (ii) warrants to purchase shares of our common stock (the
“Warrants”), and (iii) 327,521 shares of common stock (the “First Tranche
Shares” and together with the Warrants, the Notes and any shares of our common
stock issued upon conversion of the Notes or exercise of the Warrants, the
“Securities”), in exchange for Perseus’ payment to us of an aggregate purchase
price of up to $25 million (the “Financing Transaction”). The consummation
of the Financing Transaction will occur in two tranches.
The
closing of the first tranche of the Financing Transaction (the “First Tranche
Closing”) will occur simultaneously with the closing of the Photo Therapeutics
closing. In the event that the First Tranche Closing occurs, in exchange for
Perseus’ investment of $18 million, we will issue to Perseus (i) a Note in the
principal amount of $18 million (the “First Tranche Note”), convertible into
24,411,414 shares of our common stock at a conversion price per share equal
to
$0.73736 (the “First Tranche Conversion Price”), each subject to adjustment upon
certain conditions, (ii) a Warrant to purchase 7,323,424 shares of our common
stock (the “First Tranche Warrant”), at an exercise price per share equal to the
First Tranche Conversion Price, each subject to adjustment upon certain
conditions, and (iii) the First Tranche Shares. The First Tranche Conversion
Price is subject to anti-dilution provisions in connection with certain future
issuances of our securities as well as adjustments for stock splits and similar
actions. The First Tranche Note will mature on the fifth anniversary of the
date
of the First Tranche Closing and will accrue interest at 8% per annum. Interest
is payable in cash or through our issuance of an additional Note at our
election, on the six month anniversary of the date of the First Tranche Closing
and on each six month period thereafter.
27
In
the
event that the Second Tranche Closing occurs, in accordance with the terms
and
conditions of the Securities Purchase Agreement, in exchange for Perseus’
investment of a maximum of $7 million, we will issue to Perseus (i) a Note
(the
“Second Tranche Note”) in the principal amount of the investment amount,
convertible into a number of shares of our common stock at the Second Tranche
Conversion Price (as defined below), subject to adjustment upon certain
conditions, and (ii) a Warrant to purchase a number of shares of our common
stock equal to 30% of the shares of our common stock into which the Second
Tranche Note is convertible, at an exercise price per share equal to the Second
Tranche Conversion Price, subject to adjustment upon certain conditions (the
“Second Tranche Warrant”). The “Second Tranche Conversion Price” will equal the
lesser of (i) 150% of the conversion price then in effect with respect to the
First Tranche Note, and (ii) the market price of our common stock measured
in
accordance with the terms of the Securities Purchase Agreement. The Second
Tranche Conversion Price is subject to anti-dilution provisions in connection
with certain future issuances of our securities at a lower price per share
of
common stock as well as adjustments for stock splits and similar actions. The
Second Tranche Note will mature on the fifth anniversary of the date of the
First Tranche Closing and will accrue interest at 8% per annum. Interest is
payable in cash or though our issuance of an additional Note at our election,
on
the six-month anniversary of the date of the Second Tranche Closing and on
each
six-month period thereafter.
Each
of
the First Tranche Note and the Second Tranche Note will provide that if on
any date that occurs 31 trading days after the date of issuance, the market
price for our common stock, as determined in accordance with the terms and
conditions of the Securities Purchase Agreement, exceeds 300% of the
then-effective conversion price of each Note, then the entire principal amount
and all accrued but unpaid interest under such Note will automatically convert
into shares of our common stock at the then-effective conversion price (the
“Mandatory Conversion Feature”).
The
First
Tranche Warrant and the Second Tranche Warrant are exercisable at any time
after
the issue date for a period of 8 years thereafter.
We
have
begun to act as a distributor of Omnilux® products of Photo Therapeutics in the
United States. We have also leased additional office space in Carlsbad,
California and sublet some of that space to Photo Therapeutics, Inc. as its
previous lease was about to expire.
Further
information on the acquisition and investment can be obtained from our Current
Report filed on Form 8-K on August 4, 2008.
Critical
Accounting Policies
There
have been no changes to our critical accounting policies in the three and nine
months ended September 30, 2008. 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, 2007.
28
Results
of Operations
Revenues
The
following table presents revenues from our four business segments for the
periods indicated below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
XTRAC
Domestic Services
|
$
|
3,001,878
|
$
|
2,025,148
|
$
|
8,546,583
|
$
|
6,048,000
|
|||||
International
Dermatology Equipment Products
|
1,096,853
|
819,442
|
2,963,031
|
2,117,213
|
|||||||||
Skin
Care (ProCyte) Products
|
3,627,940
|
3,065,905
|
10,327,189
|
9,646,312
|
|||||||||
Total
Dermatology Revenues
|
7,726,671
|
5,910,495
|
21,836,803
|
17,811,525
|
|||||||||
Surgical
Products
|
1,070,455
|
1,112,176
|
4,680,936
|
3,730,107
|
|||||||||
Total
Surgical Revenues
|
1,070,455
|
1,112,176
|
4,680,936
|
3,730,107
|
|||||||||
Total
Revenues
|
$
|
8,797,126
|
$
|
7,022,671
|
$
|
26,517,739
|
$
|
21,541,632
|
Domestic
XTRAC Segment
Recognized
treatment revenue for the three months ended September 30, 2008 and 2007 for
domestic XTRAC procedures was $1,967,748 and $1,716,383, respectively,
reflecting billed procedures of 36,079 and 27,858, respectively. In addition,
1,800 and 1,229 procedures were performed in the three months ended September
30, 2008 and 2007, 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, 2008 and 2007 for
domestic XTRAC procedures was $5,870,803 and $4,711,075, respectively,
reflecting billed procedures of 98,374 and 80,651, respectively. In addition,
4,449 and 3,677 procedures were performed in the nine months ended September
30,
2008 and 2007, 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, 2008 compared to the comparable
periods in 2007 was largely related to our continuing progress in securing
favorable reimbursement policies from private insurance plans and to our
increased marketing programs. Increases in procedures are dependent upon
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, 2008,
we
deferred net revenues of $15,496 (238 procedures) under this program compared
to
$19,494 (300 procedures) for the three months ended September 30, 2007. For
the
nine months ended September 30, 2008, we deferred net revenues of $74,343 (1,139
procedures) under this program compared to $173,369 (2,650 procedures) for
the
nine months ended September 30, 2007. The change in deferred revenue under
this
program is presented in the table below.
For
the
three and nine months ended September 30, 2008, domestic XTRAC laser sales
were
$1,034,130 and $2,675,780, respectively. There were 21 and 51 lasers sold,
respectively. 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. Included in the three and nine months ended
September 30, 2008 laser sales was a sale of one Omnilux®
product
for which we are now a distributor. Laser sales are 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 reasonable margins, a
sector of the market that is better suited to a sale model than a per-procedure
model.
29
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,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Total
revenue
|
$
|
3,001,878
|
$
|
2,025,148
|
$
|
8,546,583
|
$
|
6,048,000
|
|||||
Less:
laser sales revenue
|
(1,034,130
|
)
|
(308,765
|
)
|
(2,675,780
|
)
|
(1,336,925
|
)
|
|||||
Recognized
treatment revenue
|
1,967,748
|
1,716,383
|
5,870,803
|
4,711,075
|
|||||||||
Change
in deferred program Revenue
|
15,496
|
19,494
|
74,343
|
173,369
|
|||||||||
Change
in deferred unused Treatments
|
367,199
|
71,893
|
474,877
|
392,635
|
|||||||||
Net
billed revenue
|
$
|
2,350,443
|
$
|
1,807,770
|
$
|
6,420,023
|
$
|
5,277,079
|
|||||
Procedure
volume total
|
37,879
|
29,087
|
102,823
|
84,328
|
|||||||||
Less:
Non-billed procedures
|
1,800
|
1,229
|
4,449
|
3,677
|
|||||||||
Net
billed procedures
|
36,079
|
27,858
|
98,374
|
80,651
|
|||||||||
Avg.
price of treatments billed
|
$
|
65.15
|
$
|
64.89
|
$
|
65.26
|
$
|
65.43
|
|||||
Change
in procedures with deferred program revenue, net
|
238
|
300
|
1,139
|
2,650
|
|||||||||
Change
in procedures with deferred unused treatments, net
|
5,636
|
1,108
|
7,277
|
6,001
|
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.
International
Dermatology Equipment Segment
International
sales of our XTRAC and VTRAC systems and related parts were $1,096,853 for
the
three months ended September 30, 2008 compared to $819,442 for the three months
ended September 30, 2007. We sold 25 and 15 systems in the three month periods
ended September 30, 2008 and 2007, respectively. International sales of our
XTRAC and VTRAC systems were $2,963,031 for the nine months ended September
30,
2008 compared to $2,117,213 for the nine months ended September 30, 2007. We
sold 63 and 40 systems in the nine months ended September 30, 2008 and 2007,
respectively. The average price of dermatology equipment sold internationally
varies due to the quantities of refurbished domestic XTRAC systems and VTRACs
sold. Both of these products have lower average selling prices than new XTRAC
laser systems. However, by adding these to our product offerings along with
expanding into new geographic territories where the products are sold, we have
been able to increase overall international dermatology equipment
revenues.
· |
We
sell refurbished domestic XTRAC laser systems into the international
market. The selling price for used equipment is substantially less
than
new equipment, some of which may be substantially depreciated in
connection with its use in the domestic market. We sold two and six
such
used lasers in the three and nine months ended September 30, 2008,
respectively, at an average price of $32,500 and $31,667, respectively.
We
sold one and four such lasers in the three and nine months ended
September
30, 2007, respectively, at an average price of $44,790 and $36,197,
respectively; and
|
· |
In
addition to the XTRAC laser system (both new and used) we sell the
VTRAC,
a lamp-based, alternative UVB light source that has a wholesale sales
price that is below our competitors’ international dermatology equipment
and below our XTRAC laser. In the three and nine months ended September
30, 2008, we sold nine and nineteen VTRAC systems respectively. In
the
three and nine months ended September 30, 2007, we sold one and ten
VTRAC
systems, respectively.
|
30
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,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Revenues
|
$
|
1,096,853
|
$
|
819,442
|
$
|
2,963,031
|
$
|
2,117,213
|
|||||
Less:
part sales
|
(138,853
|
)
|
(112,152
|
)
|
(530,031
|
)
|
(381,223
|
)
|
|||||
Laser/lamp
revenues
|
958,000
|
707,290
|
2,433,000
|
1,735,990
|
|||||||||
Laser/lamp
systems sold
|
25
|
15
|
63
|
40
|
|||||||||
Average
revenue per laser/lamp
|
$
|
38,320
|
$
|
47,153
|
$
|
38,619
|
$
|
43,400
|
Skin
Care (ProCyte) Segment
For
the
three months ended September 30, 2008, ProCyte revenues were $3,627,940 compared
to $3,065,905 in the three months ended September 30, 2007. For the nine months
ended September 30, 2008, ProCyte revenues were $10,327,189 compared to
$9,646,312 in the nine months ended September 30, 2007. 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 $80,000 for the nine months ended September 30,
2008
compared to the nine months ended September 30, 2007. Minimum contractual
royalties from Neutrogena expired in November 2007 and as such the royalties
decreased $73,387 and $220,200 for the three and nine months ended September
30,
2008, respectively, compared to the same periods in the prior year.
· |
Included
in Product sales for the three months ended September 30, 2008 were
$1,139,204 of revenues from MD Lash Factor, an eyelash conditioning
product, as part of an exclusive license to distribute in the United
States. For the nine months ended September 30, 2008, there were
$2,247,038 revenues from MD Lash Factor. In the comparable periods
in 2007
there were only $257,124 revenues as the product was launched in
August
2007. The supply chain for this product remains threatened through
litigation brought by Allergan. We understand that the domestic supplier
for a key ingredient in the product has settled with Allergan and
undertaken to cease supplying such ingredient domestically to our
licensor. This could disrupt, or even interdict, our ability to be
timely
and reliably supplied with the product.
|
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,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Product
sales
|
$
|
3,530,327
|
$
|
2,894,905
|
$
|
10,066,389
|
$
|
9,085,312
|
|||||
Bulk
compound sales
|
96,000
|
96,000
|
256,000
|
336,000
|
|||||||||
Royalties
|
1,613
|
75,000
|
4,800
|
225,000
|
|||||||||
Total
ProCyte revenues
|
$
|
3,627,940
|
$
|
3,065,905
|
$
|
10,327,189
|
$
|
9,646,312
|
31
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.
Laser
fibers and laser disposables are more profitable than laser systems, but the
sales of laser systems create the recurring revenue stream from fibers and
disposables.
For
the
three months ended September 30, 2008, surgical products revenues were
$1,070,455 compared to $1,112,176 in the three months ended September 30, 2007.
For the nine months ended September 30, 2008, surgical products revenues were
$4,680,936 compared to $3,730,107 in the nine months ended September 30, 2007.
The increase in the nine-month periods was mainly due to our OEM contract with
AngioDynamics, which had initial shipments in December 2007. Recently, however,
AngioDynamics purchased the assets of a competitive diode laser, and if it
elects to source its diodes through the assets which it has purchased, our
future sales of diode lasers to AngioDynamics may be severely limited. Sales
to
AngioDynamics were $0 for the three months ended September 30, 2008. Sales
to
AngioDynamics were $1.4 million for the nine months ended September 30, 2008.
There were no comparable sales in the prior year period.
The
change in average price per laser between the periods, as set forth in the
table
below, was largely due to the mix of lasers sold and partly due to the trade
level at which the lasers were sold (i.e. wholesale versus retail). Our diode
laser has replaced our Nd:YAG laser, which had a higher sales price. Included
in
laser sales during the three months ended September 30, 2008 and 2007 were
sales
of 7 and 19 diode lasers, respectively. Included in laser sales during the
nine
months ended September 30, 2008 and 2007 were sales of 130 and 47 diode lasers,
respectively. The diode lasers have lower sales prices than our other types
of
lasers, and thus the increase in the number of diodes sold reduced the average
price per laser. We expect that we will continue to sell more diode lasers
than
our other types of lasers into the near future.
Fiber
and
other disposables sales decreased 3% between the comparable nine-month periods
ended September 30, 2008 and 2007. 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.
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,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Revenues
|
$
|
1,070,455
|
$
|
1,112,176
|
$
|
4,680,936
|
$
|
3,730,107
|
|||||
Laser
systems sold
|
8
|
19
|
134
|
55
|
|||||||||
Laser
system revenues
|
$
|
171,393
|
$
|
285,995
|
$
|
2,080,133
|
$
|
1,120,035
|
|||||
Average
revenue per laser
|
$
|
21,424
|
$
|
15,052
|
$
|
15,523
|
$
|
20,364
|
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, as well as costs associated with royalties
and maintenance.
Product
cost of revenues for the three months ended September 30, 2008 was $2,828,986,
compared to $2,154,567 in the comparable period in 2007. The $674,419 increase
is due to the increases in product cost of sales for domestic XTRAC laser sales
in the amount of $271,321 and international dermatology equipment sales in
the
amount of $130,569, both due to an increased number of laser sales. In addition,
there was an increase in product costs in skincare products of $385,258 due
to
increased product sales. These increases were offset, in part, by a decrease
in
surgical products of $112,729.
32
Product
cost of revenues for the nine months ended September 30, 2008 was $8,682,917
compared to $6,703,251 for the nine months ended September 30, 2007. The
increase of $1,979,666 is proportionate to the increase in product cost of
sales
for domestic XTRAC laser sales in the amount of $590,315, international
dermatology equipment sales in the amount of $441,553 and surgical products
of
$449,807, all due to increased number of laser sales. In addition, there was
an
increase in product costs in skincare products of $497,991 due to increased
product sales.
Services
cost of revenues was $1,240,670 in the three months ended September 30, 2008
compared to $982,786 in the comparable period in 2007 representing an increase
of $257,884. The increase is directly related to the increase in Domestic XTRAC
segment costs of $257,506.
Services
cost of revenues was $3,539,872 in the nine months ended September 30, 2008
compared to $2,979,536 in the comparable period in 2007 representing an increase
of $560,336. The increase is directly related to the increase in Domestic XTRAC
segment costs of $560,049.
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,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Product:
|
|||||||||||||
XTRAC
Domestic
|
$
|
406,612
|
$
|
135,291
|
$
|
1,076,295
|
$
|
485,980
|
|||||
International
Dermatology Equipment
|
586,865
|
456,296
|
1,493,553
|
1,052,000
|
|||||||||
Skin
Care
|
1,288,946
|
903,688
|
3,429,410
|
2,931,419
|
|||||||||
Surgical
products
|
546,563
|
659,292
|
2,683,659
|
2,233,852
|
|||||||||
Total
Product costs
|
$
|
2,828,986
|
$
|
2,154,567
|
$
|
8,682,917
|
6,703,251
|
||||||
Services:
|
|||||||||||||
XTRAC
Domestic
|
$
|
1,213,448
|
$
|
955,942
|
$
|
3,458,349
|
$
|
2,898,300
|
|||||
Surgical
products
|
27,222
|
26,844
|
81,523
|
81,236
|
|||||||||
Total
Services costs
|
$
|
1,240,670
|
$
|
982,786
|
$
|
3,539,872
|
$
|
2,979,536
|
|||||
Total
Costs of Revenues
|
$
|
4,069,656
|
$
|
3,137,353
|
$
|
12,222,789
|
$
|
9,682,787
|
Gross
Profit Analysis
Gross
profit increased to $4,727,470 during the three months ended September 30,
2008
from $3,885,318 during the same period in 2007. As a percent of revenues, gross
margin decreased to 53.7% for the three months ended September 30, 2008 from
55.3% for the same period in 2007.
Gross
profit increased to $14,294,950 during the nine months ended September 30,
2008
from $11,858,845 during the same period in 2007. As a percent of revenues,
gross
margin decreased to 53.9% for the nine months ended September 30, 2008 from
55.1% for the same period in 2007.
33
The
following table analyzes changes in our gross profit for the periods reflected
below:
Company
Profit Analysis
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Revenues
|
$
|
8,797,126
|
$
|
7,022,671
|
$
|
26,517,739
|
$
|
21,541,632
|
|||||
Percent
increase
|
25.3
|
%
|
23.1
|
%
|
|||||||||
Cost
of revenues
|
4,069,656
|
3,137,353
|
12,222,789
|
9,682,787
|
|||||||||
Percent
increase
|
29.7
|
%
|
26.2
|
%
|
|||||||||
Gross
profit
|
$
|
4,727,470
|
$
|
3,885,318
|
$
|
14,294,950
|
$
|
11,858,845
|
|||||
Gross
margin percentage
|
53.7
|
%
|
55.3
|
%
|
53.9
|
%
|
55.1
|
%
|
The
primary reasons for the changes in gross profit and the gross margin percentage
for the three months ended September 30, 2008, compared to the same period
in
2007 were as follows
· |
XTRAC
Domestic deferred revenues increased $291,308 between the periods
without
any offset in the cost of revenues which is consistent with a
procedures-based model.
|
· |
We
sold approximately $725,000 worth of additional domestic XTRAC lasers
in
the three months ended September 30, 2008 at higher margins compared
to
the same period in 2007. Certain of these lasers were previously
being
depreciated, since they were previously placements. The margin on
these
capital equipment sales was 61% in 2008 compared to 56% in
2007.
|
· |
We
sold a greater number of XTRAC treatment procedures in 2008 than
in 2007.
An incremental treatment procedure sold to any particular customer
carries
negligible variable cost. The increase in procedure volume was a
direct
result of improving insurance reimbursement and increased marketing
efforts.
|
The
primary reasons for the changes in gross profit and the gross margin percentage
for the nine months ended September 30, 2008, compared to the same period in
2007 were as follows
· |
An
increase in depreciation of $394,400 included in the XTRAC Domestic
cost
of sales as a result of increasing the overall placements.
|
· |
XTRAC
Domestic deferred revenues decreased $16,304 between the periods
without
any offset in the cost of revenues which is consistent with a
procedures-based model.
|
· |
We
sold approximately $1,339,000 worth of additional domestic XTRAC
lasers in
the nine months ended September 30, 2008 at lower margins compared
to the
same period in 2007. Certain of these lasers were previously being
depreciated, since they were previously placements. The margin on
these
capital equipment sales was 60% in 2008 compared to 64% in
2007.
|
· |
We
sold a greater number of XTRAC treatment procedures in 2008 than
in 2007.
An incremental treatment procedure sold to any particular customer
carries
negligible variable cost. The increase in procedure volume was a
direct
result of improving insurance reimbursement and increased marketing
efforts.
|
34
The
following table analyzes the gross profit for our Domestic XTRAC segment for
the
periods presented below:
XTRAC
Domestic Segment
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Revenues
|
$
|
3,001,878
|
$
|
2,025,148
|
$
|
8,546,583
|
$
|
6,048,000
|
|||||
Percent
increase
|
48.2
|
%
|
41.3
|
%
|
|||||||||
Cost
of revenues
|
1,620,060
|
1,091,233
|
4,534,644
|
3,384,280
|
|||||||||
Percent
increase
|
48.5
|
%
|
34.0
|
%
|
|||||||||
Gross
profit
|
$
|
1,381,818
|
$
|
933,915
|
$
|
4,011,939
|
$
|
2,663,720
|
|||||
Gross
margin percentage
|
46.0
|
%
|
46.1
|
%
|
46.9
|
%
|
44.0
|
%
|
Gross
profit increased for this segment for the three and nine months ended September
30, 2008 from the comparable periods in 2007 by $447,903 and $1,348,219,
respectively. In addition to the overall higher revenues between the periods,
other key factors for the increases were as follows:
· |
XTRAC
Domestic deferred revenues increased $291,308 between the three-month
periods without any offset in the cost of revenues which is consistent
with a procedures-based model. XTRAC Domestic deferred revenues decreased
$16,304 between the nine-month periods without any offsetting reduction
in
the cost of revenues which is consistent with a procedures-based
model.
|
· |
We
sold approximately $725,000 worth of additional domestic XTRAC lasers
in
the three months ended September 30, 2008 at higher margins compared
to
the same period in 2007. Certain of these lasers were previously
being
depreciated, since they were previously placements. The margin on
these
capital equipment sales was 61% in the three months ended September
30,
2008 compared to 56% in the comparable three- month period in 2007.
We
sold approximately $1,339,000 worth of additional domestic XTRAC
lasers in
the nine months ended September 30, 2008 at lower margins compared
to the
same period in 2007. Certain of these lasers were previously being
depreciated, since they were placements. The margin on these capital
equipment sales was 60% in the nine months ended September 30, 2008
compared to 64% in the comparable six-month period in
2007.
|
· |
The
cost of revenues increased by $528,827 for the three months ended
September 30, 2008. This increase is due to an increase in depreciation
on
the lasers-in-service of $87,500 and an increase in cost of revenues
related to the laser sales of $271,300 over the comparable prior
three-month period. In addition, there were increases in certain
allocable
XTRAC manufacturing overhead costs that are charged against the XTRAC
service revenues. The depreciation costs will continue to increase
in
subsequent periods as the business
grows.
|
· |
The
cost of revenues increased by $1,150,364 for the nine months ended
September 30, 2008. This increase is due to an increase in depreciation
on
the lasers-in-service of $394,400 and an increase in cost of revenues
related to the laser sales of $590,300 over the comparable prior
nine-month period. The depreciation costs will continue to increase
in
subsequent periods as the business
grows.
|
· |
Key
drivers in increasing the fee-per-procedure revenue from 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, increase treatment
revenue accordingly. Our clinical support specialists focus their
efforts
on increasing physicians’ utilization of the XTRAC laser system.
Consequently procedure volume increased 30% from 27,858 to 36,079
billed
procedures in the three months ended September 30, 2008 compared
to the
same period in 2007. Procedure volume increased 22% from 80,651 to
98,374
billed procedures in the nine months ended September 30, 2008 compared
to
the same period in 2007. Price per procedure did not change significantly
between the periods. Each incremental treatment procedure carries
negligible variable cost.
|
35
The
following table analyzes the gross profit for our International Dermatology
Equipment segment for the periods presented below:
International
Dermatology
Equipment
Segment
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Revenues
|
$
|
1,096,853
|
$
|
819,442
|
$
|
2,963,031
|
$
|
2,117,213
|
|||||
Percent
increase
|
33.9
|
%
|
39.9
|
%
|
|||||||||
Cost
of revenues
|
586,865
|
456,296
|
1,493,553
|
1,052,000
|
|||||||||
Percent
increase
|
28.6
|
%
|
42.0
|
%
|
|||||||||
Gross
profit
|
$
|
509,988
|
$
|
363,146
|
$
|
1,469,478
|
$
|
1,065,213
|
|||||
Gross
margin percentage
|
46.5
|
%
|
44.3
|
%
|
49.6
|
%
|
50.3
|
%
|
Gross
profit for the three and nine months ended September 30, 2008 increased by
$146,842 and $404,265, respectively, from the comparable periods in 2007. The
key factors for the increase were as follows:
· |
We
sold 16 XTRAC laser systems and 9 VTRAC lamp-based excimer systems
during
the three months ended September 30, 2008 and 14 XTRAC laser systems
and 1
VTRAC system in the comparable period in 2007. Consequently, gross
profit
increased as a result of an increase in the volume of units sold.
The
gross margin percentage for the VTRAC is higher than the
XTRAC.
|
· |
We
sold 44 XTRAC laser systems and 19 VTRAC lamp-based excimer systems
during
the nine months ended September 30, 2008 and 30 XTRAC laser systems
and 10
VTRAC systems in the comparable period in 2007. Consequently, gross
profit
increased as a result of an increase in the volume of units sold.
The
gross margin percentage for the VTRAC is higher than the
XTRAC.
|
· |
International
part sales, which have a higher margin percentage than system sales,
increased for the three and nine months ended September 30, 2008
by
approximately $27,000 and $149,000, respectively compared to the
same
period in 2007.
|
The
following table analyzes the gross profit for our SkinCare (ProCyte) segment
for
the periods presented below:
Skin
Care (ProCyte) Segment
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Product
revenues
|
$
|
3,530,327
|
$
|
2,894,905
|
$
|
10,066,389
|
$
|
9,085,312
|
|||||
Bulk
compound revenues
|
96,000
|
96,000
|
256,000
|
336,000
|
|||||||||
Royalties
|
1,613
|
75,000
|
4,800
|
225,000
|
|||||||||
Total
revenues
|
3,627,940
|
3,065,905
|
10,327,189
|
9,646,312
|
|||||||||
Product
cost of revenues
|
1,220,594
|
835,336
|
3,247,138
|
2,699,497
|
|||||||||
Bulk
compound cost of revenues
|
68,352
|
68,352
|
182,272
|
231,922
|
|||||||||
Total
cost of revenues
|
1,288,946
|
903,688
|
3,429,410
|
2,931,419
|
|||||||||
Gross
profit
|
$
|
2,338,994
|
$
|
2,162,217
|
$
|
6,897,779
|
$
|
6,714,893
|
|||||
Gross
margin percentage
|
64.5
|
%
|
70.5
|
%
|
66.8
|
%
|
69.6
|
%
|
36
Gross
profit increased for the three and nine months ended September 30, 2008 from
the
comparable periods by $176,777 and $182,886, respectively. In addition to higher
revenues between the periods, other key factors for the increases were as
follows:
· |
The
decrease in gross margin percentage is related to the product mix
of
revenues. For the three months ended September 30, 2008 and 2007
product
revenues include $1,139,204 and $257,124, respectively, under a licensing
agreement which are manufactured by a third-party supplier. The margin
of
these licensed products has a lower margin than other brands which
we
distribute.
|
· |
For
the nine months ended September 30, 2008 and 2007 product revenues
include
$2,247,038 and $257,124, respectively, of products which are manufactured
by a third-party supplier in conjunction with a licensing agreement.
The
margin of these licensed products has a lower margin than other brands
which we distribute.
|
· |
Copper
peptide bulk compound is sold at a substantially lower gross margin
than
skincare products, while royalty revenues generated from licensees
have no
significant costs associated with this revenue
stream.
|
The
following table analyzes the gross profit for our Surgical Products segment
for
the periods presented below:
Surgical
Products Segment
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Revenues
|
$
|
1,070,455
|
$
|
1,112,176
|
$
|
4,680,936
|
$
|
3,730,107
|
|||||
Percent
(decrease)/increase
|
(3.8
|
%)
|
25.5
|
%
|
|||||||||
Cost
of revenues
|
573,785
|
686,135
|
2,765,182
|
2,315,088
|
|||||||||
Percent
(decrease)/ increase
|
(16.4
|
%)
|
19.4
|
%
|
|||||||||
Gross
profit
|
$
|
496,670
|
$
|
426,041
|
$
|
1,915,754
|
$
|
1,415,019
|
|||||
Gross
margin percentage
|
46.4
|
%
|
38.3
|
%
|
40.9
|
%
|
37.9
|
%
|
Gross
profit for the Surgical Products segment in the three and nine months ended
September 30, 2008 compared to the same periods in 2007 increased by $70,629
and
$500,735, respectively. The key factors impacting gross profit 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, 2008 decreased by $41,721
from
the three months ended September 30, 2007 while cost of revenues
decreased
by $112,350 between the same periods. There were 11 less laser
systems
sold in the three months ended September 30, 2008 than in the comparable
period of 2007. However, the lasers sold in the 2008 period were
at higher
prices than those sold in the comparable period in 2007. The increase
in
average price per laser was largely due to the mix of lasers sold
and
volume discounts. Included in the laser sales for the three months
ended
September 30, 2008 and 2007 were sales of $111,000, representing
7
systems, and $286,000, representing 19 systems, of diode lasers,
respectively, which have substantially lower list sales prices
than the
other types of surgical lasers.
|
·
|
Revenues
for the nine months ended September 30, 2008 increased by $950,829
from
the nine months ended September 30, 2007 while cost of revenues
increased
by $450,094 between the same periods. There were 79 more laser
systems
sold in the nine months ended September 30, 2008 than in the comparable
period of 2007. However, the lasers sold in the 2007 period were
at higher
prices than those sold in the comparable period in 2008. The decrease
in
average price per laser was largely due to the mix of lasers sold
and
volume discounts. Included in the laser sales for the nine months
ended
September 30, 2008 and 2007 were sales of $1,870,000, representing
130
systems, and $686,000, representing 47 systems, of diode lasers,
respectively, which have substantially lower list sales prices
than the
other types of surgical lasers. The sales of diode systems included
100
sales due to our OEM arrangement. Despite the lower average sales
price of
the laser systems sold compared to the prior year, the higher
manufacturing levels in 2008 caused better absorption of fixed
overheads
thereby lowering average unit costs resulting in a higher gross
margin in
2008 compared to 2007.
|
·
|
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 3% between
the
comparable nine-month periods ended September 30, 2008 and 2007.
|
37
Selling,
General and Administrative Expenses
For
the
three months ended September 30, 2008, selling, general and administrative
expenses increased to $6,209,101 from $5,377,955 for the three months ended
September 30, 2007 for the following reasons:
· |
The
majority of the increase related to a $636,000 increase in salaries,
benefits and travel expenses associated with an increase in the
sales
force, marketing programs and increased revenues which generate
higher
commission expense, particularly in the Domestic XTRAC and SkinCare
segments.
|
For
the
nine months ended September 30, 2008, selling, general and administrative
expenses increased to $18,459,602 from $16,523,894 for the nine months ended
September 30, 2007 for the following reasons:
· |
The
majority of the increase related to a $2,400,000 increase in salaries,
benefits and travel expenses associated with an increase in the
sales
force, marketing programs and increased revenues which generate
higher
commission expense, particularly in the Domestic XTRAC and SkinCare
segments;
|
· |
These
increases were offset, in part, by a lawsuit settlement for reimbursement
of legal costs of $345,000 and a decrease in option expense of
$110,000.
|
Engineering
and Product Development
Engineering
and product development expenses for the three months ended September 30,
2008
increased to $224,236 from $202,163 for the three months ended September
30,
2007. Engineering and product development expenses for the nine months ended
September 30, 2008 increased to $881,268 from $603,636 for the nine months
ended
September 30, 2007. The increase for the nine months was due to meeting our
financial sponsorship obligations in March 2008 for the severe psoriasis
study
by John Koo, MD, of the University of California at San Francisco, of $189,000.
During the 2008 and 2007 periods, the engineers at the Carlsbad plant were
primarily focused on manufacturing efforts, and therefore, their costs have
been
reflected in cost of goods sold.
Interest
Expense, Net
Net
interest expense for the three months ended September 30, 2008 increased
to
$251,883, as compared to $141,562 for the three months ended September 30,
2007.
Net interest expense for the nine months ended September 30, 2008 increased
to
$761,020, as compared to $379,947 for the nine months ended September 30,
2007.
The change in net interest expense was the result of the interest earned
on cash
reserves in the three and nine months ended September 30, 2007 due to the
equity
financing in November 2006, which offset interest expense in those periods
due
to draws on the line of credit during the fourth quarter of 2007 and the
first,
second and third quarters of 2008. The following table illustrates the change
in
interest expense, net:
Three
Months Ended
|
||||||||||
September
30, 2008
|
September
30, 2007
|
Change
|
||||||||
Interest
expense
|
$
|
276,590
|
$
|
236,728
|
$
|
39,862
|
||||
Interest
income
|
(24,707
|
)
|
(95,166
|
)
|
70,459
|
|||||
Net
interest expense
|
$
|
251,883
|
$
|
141,562
|
$
|
110,321
|
Nine
Months Ended
|
||||||||||
September
30, 2008
|
September
30, 2007
|
Change
|
||||||||
Interest
expense
|
$
|
892,932
|
$
|
700,383
|
$
|
192,549
|
||||
Interest
income
|
(131,913
|
)
|
(320,436
|
)
|
188,523
|
|||||
Net
interest expense
|
$
|
761,019
|
$
|
379,947
|
$
|
381,072
|
38
Net
Loss
The
aforementioned factors resulted in a net loss of $1,787,505 during the three
months ended September 30, 2008, as compared to a net loss of $1,652,972
during
the three months ended September 30, 2007, an increase of 8.1%. The
aforementioned factors resulted in a net loss of $5,936,669 during the nine
months ended September 30, 2008, as compared to a net loss of $5,372,211
during
the nine months ended September 30, 2007, an increase of 10.5%. The three
months
ended September 30, 2008 included a change in the loss on sale of discontinued
operations of $131,186. The nine months ended September 30, 2008 included
a loss
on sale of discontinued operations of $414,658.
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,
|
||||||||||
2008
|
2007
|
Change
|
||||||||
Net
loss
|
$
|
1,787,505
|
$
|
1,652,972
|
$
|
134,533
|
||||
Select
major expenses included in net loss:
|
||||||||||
Depreciation
and amortization
|
1,038,428
|
1,231,111
|
(192,683
|
)
|
||||||
Stock-based
compensation
|
382,228
|
395,058
|
(12,830
|
)
|
||||||
Total
select major expenses
|
$
|
1,420,656
|
$
|
1,626,169
|
($205,513
|
)
|
For
the Nine months ended September 30,
|
||||||||||
2008
|
2007
|
Change
|
||||||||
Net
loss
|
$
|
5,936,669
|
$
|
5,372,211
|
$
|
564,458
|
||||
Select
major expenses included in net loss:
|
||||||||||
Depreciation
and amortization
|
3,447,891
|
3,563,026
|
(115,135
|
)
|
||||||
Stock-based
compensation
|
1,087,699
|
1,197,150
|
(109,451
|
)
|
||||||
Total
select major expenses
|
$
|
4,535,590
|
$
|
4,760,176
|
($224,586
|
)
|
Liquidity
and Capital Resources
We
have
historically financed our operations with cash provided by equity financing
and
from lines of credit and, more recently, occasionally from positive cash
flows
from operations.
At
September 30, 2008, our current ratio was 1.54 compared to 2.20 at December
31,
2007. As of September 30, 2008, we had $7,511,538 of working capital compared
to
$13,705,775 as of December 31, 2007. Cash and cash equivalents were $6,808,793
as of September 30, 2008, as compared to $9,954,303 as of December 31, 2007.
We
had $78,000 and $117,000 of cash that was classified as restricted as of
September 30, 2008 and December 31, 2007, respectively.
39
We
believe that our existing cash balance together with our other existing
potential financial resources and any revenues from sales and distribution,
will
be sufficient to meet our operating and capital requirements beyond the end
of
fourth quarter of 2009. The 2008 operating plan reflects anticipated growth
from
both increased 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 2008 operating plan calls for increased revenues
and profits from our Skin Care business, much of which will be based on new
products recently introduced into the market.
On
December 31, 2007, we entered into a term-note credit facility from CIT
Healthcare and Life Sciences Capital (collectively “CIT”). The credit facility
has a commitment term of one year, expiring on December 31, 2008. We account
for
each draw as funded indebtedness, with ownership in the lasers remaining
with
us. CIT holds a security interest in the lasers and in their revenue streams.
Each draw against the credit facility has a repayment period of three years,
except for legacy components from GE and Leaf in the first draw. The facility
was amended to permit us to make a fourth draw of $1.9 million in the third
quarter of 2008; Life Sciences Capital did not participate in the fourth
draw.
The
Company has used its entire availability under the CIT credit facility and
is
considering multiple written proposals, including from CIT, for additional
debt
financing, however, no assurance can be given that any such proposal will
materialize on terms favorable to us. We also have proposal from Perseus,
LLC to
fund $5 million of working capital as part of the first tranche of the
convertible debt contemplated for its acquisition of Photo Therapeutics.
A
summary of the terms and activity under the CIT credit facility is presented
in
Note 9, “Long-term
Debt”,
of the
Financial Statements included in this Report.
Net
cash
and cash equivalents used in operating activities - continuing operations
was
$95,661 for the nine months ended September 30, 2008 compared to cash used
of
$1,450,090 for the nine months ended September 30, 2007. The decrease was
mostly
due to the increases in accounts payable and other accrued liabilities offset,
in part, by increases in accounts receivables.
Net
cash
and cash equivalents used in investing activities - continuing operations
was
$4,082,859 for the nine months ended September 30, 2008 compared to $3,268,379
for the nine months ended September 30, 2007. This was primarily for the
placement of lasers into service.
When
we
retire a laser from service, we transfer the laser into inventory and then
write
off the net book value of the laser, which is typically negligible. Over
the
last few years, in fact, the retirements of lasers from service have been
minor
or immaterial and, therefore, they are reported with placements on a net
basis.
Net
cash
and cash equivalents used in financing activities was $1,013,091 for the
nine
months ended September 30, 2008 compared to $201,005 for the nine months
ended
September 30, 2007. In the nine months ended September 30, 2008 we repaid
$272,316 on the lease and term-note lines of credit, net of advances and
$779,775 for the payment of certain notes payable and capital lease
obligations.
Commitments
and Contingencies
Except
for items discussed in Legal
Proceedings
below,
during the three and nine months ended September 30, 2008, there were no
other
items that significantly impacted our commitments and contingencies as discussed
in the notes to our 2007 annual financial statements included in our Annual
Report on Form 10-K. In addition, we have no significant off-balance sheet
arrangements.
Impact
of Inflation
We
have
not operated in a highly inflationary period, and we do not believe that
inflation has had a material effect on sales or expenses.
ITEM
3. Quantitative and Qualitative Disclosure about Market
Risk
We
are
not currently exposed to market risks due to changes in interest rates and
foreign currency rates and, therefore, we do not use derivative financial
instruments to address treasury risk management issues in connection with
changes in interest rates and foreign currency rates.
40
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, 2008 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, 2007 for descriptions
of our legal proceedings.
In
the
matter brought by the Company in January 2004 against Ra Medical Systems,
Inc.
and Dean Irwin in the United States District Court for the Southern District
of
California, we appealed from the new judge’s grant of summary judgment to the
defendants. All parties have filed their briefs with the Ninth Circuit of
Appeals, and we continue to await a date for oral argument.
In
the
matter which Ra Medical brought against the Company in June 2006 for unfair
competition and which the Company removed to the United States District Court
for the Southern District of California, the Company has filed a new notice
of
appeal to the Ninth Circuit from the new judge's dismissal, among other things,
of the Company's counterclaims of misappropriation. Our opening brief on
appeal
is currently due January 20, 2009. Ra Medical filed a motion for summary
adjudication in the District Court on its sole claim that we had violated
provisions of the California Health & Safety Code and thus violated Section
17200 of the California Business & Professions Code. The District Court has
partially granted that motion, finding as a matter of fact which requires
no
further proof that we operated our business for a period of time without
the
required licensing under California law. The plaintiffs, however, failed
to
prove that the lack of such a license constituted unfair competition under
Section 17200. We are in process of bringing our own motion for summary judgment
that our actions did not amount to unfair competition under that section
of the
California Code.
In
the
patent infringement suit brought in November 2007, Allergan, Inc. brought
an
infringement suit under the Johnstone ‘105 patent against PhotoMedex, Inc., as
well as against a number of other co-defendants, in the United States District
Court for the Central District of California. Allergan has also amended its
complaint, alleging that PhotoMedex and others have also infringed its US
Patent
No. 7,351,404, the Woodward ‘404 patent and that ProCyte Corporation infringes
both the ‘105 and ‘404 patents. Discovery continues in the case at considerable
cost. We understand that the co-defendant domestic supplier for a key ingredient
in the product has settled with Allergan and undertaken to cease supplying
such
ingredient domestically to our licensor. We are concerned that this could
disrupt, or interdict, our ability to be timely and reliably supplied with
the
product.
In
the
patent infringement action brought in February 2008 by Cardiofocus, Inc.
against
PhotoMedex, Inc., as well as against a number of other co-defendants, we
have
settled the matter with Cardiofocus on July 16, 2008, on terms fair and
favorable to us.
41
In
the
patent infringement action brought by Bella Bella, Inc. against a number
of
companies, including PhotoMedex, Inc. and ProCyte Corporation, in the United
States District Court for the Central District of California, plaintiff’s
attorneys have allowed the case to be dismissed without prejudice on July
11,
2008.
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,
the
above litigation and claims will likely be resolved without a material effect
on
our consolidated financial position, results of operations or
liquidity.
ITEM
1A. Risk Factors
In
response to turmoil in the stock markets in October 2008, Nasdaq has suspended,
until January 16, 2009, the enforcement of its minimum bid requirement. We
expect that Nasdaq will issue a delisting notice to us on January 22, 2009
if we
have not regained compliance by that time.
Consummation
of the acquisition of Photo Therapeutics is contingent on obtaining financing
for it. The proposed financing from Perseus is contingent on approval of
our
stockholders not only of the terms of that financing, but also of a reverse
split of our shares and of an increase in the number of our authorized shares
of
common stock. We have filed a preliminary proxy with the SEC to effect these
and
other matters; the SEC has elected to review our proxy, and this review will
have the likely effect of moving the necessary meeting of stockholders into
2009.
Current
economic conditions may cause a decline in business and consumer spending
which
could adversely affect our business and financial performance. Our operating
results are impacted by the health of the North American economies. Our business
and financial performance, including collection of our accounts receivable,
realization of inventory, recoverability of assets including investments,
may be
adversely affected by current and future economic conditions, such as a
reduction in the availability of credit, financial market volatility, recession,
etc. Additionally, we may experience difficulties in scaling our operations
to
react to economic pressures in the United States.
ITEM
5. Other Information
The
SEC
has elected to review our preliminary proxy filing, filed October 2, 2008.
We
are in the process of responding to the SEC’s comments. It will be impracticable
to hold the Stockholders’ meeting in November 2008; it is uncertain whether we
will be able to hold a meeting for non-routine matters by December 31,
2008.
ITEM
6. Exhibits
10.43
|
Asset
Purchase Agreement, dated August 1, 2008, by and between PhotoMedex,
Inc.
and PRI Medical Technologies, Inc., filed August 4, 2008, on Form
8-K
Current Report.
|
10.44
|
Purchase
Agreement, dated August 4, 2008, by and among PhotoMedex, Inc.,
Photo
Therapeutics Group Limited and Neil Crabb, filed August 4, 2008,
on Form
8-K Current Report.
|
10.45
|
Securities
Purchase Agreement, dated August 4, 2008, by and between PhotoMedex,
Inc.
and Perseus Partners VII, LP, filed August 4, 2008 on Form 8-K
Current
Report.
|
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
|
42
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 7, 2008 | By: | /s/ Jeffrey F. O’Donnell |
Jeffrey
F. O’Donnell
President
and Chief Executive Officer
|
|
|
|
Date: November 7, 2008 | By: | /s/ Dennis M. McGrath |
Dennis
M. McGrath
Chief
Financial Officer
|
43