Gadsden Properties, Inc. - Quarter Report: 2005 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, 2005
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
|
59-2058100
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
incorporation
or organization)
|
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 an accelerated filer (as defined
in Rule
12b-2 of the Exchange Act.)
Yes
ý
No
¨
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
8, 2005
was 51,285,725 shares.
1
PHOTOMEDEX,
INC. AND SUBSIDIARIES
INDEX
Part
I. Financial Information:
|
PAGE
|
||
ITEM
1. Financial Statements:
|
|||
a.
|
Consolidated
Balance Sheets, September 30, 2005 (unaudited) and
December
31, 2004
|
3
|
|
b.
|
Consolidated
Statements of Operations for the three months
ended
September 30, 2005 and 2004 (unaudited)
|
4
|
|
c.
|
Consolidated
Statements of Operations for the nine months
ended
September 30, 2005 and 2004 (unaudited)
|
5
|
|
d.
|
Consolidated
Statement of Stockholders’ Equity for the nine months
ended
September 30, 2005 (unaudited)
|
6
|
|
e.
|
Consolidated
Statements of Cash Flows for the nine months
ended
September 30, 2005 and 2004 (unaudited)
|
7
|
|
f.
|
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
|
44
|
||
ITEM
4. Controls and Procedures
|
44
|
||
Part
II. Other Information:
|
|||
ITEM
1. Legal Proceedings
|
45
|
||
ITEM
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
45
|
||
ITEM
3. Defaults Upon Senior Securities
|
45
|
||
ITEM
4. Submission of Matters to a Vote of Security Holders
|
45
|
||
ITEM
5. Other Information
|
45
|
||
ITEM
6. Exhibits
|
45
|
||
Signatures
|
46
|
||
Certifications
|
47
|
2
PART
I - Financial Information
ITEM
1. Financial Statements
PHOTOMEDEX,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
September
30, 2005
|
December
31, 2004
|
||||||
(Unaudited)
|
*
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
5,177,150
|
$
|
3,884,817
|
|||
Restricted
cash
|
206,802
|
112,200
|
|||||
Accounts
receivable, net of allowance for doubtful accounts of $675,795
and
$736,505, respectively
|
4,718,423
|
4,117,399
|
|||||
Inventories
|
7,818,794
|
4,585,631
|
|||||
Prepaid
expenses and other current assets
|
984,916
|
401,989
|
|||||
Total
current assets
|
18,906,085
|
13,102,036
|
|||||
Property
and equipment, net
|
6,677,895
|
4,996,688
|
|||||
Goodwill,
net
|
16,375,384
|
2,944,423
|
|||||
Patents
and licensed technologies, net
|
1,473,123
|
929,434
|
|||||
Other
intangible assets, net
|
4,700,125
|
-
|
|||||
Other
assets
|
289,579
|
989,345
|
|||||
Total
assets
|
$
|
48,422,191
|
$
|
22,961,926
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Current
portion of notes payable
|
$
|
481,117
|
$
|
69,655
|
|||
Current
portion of long-term debt
|
1,457,163
|
873,754
|
|||||
Accounts
payable
|
2,979,704
|
3,515,293
|
|||||
Accrued
compensation and related expenses
|
956,871
|
963,070
|
|||||
Other
accrued liabilities
|
938,002
|
924,054
|
|||||
Deferred
revenues
|
531,328
|
636,962
|
|||||
Other
current liabilities
|
23,252
|
-
|
|||||
Total
current liabilities
|
7,367,437
|
6,982,788
|
|||||
Long-term
liabilities:
|
|||||||
Notes
payable
|
170,728
|
26,736
|
|||||
Long-term
debt
|
2,043,425
|
1,372,119
|
|||||
Other
liabilities
|
24,671
|
-
|
|||||
Total
liabilities
|
9,606,261
|
8,381,643
|
|||||
Commitments
and Contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Common
stock, $.01 par value, 75,000,000 shares authorized; 51,247,881
and
40,075,019 shares issued and outstanding, respectively
|
512,478
|
400,750
|
|||||
Additional
paid-in capital
|
117,758,742
|
90,427,632
|
|||||
Accumulated
deficit
|
(79,385,225
|
)
|
(76,246,562
|
)
|
|||
Deferred
compensation
|
(70,065
|
)
|
(1,537
|
)
|
|||
Total
stockholders' equity
|
38,815,930
|
14,580,283
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
48,422,191
|
$
|
22,961,926
|
*
The
December 31, 2004 balance sheet was derived from our 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,
|
|||||||
2005
|
2004
|
||||||
Revenues:
|
|||||||
Product
sales
|
$
|
4,537,938
|
$
|
1,401,981
|
|||
Services
|
3,085,900
|
3,053,415
|
|||||
7,623,838
|
4,455,396
|
||||||
Cost
of revenues:
|
|||||||
Product
cost of revenues
|
1,956,022
|
747,689
|
|||||
Services
cost of revenues
|
2,347,362
|
1,753,727
|
|||||
|
4,303,384
|
2,501,416
|
|||||
Gross
profit
|
3,320,454
|
1,953,980
|
|||||
Operating
expenses:
|
|||||||
Selling,
general and administrative
|
4,526,178
|
2,634,394
|
|||||
Engineering
and product development
|
304,935
|
428,206
|
|||||
4,831,113
|
3,062,600
|
||||||
Loss
from operations
|
(1,510,659
|
)
|
(1,108,620
|
)
|
|||
Other
income
|
244,988
|
-
|
|||||
Interest
expense, net
|
(84,229
|
)
|
(47,189
|
)
|
|||
Net
loss
|
($
1,349,900
|
)
|
($
1,155,809
|
)
|
|||
Basic
and diluted net loss per share
|
($0.03
|
)
|
($0.03
|
)
|
|||
Shares
used in computing basic and diluted net loss per share
|
51,198,095
|
38,960,250
|
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,
|
|||||||
2005
|
2004
|
||||||
Revenues:
|
|||||||
Product
sales
|
$
|
11,718,700
|
$
|
4,823,738
|
|||
Services
|
8,943,640
|
7,980,022
|
|||||
20,662,340
|
12,803,760
|
||||||
Cost
of revenues:
|
|||||||
Product
cost of revenues
|
4,856,858
|
2,512,794
|
|||||
Services
cost of revenues
|
6,301,086
|
5,114,057
|
|||||
|
11,157,944
|
7,626,851
|
|||||
Gross
profit
|
9,504,396
|
5,176,909
|
|||||
Operating
expenses:
|
|||||||
Selling,
general and administrative
|
11,944,593
|
7,511,265
|
|||||
Engineering
and product development
|
819,845
|
1,325,399
|
|||||
12,764,438
|
8,836,664
|
||||||
Loss
from operations
|
(3,260,042
|
)
|
(3,659,755
|
)
|
|||
Other
income
|
333,655
|
-
|
|||||
Interest
expense, net
|
(212,276
|
)
|
(66,297
|
)
|
|||
Net
loss
|
($
3,138,663
|
)
|
($
3,726,052
|
)
|
|||
Basic
and diluted net loss per share
|
($0.07
|
)
|
($0.10
|
)
|
|||
Shares
used in computing basic and diluted net loss per share
|
47,972,456
|
38,428,632
|
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, 2005
(Unaudited)
|
|||||||||||||||||||
Common
Stock
|
|
|
|
||||||||||||||||
Shares
|
Amount
|
Additional
Paid-In Capital |
Accumulated
Deficit |
Deferred
Compensation |
Total
|
||||||||||||||
BALANCE,
DECEMBER 31, 2004
|
40,075,019
|
$
|
400,750
|
$
|
90,427,632
|
($76,246,562
|
)
|
($
1,537
|
)
|
$
|
14,580,283
|
||||||||
Exercise
of warrants
|
73,530
|
735
|
146,325
|
-
|
-
|
147,060
|
|||||||||||||
Exercise
of stock options
|
310,358
|
3,103
|
552,582
|
-
|
-
|
555,685
|
|||||||||||||
Stock
options issued to consultants for services
|
31,859
|
31,859
|
|||||||||||||||||
Issuance
of stock
|
248,395
|
2,484
|
523,416
|
525,900
|
|||||||||||||||
Issuance
of stock in connection with the acquisition of ProCyte
|
10,540,579
|
105,406
|
26,197,732
|
-
|
(132,081
|
)
|
26,171,057
|
||||||||||||
Amortization
of deferred compensation
|
-
|
-
|
-
|
-
|
62,019
|
62,019
|
|||||||||||||
Reversal
of unamortized portion of deferred compensation for terminated
employee
|
-
|
-
|
(1,534
|
)
|
-
|
1,534
|
-
|
||||||||||||
Registration
expenses
|
-
|
-
|
(161,739
|
)
|
-
|
-
|
(161,739
|
)
|
|||||||||||
Issuance
of warrants
|
42,469
|
42,469
|
|||||||||||||||||
Net
loss for the nine months ended September 30, 2005
|
-
|
-
|
-
|
(3,138,663
|
)
|
-
|
(3,138,663
|
)
|
|||||||||||
BALANCE,
SEPTEMBER 30, 2005
|
51,247,881
|
$
|
512,478
|
$
|
117,758,742
|
($79,385,225
|
)
|
($70,065
|
)
|
$
|
38,815,930
|
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,
|
|||||||
2005
|
2004
|
||||||
Cash
Flows From Operating Activities:
|
|||||||
Net
loss
|
($
3,138,663
|
)
|
($
3,726,052
|
)
|
|||
Adjustments
to reconcile net loss to net cash used
|
|||||||
in
operating activities:
|
|||||||
Depreciation
and amortization
|
2,216,715
|
1,314,435
|
|||||
Stock
options issued to consultants for services
|
31,859
|
48,192
|
|||||
Amortization
of deferred compensation
|
62,019
|
4,879
|
|||||
Nonmonetary
exchange of assets
|
(88,667
|
)
|
-
|
||||
Provision
for bad debts
|
276,124
|
239,120
|
|||||
Loss
on disposal of assets
|
64,937
|
-
|
|||||
Changes
in operating assets and liabilities, net of effects on acquired
assets and
liabilities:
|
|||||||
Accounts
receivable
|
260,265
|
(654,562
|
)
|
||||
Inventories
|
(403,335
|
)
|
(254,118
|
)
|
|||
Prepaid
expenses and other assets
|
545,943
|
202,354
|
|||||
Accounts
payable
|
(1,110,661
|
)
|
147,038
|
||||
Accrued
compensation and related expenses
|
(157,504
|
)
|
(113,450
|
)
|
|||
Other
accrued liabilities
|
(977,626
|
)
|
168,626
|
||||
Cash
deposits
|
8,000
|
(125,500
|
)
|
||||
Deferred
revenues
|
(201,070
|
)
|
71,733
|
||||
Other
liabilities
|
(4,962
|
)
|
-
|
||||
Net
cash used in operating activities
|
(2,616,626
|
)
|
(2,677,305
|
)
|
|||
Cash
Flows From Investing Activities:
|
|||||||
Purchases
of property and equipment
|
(87,488
|
)
|
(578,051
|
)
|
|||
Lasers
placed into service
|
(2,548,535
|
)
|
(1,021,766
|
)
|
|||
Licensed
technology acquisition
|
-
|
(108,273
|
)
|
||||
Cash
received from acquisition, net of costs incurred
|
5,578,416
|
-
|
|||||
Net
cash provided by (used in) investing activities
|
2,942,393
|
(1,708,090
|
)
|
||||
Cash
Flows From Financing Activities:
|
|||||||
Proceeds
from issuance of common stock, net of direct issuance
costs
|
(169,524
|
)
|
11,199
|
||||
Proceeds
from exercise of options
|
555,685
|
98,837
|
|||||
Proceeds
from exercise of warrants
|
147,060
|
3,086,468
|
|||||
Payments
on long-term debt
|
(202,199
|
)
|
(330,086
|
)
|
|||
Payments
on notes payable
|
(617,799
|
)
|
(446,875
|
)
|
|||
Net
advancements on lease line of credit
|
1,347,945
|
654,427
|
|||||
Increase
in restricted cash and cash equivalents
|
(94,602
|
)
|
(110,062
|
)
|
|||
Net
cash provided by financing activities
|
966,566
|
2,963,908
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
1,292,333
|
(1,421,487
|
)
|
||||
Cash
and cash equivalents, beginning of period
|
3,884,817
|
6,633,468
|
|||||
Cash
and cash equivalents, end of period
|
$
|
5,177,150
|
$
|
5,211,981
|
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 subsidiaries (the “Company”) is a medical device and specialty
pharmaceutical company focused on facilitating the cost-effective use of
technologies for doctors, hospitals and surgery centers to enable their patients
to achieve a higher quality of life. The Company develops, manufactures and
markets excimer-laser-based instrumentation designed to phototherapeutically
treat psoriasis, vitiligo, atopic dermatitis and leukoderma. In January 2000,
the Company received the first Food and Drug Administration (“FDA”) clearance to
market an excimer laser system, the XTRAC® system, for the treatment of
psoriasis. In March 2001, the Company received FDA clearance to treat vitiligo;
in August 2001, the Company received FDA clearance to treat atopic dermatitis;
and in May 2002, the FDA granted 510(k) clearance to market the XTRAC system
for
the treatment of leukoderma. The Company launched the XTRAC phototherapy
treatment system commercially in the United States in August 2000.
As
a
result of the acquisition of Surgical Laser Technologies, Inc. (“SLT”) on
December 27, 2002, the Company also develops, manufactures and markets
proprietary lasers and delivery systems for both contact and non-contact
surgery
and provides surgical services utilizing these and other manufacturers’
products.
Through
the acquisition of ProCyte Corporation (“ProCyte”) on March 18, 2005, the
Company also develops, manufactures and markets products for skin health,
hair
care and wound care. Many of the Company’s products incorporate its
patented copper peptide technologies.
Liquidity
and Going Concern
The
Company has incurred significant losses and negative cash flows from operations
since emerging from bankruptcy in May 1995. As of September 30, 2005, the
Company had an accumulated deficit of $79,385,225. The Company has reduced
its
net loss for the nine months ended September 30, 2005 by $587,389, a 16%
improvement, compared to the nine months ended September 30, 2004. The Company
has historically financed its activities from operations and the private
placement of equity securities. To date, the Company has dedicated most of
its
financial resources to research and development, marketing and general and
administrative expenses.
Cash
and
cash equivalents as of September 30, 2005 were $5,383,952, including restricted
cash of $206,802. Management believes that the existing cash balance together
with its existing financial resources, including the leasing credit line
facility with a remaining availability of $2,972,082 (see Note 9), and any
revenues from sales, distribution, licensing and manufacturing relationships,
will be sufficient to meet the Company’s operating and capital requirements
beyond the third quarter of 2006. The 2005 operating plan reflects anticipated
growth from an increase in per-treatment fee revenues for use of the XTRAC
system based on wider insurance coverage in the United States and continuing
cost savings from the integration of business operations acquired from ProCyte.
In addition, the 2005 operating plan calls for increased revenues and profits
from the ProCyte business and the continued growth of its skin care products.
However, depending upon the Company’s rate of growth and other operating
factors, the Company may require additional equity or debt financing to meet
its
working capital requirements or capital expenditure needs for the balance
of
2005. There can be no assurance that additional financing, if needed, will
be
available when required or, if available, can be obtained on terms satisfactory
to the Company.
Since
2002, the Company has made significant progress in obtaining more extensive
reimbursement approval from the Centers for Medicare and Medicaid Services
and
various private health plans for the treatment of skin disorders using the
XTRAC
system.
The
Company plans to continue to focus on securing reimbursement from more private
insurers and to devote sales and marketing efforts where such reimbursement
has
become available. As approvals for reimbursements are obtained, the Company
will
increase spending on the marketing of its psoriasis, vitiligo, atopic dermatitis
and leukoderma treatment products and, if necessary, expansion of its
manufacturing facilities. Notwithstanding the approval for reimbursement
by
Centers for Medicare and Medicaid Services and recent approvals by certain
private insurers, the Company may continue to face resistance from some private
healthcare insurers to adopt the excimer-laser-based therapy as an approved
procedure or to provide adequate levels of reimbursement. Management cannot
provide assurance that the Company will market the product successfully or
operate profitably in the future, or that it will not require significant
additional financing in order to accomplish its business plan objectives.
8
The
Company’s future success depends in part upon increased patient acceptance of
its excimer-laser-based systems for the treatment of a variety of skin
disorders. The Company’s ability to introduce successful new products may be
adversely affected by a number of factors, such as unforeseen costs and
expenses, technological change, economic downturns, increased competition
or
other factors beyond the Company’s control. Consequently, the Company’s
historical operating results cannot be relied on to be an indicator of future
performance, and management cannot predict whether the Company will obtain
or
sustain positive operating cash flow or generate net income in the
future.
Summary
of Significant Accounting Policies:
Quarterly
Financial Information and Results of Operations
The
financial statements as of September 30, 2005 and for the nine months ended
September 30, 2005 and 2004, 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, 2005, and the results of operations and cash flows for
the
nine months ended September 30, 2005 and 2004. The results for the
nine
months ended September 30, 2005 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 fiscal year ended December
31,
2004.
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 Revenue
Recognition
for
discussion of updates and changes in estimates for XTRAC domestic revenues
in
accordance with Staff Accounting Bulletin Nos. 101 and 104 and Statement
of
Financial Accounting Standards (“SFAS”) No. 48.
See
“Summary of Significant Accounting Policies” in the Company’s 2004 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 lasers in physician’s offices (at no charge to the
physician) and charges the physician a fee for an agreed upon number of
treatments. When the Company sells an XTRAC laser to a distributor or directly
to a physician, revenue is recognized when the following four criteria under
Staff Accounting Bulletin No. 104 have been met: (i) the product has been
shipped and the Company has no significant remaining obligations; (ii)
persuasive evidence of an arrangement exists; (iii) the price to the buyer
is
fixed or determinable; (iv) and collection is probable (the “SAB 104 Criteria”).
At times, units are shipped, but revenue is not recognized until all of the
criteria are met, and until that time, the unit is carried on the books of
the
Company as inventory.
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 that do not
fully
satisfy the collection criteria are recognized when invoiced amounts are
fully
paid.
Under
the
terms of the distributor agreements, the distributors do not have the right
to
return any unit that they have purchased. However, the Company does allow
products to be returned by its distributors in redress of product defects
or
other claims.
When
the
Company places a laser in a physician’s office, it recognizes service revenue
based on the number of patient treatments used by the physician. Treatments
in
the form of random laser-access codes that are sold to physicians, but not
yet
used, are deferred and recognized as a liability until the physician performs
the treatment. Unused treatments remain an obligation of the Company inasmuch
as
the treatments can only be performed on Company-owned equipment. Once the
treatments are delivered to a patient, this obligation has been satisfied.
The
calculation of unused treatments has historically been based upon an estimate
that at the end of each accounting period, 15 unused treatments existed at
each
laser location. This was based upon the reasoning that the Company generally
sells treatments in packages of 30 treatments. Fifteen treatments generally
represents about one-half the quantity purchased by a physician or approximately
a one-week supply for 6 to 8 patients. This policy had been used on a consistent
basis. The Company believed this approach to have been reasonable and systematic
given that: (a) physicians have little motivation to purchase quantities
(which
they are obligated to pay for irrespective of actual use and are unable to
seek
a credit or refund for unused treatments) that will not be used in a relatively
short period of time, particularly since in most cases they can obtain
incremental treatments instantaneously over the phone; and (b) senior management
regularly reviews purchase patterns by physicians to identify unusual buildup
of
unused treatment codes at a laser site. Moreover, the Company continually
looks
at its estimation model based upon data received from its
customers.
In
the
fourth quarter of 2004, the Company updated the calculations for the estimated
amount of unused treatments to reflect recent purchasing patterns by physicians
near year-end. The Company estimated the amount of unused treatments at December
31, 2004 to include all sales of treatment codes made within the last two
weeks
of the period. Management believes this approach more closely approximates
the
actual amount of unused treatments that existed at that date than the previous
approach. Accounting Principles Board (“APB”) Opinion No. 20 provides that
accounting estimates change as new events occur, as more experience is acquired,
or as additional information is obtained and that the effect of the change
in
accounting estimate should be accounted for in the current period and the
future
periods that it affects. The Company accounted for this change in the estimate
of unused treatments in accordance with APB No. 20 and SFAS No. 48. Accordingly,
the Company’s change in accounting estimate was reported in revenues for the
fourth quarter of 2004, and was not accounted for by restating amounts reported
in financial statements of prior periods or by reporting pro-forma amounts
for
prior periods.
The
Company has continued this approach or method for estimating the amount of
unused treatments at September 30, 2005. Due to this updated approach in
estimates, XTRAC domestic revenues were increased by $159,000 and $97,000
for
the three and nine months ended September 30, 2005, respectively, as compared
to
the prior method of estimation.
In
the
first quarter of 2003, the Company implemented a program to support certain
physicians in addressing treatments with the XTRAC system that may be denied
reimbursement by private insurance carriers. The Company recognizes service
revenue from the sale of treatment codes to physicians participating in this
program only if and to the extent the physician has been reimbursed for the
treatments. For the three and nine months ended September 30, 2005,
the
Company deferred an additional $25,375 and $58,090, respectively, under this
program as all the criteria for revenue recognition had not been met.
Under
this program, the Company may reimburse qualifying doctors for the cost of
the
Company’s fee but only if they are ultimately denied reimbursement after appeal
of their claim with the insurance company. The key components of the program
are
as follows:
10
·
|
The
physician practice must be in an identified location where there
is still
an insufficiency of insurance companies reimbursing the
procedure;
|
·
|
The
program only covers medically necessary treatments of psoriasis
as
determined by the treating physician
;
|
·
|
The
patient must have medical insurance and a claim for the treatment
must be
timely filed with the patient’s insurance company;
|
·
|
Upon
denial by the insurance company (generally within 30 days of filing
the
claim), a standard insurance form called an EOB (“Explanation of
Benefits”) must be submitted to the Company’s in-house appeals group, who
will then prosecute the appeal. The appeal process can take 6 to
9
months;
|
·
|
After
all appeals have been exhausted by the Company and the claim remains
unpaid, the physician is entitled to receive credit for the treatment
he
or she purchased from the Company (our fee only) on behalf of the
patient
and
|
· |
Physicians
are still obligated to make timely payments for treatments purchased,
irrespective of whether reimbursement is paid or denied. Future
sale of
treatments to a physician can be denied if timely payments are
not made,
even if a patient’s appeal is still in process.
|
Historically,
the Company estimated a contingent liability for potential refunds under
this
program by estimating when the physician was paid for the insurance claim.
In
the absence of a two-year historical trend and a large pool of homogeneous
transactions to reliably predict the estimated claims for refund as required
by
Staff Accounting Bulletin Nos. 101 and 104, the Company previously deferred
revenue recognition of 100% of the current quarter revenues from the program
to
allow for the actual denied claims to be identified after processing with
the
insurance companies. After more than 106,000 treatments in the last 2 years
and
detailed record keeping of denied insurance claims and appeals processed,
the
Company has estimated that approximately 11% of a current quarter’s revenues
under this program are subject to being credited or refunded to the
physician.
As
of
December 31, 2004, the Company updated its analysis to reflect this level
of
estimated refunds. This change from the past process of deferring 100% of
the
current quarter revenues from the program represents a change in accounting
estimate, and Management recorded this change in accordance with the relevant
provisions of SFAS No. 48 and APB No. 20. These pronouncements state that
the
effect of a change in accounting estimate should be accounted for in the
current
period and the future periods that it affects. A change in accounting estimate
should not be accounted for by restating amounts reported in financial
statements of prior periods or by reporting proforma amounts for prior periods.
Due to this updated approach in estimates, XTRAC domestic revenues were
increased by $33,000 and $89,000 for the three and nine months ended September
30, 2005 as compared to the prior method of estimation.
The
net
impact on revenue recognized for the XTRAC domestic segment as a result of
the
above two changes in accounting estimate was to increase revenues by
approximately $192,000 and $186,000 for the three and nine months ended
September 30, 2005, respectively.
Through
its surgical businesses, the Company generates revenues primarily from two
channels. The first is through product sales of laser systems, related
maintenance service agreements, recurring laser delivery systems and laser
accessories; the second is through per-procedure surgical services. The Company
recognizes revenues from surgical laser and other product sales, including
sales
to distributors, when the SAB 104 Criteria have been met.
For
per-procedure surgical services, the Company recognizes revenue upon the
completion of the procedure. Revenue from maintenance service agreements
is
deferred and recognized on a straight-line basis over the term of the
agreements. Revenue from billable services, including repair activity, is
recognized when the service is provided.
The
Company generates revenues from the acquired business of ProCyte primarily
through three channels. The first is through product sales for skin health,
hair
care and wound care; the second is through sales of the copper peptide compound,
primarily to Neutrogena; a Johnson and Johnson Company, and the third is
through
royalties generated by our licenses, principally to Neutrogena. The Company
recognizes revenues on the products and copper peptide compound when they
are
shipped, net of returns and allowances. The Company ships the products FOB
shipping point. Royalty revenues are based upon sales generated by our
licensees. The Company recognizes royalty revenue at the applicable royalty
rate
applied to shipments reported by our licensee.
11
Impairment
of Long-Lived Assets and Intangibles
In
accordance with SFAS No. 144, “Accounting for the Impairment of Disposal of
Long-Lived Assets”, long-lived assets, such as property and equipment, and
purchased intangibles subject to amortization, are reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount
of
an asset may not be recoverable. Recoverability of assets to be held and
used is
measured by a comparison of the carrying amount of an asset to estimated
undiscounted future cash flows expected to be generated by the asset. If
the
carrying amount of an asset exceeds its estimated future cash flows, an
impairment charge is recognized by the amount by which the carrying amount
of
the asset exceeds the fair value of the asset. Assets to be disposed of would
be
separately presented in the balance sheet and reported at the lower of the
carrying amount or the fair value less costs to sell, and would no longer
be
depreciated. The assets and liabilities of a disposed group would be classified
as held for sale and would be presented separately in the appropriate asset
and
liability sections of the balance sheet. As of September 30, 2005, no such
impairment existed.
Patent
Costs and Licensed Technologies
Costs
incurred to obtain or defend patents and licensed technologies are capitalized
and amortized over the shorter of the remaining estimated useful lives or
8 to
12 years. Developed technology was recorded in connection with the purchase
in
August 2000 of the minority interest of Acculase, a former subsidiary of
the
Company, and is being amortized on a straight-line basis over seven years.
Developed technology was also recorded in connection with the acquisition
of
ProCyte in March 2005 and is being amortized on a straight-line basis over
seven
years.
Management
evaluates the recoverability of intangible assets based on estimates of
undiscounted future cash flows over the remaining useful life of the asset.
If
the amount of such estimated undiscounted future cash flows is less than
the net
book value of the asset, the asset is written down to fair value. As of
September 30, 2005, no such write-down was required.
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, 2005, no such write-down was required.
Accrued
Warranty Costs
The
Company offers a warranty on product sales generally for a one to two-year
period. The Company provides for the estimated future warranty claims on
the
date the product is sold. The activity in the warranty accrual during the
nine
months ended September 30, 2005 is summarized as follows:
September
30, 2005
|
||||
Accrual
at beginning of period
|
$
|
196,890
|
||
Additions
charged to warranty expense
|
63,000
|
|||
Claims
paid and expiring warranties
|
(46,147
|
)
|
||
Accrual
at end of period
|
$
|
213,743
|
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.
12
The
Company’s deferred tax asset has been fully reserved under a valuation
allowance, reflecting the uncertainties as to realizability evidenced by
the
Company’s historical results and restrictions on the usage of the net operating
loss carryforwards. Consistent with the rules of purchase accounting, the
historical deferred tax asset of ProCyte was written off when the Company
acquired ProCyte. If and when components of that asset are realized in future,
the acquired goodwill of ProCyte will be reduced.
Net
Loss Per Share
The
Company computes net loss per share in accordance with SFAS No. 128, “Earnings
per Share.” In accordance with SFAS No. 128, basic net loss per share is
calculated by dividing net loss available to common stockholders by the weighted
average of common shares outstanding for the period. Diluted net loss per
share
reflects the potential dilution from the conversion or exercise into common
stock of securities such as stock options and warrants.
In
these
consolidated financial statements, diluted net loss per share is the same
as
basic net loss per share. No additional shares for the potential dilution
from
the conversion or exercise of securities into common stock are included in
the
denominator, since the result would be anti-dilutive. Common stock options
and
warrants of 8,371,824 and 6,587,193 as of September 30, 2005 and 2004,
respectively, were excluded from the calculation of fully diluted earnings
per
share since their inclusion would have been anti-dilutive.
Exchanges
of Nonmonetary Assets
Exchanges
under SFAS No. 153, “Exchanges of Nonmonetary Assets,” are measured based on the
fair value of the assets exchanged. Further, SFAS No. 153 eliminates the
previous narrow exception for nonmonetary exchanges of similar productive
assets
and replaces it with a broader exception for exchanges of nonmonetary assets
that do not have “commercial substance.” Although SFAS No. 153 is generally
effective for financial statements for fiscal years beginning after June
15,
2005, the Company elected to adopt this Statement for the current fiscal
year.
For the nine months ended September 30, 2005, the Company has recognized
$88,667
recorded as Other Income in accordance with this Statement.
Stock
Options
The
Company applies the intrinsic-value-based method of accounting prescribed
by APB
Opinion No. 25, “Accounting for Stock Issued to Employees,” and related
interpretations, to account for its fixed-plan stock options. Under this
method,
compensation expense is recorded on the date of grant only if the current
market
price of the underlying stock exceeds the exercise price. Under the provisions
of SFAS No. 123 (revised 2004), “Share Based Payment,” the Company will,
starting January 1, 2006, discontinue intrinsic-value-based accounting and
recognize compensation expense for stock options under fair-value-based
accounting.
Options
that were assumed from ProCyte and that were unvested as of March 18, 2005
were
re-measured as of March 18, 2005 under intrinsic-value-based accounting.
Unearned compensation of $132,081 was recorded and will be amortized over
the
remaining vesting period, which is an average of two years.
13
Had
stock
compensation cost for the Company’s common stock options been determined based
upon the fair value of the options at the date of grant, as prescribed under
SFAS No. 123, the Company’s net loss and net loss per share would have been
increased to the following pro-forma amounts:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Net
loss:
|
|||||||||||||
As
reported
|
($1,349,900)
|
($1,155,809)
|
($3,138,663)
|
($3,726,052)
|
|||||||||
Less:
stock-based employee compensation expense included in reported
net
loss
|
17,787
|
1,638
|
62,019
|
4,879
|
|||||||||
Impact
of total stock-based compensation expense determined under
fair-value-based method for all grants and awards
|
(483,008
|
)
|
(437,000
|
)
|
(1,264,476
|
)
|
(1,309,524
|
)
|
|||||
Pro-forma
|
($1,815,121
|
)
|
($1,591,171
|
)
|
($4,341,120
|
)
|
($5,030,697
|
)
|
|||||
Net
loss per share:
|
|||||||||||||
As
reported
|
($0.03
|
)
|
($0.03
|
)
|
($0.07
|
)
|
($0.10
|
)
|
|||||
Pro-forma
|
($0.04
|
)
|
($0.04
|
)
|
($0.09
|
)
|
($0.13
|
)
|
The
above
pro-forma amounts may not be indicative of future pro-forma amounts because
future options are expected to be granted.
The
fair
value of the options granted is estimated using the Black-Scholes option-pricing
model with the following weighted average assumptions applicable to options
granted in the three-month and nine-month periods:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||
2005
|
2004
|
2005
|
2004
|
||||
Risk-free
interest rate
|
3.99%
|
3.695%
|
4.04%
|
3.164%
|
|||
Volatility
|
94.689%
|
100%
|
97.89%
|
100%
|
|||
Expected
dividend yield
|
0%
|
0%
|
0%
|
0%
|
|||
Expected
option life
|
5
years
|
5
years
|
5
years
|
5
years
|
Supplemental
Cash Flow Information
In
connection with the purchase of ProCyte in March 2005, the Company issued
10,540,579 shares of common stock and assumed options of 1,354,973 shares
of
common stock (see Note 2).
During
the nine months ended September 30, 2005, the Company financed insurance
policies through notes payable for $978,252, financed leasehold improvements
through a note payable for $195,000, financed certain credit facility costs
for
$70,977 and issued warrants to a leasing credit facility which are valued
at
$42,469, and which offset the carrying value of debt. During the nine months
ended September 30, 2005, the Company issued 218,895 shares of common stock
to
Stern Laser srl (“Stern”) upon attainment of certain milestones under a Master
Purchase Agreement, which is included in patents and licensed technologies.
During
the nine months ended September 30, 2004, the Company financed insurance
policies through note payables for $530,977, financed vehicle purchases of
$140,064 under capital leases, financed certain credit facility costs for
$202,027 and issued warrants to a leasing credit facility which are valued
at
$75,521, and which offset the carrying value of debt. During the nine months
ended September 30, 2004, the Company issued 113,877 shares of common stock
to
Stern upon attainment of certain milestones under a Master Purchase Agreement,
which is included in patents and licensed technologies.
14
For
the
nine months ended September 30, 2005 and 2004, the Company paid interest
of
$259,734 and $98,972, respectively. Income taxes paid in the nine months
ended
September 30, 2005 and 2004 were immaterial.
Recent
Accounting Pronouncements
In
May
2005, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 154,
“Accounting Changes and Error Corrections - replacement of APB Opinion No.
20
and FASB Statement No. 3” was issued. SFAS No. 154 changes the accounting for
and reporting of a change in accounting principle by requiring retrospective
application to prior periods’ financial statements of changes in accounting
principle unless impracticable. SFAS No. 154 is effective for accounting
changes
made in fiscal years beginning after December 15, 2005. Management believes
the
adoption of this Statement will not have an effect on the consolidated financial
statements.
On
December 16, 2004, the FASB issued SFAS No. 123(R), “Share-Based Payment,” which
is a revision of SFAS No. 123 and supersedes APB Opinion No. 25. In March
2005
the SEC issued Staff Accounting Bulletin No. 107 (“SAB 107”). SAB 107 expresses
views of the SEC staff regarding the interaction between SFAS 123R and certain
SEC rules. SFAS No. 123(R) requires all share-based payments to employees,
including grants of employee stock options, to be valued at fair value on
the
date of grant, and to be expensed over the applicable vesting period. Pro-forma
disclosure of the income statement effects of share-based payments will no
longer be an alternative. SFAS No. 123(R) is effective for all stock-based
awards granted on or after January 1, 2006. In addition, companies must also
recognize compensation expense related to any awards that are not fully vested
as of the effective date. Compensation expense for the unvested awards will
be
measured based on the fair value of the awards previously calculated in
developing the pro-forma disclosures in accordance with the provisions of
SFAS
No. 123.
The
Company plans to adopt SFAS No. 123(R) on January 1, 2006. The Company has
not
completed the calculation of the impact of applying SFAS No. 123(R). The
Company
currently accounts for share-based payments to its employees using the intrinsic
value method; consequently the results of operations have not included the
recognition of compensation expense for the issuance of stock option awards.
On
November 24, 2004, the FASB issued SFAS No. 151, “Inventory Costs,” which is an
amendment to ARB No. 43, Chapter 4. It clarifies the accounting for abnormal
amounts of idle facility expense, freight, handling costs, and wasted material
(spoilage). Under this Statement, these costs should be expensed as incurred
and
not included in overhead. Further, SFAS No. 151 requires that allocation
of
fixed production overheads to conversion costs should be based on normal
capacity of the production facilities. SFAS No. 151 is effective for inventory
costs incurred during fiscal years beginning after June 15, 2005. Management
believes the adoption of this Statement will not have a material effect on
the
consolidated financial statements.
In
December 2003, the FASB issued FASB Interpretation No. 46 (revised December
2003), “Consolidation of Variable Interest Entities,” (“VIEs”) (“FIN 46R”) which
addresses how a business enterprise should evaluate whether it has a controlling
financial interest in an entity through means other than voting rights and
accordingly should consolidate the entity. FIN 46R replaces FASB Interpretation
No. 46, “Consolidation of Variable Interest Entities,” which was issued in
January 2003. The Company has adopted FIN 46R as of March 31, 2004 for variable
interests in VIEs. For any VIEs that were created before January 1, 2004
and
that must therefore be consolidated under FIN 46R, the assets, liabilities
and
noncontrolling interests of the VIE initially would be measured at their
carrying amounts with any difference between the net amount added to the
balance
sheet and any previously recognized interest being recognized as the cumulative
effect of an accounting change. If determining the carrying amounts is not
practicable, fair value at the date FIN 46R first applies may be used to
measure
the assets, liabilities and noncontrolling interest of the VIE. The adoption
of
FIN 46R did not have an effect on the consolidated financial statements inasmuch
as the Company has no interests in any VIEs.
Note
2
Acquisitions:
ProCyte
Transaction
On
March
18, 2005, the Company completed the acquisition of ProCyte Corporation, which
was organized in 1986. ProCyte develops, manufactures and markets products
for
skin health, hair care and wound care. Many of the Company’s products
incorporate its patented copper peptide technologies. ProCyte’s
focus since 1996 has been to provide unique products primarily based upon
patented technologies for selected applications in the dermatology, plastic
and
cosmetic surgery and spa markets. The Company has also expanded the use of
its
novel copper peptide technologies into the mass retail market for skin and
hair
care through targeted technology licensing and supply
agreements.
15
ProCyte’s
products address the growing demand for skin health and hair care products,
including products designed to enhance appearance and to address the effects
of
aging on the skin and hair. ProCyte’s products are formulated, branded for and
targeted at specific markets. ProCyte’s initial products addressed the
dermatology, plastic and cosmetic surgery markets for use after various
procedures. Anti-aging skin care products were later added to expand into
a
comprehensive approach for incorporation into a patient’s skin care regimen.
The
aggregate purchase price of $27,543,784 consisted of the issuance of 10,540,579
shares of common stock valued at $2.29 per share, the assumption of 1,354,973
common stock options valued at $2,033,132 net of deferred compensation of
$132,081, and $1,372,726 of transaction costs. The merger consideration resulted
in the equivalent of a fixed ratio of 0.6622 shares of PhotoMedex common
stock
for each share of ProCyte common stock. As the exchange ratio was fixed,
the
fair value of PhotoMedex common stock for accounting purposes was based upon
a
five-day average stock price of $2.29 per share. The five-day average included
the closing prices on the date of the announcement of the planned merger
and the
two days prior and afterwards.
Based
on
the purchase price allocation, the following table summarizes the estimated
fair
value of the assets acquired and liabilities assumed at the date of
acquisition:
Cash
and cash equivalents
|
$
|
6,272,540
|
||
Accounts
receivable
|
1,137,413
|
|||
Inventories
|
2,845,698
|
|||
Prepaid
expenses and other current assets
|
134,574
|
|||
Property
and equipment
|
340,531
|
|||
Patents
and licensed technologies
|
200,000
|
|||
Other
intangible assets
|
5,200,000
|
|||
Other
assets
|
38,277
|
|||
Total
assets acquired
|
16,169,033
|
|||
Accounts
payable
|
(605,520
|
)
|
||
Accrued
compensation and related expenses
|
(158,610
|
)
|
||
Other
accrued liabilities
|
(1,143,761
|
)
|
||
Deferred
revenues
|
(95,436
|
)
|
||
Other
liabilities
|
(52,883
|
)
|
||
Total
liabilities assumed
|
(2,056,210
|
)
|
||
Net
assets acquired
|
$
|
14,112,823
|
The
purchase price exceeded the fair value of the net assets acquired by
$13,430,961, which was recorded as goodwill.
16
The
accompanying consolidated financial statements do not include any revenues
or
expenses related to the acquisition on or prior to March 18, 2005, the closing
date. Following are the Company’s unaudited pro-forma results for the three and
nine months ended September 30, 2005 and 2004, assuming the acquisition had
occurred on January 1, 2004:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Net
revenues
|
$
|
7,623,838
|
$
|
7,692,498
|
$
|
23,631,905
|
$
|
22,945,300
|
|||||
Net
loss
|
(1,349,900
|
)
|
(1,166,644
|
)
|
(3,240,715
|
)
|
(3,905,527
|
)
|
|||||
Basic
and diluted loss per share
|
(0.03
|
)
|
(0.02
|
)
|
(0.06
|
)
|
(0.08
|
)
|
|||||
Shares
used in calculating basic and diluted loss per share
|
51,198,095
|
49,500,829
|
50,906,830
|
48,969,211
|
These
unaudited pro-forma results have been prepared for comparative purposes only
and
do not purport to be indicative of the results of operations which would
have
actually resulted had the acquisition occurred on January 1, 2004, nor to
be
indicative of future results of operations.
Stern
Laser Transaction
On
September 7, 2004, the Company closed the transactions set forth in a Master
Asset Purchase Agreement (the “Master Agreement”) with Stern Laser srl
(“Stern”). As of September 30, 2005, the Company has issued to Stern 362,272
shares of its restricted common stock in connection with the execution of
the
Master Agreement. The Company also agreed to pay Stern up to an additional
$650,000 based on the achievement of certain remaining milestones relating
to
the development and commercialization of certain licensed technology and
the
licensed products, which may be developed under such arrangement and may
have
certain other obligations to Stern under these arrangements. The Company
retains
the right to pay all of these conditional sums in cash or in shares of its
common stock, in its discretion. To secure the latter alternative, the Company
has reserved for issuance, and placed into escrow, 337,728 shares of its
unregistered stock. The per-share price of any future issued shares will
be
based on the average closing price of the Company’s common stock during the 10
trading days ending on the date of achievement of a particular milestone
under
the terms of the Master Agreement. Stern also has served as the distributor
of
the Company’s XTRAC laser system in South Africa and Italy since 2000.
The
Company assigned $809,515 as the fair value of the license it acquired from
Stern. Amortization of this intangible is on a straight-line basis over 10
years, which began in January 2005. As Stern completes further milestones
under
the Master Agreement, the Company expects to continue to increase the carrying
value of the license.
Note
3
Inventories:
Set
forth
below is a detailed listing of inventories:
September 30, 2005
|
December 31, 2004
|
||||||
Raw
materials and work in progress
|
$
|
4,757,029
|
$
|
2,968,728
|
|||
Finished
goods
|
3,061,765
|
1,616,903
|
|||||
Total
inventories
|
$
|
7,818,794
|
$
|
4,585,631
|
Work-in-process
is immaterial, given the typically short manufacturing cycle, and therefore
is
disclosed in conjunction with raw materials. Finished goods includes $61,213
and
$84,000 as of September 30, 2005 and December 31, 2004, respectively,
for
laser systems shipped to distributors, but not recognized as revenue until
all
the SAB 104 Criteria have been met.
17
Note
4
Property
and Equipment:
Set
forth
below is a detailed listing of property and equipment:
September
30, 2005
|
December
31, 2004
|
||||||
Lasers
in service
|
$
|
11,874,388
|
$
|
9,333,591
|
|||
Computer
hardware and software
|
334,490
|
256,340
|
|||||
Furniture
and fixtures
|
331,151
|
239,520
|
|||||
Machinery
and equipment
|
684,815
|
522,643
|
|||||
Autos
and trucks
|
382,690
|
400,570
|
|||||
Leasehold
improvements
|
209,536
|
110,441
|
|||||
13,817,070
|
10,863,105
|
||||||
Accumulated
depreciation and amortization
|
(7,139,175
|
)
|
(5,866,417
|
)
|
|||
Property
and equipment, net
|
$
|
6,677,895
|
$
|
4,996,688
|
Depreciation
expense was $1,556,847 and $1,187,871 for the nine months ended
September 30, 2005 and 2004, respectively. At September 30,
2005 and
December 31, 2004, net property and equipment included $576,596 and $710,957,
respectively, of assets recorded under capitalized lease arrangements, of
which
$363,047 and $565,246 was included in long-term debt at September 30,
2005
and December 31, 2004, respectively (see Note 9).
Note
5
Patents
and Licensed Technologies:
Set
forth
below is a detailed listing of patents and licensed technologies:
September
30, 2005
|
December
31, 2004
|
||||||
Patents,
owned and licensed, at gross costs of $464,659 and $403,023, net
of
accumulated amortization of $185,293 and $155,522,
respectively
|
|
279,366
|
|
247,501
|
|||
Other
licensed or developed technologies, at gross costs of $1,846,515
and
$1,177,568, net of accumulated amortization of $652,758and $495,635,
respectively
|
1,193,757
|
681,933
|
|||||
$
|
1,473,123
|
$
|
929,434
|
Related
amortization expense was $186,893 and $126,564 for the nine months ended
September 30, 2005 and 2004, respectively. Included in other licensed
and
developed technologies is $200,000 in developed technologies acquired from
ProCyte.
Note
6
Other
Intangible Assets:
Set
forth
below is a detailed listing of other intangible assets, all of which were
acquired from ProCyte and which have been recorded at their appraised fair
market values:
September
30, 2005
|
||||
Neutrogena
Agreement, at gross cost of $2,400,000 net of accumulated amortization
of
$258,000.
|
|
|
||
Customer
Relationships, at gross cost of $1,700,000 net of accumulated amortization
of $182,748.
|
1,517,252
|
|||
Tradename,
at gross cost of $1,100,000 net of accumulated amortization of
$59,127.
|
1,040,873
|
|||
$
|
4,700,125
|
Related
amortization expense was $499,875 for the nine months ended September 30,
2005. Under the Neutrogena Agreement, the Company has licensed to Neutrogena
rights to its copper peptide technology and for which the Company receives
royalties. Customer Relationships embody the value to the Company of
relationships that ProCyte had formed with its customers. Tradename includes
the
name of “ProCyte” and various other trademarks associated with ProCyte’s
products.
18
Note
7
Other
Accrued Liabilities:
Set
forth
below is a detailed listing of other accrued liabilities:
September
30, 2005
|
December
31, 2004
|
||||||
Accrued
warranty
|
$
|
213,743
|
$
|
196,890
|
|||
Accrued
liability from matured notes
|
-
|
245,849
|
|||||
Accrued
professional and consulting fees
|
505,949
|
412,019
|
|||||
Accrued
sales taxes
|
166,954
|
61,142
|
|||||
Other
accrued expenses
|
51,357
|
8,154
|
|||||
Total
other accrued liabilities
|
$
|
938,003
|
$
|
924,054
|
During
2002, SLT assumed direct control of $223,000 of funds previously set aside
for
the payment of SLT’s subordinated notes, which matured and ceased to bear
interest on July 30, 1999, and $31,000 of funds previously set aside to pay
related accrued interest. As of December 31, 2004, the matured principal
and
related interest was $245,849. As of July 31, 2005, the outstanding notes,
and
the related funds, were no longer redeemable.
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, 2005
|
December
31, 2004
|
||||||
Note
payable - secured creditor, interest at 16.47%, payable in monthly
principal and interest installments of $2,618 through December
2006.
|
$
|
33,309
|
$
|
51,489
|
|||
|
|||||||
Note
payable - unsecured creditor, interest at 5.75%, payable in monthly
principal and interest installments of $44,902 through January
2005.
|
-
|
44,902
|
|||||
Note
payable - unsecured creditor, interest at 7.42%, payable in monthly
principal and interest installments of $21,935 through November
2005
|
43,466
|
-
|
|||||
Note
payable - unsecured creditor, interest at 7.42%, payable in monthly
principal and interest installments of $15,600 through November
2005
|
30,914
|
-
|
|||||
Note
Payable - unsecured creditor, interest at 7.42%, payable in monthly
principal and interest installments of $61,493 through March
2006
|
354,899
|
-
|
|||||
Note
Payable - secured creditor, interest at 6%, payable in monthly
principal
and interest installments of $2,880 through June 2012
|
189,257
|
-
|
|||||
651,845
|
96,391
|
||||||
Less:
current maturities
|
(481,117
|
)
|
(69,655
|
)
|
|||
Notes
payable, net of current maturities
|
$
|
170,728
|
$
|
26,736
|
19
Note
9
Long-term
Debt:
Set
forth
below is a detailed listing of the Company’s long-term debt:
September
30, 2005
|
December
31, 2004
|
||||||
Borrowings
on credit facility
|
$
|
3,137,541
|
$
|
1,680,627
|
|||
Capital
lease obligations (see Note 4)
|
363,047
|
565,246
|
|||||
3,500,588
|
2,245,873
|
||||||
Less:
current portion
|
(1,457,163
|
)
|
(873,754
|
)
|
|||
Total
long-term debt
|
$
|
2,043,425
|
$
|
1,372,119
|
The
Company entered into a leasing credit facility with GE Capital Corporation
(“GE”) on June 25, 2004. The credit facility has a commitment term of three
years, expiring on June 25, 2007. The Company accounts for each draw as funded
indebtedness taking the form of a capital lease, with equitable ownership
in the
lasers remaining with the Company. GE retains title as a form of security
over
the lasers. The Company depreciates the lasers over their remaining useful
lives, as established when originally placed into service. Each draw against
the
credit facility has a self-amortizing repayment period of three years and
is
secured by specified lasers, which the Company has sold to GE and leased
back
for continued deployment in the field.
Under
the
first tranche, GE made available $2,500,000 under the line. A draw under
that
tranche is set at an interest rate based on 522 basis points above the
three-year Treasury note rate. Each such draw is discounted by 7.75%; the
first
monthly payment is applied directly to principal. With each draw, the Company
agreed to issue warrants to purchase shares of the Company’s common stock equal
to 5% of the draw. The number of warrants is determined by dividing 5% of
the
draw by the average closing price of the Company’s common stock for the ten days
preceding the date of the draw. The warrants have a five-year term from the
date
of each issuance and bear an exercise price set at 10% over the average closing
price for the ten days preceding the date of the draw.
As
of
September 30, 2005, the Company had made three draws against the first tranche
of the line, as follows:
Draw
1
|
Draw
2
|
Draw
3
|
||||||||
Date
of draw
|
6/30/04
|
9/24/04
|
12/30/04
|
|||||||
Amount
of draw
|
$
|
1,536,950
|
$
|
320,000
|
$
|
153,172
|
||||
Stated
interest rate
|
8.47
|
%
|
7.97
|
%
|
8.43
|
%
|
||||
Effective
interest rate
|
17.79
|
%
|
17.14
|
%
|
17.61
|
%
|
||||
Number
of warrants issued
|
23,903
|
6,656
|
3,102
|
|||||||
Exercise
price of warrants per share
|
$
|
3.54
|
$
|
2.64
|
$
|
2.73
|
||||
Fair
value of warrants
|
$
|
62,032
|
$
|
13,489
|
$
|
5,946
|
The
fair
value of the warrants granted under the draws is estimated using the
Black-Scholes option-pricing model with the following weighted average
assumptions applicable to the warrants granted:
Warrants
granted under:
|
|||||
Draw
1
|
Draw
2
|
Draw
3
|
|||
Risk-free
interest rate
|
3.81%
|
3.70%
|
3.64%
|
||
Volatility
|
99.9%
|
100%
|
99.3%
|
||
Expected
dividend yield
|
0%
|
0%
|
0%
|
||
Expected
option life
|
5
years
|
5
years
|
5
years
|
For
reporting purposes, the carrying value of the liability is reduced at the
time
of each draw by the value ascribed to the warrants. This reduction will be
amortized at the effective interest rate to interest expense over the term
of
the draw.
20
The
Company obtained from GE a second tranche under the leasing credit facility
for
$5,000,000 on June 28, 2005. The Company accounts for draws under this second
tranche in the same manner as under the first tranche except that: (i) the
stated interest rate is set at 477 basis points above the three-year Treasury
note rate; (ii) each draw is discounted by 3.50%; and (iii) with each draw,
the
Company has agreed to issue warrants to purchase shares of the Company’s common
stock equal to 3% of the draw. The number of warrants is determined by dividing
3% of the draw by the average closing price of the Company’s common stock for
the ten days preceding the date of the draw. The warrants have a five-year
term
from the date of each issuance and bear an exercise price set at 10% over
the
average closing price for the ten days preceding the date of the draw.
As
of
September 30, 2005, the Company had made 2 draws against the second tranche,
as
follows:
Draw
4
|
Draw
5
|
||||||
Date
of draw
|
6/28/05
|
9/26/05
|
|||||
Amount
of draw
|
$
|
1,113,326
|
$
|
914,592
|
|||
Stated
interest rate
|
8.42
|
%
|
8.42
|
%
|
|||
Effective
interest rate
|
12.63
|
%
|
12.94
|
%
|
|||
Number
of warrants issued
|
14,714
|
13,191
|
|||||
Exercise
price of warrants per share
|
$
|
2.50
|
$
|
2.29
|
|||
Fair
value of warrants
|
$
|
23,257
|
$
|
19,106
|
The
fair
value of the warrants granted under the draws is estimated using the
Black-Scholes option-pricing model with the following weighted average
assumptions applicable to the warrants granted:
Warrants
granted under:
|
||
Draw
4
|
Draw
5
|
|
Risk-free
interest rate
|
3.76%
|
4.11%
|
Volatility
|
94.6%
|
93.75%
|
Expected
dividend yield
|
0%
|
0%
|
Expected
option life
|
5
years
|
5
years
|
For
reporting purposes, the carrying value of the liability is reduced at the
time
of each draw by the value ascribed to the warrants. This reduction will be
amortized at the effective interest rate to interest expense over the term
of
the draw.
As
of
September 30, 2005 the Company had available $2,972,082 from the second tranche
of the line of credit with GE from which to draw on in the future.
The
obligations under capital leases are at fixed interest rates and are
collateralized by the related property and equipment (see Note 4).
Note
10
Warrant
Exercises:
In
the
nine months ended September 30, 2005, the Company received $147,060 from
the
exercise of 73,530 warrants. The warrants were issued in connection with
a
private placement of securities in June 2002 and bore an exercise price of
$2.00.
In
the
nine months ended September 30, 2004, 2,104,138 warrants on the common stock
of
the Company were exercised, resulting in an increase to the Company’s shares
outstanding as of the end of the period by the same amount. The Company received
$3,086,468 in cash proceeds from the exercises. Of these proceeds, $1,226,112
was from the exercise of warrants that were exercisable at $1.16 per share
and
were set to expire on September 30, 2004.
21
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 revenues from procedures performed by dermatologists in the United
States. The International XTRAC segment, in comparison, generates revenues
from
the sale of equipment to dermatologists outside the United States through
a
network of distributors. The Surgical Services segment generates revenues
by
providing fee-based procedures typically using the Company’s mobile surgical
laser equipment delivered and operated by a technician at hospitals and surgery
centers in the United States. The Surgical Products segment generates revenues
by selling laser products and disposables to hospitals and surgery centers
on
both a domestic and international basis. 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. For the three and
nine months ended September 30, 2005 and 2004, the Company did not
have
material revenues from any individual customer.
Unallocated
operating expenses include costs incurred for administrative and accounting
staff, general liability and other insurance, professional fees and other
similar corporate expenses. Unallocated assets include cash, prepaid expenses
and deposits. Goodwill that is carried at $2,944,423 at September 30,
2005
and December 31, 2004 has been allocated to the domestic and international
XTRAC
segments based upon its fair value as of the date of the Acculase buy-out
in the
amounts of $2,061,096 and $883,327, respectively. Goodwill of $13,430,961
at
September 30, 2005 from the ProCyte acquisition has been entirely allocated
to
the Skin Care (ProCyte) segment.
The
following tables reflect results of operations from our business segments
for
the periods indicated below:
Three
Months Ended September 30, 2005
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
XTRAC
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
SKIN
CARE
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
1,019,184
|
$
|
299,176
|
$
|
1,903,336
|
$
|
1,473,461
|
$
|
2,928,681
|
$
|
7,623,838
|
|||||||
Costs
of revenues
|
859,061
|
244,065
|
1,465,502
|
865,351
|
869,405
|
4,303,384
|
|||||||||||||
Gross
profit
|
160,123
|
55,111
|
437,834
|
608,110
|
2,059,276
|
3,320,454
|
|||||||||||||
Gross
profit %
|
15.7%
|
|
18.4%
|
|
23.0%
|
|
41.3%
|
|
70.3%
|
|
43.6%
|
|
|||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
703,924
|
46,407
|
308,701
|
157,269
|
1,574,059
|
2,790,360
|
|||||||||||||
Engineering
and product development
|
—
|
—
|
—
|
161,987
|
142,948
|
304,935
|
|||||||||||||
Unallocated
Operating expenses
|
—
|
—
|
—
|
—
|
—
|
1,735,819
|
|||||||||||||
703,924
|
46,407
|
308,701
|
319,256
|
1,717,007
|
4,831,114
|
||||||||||||||
Income
(loss) from operations
|
(543,801
|
)
|
8,704
|
129,133
|
288,854
|
342,269
|
(1,510,660
|
)
|
|||||||||||
Other
income
|
244,988
|
||||||||||||||||||
Interest
expense, net
|
—
|
—
|
—
|
—
|
—
|
(84,228
|
)
|
||||||||||||
Net
income (loss)
|
($543,801
|
)
|
$
|
8,704
|
$
|
129,133
|
$
|
288,854
|
$
|
342,269
|
($1,349,900
|
)
|
22
Three
Months Ended September 30, 2004
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
XTRAC
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
SKIN
CARE
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
945,755
|
$
|
155,024
|
$
|
2,059,714
|
$
|
1,294,903
|
-
|
$
|
4,455,396
|
||||||||
Costs
of revenues
|
429,842
|
160,588
|
1,291,004
|
619,982
|
-
|
2,501,416
|
|||||||||||||
Gross
profit
|
515,913
|
(5,564
|
)
|
768,710
|
674,921
|
-
|
1,953,980
|
||||||||||||
Gross
profit %
|
54.5
|
%
|
(3.6
|
)%
|
37.3
|
%
|
52.1
|
%
|
-
|
%
|
43.9
|
%
|
|||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
407,673
|
32,849
|
337,502
|
162,887
|
-
|
940,911
|
|||||||||||||
Engineering
and product development
|
167,377
|
104,781
|
-
|
156,048
|
-
|
428,206
|
|||||||||||||
Unallocated
Operating expenses
|
-
|
-
|
-
|
-
|
-
|
1,693,483
|
|||||||||||||
575,050
|
137,630
|
337,502
|
318,935
|
-
|
3,062,600
|
||||||||||||||
Income
(loss) from operations
|
(59,137
|
)
|
(143,194
|
)
|
431,208
|
355,986
|
-
|
(1,108,620
|
)
|
||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(47,189
|
)
|
||||||||||||
Net
income (loss)
|
($59,137
|
)
|
($143,194
|
)
|
$
|
431,208
|
$
|
355,986
|
-
|
($1,155,809
|
)
|
||||||||
Nine
Months Ended September 30, 2005
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
XTRAC
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
SKIN
CARE
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
2,542,373
|
$
|
901,561
|
$
|
5,977,366
|
$
|
4,166,844
|
$
|
7,074,196
|
$
|
20,662,340
|
|||||||
Costs
of revenues
|
1,952,232
|
637,815
|
4,283,181
|
2,130,016
|
2,154,700
|
11,157,944
|
|||||||||||||
Gross
profit
|
590,141
|
263,746
|
1,694,185
|
2,036,828
|
4,919,496
|
9,504,396
|
|||||||||||||
Gross
profit %
|
23.2
|
%
|
29.3
|
%
|
28.3
|
%
|
48.9
|
%
|
69.5
|
%
|
46.0
|
%
|
|||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
1,909,846
|
200,034
|
930,000
|
460,665
|
3,735,087
|
7,235,632
|
|||||||||||||
Engineering
and product development
|
-
|
-
|
-
|
509,184
|
310,661
|
819,845
|
|||||||||||||
|
|||||||||||||||||||
Unallocated
Operating expenses
|
-
|
-
|
-
|
-
|
-
|
4,708,961
|
|||||||||||||
1,909,846
|
200,034
|
930,000
|
969,849
|
4,045,748
|
12,764,438
|
||||||||||||||
Income
(loss) from operations
|
(1,319,705
|
)
|
63,712
|
764,185
|
1,066,982
|
873,748
|
(3,260,042
|
)
|
|||||||||||
Other
income
|
333,655
|
||||||||||||||||||
Interest
expense, net
|
-
|
-
|
-
|
-
|
-
|
(212,276
|
)
|
||||||||||||
Net
income (loss)
|
($1,319,705
|
)
|
$
|
63,712
|
$
|
764,185
|
$
|
1,066,982
|
$
|
873,748
|
($3,138,663
|
)
|
23
Nine
Months Ended September 30, 2004
|
|||||||||||||||||||
DOMESTIC
XTRAC
|
INTERN’L
XTRAC
|
SURGICAL
SERVICES
|
SURGICAL
PRODUCTS
AND
OTHER
|
SKIN
CARE
|
TOTAL
|
||||||||||||||
Revenues
|
$
|
2,215,619
|
$
|
1,190,538
|
$
|
5,633,254
|
$
|
3,764,349
|
-
|
$
|
12,803,760
|
||||||||
Costs
of revenues
|
1,456,969
|
853,348
|
3,551,079
|
1,765,455
|
-
|
7,626,851
|
|||||||||||||
Gross
profit
|
758,650
|
337,190
|
2,082,175
|
1,998,894
|
-
|
5,176,909
|
|||||||||||||
Gross
profit %
|
34.2
|
%
|
28.3
|
%
|
37.0
|
%
|
53.1
|
%
|
-
|
%
|
40.4
|
%
|
|||||||
|
|||||||||||||||||||
Allocated
Operating expenses:
|
|||||||||||||||||||
Selling,
general and administrative
|
1,368,548
|
283,895
|
1,004,569
|
465,801
|
-
|
3,122,813
|
|||||||||||||
Engineering
and product development
|
510,597
|
319,641
|
-
|
495,161
|
-
|
1,325,399
|
|||||||||||||
|
|||||||||||||||||||
Unallocated
Operating expenses
|
-
|
-
|
-
|
-
|
-
|
4,388,452
|
|||||||||||||
|
1,879,145
|
603,536
|
1,004,569
|
960,962
|
-
|
8,836,664
|
|||||||||||||
Income
(loss) from operations
|
(1,120,495
|
)
|
(266,346
|
)
|
1,077,606
|
1,037,932
|
-
|
(3,659,755
|
)
|
||||||||||
|
|||||||||||||||||||
Interest
expense (income), net
|
-
|
-
|
-
|
-
|
-
|
(66,297
|
)
|
||||||||||||
|
|||||||||||||||||||
Net
income (loss)
|
($1,120,495
|
)
|
$
|
(266,346
|
)
|
$
|
1,077,606
|
$
|
1,037,932
|
-
|
($3,726,052
|
)
|
September
30, 2005
|
December
31, 2004
|
||||||
Assets:
|
|||||||
Total
assets for reportable segments
|
$
|
42,032,156
|
$
|
18,547,510
|
|||
Other
unallocated assets
|
6,390,035
|
4,414,416
|
|||||
Consolidated
total
|
$
|
48,422,191
|
$
|
22,961,926
|
For
the
three and nine months ended September 30, 2005 and 2004, there were
no
material net revenues attributed to any individual foreign country. Net revenues
by geographic area were, as follows:
For
the Three Months Ended
September
30,
|
For
the nine Months Ended
September
30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Domestic
|
$
|
6,986,126
|
$
|
4,089,123
|
$
|
18,669,378
|
$
|
11,045,962
|
|||||
Foreign
|
637,712
|
366,273
|
1,992,962
|
1,757,798
|
|||||||||
$
|
7,623,838
|
$
|
4,455,396
|
$
|
20,662,340
|
$
|
12,803,760
|
Note
12
Significant
Alliances/Agreements:
On
March
31, 2005, the Company entered into a Sales and Marketing Agreement with
GlobalMed (Asia) Technologies Co., Inc. (“GlobalMed”). Under this Agreement,
GlobalMed will act as master distributor in the Pacific Rim for the Company’s
XTRAC excimer laser, (including the Ultra™ excimer laser), and for the Company’s
LaserPro® diode surgical laser system. The Company’s diode laser will be
marketed for, among other things, use in a gynecological procedure pioneered
by
David Matlock, MD. The
Company will engage Sanders Ergas, who is a principal of GlobalMed, and Dr.
Matlock as consultants to explore further business opportunities for the
Company. In connection with this engagement, each consultant will receive
options to purchase up to 25,000 shares of the common stock of the Company,
granted with an exercise price based on fair market value.
24
On
July
27, 2005, the Company entered a Marketing Agreement with KDS Marketing, Inc.
(“KDS”). Using money invested by each party, KDS will research market
opportunities for the Company’s diode laser and related delivery systems, and
KDS will then market the diode laser, primarily through a website on which
physicians may access for information about the lasers and which they may
use to
purchase the lasers. KDS’s return on its investment will be based primarily on
commissions earned on diode lasers that are sold under the program.
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, 2004 and that are discussed with respect to risks
relevant to the acquisition and business operations of ProCyte Corporation
under
the section entitled “Risks Factors” in Pre-Effective Amendment No. 1 to our
Registration Statement No. 333-121864 on Form S-4 filed with the Commission
on
January 21, 2005.
The
following discussion and analysis should be read in conjunction with the
consolidated financial statements and related notes included elsewhere in
this
Report.
Introduction,
Outlook and Overview of Business Operations
We
view
our business as comprised of the following five business segments:
·
|
Domestic
XTRAC,
|
·
|
International
XTRAC,
|
·
|
Surgical
Services,
|
·
|
Surgical
Products, and
|
·
|
Skin
Care (ProCyte).
|
Domestic
XTRAC
The
Domestic XTRAC segment is a U.S. business with revenues derived from procedures
performed by dermatologists. We are engaged in the development, manufacturing
and marketing of our proprietary XTRAC® excimer laser and delivery systems and
techniques used in the treatment of inflammatory skin disorders, including
psoriasis, vitiligo, atopic dermatitis and leukoderma. In January 2000, we
received approval of our 510(k) submission from the Food and Drug
Administration, or FDA, establishing that our XTRAC system is substantially
equivalent to currently marketed devices for the treatment of
psoriasis.
As
part
of our commercialization strategy in the United States, we provide the XTRAC
system to targeted dermatologists at no initial capital cost to them. We
maintain ownership of the laser and earn revenue each time the physician
treats
a patient with the equipment. We believe that this strategy will create
incentives for these dermatologists to adopt the XTRAC system and will increase
market penetration.
25
During
2003, we introduced a more reliable version of the XTRAC and increased our
efforts to obtain more favorable reimbursement policies from both the Centers
for Medicare and Medicaid Services and from private insurance plans. To help
encourage the adoption of favorable reimbursement policies, we also commissioned
a clinical and economic study of the use of the XTRAC laser as a second-step
therapy for psoriasis.
In
2004,
our primary focus was to secure favorable reimbursement policies from private
health plans for treatment of psoriasis using the XTRAC® excimer
laser. As
of the
date of this Report, we have received approval from Regence, Wellpoint, Aetna,
Anthem, Cigna, United Healthcare and Independence Blue Cross of Pennsylvania,
and we are under consideration by other plans. We cannot at this time provide
assurance that other plans will adopt the favorable policies that we desire,
and
if they do not, what further requirements may be asked of us.
In
October 2004, we received FDA concurrence under a 510(k) to market the new
XTRAC
Ultra™, a smaller-size dermatology laser with increased functionality for
inflammatory skin disorders. The increased functionality of the laser extends
its utility, broadens its clinical applications and allows shorter treatment
times.
In
2005,
we are continuing our efforts to secure a wider base of private insurance
coverage for psoriasis patients in the United States and are expanding our
selling efforts for the XTRAC in combination with the increased dermatology
sales force obtained in connection with the ProCyte merger.
International
XTRAC
In
the
international market, we derive revenues from the XTRAC by selling the
dermatology laser system to distributors and directly to physicians. In this
market, we have benefited from both our clinical studies and from the improved
reliability and functionality of the XTRAC. Compared
to the domestic segment, the international XTRAC business is more influenced
by
competition from similar laser technologies as well as non-laser lamp
alternatives. Over time, this competition has reduced the prices we charge
to
international distributors for our XTRAC products.
While
the
number of lasers sold was greater for the three months ended September 30,
2005
compared to the same period for 2004, the average price per laser system
and
parts was less in the 2005 period ($59,835) than in the 2004 period ($77,512).
For the nine months ended September 30, 2005, the average price per laser
system
and parts $56,348 compared to the prior year period $66,141 and the number
of
lasers sold was less in the 2005 period than in the 2004 period. In addition,
of
the 18 lasers recognized in the nine months ended September 30, 2004, four
of
those lasers had been shipped in 2003, but not recognized as sales due to
the
application of the SAB 104 Criteria.
Due
to
the significant financial investment requirements, we
were
reluctant previously to implement an international XTRAC fee-per-use revenue
model, similar to the domestic revenue model. However, as reimbursement in
the
domestic market has become more widespread, we have recently started to offer
version of this model overseas.
In
2005,
we also are exploring new product offerings in the treatment of dermatological
conditions to our international customers as a result of our recent acquisition
of worldwide rights to certain proprietary light-based technology from Stern
Laser.
Surgical
Services
The
Surgical Services segment generates revenues by providing fee-based procedures
typically using our mobile surgical laser equipment delivered and operated
by a
technician at hospitals and surgery centers in the United States. Although
we
intend to increase our investment in this business segment for 2005, we will
continue to pursue a very cautious growth strategy in order to conserve our
cash
resources for the XTRAC business segments. We experienced revenue growth
in
Surgical Services in 2004 and are experiencing continued growth in 2005.
We
have
growing, but still limited marketing experience in expanding our surgical
services business. The majority of this business is in the southeastern part
of
the United States. New procedures and geographical expansion, together with
new
customers and different business habits and networks, will likely pose different
challenges compared to those that we have encountered in the past. There
can be
no assurance that we will be able to overcome such challenges.
26
Surgical
Products
The
Surgical Products segment generates revenues by selling laser products and
disposables to hospitals and surgery centers both inside and outside of the
United States. Although surgical product revenues increased in 2005 compared
to
2004, we expect that sales of surgical laser systems and the related disposable
base may begin to erode as hospitals continue to seek outsourcing solutions
instead of purchasing lasers and related disposables for their operating
rooms.
We are working at offsetting this erosion by expanding our surgical services
segment and by increasing sales from the CO2 and diode surgical lasers
introduced in 2004.
In
the
second quarter 2004, we received from the FDA concurrence to market two new
surgical lasers: the LaserPro® Diode Laser System and the LaserPro® CO2 Laser
System. Each system has been designed for rugged use in our Surgical Services
business and will assist us in finding end-user buyers domestically and
overseas. We are also actively exploring opportunities to supply on an OEM
basis
or under manufacturing-marketing collaborations.
In
July
2004, we entered into an agreement with AzurTec, Inc. to develop a device
that
rapidly and accurately detects the presence of cancerous cells in excised
tissue. We intend to assist in the development of FDA-compliant prototypes
for
AzurTec’s product and have collected payments under the agreement aggregating
$240,000 through September 30, 2005. Continuing development of this project
requires additional investment by AzurTec. We will resume development once
this
investment has been satisfied.
Skin
Care (ProCyte)
On
March
18, 2005, we completed the acquisition of ProCyte Corporation. ProCyte generates
revenues from the sale of skin health, hair care and wound care products;
the
sale of copper peptide compound in bulk; and royalties on licenses for the
patented copper peptide compound. The skin care business as integrated into
the
operations of the company, now has 45 employees, consisting of 23 in sales,
12
in marketing, 8 in warehouse/research and development and 2 in
administration.
The
operating results of ProCyte for the nine months ended September 30, 2005
are
included from March 19, 2005 through September 30, 2005. Under purchase
accounting rules, the operating results of ProCyte for prior periods are
not
included in our Statement of Operations. A description of transaction and
proforma operating results are disclosed as part of Note 2, Acquisitions
to the
financial statements.
ProCyte’s
focus has been to provide unique products, primarily based upon patented
technologies for selected applications in the dermatology, plastic and cosmetic
surgery and spa markets. ProCyte has also expanded the use of its novel copper
peptide technologies into the mass retail market for skin and hair care through
targeted technology licensing and supply agreements.
ProCyte’s
products are aimed at the growing demand for skin health and hair care products,
including products to enhance appearance and address the effects of aging
on
skin and hair. ProCyte’s products are formulated, branded and targeted at
specific markets. ProCyte’s initial products addressed the dermatology, plastic
and cosmetic surgery markets for use after various procedures. Anti-aging
skin
care products were added to offer a comprehensive approach for a patient’s skin
care regimen.
Our
goals
for this acquisition are summarized below:
·
|
ProCyte's
presence in the skin health and hair care products market will
present a
growth opportunity for PhotoMedex to market its existing
products;
|
·
|
the
addition of ProCyte's sales and marketing personnel will enhance
our
ability to market the XTRAC excimer
laser;
|
27
·
|
the
addition of ProCyte's operations and existing cash balances will
improve
PhotoMedex's operating results and strengthen its balance
sheet;
|
·
|
the
combination of the senior management of ProCyte and PhotoMedex
will allow
complementary skills to strengthen the overall management team;
and
|
·
|
the
combined company may reap short-term cost savings and have the
opportunity
for additional longer-term cost
efficiencies.
|
Since
the
acquisition date, we have made progress toward the achievement of these goals.
In addition, we had targeted reasonable growth in revenues from ProCyte’s skin
care products, but have yet to realize this expected growth while we are
in the
process of integrating the sales personnel from the Skin Care and the Domestic
XTRAC segments.
Critical
Accounting Policies
The
discussion and analysis of our financial condition and results of operations
in
this Report are based upon our Consolidated Financial Statements, which have
been prepared in accordance with accounting principles generally accepted
in the
United States. The preparation of financial statements requires management
to
make estimates and judgments that affect the reported amounts of assets and
liabilities, revenues and expenses and related disclosures at the date of
the
financial statements. On an on-going basis, we evaluate our estimates,
including, but not limited to, those related to revenue recognition, accounts
receivable, inventories, impairment of property and equipment and of
intangibles, deferred taxes and accruals for warranty claims. We use
authoritative pronouncements, historical experience and other assumptions
as the
basis for making estimates. Actual results could differ from those estimates.
Management believes that the following critical accounting policies affect
our
more significant judgments and estimates in the preparation of our Consolidated
Financial Statements. These critical accounting policies and the significant
estimates made in accordance with them have been discussed with our Audit
Committee.
Revenue
Recognition
XTRAC-Related
Operations
We
have
two distribution channels for our phototherapy treatment equipment. We either
(i) sell the laser through a distributor or directly to a physician, or (ii)
place the laser in a physician’s office (at no charge to the physician) and
charge the physician a fee for an agreed upon number of treatments. When
we sell
an XTRAC laser to a distributor or directly to a physician, revenue is
recognized when the following four criteria under Staff Accounting Bulletin
No.
104 have been met: (i) the product has been shipped and we have no significant
remaining obligations; (ii) persuasive evidence of an arrangement exists;
(iii)
the price to the buyer is fixed or determinable; and (iv) collection is probable
(“SAB 104 Criteria”). At times, units are shipped, but revenue is not recognized
until all of the criteria are met, and until that time, the unit is carried
on
our books as inventory. We ship most of our products FOB shipping point,
although from time to time certain customers, for example, governmental
customers, will insist on FOB destination. Among the factors we take into
account in determining the proper time at which to recognize revenue are
when
title to the goods transfers and when the risk of loss transfers. Shipments
to
the distributors that do not fully satisfy the collection criteria are
recognized when invoiced amounts are fully paid.
Under
the
terms of the distributor agreements, our distributors do not have the right
to
return any unit that they have purchased. However, we allow products to be
returned by our distributors in redress of product defects or other claims.
When
we
place a laser in a physician’s office, we recognize service revenue based on the
number of patient treatments used by the physician. Treatments in the form
of
random laser-access codes that are sold to physicians, but not yet used,
are
deferred and recognized as a liability until the physician performs the
treatment. Unused treatments remain our obligation inasmuch as the treatments
can only be performed on equipment made by us. Once the treatments are delivered
to a patient, this obligation has been satisfied.
28
The
calculation of unused treatments has historically been based upon an estimate
that at the end of each accounting period, 15 unused treatments existed at
each
laser location. This was based upon the reasoning that we generally sell
treatments in packages of 30 treatments. Fifteen treatments generally represents
about one-half the purchase quantity by a physician or approximately a one-week
supply for 6-8 patients. This policy had been used on a consistent basis.
We
believed this approach to have been reasonable and systematic given that:
(a)
physicians have little motivation to purchase quantities (which they are
obligated to pay for irrespective of actual use and are unable to seek a
refund
for unused treatments) that will not be used in a relatively short period
of
time, particularly since in most cases they can obtain incremental treatments
instantaneously over the phone; and (b) senior management regularly reviews
purchase patterns by physicians to identify unusual buildup of unused treatment
codes at a laser site. Moreover, we continually look at our estimation model
based upon data received from our customers.
In
the
fourth quarter of 2004, we updated the calculations for the estimated amount
of
unused treatments to reflect recent purchasing patterns by physicians near
year-end. We have estimated the amount of unused treatments at December 31,
2004
to include all sales of treatment codes made within the last two weeks of
the
period. We believe this approach more closely approximates the actual amount
of
unused treatments that existed at that date than the previous approach. APB
No.
20 provides that accounting estimates change as new events occur, as more
experience is acquired, or as additional information is obtained and that
the
effect of the change in accounting estimate should be accounted for in the
current period and the future periods that it affects. We accounted for this
change in the estimate of unused treatments in accordance with APB No. 20
and
SFAS No. 48. Accordingly, our change in accounting estimate was reported
in
revenues for the fourth quarter of 2004 and was not accounted for by restating
amounts reported in financial statements of prior periods or by reporting
proforma amounts for prior periods.
We
have
continued this approach or method for estimating the amount of unused treatments
at September 30, 2005. Due to this updated approach in estimates, XTRAC domestic
revenues were increased by $159,000 and $97,000 for the three and nine months
ended September 30, 2005, respectively, as compared to the prior method of
estimation.
In
the
first quarter of 2003, we implemented a program to support certain physicians
in
addressing treatments with the XTRAC system that may be denied reimbursement
by
private insurance carriers. We recognize service revenue from the sale of
treatment codes to physicians participating in this program only if and to
the
extent the physician has been reimbursed for the treatments. For the three
and
nine months ended September 30, 2005, we deferred an additional $25,375 and
$58,090, respectively, under this program as all the criteria for revenue
recognition were not met. At September 30, 2005, we had net deferred revenues
of
$153,136 under this program.
Under
this program, we may reimburse qualifying doctors for the cost of our fee
but
only if they are ultimately denied reimbursement after appeal of their claim
with the insurance company. The key components of the program are as
follows:
·
|
The
physician practice must be in an identified location where there
is still
an insufficiency of insurance companies reimbursing the
procedure;
|
·
|
The
program only covers medically necessary treatments of psoriasis
as
determined by the treating
physician;
|
·
|
The
patient must have medical insurance and a claim for the treatment
must be
timely filed with the patient’s insurance company;
|
·
|
Upon
denial by the insurance company (generally within 30 days of filing
the
claim), a standard insurance form called an EOB (“Explanation of
Benefits”) must be submitted to our in-house appeals group, who will then
prosecute the appeal. The appeal process can take 6-9
months;
|
·
|
After
all appeals have been exhausted by us and the claim remains unpaid,
the
physician is entitled to receive credit for the treatment he or
she
purchased from us (our fee only) on behalf of the patient;
and
|
· |
Physicians
are still obligated to make timely payments for treatments purchased,
irrespective of whether reimbursement is paid or denied. Future
sale of
treatments to the physician can be denied if timely payments are
not made,
even if a patient’s appeal is still in
process.
|
29
Historically,
we estimated a contingent liability for potential refunds under this program
by
estimating when the physician was paid for the insurance claim. In the absence
of a two-year historical trend and a large pool of homogeneous transactions
to
reliably predict the estimated claims for refund as required by Staff Accounting
Bulletin Nos. 101 and 104, we previously deferred revenue recognition of
100% of
the current quarter revenues from the program to allow for the actual denied
claims to be identified after processing with the insurance companies. After
more than 106,000 treatments in the last 2 years and detailed record keeping
of
denied insurance claims and appeals processed, we have estimated that
approximately 11% of a current quarter’s revenues under this program are subject
to being credited or refunded to the physician.
As
of
December 31, 2004, we updated our analysis to reflect this level of estimated
refunds. This change from the past process of deferring 100% of the current
quarter revenues from the program represents a change in accounting estimate,
and we recorded this change in accordance with the relevant provisions of
SFAS
No. 48 and APB No. 20. These pronouncements state that the effect of a change
in
accounting estimate should be accounted for in the current period and the
future
periods that it affects. A change in accounting estimate should not be accounted
for by restating amounts reported in financial statements of prior periods
or by
reporting proforma amounts for prior periods. Due
to
this updated approach in estimates, XTRAC domestic revenues were increased
by
$33,000 and $89,000 for the three and nine months ended September 30, 2005
as
compared to the prior method of estimation.
The
net
impact on revenue recognized for the XTRAC domestic segment as a result of
the
above two changes in accounting estimate was to increase revenues by
approximately $192,000 and $186,000 for the three and nine months ended
September 30, 2005, respectively.
Surgical
Products and Service Operations
We
recognize revenues from surgical lasers and other product sales, including
sales
to distributors, when the SAB 104 Criteria have been met. At times, units
are
shipped but revenue is not recognized until all of the criteria are met,
and
until that time, the unit is carried on our books of as inventory. We ship
most
of our products FOB shipping point, although from time to time certain
customers, for example governmental customers, will insist on FOB destination.
Among the factors we take into account in determining the proper time at
which
to recognize revenue are when title to the goods transfers and when the risk
of
loss transfers.
For
per-procedure surgical services, we recognize revenue upon the completion
of the
procedure. Revenue from maintenance service agreements is deferred and
recognized on a straight-line basis over the term of the agreements. Revenue
from billable services, including repair activity, is recognized when the
service is provided.
Skin
Care Operations
Through
the acquisition of ProCyte, we generate revenues primarily through product
sales
for skin health, hair care and wound care; sales of the copper peptide compound,
primarily to Neutrogena; and royalties generated by our licenses, principally
to
Neutrogena.
We
recognize revenues on the products and copper peptide compound when they
are
shipped. We ship the products FOB shipping point. Royalty revenues are based
upon sales generated by our licensees. We recognize royalty revenue at the
applicable royalty rate applied to shipments reported by our
licensee.
Inventory.
We
account for inventory at the lower of cost (first-in, first-out) or market.
Cost
is determined to be the purchased cost for raw materials and the production
cost
(materials, labor and indirect manufacturing cost) for work-in-process and
finished goods. Throughout the laser manufacturing process, the related
production costs are recorded within inventory. Work-in-process is immaterial,
given the typically short manufacturing cycle and therefore is disclosed
in
conjunction with raw materials. We perform full physical inventory counts
for
the XTRAC and cycle counts on the other inventory to maintain controls and
obtain accurate data.
Our
XTRAC
laser is either (i) sold to distributors or physicians directly or (ii) placed
in a physician's office and remains our property. The cost to build a laser,
whether for sale or for placement, is accumulated in inventory. When a laser
is
placed in a physician’s office, the cost is transferred from inventory to
“lasers in service” within property and equipment. At times, units are shipped
to distributors, but revenue is not recognized until all of the SAB 104 criteria
have been met, and until that time, the cost of the unit is carried on our
books
as finished goods inventory. Revenue is not recognized from these distributors
until payment is either assured or paid in full.
30
Reserves
for slow moving and obsolete inventories are provided based on historical
experience and product demand. Management evaluates the adequacy of these
reserves periodically based on forecasted sales and market trend.
Allowance
for Doubtful Accounts.
Accounts
receivable are reduced by an allowance for amounts that may become uncollectible
in the future. The majority of receivables related to phototherapy sales
are due
from various distributors located outside of the United States and from
physicians located inside the United States. The majority of receivables
related
to surgical services, surgical products and skin care products are due from
various customers and distributors located inside the United States. From
time
to time, our customers dispute the amounts due to us, and, in other cases,
our
customers experience financial difficulties and cannot pay on a timely basis.
In
certain instances, these factors ultimately result in uncollectible accounts.
The determination of the appropriate reserve needed for uncollectible accounts
involves significant judgment. A change in the factors used to evaluate
collectibility could result in a significant change in the reserve needed.
Such
factors include changes in the financial condition of our customers as a
result
of industry, economic or customer-specific factors.
Property
and Equipment.
As of
September 30, 2005 and December 31, 2004, we had net property and equipment
of
$6,677,895 and $4,996,688, respectively. The most significant component of
these
amounts relates to the XTRAC lasers placed by us in physicians’ offices. We own
the equipment and charge the physician on a per-treatment basis for use of
the
equipment. The recoverability of the net carrying value of the lasers is
predicated on increasing revenues from the physicians’ use of the lasers. XTRAC
lasers-in-service are depreciated on a straight-line basis over the estimated
useful life of three years. Surgical lasers-in-service are depreciated on
a
straight-line basis over an estimated useful life of seven years if new and
five
years or less if used equipment. The straight-line depreciation basis for
lasers-in-service is reflective of the pattern of use. For other property
and
equipment, including property and equipment acquired from ProCyte, depreciation
is calculated on a straight-line basis over the estimated useful lives of
the
assets, primarily three to seven years for computer hardware and software,
furniture and fixtures, automobiles, and machinery and equipment. Leasehold
improvements are amortized over the lesser of the useful lives or lease terms.
Useful lives are determined based upon an estimate of either physical or
economic obsolescence.
Intangibles.
As of
September 30, 2005 and December 31, 2004, we had $22,548,633 and $3,873,857,
respectively, of goodwill and other intangibles, accounting for 47% and 17%
of
our total assets at the respective dates. The determination of the value
of such
intangible assets requires management to make estimates and assumptions that
affect our consolidated financial statements. We test our goodwill for
impairment, at least annually. This test is usually conducted in December
of
each year in connection with the annual budgeting and forecasting process.
Also,
on a quarterly basis, we evaluate whether events have occurred that would
negatively impact the realizable value of our intangibles or goodwill.
31
There
has
been no change to the carrying value of goodwill that is allocated to the
XTRAC
domestic segment and the XTRAC international segment in the amounts of
$2,061,096 and $883,327, respectively. The allocation of goodwill to each
segment was based upon the relative fair values of the two segments as of
August
2000, when we bought out the minority interest in Acculase and thus recognized
the goodwill. In connection with the acquisition of ProCyte on March 18,
2005,
we acquired certain intangibles recorded at fair value as of the date of
acquisition and allocated fully to the Skin Care (ProCyte) segment. Included
in
these acquired intangibles were the following:
ProCyte
Neutrogena Agreement
|
$
|
2,400,000
|
||
ProCyte
Customer Relationships
|
1,700,000
|
|||
ProCyte
Tradename
|
1,100,000
|
|||
ProCyte
Developed Technologies
|
200,000
|
|||
Goodwill
|
13,430,961
|
|||
Total
|
$
|
18,830,961
|
Deferred
Income Taxes. We
have a
deferred tax asset that is fully reserved by a valuation allowance. We have
not
recognized the deferred tax asset, given our historical losses and the lack
of
certainty of future taxable income. However, if and when we become profitable
and can reasonably foresee continuing profitability, then under SFAS No.
109 we
may recognize some of the deferred tax asset. The recognized portion may
go in
some measure to a reduction of acquired goodwill and in some measure to benefit
the statements of operations.
Warranty
Accruals.
We
establish a liability for warranty repairs based on estimated future claims
for
XTRAC systems and based on historical analysis of the cost of the repairs
for
surgical laser systems. However, future returns on defective laser systems
and
related warranty liability could differ significantly from estimates, and
historical patterns, which could adversely affect our operating
results.
Results
of Operations
Revenues
The
following table illustrates revenues from our five business segments for
the
periods listed below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
XTRAC
Domestic Services
|
$
|
1,019,184
|
$
|
945,755
|
$
|
2,542,373
|
$
|
2,215,619
|
|||||
XTRAC
International Products
|
299,176
|
155,024
|
901,561
|
1,190,538
|
|||||||||
Total
XTRAC Revenues
|
1,318,360
|
1,100,779
|
3,443,934
|
3,406,157
|
|||||||||
Surgical
Services
|
1,903,336
|
2,059,714
|
5,977,366
|
5,633,254
|
|||||||||
Surgical
Products
|
1,473,461
|
1,294,903
|
4,166,844
|
3,764,349
|
|||||||||
Total
Surgical Revenues
|
3,376,797
|
3,354,617
|
10,144,210
|
9,397,603
|
|||||||||
Skin
Care (ProCyte) Revenues
|
2,928,681
|
-
|
7,074,196
|
-
|
|||||||||
Total
Revenues
|
$
|
7,623,838
|
$
|
4,455,396
|
$
|
20,662,340
|
$
|
12,803,760
|
32
Domestic
XTRAC Segment
Recognized
revenue for the three months ended September 30, 2005 and 2004 for domestic
XTRAC procedures was $1,019,184 and $945,755, respectively, reflecting billed
procedures of 13,876 and 12,672, respectively. In addition, 1,814 and 1,169
procedures, respectively, were performed in the three months ended September
30,
2005 and 2004, respectively, without billing from us, in connection with
clinical research and customer evaluations of the XTRAC laser. Recognized
revenue for the nine months ended September 30, 2005 and 2004 for domestic
XTRAC
procedures was $2,542,373 and $2,215,619, respectively, reflecting billed
procedures of 38,991 and 34,197, respectively. In addition, 4,620 and 3,069
procedures, respectively, were performed in the nine months ended September
30,
2005 and 2004, respectively, without billing from us in connection with clinical
research and customer evaluations of the XTRAC laser. The increase in procedures
in the periods ended September 30, 2005 compared to the comparable periods
in
2004 was largely related to our continuing progress in securing favorable
reimbursement policies from private insurance plans. Increases in these levels
are dependent upon more widespread adoption of the CPT codes with comparable
rates by private healthcare insurers and on instilling confidence in our
physician partners that the XTRAC procedures will benefit their patients
and be
generally reimbursed to their practices.
In
the
first quarter of 2003, we implemented a program to support certain physicians
who may be denied reimbursement by private insurance carriers for XTRAC
treatments. In accordance with the requirements of 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, 2005, we deferred net revenues of $25,375
under
this program compared to $96,323 of net recognized revenue for the three
months
ended September 30, 2004. For the nine months ended September 30, 2005, we
deferred net revenues of $58,090 under this program compared to $153,438
for the
nine months ended September 30, 2004. The change in deferred revenue under
this
program is presented in the table below.
In
the
three and nine months ending September 30, 2005, recognized revenues for
the
domestic XTRAC segment increased by approximately $33,000 and $89,000,
respectively, due to a change in accounting estimate for potential credits
or
refunds under the reimbursement program. In addition, in the three and nine
months ending September 30, 2005, recognized revenues for the domestic XTRAC
segment increased by approximately $159,000 and by approximately $97,000,
respectively, due to a change in the accounting estimate for unused physician
treatments that existed at September 30, 2005. The net impact on revenue
recognized for the XTRAC domestic segment as a result of the above two changes
in accounting estimate was to increase revenues by approximately $192,000
and
$186,000 for the three and nine months ended September 30, 2005,
respectively.
The
following table illustrates the above analysis for the Domestic XTRAC segment
for the periods reflected below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||||||||||||||||||||||||||||||
2005
|
2004
|
2005
|
2004
|
|||||||||||||||||||||||||||||||||||||
Recognized
revenue
|
$
|
1,019,184
|
$
|
945,755
|
$
|
2,542,373
|
$
|
2,215,619
|
||||||||||||||||||||||||||||||||
Change
in deferred program revenue
|
25,375
|
(96,323
|
)
|
58,090
|
153,438
|
|||||||||||||||||||||||||||||||||||
Change
in deferred unused treatments
|
(128,091
|
)
|
(9,513
|
)
|
(32,291
|
)
|
(32,863
|
)
|
||||||||||||||||||||||||||||||||
Net
billed revenue
|
$
|
916,468
|
$
|
839,919
|
$
|
2,568,172
|
$
|
2,336,194
|
||||||||||||||||||||||||||||||||
Procedure
volume total
|
15,690
|
13,841
|
43,611
|
37,266
|
||||||||||||||||||||||||||||||||||||
Less:
Non-billed procedures
|
1,814
|
1,169
|
4,620
|
3,069
|
||||||||||||||||||||||||||||||||||||
Net
billed procedures
|
13,876
|
12,672
|
38,991
|
34,197
|
||||||||||||||||||||||||||||||||||||
Avg.
price of treatments billed
|
$
|
66.05
|
$
|
66.28
|
$
|
65.87
|
$
|
68.32
|
||||||||||||||||||||||||||||||||
Change
in procedures with deferred/(recognized) program revenue,
net
|
384
|
(1,453
|
)
|
882
|
2,246
|
|||||||||||||||||||||||||||||||||||
Change
in procedures with recognized unused treatments, net
|
(1,939
|
)
|
(144
|
)
|
(490
|
)
|
(481) |
33
The
average price for a treatment varies based upon the mix of mild and moderate
psoriasis patients treated by our physician partners. We charge a higher
price
per treatment for moderate psoriasis patients due to the increased body surface
area required to be treated, although there are fewer patients with moderate
psoriasis than there are with mild psoriasis. Due to the length of treatment
time required, it has not been generally practical to use our therapy to
treat
severe psoriasis patients, but, this may change as our new product, the XTRAC
Ultra, has shorter treatment times.
International
XTRAC Segment
International
XTRAC sales of our excimer laser system and related parts were $299,176 for
the
three months ended September 30, 2005 compared to $155,024 for the three
months
ended September 30, 2004. We sold five and two laser systems in the three
months
ended September 30, 2005 and 2004, respectively. International XTRAC sales
of
our excimer laser system and related parts were $901,561 for the nine months
ended September 30, 2005 compared to $1,190,538 for the nine months ended
September 30, 2004. We sold 16 laser systems in the nine months ended September
30, 2005 compared to 18 laser systems in the nine months ended September
30,
2004. Compared to the domestic business, the international XTRAC operations
are
more influenced by competition from similar laser technology from other
manufacturers and from non-laser lamps, which over time, has served to reduce
the prices we charge to international distributors. In addition, of the 18
lasers recognized in the nine months ended September 30, 2004, four of those
lasers had been shipped in 2003, but not recognized as sales due to the
application of the SAB 104 Criteria.
The
following table illustrates the key changes in the International XTRAC segment
for the periods reflected below:
Three
Months Ended September 30,
|
Nine
Months Ended September 30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
299,176
|
$
|
155,024
|
$
|
901,561
|
$
|
1,190,538
|
|||||
Laser
systems sold
|
5
|
2
|
16
|
18
|
|||||||||
Average
revenue per laser
|
$
|
59,835
|
$
|
77,512
|
$
|
56,348
|
$
|
66,141
|
Surgical
Services Segment
In
the
three months ended September 30, 2005 and 2004, surgical services revenues
were
$1,903,336 and $2,059,714, respectively, representing a 7.6% decrease from
the
comparable period in 2004. This decrease was primarily due to the three
territories that we closed during 2005 and business interruption in New Orleans
and Alabama from the hurricanes. In the nine months ended September 30, 2005
and
2004, surgical services revenues were $5,977,366 and $5,633,254, respectively
representing a 6.1% increase from the comparable period in 2004. This increase
was primarily due to growth in urological procedures performed with laser
systems purchased from a third-party manufacturer. Such procedures included
a
charge for the use of the laser and the technician to operate it, as well
as a
charge for the third party’s proprietary fiber delivery system.
34
The
following table illustrates the key changes in the Surgical Services segment
for
the periods reflected below:
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
1,903,336
|
$
|
2,059,714
|
$
|
5,977,366
|
$
|
5,633,254
|
|||||
Percent
(decrease)/increase
|
(7.6
|
%)
|
6.1
|
%
|
|||||||||
Cost
of revenues
|
1,465,502
|
1,291,004
|
4,283,180
|
3,551,079
|
|||||||||
Gross
profit
|
$
|
437,834
|
$
|
768,710
|
$
|
1,694,186
|
$
|
2,082,175
|
|||||
Percent
of revenue
|
23.0
|
%
|
37.3
|
%
|
28.3
|
%
|
37.0
|
%
|
Surgical
Products Segment
Surgical
Products revenues include revenues derived from the sales of surgical laser
systems together with sales of related laser fibers and laser disposables.
Sales
of laser systems create recurring sales of laser fibers and laser disposables
that are more profitable than laser systems.
For
the
three months ended September 30, 2005, surgical products revenues were
$1,473,461 compared to $1,294,903 in the three months ended September 30,
2004.
The increase was almost entirely due to $259,000 in additional laser system
revenues reflecting the increase in the number of systems sold (15 vs. 4),
partially offset by a decline in the average price per laser sold.
For
the
nine months ended September 30, 2005, surgical products revenues were $4,166,846
compared to $3,764,349 in the nine months ended September 30, 2004. The increase
was almost entirely due to $426,000 in additional laser system revenues
reflecting the increase in the number of systems sold (32 vs. 13), partially
offset by a decline in the average price per laser sold.
The
decrease in average price per laser was largely due to the mix of lasers
sold.
Included in the laser sales for the three and nine months ended September
30,
2005 were sales of nine and nineteen diode lasers, respectively, which have
lower sales prices than the other types of lasers. There was only one sale
of
these lasers for the nine months ended September 30, 2004, since they were
introduced in June 2004.
Disposables
and fiber sales were relatively level between the comparable three-month
and
nine-month periods ended September 30, 2005 and 2004. We have expected that
the
disposables base may continue to erode over time as hospitals continue to
seek
outsourcing solutions instead of purchasing lasers and related disposables
for
their operating rooms. We have continued to seek to offset this erosion through
expansion of our surgical services. Similarly, we believe there will be
continuing pressure on laser system sales as hospitals continue to outsource
their laser-assisted procedures to third parties, such as our surgical services
business. With the introduction of our CO2 and diode surgical lasers in the
second quarter of 2004, we hope to offset the decline in laser and disposables
revenues.
35
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,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
1,473,461
|
$
|
1,294,903
|
$
|
4,166,846
|
$
|
3,764,349
|
|||||
Percent
increase
|
13.8%
|
10.7%
|
|||||||||||
Laser
systems sold
|
15
|
4
|
32
|
13
|
|||||||||
Laser
system revenues
|
$
|
452,750
|
$
|
194,000
|
$
|
1,102,445
|
$
|
654,302
|
|||||
Average
revenue per laser
|
$
|
30,183
|
$
|
48,500
|
$
|
34,451
|
$
|
50,331
|
Skin
Care (ProCyte) Segment
For
the
three and nine months ended September 30, 2005, ProCyte revenues were $2,928,681
and $7,074,196. Since ProCyte was acquired on March 18, 2005, there are no
corresponding revenues for the three and nine months ended September 30,
2004.
ProCyte revenues are generated from the sale of various skin and hair care
products, from the sale of copper peptide compound and from royalties on
licenses, mainly from Neutrogena.
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,
|
||||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Product
sales
|
$
|
2,704,340
|
$
|
-
|
$
|
6,164,280
|
$
|
-
|
|||||
Bulk
compound sales
|
84,000
|
-
|
587,550
|
-
|
|||||||||
Royalties
|
140,341
|
322,366
|
|||||||||||
Total
ProCyte revenues
|
$
|
2,928,681
|
$
|
-
|
$
|
7,074,196
|
$
|
-
|
Cost
of Revenues
Product
cost of revenues for the three months ended September 30, 2005 were $1,956,022
compared to $747,689 for the three months ended September 30, 2004. The
$1,208,333 increase reflected the inclusion of $869,405 of costs for the
ProCyte
business acquired in 2005, and an increase of $255,452 for surgical products,
due to increased laser system sales, and $83,476 associated with the increase
in
sales of XTRAC laser equipment sold outside the United States.
Product
cost of revenues for the nine months ended September 30, 2005 was $4,856,857
compared to $2,512,794 for the nine months ended September 30, 2004. The
$2,344,063 increase reflected the inclusion of $2,154,699 of costs for the
ProCyte business acquired in 2005, and an increase of $404,898 for surgical
products due to increased laser system sales. These increases were, partly
offset by a $215,534 decrease related to the decline in sales of XTRAC laser
equipment sold outside the United States.
Services
cost of revenues was $2,347,361 in the three months ended September 30, 2005
compared to $1,753,727 in the comparable period in 2004. Contributing to
the
$593,634 increase was a $164,415 increase in the surgical services business
associated with the increase in urological procedures performed with laser
systems purchased from a third-party manufacturer, which carry a higher cost
of
sale due to the disposable fiber purchased from the third-party manufacturer
than a fiber which we manufacture. In addition, cost of revenues in the Domestic
XTRAC business segment increased $429,219 due to manufacturing inefficiencies,
an increase in excess and obsolete inventory reserve and increased depreciation
on the lasers compared to the same period in 2004. The XTRAC manufacturing
facility located in Carlsbad, California relocated to a nearby facility in
July
2005 and contributed to the inefficiencies experienced in the three months
ended
September 30, 2005.
36
Services
cost of revenues was $6,301,085 in the nine months ended September 30, 2005
compared to $5,114,057 in the comparable period in 2004. Contributing to
the
$1,187,028 increase was a $691,764 increase in the surgical services business
associated with the increase in urological procedures performed with laser
systems purchased from a third-party manufacturer, which carry a higher cost
of
sale due to the disposable fiber purchased from the third-party manufacturer
than a fiber which we manufacture. In addition, cost of revenues in the Domestic
XTRAC business segment increased $495,264 due to manufacturing inefficiencies,
an increase in excess and obsolete inventory reserve and increased depreciation
on the lasers compared to the same period in 2004.
Certain
allocable XTRAC manufacturing overhead costs are charged against the XTRAC
service revenues. The manufacturing facility in Carlsbad, California is used
exclusively for the production of the XTRAC lasers, which are placed in
physicians’ offices domestically or sold internationally. The unabsorbed costs
are allocated to the domestic XTRAC and the international XTRAC segments
based
on actual production of lasers for each segment. Included in these allocated
manufacturing costs are unabsorbed labor and direct plant costs.
Gross
Margin Analysis
Gross
margin increased to $3,320,454 during the three months ended September 30,
2005
from $1,953,980 during the same period in 2004, primarily reflecting the
impact
of the ProCyte acquisition on March 18, 2005. As a percent of revenues, the
gross margin remained relatively unchanged for the three months ended September
30, 2005, 43.6% compared to 43.9% for the same period in 2004.
Gross
margin increased to $9,504,396 during the nine months ended September 30,
2005
from $5,176,909 during the same period in 2004, primarily reflecting the
impact
of the ProCyte acquisition on March 18, 2005. As a percent of revenues, the
gross margin increased for the nine months ended September 30, 2005 to 46.0%
from 40.4% for the same period in 2004.
The
following table analyzes changes in our gross margin for the periods reflected
below:
Company
Margin Analysis
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
7,623,838
|
$
|
4,455,396
|
$
|
20,662,340
|
$
|
12,803,760
|
|||||
Percent
increase
|
71.1%
|
61.7%
|
|||||||||||
Cost
of revenues
|
4,303,384
|
2,501,416
|
11,157,944
|
7,626,851
|
|||||||||
Percent
increase
|
72.0%
|
46.3%
|
|||||||||||
Gross
profit
|
$
|
3,320,454
|
$
|
1,953,980
|
$
|
9,504,396
|
$
|
5,176,909
|
|||||
Percent
of revenue
|
43.6%
|
43.9%
|
46.0%
|
40.4%
|
The
primary reasons for changes in gross margin for the three and nine months
ended
September 30, 2005, compared to the same periods in 2004 were as
follows:
·
|
We
acquired ProCyte on March 18, 2005, so only the activity after
that date
is recorded in our financial statements. There was no activity
recorded in
our financial statements in 2004.
|
·
|
We
increased treatment procedures and lowered field service costs
for the
XTRAC laser. The increase in procedure volume was a direct result
of
improving insurance reimbursement. The lower field service costs
were a
direct result of the planned quality upgrades in 2003 and 2004
for all
lasers-in-service.
|
·
|
We
increased sales on surgical laser systems due to the introduction
of the
diode laser.
|
37
The
following table analyzes our gross margin for our Domestic XTRAC segment
for the
periods presented below:
XTRAC
Domestic Segment
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
1,019,184
|
$
|
945,755
|
$
|
2,542,373
|
$
|
2,215,619
|
|||||
Percent
increase
|
7.8%
|
14.7%
|
|||||||||||
Cost
of revenues
|
859,061
|
429,842
|
1,952,233
|
1,456,969
|
|||||||||
Percent
increase
|
99.9%
|
34.0%
|
|||||||||||
Gross
profit
|
$
|
160,123
|
$
|
515,913
|
$
|
590,140
|
$
|
758,650
|
|||||
Percent
of revenue
|
15.7%
|
54.6%
|
23.2%
|
34.2%
|
The
gross
margin decreased for this segment for the three and nine months ended September
30, 2005 from the comparable periods in 2004 by $355,790 and $168,510. The
key
factors were as follows:
·
|
A
key driver in increased revenue in this segment is insurance
reimbursement. In 2004, we focused on encouraging private health
insurance
plans to adopt the XTRAC laser therapy as an approved medical procedure
for the treatment of psoriasis. Since January 2004, several major
health
insurance plans instituted medical policies to pay claims for the
XTRAC
therapy, including Regence, Wellpoint, Aetna, Anthem, Cigna, United
Healthcare and Independence Blue Cross of
Pennsylvania.
|
·
|
Procedure
volume increased 9.5% from 12,672 to 13,876 billed procedures in
the three
months ended September 30, 2005 compared to the same period in
2004.
Procedure volume increased 14% from 34,197 to 38,991 billed procedures
in
the nine months ended September 30, 2005 compared to the same period
in
2004.
|
·
|
Price
per procedure was not a meaningful component of the revenue change
between
the periods.
|
·
|
The
cost of revenues increased by $429,219 and $495,264 for the three
and nine
months ended September 30, 2005. This increase is due to under-absorption
of overhead due to the shut down of the plant for relocation during
the
quarter, an increase in depreciation on the lasers in service and
an
increase in the excess and obsolete inventory reserve, due to the
introduction of the Ultra, the new smaller and faster excimer laser.
The
planned increases in production volume in subsequent periods should
lead
to more favorable absorption of overhead. The depreciation costs
will
continue to increase in subsequent periods as the business
grows.
|
The
following table analyzes our gross margin for our International XTRAC segment
for the periods presented below:
XTRAC
International Segment
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
299,176
|
$
|
155,024
|
$
|
901,561
|
$
|
1,190,538
|
|||||
Percent
increase/(decrease)
|
93.0%
|
(24.3%
|
)
|
||||||||||
Cost
of revenues
|
244,064
|
160,588
|
637,815
|
853,348
|
|||||||||
Percent
increase/(decrease)
|
52.0%
|
(25.3%
|
)
|
||||||||||
Gross
profit/(loss)
|
$
|
55,112
|
($5,564
|
)
|
$
|
263,746
|
$
|
337,190
|
|||||
Percent
of revenue
|
18.4%
|
(3.6%
|
)
|
29.3%
|
28.3%
|
38
The
gross
profit for the three and nine months ended September 30, 2005 increased by
$60,676 and decreased by $73,444, respectively, from the comparable periods
in
2004. The key factors in this business segment were as follows:
·
|
We
sold five XTRAC laser systems during the three months ended September
30,
2005 and two lasers in the comparable period in 2004. We sold 16
XTRAC
laser systems during the nine months ended September 30, 2005 and
18
lasers in the comparable period in 2004. In addition, four lasers
for a
total of $310,000, which had been shipped in 2003, were not recognized
as
sales until the first quarter of 2004 due to the application of
the SAB
104 Criteria.
|
·
|
The
International XTRAC operations are influenced by competition from
similar
laser technology from other manufacturers and from non-laser lamp
alternatives for treating inflammatory skin disorders, which has
served to
reduce the prices we charge international distributors for our
excimer
products. After adjusting the revenue for parts sales of approximately
$50,000, the average price for lasers sold during this period was
approximately $49,800 in the three months ended September 30, 2005,
down
from $58,900 in the comparable period in 2004. After adjusting
the revenue
for the nine months ended September 30, 2005 for parts sales of
approximately $145,000, the average price for lasers sold during
this
period was approximately $47,250 compared to $59,800 in the same
period in
2004.
|
The
following table analyzes our gross margin for our Surgical Services segment
for
the periods presented below:
Surgical
Services Segment
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
1,903,336
|
$
|
2,059,714
|
$
|
5,977,366
|
$
|
5,633,254
|
|||||
Percent
(decrease)/increase
|
(7.6%
|
)
|
6.1%
|
||||||||||
Cost
of revenues
|
1,465,502
|
1,291,004
|
4,283,180
|
3,551,079
|
|||||||||
Percent
increase
|
13.5%
|
20.6%
|
|||||||||||
Gross
profit
|
$
|
437,834
|
$
|
768,710
|
$
|
1,694,186
|
$
|
2,082,175
|
|||||
Percent
of revenue
|
23.0%
|
37.3%
|
28.3%
|
37.0%
|
Gross
margin in the Surgical Services segment for the three and nine months ended
September 30, 2005 decreased by $330,876 and $387,989, respectively, from
the
comparable periods in 2004. The key factors impacting gross margin for the
Surgical Services business were as follows:
·
|
A
significant part of the revenue was in urological procedures performed
with laser systems we purchased from a third party manufacturer.
Such
procedures included a charge for the use of the laser and the technician
to operate it, as well as a charge for the third party’s proprietary fiber
delivery system. This procedure has a lower gross margin as a percent
of
revenues than other types of procedures. As the volume of these
procedures
increases, the overall gross margin percentage decreases. In 2005,
there
was a 25% price increase on the third party’s proprietary fiber delivery
system, which also contributed to the decrease in gross margin
in 2005.
Revenues for this procedure were $550,603 and $1,882,898 for the
three and
nine months ended September 30, 2005 compared to $524,950 and $1,067,820
for the same periods in 2004.
|
·
|
We
have closed three geographic areas of business due to unacceptable
operating profit. Although closing these territories will save
costs and
improve profitability over time, the costs saved for the three
and nine
months ended September 30, 2005 have not kept pace with the revenues
lost
by closing these territories during the three and nine months ended
September 30, 2005.
|
·
|
We
have suffered business interruption due to hurricanes in the New
Orleans
and Alabama territories.
|
39
The
following table analyzes our gross margin for our Surgical Products segment
for
the periods presented below:
Surgical
Products Segment
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Revenues
|
$
|
1,473,461
|
$
|
1,294,903
|
$
|
4,166,846
|
$
|
3,764,349
|
|||||
Percent
increase
|
13.8%
|
10.7%
|
|||||||||||
Cost
of revenues
|
865,351
|
619,982
|
2,130,017
|
1,765,454
|
|||||||||
Percent
increase
|
39.6%
|
20.6%
|
|||||||||||
Gross
profit
|
$
|
608,110
|
$
|
674,921
|
$
|
2,036,829
|
$
|
1,998,895
|
|||||
Percent
of revenue
|
41.3%
|
52.1%
|
48.9%
|
53.1%
|
Gross
margin for the Surgical Products segment in the three and nine months ended
September 30, 2005 compared to the same periods in 2004 decreased by $66,811
and
increased by $37,934, respectively. The key factors in this business segment
were as follows:
·
|
This
segment includes product sales of surgical laser systems and laser
disposables. Disposables are more profitable than laser systems,
but the
sale of laser systems generates the subsequent recurring sale of
laser
disposables.
|
·
|
Revenues
for the three months ended September 30, 2005 increased by $178,558
from
the three months ended September 30, 2004 while cost of revenues
increased
by $245,368 between the same periods. There were 11 more laser
system sold
in the three months ended September 30, 2005 than in the comparable
period
of 2004. Revenues for the nine months ended September 30, 2005
increased
by $402,497 from the nine months ended September 30, 2004 while
cost of
revenues increased by $364,563 between the same periods. There
were 19
more laser system sales in the nine months ended September 30,
2005 than
in the comparable period of 2004. However, the lasers sold in the
2004
period were at higher prices than in the comparable period in 2005.
This
revenue increase was partly offset by a decrease in sales disposables
between the periods.
|
·
|
Disposables,
which have a higher gross margin as a percent of revenues than
lasers,
represented a lower percentage of revenue in the three and nine
months
September 30, 2005 compared to the same periods in
2004.
|
40
The
following table analyzes our gross margin for our SkinCare (ProCyte) segment
for
the periods presented below:
Skin
Care (ProCyte) Segment
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
2005
|
2004
|
2005
|
2004
|
||||||||||
Product
revenues
|
$
|
2,704,340
|
$
|
-
|
$
|
6,164,280
|
$
|
-
|
|||||
Bulk
compound revenues
|
84,000
|
-
|
587,550
|
-
|
|||||||||
Royalties
|
140,341
|
-
|
322,366
|
-
|
|||||||||
Total
revenues
|
2,928,681
|
-
|
7,074,196
|
-
|
|||||||||
Product
cost of revenues
|
817,272
|
-
|
1,744,225
|
-
|
|||||||||
Bulk
compound cost of revenues
|
52,133
|
-
|
410,475
|
-
|
|||||||||
Total
cost of revenues
|
869,405
|
-
|
2,154,700
|
-
|
|||||||||
Gross
profit
|
$
|
2,059,276
|
$
|
-
|
$
|
4,919,496
|
$
|
-
|
|||||
Percent
of revenue
|
70.3%
|
69.5%
|
The
key
factors in this business segment were as follows:
· |
Copper
Peptide bulk compound is sold at a substantially lower gross margin
than
skin care products, while revenues generated from licensees have
no
significant costs associated with this revenue
stream
|
· |
Product
revenues come primarily from U.S.
dermatologists.
|
· |
Lesser
product revenues come from sales directed to consumers at spas
and from
marketing directly to the consumer (e.g.
infomercials).
|
Selling,
General and Administrative Expenses
For
the
three months ended September 30, 2005, selling, general and administrative
expenses increased $1,891,784 to $4,526,178 from the three months ended
September 30, 2004. Selling, general and administrative expenses related
to the
ProCyte business accounted for $1,574,058 of the increase with the remaining
increase related to $224,000 in salaries, benefits and travel expenses
associated with an increase in the sales force, particularly in the domestic
XTRAC segment; an increase in legal and accounting expenses of $231,000;
and an
increase in corporate insurance of $83,000. Offsetting some of the increases
for
the three months ended September 30, 2005, was a reduction of bad debt expense
of $200,000 compared to the prior year period.
For
the
nine months ended September 30, 2005, selling, general and administrative
expenses increased $4,433,328 to $11,944,593 from the nine months ended
September 30, 2004. Selling, general and administrative expenses related
to the
ProCyte business accounted for $3,735,087 of the increase with the remaining
increase related to a $330,000 increase in salaries, benefits and travel
expenses associated with an increase in the sales force, particularly in
the
domestic XTRAC segment, and increases in legal and accounting expenses of
$358,000 and in corporate insurance of $163,000. Offsetting some of the
increases for the nine months ended September 30, 2005, was a reduction in
bonus
expense of $199,000 in the current year compared to the prior year
period.
Engineering
and Product Development
Engineering
and product development expenses for the three months ended September 30,
2005
decreased to $304,935 from $428,206 for the three months ended September
30,
2004. Engineering and product development expenses for the nine months ended
September 30, 2005 decreased to $819,845 from $1,325,399 for the nine months
ended September 30, 2004. The decreases are mainly in the XTRAC segments
due to
product development expenses in 2004 for the Ultra, the new smaller and faster
excimer laser, which were offset, in part, by the engineering and product
development expenses related to the ProCyte business of $142,948 and $310,661,
respectively.
41
Other
Income
Other
income for the three months ended September 30, 2005 was $244,988, reflecting
the expiration of the SLT subordinated notes. There was no other income in
the
comparable periods in 2004.
Other
income for the nine months ended September 30, 2005 was $333,655 reflecting
a
non-monetary exchange of assets during June 2005 of two depreciable engineering
development prototypes in exchange for four product units to be held for
sale
and the expiration of the SLT subordinated notes. There was no other income
in
the comparable periods in 2004.
Interest
Expense, Net
Net
interest expense for the three months ended September 30, 2005 increased
to
$84,228, as compared to $47,189 for the three months ended September 30,
2004.
Net interest expense for the nine months ended September 30, 2005 increased
to
$212,276, as compared to $66,297 for the nine months ended September 30,
2004.
The increase in net interest expense was the result of the draws on the lease
line of credit during the second, third and fourth quarters of 2004 and the
second quarter of 2005.
Net
Loss
The
aforementioned factors resulted in a net loss of $1,349,900 during the three
months ended September 30, 2005, as compared to a net loss of $1,155,809
during
the three months ended September 30, 2004, an increase of 16.8%. This increase
was primarily the result of the increase in cost of sales and resulting decrease
in gross margin. The aforementioned factors resulted in a net loss of $3,138,663
during the nine months ended September 30, 2005, as compared to a net loss
of
$3,726,052 during the nine months ended September 30, 2004, a decrease of
15.8%.
This decrease was primarily the result of the increase in revenues and resulting
gross margin, mainly related to the acquisition of ProCyte.
Income
taxes were immaterial, given our current period losses and operating loss
carryforwards.
Liquidity
and Capital Resources
We
have
historically financed our operations with cash provided by equity financing
and
from lines of credit.
On
March
18, 2005, we acquired ProCyte. The skincare products and royalties provided
by
ProCyte increased revenues for the three and nine months ended September
30,
2005 and we expect revenues of the combined companies to increase throughout
2005 as compared to 2004. We expect to realize cost savings from the
consolidation of the administrative and marketing infrastructure of the combined
company. Additionally, once the consolidated infrastructure is in place,
we
expect our revenues to grow without proportionately increasing the rate of
growth in our fixed costs.
At
September 30, 2005, the ratio of current assets to current liabilities was
2.57
to 1.00 compared to 1.88 to 1.00 at December 31, 2004. As of September 30,
2005,
we had $11,538,647 of working capital compared to $6,119,248 as of December
31,
2004. Cash and cash equivalents were $5,383,952 as September 30, 2005, as
compared to $3,997,017 as of December 31, 2004. These increases were mainly
due
to the acquisition of ProCyte. $206,802 of cash was classified as restricted
as
of September 30, 2005 compared to $112,200 at December 31, 2004.
We
believe that our existing cash balance together with our other existing
financial resources, including access to lease financing for capital
expenditures, and revenues from sales, distribution, licensing and manufacturing
relationships, will be sufficient to meet our operating and capital requirements
beyond the third quarter of 2006. The 2005 operating plan reflects costs
savings
from the integration of ProCyte and PhotoMedex as well as increases in
per-treatment fee revenues for use of the XTRAC system based on wider insurance
coverage in the United States and. In addition, the 2005 operating plan calls
for increased revenues and profits from our newly acquired business, ProCyte,
and the continued growth of its skin care products. We cannot give assurances
that our business plan will not encounter obstacles which may require us
to
obtain additional equity or debt financing to meet our working capital
requirements or capital expenditure needs. Also, if our growth exceeds the
business plan projections, we may require additional equity or debt financing.
There can be no assurance that additional financing, if needed, will be
available when required or, if available, will be on terms satisfactory to
us.
42
On
June
25, 2004, we entered into a leasing credit facility from GE Capital Corporation
(“GE”). The credit facility has a commitment term of three years, expiring on
June 25, 2007. We account for each draw as funded indebtedness taking the
form
of a capital lease, with equitable ownership in the lasers remaining with
us. GE
retains title as a form of security over the lasers. We continue to depreciate
the lasers over their remaining useful lives, as established when originally
placed into service. Each draw against the credit facility has a repayment
period of three years and is secured by specific lasers, which we have sold
to
GE and leased back for deployment in the field. A summary of the activity
under
the GE leasing credit facility is presented in Note 9, “Long-term
Debt.”
Net
cash
used in operating activities was $2,616,625 for nine months ended September
30,
2005, compared to $2,677,305 for the same period in 2004. The decrease was
mostly due to the payment of various previously recorded costs associated
with
the acquisition and increases in accounts receivables.
Net
cash
provided by investing activities was $2,942,393 for the nine months ended
September 30, 2005 compared to cash used of $1,708,090 for the nine months
ended
September 30, 2004. During the nine months ended September 30, 2005, we received
cash of $5,578,416, net of acquisition costs, in the ProCyte acquisition
and
used $2,548,535 for production of our lasers in service compared to $1,021,766
for the same period in 2004.
Net
cash
provided by financing activities was $966,565 for the nine months ended
September 30, 2005 compared to $2,963,908 for the nine months ended September
30, 2004. In the nine months ended September 30, 2005 we made payments of
$819,998 on certain notes payable and capital lease obligations and $169,524
in
registration costs. These payments were offset, in part, by the advances
under
the lease line of credit, net of payments, of $1,347,945 and by receipts
of
$702,744 from the exercise of common stock options and warrants. In the nine
months ended September 30, 2004, we received $3,185,305 from the exercise
of
common stock options and warrants and a net increase of $654,427 from the
lapse
of the bank line of credit and the initiation of the leasing line of credit
from
GE. These cash receipts were offset by $776,961 for the payment of certain
notes
payable and capital lease obligations.
Our
ability to expand our business operations is currently dependent in significant
part on financing from external sources. There can be no assurance that changes
in our manufacturing and marketing, engineering and product development plans
or
other changes affecting our operating expenses and business strategy will
not
require financing from external sources before we will be able to develop
profitable operations. There can be no assurance that additional capital
will be
available on terms favorable to us, if at all. To the extent that additional
capital is raised through the sale of additional equity or convertible debt
securities, the issuance of such securities could result in additional dilution
to our stockholders. Moreover, our cash requirements may differ materially
from
those now planned because of results of marketing, product testing, changes
in
the focus and direction of our marketing programs, competitive and technological
advances, the level of working capital required to sustain our planned growth,
litigation, operating results, including the extent and duration of operating
losses, and other factors. In the event that we experience the need for
additional capital, and are not able to generate capital from financing sources
or from future operations, management may be required to modify, suspend
or
discontinue our business plan.
Commitments
and Contingencies
In
April
2005, we entered into a long-term lease for approximately 8,000 square feet
in
Carlsbad, California. We moved our excimer manufacturing facility into this
space in July 2005, after tenant improvements had been completed. For $195,000
of the improvements, we have agreed to pay $2,880 monthly over a self-amortizing
five-year term. We have posted a stand-by letter of credit to secure this
obligation. Monthly rent and operating expenses for our new space amounts
to
$8,880 compared to $11,900 for our former space.
During
the three and nine months ended September 30, 2005, there were no other items
that significantly impacted our commitments and contingencies as discussed
in
the notes to our 2004 annual financial statements included in our Annual
Report
on Form 10-K. In addition, we have no significant off-balance sheet
arrangements.
43
Impact
of Inflation
We
have
not operated in a highly inflationary period, and we do not believe that
inflation has had a material effect on sales or expenses.
ITEM
3. Quantitative and Qualitative Disclosure about Market
Risk
We
are
not currently exposed to market risks due to changes in interest rates and
foreign currency rates and, therefore, we do not use derivative financial
instruments to address treasury risk management issues in connection with
changes in interest rates and foreign currency rates.
ITEM
4. Controls and Procedures
Disclosure
Controls
We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our reports filed or submitted pursuant
to the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is to
be recorded, processed, summarized and reported within the time periods
specified in the Securities and Exchange Commission’s rules and forms.
Disclosure controls and procedures include, without limitation, controls
and
procedures designed to ensure that such information is accumulated and
communicated to our management, including our Chief Executive Officer and
Chief
Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure.
Our
management, including the Chief Executive Officer and Chief Financial Officer,
conducted an evaluation of the effectiveness of our disclosure controls and
procedures as of September 30, 2005. Based upon the evaluation, the Chief
Executive Officer and Chief Financial Officer concluded that our disclosure
controls and procedures were effective as of September 30, 2005.
Changes
in Internal Controls
There
has
been no significant change in our internal controls over financial reporting
that occurred during the third quarter 2005 that has materially affected,
or is
reasonably likely to materially affect, our internal control over financial
reporting, except for the addition of ProCyte’s internal control structures.
Management processed ProCyte transactions through existing ProCyte internal
control structures through the second quarter of this year, and has begun
to
process such transactions through existing PhotoMedex internal control
structures in the third quarter of this year. Management will evaluate in
2005
the other ProCyte internal control structures and determine what structures
should be adopted, conformed or eliminated.
44
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, 2004 for descriptions
of our legal proceedings.
In
the
action brought by the Company against Edwards Lifesciences Corporation and
Baxter Healthcare Corporation in the Superior Court for Orange County,
California, the defendants have answered our amended complaint Each of the
defendant and the plaintiff is engaged in discovery activity in preparation
for
trial, notwithstanding that each of the defendant and the plaintiff has brought
a motion for summary judgment.
In
the
matter brought against us by City National Bank of Florida, our former landlord
in Orlando, Florida, our motion for summary judgment was heard in limine
and
denied. After a trial of the facts, judgment was awarded to the landlord
in the
amount of $77,000. Offsetting the judgment are proceeds, approximating $43,000,
which are held by the landlord from the sale of assets left on the leased
premises by the party that bought the assets from us. We have reached a
settlement with the landlord which embodies terms which we deem favorable
and
which have mooted post-trial motions and appeals.
In
the
matter brought by us against RA against Medical Systems, Inc. and Dean Stewart
Irwin in the United States District Court for the Southern District of
California, a new magistrate judge in the case has ruled that discovery will
be
stayed until the trial judge rules on the defendants’ motion for summary
judgment, based on a theory of res judicata.
In
the
matter brought by us against RA Medical Systems, Inc. and Dean Stewart Irwin
in
the Superior Court for San Diego County, California, Defendants have petitioned
the Superior Court for further fees and costs incurred in collecting the
judgment and defending against our appeal. The petition has not been heard
by
the Court, insofar as the trial judge originally set to hear the matter has,
at
our objection, recused himself as has the new judge assigned the matter.
In
the
matter brought for malicious prosecution by RA Medical Systems and Dean Irwin
against PhotoMedex, Inc., et al., we filed our appeal brief and respondents
have
filed their opposition brief. Our reply brief is due the end of November,
2005.
In
the
matter brought by Vida Brown in the Circuit Court, 20th
Judicial
Circuit for Charlotte County, Florida, we have begun to respond to the
plaintiff’s requests for discovery.
ITEM
2. Unregistered Sales of Equity Securities and Use of
Proceeds
Recent
Issuances of Unregistered Securities
None.
ITEM
3. Defaults Upon Senior Securities
Not
applicable.
ITEM
4. Submission of Matter to a Vote of Security Holders
None.
ITEM
5. Other Information
None.
ITEM
6. Exhibits
31.1
|
Rule 13a-14(a)/15d-14(a) Certificate of Chief Executive Officer
|
31.2
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer
|
32.1
|
Certificate of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
32.2
|
Certificate of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
45
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1934, the registrant has duly
caused this Report to be signed on its behalf by the undersigned, thereunto
duly
authorized.
PHOTOMEDEX, INC. | ||
|
|
|
Date: November 9, 2005 | By: | /s/ Jeffrey F. O’Donnell |
Jeffrey F. O’Donnell |
||
President and Chief Executive Officer |
Date: November 9, 2005 | By: | /s/ Dennis M. McGrath |
Dennis M. McGrath |
||
Chief Financial Officer |
46